December 2004 Bulletin

Get in step with ethics guidelines

New codes are redefining relationships between physicians and industry

By Kathleen Misovic

Now, more than ever, it’s important to know if you should accept industry gifts, such as reimbursement for attending conferences. Within the past two years, three organizations, including the AAOS, have issued or updated their ethics guidelines regarding interactions between industry and health care providers.

Some orthopaedic surgeons may not realize the free perks they enjoyed from industry in the past, such as meals and golf outings, are no longer allowed under the guidelines. Others may realize restrictions are in place, but may not want to accept them.

“Even though some members of the Academy don’t want to hear this, business as usual cannot continue,” said Richard N. Peterson, AAOS general counsel.

Before the industry guidelines came out, “bribery was alive and well,” said Jeanne DelSignore, MD, chair of the AAOS Ethics Committee. She said that although the Academy had its own set of ethics guidelines for orthopaedic surgeons, the committee was pleased when industry produced a more stringent set of their own.

“We’re happy that the temptation to receive inappropriate gifts has been minimized,” Dr. DelSignore said.

Follow the guidelines

There are three sets of guidelines regulating interactions between drug and device industry representatives and physicians: the Advanced Medical Technology Association’s (AdvaMed) Code of Ethics on Interactions with Health Care Professionals, the Pharmaceutical Research and Manufacturers’ Association (PhRMA) Code on Interactions with Healthcare Professionals, and the AAOS Opinions on Ethics and Professionalism on Gifts and the Orthopaedic Surgeon’s Relationship with Industry.

Although the PhRMA and AdvaMed codes are known as “voluntary guidelines,” they are not truly voluntary. The federal government has indicated it will interpret them as minimum standards, and industry representatives who don’t follow them may face criminal or civic penalties, said Peterson. He added that on September 30, 2004, California Governor Arnold Schwarzenegger signed a bill that requires all pharmaceutical companies doing business in that state to follow the PhRMA guidelines on gifts to providers by July 1, 2005.

The PhRMA code, adopted in July 2002, spells out in great detail what is acceptable and unacceptable behavior between health care professionals and drug company sales representatives. For example, it states that drug reps may offer health care professionals items only if they are intended primarily for the benefit of patients (such as an anatomical model for use in an examination room) or primarily for the benefit of the provider’s practice (such as pens or notepads). All such gifts must be worth no more than $100.

The code also features a lengthy series of questions and answers to address specific concerns. One question asks whether drug reps may present health care providers with golf balls and sports bags that bear a company or product name. The answer is no. Even if these items are of minimal value, they do not primarily entail a benefit to patients and are not associated with the health care professional’s practice.

The AdvaMed code, adopted in January 2004, is similar to the PhRMA code in that it contains a list of frequently asked questions and answers. It also states that AdvaMed employees may provide only modest gifts, valued at less than $100, to health care professionals. These gifts must benefit patients or serve a genuine educational function. However, it makes an exception to the price limit in the case of anatomical models or textbooks.

The AAOS Opinions on Ethics are less specific than the two industry codes. The opinions apply to orthopaedic surgeons and rely on members to use their own judgment. For example, although the opinions state, “it is of the utmost importance that any gift or other financial support accepted by an orthopaedic surgeon should primarily entail a benefit to his or her patient,” they set no monetary limits on gifts.

“Our guidelines are based on trust and integrity,” said Dr. DelSignore.

“We have no policing body to enforce them,” added James Capozzi, MD, a member of the AAOS Ethics Committee.

Avoid conflicts of interest

So is it really a problem if orthopaedic surgeons accept an occasional gift from industry? With today’s regulatory climate, it certainly is. Questionable relationships between health professionals and industry have been featured in the news recently, including a case involving medical researchers who were receiving salaries from the U.S. government to study products at the same time they were paid consulting fees by the manufacturers whose products they were researching.

Patients could suffer if industry perks become the main influence providers consider when deciding which devices or medications to use.

“Most doctors understand the conflict of interest between the perks and their ability to make a non-conflicted decision,” Dr. Capozzi said. “They also understand the importance of public perception.”

Even though orthopaedic surgeons may believe they are above being influenced by perks, they are probably a lot more susceptible to persuasion than they think.

“Many physicians have personalities that are susceptible to pleasing other people and keeping them happy,” Dr. Capozzi said. “Those kinds of personalities are more susceptible to persuasion.”

So the three sets of guidelines work under the premise that it’s better to avoid the temptation all together.

Why all the confusion?

At a meeting of the AAOS Corporate Advisory Council last June, industry members expressed concern that many orthopaedic surgeons do not understand the guidelines, or even realize they exist. Dr. Capozzi, who attended the meeting, said some of the confusion might be caused by orthopaedic surgeons falling behind in their reading.

“We have a million other things to read; reading the PhRMA Code is not high on our list,” he admitted.

The three different sets of guidelines may also be complicating matters. “They may not be 100 percent in agreement; there might be some discrepancies between them,” he said.

However, Dr. Capozzi believes most of the confusion stems from the abrupt change to what had become accepted behavior.

“Obviously it’s nicer to sit through a two-day conference knowing there’s a game of golf coming up, than to just sit through a two-day conference,” Dr. Capozzi said. “Doctors became used to these perks and were taken aback by the abrupt changes. Many surgeons were booked for classes that implant companies cancelled literally overnight when the AdvaMed guidelines were announced, simply because they included a golf outing.”

CME vs. Non-CME

You may be wondering if it is ever permissible to accept compensation for attending an educational conference. According to a revision to the AAOS Opinions on Ethics made in June 2004, it is ethical for an orthopaedic surgeon to receive modest compensation for attending industry-sponsored events that promote their products and don’t offer CME credits, said Dr. DelSignore. Acceptable compensation for these events would include modest travel, food and lodging costs. Reimbursement for lodging at exclusive resorts with numerous golf games would not be ethical. Reimbursement for time off to attend the course, or acceptance of token honoraria, would also be unethical.

Why is reimbursement allowed for these types of courses? Dr. DelSignore explained that providers who attend these “infomercial”–type courses are more likely to realize they are being shown a biased point of view and keep that bias in mind when determining what is best for their patients. Although courses sponsored by industry can provide a valuable source of education and a direct benefit to patients, they typically present only one point of view. Such courses do not meet the Accreditation Council for Continuing Medical Education criteria, which define CME events.

If you attend CME courses offered by an accredited institution, you must pay your own way. “CME courses are held to the highest standard because they offer education in its purest form and nonbiased information,” Dr. DelSignore explained.

Industry may give providers educational grants to help defray the cost of attending third-party conferences, Dr. DelSignore said. Industry may also support CME events by hosting modest receptions and exhibitor’s booths, and providing honoraria to the course sponsor to pay presenting faculty members. But providers should not accept industry subsidies to attend these conferences.

The reason why industry may not pay providers’ expenses for CME courses is that it may put providers in the position of feeling obligated to somehow pay industry back for their CME credits.

“If doctors have a personal relationship with the [industry] reps, they may feel an obligation to use their product as a way of giving back something in return,” Dr. DelSignore explained. “If doctors are accustomed to having their expenses paid at CME courses, they need to be re-educated as to the new guidelines.”

Whether you’re planning to attend a conference or not, it’s always a good idea to review the ethics guidelines if you’re not up to date on them. In the meantime, the easiest guideline to follow is to simply ensure all your actions will benefit your patients and will be able to withstand public scrutiny.

“The onus is on the physician to act like a physician whose primary objective is the health and benefit of the patient,” Dr. Capozzi said. “If you can’t justify an action with industry as helping your patients, you shouldn’t be having that interaction.”

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