FEDS TO BIOTECH FIRMS: SHUT UP
- JUNE 6, 2011
Medicine will suffer if Washington controls the flow of scientific information.
Scott Harkonen is the former CEO of InterMune, which marketed the drug Actimmune to treat a rare and deadly lung disorder called chronic granulomatous disease. However, most of the drug’s sales were to doctors who used it “off label” to treat a different fatal lung disease called idiopathic pulmonary fibrosis.
In 2002, InterMune ran a large trial to seek Food and Drug Administration approval to sell the drug explicitly for this second disease. That study didn’t meet its primary goal: showing that the drug slowed progression of lung fibrosis. But the results did suggest that patients with “mild to moderate” fibrosis lived longer.
There were plausible reasons why the drug might work only in patients with mild disease and not those with advanced fibrosis. Yet some of the analysis that led to this conclusion was nonetheless “retrospective”—meaning statisticians had selectively mined the data to find that positive benefit.
Since the study didn’t set out to test the drug in only mild patients, the finding wasn’t firm enough to satisfy FDA. So when Dr. Harkonen subsequently issued a press release that publicized the study’s findings, the Justice Department says he committed the crime of wire fraud.
Prosecutors presented a statistician in court who said that it wasn’t possible to conclude that a drug prolonged survival simply from the results of a retrospective study. Only more rigorous trials, the prosecutors argued, could establish such a conclusion.
Dr. Harkonen was known in biotech circles for being an assertive personality, so industry insiders dismissed his prosecution as an aberration. It’s not. Civil charges against companies based on similar commercial speech violations are routine, and the feds are bent on targeting individuals. Last month, the government said it will force the CEO of drug maker Forest Labs to resign as punishment for marketing violations involving two of its drugs. Forest Labs had already settled with the government, paying a $313 million fine in September 2010.
At stake in the Harkonen case is a much broader debate over the standard for drawing clinical conclusions from scientific data. FDA typically requires two forward-looking or prospective trials, in which patients are randomly picked to get either an experimental drug or a placebo. That might be an appropriate standard for FDA approval, but it’s an excessive burden for private firms that merely want to share their truthful research conclusions with doctors. The restrictions may also violate the First Amendment; Dr. Harkonen is appealing on those grounds to the Ninth Circuit.
At the same time government is limiting what private companies can legally communicate about their drugs, it has set a much lower standard for federal health agencies. President Obama has created new institutions with the sole mandate of running trials based on softer statistical standards. Retrospective studies will be the core occupation of a new “comparative effectiveness” research agency that has $4.1 billion to conduct government studies on medical products. The results will be used to inform federal treatment guidelines, as well as Medicare’s payment policies.
At least $100 million of that $4.1 billion is being spent on promoting research results. The Agency for Healthcare Research and Quality recently paid $26 million to the PR firm Ogilvy to “market and promote the adoption” of the findings.
The bottom line is that Washington is attempting to reduce health-care spending by constraining the speech of private firms that promote pricey drugs while promoting government research that discourages their use. The advance of medical practice will suffer if Washington can decide the standards for medical decision-making and control the flow of scientific information.
Dr. Gottlieb, a resident fellow at the American Enterprise Institute, was a deputy commissioner of the FDA from 2005 to 2007. He invests in and consults with drug companies.
