Orthopedic Medical Legal Advisor

Pushing drugs: Pharmaceutical industry and physician relationships explored

Editor’s Note: This article is the first in a two-part series dealing with the medical legal implications that arise from mass marketing efforts by the drug industry.

Marcia Angell, MD, senior lecturer in social medicine at Harvard Medical School and former editor in chief of the New England Journal of Medicine, wrote an article on July 14, 2011 in the New York Review of Books titled, “The Illusion of Psychiatry.” In her article, she discusses the pervasive influence of the drug industry on the psychiatric profession. She noted, “Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers.” The reason why Angell asserts that drug companies are so eager to win over these academic physicians is because of their influence on the decision-making of the broader medical community.

The role of the pharmaceutical industry in medical decision-making is also the subject of the book, Our Daily Meds: How the Pharmaceutical Companies Transform Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, by award-winning journalist Melody Petersen. Despite the sensationalist title of her book, it is a thoughtful, scholarly treatise on the extraordinary and frequently negative impact that marketing strategies by the drug industry have on patient care quality. The theme of Petersen’s book is that the drug industry attempts to create “blockbuster drugs,” i.e. drugs with gross sales of more than $1 billion dollars per year, by heavily marketing selected products. Physicians and surgeons have most frequently been the targets of these marketing efforts since they are viewed as the customers, even though patients are the ultimate consumers of the drugs.

As an example of how influential the marketing of drugs can be, Petersen noted that in 2003, for the first time, more psychotropic drugs were prescribed to children than antibiotics and asthma medications in the United States. Petersen suggests that the mass drug marketing has transformed pediatrics from a specialty whose sole purpose was the diagnosis and treatment of physical illness, to a specialty that focuses on altering children’s undesired behavior by medicating them. Petersen describes a variety of ways in which drug manufacturers aggressively mass market their drugs to physicians and surgeons. The story she tells is a sad one. The following are among the strategies she discusses:

1. Ghost-written articles

Petersen details the prevalence of corporations that have been created to ghost-write articles for the medical literature, which portray new medications as being comparatively more advantageous than existing medications, safer for the patient and, as a result, an advancement in the treatment of disease or illness. These ghost-written articles invariably present the results of clinical trials in a manner that distort the drug’s potential advantages, while simultaneously minimizing potential short-term, long-term and even fatal complications. This is often accomplished by selecting clinical trials that appear to demonstrate the new medication’s advantages, while eliminating those clinical trials that do not support its efficacy and safety.

2. Marketing themes

Petersen describes classic Madison Avenue marketing approaches by drug companies to promote their medications much in the same way that non-medical commercial products are marketed to consumers. The drug companies create a marketing theme and relentlessly promote that theme, creating sometimes false, and often dangerous, impressions about their newer and profitable medications.

As an example, Petersen goes into great detail about the marketing of narcotic painkillers. These painkillers were formally thought of as appropriate for cancer patients, but not appropriate for the generalized treatment of chronic pain. The theme of the marketing efforts was, and continues to be, that the dangers of narcotic painkillers have been overstated and that patients are needlessly suffering because of the “myth” of drug dependence or addiction. One company in particular flew health care professionals to resorts like Boca Raton, Fla. and Scottsdale, Ariz. “…where they were wined and dined and trained as speakers to spread the word that painkillers like OxyContin were safe.” As Peterson noted, “For thousands of Americans, this proved untrue.”

3. Wining and dining physicians and surgeons

Petersen documents that drug companies fastidiously collect information on the prescription patterns of physicians and surgeons by collecting pharmaceutical information. By collecting data on their prescription habits, drug companies can identify the physicians to target in their effort to reward those who prescribe their medications, as well as influence those who do not. Petersen describes the direct financial rewards provided to physicians and surgeons which have included trips, meals and direct cash payments. As Petersen noted, “Doctors have continued taking the loot, despite studies showing that even gifts as small as a pen could imbue them with the sense that they owe the pharmaceutical company a favor, a quandary that could be quickly solved by writing more prescriptions.”

4. Compensating physicians and surgeons as speakers and/or consultants

One method of rewarding physicians who frequently prescribe a company’s medications to their patients is by compensating them as speakers for the company. Petersen documents that, “A marketing firm called Thompson Physician World said in a 2002 brochure that it had signed up more than 20,000 physicians to speak on behalf of the drug industry. These doctors, Physician World stated, would ‘become critical lynchpins in product positioning.’” The speaker fees are also a reward for the use and promotion of a company’s drugs.

5. Drug representatives as a sales force

Although theoretically drug representatives are supposed to provide objective information, Petersen leaves little doubt that they are highly trained sales personnel. Their function is to persuade physicians and surgeons to increase sales volume by persuading the medical profession to prescribe newer and more expensive drugs to patients, even though most of these drugs are variations that offer little more than older medications. A secondary function of the sales representative is to assuage concerns physicians have when there are reports of potentially serious adverse consequences to drugs that have been heavily marketed to physicians and surgeons. The sales reps receive training in assuaging physician concerns related to adverse drug effects and in effective promotion of the drugs in the face of reports of these adverse outcomes.

The sales reps are taught to use “talking points” when there are concerns raised by physicians and surgeons regarding a drugs safety or effectiveness. These techniques are highly refined and designed to deflect, rather than directly answer concerns that are raised by the physician or surgeon when early reports of adverse drug events begin to surface.

6. Promoting off-label use

The FDA approves medications for a limited number of purposes. While drug companies are prevented from marketing these medications for other purposes, physicians and surgeons are not restricted in how they prescribe these medications. This practice is referred to as the off-label use of a drug.

Petersen extensively examines the off-label use of Neurontin, which had been a relatively weak, ineffective, marginally profitable drug for the treatment of epilepsy. As Petersen stated, “The executives decided, however, they were not satisfied in selling Neurontin for the limited use for epilepsy as the government had approved. Instead, they resolved to expand their sales greatly by promoting the drug for other medical conditions that had nothing to do with epilepsy, other than they also involved the brain. The executives created an internal wish list of the other neurological conditions, each of them representing tens of thousands of other prescriptions.” Petersen then discussed the illegal off-label marketing of Neurontin and the willingness of physicians and surgeons to prescribe Neurontin for off-label uses as wide-ranging as attention deficit disorder, bipolar disorder, pain and countless conditions for which there was no evidence that it was effective.

7. Continuing education

Another method that the drug industry uses to promote their products is continuing medical education. As Petersen noted, “By 2005, the drug industry and other medical companies were paying hundreds of millions of dollars to the nation’s accredited medical education courses, enough to cover 65% to 80% of the cost. As a result, most of the events have become little more than a pharmaceutical sales bazaar. By paying for the doctors’ continuing education, the drug companies made sure they [physicians] learn what is important for the corporate bottom line.”

While there have been significant positive changes since 2008, when Petersen wrote her book, there is little doubt that the drug industry will continue to mass market its drugs, even if that mass marketing takes other forms such as direct to consumer marketing, or compensating high-profile celebrities to conduct interviews or make public statements about the virtues of new medications. Whatever forms the mass marketing may take, it will impact the practice of medicine and surgery and likely raise significant legal medical issues. The second article in this series of will discuss those medical legal issues.

What do you think?

orthomind

  1. Should physicians or surgeons be allowed to prescribe drugs for off-label use? If so, should the patients be informed that they are being prescribed a medication for off-label use?
  2. Is there any clinically useful reason why a physician or surgeon should meet with a drug representative? If so, should the physician or surgeon request copies of unpublished clinical trials that did not produce favorable results?
  3. Should physicians or surgeons be more skeptical in reading articles in the medical literature that suggest a new drug or medication as a significant medical advancement?
  4. Are aggressive marketing efforts by drug companies simply a legitimate exercise of their First Amendment free speech rights? If so, is the onus upon the consumers, ie., doctors and patients to understand and protect themselves against manipulative marketing tactics? Or should the government step in, albeit at a public cost, and regulate drug company marketing?
References:
  • Angell M. The illusion of psychiatry. New York Review of Books. July 14, 2011.
  • Petersen M. Our daily meds: How the pharmaceutical companies transformed themselves into slick marketing machines and hooked the nation on prescription drugs. Picador. 2009.
  • B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
  • Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.

Editor’s Note: This article is the first in a two-part series dealing with the medical legal implications that arise from mass marketing efforts by the drug industry.

Marcia Angell, MD, senior lecturer in social medicine at Harvard Medical School and former editor in chief of the New England Journal of Medicine, wrote an article on July 14, 2011 in the New York Review of Books titled, “The Illusion of Psychiatry.” In her article, she discusses the pervasive influence of the drug industry on the psychiatric profession. She noted, “Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers.” The reason why Angell asserts that drug companies are so eager to win over these academic physicians is because of their influence on the decision-making of the broader medical community.

The role of the pharmaceutical industry in medical decision-making is also the subject of the book, Our Daily Meds: How the Pharmaceutical Companies Transform Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs, by award-winning journalist Melody Petersen. Despite the sensationalist title of her book, it is a thoughtful, scholarly treatise on the extraordinary and frequently negative impact that marketing strategies by the drug industry have on patient care quality. The theme of Petersen’s book is that the drug industry attempts to create “blockbuster drugs,” i.e. drugs with gross sales of more than $1 billion dollars per year, by heavily marketing selected products. Physicians and surgeons have most frequently been the targets of these marketing efforts since they are viewed as the customers, even though patients are the ultimate consumers of the drugs.

As an example of how influential the marketing of drugs can be, Petersen noted that in 2003, for the first time, more psychotropic drugs were prescribed to children than antibiotics and asthma medications in the United States. Petersen suggests that the mass drug marketing has transformed pediatrics from a specialty whose sole purpose was the diagnosis and treatment of physical illness, to a specialty that focuses on altering children’s undesired behavior by medicating them. Petersen describes a variety of ways in which drug manufacturers aggressively mass market their drugs to physicians and surgeons. The story she tells is a sad one. The following are among the strategies she discusses:

1. Ghost-written articles

Petersen details the prevalence of corporations that have been created to ghost-write articles for the medical literature, which portray new medications as being comparatively more advantageous than existing medications, safer for the patient and, as a result, an advancement in the treatment of disease or illness. These ghost-written articles invariably present the results of clinical trials in a manner that distort the drug’s potential advantages, while simultaneously minimizing potential short-term, long-term and even fatal complications. This is often accomplished by selecting clinical trials that appear to demonstrate the new medication’s advantages, while eliminating those clinical trials that do not support its efficacy and safety.

2. Marketing themes

Petersen describes classic Madison Avenue marketing approaches by drug companies to promote their medications much in the same way that non-medical commercial products are marketed to consumers. The drug companies create a marketing theme and relentlessly promote that theme, creating sometimes false, and often dangerous, impressions about their newer and profitable medications.

As an example, Petersen goes into great detail about the marketing of narcotic painkillers. These painkillers were formally thought of as appropriate for cancer patients, but not appropriate for the generalized treatment of chronic pain. The theme of the marketing efforts was, and continues to be, that the dangers of narcotic painkillers have been overstated and that patients are needlessly suffering because of the “myth” of drug dependence or addiction. One company in particular flew health care professionals to resorts like Boca Raton, Fla. and Scottsdale, Ariz. “…where they were wined and dined and trained as speakers to spread the word that painkillers like OxyContin were safe.” As Peterson noted, “For thousands of Americans, this proved untrue.”

3. Wining and dining physicians and surgeons

Petersen documents that drug companies fastidiously collect information on the prescription patterns of physicians and surgeons by collecting pharmaceutical information. By collecting data on their prescription habits, drug companies can identify the physicians to target in their effort to reward those who prescribe their medications, as well as influence those who do not. Petersen describes the direct financial rewards provided to physicians and surgeons which have included trips, meals and direct cash payments. As Petersen noted, “Doctors have continued taking the loot, despite studies showing that even gifts as small as a pen could imbue them with the sense that they owe the pharmaceutical company a favor, a quandary that could be quickly solved by writing more prescriptions.”

4. Compensating physicians and surgeons as speakers and/or consultants

One method of rewarding physicians who frequently prescribe a company’s medications to their patients is by compensating them as speakers for the company. Petersen documents that, “A marketing firm called Thompson Physician World said in a 2002 brochure that it had signed up more than 20,000 physicians to speak on behalf of the drug industry. These doctors, Physician World stated, would ‘become critical lynchpins in product positioning.’” The speaker fees are also a reward for the use and promotion of a company’s drugs.

5. Drug representatives as a sales force

Although theoretically drug representatives are supposed to provide objective information, Petersen leaves little doubt that they are highly trained sales personnel. Their function is to persuade physicians and surgeons to increase sales volume by persuading the medical profession to prescribe newer and more expensive drugs to patients, even though most of these drugs are variations that offer little more than older medications. A secondary function of the sales representative is to assuage concerns physicians have when there are reports of potentially serious adverse consequences to drugs that have been heavily marketed to physicians and surgeons. The sales reps receive training in assuaging physician concerns related to adverse drug effects and in effective promotion of the drugs in the face of reports of these adverse outcomes.

The sales reps are taught to use “talking points” when there are concerns raised by physicians and surgeons regarding a drugs safety or effectiveness. These techniques are highly refined and designed to deflect, rather than directly answer concerns that are raised by the physician or surgeon when early reports of adverse drug events begin to surface.

6. Promoting off-label use

The FDA approves medications for a limited number of purposes. While drug companies are prevented from marketing these medications for other purposes, physicians and surgeons are not restricted in how they prescribe these medications. This practice is referred to as the off-label use of a drug.

Petersen extensively examines the off-label use of Neurontin, which had been a relatively weak, ineffective, marginally profitable drug for the treatment of epilepsy. As Petersen stated, “The executives decided, however, they were not satisfied in selling Neurontin for the limited use for epilepsy as the government had approved. Instead, they resolved to expand their sales greatly by promoting the drug for other medical conditions that had nothing to do with epilepsy, other than they also involved the brain. The executives created an internal wish list of the other neurological conditions, each of them representing tens of thousands of other prescriptions.” Petersen then discussed the illegal off-label marketing of Neurontin and the willingness of physicians and surgeons to prescribe Neurontin for off-label uses as wide-ranging as attention deficit disorder, bipolar disorder, pain and countless conditions for which there was no evidence that it was effective.

7. Continuing education

Another method that the drug industry uses to promote their products is continuing medical education. As Petersen noted, “By 2005, the drug industry and other medical companies were paying hundreds of millions of dollars to the nation’s accredited medical education courses, enough to cover 65% to 80% of the cost. As a result, most of the events have become little more than a pharmaceutical sales bazaar. By paying for the doctors’ continuing education, the drug companies made sure they [physicians] learn what is important for the corporate bottom line.”

While there have been significant positive changes since 2008, when Petersen wrote her book, there is little doubt that the drug industry will continue to mass market its drugs, even if that mass marketing takes other forms such as direct to consumer marketing, or compensating high-profile celebrities to conduct interviews or make public statements about the virtues of new medications. Whatever forms the mass marketing may take, it will impact the practice of medicine and surgery and likely raise significant legal medical issues. The second article in this series of will discuss those medical legal issues.

What do you think?

orthomind

  1. Should physicians or surgeons be allowed to prescribe drugs for off-label use? If so, should the patients be informed that they are being prescribed a medication for off-label use?
  2. Is there any clinically useful reason why a physician or surgeon should meet with a drug representative? If so, should the physician or surgeon request copies of unpublished clinical trials that did not produce favorable results?
  3. Should physicians or surgeons be more skeptical in reading articles in the medical literature that suggest a new drug or medication as a significant medical advancement?
  4. Are aggressive marketing efforts by drug companies simply a legitimate exercise of their First Amendment free speech rights? If so, is the onus upon the consumers, ie., doctors and patients to understand and protect themselves against manipulative marketing tactics? Or should the government step in, albeit at a public cost, and regulate drug company marketing?
References:
  • Angell M. The illusion of psychiatry. New York Review of Books. July 14, 2011.
  • Petersen M. Our daily meds: How the pharmaceutical companies transformed themselves into slick marketing machines and hooked the nation on prescription drugs. Picador. 2009.
  • B. Sonny Bal, MD, JD, MBA, is associate professor of hip and knee replacement in the department of orthopedic surgery, University of Missouri School of Medicine.
  • Lawrence H. Brenner, JD, is on the faculties of orthopedics at Yale University and the University of Southern California and practices in Chapel Hill, N.C. Address all correspondence to Brenner at lb@lawrencebrennerlaw.com.