Overdosed America (25 page)

The drug industry would probably argue that these successful requests are evidence of their excellent consumer education, and that better-informed patients get better medical care. Doctors, however, have a different opinion. Not surprisingly, most doctors do not agree with the
drug industry’s claims
that advertising “can help to improve public health because a number of leading diseases are underdiagnosed and undertreated” or because it “enhances the patient-physician relationship.” More than
four out of five family doctors
feel that direct-to-consumer advertising is not a good idea. Interestingly, although primary care doctors consistently express unfavorable opinions about the impact of DTC advertising on medical care, dermatologists have a positive view, perhaps reflecting the increase in visits generated by advertisements for skin products.

At its best, the trust between doctor and patient creates the opportunity for open discussion of symptoms, fears, models of disease, life circumstances, and expectations. Once all of these are on the table, an optimal approach can be developed to meet individual patient’s needs. Often approaches and solutions to health problems emerge through these open encounters that had not been previously apparent to either the doctor or the patient. Rarely can the best solutions be achieved simply by prescribing a drug and being done with the issue.

From my perspective as a family doctor, I found the requests for specific drugs deleterious to both the process and content of good doctoring. Once a patient made a request for a specific drug, the success of the visit from the patient’s point of view became defined by whether or not the drug was prescribed. At that point, it became hard to recoup the full potential of the encounter. I was less able to broaden discussion beyond the use (or not) of the latest drugs to more effective ways to control symptoms and preserve health—like avoiding allergens or adopting a more active lifestyle.

It seems obvious to Americans that drug companies should be allowed to advertise. DTC drug ads have become such a prominent part of our cultural landscape that they seem completely normal, appropriately protected by the First Amendment. But outside the United States, DTC advertising is anything but normal, allowed in only one other industrialized country in the world, New Zealand, with a population of only 4 million people. An editorial in the
Canadian Medical Association Journal
summed up the issue: “By being marketed in
media traditionally used to flog cars
, fast food and shampoo, prescription drugs have become name-brand commodities, enveloped in the kind of fantasy and desire that surrounds the purchase of lifestyle products.”

The
European Union voted in 2003
to continue its ban on DTC drug ads. In the debate, consumer groups argued that medical information should be disseminated by independent national sources, not drug companies. A spokesperson for the European Union went even further, saying that the ban on drug company ads was not sufficient to protect its citizens from commercially sponsored misinformation coming from the United States. “The problem is you now have all sorts of medical data and claims on American websites,” he said, “and that issue is still not being addressed.”

In the United States the rights of commercial speech are given far greater priority than in the other countries—a balance that is tipping ever more in favor of commercial activity. With the explosion of marketing for prescription drugs, for example, an expansion of oversight by the FDA would seem essential. (After all, it took only
11 days after the 1997 rule change
for Schering-Plough to be cited for two advertising infractions about its marketing of Claritin.) Yet just the opposite has occurred. The
number of letters citing drug companies
for advertising violations declined from an average of 95 in 1999 and 2000 to only 27 in 2002 and 24 in 2003. Why the precipitous drop when the number of ads was increasing?

In August 2001, at a time when the FDA was without a commissioner, President George W. Bush chose an accomplished lawyer,
Daniel Troy, to be the FDA’s new chief counsel
. Daniel Troy had extensive experience in First Amendment issues, with a particularly strong record in defending the right of commercial speech. He successfully represented the Brown & Williamson Tobacco Corporation before the Supreme Court in the company’s bid to block the FDA from assuming regulatory authority over tobacco products. He was also part of a legal team that sued the FDA to allow drug companies to promote “off-label” (non–FDA-approved) use of prescription drugs, partially bypassing the FDA’s review process. In short, one of the FDA’s chief adversaries became its chief counsel.

Three months after Troy had assumed his new position, the Department of Health and Human Services instructed the FDA that all letters to drug companies concerning marketing violations must be reviewed by its Office of the Chief Counsel prior to being sent out. In a 2002 report,
the U.S. General Accounting Office (GAO)
noted that prior to this change, letters had been issued within several days of identifying a violation, but the additional legal review was taking so long, an average of 41 days and as many as 78, that “misleading advertisements may have completed their broadcast life cycle before FDA issued the letters.”

In response to the concerns raised about increased public misinformation resulting from these delays, FDA commissioner Mark McClellan wrote a letter to Representative Henry A. Waxman (D-CA), saying that a goal of completing legal reviews of FDA notification letters within 15 days would be established. The result? A report issued by the
Special Investigations Division
of the U.S. House of Representatives’ Committee on Government Reform—Minority Staff in January 2004 found that the average delay had increased from 41 days in 2002 to 177 days for many of the ads in 2003.

One thing about direct-to-consumer advertising is not in question: since the advertising began in earnest in 1991 it has been a financial boon for the drug industry. Since 1991, when spending on DTC advertising was a mere $55 million, expenditures on drugs have increased at about four times the rate of expenditures on hospital or physician services.
Melody Petersen reported in the
New York Times
that in 1998 the largest drug companies generated $22.50 in sales for every dollar spent on advertising to consumers and primary care doctors. It should come as no surprise, then, that the biggest drug companies increased their marketing budgets by more than 32 percent each year for the next three years. For comparison, marketing expenditures in France and England, which don’t allow DTC advertising, went down 4 percent annually during the same period. Between 1991 and 2003, spending on DTC ads in the United States increased 58-fold,
reaching $3.2 billion
per year.

During the same years,
drug industry profit margins have skyrocketed
from about 12 percent of revenues (net of all research and development expenses) in 1991 to 18 percent of revenues in 2001, while the rest of the Fortune 500 industries averaged 5 percent or less.

Even more insidious than misleading advertising is the subtle influence of public relations campaigns. At least with advertising, the fundamentally commercial purpose of the message is clear. With public relations campaigns, news stories and supposed public service messages from nonprofit organizations about a particular drug or issue just seem to emerge spontaneously, usually with no obvious connection to a commercial source. Public relations firms earn their keep by skillfully blurring the line between independent news and commercially planted “information.” With repetition in trusted sources—television, newspapers, radio, and magazines—the messages carried in these so-called news stories gradually take hold. It is a very effective way to influence both public opinion and health policy.

The issue of counterfeit drugs provides a good example. In the past few years, many
American senior citizens have been taking bus rides
to Canada to buy prescription drugs to avoid prices in the United States that average up to 70 percent higher. Others are ordering drugs by mail and over the Internet from Canadian pharmacies. This end run around the high price of drugs in the United States is costing the drug companies significant profits—about
$350 million to $650 million worth of drugs
are purchased by Americans at the lower Canadian prices each year. PhRMA wanted to curb this trend, especially while Medicare prescription drug coverage was being debated on Capitol Hill.

As if out of nowhere, the safety of drugs purchased from other countries became a major issue in the United States. In July 2003,
FDA Commissioner Mark McClellan announced a new initiative
to protect Americans from counterfeit drugs that were purportedly being substituted for drugs that were “safe and effective.” For example, an article in the September 22, 2003,
Wall Street Journal
was headlined
“Fakes in the Medicine Chest.”
The article reported that the FDA had noted an alarming increase in counterfeit prescription drugs entering the United States. According to this report, state and federal regulators said that counterfeits may get into the United States through a “growing number of online vendors [who] promise cheaper Canadian or ‘generic’ drugs.” The same story was all over the news. But there was something odd about the big concern over drugs imported from Canada. A spokeswoman for the Canadian drug authority told the
Wall Street Journal:
“We’re not aware of any counterfeit activity at this time.”

Appearing on the very same page of the
Wall Street Journal,
but with a much smaller headline, was an article that explained the real story behind the story.
“Drug Companies Cry ‘Danger’ Over Imports,”
by Scott Hensley, reported that PhRMA had hired a public relations firm, Edelman, to help it develop an effective “communications campaign” to stop drug importation. The first step was to find the themes that would have the greatest impact. Focus groups of people without insurance coverage for drugs (like many senior citizens covered by Medicare alone) were convened. Edelman found that people were not fazed by the illegality of importing drugs. But Edelman was successful in finding an issue that did get people’s attention: “fear and accountability ‘move the needle’ of consumer perceptions.” Edelman’s report, according to Hensley, suggested that PhRMA could create doubts about the wisdom of saving money by importing drugs if they focused on the “safety and effectiveness” of drugs bought from foreign sources.

The PR campaign to raise concern about the safety of imported drugs has succeeded in the short term: included in the Medicare prescription drug bill are provisions that make drug importation cumbersome and therefore unlikely. Ironically, as pointed out in a
New York Times
editorial
, “While the drug industry has been railing against the dangers of foreign imports, it has increasingly transferred its own production to foreign factories to save on labor costs.” So it turns out that the biggest importer of foreign drugs is the American pharmaceutical industry itself. Just how concerned is the drug industry about protecting the public from the danger of imported drugs? While 1300 people were being added to the division of the FDA that approves new drugs (to decrease new drug approval time), 1000 were being taken off other FDA surveillance duties, including inspection of drug manufacturing sites. And the real truth about counterfeit drugs from Canada? Jirina Vlk, spokesperson for Health Canada, the equivalent of the FDA, told me on January 28, 2004, that she was not aware of any counterfeit drug’s
ever
having been sent from a registered Canadian pharmacy or pharmacist to the United States.

Public relations campaigns are also waged in support of specific drugs. This occurs both around the initial introduction of a new drug and to help a drug that is not living up to its anticipated market potential. For example, Eli Lilly thought it had a real winner in 2001 when the FDA approved Xigris. This breakthrough high-tech drug had been shown to improve the survival rate of people who were critically ill with septic shock—an extremely serious condition caused by bacterial infection in the bloodstream, which is responsible for 225,000 deaths in the United States each year.
The
New England Journal of Medicine
published a report in 2001
showing that Xigris decreased the mortality rate from this dreaded condition by 6.1 percent, saving the life of 1 out of every 16 patients treated. Another article in the NEJM concluded that
Xigris was “relatively cost-effective
when targeted to patients with severe sepsis.”

The
future of Xigris (and Eli Lilly) seemed bright
. According to
Business Week,
Xigris had “one of the higher profit margins in the business.” But sales were soon lagging far below projections: up to $475 million in sales had been projected for 2002, but actual sales came in at
less than a quarter of that
. Sales for 2003 had been projected to be as high as $700 million, but Eli Lilly’s data from the first two quarters of 2003 showed Xigris sales of only $72 million, less than one-ninth of projections. Why was Xigris such an underperformer?

It turns out that the study published in the
New England Journal of Medicine
didn’t tell the whole story. Data provided to the FDA by Eli Lilly showed that of the six extra patients out of 100 who survived after being treated with Xigris,
only one had been well enough
to be discharged from the hospital 28 days later. The other five were still too sick to go home, and some of them were still in the ICU. The FDA reviewer who analyzed these data concluded that “without longer follow-up,
the ultimate outcomes of the hospitalized patients
cannot be determined.”

Furthermore, Xigris is very expensive, costing about $6800 for each patient treated. Medicare and Medicaid agreed to Eli Lilly’s request to cover half of the cost of Xigris as a new medical technology, but this still leaves hospitals paying about $3400 for each patient treated.