Sunday, May 25, 2008

Our Daily Meds


How the Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines and Hooked the Nation on Prescription Drugs

By Melody Petersen

NYTIMES REVIEW
Petersen gets around to interviewing Iowa’s state nosologist near the end of “Our Daily Meds,” the facts that she cites don’t even sound that grim. The nosologist’s job is to catalog Iowa’s deceased according to cause of death. He processes about 27,000 death certificates a year. And by his reckoning there were only five deaths caused by adverse reactions to prescription drugs in 2002. That low figure is jarringly out of whack with Ms. Petersen’s investigative reporting in an angrily illuminating book on drug-related corporate malfeasance and patient peril.

“Could drugs be killing people but escaping all blame, leaving them to harm even more Americans until someone, finally, catches on?” Ms. Petersen asks. Given the information that her book uncovers, this a purely rhetorical question. Her study cites reckless and questionable behavior in all aspects of drug companies’ research and marketing ploys, even if much of this is familiar territory. It has been explored by earlier crusaders (notably Marcia Angell in “The Truth About the Drug Companies”) and in Ms. Petersen’s own journalism. She spent four years as a reporter covering the drug industry for The New York Times.

The newer and scarier material in “Our Daily Meds” concerns the increasingly serious consequences of Americans’ dependency on prescription drugs. Disagreeing with Iowa’s nosologist, Ms. Petersen says the lethal consequences of overprescribed or misprescribed drugs are too readily accepted as “natural” death. She cites the unwillingness of pathologists to question the wisdom with which doctors dispense medications. The reluctance of hospitals to perform autopsies, she says, has impeded medical research into what these interactions can do.

“Our Daily Meds” begins by illustrating the established drug-company practices that have led to this sorry juncture. There is the rigging of studies, so that to be deemed “effective” a drug need only perform better than a sugar pill. There are the promotional strategies that evade the need for F.D.A. warnings by, say, planting logos for the sexual enhancement drug Viagra and the antidepressant Wellbutrin on Nascar vehicles. There is the co-option of doctors and university researchers by aggressive, payola-dispensing drug company representatives.

Ms. Petersen, who has done much of her digging with the help of obscure but gratifying corporate documents, even finds feedback from doctors about the bribe-style amenities offered by drug company junkets. (“Hotel too cold inside,” one said, in an evaluation of a June 1998 drug company program, adding, “Resort places preferred.” From a different doctor, miffed at the lack of a chauffeur at another event: “Hired car would have been much preferable.”

But she moves to weightier matters in assessing the directions in which heavy drug dependence is leading Americans. First of all there are the business strategies that have created illnesses out of what used to be facts of life, labeled them as syndromes, and have hooked customers into long-term use of medication to cure them. (Detrol, the obnoxiously advertised cure for what its manufacturer calls “overactive bladder,” is a case in point, especially since it can cause hallucinations that resemble symptoms of Alzheimer’s disease.) Second, there are the economics of creating chronic consumers for marginally necessary drugs.

Irate as she is that in a period (1980-2003) when Americans doubled what they spent on cars they increased their spending on prescription drugs by 17 times, Ms. Petersen steps back to consider the long-term consequences of this shift in consumption. She notes that the first generation of children raised in front of ubiquitous, sunny drug-company advertisements (which became legal in 1997) has acquired the notions that prescription pills fix everything, and that they are less dangerous than street drugs. Then, looking to the elderly, she points out that increasing numbers of drugs are accumulating in these patients, with little regard for the consequences.

“As older patients move through time, often from physician to physician,” one doctor tells her, “they are at increasing risk of accumulating layer upon layer of drug therapy, as a reef accumulates layer upon layer of coral.” And when the side effects of sleeping pills or antidepressants mean more elderly people fall down, the solution is not likely to be the scaling back of such prescriptions. “Instead,” she writes, “the companies have used the statistics on falls to create a new blockbuster pharmaceutical market for drugs they claim will reduce the chances of breaking a bone.” The market for just two of these drugs, Fosamax and Actonel, is expected to be worth $10 billion by 2011.

Ms. Petersen compiles this data in anecdotal style, even though they would have hit harder in more crystallized, succinct form. But although she rambles and repeats herself at times, this material remains tough, cogent and disturbing enough to have a serious impact. So do her recommendations at the end of this chilling investigation.

Among them: Look at the pens and tissue boxes in your doctor’s office. If they feature drug ads, then a drug company representative has been courting your doctor, trying to influence the ways in which that doctor issues prescriptions. Don’t trust paid celebrity drug endorsements. Be aware that your symptoms may be caused not by illness but by medication, especially when more than one medication is involved. Ms. Petersen urges more study of these interactions, particularly on the part of police officers who can assess drunk drivers but not overmedicated ones.

“Our Daily Meds” also advocates more supervision of doctors’ research articles, many of which are ghostwritten by drug company spokesmen. It calls for drug watchdog agencies that are not overseen by the government, since government officials can so easily be lobbied. Most drastically, she advocates prison time for executives implicated in pharmaceutical crimes. But those crimes are part of a time-honored tradition. As a federal investigator put it in 1937, after a barely tested elixir killed as many as 30 percent of the people who took it: “Apparently they just throw drugs together and if they don’t explode they are placed on sale.”

WAPO REVIEW
Once upon a time there was an industry called pharma that was interested in doing well and doing good. Run by doctors and chemists, drug companies employed battalions of researchers whose scientific efforts resulted by mid-century in a flood of life-saving drugs, including antibiotics, vaccines, tranquilizers, antihistamines and steroids. As George Merck, president of the company founded by his father, put it in 1950, "We try never to forget that medicine is for the people. It is not for the profits. The profits follow. . . ."

And how. Today, of course, drug companies are hugely profitable enterprises and the darlings of both Wall Street and K Street, having spent more on lobbying than any other industry between 1998 and 2004. Their transformation from small chemical manufacturers to marketing machines with sidelines in drug development is owed in large measure to blockbuster drugs. This is the term for any medication that generates more than $1 billion in sales annually. Such drugs as Nexium, Celebrex, Claritin and, of course, Viagra, whose brand names are household words, became blockbusters not because they save lives, or even because they are necessarily more effective than other remedies, but because their manufacturers employ some of the cleverest marketing on the planet.

Take the selling of Zantac, an anti-ulcer drug that came on the market in 1983 and paved the way for the blockbuster drugs that followed. First, Glaxo priced its new drug above its competitor, Tagamet -- a bold move, Melody Petersen writes in Our Daily Meds, that "like an underweight boxer trying to fool the prizefighter with his swagger . . . implied that Zantac was better." In reality, Zantac was a "me-too" drug, chemically almost identical to Tagamet and no more effective.

But it was the second half of Glaxo's strategy that was truly dazzling. Rather than plowing the revenue from Zantac back into R&D, as was then customary in the drug business, the company decided to invest in marketing the daylights out of its drug. Glaxo funded studies intended to show Zantac's superiority. It hired a battalion of sales reps, who flogged the drug relentlessly to doctors. Most brilliant of all, the company pioneered a ploy now used routinely in pharmaceutical marketing: It "condition branded" Zantac.

Glaxo's novel idea was to link its drug to the relief of a common but minor condition, then make consumers and doctors worry that the condition was a sign of a more worrisome disease. In this case, the minor condition was old-fashioned heartburn. Glaxo warned that heartburn was a sign of chronic reflux, which the company dubbed Gastro-Esophageal Reflux Disease, or GERD. Soon, millions of Americans were saying goodbye plop plop, fizz fizz, hello Zantac, an expensive prescription drug they started taking every day to ward off GERD, even though most episodes of reflux go away without treatment, and most heartburn can be relieved with an over-the-counter remedy.

Glaxo's strategy has become standard operating procedure in the pharmaceutical industry. Companies now routinely condition brand their drugs not only by linking minor symptoms to real diseases but sometimes by making up diseases out of whole cloth. Pharmacia marketed a drug named Detrol for a previously unknown condition dubbed "overactive bladder." Forrest Laboratories ran a study to see if its antidepressant Celexa could be used to treat "compulsive shopping disorder," a mental illness that has yet to be recognized by psychiatrists, but that some husbands and wives undoubtedly would like to invoke when confronted with a maxed out credit card.

Drug makers also have flooded the market with me-too drugs. We don't have just one anti-cholesterol medication, we have more than 10 to choose from. Nearly a dozen antidepressants act on the same neurotransmitters in the brain, and three different drugs target erectile dysfunction. That's not to say that multiple versions of a drug are necessarily a bad thing. Having several drugs does introduce some price competition, though not much, and certain drugs often work better for some people than for others. But as Petersen argues, there's a downside to this business model.

For one thing, in pursuing blockbusters, drug makers are neglecting research that could help people with less profitable diseases. Malaria continues to be a scourge of the third world, but patients with diseases that are rare in the United States get short shrift from the drug industry. Even antibiotics are in short supply in the industry's development pipelines, largely because no amount of creative marketing can lift an antibiotic to blockbuster status. An antibiotic might well save your life, but unlike Zantac or Lipitor or Claritin, it doesn't need to be taken for years on end, day in, day out. Even more troubling, the flow of truly innovative drugs has slowed to a trickle, at least in part because companies that were once science-driven now spend twice as much on marketing existing drugs as they do on developing new ones.

Worst of all, the marketing has had a demonstrably negative effect on many patients. Merck's painkiller Vioxx, which was heavily advertised for a wide variety of ailments, is estimated to have killed as many as 60,000 people before the company withdrew it from sale in 2004. "It's a Vietnam," the sister of one deceased Vioxx user told Petersen. Unnecessary drugs and dangerous interactions between drugs are a mounting problem, as one in six Americans now takes three or more drugs per day; many patients find themselves adding prescriptions to combat the side effects of other prescriptions. Petersen tells the story of a 5-year-old who was put on the stimulant Ritalin, which triggered seizures. His doctors were considering brain surgery until he was taken off the drug and the seizures stopped.

For those who know the history of drug marketing, much of this book will be familiar. Petersen draws on her years as a crackerjack business reporter at the New York Times, where her enterprising stories were eagerly awaited by those who follow the drug makers. She occasionally appears to forget that for all their hype and hucksterism, drug companies also produce many truly beneficial products. And in places, Our Daily Meds reads like MTV on paper, with too many jump-cuts and abrupt transitions from anecdote to anecdote without enough critical analysis. But for general readers, this is a fascinating introduction to one of the most powerful industries of our time.

It's hard to imagine what the endgame will be for the era of the blockbuster drug. Having built up Wall Street's thirst for the profits that blockbusters bring, drug makers are now in a sticky spot. Without investing more in R&D, companies don't have much hope of finding new blockbusters. But no company can abandon its marketing strategy and put its money back into research without jeopardizing the sales of its current drugs. Some drug company analysts foresee a day when the federal government will fund the clinical research that's necessary to get drugs approved, and companies will be reduced to manufacturing and selling them.

That might or might not be a good idea, but until pharma kicks its marketing habit, Petersen offers patients useful suggestions for avoiding harm. She recommends that before we head to the pharmacy, we ask our doctors if there is valid evidence that patients like us will benefit from taking a particular medication. We should always inquire about side effects. Better yet, we ought to be looking for ways to improve our health without a prescription. ·

Shannon Brownlee is a senior fellow at the New America Foundation and author of "Overtreated: Why Too Much Medicine is Making Us Sicker and Poorer."