The immense power of big pharma is illustrated by the thalidomide court cases. They started in 1965 in Södertälje, the home town of Scandinavia’s biggest drug company, Astra. Astra had manufactured thalidomide, but the lawyer had enormous difficulty finding experts who were willing to testify against Astra.17 In the United States, the company that had distributed thalidomide even though it wasn’t approved by the FDA had hired every expert there was on birth defects to prevent them from testifying for the victims.
In Germany, the court cases were a complete farce. The company’s lawyers argued that it wasn’t against the law to damage a fetus, as it had no legal rights. Maybe they should have thought about the malformed children, or about the millions of people the Nazis had murdered shortly before this that were also considered to be subhuman and of no value. Three years into the trial, Grünenthal threatened journalists for what they had written and the trial ended with a ridiculously small settlement, about $11 000 for each deformed baby. No guilty verdict was ever rendered, no personal responsibility was assigned, and no one went to prison.
The United Kingdom behaved like a dictatorship state. The journalists weren’t allowed to write about the court cases and people at the highest positions in the country, including the prime minister, were more interested in defending the company and its shareholders than in helping the victims. After a stalemate that lasted for 10 years, the national scandal couldn’t be held back any longer and the company, Distillers, which also sold liquor, faced a public boycott. A chain of 260 stores actually did boycott Distillers, and Ralph Nader announced that if the victims didn’t get a similar compensation as in the United States, a US boycott would be launched. It took 16 years before the incriminating evidence that had been described in an article the Sunday Times was forbidden to print finally came to public knowledge. This was only because the affair ended in the European Court where Prime Minister Margaret Thatcher was asked to explain the mysteries of English law, the rationale of which no one on the continent could understand. The European Commission issued a report that contained the Sunday Times’ unpublished article in an appendix. It is difficult to understand that the UK censorship happened in a European country. As in Germany, no one was found guilty and no one was even charged with a crime.
Other cases
It is not only the politicians that rather consistently fail to act on industry’s crimes, apart from a few outspoken ones in the United States. The chiefs at the whistle-blower’s home institution also prefer to look the other way, as they have their own interests to protect.18 Merck selectively targeted doctors who raised questions about Vioxx and pressured some of them through deans and department chairs, often with the hint of loss of funding.19 A few days after Eric Topol had testified for a federal jury that Merck’s former chair, Raymond Gilmartin, had called the chair of the clinic’s board of trustees to complain about Topol’s views on Vioxx, his titles as provost and chief academic officer at the medical school in Cleveland were removed.20
Lawsuits against Merck have uncovered details about how the company systematically persecuted critical doctors and tried to win opinion leaders over on their side.5 A spreadsheet contained information about named doctors and the Merck people who were responsible for haunting them, and an email said: ‘We may need to seek them out and destroy them where they live’,21 as if Merck had started a rat extermination campaign. There was detailed information about each doctor’s influence and of Merck’s plans and outcomes of the harassments, e.g. ‘NEUTRALIZED’ and ‘DISCREDIT’. Some examples are shown in Table 19.1. An invitation to a ‘thought-leader event’ is like George Orwell’s thought police, which was the secret police of Oceania in his novel 1984. It seems that Merck had problems both when doctors were honest, like a doctor who would ‘only present data for approved products or information from peer-reviewed literature’, and when they were too dishonest, e.g. ‘frankly would not want this type of person speaking for my product’.
Table 19.1 Quotes from internal Merck spreadsheet concerning doctors who were critical towards Vioxx
‘Strong recommendation to discredit him’
‘Visit from a high-level senior team not necessary’
‘Needs to be on a larger clinical trial with VIOXX’
‘invitation to Merck thought-leader event’
‘He will be a good advocate once we have some published data for him to review’
‘He is being developed by G. Foster/T. Williams’
‘Invite to consultant meetings’
‘He is in the Searle camp and speaks for them’
‘Most influential rheumatologist in the state of South Carolina’
‘somewhat argumentative at the Board Meeting but has been treated well by Merck’
‘held off acceptance of Celebrex on formulary at Oschner pending approval of VIOXX’
‘National impact; speaking extensively for Searle/Pfizer (200 days this year)’
‘numerous reports of biased and inaccurate presentations’ (when speaking for other firms)
‘loose cannon, written transcript of a talk was like an advertisement for Arthrotec’
‘will only present data for approved products or information from peer-reviewed literature’
‘would be offended if offered a seed study’
‘is very influential and will have a strong effect on PCP prescribing habits’
I have given many examples that show senior staff in drug agencies can behave just as badly as bought deans and department chairs (see Chapter 10). When associate director in the FDA’s Office of Drug Safety, David Graham, had shown that Vioxx increases serious coronary heart disease, his study was pulled at the last minute from the Lancet after Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, had raised allegations of scientific misconduct with the editor, which Graham’s supervisors knew were untrue when they raised them.22,23 The study was later published,24 but just a week before Merck withdrew Vioxx from the market, senior people at the FDA questioned why Graham studied the harms of Vioxx, as FDA had no regulatory problems with it, and they also wanted him to stop, saying he had done ‘junk science’.22
There were hearings at Congress after Merck pulled the drug, but Graham’s superiors tried to prevent his testimony by telling Senator Grassley that Graham was a liar, a cheat, and a bully not worth listening to.22 Graham needed congressional protection to keep his job after threats, abuse, intimidation and lies that culminated in his sacking from the agency.6,22 Fearing for his job, Graham had contacted a public interest group, the Government Accountability Project, which uncovered what had happened.25 People who had claimed to be anonymous whistle-blowers and had accused Graham of bullying them turned out to be higher-ups at the FDA management! The FDA flunked every test of credibility while Graham passed all of them. An email showed that an FDA director promised to notify Merck before Graham’s findings became public so that Merck could prepare for the media attention.26 That left no doubt about whose side the FDA was on. Hearings were also held at the FDA, but the agency barred the participation of one of its own experts, Curt Furberg, after he had criticised Pfizer for having withheld data that showed that valdecoxib, which was later taken off the market, increased cardiovascular events, which Pfizer had denied.27,28
Considering these events, it’s not surprising that the Lancet concluded: ‘with Vioxx, Merck and the FDA acted out of ruthless, short-sighted, and irresponsible self-interest.’29 The COX-2 inhibitors have taught us a lesson, not only about fraud but also about threats. When the Lancet raised questions with the authors over a paper on COX-2 inhibitors, the drug company (not named) sponsoring the research telephoned Lancet’s editor, Richard Horton, asking him to ‘stop being so critical’, adding ‘If you carry on like this we are going to pull the paper, and that means no income for the journal.’30
Pfizer threatened a Danish physician, Preben Holme Jørgensen, with litigation after he had stated in an interview in a newspaper – in accordance w
ith the facts – that it was dishonest and unethical that the company had published only some of the data from its CLASS trial of celecoxib (see Chapter 14).31,32 Outraged by Pfizer’s conduct, many of Jørgensen’s colleagues declared publicly that they would boycott Pfizer. Pfizer dropped the charge against Jørgensen but wrote to doctors and in a press release that Jørgensen was misquoted in the newspaper. This was a lie; Jørgensen was not misquoted. Pfizer also complained to the press council alleging that the newspaper’s criticism of Pfizer was ‘undocumented’, which was also a lie. The press council ruled that the newspaper had done nothing wrong. All the wrongdoing was Pfizer’s.
The threats can be particularly malignant when scientists have found lethal harms with marketed drugs that the companies have successfully concealed. Such threats have included frightening telephone calls from the company warning that ‘very bad things could happen’, cars waiting near the researcher’s home through the night, a ghoulish funeral gift, or an anonymous letter containing a picture of the researcher’s young daughter leaving home to go to school.4 Not much difference to organised gang crime there.
Journalists have often been threatened with reprisals.16 A lawyer phoned a journalist who had written critically about the drug industry based on my research and said he called on behalf of a friend. He was interested in knowing how she had gotten access to documents that the company considered strictly confidential. He wouldn’t reveal who his client was. He called again and threatened her by saying that journalists who are critical towards the drug industry may lose everything, their family, friends and job. The journalist got very scared and didn’t sleep much that night.
Even researchers who have contracts giving them permission to publish, or who do not collaborate with the industry at all, may face legal threats if they wish to publish papers that don’t fit with the industry’s propaganda machine.33 Immune Response filed a $7 million legal action against the University of California after researchers published negative findings from a clinical trial of an AIDS vaccine, having refused to let the company insert its own misleading analysis in the report. This occurred despite the fact that the contract gave the researchers permission to publish. The company also tried to prevent publication by withholding some of the data.34
Two British dermatologists had a similar experience. They wrote a detailed review on evening primrose oil for atopic dermatitis. Out of courtesy, they showed a copy of the peer-reviewed article to the manufacturers, who threatened legal action. The article was never published, despite getting to proof stage, and it took another 12 years before the drug agency withdrew the marketing authorisation for evening primrose oil.35
A Canadian researcher wrote that all proton pump inhibitors are essentially equivalent in her draft guidelines, which she sent to the companies as a courtesy. AstraZeneca, which sold Losec, called for retraction of the guidelines claiming they were unlawful and threatened legal proceedings. How can guidelines be unlawful? The Ministry of Health didn’t promise to pay for her legal fees.7
In Germany, the president for the Society of General Practice wrote a paper with a colleague from the Drug Commission at the German Medical Association where they also concluded that the proton pump inhibitors were the same.33 Their paper was accepted for publication in Zeitschrift für Allgemeinmedizin (Journal of General Practice), but is was pulled in the last minute and caused a delay for that particular issue. The editors forgot to change the list of contents where the paper they censored still appears, but inside they published an advertisement. The journal gave in to the pressure from big pharma, which the authors considered intellectual bankruptcy.
No doubt about that. We must resist pressures and threats. And we should never show anything to drug companies as a courtesy before it is out in the public domain. The threats are bluff most of the time anyway.
But not always. When a Canadian health technology assessment concluded that the various statins had largely the same effect, Bristol-Myers Squibb sued the agency claiming ‘negligent misstatements’.36 Although the agency won the case, the legal costs amounted to 13% of its annual budget whereas this sum amounted to one day of sales revenues for Bristol-Myers Squibb’s statin. Their lawsuit was a type of abuse of power called SLAPP (strategic lawsuits against public participation).
A Danish researcher who was critical towards giving women hormones around menopause received letters with threats of legal action from drug companies,8 even though it was well documented at the time that the drugs are harmful. When another Danish researcher published convincing data on two occasions showing that the newer contraception pills, Yaz or Yasmin, result in more blood clots than older pills, he was fiercely attacked by colleagues on Bayer payroll, and studies that didn’t show the newer pills were dangerous were also financed by Bayer.9
In 2008, one of my colleagues, Jens Lundgren, received a death threat at the international AIDS congress in Mexico City in an SMS sent a few hours before he presented data showing that GlaxoSmithKline’s £600 million drug, abacavir, almost doubles the risk of heart attacks.10,11 The pressures had already been immense after he published his results in the Lancet 4 months earlier, and Lundgren described how ‘We were completely crushed in the GSK media machine when our study came out’. The organisers had also received threats, and as soon as Lundgren had finished his talk, he was escorted to the airport with eight bodyguards. Three years earlier, the international drug-monitoring centre operated by the WHO in Uppsala had warned Glaxo about the heart problems, but the company downplayed the warning and sent a reply that was in effect a no-reply. To coincide with the Lancet publication, Glaxo issued a statement to its investors that downplayed the association between abacavir and heart attacks, saying that the findings were unexpected and that no possible biological mechanism to explain it had been found. Glaxo didn’t mention in its statement that the company had been warned 3 years earlier, or that the company’s own research on animals had found that abacavir is associated with myocardial degeneration in the heart tissue of rats and mice.
In 2012, other Danish researchers came in trouble. They had shown in a publicly funded trial that hydroxyethyl starch, a plasma expander used in patients with severe sepsis, kills the patients, compared to giving them a much cheaper balanced salt solution.12 When the study was published in the New England Journal of Medicine, a letter was promptly sent by the lawyers for Fresenius Kabi AG.13 The lawyers wrote that ‘Fresenius Kabi AG is prepared to take all appropriate legal action to recover the economic losses it has suffered (and will continue to suffer) as a result of the false information you and your colleagues have reported’ and called for immediate withdrawal of the paper and correction to be made within 2 days. This was ludicrous. The researchers had written ‘HES 130/0.4’ in their paper but should have written ‘HES 130/0.42’ Did you notice the difference? If we round 0.42 to one less decimal, we’ll get 0.4, won’t we? The issue is that these two designations refer to two slightly different versions of hydroxyethyl starch, sold by two different companies, and the researchers had not studied Fresenius’ product but the other one.
The 0.4 refers to the degree of molar substitution,13 which can vary in the same bottle from 0.38 to 0.45 for Fresenius’ product and from 0.40 to 0.44 for the product they had studied.15 This means that the two products must be considered equivalent, but Fresenius was determined to defend its product even though hydroxyethyl starch kills the patients.
The lawyers’ letter noted that ‘This error is misleading readers of the article and causing them to mistakenly attribute to the Voluven product the negative effects reported to have been found with Tetraspan, resulting in significant harm to Fresenius Kabi’s reputation and economic damage through lost sales.’ Pretty ludicrous again, as both the abstract and the methods section mentioned the product that had been tested, Tetraspan, and not Voluven.
There was an outrage in the press and the hospital declared that it would support the researchers in case of legal proceedings. The researchers didn’t retract t
heir paper but published an erratum,14 which resolved the case.
The whole affair was hair-splitting ad absurdum. If I call a person John, although his name is Mike, I make an error, but if I say that Mike’s height is 1.8 m rather than 1.82 m, I don’t make an error. I merely use a lesser degree of precision, which is not lawyers’ business. In the media, Fresenius Kabi’s reputation, which the company seemed so anxious to protect, was completely lost. Its methods were described as sending a gang of thugs.
In 2000, psychiatrist David Healy from Wales was urged to apply for a post at the Centre for Addiction and Mental Health (CAMH) at the University of Toronto by chief physician David Goldbloom.37 Two months after Healy had accepted the post, he gave at lecture at a conference arranged by his new centre where he mentioned that Eli Lilly’s antidepressant, Prozac (fluoxetine) – the best-selling drug of all time37 – may cause suicide. A week later, Healy received an email from Goldbloom, saying:
Essentially, we believe that it is not a good fit between you and the role as leader of an academic program in mood and anxiety disorders at the centre and in relation to the university … This view was solidified by your recent appearance at the centre in the context of an academic lecture. While you are held in high regard as a scholar of the history of modern psychiatry, we do not feel your approach is compatible with the goals for development of the academic and clinical resource that we have.
Deadly Medicines and Organised Crime Page 42
