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Reliable Information on the Internet

Posted by medconsumers on November 1, 2005

Written by Maryann Napoli at the request of the New Zealand Guidelines Group in anticipation of her appearance at the National Consumer Summit in Auckland, October 31, 2005.

Much as I’d like to respond to this assigned topic with a list of sure-fire ways to identify trustworthy Web sites, I’m sorry to say that I cannot. From this USA-based consumer advocate’s point of view, there isn’t much I can wholeheartedly recommend out there. I wouldn’t think of relying on the standard sources like the American Heart Association and the National Cholesterol Education Program given their considerable pharmaceutical industry funding.

And the fact that a board of academic physicians oversees a Web site’s content is no guarantee of high-quality information. Case in point is the U.S. National Cancer Institute’s Physicians Data Query (PDQ) database www.cancer.gov I still see it as the best source of evidence-based cancer treatment information, despite the fact that I have found numerous gross errors in this Web site over the years. Lobular carcinoma in situ, for example, was described as a breast cancer (leading women to think immediate aggressive treatment is critical); whereas LCIS is merely a marker for cancer. In another instance, prostatectomy was described (in 1989) as the most common first choice treatment for prostate cancer—a misleading statement given the fact that there is no evidence that proves it superior to no treatment at all. Worse, the no-treatment option appeared in the “health professionals” section of the database but not in the material directed at “patients.” My critiques of the PDQ have always been taken seriously and often led to changes. “Watchful waiting”, for example, now heads the list of treatment options for men with early-stage prostate cancer…in both the “patient” and the “health professional” sections of the database.

The American Cancer Society, on the other hand, was unresponsive when I asked why it instructs doctors to tell their patients about the risks and benefits only where it concerns the PSA screening test for prostate cancer. After all, that’s not the only cancer screening test with risks as well as benefits.

Though the explosion of information available on the Internet is gratifying in many ways, it is still hard to find certain information crucial to informed decision-making. Just take a decision many of us will have to make: Should I take a prescription drug for the rest of my life? Millions of healthy adults around the world have accepted the idea that risk factors like bone loss and high cholesterol should be treated with lifelong drug therapy.

The woman with osteoporosis told to take the bone drug Fosamax will find lots of information about how the drug improves bone density. But how good is it at reducing the rate of hip fracture, the most serious consequence of osteoporosis?  It’s not easy to ferret out the three-year trial which found 2% of women on the placebo experienced a hip fracture, compared to 1% of women on Fosamax. These results are enlightening, considering how heavily promoted this drug is. Only 1% of the women on Fosamax actually benefited from the drug; and only 2% had a hip fracture without the drug. You can find this information at the U.S. Food and Drug Administration’s Web site (www.fda.gov). but it takes some doing. First, you must find your way to the right section of the site and then slog through reams of fine print of the drug labeling information that the pharmaceutical company publishes with FDA oversight.

Even then, you wouldn’t know that this three-year trial provides the best long-term effectiveness information on Fosamax—and it applies only to elderly women with osteoporosis and at least one fracture. That doesn’t represent the primary Fosamax users in the USA, thanks to misleading drug advertising aimed at physicians. When Fosamax first came on the market ten years ago, its maker Merck mounted an advertising campaign featuring white women in early middle-age. No mention of prior fractures, but plenty of encouragement for bone-density testing (screening creates customers). As an antidote to this market-driven poison, osteoporosis researcher Susan M. Ott, MD, University of Washington, maintains an advertising-free Web site that helps women and doctors determine when drug therapy is and is not appropriate (http://courses.washington.edu/bonephys).

Anyone about to go on an open-ended drug regimen would want to weigh the benefit against the odds of having a serious adverse drug reaction. Three years ago, when writing about the popular cholesterol-lowering drugs called “statins” (Lipitor, Zocor, Pravachol, etc.), I was pursuing that question on behalf of my readers with high cholesterol but no heart disease.  Fortunately, I found my way to a trustworthy source of drug information, Therapeutics Initiative in British Columbia, Canada (www.ti.ubc.ca Letter 48). It was the only place I found the odds of benefit compared to the odds of having a serious adverse drugs reaction. Five major trials have compared statins with placebos in people without heart disease. Only two trials, however, have released their serious adverse events (SAE) data! Working with what they had, the Canadian researchers combined the results of the two trials and found only one modest benefit to statins. These much-touted drugs reduced the odds of a non-fatal heart attack by 1.8% (in men only). But this modest benefit was canceled by a 1.4% increase in the rate of SAEs among the statin users! And if someone wants to check whether a particular statin—or any other drug—is so risky it should be taken off the market, there’s always the Washington, DC-based Health Research Group (www.citizen.org/hrg).

Consumer advocates willing to take the time can find some gems of hypocrisy at the most mainstream of Web sites. Every November the federal government in the form of the U.S. Centers for Disease Control and Prevention scares us (via the media) with influenza death statistics. This has the desired effect of making people think they’re going to die if they don’t get a flu shot. (The death stats, by the way, are deeply suspect.) One consumer advocacy organization, the National Vaccine Information Center (www.909shot.com), led the media to transcripts of the FDA’s Vaccines Advisory Committee meetings freely available at the FDA’s Web site (though, once again, difficult to find). There for all to read were the flu experts saying in early 2003 that they had screwed up. One key viral stain had been omitted from the flu shot that was promoted vigorously as the 2003-04 flu season approached. Federal health officials just couldn’t bring themselves to be honest with the American public until the time to get a flu shot had passed. After all, we might not line up for our shots, and then the vaccine companies would have to discard their unsold products. Go to flu vaccine reviews at the Web site of the Cochrane Collaboration (www.cochrane.org), and you’ll find that, worldwide, flu vaccines haven’t worked very well in the last 35 years.

I know people don’t want to hear this, but you practically have to become an investigative reporter to find what you want…or don’t yet know you want. One has to sift through a considerable amount of information on the Internet to learn how to determine what’s valid and what isn’t. My parting advice: No matter what the topic, start with a Google search (www.google.com). It produces a wealth of information—both good and bad—and often free access to entire articles.

Maryann Napoli, Center for Medical Consumers ©
November 2005

Posted in Advocacy, Chronic Conditions, Conflict of Interest, Drugs, Heart | Tagged: , , | Comments Off

Medicare Marketing Blitz Takes Aim at Seniors

Posted by medconsumers on October 1, 2005

Seniors are already getting an avalanche of mail and telephone solicitations as the insurance industry’s marketing of Medicare’s new prescription drug plan (known as Part D) officially takes off this month.

The Associated Press reports that the large insurers approved by Medicare to offer prescription drug insurance (Aetna and United Health among others) are each planning to spend between $30 and $80 million on marketing campaigns. At stake is an estimated $10 billion dollars in additional revenues which Wall Street has characterized as “an earnings bonanza.” I would call it “insurance industry pork.”

Medicare recipients will continue to be on the receiving end of this marketing blitz throughout the Part D enrollment period, which begins November 15, 2005 and ends in May 2006. Seniors should also be prepared for some insurers to promote their Medicare Advantage plans as a better choice than signing up only for stand-alone drug coverage.

These plans are a “managed choice” alternative to traditional Medicare and include hospital and physician coverage as well as drugs, but they limit the choice of doctors and other providers. The “bait” for switching to Advantage is that, at least during the initial enrollment period, the plans will pick up some or all of the Part D out of pocket cost of premiums and deductibles. These could easily add up to thousands of dollars for seniors who chose to remain in traditional Medicare.

The government has offered billions of dollars in subsidies to encourage insurers to offer Advantage plans. These subsidies make selling Advantage plans a much more profitable business for insurers than selling only the stand-alone drug coverage – at least over the short term. But when the subsidies end after a few years, the plans are likely to become unprofitable as the growing ranks of aging and sicker seniors run up larger medical bills. Insurers, having reaped billions in Medicare subsidies, are then free to bail out of the market, as they have in the recent past.

Unfortunately people are not being given trustworthy information to guide them in making important coverage decisions about the new plans. One would hope that Medicare itself could be counted on to provide accurate guidance. However, there are conflicts of interest that suggest otherwise.  The new plans are the “first strike” in the administration’s efforts to privatize Medicare.  And Medicare spent millions on a slick, but inaccurate, advertising campaign to sell the new plans to the public, according to the U.S. General Accountability Office (GAO). This suggests that the administration knowingly put politics ahead of the welfare of those on Medicare.

To help beneficiaries sort through a bewildering number of choices, Medicare is touting a help tool on its web site (www.medicare.gov/medicarereform/drugbenefit.asp). Seniors can supposedly enter the drugs they use to help select an appropriate plan. However, as of press time, it was not possible to do so. Because every plan will have a different list of covered drugs, people need to check to make sure that a plan covers the drugs they take. But be warned that plans can change the drugs they cover at any time. People without Internet access are told to call 1 800 MEDICARE. However, callers should keep in mind that a December 2004 report by the GAO found that hotline staff provided either inaccurate answers or no answers to four out of ten callers.

Many seniors are members of the AARP, which offers guidance at www.aarp.org/health/medicare (click on “Guide to the New Medicare Prescription Drug Coverage”).  Members should be aware of AARP’s own conflicts of interest. The organization very publically lobbied for passage of the administration’s plan; and it receives over $100 million in annual royalties from sales of health insurance  to its members.

The best advice may be to resist the inevitable appeals by marketers to make an immediate decision. Marketers may use the threat of higher premiums to push seniors to enroll on the spot. But in fact there is no penalty until after enrollment ends in May 2006. Hopefully, before then there will be more trustworthy information available. And if some in Congress get their way, enrollment may be extended and “independent” counselors available to help people navigate the new benefits.

Arthur A. Levin, MPH, Center for Medical Consumers ©
October 2005

Posted in Men's Health, Women's Health | Tagged: | Comments Off

Overdosed America

Posted by medconsumers on December 1, 2004

New Book: Overdosed America-the Broken Promise of American Medicine

No, this isn’t another book about Americans popping too many pills and paying exorbitant prices for them. Its far more worrisome premise is summed up in the long subtitle: How the Pharmaceutical Companies Distort Medical Knowledge, Mislead Doctors, and Compromise Your Health. Author John Abramson, MD, is troubled by the commercial influences that pervade all aspects of American medical care. The pharmaceutical industry’s influence can be seen in everything from the sponsoring of continuing medical education to the latest treatment guidelines that make an ever-expanding number of Americans candidates for life-long drug therapy.

A Harvard Medical School faculty member, Dr. Abramson writes that he thoroughly enjoyed practicing family medicine for over 20 years. But he had become increasingly disturbed by the new brand of medical consumerism, typified by the middle-aged male patient who came in demanding an expensive, widely advertised prescription drug (Celebrex). No amount of explaining about cheaper, safer and equally effective alternatives could change his patient’s mind.

It is not only his patients who get a skewed view of new drugs, observed Dr. Abramson, his fellow physicians were influenced by the same promotional campaigns, often masquerading as education. Whereas taxpayers once funded most medical research, the pharmaceutical industry now pays the lion’s share. By now, many Americans know that the pharmaceutical industry has one of the highest profit margins of the Fortune 500 companies. How many know that the industry spends more money on marketing (from advertising to free drug samples for doctors) than on research?

Dr. Abramson left his practice to spend the next two and a half years doing what most practicing doctors have little time to do—“researching the research.” He found that drug companies have been known to: design clinical trials in such a way that ensures their products will come out on top; withhold the trials that show negative results; focus attention on the benefits while giving short shrift to the harms; and ‘spin’ equivocal results in a way that puts their drugs in a favorable light.

What’s more, the people selected for clinical trials are often unrepresentative of the majority for whom the drug will ultimately be prescribed. Cancer drugs are offered as an example. “Nearly two-thirds of all cancer patients are 65 or older,” observes Dr. Abramson, “but only one-quarter of the people in cancer studies have reached 65.” Many of the articles published in medical journals, even the most prestigious ones, he found, are little more than infomercials for the drug.

In time, Dr. Abramson began to detect the frequent use of overblown statistics guaranteed to scare people into a life-long drug regimen. Two years ago, The New England Journal of Medicine published a study about a new, inexpensive blood test that measures blood levels of inflammation in the body called C-reactive protein, or CRP, which supposedly can predict a person’s risk of heart disease. The study followed 28,000 women over eight years and found that those with the highest CRP levels were more than twice as likely to develop heart disease. The study’s authors concluded that identifying people with elevated CRP would allow “optimal targeting of statin therapy.” In other words, a way to identify future customers for cholesterol-lowering drugs.

What’s wrong with this picture? asks Dr. Abramson after the largely uncritical media picked up the CRP story and ran with it as “ground-breaking” and “extremely important.” A closer look at the statistics from this study showed that the 28,000 female participants were less than 55 years old and healthy. Their risk of heart attack, stroke, etc. was quite small. For “every 1000 women with the highest CRP levels, there was only slightly more than one (1.3) additional episode of cardiovascular disease each year than among the 1000 women with the lowest CRP levels.” In other words, the twice-as-likely-to-develop-heart-disease statistic boiled down to a doubling of odds that were tiny to begin with.

With the relentless focus on drugs, Dr. Abramson suggests that doctors and the general public tend to overlook the considerable body of research showing that regular exercise, smoking cessation, and a healthy diet trump nearly every medical intervention as the best way to keep heart disease at bay.

Americans tend to have faith in the latest high-tech medical care, but a large Medicare study challenged some common assumptions. Areas of the country with higher concentrations of specialists have both higher health care costs and worse health care outcomes.

“The public needs access to independent expert opinion that can counterbalance the enormous influence that the medical industry wields over our beliefs about the best approach to health and medical care,” writes Dr. Abramson. (Full disclosure: The Center for Medical Consumers is mentioned twice in this book as one of the rare sources of unbiased information.) A new national public body with the independence and expertise of the Institute of Medicine , he suggests, is the only way that will ever be accomplished.

Maryann Napoli December 2004

Posted in Book Reviews, Cancer | Tagged: , , , , | Comments Off

Deceptive Drug And Device Ads

Posted by medconsumers on May 1, 2004

Center for Medical Consumers to FDA: Rein In Those Deceptive Drug Ads

The FDA is currently rethinking its guidelines for corporations that advertise their prescription drugs and medical devices to consumers. Don’t think that the regulatory agency has your best interests at heart. For one thing, the FDA cannot screen the ads for accuracy before they are unleashed upon the public, nor does it have the staff to track all the print and broadcast ads after the fact. The new guidelines currently under consideration by the FDA are just as wimpy as the old ones. The FDA can only provide guidance to the drug and device industries thereby living up to its reputation as a toothless tiger.

In a perfect world, one where the FDA actually served the public’s interest, these ads would be abolished altogether. That’s never going to happen. Here’s the Center for Medical Consumers’ pie-in-the-sky recommendations that the FDA is unlikely to follow:

  • Make those entrepreneurial radiologists hawking whole-body scans and heart scans reveal the risks in their ads. They should be made to identify the radiation doses involved, as well as the high likelihood that scans will lead to unnecessary biopsies and detection of a type of cancer that would have remained dormant. As things stand now, a company can advertise any outrageous claim about, say, its digital mammography or scans with impunity as long as the brand name of the equipment is not revealed in the ad.
  • Include the rate of effectiveness in all ads. Only about 10% of all drug ads currently address this important issue; the rest give the impression that everyone benefits from the product. To get FDA approval, a drug must prove to be better than nothing (i.e., a placebo). Let the public know how much better.
  • Stop telling us that drug advertising is a good form of consumer education. Ads are designed to sell a product, not to provide balanced information. That’s why you see so many ads devoted to new, i.e., expensive, “me-too” drugs (think: Celebrex and Vioxx, Prilosec and Nexium, Lipitor and Zocor). That’s why you see little in the way of education— just a few promising words in the headlines like power and strength .
  • Abolish all “disease awareness” ads. They masquerade as public service announcements because no drug is named. This type of ad is all about selling fear of a disease, the need for testing, and drumming up customers for lifelong drug therapy. Merck, maker of the osteoporosis drug, Fosamax, provides a classic example: “Osteoporosis—could you be at risk…. ask your doctor whether a bone density test is right for you.”
  • Don’t allow companies to advertise diagnostic or screening tests to the public without proof that the new technologies are better than the old. Ads touting the expensive Pap screening technology called ThinPrep are a case in point. Such promotional activities have raised the cost of Pap testing without improving the accuracy of finding cervical cancer. To gain FDA approval, the maker of ThinPrep (and any other screening technology) has to prove only that it could find cancer, not that it is any better at finding cancer than the standard Pap test.
  • Be straight with the public about the limits of FDA testing requirements. Each ad should have a disclaimer, such as: To be approved by the FDA, a drug has only to be proven safe and more effective than a placebo, not better than older drugs prescribed for the same condition. The drug trials required for FDA approval typically last eight to 12 weeks.
  • Require the drug companies to list a few of the most common and most serious side effects in the body of the ad. Print ads are currently mandated to include the misnamed “brief summary” in tiny type on the reverse side of the ad. Anyone who reads the entire brief summary—and not many people do—will appreciate the concept of befuddling the public with too much information.
  • Speed up the process for pulling a misleading ad. The FDA usually waits for someone to complain about a misleading ad. Then the agency takes too long to remove it, according to a report from the U.S. General Accounting Office. What’s more, there is no penalty. Corrective ads are rare, though deception is not. We were cheered to see the recent corrective ad for Pravachol, the cholesterol-lowering drug. Its maker, Bristol-Myers Squibb, had to run full-page ads in such publications as The New York Times and Parade, stating that Pravachol “has not been proven to help prevent stroke in people without heart disease. Pravachol is proven to help prevent stroke only in people with coronary heart disease.” [Note: Though most ad complaints come from a competing drug maker, according to an FDA spokesman, the Bristol-Myers Squibb lie was found by FDA staff.]

Our suggestions to the FDA were made last month in a letter written in response to the agency’s request for comments on its guidance to industry. We do not have high hopes that they will be taken seriously given the current political climate. (Political contributions from the drug industry totaled $29 million in 2002.) The FDA’s hands are tied by a Congress unwilling to release the necessary funds or rein in the pharmaceutical industry. Meanwhile, drug costs continue to rise, much of it because advertising promotes the most expensive new drugs, not necessarily the safest or best drugs.

Maryann Napoli
May 2004

Posted in Drug ads, Drugs | Tagged: , , , | Comments Off

How To Read A Prescription Drug Ad

Posted by medconsumers on December 1, 2001

How To Read a Drug Ad
By Maryann Napoli

Fear mongering is the subtext of many of the prescription drugs ads you see on TV and in print. These ads might just as well come out and say: OK, you’re healthy now, but any time in the near future you can die from a heart attack, cancer, or hip fracture. The surest route to high profits is the expensive drug that must be taken daily for years, preferably for life, out of fear of a disease that might create symptoms 10, 20, 30 years down the road.

Many of the ads play on fears of aging. Middle-aged people (with the necessary drug-coverage) are the natural targets. It helps to read these ads skeptically because many are riddled with half-truths. Here are some representative examples of the different approaches to advertising prescription drugs to the public. All are bound by the rules of the Food and Drug Administration (FDA).

Sell Fear of the Disease

Osteoporosis-Could you be at Risk? This is the headline of the current ad campaign sponsored by Eli Lilly, which does not mention its osteoporosis drug, Evista (generic name: raloxifene). Anytime the drug and its purpose appears in an ad, then the side effects and adverse reactions must also be included.

But Eli Lilly’s ad illustrates another option in drug advertising. Instead of identifying its drug, a company can choose to sell the dangers of a given disease, in this case, osteoporosis. Ads like this one must list an 800 number that will generate a free packet of information and your name on the company’s mailing list for life.

Up to half of women over age 50 will break a bone due to osteoporosis in their lifetime. And the risk increases when menopause ends, warns the Eli Lilly ad, which features a fiftyish woman. The statement is true, but choosing the age of 50 as the cut-off is guaranteed to instill fear.

The following statements are not found in the ad, but they are also true: A woman’s odds of having an osteoporosis-related hip fracture between the ages of 50 and 70 are low. Half of all hip fractures in women occur after the age of 80.

Years ago, the diagnosis of osteoporosis was made only after the person experienced a fracture due to thinning bones. Now, the definition of osteoporosis has changed to simply mean low bone mass. In other words, what was once a risk factor for fracture is now a disease. Susan M. Love, MD, author of Dr. Susan Love’s Hormone Book, writes that the panel of experts that changed the definition of osteoporosis was funded in part by pharmaceutical companies.

Sell a Test

See how beautiful 60 can look? See how invisible osteoporosis can be? This is the headline for Merck’s ad, featuring an older woman. It’s a good example of the indirect approach to selling drugs: Encourage people to go for testing and invariably you will create many new customers for your drug. Several years ago, Merck announced that it had entered a financial agreement with a major bone density measurement equipment company, in order to get these expensive machines into as many doctor offices as possible.

Merck does not mention its osteoporosis drug, Fosamax, in this ad which simply advises, Ask your doctor if a bone density test is right for you. It almost comes across as a public service announcement.

To prompt the hesitant women into action, Merck adds, ominously, The fact is, if you’re 60 or older, there’s a nearly 1 in 2 chance you have osteoporosis. Yes, this statement is probably true given the above, expanded redefinition of the “disease.” However, there is a debate among osteoporosis researchers about the value of measuring bone density because the test can’t predict who will eventually have a fracture. Some evidence indicates that bone turnover may be more relevant, but there is no available test for it.

Name the Drug…and its Side Effects

High Cholesterol Isn’t Just A Number It’s A Warning, the message screams out from Bristol-Myers Squibb’s ad for its cholesterol-lowering drug, Pravachol (generic name: pravastatin sodium). This represents the type of ad that identifies the drug and its purpose (“protect your heart”), so it must also list side effects and adverse reactions. In the case of a print ad, the side effects appear in tiny type on the next page. Surveys show that few people read the fine print, and this includes doctors.

The ad emphasizes the Pravachol’s safety because a competing cholesterol-lowering drug, Baycol, was withdrawn last summer after it caused 31 deaths. The ad attempts to get the people who just went off Baycol to: Ask your doctor to tell you more about high cholesterol, the risk of heart attack, and if Pravachol is right for you.

The safety claims in this ad are: “Pravachol is no more likely to cause side effects than a placebo (sugar pill) in landmark clinical studies.” Well, yes, that’s true, but only the people who turn the page and read the fine print will learn that this refers solely to the FDA-required trials that lasted only four months. Most people who take cholesterol drugs do so indefinitely, and the fine print has 16 lines of side effects experienced by drug-treated people in the longer trials that lasted five to six years
.
The long list of side effects was attributed to the entire class of “statin” drugs, which includes Pravachol (pravastatin) and Baycol (cervistatin), Mevacor (lovastatin), and Zocor (simvastatin). The 31 deaths attributed to Baycol were due to a rare condition called rhabdomyolysis, which causes a breakdown of muscle tissue. All statin drugs have this rare risk, according to The Medical Letter (9/10/01), a physician publication with no drug advertising.

Name the Drug, But Not the Condition

This is the strangest approach to drug advertising because it mentions the name of a drug but not what it’s for. This type of ad circumvents the FDA-requirement of listing side effects once the drug’s purpose is identified. It is best exemplified by Schering-Plough Corporation’s ads for Claritin, a drug for seasonal allergies. They usually feature a close-up of a young woman’s face against a bright blue sky and often some flowers in the background. The message is simply: Ask your doctor about Claritin.

Claritin stands as a testament to the power of advertising and as a classic example why a drug doesn’t have to be any good to become a big seller. Schering-Plough spent a record $136.8 million advertising Claritin directly to consumers in 1999 alone. It paid off. Claritin is the most profitable antihistamine of all time, with annual sales of more than $2 billion, according to The New York Times. A month’s supply costs about $85.

Claritin is no more effective than older, cheaper antihistamines. Its much-touted advantage is the lack of drowsiness that comes with other antihistamines. Two FDA-required trials showed that Claritin is better than a placebo, but not much better. At 10-milligram doses, Claritin was only 11% more effective than a placebo. Taken at higher, more effective doses, the drug causes drowsiness.

End-Run Around the FDA

TV ads are generally bound by rules similar to those of print ads. In 1997, however, the FDA relaxed the rules for broadcast advertising where it concerns side effects. From that year on, only the major side effects had to be mentioned in radio and TV ads that name the drug and its purpose. This accounts for the massive increase in TV ads for prescription drugs.

But some major side effects can be a major turn-off, and that has led to some creative bending of the FDA rules. And this is best illustrated by Roche’s ads for Xenical, a weight-loss drug. How many people would run out and ask their doctors for Xenical after hearing that anal leakage is a common side effect?

Roche has found a way to avoid this information with its two-part TV commercials for Xenical. The first ad does not mention Xenical; it simply shows quick images a baby growing up to be a heavy-set woman while describing excess weight as unhealthy. The second ad names the drug but not the condition, using the same background music and images. By separating the two ads with brief unrelated commercials, Roche has circumvented FDA rules about describing side effects. The ads appeared early this year, and thus far, no warning letter to Roche from the FDA has appeared on the agency’s Web site.

What to consider when reading a drug ad:

-Many ads leave the impression that everyone who takes the drug will benefit from it. You will want to know how effective the drug has been proven to be in terms of, say, reducing heart attacks, fractures, or cancer recurrences, etc. Rarely, will a drug ad ever provide this crucial information. Consult the Physicians’ Desk Reference, which is available at most community libraries. It can also be purchased at most chain bookstores. The book is difficult to read, but it is the only readily available source of data concerning what has been proven in drug trials and how long the trials lasted.

-Avoid taking any newly approved drug when there is an alternative. The pre-approval studies required by the FDA usually last only a few months and do not include enough participants to uncover rare side effects. In the last decade, a number of prescription drugs have been withdrawn within five years of becoming available due to life-threatening side effects. This has led many consumer advocates to advise people to wait at least five years from the date of release before taking any new drug. This also allows time for follow-up studies to determine whether the new drug is truly an improvement over the older versions of the same medication.

-These ads are increasing the cost of health care for everyone. The 50 most-advertised prescription medicines contributed significantly last year to the increase in the country’s spending on drugs, according a new report. It also found that these 50 drugs accounted for almost half of the $20.8 billion increase in drug spending last year. The report was prepared by the National Institute for Health Care Management, a nonprofit research foundation. Only the drugs still under patent, and therefore expensive, are advertised directly to the public.

-Drug ads are not checked by the FDA for accuracy beforehand, though drug companies are free to do so voluntarily. This occurs infrequently. Instead, the ads are pulled only after complaints are made and verified. This usually takes about six months, and the drug company is given several additional months grace period. Companies whose ads are judged to be misleading will receive a warning letter that is published on the FDA Web site. Offending drug companies incur no penalty for misleading the public. They are merely told to withdraw the ad. Many drug companies change their ads every six to 12 months anyway. On rare occasions, a company may be required to run a corrective ad.

-Go to the FDA’s Web site (www.fda.gov). You will find a wealth of information about drugs, as well as dietary supplements (herbs and vitamins). On the home page alone, you can go to “Safety Alerts” and see the latest recalls; “Product Approvals” for information about the new drug approvals; “How to Report a Problem to the FDA;” and “Drug Information” for standard labeling facts, such as side effects, purpose, warnings for specific drugs.

(December 2001)

Posted in Drug ads, Drugs | Tagged: , , | Comments Off

Links: Drugs

Posted by medconsumers on January 21, 1982

American Medical Students Association
AMSA grades medical schools on the presence or absence of a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. Working with The Prescription Project, the AMSA developed a rigorous and transparent methodology to assess the content of policies at medical schools throughout the country.

www.besttreatments.org/risk
British Medical Journal Publishing Groupand United HealthCare Services provide help in understanding risks and benefits when deciding to take a drug.

Consumer Reports
Free in-depth reports about safety and effectiveness of 12 commonly prescribed drugs. Emphasis is on price.

DrugAlerts.com
Latest on drug recalls, FDA warnings, and drugs in litigation. Site is sponsored by trial lawyers.

Drugs.com
DrugWatch.com
Both Web sites provide free information about drugs, including indications, side effects, and warnings.

FDA Homepage
Find out about drug recalls, recent drug approvals, and other pharmaceutical information at the Food and Drug Administration’s Web site.

MedWatch
MedWatch, the FDA medical products reporting program, allows consumers to report and read about serious reactions and problems with drugs and medical devices.

National Institute for Health Care Management Research and Educational Foundation
Learn more about the relationship between higher drug costs and the federal laws which protect the pharmaceutical industry from competition in the making and marketing of drugs. See how much the Pharmaceutical industry spends advertising the most expensive prescription rugs directly to consumers.

No Free Lunch
Physicians, medical students and residents concerned about the influence of the pharmaceutical industry – especially freebies.

Number Needed to Treat
How many people have to be treated with a drug to save one life or prevent one serious occurrence (e.g.,stroke or heart attack)?

The People’s Pharmacy
Web site of pharmacist Joe Graedon and his wife Terry, who have long written a syndicated newspaper column. Mostly about drugs but home remedies are also discussed because visitors are encouraged to ask questions.

PHARMALOT
A blog that provides commentary on the pharmaceutical industry and related litigation.

Public Citizen Health Research Group
This Ralph Nader-affiliated consumer advocacy organization serves primarily as an FDA Watchdog, petitioning the agency to get dangerous drugs and devices off the market.  Free access to several sample issues of its Health Letter.

Therapeutics Initiative
Based at University of British Columbia, Vancouver, Therapeutics Initiative publishes a free online newsletter about drugs that is aimed primarily at physicians. Check out the podcasts.

www.medicationsense.com
Dr. Jay S. Cohen provides articles about prescription drugs and how often people stop taking them because the dose is too high.

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