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The licence for Avandia was revoked in Europe, in September 2010, because of evidence that it could cause heart failure and heart attacks.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.
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.