Drug formulary and guideline committees
Doctors with financial ties to drug companies should not serve on drug or guideline committees, whether in drug agencies, hospitals, specialist societies or elsewhere.88,89 A persistent argument put forward by conflicted doctors and those who use them is that the best people will produce the best decisions and guidelines, and that it’s only to be expected that the best people collaborate with the industry for mutual benefit. This argument is amusing, as it’s so obviously incorrect. As explained in Chapter 9, people on industry payroll tend to be irrational in their views on drugs and tend to prefer expensive drugs that are not any better than cheaper alternatives. Worse still, when it’s discovered that widely used drugs are harmful, these experts are always the last to recommend against them. They find all sorts of excuses for not accepting the new evidence, no matter how strong it is.
This was, for example, very clear when it was shown that hormones given to women around menopause are harmful.90,91 Unveiled court documents show that Wyeth ran a programme of ghostwritten review articles, which touted that hormones were good for all sorts of things, and which were published in high-impact journals such as Archives of Internal Medicine with expert authors who had done very little or nothing to qualify as authors.92,93 None of the papers have been retracted although they are highly misleading. Here are some examples of titles:
Is there an association between hormone replacement therapy and breast cancer? (yes, it causes breast cancer)
The role of hormone replacement therapy in the prevention of postmenopausal heart disease (there is none, as hormones cause heart disease)
The role of hormone replacement therapy in the prevention of Alzheimer disease (there is none, as hormones increase the risk of getting the disease).
Specialist denial of harms abounds everywhere, including in non-drug areas, e.g. when it became clear that mammography screening had doubtful benefit, whereas it leads to tremendous harm in terms of overdiagnosis and overtreatment of healthy women.94
We need people to guide us who are driven by the data and not for hire. Doctors with financial conflicts of interest are not best; they are not even second best. The best are those who are skilled methodologists who have some knowledge about the area in question, as they can – and are willing to – find the flaws in the scientific documentation. The second best are skilled methodologists. The third best could be those specialists on industry payroll who are also skilled methodologists.
Many people – particularly those doctors who cash the money – think that declarations about conflicts of interest by some magic will make the problem go away, but as Sheldon Krimsky has noted, ‘we would not permit a judge … to have equity in a for profit prison, even if the judge disclosed it’.95 We would not accept either a judicial proceeding in which the judge was paid by one of the corporate litigants.36 Doctors are their patients’ advocates and their primary responsibility is to ensure they aren’t harmed, as expressed in the Hippocratic oath: First, do no harm. It is therefore untenable that doctors won’t accept a court case where the judge is paid by one of the sides whereas they willingly accept to be paid by the drug industry. Doctors suffer from this delusion to such a degree that it looks like a collective psychosis. When I lecture on this, I therefore sometimes provoke my colleagues in a desperate attempt to wake them up:
Judge Smith runs a court case against Cosa Nostra and before it starts, he declares that he:
has received travel grants from Silvio Berlusconi
is on the Advisory Board for Unmerciful Lone Sharks
has received funds from Drug Pushers International
has received unrestricted educational grants from La Camorra
is on the speaker’s bureau for Murder Incorporated.
The mob doesn’t kill many people compared to what the drug industry knowingly does, so why accept money from the industry if you aren’t willing to accept money from the mob? According to medical ethicist Carl Elliott, ‘Disclosure is an empty ritual designed to ease the consciences of academics unable to wean themselves from the industry payroll.’96 Doctors are grasping at the straw of disclosure of their conflicts because it allows them to have their cake and eat it too.14 They should ask themselves whether they would be willing to have their arrangements generally known, and if so, they should be happy for the information to be shared with their patients in their waiting room,56 particularly since doctors believe they are immune to industry favours.
According to laws of public administration, it cannot be accepted that specialists on advisory committees in drug agencies are paid consultants to the manufacturers, and it therefore defies reason that most such specialists are on industry payroll.1,14,38,97 It is equally unacceptable that those who, in formulary or guideline writing committees, recommend which drugs to use receive industry money.2 They often circumvent the problem by hiding it. We studied 45 Danish guidelines from 14 specialty societies from 2010 to 2012, and found that 43 of them (96%) had one or more authors with a conflict of interest, but only one guideline disclosed any conflict of interest.98 About half of the authors had ties to drug companies.
The US Institute of Medicine issued a report about conflicts of interest in 2009, which called for exclusion of people with conflicts of interest from guideline panels and prohibition of industry funding of guidelines.99 If, in exceptional cases, it was impossible to find experts who were not conflicted, such people should be excluded from deliberating, drafting or voting on specific recommendations. I would argue that there should be no ‘exceptional cases’. Any little economic loophole offered to doctors always tends to become very wide. Furthermore, as it is considered very prestigious to be on guidelines committees, it should be easy to require that those who wish to be on them should get rid of their financial arrangements with the industry. Finally, about one-third of US professors don’t collaborate with industry,100 so what’s the problem? Choose them instead.
In France, doctors with the non-profit organisation Formindep (Formation Indépendante) charged that guidelines issued by the French Health Authority should be withdrawn because they contravened national law on conflicts of interests and the agency’s own internal rules.101 The authority refused, although, for example, the chairpersons of the working groups on type 2 diabetes and Alzheimer’s disease had major financial conflicts. Formindep went to court and the highest administrative court in France ruled that the guidelines must be withdrawn immediately because of potential bias and undeclared conflicts of interest among its authors. I regard this as a great victory for common sense, which is met with so much resistance in healthcare.
Drug marketing
There is no need for drug marketing, as the products should speak for themselves. Marketing of drugs is similarly harmful as marketing of tobacco, and it should therefore be banned, just like marketing of tobacco is. What a victory for public health it would be if there would no longer be any ads for drugs, no salespeople, no seeding trials and no ‘education’ sponsored by industry. Try to imagine what a world that would be. People would be much healthier and richer.
We might never get there, but we can make progress within the system we have. It should be a crime for companies and doctors to participate in seeding trials and other studies of no scientific value, as it is a form of bribery, and sanctions should not be restricted to fines, but should also involve a period of quarantine where doctors and companies are banned from doing clinical research. Drug agencies – and research ethics committees, in case the studies are submitted to such committees – currently don’t disapprove of such studies but they should.
Drug companies should be prohibited from financing continuing medical education,89 as the purpose is to sell drugs and as it’s harmful.1 In the interim, speakers should declare their conflicts of interest and the size of their honorarium and other benefits, from all company-sponsored events within the last 3 years. If it became obligatory to list these in the advance programme, there would be fewer attenders a
nd fewer events, as it would be easy to identify ‘education whores’ who are willing to say anything for money.
Fines for illegal marketing should be large enough to have a preventive effect. If fines for cheating the tax authorities were far smaller than the revenue from the cheating, there would be little incentive for honest declarations. Danish taxpayers get fined three times the amount they cheated for, even though the cheating doesn’t harm other people directly, as drugs do. In 1979, a bill in the United States would have allowed judges to fine defendants twice the loss or gain resulting from their crimes, but Senator Edward Kennedy deleted this from the bill after pressure from corporations.102 We need legislation that ensures that both companies’ and top executives’ earnings that are based on crimes will be fined at least thrice the gain from the crimes. Currently, the companies see even the large fines in the United States as a marketing cost. To deter bad behaviour, the fines would need to be so large that the companies would risk going bankrupt, but this is unlikely to happen. The largest companies earn so much money to their home country that the governments wouldn’t dare run such a risk. In 2010, the 10 largest companies sold drugs for $303 billion,103 which is more than the gross national product for all but the richest 34 countries in the world.104 US federal law requires that any company found guilty of marketing fraud be automatically excluded from Medicare and Medicaid, but government prosecutors decided that this exclusion would lead to the collapse of ‘too big to fail’ Pfizer.105 Exclusion from the Medicare and Medicaid programmes has occurred in only a handful of cases, and rarely in a case involving a major pharmaceutical company.106
Also in this way, the drug industry resembles other types of organised crime, which in some countries or cities have acquired so much influence on society that they have become ‘too big to fail’. Another similarity relates to the behaviour at the top. Both in the mob and in big pharma, the top bosses prefer to be kept ignorant about the uncomfortable details of the trade, as long as the dirty work gets done and ensures a copious flow of money.102
To bring the crimes to light also outside the United States, we need laws that protect whistle-blowers and ensure they get a fair proportion of the fines. Fines of US size would ensure that it is cost-effective also in other countries to investigate the crimes and bring them to court. The US Justice Department has estimated that the prosecutions reap more than $15 in recoveries for every $1 spent.106
We need to avoid the situation that, by settling accusations of crimes, the drug companies can pretend they are innocent, claiming they have not been convicted of a crime.106,107 By avoiding a verdict, companies furthermore get the advantage that there is no precedent next time they come under attack.
Top executives should be held personally accountable for the crimes so that they would need to pay attention to the risk of going to jail when they consider performing or acquiescing in crimes, and we need prison sentences as deterrents. Charges of involuntary manslaughter were raised against Grünenthal, the manufacturer of thalidomide, because the company had withheld data on the horrific harms of this drug.39,108 Such charges could be raised against those who, by fraudulent research or marketing, or by withholding data on lethal harms of drugs, cause the deaths of patients, whether they are employed by industry, by drug agencies, or elsewhere. If someone kills a pedestrian in a street crossing through reckless driving, that person goes to jail. No question about it. Compare with top industry executives who kill many people through reckless and deliberate neglect. The only thing that happens to them is that they get rich. We need to prosecute corporate criminals with at least as much vigour as traditional criminals, and if we did, there might be more white-collar criminals in prison than blue-collar ones.39 The industry is already prepared for this, as some companies hold the position of ‘vice president responsible for going to jail’. This, however, cannot provide immunity for the CEO, as corporate ethics indisputably is determined by that person.39
In some countries, e.g. in the United States, drug firms can buy prescription data allowing them to spy on individual doctors.12 This is highly unethical, as it so obviously invites corruption through ‘rewards’ to high-volume prescribers. It must be banned.
Doctors and their organisations
Physicians’ organisations should declare that it’s against the patients’ interests that physicians participate in meetings or educational events sponsored by the industry, accept visits from drug salespeople, or accept donations from industry, including free travel and free samples of drugs (the delivery of which should be prohibited by law), as this has clear negative consequences for patients.2,14,29,39,67,88,109,110,111,112,113,114 Some universities and hospitals have introduced policies that prevent this from occurring,115 and for many years, the Danish Medical Association has refused to offer industry-sponsored ‘education’ to its members.
Doctors are delearning their bad habits, but slowly. A study of 105 residents at a university-based internal medicine residency programme showed that 61% believed that contact with industry didn’t influence their own prescribing, while only 16% believed that other physicians were similarly unaffected.116 Jerome Kassirer considers it one of the greatest scandals of our time that physicians are not held to the standards of journalists, attorneys and other professionals.14 Physicians should live up to the same rules that apply to journalists. A journalist who writes press releases for Pfizer to supplement her income will not be allowed to write a story for the New York Times about new drugs for treating impotence.117 Why have we accepted that this rule somehow shouldn’t apply to doctors? Doctors’ relationships with pharma don’t even live up to the criteria for wine testing in the Wall Street Journal,14 although doctors’ choice of drugs, or no drugs at all, is far more important for people’s health than the type of wine they drink: ‘We do not accept free wine, free trips, or free meals … We taste wines blind unless noted otherwise. We believe wines should speak for themselves.’ So should drugs!
Doctors suffer from the delusion that their financial relationships with industry can be managed, and numerous foolish – so-called ethical – guidelines have been construed, which often speak about some cash amount below which there should be no problem. This is self-serving rationalisation.117 The relationships cannot be managed; they should be avoided. Some sort of contact with the industry is of course needed, e.g. in relation to conducting important trials, but the knee-jerk reaction that this must involve exchange of financial benefits is simply wrong. Similarly, if a doctor is desperate to sit at a company’s advisory board or give good advice in other ways, it can be done for free. It takes two to tango and what we need more than anything else is for doctors to stay clean and say no to the money. It should be illegal in all countries, like it is in Denmark, for a doctor to help a company in its marketing, although this is what many doctors actually do when they consult for the industry, sit on an advisory board, or ‘educate’, also in Denmark.
We have a very long way to go. A US survey found that a staggering 94% of a broad range of physicians had interacted with the drug industry within the last year.118 Most of these interactions involved receiving food in the workplace (83%) and drug samples (78%), and 28% had been paid for consulting, lectures or enrolling patients in studies. The extent of these interactions are likely underestimated, as social desirability bias may have caused people to under-report what may be viewed as negative, and the survey wasn’t anonymous.
When the American Medical Association in 2001 launched a campaign to convince physicians not to accept gifts from the industry, the campaign was funded by Eli Lilly, Bayer, GlaxoSmithKline, AstraZeneca, Merck, Pfizer and Wyeth-Ayerst,14 which include some of the worst companies on earth whose ruthless actions have led to the deaths of thousands of patients.
The Association itself continued to accept gifts. When, in 2009, US senator Charles Grassley asked for financial information from 33 professional associations and groups that conduct research or promote disease awareness, the American Medical Association r
eported that 16 drug, device and communications companies donated nearly $5 million in 2007 for ‘continuing medical education’ programmes and ‘communications conferences’.119 It didn’t respond to an inquiry by the BMJ regarding the issues. Manufacturers provided more than half of the total funding of the North American Spine Society and nearly half the funding of the Heart Rhythm Society and the American Academy of Allergy, Asthma and Immunology. Jerome Kassirer has given many egregious examples of academic prostitution in specialist societies.14
Restricted uneducational grants
There is a widespread form of ‘collaboration’ between academia and industry that doesn’t require approval from an authority. It goes under various names and here is an example. A 2007 paper surveying US department chairs of medicine and psychiatry reported that 67% of them had received discretionary funds from industry within the last year.120 This is likely an underestimate, as the survey was not anonymous. The donations to department chairs and other decision-makers are sometimes called unrestricted educational grants, although – as a witty person once put it – they are in reality restricted uneducational grants, as their purpose is to buy doctors.39 In one case, such a grant was used for paying for a doctor’s swimming pool.16
Industry is very careful about how it spends shareholders’ money, and if it gives away some, it’s not a sudden outburst of altruism but because it expects more in return than it spends. The purpose of discretionary funds, which the department may use for research, education or whatever its chair deems relevant, is to buy loyalty, and it works. Department chairs know all too well that if they start using cheap generics instead of the donor’s expensive products, the funding stream will dry out. And the industry knows that if someone at the department finds serious harms with one of the company’s drugs, the department chair will be more tempted to protect the drug than the whistle-blower. It’s unbelievable that doctors cannot see that acceptance of money with ‘no strings attached’ is corruption. I believe everybody else can. Academic institutions should not accept financial support from industry.39,97,121
Deadly Medicines and Organised Crime Page 48