Cures or `Quackery'?
How Senator Harkin shaped federal research on alternative medicine
As Sen. Tom Harkin tells it, it was a personal experience that made him a real believer in "alternative" medicine--and, more to the point, in diverting several million dollars out of the National Institutes of Health research budget each year to look into unconventional therapies. A "guy from Arizona" who claimed that bee-pollen capsules could cure Harkin's allergies came to see him; Harkin swallowed 250 of the pills over the next five days; and, sure enough, he says, his allergies were gone. "Something has to be done to investigate these things," the Iowa Democrat told a 1993 Senate hearing, "because it sure worked for me."
Just a few months before his visit to the halls of Congress, however, the guy from Arizona, Royden Brown of the C C Pollen Co., paid a $200,000 settlement under a consent agreement with the Federal Trade Commission. He promised to cease making false claims for his High Desert bee-pollen capsules and misrepresenting as objective news programs what were paid television ads for his wares. Brown's infomercials claimed, among other things, that the company's bee-pollen capsules could cure heart disease, reverse the aging process, prevent memory loss, improve one's sex life, kill bacteria, promote weight loss, prevent premenstrual syndrome and provide "an energy source" for athletes who don't have time to work out. ("I stopped counting at 59 claims," says an FTC lawyer who handled the case.) The ads also asserted that both Ronald Reagan and "the risen Jesus Christ, when he came back to Earth," consumed bee pollen. Harkin says he became aware of the FTC complaint against Brown only a year later, in 1994.
Now hear this. The friend who introduced Harkin to Brown and whom Harkin credits with getting him interested in alternative medicine--fellow Iowan and former Democratic Rep. Berkeley Bedell--has been touting some even more dubious characters. Bedell claims he was cured of prostate cancer by Gaston Naessens, who, Bedell says, invented a special microscope that allows him to "look at blood samples and diagnose cancer well before a victim has any symptoms."
Naessens, who lives in Canada, was twice convicted of practicing medicine illegally in Europe in the 1950s and 1960s. The cancer "cure" he currently peddles, which he calls 714-X, was described by Canadian health authorities as consisting of camphor, mineral salts, alcohol and water; Canada has issued a warning against this product, deploring its use in treating cancer and AIDS and cautioning of side effects. 714-X is at least the third such "secret" formula Naessens has tried to pass off as a cancer cure, according to the American Cancer Society and the National Council Against Health Fraud (NCAHF), a nonprofit group that monitors questionable therapies. Naessens could not be reached for comment. (A footnote to this story: Bedell had received conventional treatment for his cancer before taking Naessens's "cure.")
All of this might simply be considered harmless wackiness were it not for the fact that the NIH Office of Alternative Medicine (OAM), which Harkin was instrumental in establishing in 1992, has been strongly influenced by a small group of advocates of outlandish therapies with whom Harkin has allied himself. As chairman (until last fall's election) of the Senate Appropriations subcommittee in charge of NIH's funding, Harkin used his power to shape the makeup of the OAM's advisory council and to push particular research areas, say current and former NIH officials.
Even strong proponents of the idea that NIH ought to be taking a serious look at promising alternative therapies, such as natural plant products for cancer treatment or acupuncture for pain relief, complain that the entire office has been tainted by what the OAM's former director, Dr. Joseph Jacobs, calls the "Harkin cronies."
Bedell is one of four members of the alternative-medicine office's 18-person advisory council who Jacobs says were appointed at the specific insistence of Harkin. Harkin's office flatly denies that he ever requested any appointments to the council, though Jacobs's boss at the time, NIH Deputy Director Ruth Kirchstein, says the senator did offer some "recommendations."
Jacobs says he also was repeatedly pressed by Harkin and his staff to fund pet interests of the "Harkinites"; in one instance, Jacobs says, a Harkin aide told him to issue a $200,000 grant to Brown to study bee pollen. The grant was never made, though the OAM did send a staffer to Arizona to conduct a "field investigation" of Brown's claims--which yielded "nothing conclusive," according to an NIH spokesman. (Harkin says the OAM initiated its investigation "separate and apart from my endorsements.")
"I don't think the Harkin cronies really represented the alternative-medical community or the patient community--I think they represented themselves and their own particular agenda," says Jacobs, who resigned as director of the OAM last August. Jacobs says he left because he was fed up with the political pressure; Kirchstein says the "office was floundering administratively."
Critics of the OAM complain that some advisory council members, including at least one of the Harkinites, have exploited the NIH name to peddle their wares. "It's really shameful," says Barrie Cassileth, a consulting professor of community and family medicine at Duke University, who describes herself as one of the few council members who are not "promoters" of one alternative therapy or another. "Proponents of unproven methods are using their affiliation with the OAM to give themselves some legitimacy and give the products they promote some legitimacy." William Jarvis, president of the NCAHF, is blunter: "It's the greatest public-relations victory for quackery."
Curious fund-raising. Frank Wiewel, one of the four advisory council members with Harkin ties, is one who critics complain has used his NIH affiliation in this manner. Wiewel runs an organization called People Against Cancer, based in Otho, Iowa. The group, which he describes as a "nonprofit, public benefit group dedicated to new directions to the war on cancer," has a curious approach to fund-raising, however. "We ask people to join us, and we become their advocate," he explains. For a $250-a-year "sustaining membership," the organization will fax a member's cancer diagnosis to a "group of doctors and researchers throughout the world," who will then suggest treatment alternatives. "The problem with conventional therapy is that radiation and chemotherapy are extremely dangerous and they don't make people live longer," Wiewel told this reporter when he called the People Against Cancer phone number posing as a relative of a cancer patient seeking information about alternative treatments. "We have a program set up to help people access options." ("He clearly doesn't know what he's talking about," replies Dr. Hugh Shingleton, vice president for cancer detection and treatment of the American Cancer Society. "Radiation therapy used properly for primary treatment of many cancers offers not only longer survival but cure in the majority of instances.")
In the course of the telephone conversation, Wiewel mentioned that he was on the OAM's advisory council. A packet of literature from Wiewel containing membership application forms mentioned his NIH affiliation in four separate places.
Kirchstein of NIH acknowledges there were concerns about the misuse of NIH's imprimatur by advisory council members, but she says that "we do not go out and police." Wiewel was, however, sent what one NIH official calls a "cautionary note" earlier this year reiterating NIH's policy forbidding any NIH advisory council member from using his affiliation to promote a product or service. Wiewel confirms receiving such a letter but says it was "more of a clarification letter." He says he has not been required to change any of his literature.
Wiewel, in his telephone sales pitch to a prospective member of his group, also asserted that NIH was studying a number of alternative cancer treatments, including "immunoaugmentative therapy," or IAT, an unapproved cancer cure banned after the Food and Drug Administration found that the injectable "therapy" was tainted with bacteria, hepatitis and HIV. Wiewel has promoted IAT in the past through a group called the IAT Patients' Association, which operated from the same post office box and telephone number as People Against Cancer. (A spokesman for NIH denies that the OAM has ever studied IAT.) Wiewel's organization still advertises a travel agency that can help cancer patients arrange trips to the Bahamas to obtain the IAT treatment.
Marketers of dubious treatments also have recently begun to refer to a massive report issued this spring by an earlier ad hoc advisory council to the OAM--which included many of the same people who now serve on the regular council. The report was an uncritical catalog of virtually every dubious and unproven treatment method of the past 100 years, from shark cartilage to treat arthritis and cancer to hypnosis as a way to increase breast size. The list of consultants brought in to produce the report included a number of promoters of questionable and even fraudulent treatments. In the latter category was Edward Sopcak, who in 1992 was found in contempt by a federal court for violating an injunction that barred him from selling "CanCell"--a potion he made in his kitchen from ingredients that included sulfuric and nitric acids and that he peddled as a cure for cancer, arthritis, diabetes and AIDS.
"Success rates." Part of the Harkinites' agenda has been to promote what they call "field investigations" or "outcomes research." "You go out and just simply find out whether what [someone] claims is correct or not. You check patients before they are treated; you check them after they are treated," Bedell told a Senate hearing. In an interview, he added that anyone who argued clinical trials were necessary was only going to "help more and more people to die."
Bedell, Wiewel and Ralph Moss, another council member identified as a Harkinite, have said that rather than award research grants, the OAM should visit alternative-medicine clinics and report on their "success rates." Moss, who edits a newsletter sent to members of People Against Cancer, was fired from Memorial Sloan-Kettering Cancer Center's public-affairs office in 1977 after he appeared at a press conference to denounce the hospital for supposedly covering up the benefits of laetrile, a discredited cancer cure. He could not be reached for comment.
Cassileth says she has tried in vain to point out at the advisory council meetings that clinical trials are the only way to know for sure if a treatment does anything. She points out three fundamental flaws in taking a clinic's apparent success rate at face value. First, many people who go to alternative clinics do not even have the disease for which they are being "treated." Second, "most people with serious illnesses who seek unproven methods have already received conventional care." Finally, most people who use unproven methods have minor problems such as temporary backaches, colds, allergies and headaches that will go away no matter what therapy, if any, is used. "Unless you compare people with the same problem who don't get the treatment, you never know" if the treatment actually is responsible for the patient's improvement, says Cassileth. "That's the comparison they're so afraid of."
Beyond all this, it also is not even clear that the OAM has fulfilled its charge of seriously evaluating promising alternatives. The office has awarded $4.8 million in grants to date; eight grants, totaling $1.9 million, were made with other NIH institutes to fund relatively straightforward clinical studies, but most of the grants--42 to date--have been made for "exploratory pilot projects" of $30,000 apiece. A review of the grants reveals many vague studies unlikely to yield conclusive results. A study of ayurvedic medicine, the traditional medicine of India, divided patients into three groups: One group received a one-time "risk assessment"; one received information on aerobic exercise, low-fat diets and relaxation; and the third received instruction on yoga, "primordial sound meditation" and ayurvedic dietary principles. The study is to follow the patients' cholesterol, blood pressure and general health status for a year. But with only 30 patients in each group, the study's director, Dr. David Simon of the Center for Mind-Body Medicine in San Diego, maintains that even if no significant differences emerge among the groups, that doesn't discredit ayurvedic medicine--it may just mean the sample size is too small.
"Pray-ers." Another one of the $30,000 studies seemingly unlikely to yield definitive results, conducted at the University of New Mexico, has looked at "intercessory prayer" to treat drug addiction. A group of "pray-ers" from the Albuquerque religious community agreed to pray for drug addicts in the experimental group at least once a week; the success rate of the prayed-for was to be compared with that of the not-prayed-for. (To safeguard patient confidentiality, the pray-ers were given only the first names of patients. But then to make sure the Almighty did not become confused as to which "Jim" was being referred to--the experimental-group Jim or the control-group Jim--the pray-ers were also provided with the patient identification numbers for the intended recipients of their prayers.) The principal investigator, Dr. Scott Walker, did not respond to requests for the results of this study.
Critics of the OAM are hopeful that with last November's election, the scheduled rotation of several of the Harkinites off the advisory council and the arrival on July 1 of a new director of the office, Dr. Wayne Jonas, a researcher at the Walter Reed Army Institute of Research, the office may yet get back on track. "I think it was something very well intended," says Jacobs, "but politicians and has-been politicians can't seem to leave well enough alone."
This story appears in the July 17, 1995 print edition of U.S. News & World Report.