Prescribing Above the Influence

Call it the New Age of Transparency and Accountability: So far this year, two states—Massachusetts and Vermont—have enacted strict laws that codify and regulate the interactions between health care providers and pharmaceutical sales and marketing representatives. Whether you consider such legislation “draconian” (as some critics do) or essential, it appears to be part of a trend that advocates hope will continue.

While lauding Massachusetts and Vermont for “taking the lead” in these matters—going beyond other states’ laws that allow gifts and payments from pharmaceutical and device manufacturers to health care providers, as long as they are disclosed—Howard Brody, MD, PhD, Director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, laments that legislation has been necessary.

“I think it would really be ideal if professionally, we just decided among ourselves—doctors, nurse practitioners, physician assistants, and so on—that we would not accept this money,” Brody says. “Because it’s tainted money, really, and it compromises our commitment to our patients.”

Massachusetts: The Microcosm
The Massachusetts code of conduct—officially designated “105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct”—is outlined in a 13-page document available at the Web site for the state’s Department of Public Health (www.mass.gov/dph). The code applies to industry interactions with any health care provider licensed to practice in Massachusetts—even if the encounter occurs in another state (say, at a national conference). Helpfully, there are three “frequently asked questions” sections in which the finer points of the regulations are explained, often with specific examples.

In a nutshell, the code prohibits gifts of entertainment or recreation (eg, trips, tickets to concerts or sporting events); complimentary branded items (eg, pens, mugs, calendars); and meals, unless certain circumstances are met. All provided meals must be “modest” and “occasional,” must take place in the practitioner’s office or hospital setting, and must be accompanied by an informational presentation. Items that have potential benefit to patients—such as drug samples or demonstration models of medical devices—are permissible under the new regulations.

With regard to sponsorship of continuing medical education (CME) programs, the code stipulates that pharmaceutical and medical device manufacturers may not provide financial support for travel, lodging, meals, or personal expenses to nonfaculty health care providers attending such events. They are also prohibited from sponsoring or paying for CME that does not comply with the Standards for Commercial Support set forth by the Accreditation Council for Continuing Medical Education or an equivalent accrediting body. Further, companies are also barred from providing “any advice or guidance to the CME provider regarding the content or faculty for a particular CME program funded by the company.”

Pharmaceutical and medical device manufacturers are required to disclose “the value, nature, purpose, and particular recipient of any fee, payment, subsidy, or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities.” Disclosure reports must be filed by July 1 each year, beginning in 2010, and must be accompanied by a $2,000 fee. The first reports will cover the six-month period from the regulations’ implementation on July 1, 2009, through December 31, 2009. Subsequent annual reports will cover the entire previous calendar year.

While the demise of the “free lunch” has received the most media attention, it is the CME restrictions that may pose the biggest challenges to clinicians in Massachusetts. Both the NP and PA professional organizations in the state have already started planning how they will continue to provide CME opportunities to their members while complying with the code.

“Since the change in attitude toward pharmaceutical company funding of CME events, we have had to be more creative in how we provide CME to our members,” says David Probert, PA-C, the Massachusetts Association of Physician Assistants (MAPA) Delegate to the American Academy of Physician Assistants, who has served on MAPA’s CME committee. “The continued operation of our professional organization will rely more on member support—ie, dues—than in the past.” MAPA is applying for grants from nonpharmaceutical sources, including the AAPA, local hospitals, and other employers of PAs.

The Massachusetts Coalition of Nurse Practitioners (MCNP) is also working to develop educational programs in partnership with larger institutions and universities. “We’re looking at how we can develop quarterly educational offerings … that we could open to our members for a small fee,” says MCNP President Nancy O’Rourke, MSN, ACNP, ANP, RnC, FAANP. “We haven’t had to charge them anything for their educational opportunities, but at this point, we’re going to have to start. It’s probably going to be a nominal fee, but it still has to cover the cost of putting on the program. Speakers for these programs typically get a large honorarium, and that’s where the pharmaceutical companies were helping us—paying that honorarium.”

O’Rourke also points out that the location restrictions, while understandable, may pose challenges for those who are not in major urban areas such as Boston. “If you’re practicing out in central or western Massachusetts, you might be 100 miles from the nearest hospital setting,” she points out. But the law is the law, as she observes, and “there are still ways that you can provide education—you just have to work within that structure.”

Industry, Police Thyself?
The Massachusetts code mirrors, to a large extent, the voluntary code established by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA actually updated its code last year, and the changes took effect on January 1, 2009. Among them was the banning of gifts that are either “reminder items” (eg, the pens and preprinted notepads that everyone used to collect in the exhibit halls at conferences) or items that are of benefit to the prescriber. The updated PhRMA code is also more explicit about the situations in which provision of meals is appropriate and about the need for disclosure of any relationship between a pharmaceutical company and a health care provider if the latter is involved in the development of CME programs, clinical practice guidelines, or formulary decisions.

This industry-wide code is part of the reason that PhRMA opposed the Massachusetts legislation. “We’ve said consistently that it is the most draconian law in the country,” says Marjorie Powell, Senior Assistant General Counsel for PhRMA. “We think it’s not necessary—in part, because of the PhRMA code. We think it doesn’t do anything to improve patient care. It simply involves everybody in the health care system in much more recordkeeping and potential disputes over potential violations.”

 All PhRMA member companies and some nonmember companies have agreed to comply with the organization’s code; the names of all the companies’ compliance officers are listed on the PhRMA Web site (www.phrma.org), making it easy, Powell says, for a clinician to report a potential violation to the appropriate party. She adds that this provides “a great deal of both peer pressure and public pressure” for company representatives to comply with the code of conduct.

There are those who would suggest that a voluntary code administered by a leading industry organization may not be effective enough; that’s why laws like the ones in Massachusetts and Vermont become necessary. While it is not an apples-to-apples comparison, no one has been very impressed with the financial industry’s efforts at policing itself.

Brody, who authored the book Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, says the effectiveness of the more robust PhRMA code will be proven if marketing expenses decrease. “If they’re not doing all those things anymore—the lavish dinners, giving out pens and notepads and so on—shouldn’t there be a reduction in cost somewhere?” he asks. “Until I see some hard numbers, I’m going to be skeptical. I’m going to look for some evidence that it actually is working. And I can see why a state would say, ‘Well, the track record being what it is, maybe your voluntary code will work, but maybe it won’t. Just in case, we’re going to have this law on the books.’”

But Powell points out that pharmaceutical and medical device manufacturers, like all health care companies, are subject to the federal Anti-Kickback Statute. The FDA reviews all materials that are presented to prescribers and surveys health care providers to determine what types of information sales reps have provided about medications and devices. And the Centers for Medicare and Medicaid Services, the Department of Justice, and state attorneys general all have enforcement authority.

“Frankly, they have very strong enforcement authority,” Powell says, “and they bring actions if they think companies either have been failing to abide by the federal requirements or have been lax in their own enforcement…. It’s sort of a misunderstanding to say that the only thing that regulates the industry is this voluntary code. 

And while other states—including Oregon, Texas, Connecticut, Colorado, Illinois, and Maryland—are considering legislation that would either ban gift-giving or require public disclosure of it, the real battleground on this issue may be the US Congress. The devil may end up being in the details, but all parties are watching to see what progress the Physician Payments Sunshine Act will make at the federal level.

“We have consistently said that we think transparency has a place in the health care system, but that if there is going to be that kind of transparency, national reporting—one uniform standard—makes much more sense than 55 different standards,” Powell says. “So we in fact supported last year’s [version of the bill] because it had a national uniformity provision. This year, [that] provision is much weaker; it allows states to have their own additional reporting requirements.”

Brody, on the other hand, will be among those watching to see whether industry influence waters down the bill to a degree that would render it ineffective. “The fact of the matter is that if you follow the track record of the pharmaceutical industry, they almost always get their way in Washington,” he observes. “And they don’t get their way by shouting and screaming and making noise…. So you always have to be very careful and very cautious with any legislation.”

Under the Influence?
The entire ethics debate begs the question: How much influence does a pen or a notepad—or even a slice of pizza—really have on a health care provider’s prescribing habits, anyway? Obviously, there are what Brody calls “high rollers,” the physicians (predominantly) who receive consulting fees totaling millions of dollars in exchange for lending their expertise as “key opinion leaders” on behalf of pharmaceutical companies. But what about the average clinician?

“It’s true that it’s a very large industry, and there are always kids who will throw spitballs in class,” Powell admits. “But it’s a bit like saying, ‘OK, we’ve all lost our recess for the week because Johnny misbehaved.’”

The Massachusetts law “does not convey a lot of faith in the people of these professions to prescribe based on the research and the standard of care,” in the opinion of MAPA President Jillian Crowley, PA-C. “Personally, I cannot think of anyone who would be influenced to prescribe a drug based on a pen—or even remember the pharmaceutical company that produces the drug!”

MCNP President O’Rourke echoes that assessment, calling the Massachusetts code “almost like a slap on the wrist and ‘Big Brother is watching’ kind of stuff.” Her professional viewpoint, she says, has always been to go with the evidence-based data, with the acknowledgment that “pharmaceutical studies are usually skewed in some way. So you take the information and you prescribe what’s appropriate for the patient—not because of the pharmaceutical rep. I think I could say that probably 99.9% of the NP and medical communities feel that way. I think the law didn’t take that into consideration.”

But Brody cautions against assuming that any individual is immune to marketing. He recalls a pharmacist colleague from the hospital where he taught in the family practice residency program, who used to say: “There’s never any doubt in my mind when a drug rep has just come through, because there’s a spike in the prescriptions for the drug that that guy markets.”

“Smart people, profitable people, don’t waste money to the tune of billions of dollars in the US with a marketing strategy that does not work,” Brody argues. “The point is to recognize that we’re all human and we’re all susceptible to these kinds of influences.”

Powell points out that the focus on the pharmaceutical industry overlooks other potentially influencing factors. “When you talk to prescribers, they consistently say that the largest influence on their prescribing decisions is the formulary that the patient’s health insurer establishes,” she says. “But nobody regulates their medical decisions. And in fact, some insurers are paying prescribers to switch patients’ medications, which for a pharmaceutical manufacturer would be a violation of the Anti-Kickback Statute.”

Powell also says that companies have “an obligation” to disseminate relevant information about medications to health care providers. “It’s vitally important that everybody in the health care system have the most current information about new medicines and medicine where there has been a change in the labeling,” she says. “Without that information, prescription medicines can’t be used effectively.”

Brody, on the other hand, says that every health care provider “should have a source of information they know they can go to and they can say, ‘I know that the drug companies are not controlling the information that I’m getting from this source.’”

Money Better Spent
Clearly, the conversation about interactions between pharmaceutical sales reps and health care providers will continue for the foreseeable future. But for PAs and NPs like Crowley and O’Rourke in Massachusetts, the bottom line is really that the money pharmaceutical companies (used to) spend on wining and dining them and their colleagues—an estimated $7 billion annually across the United States—could certainly be put to better use.

Crowley thinks there should be “some regulations on the amount of money [pharmaceutical companies] spend on advertising, so that we cut down on the costs that need to be relayed to the consumer… I think a balance needs to be obtained between the pharmaceutical companies and the state to achieve education for providers and marketing and the lowest cost of the drug to consumers.”

O’Rourke also sees more effective ways to use the thousands of dollars that would, in the past, have been spent to take a group of 20 or 25 NPs to dinner at a fancy restaurant in Boston and provide an expert speaker. “It’s an expensive proposition, and if you’re doing that across the country for many, many groups, you’re talking millions of dollars,” she says. “That money could absolutely go into research and development. It could clearly go to supporting the indigent drug programs for patients who don’t have any health insurance. Instead of being able to give them a sample pack of five pills, maybe they could get a month’s supply of their prescription.

“It has to come back to the patient. In health care, at some point, you lose sight of what’s right and what’s wrong for the patient.We have to bring health care back to that and have to focus on what’s good for patients and not necessarily what’s good for us.”        

Call it the New Age of Transparency and Accountability: So far this year, two states—Massachusetts and Vermont—have enacted strict laws that codify and regulate the interactions between health care providers and pharmaceutical sales and marketing representatives. Whether you consider such legislation “draconian” (as some critics do) or essential, it appears to be part of a trend that advocates hope will continue.

While lauding Massachusetts and Vermont for “taking the lead” in these matters—going beyond other states’ laws that allow gifts and payments from pharmaceutical and device manufacturers to health care providers, as long as they are disclosed—Howard Brody, MD, PhD, Director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, laments that legislation has been necessary.

“I think it would really be ideal if professionally, we just decided among ourselves—doctors, nurse practitioners, physician assistants, and so on—that we would not accept this money,” Brody says. “Because it’s tainted money, really, and it compromises our commitment to our patients.”

Massachusetts: The Microcosm
The Massachusetts code of conduct—officially designated “105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct”—is outlined in a 13-page document available at the Web site for the state’s Department of Public Health (www.mass.gov/dph). The code applies to industry interactions with any health care provider licensed to practice in Massachusetts—even if the encounter occurs in another state (say, at a national conference). Helpfully, there are three “frequently asked questions” sections in which the finer points of the regulations are explained, often with specific examples.

In a nutshell, the code prohibits gifts of entertainment or recreation (eg, trips, tickets to concerts or sporting events); complimentary branded items (eg, pens, mugs, calendars); and meals, unless certain circumstances are met. All provided meals must be “modest” and “occasional,” must take place in the practitioner’s office or hospital setting, and must be accompanied by an informational presentation. Items that have potential benefit to patients—such as drug samples or demonstration models of medical devices—are permissible under the new regulations.

With regard to sponsorship of continuing medical education (CME) programs, the code stipulates that pharmaceutical and medical device manufacturers may not provide financial support for travel, lodging, meals, or personal expenses to nonfaculty health care providers attending such events. They are also prohibited from sponsoring or paying for CME that does not comply with the Standards for Commercial Support set forth by the Accreditation Council for Continuing Medical Education or an equivalent accrediting body. Further, companies are also barred from providing “any advice or guidance to the CME provider regarding the content or faculty for a particular CME program funded by the company.”

Pharmaceutical and medical device manufacturers are required to disclose “the value, nature, purpose, and particular recipient of any fee, payment, subsidy, or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities.” Disclosure reports must be filed by July 1 each year, beginning in 2010, and must be accompanied by a $2,000 fee. The first reports will cover the six-month period from the regulations’ implementation on July 1, 2009, through December 31, 2009. Subsequent annual reports will cover the entire previous calendar year.

While the demise of the “free lunch” has received the most media attention, it is the CME restrictions that may pose the biggest challenges to clinicians in Massachusetts. Both the NP and PA professional organizations in the state have already started planning how they will continue to provide CME opportunities to their members while complying with the code.

“Since the change in attitude toward pharmaceutical company funding of CME events, we have had to be more creative in how we provide CME to our members,” says David Probert, PA-C, the Massachusetts Association of Physician Assistants (MAPA) Delegate to the American Academy of Physician Assistants, who has served on MAPA’s CME committee. “The continued operation of our professional organization will rely more on member support—ie, dues—than in the past.” MAPA is applying for grants from nonpharmaceutical sources, including the AAPA, local hospitals, and other employers of PAs.

The Massachusetts Coalition of Nurse Practitioners (MCNP) is also working to develop educational programs in partnership with larger institutions and universities. “We’re looking at how we can develop quarterly educational offerings … that we could open to our members for a small fee,” says MCNP President Nancy O’Rourke, MSN, ACNP, ANP, RnC, FAANP. “We haven’t had to charge them anything for their educational opportunities, but at this point, we’re going to have to start. It’s probably going to be a nominal fee, but it still has to cover the cost of putting on the program. Speakers for these programs typically get a large honorarium, and that’s where the pharmaceutical companies were helping us—paying that honorarium.”

O’Rourke also points out that the location restrictions, while understandable, may pose challenges for those who are not in major urban areas such as Boston. “If you’re practicing out in central or western Massachusetts, you might be 100 miles from the nearest hospital setting,” she points out. But the law is the law, as she observes, and “there are still ways that you can provide education—you just have to work within that structure.”

Industry, Police Thyself?
The Massachusetts code mirrors, to a large extent, the voluntary code established by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA actually updated its code last year, and the changes took effect on January 1, 2009. Among them was the banning of gifts that are either “reminder items” (eg, the pens and preprinted notepads that everyone used to collect in the exhibit halls at conferences) or items that are of benefit to the prescriber. The updated PhRMA code is also more explicit about the situations in which provision of meals is appropriate and about the need for disclosure of any relationship between a pharmaceutical company and a health care provider if the latter is involved in the development of CME programs, clinical practice guidelines, or formulary decisions.

This industry-wide code is part of the reason that PhRMA opposed the Massachusetts legislation. “We’ve said consistently that it is the most draconian law in the country,” says Marjorie Powell, Senior Assistant General Counsel for PhRMA. “We think it’s not necessary—in part, because of the PhRMA code. We think it doesn’t do anything to improve patient care. It simply involves everybody in the health care system in much more recordkeeping and potential disputes over potential violations.”

 All PhRMA member companies and some nonmember companies have agreed to comply with the organization’s code; the names of all the companies’ compliance officers are listed on the PhRMA Web site (www.phrma.org), making it easy, Powell says, for a clinician to report a potential violation to the appropriate party. She adds that this provides “a great deal of both peer pressure and public pressure” for company representatives to comply with the code of conduct.

There are those who would suggest that a voluntary code administered by a leading industry organization may not be effective enough; that’s why laws like the ones in Massachusetts and Vermont become necessary. While it is not an apples-to-apples comparison, no one has been very impressed with the financial industry’s efforts at policing itself.

Brody, who authored the book Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, says the effectiveness of the more robust PhRMA code will be proven if marketing expenses decrease. “If they’re not doing all those things anymore—the lavish dinners, giving out pens and notepads and so on—shouldn’t there be a reduction in cost somewhere?” he asks. “Until I see some hard numbers, I’m going to be skeptical. I’m going to look for some evidence that it actually is working. And I can see why a state would say, ‘Well, the track record being what it is, maybe your voluntary code will work, but maybe it won’t. Just in case, we’re going to have this law on the books.’”

But Powell points out that pharmaceutical and medical device manufacturers, like all health care companies, are subject to the federal Anti-Kickback Statute. The FDA reviews all materials that are presented to prescribers and surveys health care providers to determine what types of information sales reps have provided about medications and devices. And the Centers for Medicare and Medicaid Services, the Department of Justice, and state attorneys general all have enforcement authority.

“Frankly, they have very strong enforcement authority,” Powell says, “and they bring actions if they think companies either have been failing to abide by the federal requirements or have been lax in their own enforcement…. It’s sort of a misunderstanding to say that the only thing that regulates the industry is this voluntary code. 

And while other states—including Oregon, Texas, Connecticut, Colorado, Illinois, and Maryland—are considering legislation that would either ban gift-giving or require public disclosure of it, the real battleground on this issue may be the US Congress. The devil may end up being in the details, but all parties are watching to see what progress the Physician Payments Sunshine Act will make at the federal level.

“We have consistently said that we think transparency has a place in the health care system, but that if there is going to be that kind of transparency, national reporting—one uniform standard—makes much more sense than 55 different standards,” Powell says. “So we in fact supported last year’s [version of the bill] because it had a national uniformity provision. This year, [that] provision is much weaker; it allows states to have their own additional reporting requirements.”

Brody, on the other hand, will be among those watching to see whether industry influence waters down the bill to a degree that would render it ineffective. “The fact of the matter is that if you follow the track record of the pharmaceutical industry, they almost always get their way in Washington,” he observes. “And they don’t get their way by shouting and screaming and making noise…. So you always have to be very careful and very cautious with any legislation.”

Under the Influence?
The entire ethics debate begs the question: How much influence does a pen or a notepad—or even a slice of pizza—really have on a health care provider’s prescribing habits, anyway? Obviously, there are what Brody calls “high rollers,” the physicians (predominantly) who receive consulting fees totaling millions of dollars in exchange for lending their expertise as “key opinion leaders” on behalf of pharmaceutical companies. But what about the average clinician?

“It’s true that it’s a very large industry, and there are always kids who will throw spitballs in class,” Powell admits. “But it’s a bit like saying, ‘OK, we’ve all lost our recess for the week because Johnny misbehaved.’”

The Massachusetts law “does not convey a lot of faith in the people of these professions to prescribe based on the research and the standard of care,” in the opinion of MAPA President Jillian Crowley, PA-C. “Personally, I cannot think of anyone who would be influenced to prescribe a drug based on a pen—or even remember the pharmaceutical company that produces the drug!”

MCNP President O’Rourke echoes that assessment, calling the Massachusetts code “almost like a slap on the wrist and ‘Big Brother is watching’ kind of stuff.” Her professional viewpoint, she says, has always been to go with the evidence-based data, with the acknowledgment that “pharmaceutical studies are usually skewed in some way. So you take the information and you prescribe what’s appropriate for the patient—not because of the pharmaceutical rep. I think I could say that probably 99.9% of the NP and medical communities feel that way. I think the law didn’t take that into consideration.”

But Brody cautions against assuming that any individual is immune to marketing. He recalls a pharmacist colleague from the hospital where he taught in the family practice residency program, who used to say: “There’s never any doubt in my mind when a drug rep has just come through, because there’s a spike in the prescriptions for the drug that that guy markets.”

“Smart people, profitable people, don’t waste money to the tune of billions of dollars in the US with a marketing strategy that does not work,” Brody argues. “The point is to recognize that we’re all human and we’re all susceptible to these kinds of influences.”

Powell points out that the focus on the pharmaceutical industry overlooks other potentially influencing factors. “When you talk to prescribers, they consistently say that the largest influence on their prescribing decisions is the formulary that the patient’s health insurer establishes,” she says. “But nobody regulates their medical decisions. And in fact, some insurers are paying prescribers to switch patients’ medications, which for a pharmaceutical manufacturer would be a violation of the Anti-Kickback Statute.”

Powell also says that companies have “an obligation” to disseminate relevant information about medications to health care providers. “It’s vitally important that everybody in the health care system have the most current information about new medicines and medicine where there has been a change in the labeling,” she says. “Without that information, prescription medicines can’t be used effectively.”

Brody, on the other hand, says that every health care provider “should have a source of information they know they can go to and they can say, ‘I know that the drug companies are not controlling the information that I’m getting from this source.’”

Money Better Spent
Clearly, the conversation about interactions between pharmaceutical sales reps and health care providers will continue for the foreseeable future. But for PAs and NPs like Crowley and O’Rourke in Massachusetts, the bottom line is really that the money pharmaceutical companies (used to) spend on wining and dining them and their colleagues—an estimated $7 billion annually across the United States—could certainly be put to better use.

Crowley thinks there should be “some regulations on the amount of money [pharmaceutical companies] spend on advertising, so that we cut down on the costs that need to be relayed to the consumer… I think a balance needs to be obtained between the pharmaceutical companies and the state to achieve education for providers and marketing and the lowest cost of the drug to consumers.”

O’Rourke also sees more effective ways to use the thousands of dollars that would, in the past, have been spent to take a group of 20 or 25 NPs to dinner at a fancy restaurant in Boston and provide an expert speaker. “It’s an expensive proposition, and if you’re doing that across the country for many, many groups, you’re talking millions of dollars,” she says. “That money could absolutely go into research and development. It could clearly go to supporting the indigent drug programs for patients who don’t have any health insurance. Instead of being able to give them a sample pack of five pills, maybe they could get a month’s supply of their prescription.

“It has to come back to the patient. In health care, at some point, you lose sight of what’s right and what’s wrong for the patient.We have to bring health care back to that and have to focus on what’s good for patients and not necessarily what’s good for us.”        

Call it the New Age of Transparency and Accountability: So far this year, two states—Massachusetts and Vermont—have enacted strict laws that codify and regulate the interactions between health care providers and pharmaceutical sales and marketing representatives. Whether you consider such legislation “draconian” (as some critics do) or essential, it appears to be part of a trend that advocates hope will continue.

While lauding Massachusetts and Vermont for “taking the lead” in these matters—going beyond other states’ laws that allow gifts and payments from pharmaceutical and device manufacturers to health care providers, as long as they are disclosed—Howard Brody, MD, PhD, Director of the Institute for the Medical Humanities at the University of Texas Medical Branch in Galveston, laments that legislation has been necessary.

“I think it would really be ideal if professionally, we just decided among ourselves—doctors, nurse practitioners, physician assistants, and so on—that we would not accept this money,” Brody says. “Because it’s tainted money, really, and it compromises our commitment to our patients.”

Massachusetts: The Microcosm
The Massachusetts code of conduct—officially designated “105 CMR 970.000: Pharmaceutical and Medical Device Manufacturer Conduct”—is outlined in a 13-page document available at the Web site for the state’s Department of Public Health (www.mass.gov/dph). The code applies to industry interactions with any health care provider licensed to practice in Massachusetts—even if the encounter occurs in another state (say, at a national conference). Helpfully, there are three “frequently asked questions” sections in which the finer points of the regulations are explained, often with specific examples.

In a nutshell, the code prohibits gifts of entertainment or recreation (eg, trips, tickets to concerts or sporting events); complimentary branded items (eg, pens, mugs, calendars); and meals, unless certain circumstances are met. All provided meals must be “modest” and “occasional,” must take place in the practitioner’s office or hospital setting, and must be accompanied by an informational presentation. Items that have potential benefit to patients—such as drug samples or demonstration models of medical devices—are permissible under the new regulations.

With regard to sponsorship of continuing medical education (CME) programs, the code stipulates that pharmaceutical and medical device manufacturers may not provide financial support for travel, lodging, meals, or personal expenses to nonfaculty health care providers attending such events. They are also prohibited from sponsoring or paying for CME that does not comply with the Standards for Commercial Support set forth by the Accreditation Council for Continuing Medical Education or an equivalent accrediting body. Further, companies are also barred from providing “any advice or guidance to the CME provider regarding the content or faculty for a particular CME program funded by the company.”

Pharmaceutical and medical device manufacturers are required to disclose “the value, nature, purpose, and particular recipient of any fee, payment, subsidy, or other economic benefit with a value of at least $50 to any covered recipient in connection with the company’s sales and marketing activities.” Disclosure reports must be filed by July 1 each year, beginning in 2010, and must be accompanied by a $2,000 fee. The first reports will cover the six-month period from the regulations’ implementation on July 1, 2009, through December 31, 2009. Subsequent annual reports will cover the entire previous calendar year.

While the demise of the “free lunch” has received the most media attention, it is the CME restrictions that may pose the biggest challenges to clinicians in Massachusetts. Both the NP and PA professional organizations in the state have already started planning how they will continue to provide CME opportunities to their members while complying with the code.

“Since the change in attitude toward pharmaceutical company funding of CME events, we have had to be more creative in how we provide CME to our members,” says David Probert, PA-C, the Massachusetts Association of Physician Assistants (MAPA) Delegate to the American Academy of Physician Assistants, who has served on MAPA’s CME committee. “The continued operation of our professional organization will rely more on member support—ie, dues—than in the past.” MAPA is applying for grants from nonpharmaceutical sources, including the AAPA, local hospitals, and other employers of PAs.

The Massachusetts Coalition of Nurse Practitioners (MCNP) is also working to develop educational programs in partnership with larger institutions and universities. “We’re looking at how we can develop quarterly educational offerings … that we could open to our members for a small fee,” says MCNP President Nancy O’Rourke, MSN, ACNP, ANP, RnC, FAANP. “We haven’t had to charge them anything for their educational opportunities, but at this point, we’re going to have to start. It’s probably going to be a nominal fee, but it still has to cover the cost of putting on the program. Speakers for these programs typically get a large honorarium, and that’s where the pharmaceutical companies were helping us—paying that honorarium.”

O’Rourke also points out that the location restrictions, while understandable, may pose challenges for those who are not in major urban areas such as Boston. “If you’re practicing out in central or western Massachusetts, you might be 100 miles from the nearest hospital setting,” she points out. But the law is the law, as she observes, and “there are still ways that you can provide education—you just have to work within that structure.”

Industry, Police Thyself?
The Massachusetts code mirrors, to a large extent, the voluntary code established by the Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA actually updated its code last year, and the changes took effect on January 1, 2009. Among them was the banning of gifts that are either “reminder items” (eg, the pens and preprinted notepads that everyone used to collect in the exhibit halls at conferences) or items that are of benefit to the prescriber. The updated PhRMA code is also more explicit about the situations in which provision of meals is appropriate and about the need for disclosure of any relationship between a pharmaceutical company and a health care provider if the latter is involved in the development of CME programs, clinical practice guidelines, or formulary decisions.

This industry-wide code is part of the reason that PhRMA opposed the Massachusetts legislation. “We’ve said consistently that it is the most draconian law in the country,” says Marjorie Powell, Senior Assistant General Counsel for PhRMA. “We think it’s not necessary—in part, because of the PhRMA code. We think it doesn’t do anything to improve patient care. It simply involves everybody in the health care system in much more recordkeeping and potential disputes over potential violations.”

 All PhRMA member companies and some nonmember companies have agreed to comply with the organization’s code; the names of all the companies’ compliance officers are listed on the PhRMA Web site (www.phrma.org), making it easy, Powell says, for a clinician to report a potential violation to the appropriate party. She adds that this provides “a great deal of both peer pressure and public pressure” for company representatives to comply with the code of conduct.

There are those who would suggest that a voluntary code administered by a leading industry organization may not be effective enough; that’s why laws like the ones in Massachusetts and Vermont become necessary. While it is not an apples-to-apples comparison, no one has been very impressed with the financial industry’s efforts at policing itself.

Brody, who authored the book Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, says the effectiveness of the more robust PhRMA code will be proven if marketing expenses decrease. “If they’re not doing all those things anymore—the lavish dinners, giving out pens and notepads and so on—shouldn’t there be a reduction in cost somewhere?” he asks. “Until I see some hard numbers, I’m going to be skeptical. I’m going to look for some evidence that it actually is working. And I can see why a state would say, ‘Well, the track record being what it is, maybe your voluntary code will work, but maybe it won’t. Just in case, we’re going to have this law on the books.’”

But Powell points out that pharmaceutical and medical device manufacturers, like all health care companies, are subject to the federal Anti-Kickback Statute. The FDA reviews all materials that are presented to prescribers and surveys health care providers to determine what types of information sales reps have provided about medications and devices. And the Centers for Medicare and Medicaid Services, the Department of Justice, and state attorneys general all have enforcement authority.

“Frankly, they have very strong enforcement authority,” Powell says, “and they bring actions if they think companies either have been failing to abide by the federal requirements or have been lax in their own enforcement…. It’s sort of a misunderstanding to say that the only thing that regulates the industry is this voluntary code. 

And while other states—including Oregon, Texas, Connecticut, Colorado, Illinois, and Maryland—are considering legislation that would either ban gift-giving or require public disclosure of it, the real battleground on this issue may be the US Congress. The devil may end up being in the details, but all parties are watching to see what progress the Physician Payments Sunshine Act will make at the federal level.

“We have consistently said that we think transparency has a place in the health care system, but that if there is going to be that kind of transparency, national reporting—one uniform standard—makes much more sense than 55 different standards,” Powell says. “So we in fact supported last year’s [version of the bill] because it had a national uniformity provision. This year, [that] provision is much weaker; it allows states to have their own additional reporting requirements.”

Brody, on the other hand, will be among those watching to see whether industry influence waters down the bill to a degree that would render it ineffective. “The fact of the matter is that if you follow the track record of the pharmaceutical industry, they almost always get their way in Washington,” he observes. “And they don’t get their way by shouting and screaming and making noise…. So you always have to be very careful and very cautious with any legislation.”

Under the Influence?
The entire ethics debate begs the question: How much influence does a pen or a notepad—or even a slice of pizza—really have on a health care provider’s prescribing habits, anyway? Obviously, there are what Brody calls “high rollers,” the physicians (predominantly) who receive consulting fees totaling millions of dollars in exchange for lending their expertise as “key opinion leaders” on behalf of pharmaceutical companies. But what about the average clinician?

“It’s true that it’s a very large industry, and there are always kids who will throw spitballs in class,” Powell admits. “But it’s a bit like saying, ‘OK, we’ve all lost our recess for the week because Johnny misbehaved.’”

The Massachusetts law “does not convey a lot of faith in the people of these professions to prescribe based on the research and the standard of care,” in the opinion of MAPA President Jillian Crowley, PA-C. “Personally, I cannot think of anyone who would be influenced to prescribe a drug based on a pen—or even remember the pharmaceutical company that produces the drug!”

MCNP President O’Rourke echoes that assessment, calling the Massachusetts code “almost like a slap on the wrist and ‘Big Brother is watching’ kind of stuff.” Her professional viewpoint, she says, has always been to go with the evidence-based data, with the acknowledgment that “pharmaceutical studies are usually skewed in some way. So you take the information and you prescribe what’s appropriate for the patient—not because of the pharmaceutical rep. I think I could say that probably 99.9% of the NP and medical communities feel that way. I think the law didn’t take that into consideration.”

But Brody cautions against assuming that any individual is immune to marketing. He recalls a pharmacist colleague from the hospital where he taught in the family practice residency program, who used to say: “There’s never any doubt in my mind when a drug rep has just come through, because there’s a spike in the prescriptions for the drug that that guy markets.”

“Smart people, profitable people, don’t waste money to the tune of billions of dollars in the US with a marketing strategy that does not work,” Brody argues. “The point is to recognize that we’re all human and we’re all susceptible to these kinds of influences.”

Powell points out that the focus on the pharmaceutical industry overlooks other potentially influencing factors. “When you talk to prescribers, they consistently say that the largest influence on their prescribing decisions is the formulary that the patient’s health insurer establishes,” she says. “But nobody regulates their medical decisions. And in fact, some insurers are paying prescribers to switch patients’ medications, which for a pharmaceutical manufacturer would be a violation of the Anti-Kickback Statute.”

Powell also says that companies have “an obligation” to disseminate relevant information about medications to health care providers. “It’s vitally important that everybody in the health care system have the most current information about new medicines and medicine where there has been a change in the labeling,” she says. “Without that information, prescription medicines can’t be used effectively.”

Brody, on the other hand, says that every health care provider “should have a source of information they know they can go to and they can say, ‘I know that the drug companies are not controlling the information that I’m getting from this source.’”

Money Better Spent
Clearly, the conversation about interactions between pharmaceutical sales reps and health care providers will continue for the foreseeable future. But for PAs and NPs like Crowley and O’Rourke in Massachusetts, the bottom line is really that the money pharmaceutical companies (used to) spend on wining and dining them and their colleagues—an estimated $7 billion annually across the United States—could certainly be put to better use.

Crowley thinks there should be “some regulations on the amount of money [pharmaceutical companies] spend on advertising, so that we cut down on the costs that need to be relayed to the consumer… I think a balance needs to be obtained between the pharmaceutical companies and the state to achieve education for providers and marketing and the lowest cost of the drug to consumers.”

O’Rourke also sees more effective ways to use the thousands of dollars that would, in the past, have been spent to take a group of 20 or 25 NPs to dinner at a fancy restaurant in Boston and provide an expert speaker. “It’s an expensive proposition, and if you’re doing that across the country for many, many groups, you’re talking millions of dollars,” she says. “That money could absolutely go into research and development. It could clearly go to supporting the indigent drug programs for patients who don’t have any health insurance. Instead of being able to give them a sample pack of five pills, maybe they could get a month’s supply of their prescription.

“It has to come back to the patient. In health care, at some point, you lose sight of what’s right and what’s wrong for the patient.We have to bring health care back to that and have to focus on what’s good for patients and not necessarily what’s good for us.”