Never mind the pens and donuts

Dismissing information or research out of hand simply because of the source — whether it’s connected to groups whose politics we don’t agree with, is reporting something we don’t want to believe, or the author once received funding or consulted for a stakeholder — is a fallacy of logic known as ad hominem. It’s a simplistic response used by those unable to examine the accuracy and scientific integrity of the information itself. While it may be instinctive, it also leaves us more susceptible to bad science and to miss some of the best.

It’s not the source, it’s the science that matters.

Increasingly, ad hominem campaigns against doctors and researchers have taken on a witch-hunt fervor. According to Warren Ross, Editor of Medical Media Marketing, “the question is no longer whether consultants' advice is honest, knowledgeable and useful, or whether the educational materials are accurate and fair,” but whether it looks biased.

Focusing on eliminating pens and donuts handed out by pharmaceutical companies, or on financial disclosure statements alone, are popular solutions but won’t make bad science better or false information more credible. It won't help arm people with the scientific process. Nor will standards and regulations ever completely weed out those who can be corrupted. The fact is, “some physicians are corruptible and the evidence suggests that so are some legislators, and for all I know even some columnists,” said Mr. Ross.

That said, it can be helpful for us to be aware of some of the ways medical professionals, and consumers, can unknowingly be influenced — things that don’t show up on financial disclosures or appear visible like office supplies with logos on them. Sometimes, they take the form of education and good will.

North Carolina internists, led by Dr. David Miller, M.D., at Wake Forest University School of Medicine in Winston-Salem, examined the influence of free drug samples and published their findings in a recent issue of the Southern Medical Journal. Pharmaceutical companies distribute more than 15 billion dollars worth of medication samples to office-based doctors in the United States, which some have said lead physicians to prescribe those drugs more frequently. While there have been calls to ban free samples, others have pointed out that they are important sources of free medications for the poor and uninsured, notably elderly. Most of us probably felt the latter.

But drug samples tend to be the newest, brand name medications, rather than less costly generics and older medications, wrote Dr. Miller and colleagues. These authors wondered if samples could actually paradoxically be raising drug costs for the uninsured, as a result of more costly prescriptions.

They studied a large community-based internal medicine practice affiliated with their university, that had 63 internal medicine residents, 10 attendings and 5 mid-level providers, who cared for predominately minority patients, fewer than 8% with commercial insurance. The patients were mostly uninsured or on Medicare or Medicaid. The practice had an on-site pharmacy and had had an extensive drug sample closet for years, until free samples were discontinued when the practice moved a few blocks away and no longer had the storage space.

The authors analyzed the on-site pharmacy electronic database for all prescriptions written by the clinic’s providers and filled at pharmacy 9 months before and after the drug sample closet was discontinued. They limited their study to the four major classes of chronic medications written for uninsured and Medicaid patients with comprehensive drug coverage benefits. Both groups averaged in age in their mid-50s, with Medicaid recipients more likely to be female (66% versus 50%). During the 18 months; 1,973 such prescriptions were written.

During the first half of the study, the Medicaid recipients were prescribed nearly three times the number of drugs as the uninsured patients — an average of 4 prescriptions apiece compared to 1.5 for each uninsured patient. Drug coverage benefits were associated with more prescriptions written. There was no change in the percentage of generic drug prescriptions written for the Medicaid patients before or after the drug samples were discontinued, as they consistently received a high percentage of generics. Nor did the average prescription costs change significantly for the Medicaid patients. As the investigators noted, because doctors know that these patients have access to affordable drugs through Medicaid they were less likely to turn to the drug samples for them… and more likely to prescribe generics. The authors said the high level of generics for Medicaid patients likely resemble what prescribing practices without drug samples look like.

But over time, prescriptions for generics steadily and dramatically rose among the uninsured — from a low of 10% to 40% — and the average number of prescriptions dropped slightly to about one. By the last three months of the study, medication costs for the uninsured had dropped 11%. [More experienced attending doctors were three times as likely to prescribe generics for the patients, by the way, than the lesser experienced residents.]

In other words, drug samples were associated with higher prescription costs for uninsured patients. The authors proposed three explanations for this, supported by other studies. When doctors give free samples, they are more likely to subsequently prescribe the same medication for that patient. Availability of specific drug samples have been reported to be more erratic so when patients come back for a refill of a sample that wasn’t in the closet, they were more likely to be prescribed the same drug rather than switching to a different drug. When a drug is discontinued for good from a drug sample closet, physicians were motivated to find a generic and more affordable option for those patients without insurance and increasingly prescribed more generics.

The authors did not believe that the increase in generic prescriptions after the drug samples were discontinued was due to influences of pharmaceutical reps on prescribing practices. Their visits to the doctors' practice ceased when the practice stopped accepting drug samples, but the reps continued to have regular contact with the doctors through the university’s teaching hospital. It wasn’t the pens and donuts… it was the drug samples.

They concluded that their findings, if confirmed, could have important implications for controlling rising healthcare costs:

[W]e found physicians are over three times more likely to prescribe generic medications to uninsured patients when drug samples are not available. Although many physicians believe drug samples benefit their uninsured patients by serving as a source of free medications, samples are likely to lead to higher costs for the uninsured as physicians tend to prescribe more nongeneric, expensive products.

But believing that doctors are the only ones influenced by the newest, most expensive brand name drugs, ignores that consumers can be, too. Direct-to-consumer pharmaceutical advertising have come under fire over recent years, too. The ads are quite effective, as virtually everyone now believes they have some malady in need of a prescription to “talk to their doctor about.” Perhaps, the most publicized scandal this year was over Pfizer’s ad campaign for Lipitor centering on Dr. Robert Jarvik who turned out to have never had a medical license or practiced medicine; he had been shown rowing a racing scull that was really an actor double; and he had only been taking Lipitor for a month before signing a $1.35 million 2-year contract as a spokesperson for Pfizer. While the Dr. Jarvis segments were discontinued, Lipitor’s Heart to Heart advertising campaign has continued, with real life patients talking heart to heart to others.

Today, Dr. Wesby Fisher, M.D., learned of a new way they’re reaching people with this campaign using the trust patients have for their doctors. He received an email from Pfizer asking for his “help” in identifying among his patients those on Lipitor to share their story for its Heart to Heart ads and who could “motivate other at-risk patients to talk to their own doctor about their CV risk.” All Dr. Wes had to do was “click here and download ‘What was your wake-up call?’” It was described as an instructional letter he could provide to potential candidates. If their story was selected for TV, print, internet or patient education literature, Dr. Wes would be contacted to provide copies of their medical records. He was also offered literature to place in his office to help his patients have a heart to heart with him.

Dr. Wes was having no part of violating his patient’s trust or privacy like that and wrote a snappy response he titled: “Can you say HIPAA?”

Last week, a new certification program was launched for healthcare advertising and promotional medical education professionals to train them in how to comply with the new PhRMA regulations that go into effect next month. The new 2009 PhRMA Code on Interactions with Healthcare Professionals will require all promotional materials to be “accurate and not misleading; make claims about a product only when properly substantiated, reflect the balance between risks and benefits, and be consistent with all other FDA requirements governing such communications.”

Did you even know there was a public relations specialty called promotional medical education?