Pharmaceuticals: A market for producing 'lemons' and serious harm

Aug 17, 2010

The pharmaceutical industry is a "market for lemons," a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe, according to an analysis that will be presented at the 105th Annual Meeting of the American Sociological Association.

"Sometimes companies hide or downplay information about serious side effects of new drugs and overstate the drugs' benefits," said Donald Light, the sociologist who authored the study and who is a professor of comparative health policy at the University of Medicine and Dentistry of New Jersey. "Then, they spend two to three times more on marketing than on research to persuade doctors to prescribe these new drugs. Doctors may get misleading information and then misinform patients about the risks of a new drug. It's really a two-tier market for lemons."

Three reasons why the pharmaceutical market produces "lemons" are: Having companies in charge of testing new drugs, providing firewalls of legal protection behind which information about harms or effectiveness can be hidden, and the relatively low bar set for drug efficacy in order for a new drug to be approved, Light said.

According to his study, independent reviewers found that about 85 percent of new drugs offer few if any new benefits. Yet, or misuse of prescription drugs now make prescription drugs a significant cause of death in the United States.

Light's paper, "Pharmaceuticals: A Two-Tier Market for Producing 'Lemons' and Serious Harm," is an institutional analysis of the and how it works based on a range of independent sources and studies, including the Canadian Patented Medicine Prices Review Board, the , and Prescrire International.

The foundation for the paper is the work Light did for a forthcoming book he edited, titled The Risk of Prescription Drugs, which is scheduled for publication this fall by Columbia University Press.

In both his paper and his book, Light describes the "Risk Proliferation Syndrome" that is maximizing the number of patients exposed to new drugs that have relatively low efficacy and effectiveness but have greater risk of adverse side effects. Building on clinical trials designed to minimize evidence of harm and published literature that emphasizes a drug's advantages, companies launch massive campaigns to sell it, when a controlled, limited launch would allow evidence to be gathered about the drug's effects. Companies recruit leading clinicians to try using the drug for conditions other than those for which it is approved and to promote such off-label or unapproved uses. Physicians inadvertently become "double agents" — promoters of the new drug, yet trusted stewards of patients' well-being, said Light. When patients complain of adverse reactions, studies show their doctors are likely to discount or dismiss them, according to Light.

Despite the extensive requirements for testing the efficacy and safety of each new drug, companies "swamp the regulator" with large numbers of incomplete, partial, substandard clinical trials, Light said. For example, in one study of 111 final applications for approval, 42% lacked adequately randomized trials, 40% had flawed testing of dosages, 39% lacked evidence of clinical efficacy, and 49% raised concerns about serious adverse side effects, said Light.

"Just recently, major reports have come out about biased, poor trials for Avandia and Avastin," Light said, who noted that orphan drugs are tested even less well.

"The result is that drugs get approved without anyone being able to know how effective they really are or how much serious harm they will cause," Light said. The companies control the making of scientific knowledge and then control which findings will go to the FDA or be published.

"A few basic changes could improve the quality of trials and evidence about the real risks and benefits of new drugs," Light said. "We could also increase the percentage of new drugs that are really better for patients."

Explore further: FDA OKs Merck tablet to reduce ragweed allergies

add to favorites email to friend print save as pdf

Related Stories

New paper from internists calls for increased role for FDA

Sep 24, 2009

A new policy paper that calls for broader authority and increased funding for the Food and Drug Administration (FDA) was released today by the American College of Physicians (ACP). Improving FDA Regulation of Prescription ...

Recommended for you

Study recalculates costs of combination vaccines

14 hours ago

One of the most popular vaccine brands for children may not be the most cost-effective choice. And doctors may be overlooking some cost factors when choosing vaccines, driving the market toward what is actually a more expensive ...

Drug watchdog urges vigilance in cancer drug theft

17 hours ago

Europe's medicine watchdog urged doctors Thursday to be vigilant in administering the cancer drug Herceptin, vials of which had been stolen in Italy and tampered with before being sold back into the supply chain.

Pyridoxine-doxylamine drug safety data lacking

Apr 16, 2014

(Medical Xpress)—The most commonly prescribed drug for pregnant women suffering from morning sickness in their first trimester does not prevent birth defects even though drug safety data says it does, according to research ...

User comments : 0

More news stories

Leeches help save woman's ear after pit bull mauling

(HealthDay)—A pit bull attack in July 2013 left a 19-year-old woman with her left ear ripped from her head, leaving an open wound. After preserving the ear, the surgical team started with a reconnection ...

Scientists tether lionfish to Cayman reefs

Research done by U.S. scientists in the Cayman Islands suggests that native predators can be trained to gobble up invasive lionfish that colonize regional reefs and voraciously prey on juvenile marine creatures.

Venture investments jump to $9.5B in 1Q

Funding for U.S. startup companies soared 57 percent in the first quarter to a level not seen since 2001, as venture capitalists piled more money into an increasing number of deals, according to a report due out Friday.