First Big Pharma Company Announces Support For Clinical Data Transparency Campaign: Who's Next?
from the saving-lives dept
It would be something of understatement to say that the spiralling cost of healthcare has become a highly-charged political issue in the US (and elsewhere). But wherever people stand on the funding of medicine, there is an implicit assumption that it works, and is worth even the exorbitant prices that pharmaceutical companies may charge. Sadly, that’s often not true.
The reason is that drug approval is frequently based on partial or even misleading evidence from the crucially-important clinical trials that are conducted to check that a new treatment is safe and efficacious. Similarly, prescribing doctors often only have access to incomplete information when they are choosing drugs for a patient. Not knowing all the facts about medicines not only leads to a huge waste of money, since ineffectual or inappropriate drugs are sometimes prescribed, but can have life-threatening side effects. Here, for example, is a recent case involving the pharma giant GlaxoSmithKline (GSK) and its diabetes drug Avandia:
The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks. The drug can still be prescribed in the US, but not to patients at risk of heart problems.
A scientist with the Food and Drug Administration estimated that Avandia could have been responsible for 100,000 heart attacks in the US.
The manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging side-effects of the drug, and there is evidence of the drug’s harmful effects.
Here’s why that critical data isn’t always to hand:
companies and researchers can withhold the results of clinical trials even when asked for them. The best available evidence shows that about half of all clinical trials have never been published, and trials with negative results about a treatment are much more likely to be brushed under the carpet.
This is a serious problem for evidence based medicine because we need all the evidence about a treatment to understand its risks and benefits. If you tossed a coin 50 times, but only shared the outcome when it came up heads and you didn’t tell people how many times you had tossed it, you could make it look as if your coin always came up heads. This is very similar to the absurd situation that we permit in medicine, a situation that distorts the evidence and exposes patients to unnecessary risk that the wrong treatment may be prescribed.
That comes from a site called AllTrials (disclosure: I am on the advisory board of the Open Knowledge Foundation, which is one of the supporters of AllTrials). It has a very simple, but very ambitious aim:
The AllTrials initiative is campaigning for the publication of the results (that is, full clinical study reports) from all clinical trials — past, present and future — on all treatments currently being used.
If doctors have the full facts about all the drugs they can prescribe, they are in a better position to choose wisely. That will almost certainly save both money and lives. Despite that undeniable fact, pharmaceutical companies continue to withhold data from clinical trials, defying a US law that requires them to provide it:
Since 2008 in the US the FDA has required results of all trials to be posted within a year of completion of the trial. However an audit published in 2012 has shown that 80% of trials failed to comply with this law. Despite this fact, no fines have ever been issued for non-compliance.
Of course, it’s not hard to see why drug companies don’t want all that data out there: it would mean that independent analyses could be conducted, with the danger that they might come to very different conclusions about the efficacy and safety profile of the medicine in question.
Against that background of the pharma industry’s dogged refusal to cooperate in the opening up of clinical data, this announcement, from the same GSK discussed above, was unexpected:
GSK today further demonstrated its commitment to clinical trial transparency by announcing its support for the AllTrials campaign. The campaign is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs) to help drive further scientific understanding.
Specifically:
GSK is committing to make CSRs publicly available through its clinical trials register. CSRs are formal study reports that provide more details on the design, methods and results of clinical trials and form the basis of submissions to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies. From now, GSK will publish CSRs for all of its medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.
In addition, while there are practical challenges, the company also intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.
If GSK follows through on those promises, and really does provide all that data in a timely fashion, this is potentially huge. As Ben Goldacre, author of the book “Bad Pharma” about the betrayal of doctors and their patients by drug companies through the withholding of vital information, and a prime mover of the AllTrials campaign, explains:
The eccentric position is now not supporting alltrials.net. There is no serious defense for withholding information about clinical trials from doctors and patients. It is simply unethical, and it harms patients.
GSK’s move is a breakthrough for the campaign because it negates arguments that it’s simply not possible to provide detailed clinical trial information as a matter of course. This means that the pressure will be on the other pharmaceutical companies to follow suit — or to give the impression they have something to hide about their products.
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Filed Under: alltrials, clinical trials, drugs, healthcare, open data, pharmaceuticals, secrecy
Companies: glaxosmithkline
Comments on “First Big Pharma Company Announces Support For Clinical Data Transparency Campaign: Who's Next?”
While it would be a game-changer if GSK does this, given their record, and the record of every major big pharma player, it’s too easy for me to take a jaded look at the statement in the belief they’ll find loopholes or may already have found them and thus it’s why they’re willing to support them.
The only other possibility is they reached a point where the lawsuits mounting against them or about to for the latest deaths, etc. must be so great that they’re going to use this as a pre-positioning of “but we’re already changing our ways, so please be lenient…” strategy.
Re: Re:
That. I’m highly skeptical about this one. Once a liar most often always a liar.
Re: Re:
There is a post on hold showing how open source, databases and crowd sourcing can become a problem if they try to hide it.
The problem is, people can now check those claims, every single person taking those medications can log their results in an online database if they choose to do so and that data can contradict false claims in a very public way, with a sample size that would be very difficult to negate.
They are not doing this because they care about patients, they are probably doing this because they know that the patients will come after them with a vengeance if they catch them lying and hiding stuff and it is getting easier to find out about those.
I think they don’t want to end up like the tabaco companies that is all.
Is not that pharma companies don’t want to hide things, is just that they probably can’t do it with that set of data anymore.
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? agree. I think the cost of hiding possible side-effects has increased and the “user-generated” data on a field by doctors reporting any complications that is related to the medicine is starting to be a severe burden for them.
I think that GSK wants to use these extended studies as an argument against previous knowledge claims and to avoid myths about their products. If they can hurt the competitors playing dirty in the process, it is a bonus!
I am still reluctant to see this as a voluntary move here is why:
– Social media changed a lot of things and websites like Patients Like Me are starting to appear more frequently and actually have useful information in it.
Other sources: Wikipedia: Health Websites
– Open source initiatives for test trials are enablers of crowd sourcing studies.
PubMed: Learning from hackers: open-source clinical trials.
Wikipedia: Open Source Healthcare Software
CNET: Now we have open source for clinical trials, too
openCDMS – The open source clinical data management system
Before we really didn’t have the means to check up on claims, now people actually can do it by themselves, every person that uses a medication can report what it happens to them, how they feel and that can all be put into a database for all to see, hiding that stuff could become a risk proposition from now on.
So I just think they saw the writing on the wall and what it would mean to them to be caught trying to put that dirt under the rug, maybe they looked the tabaco industry history and thought, “hey that could be us in a couple of years, what can we do?”
That Ben Goldacre also has some talks on TED talks for those who are interested:
http://www.ted.com/talks/ben_goldacre_battling_bad_science.html
http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_the_drugs_they_prescribe.html
Maybe next, a complete investigation of the pharma industry is in order. Every public shooting incident of the modern era has one underlying thread that binds them together: every one of the perpetrators was on prescribed psychotropic drugs at the time of the shooting in which they were involved. These drugs are known by their very nature to alter one’s mental state and often make things worse for the one taking them rather than better. I know this firsthand, as I once was on Zoloft, one such drug, for a time and I still remember how, despite being an antidepressant, it actually had the opposite effect instead. Fortunately I’m long since off of it, but you all should know that these drugs can kill a person’s empathy and cause extreme changes from his or her normal state of mind. Yet they are one of pharma’s deliberately designed legal addictions. After all, a person dependent on their product is more profitable for them than a healthy person who doesn’t need it.
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While psychotic side-effects to some modern psychotropic drugs are known and a concern, you really have to be careful about inferring causation.
Assuming this is true (I don’t know one way or the other), I don’t find it surprising. Not because the drugs are causing the behavior, but because these people were already mentally ill and therefore very likely to be receiving treatment.
I’m not saying that the drugs didn’t contribute to the actions, but that the fact that all the shooters were on them is not nearly solid enough evidence to make that claim.
It is enough evidence to investigate the situation, though.
What's Next?
What’s next? That these asshats will just lie about the results of their testing, or skew the results? GSK and others have no real interest in truth, just in selling us more crud to make them more $$. Am I cynical? Nah! Just observant of their past/present/continued behavior… 🙁
Time to call for the death penalty
If GSK knowingly put an unsafe product on the market that caused 100,000 heart attacks, (in the US alone, and who knows how many elsewhere), and statistically a non-trivial fraction of them ended up dead, this makes GSK a mass murderer.
Where is the accountability? If an individual had killed that many people, the news would be calling for his head. But when an individual who is a corporate executive makes a decision for his corporation that ends up killing that many people… the silence is deafening.
Re: Time to call for the death penalty
Where’s the accountability?
It’s in those TV commercials, where they rattle off the possible side effects. More and more include death as one of the side effects. So uh, they’re covered.
Decision Making
“If doctors have the full facts about all the drugs they can prescribe, they are in a better position to choose wisely”.
I’d love to see doctors prescribe based on anything besides which sales rep. schmoozes them.
High costs
It would be something of understatement to say that the spiralling cost of healthcare has become a highly-charged political issue
Oh well, and they did give some companies the possibility to apply for government granted monopolies on drugs? And now they’re astonished that some drugs cost $1500 instead of $10 (
http://boingboing.net/2011/03/14/10-drug-becomes-1500.html)?
While it’s possible the patent system might indeed work for drugs as expected (within the frame of the patent system), it obviously leads to high cost in healthcare.
MONEY > HUMAN LIVES
nuff said. needa go puke now.