The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience

One Click Note: Succinctly put for the layman, this paper means that many of the big-seller pharma drugs doled out to you by your drug dealer doctor are suss because their data has been purposefully suppressed by the pharmaceutical industry. Moreover this data suppression has been actively sanctioned by the various authorities charged with the overview of drug 'safety'. Combine this with the cosy relationship enjoyed by pharma with the medical press stuffed with ghost writers and bent academics means that the general public are experiencing drug deception on a truly monstrous scale.

People like Peter Doshi and Tom Jefferson who are amongst the authors of the paper published below have been banging on about pharma corruption in its many guises for years. Neetu Vashisht and Jacob Puliyel in the Indian Journal of Medical Ethics have just outed the fact that the very polio vaccine itself is causing paralysis and death. The WHO gets round this by breathtaking semantics, declaring India a polio-free zone by renaming the disease. The WHO is refusing to count the numbers in their multiple thousands destroyed by a form of polio paralysis generated precisely by the polio vaccine itself. This is the same WHO that, prompted by pharma, decided to recalibrate its pandemic criteria thus unleashing Swine Flu hysteria upon the world.

The noxious smell currently wafting over the medical industry in all its guises is beginning to stink as badly as Bhopal.

Congratulations to all those authors with the courage to challenge the pharma behemoth, placing their valuable work freely in the public domain.

The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience

1 Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America, 2 The Cochrane Collaboration, Roma, Italy, 3 Centre for Research in Evidence-Based Practice, Bond University, Gold Coast, Australia

Citation: Doshi P, Jefferson T, Del Mar C (2012) The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience. PLoS Med 9(4): e1001201. doi:10.1371/journal.pmed.1001201

Summary Points

Systematic reviews of published randomized clinical trials (RCTs) are considered the gold standard source of synthesized evidence for interventions, but their conclusions are vulnerable to distortion when trial sponsors have strong interests that might benefit from suppressing or promoting selected data.
More reliable evidence synthesis would result from systematic reviewing of clinical study reports—standardized documents representing the most complete record of the planning, execution, and results of clinical trials, which are submitted by industry to government drug regulators.
Unfortunately, industry and regulators have historically treated clinical study reports as confidential documents, impeding additional scrutiny by independent researchers.
We propose clinical study reports become available to such scrutiny, and describe one manufacturer's unconvincing reasons for refusing to provide us access to full clinical study reports. We challenge industry to either provide open access to clinical study reports or publically defend their current position of RCT data secrecy.

Regulatory approval of new drugs is assumed to reflect a judgment that a medication's benefits outweigh its harms. Despite this, controversy over approved drugs is common. If sales can be considered a proxy for utility, the controversies surrounding even the most successful drugs (such as blockbuster drugs) seem all the more paradoxical, and have revealed the extent to which the success of many drugs has been driven by sophisticated marketing rather than verifiable evidence [1],[2]. But even among institutions that aim to provide the least biased, objective assessments of a drug's effects, determining “the truth” can be extremely difficult.

While the WHO recently added Tamiflu to its Essential Medicines list, if FDA is right, the drug's effectiveness may be no better than aspirin or acetaminophen (paracetemol).

In updating our Cochrane review of neuraminidase inhibitors, we have become convinced that the answer lies in analyzing clinical study reports rather than the traditional published trials appearing in biomedical journals

There are strong ethical arguments for ensuring that all clinical study reports are publicly accessible. It is the public who take and pay for approved drugs, and therefore the public should have access to complete information about those drugs. We should also not lose sight of the fact that clinical trials are experiments conducted on humans that carry an assumption of contributing to medical knowledge. Non-disclosure of complete trial results undermines the philanthropy of human participants and sets back the pursuit of knowledge.

FULL TEXT
The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience
Peter Doshi, Tom Jefferson, Chris Del Marm, PLoS Medicine

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Related Links:
* Drug Data Shouldn’t Be Secret
Peter Doshi & Tom Jefferson, The New York Times
* Roche's Tamiflu scandal questions the entire process of systematic review
Michael Smith, medpage TODAY
* 14 Year-Old Boy Jumps From Apartment Window After Taking Tamiflu
BERNAMA, Malaysian National News Agency
* Fatal Reactions And Injuries Occurring With Tamiflu 'Swine Flu' Drug
Jeremy Laurance, New Zealand Herald
* US reviews risks of Tamiflu after 12 children die
Jeremy Laurance, The Independent
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