Healthy Skepticism Library item: 810

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Harris G.
Drug Industry's Longtime Critic Says 'I Told You So'
The New York Times 2005 Feb 15

Full text:

Dr. Sidney M. Wolfe, the drug safety gadfly, flew down the stairs of his headquarters here and swept out the door.

“I am so angry with the F.D.A.,” he said. “Let’s go get a cup of coffee because I’ve talked myself hoarse.”

Set to music, this scene could serve as the opening sequence for one of the longest-running advocacy shows in Washington.

Dr. Wolfe, a director at Public Citizen, a consumer advocacy group, has been angry with the Food and Drug Administration and talking himself hoarse about it for nearly 34 years. He has condemned dozens of high-priced medicines and denounced their makers. He has castigated state medical boards and railed about rates for Caesarean sections. He has sought to ban unpasteurized milk and some herbal supplements.

In short, he has fought companies rich and poor and has angered just about every constituency in the health care industry. Even friends start remarks about him by saying, “Although I have disagreed with Sid in the past . . .”

Still, despite having a staff of just eight, he has often won. In fact, Dr.
Wolfe is on something of a roll.

Merck announced in September that it was withdrawing its huge-selling pain pill, Vioxx. Recent studies have cast doubt on the safety of Celebrex and Bextra, similar big sellers from Pfizer. An F.D.A. whistleblower told a Congressional panel in November that the agency was “virtually incapable” of protecting the public against unsafe drugs.

And through it all, Dr. Wolfe has been able to say that he told us so. He warned as early as April 2001 that patients should avoid taking Vioxx and Celebrex. He issued a similar warning on Bextra in September. He has been shouting about deficiencies at the F.D.A. since the first Nixon administration.

He routinely testifies at F.D.A. hearings and often appears on Capitol Hill.
He is regularly quoted by major news organizations.

“He’s almost unique in the world of drugs,” said Dr. Michael Jacobson, executive director of the Center for Science in the Public Interest, who has a parallel life in the world of food safety. “He spends his life systematically looking for problems, and he finds a remarkable number.”

Those findings have made Dr. Wolfe few friends in the pharmaceutical industry.

“Unfortunately, Dr. Wolfe often presents a distorted picture of today’s innovative industry and its medicines,” said Dr. Alan Goldhammer, associate vice president of the Pharmaceutical Research and Manufacturers of America, the drug industry’s trade organization. “He ignores important benefits that new drugs bring to millions of patients.”

In one of his more remarkable recent feats, Dr. Wolfe was scanning a pharmaceutical industry Web site in January when he stumbled on the results of an unpublished 1999 trial of Celebrex. Patients taking it in the trial were more likely to experience heart problems than those taking a placebo.

The trial itself was rather small and its heart results barely reached statistical significance. But Pfizer’s conclusions about the results, posted on the site, contradicted statements it had been making for years, that no trial of Celebrex had ever shown that the medicine hurt the heart.

“I nearly fell off my chair when I saw this” trial, Dr. Wolfe said.

Pfizer executives said the study was flawed. Still, Dr. Wolfe’s discovery made headlines around the country.

He walks briskly, bouncing on the balls of his feet. At a coffee shop, he orders a decaffeinated latte with skim milk. He agrees to share a cookie, but only if it is oatmeal raisin. Although his hair is shorter, Dr. Wolfe, 67, is still a hippie who lives his ideals.

He rarely eats processed food. He runs 10 miles a week. He presently takes no prescription or over-the-counter medications – even though his cholesterol is about 230. He insists that there is no research to suggest that a cholesterol-lowering drug will help low-risk people like him.

This kind of doctrinaire consistency can be insufferable, of course. But in Dr. Wolfe’s case, his exasperating sincerity is relieved by a deep-throated laugh and a few dire character flaws. For one, his office is a fire hazard.
His desktop is buried under two feet of paper that drips off the sides into more piles that appear to have aged considerably.

And then there are his clothes.

Seated in the coffee shop, Dr. Wolfe is wearing a somewhat rumpled white, button-down shirt. Through it, the lettering of an ABC News T-shirt can just be deciphered. He sports green khakis, sensible brown shoes and a Harris tweed jacket.

The jacket is identical to one he retired five years ago after wearing it nonstop for 10 years. He bought both at J. Press, the preppy clothing store.
Dr. Wolfe’s wife says he hasn’t changed his clothing style since high school.

The coffee shop conversation shifts from Celebrex and Bextra to civil rights. He describes seeing, on a college road trip to Florida in 1957, his first “Whites Only” sign, at a filling station in Virginia.

“That wasn’t more than 50 miles from Washington,” he said, still amazed.

He grew up in Cleveland and went to Cornell and Case Western Reserve University for medical school, then joined the National Institutes of Health in 1966 to avoid the Vietnam War.

In 1971, he discovered that intravenous drugs being made by Abbott Laboratories were contaminated. Patients were dying from the infections that resulted. The F.D.A. had decided to allow the contaminated products to continue to be sold, instructing hospitals to disconnect the fluids at the first sign of infection. He was incensed.

He had met Ralph Nader, and the two wrote a letter insisting that the F.D.A.
force the drugs’ withdrawal. The two gave the letter to every major news organization. Within days, Abbott announced a recall. Dr. Wolfe started getting calls on other issues. He was hooked. He proposed that he and Mr.
Nader begin a health research group, the first specialty group within Public Citizen.

Since then, Dr. Wolfe has petitioned the F.D.A. to withdraw 27 medicines; 16 of them were eventually removed. Among the others are Crestor, a cholesterol reducer from AstraZeneca, which is still widely used.

But Dr. Wolfe’s contention that Crestor patients have suffered far more kidney and muscle-weakening problems than patients taking similar pills has hurt its sales. AstraZeneca executives had once hoped that the drug would battle Pfizer’s Lipitor for the top spot among cholesterol-lowering pills.
Last year, Crestor had $908 million in sales; Lipitor had $10.8 billion.

Dr. Wolfe’s “analysis is inappropriate and misleading and doesn’t provide a true picture of Crestor,” said Rachel Bloom-Baglin, a spokeswoman for AstraZeneca. “If you’re going to be advocating for patients, you should be accurate and responsible.”

The knock on Dr. Wolfe is that he hates all drugs. Sam Kazman, general counsel of the libertarian Competitive Enterprise Institute, said that Dr.
Wolfe wanted drug approvals to be far slower, “and that amounts to a death sentence to lots of people who are in desperate need.” Dr. Wolfe said that he had always supported quick approval for drugs that were true breakthroughs and that he found many medicines beneficial. “That’s why our book is called ‘Worst Pills, Best Pills,’ “ Dr. Wolfe said, stressing the latter words. The book, by Dr. Wolfe and his Public Citizen colleagues, is an almanac of drugs, their effectiveness and their adverse reactions.

The other knock is that he is a tool of trial lawyers. But while Public Citizen has provided information to plaintiffs’ lawyers, the group gets no money from trial lawyers’ groups, trade associations or corporations, Dr.
Wolfe said. Public Citizen’s 2003 tax return shows that most of its $3.8 million budget came from membership dues. Legal fees from successful court actions, book sales and rental income are also contributors.

Dr. Wolfe said he made about $90,000 a year at Public Citizen. “That’s after spending more than 30 years here,” he adds defensively.

Mr. Nader, who long ago left Public Citizen, said that there were differences between Dr. Wolfe and him. “I’m much more congenial than he is,”
Mr. Nader said. “He doesn’t suffer fools gladly.”

Mr. Nader tells a story in which Dr. Wolfe calls a senator a liar in a hearing. “When someone contradicts what Sid thinks is scientific truth, he goes ballistic,” Mr. Nader said.

Dr. Wolfe agrees that he has trouble being polite with adversaries. He almost never speaks with drug company executives, and he avoids lobbying on Capitol Hill because his tendency to speak his mind hurts his cause.

Still, he has fans on Capitol Hill.

“It doesn’t matter who you are or where you sit on the political spectrum, he’ll let you know when something is wrong,” said Senator Edward M. Kennedy, Democrat of Massachusetts, when asked about Dr. Wolfe.

Mr. Nader said that another difference between him and Dr. Wolfe was that Dr. Wolfe never brought his work home and that he took a yearly three-week vacation in the south of France. Mr. Nader said he did not understand the need for such leisure.

Dr. Wolfe, the father of four grown daughters, says he likes spending time with his wife, Suzanne, and is an avid piano player. When he won a $350,000 MacArthur “genius” award in 1990, he spent the money on a piano and “paying off debts.”

Many evenings, he walks home from work with Suzanne, who works nearby and did not want her last name used because of her work. They pass the Colombian Embassy, which reminds Dr. Wolfe of a story about a drug made from fetuses collected at a Colombian hospital.

Such stories bubble out of Dr. Wolfe like scalding water from a boiling pot.
Pass a baby stroller and he recalls a series of unethical tests in developing countries in which a drug that would have prevented babies from being infected by H.I.V. was withheld from some mothers.

Pass a pharmacy with an old Bayer aspirin sign and he recalls the years it took to get a warning placed on aspirin bottles about Reye’s syndrome, a rare but sometimes fatal disorder brought on by aspirin use in children with chickenpox or flu.

At home, Dr. Wolfe opens a bottle of French wine. Suzanne relates how the two met as college lab partners. She soon developed a crush on him, but he was long oblivious. They went on to marry other people but found each other again after each divorced.

“There’s no pretense or hidden message to him,” Suzanne said. “I never have to worry about what he’s really thinking.”