Drug Industry's Longtime Critic Says 'I Told You So'

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February 15, 2005

Drug Industry's Longtime Critic Says 'I Told You So'

By GARDINER HARRIS

ASHINGTON, Feb. 14 - 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.

son, 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 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

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 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. "