Putting A Curb On Perks Drug Firms Reduce Abuses In Marketing

Recognizing a growing concern over the use of expensive perks to influence physicians, the nation’s top coalition of pharmaceutical firms has taken steps to curb potential abuses.
As of July 1, the Pharmaceutical Research and Manufacturers of America (PhRMA) officially adopted a new, voluntary marketing code to govern the pharmaceutical industry’s relationships with physicians and other health care professionals.

“The new code makes it crystal clear that the interactions of company sales representatives with health care professionals are to benefit patients and enhance the practice of medicine,” PhRMA President Alan F. Holmer said. “It explicitly spells out that all interactions should be focused on informing health care professionals about products, providing scientific and educational information, and supporting medical research and education.”

It also gets specific about what is and isn’t ethically acceptable in one-on-one marketing efforts: pizzas and hoagies are fine, but expensive dinners are not. Small gifts that benefit patients are acceptable, but evenings at the opera or professional ballgames are called into question. Not everyone will comply with such a code, of course, but to those calling for reforms in the physician-drug company relationship, it’s a welcome step.

“We now say all sporting events and theater tickets are out,” said Jeff Trewhitt, spokesman for the PhRMA, an organization which represents about 80 drug and biotechnology companies. “The main focus of a physician-pharmaceutical representative meeting has to be on the product and not how the Cubs are doing.”

In the high-stakes world of pharmaceutical development and sales, such a shift is significant. Drug companies spend tens of billions annually to develop and market their products, and it isn’t always easy to get physicians’ attention. As a result, a culture of perks, many of them luxurious and expensive, has arisen under the guise of medical education. But in the view of the PhRMA and some other groups, a line must be drawn somewhere.

“I don’t think that it’s realistic to expect abrupt change,” said Dr. Alan R. Nelson, a former American Medical Association (AMA) president. “This kind of change takes place gradually. Adherence to the guidelines is going to be an ongoing challenge for the profession.”

Culture Change
To make its position clear, the PhRMA Code on Interactions with Healthcare Professionals, as the new guidelines are known, lays down specific rules for what is and isn’t acceptable. In short, if a gift is expensive or doesn’t benefit patients, it’s probably a red flag.

For example, according to the code, informational presentations and forums that provide valuable scientific and educational benefits are acceptable, of course, but the meals and other amenities provided must be modest by local standards – automatically calling into question the weekend seminars at luxury resorts which have been commonplace among some pharmaceutical marketers.

And, speaking of meals, inclusion of a health care professional’s spouse or other guests is not appropriate. Neither is offering take-out meals or meals to be eaten in the absence of a company representative, known as ‘dine and dash’ programs. The code also provides that token consulting or advisory arrangements do not justify compensating physicians for their time or their travel, lodging, and other out-of-pocket expenses.

But all this doesn’t mean marketing still can’t be effective, Trewhitt said. “The two most common approaches are the office visit where the doctor says, ‘you have five to 10 minutes; make it good’ — that will continue,” he explained. “And the 35- to 45-minute session over a pizza or hoagie lunch with all the health care professionals at the clinic discussing the product and asking questions, that will continue, too.”

As for gifts, the code specifies that items primarily for the benefit of patients may be offered to health professionals if they are not of substantial value – $100 or less, as a general rule. For example, the PhRMA outlines, “an anatomical model for use in an examination room primarily involves a patient benefit, whereas a VCR or CD player does not.” Golf balls and sports bags, a common gift, would not be ethical to receive under the code, even if they bear a company or product name.
Traditionally, one way pharmaceutical companies expose physicians to new products is to invite them to symposiums with the intent of promoting their own products.

Writing recently in the Journal of the American Medical Association (JAMA), Dr. Robert Tenery, a Dallas ophthalmologist and a member of the AMA’s Council on Ethical and Judicial Affairs, said he was invited to attend such a conference for information about a new allergy medicine. In return for his presence, he was offered round-trip airfare to California, a room at a luxury hotel, a fee of $1,000, and the promise of participation in other such programs. Tenery called it the most flagrant offer he had ever heard of.

Therefore, the new PhRMA code states that companies can provide support to the conference sponsor but should not fund individual participants. That sponsor may in turn provide grants to individuals to participate or to reduce the overall registration fees for all attendees.

The new guidelines also set standards for consulting arrangements, in which health professionals are retained as consultants and compensated by drug firms. Characteristics of legitimate consulting arrangements, the organization states, should include the retention of professionals based on their expertise, not as a reward or inducement for prescribing, and the retention of no more consultants than needed for the specific program.

Finally, PhRMA asserts that no grants, scholarships, subsidies, support, consulting contracts, or educational or practice-related items should be given to a physician in exchange for prescribing certain medications. The reasoning is that such gifts interfere with the independence of a medical professional’s prescribing practices, when what is best for patients should always come first.

A Rising Tide
For individual pharmaceutical companies, there’s plenty at stake. It takes years to bring a new product through the rigorous series of trials required by the U.S. Food and Drug Administration — and that means high costs.

While previous studies have estimated the cost of developing a new drug at anywhere from $100 million to nearly $900 million, a report released in December by the Tufts Center for the Study of Drug Development pegs the average cost at $802 million — a sharp increase over the center’s estimate of $231 million in 1987.
That’s a more than threefold cost jump in less than 15 years. When considered along with the fact that considerably less than one-third of all proposed drugs ever see a pharmacy shelf, it’s not difficult to see the rationale behind aggressive marketing by pharmaceutical companies.

To get their drugs to the marketplace, companies must work through clinical research centers to obtain data about the safety and effectiveness of the medication, and to do that, they often have to provide financial support for the people doing the studies.

Recognizing the potential for abuse, 12 leading medical journals – including JAMA and the New England Journal of Medicine – set guidelines last year preventing firms that fund research from manipulating results to favor their products or burying results that are unfavorable to them.

With drug companies emerging as the primary backers of such research — yet another marketing tool — concerns had been raised for some time about ethical compromises in the way journal reports were presented.

“We will not review or publish articles based on studies that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication,” the editors stated.

Clearly, much is at stake, not only the financial well-being of pharmaceutical companies but physicians’ ethics and patients’ safety. Such disparate concepts must co-exist, but it’s an often uneasy mix — especially when one considers that the pharmaceutical industry invested more than $30 billion in 2001 discovering and developing new medicines and up to $15 billion more marketing their products through advertising, perks for health care professionals, and sponsorship of journal studies. The efforts are effective, as non-generic drug sales total close to 95{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5} of all drug purchases.

And, as Nelson said, not all drug companies are part of PhRMA, so compliance will never be 100{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5}. “After all,” he noted, “this is voluntary.”

The Mass. Medical Society has established its own guidelines concerning the amount of influence drug companies may have on continuing education programs that physicians attend for credit. But physicians say many of these symposiums offer quality resources and speakers doctors might not otherwise get a chance to hear. Individual physicians, they say, must determine how many perks to accept and how they will affect their decision making.

Of the drug industry’s marketing costs, an estimated 12{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5} are for entertaining physicians. In a Kaiser Family Foundation poll released in March, 61{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5} of the 2,608 doctors surveyed said they received meals, tickets, or free travel from a drug company detailer, and 92{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5} said they received free drug samples.

Zero Tolerance
However, even though the current marketing culture is so ingrained, it can be changed, and the blatant abuses will decrease, said Timothy A. Margraf, president of ImpactRx, a New Jersey company that tracks drug marketing. “This is not how they want to promote their product,” he insisted. “You’ll see a zero-tolerance policy from most of the major companies, and that 12{06cf2b9696b159f874511d23dbc893eb1ac83014175ed30550cfff22781411e5} will go away.”

To Trewhitt, that would be a positive development. After all, physicians will feel freer to make their own decisions if questionable influences are eliminated.
“It may mean, in a few cases, doctors won’t get fancy dinners,” he said. “They’ll get a modest meal and serious discussion about a product. You’re not going to buy a doctor’s soul for the price of a pizza.”