The brand-name pharmaceutical industry constantly pushes the myth that its expensive blockbusters are breakthrough treatments that greatly increase people’s health and well-being, and thus are worth the high price-tag. That myth has more holes than a slice of swiss cheese, yet they keep pushing it on the American public like it’s one of their drugs.

As Dr. Marcia Angell, former editor of the New England Journal of Medicine and author of “The Truth About the Drug Companies” (see an interview with Dr. Angell in PAL’s newsletter here) famously said, “Important new drugs do not need much promotion. Me-too drugs do.” So drugs which offer little breakthrough in treatment need to be (over)hyped.

For years, the drug industry has touted antidepressants (particularly SSRIs - Selective Serontin Reuptake Inhibitors — Prozac, Paxil, Wellbutrin, Zoloft, Celexa, Lexapro, etc. as one of its major successes. Yet, this week, a major meta-analysis (a study that reviews the full range of studies and articles on a particular drug) was published in the open-access medical journal PLoS (Public Library of Science) Medicine. That article concluded that, for the majority of patients, SSRI antidepressants are barely better than a placebo.

It’s likely that patients in the U.S. (and their health plans, and government health care programs like Medicare, Medicaid, the Veterans Administration, the military health care plan Tri-Care, etc) have spent tens of billions of dollars on antidepressants in the past decade, despite the fact that for many of them, it was likely a waste of money, exposed them to the risk of side effects, and may have resulted in their not availing themselves of other non-pharmaceutical options for treating their depression.

The billions that the industry spent on marketing these drugs, both to consumers and to doctors, led millions to believe that relief was just a pill away (We gave the makers of Paxil, one of these antidepressants, one of our Bitter Pill Awards in 2005, the Cure for the Human Condition Award: For Hawking Pills to Treat the Trials of Everyday Life).

Drugs for depression are just one of numerous groups of drugs for which the benefits are overhyped and people for whom an expensive drug is unnecessary or overkill are convinced to take it in lieu of something cheaper, that’s been around longer and whose risks and benefits are more well known.

“Statin” drugs for reducing high cholesterol are another group of drugs that have been massively overhyped, and that also have been in the news a great deal lately. Last month, the results of a study of Schering-Plough and Merck’s combination-cholesterol drug Vytorin, the ENHANCE study, were released, showing that it offered no benefit over simvastatin (Zocor), a statin that last year went generic. Vytorin is a combination of Zocor and Zetia, which is also sold by itself. Vytorin and Zetia together have more than $5 billion in sales.

Statin drugs have also been in the news because of the revelation that Dr. Robert Jarvik, Pfizer’s boat-rowing pitchman for Lipitor, is not a licensed physician, cannot write a prescription for Lipitor or any drug for that matter, and is not even a rower (a stunt double was used in the Lipitor ads). We’ve blogged about Jarvik-gate here on several occasions, including proposing some other famous “doctors” who aren’t licensed physicians that Pharma ought consider using as paid flaks — including Dr. Teeth from the Muppets, Basketball legend Dr. J, Dr. Nick Riviera from the Simpsons, and New Orleans musical legend Dr. John).

Of course, the real Lipitor story is not Dr. Robert Jarvik and his rowing and prescribing credentials. At best, he’s a bit player in this drama. The real story is how incredibly overhyped Lipitor is. Pfizer boasts it’s the “most powerful” statin as though that means that everyone with high cholesterol should be on it. But for many (perhaps most) people with high cholesterol, using Lipitor is like using a chainsaw to cut paper instead of scissors: that is, unnecessary overkill. Members of the PAL coalition filed a lawsuit against Pfizer in 2005, alleging that Lipitor had been overhyped and promoted to patients for whom it offered no benefit, and we gave them and AstraZeneca, the makers of Crestor, a Bitter Pill Award in 2006: The “Got Cholesterol?” Award: For Overpromoting Expensive Brand-Name Statins.

But even that’s not the real story — there are larger questions about statins. For instance, does lowering your cholesterol translate into a lower risk of heart attack or heart deaths on January 17 was Do Cholesterol Drugs Do Any Good? Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated.

Here are a few choice excerpts:

[Statins] are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006. Half of that went to Pfizer for its leading statin…
The second crucial point is hiding in plain sight in Pfizer’s own Lipitor newspaper ad. The dramatic 36% figure has an asterisk. Read the smaller type. It says: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”

Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100.

Compare that with, say, today’s standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1. Give the drugs to 11 people, and 10 will be cured.

A low NNT is the sort of effective response many patients expect from the drugs they take. When Wright and others explain to patients without prior heart disease that only 1 in 100 is likely to benefit from taking statins for years, most are astonished. Many, like Winn, choose to opt out…

NNTs are the “dirty little secret” of the world of prescription drugs. And a perfect illustration of how hyping drugs through advertising to consumers and marketing to doctors (through the 100,000 salespeople employed by drug companies, self-serving biased clinical trials and corporate-influenced “continuing medical education”) doesn’t benefit patients. As the article says,

The truth about drugs’ effectiveness wouldn’t be as worrisome if consumers and doctors had an accurate picture of the state of knowledge and could make rational decisions about treatments. Studies by Darlington Hospital’s Trewby, UBC’s Wright, and others, however, show that patients expect far more than what the drugs actually deliver…

The whole statin story is a classic case of good drugs pushed too far, argues Dr. Howard Brody, professor of family medicine at the University of Texas Medical Branch at Galveston. The drug business is, after all, a business. Companies are supposed to boost sales and returns to shareholders. The problem they face, though, is that many drugs are most effective in relatively small subgroups of sufferers. With statins, these are the patients who already have heart disease. But that’s not a blockbuster market. So companies have every incentive to market their drugs as being essential for wider groups of people, for whom the benefits are, by definition, smaller.

Finally, an excellent piece posted today on Alternet examines the statin and cholesterol controversy in detail: The Cholesterol Con — Where Were the Doctors?

The New York Times ran an excellent op-ed on Sept 21, “Shy on Drugs,” by Christopher Lane. Professor Lane takes psychiatrists to task for too readily diagnosing shy children as having “social anxiety disorder.” He pins a chunk of the blame on the Diagnostic and Statistical Manual of Mental Disorders (“DSM” for short), the diagnostic bible of the psychiatric profession:

[A] glance at the manual reveals that the diagnostic criteria for shyness are far from clear. The third edition, which was published in 1980, said that a person could receive a diagnosis of what was then called “social phobia” if he was afraid of eating alone in restaurants, avoided public restrooms or was concerned about hand-trembling when writing checks.

The same guidelines could hardly apply to youngsters heading to kindergarten, children not yet potty-trained and toddlers just learning to eat. So in 1987, the revised third edition of the manual expanded the list of symptoms by adding anticipated concern about saying the wrong thing, a trait known to just about everyone on the planet. The diagnostic bar was set so low that even a preschooler could trip over it.

The definition of this “disorder” then sets the stage for wholesale manipulation by pharmaceutical companies all too eager to offer up a pharmaceutical solution:

Then, having alerted the masses to their worrisome avoidance of public restrooms, the psychiatrists needed a remedy. Right on cue, GlaxoSmithKline [NYSE:GSK], the maker of Paxil, declared in the late 1990s that its antidepressant could also treat social anxiety and, presumably, self-consciousness in restaurants. Nudged along by a public-awareness campaign (“Imagine Being Allergic to People”) that cost the drug maker more than $92 million in one year alone…social anxiety quickly became the third most diagnosed mental illness in the nation, behind only depression and alcoholism. Studies put the total number of children affected at 15 percent — higher than the one in eight who psychiatrists had suggested were shy enough to need medical help.

In 2005, we gave one of our Bitter Pill Awards to GlaxoSmithKline for its marketing of Paxil, the Cure For the Human Condition Award. We pointed in particular to this fact:

In June [2005], the FDA issued a warning letter to GlaxoSmithKline for its “Hello, My Name is.” television ad campaign for Paxil. The FDA said that this ad wrongfully “suggests that anyone experiencing anxiety, fear, or self-consciousness in social or work situations is an appropriate candidate for Paxil CR” when these are simply not approved uses of the drug. Despite the warning letter, the harm had already been done as millions of consumers had already seen the ad.

This type of marketing, and the widespread diagnosing of shy children (and adults) as having a medical disorder as opposed to run of the mill shyness, is often cited as an example of “disease mongering.” It’s a symptom of a larger problem — the medicalization of an ever-increasing portion of the spectrum of normal human behavior. Anything that deviates from some pharmaceutically-determined median is now a candidate for an expensive, brand-name drug, from how shy we are to whether or not we occasionally can’t sleep to whether our legs twitch when we sit still to whether we have toenail fungus.

The prescribing of expensive, strong and often dangerous prescription drugs to ever growing numbers of children with shyness is ironically happening at the same time that an also every growing numbers of children are being prescribed expensive, strong and often dangerous prescription drugs for Attention Deficit Hyperactivity Disorder (ADHD). Children generally are being prescribed more and more prescription drugs, even when such drugs have often not been tested on or approved for children. (We reported on another example recently: “Doctors widely prescribing drugs for kids’ sleep problems”)

There are no doubt some children who benefit from SSRIs such as Paxil and drugs for ADHD, for whom the benefits outweigh the often considerable risks. But they are undoubtedly a fraction of those children who are prescribed these drugs. We as a society are turning too quickly to the pharmacist for a solution to complex issues. Shyness, inability to pay attention, hyperactivity — these are not merely — or often even primarily, if at all — medical or biochemical issues. They’re affected by a broad range of factors, such as class size, nutrition, sleep, the quality of housing and one’s environment, the stability of home and family life, etc. It’s far easier to write a prescription than to tackle these larger problems. But the underlying problems will remain. Pharmaceutical companies are all too willing to pitch their solution, regardless of the harm it causes or whether it actually addresses any underlying problem.