|  Aubrey Blumsohn, MBBCh, PhD, MSc, BSc(hons), MRCPath is a pathologist by training (specialist registration in Chemical Pathology) with specific interest in clinical and laboratory aspects of skeletal function in health and disease, and the impact of nutrition on skeletal function. He received his training in South Africa, Sheffield, Manchester, Leeds and Dundee.
All academics should be watching closely. The muddle of academic medicine will inevitably continue to spill over into the rest of academic life. It is hard to see how appropriate safeguards for dispassionate and honest academic discourse can be sustained when medicine so flagrantly disregards them. For this reason, academic trade unions across the Atlantic (especially the Canadian AUT) have devoted considerable and specific attention to the problem of academic freedom in medicine. They have supported many academics under pressure and have compiled relevant and extensive guidance running into several volumes, many of which are available online (7,8,9). Sadly the AUT in the UK has not been as clear sighted. Beneath the radar
These subtle compromises have already had calamitous consequences for patients and for public trust in science. There have also been some spectacular explosions. Many explosions All drugs have side effects – that is not the problem. The problem is that Merck reportedly stacked the deck in their favour and disobeyed the rules of science. We learn that they hid away or distorted bits of the jigsaw of information guiding clinical decision-making so that patients and doctors could not make rational judgments. They used university academics to do this for them. Merck carried out studies which were carefully designed to avoid exposing the risks of the drug instead of trying to challenge the nul hypothesis of no-risk. They selected research volunteers who were less likely to experience predictable adverse events. They designed studies which were too short to allow adverse effects to become manifest. They failed to include a placebo arm in studies when it was appropriate to do so. They tried to create as wide a market as possible even when it was obvious that a problem was going to arise (and perhaps precisely in order to maximise profits prior to legal challenge). Richard Horton, editor of the Lancet, wrote: "With Vioxx, Merck and the F.D.A. acted out of ruthless, short-sighted, and irresponsible self-interest." And they cheated – not declaring some worrying data in one publication, and through the use of statistical sleight of hand in another. Many fingers have pointed at Merck. They face thousands of court cases and have already lost three. No individual within that company has been prosecuted for what seems to be a corporate scientific crime. But Merck could not have achieved this without the collusion of its paid academic “thought leaders”, government drug regulatory bodies and medical journals. Misleading and selective publications were fronted by university academics, but data analyses and “key messages” were from Merck. It appears likely that university authors had not sought to check the analysis of data presented in their names, despite clear reasons to think that they should have done so. The company used these paid academics to give their research a veneer of credibility while undermining the very basis of that credibility. Academics were also carefully selected, and Merck arranged to sideline researchers who were asking awkward questions. Similar concerns have been raised about many other drugs. It is for example becoming increasing apparent that scientific findings relating to the risk of suicide with some commonly used antidepressants have been distorted. University academics were again involved in fronting misleading science. Incomplete information was provided by companies to authoring academics and the regulators, and this information was simply accepted with blind faith. Manipulated "scientific" information was written by companies as if it derived from University academics (as happened in Sheffield). It is also apparent that the drug regulator (The Medicines and Healthcare Regulatory Agency, MHRA) failed to properly investigate, and provided gobbledegook responses to the mounting barrage of concern from patient support groups and public policy analysts. Patients believe that key players within the MHRA including Sir Alasdair Breckenridge previously worked for Glaxo Smith Kline the maker of Seroxat. It is worth paying a visit to some of these patient support websites, to marvel at their tireless efforts to get answers to simple questions (10). As doctors and as researchers we should be ashamed. In the trenches: Shot at dawn In 1997, David Kern, a professor of medicine at Brown University in the USA discovered a new occupational lung disease affecting individuals in an important local industry. On notifying the company of his plans to publish a scientific paper and to disseminate these findings (as was his professional and moral obligation) the company threatened to sue him. A week after presenting his findings at an academic meeting, Brown University notified him that his teaching and research positions were being eliminated. In 1990, Betty Dong, a researcher at University of California at San Francisco (UCSF) was funded by Boots Pharmaceuticals to carry out research on a widely use thyroid treatment (Synthroid). She discovered that the Boots drug was no more effective than three much cheaper competitors. When she tried to publish her findings Boots threatened to sue, and the publication was withdrawn. She received no institutional support. Nine years later, the story was exposed in the lay press and Dong’s paper was published. In 1999/2000 the company paid $170 million to settle class action lawsuits. However it has been estimated that the company made a profit of $3billion in inflated costs during the nine year delay. In 2000, Professor David Healy, a psychiatrist, accepted an offer of an academic position at the University of Toronto. After mentioning his concerns about a possible link between the use of certain antidepressants and suicide at an academic meeting, he was fired from his post. At the time, the center was recipient of a $1.5-million gift from Eli Lilly, the manufacturer of Prozac. The questions he raised have since assumed overwhelming importance. A few years earlier, Nancy Olivieri, a paediatric haematologist at Toronto University was threatened with legal action by a company (Apotex) when she wished to publish results from a clinical trial against the interests of the sponsor. The University of Toronto fired her. It emerged that the University and hospital had been courting Apotex for grants totally $55 million. Her case formed part of the background to the recent film “The Constant Gardener”. In many such cases the involved University attempted to trivialise the academic problem, harassed the academics involved, and even colluded with the company to allow scientific fraud and suppression of findings to be obscured. Skulduggery: Collusion of government in pharmaceutical scientific fraud In 2005, an extensive report of the House of Commons Health Select Committee raised many concerns about the MHRA. The report pointed out that the agency fails to properly scrutinise data before licensing drugs (showing the same reckless disregard for patients as do academics who front company interpretations of data in the journals). It pointed out that the MHRA is 100% funded by the companies it supposedly regulates. It pointed out that user reports of often serious problems had been systematically discounted or ignored. It recommended a fundamental review of the agency. Yet nothing has happened. Despite widespread parliamentary, professional and public concern and anger about the MHRA, no meaningful steps have yet been taken by the government to safeguard pharmaceutical science, the public interest or public health by carrying forward the required review or promised criminal investigations. Those “investigations” which have been carried out have been self-investigations (such as the self investigation of the MHRA following the recent TGN1412 disaster in London in which 6 healthy volunteers were damaged) which most observers feel have been a sham. Astonishingly, the department of health seems now to be asserting (correspondence as of last week) that the MHRA does not have any legal remit to investigate scientific fraud or ghostwriting by companies in studies involving pharmaceuticals, or in the use of such science in promotional material. Things are no better across the Atlantic (6). While lawmakers search for ways to ensure that companies do not hide adverse data, the Bush administration continues to act to help drug companies escape accountability for corporate scientific crimes. Two weeks ago the FDA (Food and Drug Administration) announced an astonishing preemption rule that would disallow lawsuits against drug makers if a drug has been approved by the FDA – even in the case of scientific fraud or withholding of information by a company (6). Never in recent history has there been such a flagrant attempt by government to shield private enterprise against litigation for corporate criminality. With governments setting the standard for scientific conduct, it is hardly surprising that industry recruited academic “thought leaders” (perhaps academic prostitutes) continue to function with impunity. Sheffield The Vice Chancellor of The University of Sheffield referred in correspondence with CAFAS (the Council for Academic Freedom and Academic Standards) to an investigation by the MHRA. This was instituted following parliamentary discussion about The University of Sheffield. The University is aware that there is no such investigation (or at least one fitting the definition of an investigation). The MHRA declined to accept any documentary evidence from me. Even more astonishingly it claims that the agency has no legal remit to investigate scientific fraud in pharmaceutical research after it has licensed a drug, that it has no remit to investigate ghostwriting by companies on behalf of university academics. The MHRA have also stated that they have no procedure for investigation of scientific fraud. Finally it claims that the fact that a scientist obtained some raw data pertaining to information written in his name without the consent of a company is “illegal”! Woe be to us all. The single MHRA investigator who apparently declined to investigate appears to have no scientific publications and the agency has refused to reveal what qualifications he has to others questioning his role in another case (TGN1412). That MHRA officers understand little of medicine was apparent from a press statement noting the disinclination of the MHRA to investigate (discussed at 11). Those who have followed this story will realise that P&G eventually supplied the raw data underlying material written in my name about the drug Actonel. These data, and many documents and dozens of tape recordings show evidence of scientific fraud. The fraud is not subtle – it would be quite evident to the “average man on a bus”. Two excellent statisticians have been involved and have confirmed the obvious – Professor Martin Bland for the BBC using data it was claimed I “stole” from P&G and later Professor Jane Hutton. Yet even the obvious is possible to obfuscate for at least a period of time. The University of Sheffield is apparently involved in some sort of investigation of part of the data, but I am not involved. Quite what they are investigating, and who is doing such an investigation is by no means clear. Journals: The operational tactics The whole structure of science in pharmaceutical medicine has failed, and the MHRA, journals and clinical academics have colluded in that failure. Other academics should take heed. References Reproduced, with permission of the author, from Council for Academic Freedom and Academic Standards http://www.cafas.org.uk/update51.pdf | |||||||||||||||||||||||||||||
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