Columbia Journalism Review–The Complicity of the Media in Drug Marketing

Columbia Journalism Review–The Complicity of the Media in Drug Marketing

Wed, 27 Jul 2005

An excellent article in the Columbia Journalism Review examines pharmaceutical industry hype and the media’s role in helping that industry create false impressions about the safety and benefits of newly marketed drugs: “stories trumpeting new drugs are an easy way to get on page one or on the air.”

Front page news reports in the major press about a new drug’s benefits are no more credible than the manufacturer’s promotional hype.

“the press too often is caught up in the same drug-industry marketing web that also ensnares doctors, academic researchers, even the FDA, leaving the public without a reliable watchdog.”

By disseminating hype, the media helps companies achieve blockbuster sales for drugs lacking any scientific evidence of their health benefit:

“today a drug can move almost instantaneously from medical research to miracle cure through news media that too often seem more interested in hype and hope than in critically appraising new drugs on behalf of the public. The problem has grown dramatically in recent years as direct-to-consumer advertising has increased, delivering ever-higher ad revenues to the nation’s media.”

Trudy Lieberman, the author of the CJR article has nailed the media’s drug advertising income: “In 1999, the five networks, including CNN and Fox News, received $569 million in advertising revenue from pharmaceutical companies, according to TNS Media Intelligence. In 2004, that number had nearly tripled, to $1.5 billion. Drug ad revenue is less for print outlets, but still nothing to dismiss. At the end of 2004, for example, drug-company ad revenue for Time magazine totaled $67 million; for Newsweek $43 million; and for The New York Times, $13 million.”

Lieberman shows that the media missed the Vioxx story although the signs of trouble could be gleaned in the scientific journals. And she notes that the FDA is now regarded as “an informal partner” of the drug industry – that partnership was in evidence when Sharyl Attkisson, of CBS evening news was probing the facts about AstraZeneca’s cholesterol lowering drug, Crestor. Not only did the company try to channel, if not control her investigation, but they set a battalion of company-paid academics who offered their “expertise” to ensure she got the story right.

Even more disturbing, Attkisson reports that when she was probing a story about the contradiction between FDA’s public advisory about the COX 2, Celebrex, and the recommendations of the agency’s advisory committee, the FDA would not cooperate unless Attkisson would disclose who else (outside of the agency) she would be interviewing. Attkisson concluded that:

“The FDA is as obstructionist as the drug companies, if not more so. That may be the biggest scandal behind these drug stories.”

Other reporters echo her observations.

Much as the antidepressants had been hyped by elevating depression to the proportions of a national mental health crisis, the article shows how Lunesta, a new sleeping pill, was similarly hyped by the drug’s manufacturer, the media and the National Sleep Foundation. Suddenly, insomnia was promoted as “one of the most prevalent and growing medical needs in our society.”

No doubt, if the drug were marketed for diarrheaŠ.that “condition” would be catapulted as “one of the most prevalent and growing medical needs in our societyŠ.”

Contact: Vera Hassner Sharav
212-595-8974

http://cjr.org/issues/2005/4/lieberman.asp

Bitter Pill
By Trudy Lieberman
Columbia Journalism Review

Excerpt:

Last December, Sepracor, a company in Marlborough, Massachusetts, whose core business is concocting slight variations of the world’s best-selling drugs, got the go-ahead from the Food and Drug Administration to sell Lunesta, a new sleeping pill that could be used for months without losing its effectiveness. To prime Wall Street for the drug’s potential profitability, Sepracor’s chief executive officer, Timothy Barberich, told analysts that insomnia is “one of the most prevalent and growing medical needs in our society,” while David Southwell, the company’s chief financial officer, described insomnia to the media as “underrecognized” and “undertreated,” and estimated the U.S. market for sleep aids at $3.5 billion a year and growing. Following the industry’s modern marketing script (create a need, then a drug to fill it) Sepracor soon began selling Lunesta to the public – with the help of the press.

As with most launches of drugs, Sepracor and one of the academic medical centers involved in testing the drug (in this case, Duke University) offered journalists sources they could call, including those with financial links to Sepracor. And the company got results. For example, some of the nation’s most respected newspapers peppered their stories with quotes from Dr. Andrew Krystal, who conducted the Duke clinical trial of Lunesta and was the lead author of the study that reported the results. Krystal had designed and conducted other studies for Sepracor, and had also served on a company advisory board. Most of the news stories did not disclose his financial ties to the drugmaker.

To humanize their stories about Lunesta, the Los Angeles Times and The Washington Post both featured Terri Bagley, a forty-three-year-old owner of a North Carolina cleaning business who had been paid to participate in the Duke trial, and who was offered to the press by Duke p.r. officials. Bagley told the Times that Lunesta could reduce “road rage” since “there’ll be a lot more well-rested people out there.” In the Post she said she was counting the days until she could get a prescription. A story headlined sleepless at duke find cure, appearing in the Raleigh News & Observer, a paper near Bagley’s hometown, devoted several paragraphs to her sleeping problems.

The Washington Post, The New York Times, and Good Morning America did offer an independent opinion. Dr. Gregg Jacobs, an assistant professor of psychiatry at the Harvard Medical School, said that other treatments for sleep disorders, such as talk therapy, may work better than sleeping pills. Jacobs himself, though, was amazed at the tone of the coverage. “You would think that, the way the media covered it, it was a new miracle drug,” he says. “It’s not even close.”

Americans have always been obsessed with all things health-related, but today a drug can move almost instantaneously from medical research to miracle cure through news media that too often seem more interested in hype and hope than in critically appraising new drugs on behalf of the public. The problem has grown dramatically in recent years as direct-to-consumer advertising has increased, delivering ever-higher ad revenues to the nation’s media. Instead of standing apart from the phenomenon and earning the public’s trust, the press too often is caught up in the same drug-industry marketing web that also ensnares doctors, academic researchers, even the FDA, leaving the public without a reliable watchdog.

Consider the case of the National Sleep Foundation’s annual poll to promote National Sleep Awareness Week. The poll, released in March, found that 75 percent of adult respondents said they had frequent difficulty sleeping, a problem serious enough, they said, to affect their sex lives. “It was an important story,” says Richard Gelula, the foundation’s chief executive officer. “The poll gets treated as news, and this year it got good news coverage” (at least twenty-four stories by CJR’s count). As the poll gathered headlines, Sepracor was dispatching 1,250 sales representatives to physicians’ offices to educate them about Lunesta, part of a $60 million advertising push. The foundation’s mission, Gelula says, is to tell people what good sleep is, how to get it, how to recognize the signs and symptoms of sleep disorders, and to talk to their doctors if they have any of them. It is a message that dovetails with Sepracor’s advertising pitch, which like all direct-to-consumer advertising instructs patients to talk to their doctor.

Virtually all the news stories about the poll failed to identify the National Sleep Foundation’s ties to the drug industry. According to Gelula himself, nearly $1 million of his $3.6 million budget comes from makers of sleeping pills, including Sepracor, which gave the foundation a $300,000 grant to produce a series of “Sleep Medicine Alerts” – brochures designed to educate doctors about insomnia. Sepracor, along with other companies that make competing products, is also a $250,000 platinum sponsor of National Sleep Awareness Week. The foundation’s own Web site reveals that the group is funded by drug companies, physicians, patients, medical centers, and makers of sleep aids, most of which have an interest in new drugs and treatments. But with the exception of CBS Evening News, the press did not disclose the financial link between the foundation and the companies that would benefit from the poll’s results. “The media are victims of the same problem as doctors and patients,” says Dr. Jerry Avorn, a professor of medicine at the Harvard Medical School. “Too often they get industry-sponsored sources of information that look like they are from unbiased, scientifically driven public-interest groups when in fact they are thickly veiled marketing activities.”

In its public comments, Sepracor contends that Lunesta is safe because the older drugs from which it is derived have generated no safety problems. Like all drugs, though, Lunesta has side effects. For example, it apparently lingers in the body: the professional product label, written for physicians and pharmacists and not routinely seen by patients, warns users not to engage in any hazardous occupations that require complete mental alertness or motor coordination, such as driving a car or operating machinery, after taking the drug, and also to be cautious of “potential impairment” in performing such activities on the day after taking the pill. Most of the press coverage did not discuss this drawback, which might make it problematic for patients to get to work the next day. Meanwhile, evidence is accumulating of problems with all sleep drugs, which reporters could have examined but did not. In a meta-analysis of all available research on sleep medicines, the Canadian Medical Association Journal noted that users of a drug similar to Lunesta were at increased risk of traffic accidents. The National Institute for Clinical Excellence, a British government watchdog for health spending, found no consistent difference in safety or effectiveness between the class of drugs Lunesta belongs to and older sleeping medications. What’s more significant, an editorial in the British Medical Journal observed that no sleeping drug has yet to be shown more effective than placebos for improving the quality of life and daytime functioning, or for avoiding such outcomes as falls and fractures. Terri Bagley’s testimonials that Lunesta made her feel better hardly count as medical evidence. The British Medical Journal editorial placed Lunesta within the overall scientific knowledge about insomnia and its treatment – vital context absent from U.S. press accounts, where the science of a new drug comes last, if at all.

Press acquiescence to industry public relations stems in part from an American cultural belief in the inherent goodness of medicine and its corollary – that every new pill, every new treatment, works and should be treated as safe and effective unless proven otherwise. In his landmark 1982 book, The Social Transformation of American Medicine, Paul Starr explains how in the late nineteenth and early twentieth centuries the medical profession benefited from the cultural and social upheaval – including the embrace of science – to establish itself (and thus its money-making medicines) as the unquestioned authority on matters of health, a position it has enjoyed ever since.

Even without that cultural baggage, though, the pharmaceutical beat is a challenge. For one thing it is huge. The American pharmaceutical industry logs more than $250 billion in annual sales. Drug spending has been doubling roughly every five years; an increasing number of Americans will be taking medicines daily for the rest of their lives. And the public has a growing appetite for news about drugs. It’s an industry, meanwhile, that produces many medicines that improve and extend lives, and sometimes save them, such as diuretics for high blood pressure, and drugs that mitigate the symptoms of Parkinson’s disease or prevent blindness from glaucoma.

But not all the medicines these companies produce are beneficial, and some of them are dangerous. “The public is being allowed to believe that drugs are safer and more effective than they really are,” says Dr. Marcia Angell, who for two decades was editor-in-chief of The New England Journal of Medicine. “Journalists, as well as the public and physicians, have bought hook, line, and sinker the idea that these drugs are getting better.”

In reality, she says, based on research for her 2004 book, The Truth About the Drug Companies, of the 415 drugs approved between 1998 and 2002, only 14 percent were truly innovative, 9 percent were drugs that had been modified in some way, and 77 percent were simply “me-too” drugs, copies of medicines already on the market, created not necessarily to improve health but to fill a spot in a company’s product portfolio.

The news media have tended to see drug coverage as fitting into two discrete compartments. The pharmaceutical industry is covered in the business pages and, sometimes, in the health sections. But a vast middle ground between business coverage and consumer health reporting and advice remains largely unexplored by the press – the territory of corporate marketing and sponsored scientific research that connects the bottom line to the latest “breakthrough.” Reporters who want to write about this middle ground must be wary not only of the companies’ sophisticated marketing techniques, but also of other competing interests that try to use reporters to pitch their journals and university medical centers, or spin their political positions about drug policy. “Everyone is in cahoots,” says a woman who spent several years conducting medical-education activities for pharmaceutical companies. She asked to remain anonymous because she is currently consulting in the health-care industry. “The money spent is outrageous.”

On the drug beat, the stakes are high, and sometimes they involve life and death. This is evident in an examination of the coverage of Vioxx and the other Cox 2 pain relievers, once hailed in the media as “super aspirin.” In the case of Vioxx, thousands of people have died from heart attacks while taking the drug, making Vioxx the biggest drug disaster in U.S. history. In hindsight, few would argue that the public was well served by media coverage of any of the Cox 2 drugs, from the beginning when a Vioxx researcher told The Buffalo News it was inappropriate to provide precise statistics on side effects, to the end, last February, when reporters missed the point made by an FDA advisory committee whose thirty-two members unanimously concluded that all the Cox 2 drugs cause heart attacks. Reporters, instead, focused on a recommendation, narrowly approved by the committee, that Celebrex and Bextra remain on the market; some speculated that Vioxx might soon be back. Seven weeks later the FDA ordered Bextra off the market and issued the strongest possible “black box” warning for Celebrex, effectively curtailing further advertising for the drug.

Four years before Merck, the maker of Vioxx, pulled the drug from the market on September 30, 2004, reporters could have discovered signs of trouble by reading about the Cox 2 drugs in the medical journals. In November 2000, for instance, the New England Journal published results of the VIGOR (Vioxx gastrointestinal outcomes research) study, which questioned the cardiovascular safety of Vioxx. Several months later The Journal of the American Medical Association (JAMA) published a study that examined all the research that had been done on the Cox 2 drugs and concluded that the “available data raise a cautionary flag” about the risk of heart attacks and strokes. Dr. David Graham, the associate director of the FDA’s Office of Drug Safety, who testified before the Senate Finance Committee about the FDA’s failure to protect the public from unsafe drugs, calculates that from the time Vioxx came on the market until its withdrawal 61,000 people died from heart attacks associated with the drug, and another 79,000 had nonfatal heart attacks. As the timeline on pages 46 and 47 shows, the press barely paid attention. In fact, as the chart demonstrates, the media missed a number of warning flags that might have led to stories that saved lives.

Rita Rubin, who covers the pharmaceutical industry for USA Today, tried to sound the alarm on Vioxx in a story published in early February 2001. Her story drew on the VIGOR study cited in the New England Journal, which found that patients taking Vioxx had five times more heart attacks than those taking the pain reliever naproxen, sold under the brand names Aleve and Naprosyn.

xxxxxcut xxxxx see: http://cjr.org/issues/2005/4/lieberman.asp

Trudy Lieberman is a contributing editor to CJR. The magazine gratefully acknowledges support for this article from the Fund for Investigative Journalism.

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