We are moving in the right direction but much too slowly and timidly. In 2009, the Association of American Medical Colleges urged all medical schools and teaching hospitals to adopt policies prohibiting physicians, faculty or staff members, residents and students from accepting any industry gifts, including industry-supplied food and meals unrelated to accredited continuing medical education programmes.122 The same year, the US Institute of Medicine went one step further. It suggested that doctors should decline all gifts from industry, including meals; that product promotion among doctors by drug and device companies should be virtually eliminated; that doctors should refuse to participate in activities and publications where contents are controlled by the industry; and that professionals with conflicts of interest should not participate in writing practice guidelines.123
In 2012, the American Medical Association – at last – changed its pro-industry position and announced that ‘when possible’, CME activities should be developed without industry support and without the participation of teachers or programme planners who have financial interests in the subject matter.124 The next step will be to close the foolish loophole that is a carte blanche to do business as usual. It is always possible to avoid industry influence.
Currently, we have a culture among doctors where accepting industry largesse and accepting ‘authoring’ highly flawed industry papers is not a career impediment; in fact, it seems to advance people’s careers as they get many more publications and become known speakers. We need to reverse this culture into one of professional ostracism so that such a person would no longer show their face in places where their academic colleagues gathered.117 Ghostwritten articles should be seen as scientific fraud, and the honorary authors should be treated like students who sign their names to papers they buy on the internet.96 There should be substantial fines for concealing ghost authorship, as it erodes the trust that is so fundamental in medical publishing. Legislation is needed to hold physicians accountable when they contribute to illegal marketing with harmful consequences for patients – whether by ‘authors’ of ghost papers or in other ways – including the possibility of being struck off the medical register.
Doctors should decline to accept drug industry awards, and specialists societies should decline to offer them. The Danish Society of Clinical Microbiology handed out a Wyeth Prize for many years, worth €1300, but decided to stop this and pay for the award themselves through membership fees. That’s the way to go.
All countries should have publicly accessible registers of doctors’ collaboration with industry detailing the monetary amounts and other benefits. There is no disinfectant like sunshine, and in the United States, the Physician Payments Sunshine Act requires that pharmaceutical, medical device, biological and medical supply manufacturers report to the Department of Health and Human Services payments that are more than $10 to physicians and teaching hospitals.125 The law requires reporting of stock options, royalties, consulting fees, honoraria, education, research grants, meals, gifts, entertainment and travel. The database provides information on the physicians receiving the payment, their address, payment date, and drug or device that the physician helped promote. There will be stiff penalties for both inadvertent lapses (up to $150 000 annually for failure to report) and intentional nondisclosure (up to $1 million annually).
One of the worst types of academic prostitution is when doctors contact politicians and pretend they are independent experts when in reality they are hired guns. Our societies build on trust and our politicians cannot rule our countries prudently when they are being misled. Understandably, they get very upset when they discover incidentally that they have been fooled.126
Last, but not least, doctors and their organisations should consider carefully whether they find it ethically acceptable to receive money that has been partly earned by crimes that have harmed their patients. As noted in Chapter 3 and elsewhere, many crimes would be impossible to carry out if doctors weren’t willing to participate in them.
Patients and their organisations
Patient organisations have the same problems as physician organisations. They are often sponsored by industry and often support industry’s marketing goals rather than taking care of patients’ interests. Patient organisations have done absolutely nothing to stop the blatant abuse of patients in industry-sponsored trials.56 Many clinical trials are unethical because the patients don’t know that they don’t contribute to science but only to the income of the sponsoring company and because many trials or results never get published. According to the Helsinki Declaration, ‘Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.’71 When did we ever see a patient organisation take the industry to task for failing to do this?
Another example of the total failure of patient organisations is that they often complain loudly when national bodies have decided a drug is too expensive to be used compared to what it has to offer, whereas I have never heard any patient organisation complain that the price was too high and that the drug company should lower it. It seems to be a vicious circle: a lot of what we pay for drugs goes to marketing, which includes support to patient groups and physician experts, which in turn insist that we should pay very high prices for these drugs, undermining independent organisations like NICE that provide advice to our governments about which drugs to use.56
Patient organisations should warn their members not to get information from drug companies or from websites funded by drug companies. Companies have found out that they can circumvent the law forbidding direct-to-consumer advertising by selling diseases instead of drugs. This is highly lucrative,2 and an overwhelming amount of disease websites are made up by drug companies, either directly or via some willing patient organisation.127 Further, patient organisations supported by industry sometimes distribute marketing material from drug companies. The Danish ADHD Association visited schools and distributed leaflets written by a drug company alerting people that they might have ADHD, although this diagnosis is already widely overused. The only type of treatment that was discussed in the leaflets was drugs, and the director of the association was hired because of her ‘commercial orientation’, with a focus on establishing ‘partnerships with private companies’.128 It’s disgusting.
Patient organisations are often set up by drug companies, although they hide this. Between 1996 and 1999, the US National Alliance for the Mentally Ill, ‘a grassroots organisation of individuals with brain disorders and their family members’, received almost $12 million from 18 drug companies, led by Eli Lilly.129 It is hugely rewarding for companies to brainwash leaders of patient organisations, as they can allow themselves to be much more vocal and belligerent than the companies themselves. I have often witnessed this, and it’s among my worst professional experiences. To hear leaders of such organisations crave drugs that I know are harmful and terribly expensive as well is just too much for me. Very often they start scare campaigns that push hundreds of thousands of patients into using drugs they don’t need. In 2005, the Danish Heart Foundation announced that 30 000 people would die within 10 years if not an additional 900 000 started cholesterol-lowering drugs.130 An additional nine hundred thousand? There are only about 5.4 million Danes!
I have a brief from 2005 with two logos at the top, one from The Oxford Health Alliance and one from Novo Nordisk. It says: ‘The Oxford Dialogue on Patient Rights is being convened by Novo Nordisk Denmark under the umbrella of the Oxford Health Alliance Dialogues Program.’ When the drug industry talks about ethics and patient rights, it is really time to wake up and say: ‘That’s none of your business. We doctors take care of this.’
Large international patient federations have successfully lobbied the European Commission to propose allowing industry to provide direct-to-consumer ‘information’ about prescription medicines, which would be immensely harmful for the patients. Luckily, the European Parliament has for many years fiercely op
posed this proposal, which comes up again and again.
In 2011, there was no beating about the bush. The International Alliance of Patients’ Organizations (IAPO) bills itself as the only global organisation promoting patient-centred healthcare around the world and representing patients of all nationalities across all disease areas, with more than 200 members in more than 50 countries, encompassing an estimated 365 million patients, their families, and carers.131 Healthcare companies interested in becoming members of the alliance’s ‘Healthcare Industry Partners Framework’ are invited to provide four levels of financial support: gold ($50 000 per year), silver ($25 000 per year), bronze ($10 000 per year) and standard ($5000 per year). And what’s it all about? A guide funded by Novo Nordisk sets up tips on working with various stakeholders, including pharmaceutical companies; such businesses are key partners in improving patient health and quality of life and an excellent source of expertise, information and contacts. The benefits of working with the drugs and healthcare industry, according to the guide, include providing an additional voice for lobbying policy makers.
Have you had enough? Luckily, there are some broad consumer organisations that are radically different and actually do work for patients. I enjoy collaborating with several of these, e.g. Trans Atlantic Consumer Dialogue and one of its member organisations, Health Action International Europe.
In 2010, the Danish Association of the Pharmaceutical Industry published data showing that the industry had reported 163 cases of support to patient organisations.132 There should be no support at all. When asked about gifts to physicians, half of the patients were against;117 it’s therefore not consistent to accept gifts to their own organisations. It should be made illegal for the industry to communicate with patients, e.g. through ads, disease awareness campaigns, and leaflets about diseases and their treatment.
Patient organisations generally believe they can enter into partnerships with the industry for mutual benefit, which is extremely naïve. Just like doctors should, patient organisations should also consider carefully whether they find it ethically acceptable to receive money that has been partly earned by crimes that are harmful to patients.
Here is what you can do:
Withdraw your membership if your patient organisation accepts industry favours.
Ask your doctor whether he or she receives money or other benefits from the industry, has shares in a company or is visited by drug salespeople, and if so, find yourself another doctor.
Avoid taking drugs unless they are absolutely necessary, which they rarely are. Ask if there are other options and whether you’ll be better also without treatment; remember that very few patients benefit from the drugs they take (see Chapter 4).
Ask if there are cheaper drugs than the one your doctor suggests.
Avoid taking new drugs the first 7 years they are on the market because, unless it is one of those very rare ‘breakthrough’ drugs that offers you a documented therapeutic advantage over older drugs, most drugs that are withdrawn for safety reasons get withdrawn within the first 7 years.133
Remind yourself constantly that we cannot believe a word of what drug companies tell us, neither in their research nor in their marketing or information to patients.
Medical journals
In 2011, Emergency Medicine Australasia announced that the journal would no longer publish ads because the prime aim of marketing of drugs is to bias readers towards prescribing a particular product, which is fundamentally at odds with the mission of medical journals.134 The editors added that their move was a response to growing evidence about the detrimental effects of the drug industry in medicine, including claims that the industry distorts research findings and engages in dubious and unethical publishing practices.
Medical journals have generally failed us on this point. They should stop advertising drugs, just like all journals have stopped advertising tobacco, as both activities are very harmful for public health. Many medical journals might not survive without ads, but so be it. There are far too many anyway and most of them publish substandard research that merely contributes to the pollution of science. A biostatistician who was a consultant to the BMJ expressed this in the title of his editorial:135
The scandal of poor medical research: we need less research, better research, and research done for the right reasons.
Medical journals have major conflicts of interest and they should publish the amount they get from sales of reprints, supplements and advertising,136,137 and should check manuscripts about drugs or devices particularly carefully to ensure that they don’t contribute to illegal marketing or ghost authorship. To mention just one example, editors should always ask what is behind ‘editorial assistance’ in an acknowledgment, as it usually means ‘this person wrote the paper’.
As noted earlier, randomised trials are so important for all of us that they should not be hidden behind a paywall. Reports of drug trials should not be published in traditional subscription journals that have drug ads and sell reprints, but in electronically published, open-access journals or on the web, where the protocol, amendments to the protocol and the full dataset should also be posted.138 It was a great leap forward when Harvard University in Boston in 2008 made a commitment to open-access publishing. The university forbids assigning exclusive copyright to the faculty’s work to a scientific society or a commercial publisher.139 Some journals, e.g. the BMJ and Lancet, already ask for the trial protocol, and the BMJ also asks authors if they are willing to share their data with other researchers.
Finally, journals should not accept editors that have conflicts of interest in relation to drug and device companies. There are very few journals that have such a requirement, e.g. La Revue Prescrire, which comes out in French and English. This journal aims at providing doctors unbiased information about interventions, it’s a non-profit continuing education organisation committed to better patient care, and it doesn’t accept advertising or other outside support. This is exactly the type of journal we need to help us decide what is right and what is wrong about healthcare interventions.
Journalists
Industry’s long tentacles also reach healthcare journalists. It funds professorships and scholarships at US universities and offers awards to journalists that write about issues that may boost sales.140 Eli Lilly and Boehringer Ingelheim have co-sponsored an award for reporting on urinary incontinence, Boehringer has an award for chronic obstructive pulmonary disease, Eli Lilly and AstraZeneca for cancer, Roche for obesity and Novo Nordisk for diabetes.111,140 Sometimes, the relationship is not obvious, as awards can be sponsored by organisations that are themselves heavily funded by industry, such as the non-profit Mental Health America. Its 2007 annual report shows that almost half of its funds came from drug companies, including more than $1 million each from Bristol-Myers Squibb, Lilly and Wyeth.
Sponsored patient organisations can be particularly disruptive for rational priority setting in healthcare when they provide patients for journalists to interview to add a ‘human dimension’ to stories, which journalists love. The main problem with these compelling anecdotes of treatment success is that they represent the exception, rather than a more typical experience, misleading audiences. Since most patient organisations pocket industry money, they are not likely to provide patients for the ‘human dimension’ who have been harmed by drugs.
The way forward is simple.140 Journalism educators should not accept funding from the healthcare and drug industries, journalists should not accept gifts, awards or any financial support from the industries they cover, and journalists should routinely disclose their own conflicts of interest and those of their sources. They should remember that they only get awards if they write stories that are good for drug sales. Further, the media should be less focused on a single murder here and there and more focused on drugs that kill thousands of patients. The public knows very little about this and virtually nothing about organised crime in the drug industry. Wake up, journalists!
References
<
br /> 1 Angell M. The Truth about the Drug Companies: how they deceive us and what to do about it. New York: Random House; 2004.
2 Moynihan R, Cassels A. Selling Sickness: how the world’s biggest pharmaceutical companies are turning us all into patients. New York: Nation Books; 2005.
3 Weingart SN, Wilson RM, Gibberd RW, et al. Epidemiology of medical error. BMJ. 2000; 320: 774–7.
4 Starfield B. Is US health really the best in the world? JAMA. 2000; 284: 483–5.
5 Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998; 279: 1200–5.
6 Ebbesen J, Buajordet I, Erikssen J, et al. Drug-related deaths in a department of internal medicine. Arch Intern Med. 2001; 161: 2317–23.
7 Archibald K, Coleman R, Foster C. Open letter to UK Prime Minister David Cameron and Health Secretary Andrew Lansley on safety of medicines. Lancet. 2011; 377: 1915.
8 Centers for Disease Control and Prevention. Leading Causes of Death. Available online at: www.cdc.gov/nchs/fastats/lcod.htm (accessed 5 February 2013).
Deadly Medicines and Organised Crime Page 49