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24 December 2011

The Financing of Drug Trials by Pharmaceutical Companies and Its Consequences

RebornHammer accused me of not reading the meta-study "The Financing of Drug Trials by Pharmaceutical Companies and its Consequences" (Schott et al, 2010) (I referred to the authors as Lieb et al in the discussion). I disagree as I did read it and I think my understanding of the meta-study is better than RebornHammer's.

RebornHammer:
tinyurl com/6qjmgb4 PROZAC is so great!! A study on trials of SSRIs revealed that those with significant results were more likely to be published, sometimes more than once, whereas trials with non- significant results or findings unfavorable to the drug under investigation (intention-to-treat analyses versus per-protocol analyses) were not published
wstevenschneider:
1) This article is not a criticism of peer review or science, it's a criticism of pharmaceutical companies and how they try to thwart the science that exposes inefficacy or side-effects of their products. Lieb et al are encouraging government to take steps to see that this doesn't happen and that science continues to hold pharmaceutical companies accountable for evidence.

2) This in no way is evidence supporting Homeopathy.
RebornHammer:
@wstevenschneider thats evidence for a bias against homeopathy and any research or peer review that might prove it to work..

@wstevenschneider And that is why every time you ask for peer review proving homeopathy you are asking for something that is unlikely to ever exist under the current political/ medical situation on the planet earth.

@wstevenschneider hello? can you read? what this is is a criticism of peer review that is used by the medical community to choose treatments for their patients. The point is that the pharmaceutical industry is out of control, and owns(through contributions and donations) most of the most highly respected peer review for medicine out there. This means that if it's not a pharmaceutical drug it does not get the light of day. Homeopathy is not a pharmaceutical drug.
Let's read "The Financing of Drug Trials by Pharmaceutical Companies and its Consequences" (Schott et al, 2010) together.

Methodology

Fifty-seven independent studies looked at various trials that were funded by pharmaceutical companies. These studies were then organized into a meta-study to get a more comprehensive view of what is going on when pharmaceutical companies fund research.

Results

Incomplete registration
With the aim of facilitating public access to clinical trial data and preventing pharmaceutical companies from influencing the publication of results, in 2004 the International Committee of Medical Journal Editors (ICMJE) made registration a condition for publication in any of the 11 leading medical journals (7): new trials had to be registered by 1 July 2005; those already under way, by 13 September 2005. Meanwhile several reg- isters fulfill the ICMJE standards.

In January 2005 major pharmaceutical organi- zations, among them the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Inter- national Federation of Pharmaceutical Manufacturers and Associations (IFPMA), implemented guidelines that obliged their members to enter trials prospectively in publicly accessible registers (8, 9).

Despite this, two of the 57 studies included in the present investigation contain data suggesting that phar- maceutical companies are still not registering important information on clinical drug trials.
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Evidence that some pharmaceuticals are not disclosing their funding of drug-trials.
Concealment of adverse drug reactions
Seven of the studies investigated concerned themselves with adverse drug reactions (ADRs) in industrially sup- ported drug trials (Table).
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Evidence that some pharmaceuticals are repressing the publication of self-funded trials that reflect negatively on their product.
Publication bias
Of the 57 studies included in this investigation, 14 ana- lyzed the connection between the type of funding of a trial and publication bias.
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Evidence that some pharmaceuticals only present the self-funded trials that reflect positively on their product to the FDA.
Rights over trial data and restricted publication rights
Two investigations on this topic were identified. Both an analysis of the protocols of all studies initiated and published by pharmaceutical companies in a particular region of Denmark in 1994 and 1995 (e28) and a ques- tionnaire survey of medical specialists in Australia (e29) indicated that in some trials pharmaceutical companies secure the rights over the data and place constraints on publication rights.
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Evidence that some pharmaceuticals consider the methodology, results and data from the drug trials on their product to be propriety information, particularly if they are funding the trial.
Ghostwriters and guest authors
A case study on rofecoxib (e5) and an investigation into the above-mentioned studies in Denmark both found evidence of frequent resort to ghostwriters and guest authors in industry-funded publications. The Denmark investigation showed that statisticians employed by pharmaceutical companies are frequently not men- tioned in the published articles (e4).
Evidence that some pharmaceuticals attempt (and succeed in some cases) to control the direction of and what is said in the report of a trail they are funding.

Conclusion


This systematic review clearly shows that clinical trials with the involvement of pharmaceutical companies often present the therapeutic benefit of a drug in too positive a light and also fail to mention risks. Clinical studies are increasingly being funded by pharmaceuti- cal companies (e32­e35). Professional medical bodies construct evidence-based guidelines on the basis of published trial results, so their recommendations may be flawed. This contributes to excessive prescription of expensive new drugs whose efficacy is overestimated and risks underestimated. Moreover, because the evi- dence is distorted patients do not receive adequate in- formation (14).

In the past few years measures have been taken worldwide to deal with the problems described here. Laws have been enacted, for example, with the inten- tion of securing public access to research data (15­18). In the USA, for instance, a law of 27 September 2008 prescribes the registration and publication of the results of clinical trials in a register accessible on the internet (15, 19). In the European Union, directive 2001/20/EC requires registration of all clinical studies (16). A guideline implemented in 2008 lays down what classes of information from the EudraCT database-- accessible only to governmental authorities--should be made available in the publicly accessible EudraPharm drug database, which thus remains incomplete (17, 18).

Pharmaceutical organizations have implemented recommendations that are intended to ensure compre- hensive publication of research findings, whether posi- tive or negative (9, 12, 20). This initiative on the part of the pharmaceutical industry is welcome; however, the present investigation shows that negative results are still not being published in timely fashion and control mechanisms have failed.

Official regulatory measures to guarantee public access to study protocols and results and prevent the withholding of information about dangerous ADRs are urgently required. This would also give independent drug bulletins and bodies representing physicians, e.g., the Drug Commission of the German Medical Associ- ation, the opportunity to obtain detailed, unbiased in- formation about new drugs. Furthermore, it should be obligatory to prove that a new drug provides additional benefit compared with existing pharmacological and non-pharmacological forms of treatment. More public funding should be made available for independent studies (21, 22).

Measures must be taken at many levels to ensure that commercial interests do not undermine the knowledge of scientifically correct study planning, study execu- tion, and publication (4, 5, e15, 15, 23­25, e36, e37). A large number of physicians are involved in the planning and conduct of drug trials. For the benefit of their pa- tients, they should assume greater responsibility and work to counteract the economic self-interest of pharmaceutical companies in research and clinical practice.
This meta-study is not an indication of the corruption of peer review though it does indicate that some pharmaceutical companies attempt to subvert the peer review process in pursuit of profits. What the meta-study does show, albeit indirectly, is the self-correcting nature of peer review at work. Science is always questioning things, even its own conclusions. Peer review is also subject to this scrutiny.

Here we see scientists taking a look at a particular portion of peer review, in this case drug-trials, and finding evidence of pharmaceutical companies trying to subvert the peer review process. This meta-study serves to alert researchers, journal editors, medical doctors and policy makers of these subversion attempts.

Furthermore, the meta-study acknowledges that, while progress has been made countering some of these threats to peer review, more effort is required as more pharmaceutical companies are starting to fund research. Schott et al calls for several things:
  • Official regulation of drug-trails to guarantee public access to studies and provide disclosure of adverse drug reactions.
  • New drugs should provide benefits beyond that provided by old regimes.
  • Increase public funding for more independent studies.
  • Improved measures to prevent commercial interests from subverting the research and the peer-review process.
  • Doctors to be proactive in countering the commercialization of medical science.
It does not follow that because there are pharmaceutical companies that attempt to subvert research and peer review that the peer review process is unreliable.

In fact, much of the message that comes from this meta-study is that the reader should be wary of pharmaceutical-funded clinical trials. As usual, the trials to go to are the publicly-funded, independent third-party studies that have no vested interest in the success of the drug being reviewed.

Far from being evidence that peer review and medical science are corrupt and unreliable, this meta-study shows us that peer review allows scientists to verify attempts to corrupt the process and to suggest corrections. It also demonstrates that science is out to protect the well-being of the general public and that pharmaceutical companies must continue to be held accountable.

While no one disputes peer review is not without its flaws, it is the only thing preventing pharmaceuticals from corporately raping the public. This meta-study serves as a call-to-arms to protect the integrity of peer review from being subverted by pharmaceuticals whose main interest is producing profit for their share-holders.

So, RebornHammer I'm curious as how you got, "The point is that the pharmaceutical industry is out of control, and owns(through contributions and donations) most of the most highly respected peer review for medicine out there," from Schott et al when this is clearly not what the meta-study says. I get the impression that you read the abstract and drew your own conclusions without bothering to find out what the meta-study actually said.