Update on Pharmaceutical Industry: New threats to Pharma’s public reputation

In the past, the pharmaceutical industry was often seen as a positive social force, contributing life saving drugs and bringing new developments in medicine and science to the public. In recent years, however, public opinion has begun to shift. In 2005, for example, a Kaiser poll showed that for first time, more people said drug companies generally do a “bad job” (48%) than a “good job” (44%) of serving consumers, marking a nine year decline in such ratings. While drug companies were still rated more favorably than tobacco and oil companies, banks, airlines and HMOs were rated more favorably. In a 2005 Harris poll, a majority of US adults(51%) thought that pharmaceutical industries should be more regulated , a larger proportion than supported more regulation of tobacco companies(36%) or the health insurance industry (46%). Between 2003 and 2005, the proportion of respondents who believed that the pharmaceutical industry could be considered “honest and trustworthy” fell by 31%, from 13% in 2003 to 9% in 2005.

In this report, we highlight some recent reports that might explain the declining public perceptions of the pharmaceutical industry.

Marketing to Doctors

In order to maintain a license to practice medicine, most states have an ongoing medical education requirement for physicians. While many doctors seek out such education at accredited universities and medical associations, increasingly medical providers attend educational courses funded by the pharmaceutical industry. Since 1998, funding by Big Pharma for continuing medical education has quadrupled and now totals more than $1 billion (1). In order to fund medical education, pharmaceutical companies hire for-profit – medical education communication companies – which receive their content from the drug industry and then deliver the educational material to physicians in continuing education courses. Such practices have come under fire and recently Senators Max Baucus and Charles Grassley released a report on the unethical funding of medical education by the pharmaceutical industry.Read more about marketing to physicians here.

In medical education courses paid for by drug companies, often the benefits of a specific drug are touted without mention of potential side effects. For example, pharmaceutical makers plug sleep aids to consumers and physicians as an effective solution to insomnia, again often failing to mention concerns about efficacy, and potential side effects ranging to dependence to increased mortality amongst adults. (2) Now new research demonstrates that sleep aids are increasingly being prescribed to children.

In July, a subsidiary of Jazz Pharmaceuticals pleaded guilty in federal court to felony charges of improperly promoting their narcolepsy drug “Xyrem” for unapproved uses. Jazz Pharmaceuticals promoted the drug for depression, insomnia, and fibromyalgia. Xyrem is a powerful anesthetic and is the prescription version of the street drug “gamma hydroxybutyrate,” which has been linked to date rape and has a high risk of overdoes. The street version of Xyrem is listed by the Drug Enforcement Administration as a Schedule I drug, a drug considered to be the most dangerous. As part of their off label marketing campaign, Jazz Pharmaceuticals worked with doctors to improperly promote the drug on their behalf. Read more.

Marketing to doctors and patients

In 2006, drug company Merck launched its Human papillomavirus (HPV) vaccine “Gardasil” in the United States and in the European Union. With over 20 million people in the United States believed to be infected with HPV and with rates rampant around the world, Gardasil was touted as a “wonder drug” as it targeted four subtypes of HPV. HPV is the umbrella term used to describe a group of viruses that includes more than 100 unique types. Escalating rates of HPV have raised concern as more than 30 of these strains are sexually transmitted and of those, approximately one third can lead to the development of cervical cancer. With vaccination, it has been hoped that the rates of cervical cancer could be drastically reduced. Given this, lawmakers in the US and around the world have pushed for mandatory HPV vaccination. However, there is reason to doubt the “wonder drug” status of Gardasil. In a four part series, Judith Siers-Poisson examines the facts and hype around Gardasil, explores what pharmaceutical giant Merck stands to gain through practices such as mandatory vaccination, and reviews the reception of Gardasil on the global front. Read the articles.

Direct-to-consumer marketing, a strategy Big Pharma uses to create brand loyalty and encourage patients to ask for specific drugs, has been a controversial practice and is currently legal only in the United States and New Zealand. In an attempt to create interest in and a market for “Restylane,” a dermal injection designed to reduce the appearance of wrinkles, Medicis Pharmaceutical Company recently paired with YouTube to target middle-income consumers. While generally products such as Botox or Restylane have been considered safe, they have been known to result in side effects from rashes to flu-like symptoms to temporary facial “drooping.” The market for these products is large and growing; in 2005, $12.4 billion was spent on such cosmetic treatments (3). Until now, these cosmetic products have been considered the bastion of the wealthy. Thus, to broaden the market Medicis is finding new ways to reach potential consumers such as the YouTube advertisement. Read about Medicis “Hottest Mom” contest and its other advertising campaigns.

Lobbying

During the first half of 2007, The Pharmaceutical Research and Manufacturers of America, (PHRMA), a drug industry lobby group, spent $10.7 million to lobby the U.S. government. PHRMA’s members include Eli Lily & Co., Pfizer Inc., Amgen Inc. and other major drug companies. The lobby pressured lawmakers on Medicare, drug fees safety, importation, patient reform and international trade. The current president and chief executive of PHRMA is former Louisiana Representative Billy Tauzin, who is also a registered lobbyist for the group. Read more.

FDA Approval

After FDA advisory panels on the diabetes drug “Avandia,” produced by GloxoSmithKline, a decision was reached that the product will now come with warnings that it may significantly increase the risk of heart attack. Gerald Del Pan, the director of the FDA’s Office of Surveillance and Epidemiology, was one of many voices criticizing the decision: “Cardiovascular disease being the leading cause of death of people with diabetes, having a treatment that causes that is something that doesn’t make sense to me.” Read more about the FDA decision.

Controversy over the drug rosiglitazone has led to further criticism over the FDA’s approval process. Dr. Clifford Rosen, who recently chaired the FDA advisory panel on rosiglitazone stated that while the new product had been considered a “wonder drug,” ultimately it was “approved prematurely and for the wrong reasons by a weakened and underfunded government agency subjected to pressure from the industry.” He further noted that the lax approval process lead to harm for patients. Read Rosen’s report on rosiglitazone and the FDA approval process.

Designer Drugs & Targeted Marketing

In “Race in a Bottle” in a recent issue of Scientific American, Jonathan Kahn writes about BiDil, a drug for heart failure marketed specifically to African-Americans. Some researchers have questioned the scientific grounding for BiDil’s race-based targeting given that in the clinical trial on which the FDA based its approval, the drug was only tested on African Americans and thus true comparisons among racial groups cannot be made. Others have pointed to the danger of race-based medicine itself, noting that it (re)locates social categories within biology. In addition, such a conceptualization of health disparities overlooks contributing structural reasons for them. More than twenty years ago, researchers began exploring the effectiveness of combining two vasodialators (hydralazine and isosorbide dinitrate, hereafter H/I) on heart failure. While angiotensin-converting enzyme (ACE) inhibitors soon gained prominence in treating heart disease, some doctors prescribed H/I for those who failed to respond to the ACE treatments. Convinced of the efficacy of H/I, in 1987 cardiologist

John Cohn, who was one of the original researchers studying their combination, applied for a patent on the method using the drugs together to treat heart failure in the population at large. Because the drugs were already available in generic form, Cohn could not patent the drug combination itself. After receiving a patent on the method, he licensed the rights to the small pharmaceutical company Medco which released the two drugs in a single pill form known as “BiDil”, a combination of two previously tested and available in generic form, was first tested in the early 1990s. After the FDA refused to approve BiDil,the cardiologist who had led these earlier studies, returned to the data from these first trials and noticed that the small number of African-Americans on whom the combination was tested, responded positively to treatment. Cohn then filed a new patent application marketing the drug specifically with Black patients. Two years ago, the FDA gave approval for BiDil to NitroMed (the pharmaceutical company to whom Cohn reliscenced the drug). The event marked the first time an “ethnic drug” was approved for use.

Taking on the Pharmaceutical Industry

One of the latest organizations fighting questionable pharmaceutical industry practices is the Prescription Project. The campaign, led by Community Catalyst – a health-care consumer advocacy group based in Boston – was funded by the Pew Charitable Trusts to reduce the influence of the drug industry on the prescribing practices of doctors. Currently, drug companies spend approximately $7.2 billion per year on marketing to doctors and provide $16 (million?) worth of samples. This amounts to more than half of what the industry spends on research and development per year. The Prescription Project promotes the creation and implementation of guidelines that would restrict or ban the pharmaceutical industry from engaging in funding continuing medical education and providing incentive items and gifts. Read more

In May 2007, Nigerian authorities filed in their state and federal courts a multi-billion dollar lawsuit and criminal charges against the pharmaceutical giant Pfizer for testing an experimental drug on children. Pfizer has asked a Nigerian court to throw out the lawsuit, which stems from its testing of the experimental drug – Trovan – in 1996 during a meningitis epidemic. Trovan resulted in the deaths of 11 children and injured an additional 189 others. While Pfizer claims that the trial was explained to parents and their consent was obtained orally before the drug was given to their children, Nigerian authorities claim the drug company did not tell families that their children would be participating in a study using an experimental drug.Read more.

 

References

1. Carlat, D. Diagnosis: Conflict of Interest. New York Times. June 13, 2007. 
2. Mozes, A. Most Sleepless Kids Prescribed Drugs: Study. Practice is widespread, even though FDA doesn’t approve pediatric use. Healthfinder.gov. 2007. 
3. Jennings, A. Contests, YouTube and Commercials Converge for Skin Product. New York Times. June 27, 2007

 

Photo Credits:
Photo 1: courtesy of Stanford University
Photo 2: copyright: Merck
Photo 3: courtesy of CA.gov