Selling Sickness

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

Monday, May 30, 2005

Article on Selling Sickness: Drug Companies 'talk up' ailments

Drug companies 'talk up' ailments
Sid Maher

AUSTRALIA'S health system is wasting up to $100 million a year prescribing expensive, patented blood-pressure drugs instead of older, cheaper medicines found to be just as effective by scientific studies.The claim is contained in a new book, Selling Sickness, which accuses pharmaceutical companies of talking up the effects of common complaints to create new markets.

"The marketing strategies of the world's biggest drug companies now aggressively target the healthy and the well," argue Australian writer Ray Moynihan and his Canadian co-author Alan Cassels.

"The ups and downs of daily life have become mental disorders, complaints are transformed into frightening conditions and more and more ordinary people are turned into patients."
Selling Sickness says a national awareness campaign on menopause in 2000 was funded by the drug giant Wyeth, which markets hormone replacement therapy.

But the campaign promoting HRT did not mention studies that showed a risk of blood clots to women on the regime and evidence that HRT, rather than cutting heart attack risk, actually increased it in a tiny number of cases.

The book also says the volume of anti-depressant prescriptions tripled between 1990 and 2000, while among 15- to 24-year-olds prescription rates had increased tenfold.

The authors cite studies that argue that spending on high blood-pressure medication could be cut by one quarter if physicians stuck to cheaper therapies.

"It has become clear from the solid scientific evidence ... that collectively the world is wasting billions on the most expensive blood-pressure drugs," the book says.

A major study funded by the US Government found the oldest, cheapest blood-pressure drugs, low-dose diuretics (or thiazides) not only did as well as the newer ones at lowering the chances of heart attacks and strokes, but came out marginally ahead because they were slightly better at preventing heart failure.

"On the question of cost, the old drugs won hands down, because they are off patent and available as generics; treatment with these pills is so low it is almost free," the book says.
Curt Furberg, a key researcher in the study, which compared the old and new drugs and was published in The Journal of the American Medical Association, argued that the findings were dwarfed by the promotional machine of the drug companies.

In 2003, sales of Pfizer's popular blood pressure drug Norvasc reached almost $US5billion ($6.5billion), making it the fourth-biggest revenue-generating drug in the world.

Kieran Schneemann, chief executive of pharmaceutical industry body Medicines Australia, was unavailable for comment.

Monday, May 09, 2005

New York Times: Marketing a disease and Also a drug to treat it

Marketing a Disease, and Also a Drug to Treat It
Is it a drug in search of a disease, or simply an affliction in need of better publicity?
One of the afflicted is Peter Pagan. After suffering a severe brain injury in a fall, he would burst into tears at the slightest provocation, even when he was not feeling sad.
"The physical therapist would say, 'You're doing well' and he would just start crying," said his wife, Julie. "He cried, I would say, 40 or 50 times a day. It was awful. I just didn't know what to do."
But Mr. Pagan, 73, a retired engineer from La Palma, Calif., who still has trouble speaking, has been keeping his tears in check, his wife said, since he started taking an experimental drug developed by Avanir Pharmaceuticals of San Diego.
Avanir hopes that the drug, Neurodex, will win federal approval by the end of this year as a treatment for the uncontrollable laughing or crying that can be caused by various neurological diseases or injuries. As one doctor described the odd syndrome in a 1989 article, "Pathologic laughter is devoid of any inner sense of joy and pathologic weeping of any feeling of inner sorrow."
Besides federal approval, though, Avanir faces two other potential obstacles. Some critics say that the condition, in people who are typically fighting much more serious health problems, does not warrant drug therapy. And many affected patients and their doctors may not be aware that it is a syndrome with a variety of names and a possible treatment.
So Avanir has recruited neurologists and psychiatrists as scientific advisers and is trying to prime the market by elevating an ill-defined group of symptoms into a condition under the name pseudobulbar affect, or PBA, in hopes of establishing awareness of it among doctors and patients.
Gerald J. Yakatan, the company's chief executive, compares the effort to the way drug companies helped make erectile dysfunction and attention deficit hyperactivity disorder into well-known terms. "Before there were drugs, these conditions didn't exist," said Dr. Yakatan, who has a doctorate in pharmaceutical sciences and a long history in the drug business.
The cause of the condition is not clear. Scientists suspect it occurs when the brain stem, which generates laughter and crying, loses communication with parts of the brain that control emotional expression. It is because the condition mimics damage to the brain stem, or bulb, that the company decided to call it pseudobulbar affect.
Avanir has conducted two clinical trials showing that Neurodex, whose active ingredient is a common cough suppressant, reduces unwanted laughter or tears. One trial involved people with Lou Gehrig's disease, or amyotrophic lateral sclerosis, and the other people with multiple sclerosis. Avanir plans to present the results to the Food and Drug Administration by the end of June as part of its approval application. Gene Mack, an analyst at Lazard who recommends Avanir stock, estimates that sales of Neurodex, if approved, could exceed $500 million annually in a few years.
Avanir, founded as Lidak Pharmaceuticals in 1988, also developed the over-the-counter cold-sore cream Abreva, which is sold by GlaxoSmithKline. But Avanir is still unprofitable. In its last fiscal year, it lost $28.2 million on revenues of $3.6 million.
Critics have accused pharmaceutical companies of hyping dysfunctions into diseases to sell drugs. And some skeptics of Avanir's drug say that inappropriate laughing or crying is the least of the problems for people with life-threatening diseases.
"They don't need to be treated; they don't ask to be treated," said Vincent Meininger, head of the national referral center in France for amyotrophic lateral sclerosis.
Harry M. Tracy, publisher of NeuroInvestment, a newsletter about companies developing neurological drugs, is another skeptic. "Basically," he said, "they've had a drug they've been trying to find a disease for."
But some doctors and patients say the syndrome is real and can be a social liability.
"Some of my patients have had it and would suddenly start laughing in the middle of a funeral or church service," said Hillel Panitch, a professor of neurology at the University of Vermont, who presented the results of Avanir's multiple sclerosis trial at the recent meeting of the American Academy of Neurology.
"It's socially disabling and people tend to hide it, which is one reason you don't hear much about it," said Dr. Panitch, who has agreed to give speeches for Avanir but has not yet done so.
Some doctors prescribe antidepressants, with mixed success, for the condition. But no drug has yet been specifically approved for pseudobulbar affect.
Last year, after Avanir signed up more than a dozen neurologists and psychiatrists to help devise a strategy and try to influence other doctors, one of group's first tasks was to decide which to use for the syndrome. The condition has been variously been known as emotional lability, emotional incontinence, pathological laughing and crying, or uncontrollable laughing and crying, in addition to pseudobulbar affect.
"When you have a syndrome that's not widely recognized, what you call it is important," said Randolph B. Schiffer, chairman of neuropsychiatry at Texas Tech University Health Sciences Center and the chairman of Avanir's scientific advisory board.
He said that the board opted for pseudobulbar affect because it was more medically precise than emotional lability, which can encompass other syndromes. Dr. Yakatan, Avanir's chief, said that he would have preferred a name easier to understand, but he deferred to the board.
Avanir and its advisers, on the basis of a few papers in the medical literature, came up with an estimate that 880,000 Americans have pseudobulbar affect, which the company rounds to about 1 million in its corporate literature and presentations. These include about 10 percent of the people with multiple sclerosis, half of those with Lou Gehrig's disease, 18 percent of those with Alzheimer's, 18 percent with stroke and 5 percent with traumatic brain injury.
Avanir has been sponsoring speeches, symposiums and continuing medical education courses for doctors. It sponsors a quarterly newsletter called "PBA Update," much of it written by its consultants, that is sent to more than 10,000 neurologists and psychiatrists.
The company also recently took out its first advertisement in a psychiatric journal. The ad could not mention the name of the drug, which is unapproved, but talked about Avanir's new approach to therapy for pseudobulbar affect.
The company has also approached patient advocacy groups to publicize the condition. "You want the patient to know 'You're not alone, you're not crazy,' " Dr. Yakatan said.
With a grant from Avanir, the National Multiple Sclerosis Society commissioned an article, which is has posted on its Web site, telling doctors how to diagnose pseudobulbar affect. The patient-oriented magazine of the National Stroke Association published an article late in 2003 entitled, "New Hope for Emotional Lability Patients." Avanir has set up its own Web site,, and is even considering helping to start a patient advocacy group.
In one clinical trial involving 140 patients with Lou Gehrig's disease, symptoms of pseudobulbar affect were reduced roughly 50 percent in those getting Neurodex compared with those getting only one or the other of the drug's two ingredients. A multiple sclerosis trial, in which 150 patients were treated for three months, showed about a 60 percent decrease in symptoms in patients receiving Neurodex compared with those getting a placebo.
But there are side effects.
One-quarter of the patients getting Neurodex in the Lou Gehrig's trial dropped out because of adverse side effects including nausea, dizziness and sleepiness, compared with only 6 percent to 8 percent of those getting just one of the drug's ingredients.
And Dr. Meininger of France wrote in the journal, Lancet Neurology, in February that there was some evidence that dextromethorphan - the cough suppressant in Neurodex - might worsen Lou Gehrig's disease but that Avanir's trial was too short to examine that possibility. Dr. Richard A. Smith, the inventor of Neurodex, in a response published in the journal, said that the drug had no adverse effect on the disease in animal studies.
Avanir has not run a trial with Alzheimer's patients, which accounts for the largest number by far of people with pseudobulbar affect. But Avanir executives say that the F.D.A. has told them it would approve Neurodex for pseudobulbar affect regardless of the underlying disease, if it succeeded in two clinical trials based on different diseases. The F.D.A., by policy, does not comment on its discussions with companies.
Avanir is also testing Neurodex for neuropathic pain, a much bigger potential market. Dr. Yakatan said that the drug might help limit anger outbursts as well. "I call this drug, dextromethorphan, the aspirin of the neurology world," he said.
Dr. Schiffer of Texas Tech said there was a risk the drug might be used for other conditions. "If it works for road rage, everyone in Los Angeles is going to take it," he said.

Wednesday, May 04, 2005

Book Review: Adelaide Indy Media

Book Review: 'Selling Sickness'
by Robyn Williams
03 May 2005
Printed from Adelaide IMC :

In a market driven economy, is the pharmaceutical industry hyping disease to improve their bottom line? Are we as sick as the industry would like us to believe?

I'm no economist but even I know we live in a market economy. Ever wondered where the market comes from? It's a big issue for the pharmaceutical industry. Is it in fact now in the business of creating disease markets?

Let me be clear - a small proportion of the population have serious illnesses or are at high risk of disease, and these people may benefit very greatly from drug treatments. No doubt about that. But the more of us that can be considered diseased or at risk of disease, the bigger the potential market and the potential profit. So there is plenty of rationale for drug companies to manufacture disease as well as drugs.

This the fundamental argument of Selling Sickness, a book about big drug companies by Ray Moynihan and Alan Cassels. Take the market for SAD, Social Anxiety Disorder. GlaxoSmithKline are the makers of Paxil, the first drug approved for the treatment of SAD. According to the book, GlaxoSmithKline (then SmithKlineBeecham) claimed that SAD affects 1 in 8 Americans - a very tidy market - and a big expansion of what was previously considered a rare disorder. Indeed other estimates put the prevalence at less than 1%, and up to 4%. Presumably the rest of the people in the SAD market just have ordinary shyness.

Or what about the market for osteoporosis prevention drugs? Recent definitions of low bone density put 30-50% of post-menopausal women in this market. That's a big market. Osteoporosis prevention drugs currently are worth about $5billion per year - expectations are that could increase to $10billion per year. Just after I read this bit of the book, I opened my copy of a doctor's magazine that had arrived in the mail, and sure enough, there was an ad featuring an attractive woman, Id say in her forties.

The marketing promotes the idea of taking tablets to prevent bone loss, but what really matters is preventing fractures. Taking a drug to reduce hip fracture might be beneficial for women in their 70s and 80s when the risk of hip fracture is high. But for a woman in her forties or fifties the risk is very small.
Most women of this age will be better off taking exercise rather than pills. Even in older women low bone density is only one of many factors contributing to hip fracture, along with poor balance, failing eyesight and muscle loss. But in the US, drug marketing keeps conditions like osteoporosis prominent in the consumer's mind, fuelling the desire for drug treatment.

A refinement of the strategy of expanding the disease market is to recast common experiences of human life as disease. Examples outlined by Moynihan and Cassels include menopause (think estrogen deficiency disorder), treatable by hormone replacement therapy - one of the most prescribed drug therapies ever. Or ageing (in men think erectile dysfunction) treatable by maybe the most famous lifestyle drug so far, Viagra. Or what about attention deficit disorder, perhaps otherwise known as childhood? It makes you wonder if they trying to convince us that we all need treatment?

Stand by for the next disease expansion - female sexual dysfunction. Suffered by 43% of women - yes you heard that right, 43% of women according to its proponents with a market that might hit a cool $1billion by 2008. The treatment ? A Viagra like pill for women, or a testosterone patch.

Of course this presupposes that the causes of female sexual dysfunction are largely physical (vascular, neurological and so on) and so curable by a chemical. I ask you, dear sceptical listener, does that sound likely to you? What about relationship issues, tiredness, stress, low self-esteem?

Anyway, watch out for the new bedtime line: Not tonight darling, the dog ate my patch. (By the way, I cant take credit for that, its from Dr Leonore Tiefer, founder of a US based campaign against the medicalisation of women's sexuality. For more on her confrontations with Pfizer, you'll have to read the book. )

So what you might say - take a drug, who cares? Except that, if drugs have effects, they also tend to have side-effects. In our quest for quick fixes , its easy to forget this. True, most side effects are minor but important, even life-threatening side effects do occur - as we've seen lately with Vioxx. Other examples are chronicled in Selling Sickness. So its important to think about both potential benefits and potential risks of prescription drugs, and to try to strike the right balance.

The darkest side of this book though is the reported complicity between big pharma and doctors, researchers and regulatory authorities. According to Moynihan and Cassels

90% of people who write clinical guidelines for doctors (for example on how to treat high cholesterol or depression) have conflicts of interest, because of financial ties to the pharmaceutical industry

60% of biomedical research in the US is funded by private sources mostly drug companies. In some fields like depression, its even higher.

Half of the budget for the US regulator, the Food and Drug Administration, comes from drug companies on a user pays basis.

That might be ok if FDA staff remained free and unconstrained in their views. But there is evidence emerging that freedom within the FDA is seriously under threat.

Moynihan and Cassels are not alone in their assessment that some restraint on big pharma is needed.

Last week the British Medical Journal published editorial comments that were deeply critical of the strategies of the industry , and recommended doctors just say no to drug company lunches and the like. This followed the release of a House of Commons Health Committee report on the pharmaceutical industry. They found an industry that buys influence over doctors, charities, patient groups, journalists and politicians and whose regulation is sometimes weak or ambiguous.

The report recommends closer scrutiny of advertisements and limits on the marketing of new drugs.

I want to say again, many prescription drugs deliver important benefits, and Moynihan and Cassels acknowledge this. Drug companies are of course commercial organizations under pressure to also deliver profits to their shareholders.

They spend substantial money on research and development, resources that are not spent by government. They are in the world of private enterprise, and therefore the world of marketing. We need to be realistic about this two edged sword. I think the problem comes when drug company marketing becomes uncontrolled and unscrutinised.

Then balancing benefits against risks and costs can get lost in the drive for ever bigger profits. This is what Moynihan and Cassels argue is happening . They make an interesting and thought provoking case.

Their book is heavily based on US experience. In Australia we're somewhat protected by the evidence based approach of the PBS - the Pharmaceutical Benefits Scheme and by marketing controls already in place on the pharmaceutical industry. Its important I think that at a minimum these controls are kept in place. Also it wont hurt if consumers keep an open and sceptical mind about the claimed benefits of all kinds of treatments.

Guests on this program:

Assoc Prof Alexandra Barratt,
Senior Lecturer
Screening and Test Evaluation Program
School of Public Health
Edward Ford Building
The University of Sydney
NSW 2006 Australia

'Selling Sickness'
Author: Ray Moynihan
Alan Cassels
Publisher: Alan & Unwin
Presenter: Robyn Williams
Producer: Polly Rickard and David Fisher