The slippery slope between academia and pharma

I want to be very careful about how I present the following information, as I mean to suggest no improper or illegal behavior on the part of any individual.  Instead, consistent with my previous columns on these matters, I mean to suggest that it is a slippery slope when people in academic medical centers join the boards of directors of pharmaceutical companies. The issue is not their honesty or expertise.  The issue is that we lose the expertise of key people in helping us resolve thorny public policy debates.  A further issue is that, in serving two masters, they contribute to the erosion of public confidence in the research and clinical activities of the health care sector.

We start with a story by Andrew Pollack in the New York Times.  The lede:

Record sales of a new hepatitis C drug pushed the first-quarter earnings of Gilead Sciences far beyond expectations, the company reported on Tuesday, but could also heighten concerns about the high cost of the drug, known as Sovaldi, and the ability of the health care system to pay for it.

He explains:

The rapid uptake of Sovaldi to some degree reflects pent-up demand, as many patients were holding off treatment until it was approved in December. The drug, a pill taken once a day, has a higher cure rate, a shorter duration of treatment and fewer side effects than previous treatments.

But Sovaldi, which has a list price of $1,000 per pill, or $84,000 for a typical course of treatment, has become a flash point in a debate over drug prices.

Paying for Sovaldi for all the patients who need it could put financial strain on insurers, state Medicaid programs, the Department of Veterans Affairs and prison systems. UnitedHealth Group, one of the largest insurers, said last week that its first-quarter earnings had declined in part because it had spent more than $100 million on hepatitis C treatments, including Sovaldi, far more than it expected.

Some doctors say there is a benefit to treating even early stages of the disease, to prevent scarring of the liver.

“If cost were not a factor, we would want to treat the entire population,” said Dr. Rena Fox, a professor of medicine at the University of California, San Francisco. She said it was frustrating that “we finally get this great treatment and then we withhold it.”

Now, let's look at the membership of the Gilead Board of Directors.  It is not atypical in including luminaries from many fields, and among the group is Professor Richard Whitley, from the University of Alabama at Birmingham. His compensation from Gilead has been reported as $425,000.  A truly impressive physician, Dr. Whitley is:

Distinguished Professor of Pediatrics, Professor of Microbiology, Medicine and Neurosurgery; Loeb Eminent Scholar Chair in Pediatrics; Co-Director, Division of Pediatric Infectious Diseases; Vice-Chair, Department of Pediatrics; Senior Scientist, Department of Gene Therapy; Scientist, Cancer Research and Training Center; Faculty, Gene Therapy Center; Associate Director for Drug Discovery and Development and Senior Leader, Pediatric Oncology Program, Comprehensive Cancer Center; Director, UAB Center for Emerging Drug Discovery; Co-Founder and Co-Director, Alabama Drug Discovery Alliance. 

He is also "responsible for the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group whose role is to perform clinical trials of antiviral therapies directed against medically important viral diseases of children and adults including viruses considered as threats to human health." 

A more detailed description follows:

Through the NIAID-CASG we perform clinical trials of antiviral therapies directed against medically important viral diseases of children and adults. These include studies of neonatal herpes simplex virus infection, herpes simplex encephalitis, herpes zoster, enteroviral infections of the newborn, therapeutic interventions for congenital cytomegalovirus infections, hepatitis C, and respiratory virus diseases in the immunocompromised host. Work in these areas includes protocol design, assessment of efficacy and toxicity endpoints, application of contemporary clinical trial methodology and monitoring principals, and evaluation of biologic specimens obtained from volunteers in these studies.  [Emphasis added.]

According to this report, Dr. Whitley is an Editor of Antiviral Research, and is a member of the Editorial Boards of the Journal of Infectious Diseases, Sexually Transmitted Diseases, Reviews in Medical Virology, Antimicrobial Agents and Chemotherapy, Antiviral Chemistry and Chemotherapy, Infectious Diseases Watch for Pediatricians, Seminars in Pediatric Infectious Diseases, Gene Therapy, and Medscape Infectious Disease.

As we view all of this, we can only imagine the extent of Dr. Whitley's personal commitment to eradicating disease.  This is truly an outstanding record.  I'd bet, too, that he would strongly support expanded access to Sovaldi for humanitarian reasons.  But in all the searches I have done, I can find no public statements from him concerning the financial issue raised in Andrew Pollack's story.  Indeed, it would be very difficult for someone on the Gilead board to make a statement about such matters, as it would be viewed as inconsistent with the duty of loyalty and care required of corporate directors.

I note that Gilead has made the drug available at a dramatically lower cost in some other countries in the world.  As reported here,

The company’s reduced prices came after the World Health Organization worked with Gilead directly to help spread the drug's usage. So what determines who gets a discount and who doesn't? It's simple. Gilead admits their “global pricing model is based on a country’s ability to pay.”

As for the $1,000 a day American price for the extremely effective (and life-saving) medication, Gilead is holding firm that they “think the price is fair. It’s a one-time cost that is your lifetime cost.”

So, there we have the nub of the issue. An extremely respected scientist with Dr. Whitley's credentials could be among the most qualified in society to "referee" this kind of issue--to help us understand and balance the legitimate financial needs of the pharmaceutical industry with the equally important humanitarian concerns about a drug's availability and cost in America.  He cannot do so while on the board of the company producing the drug. The loss to society is that someone of Dr. Whitley's expertise and compassion is taken out of the public debate on these matters.

Beyond that, what does his silence on this issue say to the country about his duty to two masters, a federally subsidized drug research effort and a pharmaceutical company? What message does that send to the public about how they should view the relationships between academic medical centers and industry? I think it doesn't help either sector retain the public's confidence.

Distinguished Professor, Loeb Scholar Chair in Pediatrics, Professor of Pediatrics, Microbiology, Medicine, and Neurosurgery, University of Alabama at Birmingham - See more at: http://www.gilead.com/about/leadership/board-of-directors#sthash.f1uR5D5k.dpuf

Distinguished Professor, Loeb Scholar Chair in Pediatrics, Professor of Pediatrics, Microbiology, Medicine, and Neurosurgery, University of Alabama at Birmingham - See more at: http://www.gilead.com/about/leadership/board-of-directors#sthash.f1uR5D5k.dpuf

Distinguished Professor, Loeb Scholar Chair in Pediatrics, Professor of Pediatrics, Microbiology, Medicine, and Neurosurgery, University of Alabama at Birmingham - See more at: http://www.gilead.com/about/leadership/board-of-directors#sthash.f1uR5D5k.dpuf