Junkfood Science: Are you being detailed?

August 10, 2007

Are you being detailed?

In case you missed it this week, the Los Angeles Times published a large special series on prescription drug marketing and its influence on consumers, doctors and researchers. Much of it was review, but it may be shocking news to many readers. And for everyone else, seeing it all together serves as a valuable reminder of the need to think critically about health information we hear, regardless of how trusting the source.

Prescription drugs are no longer things people take just when they’re sick, but are being increasingly prescribed purportedly to keep people healthy. As the Kaiser Family Foundation reported in May, Americans spent $200.7 billion on prescription drugs in 2005 and in one year that figure had grown to $279 billion. In 2006, the share paid by taxpayers from public funds rose from 27 percent to 39 percent. So, this issue affects everyone. In the first article of the LA Times series, author Melissa Healy gave an overview of the extent of drug marketing:

Under the influence

FOR many Americans, a doctor's decision to prescribe medication is something of a sacred transaction....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....

In 2006, drug-makers spent almost $5 billion to reach out to consumers with direct advertising. But ... 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....[T]heir 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.... 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....

“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."

Dr. Kassirer’s point was a valuable one, as this isn’t about being anti- Big Pharma or keeping companies from legitimately advertising their products. The problem comes in when the claims and influences cross the line beyond quality science and sound guidance that’s in the best interests of patients.

The pharmaceutical companies argue, noted Ms Healy, that “the industry’s sponsorship of research and education pushes the process of drug discovery and development forward.” This is a worthwhile point, too. Much of the drug research comes from the U.S., with 18 of the last 25 winners of the Nobel Prize in Medicine either U.S. citizens or working here. According the president’s Council of Economic Advisors, U.S. companies have developed half of all the major new medicines introduced worldwide over the past 20 years. In fact, Americans have played a key role in 80 percent of the most important medical advances of the past 30 years. We have much greater access to life-saving technologies and drugs, too. We’re better able to benefit from new cancer drugs, for example, whereas British cancer patients die from their cancers at much higher rates than other western countries because they don’t have that access. And a delegation from Witness for Peace reported a few years ago that Cuban doctors have access to less than half of the new medications available to the rest of the world, including chemotherapy medications for childhood leukemias and breast cancer.

And those innovative medicines can take unbelievable amounts of money and years of effort to develop. That was brought home to me while listening to a presentation given last month at ASCO (the American Society of Clinical Oncology) in Chicago. The results of a large international, multi-center phase III randomized clinical trial of a new drug for liver cancer were being reported. Currently, there are no effective medications that can improve survival for people with liver cancer. Very few (about 7%) live even five years after being diagnosed. It is the third cause of cancer deaths around the world — resulting in more than 600,000 deaths each year — and expected to grow over the next few decades largely due to rising rates of viral hepatitis infections. In fact, it’s one of the very few cancers in our country that’s not dropping in frequency and mortality. Dr. Josep Llovet, M.D., of Mount Sinai School of Medicine in New York, said that finally after 30 years and 100 clinical trials, they encountered the first drug to show a significant response, extending survival by 44%. It may one day lead to an even better treatment.

Still, many have pointed out that most of the big-selling “new” drugs aren’t really new, better or safer, but me-too variations to get another twenty years of patent rights and sales, as reported here:

Of the seventy-eight drugs approved by the FDA in 2002, only seventeen contained new active ingredients, and only seven of these were classified by the FDA as improvements over older drugs. The other seventy-one drugs approved that year were variations of old drugs or deemed no better than drugs already on the market..

It’s a complicated issue because we all want the best, but we want meds to be sound and sensible, be actually necessary and beneficial, and be in people’s best interests. And we want to be free to choose to take them or not based on full, objective and accurate information. The next article in Ms Healy’s series revealed the influence of drug sales reps on doctors:

Doctor, just a little something for you

... “There is a big bucket of money sitting in every office" a drug representative visits, said an AstraZeneca marketing director... Each day in the United States, an army of roughly 100,000 pharmaceutical company sales reps storms the waiting rooms and offices of the nation's 311,000 office-based physicians. Called “detailers" — and earning, on average, $81,700 per year — they are the smiling, well-dressed men and women often seen in a physicians' waiting room toting a cavernous briefcase and making small-talk with the receptionists. Their ranks have more than doubled in the last 10 years.... In recent years, drug-company insiders have come forward to detail the enticements, persuasive techniques and market-tracking systems that their organizations use to nudge doctors' prescribing decisions to boost sales. The picture they provide is of an industry in hot pursuit of physicians' hearts and minds....

In fact, if you haven’t read the article, “Following the Script: How Drug Reps Make Friends and Influence Doctors,” by Adriane Fugh-Berman, an Associate Professor in the Department of Physiology and Biophysics, Georgetown University Medical Center, Washington, D.C., and Shahram Ahari of School of Pharmacy at the University of California San Francisco and a former pharmaceutical sales rep, you may want to. The tactics used to “detail” (manipulate) doctors are eye-opening. The key, they said, is to build false friendships and convince doctors that the rep is the doctor’s best friend … and doctors are taken in. A wonderful examination of the ethical issues raised in this paper, written by Dr. Roy M. Poses M.D. at Healthcare Renewal, is also worthwhile reading. [A well-known secret in the drug rep world are the benefits of certain physical attributes, medical expertise not required. Today, eDrugSearch shares an enlightening debate among female drug reps on cleavage.]

The LA Times series also mentioned a national survey of doctors published in this past April issue of the New England Journal of Medicine. It “found that 94% of physicians in the six specialties studied reported some type of relationship with pharmaceutical companies' representatives.” This survey was led by Dr. Eric G. Campbell, Ph.D., at the Institute for Health Policy in Boston, Mass. It found that 83% of doctors had accepted food in the workplace, 78% had taken drug samples, 35% had been reimbursed for the costs of professional meetings or continuing education and 28% had taken money for consulting, giving talks or enrolling patients in trials. This wasn’t a new phenomenon, either, as they reviewed 16 studies published from 1982 through 1997 and found that doctors on average met with an industry rep weekly — family practitioners most often (at 4 times a week), followed by internists, cardiologists, pediatricians and surgeons. But peer influence was especially targeted, the researchers found: “Cardiologists, whose prescribing patterns as specialists and opinion leaders are thought to influence the prescribing patterns of nonspecialists, are significantly more likely to receive direct payments from companies than are physicians in other specialties.”

The LA Times noted the importance of those drug samples, far beyond educational purposes:

Sales reps bear many gifts, but none is more important than the prescription drug samples they bring to doctors. In 2003, the pharmaceutical industry distributed $16.4 million worth of them to doctors, according to PhRMA, the industry's most important trade group. “For me, that's access," Ahari says. “The doctors are first grateful that you're giving them samples, because it makes them seem like a hero to patients...and when they feel that sense of gratitude, they feel obliged to spend some time with the drug rep delivering them." But in the end, it is the patient who often will pay more, because even a short course of sample use builds customer loyalty to a brand-name drug, even when a generic or a cheaper, older drug might be just as effective.

But the influence of drug reps at private doctors’ offices I’ve worked at pale in comparison to what I witnessed at a for-profit heart hospital, where the drug reps were given unhindered access to patient areas, sitting at the nurses station, following the doctors and nurses around, peering into charts and not only flooding the place with all sorts of paraphernalia (imprinted cups, pens, clocks, notebooks, free Starbuck’s coupons and food) but employing heavy handed marketing tactics. Not a single doctor appeared to recognize the influences and they never questioned the information they were given. A nurse who expressed concern about the drug reps was let go without notice. Patients were discharged with prescriptions for large quantities of brand-name medications, even when the need for them was questionable or less expensive generics were available, and even when it was brought to the doctors’ attention that poor, elderly patients were unable to afford them.

The LA Times also recognized that “outside the confines of a doctor’s office, pharmaceutical marketing efforts become more extravagant.” Drug companies also score favor, spending $1.12 billion in 2005 just to fund medical education seminars:

At physicians' association meetings and at conferences and seminars that provide “continuing medical education" for doctors, drug-company sponsorship is substantial.... Dr. Jerome Kassirer of Tufts University School of Medicine described meetings of medical societies and associations.... Although couched as education," he added, “these marketing efforts are thinly disguised bribes."

Medical societies “have become dependent on the infamous ‘unrestricted grant' from numerous pharmaceutical companies," Dr. J. Gregory Rosenthal, a Toledo, Ohio-based retinal surgeon, told the Senate Committee on Aging in June. “In this context, ‘unrestricted' means, ‘Use this for whatever you want, but if you ever want another, don't displease us.' "

The next article in the LA Times series addressed an aspect that’s been extensively covered here: marketing direct to the public using tactics that are often hard to recognize as marketing. They can seem like patient advocacy or health education, when they’re actually playing with our emotions and bringing fears and some supposed new health crisis or disease for which we all need to be screened for and treated. As we reviewed, the accuracy of direct-to-consumer advertising isn’t evident, and less than a quarter offers any educational value. The LA Times said:

Next step: Create the demand

...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...95% used emotional appeals to sell the medication...58% portrayed the advertised drug as a medical breakthrough — a pharmaceutical twist on Madison Avenue's “new and improved" message.

[When a] study suggested some safety concerns with Xigris [a drug for sepsis] and an FDA advisory panel had urged more thorough study of the drug before its approval....[Eli] Lilly's response was to secure the services of a small public relations firm [to] 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....

This will remind many Junkfood Science readers of the efforts of the bariatric and weight loss industry, such as GlaxoSmithKline’s massive guerilla marketing campaign of Alli, which included sponsoring a trade organization of health professionals (the ADA) to lobby for them; their PR firm creating an organization of weight loss doctors called the Reality Council; and even underwriting a PBS educational special on obesity.

But the public often comes into personal contact with industry-sponsored patient advocacy groups, support groups and online communities that are really about selling the disease and treatments (i.e. obesity and bariatric surgeries to weight loss diets). And the lobbying purposes of industry-sponsored professional organizations is often not recognized. As the LA Times wrote:

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.... “There's an inherent conflict of interest," says Merrill Goozner, editor of Integrity in Science... 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)...

Patient groups also mobilize patients — sometimes armies of them — to push for coverage of prescription drugs [or obesity “treatment” and bariatrics] 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.

Regardless how anyone feels about drug company marketing, the bottom line is that it works, as the next article in the LA Times’ series revealed. Every dollar spent in medical journal advertising brings in $5 of sales, and every dollar spent on sponsoring a medical educational seminar nets $3.56. So, not surprising, companies are spending more than ever on marketing:

In short, marketing works

....As marketing budgets climbed toward a 2006 high of $28 billion, sales of prescription drugs have never been higher. According to estimates published by the Kaiser Family Foundation, the number of individual prescriptions filled in the United States 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, including refills; by 2005, that number had risen to 12.4.

Prodding patients to prod their physicians, apparently, works....But ask the doctors whether the marketing influences their clinical judgments or prescribing behavior, and a chill will descend upon the room, say those who have run the experiment. “Physicians are heavily socialized to believe that they have risen above the normal human foibles," said Harvard University's David Blumenthal, co-author of the most recent survey detailing doctor-drug company interactions....

In a widely cited 2001 study published in the American Journal of Medicine, 84% of young physicians surveyed said they believed that drug industry promotions, including gifts and meals, influenced the prescribing practices of fellow physicians. Although ...61% said they considered themselves immune to marketing's effects. They are not. A 1994 study found that hospital-based doctors were more likely to request the addition of brand-name prescription drugs to their institution's medicine chest after they had met with sales representatives detailing those drugs….

After a strong start, the last of the LA Times series faltered a bit. It didn’t expose the results of these industry influences and how they may be harming and costing patients, doctors and our healthcare system. Nor did it identify the bigger problem and the biggest influences on drug prescribing. It went right to advocate for legislation.

And now, a push for change

...Medical societies and patients groups are quietly debating the wisdom of their dependence on drug companies' largesse. Doctors are rethinking, or at least disclosing, their ties to drug companies. Legislators are drafting and passing bills aimed at blunting the effects of prescription-drug marketing... “The research community is getting progressively more entangled with industry, as became evident to me when I tried to find thyroid experts to review the paper who did not have financial ties", wrote then-JAMA editor Dr. Drummond Rennie... “There had been this gradually creeping seduction going on all these years ...and the pharmaceutical industry had happily supplied us with justifications for it. We doctors lapped them up eagerly."...

To date, at least 30 states have enacted laws, or have considered legislation, that would do so. Those include bills requiring the disclosure of gifts and payments by drug makers to physicians, limits on pharmaceutical companies' access to prescription information used for marketing purposes, advertising restrictions and limits on pharmaceutical sales representatives' gift-giving to doctors.... Virtually all have been opposed by the drug industry, which, according to estimates by the Center for Public Integrity, has spent $758 million on lobbying — more than any other industry — since 1998.

The LA Times reported of welcome changes in attitudes among doctors about drug marketing and of interest in reducing the influences, especially among younger doctors and medical students. Their focus is on campaigns to shun drug company perks. While well-intentioned, these disregard that financial disclosures address only a small part of conflicts of interest. How many doctors are critically looking at clinical practice guidelines, government agency and legislated mandates, and their own medical educations to see how heavily they’ve been domineered by pharmaceutical and other special interests? The influence has been so intense and widespread all the way to the highest levels, that one wonders if turning down pens and conference tuitions is bringing awareness of the larger significance of this issue.

There is so much money at stake, pharmaceutical interests are taking a newer tactic to secure the cooperation of both doctors and their patients. We’ll look at that in an upcoming post.

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