Psychopharmacology. Psychotropic Drug Promotion

The money spent on drug advertising is truly astounding and estimates are no longer in the billions but in the tens of billions, and increasing rapidly.

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According to a December 12, 2002, New York Times article, “Promotional spending in the United States by the 14 largest pharmaceutical companies increased at an average annual rate of 32.4 percent from 1998 to 2001” (Engler, 2003) According to a June 24, 2002, Wall Street Journal article, “There is little dispute that drug makers spend big money–more than $16 billion in 2001, according to one estimate – cultivating physicians and medical students” (Engler, 2003).

The Food and Drug Administration, concerned about the increased use of prescriptions drugs amid a barrage of advertising, is looking into whether consumers are taking more medications than they really need. Doctors, in 2000, issued 2.9 billion prescriptions totaling $131.9 billion, a 19 percent increase from the previous year, according to a study by the National Institute for Health Care Management (Stefanova, 2001).

Increased advertising by pharmaceutical companies is a major factor causing the rise, according to industry observers. Drugmakers spent $13.9 billion on advertising and marketing in 1999, with the largest chunk of that – $7.2 billion – is spent on free samples handed out to physicians, according to the Pharmaceutical Research and Manufacturers of America, a Washington group whose members are the top 80 drug makers in the nation (Stefanova, 2001).

The disturbing part of this analysis is that the most advertised drugs have been found to be most prescribed despite negative side effects. “As we surmised from a couple of years of data, the drugs that are the top sellers – the ones that sell the most and drive the increase of prescription drug spending – are the drugs that are the most heavily advertised,” said Stephen Finley, director of research at the health care institute, a Washington nonprofit research, and policy analysis group (Stefanova, 2001).

Psychotropic drug spending increased 15-17 percent per year from 1991 to 2001, contributing to overall growth in drug spending. By comparison, growth of total health spending peaked at 9.3 percent in 2001-02. The rise in psychotropic drug spending reflects the introduction of new, costly medications as well as a long-term shift in U.S. mental health care: Medication use has increased, while psychotherapy and other outpatient treatments have decreased. Nationally, eight of the twenty-five top-selling drugs in 2001 were psychotropics. Antidepressants had the highest retail sales ($12.5 billion), and antipsychotics ranked thirteenth ($4 billion).

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The FDA started researching the connection between advertising and sales late last year to make sure the relationship is good for consumers, an FDA spokeswoman said.

The 50 best-selling drugs during 2000 averaged $75.88 per prescription. That is more than twice the average cost of other drugs, which cost $35.72, according to the institute. Drugmakers did not advertise their products until four years ago because the FDA required them to describe drugs thoroughly. But in 1997 the FDA eased its rules, requiring them to only list major side effects. This resulted in a flood of advertising.

Ms. Bagapor-O’Harrow comments that a two-page magazine ad for the popular antidepressant drug Prozac, made by Eli Lilly seems “insane.” “On the left hand there was like a gray cloud on a black background and the tag line read Sad? Under the weather?’ ” she said. “And on the right side there was a blue sky, a field of happy flowers, and the tag line said, It doesn’t have to be this way. Ask your doctor about Prozac.’ As promotion increases, so does consumer spending, particularly on the advertised drugs.

The sales growth of just 23 of the market’s 9,911 prescription medications accounted for half of the $20.8 billion increase in pharmaceutical spending last year. Antidepressants are at the top of the list of top prescription drug categories. Their sales in 2001 are $10.4 billion and growth 21%. The major medications of this category are Prozac (Eli Lilly), Zoloft (Pfizer), Paxil (SmithKline Beecham), Wellbutrin Sr (GlaxoSmithKline), and Celex (Stefenova, 2001).

When Prozac was introduced in 1987, it was the first wave of new antidepressants called selective serotonin reuptake inhibitors. They were promoted in the market as being as effective as older antidepressants or better, with fewer side effects. SSRIs caused a revolution in the market (Healy, 1997) and have become the best-selling class of drugs in the US (IMS Health, 2004). Glenmullen, a Harvard Medical School graduate and untenured clinical psychiatry instructor at Harvard University has studied the effects of Prozac-type antidepressants.

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In his book titled “Prozac Backlash” (2000), he cites dozens of studies from medical journals, magazine articles, FDA documents, and his own clinical experiences to chronicle the dangers of Prozac-type antidepressants. Some of the side effects according to Glenmullen are sexual dysfunction, weight gain, and tremors. “The fact is that any drug, and certainly all of the antidepressants, has side effects,” says Dr. Harvey Ruben, the director of continuing education for the department of psychiatry at Yale University. Glenmullen also suggested that people taking antidepressants like Prozac for a long term are likely to have suicidal tendencies (Glenmullen, 2000).

He estimates that between 1 and 3 percent of his patients became suicidal on antidepressants, percentage experts consider serious. He also believes Eli Lilly has suppressed this information when they promoted their antidepressant Paxil (Glenmullen, 2000). GlaxoSmithKline promoted Paxil as a product for the anxiety market, especially social anxiety disorder (SAD) and generalized anxiety disorder (GAD). In an advertising campaign, SAD was promoted as a common health issue with Paxil as its treatment. Instantly, the demand for Paxil increased and in 2001 was ranked as the number nine prescription drug.

By 2004, however, Paxil’s sales ranking dropped after some well-publicized reports of its adverse effects (www.p-d-r.com/ranking/WoodMac_Top100.pdf ). It is now clear that GlaxoSmithKline’s campaign for Paxil increased the medicalization of anxiety, implying that shyness and worrying may be medical problems, with Paxil as the proper treatment. Moreover, The Boston Globe recently published an internal Lilly document that revealed that the company was aware that akathisia, a severe agitation that can lead to suicide, occurs in at least 1 percent of users. An estimated 28 million people in this country, almost one in 10 Americans, use antidepressants.

Not surprisingly, Glenmullen’s claims have caused a huge uproar in the mental health community: If his figures are correct, nearly 17 million people suffer from SSRI-related sexual dysfunction. Yet Glenmullen does not advise patients to stop using SSRIs. He advocates the use of antidepressants for patients with moderate to severe symptoms. He does, however, suggest that patients with mild depression consider other alternative medicines such as St. John’s Wort.

Pharmaceutical giant Eli Lilly is promoting Sarafem as a miracle pill for women suffering from PMDD, a mental disorder’ not yet proved to exist (O’Meara, 2001). Eli Lilly admits that Sarafem has the same active ingredient as Prozac, complete with the same dangerous side effects. This “mental disorder” which is listed in the appendix of the APA’s Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) is called a premenstrual dysphoric disorder, or PMDD (O’Meara, 2001).

Both Sarafem and Prozac are fluoxetine hydrochloride. According to Lilly’s own literature, there is no science to support the diagnosis of PMDD. The scientific explanation offered by Lilly to Insight included the ACOG paper, “Premenstrual Syndrome,” and the Lancet article, “Efficacy of Selective Serotonin-Reuptake Inhibitors (SSRIs) in Premenstrual Syndrome: A Systematic Review”. These papers suggest the efficacy of treating PMDD in women with SSRIs (Sarafem/Prozac). While there are many trials supporting the efficacy of SSRIs in making women said to have PMS/PMDD “feel better” in the two weeks before menstruation, no indication is provided that this effect is anything but psychotropic masking of discomfort (O’Meara, 2001).

In the case of adolescents, there has been a dramatic increase in the prescription of psychotropic drugs especially those prescribed for ADHD, depression, and other mood disorders. Psychotropic drug prescriptions for teenagers skyrocketed 250 percent between 1994 and 2001, rising particularly sharply after 1999, when the federal government allowed direct-to-consumer advertising and looser promotion of off-label use of prescription drugs, according to a new Brandeis University study in the journal Psychiatric Services (Brandeis University, 2006).

According to an article in the Montreal Gazette (dated January 5, 2003) “The market for hyperactivity treatments grew to $1.1 billion in 2001 from $400 million in 1995”. Companies put ads in such magazines as People just before the start of the school year, for instance, urging parents to see their physicians about concerns over their child’s behavior.” In effect, drug companies decided they could make money by exploiting parental insecurities, causing parents to medicate their children.

The study at Brandeis University (2006) shows that one in every ten of all office visits by teenage boys led to a prescription for a psychotropic drug. Other findings in the study show that a diagnosis of ADHD was given in about one-third of office visits during the study period.

Also, between 14 and 26 percent of visits in which psychotropic medications were prescribed did not have an associated mental health diagnosis, said lead author Professor Cindy Parks Thomas, an expert on prescription drug trends, at Brandeis University’s Heller School for Social Policy and Management. “There is an alarming increase in prescribing these drugs to teens, and the reasons for this trend need further scrutiny,” said Thomas. “Our study suggests a number of factors may be particularly important to assess, including the impact of direct-to-consumer advertising and other marketing strategies” (Brandeis University, 2006).

Additional factors likely to contribute to increased prescription of psychotropic drugs include greater acceptance among physicians and the public of psychotropic drugs, the advent of new medications with fewer side effects, increased screening for mental health disorders, and patient demand for such drugs. Nevertheless, the study noted that overall, pharmaceutical companies increased their spending on television advertising sixfold, to $1.5 billion, between 1996 and 2000, with the trend accelerating after 1997 when the Food and Drug Administration Modernization Act was passed (Brandeis University, 2006). According to Thomas, the dramatic increase in prescribing of psychotropic medications is of considerable concern, particularly because these medications are risky (Brandeis University, 2006).

Several recent studies have noted that the adolescent group is the one with the highest rates of increase of psychotropic use, particularly SSRIs (Conrad, 2007). Trends in psychotropic prescribing rates for adolescents have been studied during the period 1994-2001 using National Ambulatory Medical Care Surveyor NAMCS (Conrad, 2007). Analysis shows that psychotropic prescriptions rose from 3.4% in 1994-95 to 8.3% in 2000-2001.

This represented a 2.5 fold increase in eight years. Adjusting for population, this meant that the rate of physician visits resulting in adolescents receiving a psychotropic prescription increased from 52.2 per 1000 to 141.8 per 1000 in the same time period (Conrad, 2007). The greatest growth was in the post-1999 period during which the rate of increase in psychotropic drug prescriptions nearly doubled. The most interesting find was that about 20% of the individuals who visited a physician and received a prescription for psychotropics had no mental health diagnosis (Conrad, 2007). These increases were similar for both males and females and for both stimulants and antidepressants.

For each time period, about one-third of the adolescents who visited a physician and received a prescription for a psychotropic medication had a diagnosis of ADHD, most were for other diagnoses such as depression, affective psychoses, and neurotic disorder (Conrad, 2007). One-fifth had no health diagnosis at all. By 2001, one in ten of all office visits to physicians by adolescent males resulted in the prescription of psychotropic medication. All studies in the previous decade show that there are increases in psychotropic prescribing to children. The steady escalation in treatment over the past fifteen years is apparently boosted by the advent of DTC advertising which creates a greater demand for medical solutions to life problems (Conrad, 2007).

As healthcare becomes commodified and subject to market forces, the public has become consumers, choosing health insurance plans, purchasing health care in the marketplace, and selecting institutions of care. The rise in pharmaceutical advertisements is an indication of how hospitals and healthcare institutions compete in the market. The internet has become an important consumer vehicle for pharmaceutical companies.

They have websites with consumer-oriented information, self-administered screening tests for a particular disorder, bulletin boards, chat rooms, and forums. Both corporate and grassroots websites can promote the use of psychotropic drugs on an international basis. In fact, the pharmaceutical companies’ introduction and promotion of “mild depression” as an illness in Japan have resulted in a dramatic rise in SSRI treatment since 1999(Schulz, 2004).

In the case of pharmaceutical companies, there are two target groups: physicians and consumers. The practicing physicians are the people who regulate to a large extent the number of drugs sold in the market and also the direct consumers. Thus the industry spends a lot of money on influencing his prescribing habits. Beyond courting medical professionals, drug companies in the United States can engage in direct-to-consumer (DTC) advertising.

Changes to Food and Drug Administration (FDA) regulations in 1997 sparked a flood of DTC advertising of prescription drugs on television and radio (O’Malley and O’Hanrahan, 1982) (Engler, 2003). Between 12 and 40% of sales are invested in promotion (Hemminki, 1975) depending on the country and the method of arriving at the statistic. In 1967 it was estimated that the United States pharmaceutical industry spent over one billion dollars per year in promotional activities (Silverman & Lee, 1974).

Promotional methods are direct or indirect (O’Malley and O’Hanrahan, 1982). Direct promotion includes the activities of medical representatives, advertising in medical journals, and direct mail advertising. Indirect advertising, which is more difficult to identify and maybe more important ethically, involves the association of the industry with research policy, relationships with medical academic units and staff, and the financing of medical journals, medical groupings, and postgraduate education (O’Malley and O’Hanrahan, 1982).

Physicians are expected to prescribe drugs based on science, not manipulation. Unfortunately, this is not always the case. When the promotion is in the form of free samples, the patient who goes home with a pocket full of free medicine from his doctor is likely to form a debt of gratitude toward his doctor, who in turn feels gratitude toward the drug company (Pomper, 2000). This warm feeling can translate into the increased prescription of the drug.

According to a study by Dr. B. Robert Meyer in North Shore, the use of piperacillin went up from $5,000 to $15,000 in one month after a drug lunch with pizza sponsored by the piperacillin rep who also gave out pipramints’ to the house staff and some info about their drug (Pomper, 2000). One of the most pernicious kinds of promoting drugs is through industry-funded research and training. On one side are academics, which need to get published and to get grants. On the other side are companies, which want studies that make their product look good.

In a 1996 study in the Annals of Internal Medicine, Stanford University’s Mildred Cho found that on average 79 percent of papers on unsponsored research reflected favorably on the drug in question. While that’s a pretty impressive number, it’s almost modest compared to Cho’s finding that the percentage went up to 98 percent for papers on industry-sponsored research (Pomper, 2000). By contrast, if an academic publishes a couple of papers that a drug company likes, they may decide to put the publisher on the symposium circuit (Pomper, 2000).

Symposium papers often travel further than the symposia where they’re read. They may be reprinted inbound “supplements” to medical journals. These supplements can then be passed out in detail as a subtle form of promotion. Moreover, it has been found that if a television ad convinces a person that he needs it, he is likely to convince his doctor to prescribe it for him. This can’t be a good development. In the first place, the most heavily promoted drugs are often the new ones, which are least tested.

Some time ago, when the FDA was more sluggish with the approvals, drugs tended to go on the market in Europe before the US. But now, 60 percent of new drugs come on the market in the U.S. first, making its citizens the world’s guinea pigs.

And even if a new drug is safe, the fact remains that it may not be any better than the invariably cheaper stuff that’s been around for ages and gone generic. In addition to consumer advertising, drug companies get through to consumers by sponsoring “patient groups” that consume whatever drug the company is pushing. For example, it was revealed several years ago that the non-profit group CHADD (Children and Adults with Attention Deficit Disorder), which offers encouraging information on using Ritalin and other psychotropic meds to control hyperactive kids, is partly funded by Ritalin’s manufacturer, Novartis.

Pharmaceutical companies are now eyeing the adult hyperactivity market. The FDA recently approved a couple of hyperactivity drugs for adults despite the scientific debate about whether this is even a valid medical condition, and drug companies are pushing adult and child hyperactivity “disorder” (Engler, 2003) The issue of hyperactivity drug abuse was well summarized by Lawrence Diller, a physician quoted on January 5, 2003, Montreal Gazette article.

He says, “We’re looking at a major stimulant-abuse problem in the next five or 10 years.” Thus the latest trend is the branding of new illnesses. For example, twenty-five years ago depression was a problem seldom considered in the medical world. Today, however, it is generally accepted as a serious illness – a positive development for sufferers and a huge help to the profits of the drug industry. The drive to the drug is part of a deeper problem with the pharmaceutical industry, especially in the United States (Engler, 2003).

DTC advertising is only profitable within a liberalized price structure. In the United States, there is little in terms of price controls on pharmaceuticals. Companies free to charge high prices can spend huge sums on advertising and still maintain large profits. According to the article in the New York Times (dated December 12, 2002), drug companies “spend 12 times as much to promote their prescription products in the United States than in Europe’s largest medicine market, Germany” (Engler, 2003).

The United States is little more than three times the size of Germany and hence this difference is significant. Due to restrictions on drug advertising in Germany and price controls, not much money is spent on drug promotion in Germany. To overcome the present drug culture in the United States the following recommendations may be made: Drug companies should not be allowed to give gifts or provide entertainment to physicians or consumers and samples should be allowed to be given only to the indigent or uninsured.

Second, federal funding should be increased for unbiased research. Third, TV advertising and patient group promotions must be regulated like in the olden days when sponsors should have to recite a generous description of a drug’s risks if they wish to advertise it on TV. Fourth, “academic” sessions must be organized for providing the latest drug information to doctors on a professional and scientific basis. Finally, a drug safety system should be established to track the drugs being rushed into the market (Pomper, 2000).

Thus, pharmaceutical companies, in order to increase the market for their products are indulging inexpensive promotional measures aimed at both the consumer and the physician. Some of these promotional measures are unethical and try to push harmful drugs on unsuspecting citizens. In the case of psychotropic drugs, new diseases are being found in order to cater to the increasing number of drugs produced by these pharmaceutical companies. In order to maintain public safety, it is important that drug promotions are regulated in the future.

Bibliography

Brandeis University (2006) Psychotropic Drug Prescriptions For Teens Surge 250% Over 7 Year Period. ScienceDaily. Web.

Conrad, Peter (2007). The Medicalization of Society. JHU Press.

Engler, Yves (2003). The Pharmaceutical Drive to Drug. The Humanist. Volume: 63. Issue: 3. 39+.

Glenmullen, J. (2000). Prozac backlash. Simon and Schuster Publishers. New York, NY.

Hemminki, E. (1975). Review of literature on the factors affecting drug prescribing. Soc. Sci. Med., 9, 111-115.

O’Meara, Kelly Patricia (2001). Misleading Medicine. Insight on the News. Volume: 17. Issue: 16. Page 10.

O’Malley. K. and O’Hanrahan. M. (1982). Drug Promotion and the Doctor. Br. J. Clin. Pharmac. Vol. 14. Pages 661-666.

Pomper, Stephen (2000). Drug Rush: Why the prescription market is unsafe at high speeds. Washington Monthly. Web.

Silverman, M. & Lee, P. (1974). Pills, profits and politics. University of California Press. Los Angeles, California.

Stefanova, Kristina (2001). FDA is Probing Higher Drug Sales and Advertising. The Washington Times. Page: 9.

Psychopharmacology. Psychotropic Drug Promotion
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