Program Highlights: Public Health
On November 18, 2004, Dr. David Graham, a 20-year veteran Food and Drug Administration (FDA) scientist, rocked the pharmaceutical industry with Senate testimony that shook six multinational corporations, drew vital public attention to the secret life inside the FDA, and stopped the sales of a deadly, but hugely popular, arthritis medication. His testimony exposed tragic public health consequences stemming from a legalized conflict of interest: the FDA is one of the few government agencies whose funding depends largely on the success of products of the industry it regulates. Due to Graham’s appearance, the deadly market for pain relievers will never be the same.
The antibiotic Ketek (telithromycin) was approved by the FDA in April 2004. In 2005 it was prescribed over three million times in the US for respiratory infections -- sinusitis, bronchitis, and non-severe pneumonia -- and grossed nearly $200 million for its manufacturer, Sanofi-Aventis.
Yet the drug flunked the basic legal requirements for FDA approval: It was not safe, and was never been proven effective. The Ketek tale involves massive fraud which led to jail time for some involved.
In early 2006, GAP client and Sheffield University senior faculty member Dr. Aubrey Blumsohn traveled to Washington, D.C. as part of a week-long effort to inform Congressional officials and journalists about data concealment and manipulation performed on behalf of Procter & Gamble (P&G) regarding that company’s osteoporosis drug, Actonel. The popular medication was primarily used by post-menopausal women to strengthen bones and help prevent fractures.
Blumsohn told a story that worsens the image of a major pharmaceutical, and raises questions about the overall state of effectiveness of the FDA in monitoring the drug approval process. Blumsohn, the intended lead author on a P&G commissioned study, exposed his belief that the data actually disproved P&G’s therapeutic claims for Actonel, stating the company used his name in medical reports despite his not having full access to data sets – information that he repeatedly asked for.
Victoria Hampshire was a model employee of the FDA. Working as a veterinarian, she was dedicated to monitoring drug interactions in animals, and received numerous accolades for her work.
In 2004, Dr. Hampshire discovered that a popular heartworm medication for dogs was killing hundreds of animals. Her analysis and reports pulled the drug off the market. That should have been the end of it. But the drugmaker, Wyeth Pharmaceuticals, conducted a iniature smear campaign against her, and used its connections with the FDA to have her criminally investigated on trumped-up charged. Although vindicated completely in the end, the horror story that Hampshire experienced illustrates how FDA brass can be manipulated to inflict wrongful action, simply based on the will and connections of drug behemoths.