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Posts Tagged ‘FDA’

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Is your sunscreen safe?

Posted by medconsumers on June 11, 2010

Visit this excellent website where the Environmental Working Group, a non-profit research organization, does its best to answer the question…and with no help from the FDA. (There are no mandatory requirements about what sunscreen manufacturers can—and cannot—put into their products, and what kind of claims they can print on the label.) After analyzing 500 sunscreens, the EWG could recommend only 39 of them! The rest either don’t provide adequate protection or contain potentially hazardous ingredients, or both. Definitely read “Sunscreens Exposed: 9 surprising truths.” No. 1 is: there is no consensus on whether sunscreens prevent cancer. (Some studies found a higher incidence of the deadliest form of skin cancer, malignant melanoma among frequent sunscreen users.)

Spend time in this website which deals with a wide range of everyday questions. Some examples: are stainless steel water bottles safe (yes, if they don’t have a plastic liner) and can you limit your cellphone radiation exposure (choose according to the brand-name models in the EWG database).

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Osteoporosis drugs

Posted by medconsumers on March 22, 2010

Older women have long been encouraged to have their bone density measured periodically. And many who followed the advice have walked away with a prescription for Fosamax. Not surprisingly, the promotion of bone density testing has been spearheaded by Merck, maker of Fosamax, which is widely prescribed to women with bone loss. A decade after Fosamax became available in 1995 medical journals began reporting an apparently rare side effect. Spontaneous fractures of the thighbone called atypical subtrochanteric femur fractures occurred in women who had taken Fosamax for more than six years. All the drugs in the same class, known as bisphosphonates (Actonel, Fosamax, Boniva, Reclast), were under suspicion of causing this unusual fracture. In June 2008, the Food and Drug Administration requested patient data from all companies that make bisphosphonate drugs. The FDA has finished its review and recently posted this conclusion on its Web site:

“At this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather additional information that may provide more insight into this issue.” Click here for entire FDA posting.

Another Fosamax Adverse Effect?

A possible connection between bisphosphonates and another rare side effect called osteonecrosis of the jaw will be tested in court, according to recent ruling. A federal judge refused to dismiss 40 lawsuits against the Novartis Corp, maker of bisphosphonates Aredia and Zometa. Novartis is accused of failure to warn patients that these drugs can cause destruction of the jawbone, primarily in people with advanced cancer given one of these drugs intravenously. Osteonecrosis of the jaw appears to be associated with certain dental procedures. When case reports of this injury first appeared in a medical journal over five years ago, these untreatable injuries were thought to be confined solely to cancer patients given high doses of a bisphosphonate intravenously. In time, however, similar injuries were reported in long-term users of oral bisphosphonates. Read “Osteonecrosis of the jaw—more common than previously thought.”

More information
Bisphosphonate drugs are better at improving bone density than they are at reducing the chances of having a hip fracture in old age. For more, read my 2009 article for the American Journal of Nursing called “The marketing of osteoporosis—how a risk factor became a disease.”

Maryann Napoli, Center for Medical Consumers©

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Meridia: banned in Europe, but not in U.S.

Posted by medconsumers on January 24, 2010

How long does it take to get a dangerous drug off the market? The weight-loss drug Meridia provides the latest test case. At the end of last year, the Food and Drug Administration (FDA) announced that it was looking into an early finding from a large international trial. Here’s the bad news that emerged from the trial last November: There were more heart attacks, strokes, and deaths among obese people with heart problems taking Meridia than those taking a placebo. Ironically, this trial was designed specifically to prove Meridia will not just help people lose weight, but it would also spare them the heart problems associated with obesity.

Last week, drug regulators in Europe and the U.S. reacted. The European Medicines Agency took a strong stance, advising doctors and pharmacists to stop prescribing and dispensing the European equivalents of Meridia. Obviously, the EMA thought the drug’s risks outweighed its benefit. And what did the FDA do? It took the wimpy route, asking Abbott Laboratories, maker of Meridia, to put a stronger warning on Meridia label. This is one notch better than doing nothing. Unfortunately hardly anyone, including most doctors, reads the drug label that can be 20-40 pages long. (Click here to see why.) Keep in mind that both regulatory agencies were looking at the same data from the same trial.

Known as the SCOUT trial, this large study was testing the widely held assumption that weight loss itself would automatically reduce the risk of heart problems in people who are overweight and obese. It included 10,000 overweight or obese people, aged 55 or older, who had heart disease or diabetes, or both. They were randomly assigned to take Meridia or a placebo for six years. All had been advised to make the same lifestyle changes associated with weight loss. The SCOUT trial found 1.4% greater risk of heart attack, stroke and death (combined) in the participants taking Meridia, according to the FDA’s June 30, 2009 Web site notice.

FDA watchdog Sidney Wolfe, MD, Director of the Public Citizen’s Health Research Group, assessed the Meridia-related cases on the FDA’s database for adverse reactions reports, while noting the underreporting common to all drugs. “We have found that there are now, as of June, 2009, a total of 84 reports of deaths from cardiovascular causes in the FDA Adverse Event Reactions database, including 30 in people 50 or younger. Of these 30 people, 11 were 30 or younger. It must be noted that FDA’s own estimates are that no more than one in ten adverse reactions to drugs that occur are reported to the agency,” wrote Dr. Wolfe in a December 3, 2009 letter to the FDA commissioner.

Dr. Wolfe initially petitioned the FDA to ban Meridia in 2002 because the placebo-controlled trials conducted prior to its approval showed that the drug caused increases in blood pressure, pulse rate, and palpitations.

For more information

About Dr. Wolfe’s Health Research Group, here’s its Web address.

About the FDA’s position, read its January 21, 2010 alert aimed at physicians and patients.

Maryann Napoli, Center for Medical Consumers(c)

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FDA’s Warning System for Drug Adverse Reactions

Posted by medconsumers on June 10, 2009

It’s a well-acknowledged fact that it takes years for all of the harms about a drug or medical device to emerge. The Food and Drug Administration regularly publishes a list of drugs and other medical products whose prescriber labeling and/or patient information has been updated with new warnings. The Medwatch Program is the FDA’s Safety Information and Adverse Event Reporting System/a>>. It provides a list organized by the severity of the drug’s risk and describes the specific nature of the label changes, for example, a new black box warning. If you see a drug of interest on the list, just click on the product name in the left hand column and you can see the new warnings and cautions about the product’s use.

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

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Risks of Biologic Drugs

Posted by medconsumers on December 1, 2008

New Concerns About a Class of Drugs Called Biologics

The fastest growing class of new drugs in the U.S. is the so-called biologics. Although the first in this class of drugs was approved in 1982, most have been marketed for a decade or less and little information was available about their safety. A team of Dutch researchers set about to address this important knowledge gap and their findings were recently published in the Journal of The American Medical Association.

Their findings? Almost one in four new biologics approved in the US and/or the EU between 1995 and 2007 had safety problems serious enough to require regulatory action after their approval. The term biologics (also known as biologicals) refers to drugs derived from living material, which can be human, plant, animal or microorganism in origin. Production of biologics is considered to be much more complex than that of traditional drugs. According to the Dutch researchers, “small differences and changes in the production process can therefore have major [safety] implications.” Examples of popular biologics include Enbrel and Remicade for rheumatoid arthritis, Tysabri for multiple sclerosis and Avastin and Herceptin for cancer.

While no biologic has been withdrawn, 19 were found to have had safety problems severe enough for regulators to require black box warnings on the labeling. Adverse events include life-threatening infections, acute hypersensitivity reactions and worsening heart failure—among others. Most of the regulatory actions were taken between 3 ½ and 5 years after approval.

There are some important overall lessons to be learned from this study. First, the data lends supports to the advice that, if better-understood treatments are available, a newly approved drug should be used with extreme caution, if at all, for at least the first five years after marketing. Second, the Dutch researchers suggest that the mode of action and complexity of biologics should demand heightened safety scrutiny by regulatory authorities before approval. In addition, there is some evidence that biologics may have higher rates of safety problems than traditional drugs. This is especially worrisome since about one quarter of newly approved drugs are biologics and their numbers are expected to grow rapidly in the coming years.

One possible reform in the FDA approval process that I believe would address this concern, and which I strongly support, would be to create a new option for FDA to grant “conditional approval” of a new drug when there is any hint of serious safety problems. At present, the FDA can only approve or disapprove a new drug; there is no middle ground. A conditional approval option could constrain the use of a newly approved drug suspected of safety problems by imposing limits on its prescribing and distribution by requiring its makers to accept rigorous safety monitoring.

The pre-approval trials currently required by the FDA suffer from serious limitations. For example, there are often only a few patients in the trial and the trials are often too short to get a full picture of the drugs’ effects. As a result, safety problems often go undetected until the drug is in widespread use. By that time thousands of people may have been exposed to serious harm.

I believe that establishing a conditional approval option would be a win-win for patients. It would result in a better understanding of a new treatment’s safety and prevent harm. And it would provide access to new treatments for patients with life-threatening conditions that are unresponsive to other therapies.

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

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Women-in-Towels Evista Ad Critiqued

Posted by medconsumers on July 1, 2008

The women in Eli Lilly’s new ad campaign are attractive, healthy-looking and wearing nothing but towels. “Cut two risks with Evista. The only agent indicated to treat osteoporosis and reduce the risk for invasive breast cancer.”

That two-for-one claim for Evista makes it different from other drugs taken by symptom-free people. Studies showed that the harm related to each disease drops a percentage point or two in those who took Evista, compared to those who did not. The drug is better than a placebo (or it would not get FDA approval), but not much better. This is a recurring theme in Center for Medical Consumers articles because it’s a recurring theme in many drug trials. And often the small risk of a serious adverse reaction to the drug equals that small chance of benefit.

Evista (generic name: raloxifene) has been on the market since 1997 as an osteoporosis drug. It produces a 2%-3% increase in bone density; reduces the rate of vertebral (spinal) fractures; but does not prevent the most serious type of fracture (hip). Vertebral fractures can cause pain and a dowager’s hump in advanced age, but many are symptomless. The studies did not last long enough for Lilly to make claims regarding prevention of a dowager’s hump or loss of height.
Breast Cancer “Risk Reduction”

Last year Lilly received FDA approval to promote Evista as a drug that can “reduce the risk of invasive breast cancer.” This careful wording from the Evista ads is important. Lilly cannot claim its drug prevents breast cancer because the disease can take anywhere from 8 to 17 years to develop. There were, in fact, fewer breast cancers diagnosed in the women taking Evista, compared to those taking placebos. But the trials didn’t last long enough to determine whether the drug prevents breast cancer or simply delays its onset. In Evista trials that lasted up to eight years—breast cancer was diagnosed in 2.5% of the women taking a placebo and 1% of the women taking Evista.

The other claim for Evista is based on the fact that the women in the studies already had osteoporosis (bone loss). One way bone drug companies can inflate the benefit of their product is to count symptomless vertebral fractures that can be detected only on x-ray. (In other words, the women are unaware of them.) At the start of the Evista trial about half the women had painful vertebral fractures and the other half had “fractures diagnosed radiographically.” After four years, things looked better for Lilly when results for all women were combined, but less impressive when women with painful fractures were singled out. In the latter group, only about 1% fewer Evista-treated women had new painful vertebral fractures than the women taking placebos.

Thus far serious adverse reactions to Evista include deep vein thrombosis, pulmonary embolism, retinol vein thrombosis and an increased risk of fatal stroke. (See boxed warning of the FDA-approved label). Separately, each is classified as rare, which, according to FDA standards, describes any drug reaction that occurs in less than 2% of study participants. Collectively, though, these potentially fatal adverse reactions could reach 1-2% which comes close to the percentage of women who benefited from Evista in the FDA-required clinical trials.

And lastly, the visual message conveyed by the women-in-towels ad is misleading. Most of the women look to be in their fifties. At the start of the Evista trials, however, most participants were over age 65 years, a time of life when vertebral fractures are far more likely to occur.

Maryann Napoli, Center for Medical Consumers ©
July 2008

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Chantix: Another FDA Failure?

Posted by medconsumers on June 1, 2008

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

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

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

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

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

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

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

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

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

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Pharmaceutical Industry to Public: Drop Dead

Posted by medconsumers on May 1, 2008

The Pre-emption Shield Explained

The scenario has become depressingly repetitive: A heavily promoted drug prescribed to millions over the years is found to have potentially fatal adverse reactions; a hundred or so deaths are linked to the drug; the drug maker acts as if it just learned of the harm; a lawsuit precipitates the release of in-house documents showing that company officials knew of the dangers long before its drug went on the market; the injured patients have their day in court.

The last phase of this scenario, the one where people go to court to seek compensation for their injuries, will be eliminated if the pharmaceutical industry gets its way. The industry takes the position that a drug’s safety must be proven to the FDA’s satisfaction before it is allowed on the market; therefore, the drug maker should be held harmless for anything that happens thereafter. “The FDA should not be second guessed by the courts” goes the pharmaceutical industry’s legal argument for what is called pre-emption. Not surprisingly, it has the strong backing of the Bush Administration.

Proof of Safety Inadequate

The presumption that the FDA approval process guarantees safety is absurd. The two clinical trials required by the FDA are usually short-term and always conducted by the drug makers themselves. Rare or uncommon serious adverse reactions to drugs are typically not apparent until hundreds of thousands of people take the drug over the course of many years. Worse of all, drug companies are known to withhold negative trial results from the FDA.

And if that’s not bad enough, a bipartisan Congressional panel recently confirmed what has been known for years: The FDA’s ability to protect the public’s interest is obstructed by the fact that it is seriously underfinanced. This affects everything from the agency’s inability to vet all drug advertising for misleading claims to its drug-safety monitoring system that, according to the nonpartisan Government Accountability Office, captures less then 10% of all serious adverse reactions to drugs after they go on the market.

Most Recent Industry Crimes

Within a recent three-week period alone, the national media spotlighted three cases in which pharmaceutical giants misled the FDA about the safety of their products. Eli Lilly and Alaska agreed to a $15 million settlement on behalf of the state’s Medicaid patients who developed diabetes as a result of Lilly’s antipsychotic drug Zyprexa. The company hid the risks (e.g., deaths, strokes, pancreatitis) and exaggerated the benefits of Zyprexa while encouraging primary care doctors to prescribe it for unapproved uses.

Another case involved the bestselling pain-reliever Vioxx withdrawn in 2004 by its maker Merck because it increased the risk of heart attacks and strokes. And lastly, there’s Johnson & Johnson’s birth control patch, now known to cause blood clots, strokes and deaths. In all three cases, the dangers would have remained unknown—and people would continue to be injured—had it not been for lawsuits.

Among the e-mails, letters and other internal documents released during the Vioxx litigation was damning evidence that Merck knew of the drug’s dangers early-on. The company’s initial research made “the surprising discovery” that “Because selective COX-2 inhibitors [Vioxx, Celebrex, Bextra] do not affect platelet function whereas standard NSAIDs [aspirin, ibuprofen, etc] do, it was hypothesized that selective COX-2 inhibitors might…increase the risk of cardiovascular events.” This warning was repeated twice (at a meeting and in a memo), according to Merck documents—all dated prior to Vioxx’s approval by the FDA in 1999.

Vioxx made news again recently when the most comprehensive study of Merck’s internal documents released during the Vioxx litigation revealed the manipulation of the company’s clinical trial results. One example: Merck conducted several trials trying to prove that Vioxx slows the progression of cognitive impairment in people with dementia. The company’s early analysis of these trials showed “a significantly increased mortality risk” among the participants assigned to take Vioxx (their death rate was more than twice that of the placebo group). This, however, was not the way Merck reported the results to the FDA. Instead, Merck minimized the death risk by using a less-valid type of data analysis of the same trial results and concluded that Vioxx was “well tolerated.”

When the study of the Merck documents was published last month in the Journal of the American Medical Association, the accompanying editorial made it clear that the manipulation of trial results is not the sole purview of one company. The editors also noted that the evidence necessary to demonstrate Merck’s misdeeds became public—and publishable—only because of litigation. Last fall, Merck agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

This is not likely to be the way things will turn out for the young women injured by Johnson & Johnson’s popular Ortho Evra birth control patch. The patch delivered far more estrogen into the bloodstream than standard oral contraceptives, increasing the risk of potentially fatal blood clots. More than 3,000 women and their families have sued Johnson & Johnson claiming that the patch caused heart attacks, strokes and at least 40 deaths. Documents made public by this lawsuit showed that Johnson & Johnson’s own trial revealed these risks in 1999. The company, as The New York Times put it, “obscured the finding in a 435-page report to the FDA.”

The Pre-Emption Dodge

The Ortho Evra plaintiffs are now on hold while a similar lawsuit against yet-another drug company (Wyeth) becomes the test case for the pre-emption shield when it goes to the Supreme Court in November. The Court is expected to rule in favor of industry and make pre-emption the legal standard. A precedent was set in February when the Court ruled that the device industry is immune from damage suits filed by people injured by defective pacemakers, stents, etc.

Pre-emption is just the latest in a series of outrages perpetrated by the pharmaceutical industry against the public. At a time when criminal charges should be brought against company officials who withhold evidence of harm, the industry wants a pass. And it’s likely to get just that given the pro-business, anti-consumer Supreme Court decisions over the last few years.

In the meantime, if you are scheduled for a knee replacement or stent or a new heart valve, be aware that medical devices now come with an invisible warning from industry:

In event of a major defect or other serious harm: You’re on your own.

Maryann Napoli, Center for Medical Consumers © May 2008

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Anemia Drugs For Cancer Patients

Posted by medconsumers on March 13, 2008

Testimony Submitted to FDA Oncologic Drugs Advisory Committee Meeting
March 13, 2008

Maryann Napoli, Associate Director, Center for Medical Consumers

As a consumer advocate who attended the May ODAC meeting, I came away wondering why these drugs remain on the market. They cause some patients to die sooner. They have many other risks that are severe and well documented, and any quality-of-life benefit has yet to be proven. The FDA approved the first ESA because it reduced the percentage of patients transfused. But the agency has since acknowledged that the infectious disease risks of a blood transfusion are far lower now than they were in 1993.

No doubt there are many cancer patients who see these drugs as an instant cure for chemotherapy-induced fatigue or as the means of allowing chemotherapy to continue. The former indication was fostered by Johnson & Johnson’s fraudulent ad campaign for Procrit, which continued for seven years in the mainstream TV and print media. I urge ODAC to discuss the misconceptions imparted by these ads and to consider recommending that the FDA require J&J to run a corrective ad campaign.

The ability of a cancer patient to make a truly informed decision with the help of her oncologist is seriously compromised by J&J’s and Amgen’s reprehensible practice of offering rebates—that is, kickbacks—to oncologists. Patients are always encouraged to discuss their treatment decisions with their doctors. Yet it’s hard for patients to believe oncologists’ recommendations are unbiased when they are “reaping millions” from the prescription of anemia drugs, as The N.Y. Times reported last May. (1) Companies that give kickbacks and other financial incentives intended to manipulate oncologists into using the most expensive drugs are poisoning the doctor/patient relationship.

Where can people turn for unbiased information? It should be the FDA, but it’s not clear to me that black box warnings are the way to go. The changes in the product labeling in 2004 did not change clinical practice. (2) And what do we know about the effects of black box warnings on the ones who need them the most—the cancer patients? The cancer patient should be given scientifically accurate, written information about ESA well before she needs it. The time to weigh the risks and benefits is not when she’s awaiting her next chemo treatment and just learned that her hemoglobin is too low for the next round.

Patients cannot make truly informed decisions unless they are given quantitative information to help them decide whether ESA is appropriate. They need to know, for example, the chances of…1) needing a transfusion; 2) suffering harm by foregoing a transfusion, 3) experiencing a serious adverse effect from the transfusion itself, and 4) having a severe adverse effect from the ESA. Patients need to know the magnitude of each of these four risks. Telling them that ESA will reduce their risk of having a blood transfusion is simply too vague. It gives them no way to compare this purported benefit with the other risks of taking ESA. If the FDA will not remove these drugs from the market, it must find the best ways to get clearly written, accurate quantitative ESA information to cancer patients.

(1) Berenson A, Pollack A. “Doctors Reap Millions for Anemia Drugs.” N.Y. Times, May 9, 2007

(2) Blau AC. “Erythropoietin in Cancer: Presumption of Innocence?” Stem Cells 2007; 25;2094-2097; originally published online Apr 26, 2007.

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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

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