Posted on 03/19/2009 2:20:51 PM PDT by neverdem
All the wrong people are excited about Obama's FDA picks.
Over the weekend, President Barack Obama nominated Margaret Hamburg to serve as the new commissioner of the Food and Drug Administration (FDA) and Joshua Sharfstein to serve as principal deputy commissioner of the agency.
The FDA regulates about a quarter of all the consumer products that Americans buy, which roughly equals $1 trillion. Many analysts predict that Hamburg and Sharfstein will divvy up their functions in the agency with Hamburg focusing chiefly on food issues and Sharfstein being charge of drugs and medical devices. What should we expect?
To some extent, their priorities can be discerned from statements greeting their nominations to the FDA. Many activists who have been fierce critics of the agency issued highly favorable assessments of the two nominees. For instance, Michael Jacobson, head of the Center for Science in the Public Interest (which calls itself the "food police") hailed their selection. Jacobson called Hamburg "forward thinking," which should "enable her to return the FDA to its role as a trusted, effective regulatory agency." Jacobson praised Sharfstein for eliminating trans fats from Baltimore's restaurants.
Jean Halloran, Director of Food Policy Initiatives at Consumers Union predicted that Hamburg will provide "the leadership it needs at a time when it faces huge challenges." Ellen Bloom, federal policy director for Consumers Union, added that Sharfstein is "just what the doctor ordered for FDA." The Consumer Federation of America (CFA) welcomed both Hamburg and Sharfstein, calling their resumes "extremely impressive." The CFA added, "We hope that these talented and caring individuals will bring a new era to the FDA."
On the other side of the equation, some industry representatives were a bit less enthusiastic. For example, the Pharmaceutical Research and Manufacturers of America issued a press release praising President Obama's "expeditious selection" of Hamburg, while passing over Sharfstein's appointment in decorous silence.
Both have impressive resumes. Hamburg is a former health commissioner in New York City who served as assistant secretary of Health and Human Services during the administration of President Bill Clinton. She now works at the think tank Nuclear Threat Initiative, a non-profit organization focused on reducing the public safety threat from chemical, biological, and nuclear weapons. Sharfstein is a former staffer for Rep. Henry Waxman (D-Calif.) and the current Baltimore health commissioner. Sharfstein made a name for himself by challenging the safety of cough medicines for children.
In his announcement, Obama focused on food safety issues. A lot of media attention has been devoted to stories about spinach contaminated with E. coli bacteria and peppers and peanuts tainted with salmonella. However, the most recent data from the U.S. Centers for Disease Control do not find a significant change, either up or down, in foodborne illnesses in recent years—although such illnesses are down appreciably from 10 years ago. Of course, that record could be improved, and Hamburg and Sharfstein have strong credentials in this area.
Both industry representatives and activists believe that the way the FDA regulates pharmaceuticals and medical devices needs to be reformed. But they strongly disagree on how. Industry would like to get new medicines to the bedsides of patients faster, while activists want to slow down that process in order make sure that medicines are safe.
In welcoming Hamburg and Sharfstein, Bill Vaughan, a Consumers Union health analyst, declared, "The American medicine cabinet has become a little shop of horrors. In recent years, the agency has been too slow to protect consumers and too willing to give industries a pass on safety." What Vaughan means is that he and other activists believe that the agency approves drugs too fast and takes too long to withdraw "dangerous" ones.
In response to the barrage of claims from activists and their supporters in Congress that hasty action by the FDA endangers the public, agency approval of new drugs has been on a downward trend since the 1990s. In 2007, the FDA approved only 19 new drugs, the lowest number since 1983. Last year saw an uptick to 24 new medicines. Part of the reason for this drug drought is that since the 1980s the FDA has doubled the number of clinical trials and tripled the number patients required for approving a new drug. This has boosted the cost of getting a new drug past cowed regulators from about $250 million (in constant dollars) in the late 1980s to over $1 billion today. But perhaps these more stringent requirements have improved drug safety? Not really.
A 2005 report by the Tufts University Center for the Study of Drug Development found that faster approval times do not correlate with increased drug safety withdrawals. In fact, the percentage of drugs withdrawn for safety reasons in 1980-1989 was 3.2 percent, rising slightly in 1990-1999 to 3.5 percent, and falling in 2000-2004 to 1.6 percent. In addition, approval time for drugs that are withdrawn is not appreciably shorter than the average approval time for all drugs. The good news is that the FDA snatches dangerous drugs from the market much sooner than it used to. The average time between FDA approval and subsequent safety withdrawal dropped from 3.7 years in the 1980s to 1.4 years in the 1990s and is now 0.7 years.
Sam Kazman, the general counsel and head of the Death by Regulation project at the Competitive Enterprise Institute, a free market think tank, opines, "Hamburg overall has pretty good credentials." He adds, "The question is does she see FDA overcaution as a big problem or does she see problems elsewhere?" With regard to Sharfstein, Kazman says, "I am much less optimistic given Sharfstein's past association with Henry Waxman."
Sharfstein's ties to Waxman are indeed worrisome. Waxman, head of the House Energy and Commerce Committee, which oversees legislation dealing with the FDA, has a vast backlog of projects he wants to impose on the agency. These include banning direct-to-consumer advertising for new drugs for two years, extending FDA regulatory authority over tobacco products and dietary supplements, creating a separate federal food safety agency, and forbidding pharmaceutical companies to supply physicians with medical journal articles describing off-label uses of drugs. Off-label refers to the use of a drug to treat a condition for which it has not been officially approved by the government. This practice is legal and common and has thus far been seen as appropriate by the FDA. The ban on advertising and restrictions on off-label information will leave patients and physicians ignorant about the benefits and risks of medications. The FDA is supposed to regulate the safety of foods and medical drugs. Tobacco, of course, is neither, and everyone knows that while it pleasurable to use, it is not healthy to smoke or take snuff. With regard to dietary supplements, consumer education rather than increased regulation is the way to go. And finally, creating a federal food safety agency could have advantages, but food agency bureaucrats might become as risk-averse as FDA regulators currently are. In advancing Waxman's extensive FDA agenda, the signs point to Sharfstein becoming the congressman's hand puppet inside the agency.
"The big question is will Hamburg and Sharfstein treat any unexpected side effect of a new therapy as evidence that the FDA is falling down on its job?," asks Kazman. He adds, "The only way to guarantee zero unexpected side effects is to have zero new therapies."
Evidence shows that the FDA has been increasingly driven by critics and Congress towards ever more risk averse behavior. The danger here is that bureaucratic timidity kills. A 2005 study by economists at the University of Chicago calculated that the speed-up in FDA drug approvals that occurred after 1992 may have been responsible for saving the equivalent of 180,000 to 310,000 life-years (the sum of the years of life that would have been lost had the new drugs not been available). Over the same period, about 56,000 life-years—at worst—were lost to drugs that were eventually withdrawn for safety reasons.
Perhaps Hamburg and Sharfstein will buck this trend toward excessive caution and help speed up the process of getting new medicines to patients. Unfortunately, the preliminary signs are not good.
Ronald Bailey is Reason magazine's science correspondent.
Disclosure: I am an adjunct scholar at the Competitive Enterprise Institute.
Let's throw a Jeremy, Jennifer and Jessica in there and call it an 80's dance party!
Americans are guaranteed representative government by the US Constitution.
We do not have to allow the continued corruption of our government into soviet style councils.
Stand Up America! Stand up for your rights!
Ping
One can only hope. But the same was said of former commissioner David Kessler when he was appointed. He didn't restore trust or effectiveness in my book. But he did give the term "neo-nazi" an entirely new meaning.
You forgot Jason. I remember watching a little league base ball game back in the 80s and 6 of the boys on one team were named Jason.
What would anyone expect from these appointments other than two consumer-uber-alles Nazis? I was just wondering why some food and pharmaceutical stocks - which figure to be relatively good performers in a recession - haven’t been sharing in the Wall Street mini-rally this week. Now we have a better idea.
Liberal fix for social security shortfalls. Socialized medicine! Baby boomers won’t get medical care under the Zero plan. Hence, when they depart this earth due to lack of care, they, obviously, won’t need their Social Security.
Socialized medicine? Let’s beat it back now, before it’s too late. You made an interesting point: socialized medicine will likely have a negative effect on life expectancy, all other factors remaining constant. So will an FDA that is slow to approve potentially life saving drugs, as these appointments portend.
I was thinking about Jason, but he would have been the odd-man-out in an awesome foursome!!
The whole country is undergoing a trial to see if the medicine will go down. Won’t. Thanks justiceseeker93.
Is It a Gas, Fluid, Solid, or All of the Above?
New Type of Superconductivity Spotted
FReepmail me if you want on or off my health and science ping list.
Funny — the article doesn’t mention the expense of drugs. I had one once that was over $500.00 a month!
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.