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Top Drug Companies Receive ‘Honors’ For Overhyped Marketing

Wednesday, April 26, 2006

The Prescription Access Litigation Project, a national consumer coalition devoted to challenging high drug prices, recently announced the winners of their 2006 Bitter Pill Awards. The following is excerpted from their press release: 

The Prescription Access Litigation Project (PAL) announced winners of the 2006 Bitter Pill Awards earlier today through a nationwide conference call. This year, Bitter Pill Awards were presented in four categories to drug companies engaging in over-zealous and questionable marketing practices. The drug industry’s national lobbying group, PhRMA, received two awards, and the remaining three awards were shared among makers of five of the nation’s most well-known drugs: Lunesta, Ambien/AmbienCR, Lipitor, Crestor and Strattera.

The only national consumer coalition devoted solely to challenging high drug prices, PAL is a coalition of 118 state, local and national senior, labor and consumer health advocacy groups in 35 states fighting to make prescription drugs affordable for everyone. Now in their second year, PAL’s Bitter Pill Awards are handed out to highlight the serious problems caused by drug industry marketing, particularly Direct-to-Consumer Advertising (DTCA) of prescription drugs. DTCA includes television, radio, magazine and internet ads that target consumers directly, rather than targeting doctors.

“Whether you’re watching TV, reading a magazine, or browsing the web, it’s impossible to escape prescription drug advertisements,” said Alex Sugerman-Brozan, Director of PAL. “A lot of money is riding on drug companies convincing consumers that they have insomnia, acid reflux, high cholesterol, allergies, depression, toenail fungus and erectile dysfunction, and that they need to have expensive brand-name drugs to treat them.”

The drug industry spent $4.65 billion in 2005 advertising brand-name prescription drugs to consumers, a 4.7% increase over 2004. For every dollar that drug companies spend on consumer advertising, it is estimated they earn anywhere from an additional $1.50 to $4.20 in sales. Drug advertising over-promotes newer, more expensive brand-name drugs over lifestyle changes (such as better diet and exercise) and much cheaper generic drugs that are frequently just as effective as brand-name prescriptions. Drug ads also expand the market for newer drugs far beyond those patients that actually need them, interfere with the doctor-patient relationship, and perpetuate the myth that “there’s a pill for every ill” and that “newer is better.” While many doctors and patients believe that drug ads are policed by the Food and Drug Administration (FDA), that agency has far too few staff and resources devoted to reviewing drug ads, lacks real enforcement powers, and has relaxed the standards governing drug ads too far.

“As a physician, I have seen how the avalanche of direct-to-consumer drug advertising infects the doctor-patient relationship, as patients demand brand-name drugs they’ve seen promoted in magazines or on television. This aggressive marketing can lead people to take expensive drugs they may not need, driving up costs for consumers and the health care system as a whole,” said Dr. Jerry Avorn, professor of medicine at Harvard Medical School and author of Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs. While the Bitter Pill Awards were designed to the highlight serious problems caused by prescription drug advertising, a positive “Real Deal” award was also presented to call attention to MedVantx, one company that is working to provide consumers with affordable alternatives to expensive, brand-name drugs. A list of drug award names and coinciding recipients follows. 

The While You Were Sleeping Award: For Overmarketing Insomnia Medications to Anyone Who’s Ever Had a Bad Night’s Sleep
Presented to Lunesta (Sepracor) and Ambien/Ambien CR (Sanofi-Aventis)

Ads for insomnia medications are promising trouble-free sleep to an increasingly stressed and sleepless nation. 43 million prescriptions for sleeping pills were filled last year alone, and since 2004, advertising spending on prescription sleep aids increased 60%.

“Lunesta’s and Ambien/Ambien CR’s advertisements give the impression that a full night’s trouble-free sleep is just a pill away, when in fact these drugs don’t meaningfully improve how long it takes most people to fall asleep or how long they stay asleep,” said Sugerman-Brozan. “For many of the millions taking these drugs, changes in behavior would be just as effective, without the side effects. But these ads convince people these drugs are a cure-all.”

Ambien’s patent is set to expire in 2007. In October 2005, drugmaker Sanofi-Aventis introduced Ambien CR, a drug promoted as being better than Ambien at helping patients stay asleep. A review of clinical trials for Ambien CR, however, showed only a slight increase in sleep time opposed to the original Ambien. “Successor” versions of brand-name drugs have become common practice for brand-name drugs trying to hold on to their blockbuster profits in the face of imminent competition from generics.

An aggressive advertising campaign launched the arrival of Ambien CR, offering coupons for “7 day free trials” that neglected to state what the drug was used for. Last year, a $215 million advertising campaign made Lunesta the reason that pharmaceutical company Sepracor had its first profitable year ever. Sales of Lunesta earned the company $329.2 million – signifying that enormous spending on insomnia medication advertising is a trend that will likely continue.

Although Sepracor signed on to PhRMA’s “Guiding Principles” on DTCA, it has violated Principle #10, by running so-called “reminder ads,” which contain the name of the drug, but nothing about what the drug is for or its side effects. “This fierce competition in the insomnia market offers a perfect illustration of the effects of drug advertising and an example of how self-imposed industry ‘guidelines’ are likely to go out the window when competition gets tough,” said Sugerman-Brozan.

The “Got Cholesterol?” Award: For Overpromoting Expensive Brand-Name Statins
Presented to Lipitor (Pfizer) and Crestor (AstraZeneca)

Statins, drugs that treat high cholesterol and heart disease, are the best selling drugs in the United States. They are so profitable that statins have become one of the most widely-used and competitive classes of drugs on the market, selling more than 140 million annual prescriptions in the U.S. alone. While statins are important drugs for people that have heart disease, marketing campaigns conducted for two of the nation’s most widely prescribed and highest selling statins, Lipitor and Crestor, often lead consumers to believe that anyone and everyone with high cholesterol needs to be taking these brand-name drugs. In many cases, people with high cholesterol can improve their condition first by making changes to their lifestyle (diet and exercise), or by taking a much less expensive generic statin if lifestyle changes aren’t enough.

“Advertising campaigns for drugs like Lipitor and Crestor, do not distinguish between those who actually need a brand-name statin, or those who would do better on a generic drug or through lifestyle changes,” said Sugerman-Brozan. “This kind of marketing is an excellent example of what’s wrong with Direct-to-Consumer advertising, because it’s far more profitable for drug companies to sell expensive drugs to a large group of people – whether they need them or not – than to sell them only to those who really need them.” 

The over-marketing of statins is also starting to be noticed by the FDA. In late 2004, Crestor received an enforcement letter from the FDA that the drug’s advertisements were downplaying rare but serious muscle conditions it can cause. The manufacturer got a second FDA letter in 2005 for misleading claims in a television advertisement, which stated that Crestor was a more effective drug than other statins – a claim that was not supported by medical evidence.

The Driven to Distraction Award: For Hawking an Attention Deficit drug by Distracting Consumers with ADHD
Presented to Strattera (Eli Lilly)

In June 2005, the FDA sent a letter to Eli Lilly charging that a television advertisement for its Attention Deficit Hyperactivity Disorder (ADHD) drug Strattera was “false or misleading.” The ad showed a person maneuvering everyday activities as seen through the screen of a videogame – activities like leaving the house, walking to a car, and looking at a watch. These activities were overlaid with video game-style messages such as “Disorganized – Penalty,” “Distracted – Penalty,” and “Trouble Finishing Things – Penalty.” These flashy visuals were presented at the same time Strattera’s approved use and side effects were being shown.

“In short, Strattera was hawking its product to consumers with ADHD by distracting them. So egregious was this commercial, that the FDA complained to Eli Lilly that the visuals and graphics ‘[worked to] undermine the consumer’s ability to pay attention to and comprehend risk information – thereby minimizing these risks and misleadingly suggesting that Strattera is safer than has been demonstrated’,” explained Sugerman-Brozan. “This ad displayed an extreme lack of sensitivity towards the very population it was purporting to help, and exploited the very condition it claimed to be trying to treat.”

“Consumers cannot make an informed decision about a prescription drug based on a thirty-second or one-minute advertisement,” said Dr. Avorn, adding: “This Strattera advertisement is an extreme example of one of drug advertising’s core problems: prescription drugs and the conditions they treat are highly complicated matters that require a high level of information and a high degree of understanding.”

But by the time the FDA issued its letter, Eli Lilly’s campaign using the ad had already ended one month previously, illustrating the ineffectiveness of the current regulatory system. Many ads only run for several months, so in the rare case when the FDA does send a letter concerning a false or misleading ad, it is not uncommon for the ad to have already stopped running.

In September 2005, Eli Lilly received the dubious and ironic distinction of winning an award for its Strattera campaign during the Pharmaceutical Advertising and Marketing Awards (PhAME). The press release announcing these awards stated that the PhAME Awards “recognize the best [direct-to-consumer advertising] campaigns that positively inform the consumers they touch.”

The Fox Guarding the Hen House Award: For Pushing Toothless “Guiding Principles” on Drug Advertising
Presented to Pharmaceutical Research and Manufacturers of America (PhRMA)

In an initiative that many saw as an attempt to fend off Congressional action to more closely regulate drug advertising, PhRMA released its Guiding Principles on Direct-to-Consumer Advertisements about Prescription Medicines in August 2005. While PhRMA encouraged its member organizations to adopt these principles, they remain purely voluntary and there is no penalty or enforcement for failure to comply with them.

“Of PhRMA’s fifteen guiding principles, most are extremely vague and contain no measurable benchmarks to determine whether or not a particular advertisement complies with them. Only a handful call for any significant change in behavior, and Sepracor’s use of a Lunesta “reminder ad,” in violation of the principle calling for an end to such ads, demonstrates how totally inadequate it is to rely on the industry to police itself,” said Sugerman-Brozan.

Because PhRMA’s principles are voluntary, there are no enforceable standards or requirements. As such, the current guiding principles do little to address the fundamental problems caused by Direct-to-Consumer advertising.

“PhRMA’s principles force the public to rely on the voluntary compliance of drug companies – an industry of which the public is growing increasingly – and justifiably – suspicious. Now, more than ever, is the time for real standards and real oversight,” said Sugerman-Brozan.

The Truth is Stranger Than Fiction Award: For Commissioning a Hackneyed Thriller to Scare Americans about Canadian Drugs
Presented to Pharmaceutical Research and Manufacturers of America (PhRMA)

Last summer saw the release of a popular film portraying a fictional drug company engaged in evil doings, The Constant Gardener. The film demonstrated the power of popular culture to shape public opinion about the prescription drug industry.

In 2005, PhRMA consultant Mark Barodness, proposed commissioning a novel about terrorists poisoning Canadian drugs destined for the U.S., in a bizarre attempt to help the pharmaceutical industry scare Americans – particularly seniors – away from purchasing cheaper prescription drugs in Canada. Valerie Volpe, at the time PhRMA’s deputy vice president for federal and state affairs, agreed to a $300,000 deal and gave Barodness $100,000 in PhRMA funds to underwrite the effort. A publisher and ghostwriter were found, a manuscript was written, and Jayson Blair, the former New York Times reporter who was publicly fired for fabricating news articles, was briefly on board as an editor.

Then the deal began to fall apart. As the Philadelphia Inquirer reported, “In the first draft, the terrorists were Croatian nationalists angry at America over the war in Bosnia-Herzegovina. But, Spivak [the publisher] said, Barondess and Volpe wanted the terrorists to be Muslims motivated by greed. He said they also had wanted the female protagonist to be ‘frillier,’ with ‘more shopping’ in the story to appeal to women, who buy more medicine.” The deal was eventually canceled, and the publisher was later offered another $100,000 in exchange for promising never to criticize PhRMA or the drug industry in public. The publisher refused, and made public dozens of emails chronicling the episode on a web site for a revised version of the book, The Karasik Conspiracy (karasikconspiracy.com). The book that was eventually published features a pharmaceutical company behind the plot to poison the Canadian drug supply, and trying to blame it on terrorists.

The Real Deal Award: For Promoting Safe, Effective Generics and Countering Drug Industry Marketing
Presented to MedVantx

Generic drugs enter the market when a brand-name drug’s patent expires or is declared invalid. Within six months after its patent expiration, the price of the brand-name drug typically drops 70-80% as generic companies begin selling their own copies of the drug. Despite the low cost, and the fact that generics make up more than half of all prescriptions dispensed in the United States, generic drugs are still significantly underutilized. Direct-to-Consumer Advertising contributes to low generic sales by perpetuating the myth that newer is better, prompting consumers to instead demand advertised, brand-name drugs.

One company working to solve the problems associated with drug marketing is the California-based company, MedVantx. The company contracts with health insurers to place in doctors’ offices ATM-like machines that distribute free 30-day “samples” of a number of generic drugs.

“By placing generic samples within easy reach of doctors as they write prescriptions and providing an alternative to the samples of brand-name medications that drug companies shower doctors with, MedVantx is helping to educate consumers and physicians about generics and counteract the imbalance of information that currently favors expensive, over-marketed brand-name drugs,” said Sugerman-Brozan.

Prescription Access Litigation Project (PAL) is a project of Boston-based Community Catalyst. PAL is a nationwide coalition of 118 state, local, and national senior, labor and consumer health advocacy groups in 35 states fighting to make prescription drugs affordable.

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