A must read, six-part report by Melissa Healy of the Los Angeles Times (excerpts below) lays out the pharmaceutical industry’s masterful manipulation of America’s healthcare system succeeding to divert healthcare budgets for patented, expensive drugs whose benefits are uncertain at best.
The pharmaceutical industry has undermined the integrity of medicine by rendering healthcare providers, academic institutions, journals, government healthcare agencies, patient advocacy groups, and the media financially dependent on its largesse. This industry has bypassed the inconvenient scientific evidence of its products’ failure to show a positive benefit/risk ratio by use of fictitious “evidence” fashioned by sophisticated public relations firms. PR firms have also manufactured buzz about the latest “under diagnosed condition” (e.g. “female sexual dysfunction” “juvenile bipolar disorder” “restless leg syndrome”) for which there just happens to be a newly marketed drug available.
To create demand, industry has recruited influential professionals and professional associations and it has sent an army of attractive sales reps “sex icons” to woo doctors into prescribing. [Link] Industry has also recruited patient advocacy groups who can be relied on to bully third party payers to pay for the latest, most expensive drugs which are promoted as “breakthrough” therapies despite the lack of scientific evidence to back up such claims.
Drug makers are driving sales from both ends: since consumers cannot purchase drugs without a physician’s prescription, advertisements directed at consumers prod consumers to prod their doctor ( “ask your doctor”) for a specific brand of prescription drug. Companies simultaneously pitch the drug to doctors personally through an army of company detailers (sales reps), in separate ads, in ghostwritten journal articles, and by controlling the content of continuing medical education courses. To ensure that physicians write brand name prescription drugs manufacturers offer prescribing physicians gifts and financial enticements (bribes). The medical profession has accepted industry’s ‘free handouts’ and ‘fee for service’ arrangement by offering the untenable argument that physicians are incorruptible. On the contrary, several studies have found that physicians who accept and dispense free samples to their patients are far more likely to prescribe those drugs than those who don’t take or have no access to samples.
However, the most effective drug marketing is indirect but shaped by industry–as when influential “authorities” pen their names to ghostwritten journal articles and render their opinions in the media. Industry-influenced patient groups mobilize patients — sometimes armies of them — to push for coverage of prescription drugs by insurance companies and states’ Medicare and Medicaid agencies. To pharmaceutical companies, this can make or break the market prospects for a new drug because 80 million Americans — among them, the heaviest prescription-drug users — receive healthcare coverage through Medicare and Medicaid, and roughly 155 million have prescription drug coverage through private insurance companies.
Healy reports: “When insurers balk at reimbursing patients for new prescription medications, these groups typically swing into action, rallying sufferers to appear before public and consumer panels, contact lawmakers, and provide media outlets a human face to attach to a cause. Infertility patients mobilized by Resolve, for instance, have been extremely effective in extending states’ insurance coverage of infertility treatments. Groups such as the Depression and Bipolar Support Alliance have fielded experts and patients who have done the same for psychiatric conditions. And a wide range of patient groups, most with substantial backing from the makers of erectile dysfunction drugs, have mounted successful campaigns to get wary insurers to cover drugs such as Levitra, Viagra and Cialis.”
Industry’s successful marketing strategy is measureable in increased number of prescriptions, increased sales, and : In a nation that consumed $279-billion worth of prescription medications in 2006 — spending 80% of that on brand-name products that are advertised–their efforts appear to be paying off. The number of individual prescriptions filled in the US rose from 2.9 billion in 1999 to 3.7 billion in 2006; in 1994, Kaiser calculated that each American filled on average 7.9 prescriptions per year; by 2005, that number had risen to 12.4. Does that mean Americans are sicker now than in 1994, or just popping more pills? And what about the adverse effects of these pills, are they creating chronic disease in previously healthy people??
Healy suggests that there is a push for change; that doctors are rethinking, or at least disclosing, their ties to drug companies; and that legislators are drafting and passing bills aimed at blunting the effects of prescription-drug marketing. Citing a 2004 meeting of the American College of Rheumatology, she reports that physicians reeling from public outcry over the market withdrawal of the arthritis drugs Vioxx and Bextra vowed to wean their organization from its heavy dependence on pharmaceutical funding, setting off similar self-examination among other medical societies.
Unfortunately legislators are also “on the take” relying on industry’s campaign contributions. Thus, the disengagement process is painfully snail paced. There will, no doubt, be more scandals, and more preventable deaths before real changes are put in place.
[Link]
The Los Angeles Times SOLD ON DRUGS Under the influence Savvy marketing whets our appetite for prescription pharmaceuticals. Consumers, doctors, researchers — no one is immune By Melissa Healy August 6, 2007
FOR many Americans, a doctor’s decision to prescribe medication is something of a sacred transaction. A physician considers the patient and symptoms and chooses the best drug for the job, drawing upon years of training and clinical experience. It is an exchange conducted in a hushed sanctuary, far from the heat and noise of the marketplace — a place where cool judgment reigns.
That sanctuary has been breached. Today, drug manufacturers do everything in their considerable power to ensure that their brand-name prescription medications are on the lips of patients and in the minds of physicians every time the two meet across an exam table. A growing chorus of critics says their efforts have begun to rewrite the dialogue between patient and doctor, influence physicians’ judgments and open the act of prescribing to forces more profit-minded than sacred.
In 2006, drug-makers spent almost $5 billion to reach out to consumers with direct advertising. But the glossy magazine ads and buzz-generating TV spots are just the most visible parts of a campaign to build and nourish markets for brand-name prescription products. The world’s pharmaceutical companies spend an estimated $19 billion annually to woo doctors. They sponsor teaching programs and research at universities across the country, gaining goodwill along the way. They give money to patient groups. They hire public relations firms to share patient stories of illness and triumph.
In a nation that consumed $279-billion worth of prescription medications in 2006 — spending 80% of that on brand-name products — their efforts appear to be paying off. Americans filling a prescription choose brand-name products 37% of the time, even though three-quarters of all prescription drugs in the U.S. are available in cheaper generics.
“The most effective marketing is the marketing you’re not aware of,” says Dr. Peter Rost, a one-time pharmaceutical company marketing executive who has become an Internet-based industry watchdog. “If you see an ad, you know it’s marketing. But if a friend or your doctor talks to you about a drug, you don’t.”
Now the size, scope and apparent effectiveness of drug companies’ marketing efforts has begun to prompt cries of foul even from within the medical establishment, which has long been silent about its growth. In a handful of state legislatures across the country, lawmakers already have acted to blunt drug-company marketing, and many more are considering similar measures. Lawmakers on Capitol Hill have suggested that federal legislation may come next.
At stake, critics say, are patients’ health, the nation’s healthcare budget and, ultimately, the trust and esteem in which Americans hold their physicians. Costs rise as more doctors prescribe brand-name drugs when cheaper, older or more effective drugs might be available.
Under-treated conditions that threaten the lives and wellness of large swaths of the population — illnesses such as diabetes and high blood pressure — may get less attention than conditions such as erectile dysfunction or insomnia, for which pharmaceutical firms have new and potentially more profitable offerings. And patients may be steered toward newer drugs with risks and side effects that are less well-known, in lieu of medications with a longer history of safe use.
“There is nothing fundamentally wrong with advertising products,” Dr. Jerome P. Kassirer, a former editor of the New England Journal of Medicine, told a Senate committee recently. “But when financial incentives yield inappropriate or dangerous care, when they inordinately raise the cost of care, when they risk patients’ lives in clinical trials, and when they damage the profession, they have gone too far.”
The pharmaceutical industry counters by arguing that its marketing efforts are needed to recoup the cost of drug development and that they introduce Americans to medicines that can save lives and improve well-being. The industry’s sponsorship of research and education pushes the process of drug discovery and development forward, drug-makers say. Companies’ marketing to physicians keeps busy clinicians abreast of new therapies and scientific advances in a fast-changing landscape. And their advertising of drugs in mass-media outlets educates patients and improves their communication with doctors, they add.
And drug marketing improves the economic vitality of the nation, a representative of the drug industry’s largest trade group, PhRMA, said at a recent Senate hearing. Prompted by drug industry marketing, more patients in recent years have sought out a doctor, and more doctors have looked for signs of under-treated conditions such as depression, diabetes and asthma among patients, Marjorie E. Powell, an attorney for PhRMA, said to the Senate Select Committee on Aging in late June. Citing a pair of studies published in 2003, Powell said that in the long run, increasing treatment of such chronic conditions should drive down the nation’s healthcare bill.
As the debate rages — among doctors, within universities, in statehouses across the nation and in the halls of Congress — here is a look at a wide range of marketing efforts that has touched it off. ~~~~~~~~~~~~ [Link] SELLING THE PATIENT Next step: Create the demand Direct, emotional ads for prescription drugs are everywhere. But they’re just one way to get to the consumer. By Melissa Healy August 6, 2007
WITH vast and profitable markets up for grabs, drug companies are aggressively reaching beyond doctors and taking their marketing messages directly to consumers.
Some of their promotional strategies have become hard to miss. Nightly news broadcasts — a beloved habit for aging Americans — are brought to you by the makers of prescription medications for high cholesterol, arthritis, Alzheimer’s disease and erectile dysfunction; an Internet search for a specific symptom, or a visit to any popular health site, will bring up sponsored links and blinking ads for at least one prescription medication used to treat that symptom; fans of NASCAR see Viagra advertised every time No. 6 Mark Martin’s car rounds the track. And women paging through a magazine for tips on reducing clutter can scarcely avoid the faces and personal stories of actresses who are managing their depression, osteoporosis or hot flashes with a brand-name pill.
In 1997, the FDA loosened regulations governing the advertisement of prescription medications directly to consumers. The change set off explosive growth in marketing aimed at a general audience long on interest and –compared with physicians — short on professional skepticism. Today, drug makers spend roughly $5 billion a year to run advertising campaigns that use many of the same appeals that marketers use to sell breakfast cereal and toothpaste.
A study published in the Annals of Family Medicine’s January-February issue analyzed the messages of 38 advertisements then running during prime-time TV and found that 95% used emotional appeals to sell the medication, often framing prescription-drug use as a means to regain lost control over some aspect of life. None mentioned lifestyle change as an alternative to product use, although roughly 1 in 5 advertisements suggested it might be a useful complement to the drug. One in 4 described the causes of the disease the advertised drug treats, who is at risk for it or how frequently the condition occurs in the population. The study’s authors, led by UCLA researcher Dominick L. Frosh, suggested that without such information, consumers would have little reason to see prescription medication as a solution that involves risks as well as possible benefits.
In all, 58% portrayed the advertised drug as a medical breakthrough — a pharmaceutical twist on Madison Avenue’s “new and improved” message.
“It is time to ban direct-to-consumer advertising of prescription drugs,” wrote Dr. Kurt Stange, editor of the Annals, in an accompanying editorial. The advertisements consumers see “distort the relationship between patients and clinicians. [They] manipulate a patient’s agenda and steal precious time away from an evidence-based primary care clinician agenda that is attempting to promote healthy behavior, screen for early-stage treatable disease and address mental health.”
Even after 23 major pharmaceutical companies agreed to a new slate of voluntary guidelines limiting their advertising, Stange wasn’t buying it. Self-monitoring, he wrote, “is not working . . . and cannot realistically be expected to work.”
PhRMA, the drug manufacturers’ industry group, says direct-to-consumer advertising empowers patients to take an active role in their healthcare and spurs them to discuss symptoms, diseases and treatment options with their doctors that might otherwise go unraised. The industry group frequently cites a 2002 survey of consumers that found that 43% were spurred by a prescription-drug ad to look for more information about the drug or their health.
Although direct-to-consumer advertising has spurred the most political and professional debate, it is only the most visible means of prescription-drug marketing aimed at the consumer. To build markets and encourage consumer loyalty to their products, drug makers have invested heavily in a tactic known to public relations professionals as “third-party marketing.” Through voices, groups and activities that seem independent of them — but frequently are not — drug companies have found another way to get their messages to consumers.
‘Third-party’ approach ACCORDING to an article published in the British Medical Journal in 2003, the top five public relations firms specializing in healthcare earned $300 million in 2002. These firms “are expert at ‘third-party technique’ –helping the drug industry separate the message from what could be seen as a self-interested messenger,” wrote authors Bob Burton and Andy Rowell.
Last October, a commentary in the New England Journal of Medicine detailed one little-noticed third-party marketing venture. Underwritten by Eli Lilly, the campaign was designed to increase the use in hospitals of a drug commercially known as Xigris, for the treatment of sepsis, or blood poisoning. A preliminary study had suggested some safety concerns with Xigris, and an FDA advisory panel had urged more thorough study of the drug before its approval. But in 2001, the FDA approved its entry into the market. The controversy appeared to sap first-year sales of Xigris, which fell short of Lilly’s expectations.
Lilly’s response was to secure the services of a small public relations firm, New York-based Belsito and Co. Belsito would begin spreading the word to physicians and media outlets specializing in medical news that Xigris was being rationed and that physicians were being “systematically forced,” because of the drug’s high cost, to decide which patients would live and which would die. A $1.8-million educational grant from Lilly would fund the creation of a group of physicians and bioethicists — named the “Values, Ethics and Rationing of Care Task Force” — to study this rationing and its ethical implications. And a Surviving Sepsis campaign was launched “in theory to raise awareness of severe sepsis and generate momentum toward the development of treatment guidelines,” wrote Dr. Peter Q. Eichacker and two fellow investigators based at the National Institutes of Health, in the NEJM.
Lilly’s financial inspiration of the campaign aimed at physicians, patients groups and the media was not apparent to many of the audiences reached. But its effect was quite clear, concluded a case study of the campaign done by the Council of Public Relations Firms: Sales of Xigris “have begun to trend upwards. Through the first quarter of 2004, Xigris sales were up 36%.”
In such campaigns, public relations companies operate as off-site extensions of a drug company’s marketing department. But sometimes, the relationship of a drug company and a third-party voice is more complex. The tie between patient-advocacy groups and drug companies is a good example.
Drug makers richly support the nation’s proliferating patient-advocacy groups, and only a handful of the charitable organizations refuse the sponsorship of pharmaceutical firms, says Georgetown University’s Dr. Adriane Fugh-Berman, who has studied these ties. That link presents rich marketing opportunities for corporate sponsors with an interest in reaching the patients the organizations advise and represent, Fugh-Berman says. But it also raises real questions about the independence of patients groups, she adds.
In marketing trade publications, the value of patients’ groups is widely touted. As friends and allies to potential customers, groups dedicated to patients who suffer from a specific condition can be powerful marketing tools. Patients seek information and emotional support from these groups, and trust them as an unbiased source of advice. Groups that empower patients to seek treatment are eager to foster awareness of their disease and, in the process, expand their membership. When they are successful, patients groups have a natural market-building effect.
But drug makers have the deep pockets, and patients groups — until they’re very large and well-established — are constantly scrambling for money. As a result, according to those calling for reform, the relationship is not always an alliance of equals.
“There’s an inherent conflict of interest,” says Merrill Goozner, editor of Integrity in Science, a publication of the Washington-based watchdog group the Center for Science in the Public Interest. “The question becomes, ‘Are you doing the best for the patients you represent, or are you doing the best for your sponsors?’ “
Goozner says that patient-advocacy groups are especially vulnerable to carrying drug companies’ messages, untempered by skepticism, directly to their members. “They’re desperate” for a cure or treatment, he says. “And no one likes to be told that this latest breakthrough is not all it’s been cracked up to be,” especially when it’s being pushed by a company that’s been generous with funding, he adds.
Last October, the magazine New Scientist published a survey gauging the dependence of randomly selected U.S. patients’ groups on drug manufacturers. Combing through the tax returns, annual reports and voluntary disclosures of 29 nonprofit patient-advocacy groups, the publication found that most accepted financial backing by companies developing or producing drugs used to treat patients supported by the group. In some groups, such as the American Heart Assn., the drug makers’ financial backing was huge ($23 million in 2005) but represented a small portion (4%) of revenue. For seven groups, donations from interested drug companies represented more than one-fifth of revenue. The Depression and Bipolar Support Alliance said it received more than half of its 2005 funding from the drug industry, and the Colorectal Cancer Coalition got 81% of its funding from drug makers.
New Scientist’s probe found that some donations appeared directly tied to marketing interests. In 2003 and 2004, when the drug giant Pfizer was developing a drug to treat restless leg syndrome, it was a major donor to the Restless Legs Syndrome Foundation. But in 2005, after Pfizer announced it had abandoned development of the potential drug, its donations to the patient group dried up.
Many of the best-known groups, including the Alzheimer’s Assn., American Cancer Society and American Diabetes Assn., typically have a board of physicians who vet the scientific accuracy of the information they provide to patients. And most solicit “unrestricted” grants that allow them freedom to use the drug makers’ donations as they see fit.
But even large groups often provide a gateway to the products of corporate sponsors, say those who have surveyed them. Many list FDA-approved medicines available to treat the disorder that is their focus and provide Web links that lead patients directly to marketing sites. And many offer their corporate sponsors access to their members, a potential gold mine of direct-marketing opportunity.
The corporate-donor pitch posted on the website of the national infertility patient group, Resolve, is typical of many patient groups. “Whether you become a site sponsor, a resource partner, or a sponsor of Resolve’s chats, [the group’s website] is the ideal place for your company to market its products and services to thousands of men and women across the country,” the appeal states. Among the benefits the group lists for becoming a member of the group’s “Corporate Council” are access to data on utilization of the group’s programs and services and “the opportunity to establish topics and sponsor special briefings for patients, the medical community and public policy makers.” Serono and Organon, both makers of prescription medication used to treat infertility, are among the group’s corporate sponsors.
Patient groups also mobilize patients — sometimes armies of them — to push for coverage of prescription drugs by insurance companies and states’ Medicare and Medicaid agencies. To pharmaceutical companies, this can make or break the market prospects for a new drug because 80 million Americans –among them, the heaviest prescription-drug users — receive healthcare coverage through Medicare and Medicaid, and roughly 155 million have prescription drug coverage through private insurance companies.
Strength in numbers WHEN insurers balk at reimbursing patients for new prescription medications, these groups typically swing into action, rallying sufferers to appear before public and consumer panels, contact lawmakers, and provide media outlets a human face to attach to a cause. Infertility patients mobilized by Resolve, for instance, have been extremely effective in extending states’ insurance coverage of infertility treatments. Groups such as the Depression and Bipolar Support Alliance have fielded experts and patients who have done the same for psychiatric conditions. And a wide range of patient groups, most with substantial backing from the makers of erectile dysfunction drugs, have mounted successful campaigns to get wary insurers to cover drugs such as Levitra, Viagra and Cialis.
See also: Melissa Healy. THE PAYOFF In short, marketing works Why argue with success? The Los Angeles Times. [Link]
SOLD ON DRUGS And now, a push for change [Link]
BUILDING THE MARKET From funding to findings [Link]
WOOING THE GATEKEEPER Doctor, just a little something for you Complex sales strategies go way beyond freebies. [Link] And now, a push for change Legislators have begun to question the drug industry’s pervasive influence in healthcare. Some doctors are backing them up. [Link]
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