Editorial Note: This is the fourth and final post in the Trick or Treat series that started with Vampire Medicines. These posts need to be read linked to the RxISK MAP posts. These are the theoretical background. The MAP posts are the practical – what needs to be done posts.
Access to Medicines
In the 1980, we faced one of the greatest medical crises of any century – AIDs. At its height the epidemic was claiming 50,000 deaths per year in the US.
Facing the AIDS epidemic, some called on Homosexuals to change their lifestyles. But AIDS was caused by a human immunodeficiency virus (HIV) rather than lifestyle issues.
The answer lay in developing a science base and producing treatments. The treatments that emerged have arguably been the only decently effective treatments that have been developed in the last 40 years with the exception of Glivec.
One the extraordinary things about the response to AIDS was how the homosexual community embraced the stigma and mobilized around finding a cure.
Another extraordinary feature was a celebrated Access to Medicines campaign that took shape around 2000, when it became clear the greatest number of cases were in underdeveloped regions of Africa, and that these patients were being charged First World prices. Campaigners led by Bill Haddad, Jamie Love and Yussuf Hamid, working to ensure access to these life-saving treatments at affordable prices, drove the price down from from $50 per day to under 50 cents.
It was one of the greatest triumphs of the human spirit and an example of what medicine and the pharmaceutical contribution to medicine could be all about.
There is a less inspiring Access to Medicines campaign under way at present, with European politicians mobilizing to control the cost of the latest drugs to hit Western markets – drugs of much less benefit that the Triple Therapy AIDS cocktails.
Access to Real Medicines (ARMs)
Starting around 1980, a new virus emerged that has led to a new and lethal and global epidemic. One drug group alone, the opioids, now causes 50,000 deaths per year in the US.
Treatment induced drug wrecks are the leading cause of death and disability on the planet. Studies suggest treatment accounts for up to a third of deaths in hospital settings, where deaths may be caused by chemotherapy or the cardiac effects of drugs but will be put down to cardiovascular causes or cancer. The drug induced death rate can only be greater in community settings where most deaths occur and where people are less likely to have conditions that can be blamed as the cause.
As for disability rates, roughly 1 billion people are on SSRI and related antidepressants in Western settings – that’s 1 billion people with their sexual functioning disabled. If only 0.1% of these get PSSD or PGAD, that’s 100,000 people with their sexual functioning possibly eliminated forever. This is the disability toll from only one drug group and one set of problems.
Faced with a Drug Wreck epidemic, the medical establishment is playing a moral card and calling on doctors and patients to change their lifestyles – diagnose less and treat less.
The answer lies in restoring a science – adverse eventology. And in creating a climate where adverse events can be recognized and people can be got off treatments if they are maiming and killing them – something that is increasingly impossible to do at the moment.
The Drug Wreck epidemic is caused by a clinical immunodeficiency virus (CIV) whose primary mode of transmission is through major journals like BMJ, NEJM, AJP, through which it takes out the white cells of adverse event knowledge. See Vampire Medicines and Raiders of the Lost Drug Wreck.
No doctor willingly harms patients. If she dishes out drugs it’s because she has not been told about the harms, or has had them dissed. No patient would take chemicals glibly – but this is what is happening increasingly as the information needed to manage the risks linked to the chemicals we take has been steadily degraded.
The reason drugs are being dished out and taken on such a massive scale is because the harms have vanished. RCTs are one reason for this. Drugs have 100 effects. Most of them vanish in RCTs, leaving us with Vampire Medicines – actors without a shadow.
Another reason is journal funk. Our major journals are scared shitless and will not publish anything hinting at any treatment harms. Because of journals and RCTs, doctors have stopped listening to or looking at their patients – if the adverse events aren’t recognized in places like our journals it is more than a doctor’s life is worth to notice them. We might be sitting in front of our doctors but we are effectively invisible.
The hiding of harms has contributed to a growing medical nastiness, when we raise them. Faced with adverse events, some doctors get very nasty. Sensing this, and having no way to know who will and who won’t get nasty, we become increasingly nervous to mention adverse events.
Just as in 2000 the world needed an Access to Medicines campaign, we now need an Access to Real Medicines campaign. The core message of this campaign would be that a Medicine is a chemical plus information and without full access to all the information we don’t have access to the Medicine. The chemicals have always been and will always be risky. The information component has been steadily degraded since 1980 making today’s medicines riskier than the treatments we had back then.
This campaign would be about saving lives on a global basis rather than just in parts of the underdeveloped world. The wealthy of America and Europe are probably at greater risk than anyone.
Battle Plan
- Insist on access to data. No company claim to be based on science should be acceptable without access to data.
- Doctors should refuse to prescribed medicines where there is no access to the data.
- Patients should refuse to take medicines when their doctors don’t have access to the trial data.
- Restore a Poison sign to all new medicines, and all medicines without data access.
- BMJ and other journals to tell their lawyers: We are publishing harms data, among which will be case reports and articles from shady customers like Jureidini and Healy – your job is to work out how to make that happen, otherwise, although we might be a successful business, we are doing harm and may need to wind up the operation.
- Work out how to shrink the drugs regulator back to food regulator size and make doctors aware of their regulatory role.
- Before thinking about independent trials, create an independent Harms/Safety body.
- In the absence of data (Cisparency) to enable us to judge whether possible conflicts of interest have been realized, concerns about conflicts of interest (Transparency) create a counter-productive moral panic. Conflicting views are an important element of what drives science forward and should be resolved by data. Claims about conflict of interest should only feature exceptionally.
- Prepare for the day when robots that can learn take over prescribing.
You say that access to the data, not who pays for the trials, is the real problem. And I have to agree that access to the data is the heart of the matter. Here’s my question, however: As long as the companies that make the product set up and design the trials, hire and pay the contract “scientists” who conduct them, and own the results, how can “access to the data” be much more than a pipe dream?
First of all, while data ownership and control is on this level, won’t we always be left guessing as to whether important data has been held back or changed? Short of a surprise pre-dawn raid by the guys with the guns and the flak jackets, how are we to know? (And if we are planning to “shrink the regulators” as well, are individual doctors going to pull the pre-dawn raids themselves?)
Second, and even more important: Whoever designs and runs the trial determines what data is going to be collected. That’s why so many trials of SSRI’s recorded sexual dysfunction as a rare or nonexistent problem. A decision was made not to ask – so the data was never created. You can’t “access” data that doesn’t exist.
These days, when global clinical-trial companies like Covance and Quintiles coordinate the work of a hundred or more contracted trial centers, there may no longer be a piece of paper containing an unscripted record of what actually happened to the patient. The only record will be the patient’s answers to a company-selected questionnaire (or the researcher’s ratings according to a company-selected rating system), which are fed directly into a company databank.
Once you let the companies control and pay for the trials, you set the stage for a situation in which the most important data will no longer exist at all. No matter how hard I try, I can’t get around it: We have to take the process out of their hands.
Jo
Re access to the data, having been there and accessed, there is nothing mysterious about the stuff. A bunch of college students faced with a dataset would be able to work out if there was stuff missing. It doesn’t need a statistics degree or indeed any degree to work out if things are being fiddled, it just needs a bit of motivation – the kind of stuff regulators don’t have. We’re talking paper airplanes rather than rocket science.
In the meantime, doctors can refuse to prescribe. There are no on-patent drugs we need. There are enough medicines where we have the data – all drugs through to c 1990 – and medicines now off-patent like the early AIDS cocktails, that we could get by if doctors just had some backbone and asked for the data or their patients forced them to have backbone or major journals said we weren’t going to publish trials without the data.
This is an ethical and moral and perhaps legal issue – a very large number of company claims at present, are like study 329, fraudulent. Getting access to the data would change all this and all that is stopping us doing so is some form of hypnosis. The companies don’t own the data.
That said, having independent trials would also help but not as much as people think. If you’re depending on the average university academic and hospital or family doctor to run a trial without the infrastructure companies put in place – well it ain’t going to happen soon. And the next step is the that most wonderful trial ever will have little impact without a good distribution channel – which is another things companies do well.
But at the end of the day, a perfect and independent trial, done by angels, with a Bill Gates or whatever funded distribution network is worth very little. The key information about drugs comes from healthcare professionals talking to people on treatment and believing what they are told and what they see – and this is the greatest thing lacking at the moment. Access to the data from trials would help – in great part by breaking an hypnotic spell so that invisible patients suddenly reappear in front of a doctor’s eyes once again.
D
D
will it may make any difference if the regulator for medicines is moving out of UK as a result of Brexit?
nope a regulator is a bureaucrat no matter where you have him
D
Of course, now we about to have the fast track agency run by Sir Andrew Witty (you can always trust a knight).
Some years ago I wrote to the U.K. Treasury with an information request asking how much was the cost to the economy of autism. After some while they located the projected cost in a paper co-sponsored by the US Autism Speaks and the British equivalent Autistica (which increasingly sounds like a good name for the country): it was £34b annually. Of course I already knew that figure. Did the penny drop? I fear not.
Create a NO-FAULT VACCINE COMPENSATION PROGRAM FOR CANADIANS
https://www.thepetitionsite.com/882/711/468/ceate-a-no-fault…
Create a NO-FAULT VACCINE COMPENSATION PROGRAM FOR CANADIANS. by: Bob Martin; target: Petition the Canadian Federal Government and Parliament
In Ireland Regret are Challenged ..
https://www.facebook.com/notes/regret/our-story-of-social-media-abuse-the-political-culture-that-fuels-it-and-the-welf/1770758199601396/
In Canada David Carmichael for Vanessa’s Law
https://ca.news.yahoo.com/charity-declares-today-apos-know-154708897.html
A charitable organization wants Canadians to research the possible side effects and interactions of the prescription drugs they take.
Canadians for Vanessa’s Law is calling Monday “Know Your Drugs Day” in Canada.
And it is directing Canadians to a website, RxlSK, owned by a Toronto company, Data Based Medicine Americas Ltd., to get detailed information.
Young urges Canadians to become informed.
Just curious. I know data is available for short term trials, we all know the drug companies hide the negative aspects of it. But do any trials exist of long term use ? Like what happens when someone takes the poison pills then tried to get off? Is anything recorded ? In my estimation the drug wrecks are greatly increased when trying to get off the drugs, rather then start the drug. Don’t get me wrong I know it also happens often when starting the poison. But I’m just confused why a study cant be done to show how prevalent and under estimated the withdrawal symptoms are, when it seems to be such a common problem.
Data isn’t available for short term trials. The data published in journals is not the data. Its a selection of what suits the company primarily. You are right that many, perhaps most side effects occur on long term treatment and on withdrawal and there is no collection of these data
D
Isn’t it also a problem, given, as Stitch says, that many problems occur on long term use, that many patients will have been on a variety of drugs over time with, therefore, no chance of pinning one drug to a specific problem in use or on withdrawal? You can hardly list your problems and name all drugs you’ve been given can you, as each company will play off the others – an easy way out for the companies provided by a cunning plan by prescribers?
Please read my new post..
https://truthman30.wordpress.com/2017/11/21/the-creepy-corporate-capture-of-our-culture/
November 21, 2017
The Creepy Corporate Capture Of Our Culture …
Check out Russell Brand’s brilliant interview with journalist and broadcaster Jacques Peretti. Jacques Peretti discusses the macro and micro influence of corporate power in our world.
This is fascinating and essential viewing…
Under The Skin #36 Beyond Conspiracy – The Terrifying Truth Of Corporate Power
“.. Essentially Government has become a kind of a civil service for corporations…”
-Jacques Peretti
“…..The U.K. government has announced that former GlaxoSmithKline chief Sir Andrew Witty is to head up its new pathway that aims to get a handful of drugs and medical technologies to patients quicker than ever before.
The plans for the so-called Accelerated Access Review (AAR) will see Sir Andrew, once on the other side of the fence trying to get new drugs onto the market, decide which set of medications and devices can get through to U.K. patients at a much speedier rate. This also comes two months after he was hired by venture capital firm Hatteras Venture Partners; the firm tells me he will be staying on there, but did not answer questions about any potential conflicts of interest. …”
https://www.fiercebiotech.com/biotech/sir-andrew-witty-to-head-up-new-uk-speedy-drug-review-system
“….Patrick Vallance, president of research and development at the pharmaceutical giant GlaxoSmithKline, has been appointed as the Government’s chief scientific advisor.
The Government announced on Wednesday that Dr Vallance would take up the role in April next year….”
http://www.independent.co.uk/news/business/news/government-appoints-glaxosmithkline-executive-as-top-science-advisor-a8044621.html
Who is serving who?
Barely out the door of the pharmaceutical mega-beast of GlaxoSmithKline, and former GSK CEO Andrew Witty was whisked straight into a prime governmental position in the UK. Interestingly, Witty’s new job will entail heading a UK government drug fast-tracking process which is kinda handy considering his old employers -GSK (which he likely holds shares in)- are looking to fast track a new drug at the moment, and will likely need to fast track more in the future.
Does Witty’s long history and connection with GSK concern you? is it a conflict of interest which we should be worried about? Considering GSK’s unethical track record of harming patients, fraud and bribery- should Witty really be bestowed this position of influence in the UK?
Should he be in this job?
GSK are also currently under investigation with the SFO (Serious Fraud Office) in the UK, however- chillingly- none of this seems to bother those in the higher echelons on the British state.
It seems that no matter what crimes GSK has committed for decades, the executives get rewarded regardless.
How warped is that?
Alongside the bad appointment of Witty, former GSK Executive – Pat Vallance – was also appointed by the UK government into the position of their main scientific advisor. Again, should we be concerned given GSK’s unethical track record?
The press need to start asking these questions, but I won’t hold my breath. The UK press do not confront GSK, if they do it’s rare and they barely scratch the surface.
For a litany of GSK crimes- which resulted in untold harm to patients and consumers- please read GSK whistle-blower Greg Thorpe’s Department of Justice complaint (see here) from 2012, and remember folks Greg’s complaint led to GSK paying a 3 billion dollar fine for fraud. They were then caught 2 years later operating one the biggest bribery networks ever exposed in China and were fined 500 million there.
This is the tip of the ice-berg folks..
The tip of the iceberg..
Truthman
I am trying to understand what is going on here in in this perpetual gaming of the system. Vallance’s appointment is announced by the government, but Witty’s simultaneous appointment is only mentioned on an industry news site, and Witty’s appointment has possibly not been made by the government (at least technically). What is the status of AAR – a body which is both being talked about only as a future entity but for which an appointment can be made? It looks as if it does not even take an Act of Parliament to set up a body which has powers over our lives. Perhaps, it is just another agency of Public Health England (PHE). Notably, when I questioned the appointment of Andrew Pollard, the nation’s leading vaccine developer, as chair of the JCVI the Department of Health said it lay outside their remit, but was a matter for PHE. Equally, Oxford Vaccine Group, of which Pollard is chair, is another PHE agency. It looks as if Parliament has managed to set health policy adrift from its own scrutiny, and from public accountability.
I didn’t even follow the debate – if there ever was one – about the creation of PHE but you might surmise it was set up on the simple basis of enabling the industry to debauch public health without public scrutiny or sanction.
Meanwhile, BMJ have published an excellent editorial on AAR by two professors of public health from LSE (Naci and Mossialos) but have rather hidden it away, and did not publish a very low-key Rapid Response from me querying the appointment of Witty (which had not been mentioned). Indeed, so far no Rapid Responses have been published pertaining to the article and the possibility is that at least in the electronic edition almost no one knows it is there.
http://www.bmj.com/content/359/bmj.j5387
J Thebmj doesn’t publish any information about the number and the reasons why rr’s are rejected. Access to many articles is subscription only when the authors are using information collected from us/the public it should be available to us.- Open access?;Open data?;’transparency’free of influence of drugs companies when adverts are splashed all over the journal? If some one such as you, when you have been following the tangled web they weave for such a long time cannot keep up witht the shenanigans, what hope for the rest of us. In the meantime the news carries scary stories of ‘what will happen to our loved ones if you don’t take ‘your’ jabs. Very rarely any really balanced ‘stories’. In US health workers are already losing their jobs for refusing them. Big brother and big mother seem to be winning or is that too pessimistic?
I don’t know John, but if you thought that last post was a shocking indictment of just how bad things are- you should read my new one. Almost the entire house of lords in the UK have shares and/or investments in Pharmaceutical companies like GSK..
There will never be any patient rights, transparency, or ethical conduct without a profit motive, with that shocking level of obscene conflicts of interest….
And again, this is the mere tip of the iceberg in relation to Pharma’s nefarious influence on our lives…
Even I am shocked and I have been blogging for over a decade about this stuff….
https://truthman30.wordpress.com/2017/11/25/conflicts-of-interest-revolving-doors-and-the-british-lords-and-peers-with-shares-in-gsk-and-other-pharmaceutical-companies/
Dr Healy, You try so gracefully, at times pushing the boundaries of “Will I get away with this” as Dr Peter Goetszch does
Yet you are Thankfully still standing
On RTE News this evening there was an extended News piece on an investigation into Consultants in Ireland bleeding the HSE dry – For their fully well paid HSE week they do not turn up – they spend a few hours here and there and do their time at Private Hospitals whilst claiming their full HSE Salary – but what RTE fails to disclose is that when a Pharma company demands patients for clinical trials there are no waiting lists – there are no shortage of beds – even if a patient is a public patient but if that patient is a private patient – the Consultant will first take his HSE salary – then the Patient’s private healthcare and then he takes multiple Pharma payouts – this is Ireland today – with no mention of Patient abuse, torture for the Pharma industry – we are Human subjects sold out by Governments and Healthcare to satisfy the greedy satanic appetite of Pharma in their Present Day BioEngineering Trials that makes Auschwitz look like a holiday camp – Cartilage Theft – and yet the HSE Cartel leave the “subject” alive to suffer untold pain and the Gaslighting goes on – This is the Reality of Covert Clinical Trials today and if that one patient speaks up we have Irish Psychiatry to brand, label & drug into non-existence of what was one a Life!
Check out the European Health Parliament
http://www.ageofautism.com/2017/11/the-european-health-parliament-bogus-institution-is-industry-front.html
“….the European Health Parliament (which no one had heard of before) but which sounds vaguely plausible, is no more a parliament than you or I are a parliament. It does not have representatives elected by citizens, and it is not an institution of the European Union: it is an unelected body affiliated to Johnson and Johnson, Google, POLITICO, the College of Europe, the European Patients Forum (a group which receives significant funding from most of the major pharmaceutical manufacturers)and Euro40 (a group of Euro MPs under the age of 40)…”
Thanks for the info John – i would have thought it was some sub group of the ‘legitimate’ parliament. Checked out the European Patients Forum which claims to represent 67 patients’ orgs and approx 150 million patients across Europe!! Will e mail them and see how much they are willing to represent those suffering from adverse effects of psychiatric drugs – they are also requesting ideas for clinical trials – cynically but hopefully – S
Susanne
Yes, of course, very difficult to tell the difference now. The real is just as phoney. I wonder who the patients are in the “forum”?
Hi John – I looked at the site and found a whole lot of the usual banal stuff about empowerment/particiption/ aims and ethics/conferences etc which are being rehashed – there’s input from pharms of course – They may be doing some good for all I know – they seem to have loads of funds .But found a whole lot of named ‘user’ orgs which am in the middle of e mailing – will avoid wasting time using the web site form to contact the many (un-elected, as you say) Board members so the message will get to those who need it or are likely to pass it on ,which I don’t trust the unelected board members to do.as yet anyway. I have no skill at using twitter but if anybody fancies having a look there are many opportunities on their site to get the rxisk message out there.
Just sent a tweet Susanne – complementing them as being ‘listeners'(!) and asking for support for RxISK campaign.
Nice one Mary!
thank you for being there and speaking up Dr Healy
good wishes
Call to H*Arms has to rewrite and turn the Awards in to Rewards
What is totally obvious is that GMC, MHRA, NICE, PATIENT FORUMS are not allowing us to sue our doctors for negligent prescribing and allowing some us to go through tunnels of neglect where the copious drugs, the copious ignorance and the copious disregard of our feelings are not made known to anyone out with US ..
We could draw attention to an infinite number of examples known as anecdotes which sit under the radar of the puffed up – a puffed up is one whose only aim in life is self regarding importance whether giving out awards or giving out awards ..
We have the Impact Awards of GSK, we have the Awards of RCPSYCH, we have the Awards of Government and Promises but nowhere do we have the Awards for the Dead from SSRIs and associated psychotropic pills ..
We are besieged by Awards and hardly anyone spends any time giving an ounce of grace
AW is again brought under the spotlight – ‘due to the Wakefield scandal’ ..
http://www.sciencemediacentre.org/expert-reaction-to-reported-measles-outbreaks-in-leeds-and-liverpool/
And with that I yield, Game over
ARGUMENTUM AD VERECUNDIAM
http://www.auntiepsychiatry.com/Auntie%20Psychiatry.html
Hilarious!
Auntie Psychiatry definitely worth a read
D
There is a brilliant and funny book by Auntiepsychiatry as well Annie – ‘Of Course I’m Anti Psychiatry – Aren’t You?’ Cost £8.44
Have left a review on Amazon books to include a reference to RXisk – anyone can leave a review most of us seem to do it anonymously which tells a tale in itself! Novice psychiatrists and doctors and just about everyone should read it before they become paid up members of the ‘puffed up’ club.
AHRP have finally posted Vera Sharav’s very important Appendix 9 to ‘L’affaire Wakefield’ detailing the global fraud of the CDC’s vaccine policies and its lethal consequences:
http://ahrp.org/betrayal-of-public-trust-institutional-corruption-vaccine-safety-ratings-vaccine-science-falsified/
This is the link for the main text:
http://ahrp.org/laffaire-wakefield-shades-of-dreyfus-bmjs-descent-into-tabloid-science/
What a rat infested Le Carré, John, has exposed.
Quite why Fiona Godlee took the stand she did on AW/MMR is disconcertingly surprising and why she didn’t take the same stand with Study 329 by RIAT tantalisingly obscuring ..
https://www.baumhedlundlaw.com/misleading-paxil-study-exposed-in-new-bmj-study/
It has been placed where it has most effect; however ..
Petitioning class action lawyers
Have you suffered due to the use of the antidepressant Paxil (aka Paroxetine)?
Many lawyers will not go against Paxil and/or Paroxetine makers because they don’t believe that there are a large enough number of individuals who have suffered from this medication. Here is your chance to make the difference! Make it known that this is a REAL issue and it’s not something that can be ignored. This isn’t all about the money for pain and suffering, this is about change.
Making it known throughout the world what this medication has done to thousands of us.
Class Action: Paroxetine (aka Paxil) Adverse Effects
https://www.change.org/p/class-action-lawyers-class-action-paroxetine-aka-paxil-adverse-effects?recruiter=500291&utm_source=share_petition&utm_medium=twitter&utm_campaign=psf_combo_share_initial.combo_new_control_progress_sharingisfree111417&utm_term=autopublish&sharerUserId=500291
I have had the honour of interviewing dozens of people whose lives were forever changed by Paroxetine. They followed their doctor’s directions, only to see suicide, murder or some tragedy strike. The unconscionable aspect of all of this is that the victims of this drug were never warned that these ‘side effects’ could occur, mainly because of the long reach of Pharma lobbyists and executives. We seek truly informed choice before taking these powerful and sometimes mind-bending drugs.
Is that truly so unreasonable?
Kevin Miller, Cleveland, OH
16 hrs ago
Thanks for putting this here Annie. Had meant to do it myself after signing it last night but ran out of time! Also this petition below is well worth our attention I feel https://www.assembly.wales/en/gethome/e-petitions/Pages/petitiondetail.aspx?PetitionID=1235
‘Puff’ the ‘Magic’ Dragon
For Mary
https://www.youtube.com/watch?v=Y7lmAc3LKWM
Show all signatures is highly significant in the Welsh petition, Mary, skim through and see all the ‘famous names’ ..
Petition closes Tuesday, mid-day
We did put this up on Rxisk a while ago, but its definitely worth repeating.
The answers are complex, deep-rooted and tricky to excavate – a job for a creature with an elongated snout, formidable fore-claws, fearsome spirit… and a fondness for honey ants. Step forward Auntie Psychiatry.
From Susanne
There are literally thousands of people speaking out against the abuses of psychiatry and the ever increasing harms being caused globally by adverse effects of psychiatric drugs . RxISK is another group well worth reading for it’s stark messages in line with what is published in this wonderful truthful and very readable book. The message lightened by the wit allied to knowledge of how and why psychiatry is the least trusted or respected discipline Unfortunately it won’t be promoted by those who are training mental health workers –
The Ideal ‘BlueStocking’ filler ..
The essential issue underpinning clinical trials is that once a decision has been made by a pharmaceutical manufacturer to conduct a trial of a new drug, a purpose for that trial exists, and this purpose represents a pre-specified interest in the results. Inter alia, this pre-specified interest determines how trial protocols are developed, what data are to be sought, how patients are chosen to maximise the opportunity to show the new drug to advantage, how to select comparators that will show adverse performances, how to avoid monitoring and reporting of any events that could reflect adversely on the new drug, and how to manage statistical analyses to show the new drug to advantage.
That’s all true. But the single biggest factor that affects clinical prescribing is the journal article and these are written by ghosts who don’t see the data and who know others can’t see the data and check whether they are offering fair representation or not. With access and the ability to show people what the data looks like it would make a huge difference.
D