The president tapped into broadly held public sentiment in his radio address on Saturday, calling for reform at the Food and Drug Administration. But understanding why his assertion that the government can ensure "the medicines we take ... don't cause harm" is simplistic can also help us understand why his choice for the person who will have that impossible responsibility is folly.
In naming Dr. Joshua Sharfstein as deputy commissioner, the president decided that absolute drug safety should come first--even at the cost of the drugs' availability to sick patients. That doesn't bode well for our chances of getting the new medications needed to keep pace with our enviable improvements in quality of life and life expectancy.
Let's be clear: There is no such thing as a "safe" medication. All medications come with benefits and risks. It is the role of a physician to work with the patient to evaluate each person's unique circumstances to decide whether the benefits of a drug outweigh the risks. That calculation is different for everyone and, whenever possible, should be made in the doctor's office rather than a federal agency. I doubt whether the president or his new appointment agree.
An evaluation of his work makes it clear where Dr. Sharfstein falls on the spectrum between those who see the companies he is about to regulate as part of the problem or part of the solution. Dr. Sharfstein's relatively brief career is rich with examples of criticism of pharmaceutical companies--including his stint working for anti-pharmaceutical crusader Sidney Wolfe--plus support for safe-seeming but failed policies and initiatives that grab adoring headlines but do little to fix serious problems.
His shortsighted, partisan and perversely populist "attack big pharma" approach won't work at this critical time when major reform is in order. Change of this type calls for the ability to bring various and sometimes opposing stakeholders together.
Sharfstein, only 39, has a long history of antagonizing the pharmaceutical industry. Consider the example recently reported online by Scientific American, based on an October 1992 report in the Harvard Crimson, written when Sharfstein was a first-year medical student. He led a student campaign urging classmates to return textbooks donated by a pharmaceutical company.
Sharfstein and his group wrote that the texts "are paid for by consumers in the form of higher drug prices. Accepting gifts from companies violates an ethical obligation to our future patients." They set up a drop-box where, like a gun amnesty program, students were guilted to return the books. Fortunately, at the time of the Crimson report, only eight books had been returned. (Sharfstein told the Crimson that more had been returned, but some had been stolen from the box.) Even back then, it seems, Dr. Sharfstein was way to the left of his colleagues.
It is not fair to predict an official's approach to issues based only on his activism in school. But young Dr. Sharfstein's "us vs. them" view toward the pharmaceutical industry was not an outlier--it was a template for his future career. He went on to work for Rep. Henry Waxman, D-Calif., who personifies the divisive approach, which seeks to persecute innovative pharmaceutical companies.
I talked with Dr. Sharfstein while he was working on Rep. Waxman's legislation that would give the FDA authority to regulate tobacco. I tried to encourage him to be open to the concept of harm reduction for smokers. The approach would allow makers of smokeless tobacco to explain that their product was less harmful than cigarettes. Dr. Sharfstein impressed me with his familiarity of the evidence from Sweden supporting this way to help smokers reduce their risk from tobacco.
What startled me was that despite his knowledge of the facts, he was still ardently against it. Rather than acknowledge the complexity of the issues and the need to weigh the pros and cons, he dismissed the approach out of hand, choosing instead the "quit or die" approach that has been failing smokers for years. I believe his rigid ideology overshadowed his willingness to support a different, but scientifically valid, way of thinking about the country's leading public health problem.
During his tenure as commissioner of health in Baltimore, he continued to grab headlines with initiatives that drew him praise but failed to solve serious problems. Take for instance his approach to a real but diminishing public health problem: childhood lead poisoning.
Dr. Sharfstein campaigned for the notion that there is "no safe level" of exposure to lead. Yet there is little scientific support for this view. Citizens would have been better served had the commissioner placed his emphasis on the scientifically sound goal of eliminating chipping and peeling lead paint in Baltimore's inner city.
Twenty years ago, nearly a quarter of the children tested in Baltimore had elevated blood lead levels (a much lower level than that considered "lead poisoned"). Today, only 3.5% of the children tested have that level. Similar improvements across the country can be traced to the removal of lead from gasoline and interior paint over a generation ago. There is no evidence that extremely low levels of lead contribute to lead poisoning.
Dr. Sharfstein's misguided approach is the type of distorted policymaking that brought us the hugely unpopular Consumer Produce Safety Improvement Act (CPSIA), championed by his former boss, Rep. Waxman, which today is putting thousands of people out of work, causing stores to throw away safe merchandise and not making anyone any safer. This history sheds a troubling light on how Dr. Sharfstein would deal with today's most pressing and controversial issues relating to the complex and sensitive task of regulating pharmaceuticals.
The job, especially now, takes nuance and the ability to weigh benefits and risks. And it requires a willingness to put partisan approaches aside so the agency can endorse the best available science. Certainly Dr. Sharfstein has tipped his hand to how he would deal with calls by activists to forbid free drug samples to consumers. Would he allow FDA panels to benefit from top experts? Or would he consider them bias if they ever worked for industry. Would he hold anti-industry scientists to the same tough standards?
His record indicates he would blacklist scientists who were capable enough to be hired by companies and leave panels skewed with scientists who were either not competent enough to get jobs--or so anti-industry that they refused to work for them in the first place. This would hamper the agency's ability to evaluate complex science above the fray of politics. A deputy commissioner so invested against the success of the pharmaceutical industry is poised to fail consumers.
Perhaps Dr. Sharfstein's reputation for stridency explains the reported move to split the agency--one part headed by Dr. Margaret Hamburg, who will serve as commissioner for food and tobacco (if the agency gets control of it) and one part with Dr. Sharfstein as deputy commissioner fully responsible for pharmaceutical issues. This allows Dr. Sharfstein to act as FDA commissioner with regard to medicine, while circumventing a Senate confirmation, where senators who don't share his vitriol for drugmakers were prepared to ask him tough questions about his views. So much for a new, transparent way of doing the people's business in Washington.
In his Inaugural address, the president promised to "restore science to its rightful place." With this appointment, he has taken a step in the wrong direction.