Who's Minding the Drugstore?

[Guest guest]

For all intents and purposes, the FDA is subservient and an ally of the large

pharmacutical and agricultural interests rather than it's stated role as a

protecter of the citizens.

 

http://www.nytimes.com/2003/06/29/business/yourmoney/29FDAA.html?th

 

Who's Minding the Drugstore?By MELODY PETERSEN

 

 

FEDERAL regulators decided last year that a national television commercial

promoting a drug called Prevacid was misleading viewers by failing to make clear

that the medicine was for serious heartburn problems and not for occasional

indigestion.

 

But the letter that regulators wrote to Tap Pharmaceutical Products, the maker

of Prevacid, demanding that the ads be stopped, sat for 78 days in the offices

of Daniel E. Troy, the chief counsel of the Food and Drug Administration, while

millions of viewers continued to see the commercials. After the letter was

finally sent, the company pulled the ads and refashioned them to address the

F.D.A.'s grievance.

 

Government auditors warned regulators about such delays last fall, and the

F.D.A. promised to do better. But now, delays are not the problem. Far fewer

actions themselves are being taken, even though industry critics say they

continue to see promotions that illegally market unapproved uses of a drug,

understate risks, overstate benefits or make claims not backed up by studies, in

an industry that is spending more than ever to promote its products.

 

Until mid-June, when a reporter called to ask about the decline in enforcement

actions, the F.D.A. had sent only four such regulatory letters this year. After

that call, the agency issued four more letters. At that rate, it is now sending

an average of fewer than two letters a month on promotions it says are illegal.

That is down from about 10 letters a month, on average, from 1997 to 2000.

 

Critics, including members of Congress, former F.D.A. officials, lawyers,

doctors and consumer groups, say they see a clear shift in how the agency is

performing one of its main functions: policing the marketing of drugs, food and

medical devices. The agency has become willing to let some problems slip by,

these critics say, and to allow the companies it regulates to go further with

their marketing claims.

 

" The core of the agency's mission has always been protecting the public's

health, " said William B. Schultz, a lawyer who was the F.D.A.'s deputy

commissioner for policy from 1994 to 1998. " Now the agency is thinking about

allowing other considerations that would undermine that. "

 

Dr. Mark B. McClellan, the F.D.A. commissioner, defended his agency's efforts,

saying in an interview that the decline in regulatory letters had begun in the

Clinton administration and that it should not be taken to mean the agency had

become less aggressive in enforcing drug marketing laws and regulations.

 

" We will be enforcing the law on misleading promotion, " said Dr. McClellan, who

took office eight months ago. " The F.D.A. does not let important public health

problems slide. "

 

Indeed, Dr. McClellan said that regulators were now trying to work more with

drug companies before advertisements run to try to prevent misleading ads. He

also said the F.D.A.'s enforcement decisions were affected in part by the

outcome of several court cases in which the agency was found to have gone too

far in trying to rein in corporate promotion of regulated products.

 

Dr. McClellan said the agency had decided that the lawyers in Mr. Troy's office

should review each letter before it was sent to make sure it could withstand a

court challenge by the drug company.

 

Mr. Schultz and others, however, say they are especially worried about a move by

Mr. Troy last year to open up the agency's regulations to a wide-ranging review.

The aim, the regulators say, was to ensure that the rules did not violate the

First Amendment by going too far in restricting a company's right to tell the

public about its products. Dozens of drug makers, food companies and businesses

that market dietary supplements have provided written suggestions to the F.D.A.

on how the rules should be rewritten so that they can more easily promote their

products.

 

 

N a 167-page response prepared by Pfizer, for example, the company said the

F.D.A's current rules on prescription drug promotion had " led to a regime where

manufacturers are precluded from using advertising for its intended purpose. "

 

Pfizer's lawyers continued: " One has only to watch a laundry detergent ad to

realize that the vendor does not have to disclose the stains that the detergent

cannot remove in addition to the ones that it can. "

 

The review has delighted Mr. Troy's former clients. Before joining the F.D.A. in

2001, Mr. Troy was a private lawyer and prominent advocate of commercial free

speech for clients that included tobacco and pharmaceutical companies. He

brought two significant cases in which he argued that the F.D.A. had overstepped

constitutional law.

 

In one, filed by the Washington Legal Foundation, a nonprofit conservative

group, Mr. Troy contended that regulators were violating the First Amendment as

they tried to prevent drug companies from telling doctors how their medicines

could be used for conditions the drugs were not approved to treat.

 

Federal law states that drug companies cannot promote their products for

unapproved uses. The approval process ensures that drug companies perform

extensive studies to show their products are safe and effective for a condition

before that use is promoted to the public.

 

But lawsuits like the one brought by Mr. Troy and the Washington Legal

Foundation, which won a partial victory in court, have created gray areas in the

rules. Since that lawsuit, for example, the agency has generally been allowing

drug companies to distribute copies of published studies to doctors on the

effectiveness of a drug in a certain area, even though those studies may include

only small numbers of patients. The danger, according to critics of the

practice, is that other studies, of which doctors might be unaware, could have

found that the medicine did not work for that condition.

 

The agency said Mr. Troy declined to be interviewed for this article.

 

Peter Barton Hutt, a lawyer for food, pharmaceutical and other industries

regulated by the F.D.A., said Mr. Troy was doing " superbly " in his job.

 

Mr. Hutt, who was the F.D.A.'s chief counsel in the Nixon administration, said

he believed that the agency had a new policy, although unwritten, to limit its

enforcement actions so as to minimize the risk that a court could find that it

had violated the First Amendment. " Clearly, their policy now is to apply the

First Amendment, " he said.

 

One of Mr. Hutt's clients, the Grocery Manufacturers of America, was the first

to benefit from Mr. Troy's opening of regulations to a review.

 

In December, the F.D.A. took Mr. Hutt's advice, detailed in a 57-page

submission, and changed guidelines to make it easier for food companies to make

health claims about their products. Rather than requiring that a claim be backed

by " significant scientific evidence, " the F.D.A. will now allow qualified claims

in which the science is still uncertain but the evidence supporting a claim

outweighs the evidence opposing it.

 

Mr. Hutt used the example of omega-3 fatty acids, found in fish. Studies have

shown that consuming these fatty acids may reduce the risk of coronary heart

disease, though the evidence is not conclusive.

 

Dr. McClellan said the new food labeling guidelines would help consumers get

more information about possible health benefits of certain products even though

the science was not settled. " We want to see more of that type of information "

on food labels, he said.

 

UT some critics say that consumers are in danger of being misled by the new

labels.

 

" The claims on labels that consumers see will no longer be as reliable, " said

Bruce Silverglade, director of legal affairs at the Center for Science in the

Public Interest, a nonprofit consumer group in Washington. " The consumer is the

loser. "

 

Mr. Silverglade noted that there had once been promising evidence that beta

carotene supplements might reduce the risk of cancer. Studies in 1996, however,

showed that beta carotene appeared to increase the risk of lung cancer in

smokers.

 

Some lawyers for pharmaceutical companies say they expect the F.D.A. to make

changes soon in drug promotion rules.

 

James M. Beck, a lawyer who represents pharmaceutical companies at Dechert, a

law firm in Philadelphia, said he believed the F.D.A. had little choice but to

open up its regulations to review because of several court cases it had lost.

Last year, for example, the Supreme Court ruled that the First Amendment

prevented the F.D.A. from stopping a pharmacy from advertising drugs it had made

itself in a practice called compounding. The case was originally brought by the

Western States Medical Center, a compounding pharmacy in Las Vegas.

 

" The decision is emboldening some people, " Mr. Beck said. At a recent

conference, he said he had been struck by how forthcoming some pharmaceutical

executives had been in discussing the methods they were using to market products

for unapproved uses.

 

Indeed, it is not hard to find companies spreading the word about ways their

drugs can be used that have not been approved by the F.D.A.

 

Cephalon, a company in West Chester, Pa., recently paid for video and audio

segments for use in newscasts to detail how its drug Provigil can be used to

treat attention deficit disorder in children and depression in adults. The drug

is approved to treat excessive daytime sleepiness associated with narcolepsy.

The segments were distributed to hundreds of television and radio stations

around the country.

 

" The advantage of Provigil over other drugs is that it will treat the symptoms

of attention deficit hyperactivity disorder with fewer side effects, " says a

doctor in the video who was involved in a clinical trial of the drug. " This is

all very exciting news for parents of children with A.D.H.D. "

 

In an audio format distributed to radio stations, the announcer, sounding like a

news anchor, says, " Depression is a serious illness, affecting more than 10

million Americans. "

 

She adds that preliminary research data indicates that " Provigil, taken along

with the antidepressants Paxil and Prozac, helped patients almost immediately. "

 

Robert W. Grupp, a spokesman for Cephalon, said both segments were produced

after scientists presented results from Provigil studies at a medical meeting.

He said the company had paid for the videos to tell the public about important

new scientific information concerning Provigil, and not to promote the drug.

 

" We can't promote off-label, " he said. " We're very careful not to do that. "

 

He said that about 75 percent of Provigil's sales were for unapproved uses.

 

 

RODUCERS of videos like those made for Cephalon say that more local television

stations have been incorporating them into their newscasts because of limited

budgets in the sluggish economy.

 

Mr. Grupp said 2.5 million viewers had seen the videos about Provigil and

attention deficit disorder — a number the company considered small.

 

The drug companies have long used such video new releases. After the Senate

challenged the practice in hearings in 1990, the F.D.A. told the drug companies

that they should send a copy of each video news release to the agency for

review, although the productions did not have to be approved in advance.

 

Brad Stone, a spokesman for the F.D.A., said the agency policy has not changed

since then. Any video news release " that deals with the promotion of a drug

would be subject to our jurisdiction, " he said. " If we saw something that we

thought was violative, we would take action. "

 

He said he could not comment on Cephalon's videos specifically.

 

Representative Henry A. Waxman, Democrat of California, said the F.D.A. could

move drug regulation back 40 years, to a time when companies did not have to

prove the effectiveness of the products they advertised, if it began allowing

the promotion of unapproved uses.

 

Such a change, he said, " would be a terrible, terrible result that would lead to

a lot of serious health risks. "

 

But the drug industry and its lawyers say doctors need to know information about

drugs that may be important for their patients.

 

Dr. McClellan said the F.D.A. had no plans to give the companies wide leeway to

promote their products for unapproved uses. " We don't condone off-label

promotion, " he said.

 

He said, however, that he thought television ads used by the drug companies

served a good purpose. They " help people who need treatment " by prompting them

to see a doctor, he said.

 

The pharmaceutical industry spent $2.6 billion on consumer ads last year in the

United States — more than double the amount spent in 1998, according to TNS

Media Intelligence/CMR, which monitors advertising spending.

 

But while the F.D.A. sent 158 regulatory letters in 1998 to companies about ads

the agency found to be false or misleading, it sent only 26 last year.

 

Dr. Sidney Wolfe, director of the health research group at Public Citizen, the

watchdog organization founded by Ralph Nader, said he was troubled by the

decline in letters that began in 1999. " Regulation by the F.D.A. was already

diminishing then, " he said. But he called the more recent decline " really

frightful. "

 

" Ads are running now that would not be allowed to run in 1998, " Dr. Wolfe said.

" The amount of damage done to consumers by these false and misleading ads is

enormous. "

 

Representative Waxman wrote to the agency last fall, stating that while the drop

in enforcement actions " may be a welcome development for the drug industry, " it

" poses serious dangers to public health. "

 

The number of complaints to the F.D.A. about false and misleading drug ads has

not declined, Mr. Waxman said, even though the agency's drug marketing

enforcement division — which has 40 workers, 10 more than in 2000 — has been

taking far fewer actions against the companies. He said that from 1999 to 2001,

the F.D.A. sent one warning letter for every 2.8 complaints about false

advertising. But in the first six months of 2002, he said, it sent one letter

for every 13.5 complaints.

 

Dr. Michael Wilkes, vice dean for education at the School of Medicine at the

University of California at Davis, has studied prescription drug advertisements

and said he had found more problems recently. The companies, he said, seem

" willing to push the limits a bit. "

 

" The current administration is not going to step in unless there are gross

violations, " he said. " The word has gotten out. "

 

At Representative Waxman's request, Dr. Wilkes and other experts last fall

reviewed some television ads and found dozens of problems.

 

For example, a commercial for Ambien, a sleeping pill that is a controlled

substance because of its potential for abuse, includes a warning that states,

" People who abuse sleep aids may develop addiction. "

 

Dr. Wilkes said the warning was misleading because many viewers do not believe

they will ever misuse pills. Anyone, he said, can develop an addiction.

 

Leslie Hare, a spokeswoman for the manufacturer, Sanofi-Synthelabo, said that

that ad is no longer running for Ambien, although the F.D.A. had reviewed it.

 

The F.D.A. has strengthened the rules for one product area: dietary supplements.

After ephedra was cited in the death of Steve Bechler, a Baltimore Orioles

pitcher, Dr. McClellan announced new rules to require that dietary supplements

not be contaminated in manufacturing and be accurately labeled to reflect their

ingredients. The changes, however, did nothing to tell consumers whether the

supplements might be dangerous or if they worked.

 

 

THE F.D.A. has pleased drug makers on a different front, by announcing several

efforts to help speed new medicines to market. Dr. McClellan said last week in a

speech at a biotechnology industry conference that the agency was committed to

reducing by at least 10 percent the total time it took regulators to review an

experimental drug.

 

" Based on published estimates, a 10 percent reduction in regulatory review time

reduces the total investment required to develop a new medication by over $12

million, " Dr. McClellan said in the speech. " By shifting down the time and cost

of developing new medications, patients will benefit from earlier and greater

access to more safe and effective medications. "

 

Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer

Society, said he welcomed the change, as long as the agency is given the

resources to do the faster reviews properly.

 

" We need to look at the process carefully to make sure that drugs that are

clearly beneficial to patients are not held up, " he said.

 

But some consumer groups have begun to worry that the faster reviews could

result in the approval of medicines that carry dangerous side effects or do not

work.

 

Larry D. Sasich, a pharmacist and research analyst at Public Citizen, pointed to

the F.D.A.'s recent approval of Iressa, a lung cancer drug. The agency approved

Iressa in May even though the drug shrank tumors in just 10 percent of patients

and has been linked to the deaths of more than 200 patients in Japan.

 

" We're starting to get really concerned about what is happening at the F.D.A., "

Mr. Sasich said. " Drugs are only as good as the regulators. "

 

 

 

 

 

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