Selling Sickness

How the World's Biggest Pharmaceutical Companies are Turning us All into Patients

Wednesday, October 18, 2006

Selling Sickness, the book...

Friday, January 27, 2006

Book Review: the Lancet

An ill for every pill
Anne Harding

Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients
2005
Ray Moynihan and Alan Cassels


There's something very wrong here, I thought, my feverish 2-year-old in my lap, as we sat in a paediatrician's dingy waiting room one afternoon. Not a single intact children's book to take my son's mind off his misery, but plenty of colourful displays freshly stocked with glossy brochures touting drugs for attention deficit hyperactivity disorder (ADHD).

You'll see this sort of thing in almost any doctor's office in the USA?Zoloft clocks, Paxil pens, peppy pamphlets advising you to ?take charge of your health? by asking your doc about this or that medication?all of it much newer than the magazines on offer. And as Selling Sickness shows, this is just the tip of the iceberg. Beneath the surface, there's some much more sophisticated salesmanship going on.

Ray Moynihan, a journalist, and Alan Cassels, a policy researcher, describe in ten chapters?each one about a different ?sickness??how the pharmaceutical industry has pushed to widen diagnoses for various conditions, and even in some cases create them, so more people will take the drugs they sell. Given its lax regulations on drug marketing, the USA figures heavily in the book, but the authors' focus is global.

The book opens with a quote from the former head of Merck, who candidly told Forbes Magazine 30 years ago that he dreamed of being able to ?sell to everyone? by making drugs for healthy people. Using a dazzling array of techniques, and plenty of cash, the industry has come a long way toward making this dream a reality.

Enlisting doctors?from free pizza for medical students to thousands in consulting fees to physician ?opinion leaders??is an essential part of the strategy. But the key is to convince as many people as possible that they need a drug. To accomplish this, the industry creates ?patient advocacy groups?, complete with web sites; launches education campaigns for patients; and enlists celebrities willing to ?share their stories?. What these celebs don't share is that they're getting paid. Media outlets often take the bait, doing their part to raise awareness of these so-called diseases.

Moynihan and Cassels interview physicians free of drug industry influence fighting to get the word out to patients that they may not need a pill for every ill?or as one puts it, ?an ill for every pill.? And the authors close by citing what they see as two hopeful examples: the journal PloS Medicine, which takes no drug industry advertising and doesn't run pharma-funded studies, and the American Medical Student Association, which urges members to eschew free lunches from pharma and all that entails. Let's hope that by the time my son is old enough for ADHD drugs these forces prevail.

Thursday, January 12, 2006

Book Review: BC Medical Journal

Book reviews

Selling Sickness. By Ray Moynihan and Alan Cassels. Vancouver: Greystone Books, 2005. ISBN 1553651316. Hardcover, 272 pages. $32.95.

This book is a must-read if you or your patients are concerned about the way the prescription drug business works. If you have wondered why the cost of medications in our system has gone from half to more than the cost of physician services over a decade, you’ll find some answers here. The writing style is journalistic without being sensational, has well-supported observations, and is an easy read.

There is a strong British Columbia connection since Mr Cassels is a drug policy researcher at the University of Victoria whom many of us have met or heard speak on drug issues. Some of the examples given in the book are very familiar, including references to activities of the Therapeutics Initiative, the work of some BC physicians, and several Pharmacare initiatives. Mr Moynihan is an Australian medical journalist who has written in the Lancet and the New England Journal of Medicine.

The focus is on the myriad avenues through which “big pharma” constantly influences every facet of medication use—marketing, regulation and policy, upward cost pressures, research, guideline development, and the seduction of physicians with money, peer pressure, prestige, and trinkets.

Serious questions are raised that our profession should be asking itself about the reluctance to establish stronger ethical boundaries with the pharmaceutical industry, regulation of financial relationships with sellers, acceptance of financial incentives, and frank conflict of interest. Material is drawn from several countries’ experiences and it reveals the cost of shrinking government support for research and evaluation; it leaves drug development to an industry that aims to fund only what might increase sales.

The chapter titles are descriptive: Selling to Everyone (Cholesterol, the Ads), Working with Celebrities (Menopause and the Public), Making Risks into Medical Conditions (Blood Pressure), Advertising Disease (Premenstrual Dysphoric Disorder), Taming the Watchdogs (IBS and the FDA), and so on.

The information in this book confirmed many things I had suspected. Physicians reading this book should recognize big pharma’s influence on the provision and cost of services and increased testing and office visits. The overlap from consumer advertising in the United States to the Canadian system and the number of patients sent to physicians’ offices specifically to request products they have been “sold” are further evidence of the industry’s sway.

The impact of siphoning billions of dollars away from other service needs, including physician services, and how we as a profession play a role in the uncontrollable rise in pharmaceutical costs are examined.

This is a timely book and I recommend it to anyone concerned about the bigger picture in health care. It makes clear that leaving our fate to the marketplace is risky and expensive and not necessarily a good thing for our patients’ health or our health care system.

—David Blair, MD
Victoria

Tuesday, November 29, 2005

Book Review: Victoria Times Colonist

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When sickness is profitable, there's a problem
by Penny Draper

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Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients by Ray Moynihan and Alan Cassels; Greystone Books, 241 pages, $32.95

Feeling fatigued? Stressed? Anxious? Chances are there is a disease specially designed to fit your symptoms. And there's somebody out there who will sell you the drug to go with it.

Selling Sickness, by Ray Moynihan and Alan Cassels, is a meticulous study of the methods used by big drug companies to market diseases and sell them to healthy people. It's a scary book. The authors use common conditions such as high cholesterol, high blood pressure and osteoporosis to describe the techniques used by pharmaceutical companies to sell their wares to an ever-growing segment of the population. Whether they are selling drugs or fear is debatable; the only surety is that when healthy people are turned into patients, huge profits can be made.

The book is divided into 10 chapters, each devoted to a "condition," which is then attached to a marketing scheme. The section on high cholesterol, for instance, focuses on the conflict of interest that exists between the drug companies, the doctors and the organizations responsible for drug safety.

The section on social anxiety disorder (sometimes known as shyness) reflects upon the ethics of positioning a "neglected disorder" in the marketplace to create a demand even before the drug treatment is approved for use, and certainly before the addictive properties of the drug are publicly known.

In another chapter, menopause ceases to be part of the natural aging process and becomes a curable deficiency disease.

Other chapters talk about the use of paid celebrities to popularize disease, the invention and branding of diseases, flawed science, suppressed reports, statistical gimmicks, lifestyle drugs and even "astro-turfing," which is described as the creation of fake grassroots movements.

The authors prevent the book from becoming a horror story by asserting that most of the drugs profiled do indeed help some people. But the same drugs can become dangerous when prescribed to people who don't need them. Are drug companies filling "an unmet need" or "meeting an un-need"?

When faced with the fact that the United States spends $25 billion annually on drug marketing, one has to wonder what else that money could be doing.

One of the most interesting aspects of this book is its Canadian perspective. Alan Cassels is a drug policy researcher at the University of Victoria. He interprets the largely U.S.-based information, explaining the potential consequences here at home and raising questions like the potential effect over-prescribing has on a public health care system.

At times the book becomes repetitious, each chapter offering still more examples of the same nasty business. There are numerous citations, with no less than 40 pages of footnotes. For those who generally avoid the small print, be aware that in this book it's fascinating and well worth the effort. Check out some of the websites, links and articles listed in the footnotes and the depth and breadth of the research becomes evident.

The book may look like a textbook, but it reads easily.

Selling Sickness is "offered as part of an ongoing conversation ... to promote a more rational and informed public debate about human health...." In that it succeeds. No answers to the problem of big pharma are offered. But good questions are raised, questions I'll be asking when I next visit the doctor.

Penny Draper is a Victoria writer.

OTHER BOOKS OF INTEREST

Bitter Pills: Inside the Hazardous World of Legal Drugs by Stephen Fried; Bantam; $21

Journalist Stephen Fried's investigation of the international pharmaceutical industry is a personal take on the issue, begun after his wife had a severe reaction to a new antibiotic. It includes an appendix of adverse drug reactions.

Profit is Not the Cure: A Citizen's Guide to Saving Medicare by Maude Barlow; McClelland & Stewart; $21.99

Barlow raises the issue of medical profit as part of the debate over private/public health care systems.

Why We Get Sick by Randolph M. Nesse and George Williams; Vintage; $21

Nesse and Williams's older but still interesting book explores why humans are vulnerable to disease from a Darwinian point of view. He postulates that knowing why we become ill could help us decide if a pill will help -- or hinder -- our recovery

Tuesday, November 22, 2005

The marketing of Depession: Montreal Gazette

Women rely more on antidepressants, report finds
Prescriptions up 73 per cent in 4 years. Researcher blames increased
marketing of new drugs for emotional disorders

CHARLIE FIDELMAN
The Gazette
Tuesday, November 22, 2005

A majority of Canadian women seeking medical help for emotional problems
are leaving their doctor's office with a prescription for an antidepressant, a new study shows.

"Women are prescribed twice as many psychotropic drugs as men," Vancouver-based health policy researcher Jane Currie said yesterday. "Clinical trials results show these drugs have risks and we don't know what the long-term effects are."

A new class of drugs called selective serotonin reuptake inhibitors are being sold for a wide range of symptoms from anxiety, panic, shyness and insomnia to premenstrual syndrome and compulsive shopping, among other complaints.

Prescriptions jumped to 15.6 million in 2003, up from nearly 9 million in 1999, making depression the fastest-rising diagnosis in doctors' offices.

Two-thirds of users are women, Currie pointed out.

"The prevalence has skyrocketed," said Currie, who draws a link between an epidemic rise in emotional disorders and the marketing of drugs designed to treat these conditions, which are increasingly understood as "a biological phenomenon."

"It's a strange correlation that this has happened since the drugs have come on the market," Currie said, starting with the popular Prozac in the 1980s.

Women and Health Protection, a national working group funded by Health Canada, commissioned the study, titled the Marketization of Depression: Prescribing SSRI Antidepressants to women.

"There's a strong concern that more and more women are being put on them for reasons that are questionable and it's not the best use of health-care dollars," the group's co-ordinator, Anne Rochon Ford, said.

Widespread use of antidepressants among women reflects the fact that more women than men use the medical system.

That's the classic but cliche view that "women go to their doctors and men drink," Rochon said, when the problem is what is being classified as depression.

"The definition of depression is an elastic thing that has expanded to ridiculous proportions," Rochon said. "We've become a nation that pops a pill for just about anything."

Like Valium and an earlier generation of antidepressants, these drugs have always been heavily prescribed to women, Shree Mulay, director of the McGill Centre for Research and Teaching on Women, said.

"We have every reason to be concerned," Mulay said. Not only are "social problems being treated with medicine, but there's the question of (drug addiction) and side effects."

Health advocates say that non-drug therapies - exercise, nutrition counselling, support and psychotherapy - may be more effective treatment than drugs.

It's not one-size-fits-all in depression, said Remi Quirion, head of the Douglas Hospital Research Centre in Verdun.

"I'm totally convinced the increase in diagnosis is because there's less and less stigma associated with depression and other forms of mental illness," Quirion said. "Depression is a brain disorder that can be treated with SSRI or with psychotherapy, but it must be treated.

"I think it was vastly underdiagnosed before," he added.

But Alan Cassels, drug policy researcher at the University of Victoria and co-author of Selling Sickness, How the World's Biggest Pharmaceutical Companies are Turning Us All Into Patients, said the impact of marketing on therapy is undeniable.

Many people lead hectic, stressful, difficult lives, juggling careers, caring for children and aging parents, Cassels said.

"But does that mean you have a serotonin imbalance in the community? Instead of changing the social environment, we are modifying the chemical environment with drugs."

For Currie's report on the web: www.whp-apsf.ca/en/index.html

cfidelman@thegazette.canwest.com

(c) The Gazette (Montreal) 2005

Sunday, November 20, 2005

Pharmaceuticals and the push to pop: Ottawa Citizen

Shelley Page

A new book argues that drug companies are redefining what it means to be 'healthy,' turning us all into patients and pilltakers

The big guns of cardiology met this week at the American Heart Association and discussed the future of statins, cholesterol- lowering drugs that are the bestselling pills on the planet. Studies released there suggest that while statins have worked well in fighting bad cholesterol, known as LDL, beyond a certain point the benefits may be slim. Experts suggested drug companies should focus on finding drugs to push up good cholesterol, HDL.

If LDL encourages dangerous plaque to build up and clog artery walls, HDL clears away the plaque. What if a new class of drugs could increase the so-called "good" cholesterol?

The question, posed to a new generation of researchers, should be greeted with some skepticism. Reducing heart attacks and heart disease is crucial, of course. But while statins were becoming the most popular drugs in history, pharmaceutical firms were changing our very definitions of health. Almost at once, people formerly considered healthy were popping one pill or another.

In fact, the authors of a new book titled Selling Sickness argue that drug companies are turning all of us into patients. So while the cardiologists were meeting in Dallas, Alan Cassels and Roy Moynihan were voicing their concerns about the ways drug companies are widening the net of illness, until formerly healthy people have been redefined as sick.

Mr. Cassels, a drug policy researcher at the University of Victoria, and Mr. Moynihan, an Australian health-care journalist, focus on the push to make people pop statins, which generate revenues of more than $25 billion a year for their manufacturers. Canadians gobbled up $1.6 billion worth of statins last year alone.

In 2003, for example, AstraZeneca was poised to launch Crestor, its newest cholesterol-lowering drug. It was a controversial announcement because the drug was said to have double the side- effects of other such drugs. Still, fortune seemed to smile on the big pharmaceutical company.

Dr. Bryan Brewer, a giant in the cholesterol field, was raving about the drug. The senior official with the publicly funded National Institutes of Health told a meeting of the American Health Association that the drug was safe and effective.

His comments were later published in a special supplement of the American Journal of Cardiology, a journal released just as Crestor hit the U.S. market.

The authors question Dr. Brewer's ties to AstraZeneca. Turns out he was one of AstraZeneca's paid speakers. Not only was his seminar and journal supplement financed by AstraZeneca, "so too was Dr. Brewer, though his links were not disclosed in his article in the journal supplement."

Congress hearings would eventually reveal Dr. Brewer received $200,000 U.S. a year from "outside private interests including drug companies, while holding down his position as branch chief at the government's NIH," write the authors.

Before 1987, there wasn't a single statin on the market. Then Merck launched Mevacor, which was seen as a valuable option for people with heart disease. Since then, more and more statins have been developed, including Pfizer's Lipitor, the world's top-selling prescription drug -- ever.

The authors show how the definition of high cholesterol has been regularly broadened to relabel more and more healthy people as sick, thus creating a broader group of patients who could be targeted with drug therapy.

It's certainly possible that, in fact, more people require treatment than was originally thought. But the authors don't think so, and neither do a growing chorus of independent health-care research groups.

According to cholesterol guidelines from the 1990s, 13 million Americans might have required statin treatment. In 2001, a new panel rewrote the guidelines and the number increased to 36 million.

Then in 2004, yet another panel broadened the guidelines to say 40 million Americans would benefit from taking statins. While these new guidelines were being redrawn, the U.S. -- where, unlike Canada, direct-to-consumer advertising is permitted -- was bombarded with advertising that without statins healthy Americans could die of heart attacks.

Many of those who expanded the guidelines were cosy with the drug companies that would benefit. In 2001, five of the 14 authors, including the chair of the panel, had financial ties to statin manufacturers. In 2004, the "conflicts of interest were even worse."

"Eight of the nine experts who wrote the latest cholesterol guidelines also serve as paid speakers, consultants or researchers to the world's major drug companies -- Pfizer, Merck, Bristol-Myers Squibb, Novartis, Bayer, Abbott, AstraZeneca and GlaxoSmithKline. In most cases, the individual authors had multiple ties to at least four of these companies.

"One 'expert' had taken money from 10 of them," write Mr. Cassels and Mr. Moynihan. The links only became public when they were uncovered by journalists.

In Canada, the guidelines have expanded to include more and more people formerly considered "healthy." Earlier this year, the Canadian Medical Association Journal
reported that new Canadian guidelines have dramatically changed the threshold for "high" cholesterol so that an additional 500,000 Canadians should be taking statin medication -- at a cost of more than $250 million.

Almost all of the increase, according to the CMAJ, consisted of low-risk patients. The number of low-risk people for whom statins are recommended -- if lifestyle modification fails to achieve target lipid levels -- increased tenfold to 595,000 from 61,000. Yet, they reported that the relative benefit of statin therapy for many people in the low-risk group is "incredibly small."

Individuals who have heart disease may reduce the threat of heart attack by five or six per cent over 10 years by taking a statin every day. But there is no good evidence to show statins reduce the chance of premature death in low-risk groups.

Evidence also suggests high-risk individuals are being underprescribed while drugs are wildly overprescribed to low-risk individuals.

Mr. Cassels worries about the long-term consequences, especially because some of these drugs were linked recently to potentially fatal muscle-weakening disease. This summer, Health Canada warned that some of the millions of Canadians taking statins risk developing muscle-related problems that could lead to kidney failure and death.

In an interview, Mr. Cassels said doctors must stop overprescribing drugs to healthy people. He blames the cosiness between doctors and drug reps, who litter medical offices with free samples and misleading information on the benefits of drug therapy.

Mr. Cassels says some health advocacy groups are fighting to force the health-care system to again redefine the boundaries, this time reducing them. One U.S. group is campaigning for an independent review of official cholesterol guidelines.

Mr. Cassels acknowledges that many might shrug, asking what harm an extra pill a day can do. Look at the big picture, he urges. The $250 million it costs to put low-risk patients on statins could go to reducing waiting lists or buying more useful services from doctors.

Shelley Page's Second Opinion column on health-related issues runs weekly.

She can be reached at spage@thecitizen.canwest.com

Wednesday, October 05, 2005

Book Excerpt: The Nation

THE NATION

A Disease for Every Pill

by RAY MOYNIHAN & ALAN CASSELS

[from the October 17, 2005 issue]

An anonymous woman tries to disentangle a shopping cart from an interlocked row of them, outside a suburban store. She is frustrated and angry. She becomes even more exasperated when another shopper enters the frame, calmly unhooks a cart and glides smoothly on her way. Watching this TV advertisement unfold, it might look like the woman is experiencing little more than a normal bout of tension or stress. But the folks at the drug company Lilly know better. This woman may need a powerful antidepressant because she is suffering from a severe form of mental illness known as PMDD. "Think it's PMS? It could be PMDD," intones the voiceover.

Columbia University Professor Jean Endicott tells us premenstrual dysphoric disorder (PMDD) is a psychiatric condition suffered by up to 7 percent of women. Paula Caplan of Brown University claims that the condition has essentially been invented and that there is no strong scientific evidence to distinguish it from normal premenstrual difficulties. Even worse, argues Caplan, using a medical label to explain away the severe distress some women experience in the lead-up to their period runs the risk of masking the underlying causes of their suffering.

In the United States, the Food and Drug Administration has accepted that the condition PMDD exists and has approved Lilly's Prozac and several similar antidepressants for its treatment, yet in other parts of the world it is not even a recognized disease. It is not listed as a separate disorder in the World Health Organization's International Classification of Diseases. And even in the United States, despite the hard work of Endicott, Lilly and other pharmaceutical companies, PMDD still has only a partial listing in the psychiatrists' manual of diseases, the DSM, and is therefore not seen as a fully official category of illness.

Yet this scientific controversy is invisible in the avalanche of television and magazine advertisements about PMDD in the United States--much of it targeting young women. The $500 billion pharmaceutical industry has identified another new mega-market--women of childbearing age--and the world of marketing demands simple, clear messages. The emotional ups and downs preceding your period are no longer a part of normal life--they are now a telltale sign you could have a psychiatric condition. As Caplan puts it, by watching these ads "women are learning to consider themselves mentally ill."

A friendly and hardworking academic, Endicott operates from a small office buried in the basement of a psychiatric hospital in New York City. In stark contrast to Caplan, she insists PMDD is a genuine disorder that can be "very disabling" and is often not properly diagnosed or treated. She welcomes drug company efforts to have the condition taken more seriously. It was Endicott who led the key scientific meeting--funded by Lilly and attended by company representatives--that paved the way for two of the most important developments in the life of this young disorder: FDA acceptance of the condition and approval of Lilly's antidepressant as the first drug to treat it. As to the appropriateness of drug companies advertising disorders like this on television, Endicott is a strong believer. "I think it educates people," she says.

The pharmaceutical industry in the United States now spends more than $3 billion a year on direct-to-consumer advertising, promoting its most lucrative brands. Increasingly, however, these commercials are not just selling drugs but also the diseases that go with them. The shopping-cart ad for PMDD is part of a new form of TV advertising designed to introduce millions of people to previously unheard-of conditions. While the advertising claims made about the benefits and risks of medicines are regulated by law--albeit very loosely--claims about diseases remain a virtual free-for-all.

The story behind the "discovery" of PMDD illustrates how an unknown, unofficial and, for some, unreal condition can be pushed from the back pages of the psychiatrist's manual into glossy magazines and onto TV screens. In the late 1990s Lilly's antidepressant Prozac--whose chemical name is fluoxetine--was about to lose its patent, and the manufacturer stood to lose hundreds of millions of dollars because of the emergence of cheaper generic competitors. Winning approval of the drug for a new disease might re-energize sales of this blockbuster chemical.

In late 1998 Lilly helped fund a small meeting, impressively titled a "Roundtable" of researchers, which discussed PMDD. The meeting of just sixteen key experts took place in Washington, and it was attended by a group of FDA staff and at least four Lilly representatives. The chair was Columbia University's Endicott, who had by then been pushing for the acceptance of this disorder for more than a decade. This time, though, Endicott had a giant pharmaceutical company on her side.

The meeting reached two important conclusions, both highly favorable to Lilly: There was now an alleged consensus that the disorder existed, and most people present thought there was sufficient evidence to support the use of antidepressants like Prozac to treat it.

By Christmas of 1999 a meeting of advisers to the FDA had voted unanimously to approve Lilly's fluoxetine for the treatment of PMDD. Soon after, the FDA formally gave Lilly the green light to market its drug for PMDD, and Lilly organized a launch to do just that. But in an extraordinary turn of events, the pill did not debut under the name Prozac. After doing some market research with doctors and potential patients, Lilly decided to repaint Prozac in attractive lavender and pink and rename it Sarafem.

For specialists in pharmaceutical marketing like Vince Parry, the story of PMDD and Sarafem is a great example of a company "fostering the creation of a condition and aligning it with a product." He worked for Lilly on the campaign, which he describes as helping to "build awareness for both the condition and the drug." To kick it off, he says, the company sponsored a "pre-launch initiative" to raise awareness of the condition. "By changing the brand name from Prozac to Sarafem--packaged in a lavender-colored pill and promoted with images of sunflowers and smart women--Lilly created a brand that better aligned with the personality of the condition for a hand-in-glove fit." Lilly's market research investigated how best to brand both the drug and the condition to come up with language women felt most comfortable with.

Lilly's shopping-cart commercial duly followed and provoked a complaint from the FDA alleging that the ad was "lacking in fair balance" because it minimized information about the drug's side effects. In the end, the FDA simply asked Lilly to withdraw the offending ad. This is typical. Despite repeated violations across the industry, and tens of millions of Americans being regularly exposed to misleading information about the risks and benefits of widely prescribed drugs, companies are rarely fined and executives are not held accountable.

Another theme has recently emerged in pharmaceutical industry advertising. Researchers are finding more and more ads helping to sell the idea that everyday human experiences are symptoms of medical conditions requiring treatment with drugs. Together with colleagues, two doctors from Dartmouth Medical School, Steven Woloshin and Lisa Schwartz, recently analyzed some seventy drug company ads in ten popular magazines. They found that almost half tried to encourage consumers to consider medical causes for their common experiences, most often urging them to consult a physician. The ads targeted aspects of ordinary life including sneezing, hair loss and being overweight--things many people could clearly manage without seeing a doctor--and portrayed them as though they were part of a medical condition. The researchers speculated that advertising was increasingly medicalizing ordinary experience, and pushing the boundaries of medical influence far too wide.

Watching these trends closely is Canadian researcher Barbara Mintzes, who included in her PhD thesis at the University of British Columbia in Vancouver a rigorous examination of drug company advertising. She also discovered that many ads now promote medical conditions, rather than just drugs, and are helping to medicalize life, as she puts it. "To an unprecedented degree they portray the educational message of a pill for every ill--and increasingly an ill for every pill. It's a shift from a drug that's approved to treat people who are actually suffering from an illness to the idea that you just take a pill to deal with normal life situations."

Mintzes is particularly outraged by the promotion of PMDD, which has been aggressively advertised in magazines read by teenagers, as well as in TV commercials. In her view it seems designed to make younger women feel there is something wrong with the normal emotional fluctuations they experience in the lead-up to their monthly period. While accepting that for some people the problem can be severe, Mintzes worries that the ads paint a shallow picture of what it means to be a young woman. "There is pressure on people to be someone other than who they are."

With all treatments there is a balance between benefits and harms. For someone who is very sick, the chances of a great improvement may easily outweigh the risks of side effects from a drug. The antidepressants like Prozac that are being prescribed for PMDD carry many side effects, including serious sexual difficulties, and for teenagers an apparent increase in the risk of suicidal behavior. Such risks might be worth taking for someone severely debilitated by chronic clinical depression, but for a woman arguing with a boyfriend or frustrated by a shopping cart?

"When you're giving drugs to healthy people you're shifting the balance," says Mintzes. "If you're already healthy, the likelihood of benefit becomes much, much smaller, and then there's a concern that what we are actually doing at a population level is causing much more harm than benefit through drug treatment."

Professor Endicott bluntly rejects the concern that PMDD is an example of ordinary life being medicalized. "It's an insult to suggest that women with less severe symptoms would even be seeking treatment. Women are not running around saying, Give me a pill for everything."

Finding hard scientific evidence to help settle this difference of opinion is difficult. Mintzes's research has added to a body of studies suggesting that these ads do drive many people into doctors' offices, and that some doctors will prescribe the advertised drugs even when they may doubt their appropriateness for the problem at hand. But there have been few, if any, large studies that rigorously investigated whether direct-to-consumer advertising causes unnecessary medical labeling or leads to inappropriate or harmful prescription of drugs. What is crystal clear, however, is that the ads boost drug sales.

Industry executives argue that the most powerful case for direct-to-consumer advertising is evidence of underdiagnosis and undertreatment among people with serious health problems, including high cholesterol, high blood pressure, depression and, presumably, PMDD. In a special issue of the British Medical Journal devoted to the topic of medicalization titled "Too Much Medicine?" two senior officials from the drug company Merck wrote that the rules governing drug advertising should be loosened in Europe to help fix the urgent problem of undertreatment. They claimed there was little good evidence to support the view of Mintzes and others that advertising leads to inappropriate prescribing or harm: "Unfounded fears" about advertising, they wrote, were restricting people's rights "to have all the information they need to make informed choices about their health."

One of the weaknesses in this argument is the failure to acknowledge the controversy and uncertainty surrounding the definitions of the common conditions said to be massively underdiagnosed. If estimates of the numbers of people suffering from these conditions and requiring treatment are inflated to start with, as some observers consider to be the case with high cholesterol and depression, for example, then claims of widespread undertreatment deserve to be taken with extra-large doses of scrutiny and skepticism. With PMDD, claims of underdiagnosis and undertreatment make little sense if the condition itself doesn't even exist.

There is little doubt that many people in genuine need are not getting the medical attention or medication they require, particularly among the poor of wealthy nations and the wider developing world. Whether spending billions advertising disorders like PMDD on television and in women's magazines is the best way to correct that problem is highly questionable. Undertreatment may often have more to do with lack of money or access than lack of information. And as to the claim that advertising is the best way to inform, educate and encourage more choice, the deputy editor at the Journal of the American Medical Association, Dr. Drummond Rennie, disagrees. "Direct-to-consumer advertising," he says, "has got nothing to do with the public's education and it has got absolutely everything to do with...boosting product sales."

Postscript. In Europe Lilly's marketing of Sarafem/Prozac came to an abrupt stop. In mid-2003 a panel from the European Agency for the Evaluation of Medicinal Products noted that "PMDD is not a well-established disease entity across Europe.... There was considerable concern that women with less severe premenstrual symptoms might erroneously receive a diagnosis of PMDD resulting in widespread inappropriate short- and long-term use of fluoxetine."


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Thursday, September 29, 2005

"Selling Sickness" is worth reading

'Selling Sickness' is worth reading
Thursday, September 29, 2005
By Nancy Norkiewicz/Get the Beat, The Star

http://www.starnewspapers.com/star/spsports/smix/292sx4.htm

OK, so I admit it. I'm one of those people who doesn't even consider taking an aspirin until my head feels like it's about to explode. So when I sat down to watch a movie the other night on television I was totally blown away by the seemingly endless array of drug advertisements being pitched to consumers. More than that, it seemed as though some of the medical conditions were completely far-fetched, or possibly even made up.

Now, I don't normally watch a lot of TV, but I'm certain the last time I did there wasn't nearly the volume of commercials designed to entice people into believing that they have one or more of the new medical conditions that there are now. If you think that I'm being overly skeptical then you should know I'm not the only one suspicious of this overmedication of America. In researching this specific topic I came across a new book written by award-winning medical writer Ray Moynihan and drug policy researcher Alan Cassels.

The book, entitled "Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All into Patients," takes a closer look at our nation's growing obsession and reliance on "lifestyle" medications. In their words, the big pharmaceutical companies are trying to trick us into believing that we all have certain diseases and that the drugs they sell are the only answer to these problems.
Now, don't get me wrong. I'm all for medications that help people with illnesses that can be controlled or improved with medication. Think how far we've come in terms of treatments and medications for some of the most serious diseases and disorders. Many people would not be alive today if it weren't for the advancements we've made in the field of medicine. But making conditions seem far worse than they really are and stretching the symptoms to include the largest possible demographic group of potential users is ludicrous and just plain wrong.

My family physician is outraged at the strong messages that are being sent to consumers. He gets calls all of the time from patients who learn about a certain condition on television, convinced that they have the disease because they may appear to have one or more of the general symptoms described on a commercial. It probably has something to do with the way Americans have come to rely on the quick fix, seeking out a pill for every little discomfort. So, what's a suspicious consumer to do? How can you determine if a claim is legitimate or not, and if applies to you or your loved ones?

For starters, experts recommend asking lots of questions before agreeing to accept a prescription. Make sure you know the specifics of certain conditions and what medications are recommended for it. Talk with your physician extensively about the condition to decide if the medication is the best and only option for you. Determine if there are other approaches that can be taken to cure what ails you aside from drugs, such as exercise, diet, stress management, etc. Do some research to see if the medication you are considering taking has been helpful to people with similar characteristics to you such as sex, age, and severity of the condition you are being treated for.

There are several Web addresses that can help you research some of this information. Two of the best are: medicalletter.org which offers in-depth analysis of both new and older medications, and crbestbuydrugs.org which is the Consumer Reports' new site developed to provide consumers like us information about effectiveness of certain drugs.

It's time we take back our health and be more in charge of the medications we end up taking. Don't let sales happy drug companies con you into believing you need a prescription that you really don't. Remember, asking questions and educating yourself is power in that you can work with your doctor to better deal with certain conditions . Because ultimately the purpose of medicine is to benefit the individual consumer, not the individual drug company.

Tuesday, September 27, 2005

Press Release: Voiceprint

Pharmaceutical industry working to expand definition of illness to maximize profit, controversial author tells VoicePrint


Sept. 27, 2005 (Toronto, ON) The pharmaceutical industry is working to expand the boundaries of illness to maximize profit margins, claims the co-author of a new book, Selling Sickness, is the guest on Contact this Sunday on VoicePrint Canada at 6 p.m. Eastern, 3 p.m. Pacific.

“We cannot be careless about how the actual conditions for many healthy people are being created, shaped and designed into conditions which drug treatment might be pushed,” says Alan Cassels, who co-authored the book with Ray Moynihan. Cassels is the guest on Contact this Sunday on VoicePrint Canada at 6 p.m. Eastern, 3 p.m. Pacific.

During the interview with VoicePrint Canada’s Paul Daniel, Cassels discusses how drug companies create the proper sales climate for their products. For example, “social anxiety disorder,” for such things as shyness, was marketed by drug companies before the drug was even introduced to the public. “When that drug was launched, it created a huge pool of desire for this new treatment. Up to that point, we hadn’t heard of anything like social anxiety disorder,” he states.

Cassels says there is a relationship between physicians and the drug industry that needs to be scrutinized more carefully. For example, he believes the idea of doctors getting information on the latest medications from the drug companies along with samples is excessive. “What we see in Canada is spending by drug companies of approximately $20,000 per doctor per year to market drugs. That’s an awful lot of money. That’s more than we spend in all of the medical schools in Canada combined,” says Cassels. The interview can be downloaded from the web site’s Audio Archive.

VoicePrint Canada is a not-for-profit charity established in 1989 to enhance access to printed news and information by 4.4 million vision- and print-restricted Canadians. VoicePrint Canada can be accessed on the Secondary Audio Program of CBC Newsworld; Star Choice, ExpressVu and LookTV audio channels and on the Internet at www.voiceprintcanada.com.

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Wednesday, September 21, 2005

Moderated Web Chat: Washingtonpost.com

Books: Selling Sickness
Alan Cassels
Author
Wednesday, September 21, 2005; 12:00 PM
In the new book, "Selling Sickness: Pharmaceutical Companies Are Turning Us All Into Patients," authors Ray Moynihan and Alan Cassels explore the aggressive marketing campaigns used by large drug companies and how more and more healthy people are turning into patients.

Cassels, a pharmaceutical policy researcher at the University of Victoria, British Columbia studying how clinical research information and experience on prescription drugs is communicated, will be online Wednesday, Sept. 21 at Noon ET to discuss his book.

Washington, D.C.: I think that one of the biggest problems with drug companies is the excessive (and often misleading) advertising with a laundry list of common symptoms and a convincing pitch for an expensive drug. Do you think these ads should be regulated? I think this is part of what is causing the over-medication of many people and spiraling health care costs.

Alan Cassels: They are regulated. Some would argue they aren't regulated well enough. I agree that this is leading to over-medication.
_______________________
Gaithersburg, Md.: Do you think that the "disease" idiopathic short stature was invented in order to sell genetically engineered human growth hormone?
Alan Cassels: Good question which I don't know the answer to. But I will tell you this, if you are trying to sell a treatment for short kid-syndrome, or whatever it's called now, you've got an incredible challenge convincing the parents that their kid is sick and needs a pill. This won't be easy and I imagine many parents wouldn't fall for it. That is not to say some kids won't benefit from a treatment--some will. But does that mean every kid not reaching a certain height by a certain age is sick and needs treatment?
_______________________
Bethesda, Md.: Do drug companies have any kind of industry ethical standards when it comes to advertising their drugs aside from whatever Federal regulations they're bound to?
Alan Cassels: yes they do. But like any industry if those standards are not enforced then they can be conveniently ignored, without penalty. What bothers me is not the advertising of the drug, but rather the advertising of the disease, which has no standards at all (ie: companies standing to gain from your disease being treated with your drug can exaggerate the heck out of the disease. That's what Selling Sickness is about).
_______________________
Arlington, Va.: Mr. Cassels,
Do you think that pharmaceutical companies are focused more on treating illnesses, more profitable, rather than curing them. For years I have heard debates on the subject and I was wondering what your opinion is.
Alan Cassels: In their own words it's more profitable to make drugs for chronic, long term illnesses that have no 'cure' per se. I'd like to see even a small portion of that money keeping people on drugs for such a long time, towards real 'cures' in the classic sense. What we see happening with diabetes is a classic example where long term maintenance therapy is a lot more profitable than a 'cure'.
_______________________
Harrisburg, Pa.: Do we need all these medications? I keep seeing an ad for curing a yellow toenail and then the side effects are mentioned. If I had the side effects, I would rather take medication to get rid of them with a yellow toenail being the side effect. Isn't advertising just creating new things to be fearful of that probably aren't urgent needs for medication?
Alan Cassels: there are more than 20,000 drugs on the market in the US. The World Health Organization keeps a list of "Essential drugs" that any nation needs to provide to its people. Guess how many drugs are on the WHO Essential Drugs List? 306.
As for the toenail thing, my mother took that drug and when I explained the rare but serious side effects she still chose to take it. At the end of the day people need to be fully informed as to a drug's risks and benefits and when they have that information, whether or not they take the drug is up to them.
_______________________
Dayton, Ohio: There was another chat a few weeks ago that's the corollary to this, about anxiety. So many people are searching for a magic bullet that can make them live forever: whether they turn to pharmaceuticals, fad diets, or 'alternative medicine', it's all the same thing. I'm not going to blame the manufacturers too much for seeking to capitalize on demand. I will criticize them for taking prescription medications and lobbying to get them over-the-counter.
Alan Cassels: OTC (over the counter) changes to drug is very complicated. Some might say, why not put a drug over the counter because it is relatively 'safe'? Others say, that a doctor should be mediating your drug treatment. I don't know where I stand.
_______________________
Arlington, Va.: Alan:
Thanks for the discussion and taking my question.
Initially, switching costs from inpatient hospital stays to pharmaceuticals seemed like a surefire way to reduce healthcare spending. Now, it looks like pharmaceutical costs are a major component of health care inflation. Do we need more federally funded studies, like the one released the other day on anti-psychotic drugs, to determine which drugs are wasting money and which drugs are medically effective? If so, what part of the federal government would be most adept at administering the studies?
Alan Cassels: Yes, and we have such federally funded studies. Some of which I work on as well. I know the US government is very interested in funding 'effectiveness' studies. I think it is the AHRQ--the Agency for Research and Quality that is administering such studies and in my opinion, this is a very good use of tax dollars.
_______________________
Anonymous: My impression of the drug business is that it's very hard to be a critic (I'll admit pharma's no different from anything else in this way). Should the government do more to encourage "robust discussions" of drug risks and benefits, etc...?
Thanks.
Alan Cassels: It's hard to be a critic because there are so few of us. Many of those who could stand to be critical of pharma's practices work within the companies, on studies funded by pharma, and so on. They are probably critical in their own, but non-public ways. One thing I will say, because public criticism is often so muted, whenever someone does say something very harsh against the industry, it attracts a lot of attention. Witness David Graham who wanted to blow the whistle on Vioxx but was stifled by his FDA bosses. Yes we need more 'robust' discussions of the properties of drugs, but also properties of diseases...
_______________________
Arlington, Va.: I think I take a more active role in my healthcare due to drug marketing -- I ask my doctor more questions about options. Or is that what the pharmaceutical companies want me to think?
Alan Cassels: Good point. Maybe one of the side effects of drug marketing is that it forces thoughtful people to question their options. I do know, however that in research done on direct-to-consumer advertising (BTCA) of pharmaceuticals, people more exposed to such ads will go and ask for those drugs, by name. And they are more likely to get them, even when their physician thinks that the advertised drug may not be the best choice of treatment. By the way, DTCA is only allowed in two industrialized countries in the world--the US and New Zealand. Every other country has regulated against DTCA because fears that it is not in the public interest to be advertising drugs that your doctor has to mediate.
_______________________
Arlington, Va.: It's easy for drug companies to maximize profits with commercials that play to consumers fears (fear of balding or bedroom performance issues) instead of playing to consumer’s health. The public then gobbles up their pills in order to remain sexy instead of healthy. Meanwhile, real research and funds are not being devoted to meds that will help folks with real long-term health issues. My wife, who has Lupus, is taking medication designed for rheumatoid arthritis. And these drugs have not been improved upon in 40 years. Quite a disparity I would say.
Alan Cassels: agree, those rarer diseases that aren't a real big market for manufacturers get short shrift when pharmaceutical research money is being doled out. What you say about Lupus could be applied to many other 'orphan' diseases. Pity. On the bright side, for even very minor minor complaints, let's say "Sleep disturbances" which are shaping up to be a market of gargantuan proportions--there's tons of drugs you could take to help you sleep. Pharma would argue it's all about consumer choice.
_______________________
Fairfax, Va.: What role does the media play in this? How have mainstream media advertising guidelines changed in this area?
Alan Cassels: Both Ray Moynihan and myself have published in peer reviewed journals (he in the New England journal in 2000 and I in the Canadian Medical Associaion Journal in 2003) on this very topic. We analyzed the media's reporting of drugs in Canada and the US and found some very surprising things, particularly the use of misleading statistics, the lack of coverage of adverse effects or side effects, and the lack of exposure of potential conflicts of interest. As for mainstream media advertising guidelines changing, I don't know. What I can say is that the quality of news coverage of pharmaceuticals is improving because journalists are becoming a bit more savvy on how they are being manipulated.
_______________________
Washington, D.C.: How often do pharmaceutical companies fund disease advocacy groups? Are there any guidelines for focusing their marketing dollars to traditional advertising?
Alan Cassels: How often? the question you need to ask is how often do disease advocacy groups REFUSE funding from pharma companies? The answer to that is "almost never". If you have a disease and want to be out there you need money. And if a manufacturer asks to 'partner' with you and wants to hand over a few hundred thousand, that would surely capture your attention. Having said that there are some very good advocacy groups in the US that are pharma-free, and they provide an incredible public service.
_______________________
Re: critics: I'm writing to follow up on my comment about critics. Something that clued me into this was Marcia Angell's critical book "The Truth about the Drug Companies," which was very good. I don't think there was a single endorsement on the cover, despite her being the former editor of the New England Journal of Medicine. My conclusion was that everyone is bought off or scared within the industry.
Why can't someone who has some relationship with the industry still be critical in a public way?
Alan Cassels: there are some critics within pharma. Look at Dr. Peter Rost, an executive with Pfizer. He has gone very public about the industry's appalling defence of high drug prices and restriction of free trade in pharmaceuticals. But you raise a very good question: why can't people with a relationship to industry be critical? it takes good old fashioned courage to challenge the very industry that may be providing you with a job. In our book you will meet Dr. Michael Oldani, a former drug rep who became an anthropologist, studying the gifting cycle of drug reps and doctors. His thesis is that you can only be really critical once you have severed your ties to the industry.
_______________________
Rockville, Md.: Can you give any historical perspective to this kind of marketing? have they always been this aggressive or was there something in the industry that changed opening the floodgates?
Alan Cassels: Hmmm, there has always been people and companies selling snake oil, with various levels of aggressive tactics and so on. What has contributed to the presence of the current marketing tsunami, in other words, the "perfect storm" has been media concentration (less critical voices on our airwaves), pharma success (billions of new dollars to fund new ways to turn you into a patient plus a pathological need to provide blockbuster profits for investors) and cultural acceptance (at one level we WANT a pill for every ill, and seek instant gratification and immediate solutions to our health problems). What has changed? Primarily the volume and tempo of the marketing.
_______________________
Washington, D.C.: The debate over hormone replacement therapy seems to be a great example of this. Clearly there are women with extreme symptoms of menopause who are helped by HRT, but that's not the way it's marketed. For a long time it was a "birthday drug" -- you reached a certain age and your doctor automatically prescribed it, whether you had bad symptoms or not.
I am glad to see that there is more discussion now of the risks vs. the benefits, but I still think that the pharmaceutical companies have made sure that every woman over 50 is inherently diseased.
Alan Cassels: We have a whole chapter devoted to the marketing of menopause in our book. It was a mark of marketing brilliance to redefine every woman who lives long enough as "estrogen deficient". Watch what is happening to men now. We are growing "testosterone deficient" as we age, and luckily there is pharmaceutical treatment to help us...
_______________________
Alexandria, VA: Part of the problem is how commercials are regulated. From my understanding, as long as an advertisement does not specifically mention what the drug does, they do not have to mention any side effects. Consequently, drug companies can dress up their commercials to look as appealing as possible without ever mentioning what their product does. Am I correct about this regulation?
Alan Cassels: Absolutely correct. I know anecdotally that a lot of people, even very intelligent and educated people, are very confused by drug ads that don't mention what the drug does. Perhaps that too is marketing brilliance: you'll be driven by your innate curiousity to find out, and in the course of your search you may start down the road to becoming a patient...
_______________________
New York City: I think the strongest validation for Selling Sickness is the announcement this week, that the most profitable class of drugs in America, the atypical antipsychotics, are no more effective than the old cheap drugs that psychiatry had disowned because of their side effects.
Isn't it appalling that antipsychotics are racking in $10 billion in sales annually --even though they are, at best, ineffective--at worst cause potentially fatal metabolic abnormalities--such as, diabetes and cardiac arrest?
Alan Cassels: I agree. We've been studying the anti-psychotics for some time now and what is amazing is how frequently they get used in long term care facilities (ie: old folks homes). The statistics, quite frankly, are appalling. These drugs are effectively sedating our grandparents so that maybe the facility can save on not having more nurses and so on looking after them. I think more and more we are spending on expensive drugs and seeing no net benefit, and furthermore as you mention, actually buying more illness.
_______________________
Alan Cassels: These have been very interesting questions and I am glad I got asked to participate. I would say in closing that asking questions is about the best thing you can do to keep yourself healthy. Our book gives a list of suggested places you can go for 'evidence-based' information about diseases and drugs and suggests the kinds of questions you need to be asking your doctor before you accept a diagnosis and a drug. So I wish the best of "Healthy Skepticism" to all the participants today.
_______________________
Editor's Note: Washingtonpost.com moderators retain editorial control over Live Online discussions and choose the most relevant questions for guests and hosts; guests and hosts can decline to answer questions.

Monday, September 19, 2005

Press Release: Disease mongering" will bankrupt our health system

For Immediate Release
09/19/05


"Disease mongering" by pharmaceutical companies threatens
to bankrupt Canada's public health system

Authors of new book warn that drug company marketing techniques
are turning us all into patients

Daily media articles say that the Canadian public health system is in
jeopardy, and fingers are pointed at everything from doctor shortages to
government mismanagement and bureaucratic greed. But Ray Moynihan and
Alan Cassels, authors of the new book, Selling Sickness: How the world's
biggest pharmaceutical companies are turning us all into patients, point
the finger at another cause: drug company funded disease creation.

Using their dominating influence in the world of medical science, drug
companies are working to widen the very boundaries that define illness.
Mild problems are painted as serious disease, so shyness becomes a sign
of social anxiety disorder and pre-menstrual stress a mental illness
redefined as pre-menstrual dysphoric disorder. Everyday sexual
difficulties are seen as sexual dysfunctions, the natural change of life
is a disease of hormone deficiency called menopause, and distracted
office workers now have adult ADD. Just being 'at risk' by having an
elevated blood pressure or cholesterol level has become a 'disease' in
its own right.

"Too often the aim is to lower the bar and turn healthy people into
patients," says Alan Cassels, co-author of Selling Sickness, and drug
policy researcher at the University of Victoria in British Columbia.
"And lowering the bar makes more and more of us candidates for the
latest pills promoted by the pharmaceutical industry."

Selling Sickness reveals how expanding the boundaries of illness and
lowering the threshold for treatments is creating millions of new
patients and billions in new profits, in turn threatening to bankrupt
national healthcare systems all over the world. Canada's publicly
funded healthcare system is not immune.

"From their domination of guideline committees, their involvement in
physician 'education' and their marketing of fear to consumers, the
pharmaceutical industry is using its immense power to drive more and
more of us towards another prescription," warns Cassels. And, he notes,
"a health system that allows drug companies to play a role in defining
who is sick is fundamentally unhealthy."

With many health problems, there are people at the severe end of the
spectrum suffering genuine illness, or at very high risk of it, who may
benefit greatly from a medical label and a powerful medication. But for
the relatively healthy people who are spread across the rest of the
spectrum, a label and a drug may bring great inconvenience, enormous
costs, and the very real danger of rare but deadly side effects.

As the authors of Selling Sickness note, with plenty of detail,
pharmaceutical company marketing executives don't sit down and actually
write the rules for how to diagnose illness, but they increasingly
underwrite those who do. The industry now routinely sponsors key
medical meetings, in Canada and around the world, where disease
definitions are debated and updated. Eight of the nine 'experts' who
created the most recent cholesterol guidelines in the US had undisclosed
ties to the pharmaceutical industry. The new guidelines shifted the
definition of 'high' cholesterol so drastically that it meant another 40
million Americans should be taking cholesterol-lowering drugs. In
Canada, recent guideline changes to cholesterol treatment, if
implemented, would put 500,000 more people on cholesterol-lowering
drugs.

Added to this is the fact that the bulk of clinical trials on new
medication is funded directly by the drug manufactures rather than the
public or not-for-profit sources. And that this research is then
disseminated at scientific meetings, events and conferences sponsored by
the pharmaceutical industry, and often hosted by medical societies or
patient groups that are themselves partially underwritten by drug
companies. "The reach and the scale of the industry's influence is
really quite breathtaking in its scope," notes Cassels.

"Many Canadians would be horrified to know that drug company money is
also involved in funding much of the Continuing Medical Education of
Canadian physicians. Yet I feel that we are never going to achieve
rational prescription drug use in this country until we get the drug
money out of our medical education system," argues Cassels.

And then there is the barrage of drug advertisements that hit consumers
every time they turn on the TV. While direct-to-consumer advertising of
prescription drugs is illegal in Canada, drug manufacturers here mount
'disease awareness campaigns,' which constantly urge you to 'see your
doctor' for practically everything. "There are many different
promotional strategies used in the selling of sickness, but the common
factor amongst them all is the marketing of fear," says Cassels.

Soaring sales have made drug companies the most profitable corporations
on the planet during particular years of this past decade. But the flip
side of healthy returns for shareholders is the unsustainable increase
in costs for those funding the health system. Selling Sickness tells us
that we need the pendulum to swing back towards a rational and
appropriate use of pharmaceuticals for everyone who is sick. "Our
health care system will collapse if we continue to allow for-profit
enterprises to define who is sick and who needs treatment," says
Cassels. "Now is the time to start having the conversation about
whether we want to continue to allow pharmaceutical greed, not
appropriate need, to be driving our health care expenditures."

For author interviews, contact:
Alan Cassels
Cell: 250-888-7992
Email: alan@alancassels.com


About the Authors:
Alan Cassels is a drug policy researcher at the University of Victoria,
in British Columbia. He has spent most of the last ten years studying
how clinical research about prescription drugs is communicated to policy
makers, prescribers and consumers, and has produced several full-length
documentaries for CBC Ideas, including "Manufacturing Patients," which
deals with the subject of selling sickness.

Ray Moynihan has been covering the business of health care for almost a
decade as an award-winning broadcast journalist and more recently with
the British Medical Journal. He is a regular contributor to the New
England Journal of Medicine and the Lancet and was a Harkness Fellow in
health care policy based at Harvard University.


Selling Sickness: How the world's biggest pharmaceutical companies are
turning us all into patients by Ray Moynihan and Alan Cassels is
published in Canada by Greystone Books (2005) www.greystonebooks.ca and
in the US by Avalon Publishing Group, www.avalonpub.com



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Wednesday, September 14, 2005

Book Q & A: with Alternet

By Kelly Hearn, AlterNet
Posted on September 14, 2005, Printed on September 14, 2005
http://www.alternet.org/story/25418/


Last month, the state of California sued 39 drug companies for price gouging. A week earlier, a jury hit Merck & Co. with a $253 million verdict over its painkiller Vioxx, which was linked to patient deaths.


Each story of buried evidence, bogus research, physician kickbacks and other dubious marketing ploys ticks up public outrage. Feeling pressure, the Federal Drug Administration, harshly criticized as a minion of the $500 billion pharmaceutical industry, may now raise standards for new drug approvals. In September, at least four major drugs -- each potentially worth $1 billion in annual sales -- will go before FDA's expert panels, and observers say they could take a tougher line than ever before. What's more, having spent billions of dollars marketing minor variants of hot-selling drugs instead of developing novel ones, Big Pharma is short on innovative drugs as lucrative patents near their end.


Now a new book, Selling Sickness: How the World's Biggest Pharmaceutical Companies Are Turning Us All Into Patients, examines how the drug industry makes new markets by creating and expanding the definition of disease, from depression to attention deficit disorder, social anxiety to high cholesterol. Alan Cassels, a Canadian science writer, co-authored the book with Ray Moynihan, a medical writer for the Milbank Memorial Fund in New York and a contributor to the British Medical Journal. Cassels spoke to AlterNet from his home.


You use the term "the worried well." Can you describe that in the context of your book's thesis?


I think we would define the worried well as people who are relative healthy but have had the seed of concern or anxiety planted, whether it's over cholesterol level, density of bones or whether they have problems paying attention, that sort of thing. You're taking something perhaps that wasn't worried about in the past and ramping it up and doing it in a number of ways. It is a kind of fear-mongering to create a sense of worry.


Can you talk about some of those ways?


One simple way is for companies to feature celebrities on television or being interviewed talking about a type of test he or she might have undergone. They say this or that saved their life and everyone should be getting it.


Books like yours help confirm many people's suspicions that the pharmaceutical industry pathologizes much of the unpleasant parts of the human experience in order to sell more medicines --


Well, also it's just pathologizing what's normal or what in the past was considered normal. Years ago, for example, a child who behaved a certain way would be considered boisterous. Today, those kinds of kids are being diagnosed with ADD and prescribed stimulants to calm them down.


The pharmaceutical industry has obviously done well at selling sickness. With so much money at stake, is there any hope for reform, for stopping or at least tempering this trend?


Yes, I think the seeds are planted. People are more skeptical and there's a backlash to the massive increase in direct-to-consumer marketing, that in your face marketing barrage. The political and legislative climate may be turning on direct marking. This is the post-Vioxx world. Vioxx is as big of an event as the thalidomide disaster was 40 years ago and now the FDA is using a bit of teeth.


Recently, for example, drugs for female sex dysfunction were refused by the U.S. FDA. They said, we are not going to approve this because we are not sure it is even a disease. They were concerned about not having any long-term safety data on treating with testosterone. Why are they doing it? They are probably feeling stung by previous regulatory failures.


Speaking of advertising, many complain that the FDA does not get to approve an advertisement before it goes on television. By the time a misleading or inappropriate ad becomes the subject of enforcement, the damage is already done, right?


Exactly, and punishments are small. Nobody goes to jail for a misleading ad or for getting thousands to take a drug they don't need or a drug that they could be harmed by. The regulatory agencies need to be able to mete out punishments with real consequences.


Patent laws often allow extended monopolies for so-called me-too drugs, which are minor variants of existing drugs that have few if any new advantages. The laws also extend patents when a drug is used to treat a new condition, even if that condition is not generally agreed to be a real disease. What would you recommend to a reformist politician?


Probably I would recommend Marcia Angell's book. Just in simple terms, we should be rethinking whether we want to be automatically giving 20 year monopolies on something that already exists. The whole idea of me-too categories is troublesome. If there is a newer and demonstrably better drug, there is a reason to reward that manufacturer with monopoly sales. But society should not be hoodwinked to pay extortionist prices for me-too drugs. What advice for reformists? We have to look what the value added is of any new product and price it accordingly.


You've suggested a publicly funded institution should review all scientific studies, published and unpublished, on a particular treatment. Given the extent of financial collusion between leading researchers and pharmaceutical companies, do you think it would be hard, if not impossible, to find experts for the job who were not already touched in some way by Big Pharma's influence?


Luckily we already have them out there. One is the Cochrane Collaboration where volunteers from around the world do systematic reviews of clinical trials and they don't take money from pharmaceutical companies. They try to answer important scientific questions. That is one of many kinds of groups already doing it. Probably most of clinical research is going to be done by the pharmaceutical companies themselves, which means the public can get biased information. If I'm a drug company, I do eight studies, five are negative so I bury and never publish those. That's how the public and prescribers get a skewed impression.


Given then that drug companies have the option of burying unfavorable studies or tweaking the intent of a study to match the findings, do you support the creation of a national drug trial registry where companies register the intent of all trials beforehand?


Yes, and it's not just me. Lots of experts, including editors of major medical journals, have called for a registry. The industry has embraced the idea but they are not registering their trials.


What is the media's role, both in terms of culpability and potential for correcting the problem?


The media has done a lot of good covering major scandals such as Vioxx. Some of your colleagues, such as David Willman at the L.A. Times, have done fabulous work in exposing conflicts of interest and problems in regulation. So I think in many cases journalists have done a great job. The problem is that oftentimes much of journalism looks like marketing when journalists write about newest wonder drug or miracle pill. That's not really journalism.


Kelly Hearn is a former UPI staff writer who lives in Montana and Latin America. His work has appeared in the Christian Science Monitor, American Prospect, and other publications.

Wednesday, September 07, 2005

Book Review in the Journal of the American Medical Association

BOOK Review JAMA, September 7, 2005—Vol 294, No. 9
Selling Sickness: How the World’s Pharmaceutical Companies Are Turning Us All IntoPatients, by Ray Moynihan and Alan Cassels, 241

pp, $26, ISBN 1-56025-697-4, New York, NY, Nation Books, 2005.
Selling Sickness, directed by Catherine Scott, produced by Pat Fiske, cowritten by Ray Moynihan, videocassette, 52 min, color, $390, rental $75, New York, NY, First Run/Icarus Films, 2004.

At the American Medical Association meeting in June 2005, six separate resolutions were introduced advocating for limitations or outright bans on direct-to-consumer marketing of prescription drugs.1 Marketing, an important if not critical preoccupation of the major pharmaceutical producers, is no longer aimed just at physicians. Since the 1990s, research has confirmed that drug company–sponsored research funding and gift giving could significantly affect clinical trial outcomes and individual physicians’ prescribing patterns.2,3

Selling Sickness goes one step further, alleging that, in an effort to increase sales, drug manufacturers have begun to repackage medical conditions and advertise them directly to the general public as diseases in need of pharmaceutical treatment. Companies have benefited from the more permissive climate established in 1997 by Food and Drug Administration (FDA) relaxation of drug advertising regulations.

As a result, the authors argue, current advertisements provide little realistic information about the marginal benefits of drug treatment for most people, while leaving out potentially serious adverse effects. This provocative hypothesis comes at a time of tremendous turmoil in the pharmaceutical industry. In August 2004, GlaxoSmithKline (GSK) settled a lawsuit brought by the New York attorney general alleging concealment of data showing increased suicidal and violent impulses in children and adolescents taking Paxil. As part of the settlement, GSK agreed to establish an online registry of all sponsored clinical studies.

Congressional hearings were held on Paxil in September 2004, and in November 2004, hearings were called yet again on Vioxx, a top-selling antiarthritis

drug. It was alleged that despite aggressive public advertising, Merck had not fully disclosed its own research showing increased risks of heart attack and stroke associated with the drug. Amid national headlines, in October 2004 companion proposals were introduced in the Senate and House for the establishment of a national clinical trials registry.4,5 The legislation was reintroduced as a bipartisan Senate bill in March 2005.6 The motivation for the registry is to provide a comprehensive, publicly available, and unbiased source of information about the safety and effectiveness of any drug, biological product, or medical device.

Selling Sickness and its accompanying documentary film claim that consumer- oriented advertising is designed not only to support drug sales, but also to create new markets for drugs by convincing people they need more medicine.

Moynihan, an award winning Australian health care journalist, and Cassels, a researcher at the University of Victoria in Canada, bring an international perspective to bear on the United States, which with less than 5% of the population accounts for almost 50% of the global market in prescription drugs (p ix).

While drug companies defend their advertising efforts as a means of educating the public and preventing undertreatment, Moynihan and Cassels make the rhetorical point that, in fact, most undertreatment is not located in the industrialized Western nations. On the other hand, the risks of overtreatment, a more probable state of affairs in the United States, are much less recognized and publicized.

As a contrast, the authors cite Europe, where in 2003 the central drug regulatory agency put an abrupt stop to Eli Lilly’s attempt to advertise Sarafem/Prozac because of “considerable concern that women with less severe pre-menstrual symptoms might erroneously receive a diagnosis of PMDD [pre-menstrual dysphoric disorder] resulting in widespread and inappropriate short and long-term use of fluoxetine” (p 116).

The book is organized as a series of case studies, each focused on a particular drug. Each chapter explores a different aspect of drug marketing, with evidence drawn from published editorials, news reports, academic journals, and, most interestingly, original interviews with physician-spokespersons and pharmaceutical sales experts. One sales executive describes “the art of branding a condition” (p 70) as the synergy created when pharmaceutical companies bring so-called physician thought-leaders, prescribing physicians, and patient advocacy groups together—usually through personal network development and funding for community outreach and scientific study.

This same executive notes, “the area that has been most ripe for condition branding has been anxiety and mood disorders” (p 127). Indeed, while the book addresses a variety of medical conditions, including hypercholesterolemia, hypertension, and osteoporosis, the film focuses primarily on the treatment of depression, using the example of Paxil as a focal point. The film emphasizes interviews with patients and parents of former patients and concludes with dramatic excerpts from testimony taken at congressional hearings on the drug.

The book provides a more methodical examination of the specific mechanisms of marketing a drug. These are laid out as a broad survey of a landscape dominated by industry efforts to increase drug sales: advocacy for expanded medical testing and stricter definitions of risk levels to expand the range of use, gifts and research grants as well as cultivation of leading academic physicians as spokespersons, advertisements and publicity appearances featuring celebrities without disclosure of their paid status, funding of promotional activities and materials distributed by patient advocacy groups, publicizing of misleading statistics and downplaying of negative or inconclusive research, lobbying of the FDA for rapid approval or approval of marginally beneficial drugs, and, finally, promotion of drugs as a means of functional enhancement for an otherwise healthy individual.

Some of these promotional activities are notable for their subtlety; they pose as educational efforts to increase the public’s health. A former sales representative writes that the best “product champions” were physicians who delivered a seemingly balanced message, who were not crude, and who could “sell without selling” (p 39). The running theme of these individual analyses is that marketing drugs is, for the most part, based on a misconception of actual risk-benefit ratios.

While many patients are aptly treated for what may be life-threatening conditions, a great number are not and are instead taking drugs under what amounts to a false premise of great benefit or greatly decreased risk. Selling Sickness is a bracing condemnation of contemporary pharmaceutical marketing techniques. It suffers perhaps from an overly broad brush, and the authors at times seem to apply the general premise of overtreatment with excessive liberality to all drugs.

Nonetheless, this book is a welcome, bitter tonic to the surfeit of glossy advertising and lucrative enticements that surround any practicing physician today. It provides substance and legitimacy to the rationale behind emerging efforts to counteract the pervasive influence of the pharmaceutical industry: minimizing conflicts of interest in medical practice and research, publishing the work of authors who are free of excessive industry ties, specifying and clarifying the indications for drug therapy, and providing balanced and dependable sources of information about the risks and benefits of medication use to patients. In our current climate, these are aims with which any ethical physician would agree.

Sue Sun Yom, MD, PhD
M. D. Anderson Cancer Center, Houston, Tex
ssyom@mdanderson.org

1. American Medical Association. Resolutions 507, 519, 532, 533, 534, 536 (Reference Committee E). In: Delegates’ Handbook. June 2005. Chicago, Ill: American Medical Association, 2005.
2. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL. Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse
events? JAMA. 2003;290:921-928.
3. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283:373- 380.
4. Fair Access to Clinical Trials Act of 2004 (FACT Act), S 2933, 108th Cong, 2nd Sess (2004).
5. Fair Access to Clinical Trials Act of 2004 (FACT Act), HR 5252, 108th Cong, 2nd Sess (2004).
6. Fair Access to Clinical Trials Act of 2005 (FACT Act), S 470, 109th Cong, 1st Sess (2005).

Review in Greenleft.org

Corporate power threatening our health

Selling Sickness: How Drug Companies are Turning Us All into Patients
By Ray Moynihan & Alan Cassels
Allen & Unwin, 2005
254 pages, $26.95 (pb)

REVIEW BY PHIL SHANNON

Thirty years ago, the retiring head of the Merck pharmaceutical company told Fortune magazine that he was distressed that the market for his company’s drugs was limited to only sick people. If he could make drugs for healthy people, he would be able to “sell to everyone”. That dream is now coming true.

One of the reasons why the global pharmaceutical industry has stacked the weight on its 12-digit bottom line, say Ray Moynihan and Alan Cassels in Selling Sickness, is its strategy for selling new perceptions of disease to the healthy. Drug companies have marketed common complaints as frightening and widespread diseases for which they have the answer in a new drug.

Cholesterol-lowering drugs (statins) are the biggest selling of these new drugs. Although high cholesterol is a risk factor for cardiovascular disease, drug companies have successfully narrowed the focus on heart health to blood-cholesterol, despite it being only one of a suite of risk factors (among smoking, physical inactivity, diet and diabetes), all of which could be more effectively addressed, without the risk of the serious side-effects of statins, through prevention.

The rise of statins up the revenue charts has been aided by drug companies greatly exaggerating the almost non-existent benefits of statins for those without a heart condition, and by lowering the threshold for high cholesterol to catch in its net more of the healthy, an outcome achieved through funding the medical experts who set the official threshold. Eight of the nine members of the US expert panel that in 2004 revised the cholesterol threshold downwards, so trebling the US market to 40 million (one in every four) adults, were on drug company payrolls.

As with cholesterol, so has hypertension (high blood pressure) been turned from a risk factor into a disease treatable by drugs. Nine of the 11 experts who lowered the official US threshold to redefine millions more people as sick and in need of anti-hypertensive drugs, had financial links to drug companies whose anti-hypertensives have had their modest benefits overblown by the drug company promotional machine.

Mental health offers a field day for drug marketing. Depression, inflated to include people often just going through ordinary life experiences such as teenager angst, has been successfully sold as a chemical (serotonin) imbalance in the brain treatable by anti-depressants such as Prozac, despite the scientific debate over the causes, and therefore treatments, of depression. Anti-depressants, however, show only modest advantage over placebo drugs and carry with them serious side effects including, ironically, increased risk of suicidal thinking and behaviour among the young.

“Social anxiety disorder” is a pure marketing construct that has been so successfully promoted in the US as a disease affecting all those who may suffer shyness or uneasiness in social situations, that GSK’s anti-depressant Paxil, approved for its “treatment”, succeeded in outstripping sales of Prozac in 2002.

Attention-Deficit/Hyperactivity Disorder (ADHD) has been another spectacular success story in transforming public perceptions about a mental health disorder. Psychiatrists on drug-company payrolls have sold a neurobiological explanation for ADHD, and scripts for amphetamine-based drugs such as Ritalin have soared. ADHD, however, is a condition whose prevalence is inappropriately expanded to encompass not just children with severe symptoms of hyperactivity or inattention, but a vastly greater number of kids who fidget and can’t sit still or who drift off in class. Prescribing lifelong speed to adults (whose “symptoms” include that they “drum their fingers”) has also been a marketing spin-off, “one obscenity too many”, says a livid Moynihan, “when each year millions of adults and children ... will die early from preventable and treatable life-threatening diseases”.

Women’s health is a profitable hunting ground for drug companies. Menopause has been successfully turned from a normal physiological state into a disease requiring long-term treatment through Hormone Replacement Therapy. HRT, however, whilst useful for short-term treatment of hot flushes and sleeping problems, makes no difference to general health and vitality, mental health or sexual satisfaction, and its long-term use increases the risk of many of the problems it is supposed to prevent, such as heart attack, stroke, blood clots, breast cancer and dementia.

Similarly, the drug company Lilley, seeking to save the profitability of its soon-to-be-off-patent and therefore less profitable Prozac, has turned pre-menstrual symptoms, which can be severely disabling for some women, into an entirely invented mental illness called “pre-menstrual dysphoric disorder”, claimed to affect 7% of women and treatable by Prozac (renamed Sarafem), with its exorbitant mark-up from its new patent-protected use.

Another marketing construct is “female sexual dysfunction”, a “disease” made to order for Proctor and Gamble’s testosterone patch. Testosterone is useful for the small numbers of women with chronic, biologically based sexual problems, but is useless and potentially harmful for the 43% of healthy women who report occasional lack of sexual desire and sexual performance anxiety.

Osteoporosis has also been the subject of marketing propaganda, exploiting the natural tendency for bone density to decrease with age and thus increasing the risk of hip and other bone fractures, particularly among elderly women. Drug company money lies behind the experts who set the World Health Organisation’s definition of normal bone density to classify half of all women over 50 as suffering from osteoporosis and osteopenia (pre-osteoporosis). Sales of drugs to slow bone density loss have benefited, despite their modest benefits and serious side-effects, at the expense of prevention through diet, lifestyle and reduction of falls hazards.

In all these cases, drug companies have sold a perception of a disease as widespread, severe and above all treatable by drugs. The creative engines behind this strategy are the marketing wizards “working from chic offices in Manhattan, London, Toronto or Sydney”, paid by drug companies to change the way we think about health conditions. The internal documents from the public relations world give the game away with refreshing candour. They write about “creating markets” for drugs, “expanding the patient pool” by changing public perceptions of what is normal and what is sickness, and exploiting “market opportunities” through the “corporate sponsored creation of disease”.

The PR glitz is multifaceted and sophisticated. Massive advertising blitzkriegs selling drugs and fear scare people to their doctors. An army of drug company sales reps (80,000 in the US) — bearing warm doughnuts for their clients, invitations to lavish banquets at conferences in five-star hotels, and sponsorship of medical education of practising doctors — prime doctors to sell the companies’ drugs.

Although doctors tend to deny that they are influenced by drug company advertising, sales reps and perks, researchers have demonstrated that doctors exposed to drug company cultivation are more likely to diagnose a debatable disease, to favour drugs over non-drug treatment and to prescribe more expensive drugs over cheaper ones.

Drug companies are also masters of advertising posing as educational “awareness raising” campaigns. They also fund patient advocacy groups that pitch the same line as the drug companies about the cause and (drug) treatment of a disease. Two-thirds of charities and patient advocacy groups accept sponsorship from drug companies.

The political reach of drug companies is extensive, aided by drug company user-funding (50% in the US, 100% in Australia) of government regulatory agencies. These agencies, funded by the companies whose drugs they are assessing, can be inclined to soft pedal on the rigour of drug approval and monitoring. Corporate-friendly management, regularly replenished with industry blood and political appointments, sidelines and suppresses scientists who adhere to evidence rather than pleasing the drug companies.

It has been 30 years since drug bosses once saw health as the absence of a drug sale. They have worked hard with the marketing spivs to correct this barrier to profits. Without saying so directly, Moynihan’s excellent book shows that one of the major disease threats to people’s health and financial well-being is the corporate power of the pharmaceutical companies.

From Green Left Weekly, September 7, 2005.

Sunday, September 04, 2005

Book Review in the New York Times

SELLING SICKNESS: How the World's Biggest Pharmaceutical Companies Are
Turning Us All Into Patients. By Ray Moynihan and Alan Cassels. (Nation
Books, $25.)

Is menopause a disease? Maybe not, but drug companies encouraged people to think so in order to sell hormone replacement therapy, until the news broke that the hormones increased the risk of heart attacks, strokes and breast cancer. Moynihan and Cassels quote a cheery report by a pharmaceutical analyst in 2003: ''The coming years will bear greater witness to the corporate sponsored creation of disease.''

Case by case, Moynihan and Cassels explain how corporations market disease. They lavish funding on the experts who set the thresholds for conditions like high cholesterol and high blood pressure; the lower the thresholds, the more customers.

The corporations scare the healthy into taking tests of little benefit. They cozen so many ''thought leaders'' in psychiatry with dinners, swag and research dollars that the former editor of The New England Journal of Medicine complained she had trouble finding a qualified reviewer free of drug company money. To throw their corporate voice, they construct patient advocacy groups, such as high cholesterol's Boomer Coalition, or heavily subsidize existing ones. And to skirt F.D.A. ad regulations, they deploy the ultimate corporate weapon: celebrities.

Lauren Hutton praised hormone replacement therapy in 2000 without a word about its emerging dangers, and when running back Ricky Williams gushed about Paxil in 2002, no law obliged him to mention its sci-fi withdrawal symptoms (today's fine print warns of ''electric shock sensations'' and ''abnormal dreams'').

Moynihan and Cassels seem to have written in a hurry, and some of their endnotes are confusing, but they make a compelling case.