Editors 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
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 Petersens 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 childrens 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
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 drugs 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 medications advantages, while
eliminating those clinical trials that do not support its efficacy and
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
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
One method of rewarding physicians who frequently prescribe a
companys 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 companys 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 nations 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
What do you think?
- 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?
- 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
- 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?
- 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?
- 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