Healthy Skepticism Library item: 14903

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Publication type: news

Mundy A.
Regulator's Clothing: Drug Industry Critic Joins the FDA
The Wall Street Journal 2009 Jan 9
http://online.wsj.com/article/SB123145489435265929.html?mod=googlenews_wsj

Full text:

The pharmaceutical industry has a recurring nightmare: Drug-safety crusader Sidney Wolfe becomes a player at the Food and Drug Administration.

Dr. Wolfe also has a nightmare: One of his children goes to work for a drug maker.

Of the two, the doctor is sleeping more soundly.

Over three decades, Dr. Wolfe, head of the health group at advocacy organization Public Citizen that Ralph Nader founded, has helped push 16 drugs off the market and slap restrictions on several multibillion-dollar products. He has been so hostile to the FDA under President George W. Bush that he decried its 100th-anniversary celebration in 2006 as a “propaganda campaign” to hide its “unprecedented assault on the American public.”

Now the outsider is going inside, mirroring a larger shift in the Washington pendulum toward tougher company regulation. To the consternation of the drug industry, Dr. Wolfe has been appointed to a four-year term on the FDA’s Drug Safety and Risk Management Committee, which plays a key role in telling the agency which drugs are safe.

Cassie M. Chew for The Wall Street Journal
Dr. Sidney Wolfe
What’s more, he has the ear of several health leaders and members of Congress expected to influence FDA policy in the Obama administration. Joshua Sharfstein, a former aide to liberal Rep. Henry Waxman, who is leading the Obama transition team assessing the FDA, worked for Dr. Wolfe years ago.

Dr. Wolfe’s critics say his judgments are just as one-sided as those he likes to blast. A pro-industry blog, Drugwonks.com, calls him the “general secretary of junk science,” citing his group’s call for a strong “black box” warning about blindness as a possible result of taking erectile-dysfunction drugs. Drugwonks says that is too rare a side effect for a black box.

Some patient-advocate groups say that if Dr. Wolfe gets his way, FDA approvals for new drugs will involve more bureaucracy, raise the costs of drug trials and keep life-saving drugs from reaching dying patients.

Dr. Wolfe was invited once to the safety panel in May, when he helped torpedo Cephalon Inc.‘s application to expand the use of its popular painkiller Fentora.

The FDA named him to the panel full-time in August, at the urging of consumer groups who were owed a seat on the committee. Few were aware of the news until Oct. 31, when an industry blog reported it under the headline “Happy Halloween.”

The industry was so surprised that several companies flew representatives to Washington for an FDA meeting of the panel in November — not because they had a drug being discussed that day, but because they wanted to watch for hints of coming trouble in Dr. Wolfe’s formal debut.

Off the Market

Over three decades, Dr. Sid Wolfe has helped push 16 drugs off the market. Below, a look at some of those.

Drug Manufacturer Use
Atromid-S Wyeth Cholesterol
Bendectin Sanofi Aventis Nausea — pregnancy
Bextra Pfizer NSAID
Butazolidin Novartis NSAID
Cylert Abbott Attention deficit
Lotronex* Prometheus Labs Irritable bowel
Oraflex Eli Lilly NSAID
Parlodel** Novartis Lactation suppressant
Propulsid Johnson & Johnson Gasto-intestinal disorders
Rezulin Pfizer Diabetes
Serzone*** Bristol-Myers Squibb Depression
Tandearil Novartis NSAID
Trovan Pfizer Antibiotic

Notes: *Taken off the market then reintroduced under very tight restrictions: little use **Petition succeeded in ban of its major use, lactation suppression ***After petition and lawsuit, Bristol-Myers Squibb withdrew drug as did one generic manufacturer. Other generic manufacturers still sell it.

A pharmaceutical lobbyist said, “I get along with Sid, but I don’t see an up side to this.” Dr. Wolfe relishes such criticism.

Dr. Wolfe can’t quite believe his newfound power, recalling days when his only way to influence FDA policy was to show up at chaotic public meetings. In his new role, “I won’t get the usual one minute to air my views in a line of 100 speakers,” he says.

A graduate of Case Western Reserve Medical School in Cleveland and former researcher at the National Institutes of Health, Dr. Wolfe helped found Public Citizen’s health group in 1971 and later picked up a MacArthur “genius” grant along the way.

His views haven’t changed much over the years. The FDA, as he sees it, is a tool of its corporate “clients.”

While noting life-saving drugs for heart disease and cancer, Dr. Wolfe says, “The history of the last 20 years is one of crises with drugs and medical devices, many approved despite the objections of the FDA’s own scientists.”

In the 1990s, a top FDA official defended drug companies to Dr. Wolfe as honest and reliable. “I told her that if industry did what it was supposed to, it would be self-regulated, and she would be out of a job,” he recalls.

Among changes he would like to see are fewer “copycats” of popular drugs and limits on direct-to-consumer advertising, both topics that have drawn attention from lawmakers.

Like his old friend Mr. Nader, Dr. Wolfe is ascetic in his personal life. He is a jogger and avoids drugs, both prescription and over-the-counter. His eldest daughter, Hannah, who counsels AIDS patients, admits, “There was a time in junior high when I wanted to be like other kids — drink Kool-Aid, drive a real car and watch TV.”

Family activities included protest marches. His mother paraded with him a few years back, when she was 90, for women’s reproductive rights. Suzanne, his wife of 30 years, is also an activist. His four daughters with his first wife and his two stepsons include a doctor, two AIDS patient psychologists and a musician. None are in pharmaceuticals.

Mr. Nader says his friend tends to be an absolutist. “If Sid thinks you’re selling out, you’re off his Rolodex,” he says.

“Living with a crusader takes a lot of patience,” Dr. Wolfe concedes.

Pharmaceuticals Rebel with a Cause
4:03
WSJ’s Alicia Mundy speaks with consumer advocate Sidney Wolfe about what his appointment to an FDA committee means for his fight for better drug safety.
More

See Dr. Wolfe’s Web site: worstpills.org
At his 70th birthday party in 2007 — with Marlo Thomas and husband Phil Donohue in attendance — his children serenaded him with a song tweaking his obsession. The chorus was: “A drug, a drug: Sidney pans a drug.”

Over the years, his targets have included the painkiller Vioxx, which Merck & Co. withdrew from the market in 2004, and GlaxoSmithKline PLC’s diabetes drug Avandia, whose sales have plunged after the company was forced to add a black-box label warning about heart risks.

Dr. Wolfe’s single-mindedness occasionally ticks off his own groupies. Years ago, he opposed painkiller lollipops for kids dying from cancer, leading Boston anesthesiologist Maureen Strafford, a drug-safety proponent, to snap: “Is there any drug Sid Wolfe likes?”

Yes, he says emphatically. His 1999 book “Worst Pills Best Pills” lists many. But he notes, “They generally have a longer history on the market” — which means many are off-patent and no longer big profit-makers.