Since 1971, when U.S. President Richard M. Nixon declared a “War on Cancer,” doctors and researchers around the world have worked diligently to find a cure for this life-threatening and life-altering disease.
Thirty years later, though, an investigative report published by CBS News and Business Week found the U.S. Food and Drug Administration (FDA) might be responsible for many treatments failing to reach the market.
Other recent reports and studies confirm that conclusion
FDA Methods ‘Oudated’
The CBS/Business Week report, “Cancer’s Cruel Economics,” written by Catherine Arnst, notes researchers, companies, and patients alike are blaming FDA for the lack of progress in the search for a cure for cancer, largely because they believe FDA is using outdated and overly rigorous methods for assessing a new generation of cancer treatments instead of doing everything possible to provide cancer patients with more effective drugs.
The U.S. government has spent more than $75 billion on oncology research over the past 30 years, Arnst notes, yet the death rate from cancer has fallen by only 7 percent. Further, cancer continues to strike 1 in 3 Americans, killing 1 in 4 annually. On average, 1,500 Americans fall prey to the disease every day.
In addition to the tragic loss of life, cancer deaths result in an annual cost to the nation of $210 billion in treatment costs and lost productivity, the CBS/Business Week report notes.
Approvals Slowed to Trickle
“Although the number of new cancer drugs entering clinical development more than doubled between the early 1990s and mid-2000s, only 8 percent of candidates with known fates won marketing approval in the United States,” the study noted. “This approval rate compares with an overall U.S. marketing approval rate of 20 percent for all new drugs that began human testing in 1993-97.”
In total, Arnst notes in her report, only 32 new cancer medications have been approved by FDA since 1990.
FDA ‘Too Conservative’
“The FDA knows there’s a problem,” Arnst writes. “In 2004 it announced with much fanfare an effort, dubbed the Critical Path Initiative, to make clinical trials more productive. But the initiative never got much funding.”
Although the number of approvals has increased significantly in the past three years, Arnst notes, totaling more (18) than in the entire decade before (when only 14 drugs were approved), it has still failed to keep pace with the even more rapidly increasing number of applications, according to a 2007 report by the Tufts University Center for the Study of Drug Development (CSDD).
Cancer victims and researchers are questioning the agency’s methods for drug selection. “Outside the agency, academic and industry researchers who come up with creative ideas for evaluating drugs routinely complain that the FDA is too conservative to embrace new methods,” Arnst writes.
Other Countries’ Policies Better
Several cancer vaccines have entered clinical trials, but to date none has been approved by FDA. As a result, drug manufacturers are increasingly looking to foreign countries where the approval process is faster and more open to discoveries of alternative benefits of drug treatments.
“It’s nearly impossible to pinpoint the right patients for a drug without staging a large-scale clinical trial that includes a lot of wrong patients,” writes Arnst. “But [inclusion of] the wrong patients cause the trial to fall short of its goal, and the drug isn’t approved.”
“We are learning more and more every day about how patients respond to a treatment,” said Dr. Andrew Parsa of the University of California at San Francisco. He is testing Oncophage, a cancer drug for treating brain tumors, which failed to gain FDA approval but was quickly adopted in Russia.
“We can have new information retrospectively that would allow us to come up with a much better result, but the FDA won’t let you use it,” Parsa noted.
Katie Flanigan ([email protected]) writes from Georgia.
For more information …
“Cancer’s Cruel Economics,” Business Week, July 2008: http://www.businessweek.com/magazine/content/08_22/b4086000467675.htm
“Despite more cancer drugs in R&D, overall U.S. approval rate is 8%,” Tufts University Center for the Study of Drug Development, September 5, 2007: http://csdd.tufts.edu/NewsEvents/RecentNews.asp?newsid=83
“Cancer Facts and Figures 2008,” American Cancer Society, 2008: http://www.cancer.org/docroot/STT/STT_0.asp
“More Choices, Better Health: Free to Choose Experimental Drugs,” by Bartley J. Madden, May 2007: http://www.heartland.org/Article.cfm?artId=21194