Federal center pays good money for suspect medicine
Feds dole out millions of dollars for questionable studies on treatments ranging from energy healing to acupuncture
Harry Bosk receives an acupuncture treatment for a pulled calf muscle from Marcos Y. Hsu, a licensed acupunturist at the University of Maryland School of Medicine, Center for Integrated Medicine. (Lloyd Fox/Baltimore Sun)
And yet, instead of declaring these studies convincingly negative, NCCAM is pouring more research money into acupuncture.
"The intellectual dishonesty is just astounding," said Dr. Steven Novella, a neurologist at Yale School of Medicine and a critic of NCCAM. "They are just quietly changing the question and the rules."
Acupuncture researcher Dr. Brian Berman, principal investigator for $24 million in NCCAM grants since 1999, wrote in a paper published in the New England Journal of Medicine that a 2008 analysis of acupuncture studies involving 6,000 patients with lower back pain found no significant difference between true acupuncture and sham acupuncture, though both did better than usual care.
Berman, founder of the Center for Integrative Medicine at the University of Maryland School of Medicine, recommended in the paper that a hypothetical person with lower back pain who had not responded to standard medical treatments should receive 10 to 12 acupuncture treatments in addition to usual care. That series of sessions could cost hundreds of dollars.
In an email, Berman wrote that he based his recommendation on evidence that acupuncture is relatively safe and helps people. It's unclear, he said, why true acupuncture and sham acupuncture may produce similar effects.
Both Berman and Briggs said it is difficult to design trials of complex therapies like acupuncture.
"It is generally impossible to isolate a single element," Briggs wrote in an email. "A sham control in a mind-and-body study could easily miss answering the most important question of whether the patient experiences benefit (e.g., relief of pain) from the procedure as a whole."
Physicians who work with patients in pain say they welcome any new tools, especially ones without side effects of narcotics. If that means offering a treatment that may be a placebo, so be it.
"We have lots of people out there with a problem that isn't being addressed with conventional approaches," said Seattle researcher Dr. Daniel Cherkin, who also sits on the NCCAM advisory council. "What do we do with those people? To say we shouldn't do these things because it is a placebo denies them something safe and available and works. What do we replace that with?"
Critics respond that it's not right to charge people hundreds or thousands of dollars for treatments that amount to nothing more than an elaborate placebo without telling them so.
"There is another side of the coin. It is essentially deluding somebody," said Sampson of Stanford. "In other parts of our social life, it is a crime."
Coffee vs. cancer
In fiscal years 2002 and 2003, NCCAM helped fund a study with the National Cancer Institute of an arduous regimen for pancreatic cancer that is best known for frequent "detoxifying" coffee enemas. The study was troubled from beginning to end.
The research design pitted standard chemotherapy against a regimen developed by Dr. Nicholas Gonzalez, a New York City physician. In the study, volunteers on the Gonzalez protocol were to take dozens of supplements each day, including between 69 and 81 capsules of pancreatic enzymes; undergo twice-daily coffee enemas; maintain a strict diet; and engage in other "detoxifying" activities like "skin brushing."
There was little scientific evidence to suggest all of this would work other than a paper Gonzalez published in 1999 on a pilot study of 11 pancreatic cancer patients. Five were reported to have lived at least two years, a long time for pancreatic cancer, which usually kills swiftly.
The hypothesis behind his treatment — that pancreatic enzymes are the body's primary defense against cancer and can be used to fight it — is based on an unproven idea from the early 1900s.
"We have learned a lot since 1906 about cell transformation and how these cells change," said Dr. Mary Mulcahy, a gastroenterology medical oncologist at Northwestern University Feinberg School of Medicine.
Meanwhile, one of the protocol's components — coffee enemas — has been linked to infections and electrolyte imbalances that can be fatal.
Despite the risks and the lack of evidence that the regimen would help patients, the taxpayer-funded study enrolled 55 volunteers with pancreatic cancer. As the project continued, the U.S. Food and Drug Administration and the federal Office of Human Research Protections identified problems, including issues with the subjects' consent.