DRUG COMPANY ADS: SELLING A PRODUCT OR SELLING OUT THE PUBLIC?

[Guest guest]

http://www.cancer-coverup.com/newsletter/04-2003/default.htm

 

DRUG COMPANY ADS:

SELLING A PRODUCT OR SELLING OUT THE PUBLIC?

According to Eli Lily, if you’re a woman, you have a problem and they have the

solution. In 2001, Lily began “Direct to Consumer” ads for its drug Sarafem “a

new treatment that offers hope for millions of women.” And what was this hope?

Was it a cure for breast cancer? Did it offer relief to those afflicted with

fibromyalgia? Did it ease the pain of childbirth? No, according to Lily, it

addressed a problem many women didn’t know existed: Premenstrual Dysphoric

Disorder, or PMDD!

 

 

 

According to Lily’s slick ads, up to 5 percent of all women suffer from PMDD –

that’s over 7.2 million victims according to current Census Bureau population

estimates! According to Lily the symptoms include “irritability, tension, mood

swings, breast tenderness and bloating.”

 

It all sounds very scientific and very authoritative, and implies that Lily’s

breakthrough, Sarafem, is a godsend! The only trouble is, there are a couple of

things the ads don’t mention.

 

First, while many women do undoubtedly suffer severe symptoms in connection with

their monthly cycle, there is no general agreement among health professionals

about the PMDD.

 

Second, Sarafem, Lily’s wonder drug, is actually nothing more than Prozac, an

antidepressant, repackaged in a more feminine pink and lavender capsule. As a

result, it would do nothing to ease physical symptoms such as cramps or

bloating.

 

Third, Prozac is not a new drug. What was actually happening was that Lily’s

patent on Prozac expired in August of 2001, allowing generic versions to compete

with their blockbuster. By creating a new “indication” and new capsule, the

company was able to open a new, exclusive market for their product to offset

inroads by generics on more traditional uses.

 

What is perhaps most disturbing is the fact that Prozac is a psychiatric drug –

used to treat clinical depression, obsessive-compulsive disorder, and other

serious mental health problems. What Lily is implying through its advertising is

that millions of American women become mentally disturbed every month! But how

do drug companies such as Eli Lily get away with such excess?

 

The answer is simple: the FDA lets them!

 

In 1997, the FDA loosened the rules governing so-called " Direct to Consumer "

ads. With that move it opened a Pandora's Box of drug company lies, deceit and

excess. A few examples cited in a recent congressional investigation illustrate

this point:

 

The allergy drug Zyrtec claims that there are two kinds of allergies: indoor and

outdoor. According to Dr. Michael Wilkes, Vice Dean for medicine at the

University of California, Davis, however, this is nonsense. He told the

Committee " The advert is simply wrong. "

In regard to ads for Ambien, a sleeping aid, Dr. Wilkes found a more serious

problem. " This is a drug with high abuse potential. " He wrote. Wilkes was

concerned that the ads greatly understated the addictive qualities of the drug.

 

His criticism of ads for Celebrex was simpler: " This is an advert for a pain

reliever that is no stronger than others such as ibuprofen. However, it suggests

that it is stronger and more effective. " In short, the company was lying so that

consumers would spend $150 a month to buy their product instead of $5 for an

over-the-counter drug that was just as good.

 

Of Clarinex's assertion that it " Provides receptor protection, " Wilkes said

" This is a meaningless claim and if this drug provides such protection so do all

others in its class. It also claims 'any allergy any time'. This is grossly

misleading. "

 

Wilkes said that the statement " Multi-system Flonase relieves them all, " was

" not true and creates a sense of superiority over other drugs that does not

exist. "

 

And how about the claim by the migraine drug Imitrex that it constituted " total

treatment? " Wilkes said it was " counter to research. "

 

And mind you, these are just a few examples.

 

Dr. Barbara Mintzes of the Centre for Health Services and Policy at the

University of British Columbia reviewed some 74 Direct to Consumer ads for the

Committee, and came up with a laundry list of criticisms.

 

Perhaps the single most important problem Dr. Mintzes uncovered was the failure

of the ads to present the risks associated with taking the drug being

advertised. For example, an ad for Paxil states it is non-habit forming. This,

however, is flatly untrue. In fact a federal judge recently banned television

ads for Paxil that claimed it was not habit forming.

 

Even where the risks were presented, they were often done so in a way that

prevented the viewer from becoming fully aware of them. In some cases they were

presented in a different and softer voice than other material in the commercial.

In other cases, they only appeared in small type while other activity was taking

place on the screen and was likely to distract the viewer. Whatever the

technique, though, the end result was to minimize the viewer's awareness and

understanding of what the risks truly were.

 

Another criticism was that the content of the ads did not accurately reflect the

information on the product label. This is no minor failure: product labels are

the primary way both doctors and patients are informed about a drug's risks, and

are the product of a painstaking scientific review.

 

Dr. Mintzes also found that the ads routinely overstated the effectiveness of

the drug. For example she cited an ad for Lipitor in which the action on the

screen depicting a man having a heart attacks implied it could prevent their

occurrence. The only way anyone would know this was false would be by reading a

disclaimer in extremely small white print that stated " Lipitor had not been

shown to prevent heart disease or heart attacks. " The audio portion of the ad,

however makes no mention of this important fact.

 

Dr. Mintzes found similar problems with ads for Detrol and Ditropan, two drugs

used to treat overactive bladders. The ads claim the drugs are " proven

effective " and yet according to Mintzes:

 

" Two double-blind RCTs are available comparing the effectiveness of tolterodine,

2 mg BID with oxybutynin 5 mg TID and placebo .. There was no significant

difference in the proportion of patients who perceived an improvement in bladder

symptoms: placebo 47%, tolterodine (Detrol) 50%, and oxybutynin (Ditropan) 49%. "

 

In other words, the best a patient could hope for was a slight improvement, not

the dramatic change the ads implied.

 

The same is true for the asthma drug Singulair, which has characters in its ads

proudly proclaim that the drug is " …what I do for my asthma every day. " What the

ads don't mention is that Singulair is less effective than the traditional

treatment: inhaled steroids! Indeed, one review of the drug flatly stated " The

average effects in the trials, though statistically significant, are small and

of questionable clinical significance. "

 

What is more disturbing than the ads themselves, is the FDA's attitude toward

them. Since 1997, the agency has issued some 564 warning letters concerning

misleading or inaccurate Direct to Consumer ads. Among the most serious

offenders were:

 

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, 5 citations)

Allegra ( allergy drug, 5 citations)

Avandia ( diabetes drug, 5 citations)

Ditropan ( bladder control drug, 5 citations)

Provachol ( cholesterol drug, 5 citations)

 

Yet, despite these repeated citations, at best, the companies are merely asked

to stop running the ad, and in extreme cases, run corrections. Since these

actions generally occur long after the ad has run, and the damage has been done,

they amount to little more than a slap on the wrist. But even this tepid

regulatory response seems to be on the way out.

 

Between January of 1999 and December of 2001, the FDA issued some 250 warning

letters to companies about false, misleading or otherwise objectionable ads.

Between December of 2001 and September 1, 2002, however, only 19 such letters

were issued. During that same period, though, the number of ads drug companies

ran increased by 20%! This means that in relative terms, the number of citations

the FDA issued dropped by 80%!

 

Something is clearly amiss.

 

Of course, some might argue that there were fewer citations because there were

fewer violations - that drug companies were learning the rules. Unfortunately,

the statistics tell a different story.

 

One measure of how active the FDA is in policing drug company ads, is the way

they respond to complaints concerning those ads.

 

Between 1999 and 2001 the agency received a total of 715 complaints from

doctors, consumers and drug companies concerning the promotions for prescription

drugs. After reviewing these complaints, the FDA issued 253 Notice of Violation

or Warning letters. This was an average of one letter for every 2.8 complaints.

In contrast, during the first six months of 2002, the FDA received 111

complaints but only sent out eight Notice of Violation or Warning letters - an

average of one for each 13.5 complaints.

 

This amounted to an 80% reduction in enforcement actions!

 

But why has this happened?

 

One reason is a change in policy.

 

In November of 2001, the FDA decided that each Notice of Violation or Warning

letter had to be reviewed and approved by the agency's General Counsel before

being issued. The result was a dramatic reduction in the number of letters

issued, and an enormous extension the amount of time that passed between the

point at which a complaint was received and the issuance of a letter. This meant

that even when letters were issued, they came long after the damage was done.

 

For example, in August of 2002, a letter was sent to TAP pharmaceuticals

concerning misleading statements about their drug, Prevacid, contained in an ad

submitted for approval. The only trouble was that the ad had been submitted five

months previously and had been running throughout the review period.

 

In another case, a Warning letter was sent to the manufacturer of Tamiflu

because their radio ad was deemed false and misleading. The letter was not

issued, however, until May of 2002, long after the flu season had ended.

 

Such delays can have serious consequences, especially when the material in

question concerns safety or potential side effects.

 

Consumers can be misinformed, or have information on potentially

life-threatening side effects withheld as a result of such delays, literally

putting their lives at risk. At a minimum, they run the risk of having their

pocketbooks picked by pharmaceutical companies more interested in profits than

patients.

 

But do ads really effect consumer spending habits? According to a survey by the

respected Kaiser Foundation for a substantial percentage of the American public,

the answer is an emphatic yes!

 

The Kaiser survey examined a number of questions related to Direct to Consumer

Ads. Perhaps the most important was whether or not such ads actually influenced

patients and doctors in choosing prescription drugs.

 

According to the survey, about thirty percent of Americans were likely to ask

their doctor about a drug that they saw advertised.

 

While this might seem like a small percentage, it turned out that the

individuals who asked about the drug did so because they suffered from the

condition it was supposed to treat. Therefore, the ads were clearly very

effective in reaching their target audience, and in getting that audience to

actually buy the product.

 

Moreover, the respondents who expressed an interest in the drugs also indicated

that if their doctor were unwilling to prescribe the drug they asked about, they

were likely to switch doctors. Physicians are well aware of this, and therefore

are likely to give in to their patient's wishes. Again, the survey results seem

to support this conclusion.

 

Of the individuals who asked their doctor about the advertised drug, 44% said

that the doctor subsequently wrote them a prescription for it.

 

The Kaiser survey also looked at the impact of specific ads on public

perceptions. Here, the impact on public understanding became clear.

 

One ad they asked about was for Lipitor, a cholesterol-lowering drug. Most

people know that such drugs exist, and a substantial proportion of the public

knows that such drugs do not prevent heart attacks. Their responses to the

questions reflected that knowledge, although a significant minority - 15% -

apparently believed the implication in Lipitor ads that it could prevent heart

attacks and 50% weren't sure.

 

In the second example, though, the survey asked questions about Singulair, an

asthma drug. The public is not as familiar with asthma as it is with heart

disease. Here, the ads impact was more significant. When asked if there were

pills people could take during an asthma attack instead of using an inhaler, 25%

of the people who had seen ads for Singulair said there were. This is not true.

Among people who had not seen the ad, however, only 12% gave the wrong answer.

Clearly, the ad had influenced the opinion of those who had seen it - and left

them with an incorrect impression.

 

What was also clear was that the ads did not leave accurate impressions

concerning side effects. In the case of Lipitor, only 42% of the people who had

seen the ad realized that muscle weakness was a major side effect. Similarly,

less than a third of those who saw ads for Singulair were aware that potential

side effects of the drug included getting the flu, having a runny nose or

getting an ear infection. What makes this fact important is the FDA's

requirement that ads contain a thorough, " major statement " of all major risks

associated with the drug. Further analysis by Kaiser left little doubt that this

requirement was not being met.

 

The Kaiser researchers compared the perceptions of side effects between people

who had seen ads for three drugs: Lipitor, Nexum, and Singulair.

 

People who had not seen the ads overwhelmingly said they simply didn't know.

Among those who had seen the ads, a very different picture emerged.

 

Among those who had seen ads for Lipitor, 15% said that its potential side

effects were either not at all serious or not too serious. Another 44% said they

were somewhat serious. Only 26% said that very serious potential side effects

were associated with the drug. Yet, the potential for liver damage is so

significant with Lipitor that those using it must have their liver functions

tested regularly. Similarly, up to 25% of those using Lipitor have reported

muscle weakness as a side effect, and for a substantial portion of those using

the drug, the muscle weakness was so severe that the drug was discontinued.

 

In the case of Singulair, even more people who had seen the ad were convinced

that the potential side effects were minimal. Some 37% said they were not at all

serious or not too serious, and 34% said they were somewhat serious. Only 5%

felt that there were potentially serious side effects. Again, those who had not

seen the ads by and large said they didn't know. Yet there are potentially

serious side effects from Singulair including irregular heart beat and

respiratory problems.

 

Like those who had seen ads for the other two drugs, viewers of ads for Nexium

by and large believed it to be benign. The warning label for Nexium however,

cautions patients that when taken in conjunction with certain antibiotics it can

cause fatal allergic reactions and that individuals with liver problems should

use only the lowest dose.

 

What the Kaiser survey showed, is what anyone who has viewed prescription drug

ads already knows: as far as the FDA is concerned, Big Pharma can do no wrong.

 

But the influence of Big Pharma's advertising and drug promotion goes far beyond

its impact on the individual consumer. It reaches into the highest levels of the

media and the academic community and the government.

 

Next month's newsletter will reveal more about the influence of Big Pharma's

promotional campaigns and how their leverage with the media and the government

is responsible for making health care costs skyrocket.