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With Mental Health Drugs, Greater Risk Means More Marketing

Posted: 09/06/2011 8:43 am

"Television has done much for psychiatry," Alfred Hitchcock remarked, "by spreading information about it, as well as contributing to the need for it." Hitch did not live long enough to become acquainted with the dizzying number of commercials for psychiatric medications that promise relief from suffering, performance enhancement and healthy outcomes. These ads always conclude with a plea to "ask your doctor about adding drug X to your regimen" followed by a breakneck telling of side effects and warnings called the "Fair Balance", required by the U.S. Food and Drug Administration (FDA). But just how fair and balanced is this type of advertising?

From 1962 to 1997, drug advertising was restricted to print advertisements. But in 1997 an FDA guideline opened up broadcast and Internet commercials to the pharmaceutical industry -- and Big Pharma responded with gusto. The now-familiar commercials for depression, bipolar disorder, social anxiety, and the like -- called "DTCA" for direct to consumer advertising -- are specifically targeted to the home viewer on a couch, rather than the psychiatrist in an office. (Interestingly, only the United States and New Zealand carry televised drug ads; the rest of the industrialized world has refrained.)

Appealing directly to the consumer at home has become a very lucrative business. Far more effective than advertising to doctors, drug companies spend an average of 4 to 5 billion dollars per year on DTCA. Moreover, reports indicate that pharma spends twice as much on advertising as on research and development (1). Pharmaceutical companies understand that profits accrue when viewers' interest in attractive products has been peaked and doctors are encouraged to be responsive to their patients. While broadcast advertising of psychiatric medications has boosted sales and filled the coffers of drug companies, we need to be concerned about what this costs consumers -- namely, all of us.

Pharma companies, in their own defense, contend that they are providing a public health service by educating consumers about a drug's potential benefits or the medical condition the drug purports to treat. But what about the potential public health risk that DTCA can unduly influence the consumer and impair the physician's decision-making skills? Can this lead to unnecessary, or worse, unsafe prescribing?

As consumer suspicion and awareness of hazardous side effects have grown over time, one would think that drug ads would decrease. Not so: Drug companies have, instead, increased their advertising budgets for riskier drugs in order to promote sales. This is called the "Inverse Benefit Law," a title coined by Drs. Brody and Light (2). The law says that the riskier the drug, the more pharma companies will allocate to its marketing, in order to boost sales of a drug. For example, a drug might effectively treat a condition from which a very limited group of patients suffer; but the company needs to sell the drug to a larger audience in order to cover its costs and achieve profits.

To increase sales, multiple strategies are used, including: exaggerating the benefits of a medication while minimizing the risk; encouraging "off-label" (or unapproved) use, despite limited evidence that the drug is effective for the "off-label" purpose; and exaggerating symptoms or even inventing new "diseases" -- such as excessive shyness, restless leg syndrome, or the ubiquitous sexual dysfunction. These claims expand the potential customer (or patient) population. In short, aggressive advertising of medications can produce a hazardous environment for patients.

Doctors as well as patients need to be alert to these marketing strategies. Physicians need to better understand the claims, studies and evidence put forth by pharma companies. If the "Inverse Benefit Law" is correct, the more heavily marketed the drug is, the more likely that studies and claims about it are apt to be biased. Physicians today need to be detectives (more like Lt. Columbo than Dr. House) and question the evidence: Who were the subjects in a trial, what benefits were shown, how rigorous a trial was done? Using medications "off-label" can be helpful in treating certain maladies, but doing so requires a firm knowledge of the scientific justification and the risks and benefits -- and underlines the critical importance of discussing this option fully with patients.

TV watchers are not the only ones misled. Psychiatry News recently reported that print ads in scientific journals also fail to report drug risks or provide demonstrable evidence (3). The FDA lacks the resources to be ever-vigilant, but they now offer a website to help physicians decode the tricks of the drug advertising trade and report any potentially illegal claims or promotions.

What can you do?

First, be an informed consumer. Don't believe everything you see on TV or read on the Internet. You need to know where to turn for trustworthy information. Go to websites by your state mental health agency or the National Institute for Mental Health, the National Mental Health Association and the National Alliance for Mental Illness. Google key words about what you want to know, as you would for breast or prostate cancer, diabetes or heart disease. Ask others who have successfully navigated the mental health care system and have taken medications.

Second, engage your doctor and other health professionals by asking questions about treatment (including, but not only, medication) and seek further opinions when you feel in doubt.

Third, consider approaches beyond pharmaceuticals. Medications are an integral part of the care for serious mental health disorders, but there are other effective treatments as well, including therapy, exercise, spiritual practices, and physical well-being.

"Fair Balance" requires more than speed-reading the risks of a medication while music is playing and a pleasant person is smiling at you from a TV screen. But that will not happen unless an informed consumer and prudent doctor team up. If they don't, they risk falling prey to DTCA and proving once again what P.T. Barnum said: "Never give a sucker an even break.".

(1) Gagnon M-A, Lexchin J, 2008 The Cost of Pushing Pills: A New Estimate of Pharmaceutical Promotion Expenditures in the United States. PLoS Med 5(1): e1. doi:10.1371/journal.pmed.0050001
(2) Brody, H. and Light, D.W. "The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health." American Journal of Public Health. 2011 Mar; 101 (3): 399-404.

(3) http://alert.psychiatricnews.org/2011/08/drug-ads-for-doctors-fail-fdas.html

The opinions expressed here are solely those of Drs. Erlich and Sederer, as doctors and public health advocates. Neither receives support from any pharmaceutical or medical device company.

Visit Dr. Sederer's website for questions you want answered, reviews and stories.
www.askdrlloyd.com

 
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