Guest guest Posted June 16, 2005 Report Share Posted June 16, 2005 SSRI-Research@ Thu, 16 Jun 2005 01:10:03 -0000 [sSRI-Research] Pill Poppers Salt Lake City Weekly, Wed, 15 Jun 2005 8:44 AM PDT http://www.slweekly.com/editorial/2005/feature_2005-06-16.cfm Feature - June 16, 2005 Pill Poppers Doctors " just say no " to drug company hype and freebies. by Ted McDonough Next time you're watching TV and feel that sudden urge to " ask your doctor " about your cholesterol level or heartburn, you may want to ask more than simply, " Is the advertised drug `right for me?' " Is the expensive pill you want, aside from its pretty color, any different than the one you are already taking? More importantly, does your doctor accept lunch, cash or other freebies from drug companies? While you're at it, ask yourself this question: Do you need the drugs, or do the drugs need you? St. George physician Catherine Bonomo, 46, tries to get her patients, and other doctors, to ask those questions every day. Mostly she finds it's like hitting her head against a wall. " You see a commercial on TV 75 times and these nice people on television are telling you this is the medicine you need. They are happy people, floating around. Their lives are good. That is already ingrained in your memory bank. You go to visit the doctor. He makes an attempt to explain to you why this medicine may not be the one for you, but you've already been conditioned, " Bonomo says. It's an increasingly common predicament for doctors: patients showing up pre-diagnosed by advertising and demanding a drug by brand name. Try suggesting a different drug, or be even bolder—like Bonomo—and tell the patient they don't need the drug at all, that drug companies may be no different from other salesmen, and you'll get an earful. " A few [patients] are receptive, but most of them aren't, " says Bonomo. " They get frustrated. `But it was on TV, so it must be true.' " Bonomo doesn't give in. " I make a few people unhappy, but I think medicine is one of those fields that you have to maintain some integrity and some intellectual honesty about what you're doing. There are business aspects about medicine, but I would hope that most physicians would remember that it's a little bit more than that. " Bonomo is hyperaware of the impact of drug-company marketing on patients and the doctors who serve them. She is the only physician in the state of Utah to have sworn off the drug companies—at least officially. Bonomo said drug companies are not all bad: " They peddle some good drugs, " she says. What she doesn't want is for her medical decisions to be influenced by advertising. Her quarters at the emergency department of Dixie Regional Medical Center are remarkable for being devoid of pens and calendars bearing logos of pharmaceutical manufacturers. She gets quizzical looks from fellow doctors and patients for the " No Free Lunch " button she wears on her scrubs every day to work. It's the moniker of a growing movement of physicians who say they can't be bought off by drug-company giveaways. The same sort of giveaways—free lunches, golfing junkets, cash " consulting fees, " or, a past drug-company favorite, ski vacations to Utah—that were once the staples of U.S. congressmen until public outrage put a stop to them. For all the money drug companies spend advertising new or improved products—around $4 billion last year—it's just a tiny portion of the amount drug companies spend to sell their wares in other ways. The total marketing budget of U.S. pharmaceutical companies—everything from ads, to sponsoring medical conferences to buying lunch for doctors—topped $22 billion in 2003, according to IMS Health, a company that tracks drug sales for its drug-industry clients. The vast majority of that $22 billion went to directly influence doctors, primarily through $16 billion worth of free drug samples delivered to physicians' offices by an army of drug reps bearing lunch. Doctors are routinely paid " consulting " fees to listen to drug-company talks at resorts. And drug companies are significant sponsors of lectures at medical schools and conferences where doctors sit through required continuing medical education courses. In Utah, Bonomo isn't altogether alone in fighting such tactics. At the University of Utah School of Medicine, American Medical Student Association co-president Nick Warner says he is having little luck trying to get fellow students to " just say no " to the drug reps who routinely take third- and fourth-year students to lunch. What Drug Companies Feed On In a recent book, Dr. Marcia Angell, a former editor of The New England Journal of Medicine, takes issue with the long-touted pharmaceutical-industry assertion that drug prices are high because pharmaceutical companies invest so much in researching new cures for the world's diseases. Angell claims drug-company marketing budgets now far outstrip the amount spent on research and development. By her estimate, twice as much is spent selling drugs as researching them. " The drug companies have done very little recently that's new, " Angell said from her home in Cambridge, Mass., pointing out that cholesterol-lowering Lipitor, the best-selling drug in the world, is patterned after a drug that came on the market in the mid-1980s. " In most cases the basic research is publicly funded, done mainly in universities with [National Institutes of Health] funding. … That's what they feed on. " Angell, author of The Truth About the Drug Companies, claims what research drug companies do is devoted to creating their own versions of drugs already invented by others, resulting in an assembly-line stream of pills barely better than generic versions available for years. Pharmaceutical companies have essentially turned into marketing machines, she says, concerned mostly with promoting diseases to fit the drugs they make. Developing a cure for a previously incurable disease is much less profitable than, for example, making a slight change to the makeup of an existing drug, patenting it, coloring the resulting pill purple and selling it as something new and expensive, as happened with Nexium, the " Purple Pill, " which is chemically similar to AstraZeneca's earlier acid-reducing drug. Instead of research, Angell claims the pharmaceutical industry spends most of its time making up scary names for common ailments to sell drugs of little value to a wealthy population. Meanwhile, the industry largely eschews research on diseases such as malaria that kill thousands of the poor. It's the market at work, Angell says. " There are more healthy people in the country than there are sick people, so if you want a really big market what you are going to do is push drugs to essentially healthy people, " she said. " If you look at direct-to-consumer advertising, you see that much of it is promoting a medical condition, not a drug, so that people will think that they need drugs when they may not need them. " She blames drug-company ads for duping many into believing they have " dubious or exaggerated ailments " such as " generalized anxiety disorder " —otherwise known as shyness, " premenstrual dysphoric disorder " —aka PMS, or " gastro esophageal reflux disease " —aka GERD. Today, thousands of Americans have prescriptions for Nexium—the fourth-best-selling drug in the country—or similar prescription drugs developed to treat the serious problems of stomach acid eating the esophagus. Many, Angell alleges, just have heartburn. " The implication in the direct-to-consumer ads is if you have heartburn you're well on your way to cancer of the esophagus, " Angell said with a sarcastic laugh. " It's playing into a drug-intensive style of medicine that teaches for every ailment or discontent there is a pill. For most people who have heartburn, the best way to treat it is probably to lose a little weight, get out and take a walk or drink a glass of milk, but that somehow is seen as less good than taking a prescription drug. " An ongoing class-action lawsuit alleges AstraZeneca duped the nation by heavily marketing Nexium just as its old version of the drug was losing patent protection, opening it up for competition from generics. Drugmaker Eli Lilly took a similar tack when it got approval from the Food and Drug Administration to market the antidepressant Prozac for severe premenstrual syndrome. It colored the drug pink and sold it as Sarafem, a " new " drug that costs several times the now-generic Prozac. The condition the drug is supposed to treat has never been recognized by the American Psychiatric Association, but the APA is now considering adding " premenstrual dysphoric disorder " to its manual of mental problems based on the FDA approving a drug for it. Of 78 drugs approved by the FDA in 2002, only 17 were new chemical compounds, Angell claims. None of the new drugs put out by U.S. drug companies that year were classified by the FDA as likely improvements over drugs already on the market. And, she notes, drug companies are taking more in profits than any other industry, a 17 percent average profit rake for the top 10 American drug companies in 2002, compared to 3 percent average profits for other Fortune 500 companies. The No Free Lunch Bunch Bonomo says most of her professional colleagues deny that drug-company gifts—a slice of pizza or a few logo-emblazoned pens—influence their prescribing habits. However, she knows the impact is real because she sees new drugs in circulation at the hospital where she works every time the drug reps pay a visit. Too often, Bonomo said, a drug rep arriving with lunch from the Olive Garden substitutes for careful review of the medical journals when it comes time to decide which drugs to buy. Her outlook on drug-company marketing differs because she didn't enter the medical profession believing perks and constant advertising came with the job. In her mid-40s, Bonomo has been a doctor just four years. She never thought about entering medical school until after her two children were raised and she was divorced. Then, " I decided if my life is going to change, it ought to really change, " said Bonomo, a former ambulance driver. Bonomo entered the University of Utah School of Medicine at age 33. She served her medical residency in Los Angeles under a doctor who was a member of No Free Lunch, a New York organization enlisting physicians nationwide with the pledge to " accept no money, gifts or hospitality from the pharmaceutical industry " and " seek unbiased sources of information " apart from drug-company marketers about which drugs are best for their patients. Bonomo later signed up with No Free Lunch herself because she is convinced the ties between the pharmaceutical industry and the medical establishment are now so tight that many doctors can't tell the difference. The result, Bonomo believes, is that some ineffective, possibly dangerous, treatments have become standard despite scientific evidence against them. Her prime example is the promotion of a blood-clot-busting drug as something of a miracle cure for stroke. The treatment became standard in 2000 when the American Heart Association (AHA) trumpeted that the drug " saved lives " in stroke victims—a claim withdrawn when it came to light the drug's maker, Genentech, had built the heart association a new conference center. The AHA's green light came despite several studies showing that, unless given very carefully, stroke patients given the drug were up to three times as likely to die as patients given a placebo. Still, ask any doctor today, and nine out of 10 will tell you to administer the drug within three hours of a stroke, Bonomo says. " The scientific evidence out there does not support this; in fact, it says just the opposite, " said Bonomo, her voice rising. " But this was pushed and marketed so heavily by the pharmaceutical companies that it has been entrenched into the thought processes of many physicians. " Eight of nine AHA experts who wrote the stroke guidelines had financial ties to the drugmaker. That is not uncommon. In a 2002 review, The Journal of the American Medical Association found 60 percent of doctors defending a drug's use had relationships with the drug's makers. Drug companies provide a significant portion of the budget for the FDA. One-third of the experts who recently recommended putting Vioxx and other arthritis medications recalled for increasing the risk of heart attack back on the market worked as consultants to makers of the drugs, according to the Center for Science in the Public Interest. Vioxx is just the most prominent example of alleged bad behavior by drug companies. Patients and lawyers are lining up in huge class-action lawsuits against the makers of some of the most popular medications. Allegations range from hiding information about dangerous side effects, to price-fixing, to paying other drug companies not to market generic versions, to cornering the market on a drug's active ingredient, then hiking prices. In April, Mark Shurtleff, Utah's attorney general, announced settlements in two lawsuits against drugmakers. In one, Pfizer subsidiary Warner-Lambert paid Utah $1 million to settle Medicaid fraud allegations Shurtleff said demonstrated " the company was more concerned about profits than the health of its customers. " The company was charged with illegally promoting its epilepsy drug Neurontin for a long list of unapproved conditions, including bipolar disorder for which the drug was found to have no effect. Allegations included paying doctors illegal kickbacks to promote the " off-label " uses, lying about the drug's safety in medical literature and illegally billing Medicaid. The 50-state $430 million settlement paled in comparison to the drug's $2.7 billion in sales for 2003, 90 percent of which came through " off-label " prescriptions. Among the biggest lawsuits are giant class-action cases against the makers of antidepressants linked to suicide in young people and arthritis drugs, like Vioxx, found to promote heart attacks. Scares over some arthritis drugs were exacerbated by revelations that drug companies knew of problems, but hadn't made findings public. Among the most startling aspects of Vioxx to anyone who has seen television commercials for the drug is that while it is one of the best-selling medications for arthritis—$1.3 billion in 2004—it has never been proven any better than aspirin at relieving pain. The drug's maker never claimed it was—at least not in the medical literature—where its benefit was given as a lower incidence of ulcers. It's one of the drugs Angell argues is more marketing than drug. " For most Americans, and certainly for Americans who have good insurance, we're overmedicated, " she says. And in many cases " we're taking drugs that have never been shown to be more effective or safer than older, cheaper drugs. " Among the " ask your doctor " television ads running in recent months, one tells viewers that although they may think they have their cholesterol under control, they should think again. That's because the definition of high cholesterol was changed last year. Eight of nine experts who sat on the government National Cholesterol Education Program panel that recommended the new guidelines had financial ties to companies marketing cholesterol-lowering drugs, according to the Center for Science in the Public Interest. In a letter of complaint, the Center noted no studies had proven that increasing use of such drugs helped elderly men likely to take them, but the drugs were known to increase the risk of cancer. Angell claims the big drug companies control not only the drug-approval panels, but, with heavy political contributions, call all the shots in Congress. Last year, Congress passed a law creating a new drug benefit for Medicare. The industry successfully lobbied for a line in the legislation specifically barring the nation's Department of Health and Human Services—now headed by former Utah Gov. Mike Leavitt—from negotiating lower drug prices. The administration argues the free market will provide lower prices than a government monopoly. Tommy Thompson, Leavitt's predecessor in the HHS job, loudly grumbled about the negotiation ban, but Leavitt—to whom the drug-company lobby gave $9,500 over his last two Utah gubernatorial races—hasn't argued against the policy. The new federal coverage for seniors' drugs is projected to increase drug-company profits by 38 percent over its first eight years. Ethics and Erectile Dysfunction The shock troops in the drug companies' selling efforts are the " detail men " who descend daily on hospitals, medical schools and doctors' offices. " They'll come in with pizzas. I've seen them come in with shaved ice machines, doughnuts, sometimes meals, drop them off in the back, say, `Hi,' smile a lot. They look nice, " Bonomo said, her measured doctor voice giving way to her more usual folksy speech pattern. " They will drop off food, but they also will drop off pens, napkins or calendars, something so their name is seen over and over and over and over again. " Under pressure from doctors like Bonomo, the drug companies' lobbying association, the Pharmaceutical Research and Manufacturers of America (PhRMA), came up with a new code of ethics in 2002 instructing member companies in the ways of influencing doctors. Under the rules, giving doctors cash for writing prescriptions is bad—not to mention illegal. Paying doctors a handsome " consulting " fee to come to a resort golf course for training as company " speakers, " however, is just fine. So, while pharmaceutical companies cannot bribe docs directly, they can form alliances with them in plenty of other ways, just as political lobbyists often form alliances with elected officials. One maker of a popular erectile-dysfunction drug paid doctors cash after they wrote prescriptions. Ostensibly the money was to compensate doctors for time spent enrolling the newly prescribed patients in a study. The practice is perfectly acceptable under PhRMA's ethical guidelines and there is no formal regulation. The rules are purely voluntary. The American College of Physicians also has a new ethics manual strongly discouraging doctors from accepting " gifts, hospitality, trips and subsidies of all types. " But that didn't stop the ACP from financing its annual meeting, in April, largely through the drug industry. Drug companies were inspired to fork over money to sponsor $60,000 in tote bags after ACP's promise that the annual meeting " offers an unparalleled opportunity to meet with physicians of power—prescribing power. " No Free Lunch asked to exhibit but was turned down. PhRMA spokesman Jeff Trewhitt notes that a large portion of drug-company-marketing spending goes for free samples that give doctors " early hands-on experience with a new medicine " and often are the only source of medication for the poor. But the more drug companies advertise products, the worse the public's view of the industry, polls show. PhRMA now recognizes that the brand as a whole needs promotion. As the industry struggles not to become the next " big tobacco " in the mind of the public, PhRMA is getting ready to counter what Trewhitt calls a " barrage of distorted allegations. " If you thought the television was filled with drug ads before, get ready for a blitz. Trewhitt said PhRMA will be " talking about the innovation of the industry " and advertising its efforts to get drugs into the hands of the one-fourth of Americans who don't have drug coverage. A new wave of drug-industry commercials already has aired touting drug-giveaway programs for the indigent, to whom PhRMA member companies provided about 40 million free prescriptions during the past two years. The ads may be just in time. Bonomo is the only No Free Lunch member in Utah, but following last year's scandals of allegedly dangerous—but widely advertised—drugs being pulled off the market, there is a growing wave of suspicion of the pharmaceutical companies. In Salt Lake City, family doctor Ross Brunetti hasn't officially sworn off the drug companies, but he has taken an increasingly common position of limiting his interactions with their reps, whom he refers to as " overdressed used-car salesmen. " He says he doesn't have a choice. The number of drug reps plying their wares doubled in the late 1990s reaching the point where, today, there is more than one drug rep for every five office physicians. If Brunetti visited with every rep who dropped by his office, that would be all he could do. He estimates that six reps drop by his office every morning, followed by six more in the afternoon. " In a week, I might see three people trying to sell me the same thing, " he said. " On Friday, when they want to get out early and go skiing, they're all here, all in the morning. There are more drug reps than patients. It's like a minefield. " Brunetti is offended by the sheer amount of money spent peddling drugs, which he believes drives up costs, but he also thinks constant meetings with drug salespeople are a serious liability issue for doctors. " The biggest cause of medical malpractice is interruptions. That's their job, to interrupt me. I don't let 'em. I let 'em stand there 'til I'm good and done with a patient, " he said. " As far as we're concerned [drug reps] are lying when their lips are moving, " he said. " We tolerate them only because they leave [drug] samples for people who can't pay. " The charity drug programs PhRMA is touting in new ads provide a large portion of the prescriptions issued through the Salt Lake Community Health Centers. David Keahey, a physicians assistant who regularly volunteers at the Central City clinic, appreciates the programs, but says the drug companies aren't giving it away strictly out of the goodness of their hearts. The drug companies " have donated a lot of stuff over the years, " he said. " There is another issue. The drug companies, in my opinion, do this not only out of a sense of altruism … but to keep the status quo. They can say, `Well, we're taking care of the problem, we have these programs so we're doing our part.' " Twenty years ago, when Keahey began volunteering, drug companies helped by dropping off large numbers of samples. Now, the samples largely have been replaced by charity programs and accompanying large amounts of red tape with which not all low-income clinics can cope. Keahey's clinic has resorted to hiring employees who do nothing but fill out drug-company forms. Keahey can't see much reason for the constant form filling, but noted " anytime you put requirements of paperwork and bureaucracy between patients and service you're going to reduce utilization. " Angell remains one of the biggest thorns in the side of the industry. PhRMA's Website prominently featured a lengthy rebuttal to her book, particularly her claim that drug companies skimp on research spending in favor of marketing and profit. The drug industry argues with Angell's numbers, saying she incorrectly lumps administrative costs with marketing when she compares advertising to research spending. Angell shoots back that most drug companies report the costs together, " which obfuscates how much they spend on both. " PhRMA's numbers, she claims, leave out billions spent on so-called " education " of doctors through sponsorship of medical conferences and meetings of professional societies. The industry's own numbers show marketing making up a huge portion of spending, $21 billion in 2003 compared to $33 billion spent on research and development. PhRMA also looks to different statistics to refute Angell's allegation that drug companies sponge off government research. Trewhitt points to a 2001 study by Congress that found nearly all top-selling drugs that year were developed without help from the government. Angell says that's a misreading of the report that found four drugs were certainly developed without government help but couldn't make a determination for many others because of missing records. Trewhitt acknowledges the nation faces a drug " crisis, " but paints the problem as one of lack of insurance coverage to pay for drugs. The drug companies argue it's a whole new world. Spending on drugs is increasing because drugs are now available to treat and prevent conditions that used to land people in the hospital. Under this analysis, the growing chunk of the health-care pie that goes for cholesterol drugs, for example, is made up for by savings on heart surgeries. Bottom line: Everyone may be on something, but we'll all be healthier for it. Indeed, more Americans are medicated than ever before. In the past decade the number of prescriptions ingested by Americans has jumped by two-thirds, according to IMS Health. Americans lead the world in per-person drug purchases, spending 18 percent more than France, the next leading drug-consumer, according to the Organization for Economic Cooperation and Development. Sales have increased at an average rate of 11 percent per year during the past five years. A significant increase also has been recorded in bad drug reactions reported to the FDA, which went up more than 200 percent during the past decade. To criticism that U.S. drug companies aren't inventing many new drugs, Trewhitt acknowledges " it would appear " to be the case, but adds that's a temporary phenomenon. Inventing drugs is a lot harder than it used to be, Trewhitt said. Drug companies are geared to solve medical problems with chemicals, but today's unsolved conditions, such as Alzheimer's, must be cured through still-developing biotechnology. " This is a steep learning process for many companies as they make the transition, " he said. While pharmaceutical companies remain among the most profitable in the nation, it's getting harder to make a buck as competition heats up and health plans lean on patients to use low-cost generic drugs, notes IMS Health. " A single point of market share can mean tens of millions of dollars of profitability, " states the Website of IMS Health, which keeps detailed lists of doctors' prescribing habits to help drugmakers identify " key prescribers driving brand performance. " " Now, more than ever, brand managers are facing increased pressure to achieve aggressive revenue targets with tighter budgets, " the Website notes. " Marketers must optimize brand performance … focusing on reaching every stakeholder, from physicians to consumers. " The Website might just as well have added " reaching politicians, " another target of pharmaceutical company largesse. As the political debate over drug costs heats up, drug companies are making sure politicians know where their bread is buttered. In Washington, D.C., Utah Sen. Orrin Hatch is ferried to speeches in drug-company jets. In Utah, the State Health Department is encountering resistance to its idea for controlling Medicaid spending by promoting generic drug use. The department estimated a generic shift could help save $12 million per year, but some legislators balked, citing states that have tried similar tactics only to lose money on new bureaucracy. Drugmakers gave Utah lawmakers more than $56,000 for last year's elections. Increasingly, industry critics see little difference between such campaign contributions and the freebies and cash provided to doctors. What the typical patient doesn't know, Bonomo says, is that the typical physician doesn't know a whole lot about drugs. Reading scientific studies isn't in the standard course for doctors. While there are widely available sources of information on drugs not written by the drug companies, reading the literature dropped off by the drug reps, along with a pizza, is much easier. Sporting her " No Free Lunch " badge, Bonomo often gets looked at like she's a crazy person. She sometimes feels like a lone prophet in the wilderness decrying the false God raining doughnuts and drug samples from the sky. Often, she'll walk in on a group of doctors surrounding a pizza dropped off by a drug rep and chide them, " You're selling your soul to the devil. You guys are eating the drug food again. Haven't you been listening to me? " Sometimes, when she hasn't eaten for 10 hours, that slice of pizza looks good. But " No Free Lunch " Bonomo keeps her fast. Quote Link to comment Share on other sites More sharing options...
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