With thanks to the One Click Group 12.4.12:
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.
The noxious smell currently wafting over the medical industry in all its guises is beginning to stink as badly as Bhopal.
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.
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. Peter Doshi1*, Tom Jefferson2, Chris Del Mar3. 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. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1001201 Published: April 10, 2012
ONE CLICK EXTRACTS: 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 ,. 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.
See Why Most Published Research Findings Are False Ioannidis JPA (2005) Why Most Published Research Findings Are False. PLoS Med 2(8): e124. doi:10.1371/journal.pmed.0020124 ‘… There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research…’
See A key player in stoking this Swine Flu hysteria was Dr Iain Stephenson, a Consultant at University Hospital of Leicester NHS Trust who has been found guilty of vaccine research fraud on a grand scale by the General Medical Council (GMC).
See Thirteen per cent of scientists or doctors have said they know of colleagues who have fabricated data in order to get research published. More than one in ten (13%) scientists or doctors have witnessed colleagues intentionally altering or fabricating data to get published or during their research, a poll suggests. The survey of almost 2,800 experts in the UK also found 6% knew of possible research misconduct at their institution that has not been properly investigated. The poll, for the British Medical Journal (BMJ), is being presented at a meeting aimed at tackling research misconduct in the UK. 13 January 2012
See Mental scores decline precipitously at 30 months after anthrax vaccine, but CDC spins study to say vaccine safe Thursday, January 12, 2012
See http://www.theoneclickgroup.co.uk/news.php?id=6732#newspost Patient No. 28665 was helping a Chesterfield company test a drug dubbed the “female Viagra” but stopped showing up for exams in December 2007. That didn’t stop a staffer of the company, PPS Clinical Research STL, from claiming that six months later the patient came in for an exam, was diagnosed with medical conditions, had undergone tests and even had given a urine sample. That admission was made in the company’s guilty plea to a federal felony charge of obstructing a proceeding of a federal agency. The drug the company helped test, aimed at women who suffered from an unexplained lack of sexual desire, never made it to market. As part of the plea, PPS admitted that it “corruptly influenced, obstructed, and impeded” an inspection by the Food and Drug Administration by providing false patient records in May 2010. During the trials, the drug’s manufacturer faulted PPS for failing to have a trained investigator conduct some exams, for back dating records and for failing to properly oversee one patient’s selection for the study, according to prosecutors. Boehringer did not respond to emails seeking comment.
See http://www.theoneclickgroup.co.uk/news.php?id=6610#newspost A well-known psychologist in the Netherlands whose work has been published widely in professional journals falsified data and made up entire experiments, an investigating committee has found. Experts say the case exposes deep flaws in the way science is done in a field, psychology, that has only recently earned a fragile respectability.
See Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments. Michelle Roseman, BA; Katherine Milette, BSc; Lisa A. Bero, PhD; James C. Coyne, PhD; Joel Lexchin, MD; Erick H. Turner, MD; Brett D. Thombs, PhD. JAMA. 2011;305(10):1008-1017. doi: 10.1001/jama.2011.257