Editorial Note: This is the eighteenth post in the Persecution series, and a sequel to Dangerous Liaisons. See Brand Fascism for a listing of prior posts in the sequence.
Slightly over a week ago in New York I was subject to a blizzard of questions from a lawyer for Forest, who taking great pleasure in using the word Fucked in a deposition asked among others questions whether it was reasonable for me to compare what happens in clinical trials to Rape as was done in the Fucked post:
“you’re accusing industry of raping folks that are engaging in the consent process”.
Informed consent and women
The idea of Informed Consent came from women. It took shape in the 1950s centered on access to data about treatments in legal cases around breast cancer treatment and the use of ECT. It moved to center stage in 1965 when Harvard’s Henry Beecher published an article outlining a series of cases from the best institutions in the United States where patients were being exposed to experimental treatments or other forms of research without being aware of what was happening.
Even before this, Louis Lasagna a colleague of Beecher’s, and the first clinical pharmacologist, while based at Johns Hopkins, had introduced consent forms into clinical trials for new investigational agents. Lasagna figured that all patients taking part in an investigation of a new not-yet marketed drug produced by a pharmaceutical company should be aware that the drug was new and not yet approved – many people were simply not told this.
This led him to create the first consent forms – see above. Lasagna raised the idea of consent for drug trials in the Kefauver hearings on the pharmaceutical industry that began in 1959. But these hearings sank out of sight in a political quagmire.
Then in 1962 thalidomide struck. The politicians had to be seen to do something fast. They rushed through a set of amendments to the Food and Drugs Act that required companies to prove their drugs are effective and to do so using controlled trials. They maintained the prescription-only status for new drugs that Kefauver found problematic on so many fronts.
To top it off, for good measure they endorsed consent forms for investigational new drugs and a few years later FDA made them mandatory.
Fifty shades of grey
A good idea? Well it meant that FDA had to be involved from the very start of the very first investigation of a new drug. Partly because of that, the length of time a drug spends with FDA increased from a little over a year in the 1950s to over ten years in the 1970s. Companies were handed a stick to beat FDA with.
Industry were also handed a blank piece of paper. Once they had a chance to think about it, companies felt increasingly strongly that they had to do more to protect the rights of patients. In particular they had to make sure that patients data would remain private. The consent form evolved to include clauses telling study participants that their data would be shown to no-one other than the regulator – what we consenting adults do will remain private.
Translated into English this meant your data and our privacy will be hidden for ever.
Informed consent which was designed to inform and safeguard patients has become a key to abuse and safeguard abusers.
Legal jeopardy
It does more. If you participate in a clinical trial the new industry forms mean you put your children and your wider family and community in a state of legal jeopardy. Because they can hide the data of your experience in the trial, even if you have been significantly injured by the treatment, companies can declare there were no side effects and your invalidated experience can then be used to deny justice to someone who is injured in exactly the same way you have been.
See Clinical Trials and Legal Jeopardy – its a slow load.
When these arrangements were introduced, doctors were in charge – they ran the trials and designed the consent forms and had your data in their filing cabinets. But now groups like AllTrials supported by GSK and other companies are lobbying for restricted access to Trial data that would put you in an even worse position.
Reclaim the streets
This is not the way things have to be.
We still think we are consenting in the way we were up to about the 1970s, when a consensual exploration of the effects of drugs turned into commercial exploitation of our bodies. But we are not. This is rape.
It is happening most often in places like India and South Africa now where perhaps inhibited by political correctness – the fact that the abuse is predominantly linked to white people of Western origin – the locals have not been complaining. (Something perhaps for Jose Mario Bergoglio to think about as part of his outreach to Asia).
At a time when Britain is grappling with scandals linked to historical sexual abuse by establishment figures, UK PLC is moving toward making health service funding conditional in part on encouraging the rest of us to participate in industry linked trials, and industry are threatening to abandon the UK if the authorities don’t do more to facilitate them. (Something similar is probably true wherever you live also).
If this is not the way you think things should be, you should refuse to participate in trials. You might also consider explaining what’s going on to any one you know contemplating participating on these terms.
Another very riveting and informative post. The persecution series has certainly opened my eyes. I hope it has for others.
Thank you for your dedication to the truth.
enjoyable reading again.There I was -thinking that Alltrials were on to something good; how misguided I was! Shall look forward to your next post.
Behind every scandal is a ruthless desire to appease the perpetrator…think Seroxat.
Sounds like the lawyer for Forest is bent on discrediting Dr. Healy in an all too familiar, *The Healy Problem* fashion.
“you’re accusing industry of raping folks that are engaging in the consent process”. –
It isn’t likely that any of Forest’s lawyers would comprehend, mainly because they have no inclination to grapple with the contents of this post–not being concerned with the heinous crimes committed by his/her employer, much less realize that analogies explaining the violations perpetrated by Pharma require language that shocks our sensibilities.
As for the *informed consent* issue itself, relating to another lame excuse for withholding crucial CT data, it is probably the one issue that best exposes the absence of scientific minded forethought. It wreaks of intent to manipulate medical practice through covert deception. I find it hard to believe that some of the renowned psychiatrists who are still lurking about the Northeastern region of the U.S., are innocent victims of Pharma’s deceit. These doctors who hold tenure in leading academic medical centers in this region, did NOT flinch at any of the bells and whistles sounded by direct to consumer *disease mongering* adverts/marketing strategies, nor did they attend to the responses of their patients, which is by far the most compelling example of intent to promote an agenda that is the antithesis of academic medical practice.
Participants in clinical trials are a means to legitimize the filthiest business on the planet, and protect physicians who have raped the medical profession.
I only wish *The Healy Problem* was contagious. We desperately need an epidemic of physician’s with both moral conscience and courage.
Investigations of drugs are carried out every single time a patient agrees to take a prescribed drug . No one really knows how a drug will perform with a particular patient until they have tried it. I have to say my GPs seem to be very drug aware which is a kind of blessing. I do count myself fortunate – there are just one or two Doctors I have encountered that seem to resent any patient trying to observe side effects resulting from medicines that have been prescribed by them – they take it far too personally instead of accepting that side effects can and do happen! It’s a relief to have a Doctor actually listen to you and agree that the medicine you are /have been taking is responsible for the nasty side effects you have been experiencing instead of receiving a derisory comment.
@GX,
Not sure what you mean to say here: “Investigations of drugs are carried out every single time a patient agrees to take a prescribed drug . ”
Beyond any doubt *scientific* investigations are not conducted on the drugs – before your doctor writes your prescription – so it would be impossible for your GP to be *drug aware*–. Apparently, your GP is not informing you that you are his/her own research subject? This is something you definitely should ask your doctor about.
Do you imagine drugs are *scientifically*investigated during clinical trials– *every single time someone takes a new drug*? Not so! The data compiled on clinical trials stays in the hands of the business tycoons who hide quite of bit of evidence that their methods are unscrupulous at best– but dangerous, is more to the point. Everyone should begin asking their doctor, “Are you okay with that?”
IF the doctor presumes , like you, that a real scientific investigation with verifiable results has been documented, then he/she has no particular angst over prescribing and no pressing reason to educate his patient regarding the *experiment* they are launching together–. THIS crucial info, however, was definitely not included in the spiel you or your doctor heard about the pill you agree to swallow– so forget about *informed consent*, too. Just not within the realm of the possible — however it may be possible that your GP would welcome the chance to do his/her own *scientific* investigation of a drug that was flown under the radar of the FDA and not challenged by any academic medical *peers* along the way– all of whom have no access to the CT data.
I rather doubt that your GP has spilled the beans– that prescribing is a crap shoot. How *drug aware* do you believe your GP could possibly be, given the covert methods employed to hide the data that tells the real story about the drug you are willing to swallow at his command? You, at least, need to know, that is is risky to volunteer to test out the drugs that may have already shown potential for dangerous – even life threatening reactions– Pharma has been busted more than a few times for guarding these nasty little secrets–. Maybe you should ask your GP if she knows that the info on the *toxin* she is prescribing you has not yet been *scientifically* investigated- I would love to hear about that conversation!
Hello Sinead, sorry I meant to say that it is as if we are taking part in an experiment almost every time we take drugs prescribed to us – no one really can see how we are going to respond to a drug:) My Doctors seem to be drug aware in that they are careful about what they are prescribing and warn you of any possible dangers -:)
Hi Gx, after reading Dr. Healy’s post, you maintain that *your doctors’ seem to be *drug aware*? And they are carefully warning you about *any possible dangers* regarding the drugs they prescribe for you?
I can only assume that your doctors have top secret clearance at whichever pharmaceutical company has archived the raw data for the clinical trials of the drugs they prescribed for you. Short of that, what you are claiming is impossible.
There is absolutely, always an inherent risk to us any time we ingest a toxin. All drugs are essentially toxic, or poison– and there is an added risk of allergic reactions. But, I wonder how many instances of serious, even potentially fatal adverse effects revealed during the clinical trials of drugs , hidden away – ignored or otherwise concealed from prescribers; how many such instances need to be exposed before doctors themselves realize they are putting their patients at risk– unnecessary risk? dangerous risk?
You could just as easily argue that we are taking a risk every time we drive our automobiles. So true. But, even if you have been a safe, skilled and thoughtful driver for years, I doubt that you would consider driving while blindfolded–
Essentially– all doctors and all prescribers for that matter, regardless of skill and experience, are blindfolded when it comes to the safety and effectiveness of the drugs they prescribe— unless they are also high level Pharma insiders 😉
All of Society belonging to the ‘Humane’ are eternally grateful to Dr. Healy’s continued desire to expose the truth
Today I learned that Monsanto’s Roundup is actually altering CYP metabolism now.
The attack on mankind has to stop.
Hello Sinead, I understand that Doctors do not have all the data belonging to clinical trials at their fingertips- My Doctors quite simply refer to a book which lists known side effects of drugs – as simple as that, although I do realise it is nowhere near as simple as that – because as you say there is raw data they will never know about. They are trying as best as they can to help with the information they have at hand:) So they are trying their best to be drug aware:) I am also concerned that there will always be a possibility of something occurring which has caused/will cause a side effect and is known about through trials, yet remains hidden from the public view:) The fight for transparency continues:)
Hi Gx , why do you suppose Pharma began and continues to operate without ethics or conscience regarding the *transparency* that amounts to their refusal to conduct their business in concert with basic scientific methods? You don’t seem to recognize that taking *science* out of the marketing of drugs was/ is a very dangerous practice. Your comments seem to be reflecting complacency that is based solely on your personal level of comfort, which has an eery ring to it.
You appear to be in concert with those doctors and with Pharma themselves, all of whom demonstrate a lack of concern for the many who have been and will be harmed by what I will continue to call, heinous disregard for the most vulnerable people and total disregard for the responsibilities and duties of ALL doctors.
It is rare to encounter comments here that downplay the true significance of this issue. On the other hand, comments like yours do explain how something so fundamental to safe, conscientious medical practice has been ignored. 🙁
Hello Sinead, I am not a medical professional and am not in concert with any one – just trying to understand what the ? is going on. I only came into knowing about this site due to a massive side effect I had with a drug I was on – now as far as I can make out there is a lot more missing from the everyday nature of appointments with Doctors. I never realised about all the underground stuff that happens – I read Pharmageddon and other reports on this site and am shocked to the hilt. I look at a Doctor now and see someone who has the huge gigantic task of prescribing drugs to me that he/she probably doesn’t know the full story about.
I always was under the impression that the research behind drugs was carried out with integrity – I agree that to take the science out of marketing drugs is dangerous. I am in no way complacent – and am concerned about the vulnerability of the many . I know I am able to conduct my own appointments with Doctors in a way which makes me more aware and hopefully less vulnerable – but I don’t want to sound patronising, there are so many people who will not be able to do this for themselves and are open to all sorts of problems occurring.
By stating what my Doctor does for me I am hoping people will read my comments and realise that it is good to try to take control of your interview with your Doctor and get them to work with you. Not everyone reading this site is a Professional medical and there is a need for everyday patients to show what is happening to them. I submitted a Rxisk report and it was reported online – but it doesn’t end there and the feeling doesn’t disappear entirely that a drug I took did damage me but the drug company possibly will never know – and somewhere in their records they may have experienced what happened to me in a trial with someone else – I’ll never know. On a more positive note I always remind the Doctors what happened to me – and I won’t ever be silenced
into complacency – my attitude to taking prescribed medicines has changed forever – but there isn’t a lot else I can do:) I wish I could have written a letter to the Drug Company or done something more direct. I hope my comments on this site may help another individual in some small way:)
I feel that we must give praise to GPs where it’s due – yours, Gx, seems to be doing the best that he/she can by refering to “the book” and informing you of known side effects. Many other GPs, I am sure, do this too. What a shame that “the book” only tells them part of the truth – the part that the Pharma companies are happy to share with us – which actually is one little piece of the whole jigsaw!
“The Book”? are you referring to the Physicians Desk Reference? The PDR, as it is commonly called in the U.S.? Residents and interns may still open this giant dictionary for quick reference, though I seriously doubt it–.However,I have never seen an attending, board certified physician expend the physical energy, much less the time consuming procedure involved in looking up and reading about a drug. You may see a PDR on a shelf in your doctor’s office, but I will bet you a dollar to a donut it is covered with dust.
Doctors are way too busy to bother with this heavy, thick book that I have heard them call a cumbersome source for learning more and more about less and less, until you reach the point of knowing everything about nothing.
Doctors in my area routinely consult the online formulary published by the in- house pharmacy where they are treating patients-, or other web sites that are also accessible on the hospital’s computer server.
Just out of curiosity I did a cursory survey of *drug info* reference materials in the offices of a dozen doctors I know. Guess what? None had a current edition of the PDR; only one knew where the outdated one was kept. All claimed they occasionally used computer web sites to review *new* drugs. All had stacks of brand name folders — freebies from conferences the attended, or hand outs to support tutorials given by Pharma reps. All had their professional journals lying about , and claimed to be doing their best to prescribe drugs responsibly, given the *less than ideal circumstances*.
And finally, none have felt it necessary to become actively engaged in holding Pharma’s heel to the fire over withheld CT data; manipulating CTs to enhance the most marketable outcome for a new drug, or Ghost /writing articles for their scholarly professional journals. Aware? Oh, yes– but not pressed to rock the boat–
I thanked them all for their time, but I did not praise any of them– lest they be left thinking I, too have lowered my standards for exemplary practice by doctors in private practice.
For what it is worth, the PDR is nothing more than a compilation of the information already provided by the pharmaceutical companies themselves as package inserts–the ones stuck to the side of every bottle of prescription medicine or in every box if it comes surrounded by a box. To my knowledge, there is nothing in it that cannot be found online or, for that matter, from the drug sales reps that drop off the free samples.
Certainly there is much to be desired in how prescription drug information is disseminated (or not) and how much effort physicians make (or not) to access that information, but the Physician’s Desk Reference is not the hallowed, objective source that many of us patients have been led to believe. It was once very difficult for laypeople to obtain a copy of their own and perhaps that added to its mystique. But now you can go and download it for free at http://www.pdr.com.
It may well be that the doctors you are spying on have digital copies that they use. But either way, it is still nothing more than the information supplied by the manufacturers.
Whoops. Sorry. That would be http://www.pdr.net. Unless you need help moving your headquarters or maybe a warehouse or two..
Hello Mary, thank you , yes whilst some GPs are trying to use the information given to them to the best advantage-there seems to be a whole lot more missing from the picture – 🙂
I would like to see a copy of the consent forms given to participants in CTs of new drugs.
I would also like know IF the doctors whose names and reputations are used to legitimize the current unscrupulous, unscientific practices that are being exposed; like to know how these doctors respond to the *consent* process– especially the shady part that argues against releasing vital data from the trial to the scientific community– to maintain *participant* confidentiality.
Plenty of high profile psychiatrists to poll on this question: What is the basis for NOT seeking consent from participants to have their data released to the scientific community. This level of collusion needs to be called out–, imo.
A campaign to inform participants currently volunteering for CTs of new drugs– or new uses for drugs still on patent, makes the most sense–. An informed person, meeting criteria for a CT, could even infiltrate the *study* — draw out the consent process with pertinent questions– refuse to consent on solid grounds — and make a bit of a scene in the process– seek media attention?
Ultimately, I think that the doctors who benefit directly from being Pharma’s henchmen in the clinical trial stage have some more explaining to do– Surely, they should have a solid grasp of the NEED for thorough, scientific review of all of the
data from these CTs.
And BTW– why is it that the doctor who lends his/her name to the study and the ghost written article, is NOT answering directly for being totally ignorant of the *raw data*–
The more I ponder this consent/confidentialty issue used by Pharma to withhold patient data, the more I wonder why doctors involved in the process are not the ones to challenge and expose. After all, aren’t the Biederman’s, Ryan’s and Keller’s in this scandal really the most culpable at the end of the day?