The decision to rescind Healy’s job offer caused uproar in Canadian academic circles because Lilly had donated $1.5 million to the centre. James Turk, executive director of the Canadian Association of University Teachers, explained that ‘Development is a euphemism here for fundraising. I read that as meaning your appointment will make it more difficult to raise the money that we need to pursue our programmes.’37 An international group of physicians that included two Nobel Prize winners published an open letter to the president of the university where they wrote that ‘To have sullied Dr Healy’s reputation by withdrawing the job offer is an affront to the standards of free speech and academic freedom.’38
The stakes were huge. Lilly made $2.6 billion from Prozac in 2000 alone and had just succeeded in getting the drug renamed and repackaged as Sarafem, for severe premenstrual tension, which would keep the profits rolling in until 2007, although the patent for Prozac was just about to expire.37 Healy’s findings weren’t new. Six months earlier, Healy had published his concerns in the Hastings Center Report, which caused Eli Lilly to withdraw its support to the Hastings Center.38 Industry money is everywhere, like a metastatic cancer that threatens to kill our societies as we know them and our free speech.
Healy suspects that Charles Nemeroff (see Chapter 17) was behind his rescindment.37 Nemeroff had strong links, including shareholdings, to manufacturers of SSRIs that had been involved in court cases where Healy was an expert witness. Nemeroff was present at the Toronto meeting and announced at another psychiatric gathering the next day that Healy had lost his job, before Healy knew it himself. Nemeroff was hostile to Healy’s work and had berated him a year earlier over Healy’s study that showed that two out of 20 healthy volunteers became suicidal on sertraline.39According to Healy, Nemeroff had stated that Healy had no right publishing material like that, and that it was immaterial what psychiatrists did, as the companies were answerable to their shareholders and profit was the bottom line.
David Healy has written more than anybody else about the outrageous frauds big pharma has committed in their research and marketing of SSRIs. He describes how he has run into a legal wall with publishers with about 10 of his papers, even with the journal Index on Censorship, which self-censored.40 Another author who wrote a book about the risks of suicide and homicide made Lilly threaten to sue him in 50 different countries.
Planting industry friends in the auditorium works like spies under dictatorship rule who report their observations about enemies of the state. Under a freedom of information request, Healy saw a document from Lilly about informants ‘to monitor what he says and see whether he can be sued’. Lilly seems also to have threatened to pull out of its business in the United Kingdom if Zyprexa wasn’t featured prominently in NICE guidelines!
Nancy Olivieri from the Hospital for Sick Children, the University of Toronto, was fired after having communicated her concerns about the harms of a drug she was investigating. The university was negotiating a donation of $20 million from Apotex, the company involved, and Apotex sued her for breaching a confidentiality clause she had signed when she started her research.38,41
What both cases at the University of Toronto illustrate is the danger that can arise from university reliance upon industry ‘philantropy’.38 When career success for deans and other higher-ups is measured in significant part by their ability of raise vast sums of money from corporate donors, whistle-blowers and other critics of drugs cannot expect much support.
Another university affair took place in the United Kingdom in 2005 at the University of Sheffield. Aubrey Blumsohn, the lead author of two papers on Actonel (risedronate), an osteoporosis drug marketed by Procter & Gamble, was prevented from seeing the full data that were to be published in his name,42 although he had concerns about the interpretation of the data.43 The research dean at the university, Richard Eastell, who was on the company’s advisory board and had attracted grants from the company to the university of £1.6 million in recent years, advised caution.44
But only towards the company it seemed. He didn’t proceed cautiously towards Blumsohn, who was suspended from his university post 2 years later after he had threatened to speak to medical journalists about the issue.43,44 Blumsohn taped secretly a conversation with Eastell where Eastell said, ‘The only thing that we have to watch all the time is our relationship with P & G.’ Procter & Gamble had told Blumsohn that a ghostwriter was familiar with the ‘key messages’ they wanted to convey about the drug.
Procter & Gamble’s defence for not sharing the data was pathetic and even ironic. They said that by doing so, they would lose the opportunity to demonstrate their ability to be ‘a true partner in scientific endeavours’. In contrast, Blumsohn had stated in a letter to Eastell that ‘no self-respecting scientist could ever be expected to publish findings based on data to which they do not have free and full access’. Eastell had some sympathy with this view, as questions had been raised about how much of the data on the drug’s performance he himself had seen in the past in relation to papers he had his name on. Eastell later had to admit that the statement – that he and the other authors had seen all the data – was wrong, and he was subjected to a General Medical Council hearing about this falsehood.45
When, after numerous approaches, Blumsohn was finally allowed to see limited data, including the key graphs, 40% of the data had been left out and ‘everything we’d been told was just nonsense’.
Blumsohn was suspended on the grounds that ‘his conduct over these past months amounts to and constitutes conduct that is quite incompatible with the duties of office’. The university could equally well have copied the text David Healy received when he was kicked out of Toronto. In plain language, both pompous messages mean: ‘If you are not willing to prostitute yourself to the interests of big pharma, just as we do, you are not welcome here.’
UK cardiologist Peter Wilmshurst was instrumental in setting up a trial studying whether closure of the foramen ovale in the heart with a medical device would help patients with migraine.46 The results were disappointing even though they were positively biased, as the implanting cardiologists were also the ones to determine whether the hole in the heart had been successfully closed. The steering committee for the trial was unhappy that there wasn’t an independent assessment of the outcome, but it was overruled by NMT, the trial sponsor.
Independently of each other, Wilmshurst and another cardiologist assessed the outcome and both came to much more negative results than what was published in Circulation in March 2008 with Andrew Dowson as first author. Dowson owned shares in NMT but had assured the ethics committee in writing that he didn’t own shares, and he also gave his affiliation as a well-known hospital although he had treated his patients in private practice. Dowson also published a paper with Wilmshurst as co-author that Wilmshurst had never seen.47
In the Circulation paper, there were only four residual shunts whereas the two assessors had identified 27 and 33 residual shunts, respectively. When the paper was accepted for publication, Wilmshurst and another colleague, who together had contributed more than 30% of the patients and had written a substantial part of the paper, refused to sign the journal’s copyright agreement because it said that they had seen the data and took responsibility for their integrity. They had only seen the data analysis, not the data.
Wilmshurst’s name didn’t appear anywhere in the published paper, not even in the acknowledgements, although his work had inspired the study, he had been joint principal investigator, had taken a major role in designing the trial, had written much of the paper, and had been a member of the steering committee. In contrast, a prominent cardiologist, who died before the trial began, appeared as author, a rare but genuine type of ghost author so to speak. He also co-authored a letter in Circulation 5 years after his death in reply to criticism of the trial, even though Wilmshurst had told the editors that he was dead.
After Wilmshurst had mentioned the problems with the trial at a congress and had given an interview, he was su
ed by NMT for slander and libel in the High Court in London, although the company was American. England has the worst libel laws in the world, which don’t protect the whistle-blower but the perpetrator. Simon Singh wrote in The Guardian in 2008 that the British Chiropractic Association happily promotes bogus treatments, as the association claims that their members can help treat children with colic, sleeping and feeding problems, frequent ear infections, asthma and prolonged crying.48 He had to spend 44 solid weeks on a libel action and wrote afterwards that ‘in terms of free speech and access to information, our nation would become the European equivalent of China’.49 He also wrote that Wilmshurst was put under immense stress when he received legal papers on Friday, 21 December 2007 at 5.09 p.m., 9 minutes after most solicitors closed for their Christmas holiday. It was not until the New Year that Wilmshurst was able to get any legal advice. Already 9 months after the Circulation paper, Wilmshurst had run up legal bills of nearly £60 000;50 the lawsuit only ended because NMT went bankrupt.
When the incoming president of the American Diabetes Association, John Buse, had spoken out with his concerns about rosiglitazone’s cardiovascular safety in 1999, employees of SmithKline Beecham had told him that ‘there were some in the company who felt that my actions were scurrilous enough to attempt to hold me liable for a loss in market capitalisation [share value]’.51 A US Senate report showed that after Buse had raised questions at a symposium, GlaxoSmithKline’s chairman for research and development, Tadataka Yamada, had suggested either ‘to sue him for knowingly defaming our product even after we have set him straight on the facts’ or to ‘launch a well planned offensive on behalf of Avandia’.52 Yamada telephoned the chairman of Buse’s department.
Glaxo prepared and required Buse to sign a letter claiming that he was no longer worried about cardiovascular risks associated with Avandia.53 It would be interesting to know what made Buse sign the letter contrasting his own conviction, but after he had signed it, Glaxo officials unscrupulously began referring to it as Buse’s ‘retraction letter’ to curry favour with a financial consulting company that was evaluating Glaxo’s products for investors.
The company intimidated other physicians raising uncomfortable questions.54 A doctor in Maryland became alarmed in 1999 after several of her patients on Avandia developed symptoms of congestive heart failure, and a review of the records for all the patients showed an unexpectedly high percentage with this problem.55 She alerted the manufacturer to the problem, but the company sent a letter to the chief of staff at the hospital telling him that she should not be permitted to talk about the problem since congestive heart failure was not proved to be an effect of the drug. The doctor felt ‘highly intimidated’ by the letter and what she perceived as an implicit threat of a lawsuit. She had planned to publish her findings, but after the hospital received the letter, one of her intended co-authors, an epidemiologist, stopped responding to her emails, effectively killing publication.
In 2006, as previously noted, we published a rather uncontroversial study in JAMA that compared industry trial protocols with published reports and found that the academics generally had their hands tied in their collaborations with the drug industry, which wasn’t revealed in any of the publications.56 When I translated our paper into Danish and published it in the Ugeskrift for Læger (Journal of the Danish Medical Association),57 The Danish Association of the Pharmaceutical Industry said in a newspaper that it was ‘shaken and enraged about the criticism’ that it could not recognise. Although the Association knows very well what its member companies write in their protocols and therefore that our findings were correct, in contrast to its public statement, the Association nevertheless harassed us by filing a groundless case alleging we had committed scientific misconduct by deliberately distorting the data. The Association copied some of its letters to the management at the Rigshospitalet, where four of us worked, and to the Copenhagen Hospital Corporation, the Central Scientific-Ethics Committee, the Danish Medical Association, the Danish Drug Agency, the Ministry of Health, the Ministry of Science, and the Journal of the Danish Medical Association. They spared our Queen and Prime Minister, but even after we had been acquitted, the Association continued to insist we were guilty of misconduct. The lies never stop. We described the affair in a paper, but BMJ’s lawyer was worried about possible litigation, and our paper was therefore transformed into an article written by a journalist.58
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