Free Drug Samples the New Threat to Children

Washington, DCPatients love 'em because they're free, and will save them a buck or two at the drug store. Doctors love 'em because their patients love 'em—plus the added benefit of ensuring a patient without the means to afford expensive prescription drugs can have access to them. However a new study out today suggests that free drug samples do little to help the poor, and in actual fact may pose a risk to children's health.

One of the concerns outlined in the report, which appears today in the medical journal Pediatrics, is the simple fact that most drug samples tend to be the newer, cutting-edge drugs—the safety of which may not have been thoroughly vetted. It was also noted that many of the drug samples often lack instructions for children, together with additional safety information—and, more importantly—how a parent is supposed to respond in the event of an overdose, or an adverse reaction.

An example of the forgoing is revealed in the results of a 2004 survey conducted by the Centers for Disease Control and Prevention (CDC) in Atlanta. That year it was determined that 500,000 children were at the receiving end of four drugs which were later found to have safety issues by the US Food and Drug Administration (FDA).

The drugs in question were Advair, for asthma; Adderall and Strattera, both for attention deficit disorder; and Elidel, for eczema.

Elidel, it turns out, is a classic example. Long after Elidel was dispensed via the freebie train in the doctor's office, the FDA began receiving reports of skin cancer in patients who took Elidel. In the absence of absolute proof that Elidel was to blame, the FDA nonetheless beefed up the warning label together with a stern reminder that the drug was not approved for use in children less than 2 years of age.

Even so, the survey revealed that free samples of Elidel were granted to the parents of more than 38,000 children under the age of 2 that year.

Lead author of the study, Dr. Sarah Cutrona of the Harvard Medical School, suggested to the New York Times that more research was needed to adequately weigh the risks, as well as the 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."

That is unlikely to happen, as the freebie is integral to the marketing strategies of pharmaceuticals. It's a way to put new, and emerging products in front of the doctor as well as the patient. The drug companies point to the fact that without free samples, the poor might be denied access to the drugs they need.

It is also true, according to data mined from the 2004 CDC survey, that children who lack health insurance are more likely to receive free drug samples than their well-insured counterparts.

While it was found that, overall poor children were no more likely to receive free samples than their more affluent peers, the researchers pointed out that poorer families were less likely to show up at doctor's offices due to income restrictions. Once that data was broken out of the survey, a truer picture emerges.

Still, there are points on both sides:

"Free samples have helped improve the quality of life for millions of Americans," says Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America. The benefit is in play, "regardless of their income."

And there are doctors who defend the practice of accepting and dispensing free samples.

"Patients appreciate when we give them something that can potentially help their child," said Dr. David Namerow, a founder of a large pediatric practice based in Fair Lawn, New Jersey, "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.

However, the critics view the practice as little more than a marketing ploy by the manufacturers. Dr. Lisa Asta, a pediatrician in Walnut Creek, California makes the point that drugs being promoted generally require higher co-payments for prescriptions.

And Dr. Andrew Racine of Children's Hospital at Montefiore, in the Bronx, said in a statement published today in the New York Times that the dispensation of free drug samples distorts the decision-making ability of the doctor.

"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."

As for Dr. Sydney Wolfe, director of Public Citizen—the hard-charging advocacy group known for its vigorous campaigns against allegedly harmful products—he wants them gone. Wolfe remains a fierce opponent of free drug samples, adding that the practice encourages doctors "to overuse dangerous drugs."

The debate continues. It will be interesting to see, however, what effect this issue has on the courts of law, and upon litigation stemming from harm a drug may have inflicted on a patient. Rather than restricting the pursuit of damages from the manufacturer alone, litigants may now broaden their focus to include the dispensation of free samples, together with the alleged lack of information that often goes along with it.