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.
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.
[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.
The most recent issue of Health Affairs (subscription required) has an intriguing proposal on how we might pay for drugs to maximize the number of people who need drugs actually taking them while minimizing cost. (“Drug Licenses: A New Model For Pharmaceutical Pricing”). The authors introduce the problem:
High drug prices are a major barrier to patients’ access to drugs and compliance with treatment. Yet low drug prices are often argued to provide inadequate incentives for innovation.
While their analysis of whether prices really influence R&D is, in my opinion, flawed, their underlying point is accurate: High drug prices reduce patients’ compliance (i.e. whether patients actually take the drugs they’re prescribed). For conditions where drug treatment has a significant impact, that can affect the patients’ health and also increase health costs overall. The drugs the authors focus on are a good example: statins for high cholesterol. Ensuring that patients who actually needs statins can afford to take them can prevent heart attacks and hospitalizations, which are of course far more expensive than the drugs. The authors point to studies showing that even modest increases in the copayments that patients have to pay for statins under their insurance can significantly reduce patient compliance.
The authors’ proposed solution is to change how we pay for drugs like these. The main costs associated with a producing a drug are upfront: the research, the clinical trials, the steps to get the drug approved, etc. Once approved, the cost of producing each tablet or capsule is, for most drugs, very low. Thus, paying by the pill it is not necessarily the only, or the best, way to compensate the drug company. We already pay for certain products the way the authors propose, the most familiar example being computer software and cable TV:
The licensing model we propose is referred to by economists as “two-part pricing.” Numerous examples of this exist in the nonmedical world, including Internet service, cable and satellite television, all-you-can-eat buffets, country club memberships, and cell phone plans. But perhaps the most relevant example is software. Instead of charging a fee every time a person starts his or her computer, Microsoft charges a one-time fee for the use of Windows. What makes pharmaceuticals similar to these products—and distinguishes them from other health services—are the very low costs of production and the existence of few good substitutes.
Uncoupling the cost of the treatment from each pill (or each monthly supply of pills) ensures that patients won’t stop taking the drug, or stop filling the prescription because of the cost of a particular bottle of pills.
It’s an interesting model to consider: That patients purchase not the pills themselves, but the right to as many pills as they need for a given year.
Whether this is the right model, or whether there are others that are better, remains to be seen. But our current system in which drug companies hyper-market drugs to consumers regardless of whether those drugs are truly needed, in which many consumers are shielded from the true cost of those drugs, and in which ironically many patients who actually need certain drugs can’t afford them, clearly isn’t working. This is one alternative worth considering.
Pfizer’s commercials for Lipitor featuring Dr. Robert Jarvik, “inventor of the artificial heart,” are probably among the most recognized drug ads on TV today. The ads rely on us viewers assuming that because Dr. Jarvik supposedly invented the artificial heart, he must be an authority on cholesterol… Right? The ad above has Dr. Jarvik saying “Just because I’m a doctor doesn’t mean I don’t worry about my cholesterol.”
Hmmm… What if the ads also said that Dr. Jarvik never actually practiced medicine, and in fact never even got licensed to practice medicine? Suddenly, he doesn’t seem like that much of an authority, does he?
Well, apparently that is the case. The Energy and Commerce Committee of the US House of Representatives is investigating “the use of celebrity endorsements of prescription medications in direct-to-consumer advertising, specific to Dr. Robert Jarvik’s appearance in Pfizer’s Lipitor Commercials,” according to the Committee’s press release:
Washington, D.C. – Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations, announced today that they are opening an investigation into the use of celebrity endorsements of prescription medications in direct-to-consumer advertising, specific to Dr. Robert Jarvik’s appearance in Pfizer’s Lipitor Commercials.
“We are concerned that consumers might be misled by Pfizer’s television ads for Lipitor starring Dr. Jarvik,” said Dingell. “In the ads, Dr. Jarvik appears to be giving medical advice, but apparently, he has never obtained a license to practice or prescribe medicine.”
“Dr. Jarvik’s appearance in the ads could influence consumers into taking the medical advice of someone who may not be licensed to practice medicine in the United States,” said Stupak. “Americans with heart disease should make medical decisions based on consultations with their doctors, not on paid advertisements during a commercial break.”
It’s not surprising that Pfizer chose Dr. Jarvik as its spokesperson. In the past three years, we’ve seen a stampede of white coats in drug ads — either actual doctors or actors dressed up like doctors. The white coat conveys authority and gravity to the ads.
But there’s something very bothersome about using a “Doctor” who has no license to practice medicine, and who in fact apparently has never done so, to advertise Lipitor. And that is the fact that particularly when it comes to cholesterol medications, the prescribing details matter. The decision of whether to prescribe a statin (such as Lipitor, Crestor, Zocor, Pravachol, etc.) and which statin to prescribe are ones that require a fair amount of knowledge and experience on the part of the doctor — different patients need different statins, different statins have different side effects. So who should use Lipitor -versus another statin or even versus just changes to diet and exercise – are complicated questions requiring doctors to know a fair amount. Yet Pfizer has Dr. Jarvik, who can’t even practice medicine, advising consumers to take Lipitor!
It’s a measure of what Pfizer thinks of us lowly consumers that they use a celebrity doctor spokesperson who can’t even prescribe the product they’re endorsing.
What with the recent flap over Montel Williams, PhRMA’s patient assistance spokesperson, threatening to “blow up” a high school student, and now the revelation about “Doctor” Jarvik, it makes us wonder whether celebrities are the best choice for drug ads…
Jane Brody’s column today in the NY Times, “Cutting Cholesterol, an Uphill Battle,” is an excellent overview of the lifestyle changes that one should make to lower high cholesterol, BEFORE resorting to prescription statins (Lipitor, Crestor, Zocor, etc).
In addition to the very useful specific advice that she offers (below), perhaps the more important message of her column is “don’t turn to a pill first.” The ubiquitous TV ads for statins, including the ones featuring Dr. Robert Jarvik, have convinced millions of people that all they need to do to lower their cholesterol is take a statin — and an expensive brand-name one at that. Statins can be very helpful and there are no doubt millions of people who can and do benefit from them. But our culture of a “pill for every ill” has given short shrift to the important — but often harder — changes in diet and exercise. The upside is that a better diet and increased exercise have countless other benefits beyond just reducing cholesterol. But when was the last time you saw an ad that said “Ask your Doctor if Broccoli is right for you.”
Even people who do need statins don’t necessarily need the most expensive, newest brand-name ones. Visit Consumer Reports Best Buy Drugs’ report on statins to see which statins are the “Best Buy” and right for different types of patients. Best Buy Drugs reviews a number of different categories of drugs, including drugs of heartburn, migraines, depression, diabetes and others.
Here’s Jane Brody’s advice:
These are the measures that have been found to work, based on randomized, controlled clinical trials, the gold standard of clinical research.
Alcohol. Consuming one or two drinks a day can lower LDLs by 4 to 10 milligrams. Red wine is considered most effective. For those who cannot drink alcohol, purple grape juice may be a reasonable, albeit less effective, substitute.
Exercise. Aerobic exercise, like brisk walking, jogging, cycling and lap swimming, can reduce LDLs by 3 to 16 milligrams and raise the good HDLs. Consistency is important. Aerobic activities should be performed at least five times a week for maximum benefit.
Weight loss. When achieved through diet and exercise, weight loss can reduce LDL levels by as much as 42 milligrams. When achieved through drug therapy, weight loss has been associated with an LDL drop of 10 to 31 milligrams.
Yoga and tai chi. These forms of exercise, which are accessible to just about everyone who can walk, even the elderly, have reduced LDLs by 20 to 26 milligrams when done for 12 to 14 weeks.
Smoking. An analysis of several studies found that LDL cholesterol was 1.7 percent higher in smokers, but two smoking cessation studies found little or no difference. In any case, smoking is a strong independent risk factor for heart disease and sudden coronary death, so it is best avoided.
Modifying Your Diet
About 85 percent of the cholesterol in your blood is made in your body. The remaining 15 percent comes from food. But by reducing dietary sources of saturated fats and cholesterol and increasing consumption of cholesterol-fighting foods and drink, you can usually lower the amount of harmful cholesterol in your blood. My college roommate, for example, recently adopted a mostly vegetarian-and-fish diet, minus cheese but with occasional meat and chicken, and lowered her total cholesterol from 240 to 160 milligrams.
There are exceptions, of course, and I happen to be one of them. Still, I intend to continue to follow a heart-healthy diet, because that will enhance the effectiveness of the medication I’m taking.
Start by switching to low-fat and nonfat dairy products, like skim milk and, if you can stand it, fat-free cheese. Substitute sorbet, sherbet or fruit ices for ice cream, or choose ice milk or ice cream with half the fat.
For protein, choose fish and shellfish, poultry without the skin and lean meats, all prepared with low-fat recipes. Eat more dried beans and peas (cooked, of course), soy products like tofu, and nuts like walnuts and almonds. Grains should be mostly or entirely whole — 100 percent whole wheat bread and cereals made from whole wheat or oats, brown rice, bulgur and the like. Oats and oatmeal are rich in soluble fiber, which lowers cholesterol.
Pile on the vegetables and fruits. Especially helpful are those high in fiber like Brussels sprouts, cabbage, spinach, carrots, blueberries, oranges and apples.
Cook with canola or olive oil, and use margarine made from plant stanols.
And enjoy a glass of wine with dinner.
Equally important are the foods to limit or avoid: organ meats like liver, egg yolks, most fried and fast foods, doughnuts and pastries, full-fat cheeses and ice cream, processed meats like salami, bacon and other fatty cuts of pork, and untrimmed red meats.
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