Posts Tagged ‘pharmaceutical industry’

Heart News 2007

Posted by medconsumers on December 31, 2007

The heart-related news has lately been a roller coaster of good, bad, and maybe not so bad. One popular prescription cholesterol-lowering statin drug might soon be sold over the counter. Defibrillators of the kind implanted years ago in Vice President Dick Cheney were in the news last month when studies showed they are more likely to be given to white men. But this needn’t be seen as yet-another example of women and minorities deprived of appropriate heart care. A new study showed that men with implanted defibrillators had a higher death rate than women with exactly the same heart condition who were not given implanted defibrillators.

And remember those drug-coated stents that scared heart patients over a year ago when it was announced that they increased the risk of potentially fatal blood clots long after they were inserted to prop open a constricted artery? Well, drug-coated stents made headlines again last month suggesting that they may not be so dangerous after all.

What do we make of all this?

For starters, an over-the-counter cholesterol-lowering drug might be a good idea for certain people. Not simply as a money-saver, but as a means of getting good-quality written drug information to the user. With a few exceptions, prescription drugs do not automatically come with FDA-approved printed information, though it comes tucked into the packaging of virtually all drugs sold over the counter.

We might be grasping at straws here, but mandated consumer drug information produced with FDA oversight is far better than the current situation. Then warnings like this about Lipitor—“tell your doctor if you have more than two drinks a day”—might actually reach the people who take the drug.

The prescription drug under consideration for over-the-counter status is Mevacor. That it is a statin drug and therefore a member of the top-selling drug class worldwide—$35 billion in annual sales—makes the switch all the more interesting. (Other statins are Lipitor, Crestor, Lescol, Pravachol, and Zocor.) Merck, the company that makes Mevacor, has recently applied to the FDA for permission to sell the drug over the counter. And an advisory committee of experts will decide the issue this month. (In 2005, an FDA Advisory Committee rejected a similar application for Mevacor.)

Two statin drugs Pravachol and Zocor are already available generically, which means that their patents have run out and now any company can produce these drugs under their generic names at a far lower cost than any brand-name statin. For example, Zocor, prescribed generically as simvastatin, costs from 75 cents to $1 a day at most retail drug stores and 10 cents a day, if purchased at a discount pharmacy like Costco’s. Lipitor, on the other hand, can cost $2.50 to $4 a day. From the FDA point of view, generic versions are equivalent to branded drugs because they must go through a process of proving that to the agency.

Many drug plans are encouraging members who take an expensive statin to switch to one of the generic versions with financial incentives like lower co-payments. And if Mevacor gets FDA approval for over-the-counter sale, statin users will have yet another low-cost alternative with the added feature of eliminating some doctor visit charges.

All this is cutting into the huge profits long enjoyed by Pfizer, the company that makes Lipitor, which is the most prescribed drug in the world. Naturally, the company wants to make as much money as possible before Lipitor loses its patent in March 2010. Consequently, Pfizer has escalated its long-running ad campaign featuring Dr. Robert Jarvik, inventor of the Jarvik artificial heart, who has been hugely successful in convincing many doctors and consumers that Lipitor is superior to other statins.

Currently, some of the Jarvik/Lipitor ads, say, “There’s a common misconception that all cholesterol-lowering medications are the same.” And more specifically, “In clinical studies LIPITOR lowered bad cholesterol significantly more than generic Zocor and Pravachol.”

Both points refer to a 2004 clinical trial that found people with heart disease showed a reduced degree of atherosclerosis progression if they were on high-dose Lipitor (80 mg) for 18 months, compared with those on a moderate dose of Pravachol (40 mg). There was also a greater reduction in LDL, or “bad” cholesterol, shown in the heart patients who took the high-dose Lipitor.

Three things to keep in mind about this trial, known by its acronym REVERSAL: Its participants all had heart disease (the overwhelming majority of U.S. statin-takers do not); REVERSAL was not designed to see whether Lipitor or Pravachol prevented heart attacks or strokes. And lastly, it compared a high-dose of Lipitor with a moderate-dose of Pravachol, leaving open the possibility that Pravachol at 80 mg might be just as good. Still, REVERSAL provides the basis for the Pfizer claim that Lipitor is not only better than other statins but it should also be prescribed in high doses for people with heart disease.

As for the most crucial goals of statin therapy: all statins, with the exception of Crestor, have been shown in clinical trials that predate REVERSAL to reduce the risk of heart attack and stroke in people who already have heart disease.

Healthy But High Risk

As for people without heart disease, the proven benefit of statins is largely confined to high-risk men between 30 and 69 years. The magnitude of this benefit, however, is not impressive—1.5% fewer of those taking a statin will suffer a non-fatal heart attack. But one analysis of all statin primary prevention trials showed that this 1.5% benefit was canceled out by an equivalent risk of experiencing a serious reaction to the statin.

The promotional activities of statin manufacturers have successfully focused most doctors and the general public on the excellent cholesterol-lowering effects of these drugs. But no head-to-head comparison study of all six statins has answered the most important-to-consumers questions: Which drug is best at preventing a heart attack or stroke? How large is the benefit?

There is a Jarvik/Lipitor print ad that answers the how-large-is-the-benefit question for high-risk people without heart disease. “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.” In smaller print, the same ad has this explanation of “reduces risk” under the asterisk: “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.” This ad is a rarity because it explains the 36% reduced risk. Take Lipitor for years and your risk of having a heart attack drops from 3% to 2%.

Lately, Pfizer has been trying to stem the exodus to generic statins by touting a new study that purportedly shows more heart attacks or strokes in people who switched from Lipitor to simvastatin, compared with those who stayed on Lipitor. There’s little reason to take this study too seriously.

First of all, Pfizer funded the study, and drug company-funded studies are notorious for coming up with conclusions that favor their products. Second, it was presented on a poster at a recent European cardiology conference, and has yet to be published or fully peer reviewed. (The New York Times, however, recently reported that this study has been accepted by the British Journal of Cardiology and will soon be published.) Lastly, the study is based on an analysis of medical records of British heart patients who did or did not switch from Lipitor to the generic version of Zocor (simvastatin). The study’s design is not regarded as high quality; in fact the authors describe its limitations this way: “This is an observational database study, and as such has recognizable limitations; therefore the findings should be regarded as hypothesis-generating.”

NB: There’s a consensus among cardiologists that statins are generally safe and are extensively studied. Perhaps they are, but three of the five major primary prevention randomized trials have not released all of their statistics on serious adverse reactions, according to James Wright, MD, and John Abramson, MD, who co-authored a commentary early this year in The Lancet, entitled “Are Lipid-Lowering Guidelines Evidence-Based?” The full story about the safety of statin drugs is unknown.

NEWS ABOUT DEFIBRILLATORS

An unexpected finding showed up when a team of Duke University researchers tracked elderly people with heart failure who did and did not have defibrillators implanted to prevent sudden death. Those who had a defibrillator implanted lived no longer than those who did not. That was the contrary-to-expectations finding 180 days after implantation.

But when these heart patients were followed longer, the results were worse for the men. Their mortality rate in the year after implantation was higher than that of women without defibrillators, though all had similar heart problems. To take into account the fact that women live longer than men, Leslie H. Curtis, PhD, and colleagues at Duke University School of Medicine, confined their study to men and women under the age of 75 years.

Their new findings come at a time when implantable defibrillators are, once again, in the news for having serious defects that have caused a few deaths. These devices monitor the patient’s heart rhythm and deliver an electric shock once dangerously erratic rhythms are detected.

The Duke researchers analyzed a national 5% sample of the Medicare claims filed for more than 35,000 people from 1991 through 2005. All had been diagnosed with heart attack and either heart failure or cardiomyopathy. Men were three times more likely than women to have the device implanted. Of those with heart disease but no prior cardiac arrest or tachycardia (rapid heartbeat), defibrillators were implanted in 32 per 1,000 men and about 9 per 1,000 women.

The gap between man and women didn’t close for the most seriously ill patients—those with prior cardiac arrest or tachycardia. For this group, the implanted defibrillator rate was 102 per 1,000 men and 38 per 1,000 women.

A related study, published in the same October 3 issue of the Journal of the American Medical Association, found that black men and women were also less likely to have a defibrillator implanted than white men.

“The bad news may not be for women and minorities, but for white men who are undergoing a procedure that for primary prevention does not extend their lives,” wrote Rita F. Redberg, MD, in an editorial that accompanied the two studies.

NEWS ABOUT DRUG-COATED STENTS

The bad news about this topic originally came from the World Congress of Cardiology in September 2006. Presented at this international conference were clinical trials that found a slightly increased risk of death and a higher rate of potentially fatal blood clots in people who had drug-coated stents implanted during a coronary-artery-opening procedure called angioplasty. The trials compared them with other heart patients whose constricted coronary arteries were propped open with stents not coated with a drug.

The higher risks among those given drug-coated stents did not show up until four years of follow-up. These complications were confirmed in two separate analyses of the combined results of company-sponsored trials by Boston Scientific, maker of the Taxus stent, or Johnson & Johnson, maker of the Cypher stent. The medicine coating these stents is intended to keep the constricted arteries from closing up again.

Last month the national media reported good news about drug-coated stents from the annual meeting of the American Heart Association in Orlando, Florida. Two-year follow-up results from a new, yet-to-be-published clinical trial showed that drug-coated stents are no more risky than bare-metal stents. Some media reports left the impression that the issue of stent safety had been resolved with this trial. “Heart Stent Gets a Reprieve From Doctors” was the over-the-top New York Times headline.

Keep in mind that the new trial announced at the heart meeting lasted only two years and the blood clots in the above-mentioned company-sponsored trials did not show up until four years. More details will be available when the new trial is published in Circulation, the journal of the American Heart Association, according to a “Late-Breaking News Release” from the heart meeting.

The meeting organizers managed to focus the media on stents rather than the more critical issue—overuse of artery-opening procedures. Many of the one million or so Americans who undergo angioplasty each year (with or without stents) can be treated just as successfully with drug therapy. It is generally the same multiple drug therapy advised for everyone who undergoes angioplasty. This was proven in a government-sponsored study called the Occluded Artery Trial, or OAT, published last year in The New England Journal of Medicine. A follow-up analysis of the OAT results was presented at the American Heart Association meeting. Yet no mainstream media reported the new OAT analysis, according to Health News Review, a medical media watchdog group led by journalist Gary Schwitzer.

All 2,166 OAT participants had a totally blocked major coronary artery and were 3 to 38 days away from suffering a heart attack. All were randomly assigned to receive an artery-opening procedure plus drug therapy or drug therapy alone. The multiple-drug therapy included daily aspirin, beta-blockers, ACE inhibitors and cholesterol-lowering drugs.

After four years, the OAT participants in the angioplasty/drugs group had the same rate of survival, second heart attack, and heart failure as the group given drug therapy alone. When the 469 American OAT participants were singled out (this was an international trial), the angioplasty-treated heart patients generated costs that were $10,000 higher than the drug-treated people. After three years, the cost difference had dropped to $7,000.

In an editorial that accompanied the OAT findings last year in The New England Journal of Medicine, L. David Hillis, MD, and Richard A. Lange, MD, wrote, “The open-artery hypothesis, although not previously validated in a prospective, randomized study, has nonetheless been embraced by many practicing physicians.” Translation: Heart surgeons have been opening constricted coronary arteries for years on the unproven premise that this will save lives and reduce the risk of a future heart attack. The OAT results failed to validate that hypothesis.

Opening a blocked artery during or right after a heart attack has been proven beneficial, but the OAT results showed no benefit to the common practice of performing angioplasty well after the patient had been stabilized—3 to 38 days after suffering a heart attack.

Maryann Napoli, Center for Medical Consumers ©
2007

Posted in Chronic Conditions, Heart | Tagged: Drugs, Heart, pharmaceutical industry, Screening, side effects, statins | Comments Off

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

Posted in Chronic Conditions, Drugs, Pain | Tagged: Drugs, insomnia, marketing, overtreatment, pharmaceutical industry | Comments Off

Best Pain Relievers for Diabetic Neuropathy

Posted by medconsumers on July 8, 2007

Several older drug classes were found to be superior to newer drugs for short-term pain relief for people with diabetic neuropathy, a painful nerve disorder that affects the legs. These findings came from a review of all relevant studies conducted by a Hong Kong team led by Man-chun Wong, a pain management nurse at United Christian Hospital, and published recently in the British Medical Journal Online First.

Wong and colleagues searched the published medical literature for all trials in which people with diabetic neuropathy had been randomly assigned to take either a drug or a placebo. Topical and oral drugs were included in the trial search as were prescription drugs and over-the-counter products. Only 25 trials were of high enough quality to be included in the review.

Wong and colleagues found that an older class of antidepressants called tricyclic antidepressants and an older class of anticonvulsants were best for short-term relief of pain. So are two opioids: OxyContin and Ultram. Tricyclic antidepressants were introduced in the 1950s, and have several brand names that include Tofranil, Elavil, Deprexan and Impril (Canada).

Anticonvulsants also provide pain relief for people with diabetic neuropathy, although the drugs are primarily intended to control seizures in epileptics. Wong and colleagues found the older anticonvulsants, such as Dilantin and Apo-Carbamazepine (Canada), approved in the 1930s and 1960s, respectively, to be superior to the newer anticonvulsants, such as Neurontin, approved in 1981.

The clinical trials included in this review typically lasted between two and 12 weeks. Wong and colleagues warned, “Evidence of the long-term effects of oral antidepressants and anticonvulsants is still lacking.”

Maryann Napoli, Center for Medical Consumers ©
July 2007

Posted in Chronic Conditions | Tagged: Diabetes, Drugs, pharmaceutical industry | Comments Off

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

Posted in Chronic Conditions, Mental Health | Tagged: Alzheimer's, Drugs, marketing, pharmaceutical industry | Comments Off

Avandia Debacle: Strong Medicine Needed to Cure FDA’s Ills

Posted by medconsumers on June 1, 2007

Scarcely two weeks after the Senate overwhelmingly passed legislation touted as a major fix of FDA’s failing effort to assure drug safety, The New England Journal of Medicine published an analysis linking the diabetes drug Avandia to a 40% increase in the risk of heart attack. This finding is especially troubling because people with diabetes are already at high risk of cardiovascular problems. A million diabetics are estimated to be current Avandia users in the U.S.

The review of safety data from dozens of trials was conducted by Cleveland Clinic cardiologist Steven Nissen, MD, and biostatistician Kathy Wolski, MPH. In 2005, another Nissen-led study concluded that an about-to-be-approved diabetes drug, Pargluva, had a high risk of cardiovascular problems, a finding that convinced the FDA not to grant approval. Avandia and Pargluva are both members of a class of diabetes drugs known as PPAR. Another drug in the class, Rezulin, was withdrawn in 2000 because of its liver toxicity; while a fourth, Actos, remains a best-seller.

Subsequent revelations have raised even more questions about the FDA’s ability to assure drug safety. According to The New York Times, John B. Buse, MD, Chief of Endocrinology at the University of North Carolina and President-elect of the American Diabetes Association, wrote to the FDA seven years ago warning of Avandia-associated heart problems. And almost a year ago, Glaxo, maker of Avandia, informed the FDA that its own internal analysis suggested cardiac risks associated with the drug.

But the FDA has said that the evidence of safety problems is inconclusive and that there is no cause for regulatory action. Not so with the FDA’s European counterpart. The European Medicines Agency, which apparently has a lower threshold for action, put out strong warnings about cardiovascular risk back in September 2006. And the director of the FDA division responsible for post-market safety recently told members of Congress that his staff’s recommendation of a black box warning for the drug’s label was overruled by senior management.

So, will the recently passed Senate bill fix the FDA’s poor record in assuring drug safety? In an editorial commenting on the Avandia review, drug safety experts Bruce M. Psaty, MD, and Curt D. Furberg, MD, concluded, “While the Senate bill has many strengths…none of its provisions would necessarily have identified the cardiovascular risks of rofecoxib [Vioxx] or rosiglitazone [Avandia] in a timely fashion.” I agree and suggest that any hope for meaningful changes at FDA now rests with several proposed bills being discussed in the House of Representatives. And, I believe, the Avandia experience identifies the most critical reforms that must be part of any legislation if it’s to make a difference.

First, there must be complete transparency of all trial data and FDA access to insurance industry (including Medicare) databases so the agency can determine how drugs are being used and what outcomes they are generating. The public’s health can only benefit from having good minds like those of Nissen and Wolski analyzing data and reaching their own conclusions. Second, unlike FDA’s handling of Avandia, the public should always be immediately alerted to any signals of toxicity.

Most important, Congress must mandate creation of an independent FDA drug safety office, one that is all about public protection. A dedicated safety office would likely have been watching more vigilantly for signs of problems with PPAR diabetes drugs given their poor safety record.

Arthur A. Levin, MPH, Center for Medical Consumers ©
June 2007

Posted in Advocacy, Drugs, Heart | Tagged: Diabetes, FDA, pharmaceutical industry, side effects | Comments Off

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.

Posted in Conflict of Interest | Tagged: marketing, pharmaceutical industry | Comments Off

Protopic and Elidel: Eczema Drugs Have a Cancer Risk

Posted by medconsumers on May 1, 2006

Early this year, the Food and Drug Administration issued a warning about two prescription topical creams for the common skin disease, eczema. Both Elidel and Protopic must now include written material for professionals and patients that warns of a cancer risk based on “information from animal studies, case reports in a small number of patients, and knowledge of how drugs in this class work.”

Though the warning says, “a small number” of people who have used the products “have had cancer (for example, skin or lymphoma),” evidence from the FDA’s own reporting system indicates that this may be an understatement. Pretty alarming for drugs that are applied to the skin, primarily for young children. Doubly so, considering the fact that less than 10% of all serious adverse drug reactions are reported to the FDA.

People with eczema, also known as atopic dermatitis, and parents of children with this chronic skin disorder are often desperate for a treatment that alleviates the severe itchiness and inflammation. Eczema primarily afflicts babies and children, but can continue into adulthood in about 50% or show up (rarely) for the first time in adulthood. There is no cure. A drug might beat it back for a short time, but flare-ups are common.

Elidel (generic name: pimecrolimus) and Protopic (generic name: tacrolimus) control eczema by suppressing the immune system, and they can be extremely effective in producing improvements. Until they came along, corticosteroid cream was the standard treatment. Hopes for the newer drugs stem from fears about the side effects of corticosteroid cream like thinning of the skin and adrenal gland suppression. Novartis, the company that makes Elidel, and Astellas Pharma (formerly Fujisawa), maker of Protopic, fed these fears by promoting their products as “steroid-free.”

One example is Fujisawa’s fraudulent ad for Protopic that appeared six years ago in Prevention magazine stating, “Breakthrough research has finally uncovered a new kind of medicine for eczema. Made of a natural substance, this new treatment is steroid free.” The ad implies safety. But in reality both Elidel and Protopic are in the same drug class as Prograf, a powerful immunosuppressant drug that prevents liver or kidney transplant rejections. In fact, Protopic and Prograf (generic name: tacrolimus), which comes with a warning of “infection and development of lymphoma,” are the same drug!

FDA Explains Itself

Why hasn’t the FDA withdrawn the drugs, given their obvious dangers and the existence of a safer alternative? “FDA believes that the benefits of Elidel and Protopic outweigh the risks of these products,” responded Julie Beitz, MD, of the FDA’s Center for Drug Evaluation and Research, who would answer questions only by e-mail by way of a press officer. “The new warnings in the professional labels and in the Medication Guides* for these products convey what our concerns are, however, a causal link has not been established between the reports of cancer and use of these products.”

The FDA warning states that it may “take human studies of ten years or longer to determine whether Elidel or Protopic is linked to cancer.” Despite the lack of long-term data and what is surely an undercount of cancers associated with use of these drugs, Dr. Beitz defends the FDA position, “While there is under-reporting of adverse events to the FDA, we also know that use of these products is great, so relative to all users, the number of reports we have received is small.”

To some dermatologists, the question of whether Elidel and Protopic pose more than a rare cancer risk seems to hinge on how much is absorbed into the skin. In a January 19, 2006 press release that disagrees with the FDA’s decision to issue an warning, Clay J. Cockerell, MD, president of the American Academy of Dermatology, said, “Because these medications are applied to the skin, virtually none of it gets inside the body.”

That statement was quoted to Dr. Beitz, who commented, “We agree that very little of the drug is absorbed in general, however, we have data to show that some patients do absorb the drug to greater degrees. Additional factors to consider: 1) how long the patient is using the product; 2) how large an area of skin the product is being applied to; and 3) the fact that areas affected with atopic dermatitis are not normal and may allow for more absorption.” Babies under two should not be treated with either drug, according to the FDA warning.

“Infants have higher surface area to volume so they will have higher blood levels of the drug and their skin is more permeable,” said Peter M. Elias, MD, professor of dermatology, University of California, San Francisco, in a telephone interview. “The companies have over-marketed these drugs suggesting, for example that they are safe for infants by showing images of infants [in promotional materials].” The ads implying Elidel and Protopic are safer than corticosteroids are ridiculous, he continued, adding that neither drug has been shown to be safer or more effective than topical steroids in a head-to-head comparison as maintenance therapy for eczema. “Low- to mid-potency steroids are quite safe in eczema, although many clinicians prefer an even less potent agent, such as hydrocortisone, in infants,” said Dr. Elias.

When the FDA was deciding whether to approve these drugs in 2000, Dr. Elias wrote a letter to the agency expressing concerns, particularly about Protopic, which he described as “a powerful and potentially toxic immunosuppressive drug.” In the letter, which remains on the FDA Web site, Dr. Elias told the agency that he is “alarmed at what appears to be a potentially cavalier and uncritical attitude about the indications and long-term safety of topical tacrolimus [generic name for Protopic]. [This drug] is absorbed into the circulation through inflamed skin, and in low-body weight children it can produce transient therapeutic (transplant) drug levels.”

Dr. Elias sees a limited role for the drugs, “Protopic should be reserved for severe, recalcitrant flares of eczema in children and adults, and Elidel for similar bad flares in infants. Elidel might also be useful for periorbital dermatitis due to risk of glaucoma from steroids. But in all these examples, the use should be short term—days, weeks, but not months—and only in conjunction with sunscreens, which should always be used when these drugs are applied to sun-exposed skin. There is no rationale for long-term therapy with either drug.”

Pressure Not to Warn the Public

In the five to six years since the FDA approved each drug, Novartis and Astellas/Fujisawa mounted a massive, often misleading, advertising campaign aimed at doctors and the public. And in the last two years, both companies waged an aggressive campaign against the FDA’s planned warning. Under great pressure not to act, the FDA went ahead and called a meeting of its pediatric advisory committee in February 2005, which recommended a label change warning doctors and patients about the risk associated with both Elidel and Protopic.

The next month, a cancer warning appeared on the FDA Web site. (It is not known how many doctors or patients would think to look on the FDA’s Web site for new warnings.) As of January 2006, a Medication Guide for patients with the warning is supposed to be included with all prescriptions of Elidel and Protopic. The Guide does not spell out the safe duration (if there is one) of short-term use, though makes it clear that neither drug should be the first-choice treatment for eczema.

There are reasons to think that these efforts will go unheeded. Several studies show that only one in ten doctors read the drug label which is the most complete source of information about a drug’s use and harms. (Consumers are not much better.) A recent survey showed doctors are overwhelmed with drug warnings and have difficulty keeping them all straight. In the case of Protopic and Elidel, the dermatologists’ professional organizations were actively working against the FDA’s plan to issue a warning. The Society for Pediatric Dermatology, in a letter dated November 30, 2005, advised its members to write the FDA to tell the agency that warnings are not warranted because “abrupt discontinuation of these medications out of fear [will result] in disease flares in many children.” Furthermore, the letter claimed that an analysis of the clinical data presented to the FDA have not supported a malignancy risk.

“The great resistance in the dermatologic community to the FDA warning is based in part on the fact that many of the opinion leaders are in conflict of interest situations that too often go undisclosed,” said Dr. Elias, referring to funding from Novartis and Astellas that pays for the speakers bureau, conferences, and continuing education. And he doesn’t think much of the evidence cited to support objections to the FDA warning about Elidel and Protopic. “There are 55 articles about the safety of both drugs that claim to be long term,” Dr. Elias explained. “However, they are not, in fact, long term; the longest study lasted only six months; many are repeats—the same study published in multiple journals—and others are written by the drug company journal editor.” [Note: There are longer studies indicating the drugs are safe and effective, but they are funded by either Astellas or Novartis.]

It is quite possible that one day lawsuits will generate the publicity needed to adequately warn the public about inappropriate use of Elidel and Protopic. Several law firms now have Web sites specifically devoted to the drugs. One such firm headed by Larry M. Roth has a Web site (www.protopiclawyers.com) that features his detailed article on the history of FDA approval of topical immunosuppressants and reports of serious reactions, complete with extensive footnotes. It describes cancers, deaths, and other severe reactions reported to the FDA.

In a telephone interview, Laurilyn Cook-Arrington, a paralegal at Larry M. Roth, PA, said the law firm had retrieved this information from the FDA’s Adverse Events Reporting System with a Freedom of Information Act request. (Manufacturers are required “by regulation” to report serious drugs reactions to AERS.) Ms. Cook-Arrington said the firm has been gathering information on topical immunosuppressant drugs for three years. “Hundreds of potential claimants have contacted our firm in the last year. And many of these claims include deaths. Almost 50% of them are made on behalf of children. They involve skin cancers, as well as systemic malignancies like leukemia, Hodgkin’s disease, and multiple myeloma.”

What to do:

If you are using Elidel or Protopic, inform yourself about these medications. Start with the warnings at the FDA Web site (www.FDA.gov). Consumers and doctors can report serious adverse drug reactions to the FDA’s Medwatch Program 1(800) FDA-1088.
Ask your doctor about prescription emollients to reduce the amount of topical drugs needed to control eczema. According to Dr. Elias, “Topical prescription emollients alter biochemical abnormalities in the skin, lead to fewer flare ups, and fight off infection.” They can be used as the first treatment or as maintenance after short-term treatment with an immunomodulator, explained Dr. Elias, who is also chief science officer at Ceranix, makers of a yet-to-be-available emollient, EpiCeram.

Posted in Cancer, Chronic Conditions | Tagged: Cancer, Drugs, FDA, pharmaceutical industry, product, side effects | Comments Off

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.

Posted in Conflict of Interest, Heart | Tagged: cholesterol, Drugs, marketing, pharmaceutical industry, statins, truth about statins | Comments Off

Insomnia Treatments: What Works?

Posted by medconsumers on December 1, 2005

When the U.S. National Institutes of Health convened a State-of-the-Science Conference on insomnia last June, it came down hard on the drugs most people use for this common affliction. The independent panel of experts chosen months before the conference had been given the task of assessing the supporting scientific evidence for the full range of treatments. It concluded that the drugs most often used to treat insomnia—antihistamines and antidepressants—have never been proven effective for this purpose. And though insomnia can persist for decades, the panel found that most prescription drugs approved for this condition have not been carefully evaluated for long-term use. The panel advised greater use of one non-drug approach to sleeplessness, a technique called cognitive-behavioral therapy.

Still, most insomniacs continue to turn to drugs in greater numbers. And the ubiquitous drug advertising campaigns encourage them to do so.

Ambien CR and Lunesta

Eight prescription drugs are approved by the Food and Drug Administration (FDA) for insomnia. Two of them have dominated recently in terms of advertising to the public. Ambien CR is a new extended-release version of Ambien, which has been on the market for 12 years. Ambien is so well known that full-page ads for its new extended-release version are appearing in magazines without mention of what the drug is for. The manufacturer, Sanofi-Aventis, is aggressively selling this new version to hold on to its market share as Ambien is due to go off patent next year. (Ambien was the world’s most popular prescription sleep drug in 2004, accounting for $2.1 billion in sales.) The full-page ads announce a “Free 7-Day Trial Offer” for Ambien CR. An accompanying coupon falls out of the magazine that people are encouraged to bring to their doctors for a starter kit of free pills.

It’s good to keep in mind when reading such ads that omitting the purpose of the drug allows the manufacturer to avoid identifying the harms associated with the drug and the warning that it is only for short-term use. One would have to read the packet insert, or what the FDA calls the label (for access, see page 3) to learn about adverse effects that include abnormal thinking, behavior changes, anxiety, memory loss, and addiction. Companies that make sleeping pills assert that these reactions can occur in a small number of people who take any drug in this class known as sedative/hypnotics. All drugs in this class are also known to cause what the manufacturers prefer to call “dependency,” when taken for more than a few weeks.

Ambien CR purportedly has the advantage of keeping people asleep longer. Although short-term use is never spelled out, the packet insert indicates just how brief the FDA-required trials were. Only two trials were performed to demonstrate efficacy. Both were only three weeks in duration, and assessments were conducted after two weeks of treatment.

Lunesta, which came on the market last April, is the strongest rival to Ambien. So far, it is the only prescription sleep medication approved by the FDA for long-term use. Even so, its manufacturer, Sepracor, is explicit in the fine print of its magazine and newspaper ads, stating, “It [insomnia] usually requires treatment for only a short time, usually 7 to 10 days. If your insomnia does not improve after 7 to 10 days of treatment, see your doctor, because it may be a sign of an underlying condition.”

The packet insert for Lunesta has this summary of clinical trial findings without quantifying how much sleep improvement people can expect from this drug: “Lunestra significantly improved sleep latency and improved measures of sleep maintenance (objectively measured as wake time after sleep onset and subjectively measured a total sleep time).” And here’s a key warning that might be overlooked “Be aware that you may have more sleeping problems the first night or two after stopping any sleep medication.”

Lunesta and Ambien CR pose the risk of a form of memory loss known as “traveler’s amnesia.” This can occur during an airplane flight when the person wakes up before the effect of the medicine is gone. The drug should be avoided in such a circumstance when it is impossible to get a full night of sleep. Both Lunesta and Ambien CR carry the warning not to drink alcohol. And both drugs should be taken in the smallest effective dose by people over age 65 years.

Short-Term Use of Prescription Sleep Drugs

Suppose you are one of those rare older people who use sleep medicines appropriately—no more than ten days. What are the benefits and harms of short-term use? A team of Canadian researchers led by Jennifer Glass, PhD, University of Toronto, conducted an analysis of all studies in which people over the age of 60 years had been given one of the standard prescription drugs for insomnia, including Ativan, Xanax, Restoril, Dalmane, Ambien, and Sonata. Altogether, the analysis included 24 studies involving 2,417 participants who had taken either a placebo (sugar pill) or one of the above prescription drugs. To be included, the studies had to assess any of the above drugs taken for at least five consecutive nights for insomnia. Findings were published last month in the British medical journal, BMJ.

The drugs were associated with harms that are particularly detrimental to older people, such as cognitive effects, falls, and ataxia (inability to coordinate the muscles in voluntary movement);
adverse cognitive effects were five times more common in people on a drug than in those on the placebo;
daytime fatigue was nearly three times more common in people taking a drug;
and the drugs provided only marginal improvements.

Dr. Glass and colleagues concluded that the short-term benefits of these drugs may not justify the increased harm, especially to older people who are already at risk for adverse cognitive reactions.

Other Approaches to Sleeplessness

The panel of experts at the State-of-the-Science Conference identified antihistamines as the most commonly used over-the-counter treatment for insomnia. But there is no systematic evidence to demonstrate effectiveness and there are significant concerns about risks, according to the panel. The adverse effects include “residual daytime sedation, diminished cognitive function, and delirium, the latter being of particular concern to the elderly.”

Alcohol does reduce the time it takes to fall asleep, but large amounts will result in poorer quality sleep and awakening during the night. Melatonin, a natural hormone that can be purchased over the counter, is better for jet lag than insomnia. Furthermore, there is no information about the safety of long-term use.

The panel also assessed alternatives to drugs, such as tai chi, yoga, acupuncture, and light therapy. All were deemed potentially useful, but inadequately evaluated. Only one non-pharmacological approach to sleeplessness, called cognitive-behavioral therapy (CBT), was judged to have been proven effective in moderate to high-quality trials that compared it to drug therapy. This form of therapy was shown to be as effective as prescription drugs are for short-term treatment of insomnia minus the risks.

CBT was described by the panel as “cognitive restructuring in which anxiety-producing beliefs and erroneous beliefs about sleep and sleep loss are specifically targeted.” The treatment involves a series of visits to a therapist trained in this method, a prospect that might be out of reach for many people.

To explore a lower cost, self-help version of CBT that involves $35 and access to the Internet, go to www.myselfhelp.com, which describes itself as funded in part through a series of Small Business Innovative Research Grants from the National Institute of Mental Health, National Institutes of Health, Department of Health and Human Services.

How to Obtain the Packet Insert, aka Drug Label

The packet insert, also known as the drug label, is produced by the drug’s manufacturer with FDA oversight. It is intended for the prescribing physician and is entirely different from the pharmacy-generated drug information. Only the packet insert has complete information on the drug, including what was proven in the FDA-required clinical trials. It is distinctive in its fine print and length (@20-40 pages), as opposed to the consumer friendly format of the usual pharmacy-generated drug information. The packet inserts of many drugs contain both a professional and a patient version. Read both.

There are several ways to obtain the packet insert. Ask the pharmacist for a copy when purchasing the drug; go to the public library and consult the Physicians’ Desk Reference; visit the FDA’s Web site (www.fda.gov) and click into the following sections: drugs, drugs@FDA, the drug’s name, and finally, drug label. And sometimes this works best: perform a google search with the drug’s name plus the word label.

Posted in Alternative Medicine, Men's Health, Women's Health | Tagged: Alternative Medicine, Drugs, FDA, pharmaceutical industry | Comments Off

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.

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

« Previous Entries

Next Entries »

Newest Articles

We're in the News

Search Archives

Categories