What clinical trial results? Now you can see who isn’t sharing their findings


Not a big fan of Alltrials, however good to see that Paxil induced suicide in teens, and the controversy of Seroxat study 329 is still being referenced…

For Full article see link-

https://www.statnews.com/pharmalot/2016/11/03/clinical-trials-sanofi-shire-glaxo/


 

“…The effort prompted some drug makers to comply, although there is no uniform approach to disclosure.

Last year, however, researchers sifted through newly released GlaxoSmithKline data for its Paxil antidepressant and found evidence contradicting the company’s published findings that the pill was safe and effective for youngsters….”


“…Who else is a transgressor? Novartis did not disclose results for 201 studies, or nearly 38 percent of 534 eligible trials. And GlaxoSmithKline failed to release findings for 183 trials, or almost 23 percent of 809 eligible studies. We should note that the tracker, which includes trials completed between January 2006 and two years ago, only includes sponsors with more than 30 trials and excludes Phase 1 trials….”

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Psychiatrist Mickey Nardo’s Latest Post On GSK Study 329…


http://1boringoldman.com/index.php/2016/06/22/out-of-this-mess/

Posted on Wednesday 22 June 2016

David Healy, Jon Jureidini, Bernard Carroll, and Ben Goldacre

Some day there’ll be a best seller, a popular science book that will tell a story currently still in the making – and near the beginning the book will have a chapter about the interchange between David Healy and Charlie Nemeroff in Toronto in 2000 when Healy lost a new job because he talked about the potentially fatal side effects of SSRI [and Nemeroff, then boss of bosses] undermined his job change in retaliation. And there will be a piece about how Jon Jureidini, a pediatric psychiatrist, publicly protested a published study in 2003 that fraudulently claimed that a SSRI was safe and effective in adolescent depression. And that best-selling-author-to-be will add the efforts of Bernard Carroll and Bob Rubin in 2003 and later 2006 in exposing that same Charlie Nemeroff and others for promoting treatments they had a personal financial interest in without acknowledging those interests. Then there’s Ben Goldacre who will be cited for calling attention to the essential role of data transparency in bringing the truth to light with the AllTrials initiative, or getting at a major mechanism of deceit with his COMPare project. There will be so many more who will figure into this unfolding story. But right now, in spite of a lot of prequels, that book can’t be written because the story’s not over yet. Sure enough, there’s been progress but the main story line continues, lacking an in·place general solution…

Recently, the pioneers have been mighty busy. In September, David Healy, Jon Juriedini, and their colleagues republished the 2001 study that had become a paradigm for a jury-rigged Clinical Trial report, reanalyzing it from the original dataset using the author’s own Protocol and found that despite the earlier claims, the drug was neither effective nor safe in adolescents [Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence]. Then in March, Jon Juriedini and some other colleagues were back with another SSRIs·in·adolescents·study, this time with access to internal documents showing again how a negative Clinical Trial had been published as positive [The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance]. This study had been used as a basis for FDA Approval, and used the same technique of altering the a priori protocol – something Ben Goldacre‘s COMPare project calls “outcome switching.”

We now know that this problem of misreported Clinical Trials will never be solved so long as the raw data remains hidden. Without access to that information, we’ll never put a stop to these dark days of pseudoscience in the medical literature. But that’s not enough, because it’s the analysis of that data where the misbehavior has been centered. Today, one of those pioneers has a blog post that suggests a viable next step, a concrete general solution to the problem:
Health Care Renewal
by Bernard Carroll
June 22, 2015

There is a disconnection between the FDA’s drug approval process and the reports we see in medical journals. Pharmaceutical corporations exploit this gap through adulterated, self-serving analyses, and the FDA sits on its hands. I suggest we need a new mechanism to fix the problem – by independent analyses of clinical trials data.

When they analyze and publish their clinical trials in medical journals, pharmaceutical corporations have free rein to shape the analyses. The FDA conducts independent analyses of the data submitted by the corporations, and it may deny or delay approval. But the FDA does not challenge the reports that flood our medical journals, both before and after FDA approval. It is no secret that these publications are routinely biased for marketing effect, but the FDA averts its gaze. That failure of the FDA – a posture known as enforcement discretion – has been well documented. The question is why? At the same time, exposing the biases has been difficult for outsiders because the data are considered proprietary secrets.
This is just a teaser. The whole post is on-line. In the next section, Carrol outlines the problem using Juriedini’s latest paper as a case example then proposes a solution:
A Specific Proposal
Our primary defense against such perversions of scientific reporting is fidelity to the registered IND protocol and plan of statistical analysis. The solution is not hard to see: We need independent analyses of clinical trials because we cannot trust the corporate analyses. In effect, we need something like the Underwriters Laboratory to verify the statistical analyses of clinical trials. Nobody takes the manufacturing corporation’s word for it concerning the safety and performance of X-ray machines or cardiac defibrillators. Why treat the statistical analysis of drug trials any differently? It’s highly technical work. Who should assume that responsibility? Why not the FDA? After all, they alone see all the data. My specific proposal is for Congress to mandate that the FDA analyze all clinical trials data strictly according to the registered protocols and analysis plans. That requirement should apply to new drugs or to approved drugs being tested for new indications. It should apply also to publications reporting new trials of approved drugs. Corporations and investigators should be prohibited from publishing their own in-house statistical analyses unless verified by FDA oversight.
There follows a section on why the time to act is at hand and the potential counterarguments:
It is time for Congress to grasp this nettle. The time for enforcement discretion is past, and we need Congress either to direct the FDA to act or to create a new mechanism of oversight. To do nothing would be unthinkable.

There are other suggested solutions beginning to appear and I’ll cover some of them in subsequent blog posts. But this one comes first because it’s the one that makes the most sense to me. In all of the work that went into our Paxil Study 329 paper where my part was the efficacy analysis, I became convinced that insisting that the analyses follow the a priori Protocol and Statistical Analysis Plan to the letter is the only way to insure that the analysis is worthwhile. After we finished our paper, I went back and looked and every questionable trial I’d looked at had suspicious variables. My problem was that finding those Protocols was spotty. My hat’s off to Goldacre’s team for being able to run them down. The other ubiquitous problem was from inappropriate statistical testing. So Carroll’s proposal seems right as rain. The FDA has the capabilities to do the analyses, and already does them in many cases.

I picked the four investigators up top, not because they work together, or even necessarily agree. I picked them because each has been a central part of my own growing understanding of a way out of this mess. My way of saying “thanks!”

Update: Dr. Carroll’s proposal was cross posted on Naked Capitalism with some interesting comments.

Doctor Ben Goldacre Knows Best…


Page_1

Note to Ben Goldacre (from me):



“….Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us….”

Ben Goldacre 2012

http://www.bibliotecapleyades.net/ciencia/ciencia_industrybigpharma105.htm


“…As one of the authors of the RIAT restoration of Paxil Study 329 who was around for the whole process, I don’t actually know the answer to Leonie’s question about why it was so hard to get our paper published.

I don’t know if a Conflict of Interest had anything to do with that, but in a way, that’s the whole point – when there’s a significant Conflict of Interest, you can’t ever really know.

It’s a variable that can’t be evaluated.

So her question stands whether it can be answered or not. Should the original Study 329 report be retracted?

That’s not in our hands.

My choice would be that it should never have been published in the first place..”

(Comment by Mickey Nardo one of the authors of the BMJ published- RIAT Study on GSK’s Study 329 for Paroxetine in Adolescents on “Club 329”– David Healy’s Blog- ).



There is a fascinating debate happening over on Dr David Healy’s blog about a lecture which  Dr Ben Goldacre gave in Dublin’s Royal College of Surgeons last week. It all started when (patient activist, and blogger) Leonie Fennell (an attendee of the lecture)- published her opinion of Ben’s talk in a post on Dr Healy’s blog (titled ‘Club 329‘). The post seems to be sparking some very interesting reactions, not least from Ben Goldacre himself (who  incidentally has already accused Dr. Healy of misrepresenting his views because the post is published on Healy’s web-page).

Personally I don’t think that Leonie misrepresented Ben at all, and ironically, Ben claims that the audio of the lecture itself confirms this misrepresentation, when in fact- it does the opposite: it upholds, and confirms Leonie’s views.

You can listen to the audio here:

https://soundcloud.com/truthman-thirty/bg-11-06-2016-1333https://soundcloud.com/truthman-thirty/bg-11-06-2016-1333

Ben released it on Twitter, and I thought it might be helpful (for clarity) to cut it to the exact parts which are under debate.

The following is Leonie’s full blog post, on Dr Healy’s blog.

I will follow underneath it with some commentary.


http://davidhealy.org/club-329-part-1/#comments

Club 329: Part 1

June, 7, 2016 | 24 Comments

 


https://seroxatsecrets.wordpress.com/2012/09/22/the-drugs-dont-work-a-modern-medical-scandal-by-dr-ben-goldacre/

The doctors prescribing the drugs don’t know they don’t do what they’re meant to. Nor do their patients. The manufacturers know full well, but they’re not telling. Drugs are tested by their manufacturers, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that exaggerate the benefits.

Reboxetine is a drug I have prescribed. Other drugs had done nothing for my patient, so we wanted to try something new. I’d read the trial data before I wrote the prescription, and found only well-designed, fair tests, with overwhelmingly positive results. Reboxetine was better than a placebo, and as good as any other antidepressant in head-to-head comparisons. It’s approved for use by the Medicines and Healthcare products Regulatory Agency (the MHRA), which governs all drugs in the UK. Millions of doses are prescribed every year, around the world. Reboxetine was clearly a safe and effective treatment. The patient and I discussed the evidence briefly, and agreed it was the right treatment to try next. I signed a prescription.

But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctors and researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients’ worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn’t bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they’re too complex to capture in a soundbite. This is why they’ve gone unfixed by politicians, at least to some extent; but it’s also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all.

Now, on to the details.

In 2010, researchers from Harvard and Toronto found all the trials looking at five major classes of drug – antidepressants, ulcer drugs and so on – then measured two key features: were they positive, and were they funded by industry? They found more than 500 trials in total: 85% of the industry-funded studies were positive, but only 50% of the government-funded trials were. In 2007, researchers looked at every published trial that set out to explore the benefits of a statin. These cholesterol-lowering drugs reduce your risk of having a heart attack and are prescribed in very large quantities. This study found 192 trials in total, either comparing one statin against another, or comparing a statin against a different kind of treatment. They found that industry-funded trials were 20 times more likely to give results favouring the test drug.

These are frightening results, but they come from individual studies. So let’s consider systematic reviews into this area. In 2003, two were published. They took all the studies ever published that looked at whether industry funding is associated with pro-industry results, and both found that industry-funded trials were, overall, about four times more likely to report positive results. A further review in 2007 looked at the new studies in the intervening four years: it found 20 more pieces of work, and all but two showed that industry-sponsored trials were more likely to report flattering results.

It turns out that this pattern persists even when you move away from published academic papers and look instead at trial reports from academic conferences. James Fries and Eswar Krishnan, at the Stanford University School of Medicine in California, studied all the research abstracts presented at the 2001 American College of Rheumatology meetings which reported any kind of trial and acknowledged industry sponsorship, in order to find out what proportion had results that favoured the sponsor’s drug.

In general, the results section of an academic paper is extensive: the raw numbers are given for each outcome, and for each possible causal factor, but not just as raw figures. The “ranges” are given, subgroups are explored, statistical tests conducted, and each detail is described in table form, and in shorter narrative form in the text. This lengthy process is usually spread over several pages. In Fries and Krishnan (2004), this level of detail was unnecessary. The results section is a single, simple and – I like to imagine – fairly passive-aggressive sentence:

“The results from every randomised controlled trial (45 out of 45) favoured the drug of the sponsor.”

How does this happen? How do industry-sponsored trials almost always manage to get a positive result? Sometimes trials are flawed by design. You can compare your new drug with something you know to be rubbish – an existing drug at an inadequate dose, perhaps, or a placebo sugar pill that does almost nothing. You can choose your patients very carefully, so they are more likely to get better on your treatment. You can peek at the results halfway through, and stop your trial early if they look good. But after all these methodological quirks comes one very simple insult to the integrity of the data. Sometimes, drug companies conduct lots of trials, and when they see that the results are unflattering, they simply fail to publish them.

Because researchers are free to bury any result they please, patients are exposed to harm on a staggering scale throughout the whole of medicine. Doctors can have no idea about the true effects of the treatments they give. Does this drug really work best, or have I simply been deprived of half the data? No one can tell. Is this expensive drug worth the money, or has the data simply been massaged? No one can tell. Will this drug kill patients? Is there any evidence that it’s dangerous? No one can tell. This is a bizarre situation to arise in medicine, a discipline in which everything is supposed to be based on evidence.

And this data is withheld from everyone in medicine, from top to bottom. Nice, for example, is the National Institute for Health and Clinical Excellence, created by the British government to conduct careful, unbiased summaries of all the evidence on new treatments. It is unable either to identify or to access data on a drug’s effectiveness that’s been withheld by researchers or companies: Nice has no more legal right to that data than you or I do, even though it is making decisions about effectiveness, and cost-effectiveness, on behalf of the NHS, for millions of people.

In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we’d expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors – which have a huge interest in positive results – must have no control over the data. But, despite everything we know about industry-funded research being systematically biased, this does not happen. In fact, the opposite is true: it is entirely normal for researchers and academics conducting industry-funded trials to sign contracts subjecting them to gagging clauses that forbid them to publish, discuss or analyse data from their trials without the permission of the funder.

This is such a secretive and shameful situation that even trying to document it in public can be a fraught business. In 2006, a paper was published in the Journal of the American Medical Association (Jama), one of the biggest medical journals in the world, describing how common it was for researchers doing industry-funded trials to have these kinds of constraints placed on their right to publish the results. The study was conducted by the Nordic Cochrane Centre and it looked at all the trials given approval to go ahead in Copenhagen and Frederiksberg. (If you’re wondering why these two cities were chosen, it was simply a matter of practicality: the researchers applied elsewhere without success, and were specifically refused access to data in the UK.) These trials were overwhelmingly sponsored by the pharmaceutical industry (98%) and the rules governing the management of the results tell a story that walks the now familiar line between frightening and absurd.

For 16 of the 44 trials, the sponsoring company got to see the data as it accumulated, and in a further 16 it had the right to stop the trial at any time, for any reason. This means that a company can see if a trial is going against it, and can interfere as it progresses, distorting the results. Even if the study was allowed to finish, the data could still be suppressed: there were constraints on publication rights in 40 of the 44 trials, and in half of them the contracts specifically stated that the sponsor either owned the data outright (what about the patients, you might say?), or needed to approve the final publication, or both. None of these restrictions was mentioned in any of the published papers.

When the paper describing this situation was published in Jama, Lif, the Danish pharmaceutical industry association, responded by announcing, in the Journal of the Danish Medical Association, that it was “both shaken and enraged about the criticism, that could not be recognised”. It demanded an investigation of the scientists, though it failed to say by whom or of what. Lif then wrote to the Danish Committee on Scientific Dishonesty, accusing the Cochrane researchers of scientific misconduct. We can’t see the letter, but the researchers say the allegations were extremely serious – they were accused of deliberately distorting the data – but vague, and without documents or evidence to back them up.

Nonetheless, the investigation went on for a year. Peter Gøtzsche, director of the Cochrane Centre, told the British Medical Journal that only Lif’s third letter, 10 months into this process, made specific allegations that could be investigated by the committee. Two months after that, the charges were dismissed. The Cochrane researchers had done nothing wrong. But before they were cleared, Lif copied the letters alleging scientific dishonesty to the hospital where four of them worked, and to the management organisation running that hospital, and sent similar letters to the Danish medical association, the ministry of health, the ministry of science and so on. Gøtzsche and his colleagues felt “intimidated and harassed” by Lif’s behaviour. Lif continued to insist that the researchers were guilty of misconduct even after the investigation was completed.

Paroxetine is a commonly used antidepressant, from the class of drugs known as selective serotonin reuptake inhibitors or SSRIs. It’s also a good example of how companies have exploited our long-standing permissiveness about missing trials, and found loopholes in our inadequate regulations on trial disclosure.

To understand why, we first need to go through a quirk of the licensing process. Drugs do not simply come on to the market for use in all medical conditions: for any specific use of any drug, in any specific disease, you need a separate marketing authorisation. So a drug might be licensed to treat ovarian cancer, for example, but not breast cancer. That doesn’t mean the drug doesn’t work in breast cancer. There might well be some evidence that it’s great for treating that disease, too, but maybe the company hasn’t gone to the trouble and expense of getting a formal marketing authorisation for that specific use. Doctors can still go ahead and prescribe it for breast cancer, if they want, because the drug is available for prescription, it probably works, and there are boxes of it sitting in pharmacies waiting to go out. In this situation, the doctor will be prescribing the drug legally, but “off-label”.

Now, it turns out that the use of a drug in children is treated as a separate marketing authorisation from its use in adults. This makes sense in many cases, because children can respond to drugs in very different ways and so research needs to be done in children separately. But getting a licence for a specific use is an arduous business, requiring lots of paperwork and some specific studies. Often, this will be so expensive that companies will not bother to get a licence specifically to market a drug for use in children, because that market is usually much smaller.

So it is not unusual for a drug to be licensed for use in adults but then prescribed for children. Regulators have recognised that this is a problem, so recently they have started to offer incentives for companies to conduct more research and formally seek these licences.

When GlaxoSmithKline applied for a marketing authorisation in children for paroxetine, an extraordinary situation came to light, triggering the longest investigation in the history of UK drugs regulation. Between 1994 and 2002, GSK conducted nine trials of paroxetine in children. The first two failed to show any benefit, but the company made no attempt to inform anyone of this by changing the “drug label” that is sent to all doctors and patients. In fact, after these trials were completed, an internal company management document stated: “It would be commercially unacceptable to include a statement that efficacy had not been demonstrated, as this would undermine the profile of paroxetine.” In the year after this secret internal memo, 32,000 prescriptions were issued to children for paroxetine in the UK alone: so, while the company knew the drug didn’t work in children, it was in no hurry to tell doctors that, despite knowing that large numbers of children were taking it. More trials were conducted over the coming years – nine in total – and none showed that the drug was effective at treating depression in children.

It gets much worse than that. These children weren’t simply receiving a drug that the company knew to be ineffective for them; they were also being exposed to side-effects. This should be self-evident, since any effective treatment will have some side-effects, and doctors factor this in, alongside the benefits (which in this case were nonexistent). But nobody knew how bad these side-effects were, because the company didn’t tell doctors, or patients, or even the regulator about the worrying safety data from its trials. This was because of a loophole: you have to tell the regulator only about side-effects reported in studies looking at the specific uses for which the drug has a marketing authorisation. Because the use of paroxetine in children was “off-label”, GSK had no legal obligation to tell anyone about what it had found.

People had worried for a long time that paroxetine might increase the risk of suicide, though that is quite a difficult side-effect to detect in an antidepressant. In February 2003, GSK spontaneously sent the MHRA a package of information on the risk of suicide on paroxetine, containing some analyses done in 2002 from adverse-event data in trials the company had held, going back a decade. This analysis showed that there was no increased risk of suicide. But it was misleading: although it was unclear at the time, data from trials in children had been mixed in with data from trials in adults, which had vastly greater numbers of participants. As a result, any sign of increased suicide risk among children on paroxetine had been completely diluted away.

Later in 2003, GSK had a meeting with the MHRA to discuss another issue involving paroxetine. At the end of this meeting, the GSK representatives gave out a briefing document, explaining that the company was planning to apply later that year for a specific marketing authorisation to use paroxetine in children. They mentioned, while handing out the document, that the MHRA might wish to bear in mind a safety concern the company had noted: an increased risk of suicide among children with depression who received paroxetine, compared with those on dummy placebo pills.

This was vitally important side-effect data, being presented, after an astonishing delay, casually, through an entirely inappropriate and unofficial channel. Although the data was given to completely the wrong team, the MHRA staff present at this meeting had the wit to spot that this was an important new problem. A flurry of activity followed: analyses were done, and within one month a letter was sent to all doctors advising them not to prescribe paroxetine to patients under the age of 18.

How is it possible that our systems for getting data from companies are so poor, they can simply withhold vitally important information showing that a drug is not only ineffective, but actively dangerous? Because the regulations contain ridiculous loopholes, and it’s dismal to see how GSK cheerfully exploited them: when the investigation was published in 2008, it concluded that what the company had done – withholding important data about safety and effectiveness that doctors and patients clearly needed to see – was plainly unethical, and put children around the world at risk; but our laws are so weak that GSK could not be charged with any crime.

After this episode, the MHRA and EU changed some of their regulations, though not adequately. They created an obligation for companies to hand over safety data for uses of a drug outside its marketing authorisation; but ridiculously, for example, trials conducted outside the EU were still exempt. Some of the trials GSK conducted were published in part, but that is obviously not enough: we already know that if we see only a biased sample of the data, we are misled. But we also need all the data for the more simple reason that we need lots of data: safety signals are often weak, subtle and difficult to detect. In the case of paroxetine, the dangers became apparent only when the adverse events from all of the trials were pooled and analysed together.

That leads us to the second obvious flaw in the current system: the results of these trials are given in secret to the regulator, which then sits and quietly makes a decision. This is the opposite of science, which is reliable only because everyone shows their working, explains how they know that something is effective or safe, shares their methods and results, and allows others to decide if they agree with the way in which the data was processed and analysed. Yet for the safety and efficacy of drugs, we allow it to happen behind closed doors, because drug companies have decided that they want to share their trial results discretely with the regulators. So the most important job in evidence-based medicine is carried out alone and in secret. And regulators are not infallible, as we shall see.

Rosiglitazone was first marketed in 1999. In that first year, Dr John Buse from the University of North Carolina discussed an increased risk of heart problems at a pair of academic meetings. The drug’s manufacturer, GSK, made direct contact in an attempt to silence him, then moved on to his head of department. Buse felt pressured to sign various legal documents. To cut a long story short, after wading through documents for several months, in 2007 the US Senate committee on finance released a report describing the treatment of Buse as “intimidation”.

But we are more concerned with the safety and efficacy data. In 2003 the Uppsala drug monitoring group of the World Health Organisation contacted GSK about an unusually large number of spontaneous reports associating rosiglitazone with heart problems. GSK conducted two internal meta-analyses of its own data on this, in 2005 and 2006. These showed that the risk was real, but although both GSK and the FDA had these results, neither made any public statement about them, and they were not published until 2008.

During this delay, vast numbers of patients were exposed to the drug, but doctors and patients learned about this serious problem only in 2007, when cardiologist Professor Steve Nissen and colleagues published a landmark meta-analysis. This showed a 43% increase in the risk of heart problems in patients on rosiglitazone. Since people with diabetes are already at increased risk of heart problems, and the whole point of treating diabetes is to reduce this risk, that finding was big potatoes. Nissen’s findings were confirmed in later work, and in 2010 the drug was either taken off the market or restricted, all around the world.

Now, my argument is not that this drug should have been banned sooner because, as perverse as it sounds, doctors do often need inferior drugs for use as a last resort. For example, a patient may develop idiosyncratic side-effects on the most effective pills and be unable to take them any longer. Once this has happened, it may be worth trying a less effective drug if it is at least better than nothing.

The concern is that these discussions happened with the data locked behind closed doors, visible only to regulators. In fact, Nissen’s analysis could only be done at all because of a very unusual court judgment. In 2004, when GSK was caught out withholding data showing evidence of serious side-effects from paroxetine in children, their bad behaviour resulted in a US court case over allegations of fraud, the settlement of which, alongside a significant payout, required GSK to commit to posting clinical trial results on a public website.

Nissen used the rosiglitazone data, when it became available, and found worrying signs of harm, which they then published to doctors – something the regulators had never done, despite having the information years earlier. If this information had all been freely available from the start, regulators might have felt a little more anxious about their decisions but, crucially, doctors and patients could have disagreed with them and made informed choices. This is why we need wider access to all trial reports, for all medicines.

Missing data poisons the well for everybody. If proper trials are never done, if trials with negative results are withheld, then we simply cannot know the true effects of the treatments we use. Evidence in medicine is not an abstract academic preoccupation. When we are fed bad data, we make the wrong decisions, inflicting unnecessary pain and suffering, and death, on people just like us.

Ben Goldacre on SSRI’s (2013) : “The Side Effects Are Not Horrendous By Any Stretch Of The Imagination”…


benG

I’m really quite shocked when I read about Ben Goldacre’s views on SSRI antidepressants, and ‘mental illness’. I discovered a tweet (above) from 2013, where Ben is discussing a recent BBC Panorama series on antidepressants and birth defects. One commentator tweets into the debate and says “Why is any doctor prescribing SSRI’s? the side effects are horrendous”, he then recommends, “Exercise, Vitaman D and Melotonin”.. instead of SSRI’s, and Ben retorts with: “The side effects are not horrendous, by any stretch of the imagination, patients can be informed, and then choose’…

I seriously can’t believe that Ben doesn’t know that SSRI side effects are horrendous. If we are to take the Seroxat PIL as an example of your typical SSRI side effects, we can see that the side effects are staggering both in their amount and their frequency. Bear in mind, that these are GSK’s conservative estimates, and you can bet that pharmaceutical companies don’t give accurate readings in the PIL (they are obviously going to aim for the least alarming estimate). Even at that, the Seroxat PIL remains horrendous.

However, reading a PIL on Seroxat is one thing. Try actually being on the drug, and then try being on it for a number of years, and then try and imagine what it’s like when you experience most of these side effects over those years. Seroxat is a horrendous drug; all of the SSRI’s are. It’s all very well Ben saying that “patients can be informed, and then choose”, but when I was prescribed Seroxat, I wasn’t warned, my doctor told me nothing about side effects, absolutely nothing. I didn’t have an informed choice (and most doctors still down play side effects and patients are not informed). The PIL was also different back then, GSK were forced to change the wording on the PIL’s because the public outcry from people who had taken Seroxat in the UK was unprecedented. There was widespread condemnation of GSK. In fact, the public response was so big, that Panorama did three more documentaries about Seroxat.

This was also unprecedented in BBC Panorama’s history. And all this scandal was literally because of Seroxat’s utterly horrendous side effect profile.

The types of horrendous side effects I experienced on Seroxat included :muscle spasms, anxiety, panic attacks, suicidal thoughts, mood swings, personality changes, aggression, cravings for alcohol, dis-inhibition, mania, vivid nightmares full of violence, sleepiness then insomnia, out of character behavior, akathisa, headaches nose bleeds, blood in my stool, diarrhea, IBS, depersonalization, de-realization, bloating, nervousness, twitching, sweating, zaps…. the list goes on and on and on…

That’s just a snap shot of some of the side effects I experienced. Some days I had them all at once. Imagine that Ben! Wouldn’t that be fun huh?… Would you like to spend a few years on an SSRI like Seroxat experiencing those side effects on a daily basis? and then try withdrawal, now there’s where the side effects turn into a total horror show.

Many hundreds of thousands of people have reported similar side effects.

But Ben Goldacre says that SSRI “side effects are not horrendous by any stretch of the imagination”

First of all Ben, these side effects have nothing to to with imagination, and secondly, they are horrendous, so horrendous in fact, that I have no idea how I survived those years on Seroxat. Maybe my youth had something to do with it. Others were not so lucky, I am well aware of that.

I would like to ask Ben, has he ever seen a family member experience SSRI’s long term, or has he tried them himself, or maybe he has a friend who has experienced SSRI’s long term? If not, then he has no clue and he should really educate himself on the side effects of SSRI’s…

You can start here Ben..

This is but one forum of many:

http://survivingantidepressants.org/

and when you’re finished there, just google SSRI side effects, and you’ll see that there are thousands upon thousands of reports of horrendous side effects all over the internet, and if you couldn’t be bothered doing that, just look in the PIL’s – they are horrendous enough..

http://www.tv3.ie/xpose/article/entertainment-news/173020/Leslie-Ash-feels-really-awake-after-quitting-antidepressants

“Leslie Ash feels ‘really awake’ after quitting anti-depressants”

It wasn’t until recently that she stopped taking medication

I don’t like them, because they don’t let you finish your conversation or finish your sentence even.

You have big bits of your life missing and so I really wanted to get off them and I’ve taken quite a long time to get off them because it’s not something you can just suddenly come off and I feel really awake now, it’s brilliant.”


http://www.cbn.com/cbnnews/us/2014/August/Ben-Stein-Anti-depressants-Gave-Me-Suicidal-Thoughts-/

“…But Stein said those drugs played a dangerous role in his personal battle with depression. He said the closest he came to actually taking his own life were the times he was taking anti-depressants….”

“…And then within the last several years, a drug called Wellbutrin, which is a well-known anti-depressant was prescribed to me and it actually worked quite well for about two weeks. And then I felt an overwhelming compulsion to commit suicide and I stopped taking it and it went away,” Stein said…”

“Unless there’s some gigantic breakthrough I’m unaware of, I would never think of touching anti-depressants again.

Ben Goldacre… Running With The Pharma Hares (Or Whores?) And Hunting With The Hounds..


Beng

“…Now it is unfair to say that if Ben Goldacre didn’t exist, Andrew Witty, the CEO of GlaxoSmithKline, might have had to invent him.”..

http://davidhealy.org/not-so-bad-pharma/


https://en.wikipedia.org/wiki/David_Nutt

Professor Nutt worked as an advisor to the Ministry of Defence, Department of Health and the Home Office.[9] He served on the Committee on Safety of Medicines where he participated in an enquiry into the use of SSRI anti-depressants in 2003. His participation was criticised as, owing to his financial interest in GlaxoSmithKline, he had to withdraw from discussions of the drug Seroxat.[31


Ben Goldacre really gets on my wick.

He runs with the hares and hunts with the hounds, and that grates on me.

His recent tweet made my blood boil, but I’m not going to get too deep into it now, it’s a post for a another day (and I am supposed to be on a break), but what I will say is, I used to dismiss comments on other blogs about Ben Goldacre being some sort of shill for the pharmaceutical industry, but having observed him the last few years, I’m really not so sure anymore…

His recent promotion of Prof David Nutt’s utterly reductive and unhelpful comments on SSRI’s is enough to cause alarm to anyone who knows that these drugs can be harmful. The truth about these drugs is now widely accepted amongst many in David and Ben’s profession: These drugs can be seriously dangerous and damaging, and in some cases they can cause death. That’s a fact. A well established fact.

David Nutt has been pushing his pro- SSRI agenda for years, and most of what he sprouts is misinformation.

The Seroxat Secrets blog has been drawing attention to Nutt’s bullshit for years. Nutt has done work for nearly every pharmaceutical company, and he even apparently has (or had) shares in Glaxo! And this is a guy who is supposedly considered a key opinion leader on mental health issues and SSRI’s?

Gimme a break…

If Ben agrees with Nutt, then Ben clearly sees no wrong in Seroxat, GSK or the blind promotion of SSRI’s..

If he is of David Nutt’s ilk where these issues are concerned then he just cannot be a genuine patient advocate.

Ben might not be a shill (as many claim) but he certainly is not on the side of patients, and definitely not on the side of those who have been injured by defective pharmaceutical drugs. He speaks a lot about ‘unpublished trials’ but little about the devastating effects that defective drugs like Avandia, Vioxx, Seroxat and Zyprexa have on those who suffer serious adverse reactions.

Any morsel of respect I might have had for him gets less so the more I delve into what he really thinks..

This article (quoting David Nutt), about Statins and SSRI’s, that Ben promoted on his blog, does a shameful disservice to anyone who has been harmed by SSRI’s. Furthermore, I reckon a good percentage of Ben’s readership (of Bad Pharma etc) were likely suspicious of industry already and many of them probably think Ben is on the good side of the debate because Ben presents himself as an ‘industry critic’, however I don’t believe that Ben is sincere in that regard.

His Alltrials agenda (however well intentioned it may seem) is going to give Big Pharma even more power, and sway.

How?

Read Healy’s take on it here, and find out.


http://www.theguardian.com/science/sifting-the-evidence/2015/jul/31/the-drugs-work-public-lecture-in-bristol

David (Nutt) believes there is still a great deal of stigma around mental health, which is why sensationalized headlines are still written. The suffering associated with a diagnosis of depression is not valued in the same way as, for example, that of a heart attack, and David believes that by perpetuating the idea that depressed people don’t need medication, their suffering is devalued further.

If the quote above is a clear reflection of what Ben himself thinks about Depression and medication then it’s obvious to me why Ben is not a sincere patient advocate. The pharmaceutical industry and psychiatry have stigmatized people with labels like depression for decades, and patients were further duped by nonsense such as chemical imbalances theories, and the medication for life angle etc. Those with ‘mental’ disorders under any kind of psychiatric regimen, or medication regime, have been treated appallingly for decades. If this is the type of article that Ben endorses then he clearly agrees with Nutt and is completely on the side of biological psychiatry.

However, he is shifty, because, he doesn’t just come out and give his views clearly, he relies on promoting these kinds of articles in order to articulate his own opinions without having the balls to actually say them himself. He refuses to debate with mental health awareness activist bloggers ( and ex-SSRI users) like me, and he uses his popular persona to spread these misinformed (and dangerous) ideas. It is quite clever really, you have to hand it to him, he has a lot of people fooled..

“…But are SSRIs dangerous? David discussed a recent spate of lawsuits regarding the harms from overdosing on SSRIs. However, evidence from the UK Office of National Statistics suggests that the older tricyclic depression medications are far more harmful, but continued to be prescribed due to the confusion in the public mind about the harms of SSRIs, potentially leading to unnecessary deaths…”

If Ben agrees with Nutt here about SSRI’s being confused with Tricylic’s in the public mind then he is even more disingenuous than I thought, and if these views are similar to Ben’s views then it doesn’t surprise me that he was so condescending and dismissive of my previous attempts to engage with him about Seroxat. The SSRI’s are just as harmful as the Tricylics, and in many ways they are more harmful. I’d like to see Ben debate Prof David Healy or Prof Peter Gotzsche  on these issues, but Ben wouldn’t have the balls to do that because he’s too busy self promoting, and running with the hares and hunting with the hounds.

Pick a side Ben, grow some balls, and start giving your readers, and patients, the respect they deserve..

Promoting the rubbish views of the quack Prof David Nutt is an insult to depressed patients and those who have been prescribed toxic SSRI’s…

Of course Ben will just react to a blog post like this with some attack on David Healy, and draw attention to Healy’s past work for Pharma. Healy did do some work for Pharma early in his career, but when he saw how they were hiding trials, which resulted in killing patients, he decided to speak out and stake his career on speaking his mind (that’s a sincere and true patient advocate, something Ben is clearly not).

I know which side Healy is on, with Ben, it’s not so transparent, actually it’s far from clear where Ben is concerned. His positions on issues of patient harm from pharmaceutical drugs are extremely unclear, which is ironic considering all Ben bangs on about lately is ‘transparency’ (which is another post for another day too).

If Ben is the patient advocate that he claims to be then why not debate me, or Bob Fiddaman, or Leonie Fennell, or Prof David Healy, or any number of people who have experiences of SSRI’s, psychiatry and corruption in the pharmaceutical industry? Why not engage with us? Let’s have a recorded debate Ben, with today’s technology we could do it from our laptops…

https://seroxatsecrets.wordpress.com/2008/03/01/seroxat-does-not-work-in-majority-of-depressed-patients-says-latest-study-prof-nutt-disagrees/

Seroxat does not work in majority of depressed patients says latest study – Prof Nutt disagrees

Seroxat does not work in majority of depressed patients says latest study – so writes The New Scientist – old news you might think: The antidepressant Prozac and related drugs are no better than placebo in treating all but the most severely depressed patients, according to a damaging assessment of the latest generation of antidepressants. SSRIs, or selective serotonin reuptake inhibitors, were supposed to revolutionise care of depression – by treating symptoms without the side effects of older drugs, such as tricyclics. But despite selling in vast quantities, a new meta-analysis of these drugs, from data presented to the US Food and Drug Administration (FDA), appears to suggest that for most patients they do not work. A previous study had indicated that the benefits of antidepressants might be exaggerated. UK and US researchers led by Irving Kirsch of Hull University, UK, studied all clinical trials submitted to the FDA for the licensing of the four SSRIs: fluoxetine (Prozac), venlafaxine, nefazodone, and paroxetine (Seroxat or Paxil), for which full datasets were available. They conclude that, “compared with placebo, the new-generation antidepressants do not produce clinically significant improvements in depression in patients who initially have moderate or even very severe depression”.

However not everyone agrees with these new findings – in the UK, Professor David Nutt has been speaking out against the Kirsch study – using reasoned, scientific argument: “Anti-depressants work in clinical practice,” says Nutt. “Everybody knows they work.” And there’s more – he says the study [Kirsch] itself is rubbish. He says failed drug trials often remain unpublished because their design is shoddy or their results uninteresting. He criticises the PLoS paper as a “mishmash of quality trials and lousy trials leading to a false criticism of these drugs”, which he maintains do help those with depression even if their effectiveness falls below the NICE’s “arbitrary” threshold

Dr Nutt thinks it is misleading to compare these drugs with placebos, since what matters is that they work when compared with some alternatives, such as “talk therapy”, for which he believes there is even less evidence of effectiveness. And still he goes on: “There is good evidence of antidepressant efficacy from other types of studies, especially relapse prevention, which show significant benefit over placebo.”

I wonder why David Nutt takes this point of view? Maybe the answer lies here – Professor Nutt has acted as a consultant to Pfizer, GSK, MSD, Novartis, Asahi, Organon, Cypress, Lilly, Janssen, Lundbeck, Wyeth. He has speaking honoraria (in addition to above) with Reckitt-Benkiser and Cephalon. Grants or clinical trial payments from MSD, GSK, Novartis, Servier, Janssen, Yamanouchi, Lundbeck, Pfizer, Wyeth, Organon. He has shares in GSK (ex-Wellcome). Professor Nutt also promoted Seroxat at Glaxo’s launch of Seroxat for “social anxiety disorder”. Conflict of interest, David? More about Nutt and adult ADHD here.,


Ben Goldacre Thinks “Andrew Witty Is A Good Guy”…


bengoldacre

“…I think Andrew Witty, the current head of GSK, is a good guy, and I discuss this at length in the afterword of Bad Pharma: because I don’t realistically think that we can rely on one person in one company being nice, as a strategy to address ongoing regulatory failure in a global $600bn industry where lives are at stake...”

Ben Goldacre, October 11th, 2012

(243 Pages Of GSK Crimes Detailed In The Us Dept Of Justice Whistleblower Complaint)

The quote above, from Ben Goldacre never ceases to astound me, not least because Ben said it (in Oct/Nov 2012) after GSK were fined 3 Billion in the US for decades of misconduct and fraud (in July 2012). This unethical and immoral behavior by GSK led to tens of thousands of patients being killed, damaged and harmed. Andrew Witty presided over this (whitewash) ‘deal’ with the department of Justice, Andrew Witty was the top man at GSK at the time. Witty has also worked for GSK for all of his adult life (straight out of university into management apparently). This wasn’t a ‘different era’ Ben, Witty has been with GSK since 1985, Andrew Witty IS THE ERA…

Does Ben seriously believe that Witty had absolutely no idea of the scope of off label prescribing, corruption, hidden data and trials, bribery, and just general skullduggery and shenanigans which GSK have been involved in for decades? Does Ben seriously think that Witty climbed the corporate ladder at GSK for 25 years without coming across any of the bad behavior detailed in the hundreds of pages of crimes in the department of justice complaint? Does Ben think that Witty knew nothing? It’s just not realistic to believe that is it? It’s just not..

If you’re reading this Ben, I urge you to read the Department of Justice complaint, brought about initially by whistleblower Greg Thorpe. I have had direct contact with a few GSK Whistleblowers myself over the past years, and if these ‘low level’ employees (drug reps) were aware of multitudes of examples of off label prescribing, fraud, corruption of doctors, and harm to patients, during their time at GSK (the same years as Witty), then are we seriously supposed to believe that the ones at the top of the GSK food chain were unaware? It’s just not plausible to believe that they didn’t know what was going on, in fact it’s more credible to think that perhaps they instigated, and directed, much of the various fraudulent schemes which are detailed in the department of justice complaint, isn’t it? It’s much more plausible to think that this criminal behavior was company policy, because let’s be real here, the drug reps, and marketing departments, don’t work independently of the top executives do they? They are told what to do by their superiors, and Witty has had various high profile roles in GSK even before he became CEO therefore it would be safe to assume, that after 25 years or service, perhaps Mr Witty has witnessed a good deal more than a little bit of wrongdoing at GSK, would it not? There is a pecking order, Witty is at the top of that pecking order, and orders come from the top don’t they?

I was prescribed Seroxat in 1998, around the time that Andrew Witty was busy working in GSK’s marketing department. And also around the time that Witty was making quips about Wellbutrin in the media, and how effective it was for depression, I was being prescribed one of the most toxic drugs ever created. I wasn’t warned of the dangers, because GSK lied, and deceived, all of this is documented; the BBC’s Four Panorama Documentaries on Seroxat brought my plight, and the plight of many other unsuspecting vulnerable people into the spotlight. Of course, now we know, from the department of Justice case that Wellbutrin was being promoted off label for a myriad of different things, and we also know, from this damning whistleblower complaint, that it wasn’t just Wellbutrin which GSK lied about, but they also lied about Paxil (Seroxat), Avandia and many other drugs. I don’t know what Ben Goldacre’s definition of a ‘nice guy’ and a ‘good guy’ entails, but I would certainly think that someone who could climb the greasy sociopathic ladder for 25 years in one of the most detested corporations on the planet likely didn’t get there by being nice and good; only an utter fool would believe that. However, Ben doesn’t come across like a fool, so it’s really strange that it seems he would believe in (never mind actually utter such) incredible nonsense..

So next time Ben, when you’re having a little chat with Mr Witty about some kind of pseudo – data transparency agenda or wot-not, why don’t you ask him about exhibit 329 in the Lauren Stevens trial? Or about his role in Wellbutrin marketing in the 90’s? or about Seroxat causing young people and kids to kill themselves, and GSK ghost writing articles like study 329?  Ask him what he knew about that hideous crime during his many years grafting up that greedy ladder? Actually you could spend a lot of time asking Andrew Witty various things about many many GSK misdeeds couldn’t you?.. you could ask him about Seroxat, Avandia, Wellbutrin, Tax Avoidance, Bribery, Mark Reilly, Peter Humphrey, You could ask him about harm to patients from hiding trials and data, concealing side effects, birth defects, corporate manslaughter, you could question him on so many things Ben… you could really make a difference….that’s if you were a genuine patient advocate of course…

https://truthman30.wordpress.com/2015/07/12/the-curious-case-of-lauren-stevens-and-exhibit-329/

ejej

Ben Goldacre: Start A Dialogue… Not A Diatribe…


I have written a few posts about Ben Goldace, Alltrials and David Healy on this blog, the most recent one- just yesterday- received yet another defensive response from Ben. Ben has responded to a few of my posts but to be honest I mostly find his responses do not address anything I raise in the posts themselves and they also quickly descend into a diatribe against David Healy. This is childish and serves no purpose considering the seriousness of what is happening. These kind of responses from Ben are not just inadequate, but often they are generic and have nothing to do with addressing the content or core of the points I am trying to get across. I did find this initially frustrating until I noticed that he doesn’t just ‘interact’ with me like that – he does it to most people- particularly those who differ with, or oppose, his views.

Take for example my post recently urging Ben to listen to David Healy’s warning about the possibility that GSK are misleading Alltrials, and thus also misleading Ben. David made some well researched, and very salient points, which also made a lot of sense. David is an extremely credible voice in this arena, he is a professor of psychiatry, a distinguished author and an expert in psycho-pharmacology- he also has extensive experience with how GSK operate- yet on my blog, on David Healy’s blog, and on another blog where David’s opinions were also being discussed, Ben posted the exact same generic response, literally copied and pasted, in the comments section of all 3 separate blogs. This is not a dialogue with Ben, this is glib diatribe. This is churlish defensiveness. If I didn’t know better, I could be mistaken for thinking that Ben is stonewalling me?

Anyhow,

This is the comment he posted, repeatedly :

Ben Goldacre on May 27, 2014 at 11:11 pm said: Edit

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Hi there,

I posted this on David Healy’s blog but it’s In Moderation so I’m posting it here too, since you’ve reproduced the same arguments.

This blog post by David Healy is absurd.

The AllTrials campaign is really simple: it calls for all trials to be registered, with their full methods and results made publicly available. Where CSRs have been made, we call for those to be placed in the public domain.

Healy says we’ve created a situation where people are withholding CSRs: that’s simply absurd, this is precisely what we campaign against.

Healy says we’ve created a situation where CSRs are inappropriately redacted: that’s absurd, again, this is specifically what we campaign against.

Healy says we have created a situation where drug companies get to choose who has access to CSRs: again, that is ridiculous, this is exactly what we campaign against.

GSK have signed up to the AllTrials campaign: they join over a hundred patient groups, more than 75,000 members of the public, NICE, Wellcome, MRC, almost all academic and medical professional bodies in the UK, and a growing number around the world. When Bad Pharma came out, industry and others were able to pretend that information about clinical trials is no longer withheld. We’ve transformed that, triggered two select committees and put the policy issue on the map, created a coalition, unpicked a web of dangerous false reassurances by professional bodies, and made it impossible for industry to engage in glib denialism.

I’m delighted that GSK have signed up to AllTrials, along with all the other organisations. There are lots of problems in medicine. There lots of people and organisations who’ve done – and continue to do – things I think are harmful to public health. But where people do the right thing, I will applaud them for it. I genuinely think that’s the right thing to do. It doesn’t mean you’re part of an elaborate and complex conspiracy with people. It doesn’t mean you approve of everything they do at work and at home.

It’s easy, and attractive, to scream from the sidelines, and carry on screaming forever. It’s also possible to shout out clearly and succinctly about problems, try to set out and discuss clear solutions, floodlight the path forwards, and encourage people to go down it.

Lastly, and specifically, the issue of individual personal data. The AllTrials campaign doesn’t call for all the rich individual patient data from all trials to be simply posted publicly in the public domain: that poses too much of a privacy risk, because patients are identifiable in this data. This privacy risk isn’t as big as is claimed by some of those who seek to block transparency, but we decided that the issues around graded access control to IPD are too complex for a simple headline campaign, and we didn’t want to risk industry using the issues around protecting participants’ privacy as an excuse to derail discussion on the very important separate issue of access to methods and summary results. We were absolutely right: industry have repeatedly tried to pretend that AllTrials calls for individual trial participants’ personal data to be posted online, even though AllTrials is specifically focused on registration, methods, results, and CSRs. But as David Healy knows, most of the people involved in the AllTrials campaign, myself, Iain Chalmers and the BMJ included, are closely involved in pushing for greater transparency on IPD too. It is simply absurd to claim otherwise.

The comments section on this blog is clearly the worst place to say this, but it really is a big waste of everyone’s time to have to deal with the kind of misrepresentation and abuse that David Healy keeps posting. From past experience, I don’t believe that David will engage constructively with my taking the time to correct these repeated misrepresentations, and I honestly think that’s a shame. We’re all – most of us at any rate – trying to get things improved. Everyone’s time is short, and people run things like AllTrials in their spare time. If Healy has a better way to make things better, that’s great, he should crack on with it and get others behind him. If it involves misrepresenting campaigns, smearing people, shouting abuse, and hectoring from the sidelines, then I won’t be in.

As an addendum, three brief specifics, since time is short:

David Healy, above:
“Consent processes in clinical trials were about telling you you were on a new drug that might be dangerous or might be involved in a marketing trial. Instead they have become a way for companies to justify hiding your data on the basis of a confidentiality clause they have slipped into the forms. Iain Chalmers, Ben Goldacre and AllTrials appear to have signed up to this.”
– This is complete and utter fantasy. Neither I nor AllTrials have signed up to this. David Healy will be unable to provide any evidence to show that we have. Consent forms being used to justify withholding information is exactly what I’ve campaigned against.

David Healy, above:
“That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been.”

– This is completely bizarre. AllTrials simply calls for all trials to be registered, with their full methods and results made freely publicly available, and CSRs where they’ve been created. It is impossible to argue that this “locks academics into agreeing with GSK and other companies as to what the outcomes of their trials have been”.

David Healy, above:
“Rape is a loaded word these days”.
It’s always been a loaded word, David.
http://dictionary.cambridge.org/dictionary/british/rape_1?q=rape

 


I am not going to go into the content of Ben’s comment because it has already been responded to on David Healy’s blog- by David Healy- and I have no idea why Ben posted it on my blog because it is a response to David Healy’s post, not mine- my posts have been questioning different aspects of this and they have had a different tone. It concerns me that Ben doesn’t seem to see that there are many informed, educated and wise opinions from many different people in this debate, his opinion is not the sole authority on data transparency, the ills of the industry or the direction we should all be headed to. Ben needs to listen to others and stop dictating generic responses which do not address the concerns and opinions of others but merely inflate his own sense of ego and self-importance. It would be nice to think that we can engage with Ben and those who have differing views on the same subjects without the fear of childish retorts. I won’t hold my breath for some proper adult engagement but I will always be open to it. We desperately need dialogue here…

I will finish this post with what i think was one of the most insightful- yet also humble and intelligent- comments in this debate that I have seen so far ( copied from David Healy’s blog):

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments


Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

http://davidhealy.org/fucked/#comments

 1boringoldman says:

May 29, 2014 at 12:14 am

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect.

I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all.

The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not.

If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.

In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned.

This is closer to a war than a negotiation.

The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.
– See more at: http://davidhealy.org/fucked/#comments

ben-goldacre-1

GSK: How To Provide Access To Data Without Revealing Anything At All


“The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task”..

(1boringoldman-blog- http://1boringoldman.com/index.php/2014/05/25/a-decision-to-reconsider/)


 

 

Does Ben Goldacre really believe that a multi-billion dollar corporation like GSK can’t provide an easier, more technologically advanced, and productive route- for researchers to access their data?

GSK are taking the absolute piss out of Alltrials, the BMJ, the entire scientific and medical community, and the public at large, with their ‘transparency charade’ but most of all they are harming patients -and that is utterly indefensible… the system GSK have in place is obviously a deliberate attempt to block researchers gathering data properly…

 


 

http://1boringoldman.com/index.php/2014/05/25/a-decision-to-reconsider/

 

…as a member of the RIAT team who was granted access to the Data from Paxil Study 329 to do an independent reanalysis by GSK, we’ve now had months of experience working with their “remote desktop” interface as a portal to their information. It is a single windowed multiple document interface, totally self contained that can’t be accessed by any software other than that provided inside the window. Multiple passwords are required multiple times for access, and on some days, one is frequently thrown from the system without warning, necessitating repeated logins. There’s another internal window from SAS that contains the data and allows one to run SAS programs to analyze the data. The data is also provided as text-based CSV files that can be moved outside the internal SAS window and displayed in spreadsheets [Open Office is provided]. The open source statistical program, “R” is also provided. In our case having no-one fluent in SAS procedures and programming, we are using “R” which has the necessary statistical functions. Getting the data into the proper format required by “R” means using multiple spreadsheets – which is very difficult in the cramped space provided – sometimes taking days and involving many “start-overs.” Once the data is analyzed, one can only export non-data containing files with results, and that’s only by application for approval. Using the primitive graphing functions of Open Office or “R’ in the “remote desktop” is very difficult and the graphs can’t be exported. That finally lead us to copy the information for the graphs by hand to get it into the computer proper to create our images. The process of using this interface for analysis is unnecessarily maddening and a severe obstruction to the task.

The original hand written CRFs are provided as PDF documents. In our case, there are some 275 subjects, many with several pdfs, each pdf containing 200+pages. In the interface provided, we can see only one page at a time of the nearly 60,000 pages. Tallying the adverse events from the pdfs is hard enough work, but doing to without being able to make printed copies and referring back and forth is a double nightmare, requiring days of wasted time, and delegation is impossible. Working inside of this little window brings home how important it is to have a workspace that allows simultaneous display of lots of information, and this isn’t it. One of our team has lost one assistant already over this interface. The EMA’s decision to even consider using this kind of interface is at best, ill advised, and a negation of the initial promise of Data Transparency. If I weren’t retired and instead had a job to do, I don’t think I could do it. If I were a graduate student given the task, I might go to the chairman of the department and ask for another major professor. It’s impossible to imagine that anyone contemplating this decision who knows the ins and outs of data analysis has tried it out in this kind of environment. As I said before, it’s like going to sea to see the world in a submarine, looking through a periscope.

I expect the EMA means well, and may think that since the data is available in this system, it should be okay.. But they apparently don’t realize the practical burden that it inflicts on anyone trying to have a serious look at a clinical trial. At the least, I would hope they would sit someone down in front of a computer using such a system so they can see with hands-on what I’m talking about – that I’m not being melodramatic.

From 2006: A Criticism of GSK And Their Transparency Deception : “From optimism to disillusion about commitment to transparency in the medico-industrial complex” by Iain Chalmers


Following up from my post yesterday, titled ‘Ben Goldacre: Wake The Fuck Up” concerning David Healy’s article on his blog titled ‘Fucked’, I think it might be timely to post Iain Chalmers article in the JRSM from 2006, titled :

“From optimism to disillusion about commitment to transparency in the medico-industrial complex”

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1484602/

Logo of jrsocmed

J R Soc Med. Jul 2006; 99(7): 337–341.
PMCID: PMC1484602

From optimism to disillusion about commitment to transparency in the medico-industrial complex

In the mid-1970s, I was involved with others in trying to assemble evidence about the effects of care during pregnancy and childbirth. We started by searching Medline to identify reports of controlled trials that we thought might be sufficiently reliable to be taken into account in our analyses; and then searched about 70 journals by hand, page by page, back to the issues published in 1950. We found about 3500 reports of controlled trials and, with help from the World Health Organization, we published the references to these in a classified bibliography in the mid-1980s.1

But then we thought, ‘What about trials that don’t get published? If we don’t take those into account, we might reach biased conclusions’. We knew of anecdotes about researchers who had had disappointing results of trials, and had therefore never made the results public. Furthermore, in an important analysis of controlled trials of treatments for cancer of the ovary published in 1986, an Australian oncologist, John Simes, had shown how failure to publish clinical trials could lead to misleading inferences about the effects of treatments.2 So we wrote to 42 000 obstetricians, paediatricians and other clinicians around the world to try to flush out information about studies that had been done but had never been reported. It was an almost complete waste of time; we published our experience to warn others to think carefully before using the retrospective survey approach we had used in our attempt to deal with publication bias.3

Like John Simes before us, we concluded that a prerequisite for tackling the problem of biased under-reporting of research involved registering controlled trials publicly, at inception, before their results could influence whether or not the world would come to know about them. In 1990, based on a paper I had presented at the 1st Congress on Peer Review in Biomedical Publishing, I published an article with the deliberately provocative title ‘Underreporting research is scientific misconduct’. I suggested that failing to report well-conducted clinical trials was not only scientific misconduct, but also unethical; it broke an implicit contract with the patients who had participated in clinical trials. I reiterated the call for registration of trials at inception.4

As it happens, all the examples of biased under-reporting of controlled trials I gave in that paper referred to non-commercial trials. The drug industry is not very interested in perinatal healthcare, the field in which I was researching at that time, because it does not offer very rich pickings. Ten years before my article was published, however, Elina Hemminki had shown that biased under-publication of studies funded by industry might be a particular cause for concern.5 She compared the study reports submitted by pharmaceutical companies to drug licensing authorities with subsequently published reports of the same studies. From this she found that studies in which the pre-licensing records showed that researchers had looked for adverse effects were less likely to be published than studies in which adverse effects had not been sought.

For the reasons already mentioned, I had had little contact with the pharmaceutical industry while I was a perinatal researcher. In 1992, however, I moved to the UK Cochrane Centre. As the Centre and then the Cochrane Collaboration began to become known to people in industry, representatives of the Association of the British Pharmaceutical Industry asked to meet with me. A delegation came to the UK Cochrane Centre, led by Frank Wells, the medical director of the ABPI. Our discussion lasted for about 3 h, during which I emphasized the openness with which the Cochrane Collaboration did its work: protocols for Cochrane reviews and completed reviews were published in electronic form, and could be criticized publicly, and readily amended if necessary.

After I had explained this, I felt it reasonable to suggest to my ABPI visitors that industry should be more open about its clinical research, because biased under-reporting could harm patients. Encouragingly, Frank Wells subsequently wrote in the preface of a book he had co-authored on fraud and misconduct in medical research: ‘Under-reporting of research is (another) form of misconduct, given that this can lead to seriously misleading recommendations for clinical practice and for new research’.6

The same year that this book was published, Mike Wallace, another member of the ABPI delegation and at that time the chief executive of Schering Healthcare Ltd (the British subsidiary of Schering AG), told me that he realized that biased under-reporting of research was ethically and scientifically indefensible. He felt that unless the pharmaceutical industry started to take an initiative to confront this issue voluntarily it would end up being forced to do so—probably in ways that it would rather not be. Mike Wallace said that he had decided to provide information about all his company’s controlled trials for publication in the Cochrane Controlled Trials Register. I know that he was reprimanded for breaking ranks in this way, in particular, by colleagues from other member companies of the ABPI. I am glad to be able to pay tribute to a senior nonmedical executive in the industry who stepped out of line to do something which he thought was morally correct.

Mike Wallace was not the only person within the British pharmaceutical industry taking steps towards greater openness, however. In particular, David Jackson, medical director of the British holding company of GlaxoWellcome, had persuaded his colleagues in the international parent company that the company should adopt a more open policy. The new policy was announced at the end 1997, and I was pleased to be quoted in the press release welcoming it. The following year, the chief executive of the company, Richard Sykes, wrote a landmark editorial in the BMJ entitled ‘Being a modern pharmaceutical company involves making information available on clinical trials programmes’. He made clear that one reason for Glaxo Wellcome’s new disclosure policy was ‘… to help those undertaking systematic reviews of clinical data and to help reduce the impact of publication bias’.7

GlaxoWellcome implemented the trials registration policy it had announced, and two of the people who were involved—Trevor Gibbs and Elizabeth Wager—later published an account of the challenges this had presented.8 Elizabeth Wager was head of the writers’ group within the company and she convened a group of her colleagues in other companies to agree and then publish guidelines for good publication practice. They noted that ‘… the aim of the guidelines is to ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner. The guidelines cover companies’ responsibilities to endeavour to publish results of all studies’.9,10

Things were stirring among pharmaceutical physicians more widely. In 1998 the Ethics Committee of the Faculty of Pharmaceutical Medicine declared that:

‘Pharmaceutical physicians have a particular ethical responsibility to ensure that the evidence on which doctors should make their prescribing decisions is freely available… the outcome of all clinical trials on a medicine should be reported’.11

Two years later they reiterated the ethical principle: ‘Studies are performed to increase knowledge in some way, and this knowledge should be shared with the wider world. Study findings should be communicated, whatever the outcome, for the benefit of the community at large’.12

Presumably because the ABPI felt that it could not really sit by while one of its major members, GlaxoWellcome, and the Ethics Committee of the Faculty of Pharmaceutical Medicine were showing a moral lead in this way, the Association decided to commend Glaxo Wellcome’s policy to other member companies. I was on the ABPI side of the table at the press conference announcing this policy, and I welcomed it wholeheartedly. In brief, I had become optimistic that the industry really was beginning to address the problems that I had urged should be addressed at our meeting eight years previously. Although the response was not nearly as good as the ABPI had hoped, AstraZeneca, Aventis, MSD, Novartis, Roche, Schering Healthcare and Wyeth did begin registering retrospectively those of their trials that had involved UK patients.

However, these hopeful signs were not sustained during subsequent developments. In the same year that the ABPI announced that it was leading the world in registering clinical trials, Glaxo Wellcome merged with Smith Kline Beecham. Initially, my optimism that the new company would maintain Glaxo Wellcome’s policies on trial registration seemed justified: the new company’s logo had replaced the Glaxo Wellcome logo on the trials register. I wrote to the chief executive of the merged company, Jean-Paul Garnier, to express my pleasure at this. I also mentioned that I was delighted that Elizabeth Wager and her six colleagues in the former. Glaxo Wellcome writing department, and their association with the Good Publication Practice for Pharmaceutical Companies Guidelines, continued to be supported by the new company. I never received a reply to my letter; the company abandoned the trial registration process and abolished its publications departments in the USA and the UK, headed by Elizabeth Wager and Elizabeth Field, respectively—both co-authors of the Good Publication Practice Guidelines for Pharmaceutical Companies.9,10

It was round about that time that increasing amounts of empirical evidence began to confirm doubts about the trustworthiness of research sponsored by industry. As I have noted already, Elina Hemminki had produced evidence of based under-reporting of industry research 20 years earlier: reports of studies submitted in support of new drug licences in which adverse effects had been sought were less likely subsequently to be published.5 A study using similar methods was reported in 2003 by Melander and his colleagues.13 Their paper entitled ‘Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry’ demonstrated result-dependent over-reporting and under-reporting of industry studies of new drugs. They concluded that any attempt to develop treatment recommendations using analyses based only on publicly available data were likely to be based on biased evidence.

Other evidence reported over the past 5 years has demonstrated associations between industry-sponsorship and research results favouring products made by the companies funding the research. As well as biased under-reporting of research, the associations observed may also reflect inappropriate comparison of new products with comparators of existing products in doses too low to be effective or higher than necessary, with consequent higher incidence of adverse effects.1417 Neither of these possible explanations is morally or scientifically defensible. In addition, there is evidence of more subtle forms of industry bias in the way that data are interpreted,18,19 for example, by putting a biased spin on the evidence. The title of a recent report20 says it all: ‘Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head to head comparison studies of second generation anti-psychotics’. One of the five key points emerging from the evidence presented at the 5th Congress on Peer Review in Biomedical Publishing was that ‘… the drug industry is successfully skewing the literature in its favour’.21

By now the public was starting to get interested in these matters. I was asked to write an article about under-reporting of research for the popular weekly journal New Scientist.22 In fact, I had co-authored a piece on the topic in the same journal 8 years previously.23 But now, something happened which made a real difference to the likelihood of the message about publication bias being taken seriously. Eliot Spitzer, the attorney general for New York State, took GlaxoSmithKline to court for withholding information about important possible adverse effects of drugs taken by children for depression.

The company settled out of court for a couple of million dollars, but the charge laid against it had the effect of increasing the pressure to deal with publication bias. It provoked the International Committee of Medical Journal Editors to do what the Committee should have done years earlier. It announced that the authors of any reports of clinical trials that had begun recruitment after the middle of 2005 would have to confirm that the studies had been registered publicly, at inception.

Only then did the drug industry start to try to limit the damage caused by its failure to follow the lead given by Schering Healthcare and Glaxo Wellcome nearly a decade earlier. In a press release issued in June 2004, GlaxoSmithKline announced that it would make the results of all its clinical trials publicly available. The company did not explain how, given that its trials register had been allowed to fall into disrepair, the public would know whether all results were being made available. A BMJeditorialist commented thus:

‘Last month GlaxoSmithKline announced that it would publish summaries of all its clinical trials of a new product once it had been launched. The decision followed news of a lawsuit brought by New York State alleging that the company had concealed the results of paroxetine because they might have spoiled marketing plans. GSK said it had been considering the move for some months. A similar sounding policy was announced by Glaxo Wellcome in 1998, but seems to have been quietly abandoned in 2000 after the merger with SmithKlineBeecham.’24

Industry’s attempts at damage limitation continue. Speaking on the BBC Radio 4 programme In Business on 24 June 2005, Jean-Pierre Garnier said: ‘We have responsibilities beyond those to our shareholders’, and ‘… we must be completely transparent with the public about what we do’. The gap between this statement and an analysis of the records submitted by his company (and other pharmaceutical companies) to the National Institutes of Health trials register25 suggests that GlaxoSmithKline’s understanding of what transparency implies may leave many people disappointed and cynical about the company’s expressed commitment to greater openness.

If GlaxoSmithKline really is committed to the kind of openness the public has come to realise is needed, one might have expected it to have endorsed the Good Publication Practice for Pharmaceutical Companies Guidelines developed by its dismissed former employees and colleagues in other companies.9 It has not. Indeed, at the time of writing, only six pharmaceutical companies have endorsed the guidelines—Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals.10

The public is beginning to demand stronger sanctions. During 2004 and 2005, the Health Committee of the House of Commons held an enquiry into the influence of the pharmaceutical industry. The Committee drew attention to the problem of biased under-reporting of research and recommended registration of trials at inception.26 Richard Sykes, previously chief executive of Glaxo Wellcome, now rector of Imperial College London, gave oral evidence to the Committee which clearly impressed the members. In its report, the Committee’s recommendations began by noting Richard Sykes’ view that:

‘Today the industry has got a very bad name. That is very unfortunate for an industry that we should look up to and believe in, and that we should be supporting. I think there have to be some big changes.’

On 6 January 2005, the industry announced a global commitment to clinical trial registration and publication. Whether this commitment amounts to the‘big changes’ that Richard Sykes judges are needed is an open question. First, the commitment applies to only a tiny proportion of the clinical trials which should be informing prescribing practices because it is not being applied to trials conducted in the past. Second, there is a continuing flow of empirical evidence of biased reporting and interpretation of industry trials. My judgement is, therefore, that industry’s actions are simply too little and too late to deal with its current reputation for being less than honest with its research—just as Mike Wallace feared might be the case in his conversations with me a decade ago.

Biased under-reporting of research harms and sometimes kills patients, quite apart from the waste of resources that results from this form of scientific and ethical misconduct. In 2004, a former editor of the New England Journal of Medicine published a book entitled The Truth About The Drug Companies: How They Deceive Us and What To Do About It.27. How can we expect the public to trust the pharmaceutical industry and clinical researchers who work with it while we acquiesce in this state of affairs?

Jan Vandenbroucke has noted how science as an errordetecting process simply ceases to exist in these circumstances:

‘In all scientific debates all sides always have their own biases: we have no other way to look at data but to interpret them. However, in usual clinical or epidemiologic research, studies are repeated by others, in different settings and by different means, looking for biases, flaws, and ways of remedying them, endlessly arguing whether the biases are remedied or not. That is the essence of open scientific debate and criticism, which is the only guarantee for progress. That is no longer possible with pharmaceutical products because the monopoly of the pharmaceutical industry of studies of its own products leads to persistently one-sided studies that can no longer be questioned by studies from other sides. Moreover, the one-sidedness cannot be seen from the public record, that is the published papers. Without the possibility of open debate, science simply ceases to exist’.28

Careful thought needs to be given to this analysis by governments, public and charitable organizations, and individuals who promote research collaboration with industry while remaining silent about the unethical and unscientific behaviours alluded to above. As I have made clear, biased reporting and lack of transparency is not limited to commercially-sponsored research; but the empirical evidence makes clear that it is a particularly noticeable problem in that sphere. Those who collaborate with industry need to be clear that their acquiescence in these forms of scientific misconduct inevitably casts doubt on their integrity, as reflected in the title of a book by another former editor of the New England Journal of Medicine—On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health.29 The responsibilities of doctors should be unambiguously to their patients. Yet some clinician researchers (with plenty of encouragement from government and the institutions with which they are associated) appear to have become so seduced by the financial rewards resulting from collusion with industry’s agenda and practices that they have forgotten this most fundamental of their professional duties. Indeed, that is the most depressing cause of my optimism of a decade ago becoming disillusionment today.

A few weeks before finalizing a draft of this essay for submission to the Journal of the Royal Society of Medicine I was invited by Richard Tiner, medical director of the ABPI, to address a meeting of 60 or so members of medical departments of member companies on the topic of ‘clinical trial transparency’. In response I suggested that, rather than give a talk, it might be a more useful to pre-circulate the above text so that it could be discussed at the meeting, and Dr Tiner accepted this proposal.

It came as a bit of a surprise to me that there was no serious challenge to the facts I had assembled to explain why my earlier optimism had turned to disillusion. This may have been partly because it was clear that I have tried to work with industry over the past decade to increase transparency, and to commend publicly the positive steps that some individuals, companies and the ABPI had taken in that direction. Instead of giving me the rough ride that I had been expecting, participants at the meeting asked me for suggestions about what could be done to deal with the bad reputation to which Richard Sykes had referred in his evidence to the Health Committee of the House of Commons.

Although I made one or two off the cuff suggestions at the meeting, I realized that I needed to add to this essay some suggestions for steps that might go some way to increasing confidence in the scientific integrity of the industry. So, in conclusion, here are three practical suggestions:

  1. All pharmaceutical companies should join Aventis, Amgen, LEO Pharma, Otsuka, Serono and 3M Pharmaceuticals in publicly endorsing the Good Publication Practice Guidelines for Pharmaceutical Companies9,10
  2. Industry as a whole should put in place mechanisms for promoting and monitoring adherence to these guidelines, thus making clear to the public that it regards under-reporting of research as just as serious a form of scientific misconduct as fabrication of data
  3. Industry should voluntarily take steps that go beyond the minimum currently being required for clinical trial registration,30 for example, by publishing full protocols at the inception of all randomized trials.

 

I hope that I may be able to write another essay in 5 years’ time entitled ‘From disillusion to optimism about the scientific integrity of the pharmaceutical industry and the people collaborating with it.’

Notes

Acknowledgments I am grateful to Richard Sykes, Richard Tiner, Elizabeth Wager, Mike Wallace, Frank Wells, Jan Vandenbroucke, and participants at the ABPI meeting held at BMA House on 28 February 2006, for helping me to ensure that this account is accurate.

Competing interests None declared.

Note Listen to an audio interview with Iain Chalmers on [http://www.jrsm.org]

References

1. National Perinatal Epidemiology Unit. A Classified Bibliography of Controlled Trials In Perinatal Medicine 1940-1984. Oxford: Oxford University Press (for the World Health Organization), 1985
2. Simes RJ. Publication bias: the case for an international registry of clinical trials. J Clin Oncology1986;4: 1529-41 [PubMed]
3. Hetherington J, Dickersin K, Chalmers I, Meinert CL. Retrospective and prospective identification of unpublished controlled trials: lessons from a survey of obstetricians and pediatricians. Pediatrics1989;84: 374-80 [PubMed]
4. Chalmers I. Under-reporting research is scientific misconduct. JAMA 1990;263: 1405-8 [PubMed]
5. Hemminki E. Study of information submitted by drug companies to licensing authorities. BMJ1980;280: 833-6 [PMC free article] [PubMed]
6. Lock S, Wells F. Preface to the second edition. In: Lock S, Wells F, eds. Fraud and Misconduct In Medical Research. London: BMJ Publishing Group, 1996: xi-xii
7. Sykes R. Being a modern pharmaceutical company. BMJ 1998; 317: 1172. [PMC free article][PubMed]
8. Gibbs T, Wager E. Realities of trial registration: the Glaxo Wellcome experience. Int J Pharmaceut Med 2000;14: 203-5
9. Wager E, Field EA, Grossman L. Good Publication Practice for pharmaceutical companies. Curr Med Res Opinion 2003;19: 149-54 [PubMed]
11. Faculty of Pharmaceutical Medicine. Ethical Issues Working Group. Ethics in pharmaceutical medicine. Int J Pharmaceut Med 1998;12: 193-8
12. Wells F, Lunnon MW. First Report of the Ethics Sub-Group. Society of Pharmaceutical Medicine. Int J Pharmaceut Med 2000;14: 58-64
13. Melander H, Ahlqvist-Rastad J, Meijer G, Beermann B. Evidence b(i)ased medicine—selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications. BMJ 2003;326: 1171-3 [PMC free article] [PubMed]
14. Djulbegovic B, Lacevic M, Cantor A, et al. The uncertainty principle and industry-sponsored research. Lancet 2000;356: 635-8 [PubMed]
15. Lexchin J, Bero LA, Djulbegovic B, Clark O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003;326: 1167-70 [PMC free article] [PubMed]
16. Bhandari M, Busse JW, Jackowski D, et al. Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials. Can Med Assoc J 2004;170: 477-80 [PMC free article] [PubMed]
17. Gardner W, Lidz CW. Failures to publish pharmaceutical clinical trials. Proceedings of The 5th International Congress On Peer Review and Biomedical Publication, Chicago, September2005.
18. Yank V, Rennie D, Bero L. Are authors’ financial ties with pharmaceutical companies associated with positive results or conclusions in metaanalyses on antihypertensive medications? Proceedings of The 5th International Congress On Peer Review and Biomedical Publication, Chicago, September2005.
19. Jørgensen AW, Gøtzche P. Sponsorship, bias, and methodology: Cochrane reviews compared with industry-sponsored meta-analyses of the same drugs. Proceedings of The 5th International Congress On Peer Review and Biomedical Publication, Chicago, September2005.
20. Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head to head comparison studies of second generation anti-psychotics. Am J Psychiat 2006;163: 185-94 [PubMed]
21. Fisğter K. At the frontier of biomedical publication: Chicago 2005. BMJ 2006;331: 838-40[PMC free article] [PubMed]
22. Chalmers I. In the dark. Drug companies should be forced to publish all the results of clinical trials. How else can we know the truth about their products. New Scientist 6 March 2004: 19[PubMed]
23. Pearn J, Chalmers I. Publish and be applauded. New Scientist 6 January 1996: 40.
24. Herxheimer A. Open access to industry’s clinically relevant data. BMJ 2004;329: 64-5[PMC free article] [PubMed]
25. Zarin DA, Tse T, Ide NC. Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 2006;353:2779-87 [PMC free article] [PubMed]
26. House of Commons Health Committee. The Influence of The Pharmaceutical Industry, 4th Report of Session 2004-05. London: Stationery Office, 2005
27. Angell M. The Truth About The Drug Companies: How They Deceive Us and What To Do About It. New York: Random House, 2004
28. Vandenbroucke JP. Without new rules for industry-sponsored research, science will cease to exist. Rapid response on bmj.com, posted 14 December 2005 [http://bmj.bmjjournals.com/cgi/eletters/331/7529/1350]
29. Kassirer J. On The Take: How Medicine’s Complicity With Big Business Can Endanger Your Health. New York: Oxford University Press, 2004
30. Sim I, Chan A-W, Gülmezogğlu AM, Evans T, Pang T. Clinical trial registration: transparency is the watchword. Lancet 2006;367: 1631-3 [PubMed]

Articles from Journal of the Royal Society of Medicine are provided here courtesy of Royal Society of Medicine Press
Iain Chalmers

Ben Goldacre: Wake The Fuck Up!



“That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been” (David Healy).

“Clinical trials are the gold standard way to hide adverse events” (David Healy).

“it would be better for mankind if all clinical trial data were sunk to the bottom of the sea rather than being made visible to academics stuck in a submarine and only able to view things through a periscope, which is what the GSMA-ESK system offers”. (David Healy).


bggHEALU
1362503627273.cachedI was supposed to be taking a break from blogging but reading David Healy’s latest blog post (titled ‘fucked‘ ) this morning made me very annoyed. I won’t go into detail about the post here, but I will post it in its entirety, because personally I think that David Healy is one of the few commentators out there worth listening to; particularly in matters regarding GSK and their so called ‘Transparency’ era. I seriously hope Ben Goldacre begins to wake up and smell the coffee, because if what David (and others) have observed comes to fruition and patients and consumers of pharmaceutical drugs are put at even greater risk, than they are already- because of this sham ‘transparency’ smokescreen– then Goldacre and his cohorts will be partly responsible. The sub- title of Ben’s book is ‘how drug companies mislead doctors and harm patients’. Isn’t this ironic considering GSK are misleading Dr. Ben Goldacre, and in the process- this is inevitably going to harm more patients?

If Goldacre really wants to help patients and hold pharmaceutical companies to account (as he claims) then he needs to begin to listen to people like David Healy, or at the very least begin a dialogue. So far, all I have seen and heard from his direction is arrogance and hubris. As I have said before on this blog: Would The Real Ben Goldacre Please Stand Up?

And if you can’t get real and stand up Ben, please- for the sake of those who are trying to get through to you- just maybe do yourself a favor and wake the fuck up!…


http://davidhealy.org/fucked/#comment-105798

Fucked

Editorial Note: Apologies for the Language

A year and a half ago this blog ran a series of posts about access to clinical trial data – reporting on how industry were going to engineer the appearances of transparency.  See Won’t get Fooled AgainAccess to Clinical Trial Data, and  The Data Access Wars.

Do Academics have Wild Dreams?

Several months later, soon after being fined $3 Billion, GSK trumpeted their endorsement of transparency by signing up to the AllTrials campaign and declaring their intention to put in place a method to allow researchers access to clinical trial data that would go beyond the wildest dreams of researchers.  See April Fool in Harlow, and GSK’s Journey.

Its all to easy to imagine a marketing department figuring that academics don’t have very wild dreams.

When GSK signed up to AllTrials Ben Goldacre rolled over and purred.  The BMJ featured Andrew Witty on their front cover as the candidate of hope.

Rain on the Parade

In contrast, on this blog, 1boringoldman and on RxISK a small group have warned consistently that this was not good news.  That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been.

No one wanted to rain on the AllTrials parade – it never seems like a good idea to fracture a coalition. RxISK put the AllTrials logo on its front page.

Not content with a few academic ghost authors, GSK’s maneuver has put industry well on the way to making Academia a ghost, a glove puppet manipulated by company marketing departments.

Meanwhile Iain Chalmers co-wrote an editorial with GSK endorsing the GSK approach (The Attitude of Chicks to Trojans and Horses) and the British Government produced a document on clinical trial data access that could have been written in GSK central.

The GSMA-ESK Model

The great hope for those dismayed at all this lay with EMA who following Peter Gotzsche’s initiative and a European Ombudsman’s ruling looked like a beacon of hope.  But this week EMA has come out and said it is going to put in place the GSK model of data access.

Everyone is in a spin.  AllTrials are asking for more donations to continue their successful campaign.

As someone who has been working the GSK system, I can say with confidence that this is a disaster.

The key thing that companies are trying to hide are the data on adverse events.  To get to grips with the adverse events in a clinical trial is a bit like playing the children’s game Memory – where you have a bunch of cards with faces turned face down and you get to pick up two and then have to remember where in the mixture those two were when you later turn up a possible match.

Patterns of Deception

In the same way, picking up adverse events is about recognizing patterns – patterns of events, and patterns of deception.

To do this you have to be able to spread maybe a hundred documents out over a big area and dip back into them if something in one document reminds you of something in another.  The new GSMA-ESK remote access system simply won’t allow this.

Not only will it not allow this but it is about to make things far far worse than they are at present.

At the moment when it comes to studies like Study 329, GSK have been stuck by a Court order with putting the Company’s Study Reports up on the web where they can be downloaded and pored over – all 5,500 pages of them for Study 329.  They have refused to do the same for the 77,000 pages of raw data from Study 329, making it available to a small group of us through a remote desktop system.

For all other trials – future and past – investigators won’t even be able to get the Company Study Reports in usable form.  They too will only be accessed remotely.

For anyone who wants to look at the efficacy of a drug this might just about work for outcomes that involve rating scale scores or lipid levels.   The efficacy of drugs is pretty well all that most Cochrane groups, Iain Chalmers and Ben Goldacre are interested in.  The Cochrane exceptions have been Tom Jefferson, Peter Doshi and the Tamiflu group.

But this system is a bust when it comes to adverse events and it won’t work if the efficacy outcomes are in any way complex.

What can be done?

The first point to make is this.  Clinical trials are not all they are cracked up to be.  Even if well designed, not using surrogate outcomes, of sufficient duration, done on patients who actually exist, and not written up by ghostwriters, clinical trials systematically get the wrong answer, especially on adverse events.  Clinical trials are the gold standard way to hide adverse events.

One of the risks of the data access wars is that it will put an unwarranted premium on clinical trials and their data – and in this way play straight into pharma’s hands. This is what led “Crusoe” to warn Peter Gotzsche a year ago that his data access crusade might backfire – See Marilyn’s Curse.

Let’s make no mistake here – it’s morally indefensible that there is not full access to the data from scientific experiments.  In this sense Peter is right and his outrage is well-placed and close to magnificent.

But, ceteribus paribus, it would be better for mankind if all clinical trial data were sunk to the bottom of the sea rather than being made visible to academics stuck in a submarine and only able to view things through a periscope, which is what the GSMA-ESK system offers.

It might have been better if AbbVie had won their legal action.  Instead EMA’s accomodation with them has fucked us all.

Rape is a loaded word these days but in so far as what is happening is an abuse of consent and will primarily do harm to women and children it perhaps come close to being the best word.  Consent processes in clinical trials were about telling you you were on a new drug that might be dangerous or might be involved in a marketing trial.  Instead they have become a way for companies to justify hiding your data on the basis of a confidentiality clause they have slipped into the forms. See When Does Yes Mean No.   Iain Chalmers, Ben Goldacre and AllTrials appear to have signed up to this.

Whether raped or fucked, the Dan Markingson case is a stunning example of what has gone wrong – the Markingson petition is probably a much better petition to sign if you really want to save yourself and others you know and love than the AllTrials one.

Let’s Do the AbbVie Again

Second the data companies are really hiding is their adverse event data.  There are other ways to collect adverse event data.

We invited you 18 months ago to join an AbbVie – Let’s Do The AbbVie Again.  This Irish invention is the reverse of a boycott – another Irish invention.

A boycott of a company’s drug would mean you don’t get the benefit.  If you decide to AbbVie a company’s drug, you – we – can all make these drugs better by reporting on the effects they have.

Company efforts are geared more than anything else to ensuring that doctors and patients don’t report adverse events or ensuring that these events don’t register.  If you really want to get up their nose, if you really want to send the marketing departments into a spin, if you really want a company CEO to blow a fuse, this is what you need to do.

Companies want to transform adverse events into non-information.  You can stop this happening. If an event happens to you on a drug, you are in possession of the missing information.  It’s our tolerance of the patients who have Disappeared in clinical trials that is killing medicine as we have known it.

AbbVie with us and then sit back and take pleasure in a marketer who says “Thank you for helping us make our drugs better – without you we couldn’t do it“.

Now there is of course a huge conflict of interest here.  RxISK.org was set up precisely for this purpose – to register adverse events. But we will hand all events on to FDA or MHRA or whoever you want us to.  What we will also do though, and we invite any doctors or others out there with backbone to help us do it, is to decide when a drug is causing an event – this is something no regulator will ever do for you or for anyone.

Boycott

The other option is a Boycott.  Doctors could refuse to prescribe drugs for which the information was not fully available.  The Panalba and Thalidomide cases have shown that this is the one thing industry is scared of – Report to the President.

If I made claims about a drug to my colleagues but refused to show them the data, they’d have no problem telling me to get lost. I’d be boycotted from here to kingdom come.  But when it comes to industry, 99% of doctors lack balls

Doctors have been given a license to degrade us by treating us like addicts – the origins of prescription-only status.  They have been given a license to print money – we can only get our drugs through them.  The very least they could do in return is show some backbone.

But this is a decadent situation and decadence rarely breeds courage.

Emily’s Balls

The boycott was likely invented by Irish women.  The Abbvie was too.  There is one bulwark still standing in the way of GSMA-ESK.  It’s the European Ombudsman, an Irish woman – Emily o’Reilly.

– See more at: http://davidhealy.org/fucked/#comment-105798

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