PhRMA, OIG codes spur changes in eye care industry

While many in the ophthalmic industry support the guidelines, others fear they may be unduly restrictive.

The ethical code issued by the Pharmaceutical Research and Manufacturers of America in 2002 is affecting the way industry, practitioners and educators in the ophthalmic profession conduct business.

The PhRMA guidelines, along with a draft of compliance programs promulgated by the Office of the Inspector General (OIG) in 2003, have resulted in increased scrutiny of pharmaceutical company ethics. The guidelines have also served as the catalyst for an ongoing dialogue about the role of industry in medical practice and education.

“We believe that having these kinds of guidelines in place is important for our sales team and is something we feel very strongly about,” said Christine Cassiano, senior manager of public relations at Allergan. “It is obviously something we take very seriously. Marketing the products in the most ethical of ways is what’s important.”

Delineating roles

The PhRMA guidelines focus on six main areas: informational presentations, educational or professional meetings, consultants, speaker training meetings, scholarship and educational funds, and educational and health care practice-related items.

In connection with informational presentations or discussions, the code states that occasional meals (but no entertainment or recreational events) may be offered as long as they are modest and occur in an environment conducive to informational communication.

Regarding continuing medical education, the guidelines state that financial support from companies is permissible, but that there are limitations on this support. The code stipulates that “[because] the giving of any subsidy directly to a health care professional by a company may be viewed as an inappropriate cash gift, any financial support should be given to the conference sponsor, which, in turn, can use the money to reduce the overall conference registration fee for all attendees.”

The role of consultants is also clarified in the PhRMA code, which states that “legitimate consulting or advisory arrangements are appropriate, but token consulting arrangements should not be used to justify payments to health care professionals.”

The code specifies the conditions that would constitute a genuine consulting arrangement, defining it as “retention of professionals based on their expertise, not as a reward or inducement for their ordering patterns.”

In its document, the OIG cautions that the use of physicians as consultants, advisers or researchers creates a “substantial risk of fraud and abuse.”

Going too far?

Although the guidelines for ethical conduct of pharmaceutical companies have been largely applauded, some practitioners consider certain aspects of the PhRMA and OIG guidelines to be excessive.

“Certainly, there was opportunity for abuse in terms of unsolicited personal gifts, and I would wholeheartedly agree that they were inappropriate,” said Richard L. Lindstrom, MD, chief medical editor of Ocular Surgery News. “Overall, I think the impact of the PhRMA guidelines has been positive. But there are parts of these guidelines that I believe may have gone too far.”

According to Dr. Lindstrom, one long-standing benefit of the pharmaceutical industry’s participation in medicine has been its commitment to quality educational programs.

“One of the best things that pharmaceutical companies have done over the years is to support high-quality education for physicians,” he said. “Education is expensive, and it is necessary for our physician population to continue to be practicing the most current standard of care.”

Dr. Lindstrom maintains that the PhRMA guidelines would not be serving the best interests of medicine if they prevent this support.

“One of the things I don’t want to see happen is the placing of barriers to stop pharmaceutical companies from supporting high-quality educational events,” he said. “Barriers there are inappropriate.”

Dr. Lindstrom said this issue was handled in the past by disclosure and suggested that this might be an effective method today.

“If a company is supporting an educational program for a glaucoma medication, for example, we simply disclose that the individual company is supporting the symposium,” he said. “We also disclose if the individual speaker is being paid any kind of honorarium or may be on the consulting or speaking panel.”

Dr. Lindstrom stressed that often the most knowledgeable speakers on a pharmaceutical product are those who developed the product or have otherwise worked with it.

“The physicians who know a product best are those who served as consultants for the company while the product was being developed, or who served as clinical investigators for the product,” he said.

Dr. Lindstrom said this extensive experience equips these practitioners with a comprehensive knowledge of the product.

“They have 5 to 7 years of experience using this product, and they understand the product,” he said. “They understand how it works, they understand the side effects, and they can give you small clinical pearls on how to use it.”

He added that those with a vested interest in the product would most likely care more about ensuring its proper use.

“When you are a consultant for a company, or you developed a product, or were a clinical investigator, you often become an advocate for that product,” Dr. Lindstrom said. “But the other side of that story is that you don’t want people using it improperly. So when you are teaching someone how to use that product or drug, you tend to be very committed to giving him or her all of the best information.”

Disclosure and decisions

Dr. Lindstrom said he believes in disclosure as a means of enabling physicians to make an educated decision.

“I personally like to believe that I am not so naïve as to not appreciate that, most likely, a person who is a consultant for a drug is going to advocate for it,” he said. “But primarily, I want him or her to teach me to use it properly.”

Dr. Lindstrom said he has used disclosure when participating in educational programs.

“I am obviously biased in favor of the techniques I have used, and I get paid by patients to use them,” he said. “So you disclose all of those things, and you do your level best to educate your colleagues regarding the proper use of the product. I certainly don’t want things to reach the point where that becomes unacceptable.”

Dr. Lindstrom said another approach that he finds useful is the contracting of third parties to handle the educational courses.

“Many of the manufacturers that once had their own education divisions are now contracting third parties to do educational courses,” he said. “That does allow some overview by the independent CME committee and perhaps does bring some balance to the programs.”

He expressed concern that a severe shift toward regulation and balance in CME courses could ultimately deteriorate the quality of the education.

“When I take a course about a new product, I usually am going to learn specifically about that drug. If they dilute that course by telling me about every possible alternative drug, that’s not the reason I am taking the course,” he said. “I don’t want a totally balanced course. I want 1 to 4 hours of intensive education about that drug and how to use it properly.”

Industry reactions

Some pharmaceutical companies have embraced the PhRMA and OIG guidelines.

“These kinds of regulations are very important to us,” said Ms. Cassiano of Allergan. “Obviously, it is important for us to make sales, but it is just as important to do so ethically and lawfully.”

Ms. Cassiano also discussed the value of CME courses, emphasizing the effectiveness of independent third-party programs.

“I think any pharmaceutical company believes that CME courses are incredibly important to physicians and, ultimately, to patients,” she said. “The type of education that is provided by third parties who have independent programs really serves to help medicine progress.”

She said that although third-party educational programs are sponsored by pharmaceutical companies, the courses must comply with the highest educational standards.

“The sponsorship is done in accordance with what is required by law,” she said. “The companies don’t have a say in what is being discussed, and obviously the hope is to have the information that is provided be very fair and balanced.”

Ms. Cassiano said Allergan has internal guidelines that address many of the same issues as the PhRMA and OIG regulations.

“For the past year and a half, we have worked under what is called a ‘field guide,’ to basically describe how our sales team should conduct themselves in the field,” she said. “So we already used those types of guidelines internally prior to the PhRMA code.”

According to Alcon spokeswoman Suzie DeMent, Alcon also had guidelines in place and has subsequently adapted them based on the PhRMA code.

“Alcon has long had an internal code similar to the PhRMA code, and we have adapted ours to more closely match theirs since its publication,” she said. “We have a director of compliance charged with ensuring that all of our business practices are ethical.”

Ms. DeMent said Alcon’s director of compliance has worked closely with sales and marketing groups to help them understand the changing environment. She also stressed Alcon’s commitment to supporting education.

“One aspect of our relationship with the physicians has always been to support educational opportunities,” she said. “We are continuing to provide and support rich opportunities for them to expand their practical knowledge.”

For Your Information:

• Christine Cassiano is senior manager for public relations at Allergan. She can be reached at 2525 Dupont Drive, Irvine, CA 92612; (714) 246-4500; fax: (714) 246-4800.
• Richard L. Lindstrom, MD, is chief medical editor of Ocular Surgery News. He can be reached at Minnesota Eye Associates, 710 East 24th St., Minneapolis, MN 55404; (612) 813-3600; fax: (612) 813-3660.
• Suzie DeMent is a spokeswoman for Alcon. She can be reached at 6201 South Freeway, Fort Worth, TX 76134; (817) 551-4950; fax: (800) 777-2799.