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Feature Competing Interests

Centers for Disease Control and Prevention: protecting the private good?

BMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h2362 (Published 15 May 2015) Cite this as: BMJ 2015;350:h2362

Re: Centers for Disease Control and Prevention: protecting the private good?

Thank you for this documented information.

Is this really a surprise? Or should we rather wonder if there is on earth any important national or international health institute or organization that can escape pharmaceutical companies’ influence?

The World Health Organization (WHO), Food and Drug Administration (FDA), the European Medicines Agency (EMA) or the National Health Institute (NIH) can also be criticized in this respect.

The scenario is always the same: undermining public funding of institutions devoted to public interest and then offering a quick fix in the form of private conditional funding or public private partnership.

In 1985 the United States decided to withhold its contribution to WHO budget because it disagreed with the” Essential drug program “ that was threatening the leading American pharmaceutical companies interests [1]. As a result WHO had to accept more and more conditional extrabudgetary funding and then accepted changing its policy to fit private contributors' demands, then abandoning a more global approach to health that took into account basic needs satisfaction like access to safe drinking water and shifting to a focal approach centered on communicable diseases and on selling drugs and vaccines. Extrabudgetary funding grew and represented 80% of WHO’s budget by 2010. The voluntary contributions are earmarked and the contributors are countries, institutions, foundations or agencies. In 2012 the first voluntary contributor with a funding of $264m was the Bill and Melinda Gates Foundation, and this represented nearly 5% of the total WHO budget. In 2008, one out of ten dollars spent by foundations in the world was from the Gates Foundation. In the United States, a foundation has to spend at least 5% of its endowments every year to avoid paying most of the taxes. The remaining 95% can then be invested in for profit companies. The Bill and Melinda Gates Foundation was heavily criticized by experts and other foundations because of investing in companies that” failed tests of social responsibility because of environmental lapses, employment discrimination, disregard for workers’ rights, or unethical behavior”. In 2007, an investigation by The Los Angeles Times found that 41% of Gates Foundation’s investments, totaling at least $8.7 billion, have been in companies “that countered the foundation’s charitable goals or socially concerned philosophy” [2]. In 2015 Bill Gates has been ranked the richest man in the world as he was for the last 16 years, that is since he started his Bill and Melinda Gates Foundation. His fortune has increased from $45bn in 1998 to $ 79.2 bn dollars in 2015 [2]. This represents nearly twenty times the total WHO budget [3].

The WHO's need for funding from private partners led successive WHO directors to carry out reforms tending to increase the role of private foundations and companies in the decision process. It is argued that the profit motivated actors are stakeholders equal to state representatives and legitimate to share decisions on WHO health policies and recommendations. The UN officers were then encouraged to be “favorable to business models and methods “ For Judith Richter, a Swiss independent researcher on international health issues, this threatens the safeguard of public interests and the foundation values of the WHO stated in the Health for all declaration [3].

In the same way, after cutting the FDA’s public funding that lead to inflated time for drug’s review, the United States Congress, pushed by powerful lobbying, passed the Prescription Drug User Fee Act (PDUFA) in 1992 that allowed pharmaceutical companies to contribute to FDA’s funding and is renewed every five years. This contribution increased gradually and was in 2013-2014, $760bn--that is, 60% of the total FDA review expenditure. At the same time the FDA culture changed and was less devoted to accurate control and regulation of new drugs, especially new molecular entities. It was then assumed that, in response to pharmaceutical companies' expectations, the priority should be given to “timely access” to new drugs and accelerated approval. Medical officers who reviewed drugs were urged to give positive advice or their advice was not taken into account. This resulted in a dramatic increase in the proportion of newly approved drugs retired because of safety concerns and in the proportion of drugs receiving black box warnings [4]. In 2014, 61% (25 of 41) of new molecular entities were designated for priority reviews and were reviewed in only 6 months[5] while a review of the Révue Prescrie in France, found that only 1.6% of new drugs marketed in France from 2002 to 2011 represented major or significant clinical advances. It was calculated that each ten months reduction in review time resulted in an 18.1 percent increase in seri¬ous adverse reactions, a 10.9 percent increase in hos¬pitalizations, and a 7.2 percent increase in deaths [6]. A few medical officers at the FDA tried to resist and called themselves the “termites”. David Graham, who denounced the Vioxx scandal was one of them. He declared in an interview in 2005: "FDA is inherently biased in favor of the pharmaceutical industry. It views industry as its client, whose interests it must represent and advance. It views its primary mission as approving as many drugs it can, regardless of whether the drugs are safe or needed".[7]

The former director of the European medicines agency, Thomas Lönngren, has been put under scrutiny because just after having completed his second five years mandate as director of the agency, he started working as a consultant for several pharmaceutical companies [8]. Dr Elias Zerhouni, former director at the National Health Institute of the United states, was hired as head of research and development by Sanofi Aventis a few months after quitting his post at the NIH [9]. No action was taken because this is legal. Legal but not moral.

Recently the EMA has softened (and not tightened) its policy concerning the conflicts of interests policy. [10] [11]

National and international agencies are under increasing and friendly pressure to espouse the cause of pharmaceutical companies. Are independent decisions still possible? One might doubt it.

[1] Godlee Fiona, “WHO in Retreat; Is It Losing Its Influence?” British Medical Journal 309 (1994): 1491–1495. [PMC free article] [PubMed]
[2] Piller C., Sanders E., Dixon R. Dark cloud over good works of Gate Foundation. http://www.latimes.com/news/la-na-gatesx07jan07-story.html#page=1
[3] Richter J. Who reform and public interests safeguard, Social Medicine, Volume 6, Number 3, March 2012.
[4] Wolfe M S, Does $760mn a ayear funding of drug industry affect the FDA’d drug approval process? BMJ 2014;349:g5012 doi: 10.1136/bmj.g5012 (Published 5 August 2014) http://www.bmj.com/content/bmj/349/bmj.g5012.full.pdf
[5] Jenkins J.blog, CDER approved many innovative drugs in 2014, FDA voice, January 14, 2015. http://blogs.fda.gov/fdavoice/index.php/2015/01/cder-approved-many-innov...
[6] Light DW, Lexchin J, Darrow J. Corruption of pharmaceutical and the myth of safe and effective drugs , Journal of law medicine and ethics., 2013.
[7] http://www.thenhf.com/pdf/dr_graham_article_fraud_magazine.pdf
[8] http://www.ft.com/cms/s/0/8412aed0-425c-11e0-8b34-00144feabdc0.html
[9] http://theurbanright.blogspot.fr/2010/12/former-nih-director-spins-throu...
[10] Prescrire international. European Medicines Agency (EMA) softens its conflict of interest policy: Does this further open the door to undue influence instead of closing it? (November 2014) Brussels, 28 November 2014. http://english.prescrire.org/en/79/207/46302/3982/3303/SubReportDetails....
[11] http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2...

Competing interests: No competing interests

24 May 2015
Claudina MICHAL-TEITELBAUM
MD, preventive care for children
Lyon , France