Ethics of Pharmaceutical Marketing and Sales
... National Anemia Action Council (NAAC), a group of 25 academic physicians from across the nation, recently produced a brochure for the general public called “Anemia: A Hidden Epidemic” which reports that anemia is under-recognized, under-treated and often lumped with other chronic diseases. Although the NAAC and Amgen seem like two separate entities in the business of research, it is Amgen who supports all the projects of the NAAC with “unrestricted educational grants” and pays over one third of the council members as paid consultants or speakers. Several chapters of the brochure also mention preliminary data suggesting that Amgen’s drug “has also shown to be a benefit in treating disorders” for which the FDA has not yet approved. These chapters elicit the idea that any deficit in erythropoietin might characterize many of these other conditions rather than be side-effects to other illnesses. The brochure discusses heart disease in one chapter. In this chapter, a tiny sample of a pilot study, which was too small to produce sufficient data on the effectiveness of this drug in this context, might give people a visual correlation to patients, enough that they might ask their doctor if it can help them. The NAAC also sent out emails called Anemia Alert to physicians. In two of these emails, the articles did not explicitly equate Epogen with the cure of some diseases where decrease in erythropoietin was noted. It did though note the frequency of anemia in various conditions, the risks of being anemic, the risks of blood transfusion, and the benefits of erythropoietin in certain settings. In another example, Cephalon produced Provigil as a drug for the relief for narcolepsy and only narcolepsy, as is stated in their approval with the FDA. In a supplement of the Primary Care Companion to the Journal of Clinical Psychiatry released in 2003, several articles about medical conditions characterized by fatigue were discussed, such as depression. These articles described a phenomenon coined “executive dysfunction” as an illness marked by fatigue, apathy, bad mood and an ability to communicate clearly. The illness is just a concept though and not noted as an illness by any physician or medical council as having a standard medical definition. Even though a disclaimer in the back of the supplement states that Provigil is not approved by the FDA for these symptoms, the articles are nothing more than a solicitation attempt for Provigil in the treatment of other illnesses other than narcolepsy. Even though it is not illegal for a professional to write papers or articles explaining illnesses and ways to treat them for informational purposes, Cephalon paid for the publication from the Primary Care Companion making the PCC an extension of the main pharmaceutical company, even though it is its own entity. All eight authors who comprised the writings in the supplement have received honoraria, consulting fees, speaking fees, research funds from Cephalon. The company also paid for a teleconference at which the PCC would present their findings in the pamphlet. Some might ask if this is all worth it. In 2003, Cephalon attributed more than $250 million of their $290 million in sales of Provigil are attributed to causes like depression, fatigue and attention-deficit disorder or “off-label” uses of the drug which is strictly approved by the FDA for narcolepsy. For many drugs on the market, 90% of all sales come from uses that are off-label. The losses though are severe. In May of 2004, Pfizer and a subsidiary agreed to pay $430 million to settle a variety of state and federal allegations which was in regards to the questionable marketing practices and promotions of Neurontin. Pfizer paid what was considered an unprecedented fine after the company admitted that the epilepsy drug was promoted for several unapproved uses, including migraines, chronic pain and bipolar disease. The question still remains how it should be addressed. One may address it as a brilliant marketing strategy in supply chain management theory of bringing the manufacturer closer to the retailer. Others may contend that it is nothing more than an elaborate hoax by the pharmaceutical industry to line their pockets through the bribery of the physicians with the sole intent to fraudulently mislead the public. Regardless of what you call it, it is commonplace in the pharmaceutical market and an important tool in facilitating the profitability, legally or illegally, of product by putting it in the consumer’s hand. In another case, Glaxo had released Paxil for use to people with major depressive disorder-- off-label though it has been prescribed to adolescents who suffer with depression. This drug, selling over $3 billion dollars in sales, was funded by over $150 million dollars in marketing related tactics. During the stages of marketing the drug, Glaxo said the drug was safe and efficacious. With no reason to question by the public, the marketing continued. Just recently, Glaxo and its product came under huge public and legal scrutiny. Glaxo, in its testing, had done five clinical studies to test the drug. One study showed it marginally better than the placebo it ran against. The other four found the drug was neither any better than the placebo or that it generated suicidal tendencies in adolescents who had taken it. The danger was never revealed. Now we face class action suits for the deceit involved on behalf of Glaxo to gain sales. The final result—Glaxo relabeled its product to show the suicidal tendencies. This seems a small price to pay for years of deceit and endangerment to the public’s health and safety. One of the more shocking cases involves Dr. P. Trey Sunderland III, a leading psychiatrist at the National Institutes of Health, and his involvements in this type of solicitation. Sunderland is one of the leading researchers on Alzheimer’s with an undergraduate degree from Harvard University and a medical degree from George Washington University. He joined the NIH in 1982 with the sole intent of finding ways to detect the disease before a patient develops pronounced symptoms. In 1998, the NIH and Pfizer joined together in collaboration to join forces in research in this area. Sunderland, at this time, was already in Pfizer’s back pocket. This was to correlate with Pfizer’s research on Aricept—their drug for Alzheimer’s which was to be used strictly for the treatment of symptoms for mild to moderate Alzheimer’s. Between the years of 1998 and 2003, Pfizer paid Sunderland $508,050 in “consulting and speaking fees”. This brought about a congressional subcommittee hearing due to the fact that he did not report his affiliation and any of th...