CME is an acronym for Continuing medical education. It is a type of continuing education that serves to maintain, develop, or increase the knowledge, skills, and professional performance of a physician after they leave medical school. CME activities are usually educational interventions that rely on evidence based medicine to provide unbiased direction to medical practitioners to meet educational needs and ultimately improve patient care. In April, a Senate Finance Committee study found that the Accreditation Council for Continuing Medical Education, the main accrediting body for education providers, does not scrutinize course materials for accuracy or evidence of bias toward sponsors’ products. At times, sponsors have been able to select topics, and presenters have discussed off-label uses for drugs, the report found.
Recently, pharmaceutical companies have become the biggest sponsors of CME courses, even at the nation’s top medical schools, a development that critics say raises health-care costs, skews doctors’ treatment decisions and allows the industry to skirt laws against advertising “off-label” uses for its products. The trend toward pharmaceutical industry sponsorship accelerated after the government backed off a plan to limit commercial sponsorships in 2002 at the urging of the industry.
Now, nearly two-thirds of the cost of continuing education courses sponsored by medical schools, popular for their prestige, are paid for by drug and medical device companies and other commercial interests, figures show. Overall, commercial sponsors pick up about half of the $2.25 billion annual cost of the courses doctors must attend to keep their licenses.
Scott Lassman of the Pharmaceutical Research and Manufacturers of America state the following for the practice of pharma funding:
• a way to educate physicians about the latest medical and scientific research.
• are viewed as running independently of the pharmaceutical company. The company may be providing the funding for it, but they are not directing the content.”
• Allows for physicians to learn about “off-label” uses of drugs since “A lot of times, the regulatory process lags behind the science,” Thus “[he] think it’s a benefit for physicians, as long as it’s independent and as long as the scientific information is solid.”
J. Gregory Rosenthal, of Physicians for Clinical Responsibility For doctors and others states the following against the practice:
• “[Pharma] makes it very difficult [for a physician] to know what research to believe”
• “[a physician] can’t go onto a CME Web site without being confronted by sponsorship logos.”
• the drug industry does hold some sway over which topics are covered in the courses.
• “[CME] are promotional activities disguised as education.”
Read more: Conflict Alleged in Drug Firms’ Education Role, Elizabeth Williamson and Christopher Lee, Washington Post Wednesday, June 27, 2007; Page A03 .
For the next 4 to 5 weeks, I am going to put together an educational primer for people interested in the Movie SiCKO, a political documentary film about pharmaceutical companies and of Food and Drug Administration by Michael Moore, scheduled for release in the United States on June 29, 2007. What is interesting is that Mr. Moore isn’t bringing up anything new….pharmaceutical and health insurance companies have been behaving like this for years. In any case, by reading this blog the next few weeks, I hope that you will educate yourself about several concepts before seeing the movie.
The concept: “Prescriber Profiling”
The players: Pharmaceutical Companies, American Medical Association (AMA), data mining companies.
How it works:The American Medical Association license access to it’s AMA Physician Masterfile, a database containing names, birth dates, educational background, specialties and addresses for more than 800,000 doctors to data-mining companies. The data mining companies, known as health information organizations (HIOs), then links this individual physician data to their demographic data and their prescription record. They then sell this linked database to sell them to pharmaceutical companies.
The pharmaceutical industry then employs approximately one sales representative for every 5 office-based physicians. A representative can quickly access a breakdown of pharmaceuticals prescribed by any physician on a handheld computer, enabling that representative to deliver a tailored marketing pitch to physicians selected for their current prescribing habits. Within weeks, the sales representative can monitor each physician’s response to the pitch—as well as to inducements, such as meals, gifts, and drug samples—and can make repeated visits to achieve sales goals. They can also identify physicians who prescribe a competitors’ drug and target them with campaigns touting their own products. Salespeople chart the changes in a doctor’s prescribing patterns to see whether their visits and offers of free meals and gifts are having the desired effect.
Critics claim that Prescriber Profiling biases the doctor-patient relationship, and it’s driving up costs. The pharmaceutical industry defends the practice as a way of better educating physicians about NEW drugs. Critics reply that this type of drug marketing serves mainly to influence physicians to prescribe more expensive NEW medicines, not necessarily to provide the best treatment.
After complaints from some members, the AMA last year began allowing doctors to “opt out” and shield their individual prescribing information from salespeople, although drug companies can still get it. So far, 7,476 doctors have opted out, AMA officials said. Some critics, however, contend that the AMA’s opt-out is not well publicized or tough enough, noting that doctors must renew it every three years. Furthermore critics claim that the AMA is reluctant to change it’s behavior because of it’s $44.5 million in revenue from the sale of database products (in 2005)—16% of the AMA’s total revenue for that year. They stress that patient names are encrypted early in the process and cannot be accessed, even by the data-mining companies.
Doctors, Legislators Resist Drugmakers’ Prying Eyes By Christopher Lee. Washington Post, Tuesday, May 22, 2007; Page A01.
Prescriber Profiling: Time to Call It Quits. David Grande. Annals of Internal Medicine. 15 May 2007. Volume 146 Issue 10. Pages 751-752.
For the next 4 to 5 weeks, I am going to put together an educational primer for people interested in the Movie SiCKO, a political documentary film by Michael Moore, scheduled for release in the
United States on June 29, 2007. It will investigate health care with a focus on large American pharmaceutical companies and the Food and Drug Administration. I haven’t seen the movie yet however I intend to. What’s interesting is that Mr. Moore isn’t bring up anything new….pharmaceutical and health insurance companies have been behaving badlyfor years. In any case, by reading this blog the next few weeks, I hope that you will educate yourself about several concepts before seeing the movie.
The concept: “Me-too drugs”
The players: Pharmaceutical Companies
The Scoop: The pharmaceutical industry is not especially innovative or inventive. The great majority of “new” drugs are not new at all but merely variations of older drugs already on the market. These are called “me-too” drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first. As Dr. Sharon Levine, associate executive director of the Kaiser Permanente Medical Group, put it,
“If I’m a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?”
Of the 78 drugs approved by the FDA in 2002, only 17 contained new active ingredients, of which seven of these were classified by the FDA as improvements over older drugs. The other seventy-one drugs approved that year were variations of old drugs or deemed no better than drugs already on the market. Only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). Of the 7 drugs discussed above, not one came from a major US drug company.
Case in Point: Nexium, a “me-too” drug for stomach acid, has earned approximately $5 billion for its maker, AstraZeneca, since it went on the market in 2001. Nexium illustrates the drug makers’ strategy. Many chemicals come in two versions, each a mirror image of the other: an L-isomer and an R-isomer. (The “L” is for left, the “R” is for right.) Nexium’s predecessor Prilosec is a mixture of both isomers. When Prilosec’s patent expired in 2001, the drug maker was ready with Nexium, which contains only the L-isomer.
Is Nexium better? So far, there’s no convincing evidence that it is, says Stanford drug industry watcher Randall Stafford, MD, PhD.
The problem with Me-Too drugs is that they are always marketed as BETTER than what’s already available. However, the FDA approves drugs on the basis of their superiority to placebo, not their superiority to existing drugs,” Stafford says. “I think people misunderstand the nature of FDA approval and the criteria used to allow drugs to enter the market. So consumers feel compelled to leave their current regime–even if it’s working–for these drugs. Me-Too drugs also COST SUBSTANTIALLY more–forget about lowering prices.
1. The Truth About the Drug Companies ByMarcia Angell
2. “Me-too drugs, Sometimes they’re just the same old, same old” By Rosanne Spector.