Big Pharma Taken To Task About Their Underhand Tactics

| September 17, 2013

From the end of September, the Health Research Authority will require trials to be registered before they can receive approval from an ethics committee. That’s half the battle won.

It looks like finally our message is coming through. Today, UK Members of Parliament have warned that Big Pharma and medical researchers are putting patients’ lives in danger by failing to publish negative and unfavourable results from clinical trials.

It’s a known fact that many drug trials are not registered before they have been completed. To make matters worse, in most cases Big Pharma holds negative results as private documents that cannot be scrutinised by patients or independent experts.

At Agora Health, we have been warning that drug companies will do everything in their power to get away with whatever they can to look after the interests of their shareholders… and sadly that includes not publishing the negative results of their studies or disclosing all the side effects of their drugs.

The practice skews the information that is available to doctors because trials that show new experimental drugs in the best light are more likely to be published. So, the very people who are supposed to keep their patients’ safety and care first, can’t make the right decisions and drug recommendations because they do not have the full facts.

Campaign For Safer Medicine

In a report delivered to ministers, MPs express dismay at the government’s poor efforts to tackle this problem and set out concrete proposals to make data from clinical trials more openly available.

Adding to this, in a very enlightening talk about Big Pharma’s unscrupulous tactics, researcher Ben Goldacre said that industry funded trials are 4 times more like to show flattering results than independently sponsored trials.

In other words, if Big Pharma is paying for a particular drug trial it’s far more likely that, based on their tampered results of that trial, we’ll soon see a new ‘wonder drug’ being let loose on the public.

The JUPITER Study — one of the largest and most influential cholesterol-lowering statin trials, is a shining example of this. The trial tested the effectiveness of statin drugs like Crestor. The initial results showed astounding positive effects in favour of statin drugs. Before we all knew it, Crestor became one of the top selling drugs of all time because the mainstream quickly jumped on the ‘wonder drug’ bandwagon.

It turns out, that those amazingly positive results were completely biased. Closer investigation revealed that almost all of the JUPITER researchers were guilty of receiving financial incentives (from AstraZeneca, makers of the super- strong statin, Crestor, who also sponsored JUPITER), therefore committing themselves to “selective outcome reporting”. This means that they only disclosed results that fell in favour of statins, thus painting a much rosier picture than would’ve been the case if they’d included a full list of the drug’s horrendous side effects.

JUPITER also proves that even if the negative results of a trial are not published it does not mean that the drug won’t be approved and pushed onto the market.

Andrew Miller, chair of the Commons science and technology committee, said: “Many of the trials taking place today are unregistered and unpublished, meaning the information that they generate remains invisible to both the scientific community and the public. This is unacceptable, undermining public trust, slowing the pace of medical advancement and potentially putting patients at risk.”

In recent years, the pharmaceutical industry has come under intense pressure to release more clinical trial data. Today, MPs called for government action to speed the process, by requiring all future trials to be registered, and summaries of trial results to be made public. More detailed “clinical study reports” should also be released, with redactions to protect patient privacy, when they have already been prepared for regulators.

In another recommendation, the MPs urge the government to demand the registration of past trials too, with summary results released for all publicly funded trials since 2000.

Failure to release clinical trials data has led to hefty fines for some pharmaceutical companies. In 2004, GSK paid $2.5m to settle a consumer fraud case during which it emerged that the company had lied about the safety and effectiveness of its antidepressant Paxil, also known as Seroxat.

Iain Chalmers, co-ordinator of the James Lind Initiative at Oxford University, which lobbies for better trials, said “Quite apart from the risks posed to patients of hiding the results of research, it’s completely ridiculous that people think discovering useful drugs is going to be efficient if you bury half or more of the stuff that you find.”

Dr Carl Heneghan, director of the Centre for Evidence-Based Medicine at Oxford University, said more openness was essential for the development of better healthcare and medicines in the future.

From the end of September, the Health Research Authority will require trials to be registered before they can receive approval from an ethics committee. That’s half the battle won.

Our aim with the Campaign For Safer Medicine is to collect more than 1 million email signatures. We’ll then present this evidence to the UK government and to other governments around the world and put pressure on them to change the law and to make the pharmaceutical industry fully accountable for their actions… and that includes not publishing the full results of their studies.


Take action right here and now!

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Stop Big Pharma… and help save thousands of lives.


Sources:

‘New reports: Risk of cholesterol drugs’ by DR. GIFFORD-JONES, published online, 30.04.11, torontosun.com

BMJ 2008;337:doi:10.1136/bmj.a2286 (Published 6 November 2008)

Unfavourable results from medical trials are being withheld, MPs warn, published online 17.09.13, theguardian.com

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Comments (3)

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  1. Andy says:

    The involvement of drug companies in funding their own trials create a conflict of interest and is the driving force behind these skewed positive results. That’s a fact.

    If your going to sell a drug (potentially making billions) then you will do anything to see to it that it gets sold… even at the cost of countless human lives.

    The solution is to remove drug companies from these studies. All studies should be government funded and the funds should come from the heavy taxation of drug companies.

  2. Helen says:

    The amount of people dying because of drugs side effects is hidden away. MS drugs for instance are all deadly and many cause PML too.

    TRUTH is are these corporations raking in Billions don’t care.

  3. Donnie says:

    I totally agree. All trials – big and small – must be registered. It should be a requirement to publish results when a marketing authorisation is applied for.

    No results published = No drug on the market.