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

May 28, 2015
Dear BMJ Editors,
I’m writing in response to your feature article “Centers for Disease Control and Prevention: protecting the private good?”
To begin with, the subheading beneath the headline: “After revelations that the CDC is receiving some funding from industry, Jeanne Lenzer investigates how it might have affected the organisation’s decisions” creates the illusion of secrecy and controversy, when in fact there is open transparency. There weren’t “revelations” that came about from a whistle-blower exposing corruption or leaked documents: The CDC Foundation has a website—www.cdcfoundation.org-- for all to see. It is a 501(c)(3) public charity with a Board of Directors with clear public-private partnership policies and guidelines governing its work. The Foundation’s audited financial statements are widely available on its website for anyone to research. There is nothing hidden that needed to be revealed: It has been there all along for any interested party to review.
Similarly, to state that “Jeanne Lenzer investigates” also creates the illusion of information that has been hidden. Now, Jeanne Lenzer is an excellent investigative reporter and her work for the Center for Public Integrity and Slate, to name but a few publications, is outstanding. That said, in this piece there really isn’t any investigation occurring. There are no documents linking the funding from private industry to the production of biased data and recommendations. There is no sourced information, either through documents, databases or interviews with on- or off-the-record sources to show a clear link between industry donations and biased research or skewed recommendations that favor the company making the donation. Without these, this piece is just one that speculates without evidence or proof. That is not investigative journalism.
You use the CDC’s “Recommendations for the Identification of Chronic Hepatitis C Infection among Persons Born During 1945-1965” as an example of potentially biased recommendations. Your article claims that these recommendations have been challenged, yet it only has a single footnote by an author who stands on the outside of the consensus of HCV public health officials, medical providers, advocates and patients on the benefits of HCV screening and treatment. You paint a picture of controversy where there is none. Indeed, the CDC’s HCV screening recommendations were reviewed by the United States Preventative Services Task Force (USPSTF), an independent, volunteer panel of nationally recognized experts in prevention and evidenced-based medicine and given a grade of “B,” indicating that these recommendations meet the qualities of their rigorous review process and have more benefits to patients than harms. As a member of the Agency for Healthcare Research and Quality (AHRQ), the USPSTF receive no industry funding and have no conflict of interest.
It is also not accurate to compare the CDC Foundation with the lobbying efforts of the National Rifle Association. Indeed, this is a fallacious argument: The fallacy of faulty comparison. The NRA is a lobbying organization that used its wealth and influence to get Congress to cut the $2.6 million in the CDC budget to stifle fire arm injury research. This is a very different action than one in which private companies donate money in a transparent manner to do unbranded research. Further, the outcomes of this research are not reviewed by industry and altered to meet their needs. If a firearms manufacturer had donated money to do research to dispute the fact that guns are a significant threat to the public’s health and controlled the release of said data, the comparison might hold up. As it stands, this comparison does not hold up.
Finally, let me say that this is an important issue and we do need to be mindful of the ways in which scientific research can be influenced by private funding. I am in complete agreement the statement: “The CDC must have the highest of moral ground. For if we are to believe them about public health matters, there can be no conflicts of interest.” Indeed, we need transparency in the funding of research and full disclosure of conflicts of interests. By all accounts, the CDC Foundation has done just that. We need good investigative journalism to ensure the integrity of medical and public health research. We do not need speculative articles with inflammatory headlines and no evidence of wrong-doing that only increase the mistrust of public servants doing good work to protect the public’s health.

Sincerely,
Andrew Reynolds
Hepatitis C Education Manager
Project Inform

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...

This report about the CDC receipt of money from for-profit entities that stand to gain from CDC decisions is consistent with how it stiffs ordinary citizens who ask uncomfortable questions. Had I contributed to the CDC coffers, perhaps I might have received different treatment than I did when I asked via registered mail with return receipt requested for the anonymized data underlying a published report on anthrax vaccine safety coauthored by CDC staff members, Drs. Brock Stewart and Michael O'Neil with copy to CDC Director, Dr. Thomas Frieden ( “Health-related quality of life in the Anthrax Vaccination Program for workers in the Laboratory Response Network,” Vaccine 30 (10), 27 February 2012: 1841-1846). The return receipt for my correspondence (USPS #0003 6395 3982) was signed by Stephen Grenleski on March 16, 2012. I never received the courtesy of a reply.

The CDC has an explicit policy statement that promises data sharing, subject to certain stipulations. I conclude that the CDC is either oblivious to or considers itself immune from the need for transparency and accountability. CDC intransigence signals to everybody else that they will not be held accountable for failure to provide evidence by which independent scholars can judge the reliability and validity of their published reports.

After CDC's egregiously flawed handling of the ebola crisis and confession of a pattern of safety lapses in mishandling anthrax, other pathogens (http://wapo.st/UcFXzs), who needs the CDC? Big savings could be had by cutting its budget. Unfortunately, the mantle of "national security" keeps it safe despite a track record of incompetence.

Ms. Lenzer's inquiry at least received a reply--albeit a typical public relations communique sent via email to the BMJ rather than to her directly. As reported by Ms. Lenzer, "He (Dr. Frieden) told The BMJ by email, 'Public-private partnerships allow CDC to do more, faster. The agency’s core values of accountability, respect, and integrity guide the way CDC spends the funds entrusted to it.'" Yeah. Dr. Frieden's way of responding to hard questions bespeaks arrogant disrespect rather than claimed "accountability, respect, and integrity."

I wonder if the time has come for creating a non-governmental national registry to contain reports of failed performance by government agencies like the CDC. Complaints that name names are needed to remove the anonymity that gives incentive for repeated misfeasance by political appointees and civil servants.