HEALTH CARE—CALPIRG Legislative Director Steve Blackledge testifies before the California Senate Health Committee in favor of a drug safety measure.

Prescription drug prices have increased much faster than the rate of inflation for the last decade, making prescription drugs a leading contributor to skyrocketing health care costs. Our research shows prescription drug costs and safety are a major problem, and that commonsense policies could save lives and money.

Pay More, Get Less
Americans pay more than any other nation when it comes to health care, but compared to other developed nations, reap fewer health benefits.

As a nation, we spend more than 16 percent of our gross domestic product on health care, yet in key measurements such as live births, number of insured residents and life expectancy we rank behind most developed nations.

Recent news events spotlight the escalating prices of prescription drugs and the questionable safety of the drugs that doctors prescribe.

A report by the Institute of Medicine confirmed what U.S. PIRG has said for years: The Food and Drug Administration cannot guarantee the safety of our prescription drug supply.

From 2001 to 2005, the Food and Drug Administration (FDA) has written 170 letters to drug companies, accusing them of advertising drugs in false or misleading ways.

NJPIRG Legislative Advocate Abigail Caplovitz Field examined these letters closely, and developed the ground-breaking report “Turning Medicine Into Snake Oil, How Drug Marketers Put Patients At Risk.”

The report’s discoveries were disturbing. Driven by false and misleading advertising, doctors are routinely prescribing—and consumers are demanding—potent but risky drugs.

Consumers are clamoring for drugs that have not been proven safe or effective.

In 2002, 115 million “off-label” prescriptions were written, meaning that patients were prescribed drugs for purposes other than those for which the drug has received FDA approval.

Americans are unwittingly participating in an uncontrolled clinical trial with potentially deadly consequences.

“Prescription drug marketers aren’t telling the truth to doctors or the public. Misleading marketing is everywhere, and it’s putting patients in danger,” said Field. “Our research makes it clear that drug marketers use false and misleading messages to shape today’s prescribing habits.”

More troubling, the research also shows that the FDA does not effectively address the problem, and there is no enforcement action taken in response to the violations.

Doctors Targeted
In the five years Field studied, the FDA faulted 85 different drug marketers for false or misleading advertising of 150 different drugs.

Based on the letters, doctors were targeted with more false advertising than consumers. In all, the FDA letters identified 38 different types of false or misleading advertisements aimed at doctors.

Approximately two-thirds of the false messages doctors received involved minimizing or omitting a drug’s risks, or promoting a drug for uses the FDA had not approved. Here are two examples:

• Drugmaker Pharmacia promoted Celebrex as safe for patients also taking Coumadin, although there is a significant risk, reflected in the prescribing materials, that patients taking both will experience serious bleeding.

• Drugmaker Cubist Pharmaceuticals promoted its antibiotic Cubicin for use against the bacteria that causes community-acquired pneumonia. In fact, the prescribing information specifically says Cubicin should not be used for pneumonia because clinical trial results showed that Cubicin was not effective, leading to patient deaths.

FDA: Ineffective Enforcement
While the FDA letters contain strong language, they have no regulatory or punitive effect.

Our research revealed that letters go out long after the false messages have been disseminated to the public, they rarely require corrective advertising, and they do not deter future false advertising.

Over the span of five years we reviewed, we found that 28 companies received more than one FDA letter. Pfizer, Inc. received 19. More than 20 companies received secondary letters complaining of the same kind of misleading advertising in the first letter.

Ineffective as they are, the FDA letters attempt to police only a small piece of the false advertising problem. As the New England Journal of Medicine reported, drug marketers have transformed clinical trials into marketing exercises by asking the right questions, hiring ghostwriters to shape the report and controlling the release of the results.

There is also evidence that drug marketers suppress data. As our report notes, GlaxoSmithKline failed to report clinical data showing Paxil was ineffective in adolescents because of concerns that the information would affect sales.

The New England Journal of Medicine article cites nine examples of data being suppressed or misrepresented in the final published report.

On Capitol Hill
U.S. PIRG’s Health Care Advocate Paul Brown is lobbying in Congress for reforms that will refocus the Food and Drug Administration on its original mission of ensuring that American consumers receive safe medicines.

We recommend that the FDA allocate more of its budget to drug safety and restrict prescription drug TV ads. The FDA should also have the authority to issue fines when drugmakers fail to complete safety studies.

“For too long the ‘D’ in the FDA has stood for “dysfunctional,” said Brown. “It has a track record of approving dangerous and deadly prescription drugs like Vioxx, Paxil and Accutane, failing to crack down on recalcitrant drug companies, and delaying action when evidence surfaces that a drug may pose health risks.”

The powerful pharmaceutical industry is attempting to defeat or gut the safety language in this legislation.

If they succeed, the FDA will remain “virtually incapable of protecting the public from unsafe drugs,” as the New York Times said in a May editorial.