definitive (so-called Phase III) study proving that the product is safe and that it works. For example, two rotavirus vaccines are distributed in the United States (Iâm the co-inventor of one of them). These vaccines prevent a common cause of diarrhea and dehydration in infants. Before the existence of a rotavirus vaccine, about70,000 children in the United States were hospitalized with dehydration caused by rotavirus every year; in the developing world, rotavirus killed 2,000 children every day.
Making a rotavirus vaccine wasnât easy. The Phase III trial for one rotavirus vaccine, RotaTeq, included more than 70,000 children from eleven countries, tested for four years at a cost of about $350 million. If stacked one on top of another, patientsâ records from that trial would have exceeded the height of the Sears Tower in Chicago. The FDA and EMEA allowed the manufacturer of RotaTeq to make claims about safety and effectiveness only after those claims had been supported by rigorous scientific studies; otherwise, it wouldnât have licensed the product.
The situation for plants, herbs, and dietary supplements is different. Because of the Supplement Act, the FDA doesnât regulate them, so they donât have to be tested before theyâre sold. Sometimes supplements are tested by the National Center for Complementary and Alternative Medicine (NCCAM), a branch of the National Institutes of Health. One difference between the FDA and NCCAM is that the FDA requires products to be tested
before
theyâre sold, whereas NCCAM might test some products after theyâve been put on the market. If researchers funded by NCCAM find that dietary supplements donât work or have harmful side effects, they publish their results in scientific journals. No product recall. No change in the label. No FDA warnings. If people donât read scientific journals, they wonât know that claims on the label are false and misleading.
T he driving force behind the creation of NCCAM was Tom Harkin, a popular senator from Iowa who believed his allergies had been cured by eating bee pollen. Harkin figured that the only reason alternative remedies hadnât been brought into the mainstream was that they hadnât been properly tested. Once they were tested and everyone could see that they really worked, alternative medicine would be embraced by modern science and paid for by insurance companies. Since its birth, in 1999, NCCAM officials have spent about $1.6 billion studying alternative therapies. Theyâve spent $374,000 of taxpayer money to find out that inhaling lemon and lavender scents doesnât promote wound healing; $390,000 to find out that ancient Indian remedies donât control Type 2 diabetes; $446,000 to find that magnetic mattresses donât treat arthritis; $283,000 to discover that magnets donât treat migraine headaches; $406,000 to determine that coffee enemas donât cure pancreatic cancer; and $1.8 million to find out that prayer doesnât cure AIDS or brain tumors or improve healing after breast reconstruction surgery. Fortunately, NCCAM has recently abandoned these kinds of studies, choosing instead to focus on studies of dietary supplements and pain relief.
L etâs assume for a moment that everyone wants whatâs best for the patient. Alternative healers believe that ancient medicine is of value. And mainstream doctors and pharmaceutical companies believe that modern science has the most to offer. Peter Medawar, a Nobel Prizeâwinning immunologist, calls the battle for recognition by those who promote various remedies a âkindly conspiracy.â âExaggerated claims for the efficacyof a [therapy] are very seldom the consequence of any intention to deceive,â he writes. âThey are usually the outcome of a kindly conspiracy in which everybody has the best intentions. The patient wants to get well, his physician wants to have made him better, and the
Making a rotavirus vaccine wasnât easy. The Phase III trial for one rotavirus vaccine, RotaTeq, included more than 70,000 children from eleven countries, tested for four years at a cost of about $350 million. If stacked one on top of another, patientsâ records from that trial would have exceeded the height of the Sears Tower in Chicago. The FDA and EMEA allowed the manufacturer of RotaTeq to make claims about safety and effectiveness only after those claims had been supported by rigorous scientific studies; otherwise, it wouldnât have licensed the product.
The situation for plants, herbs, and dietary supplements is different. Because of the Supplement Act, the FDA doesnât regulate them, so they donât have to be tested before theyâre sold. Sometimes supplements are tested by the National Center for Complementary and Alternative Medicine (NCCAM), a branch of the National Institutes of Health. One difference between the FDA and NCCAM is that the FDA requires products to be tested
before
theyâre sold, whereas NCCAM might test some products after theyâve been put on the market. If researchers funded by NCCAM find that dietary supplements donât work or have harmful side effects, they publish their results in scientific journals. No product recall. No change in the label. No FDA warnings. If people donât read scientific journals, they wonât know that claims on the label are false and misleading.
T he driving force behind the creation of NCCAM was Tom Harkin, a popular senator from Iowa who believed his allergies had been cured by eating bee pollen. Harkin figured that the only reason alternative remedies hadnât been brought into the mainstream was that they hadnât been properly tested. Once they were tested and everyone could see that they really worked, alternative medicine would be embraced by modern science and paid for by insurance companies. Since its birth, in 1999, NCCAM officials have spent about $1.6 billion studying alternative therapies. Theyâve spent $374,000 of taxpayer money to find out that inhaling lemon and lavender scents doesnât promote wound healing; $390,000 to find out that ancient Indian remedies donât control Type 2 diabetes; $446,000 to find that magnetic mattresses donât treat arthritis; $283,000 to discover that magnets donât treat migraine headaches; $406,000 to determine that coffee enemas donât cure pancreatic cancer; and $1.8 million to find out that prayer doesnât cure AIDS or brain tumors or improve healing after breast reconstruction surgery. Fortunately, NCCAM has recently abandoned these kinds of studies, choosing instead to focus on studies of dietary supplements and pain relief.
L etâs assume for a moment that everyone wants whatâs best for the patient. Alternative healers believe that ancient medicine is of value. And mainstream doctors and pharmaceutical companies believe that modern science has the most to offer. Peter Medawar, a Nobel Prizeâwinning immunologist, calls the battle for recognition by those who promote various remedies a âkindly conspiracy.â âExaggerated claims for the efficacyof a [therapy] are very seldom the consequence of any intention to deceive,â he writes. âThey are usually the outcome of a kindly conspiracy in which everybody has the best intentions. The patient wants to get well, his physician wants to have made him better, and the
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