Beware Drug Ads, Consumer Group Warns

[Guest guest]

Ads Can Run Without Prior FDA Approval

By DeNoon

WebMD Medical News Reviewed By , MD

on Wednesday, January 08, 2003

Jan. 8, 2003 -- You can't trust the FDA to keep drug ads honest, a consumer

group warns. That doesn't mean the ads can't be useful -- but prospective

patients had better be wary.

The February issue of Consumer Reports warns that drug ads:

Commonly minimize drug risks

Exaggerate how well drugs work

Make false claims that one drug is better than another

Suggest unapproved uses for existing drugs, and

Promote still-experimental drugs

Most people take ads with a grain of salt. Nobody believes commercials that

show cars driving straight up tall cliffs. But drug ads are supposed to be

held to a higher standard.

" Regard drug ads as carefully as you do any other kind of advertising, "

report author Doug Podolsky, Consumer Reports senior editor, tells WebMD.

" The bottom line is prescription drug ads can be useful. They may help you

talk with your doctor about conditions you didn't know could be treated. But

keep an open mind. Don't pressure your doctor to give you a drug just on the

basis of advertising. "

Lots of people think the FDA approves all drug ads -- and that all

advertised drugs have to be completely safe. That just isn't so. Drug

companies have to submit copies of their direct-to-consumer ads to the FDA.

But that sets them free to run the ads at will unless the federal agency

objects. New rules have slowed this review process to a crawl.

Nevertheless, the drug industry thinks the FDA is doing a very good job of

overseeing the ads. Jeff Trewhitt is spokesman for the Pharmaceutical

Research and Manufacturers of America (PhRMA), the industry's central

lobbying group.

" We are very comfortable making the statement that in the vast majority of

cases the ads are constructive, " Trewhitt tells WebMD. " The FDA is doing a

good job of making sure this is the case. On the rare occasion that an ad

has false and misleading information, there should be regulatory action. But

in the vast majority of cases, direct-to-consumer ads are accurate and serve

a purpose and are carefully regulated. "

Even former FDA commissioner Kessler seems to agree. Kessler opposed

television consumer drug ads. It was only after he left the FDA in 1997 that

the agency approved this kind of advertising. Last year, Kessler told a

drug-advertising convention that he was wrong.

But the U.S. General Accounting Office (GAO) -- the investigative arm of

Congress -- only last month reported that FDA oversight is quite limited.

The result: misleading drug ads persist.

Rep. Henry Waxman (D-Calif.) recently obtained from the FDA a videotape of

consumer drug ads broadcast from 2001-2002. He sent the ads to two experts:

Wilkes, MD, PhD, of the University of California, ; and Barbara

Mintzes of the Center for Health Services and Policy Research, British

Columbia, Canada. Both found the ads commonly misleading.

" My overall impression is that the adverts I reviewed contained numerous

problems (errors, omission, or misleading statements/images) and that as a

group they are often intended to mislead a consumer about the drug's

effectiveness or the seriousness of their medical condition, " Wilkes wrote

in a letter to Waxman.

Consumer Reports analyzed all FDA warning letters sent to drug makers since

1997, when consumer drug ads first were allowed on TV. There were 564

letters, including minimizing or obscuring a drug's risks, false claims of

efficacy, misleading claims that a drug was better than another, and

promoting approved drugs for unapproved uses.

The drug ads most often cited by the FDA included:

Claritin (allergy drug, 11 citations)

Avapro (blood pressure drug, 7 citations)

Flonase (allergy drug, 7 citations)

Flovent (asthma drug, 7 citations)

Celebrex (arthritis drug, 6 citations)

Vanceril (asthma drug, 6 citations)

Xenical (weight-loss drug, 6 citations)

Zyrtec (allergy drug, 6 citations)

Allegra (allergy drug, 5 citations)

Avandia (diabetes drug, 5 citations)

Ditropan (bladder problems drug, 5 citations)

Pravachol (cholesterol drug, 5 citations)

What's a consumer to do? Be wary, warns Gail Shearer, director of health

policy analysis for Consumer Reports publisher Consumers Union.

" Be skeptical of anything you hear in advertising, " Shearer tells WebMD.

" Don't assume because you see something in an ad that that is something you

should take. These ads are not telling the whole story. "

Here are Consumer Report's consumer guidelines:

If an ad makes you think you need a drug, find out more about the drug. Look

for unbiased information about the drug. Then talk to your doctor about it.

Ask your doctor these questions: Do I have the condition the drug treats?

What are the drugs benefits and risks? How does this drug compare to other

drugs and nondrug treatments? If the drug is new, do its benefits justify

its higher cost and possible side effects?

Don't pressure your doctor into prescribing a drug -- unless you have

strong, independent evidence that you really need it.

Report misleading ads to the FDA at (888) 463-6332.

Shearer also wants Congress to pass legislation that would set up panels of

experts that would compare the cost, safety, and efficacy of different

drugs. Only such panels, she says, could give consumers the unbiased

information they need.

Marilyn (Canada)

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Hey, just super, Marilyn!!! Great job of getting information. I really

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God bless you,

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Stoughton, Wisconsin

Beware Drug Ads, Consumer Group Warns

Ads Can Run Without Prior FDA Approval

By DeNoon

WebMD Medical News Reviewed By , MD

on Wednesday, January 08, 2003

Jan. 8, 2003 -- You can't trust the FDA to keep drug ads honest, a consumer

group warns. That doesn't mean the ads can't be useful -- but prospective

patients had better be wary.

The February issue of Consumer Reports warns that drug ads:

Commonly minimize drug risks

Exaggerate how well drugs work

Make false claims that one drug is better than another

Suggest unapproved uses for existing drugs, and

Promote still-experimental drugs

Most people take ads with a grain of salt. Nobody believes commercials that

show cars driving straight up tall cliffs. But drug ads are supposed to be

held to a higher standard.

" Regard drug ads as carefully as you do any other kind of advertising, "

report author Doug Podolsky, Consumer Reports senior editor, tells WebMD.

" The bottom line is prescription drug ads can be useful. They may help you

talk with your doctor about conditions you didn't know could be treated. But

keep an open mind. Don't pressure your doctor to give you a drug just on the

basis of advertising. "

Lots of people think the FDA approves all drug ads -- and that all

advertised drugs have to be completely safe. That just isn't so. Drug

companies have to submit copies of their direct-to-consumer ads to the FDA.

But that sets them free to run the ads at will unless the federal agency

objects. New rules have slowed this review process to a crawl.

Nevertheless, the drug industry thinks the FDA is doing a very good job of

overseeing the ads. Jeff Trewhitt is spokesman for the Pharmaceutical

Research and Manufacturers of America (PhRMA), the industry's central

lobbying group.

" We are very comfortable making the statement that in the vast majority of

cases the ads are constructive, " Trewhitt tells WebMD. " The FDA is doing a

good job of making sure this is the case. On the rare occasion that an ad

has false and misleading information, there should be regulatory action. But

in the vast majority of cases, direct-to-consumer ads are accurate and serve

a purpose and are carefully regulated. "

Even former FDA commissioner Kessler seems to agree. Kessler opposed

television consumer drug ads. It was only after he left the FDA in 1997 that

the agency approved this kind of advertising. Last year, Kessler told a

drug-advertising convention that he was wrong.

But the U.S. General Accounting Office (GAO) -- the investigative arm of

Congress -- only last month reported that FDA oversight is quite limited.

The result: misleading drug ads persist.

Rep. Henry Waxman (D-Calif.) recently obtained from the FDA a videotape of

consumer drug ads broadcast from 2001-2002. He sent the ads to two experts:

Wilkes, MD, PhD, of the University of California, ; and Barbara

Mintzes of the Center for Health Services and Policy Research, British

Columbia, Canada. Both found the ads commonly misleading.

" My overall impression is that the adverts I reviewed contained numerous

problems (errors, omission, or misleading statements/images) and that as a

group they are often intended to mislead a consumer about the drug's

effectiveness or the seriousness of their medical condition, " Wilkes wrote

in a letter to Waxman.

Consumer Reports analyzed all FDA warning letters sent to drug makers since

1997, when consumer drug ads first were allowed on TV. There were 564

letters, including minimizing or obscuring a drug's risks, false claims of

efficacy, misleading claims that a drug was better than another, and

promoting approved drugs for unapproved uses.

The drug ads most often cited by the FDA included:

Claritin (allergy drug, 11 citations)

Avapro (blood pressure drug, 7 citations)

Flonase (allergy drug, 7 citations)

Flovent (asthma drug, 7 citations)

Celebrex (arthritis drug, 6 citations)

Vanceril (asthma drug, 6 citations)

Xenical (weight-loss drug, 6 citations)

Zyrtec (allergy drug, 6 citations)

Allegra (allergy drug, 5 citations)

Avandia (diabetes drug, 5 citations)

Ditropan (bladder problems drug, 5 citations)

Pravachol (cholesterol drug, 5 citations)

What's a consumer to do? Be wary, warns Gail Shearer, director of health

policy analysis for Consumer Reports publisher Consumers Union.

" Be skeptical of anything you hear in advertising, " Shearer tells WebMD.

" Don't assume because you see something in an ad that that is something you

should take. These ads are not telling the whole story. "

Here are Consumer Report's consumer guidelines:

If an ad makes you think you need a drug, find out more about the drug. Look

for unbiased information about the drug. Then talk to your doctor about it.

Ask your doctor these questions: Do I have the condition the drug treats?

What are the drugs benefits and risks? How does this drug compare to other

drugs and nondrug treatments? If the drug is new, do its benefits justify

its higher cost and possible side effects?

Don't pressure your doctor into prescribing a drug -- unless you have

strong, independent evidence that you really need it.

Report misleading ads to the FDA at (888) 463-6332.

Shearer also wants Congress to pass legislation that would set up panels of

experts that would compare the cost, safety, and efficacy of different

drugs. Only such panels, she says, could give consumers the unbiased

information they need.

Marilyn (Canada)

_________________________________________________________________

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