Most Recently Approved Rx Drugs are Modifications, Copies of Existing Treatments, Study Finds
Two-thirds of prescription drugs approved by the FDA between 1989 and 2000 were either modified versions of existing treatments or "copycats of drugs already on the market," rather than innovative medications, according to a new study released yesterday, USA Today reports (Appleby, USA Today, 5/29). The study, conducted by the National Institute for Health Care Management, found that the increase in drug spending between 1995 and 2000 was largely due to spending on medications that the FDA did not categorize as providing significantly improved efficacy or safety (NIHCM release, 5/28). "Highly innovative drugs are rare," NIHCM President Nancy Chockley said (Tobin, Reuters/Boston Globe, 5/29). She added, "This does not mean that many of the incrementally modified and improved drugs the FDA approves don't benefit patients. ... [But t]he plain fact is that many new drugs are altered or slightly changed versions of existing drugs, and they may or may not be all that much better than what's available already. Consumers should be more aware of that" (NIHCM release, 5/28).
The study found that of the 1,035 drugs approved by the FDA from 1989 to 2000, only 361, or 35%, contained new active ingredients. The remainder contained active ingredients already available in other drugs on the market, the New York Times reports. Examples of drugs in the latter category include Nexium, the new version of AstraZeneca's ulcer drug Prilosec, and Clarinex, a reformulation of Schering-Plough's allergy drug Claritin (Petersen, New York Times, 5/29). The study found that only 153 of the drugs approved during that period were "highly innovative" medications -- those that contain a new active ingredient and receive "priority" status because their safety and efficacy profiles promise a significant improvement over existing treatments. In addition, the study found that innovation decreased over the latter years of the study: the FDA approved 304 modified versions of drugs between 1995 and 2000, compared with 168 over the previous six years (Neergaard, AP/Nando Times, 5/29). The study also concluded that the "doubling of prescription drug spending from 1995 to 2000 -- from $64.7 billion to $132 billion -- was largely attributable" to the least innovative new drugs (Kaufman, Washington Post, 5/29). The report said that drug makers are increasingly relying on such medications -- so-called "me-too drugs" -- to replace treatments that are set to lose their patents and to bolster companies' sales. Modified drugs also "provide a high return on investment ... since developing them is much less expensive and also less-time consuming than trying to find a new medicine," the New York Times reports. "This is more evidence that pharmaceutical companies are turning more into marketing companies," Chockley said.
The drug industry reacted strongly to the report, calling it "flawed" as well as biased because the NIHCM receives 40% of its funding from Blue Cross Blue Shield plans (New York Times, 5/29). Richard Smith, vice president for policy and research at the Pharmaceutical Research and Manufacturers of America, called the organization a "tool" of the health plans, which are interested in holding down drug costs (McGinley, Wall Street Journal, 5/29). The study "appears to be little more than a political and financially motivated cheap shot masquerading as science in the public interest," Smith said, adding, "It comes as no surprise that its report conveniently ignores many of the basic facts about drug research, not the least of which is that innovation rests in the lives of its beholders." Smith said that while many anti-depression medications could be deemed "copycats," studies have found that 50% of depression patients try two or three drugs before finding one that works for them (Washington Post, 5/29). Chockley defended the report, saying that the bulk of NIHCM's funding comes from the federal government and that the organization's advisory board, and not its board of directors -- most of whom come from Blue Cross and Blue Shield plans -- reviewed the study.
The report could bolster efforts on Capitol Hill to tighten patent laws to make it harder for drug makers to win extensions on existing medicines (Wall Street Journal, 5/29). It also comes as federal and state investigators target the industry for attempting to retain patent extension on drugs, a practice that also has prompted several lawsuits by consumer groups. Despite these growing challenges to the industry, its use of modified versions of drugs is "likely to accelerate" in the near future, the Philadelphia Inquirer reports. Seventeen brand-name drugs with U.S. sales of nearly $20 billion are set to lose patent protection over the next four years, and most drug makers have few potential breakthroughs in their pipelines (Pugh, Philadelphia Inquirer, 5/29). The study is available online. Note: You will need Adobe Acrobat Reader to view the study.
The study's findings will be discussed tonight in an hour-long ABC News special, "Bitter Medicine: Pills, Profit and the Public Health." Hosted by Peter Jennings, the report examines whether newer drugs on the market are "really better than the old drugs" and includes interviews with PhRMA President and CEO Alan Holmer and Chockley. "Bitter Medicine" airs May 29 at 10 p.m. ET. (ABC News release, 5/21). The New York Times today reviews the ABC News special (Genzlinger, New York Times, 5/29).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.