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The Healthy Skeptic

Posted by medconsumers on December 31, 2008

The Healthy Skeptic (University of California Press: 2008)

Sometimes it’s the opening anecdote that draws you into a book. In the introduction of The Healthy Skeptic: Cutting through the HYPE about your Health, author Robert J. Davis describes a youthful encounter that jump-started his own quest for truth. It was the early years of the low-fat-diet-for-all heart disease prevention message to the public. A college student at the time, Davis bragged to friends that his “highly enlightened family” (father a physician) shunned whole milk and drank only 2%, the type that is low in fat.

Another student challenged him saying, “2% milk is not really low in fat.” Incredulous, Davis cited the claim on the milk carton to support his contention. “Well, the carton lies; the fat content in 2% is closer to whole milk than to skim milk,” countered his challenger. “If you want low fat, you need to drink skim or 1%.” A trip to the library to consult a nutrition textbook led Davis to the conclusion that the other student was correct. “A glass of 2% milk has about five grams of fat, compared with eight grams of fat in whole milk and nearly zero in skim.”

Thus, the stage is set for the message of The Healthy Skeptic. Do your own searching for the evidence to support health claims. Davis, a health journalist and teacher at Emory University’s Rollins School of Public Health, makes a clear distinction between skepticism and cynicism. The former demands much more of us. He cites this quote from Marcia Angell, former editor-in-chief of The New England Journal of Medicine:

Cynicism is much easier than skepticism because it requires no distinctions. We needn’t distinguish between reliable evidence and unreliable evidence, between big dangers and small ones, between likely effects and unlikely ones, between the reasonable and the bizarre. Yielding to cynicism over skepticism is therefore an easy way out.

Thanks to the Internet, searching for reliable evidence is much easier today. The Healthy Skeptic does much of the research for you, taking on some of the most common health messages about foods, beverages, drugs, vitamins, herbal remedies, sunscreen and other products that bombard the public, mostly by way of the news media. Sometimes the hype is obvious; for example, the selling of yet-another exercise gadget in one of those middle-of-the-night infomercials.

Too often, however, it’s not so obvious that you are viewing a sales pitch. Exhibit A is the notorious video news releases, or VNRs, used for years by TV stations large and small. The VNR can look like an objective news item; for example, a reporter interviewing a physician who comes across as an independent expert about a new superfood or drug. VNRs are, in fact, what Davis calls “propaganda disguised as news,” bought and paid for by the company that makes the product. Sometimes that fact is mentioned briefly at the end of the VNR; sometimes it isn’t.

Celebrity pill-pushing can be mistaken for morning show chitchat. Years ago, actress Kathleen Turner did a round of TV and print interviews, discussing her “battle” with rheumatoid arthritis. Her mention of a helpful Web site in each interview came across as information-sharing—that is, until it was revealed in 2002 that Turner was a well-paid spokeswoman for Immunex, a bio-pharmaceutical company, which along with Wyeth, makes the RA drug Enbrel. The recommended Web site was theirs.

There was a backlash in the media after Turner was outed as an industry-funded shill. Now such financial arrangements are usually disclosed during the “interview,” but as The Healthy Skeptic notes, it can be acknowledged so quickly and offhand that the disclosure can go unnoticed.

In a section entitled, “Sunscreen Science,” we learn that sunscreens have become a $500 million-a-year business since these products were introduced in the early 1970s. But increased sunscreen use has not reduced the rate of melanoma, the deadliest form of skin cancer. In fact, studies have produced conflicting results about their most important protective benefit.

Some studies found sunscreen use decreases the rate of melanoma; some found usage increases the rate of melanoma; and others showed no effect either way. On the other hand, there is clear evidence that sunscreens protect against squamous cell carcinoma, which can be disfiguring but rarely fatal. As for basal cell carcinoma, the least dangerous and most common type of skin cancer, there is little solid evidence that sunscreens reduce its risk.

You are not likely to hear these uncertainties from your doctor. The leading supplier of information about sunscreens to the public as well as health professionals is the Skin Cancer Foundation. Despite its seemingly non-commercial name, Davis says the Foundation’s list of corporate benefactors reads like a “who’s who of sunscreen manufacturers”.

This small book does not simply expose such things as the “iffy assertions” of doctors who practice anti-aging medicine; the lack of definitive evidence about calcium’s benefit to bone health; the overselling of prevention and the exaggerated dangers of high cholesterol. It also provides a way of assessing public-health messages, their funding sources, and most important, the quality (or absence) of the supporting evidence.

(Disclosure: The Center for Medical Consumers is described as a “trustworthy source of information” in the chapter about cholesterol.)

Whether you choose to be a cynic or a skeptic is entirely up to you.

Maryann Napoli, Center for Medical Consumers© 2008

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Why is Anyone Taking Zetia or Vytorin?

Posted by medconsumers on October 1, 2008

Vytorin and Zetia Continue to be Prescribed Despite Hints of Harms and No Proof of Benefit

There is no proof that Zetia can do anything beyond lowering cholesterol—no evidence that it can reduce heart attacks or cardiovascular disease, which, of course, is the ultimate goal. Once again, this blockbuster drug sold alone or as a combination medicine has produced negative clinical trial results. This time it failed to provide any benefit to people with heart-valve disease. Worse, there were more cancers and cancer deaths among the drug-treated participants than in those taking a placebo, though these findings are described as “due to chance.”

Release of preliminary results of this trial had generated so much interest in the media last summer that The New England Journal of Medicine allowed the final results to be available on its Web site in early September—well in advance of the planned publication date.

Zetia is a relatively new cholesterol-lowering drug that can be prescribed alone. Vytorin combines Zetia with the 22-year-old statin drug, called simvastatin (brand name Zocor), into a single pill. Last year this expensive, heavily promoted combination drug became what only can be described as a drug maker’s worst nightmare. Study results showed that Vytorin was no better at reducing atherosclerosis of the carotid (neck) arteries than the older, cheaper simvastatin alone. There was also a hint that Vytorin might actually worsen artery disease.

And if that’s not bad enough, Merck and Schering-Plough Corp., which jointly market Vytorin, had withheld these unfavorable study results for nearly two years. It was, of course, in the financial interest of both companies to do so because Vytorin and Zetia are among the top-selling drugs worldwide. Four years after both drugs went on the market, backed by an aggressive ad campaign that featured a “food and family” cholesterol theme, yearly sales reached $5.2 billion.

On its Web site last month, The New England Journal of Medicine also published an editorial and an analysis that addressed Vytorin’s possible cancer-causing effect. The analysis was based on all the people diagnosed during the new heart-valve study and two other, much larger ongoing Vytorin trials. It was conducted by an Oxford University, U.K, research team, which found no increase in cancer incidence, but did find an increase in cancer deaths among those taking Vytorin. This finding was described as due “entirely to the play of chance rather than to a true increase in cancer mortality.”

The New England Journal of Medicine editors, however, are not so sure. In an editorial, they described a plausible mechanism for a cancer-causing effect, “[Zetia] interferes with the gastrointestinal absorption not only of cholesterol, but also other molecular entities that could conceivably affect the growth of cancer cells.” Once the cancer concerns were made public again last month, the FDA announced that its own analysis is in the works.

What makes this Vytorin/Zetia story so appalling is the fact that Zetia’s only advantage over the older statin drugs is a 17% greater reduction in LDL cholesterol. Incredibly, Merck and Schering-Plough were able to sell doctors and the public on the idea that this is more important than proof that this drug can cut the risk of heart attack (which has been proven for statins prescribed to high-risk men and people with heart disease). Zetia was studied for only 12 weeks before it went on the market.

Despite their uncertain safety records, Zetia and Vytorin continue to be prescribed to people with high LDL cholesterol. After the initial bad publicity, sales of Vytorin and Zetia dropped 40% in the first six months of 2008. That’s encouraging. But the question remains: Why is anyone still taking these drugs?

Maryann Napoli, Center for Medical Consumers ©
October 2008

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Chantix: Another FDA Failure?

Posted by medconsumers on June 1, 2008

For an inveterate FDA watcher like me it was an interesting spring. First, the agency’s failure to police the safety of imported medical products became front-page news when it was revealed that batches of the blood-thinner heparin caused fatal allergic reactions because of contaminated ingredients imported from China. Coming on top of the lead-painted children’s toy and poisoned pet food episodes of a year earlier, the incident confirmed that the FDA lacked sufficient resources to carry out the requisite inspections of overseas manufacturers under its jurisdiction.

The predictable result was a firestorm of criticism from Congress and the press. For the first time that anyone could remember an FDA Commissioner violated the Washington protocol that political appointees do not lobby Congress on behalf of their own agency. Andrew von Eschenbach did just that in a letter to a key Senator requesting $275 million as a supplemental appropriation

Predictably, a Bush Administration spokesperson said that the additional funds are not necessary.
Besides introducing legislation to provide additional funding, lawmakers are considering a requirement that imported drugs, medical devices and food products be labeled with the country of origin and a special identification number to help FDA track unsafe products back to their manufacturer. Legislation has also been proposed that would impose fees on manufacturers and importers to fund overseas inspections of their manufacturing facilities. Significantly, some lawmakers want to give the FDA the power to order recalls of unsafe imported food and medical products. At present the FDA can only ask a manufacturer to withdraw its product.

On the domestic front, a report linking the antismoking drug Chantix to a large number of deaths and serious injuries was released recently by the Institute for Safe Medication Practices (ISMP). Earlier, the FDA had issued a Public Health Advisory warning that the drug was associated with serious neuropsychiatric reactions, including suicide.

The ISMP researchers found that Chantix users had an inordinately large number of severe injuries, major seizures, movement disorders and heart rhythm disturbances often leading to loss of consciousness, as well as transient blindness.

Chantix, which is made by Pfizer, has become the most frequently mentioned drug in serious injury reports to FDA after only 18 months of availability. From October to December 2007, almost 1,000 Chantix injury reports were received by the FDA compared to a median of five injury reports for other problem drugs over the same time span, according to the ISMP.

Because the antismoking drug’s side effects could render a user unconscious or temporarily blind, the ISMP findings set off immediate alarms about Chantix’s risks to airline pilots, train, bus, and subway operators, truck drivers and those who operate any other heavy machinery. To avoid the possibility of a catastrophic airline accident, the FAA promptly banned the drug’s use by flight crews. And, the Federal Motor Carrier Safety Administration issued a warning advising medical examiners “to not qualify anyone currently using this medication for commercial motor vehicle licenses.”

Since drivers of motor vehicles include almost the entire U.S. population over age 16, the FDA should be asking Pfizer to immediately withdraw Chantix from the market. Helping people stop smoking may be an important public health goal but not when the trade-off is an even earlier drug-related death.

Arthur A. Levin, MPH, Center for Medical Consumers ©
June 2008

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Failed Vytorin Study Raises Questions About Cholesterol

Posted by medconsumers on February 1, 2008

A firestorm of bad publicity erupted over cholesterol drugs last month when an expensive combination drug proved to be no better than an older drug alone. This finding was suppressed for 20 months by Merck and Schering-Plough, the two companies that make Vytorin, which is a one-pill combination of Zetia and Zocor. Their two-year trial failed to prove that Vytorin is better than Zocor alone for slowing plaque accumulation; instead atherosclerosis worsened in those taking Vytorin.

But the study results were not revealed until the two drug companies were pressured into doing so by an article in The New York Times and a Congressional inquiry. Worldwide, about one million prescriptions for Vytorin and Zetia are written each week, and they generated about $5 billion in sales last year. Zocor can be purchased under its generic name simvastatin for less than $6 for a month’s supply; whereas an equivalent amount of Vytorin costs about $100. It was obviously in the two companies’ interest to withhold the negative results for as long as they could get away with it.

When Vytorin came on the market two years ago, it was impossible not to be cynical about its purpose. Merck’s patent for Zocor was running out, and its blockbuster status would soon be diminished with generic competition. The company joined forces with Schering-Plough, maker of Zetia, and sought FDA approval for Vytorin. Their FDA-required trials showed a 17% greater reduction in LDL, the so-called bad cholesterol, than Zocor alone.

Making this 17% reduction in LDL look like an amazing achievement was not much of a stretch. Merck and the makers of other statin drugs like Lipitor and Pravachol had already paved the way. Their respective marketing machines had long ago misled most of us (doctors included) into thinking that cholesterol reductions equal heart attack reductions. One consistently overlooked fact about statins: They are far better at lowering cholesterol than preventing heart attacks or strokes. And those small reductions in heart attacks and strokes shown in clinical trials are largely confined to high-risk middle-aged men and those with heart disease or diabetes. Vytorin, on the other hand, has not been proven to reduce heart attacks or strokes in anyone.

LDL Reduction Irrelevant

Though doctors tend to focus their statin-taking patients on the size of their LDL reductions, heart disease researchers have long ago noted that this is likely irrelevant. Statin trials often show that the size of the cholesterol reductions are not consistent with reductions in heart attacks. Such observations led researchers to suspect that the ability of statins to reduce heart attacks and strokes has less to do with cholesterol reduction and more to do with other biological effects like plaque stability and anti-inflammatory effects. Another important but overlooked observation: “Elevated LDL identify less than one half of individuals who will die from coronary heart disease” (Rosenson et al. Antithrombotic Properties of Statins, JAMA, May 27, 1998).

The fall-out from the Vytorin debacle continues to reverberate. At this writing, Merck and Schering-Plough are running full-page ads daily in the Times and Wall Street Journal, warning people not to be confused by a single study and to continue taking Vytorin. The advice was backed by the American Heart Association, which appeared to be an independent source until The Times reported that the AHA receives nearly $2 million a year from Merck/Schering-Plough Pharmaceuticals.

One of the unintended consequences of two drug companies withholding their negative trial results is that it led some in the media, notably Alex Berenson, an investigative reporter for the Times, to look back at another important failed cholesterol drug trial and question the very foundation of heart disease prevention. In his heretically titled article “Cholesterol as a Danger Has Skeptics,” Berenson cites Pfizer’s trial of its much-anticipated drug torcetrapib that raised HDL, the good cholesterol, and lowered LDL. The trial had to be stopped in 2006 because the drug caused heart attacks and strokes. (Sound familiar? Postmenopausal hormones were widely prescribed because they were so good at improving cholesterol levels but they also increased the risk of heart attack, stroke and blood clots.) “Torcetrapib’s failure shows that lowering cholesterol does not prove a drug will benefit patients,” said a skeptical Walter Reed cardiologist quoted in Berenson’s article.

Many researchers, physicians and scientists around the world have long questioned the import of high cholesterol for anyone other than middle-aged men. In fact there is an International Network of Cholesterol Skeptics (disclosure: we belong), but the skeptics have been marginalized over the years. Now some mainstream media like Business Week and the cardiology Web site, TheHeart.org are willing to give them voice.

Could the house of cards be falling? Would the house of cards be allowed to fall when a worldwide $40 billion-a-year industry is at stake?

For More Information

The International Network of Cholesterol Skeptics www.thincs.org

Business Week magazine (www.businessweek.com) click into past issues, January 17, 2008 Lipitor cover story: “Do Cholesterol Drugs do any Good?”

TheHeart.org from Web MD www.theheart.org, see video blog of Eric J. Topol, MD, who questions the import of LDL reduction in “Temple of the LDL Cholesterol.”

Maryann Napoli, Center for Medical Consumers ©
February 2008

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Restless Legs Syndrome: Two Heavily Promoted Drugs

Posted by medconsumers on September 1, 2007

Very likely you never heard of restless leg syndrome (RLS) before 2003. That’s when Glaxo-SmithKline launched a media campaign to promote awareness of this condition that the company described as “underdiagnosed.” Not incidentally, two years later Glaxo’s drug Requip received FDA approval for the treatment of RLS. The drug was already on the market as a treatment for Parkinson’s disease.

Within a year of its RLS approval, Requip was on track to post sales of $500 million, making it one of the fastest-growing drugs in Glaxo’s portfolio, according to the Wall Street Journal. Predictably, another company Boehringer Ingelheim got in on the action with its Parkinson’s drug, Mirapex.

Though RLS invites the usual suspicions that this is yet another illness made up by drug companies intent on expanding their markets, it appears to be real. For some people it can be disabling enough to interfere with sleep on a regular basis. But it is also likely, thanks to Glaxo’s ongoing promotional campaign with its ads aimed at doctors and the general public, that RLS is now overdiagnosed. And many people may be taking a serious drug indefinitely for a minor annoyance that could be treated non-pharmacologically or not at all.

How do you know you have it? These four criteria must be met for a diagnosis of RLS:

  • An urge to move the legs due to an unpleasant feeling in the legs;
  • Onset or worsening of symptoms when at rest or not moving around frequently;
  • Partial or complete relief by movement (e.g., walking) for as long as the movement continues;
  • Symptoms that occur primarily at night and that can interfere with sleep or rest.

Several things to keep in mind if you are taking Requip or Mirapex:

  • According to company-sponsored trials, about 70% of the people on Mirapex or Requip reported a reduction in symptoms; so did more than 50% of those on placebo.
  • These FDA required pre-approval trials lasted only 3 to 36 weeks; therefore the safety and effectiveness of taking a RLS drug longer is unknown.
  • The precise mechanism of action of Requip and Mirapex as a treatment for RLS is unknown, according to company-generated label information.
  • Because the FDA-required pre-approval studies have a relatively small number of participants and are short-term, information about a drug’s serious adverse effects usually comes out years after it comes on the market (if at all). Here is what is known to date: Both drugs can cause some people to fall asleep during everyday activities like driving, eating or talking to someone.

Have all non-pharmacological alternatives been explored?

  • Try doing without any drug that can precipitate RLS, such as antihistamines, caffeine, alcohol, nicotine, as well as numerous prescription drugs, including antidepressants, anti-nausea, neuroleptics (e.g., antipsychotic drugs, major tranquilizers).
  • Engage in moderate exercise, for example, a brief walk before bedtime. Avoid unusual and excessive exercise, which may precipitate RLS.

Maryann Napoli, Center for Medical Consumers ©
September 2007

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Zyprexa and Other Drugs for Dementia

Posted by medconsumers on July 1, 2007

The frequently prescribed antipsychotic drugs are causing a slight increase in deaths in demented elderly people, according to a study published recently in Annals of Internal Medicine. You might wonder: Why on earth would a doctor prescribe antipsychotics—drugs that are used to treat schizophrenia and bipolar disorders—to a demented elderly person? In fact, doctors have been prescribing these drugs to demented elderly people for nearly 50 years with little or no evidence to support the practice, and misleading promotion of the newer, far more expensive antipsychotics have made things worse in the last seven years.

The newer antipsychotic drugs, sold under the brand names of Zyprexa, Risperdal and Seroquel, began to come on the market in 1996. Strong promotional campaigns on the part of the drug makers have had their intended effect, and doctors began to favor them over the older drugs because they are thought to have fewer adverse effects. (No head-to-head comparison trial with elderly demented participants has proven this commonly held belief.) The prescription of any antipsychotic for dementia is an off-label use, which means their safety and effectiveness are unproven according to FDA standards. But that rarely stops doctors who can prescribe drugs as they wish.

What’s more, the small increase in deaths associated with the newer antipsychotic drugs has been known for years. Fifteen out of 17 clinical trials reviewed by the FDA in 2005 found a 1.6 to 1.7 higher death rate in people taking one of these drugs compared to people taking a placebo.

The usual next step for the FDA is to mandate a black box warning in the drug “label,” which hardly anyone reads, including most doctors. (A drug label is a 20- to 40-page insert largely aimed at physicians and rarely comes with the drug.) In 2005, the FDA issued a public health advisory, stating that use of all three newer antipsychotics to treat elderly people with dementia is associated with an increased risk of death. The deaths appeared to be heart- or infection-related (mostly pneumonia). The Canadian regulatory agency, Health Canada, issued its own warning to doctors the same year.

The warnings seem to have made only a small difference. Sales temporarily dipped a bit, as some doctors thought it would be safer to switch their demented patients to one of the older antipsychotics like haloperidol (brand name: Haldol).

That brings us back to the latest antipsychotic drug study, which not only confirmed the slight increase in deaths but also found that the mortality risk may be even greater with the older antipsychotics that have been prescribed since 1958. This study involved over 27,000 elderly people living in Ontario, Canada, who were a mixture of people living in nursing homes or in the community.

The research team led by Sudeep S. Gill, MD, drew information from several databases, including pharmacy records, hospitalization records, billing information for health services and death records. From these sources, the researchers identified people with dementia who did and did not receive prescriptions for antipsychotic drugs. They then looked to see if the people were alive at 30, 60, 120, and 180 days after the initial prescription for the antipsychotic. The death rate of those who had received prescriptions was compared with the death rate of those who had not.

What Now?

Will this and the 15 other studies showing an increased death rate make any difference in the way doctors prescribe antipsychotics? Maybe not, but at least there is now an explanation for why they continued to prescribe the drugs despite the warnings. The story became public at the end of last year thanks to The New York Times reporting of the lawsuits against Eli Lilly, maker of Zyprexa.

Fraudulent Promotion

The 18,000 lawsuits were not filed on behalf of demented elderly people, but on behalf of people with schizophrenia and bipolar disorders who developed diabetes as a result of taking Zyprexa. The lawyer representing the plaintiffs provided New York Times reporter, Alex Berenson, with documents that revealed the fraudulent nature of Lilly’s campaign to get doctors to prescribe Zyprexa to a broader segment of the population.

In late 2000, Lilly began a campaign instructing its sales representatives to encourage primary care doctors to treat the symptoms and behaviors of schizophrenia and bipolar disorder, even though this specialty has no training in diagnosing or treating either illness.

According to The New York Times, Lilly’s sales representatives were trained to present physicians with misleading profiles of the perfect candidate for Zyprexa. One of the more outrageous examples was “Donna, a single mother in her mid-30s whose chief complaint is, ‘I feel so anxious and irritable lately.’”

The campaign was successful in increasing sales. By 2005 Zyprexa became Lilly’s best-selling product with $4.2 billion in global sales. Zyprexa and the other newer antipsychotics are three to nine times more expensive than the older drugs like Haldol.

By law, drug makers may promote their drugs only for diseases for which the FDA has found the medicines to be safe and effective. But they are rarely prosecuted for Lilly’s type of fraudulent drug promotion that could result in deaths of people who are not even appropriate candidates for the drug.

All drugs have their risks that must be accepted along with their benefits. So goes the justification for allowing drugs to remain on the market after fatalities are reported. But in the case of antipsychotics for dementia, an important question lingers: What are their benefits? No one tried to answer this question in a systematic way until 2002 when the Cochrane Collaboration published a review of all trials about Haldol, the oldest antipsychotic.

The Cochrane reviewers found that by 1989, there was some evidence that Haldol provided “a modest overall benefit” compared to nothing (i.e., a placebo). But two advances occurred after 1997—better trials were published (five in all, lasting 3-16 weeks) and a better understanding of the various behaviors associated with dementia. As a result, the Cochrane reviewers were able to identify a subgroup of demented people who benefited from Haldol: those whose dementia-related agitation takes the form of aggression.

The drug’s adverse reactions that include Parkinson-like symptoms, such as rigidity, and involuntary movements were found to be acceptable to this subgroup of demented patients as well as their caregivers. In return, Haldol reduced the risk of aggressive behavior.

A more recent Cochrane review, published in 2006, looked at two newer antipsychotics—Zyprexa and Risperdal—for people with Alzheimer’s disease. The review concluded that the adverse effects of these drugs may be too severe to justify their “modest efficacy.”

Maryann Napoli, Center for Medical Consumers ©
July 2007

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Honesty in Drug Advertising: Some rare examples

Posted by medconsumers on May 1, 2007

“In patients with multiple risk factors for heart disease, LIPITOR REDUCES RISK OF HEART ATTACK BY 36%* If you have risk factors such as family history, high blood pressure, age, low HDL (‘good’ cholesterol) or smoking.”

The noteworthy part of this New York Times ad is the asterisk and this explanation of the 36% statistic: “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.”

Take a moment to appreciate the significance of this rare finding of candor in one of those ubiquitous Lipitor ads featuring Dr. Robert Jarvik, “inventor of the Jarvik Artificial Heart and Lipitor user.” Most drug ads would rather proclaim a “36% reduction” and leave it at that, but this version shows exactly what it means. Take Lipitor for years and your risk of having a heart attack drops 1%. Granted, the explanation is in much smaller type than the 36%, but at least it’s there.

Another Jarvik/Lipitor Times ad proclaims: “In patients with type 2 diabetes, LIPITOR REDUCES RISK OF STROKE BY 48%* If you also have at least one other risk factor for heart disease…” The explanation: “That means in a large clinical study, 2.8% of patients taking a sugar pill or placebo had a stroke compared to 1.5% of patients taking Lipitor.”

It’s rare to see ads with drug benefits expressed in what statisticians call absolute risk terms, which are more understandable to the public as well as doctors. Tom Abrams, director of the FDA Division of Drug Marketing, Advertising and Communications, explained in a telephone interview that the FDA encourages drug companies that provide quantitative information (e.g., 36% reduced risk of heart attack) in their ads to show what it means. In other words, the ad must answer the question: 36% of what?

Whether quantitative information goes into an ad is up to the drug companies, but once it does, the FDA wants them to put in the explanation, Abrams said, though only the most egregious non-compliers get a warning letter. Why no explanation of the quantitative information in all TV versions of these ads? “This is a quicker media and companies believe that people can’t process the information?” he said.

Well, honesty in some print ads is better than nothing. The next thing to look for is the quantification of the drug’s severe adverse effects…in absolute risk terms.

Maryann Napoli, Center for Medical Consumers ©
May 2007

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Reporting Drug Company Gifts to Doctors

Posted by medconsumers on June 1, 2006

“DODGEBALL”
The Pharmaceutical Companies’ Direct Marketing To Doctors and The Impact on Health Care Costs and Patient Safety

Written by:
Blair Horner
Michael Hartwell
Arthur Levin, MPH

Recommendations endorsed by:
AARP
Center for Medical Consumers
Consumers Union
New York Public Interest Research Group
New York State Alliance for Retired Americans
New York StateWide Senior Action Council

June 2006

Read the full report.

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Vytorin: Yet Another Cholesterol Drug

Posted by medconsumers on February 1, 2006

Vytorin Ads Aimed at Keeping Profits High

“Pay no attention to direct-to-consumer ads for prescription drugs. These are meant to sell drugs, not educate consumers, and they only add to the prices you pay.” Even if you follow this wise advice offered by Marcia Angell, MD, in her acclaimed 2004 book, The Truth About Drug Companies, chances are you will have one of the following drugs prescribed by a physician. They are currently advertised heavily to doctors as well as the general public. Not surprisingly, the most aggressively promoted drugs wind up to be the most frequently prescribed…and the most frequently given out as free samples. In many cases, there are lower cost alternatives.

Vytorin to Lower Cholesterol

When a blockbuster drug is due to lose its patent protection—and blockbuster is usually defined as sales over a billion dollars a year—the drug company must find creative ways to keep the profits high. Vytorin illustrates one path commonly taken by drug companies. This drug is the creation of the pharmaceutical giant Merck, which will soon face competition from cost-cutting generic drug companies when its blockbuster cholesterol-lowering drug, Zocor, goes off patent this year.

Working with another drug company, Schering-Plough, Merck has come up with Vytorin.  Sometimes referred to as the newest statin, the top-selling class of cholesterol-lowering drugs in the world, Vytorin combines an older statin, Zocor (generic name: simvastatin), with a newer cholesterol-blocking drug called Zetia, made by Schering-Plough. To allow plenty of time to sell doctors the idea that they should prescribe a newer, more expensive drug, Vytorin came on the market in 2004—well before Zocor’s patent runs out. Its sales have risen steadily ever since.

How Long Did the Vytorin Studies Last?

People are usually on cholesterol therapy for life; yet the two FDA-required clinical trials lasted only 12 and 23 weeks, respectively. In both trials, participants were randomly assigned to take either Vytorin, a placebo (sugar pill), Zocor, or Zetia. The study participants taking Vytorin showed greater reductions in the so-called “bad cholesterol,” or low-density lipoproteins. Whether Vytorin is better than any other single-ingredient statin drug at reducing the risk of a heart attack or stroke has not been studied.

Cautions:

Statins are great at lowering cholesterol; but they are much less impressive at lowering the risk of heart attack and stroke in people without heart disease. Media reports usually refer to statins as safe or well tolerated. Rarely is it mentioned that virtually all the clinical trials involving statins were conducted by the drug’s manufacturer. And many of these drug trials have failed to release all the data involving adverse reactions. [See the review of primary prevention trials www.ti.ubc.ca, Letter #48.] Therefore, the safety of long-term statin use remains unknown. Even less is known about the safety of the other drug in Vytorin, called Zetia, which works by partially blocking the absorption of cholesterol in the small intestine. Zetia was approved by the FDA in 2002 based on its cholesterol-lowering ability, shown in two trials that lasted only two and eight weeks, respectively.

Alternatives:

Two statins, Zocor and Pravachol, will become available generically this year, and only one, lovastatin (brand name: Mevacor), is already available generically for $1.00 to $1.88 a day, compared with $4.00 a day for the top-selling statin, Lipitor. If you are taking an expensive statin, ask your doctor whether you can switch to generic lovastatin. No long-term head-to-head comparison trial of all six statin drugs has been conducted to determine whether Lipitor is superior to the others in reducing the risk of heart attack or stroke.

Maryann Napoli, Center for Medical Consumers ©
February 2006

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Selling Sickness

Posted by medconsumers on January 1, 2006

BOOKS WE LIKE

Selling Sickness: How the World’s Biggest Pharmaceutical Companies Are Turning Us All Into Patients (New York: Nation Books, 2005)

We are being manipulated by the pharmaceutical industry. The we in this case includes the general public, doctors, researchers, consumer advocacy groups, federal health officials, and politicians. The pharmaceutical industry exerts its influence over virtually all aspects of the medical care system. It sets a lion’s share of the research agenda; has a strong say in the ever-changing definitions of normal; controls most of the average doctor’s postgraduate pharmacological education; and is changing the way we think about illness in order to sell more drugs. Just to name a few.

With predictable regularity, one “silent epidemic” after another—high blood pressure, high cholesterol, bone loss, depression—is promoted either directly with “educational” advertising or indirectly through media stories inspired by the press releases of multi-national pharmaceutical giants that stand to profit from our fears. And the industry isn’t above creating a few diseases of its own. Shyness is now a social anxiety disorder; whereas menopause has long been a hormone-deficiency disease. Both, of course, have prolonged drug therapy as the solution.

More often the pharmaceutical industry has a hand in broadening the definition of illness so that more and more people can be funneled into long-term drug therapy. In the not-so-distant past, for example, one did not have osteoporosis until a fracture had occurred; now the diagnosis can be applied to anyone who shows more bone loss than the average 35-year-old (on a bone density test). How this particular diagnostic change occurred can be traced to a World Health Organization meeting funded by producers of drugs that stop bone loss.

In “Selling Sickness,” Ray Moynihan, a journalist, and Alan Cassels, a pharmaceutical policy researcher at the University of Victoria, British Columbia, carefully document pharmaceutical industry tactics in hyping awareness of and selling drugs for ten common conditions. Moynihan and Cassels do not dispute the fact that conditions like hypertension and osteoporosis can in fact lead to heart attacks and hip fractures, respectively, in some people. And others like depression and irritable bowel syndrome cause undeniable suffering.

Moynihan and Cassels object to industry-influenced expanding definitions of illness that turn millions of healthy people into lifelong patients. Too often thresholds for normal blood pressure and cholesterol are lowered, resulting in the same effect. Too often the normal travails of life or afflictions of aging are “medicalized.” Moynihan and Cassels found that 90% of the experts who sit on committees that set disease definitions and treatment guidelines for their peers have a conflict of interest because of financial ties to the drug industry.

For many doctors, the bulk of their information about new drugs comes from the materials supplied by the ubiquitous drug salespeople who regularly visit doctors at their offices armed with gifts and detailed information about their prescribing practices. (The Wall Street Journal once reported that there are 7,000 salespeople in the U.S. solely selling the cholesterol-lowering drug, Lipitor.) Moynihan and Cassels report how two Canadian health professionals are working to counter industry tactics by bringing unbiased information directly to doctors as well as the general public.

Bob Rangno, a physician, and James McCormick, a doctor of pharmacy—both members of Therapeutics Initiative at the University of British Columbia—travel the province delivering the same lecture. As recounted in “Selling Sickness,” they explain to a group of retirees that high blood pressure is not a disease in itself. Rather, it is one factor that can raise their risk of a future heart attack or stroke. Then Rangno and McCormick go on to demonstrate how easy it is to mislead with statistics, a common drug industry tactic. Their powerpoint slide shows the following questions based on study results:

Would you take a drug every day for five years if it…

A) lowered your chance of having a heart attack by 33%?

B) lowered your chances of having a heart attack from 3% down to 2%, a difference of 1%?

C) saved one person in a hundred from having a heart attack but there is no way to know in advance who that one person will be?

Rangno and McCormick ask the audience how many would take the drug based on question A, and about 80-90% raised their hands. Only about 20% indicated that they would take the drug based on questions B and C.

Then Rangno and McCormick reveal that all three questions are based on exactly the same study results. They explain that if a person’s risk of having a heart attack is 3% to start with, taking an antihypertensive drug to reduce that by 33% would bring that risk down to 2%. The 1% difference explains the one in a hundred who will benefit from the drug. “Advertisements to doctors and patients will claim, for example, that a drug offers a 33% reduction in the risk of heart attack without explaining that in actual fact you may have to take the medicine for five years in order to lower risks from 3% to 2%.” The surprised reactions they elicited from this audience of senior citizens, say Rangno and McCormick who have given this lecture numerous times, is no different from those expressed by an audience of physicians.

Industry’s marketing strategies are illustrated aptly in the chapter on female sexual dysfunction. To show how “new disease markets” are created, Moynihan and Cassels cite a business report, intended only for drug company marketing executives and potential investors, that “outlines how companies are ‘expanding the patient pool’ by using marketing campaigns to change public perceptions about what used to be considered normal life.”

Companies that make erectile dysfunction drugs are expanding their market to include women. But activists are fighting back. Chief among them is psychologist Dr. Leonore Tiefer, New York University School of Medicine, who is said to have documented the fact that for almost every key meeting where this new condition was being defined, the funding came directly from the pharmaceutical companies. She attends many of these meetings objecting to the narrow focus on genitalia and voicing another view of women’s sexual difficulties, which she acknowledges are widespread. “Women’s sexual problems and satisfactions have far more to do with relationship difficulties, life stress, and cultural expectations than with clitoral blood flow or testosterone levels.”

Tiefer’s five-year campaign of activism, which has had a strong impact on public debate via the media, merits imitation, say Moynihan and Cassel, “Her colorful campaign could well become a guide for others looking to expose and combat corporate attempts to inappropriately widen the boundaries of human illness.”±

Maryann Napoli, Center for Medical Consumers © January 2006

Posted in Book Reviews, Conflict of Interest, Drug ads, Heart, Women's Health | Tagged: , , , | Comments Off

 
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