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Alternative medicine centre aims for mainstream status
FEATURE
Alternative medicine centre aims for mainstream status he Office of Alternative Medicine (OAM) was founded in 1992 under pressure from alternative medicine enthusiasts in the US congress, and speedily rose in stature and funding largely because of its political appeal. In 1999, it became the National Center for Complementary and Alternative Medicine (NCCAM; nccam.nih.gov)—and, if NCCAM director Stephen Straus has his way, the centre ultimately will become a fully fledged “institute” of the National Institutes of Health (NIH). Straus notes that since he took over, soon after OAM became NCCAM, the number of grant applications increased 25-fold, and NCCAM “is funding one in six applications, probably the smallest percentage of any NIH institute or centre”. With a budget of about US$90 million (up from US$2 million at OAM’s inception and US$50 million for NCCAM’s first year), Straus has “quadrupled” the staff, developed a strategic plan, added intramural and international research components, and started working with industry to develop product standards. To “transition the field from anecdotes to evidence”, NCCAM is sponsoring “large, pivotal clinical trials” of agents such as St John’s wort for depression, glucosamine and chondroitin for osteoarthritis, and shark cartilage as adjunctive therapy for lung cancer—and “controversial therapies with mechanisms not known or understood, such as magnets, energy healing, and therapeutic touch and prayer” (see panel). Endocrinologist Marc Blackman, director of NCCAM’s new intramural research programme, shares Straus’ enthusiasm for the “exciting and very important, yet daunting task” of investigating alternative interventions. He will focus first on “biologically based therapies and mind-body interventions that might allay depression, cognitive decline, chronic pain, sleep disorders, and frailty, especially in the elderly”. But Saul Green, a retired cancer researcher (Sloan Kettering Institute,
T
New York, NY, USA), questions whether these goals can be met. “Each new [OAM/NCCAM] regime makes the same promise. They say the research that was done before was
Stephen Straus
incomplete, and they’re going to straighten it all out”, he says. “But the same thing always happens. The studies come out, mainly as reviews in alternative medicine publications, and they all end up saying either that the evidence is too weak for us to draw conclusions or the evidence is interesting and we need more research, so give us another grant. Meanwhile, practitioners who are doing coffee enemas and other worthless treatments get money year after year without having to produce results, and they can claim that NCCAM sees value in what they’re doing.” Medical quackery critic Stephen Barrett (www.quackwatch.com) adds that “the overall message that the office or centre has been sending since before it opened is that there’s really something here that the scientific community is overlooking, and if we study it, then we’re going to find out what it is. That message is nonsense.” What’s needed, he insists, is “some accountability in the form of a report that lists the amount of each grant, when it was given, when the research was concluded, and what the results were. Enough information should be given that a team of experts can rate the protocol design up front and then score the quality of the finished report.” Even though NCCAM is now funding “some serious research”, says Barrett, “I don’t think there is A peek at NCCAM-funded research any justification for Meditation’s effects on the US$712 467 its existence. The mechanisms of CHD premise was that Echinacea in children US$705 663 so-called alternaAcupuncture for dental pain US$680 306 tives were not Omega-3 fatty acids in prophylaxis getting sufficient aof bipolar disorder US$525 742 ttention from the Distance healing in glioblastoma US$202 596 research commutreatment nity because there’s Source: Fiscal year 2000 budget; http://nccam.nih.gov no money in it for
566
the drug companies. What congress could do is earmark a certain amount of NIH money for the study of nonpatentable agents and lifestyle interventions and let these things compete among themselves for funding, rather than having a separate centre.” Despite such criticism, NCCAM is unlikely to be dismantled any time soon. Studies are underway, but for established scientists such as rheumatologist Daniel Clegg (University of Utah, Salt Lake City, UT, USA), the work is not easy. Clegg was sceptical when asked to design “what was essentially a phase 3 trial of glucosamine and chondroitin with no previous safety studies, but some small efficacy studies that had deficiencies, but suggest possible efficacy”. He designed a 6 month, five-arm trial in which participants receive paracetamol as analgesic rescue and glucosamine alone, chondroitin alone, glucosamine and chondroitin together, or a cyclo-oxygenase 2 (COX-2) inhibitor alone. Studying glucosamine and chondroitin “legitimises” the agents, says Clegg, “but it is a very important question that if well done will be important, whether the outcome is positive or negative”. One hurdle was finding a manufacturer that could provide glucosamine and chondroitin that met US Food and Drug Administration requirements. This ultimately proved impossible, so the team is manufacturing the agents themselves under contract with the Department of Veterans Affairs Cooperative Study Program “to be sure to be sure the study is not fatally flawed from the start because of variation in the agents selected”, he says. “NCCAM is under enormous pressure to produce results. The centre wants to show where the [grant] money is going and be able to give a yes/no answer about whether a drug is helpful. This takes a huge amount of work that’s usually done by drug companies”, says Clegg. “The clock doesn’t appear to be running on them because their research and development occurs out of the public spotlight. However, with NCCAM, the clock is running from the minute that Congress approves the funds.” But despite the pressure, Clegg insists that “the studies have to be done rigorously or the answers will be just as fuzzy as they are now.” Marilynn Larkin
THE LANCET • Vol 358 • August 18, 2001
For personal use. Only reproduce with permission from The Lancet Publishing Group.
Alternative medicine centre aims for mainstream status he Office of Alternative Medicine (OAM) was founded in 1992 under pressure from alternative medicine enthusiasts in the US congress, and speedily rose in stature and funding largely because of its political appeal. In 1999, it became the National Center for Complementary and Alternative Medicine (NCCAM; nccam.nih.gov)—and, if NCCAM director Stephen Straus has his way, the centre ultimately will become a fully fledged “institute” of the National Institutes of Health (NIH). Straus notes that since he took over, soon after OAM became NCCAM, the number of grant applications increased 25-fold, and NCCAM “is funding one in six applications, probably the smallest percentage of any NIH institute or centre”. With a budget of about US$90 million (up from US$2 million at OAM’s inception and US$50 million for NCCAM’s first year), Straus has “quadrupled” the staff, developed a strategic plan, added intramural and international research components, and started working with industry to develop product standards. To “transition the field from anecdotes to evidence”, NCCAM is sponsoring “large, pivotal clinical trials” of agents such as St John’s wort for depression, glucosamine and chondroitin for osteoarthritis, and shark cartilage as adjunctive therapy for lung cancer—and “controversial therapies with mechanisms not known or understood, such as magnets, energy healing, and therapeutic touch and prayer” (see panel). Endocrinologist Marc Blackman, director of NCCAM’s new intramural research programme, shares Straus’ enthusiasm for the “exciting and very important, yet daunting task” of investigating alternative interventions. He will focus first on “biologically based therapies and mind-body interventions that might allay depression, cognitive decline, chronic pain, sleep disorders, and frailty, especially in the elderly”. But Saul Green, a retired cancer researcher (Sloan Kettering Institute,
T
New York, NY, USA), questions whether these goals can be met. “Each new [OAM/NCCAM] regime makes the same promise. They say the research that was done before was
Stephen Straus
incomplete, and they’re going to straighten it all out”, he says. “But the same thing always happens. The studies come out, mainly as reviews in alternative medicine publications, and they all end up saying either that the evidence is too weak for us to draw conclusions or the evidence is interesting and we need more research, so give us another grant. Meanwhile, practitioners who are doing coffee enemas and other worthless treatments get money year after year without having to produce results, and they can claim that NCCAM sees value in what they’re doing.” Medical quackery critic Stephen Barrett (www.quackwatch.com) adds that “the overall message that the office or centre has been sending since before it opened is that there’s really something here that the scientific community is overlooking, and if we study it, then we’re going to find out what it is. That message is nonsense.” What’s needed, he insists, is “some accountability in the form of a report that lists the amount of each grant, when it was given, when the research was concluded, and what the results were. Enough information should be given that a team of experts can rate the protocol design up front and then score the quality of the finished report.” Even though NCCAM is now funding “some serious research”, says Barrett, “I don’t think there is A peek at NCCAM-funded research any justification for Meditation’s effects on the US$712 467 its existence. The mechanisms of CHD premise was that Echinacea in children US$705 663 so-called alternaAcupuncture for dental pain US$680 306 tives were not Omega-3 fatty acids in prophylaxis getting sufficient aof bipolar disorder US$525 742 ttention from the Distance healing in glioblastoma US$202 596 research commutreatment nity because there’s Source: Fiscal year 2000 budget; http://nccam.nih.gov no money in it for
566
the drug companies. What congress could do is earmark a certain amount of NIH money for the study of nonpatentable agents and lifestyle interventions and let these things compete among themselves for funding, rather than having a separate centre.” Despite such criticism, NCCAM is unlikely to be dismantled any time soon. Studies are underway, but for established scientists such as rheumatologist Daniel Clegg (University of Utah, Salt Lake City, UT, USA), the work is not easy. Clegg was sceptical when asked to design “what was essentially a phase 3 trial of glucosamine and chondroitin with no previous safety studies, but some small efficacy studies that had deficiencies, but suggest possible efficacy”. He designed a 6 month, five-arm trial in which participants receive paracetamol as analgesic rescue and glucosamine alone, chondroitin alone, glucosamine and chondroitin together, or a cyclo-oxygenase 2 (COX-2) inhibitor alone. Studying glucosamine and chondroitin “legitimises” the agents, says Clegg, “but it is a very important question that if well done will be important, whether the outcome is positive or negative”. One hurdle was finding a manufacturer that could provide glucosamine and chondroitin that met US Food and Drug Administration requirements. This ultimately proved impossible, so the team is manufacturing the agents themselves under contract with the Department of Veterans Affairs Cooperative Study Program “to be sure to be sure the study is not fatally flawed from the start because of variation in the agents selected”, he says. “NCCAM is under enormous pressure to produce results. The centre wants to show where the [grant] money is going and be able to give a yes/no answer about whether a drug is helpful. This takes a huge amount of work that’s usually done by drug companies”, says Clegg. “The clock doesn’t appear to be running on them because their research and development occurs out of the public spotlight. However, with NCCAM, the clock is running from the minute that Congress approves the funds.” But despite the pressure, Clegg insists that “the studies have to be done rigorously or the answers will be just as fuzzy as they are now.” Marilynn Larkin
THE LANCET • Vol 358 • August 18, 2001
For personal use. Only reproduce with permission from The Lancet Publishing Group.