Healthy Skepticism Library item: 14417

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Harris G.
Study Says Drug Samples May Endanger Children
The New York Times 2008 Oct 6
http://www.nytimes.com/2008/10/06/health/research/06sample.html

Full text:

A new study suggests that free drug samples, an effective marketing tool for the drug industry, do little to help the poor and may put children’s health at risk.

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The study, being published Monday in the journal Pediatrics, analyzed an in-depth survey conducted in 2004 by the Centers for Disease Control and Prevention that asked people how they got health care. As part of the survey, respondents were asked if they received free drug samples. It was found that children in the lowest income group were no more likely to receive the samples than were those in the highest income group, in part because the poor are less likely to see doctors.

Once in a doctor’s office, children who lack health insurance are more likely to receive free drug samples than their well-insured counterparts, the study reported.

But of greater concern, the authors wrote, are the kinds of drug samples that physicians provide. In 2004, the year of the C.D.C. survey, more than 500,000 children received samples of four medicines that were later the subject of serious safety warnings required by the Food and Drug Administration: Advair, for asthma; Adderall and Strattera, both for attention deficit disorder; and Elidel, for eczema.

Elidel, for example, was given to the parents of more than 38,000 children under age 2. The F.D.A. later received reports of skin cancer in patients who took Elidel. Although the agency was not sure whether the drug was to blame, the drug’s label got a strong warning and a reminder that it was not approved for use in children under 2.

The study’s lead author, Dr. Sarah L. Cutrona, an instructor at Harvard Medical School, said in an interview that the drugs provided as free samples tended to be the newest, so their safety had often not been thoroughly vetted. Samples also often lack instructions for children or information about what parents should do in the event of an overdose.

Dr. Cutrona said more research was needed on the risks and benefits of samples.

“We need to discuss it more,” she said, “and maybe consider stopping the use of free samples entirely, if there are such potential harms.”

In response, Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, said that “free samples have helped improve the quality of life for millions of Americans, regardless of their income.”

It is hard to overstate the importance of free samples to the drug industry’s marketing efforts. Sales representatives generally require doctors to sign a receipt for the samples; during those precious seconds the representatives can make their marketing pitches. Many doctors might refuse to see the representatives if they did not provide the samples.

Dr. David M. Namerow, a founder of a large pediatric practice based in Fair Lawn, N.J., defended the practice of accepting and dispensing free samples.

“Patients appreciate when we give them something that can potentially help their child,” he said, “and that’s what we’re in this business for.” Free samples save parents from having to make an immediate trip to the pharmacy, Dr. Namerow added, and they allow parents to make sure a medicine works for their child before buying it.

But Dr. Andrew D. Racine, director of general pediatrics at the Children’s Hospital at Montefiore in the Bronx, said free samples distorted doctors’ decision-making and added that he did not use them.

“As a physician, the way you should be making treatment decisions should not be based on which sales representatives come to your door,” Dr. Racine said. “This is just a marketing technique.”

Dr. Sidney Wolfe, director of Public Citizen’s health research group and a fierce opponent of free drug samples, said the practice encouraged doctors “to overuse dangerous drugs.”

Dr. Lisa Asta, a pediatrician in Walnut Creek, Calif., said she might soon ban free samples from her practice because the drugs being promoted generally required high co-payments for prescriptions.

“I’m tired of my patients getting burned by a $40 co-pay,” Dr. Asta said.