Diagnosis

Legal Drug-Pushing: How Disease Mongers Keep Us All Doped Up

By John-Manuel Andriote  http://www.theatlantic.com

y manipulating our fear of suffering and death, big pharmaceutical companies are able to keep us coming back for expensive medications.

Paul Matthew Photography/Shutterstock

Pharmaceutical giants, like small-town pizza parlors, have two options for making more money: convince regulars to buy more of what they obviously like, or find ways to persuade more people that they will be happier with this drug or that thin crust with extra cheese.

In the case of the drug companies, it's not our taste buds they're appealing to. Instead, they market prescription drugs directly to consumers -- a practice legal only in the United States and New Zealand -- by, basically, manipulating our fear of suffering and death.

These "disease mongers" -- as science writer Lynne Payer in her 1992 book of that name called the drug industry and the doctors, insurers, and others who comprise its unofficial sales force -- spin and toil "to convince essentially well people that they are sick, or slightly sick people that they are very ill."

Changing the metrics for diagnosing a disease is one reliable technique. Dr. Adriane Fugh-Berman, associate professor of pharmacology and director of the industry watchdog group PharmedOut.org at Georgetown University School of Medicine, pointed to how the numbers used to diagnose diabetes and high cholesterol have been lowered over time. "The very numbers we use have been reduced to the point of absurdity," she said. "120/80 was considered normal blood pressure; now it's considered 'pre-hypertension.'"

Entirely new diseases can be, and have been, invented to extend a manufacturer's patent on a highly profitable drug. Fugh-Berman said Eli Lilly stood to lose a lot of profits once the patent expired on its hugely popular antidepressant Prozac. "So they positioned this new condition, PMDD (Pre-Menstrual Dysphoric Disorder), and then went to physicians and the FDA with their highly paid experts who said PMDD is a tragic disease, and they got approved for Sarafem, the same drug. It's an on-label use for a repackaged drug; they created the disease and then got a drug re-approved that was going off patent."

You may not need chemical enhancement for the E.D. or the baldness. The best remedy for both may be to reexamine your beliefs about why hair or hardness are so important.

Just how sly a move was it? "If I as a physician write a prescription for Prozac 20 mg," Fugh-Berman said, "the pharmacist can substitute fluoxetine, the generic. If I write a prescription for Serafem, they can't substitute another drug."

A TEXTBOOK CASE

Dr. Leonore Tiefer, a noted sexologist and associate clinical professor of psychiatry at New York University School of Medicine, said the 1998 approval of Viagra for "erectile dysfunction" -- formerly known as impotence -- created a "sea change" in the field of urology. "It was like being sucked into a very medical model and treatment orientation," she told me.

People immediately started asking about Viagra for women. As it was doing for men, Tiefer said that, as a feminist, writing about women, "I knew what would happen if there was a Viagra for women -- the isolation of the function from the person, the isolation of the genitalia from the rest of the body."

The only way to redefine "what a woman wants" -- and build a case for a drug to "treat" it -- was to turn "it" into a medical condition. Without widespread agreement on its definition, pathophysiology, or clinical manifestations, Female Sexual Dysfunction (FSD) was created. Tiefer called the development of FSD "a textbook case of disease mongering by the pharmaceutical industry and by other agents of medicalization."

With Pfizer's 2011 U.S. Viagra sales pushing $2 billion, and Eli Lilly's Cialis catching up, the booming "enhancement" market suggests that either there has been an extraordinary uptick in male impotence -- or that Pharma has convinced multitudes of men that erectile dysfunction, "E.D." for short, has reached epidemic proportions (40 percent of men are allegedly "at risk"), and drugs are the only solution.

It pains to think of the men who aren't ready when the moment is right as a result of taking Propecia to "treat" another natural effect of aging nearly as widespread among men as occasionally uncooperative equipment: male pattern baldness, or, in medicalese, alopecia.

The fact is you may not need chemical enhancement for the E.D. or the baldness. The best remedy for both may be to reexamine your beliefs about why hair or hardness are so important. A shot of redefined meanings can do wonders to restore normal functioning.

THE MEDICAL INDUSTRIAL COMPLEX

Australia-based journalist and disease-mongering researcher Ray Moynihan, author of Selling Sickness, said in an email, "We seem to be living through the most extraordinary paradox: We have never been healthier, yet we seem to consider ourselves sicker and sicker than ever. Mild symptoms, inconvenience, being at low-risk, aging, human life, and death, are rapidly being medicalized."

No other medical specialty has turned more aspects of human life into diagnoses than psychiatry. Not coincidentally, no other medical specialty shares a cozier relationship with the pharmaceutical industry -- its resources flowing lavishly through conference and continuing medical education (CME) funding, medical research support, and generous contributions to patient advocacy groups happy for the donations and glad to endorse a drug if it will help others.

Dr. Marcia Angell, the editor of the New England Journal of Medicine for more than 20 years, in a two-part 2011 essay in the New York Review of Books singled out psychiatry for its "subjective and expandable" diagnostic categories. She noted that in the fifth edition of the American Psychiatric Association's Diagnostic and Statistical Manual (DSM-V), to be published in 2013, "diagnostic boundaries will be broadened to include even precursors of disorders, such as 'psychosis risk syndrome' and 'mild cognitive impairment' (possibly early Alzheimer's disease)."

As Angell said, "It looks as though it will be harder and harder to be normal."

ARE YOU BEING OVERDIAGNOSED?

Two doctors, a husband and wife team, both medical professors at the Dartmouth Institute for Health Policy and Clinical Practice, have warned for years in major medical journals that direct-to-consumer advertisements of prescription drugs have created an overly medicalized and over-drugged culture.

Dr. Steven Woloshin and Dr. Lisa M. Schwartz, co-authors of Know Your Chances and Overdiagnosed: Making People Sick in the Pursuit of Health, said in an interview that people need to know about a drug's potential benefits and harms -- in detail. "People need to ask, what is this going to do for me?" Schwartz said. "How likely is it that taking this drug will help me, and by how much? And what are the side-effects? How likely are they? Are they dangerous? Bothersome?"

Woloshin said consumers deserve to know, as specifically as possible, what clinical trials have revealed about a drug. "What percentage of people taking this cholesterol medication had a heart attack vs. the percentage who had a heart attack taking placebo. That's what you want to look for: What is my chance of having a good or bad thing come from taking the drug?"

Woloshin and Schwartz have long advocated for the FDA to require drug facts boxes for prescription drugs: short summaries of benefits and side-effects inspired by the nutrition facts boxes on food packaging. In a July 4, 2011, commentary in The New York Times, the pair noted, "The only way to truly know a drug's benefit is by seeing data from randomized clinical trials of people, data that may be very hard to find."

Otherwise, Woloshin explained, the manufacturer "may exaggerate. For example, just present what is found in the drug group and not the placebo group. It's to make the benefit seem big by saying 'twice as many' improved on the drug when in fact only two percent improved with the drug vs. one percent with placebo."

WHAT'S A BODY TO DO?

"Sadly," Ray Moynihan said, "it is very difficult to work out what is valuable information and what is misleading marketing disguised as news or scientific information -- particularly on television, but also in other media, including, of course, the Net." He recommends finding "reliable independent sources and go[ing] to them when you need to." He suggested the Cochrane Systematic Reviews and Consumer Reports, and the Therapeutics Initiative in Canada as good choices.

"Follow the money," advises PharmedOut.org director Fugh-Berman. "You want to trust sources of information that aren't industry paid." She recommends seeking information from advocacy organizations, media, and other sources that don't take drug money. "If you look at what these groups are saying about therapies and treatments and compare it to what groups that are taking money from pharmaceutical companies are saying, they're different," she said.

Some reformers call for government regulators to prohibit all direct-to-consumer advertising of prescription drugs. Others see the need for multiple parties to accept their role in resisting the disease mongers. "I think the responsibilities are distributed equally and include those contributing to the culture of society -- artists; writers, including journalists; film makers; etc.," said Dr. Iona Heath, president of the Royal College of General Practitioners, in London, via email. In a follow-up, she added, "I don't want to be seen to be offloading the medical responsibility for putting our own house in order in relation to pharma funding for both research and education. I also deplore DTCA."

A leading critic of disease mongering, Heath believes doctors must stop accepting pharmaceutical money for things like conferences, continuing medical education, and speaking engagements. But simply swearing off Pharma support won't solve the problem of overdiagnosis and the corresponding overprescription of drugs.

Heath said in her Harveian Oration, delivered to the Royal College of Physicians on October 18, 2011, that the root of the problem -- the reason disease mongering works -- is the mind-body split in medicine. She said doctors need to be students of what she calls "the biology of biography" -- the impact on health of trauma, poverty, racism, violence, and the hurtful things human beings do to one another. "When symptoms rooted in a traumatic and damaging biography are treated as biotechnical problems," she said, "medicine has an alarming tendency to cause more harm than good."

Many of us don't get to "the causes of the causes" of our illnesses and malfunctions. We learn to adjust and accommodate. Others of us learn to attach different meanings to the medical labels imposed on us so that we can live in relative peace with what may be a stigmatizing diagnosis.

Still others are content simply to medicate what may well be the symptom of an underlying condition. Out of sight, out of mind. Exactly as the disease mongers need it to be.