Access to RxISK data: conflicts of interest

Won’t get fooled again outlined a stunning propaganda coup by GSK. On the back of a campaign for open access to clinical trial data that has drawn its inspiration from efforts by the Cochrane Tamiflu reviewers to get access to Roche’s clinical trial data, Andrew Witty came out and proclaimed that GSK were all in favor of access to clinical trial data. The BMJ threw its hat in the air and said whoopee.

In fact GSK had only issued a press release. They don’t have a policy. They have at best an aspiration or perhaps more ominously a strategy. Getting such great publicity out of a press release shows considerable tactical skills at the very least.

The GSK press release came a week before a key European Medicines’ Agency meeting on access to clinical trial data. It was aimed at shutting an open door – EMA have granted access, industry want to close it down. Industry representatives at the EMA Access to Data meeting on November 22nd sang from the same song sheet as GSK – of course we are in favor of access and transparency but we have to respect patient privacy and we have to have good governance. Access should be restricted to serious scientists. (These are red herrings – see the next post Access to data: privacy issues).

RxISK has data that GSK should want 

At the end of Won’t get fooled again, I said the post had been written against the background of a serious undeclared conflict of interest. Since then, coincidentally probably, I’ve been critiqued by Arthur Schafer on Biojest for an overly casual approach to conflict of interest. This makes it of even greater importance to spell out the conflict (see Medical Partisans).

Here it is. We on Rxisk.org have data GSK should want, should need. We have raised the issue of accessing the data with them. They don’t seem to want access. They do not seem keen to have the issue raised. Interests seem to be conflicting.

data on hazards – the key to good medical care

So let’s back up a minute. The campaign for access to clinical trial data is about getting a proper picture of the effects of a drug, both the possible therapeutic effects and the hazards. Restricting access is in fact more about restricting access to information about the hazards than about the relative inefficacy of treatment.

Clinical trials are not the correct way to establish the hazards of a drug – the diseases in which they are conducted commonly mask the hazards of treatment (The Spin that no Data can Overcome, Cri de CoeurOnce is Never, The Unbearable Lightness of Being.)

The best approach to hazards is to do what RxISK is trying to do. That is harness the real world experience of people taking a medication to get best quality descriptions of events as well as applying standard approaches to causality such as checking for dose response, challenge-dechallenge-rechallenge and other related methods. The best way to determine risk-benefit ratios is to ask doctors and patients what they think of the possible trade-offs between the effects of a drug – as RxISK asks but clinical trials don’t. We get both doctors and patients to look at the wider impact of an event in a person’s life in addition to reporting on just the event.

There is an industry out there almost it seems aimed at ensuring that we get the most degraded possible descriptions of events with no accompanying details (American Woman, American Woman 2). An industry that has succeeded in building a culture in which even good descriptions of the effects of drugs are dismissed as anecdotes – except of course for patients reporting stunning benefits on treatment. Those who unwittingly repeat the mantra of RCTs offering gold standard evidence on the effects of drugs play straight into industry’s hand in this regard. Words come before numbers – without the right words, the numbers are meaningless.

Andrew Witty eavesdropping on the train

The second consideration is this. If Andrew Witty was to take a train tomorrow and I was sitting in the seat behind him and he overheard me mention a side effect I was having on one of GSK’s drugs he is legally bound to report this to the regulator. Here is Leigh Thompson then the Chief Scientific Officer of Eli Lilly being deposed by Paul Smith on this issue in 1994 for the Fentress trial in Louisville Kentucky after Joseph Wesbecker, shortly after going on Prozac, had shot dead 8 of his co-workers and seriously injured 12 more before killing himself.

Q. The other day you said something that I have a
question about. You said something about….
employees calling adverse event reports in?
A. I can’t recall that. The
rules under the DEN system that I put in place, I
think it was ’83 or maybe ’84 — no, it was ’83 we
began it, was that any Lilly employee anywhere in
the world that learns of any adverse event through
any source, and I’ve done it from cocktail parties
and overhearing conversations, should in fact
report by telecommunications to DEN within
twenty-four or seventy-two hours, depending on
where they are in the world. So, yes, we got a
lot of adverse events, including ones I report
because I’ve literally called up DEN and said, you
know, that I overheard a conversation in the
hallway just now that somebody’s wife was taking
Ceclor and had an allergic reaction.
Q. Do you usually stop and
ask for more information about that adverse event
or do you just report what you overheard in a
conversation in the hallway?
A. Depending on who the
individual is, but, for example, you remember you
showed me the document about that meeting of the
expert opinion leaders that I had gone to
wherever it was, I had another Lilly employee come
to that meeting and follow me around so that that
person could in fact report all the adverse events
that I was hearing, so that I wouldn’t have to do
it myself.
A. I think it
fulfills a regulatory requirement.. if you
right now told me that you had heard of a patient
who had taken one of our drugs and who had their
hair turn blue, I will guarantee you that I would
call DEN up within two days and that would be in
the DEN database. And I may or may not ask you
for more information, but I would identify you.
Q. What if their hair turned loose?
A. You’re the lawyer, but if
you read the law and the regulations, I think
that’s exactly what it requires. The NDA, for
example, requires all information…
Q. So let me make sure I
understand. You feel it is your absolute duty to
report a conversation that you have overheard in
the hallway, but you don’t necessarily feel it’s
your duty to report an issue raised by another
regulatory agency and the analyses that were done
by the drug company in response to that issue
being raised?
A. Under the FDA laws and
regulations, I think you’ve stated it correctly.

Writing to GSK about access to data

Against this background it seemed appropriate to alert Andrew Witty last March to the fact that we expected RxISK to start generating data on GSK’s and other drugs – mentioning that despite everything many still considered GSK to be among the more responsible pharmaceutical companies. GSK’s response was to misattribute the remark that they were a responsible company to me and to thank me for this recognition, but to turn down a possible collaboration while in a follow up letter stating their full commitment to their regulatory obligations.

The growing Data Set

It is now November and RxISK.org has been up and functioning for two months. It is getting on average 10 treatment effects reported per day directly from the public. In two months it has had more patients report effects to it than the Irish Medicine’s Board has had since opening up for patient adverse event reporting in 2009. RxISK has had more treatment effects reported to it by Germans than Germany has ever had – reporting by the public is still not facilitated in Germany. Within a year we expect to have more treatment effect reports from the public than anyone except FDA.

RxISK & free appetizers?

FDA have 4.1 million adverse event reports from around the world collected since 2004. A number of companies have set up businesses, selling these reports to doctors, patients or anyone else for $200 for basic information on a drug and a possible problem linked to it – we make this information available for free to anyone who accesses RxISK.

We are on our way to having a substantial amount of RxISK data. We will make the key components of this available for free from the get-go. We are particularly keen not just to give people the number of reports of Leigh Thompson’s side effect – Hair turning blue on Prozac – but want to make the data local in the belief that if people in Baltimore, Brisbane, Birmingham or Bordeaux find its happening there and not in Calgary, Cologne, Chicago or Chenai, they may be able to bring local knowledge to bear on the issue and help work out what is going on.

We also want to bring the stories to life so that people can identify their own stories with those of others. These collected stories can help us all understanding the real story about these drugs. We think everyone can play a part in understanding and interpreting the stories – that access should not be restricted to just a few people who want to “guide” the narrative.

Leigh Thompson is now dead. But from his testimony above it seems like he would probably have been delighted to know we have a Hair Zone opening up soon, to complement the Violence and Suicide Zones already on RxISK, and the Skin and Sex and Relationships Zones still to come.

But then again maybe not. There are endless ways to adhere to the letter of a regulation but not its spirit. This is why you hire lawyers. Or perhaps GSK thought we were at the press release before the policy stage. Or perhaps they don’t have a policy on access to data yet.

how does RxISK move forward?

The issues for anyone reading this blog from Arthur Schafer to Andrew Witty, to Aetna Insurance, to lawyers like Andy Vickery, to Anne-Marie and all the people who have reported on RxISK stories and our still anonymous American Woman are:

  • what interests conflict,
  • where exactly do the conflicts arise, and
  • what should RxISK be doing with its data?

We welcome your ideas and will respond.


RxISK: Research and report prescription drug side effects on RxISK.org.

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You and your meds. Give the real story. Get the real story.

Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. GSK tend to accept patient reports but they do so under their terms. They will ask for access to the reporting patient’s medical records, I believe they do this so they can blame an illness or other med found in these records. They will call it a process of elimination, ie; ruling out any other drug that may be causing the adverse event – I beg to differ – they do it to rule out their drug as the cause and won’t stop until they have found a link to anything that puts the blame on another company drug or an “underlying illness” the patient may have or had.

    It’s deflection – it’s not taking accountability.

  2. This was something I read during my time off Seroxat in 2002.

    “It is absolutely imperative that patient are warned NOT to abruptedly cease anti-depressant or stress medication.

    Stopping the medication too quickly can lead to psychotic decompensation and suicide. Withdrawal should be assessed, and closely monitored, by an experienced psychiatrist whose knowledge is up to date, otherwise things can go horribly wrong.

    Professor Healy, a very highly respected British psychiatrist describes three symptoms (“the Psychotropic suicidogenic triumvirate”) which indicate an impending suicide caused by psychiatric medication. The three symptoms are:-

    1. akathisia – feeling numb as if nothing matters, restlessness, turmoil, and feeling one is going mad.

    2. emotional blunting – “I cannot feel anything, do not care”

    and/or

    3. psychotic decompensation – losing touch with reality

    The symptoms can last for weeks or unpredictably and suddenly induce suicide.

    If you see a patient on medication display any of these symptoms do not let the patient drive. Stay calm, call an ambulance or drive them to hospital with doors locked. Speak calmly and listen patiently to the person who will probably be speaking a lot of nonsense. At the hospital insist on seeing a senior psychiatrist and express concern that sedatives, rather than antipsychotic drugs are administered.
    Antipsychotic drugs cause permanent brain damage.”

    This was something I read early on in my withdrawal from Seroxat and it sustained me. I realised what I was up against.

    I stopped Seroxat abruptedly. I drove myself to the mental hospital. I drove home after a week. ‘Decompensated’ was probably the best way to live that experience.

    Of course, four days later the inevitable happened. Suicide from Seroxat.

    In Argyll, suicide from Seroxat is not an every day occurence. So, this was a first for the hospital presented with me with akathisia, emotional blunting and psychotic decompensation.

    In reply to your question, what should Rxisk do with it’s data.

    I can honestly say, with a heavy heart, that my gp would not have approached Rxisk for advice on Seroxat withdrawal. She was too arrogant, too quick to get a wrong diagnosis, from her own life experiences, and not having had to deal with a situation life this before.

    However, the psychiatrist may have dipped his toe in. He might have taken a look, after all, isn’t the job of a psychiatrist a quest for learning. A job to confront all aspects of human behaviour and to perhaps gain a little understanding of what happens when things go wrong.

    So, what to about Rxisk and it’s data.

    Perhaps we could have litigation in the UK.
    Perhaps we could put GSK under the spotlight and perhaps, Sir Andrew Witty, would like to defend his claims that ‘Seroxat does not cause suicide, it does not cause self-harm, it does not cause anger and aggession, it does not lead to miserable lives trying to get off the drug, and, despite thousands, of people, crying, otherwise, it can be so easily stopped. (Two weeks – come on Andy – get real).

    Could we not have penalites in the UK, so easily paid.
    Could we not have the chief spokesperson from GSK, putting one over on us.

    Could we??

  3. Anne-Marie says:

    Rxisk.org is a very important website for us all. I know for a fact that had Rxisk.org been around when I needed it I would never have ended up in prison or lost my job. One of my side effect’s alcohol craving’s would have been resolved a lot sooner. I know that many people are going to get help from this brilliant website.

  4. Stevie Godivala says:

    What interests conflict?
    Hard for me as I sit here feeling ill to think objectively about anyone’s interests but my own and how they seem to conflict with all medical professionals I have had any dealings with over the past 16 years – since December 1996 and that fateful day I went to see my doctor and was given a prescription for Seroxat. And then January 2009? when I was virtually bullied into taking alendronic acid. The theory is being tested that these two drugs are clashing and are responsible for the fact that my health is failing, slowly but surely.

    I find it hard to imagine that any person going to consult a doctor does not want to be given a clear risk/benefit analysis of a drug. Ask the question and the patient is going to say “of course”. Ask a doctor and he/she will assure you that this is exactly what will be done. Doctors press a button on the computer and a document is presented to you with “information” about the drug you are being given to take. Lots of words to tell you about your “options”, and a few gentle words about side effects. You want to get better. Your doctor wants you to get better (a fair assumption, I think). You have been informed. So wherein lies the conflict?

    Doctors want drugs which make their patients better and drug companies want to make drugs which achieve that. Don’t they? So wherein lies the conflict?

    We know, though, that the whole system is fundamentally flawed; as long as global drug companies are rewarded for how much money they can make for shareholders rather than how many people their drugs make better, the likelihood of my health being improved is fairly low down the list of priorities. The companies can give the impression my health is a priority by slick marketing and advertising, but for some people it would appear that if their health does improve it’s a happy accident. My impression is that doctors cannot and do not accept that drugs cause harm as well as good. Perhaps they do? Perhaps they go home at night and worry about some of the drugs they are prescribing, and fear someone like me turning up and saying “I am more ill than the day you gave me this, and I know my body well enough to know that the drug has caused it”. But what can they do about it, if the data they call upon, if so inclined, are at best misleading and at worst untruthful? (Seroxat is NOT addictive…..) Isn’t so much easier for the system to be, very simply, that you, the patient, is the problem and that you may even be causing your own symptoms?

    Now we have moved from simple conflicts of interest into a status quo which murky and slippery and very hard to unpick. What motivation is there for anyone other than people like me and the others who have reported their situation to the RxISK database to change this system? That is the key question. For everyone else this system appears to work just fine!

    I think that the medical profession now is made up of people who are becoming more and more ignorant. Whether GPs or Consultants, they are ignorant of the complexities that today’s drugs have introduced into a physiological system that was, until relatively recently, predictable in the way it behaved in given circumstances as it ailed and recovered and aged. I see the RxISK database as an educator, to fill those knowledge gaps. Assuming you can get them to admit there’s a gap that needs filling. Back to motivation…….. It’s very hard to get human beings to change and do things differently because implicit in the request for change is that what they were doing before was wrong. Drug companies create change via reward. So our challenge is to make the doctors feel they are being rewarded in some way by having access to and utilising RxISK’s database. Interesting concept!

  5. One tends to get the attention of a physician when the potential for malpractice is mentioned. The Canadian Medical Protective Association spends a great deal of time on the topic of consent and makes it quite clear that informed consent consists of the discussion between doctor and patient about all aspects of any proposed treatment. In its handbook on consent, it states “A physician may be liable in assault and battery when no consent was given at all, when the treatment went beyond or deviated significantly from that for which the consent was given, or if consent to treatment was obtained through serious or fraudulent misrepresentation in what was explained to the patient.” Now let’s take a hypothetical situation. Dr A wants Ms G. to take a psychotropic drug. She asks for information about her need for such a drug, its expected effects, any adverse effects and all of the questions to which one should obtain answers before allowing anything to be done to one’s body or placed in it. Dr A discusses, as required, all of these issues but gives her only the information about the drug supplied by the manufacturer, believing that he is answering her questions appropriately. After Ms G commits suicide, her estate sues Dr A for medical battery and negligence. He, in turn, sues the manufacturer for “fraudulent misrepresentation” of the drug to him that he, in good faith, passed on to his patient. He would probably be bankrupt by the time the legal smoke cleared but it would be an interesting case. If this scenario became reality we might see more physicians taking the trouble to find out the actual dangers of the prescriptions they write by assuming that the facts are not going to be supplied by the company devoted to selling as many pills as possible. Simple common sense on the part of anyone who has ever bought a car should indicate that only the rosy picture is presented and never the actual facts about performance. Does any physician actually believe that the promotional material flooding their mail box represents truth? I would want a doctor with more intelligence and a lot less naivete.

  6. The following appeared today: A Syracuse, N.Y. jury has awarded a $1.5 million medical malpractice verdict to the family of a man who committed suicide. After the verdict, plaintiff’s attorney Ernest DelDuchetto (said) “It was comforting to see a jury agree with our proposition that these drugs (antidepressants) are not panaceas for all sadness,” and that they can have serious harmful effects.” The decision was, however, based as much on the physician’s behaviour as on the drugs prescribed. “Family physician William Beals, M.D., who had a reputation for treating psychiatric and addiction patients, had prescribed Paxil for Mr. Mazella for 10 years without seeing him. When Mr. Mazella began to feel anxious and depressed again, on Aug. 9, 2009 he and his wife telephoned the doctor, who was reportedly on vacation on Cape Cod. Despite having no contact with the patient for a decade, by telephone Dr. Beals doubled his Paxil from 20 mg to 40 mg and added the antipsychotic drug, Zyprexa (olanzapine). This began an escalating decline in his mental condition that ended a little more than one month later with his suicide.”

  7. Stevie Godivala says:

    Collateral damage and friendly fire

    The importance of the RxISK website was underlined as I watched a programme about a drug called Roaccutane prescribed for severe acne. It is prescribed by dermatologists as a last line of attack when topical treatments have failed and it is, of course, predominantly taken by teenagers and young people in their early twenties. The programme followed the stories of two young men who went on to become severely depressed and then commit suicide, plus another who now has clear skin but also sexual dysfunction which he believes was caused by the drug. A leading dermatologist was interviewed and he stated that when he prescribes it, he cannot be sure which if any of his patients are going to suffer from any side effects, which include “nasty and severe rare ones of severe depression and suicidal thoughts”. He said in all the people he has treated he is not aware of this happening. Roaccutane is a relatively cheap and quick fix on the NHS, providing clear skin in 4 to 6 weeks. Other treatments are more expensive and take longer.

    This story is one we are hearing about more frequently, and fits into the “where lies the root cause?” pattern that those of us who read and contribute to this blog know so well. Acne can cause young people to feel very bad about themselves and become depressed. In order to make them look and feel better they are prescribed a drug which can cause severe depression and suicidal thoughts. When they claim to be depressed they are then prescribed anti-depressants, which can cause people to have suicidal thoughts. In instances like this, and many others, doctors are providing treatment with one hand behind their backs with their fingers crossed, and society condones this.

    At the level of society, we now have been conditioned to want and expect instant gratification in all things, including medication. Medication is “good”. The front pages of certain newspapers over the past few months, and again today, regularly proclaim that statins are the answer to a number of ills and will prolong life. Medication taken permanently is “good”, and is becoming a fact of life. All new drugs which come along proclaiming to treat and cure our various ills are pored over and lauded. What goes hand in hand with that, I believe, is a implicit acknowledgement within our society that some casualties are an acceptable compromise for the apparent freedoms we enjoy by having these drugs available for relief from any ailment. How else can we explain the lack of outrage that companies can market drugs which cause damage, even “rarely”?

    Somehow we have to become more open about this collateral damage and this I foresee is the role of the RxISK website, pushing the information and stories it holds out into the public domain. Particularly as a resource for coroners – in the Roaccutane story, the drug was not mentioned at the inquest of one the young men who died, so again an opportunity to have a complete and open discussion about the life and death of a young person was missed.

  8. The issue of forensic determination of suicide has been raised many times in the context of medication-induced suicide. It is repeatedly stated that suicide is under-reported because of such issues as the lack of witnesses, social stigma for the families, insurance requirements etc. The Centers for Disease Control have criteria for the determination of suicide by medical examiners. These include expression of intent, previous attempts or expression of attempt, significant losses and major depression. Many deaths reported as “undetermined” or “accidental” are believed to be suicides.
    The criteria for suicide determination seem obvious and rational but suicide induced by antidepressants may be entirely different. Patients on SSRIs prescribed often by their GPs, have told me, when wanting to stop taking them, that the urge to commit suicide “came from nowhere” and was almost overwhelming. They did not fit any of the CDC criteria and were, in fact, terrified by the experience of suddenly feeling despair and hopelessness that made self-killing seem to be the only answer. I have a friend, a Chief Medical Examiner, who tells me that the very fact of the deceased’s taking antidepressants is sufficient to make him lean toward suicide but not as a result of the medications themselves. After our discussion, he is now making note of the type and dosage of antidepressant involved. Unfortunately, like most under-funded forensic pathology institutes, he does not have the budget to employ forensic psychologists to interview family and friends to do what is referred to as a “psychological autopsy.” If more medical examiners could be convinced of the importance of these issues – type and dosage of drug and in-depth investigation of state of mind- we might have a clearer picture of the extent and degree of medication-induced suicide.

  9. Arthur Schafer says:

    When, if ever, is it justifiable to sell one’s soul to the devil?

    Sartre calls this the problem of “dirty hands”. If one wants to make an effective contribution in the world then one must be willing to make “shabby compromises”. Anyone who insists on keeping his/her hands clean and conscience pure will be irrelevant at best in the struggle to make the world a better place or at least a somewhat less bad place.

    If one wills the end then one must will the means that are necessary to achieve the end, it is plausibly claimed.

    Let’s suppose that the end/goal /objective in question morally worthwhile. In this case that seems a sound assumption. The survival and flourishing of Rxisk – as a web site that collects good data on adverse events associated with various drugs and that makes this data available to patients and others who need objective information – is an eminently worthwhile objective/end.

    Raising a significant sum of money is a necessary condition for the survival and flourishing of Rxisk. But whether the necessary amount of money can only be raised by donations from Pharma, brand or generic, is at least questionable. One should not sell one’s soul to the devil if one can achieve one’s objective without doing anything this dire. So, what are the possible better alternatives? Support from one or more charitable foundations (with no connection to Pharma, tobacco, or other blatantly unethical sources) or wealthy individuals or from a large number of people with modest means. Support from subscriptions to the web site; support from a university or government keen to promote public health and to save money by identifying dangerous and/or useless medications. This list is not meant to be exhaustive, merely suggestive.

    Moreover, attempting to raise money from Pharma (brand name or generic) will not be justifiable unless Pharma is a reasonably likely source of funding. That is, there’s little point in selling one’s soul to Mephistopheles if he is not likely to grant one’s wish to possess the incomparably lovely Margareta. Is Pharma likely to fund Rxisk? To me the question is a no-brainer. It’s totally unlikely – as unlikely as Nestlé’s funding the La Leche League. Alternatively, if they are fiendishly clever and if they calculate that by funding Rxisk they will white-wash their own nefarious activities and totally discredit Rxisk then they might be willing to give funding. But, of course, if they fund Rxisk for those reasons and if they are correct in their calculations that such funding will “pay off” big-time for their bottom line then Rxisk would be losing more than it would be gaining. That is, the project would produce more bad than good results. So, Rxisk has to hope both that Pharma will give major funding and that Pharma’s reasons for doing so are the result of a miscalculation of their own best interests. Frankly, I think that Pharma would be crazy to fund Rxisk and wouldn’t dream of doing so.
    We’re assuming that Rxisk is a highly worthy project, which it is. Let’s also assume that Pharma will fund it to an adequate level (although this seems to me to be almost certainly false), and that no other (less ethically dubious) source of funding is available (which may also be false).

    Would it then be acceptable to solicit and accept Pharma funding?

    I think that the answer to this question is still “no”. Pharma funding would be a poisoned chalice. Consider: patients and others will turn to Rxisk for information and analysis because (and only because) they see Pharma-funded sources of information, including most articles published in the leading journals, as discreditable and discredited by problems relating to conflict of interest. The currently trusted sources of information – such as Cochrane Collaboration studies, the Therapeutic Initiative, Worst Pills, to mention just a few – are trusted to be objective largely because they are NOT funded by Pharma. Why would anyone trust Rxisk if it were dependent (entirely or in large measure) upon Pharma funding? Its entire raison d’etre would be undercut.

    Nor is the fear merely that appearances will be terrible. The reality may be terrible as well. That is, once Rxisk becomes heavily dependent on Pharma funding will this fact not have a tendency, perhaps an unconscious tendency, to bias the judgement of the people running it? If information begins to emerge that is discrediting to a funder’s blockbuster drug will this not induce anxiety that funding may be put at risk? David Healy accepted money from Pharma and then turned round and bit his benefactors on the ankles (and possibly other more tender places). Nancy Olivieri accepted funding and a consultancy from pharma and then stood by her principles and risked everything to protect patient safety and research integrity. But we know about these cases precisely because they are highly unusual. Those who become accustomed to first class travel and all-expenses paid luxurious vacations plus pots of “extra” money are typically reluctant to give these up.

    Moreover, if most of the people involved in Rxisk (with the exception, perhaps, of David H) see financial conflict of interest as the central driving force of much that is wrong with modern medicine and modern medical research then how can they write and lecture on this theme while themselves taking money from pharma?

    The hypocrisy would be stunning. And it would be utterly discrediting.

    If Rxisk can survive only by taking funding from Pharma and thereby destroying its own credibility then it will be a Pyrrhic survival (if I may coin a phrase).
    Don’t do it.

    One final word. David has asked me to comment on whether it would be more acceptable (or, perhaps, less unacceptable) to accept money from generic pharma rather than brand name pharma. It would not be more acceptable for all the reasons given above. And, in a curious way, it might be worse. After all, think about it. Which drugs go generic? It’s the blockbuster drugs that go generic when patents expire. And it’s precisely these blockbuster drugs that are the least beneficial to patients because they are aimed at patients who are healthy but have such “risk factors” as low bone density, high bad cholesterol, high blood pressure, low renal function, pre-diabetes, etc. In short, generic companies won’t fund Rxisk because if Rxisk does its job properly then these companies (along with their brand name competitors) will be out of business. Arthur Schafer, 29/11/12

    • I agree with this comment from Arther Schafer and can’t see how going into partnership with pharma, in any way, would be the ‘right’ thing to do. For how can you challenge the hand that feeds you, the piper who calls your tune? It would be a compromised debate and lacking in power, if not powerless, in terms of the marginalised and psychiatric drug addicts.

  10. David_Healy says:

    From Warren Bell

    Hi David: you’ve probably seen some of my posts from Biojest.

    I’ve been a Pharma-watcher, from a clinical perspective, from the mid-1970s, when I began writing the first, and still the only published and detailed research critique of the CPS.

    I would urge you to eschew funding support from the drug industry absolutely. The research on the science of gift-giving is crystal clear: you receive a gift, you change your attitude. If you don’t, then when it comes to corporate gifts, then the gift will be withdrawn.

    I’ve been part of many civil society groups, some physician-led, some non-professional, some ad-hoc, some long-term and policy-oriented. I have not seen a single one take on funding from a commercial entity with shareholders that didn’t start to sway noticeably away from clear-cut principles of transparency, independent data gathering and use, and strong and meaningful linkages with the grassroots.

    The rspected Canadian Institute for Child Health, founded by pediatrician Graham Chance, took a grant from Nestlé about 9-10 years ago, and let the former CEO of the PMAC (now Rx&D) on their board; in the subsequent NGO uproar, they disappeared within a year. CAPE (Can Assoc of Phys for the Environment) accepted logistical support from GSK through the offices of one of CAPE’s 3 founders (I was another one of the them, and dead against this; true to form, GSK abruptly dropped CAPE within 18 months, because we wouldn’t stop critiquing corporate behaviour.

    The nature of corporate drug industry money is that it is spent to enhance the bottom line. If it doesn’t, or ceases to do so, then it is not spent, or it is diverted elsewhere.

    Better to be smaller, more lean, more modest, use more volunteers, enlist funds from the public — anything other than to fall into a tender trap which has jagged steel teeth buried in its centre.

    Cheers,

    Warren Bell

  11. Could not agree more on the question of pharma money! It is never given by accident, and never truly “unrestricted.” There may have been a time, long long ago, when pharma support for research was no big problem because the balance of power was different; companies would not dare demand control of the data or suppression of embarrassing results. Those days are clearly over, and what happened to David’s and Nancy Olivieri’s research careers are the clearest signal. Even the local “expert” who gets paid $1500 to go lecture the staff of Dogpatch Hospital about the latest medical developments is not free, as Dan Carlat’s Effexor experience showed. They’ll be expected to adhere to a company script and show company slides, or no more side gig. The fact that the money doesn’t appear big enough to buy the soul of an MD is beside the point. The opportunity to be supported in doing what you would have done anyway, because it happens to be largely in synch with some drug company’s agenda, is gone, baby, gone.

    To me there is a BIG difference between “bias” and “conflict of interest.” What RxISK directors presently have is a bias. Based on their experiences and the facts they’ve seen, they tend to believe that pharma is overhyping the benefits and hiding the dangers of its on-patent products. They can manage their bias through tools like their “algorithms” so they are less likely to be suckered into believing an attractive horror story that has no basis. As long as it’s well-managed, I’m glad they have a bias — it makes me trust them more.

    Conflict of interest is another beast altogether. That’s when your career and financial interests are potentially on a collision course with your duty to your patients and the public. Suppose RxISK took funding from Eli Lilly? They’d soon be under pressure to say no more about Cymbalta or Zyprexa — and maybe under pressure to aggressively collect bad reviews for competitors like Pfizer’s Lyrica. We the users could no longer trust them.

    American consumers of fee for service medicine are used to watching out for this conflict of interest on at least one level — elective surgery. A doctor who makes only $150 on your office visits but can make $10,000 in an afternoon by giving you a spinal fusion is NOT a guy with a “bias.” He is a guy with a conflict of interest, and you had best get yourself a second opinion from a surgeon who knows he will not be the one to collect the fee if he does recommend the fusion. Your second-opinion doc may have a bias: he likes fusions, he likes laminectomies, he likes physical therapy, whatever. But unless he has a concealed relationship with Doctor #1 (and watch out!) he does not have a conflict of interest.

    There may be a lot of other paths we can pursue to keep RxISK running. I get solicited on this issue by groups like Public Citizen and the Union of Concerned Scientists — don’t know if their agendas are close enough of a match to work with. Likewise Pro Publica and the Pew Prescription Project. We could raise a more modest amount of money ourselves — 100 people who agree to give $10 a month is a grand a month; ten people who can give $100 is another grand. Volunteers to do the daily work of data entry, etc. are an awful lot easier to organize in the internet age — they might not have to live anywhere near Toronto. I’d also like to hear from some of the labor unions who, in their role as insurance funds, have been plaintiffs in suits against Pharma. Especially health care unions like 1199. That’s just a start on the fund ideas front; there’s people who do this for a living who might let us pick their brains for free…

  12. David_Healy says:

    From John Abramson

    I apologize for being so late into this important conversation. I fear that I have earned unique privilege in commenting in that I promised David Healy that I would write a section for Rxisk on statins many months ago and have failed to deliver because of lack of time and energy. Money would not have helped, but surely adequate financing is essential to the many of the other tasks of running an up to date and comprehensive website.

    I think there are two major perspectives from which to assess the issue of conflict of interest. From an analytic point of view, of course all action has ulterior motive, even pure altruism. From that perspective, the conflict of interest associated with financial ties to PhRMA exist as well as the COI that comes from the academic cache and ego-satisfaction in publishing, as well as the psychological agendae that we all carry forward as we observe and respond to the happenings in the real world. One could conclude there is no action that is free of personal conflict of interest so let’s just move on and judge each particular action/position/publication on its own merit.

    On the other hand, a look at the practical consequences of conflict of interest leads to a very different conclusion. The interests of capital are coherent (like the light rays in a laser), and therefore results of the financial relationships that are a consequence of such conflicts will have the consistent effect of serving the interests of capital, irrespective of the effect on public welfare. Ted’s recent post about the Cardiometabolic Risk Working Group and the conflicts of interest that pervaded the U.S. National Cholesterol Education Program 2001 guidelines are important examples of the very real consequences of such conflicts.

    The coincident diminution of funding to independent critical entities and the virtual takeover of the production and dissemination of medical knowledge by private industry (i.e. capital) has ripened (analogous to the market for mortgage backed derivatives) into market failure in what is taken for medical knowledge.

    The confidential corporate scientific and marketing documents that I get to analyze as an expert in litigation often show a gobsmacking disregard for public welfare. And the outcomes of the PhRMA litigation to date have played more of a role in providing the appearance of legitimacy and effectiveness of the over-arching system of justice, when –in fact– even penalties of several billion dollars are only a fraction of the ill-begotten gains and serve as minor slaps on the wrist.

    All that said, I believe that accepting money from corporations whose interests are diametrically opposed to critical appraisal of medical knowledge is worse than a Faustian bargain. Such a financial relationship makes no more sense than allowing drug reps to bring lunch into a doctors office along with a PhRMA-paid speaker who has promised to promote open dialogue.

    Which raises the question: what is the alternative? One relationship that might be sought might be plaintiffs’ attorneys who are the beneficiaries of the settlements and awards levied against PhRMA. Perhaps individually or together those of us who participate in litigation might discuss the possibility of establishing a fund to support critical work in the public interest. Of course, this too would come with a conflict of interest–but at least not the healthcare industry’s coherent and single-purposed interest to generate profits (the work would be outside the context of current litigation).

    John

  13. David_Healy says:

    From Joyce Bichler

    Just picking up on this interesting discussion. I can speak to Breast Cancer Action’s position on this issue. Whom we take money from is critical to our ability to speak about issues, and to garner the trust of our members. As the independent watchdog of the breast cancer movement, BCAction has a strict policy against taking money from the pharmaceutical industry or from any entity that profits from cancer. This policy gives us the freedom to tell the truth about breast cancer and ensures that we always put patients before corporate profits. Case in point, we are the only breast cancer organization that is a plaintiff in the suit against Myriad Genetics challenging their patent of the BRCA 1 and 2 genes. (A case that was just last week accepted to be heard in front of the US Supreme Court). Why are we the only ones? It’s not because other breast cancer organizations don’t care about the issue. It’s because Myriad has been very ‘generous’ making sure most breast cancer organizations have been receiving funds from them. You’re not going to sue the hand that feeds you.

    There’s nothing inherently bad or evil in taking funds from Pharma or others, but it is delusional to then tell yourself you or your organization is not influenced by those donations. Because of the work we do, having a strict corporate contributions policy is essential. Do we have to work harder to raise funds? Sure. But it can be done and we get the benefit of sleeping sounder at night! Saying it can’t be done is just a way to justify not doing it.

    Joyce

    From Colleen Fuller

    I think this discussion about funding needs a gender lens. Women fought long and hard to get public funding for things like rape crisis centres, shelters for women fleeing domestic violence and, yes, for advocacy as well (and lest we forget, Women & Health Protection was able to produce a fantastic body of work – and to launch Biojest – because it was able to obtain public funding). Spurning public funding is a position of privilege, in my opinion. The question about Pharma funding is complex – it can be seen as an ethical issue, but taking the high road can be the path to defeat as well. I don’t see this issues as black and white at all.

    • I think, re the black and white of it, that it will depend on timing as to whether pharma monies are corrupting or not. There may come a time when pharma admits their drugs are not all in all to psychiatry. But that would require the psychiatric system considering alternatives to only drugs and also to make reparation to all the people who have been disabled by the long term prescribing of neuroleptics. People who weren’t informed properly of the risks and might even have been misled.

  14. David_Healy says:

    From: Arthur Schafer

    Joyce:

    The case you describe illustrates beautifully an important point. But you should not have written “There’s nothing inherently bad or evil in taking funds from Pharma or others”.

    What is “wrong” (or “bad” or “evil”) in a disease society’s decision to take money from Pharma is that (1) these societies have an obligation to exercise their judgement impartially – the old-fashioned and somewhat better term is “disinterestedly” – on behalf of patients who are suffering from (or at risk for) breast cancer (or some other disease) and (2) the acceptance of money from Pharma has a marked tendency to undermine that obligation (by biasing judgement).

    The reason that Breast Cancer Action is the only breast cancer disease society to fulfill its obligation is likely to be that it is the only breast cancer disease society that is unconflicted. In short, it is wrong, bad (or evil) for the other disease societies to take money from a source which is likely to prevent them from fulfilling their obligation to exercise their judgement/discretion on behalf of present or future patients.

  15. It’s tricky to bite the hand that feeds you. But it can be done.

    Take a look at Forest Ethics, an independent non-profit that is working in the environmental sector as an advocate to protect the forests. They get some funding from lumber companies, paper companies, and other corporations. But they bite back. And bite hard! Perhaps RxISK could use them as a role model…

    See: http://www.forestethics.org/,

  16. Just a note to Colleen: You are right that being solely “member funded” is usually not a viable option for the underdogs, female or male. Public funding for vital social services (and even community organizing) is something we should not just tolerate, but demand! Even if the people running these projects have to watch out for politicians trying to muzzle us … we can at least appeal to the people, who pay their salaries. Come to think of it, nothing would make me happier than to go to a RxISK retirement party because the publicly-funded agencies like FDA and NICE had finally decided to do their job.

    So, for example, if we were trying to start a shelter for street kids in Chicago, I would be all for taking public funding, even if it meant we had to constantly arm-wrestle the alderman to keep it open. I’d even take foundation funding if it didn’t come with too many strings attached (like, say, teaching “abstinence” or some nonsense).

    But Pharma funding for a health care consumers’ group — or BP funding for environmentalists? That’s more like the neighborhood pimps and their pals on the police force forming a consortium to fund our shelter for street kids. You know it would not be out of civic responsibility. And you know they’d be pushing an agenda that had nothing to do with safety or progress for the youth. Funding from the powerful people you are fighting is just plain dangerous. One of the many ways for them to kill you off is to hug you to death, and they are experts at it.

  17. Why dont, we ask the goverment for funding, as
    the MRC, and ABPI, are now run by pharma industry,
    and Jeremy Hunt who has ties to Pfizer. Who pays then,
    the goverment, their ways have not worked, RXISK is clearly
    working. Plus not just for UK its working world wide.
    The public are able to take non bias advice and, advice
    from people who have lived it. Experience over stats, anyday.
    Or possably, get solicitors on board so, they can get these people
    compansation for there suffering, and if the person wants to
    go for compo, through a solicitor or lawyer, they have been put
    in touch with through RXISK. Then they should make some kind
    of claws, that if Drug company found guilty, not only do they
    have to pay, the court fees, compo to the person, and the solicitor.
    But they also have to give so much to RXISK, as way of good deed
    for bringing the problem to their attention, more quickly than the MHRA,
    or FDA. So in the long run it should save them money, because they could
    take a drug off the market, or use it in correct area, much sooner therefore
    stopping as many people becoming ill from side effects. God i went on a bit there
    but, that way these drug compaies would be more upfront, they would have to be.
    And we should all get a better service, from people with non bias opinions.

  18. David_Healy says:

    From: Neil Carlin

    I think the thing that is missing from all of these discussions is the issue of marketing the message – you cannot assume that “If you build it, he [they] will come”. There is a huge marketing imbalance that only money can correct. It is a time to put all of the academic BS aside and to fight back. If taking corporate money is the only way for RxISK.org to survive, then they should take it. They can clear their collective conscience later.

    People are dying daily from prescription drug ADRs. It is a high time to think outside of the box.

    This is my my humble, non-academic, victim advocate, opinion.

    Best
    Neil Carlin
    Toronto, ON

    On Mon, Dec 3, 2012 at 9:11 PM, Janet Currie wrote:

    Champix another really really good place to start.

    I mean..what about having a quick response website..not much money to construct with a “drug of the month” Problems with Champix …..we need to know….etc. You can build in very quick pop up for embedded surveys for very little money. The data will be slotted into tables…simple, not sophisticated…..I realize the limitations.

    And of course it will be discredited as not being “scientific” But can we actually get there going head to head with Pharma…we would need millions and millions of dollars. All of us working in the field of “consumer advocacy” became “informed” because of what happened to us personally or what we soon learned happened to others. Think statins, think benzos, think synthetic insulin etc. etc. etc.

    Champix yes, a really good one and so popular these days.
    PPIs…love them too…so popular….so under estimated in terms of adrs.

    Janet Currie
    Director

  19. David_Healy says:

    From: Janet Currie

    Again, I apologize for coming late to this discussion. Personally I do not feel it is feasible for a citizen group or initiative to substitute for the role our public regulators SHOULD be doing in collecting, supporting the collection of and effectively analyzing adrs in a timely way (as well as actually taking ACTION on them which is where the real problem lies).

    I wonder though if there is not a citizen based way of collecting targeted time-limited data which would have the effect of requiring fewer resources, being very focussed, elucidating real problems faced by people and that would have the effect of increasing “prescription drug literacy.”
    I keep thinking of what Charles Medawar did in England in relation to Paxil. Remember it was the BBC and the Panorama program in 2002 that blew the lid off of the so-called withdrawal effects of the SSRIs. Consumer complaints made mainly by email talked for the first time of the possibility of violence and self -harm. Until then victims were simply islands onto themselves and addiction was said to effect only a few dozen people. After that program, which wasn’t really “scientific” in some senses but looked at “signals” from patients, pharma had to change its tune. I like a more targeted signal approach if it can be done.

    IN a similar example, the “turning point” for benzos was in 1985 when another BBC program gave a lot of prominence to benzo effects. Before this time benzo addicts were “blamed” for their addiction and were told they had “addictive personalities” After this there was a lot more credence given to the terrible problems of addiction and withdrawal although the medical literature had been talking about this for over a decade.

    I don’t think it would be hard to collect short term targeted results related to specific drugs on a website that would have features collecting basic “survey” data. I would start with statins and then proceed to the atypical anti-psychotics :-)

    My two cents worth.

    Janet

  20. With Rxisk, the patient has to do all the donkey work. Filling in the questionnaire and getting the results to take to their prescriber.

    Of course, it should be the other way round. The prescribers should be doing the donkey work.

    Rxisk is a brilliant idea. But, we need to turn it around.

    The consumer comes first, is not the way it is happening at all, at present, in the world of pharma marketing.

    If I were marketing Rxisk, I would attempt to make it a subscription based facility for gps and psychiatrists. An annual fee, not necessarily a huge amount, say £250, whereby the huge data bank could be accessed. I would suggest this is morally correct.

    This would necessitate a marketing campaign in the press, in medical journals, and to surgeries and hospitals.

    The is what, maybe, should happen in an ideal world.

    If more litigation took place, if the MHRA, were deemed to be a failure, then there is nothing else available, except for Rxisk. Rxisk, is doing what the MHRA are doing badly. They have not produced a data bank showing evidence of side-effects because they are not up to the job. We all know that a regulatory agency funded by pharma is complete and utter nonsense.

    This will take a long time, but it really doesn’t matter how long it takes. Rxisk is the safety net for consumers and prescribers. It should not be one-sided, patient only access.
    If pharma can market their drugs based on a false premise, then Rxisk is there to shoot them in the foot with sound evidence and no spin.

    I have yet to understand why Rxisk has not been heavily promoted in the press, every time there is some sort of terrible story which is obviously drug-related.

    If all our stories and comments were reproduced in main-stream media, there would be a public outcry. All talking to ourselves is not putting the message out there.

    All credit to Rxisk for amassing huge amounts of data so quickly.
    Academic brains are working hard.
    Pharma spends billions on marketing, employs specialist marketing tacticians, is rewarded with billions of profits.

    There is no product with Rxisk, apart from data, and this cannot be sold.
    But, the Risk can be minimised with Rxisk and this has an outstanding role to play in our society. A first for turning pharma on it’s head.

    There is something blowing in the wind, and government funding is not beyond the realm of possibilities somewhere down the line.

    When I was voluntarily trying to keep a small child’s playgroup going, I wrote to a list a charities with a very persuasive letter. I was astounded when the cheques started arriving in the post. Anything is possible, if you put your mind to it and think clearly about what the result is you want and then go and get it. There are many philanthropic benefactors out there if funds are an issue.

    It just seems to me that having reached this amazing point in it’s first few months, Rxisk should apply it’s mind to where it wants to be in five or ten years time when dodgy pharmaceutical drugs have perhaps been made more transparent.

    How difficult is it to write a press release Rxisk.org to be sent out to mainstream media. When is the Rxisk product launch going to occur? Perhaps, now is not quite the right time, but it is surely not long off?

    Just a few of my thoughts, off the top of my head, to keep the dialogue going, on where Rxisk.org is going.
    Marvellous, and all credit to you all at Rxisk.

    • Samantha Dearnaley says:

      I agree with Annie, all these stories need being sent to media, I have sent them lots, of stuff, but they need to see, the real numbers, they seem to think that its only a few of us, who have suffered side effects of these drugs. And then because they hear from doctors and government bodies, that all drugs have side effects, they just think its normal to have side effects from drugs, they don’t realise just how nasty some of these side effects are, its a bout time people are told the truth.
      I told my doctor the other week that, the government class the side effects of prescribed drugs, as the four biggest cost to our NHS, she said really, she didn’t have a clue.

  21. “We on Rxisk.org have data GSK should want, should need. We have raised the issue of accessing the data with them. They don’t seem to want access. They do not seem keen to have the issue raised. Interests seem to be conflicting.”

    Why would they want data on their own drugs? Tell a stubborn individual that what they are doing is wrong and the likelihood is that they will continue to be stubborn.

    If you show Glaxo, for example, how many consumers are struggling with the withdrawal effects of Paxil, they will want more than just anecdotes. They will seek patient records then, as I have said in the past, find every possible reason why the withdrawal problems are related to the illness rather than the product.

    Industry money is, in essence, money that consumers have handed over for industry products, Paxil just being one example.

    There are other avenues to explore re funding. Don’t go down the government route, you’ll be told what to do and how to do it and if you refuse they will, more than likely, pull any funding. Target businesses outside the loop. Start preaching to those that don’t know opposed to those that already know.

    Rxisk is in its infancy – it will take a united front from activists, bloggers and support groups to help spread the word. All of us play a part in getting messages out there be it by the written word or word of mouth.

    This from Wikipedia regarding Hallmark Cards:

    Joyce Clyde Hall became captivated by a salesman who stopped by his family’s store in 1906 in Norfolk, Nebraska. Driven by the postcard craze of 1903, Hall decided to venture from retail of various products to wholesale of postcards. He moved his business to a larger market of Kansas City. As time went on, Hall became more convinced that greeting cards would become more prominent than postcards. Greeting cards, according to J.C. Hall, represented class, promised discretion and “they were more than a form of communication—they were a social custom

    Reporting adverse events to Rxisk needs to become a social custom.

  22. At present, in it’s very short life, Rxisk is slowly gaining ground with patients looking up drugs and reporting back to their prescribers and doing all the donkey work.
    Surely, this should be the other way around and gps and psychiatrists should be doing all the donkey work.
    In five or ten years, I would expect Rxisk to be available, on subscription, by prescribers.
    It’s enormous data base holds crucial information, without which, more and more accidents will happen.
    A new product needs clever marketing skills. It needs a marketing strategy, product launch and unceasing pr skills which puts the message in front of patients and prescribers. It needs a dedicated professional to be one step ahead.
    Pharma spend billions on marketing, have extremely clever marketing tacticians, and manage, to, dupe patients, prescribers, regulators, from the top trickling down to the patient.
    I keep expecting to see a whole page in the media devoted to Rxisk.org.
    To succeed, Rxisk needs to be the right arm of each and every gp and psychiatrist, ideally the world over.
    Academic brains are working hard creating this database.
    A marketing brain could completely alter the way, prescribers think. This is how it works and this is how something you didn’t think you wanted, suddenly becomes something without which you couldn’t function.
    You have a unique selling point versus an uninterested audience.
    You are doing what the MHRA are doing irresponsibly and badly, and they are deemed to fail, which they will, at some point. At this point, Rxisk will be the only facility available and could well be grabbed, with open arms, playing a huge part with a new type of regulator, who has no links to pharma or bias.
    This is what is happening at the moment with the Levenson enquiry. The arm has been forced for the press to have an independent regulator.
    It won’t be that long before all eyes are on our, particular, medical health regulator.
    There is little point in having a morally correct service, produced by academics, if it is not universally marketed and all marketing strategems put in place, in front of all patients and prescribers.

    • I don’t agree with RxISK or with any organisation or database being the only or right arm of any body. Nothing is perfect and no group or database has the whole story. Anyway science isn’t about truth but about relationship, and searching for meaning. And never absolutely finding it. For each of us have to make our minds up about who and what to believe. There are many ‘unique selling points’, as in unique to the person who’s selling the product. It’s a sales pitch.

  23. David_Healy says:

    From: Sharon Batt

    Hi Neil, I agree there’s a huge marketing imbalance when it comes to advertising adverse prescription drug effects but I don’t agree it’s academic BS to question the problems inherent in a project like RxISK taking pharma money to survive. Pharma created the imbalance, why would pharma fund a project designed to undo its marketing advantage? If pharma companies begin funding RxISK, they will only continue their funding if RxISK stays silent when evidence of a major ADR starts to emerge in a particular case. But if RxISK remains silent when it should be speaking out it is no longer performing its role — it’s part of the problem. I don’t see any way out of that particular box (and taking money from pharma doesn’t strike me as “thinking outside the box” – lots of organizations are doing under the guise that their survival is so important they can worry about ethics later). Sadly, I think it’s preferable for an organization to cease to be rather than continue under a funding arrangement that contradicts its very purpose. A better option, of course, is to try to fund alternative funding but that’s not easy to do, especially for a new organization and in the present economic climate. Groups that speak out on ADRs, like BCA, Public Citizen, the National Women’s Health Network, PharmedOut and HAI have been able to establish core funding through a member base or some other avenue – but they still struggle and have nothing like the resources of big pharma. If RxISK is to survive and fulfil its mandate, it needs to look to these groups as models, not to the dozens of pharma-funded organizations which have, in one way or another, strengthened pharma’s hand.

    That’s my two cents… Sharon

  24. David_Healy says:

    From: Colleen Fuller

    Those who are forced into the arms of Pharma because of a chronic condition often have very complex feelings about the industry. I’m speaking in generalities here (and also personally), but often people in this position hate the industry, not least because of the amount of money they’re shelling out on a daily basis to stay alive and because of real or potential side effects associated with drugs that they need. But it’s also because of the oppressive relationship they have – people can be afraid to speak out because they believe Pharma is so powerful that something bad will happen – their drugs will be denied them, whatever. They also, for these reasons, often resent astroturf groups when they find out about the relationship these groups have with the industry. I don’t think diabetes is different, in that sense, from other groups – like arthritis, for example. Some years ago there was a group that broke away from The Arthritis Society to form the Canadian Arthritis Patient Alliance – specifically because of the TAS/pharma link. Unfortunately, CAPA wasn’t able to make it on their own so now, if I remember correctly, they get money from the Arthritis Society. Over the last 20 years there have been numerous attempts to form advocacy groups in the diabetes area, again specifically because of the relationship between the CDA and the industry. All of these folks knew that Pharma funded advocates would never say what needed to be said.

    So this isn’t just academic BS. People are struggling to develop an independent voice because they know the industry will silence them at every turn, that the money from the industry is tainted, and it soils everything it touches. People don’t only experience ADRs because they’re using a drug produced by Pharma – if you have a chronic disease you live or die depending on whether you have access to the medicine you need. When you use drugs all the time you have a different relationship with Pharma, it’s not just about hard-to-deal with side effects. People like that need independent voices that are truly not compromised by Pharma to speak on their behalves – and those voices are already few and far between. It would be too bad if RxISK took money from the industry.

    Colleen Fuller

  25. David_Healy says:

    From: Sara Bostock

    I have to agree with Sharon here. You only have to look as far as NAMI (National Alliance for the Mentally Ill) here in the states to see the insidious influence pharma funding had on what probably started out as a benign, patient, grass roots supported, well intentioned organization that ended up launching all sorts of initiatives in pharma’s interests (demonstrations, screening, “brain disease” education — you name it, they did it, including peddling all sorts of books with a very one sided approach to emotional distress), Furthermore even the most caring and well intentioned doctors have trouble staying objective in the face of pharma money pouring their way (read some of Danny Carlat’s writing — he never really saw the light about harmful adverse effects but he was self aware enough to know that he wasn’t speaking entirely objectively when he was being handed big bucks to make presentations about various psych drugs). In fact, I’m cynical enough to think that the only reason pharma would be offering money to RSisk.org is because they want to keep a close eye on it and ultimately influence what it’s doing.

    Some of you may remember that I helped to start the website ssristories.com (that David actually credits with inspiring him in a small way to do his site). One of the strangest calls I ever got in relation to the site was from someone wanting to put me in touch with a pharma contact who claimed to want to purchase the site. There would be one reason and one reason only that a pharma interest would want to purchase ssristories and that would be to take it down. Rosie, the administrator and true creator of the site, checked hits on a regular basis and we were being “watched” closely by pharma. It’s amazing how much time (and money) they must spend monitoring what goes on on the WWW and trying to diffuse things that go against their interests.

  26. David_Healy says:

    Jacques Thivierge

    to Sharon, David

    Sharon,

    I completely agree with your viewpoint that it’s preferable for an organization to cease to be rather than continue under a funding arrangement that contradicts its very purpose. As for RxISK, can we not imagine a situation where many doctors throughout the planet would be willing to pay for RxISK to keep on going ? How about finding ways to let them know that RxISK exists and what it can do for them. For example, send them a personal e-mail obtained through their medical organizations ? It could be worth the trial

    jt

  27. Email marketing is not a good idea.

    I suggested above that Rxisk should be subscription orientated, which it should be, to gps and psychiatrists. It is the only moral route.

    Forgetting the cost of such an exercise, each and every gp and psychiatrist in this country, you cannot access the world, needs a nicely planned, well executed, mail-shot.

    For every thousand, sent out, you might get one, signing up. This is what happens in marketing mail-shots. That one, might save a life, or, at least, save a few months of suffering for the patient.

    I would envisage, as I said above, subscriptions from gps and psychiatrists. It is entirely possible. I have helped out many a small company, but word of mouth spreads like wildfire, and it would not be long before Rxisk takes off, as the ‘official’ helping hand.

    I see a box, with a Rxisk leaflet, sitting in the gp surgery. The frantic, fractious, patient picks it up, and says, hey doc, what about this?
    The overworked, tired gp, not many of them around, these days, thinks there might be some merit in contacting Rxisk with a patient, who seems to be suffering acutely from something he/she doesn’t understand.

    This will take-off, I know it will.
    It will take a bit of an investment from Rxisk, but who ever said doctor’s were poor. Grants are two a penny at the moment, also.

    I know this will happen. If I had sat, hyperventilating and ‘away with the fairies from Seroxat withdrawal’, it would have saved me a lot of grief to see a box with a leaflet, inviting me to get help out of my misery, which the doc could not explain.
    As I keep saying, you only have to change the mindset, it is not difficult.
    My mind was changed beyond repair, I thought, but I changed it back.
    Rxisk will be an invaluable tool, one day, but only if we all take it to it’s conclusion.
    I don’t get upstaged anymore, I know Rxisk is going to beat the MHRA, hands down, for unrivalled intelligence and evidence based data.
    Can we get on with it and create the marketing strategy for 2013, and do what, David, wanted to do, so many years ago?
    Can we??

  28. Two studies suggest that incentives may change behaviour:

    The first study looked at what drugs doctors prescribed when they were offered all-expenses-paid trips by drug companies to conferences sponsored by the drug company.

    This was done by checking the doctors’ prescribing patterns with the hospital pharmacy inventory FOR two drugs, for 22 months before each conference and 17 months after each conference.

    Ten doctors invited to each conference were interviewed about how likely they thought that such an incentive might affect their prescribing patterns.

    There was a significant increase in doctors prescribing both drugs after the all-expenses trips to the conferences.

    This alteration took place even though the majority of physicians who attended the symposia were sure that such incentives would not alter what they prescribed.

    Orlowski and Wateska.
    Chest. (1992; 102:270-273.
    “The effects of pharmaceutical firm enticements on physician prescribing patterns”
    URL: http://www.ncbi.nlm.nih.gov/sites/entrez?db=PubMed&cmd=Retrieve&list_uids=1623766&dopt=Abstract)

    The second study was the first large-scale study of its kind.
    It demonstrated that:
    1) gift-giving in radiation oncology was endemic;
    2) although each physician was likely to consider himself or herself immune from being influenced by gift-giving,
    3) he or she was suspicious that the “next person” might be influenced.

    There was a correlation between the willingness of individual physician to accept gifts of high value and their sympathy toward this practice.

    Halperin et al.
    “A population-based study of the prevalence and influence of gifts to radiation oncologists”
    International Journal of Radiation Oncology, Biology and Physics: 2004 Aug 1;59(5):1477-83
    URL: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15275735)

    From the two studies, it sounds as if decision-makers worry that others are too easily persuaded but are quite confident that they themselves can’t be – even though their own behaviour suggests that something quite different may be happening.

  29. Sara Bostock wrote:

    “Rosie, the administrator and true creator of the site, checked hits on a regular basis and we were being “watched” closely by pharma. It’s amazing how much time (and money) they must spend monitoring what goes on on the WWW and trying to diffuse things that go against their interests.”

    Firstly, Hi Sara, long time no speak. I hope things are as well as can be expected your end.

    Pharma use grass roots monitoring to monitor websites. GSK and others often make an appearance on my blog as do the MHRA. I’m not sure but I think one can use the privacy act to ask pharma for any emails with reference to your name or your website. They, by law, would have to provide emails that mention ‘SSRistories.com’and/or ‘Sara Bostock’. I may be wrong about this so it’s worth looking into first.

    The internet is the Achilles heel for the pharmaceutical industry, it not only allows criticism of their popular drugs, it also shows how, over the years, they have promoted drugs. The Wayback Machine has been a great tool for me regarding the marketing of Paxil throughout the years in the States.

    Anyway, I’m going off topic here. Interesting comments from people in this thread.

  30. David_Healy says:

    From Jacques Thivierge:

    I am a latecomer to this discussion because of problems with sending my messages out to the group.

    I would like to start from Arthur’s issue about the definition of words (bias, prejudice). Whenever I see myself going into an argument about the definition of words, I quickly see a red flag popping out in my mind telling me that I am about to lose some precious time. Being a psychiatrist, I completely agree with Harriet when she says “I am an anthropologist and so I think I know the value of imprecision – definitions, concepts, meaning evolve and are contested”. The great philosopher of science Karl Popper had a similar attitude; he would say he never accepted to fight for word definitions, suggesting we give him up front the definition we prefer and that he would have no objections initiating the discussion from thereon without fighting for word definitions. We use words to define what is going on out there in the real world, to draw a picture of what we call the reality of things. The important thing is the picture, not the words; the level of precision of words defining the real world has limits; pushing these limits takes us back to a new state of imprecision. Aristotle initiated a way to define reality through precise definitions of terms and the disciplines that used the Aristotelian method of definition, have remained arrested in a state of empty verbiage and barren scholasticism (See Popper K, The Open Society and its enemies Chapter 11) . The best we can hope for in our grasping of realities is to progressively get closer to what reality is really like.

    What picture are we looking at here? Our main picture is the one of different groups of people (industry, government and medical institutions…) manipulating or oblivious of the manipulation of medical research data in order to secure advantages for themselves (money, career advancement, prestige …) even though an unacceptable number of patients are to suffer or die from their attitude. We all agree we are talking about COI and bias here. These bias are necessarily seen in many a context. Let us describe three of them:

    1- A situation where A is fraudulently manipulating the data or their presentations to its advantage. The examples go on accumulating themselves nowadays.

    A = Merck with Vioxx and Fosamax
    GSK with Avandia and Paxil
    Lilly with Prozac and Zyprexa
    Wyeth with Premarin
    Bristol Myers-Squibbs with Pravachol

    Clear-cut cases of COI and unacceptable bias

    2- A situation where B has important decisions to make on the basis of these research data, has some slight reserves about his/her being manipulated through what is being presented but does not bother to investigate any further and complies with the suggested guidelines. Examples of B: some of the doctors who have prescribes Vioxx, Fosamax, Paxil, Premarin,provachol…

    Less clear-cut cases of COI and unacceptable bias.

    3- A situation where C has some important decision to make on the basis of these research data, sincerely believes that the evidences presented to him in the top medical journals of his profession are trustworthy and goes along with the guidelines recommendations. (See John Abramson’s reflexion about this topic in his Overdosed America.) Examples of C: many of the doctors who have prescribed Vioxx, Fosamax, Paxil,Premarin,provachol

    A case of transitory acceptable bias.

    C is the normal and inescapable situation of bias for every human being. I understand this is what David Healy is talking about when he says he prefers the real doctor’s prejudices to the herbalist’s. I respectfully have to disagree with Arthur when he compares David to the imperious Humpty Dumpty; the imperious Humpty Dumpty doesn’t bother about the parcel of reality left out in his own conception of it whereas David obviously does (he wouldn’t have written so many books if he didn’t).

    Back to our biomedical civil war (I love Harriet’s expression). We fight against situations A and B. It seems fair to admit that doctors are a key ingredient in big Pharma’s power. It also appears fair to admit that the majority of doctors want to be good doctors to their patients, which means to say that the majority of them are in the C group above described. So they don’t want to be told, and they don’t want to believe, that following the evidence best principles, they harmed their patients and killed an unacceptable number of them because they were fooled by the industry propaganda. I am not being very popular with my colleagues when I open on this topic with them. But I believe that the very force with which they try to keep me and others like me at a distance, namely that they value their image of being good doctors to their patients, will one day force the door open to our message. And here comes RxISK. Arthur and all the biojesters I heard realize the importance of this movement. This is a magnificent instrument to learn about the practical aspects of all the medications we currently use and to become more aware of the side effects. In a drug for prescription context, the doctors are an inescapable force to be used either for commercial or academic manipulation. Why not through RxISK try the latter. Jerry Avord has successfully done something similar to an academic manipulation in his area which he called Academic Detailing (See J.Avorn , Powerful Medicines chapter 18). He used the very same efficient propaganda means used by the industry. So the question becomes how can we sell RxISK to the doctors ? How can we sell them the idea that through RxISK they have at hand one of the best mean to obtain the best ongoing available industry unbiaised information on the current drugs they prescribed so that they minimize their chance to unknowingly and unduly harm or kill an unacceptable number of their patients ? Is it unrealistic to think hiring a communication firm to pass this message onto them? I would not be surprised that a growing number of doctors would be willing to contribute financially to keep such a movement alive if they were given to know that one exists.

    Am I the only one thinking this idea holds water?

  31. David_Healy says:

    From Carol Kushner:

    Dear Jacques:

    First thank you so much for providing such clear examples of COI.
    I think your idea about hiring professional communicators to “sell” the idea of RxISK is a very good one. After all, we are attempting to counter the very well crafted yet misleading messages from industry and those doctors who shill for them wittingly or unwittingly. You will need both breadth and depth for this website to gain traction and I think professional help to make this happen would be well worth the investment. How to fund it? That I will leave to those with more fundraising experience than I have.

    Carol

  32. David_Healy says:

    From Arthur
    Dear Jacques,

    You claim that the meaning of all words is contested. I think that this is a grossly over-simplified generalization but I’ll let that pass.

    However, let’s look again at how David Healy wants to use the word “bias”. David illustrates his definition of “bias” with the case of a physician whose treatment decision is based on objective scientific evidence. Such a physician is said to be “biased”; and David then explains that this is illustrates precisely why he wants his physician to be biased (i.e., to base his/her treatment decisions on objective evidence).

    So far so good. But look at what David (and you?) are embracing (by your promiscuous re-definition of the meaning of the word “bias”). You are telling us that “bias is OK; it’s a good thing”. So, when critics of Pharma then point out that pharma-funding biases research findings what are ordinary people to think? If they are listening to David then they are thinking: Hurrah. We want our doctors to be biased. Pharma- funding biases them. So, everything is for the best in the best of all possible worlds.

    Now, in fairness to David, he doesn’t conclude that everything is for the best. He insists that we need somehow to compel the industry to provide access to raw data. That’s a worthwhile goal. David [in Pharmageddon] offers other worthwhile proposals, such as a rejection of the concept of “statistical significance” in favour of “clinical significance”.

    But David’s legerdemain with “bias”, which you endorse, assists him in dismissing concerns about the biasing effects of pharma funding of research and of pharma gifts and financial benefits to researchers and doctors (e.g.., gifts and free samples and consultancies and speakers’ bureaux fees, etc.].

    Warning people (by explicit stipulation) that when you use “bias” you mean what everyone else means when they say/write “objective/impartial concern for evidence” is all well and good. Writers are free to stipulate how they intend to use words. But readers easily forget that the writer is using this key concept to mean the opposite of what it really means (in the English language, when used by ordinary literate users of the language). The end result is the fallacy of persuasive definition. David’s loaded definition of bias, of which you apparently approve, makes it more difficult to persuade researchers and the public that there is a huge and dangerous problem in modern medicine, namely, the ubiquitous role of pharma money in the funding of research, funding of CME, funding of medical schools and universities, provision of gifts and travel and free samples to docs, etc. etc.

    The commercialization of modern medicine has been a poison precisely because it has biased what purports to be “evidence based medicine” so that it is little more than marketing, i.e., pseudo-evidence based medicine.

    This is not merely a dispute about “words”. It goes to the heart of why/how modern medicine has been corrupted by allowing the values of the marketplace to swamp and displace the values of health care professionalism (research integrity and patient safety).

    David likes to point out that he has accepted funding and consultancies from many different drug companies. The inference he invites his colleagues to draw is “and since it didn’t do me any irremediable harm or prevent me from doing my professional duty then it won’t do you any harm either”. That’s a dangerous message to deliver, in my view. Or, to be more accurate, what David argues – not in Pharmageddon but elsewhere – is that he has been biased by pharma funding but, he insists, he has been biased by many other factors as well. So, not to worry. Bias is inevitable and we should not count on researchers or docs to strive for disinterestedness. We should instead rely on the scientific method, given access to raw data, to correct the mistakes that will be introduced by the inevitable bias introduced because researchers are human beings.

    Nothing to worry about when it comes to pharma funding of research or pharma provision of financial benefits to researchers and doctors.

    In line with this reasoning, David dismisses conflict of interest as a side-show, something unimportant. Indeed, he argues that critics who raise ethical concerns about conflict of interest play into the hands of Big Pharma. In this I believe that he is profoundly mistaken. Someone is playing into the hands of Big Pharma but it’s not the critics who are fighting to eliminate conflicts of interest from medical research and medical practice.

  33. David_Healy says:

    Arthur

    I have never discounted bias. The argument is that science offers a way to overcome bias and indeed thrives on bias.

    Long before James Coyne went around saying Healy was more biased than most – having lectured on behalf of the makers of Reboxetine – I had been deposed by Lilly on this issue and to their evident surprise when asked did the fact that I had lectured on a handful of occasions on a reboxetine platform not bias me – I said yes it did. That beyond the money you make friends with company people and this biases you even more than any money to look favorably on their drug.

    So I don’t dismiss this source of corruption. Lots of others have been paid by pharma and it seems to corrupt even more leading them to go around engaging in ad hominem set pieces. Whatever the character pathology might be in these instances, when it comes to a scientific question, even someone like Charlie Nemeroff can potentially contribute usefully and it may be that whatever quirk it is that leads to a lot of the other unsavory things could conceivably assist in the resolution of tricky problems in some scientific domain.

    It sometimes takes all sorts of weirdnesses and motivations to solve scientific problems – which seem to be amoral in this sense. Being weird or being paid is not usually thought of as being a contributor to being good and proper. Where we get progress from lies in a group process rather than individual virtue.

    Science is fundamentally different to debate within bioethics or the humanities in this respect. It appeals to data not argument. And this is why access to the data goes to the heart of the issue in this case. If there is no access to the data its not science.

    Now we might find that with access to the data that because they are privately funded etc that its not very good science. And I would agree with you on this.

    I would short-circuit the argument at this point and say the tens of thousands of medical scientists out there who have no links to industry, campaign for access to the data from clinical trials, and adhere to evidence based medicine, have nevertheless been co-opted into industry’s marketing machinery.

    This is a deeply unwelcome message to many. Its caused something close to apoplexy in many quarters. It appears to remove a cornerstone, or a building block too many in the Jenga Tower.

    And here is where the importance of the question I’m asking you lies. The absolutely one thing industry don’t want you to have is not clinical trial data but good adverse event data.

    If we got good adverse event data in the absence of clinical trials how would we then work out whether drug A had caused problem X? Through teamwork. Objectivity lies in getting people together – patients, doctors, pharmacists and others – and bringing their collective perspectives, experience and biases to bear on an issue. If out of this process, we get a consensus the drug has likely caused a problem, it becomes reasonable to take the next step which may be critical to saving or costing lives and say this drug can in some circumstances cause that problem. If the process happens this way, we might be able to generate a scientific consensus so that the physiological underpinnings of the effect are mapped out and we can stop it happening in future – and perhaps coincidentally discover new treatments.

    At present the field is unable to engage in this process. RxISK data is one step. What I’m asking all of you who have contributed here is how to turn the data drops into a trickle and then a torrent. With enough data we can clean out plenty of Augean stables.

  34. I am so glad I am not an academic. Academics spend too much time hair-splitting, and too much time ‘defining terms’ for psychiatric illnesses.
    The amount of time spent defining terms for psychiatric illnesses and, thereby, putting patients in boxes, when they should be just talking defies belief.
    Once upon a time, there was not a ubiquitous psychiatric manual.
    The ssri scandal has grown up out of too much attention paid to dangerous words from pharma who seem to have no conscience, whatsoever, in what they are doing.
    The prescriber is the mechanic. He trusts his manual, his leaflet telling him what to do.
    Even though, they can be wrong in their diagnosis, truly, the ssri withdrawal problem is so unique, that really, at the end of the day, it is hardly surprising that ssri withdrawal is hardly recognised.
    Back to Rxisk.
    I will continue to apply my mind, as, I am sure, we will all do, as to how a massive and crucial data-bank can offset pharma spin and deceit to the point where companies, such as GSK, for instance, are paying mind-boggling penalities and are arguing ludicrous spin and are fast becoming a laughing stock.
    The only answer to this, is litigation for the corrupters of science. Science is not about hiding data. Science is about upfront clinical trials and a man at the helm who is not hell bent on betrayal.
    Sir Witty is an out and out marketing pro; corrupt, probably, but smart, also.
    He is not a scientist, he doesn’t know what ‘selective serotonin re-uptake inhibitors’ means. He was put in his position to market a product and that is what he has done, successfully and gainfully.
    But, at the end of the day, the chief is the one who falls on his sword……

  35. David_Healy says:

    From Jacques

    “ Bias is inevitable and we should not count on researchers or docs to strive for disinterestedness. We should instead rely on the scientific method, given access to raw data, to correct the mistakes that will be introduced by the inevitable bias introduced because researchers are human beings”.

    I think that when you say this you identify a basic fact of life we unfortunately have no choice to accept and cope with. We can be mad at it, as I am mad to the fact that we as most other vertebrates, have to kill other animals to get our proteins, but I can assure you I have nothing to do with the decision to set up things this way. Admitting this does not mean I find bias is OK and a good thing. The two of us could probably easily agree on the fact that talking of bias within the context of a person who deliberately tries to take advantage of you by lying, means something different than talking of bias within the context of a person who honestly admits a number of hypothesis about the reality of things in order to make some decisions. We describe both situations with the same word probably due a common basic idea of being somewhat off target in the initial process, but the word has very different interactional, moral and emotional connotations from one context to the other, which means it means quite different things from the one to the other. On the long run, this situation implies that there is only one person one can fully trust for a final decision in life, namely ourself. Imagine living in the XVIII century and having porphyria; this happened to George the third; Dr Francis Willis convinced the English Parliament he could cure 9 out of 10 madmen and got the contract to cure the king who was going through a temporary delirium; he clapped him into a straight-waistcoat, tied his legs to the bed, raised blisters on his legs that got infected, repeatedly bled him with leeches on his temples, put strong emetics in his food (see Robert Whitaker, Mad in America.2002); in other word, he tortured him and took as much energy out of him as he could. The king went out of his delirium, as he would have anyway, and became a medical triumph. In those days, David would probably have opted for the herbalist’s rather than the doctor’s bias.

    When David asks for ideas about turning the data drops into a trickle and then a torrent, let me speak from my perspective of a clinician who daily has to take decisions about taking patients off or on medication. I would so much appreciate having at my disposal an open channel of communication with other doctors throughout the world on the adverse events they see in their patients when they are using the medication I myself use. I have the secret some hope to find something akin to this in RxISK. I probably do not realize the huge technical difficulties behind this simple idea. Can someone offer an opinion about the feasibility of such a project? In my sense this could generate a lot of interests from many doctors and create a sound community for sharing important information and eventually a torrent made of a community of persons openly talking to each other about their experiences with the drugs they use.

    Jacques

  36. I’d like to pass along a journal editorial from the Wild West world of spine surgery – the only branch of medicine I know that makes the psychiatrists look like Sunday school teachers.

    A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors: Caragee et al, Spine Journal 11 (2011):

    http://www.spine.org/Documents/TSJJune2011_Carragee_etal_Editorial.pdf

    I liked it, not just because one of the research studies they denounce appeared in their own journal. But they also acknowledge the system we have now goes beyond mere “potential” conflict of interest. At the top, it provides powerful financial incentives for some to actively harm patients and for others to look the other way. What’s at stake, the authors say, is not only the physician’s core pledge to first do no harm, but “the human right in our society to basic protections.” I don’t know how much actual change they’ll achieve – the medical device industry is at least as tough as Pharma – but at least they seemed to be taking the problem as seriously as it deserves.

    I believe what Nemeroff, some of these spine surgeons, and other top researchers have done in the service of powerful corporations does not need to be “disclosed,” “monitored” or “regulated” but outlawed—and the whole disastrous privatization of medical research in the past thirty years recognized as a crime against society. It wouldn’t solve all our problems by a long shot. (For that, we’d have to consider nationalizing the drug and device industries themselves, at least!) But if no one dares say “nationalize” at least we could fight to “de-privatize.” The market has had its chance with medical research, and it’s led us to a system that is harder and harder to separate from organized crime.

  37. I’m a little surprised at how little of this discussion has focused on what sorts of safeguards or governance systems *could* (even hypothetically, or counterfactually) allow RxISK to take money from pharma and still maintain (and be seen to maintain) its integrity and independence.

    Even if you don’t think doing so is possible, contemplating the kinds of safeguards it *would* take is a useful thought-experiment.

    So, for example, what if all pharma money came as part of a 10-year deal? What if independent audits (financial and otherwise) were written into the contract? What if…? What if companies had to pre-commit (in writing) to certain behaviours contingent on RxISK’s data analysis? Etc.

    If we can’t even *imagine* appropriate safeguards, that’s a very important acknowledgment.

    (This is something I wrote about nearly a decade ago, when I wrote “Will the ‘High Priests’ of Bioethics Work Among the Sinners?” http://www.ncbi.nlm.nih.gov/pubmed/14635634 )

    • David_Healy says:

      Chris

      Thank you for this comment – which is where I would like to see the debate going.

      Abstract from CMD paper: In this paper I explore briefly the “secular priesthood” metaphor often applied to bioethicists. I next ask: if, despite our discomfort with the metaphor, we were to embrace the best aspects of the priesthood(s)–which I identify as the missionaries’ willingness to work among sinners and lepers, at their own peril–would we be able to live up to that standard of bravery? I then draw a parallel with the fears of contagion currently be voiced (by Carl Elliott and others), with regard to bioethicists working in or near coporate settings. I argue that such fears may themselves have a number of deleterious effects, and I suggest several possible positive steps in response to that fear.

  38. There are a variety of uses to which this database can be put. One possible use is to create an extensive listing of adverse effects of drugs that is independent of industry. I can imagine the appeal of this to many who distrust pharma, but its difficult for me to see how it has a real impact in this role, as it would primarily be duplicating the efforts of the US AERS system (to which anyone can report AEs directly without going through the drug manufacturer). User friendly interfaces for this database are available from a variety of sources including AdverseEvents.com.

    I think that David had a broader vision when he put this together. All drugs have a multiplicity of effects, some of which are intrinsically harmful, but others which can be useful. A fascinating example of this was the recent publication of a paper showing that Abbott’s HIV protease inhibitor provides protection against malaria. I don’t know if this can work, but think it is worth a try.

    Many here say they don’t trust pharma. I say you don’t need to. If the database leads to new uses for existing drugs, the safety is probably there, as these will be drugs that have been on the market for several years and thus have well known and publicly accessible profiles. And they are likely to be efficacious, because no matter how much you distrust industry’s reports of efficacy outcomes, the original efficacy data is drawn from a spontaneous reporting database.

  39. David_Healy says:

    From Arthur

    David,

    I cannot agree with your claim that science thrives on bias. It sometimes succeeds despite bias but more often it fails because of bias. Despite your claim that “I have never discounted bias” you most certainly discount the importance of bias in undermining what purports to be “evidence-based science”. Or, rather, you argue that it is inevitable: you are biased, I am biased, everyone is biased, you claim. So, you invite us to conclude: let’s not worry about bias. Let’s put our trust in “science”, given access to raw data, to correct the errors of bias. So, where is the self-correction with respect to the Block Buster drugs, most of which – long after the data show their poor efficacy and their heightened dangers – continue to be prescribed and consumed by the millions? It’s wonderfully charitable of you to suggest that even Charlie Nemeroff (and Gideon Koren and Joseph Biederman and…?) can potentially contribute usefully. But if I may be permitted a less charitable thought: researchers who accept industry coin and then promote powerfully dangerous drugs to young children (and vulnerable elderly people and pregnant women) should finish their careers in prison rather than in prestigious university Chairs. “If there is no access to data, it is not science”, you write. I agree. What you seem not to acknowledge, however, is that access to data is a necessary but NOT a sufficient marker of “science”. As I mentioned a moment ago, in the course of responding briefly to Jacques, many researchers and physicians have ample access to data showing that the SSRIs and the statins (to take but two examples) are useless at best and harmful at worst for most of the patients to whom they are prescribed – but that has scarcely made a dent in sales. Even Celebrex, which should surely have been pulled from the market in 2004 when its Cox 2 twin, Vioxx, was pulled. Instead, despite the exposure of research fraud and serious risks (without compensating benefits) Celebrex remains today a massive money spinner, in Canada (and elsewhere) for Pfizer. Note well, David, we now have good adverse event data about Celebrex and Lipitor and their close relatives and still they dominate the marketplace, touted by researchers and prescribed by the millions in doctors’ offices across Canada, the USA, and Europe. In sum: access to data is absolutely necessary if patients and their physicians are to make sensible choices and access to adverse event data is especially important. We agree on that. But your cavalier dismissal of the critical role played by COI in biasing the judgement of researchers and physicians plays straight into the hands of industry and perpetuates the corruption you seek to counteract.

  40. David_Healy says:

    From Jacques

    Arthur,
    I agree with you that if RxISK accepts funding from the drug industry it will utterly discredit itself and undermine its own raison d’être. I also think you are right about the reason you state explaining why millions of prescriptions are still being written for these drugs. There is no panacea in resolving such a complex problem but I think access to data can be an efficient way to slowly modify the effect of the industry propaganda on our minds. How come do you think the industry fights so hard to keep its raw data in secrecy, to the point of taking them out of the country to escape the eye of the justice ? N.B. saying you are the only person to trust for taking final personal decision does not mean you do not consult and listen to what others have to say.
    Best, Jacques

  41. David_Healy says:

    Its a bad idea to respond to things quickly and in a rush. This response is rushed – it is also personal and not a RxISK position.

    But I am with John T and Chris M in this debate, not Arthur. (Except John under-estimates how FDA’s AERS has been turned into a machine to hide adverse events).

    The problem with Arthur’s position for me is he is treating science as just another field of enquiry and failing to pinpoint what is distinctive about that and following through on the logic. He is also failing to distinguish brand from generic pharmaceutical companies.

    Access to data is an absolutely necessary condition for science. Its what differentiates it from ethics, theology, and other areas of debate. If Pharma want to market their medicines under the banner of science – this data is critical.

    The problems Arthur says cannot stem from lack of access because we have access now and the pills are still used in huge amounts, do in fact stem from a lack of access to data on these drugs in the first instance when SSRIs and statins came on the market. Its very hard to reverse a culture that has been built over 20 years when a greater amount of access but still limited access becomes available

    Even in a world of perfect access from the start though some doctors will prescribe the latest new drug even if its not clearly all that efficacious and some patients will ask for it – both are driven by Hope – not by industry payments. Industry avail of this bias inherent in all of us – they do not create it.

    Perhaps because I have had better support from industry colleagues in terms of raising drug hazards than I have ever had from clinical colleagues, I simply cannot take the view of industry that Arthur is offering. I see industry and medicine as being caught in a system that makes the biases of individual company people and doctors close to irrelevant – see the next three blog posts – where this will be laid out in greater detail.

    Caught in this web, we have many senior industry people behaving like politicians – using words in weasel ways – an enhanced service being one that has just been closed down. And on this level you have to admire the way GSK and Andrew Witty have played the politics of data access in recent weeks.

    Its much harder to admire the doctors caught in the web. Some are caught because they are timid – see the next post – If you want to look after patients, Man Up. A small number are venal or maybe even twisted.

    The problem we have is that in the therapeutics domain we have not had science – we have marketing under the appearances of science. We in fact haven’t had a free market. We have had something close to a company controlled totalitarianism. While company control needs to be rolled back, I wouldn’t want to replace one set of masters with a set of bioethicists.

    Bioethics is in a curious position – Chris MacDonald’s paper brings this out. Its nice to have a friendly bioethicist – they are very decent people but they’re not much practical help. Some when they embrace industry as in Raul Dhanda’s Guiding Icarus become the most dangerous of the most dangerous – a bit like Eurordis – see Data Access Wars.

    What we need are doctors and patients working as teams finding their own values and hopefully finding a voice that industry both in terms of science and the marketplace (note the marketplace and marketing are different things) will have to listen to. There is no getting away from the fact that RxISK data if it is going to create a meaningful difference will be in the marketplace.

    What if you were the CEO of a major generic company, competing at present on the basis of price alone against the big branded companies. But a drug is a chemical plus information. You can produce the chemical cheaper. You can also improve the quality of the information. The problem with branded drugs is that the informational component is positively dangerous. A generic company could well produce a better quality as well as cheaper drug by allying with RxISK. Are we really saying there should in principle be no circumstances under which something like this should happen?

  42. End of the day, the FDA, MHRA have worked with the industry and it’s got us nowhere. That common link just raises eyebrows and would do so if Rxisk went down the same avenue.

    What are the benefits of accepting funding from corporations that are in and out of court every 5 minutes?

    End of the day, the likes of GSK, Lilly, Pfizer etc, have, with their products, sat back and watched people struggle and die as a result of their products/actions.

    Would Rxisk, if they were a babysitting service, accept funding from the Moors murderers?

    For so many years many people have called for an independent regulator, one without ties to the industry.

    Rxisk should choose their sponsors wisely. Opting for pharma funding would, I believe, turn people away

  43. David_Healy says:

    From Johanna Ryan:

    Dear David – I didn’t want to post this anywhere on the blog because it is too negative, and if I am off base who needs to see it? But I found the last round of postings on the “Conflicts of Interest” discussion quite alarming in terms of your/RxISK’s apparent readiness to take Pharma sponsorship and dismissal of the motives of anyone who would oppose this.

    I can’t stop thinking of “American Woman” and her experience with GSK. Thanks to your good work we know exactly how GSK treated her data: analyzed it thoroughly, made a decision, made sure it was buried. No reply to A.W. as to what she should do for her 2d pregnancy, and no chance that the public would find out what was happening to pregnant women on Paxil. Bring out the bought-and-paid-for experts to drone on about how depression causes birth defects.

    Until recently I had confidence that if she wrote in to RxISK the response would be completely different. But if RxISK becomes a partnership with one or more of the drug companies … well, what would make us believe that they have any interest in acting any differently than they did the last time she called?

    If, in fact, RxISK continued to exist at all. Because there’s only one commodity these guys want to buy, and it’s not your scientific expertise or RxISK’s data, good as both those things are. It’s your credibility – that of RxISK and especially yours personally. Of course a lot of it will be gone the moment the ink is dry on any agreement, and they’ll be quite pleased with that. Any remaining credibility they can rub on themselves for a few months in an attempt to smell better, until it is worn out. Then they kick you aside and RxISK is probably history. And the credibility? Just try to get it back once it’s gone. I really don’t think you can live that long. What a loss. What a waste. What an old familiar story.

    I hope to hell this is just a “thought experiment” that went nuclear or a flame war among academics that needs a time out. But it’s not at all clear. Is this just theoretical, or are you already out prospecting? And has anyone slowed down to look yet? Is there a RxISK body that is gonna vote on this at some point? Do they agree with you? I was hoping I could wait until after Xmas to see how this all shook out, before I resumed trying to organize any meetings here in February. But no … looks like the state Single Payer Network will be meeting tomorrow night, and I find myself completely tongue-tied as to whether I could ask them to take part in any RxISK activity whatsoever. I’m hard put to answer the question for myself. I have put some work into this project already, and am willing to work a lot harder; have leaned on my friends and called up a bunch of people I don’t know from Adam, etc. It’s all been very worthwhile, even when it doesn’t pan out immediately, and I want to keep doing it. So I really hope there are some answers soon, because as long as this cloud hovers over the whole project, everything else on the blog is pretty much meaningless.

    Help us out, will you? Soon as you think you can?

    • I agree wholeheartedly with you Johanna. First I thought it was just a debate but if Rxisk is thinking of joining hands with Pharma well that is a sell-out, a betrayal and very disappointing indeed.

      It would negate all the experiences of folk like me who have been damaged by psychiatric drugs. And it would actually seem that we have been used to further the aims of Rxisk. A stepping stone rather than a colleague.

  44. David_Healy says:

    There seems to me a fundamental problem with the way the debate is going. A number of posts say any link to pharma is instant death and as Johanna puts it my reaction to my critics is pretty extreme. Doesn’t feel like that from here – seems to me more like Arthur in particular has only one club in his bag where I concede conflict of interest is an issue but only one among many and not necessarily the primary one.

    My last comments did though seem to produce a silence that was ominous – the silence may have been because it didn’t get dropped into the biojest listserve – and then the post from Johanna turned up. So there is a perception issue at the very least.

    In the face of what I see as absolutism from Arthur (and I use Arthur as a figurehead for this side of the argument – he’s used to receiving blows like this and well able to trade them – my initial reaction is to head in the opposite direction. I also wonder if this kind of argument can only come from someone who has no dealings with the “enemy” and no idea that he’s rather like us.

    Are we saying pharma is full of evil people or maybe has a lot of evil people in it with some misguided presumably close to blind people who are there primarily because they have to earn a living? And that medicine in contrast is full of saints like Nancy Olivieri who stand up to pharma – with some unfortunate Gollums who take and are corrupted by the pharma shilling?

    Its difficult to reconcile this vision with the fact that most of the whisteblower cases that have told us all we know about pharma have come from pharma insiders. We can say they’ve been rewarded handsomely and this is why they’ve done it but for every Qui Tam or Dept of Justice case taken by someone from industry there are likely ten more that fail and the employee becomes a former employee whose life and prospects are severely compromised as a result.

    I also have the personal experience of being helped far more by industry insiders in getting the message out than I have ever been helped by clinical colleagues – in fact a great deal of the grief has come from clinical colleagues.

    I’ve had consultancies with Lilly, GSK, Janssen, Lundbeck, Pfizer, Rhone-Poulenc, Astra-Zeneca, Pharmacia & Upjohn who marketed the increasingly notorious reboxetine – and lots of other companies. I haven’t fallen off a horse since and had a Damascene conversion. I was publishing material exactly like what I write now before the first ever consultancy – which came from Lilly after I published early reports on Prozac making people suicidal.

    So I am much more inclined to believe that we are pretty much the same on either side of the fence and the problem is that we are all caught in a system. Pharmageddon tries to outline the system – it has a number of components including drug patents, prescription only status and a fetish for clinical trials. If the system is the problem, the answer lies in understanding it so that we can defuse it rather than in an almost ad hominem vilification of pharma.

    The absolutism of the vilification of pharma in some of the responses makes me want to seek nuance – does anyone see a distinction between branded and generic companies? Does anyone see any merit in stressing that a drug is a chemical plus information and that a generic company might be able to provide a better drug by providing better information and might do so through Rxisk?

    Is the problem pharma or is it industry? What about links to an insurance company? While insurance companies are in very bad odor in the US, this is much less the case in Europe. But wherever they are based, preventing adverse events is the one point where the interests of patient, prescriber and insurance company line up? So what about insurance company support for RxISK?

    The problem here may be the word support. Clearly support from a completely hands-off philanthropist would be great or convenient or simple. But this debate is not about pharma sponsorship of RxISK or support for RxISK in this sense. Its not about pharma sitting on the board of RxISK. Its about what happens to the data RxISK generates.

    RxISK is about changing things. Pharmageddon recognizes that as a book it will probably just increase the sales of drugs, as may Ben Goldacre’s Bad Pharma and anything by Arthur Shafer that endorses Evidence Based Medicine provided its publicly funded. Talking entrenches the current culture even by critiquing it.

    RxISK in contrast does something. It is an experiment. Short of changing patent law or prescription status and both making trial data available and defetishing trials, the one thing that can be done is to generate new data.

    Two things happen when this data comes into existence that are of interest. One is how pharma react and we are now watching a fascinating experiment play out – as the original blog post makes clear Pharma seem obliged to come and seek this data. There may be ways to weasel out of this – there is a distinction between solicited and spontaneous reports that companies could appeal to. But if a few years up the road if GSK’s new Pill-U-Like (thanks to SR for this) shows up as causing liver cancer and Rxisk has data showing this and Andrew Witty is called before Congress and is asked whether he accessed this information or not – he has a problem if he says no.

    I don’t know how this will play out. I’m not sure Pharma do either. So if they decide to come to RxISK and ask for the data – what do we do? Do we hand it over for free? Do we hand it over for a fee but post on the RxISK site the exact contract? Do we have a community advisory board who monitor what is being one – someone like Bob Whitaker. If Bob and other like minded people could live with it, would others?

    One of the benefits of handing the data over is this – we will then know exactly what Pharma cannot deny it has.

    This leads to the second point. At present it is a complete waste of time for any doctor or patient to report to FDA, Health Canada, TGA, MHRA or other national regulator. These regulators will never say a drug has caused a problem – until after the company signals it is going to remove it from the market. In the case of thalidomide they are still arguing the toss as to whether the drug causes phocomelia or prevents spontaneous miscarriages so that babies with this problem are borne rather than being aborted.

    I can’t speak for everyone in RxISK but the one thing I intend to do is to use the word cause in its usual sense. We have built a causality algorithm into RxISK and based on this and the quality of reports and the consistency across sites etc, I will be sticking my neck out pretty early on and saying this drug causes that.

    The fact that GSK may have bought the data won’t change that. I would welcome them saying we don’t think it does – because they may be right – but also because having a debate about the issues alerts more doctors and patients that there is an issue. This is getting GSK to do our marketing for us.

    There are two critical posts coming soon on this site – both Crusoe myths. The Shipwreck of the Singular and The Girl who wasn’t heard when she cried Wolf.

    The word myth is used here not in the sense of a falsehood as in the sense of The Face we try to put on the unknown. The advantage of a good myth in this sense is that sometimes people with quite different views find that they have the same mythic goals – just quite different ways to get there.

    And that is exactly what RxISK needs – it needs to be a society of all the talents in which very different perspectives can be brought to bear on knotty issues – knotty issues that are some of the most important problems any of us will ever face.

    So to reprise Johanna’s parting comment – Help us out will you? Soon as you think you can ?

  45. But what does Rxisk want to change things to David? We don’t want less drugs and more ECT/shock treatment and brain surgery for mental illness. What we, the people with lived experience of the psychiatric system, and survivors of mental ill health and the system, want are choices and alternatives. Some of us may want the drugs but with the correct information. And you will always need the views of the folk taking the drugs, positive and negative.

    Clinical ‘colleagues’ will be the folk administering the drugs in psychiatric settings, dealing with the patients/clients face to face. We are all in this together. But surely it’s not about conquering or vanquishing, as in many of the myths of old? Everyday life is more about the ordinary, the relationships, the listening and the supporting. While fairy tales contain something of the truth in them, wrapped up in adventures, battles and good triumphing over evil.

    And we don’t want another empire with experts and hierarchical shenanigans. There’s too much of that already in our overcrowded universe.

  46. David_Healy says:

    From Johanna

    Dear David —

    I do think you draw a rather cartoonish portrait of those who disagree with you, who are of all stripes and mostly don’t know each other. It’s not good to fall into the trap of thinking that none of your critics have any contact with the “real world”. They may simply have contact with different corners of it than yourself — corners where they learned something, just as you have. I have not been in your corner; you have not been in mine.

    Certainly as patients we have no tendency to canonize doctors — you gotta remember in my professional life I have to mess with orthopedic surgeons! Some of those guys, when they blink their eyes they go ka-ching, ka-ching. And I have no, repeat no, problem believing that many professionals working for the drug companies are decent folk caught in an indecent system, who are worth talking to and occasionally do decent things. No one minds a bit if you talk to them, and if they tell you something useful, great. I even think there’s a line between a doc who takes pharma support for a research project (possibly not doing anything wrong at all in his individual project, although I think that system is an invitation to corruption) versus a pharma “watchdog” organization which takes pharma support (probably asking for trouble, and ridiculous of them to act surprised if they find themselves mistrusted).

    I’m curious about your declaration that this would not involve pharma sponsorship or pharma involvement on the board of directors. There may be wealthy people who give money to a cause unrelated to the source of their wealth, who are willing to give it without significant strings. As a matter of fact I’ve seen that happen in the anti-death penalty movement. Certainly no one in this debate is opposed to money or insists that it come only from the purest of the pure. That, again, is a cartoon.

    However, when it bears directly on the source of their wealth the wealthy are a lot more hands-on in their giving, as we can see in the Pritzker support for Bobby Gibbons and his Center for Health Statistics. Or, face it, in many Pharma-supported research projects. There are cases where you can clearly say that he who pays the piper calls the tune (just like they did, I hope you’d admit, at the Hastings Center and the CAMH). A leading academic who agrees to sign his name to a 62-center study in which he never personally set foot in even one of the 62 centers, and is relying on company employees to prepare tables telling him what happened? That is a person who is knowingly and willfully choosing to commit fraud and to endanger patients. And is probably doing so for either heavy compensation and/or professional “advancement” beyond what he could ever dream of based on his own capacities and work.

    As for the CEO, CFO and banker above him, I see no reason to believe they care about anything but profit. As a matter of fact, that is officially their job, and if they do anything to diminish shareholder value they will be replaced. As an establishment, they have shown a clear and consistent willingness to suppress information that is vital to avoiding death and suffering for thousands of people. That’s just a fact. How to psychoanalyze them as people is someone else’s job.

    I’m also interested in knowing what RxISK’s financial needs are, and if you are at all interested in other ways of meeting them. There are so many things we can do! And so many sources of support if we can just challenge all those who sympathize to get to work.

    I am glad to hear that your vision of taking Pharma money does not include ceding Pharma control — you’ll have to allow me my opinion that it’s an ice-cream-sundae fantasy, but maybe you can prove me wrong. And if not, well, everyone’s entitled to his fantasies.

    It does not sound like you are anywhere close to inking a deal that would make me or most of your other supporters back away from being RxISK supporters.

  47. David_Healy says:

    Unfortunately we have had little or no input to this from the pharma side of the fence. One thing to make clear is RxISK is not primarily a mental health tool. The greatest number of reports to date have been from people reporting fluoroquinolone toxicity.

    Sitting here in what feels like the middle, the opposite sides of the argument look somewhat similar. Chrys M seems to be dictating what treatment has to look like for everyone just as much as GSK are. Pharma are denying access to one dataset – their opponents want to deny access to another. If forced Pharma offer controlled transparency – the opposition might contemplate something similar. Pharma celebrate controlled trials but funded by them – the opposition celebrate publicly funded evidence based medicine. Are both bowing down before the same hierarchy but with a different idol on top?

    Where has the Marian Hood spirit gone? Pharma is as splinterable as its opposition is fractured. They work the system but probably don’t fully understand it themselves. The safest room in the Nottingham area might be Robin’s right in the heart of the establishment.

    If data is generated by a grassroots group who refuse to do any kind of business with pharma, then companies and regulators can ignore it and doctors likely will too – it will sit and wither in the desert air. If data is generated and not with-held from pharma it starts ticking. If doctors use it the ticking gets louder.

    If the data generated is the kind of data that companies will do anything to suppress – so much so that they will offer access to their clinical trial data rather than engage in collecting this kind of data and making it available, does this not say something. If GSK could destroy RxISK so easily by cosying up and doing a deal, how come they haven’t made overtures already?

    No one knows what happens next. There are now hundreds of RxISK reports – having hundreds of much better quality reports than anyone else has is something that has never happened before. There are more reports than Ireland collected in over 3 years – more than Germany has. The bigger the databank grows the more interesting the situation. Potentially as interesting for governments as for pharmaceutical companies.

    • Chrys M here. I don’t accept that I’m dictating what treatment for mental distress has to look like but I am expressing concern that the neuroscientists seem poised to jump in and offer brain surgery solutions for supposed ‘mental disorder’. A term that some or even many of us don’t accept, neither do we believe in the biomedical model of mental illness.

      The issue with ECT, and I know something of this for my mother had many courses of it, against her will, in the 50’s and 60’s, also other family members, is that it doesn’t cure anything but requires maintenance doses over a period and even maybe a lifetime. People who are supporters of it even say they’ve lost chunks of their memory, bits they wanted to remember. So it’s far from ideal. And a requirement for NMD or brain surgery for mental illness is that a person has to have had 2 courses of ECT and be deemed ‘treatment resistant’. Or as I see it useless treatment that didn’t work and why blame the person for a deficient service?

      What people in psychosis or mental distress I think should have choice and alternatives to psychiatric drugs, therapeutic alternatives that aren’t like a kick in the head or even worse a probe in the brain, killing brain tissue etc. Mental distress is a whole body experience which affects the mind, it’s not a brain thing that requires surgical intervention or electrodes and shocks. In my opinion. Of course if there aren’t many choices then what is a person to do? They will be guided by their psychiatrist. Although I didn’t choose this option, preferring to take charge of my own mental health and eventually recover.

  48. Quite right, David.
    If I may make a boldish sort of statement……..kindly…
    Pharma don’t give a toss about David Healy and his books or Rxisk and it’s data.
    They are gigantic companies on a roll because no-one will stop them. It is impossible to stop them.
    All the evidence in the world will not shut down GSK, or any of the others, and all the evidence in the world will not make GSK, or any of the others, reveal what was hidden in their clinical trials.
    So, I agree, totally with David, he has created something which can go in any manner of directions and he has to dissect the stories, the comments, the reports and one day, this may lead to some sort of deal with someone or something.
    This is what sorts the men from the boys; the ability to soak up all the information given and to let the thought processes work to their zenith, by not taking rushed decisions but slowly letting the ‘history’ work itself out to a conclusion……that not only benefits patients, but prescribers, and even, pharma.
    One day the ‘trail’ will lead to a result.
    You have to think ‘out of the box’ and be a bit more philosophical.
    David is not Mephisto………….and I don’t think he is planning to be, either……..
    Sir Andrew Witty, was knighted, don’t forget, for services to industry, for making a UK company one of the largest giants in the world; he is not stupid, naive, or dumb. He is a master of the tork, and can wriggle out of most situations.
    We, of course, see through him, it is not rocket science seeing a man, succumb to abuse and fraud, so the battle for transparency goes on……
    We don’t know, at this point, whether Sirs are sires, so it is an interesting time for all of us interested in mental health………and where it is now going………….
    Without drugs half the world would be dead; it’s just whether the choice of drug was a ‘given’ or a ’cause’ of the dead…….

  49. If what we are talking about is letting drug companies have access to the data – properly anonymized I assume – then hell yeah, no problem! We are already passing it along to the FDA and Health Canada, right? As long as they don’t get control of the data (i.e. the opportunity to change it and/or keep others from seeing it) that sounds fine to me. Surely the FDA, under PDUFA, shares everything with them anyway.

    And I would not mind a bit if RxISK sells this data. Damn good idea, I say. I hope we can keep it free for consumers who want to search a couple drugs at a time. But if anyone wants the whole data-dump they should have to pay, whether it’s a drug company or an academic with a funded research project. There may even be reports we can run, and charge for, that those people would want. Reports that go beyond what’s available on RxISK. Suppose I wanted, say, a head-to-head comparison of all the oral diabetes drugs in terms of heart complaints – including only the year 2010? I should expect to pay for such a thing, and we could split the fee between RxISK and our lovely techies in Toronto who know how to extract such a report. Or even get volunteer geeks to run it.

    We will have to see who from Pharma shows up to request such things. Initially I suspect they won’t – they’ll just dismiss our data as unscientific or unverified even though it’s just as good as the FDA’s. We will have to get a bit bigger and more widely known/respected before they feel pressure to get ahold of RxISK generated data. It will be a good sign when they do.

    If we can get a PayPal button installed … might as well start asking doctors for $25 a month or $250 per year, maybe? Even if we started with an honor system and only a third of ‘em paid, that would be some income. Plus we could start soliciting donations from the rank and file user.

    Finally, HALLELUJAH! This is all light-years away from what I feared was being proposed: keeping RxISK financially afloat by getting some drug company or companies to sponsor it. Now that slightly sick feeling of the past two days has eased, I’m gonna go dig into the Xmas goodies sent us by the orthopedic surgeons. There’s no blood on them there brownies, I swear.

  50. Neil Gorman says:

    I am very happy to see this subject being discussed openly where we can all read it. I can see it is making some people uncomfortable but as long as transparency is maintained I believe these difficult subjects are essential to a project like this.

    I don’t think any sensible person thinks that the Pharma industry is full of evil people, in the same way most people understand not all bankers are financial terrorists. I am not going to defend pharma, because along with financial institutions, energy companies and the political elite, they embody most of what is wrong with western society in my opinion. But Rxisk isn’t here to fix society it is here to make medicines safer, is it not?

    Someone mentioned a civil war. I like that, it makes sense to me. So what role should rxisk play in this conflict? Should it collect data then launch evidence based rockets at Pharma until they mend their ways? I think big pharma’s Iron dome would make short work of this approach and when they are finished defending the Rxisk attacks, they will mop the floor with its credibility and leave it languishing alongside the cchr in the minds of many prescribers.

    Rxisk can’t be the armed group, the political wing or even be the amnesty international of this conflict. It needs to be the independent press, on the ground, documenting the situation and making its findings available to whoever is interested.

    My expectation is that Rxisk will paint an awful picture of some drugs, and of course Big Pharma won’t like that very much. But I expect that Rxisk may paint a positive picture of some drugs too. Surely this information would be useful to industry and if so, could it not be sold to them with a clear conscience?

    Someone said that all money spent by pharma is to enhance profit and I definitely agree with that. But the data that Rxisk gathers may enable industry to make a more honest profit. Would a safe drug not be easier to sell than a dangerous one? When thinking about pharma and rxisk, the thought of Partnership or funding sends chills up my spine. But the idea of pharma buying a service from Rxisk seems better than good.

    Of course right now they aren’t interested, but get the prescribers interested and that will change fast.
    As the data grows it should become more valuable but it will only grow if doctors start using Rxisk. That means free. It has to be free to medical professionals and the public.

    If Doctors start to value the data and services that Rxisk provides them, then pharma will value it too. If pharma start to use Rxisk data to show prescribers how good their drugs safety profile is, this will surely give Rxisk credibility with prescribers. How satisfying would it be to know that the reports you were submitting to Rxisk were helping create evidence that was shaping the direction of Big Pharma’s products.

    If Rxisk has a reputation as being an anti-pharma organisation surely it would damage its credibility among prescribers just as much as pharma funding or partnership would. Rxisk should only worry about collecting its data and sharing the results. The other parts of this civil war are for other groups to tackle. Let Cochrane, Ben Goldacre and David Healy fight the COI or the data access wars. Let the wonderful investigative journalists like Bob Whitaker expose the problems. Let Rxisk collect good quality evidence, give a voice to sufferers and give ammunition to activists and the manufacturers of safer medicines.

    It’s good to dream about what could be, where this could lead. My perfect vision would be this. Doctors’ surgeries around the world proudly display a sticker on their window saying they participate in the Rxisk Adverse event reporting scheme. Helping make medicines safer for all of us…

    In the waiting room there are some eye catching rxisk public information posters on drug safety and the importance of reporting side effects. They are the same amusing cartoons I saw in the local A&E streaming across the plasma. The pharma rep arrives at the door. He already knows this surgery use the reporting scheme. But this doesn’t scare this particular rep away, because he has a genuine Rxisk report in his hands that shows his drug has one of the best side effect profiles in its class.

    The patients sitting in the waiting room take some comfort in the fact that this surgery contributes to and supports a scheme that is trying to improve the safety of their medicines. At this surgery they have a voice, and the problems they encounter with their medications add to a greater understanding of medicine.

    The Doctor, having spoken to the rep is very pleased with the meeting. The genuine Rxisk report the rep left with him gave new evidence that suggests drug ‘A’ could solve a lot of that misery x patients were suffering. A problem he had reported to Rxisk many times and had recently been highlighted by a Rxisk bulletin. He logs onto the networking section of Rxisk and tells his colleagues the news. Some of them haven’t had a visit from that companies rep yet, but are very interested to read the report and decide to make some enquiries about this drug. And then I woke up…

    I know, it sounds almost impossible doesn’t it, but in my opinion it’s a far more realistic goal than bringing big pharma to its knees….because the reality is that just isn’t going to happen.

  51. David Healy says:

    From Johanna Ryan

    I took a look at the lore on Lady Marian. Don’t think I could fill those shoes, for the same reason I’d never be a decent poker player or trial lawyer. Just too easy to read. Not to mention no talent for archery. Marian was quite an operator! No Walt Disney princess, that’s for sure. She turned out to be a great bandit, though. And an ace negotiator.

    So in that spirit I went back over the debate on the blog. Seems like almost everyone (me included) thought it was a debate on: “Should RxISK take grants from Pharma to survive, or grow?” At least starting with post #9 (from Arthur).

    If you took it for a different debate – “Should we share our data with all comers, including Pharma? And is it OK if they pay for it?” – no wonder you were amazed at all these people jumping down your throat!

    My answers to those two basic questions are 1. Hell no! and 2. Hell yes! Which explains my confusion and stress level then, and my current mellow attitude. I notice Neal Gorman just gave the same answers. I wonder how the others would respond to a poll like that? We might find out how big a divide we do or don’t have. So before anyone on Biojest freaks out and starts saying Kaddish over David Healy – or before you throw up your hands and write any of them off as academic twits – maybe try it?

    One problem was the debate was taking place on at least two sites. The Biojest crowd may have missed a lot of what was posted on your blog, and are having debates of their own we know nothing about. I have no idea who Arthur, Jacques, etc. are, and they don’t know Fiddaman, Chrys, Annie or me. (Although it was great to hear from people like Sara Bostock, John Abramson and the Breast Cancer Action crew whom I know by their works.)

    The other problem, of course, is blisters on the hard-drive. Get me on a good rant, and pretty soon I’ve got analogies going to the Nazis, the Mafia, the FBI, prostitution, strike-breaking, Abu Ghraib, you name it. Hopefully I go back and take most of that stuff out before I hit Send – but not always. So it probably wouldn’t hurt any of us to avoid starting with “selling one’s soul” (Hi Arthur!) or “academic BS while people are dying” (I will cut Neil a little slack, as someone who’s actually lost a child). We can try anyway.

  52. David Healy says:

    From Arthur: The Conflict of Interest Debate

    David Healy mis-describes his own position.

    David writes (below): seems to me more like Arthur in particular has only one club in his bag where I concede conflict of interest is an issue but only one among many and not necessarily the primary one.

    I will start with David’s concession that “conflict of interest is an issue”. It must be pointed out, however, that this is not the position that he has defended in Pharmageddon or in his debate with me at the University of Toronto or in our lengthy correspondence over a period of years. David’s argument has consistently been that it is wrong and damaging for Pharma critics to focus on COI. On p. 261 of Pharmageddon, e.g., he describes the COI critique as “superficial” and argues that it actually “helps industry by focusing attention away from their unwillingness to allow access to the data”. Elsewhere he writes that industry loves the COI critique. [I’ll bet they do. What hooey.]

    So, far from “conceding” that COI is an important factor – one which explains the transmogrification of medical research and medical practice into industry marketing – David disparages those who argue that industry funding corrupts the integrity of medical research and medical practice. He argues that by calling attention to industry funding of research (and industry payments to researchers and doctors) one is playing into the hands of Pharma. He argues that government funding – even when channelled through independent agencies? – is at least as bad as industry funding. We have massive evidence, from Joel Lexchin and many others – of the pervasive bias introduced into research by industry funding. Where is the evidence that industry-independent funding (including funding from government funded arm’s length agencies) introduces the same pervasive bias?

    Could we have some data, please?

    Dwight Eisenhower wasn’t mistaken when he warned that the public funding of research might lead to a military-industrial complex. Eisenhower was bang on target with his warning. The underlying problem is generated by the phenomenon of industry capture of both government and of governmental regulatory agencies (such as the U.S. FDA and Health Canada’s HPB). This capture or co-optation has meant that governments can become the servants of industry and the enemy of their citizens. But the explanation for this is precisely to be found by applying the concept of COI. Top government officials regularly float between government and industry, parlaying their contacts into wonderful personal profit. That is, when they are meant to be exercising their judgement on behalf of citizens they are instead allowing their private interests (e.g., their interest in future employment with the industry they meant to be regulating) to bias their judgement and thereby to violate their public duty. Politicians/governments promote industry-friendly policies because they want/need huge political donations from industry. That puts politicians in a COI situation and it’s a powerful argument for state funding of political parties instead of private funding. The US Supreme Court’s decision in Citizen’s United, allowing so-called PACs to give unlimited anonymous funding to parties and candidates was a terrible blow to American democracy. It has made President Obama beholden to the large Wall Street investment firms (such as Goldman Sachs) and to the Health Insurance Industry and Big Pharma. Oil industry and pharma funding of the Conservatives (and Liberals) in Canada has produced the same predictable effects.

    So, those who understand the utterly corrosive effects of industry funding on research of every kind [including environmental research, food and nutrition, etc] must strive to end the dependence of universities (and research hospitals) and researchers on industry funding. If we want public science in the public interest it must be funded by public tax dollars AND those dollars should be distributed by arm’s length funding agencies and not directly by the government.

    David’s message to his colleagues (in medicine generally and psychiatry in particular) is: don’t worry about accepting funding and consultancies from the drug industry. They’re not such bad folks and are certainly no worse than governments as a source of funding. I [DH] accept such funding and numerous consultancies and although I concede that this has biased my scientific judgement I insist that this is unimportant. Bias is unimportant because, hey, we’re all biased anyway (being human) and because science is self-correcting if given access to data. David sometimes goes further and declares that bias is a positively good thing. I will pass over this claim in silence. I have discussed it in previous posts. It strikes me as absurd.

    When confronted with the fact that doctors continue to write millions of prescriptions for SSRIs and Cox 2 inhibitors (such as Celebrex) long after data have been made public that show the uselessness of these drugs, their sometimes dire side effects and the scandalous corruption of the research that floated them into block-buster status [about which I have written elsewhere], David replies: If doctors had access to the data ab initio these drugs would never have become blockbusters. Again, hooey. Doctors did have access, ab initio, to the extremely limited benefits of Vioxx and Celebrex and their serious potential CV harms and they nevertheless embraced both drugs with a passion. Ditto for the SSRIs, the anti-psychotics and virtually all of the block-busters. Doctors had access to enough data to make them sceptical; but they had esteemed colleagues from our leading universities and hospitals – KOLs, of course – to assure them that the side effects were not statistically significant and the benefits near-miraculous. The only explanation that makes sense for the behaviour of these market-place shills, masquerading as health care leaders, is COI.

    David was fired by CAMH for criticizing Prozac a few weeks before CAMH opened its Eli Lilly wing. Presumably the notorious Charles Nemeroff played a significant role, as industry’s leading tool for dominating psycho-pharmacology. Does David not recognize that when public institutions are beholden to private corporations this institutional COI can be corrosive of research integrity? Nancy Olivieri was fired by Sick Kids for insisting that she had a duty to warn parents and others that the drug she was testing might be seriously harmful to the children on whom she was testing it. Was it a mere coincidence that she was treated abominably by her hospital and her university at the same time as Apotex, the drug’s sponsor, was negotiating to give a $55 million donation to the U of T for its molecular medicine building? Or does David recognize the problem of institutional COI while he denies the importance of COI in the biasing of research?

    I am accused of “having only one club in my bag”. I want to plead guilty. “Guilty” because I do believe that until/unless we can make dramatic progress in reducing COI in biomedical research and practice, the corruption of research and practice will continue unabated. Guilty because I believe that the numerous reforms that some of my colleagues favour – many of which I favour, as well – will never be effectively implemented so long as medicine and medical research float on a sea of drug industry money. Reforms and regulations will never succeed in much more than a token manner so long as the entire system (including the government regulatory agencies, hospitals, universities, researchers, CME, medical faculties, medical journals, etc.) is suborned by Pharma money.

    Forgive me, but David’s anecdotes about industry researchers who have helped him (and clinical colleagues who have not), and his anecdotes about the possibility of finding soulful responses from Pharma executives and employees leave me cold. When I read the insider gloating in private industry emails (e.g., “they swallowed it hook, line and sinker” from Celebrex/Pharmacia/Pfizer top people after their research fraud succeeded) my reaction is that these people should be marched off to prison for lengthy sentences. Whistleblowers, of course, deserve our gratitude, praise and compensation. In fairness, I want to add that some of the most damning evidence has come to light because of David’s efforts in litigation against Pharma. How ironical, then, that his failure to connect the dots should turn him into a quasi-apologist for the industry whose villainy he has helped to expose. Stockholm syndrome?

    Ps: David repeatedly asks whether the generic industry might be an acceptable source of funding for Rxisk. As if the generic industry were not heavily dependent upon the same useless/harmful blockbuster drugs that dominate the brand name marketplace: the statins, the anti-depressants, the bone density drugs, the anti-psychotics. Generic manufacturers are not one whit more likely to fund Rxisk than the brand name companies AND if either did fund Rxisk it would only be to capture (and discredit) the project

  53. David_Healy says:

    We have some progress here. We both agree I have described Arthur’s position correctly.

    We disagree on my position.

    Here’s a critical experiment. Over 99% of doctors get paid more by their employer than they get paid by drug companies. Over 90% get paid vastly more by their employer. There are only a very few like Charlie Nemeroff for whom the figures get reversed. At a rough guess the figures on average across developed countries are something like $250K USD per annum from an employer and maybe on average $5-10K USD from drug companies.

    Arthur can’t wriggle out of this one by saying that the guys being paid more by companies are the thought leaders, the brightest etc – because they aren’t Company KOLs are second raters for the most part who drift into this position because they miss out on the big academic prizes. They are no smarter than the average doctor.

    Doctors get paid for being a prescriber. Increasingly they are in a world where pharmacists and nurses and clinical psychologists can also prescribe, and will be far cheaper prescribers for healthcare companies than doctors are. Doctors will have no brand value in this marketplace unless they speak up about the adverse effects of drugs. Unless as I’ve posted on this blog, they become scaremongers – see also professional suicide.

    If they do so, they will be led to do so out of an interest that potentially conflicts with that of their patients – professional survival. It will only be when the interests of doctors actually do conflict with those of industry, when the market really works that patients stand a chance. Because no one puts or possibly can put the interests of patients first – unless they are a saint.

    The problem we have is that doctors and patients are imprisoned in a system designed for addicts and this has played a far greater role in what happens to patients than the relative peanuts doctors have had from industry en passant.

    Arthur will no doubt be able to deconstruct this to show that i don’t understand what I’m saying.

  54. Hi Arthur! Hi David! And all you other good people. I would like to take a quick opinion poll here, which might clear up some confusion. Could you take a moment to answer these two questions, yes or no?

    1. Should RxISK take funding from Pharma in order to survive or grow?

    2. Should RxISK share its data with all comers, including Pharma? And is it OK if we charge them for it?

    I am hoping this can help us figure out what our action plan is, now, so we can get to work in as unified a way as possible. The debate on industry money vs. doctors’ prescription privileges, and which is the greater conflict of interest, is important! But maybe we will learn a bit more in practice as we see who welcomes our efforts and who tries to shut them down. Many thanks!

    PS: as indicated above, I vote NO on #1, and YES on #2.

  55. David_Healy says:

    Here’s another version of the argument above.

    If it were as easy for gifts, even little gifts as Arthur keeps stressing, to corrupt doctors, why haven’t the tobacco companies taken this approach to buying doctor’s silence on the hazards of tobacco.

    If the statins and other drugs were being marketed wildly to the entire population as over the counter remedies, does Arthur really think that doctors would not have recognized their hazards much earlier. Doctors certainly would not have been the enthusiastic advocates for inflicting them on as many people as possible as they have been.

    David

  56. The tobacco problems became too big for anyone to ignore or for paybacks to silence the voices. And anyway tobacco, cigarettes and the like, are enjoyed by all society, not just the ‘mentally ill’.

    But I suppose that psychiatric drugs are being given to society through the GP gatekeepers. Although it’s us unfortunates who were forcibly drugged and some who were kept on them for years who are the biggest losers, in terms of being inflicted on by doctors.

    Then there are those of us for whom the anti-ps and anti-ds didn’t work at all, made us flat and zombie-like, depressed and suicidal. If fortunate to survive we had to take charge of our own mental health and recover. Defying the psychiatrists, denying the labels and getting back on with our lives.

  57. From Marc-Andre Gagnon

    I must admit I did not follow the whole COI debate.

    I just want to say that I agree with David Healy that access to data should be a priority. However, I simply do not understand the idea that financial COI does not matter since we all have some bias. Financial COI participate to what Sergio Sismondo calls “the political economy of influence” in the backroom of scientific research. It is a systematic organization of influence to shape science in favor of specific corporate interests, which is different in nature than our “ordinary” bias (intellectual, political, etc.). And this systematic external influence on our bias cannot be dismissed as not really having an impact. With access to the same disclosed data, different researchers will end up with completely different interpretations based on financial COI.

    An interesting example is a study of the Mayo clinic: http://www.nature.com/scientificamerican/journal/v307/n6/box/scientificamerican1212-56_BX1.html (also below).

    From what I read of the debate, I totally agree with Arthur Schafer that financial COI creates bias in the science itself.I think my position on this is best summarized by a quote from Jerry Avorn (From Circulation, # 121):

    Before World War II, many clinical trials did not require randomization or control groups or blinding of investigators or patients, in the mistaken belief that patient selection, observer bias, or the placebo effect could never color the interpretation of whether a given treatment worked or not.

    “After all, we are astute scientific observers and would never let our own expectations or apatient’s self-report influence our judgment about how well a treatment works.”

    We now know better and understand that a trial that lacks these methodological safeguards can be fatally flawed, and its results would not be taken seriously. [...] Similarly, as recently as the 1980s, the medical profession generally ignored the potential influence of commercial ties on clinical research; rules about conflict of interest were vague, incomplete, or ignored:

    “After all, as researchers we would never allow the prospect of personal gain to distort the conduct and interpretation of our clinical studies.” We now know better, and most universities and academic medical centers enforce strict rules that prohibit those with financial interest in a given treatment from studying it in patients.

    All the best,Marc-André

  58. From Jacques Thivierge

    Last year, a friend of mine who holds an important administrative function in one of our professional medical organization and who had previously worked as a specialist for numerous years told me he had never heard about the details I was lining up in front of him as regard the Vioxx saga; and he admitted himself being flabbergasted because in those very years he was working in a cardiology environment. And so many other colleagues I met who ignored the significant details about this saga.

    When Arthur says: “Doctors had access to enough data to make them sceptical” this is theoretically correct, but the information is buried under the KOL’s messages, the industry manipulated messages found in the leading medical journals, the peer culture pressure and so on. Like it or not we live in a corporate driven world and the pharmaceutical companies are among the most financially and politically powerful of them all. What are the most powerful ones of this world most afraid of ? Of the hombre-masa’s power was Ortega Y Gasset’s prophetic answer in 1937.

    This is why I believe David Healy’s direction is the right one when he says: “What we need are doctors and patients working as teams finding their own values and hopefully finding a voice…” . The way to mobilize this group through RxISK is where I would put my money.

    Listen to what Neil Gorman has envisioned: «Doctor’s surgeries around the world proudly display a sticker on their window saying they participate in the RxISK Adverse event reporting scheme. Helping make medicines safer for all of us.” So how do I present RxISK to my colleagues for them wanting to be part of it ? From the start, with busy doctors, it’s got to be friendly user and a low time consumer. Then it has to generate clearly useful data (as available through RxISK) on a given medication. It also has to generate clear information for the patients. And a subscription campaign should be organized essentially aiming at the doctors. And I agree with Neil, that RxISK should only worry about collecting its data and sharing the results.

    Cordially

    Jacques

  59. David_Healy says:

    From Arthur

    I strongly believe that access to data is critically important and that data suppression is a moral and should be a criminal offence. Along with this, we need disinterested scientists to initiate the research project in the first place, to design the experiment, to interpret the data, to write and take responsibility for the resulting scholarly publications, and so on and so forth. I believe that widespread conflicts of interest (among researchers, institutions, regulators, journal editors, physicians) makes it extremely difficult and likely impossible to achieve any of these desiderata. Thus, eliminating COIs will be the vital necessary condition for progress towards a genuinely evidence-based medicine.

    I think that the point you now raise – that very few physician/researchers get paid more by companies than by their (university or hospital) employers – is unimportant to the point of being trivial. So what? I have had many doctors say to me something like this: “I am making $350,000 per year. Do you think that I can be bought for a free dinner, or sleeve of golf balls or first-class trip to Paris?” When they utter these words they betray the fact that all of us can be bought for much less than we think. We can be “bought” for the price of a very small gift and certainly for payments that substantially augment our salaries even if in absolute terms they are much less than our salaries, because what the industry is buying is our good-will, our friendship, our desire to reciprocate its “generosity” AND, of the course, the lovely feeling of getting some very rewarding perquisites. Physicians and researchers don’t think that they can be bought (for a sum of money less than they are already earning) because they imagine that “being bought” entails their consciously deciding to do something that they know is harmful to their patients. The key to understanding where they – and you, David – go wrong is this: bias operates mostly at an unconscious level; it operates by influencing the way we weigh the evidence. Except in a minority of cases of outright corruption, bias is an unconscious tendency to favour our own self-interest and/or an unconscious tendency to reciprocate the kindness that has been shown to us. There is very good empirical evidence for this and I would be happy to supply some of it to you if you would like to read it.

    BTW, many industry Key Opinion Leaders [KOLs] are indeed second-raters, as you say; but many are distinguished figures in medicine and medical research. They hold positions such as the Chair of the Department of Psychiatry at Harvard or Stanford or Duke. That is why the companies are so eager to buy their “services” – not their intellectual talents but their great prestige.

    Although I think that docs and researchers are ethically obliged not to put themselves in a COI situation by accepting any gifts and consultancies and speakers’ bureaux fees from Pharma, the obvious point to add is that, in the case of researchers, the most fundamental COI that arises from Pharma funding of their research is that their entire careers may be seen to hinge on continued funding and continued funding may be seen to hinge on producing results that are pleasing to the sponsor or that can somehow be spun in a positive manner. This continued funding of research by Pharma, which makes one’s career dependent upon the good will of the sponsoring company/companies, may be the most critical way in which Pharma money biases the outcome of research.

    Have I “deconstructed” your words in such a way as to demonstrate that you “don’t know what you’re saying”? I will leave that judgement to you and to others.

  60. David_Healy says:

    David

    Arthur, there are a lot of “I believes” in all this. Access to data is a norm of science – it’s not a matter of belief. Not having conflicting interests is not a norm of science. Your call is for some Garden of Eden type of science that’s never happened on Earth and never will. Disinterested scientists don’t exist – anyone who makes breakthroughs does so because they are deluded, or are paid to things they wouldn’t otherwise do and liberated by that spot things they wouldn’t ordinarily spot or for other strange reasons. When bioethicists who have never worked in a laboratory start dictating how scientists should practice, it sounds rather like Catholic priests advising people about sex.

    The other group with an interest in RxISK data are doctors – and here when you exhort them to be disinterested is in the current circumstances a recipe for professional suicide – if doctors don’t Man Up they are going out of business in soon.

    Part of my “irritation” here is that the opening post a call to tell us about RxISK data and what we should do if approached by GSK. The idea that we might be approached by GSK is somewhat academic as they have legions of lawyers who will likely be able to let them wriggle off the statute hook by claiming RxISK data is solicited rather than spontaneous and the company is only obliged to report spontaneous reports to FDA.

    But putting access to data and pharma in the same sentence seems to have triggered a Pavlovian reflex in you and produced a blanket CoI statement that’s got nothing to do with our dilemmas in RxISK.

    There are definitely studies showing that pharma sponsorship of studies is associated with for instance a penchant for a biomedical rather than a social explanation of events. But even here these studies don’t in fact prove influence on the results. However accepting that influence can have effects, what exactly is your worry re RxISK data? What exactly would influence do to adverse events? If you can get a lot more specific with your concerns, this might help us, otherwise here’s hoping for a lot of conflicting interests in 2013 – life is more interesting with than without them.

  61. David Healy says:

    From Arthur

    Dear David,

    The locus classicus for almost all contemporary discussions of the norms of science is to be found in Robert Merton’s The Sociology of Science. The key elements of scientific culture, as Merton describes them, include “disinterestedness” and “organized skepticism”. Merton claims that the soundness of scientific research should be judged by impersonal criteria, that research findings are open and shared rather than secretive or proprietary and that researchers are motivated by the pursuit of truth, rather than by financial or career self-advancement. He adds that scientific findings are accepted only after a rigorous process of testing.

    You may insist that “not having conflicting interests is not a norm of science” but in this you are, I suggest, entirely mistaken.

    Disinterestedness is a norm, an aspiration, an ideal, Merton suggests, but no one would be so naïve as to claim that it is always and everywhere achieved or that it is ever completely achieved or that its achievement does not require struggle.

    Think about it this way. Judges, like scientists, are required to be disinterested in the performance of their (legal) role. No judge can ever be completely disinterested, a critic might assert. That assertion is difficult to deny. Judges will always, to some extent, be biased by such factors as class prejudice, and much else besides. But everyone recognizes that if a judge has a commercial/financial/familial relationship with the accused (in a criminal trial) or one of the litigants (in a civil case) that judge is obliged to recuse herself – and violates professional norms if she fails to do so.

    Here’s what we know, as a result of a large body of empirical evidence: We know that when industry sponsors research the findings that reported results are dramatically more likely to favour the sponsor’s product than when research funding is industry-independent. Efficacy is exaggerated and adverse effects are underestimated. That makes industry-sponsorship a biasing factor that ought to worry anyone who cares about research integrity (and patient safety). You know all this, so the fact that it doesn’t worry you is surprising.

    As for physicians, well, again, there is massive evidence that when physicians own laboratories or imaging machines they are far more likely to prescribe these services than if they don’t stand to make an additional private profit. Virtually every medical society recognizes the importance of conflict of interest and in many place physicians are prohibited from owning laboratories or at least forbidden from sending their patients to their own facilities. Or here’s another obvious example of how the profession recognizes the importance of preventing at least some COIs. Physicians used to combine their role with that of chemists. They would prescribe medicine and then mix it up in a side room and dispense it to their patients, at a profit, of course. Why do you suppose this practice has now been (in most places) prohibited? Surely it is because both the public and the profession recognizes that, in the words of the cliché, “to a man with a hammer in his hand, everything looks like a nail”.

    These points are so simply and (I would have said) undeniably true, that your continued resistance is mystifying.

    You challenge me to explain, again, why I think that it would be ethically inappropriate for Rxisk to accept money from Pharma. I oppose the acceptance of sponsorship money/advertising/etc. because I believe that it will discredit Rxisk and will serve to legitimate researchers and institutions continuing to accept sponsorship and funding from Pharma.

    I have not said anything (yet) about the sale of data to Pharma. Do they want your data? Surely not. Do they need it? Well, if they did need your data (because, let’s say, they were required to obtain it by a regulator and could not otherwise obtain it) then there would be a strong case for selling it to them at the top price you could extract. There would also be a strong case for not having commercial dealings with Pharma, so as to avoid dependency on this revenue stream. That would mean finding alternative sources of funding. Rxisk should set a fine example to the research, medical and policy communities. Having Pharma as a client might reasonably be thought to be a bad example. (We know that regulatory agencies, such as Health Canada, become dependent for their income on Pharma money that they come to think of Pharma as their client and this obscures – when it doesn’t completely obliterate – their primary obligation to protect the health of Canadians.)

    One final observation. You have an alarming tendency to confuse COI with conflicting interests. There is a significant difference. Conflicts of interest involve a conflict between a moral/professional obligation (to truth, one’s patients, etc.) and a private interest (financial or personal). Conflicting interests involve conflicts between one of one’s private interests and another of one’s private interests (e.g., my interest in seeing an opera tonight and my interest in getting an early night’s sleep) or conflicts between one professional obligation and another (e.g., my obligation to turn in my grade sheets on time and my obligation to attend a lengthy professional meeting).

  62. David_Healy says:

    Arthur

    Great to know that the obstacles to getting you to deal with a pharmaceutical company are not in principle insuperable – in the very unlikely event that we might be approached.

    Your turn to Merton is understandable – but few laboratory or natural scientists pay any heed to him. His thinking as you outline it might apply to the human sciences where he came from. But your portrait of his thinking is somewhat misleading – the outcomes of the scientific process may indeed be disinterested but the motives of the participants aren’t.

    The key point centers on progress. The natural sciences progress and do so because things work and others can replicate claims. Replication doesn’t mean finding other people who have claimed the same thing – it means that when I take strychnine having taken activated charcoal first as per your instructions, I in fact survive. You might be the weirdest freak there is or have been entirely sponsored by Roche who now hope to bring activated charcoal on the market but if your claim can be replicated, we have a scientific fact. If you were the most disinterested bioethicist there is but advocated Buddhist meditation to manage strychnine poisoning, you would rightly end up in prison if someone followed your lead.

    This applies to anything in the real world and has done since explorers from Magellan and Cook sponsored within an inch of their lives set off to map things through to mapping of the genome by Ventner and others.

    Judges do indeed recuse themselves and I agree conflict of interest is very important in the legal domain precisely because we do not have objective ways to settle matters. But scientists never recuse themselves.

    You point out that pharma money biases the science of drug trials. It doesn’t. These are not scientific trials as such. These exercises are undertaken to get companies through a regulatory hoop. They aren’t science in their design or practice.

    But even in these exercises the primary reason companies appear to get the results they want is because the rest of us do not have access to the data – if you can write whatever you want about what the data shows you will get the results you want.

    The primary role of Health Canada is not to protect the health of Canadians. It is to ensure accuracy in the wording of drug advertisements and in so doing to perhaps make a contribution to the health of Canadians – a very different matter. It’s an empirical matter as to how much Pharma funding biases this process – but in the meantime the regulator is an easy target as by statute they cannot sue you for libel. I suspect that for the most part in so far as advertising is wrong or misleading it is because Pharma have been so innovative and play the rules to their limits that regulators simply cannot keep up.

    You paint a picture of physicians that I rather like. They can be a pretty venal bunch. But most medical discoveries I suspect came from characters like the ones you outline here rather than from more saintly guys with a more caring disposition. That being said, rather than trying to change physicians, my suggestion is our future depends on them realizing that their very survival as a profession lies in recognizing that their interests and those of pharma diverge – that if they don’t become specialists in the recognition and management of adverse events there will be no future for them. And when I say their interests diverge from those of pharma I don’t mean they put patients’ interests first, I mean they will wake up to the realization that unless they become a credible alternate voice, no healthcare provider or patient will need them.

  63. Neil Gorman says:

    This argument of access to data vs COI is very interesting, but I don’t think its that relevant to Rxisk. The two view points highlight that, true or not, there is at least a perception that both are very damaging. Rxisk should avoid both for the sake of its reputation, even if COI isn’t the real problem.

    This is from http://www.cochrane.org/about-us/commercial-sponsorship
    Which I think sums it up very nicely.

    “external perception is also important. Any perception that for-profit commercial organisations, notably but not exclusively, the pharmaceutical industry and medical device manufacturers, were influencing the conclusions of Cochrane Reviews would damage a carefully nourished reputation for impartiality and scientific rigour.”

    Sometimes it isn’t necessary to reinvent the wheel, so I think a lot of Rxisks funding strategy could be copied from the Cochrane Collaberation, (starting with a donate button). They even include a thank you list of organisations on their funding and support page that I imagine would be a good starting point for Rxisk to contact for support.

    http://www.cochrane.org/about-us/funding-support

    I understand that Rxisk is a different animal to the Cochrane Collaboration, but both organisations ultimately share the same goal. Could it be that both organisations would find support in the same places?

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