Free drug samples fail as a safety net for poor patients, study says.

One purpose of free drug samples, doctors and drug companies say, is to provide needed medications to low-income and uninsured patients who have trouble affording them. But a recent study found that few samples end up in the hands of these patients.

"Our findings suggest that free drug samples serve as a marketing tool, not a safety net," the researchers wrote. (Sarah L. Cutrona et al., Characteristics of Recipients of Free Prescription Drug Samples: A Nationally Representative Analysis, 98 Am. J. Pub. Health 284 (2008).)

The study, conducted by Cambridge Health Alliance and Harvard Medical School researchers, is the first to look at free drug samples nationally. It found that 12 percent of Americans received a free drug sample in 2003; less than one-third of recipients were low-income and less than one-fifth were uninsured; and poor and uninsured Americans were less likely to receive samples than their wealthy and insured counterparts.

Critics of free samples say they influence what doctors prescribe and represent the newest and most expensive drugs--those with the shortest safety record. Because most of a drug's dangers come to light in its first few years on the market, the use of samples may increase the risk of adverse drug reactions, said Peter Lurie, deputy director of Public Citizen's Health Research Group in Washington, D.C.

"Companies say that new equals better, but Vioxx showed us that sometimes new equals worse," said Howard Brody, a physician and director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, who wrote the book Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry. Some drugs that have had safety problems, including the Cox-2 inhibitors Vioxx and Celebrex, were among those most heavily sampled, the study found.

Typically, the new drug doesn't offer significant advantages over older drugs, Lurie said. "If it did, it wouldn't be necessary to market it this way."

Brody noted that when a doctor gives a patient a drug sample, he or she is unlikely to switch the patient to a cheaper or generic drug later, even if it would be a better choice. "The companies bank on that as part of their marketing," he said.

The study found that people who visited doctors' offices were much more likely to receive samples than people who went to hospital clinics or emergency rooms or had no usual provider. When the researchers included the site of medical care in their analysis, uninsured people appeared to be more likely to receive samples than insured people. "We interpret this finding to reflect office-based practitioners' sincere effort to give free samples to their neediest patients," they noted.

The industry group Pharmaceutical Research and Manufacturers of America (PhRMA) pointed to that finding in defending the use of samples. Senior Vice President Ken Johnson said in a statement, "Clearly, free samples often lead to improved quality of life for millions of Americans, regardless of their income."

The study authors noted, "Although physicians may target samples to needy patients who enter their offices, these individual efforts fail to counteract society-wide factors that determine access to care and selectively direct free samples to the affluent."

Although drug reps typically focus their marketing on doctors' offices--where patients can afford to pay for prescriptions--Brody explained that some make arrangements with doctors who work in clinics to provide samples for clinic patients. "In some individual cases, I'd be very sorry to see free samples dry up," he added.

The samples themselves--and the lack of recordkeeping for them--also cause concern.

"You don't know how long they sat in a drug rep's trunk or a doctor's closet," and no pharmacist is double-checking the dosage or including patient information on the package, said Allan Coukell, director of policy for the Boston-based Prescription Project, which works on issues related to conflicts of interest due to drug marketing. "They often don't go in the medical record," and tracking samples in the event of a recall is difficult, he said.

Paul Sizemore, a Los Angeles lawyer, said that this problem has come up in litigation over Cox-2 inhibitor drugs. Some patients received so many samples that they took the drug for a year without getting a prescription, he explained, so there's no prescription record. The doctor may note that he or she gave the patient samples, but if the drug is recalled, such notes are unlikely to be noticed, he said.

"The only proof you have that a patient received a sample is the patient's word," said Gerald Jowers, a Columbia, South Carolina, lawyer who handles pharmaceutical cases.

No Free Lunch--an organization of doctors that encourages physicians to refuse all gifts from drug companies, including free samples--points out on its Web site that many hospital clinics have actually banned samples because of the difficulty of complying with the Joint Commission on Accreditation of Healthcare Organizations' recordkeeping requirements.

Brody said he sees a "countermovement that suggests that physicians are seeing the benefits of refusing free samples"--at least anecdotally. In his talks with physician groups, he said, many doctors express concern that patients will leave them if they stop giving away samples, but those who have done so say they are glad they did it and have more time for patients.

If drug companies wanted to provide free samples to poor patients, they would send them directly to free clinics-not distribute them through drug reps visiting doctors' offices, Jowers said.

"It's a shame that there's this disconnect," Sizemore said. "There is no incentive for companies to push these samples through to the doctors who work in clinics" with poor patients who can't afford the drugs they need. *