SLOW PACE AT OAM
From The Cancer Chronicles #16
© August 1993 by Ralph W. Moss, Ph.D.
[In our opinion, the beginning of the end of Dr. Jacobs's tenure at OAM.
See also the actual dialogue between Sen. Harkin and Dr. Jacobs --Ed.]
A Senate subcommittee recently took a close look at the Office of Alternative
Medicine (OAM--and was not very happy with what it found. The Senate Appropriations
Subcommittee on Labor, Health and Human Services, chaired by Senator Tom
Harkin (D-IA), met on June 24, 1993, more than a year and a half after
it established and funded the office in October, 1991. An overflow crowd
in the Senate¼s Dirksen Room 192 heard nearly a dozen witnesses, including
the director of the office, Joseph J. Jacobs, M.D.
Legislators present included Sen. Barbara A. Mikulski (D-MD), who explained: "I sought out acupuncture when I faced health problems and Western medicine offered me only platitudes and pharmaceuticals," Sen. Slade Gorton (R-WA), who proclaimed that the "naturopathic movement is particularly successful in Washington state," Sen. Harry Reid (D-NV), who spoke of the openness of his state to alternative medicine, and Sen. Claiborne Pell (D-RI), a supporter of research into the mind-body link.
Sen. Harkin began the hearings with a fascinating anecdote about his own treatment for allergies. It was Harkin himself, of course, who was responsible for originally funding the office. In the first panel of the morning, Dr. David Eisenberg presented a multi-million dollar proposal to investigate alternatives at major medical schools, such as Harvard, where he teaches.
In the second panel, Charles Simone, MD of Lawrenceville, NJ presented dramatic results of three patients using shark cartilage, one of whom also appeared. Simone showed Harkin magnetic resonance images (MRIs) of the cancerous liver of one patient (taken at Memorial Sloan-Kettering), which had cleared of tumor after just a few weeks on cartilage.
Equally impressive was the testimony of Sharon Hermann and her son, 12-year-old Ryan Werthwein. Ms. Hermann told how Ryan¼s brain cancer melted away on Dr. S.R. Burzynski¼s antineoplastons (peptide treatment), after orthodox medicine failed. One would have to go back to the 1946 Pepper Hearings, when Max Gerson presented patients cured by dietary therapy, to find such an electrifying moment in U.S. history.
In the afternoon, the Hon. Berkley Bedell told how he had been forced to retire from Congress in 1987 by the effects of Lyme Disease. He was cured by a treatment consisting of a teaspoon of whey every 90 minutes, prepared on an Iowa farm. (Des Moines Register, 6/25/93).
Much of Bedell¼s talk focused on the role of the FDA. The whey treatment „will no longer be available because the producer is afraid of the FDA,¾ he said. When the developer requested permission to test this non-toxic product against herpes, the FDA responded with "ridiculous requirements that the company run a whole series of tests, which could take up to five years." This "absolutely kills the project," said Bedell. He added, ironically: "Little Miss Muffet is not available to testify that the curds and whey which she was eating are safe."
Finally, OAM Director Dr. Joe Jacobs testified, telling Harkin that public response to the OAM "has beenänothing less than phenomenal. We are in the midst of a tremendous change in the relationship between complementary and orthodox medicine." He called for an evaluation of complementary medicine "in a methodical, dispassionate manner, devoid of politics and bias."
Oddly, Jacobs seemed to credit the NIH itself, not Harkin, Bedell, or Congress, with creating the OAM "in response to increasing Congressional interest in alternative clinical practice." He warned that "important issues such as determining the scope of the assignment and determining the magnitude of the solutions need to be addressed prior to initiating a major initiative." After the first public meeting of the OAM in June, 1992 "the process was initiated to hire clinical investigators whose skills could address specific program areas of the alternative medicine community."
Later in the hearings, however, the actual lack of five investigators became a bone of contention between him and the Senator.
Jacobs called the emergence of alternative medicine "one of multiple revolutions" facing U.S. medicine. But the other 'revolutions' were not familiar to many observers from the alternative side. They included the "recognition of the importance of primary care;" the recognition of "small area variations;" "an imperative to manage re-source consumption by physicians and other providers"; and "emergence of 'mid-level' practitioners."
Jacobs claimed that "the Office is effectively able to avoid controversy" by making sure that it always complies with "existing regulations governing informed consent and peer review." One goal of the OAM, said the Director, was to "provide technical assistance to the alternative medicine community." This can range from help in "filling out an application for funding from the NIH to developing sound research methodologies for good clinical trials."
Other OAM functions are to serve as "a clearinghouse for information related to alternative medicine as well as information dissemination about the activities of the Office." The OAM also should serve "as a broker between the alternative medical community and the orthodox medical community." This means that the OAM should convince the various Institutes of the NIH to include alternatives in their well-funded protocols.
The reason for turning to the Institutes [such as NCI, which have historically been quite hostile to alternative therapies, ed.] is that these establishments "have larger budgets and staff to execute these types of trials.
"Equally important," the Dartmouth-trained pediatrician said, "observed positive results appear more credible when an alternative therapy is included as part of a larger clinical trial."
One major activity of the OAM was to put out Requests for Applications (RFAs) on March 26. This was done because "the primary method of supporting research by the NIH is through the grant-making process." Each grant is for a maximum of $30,000, which is generally agreed to be not enough money to generate any significant findings. However, Jacobs said the benefit of the RFAs was to "encourage the collaboration between alternative medical practitioners and health care institutions"; they are basically support for "pilot projects." As critics feared, the tiny OAM has now been inundated by requests for money: 800 "letters of intent" and 500 applications for these funds, so far.
Jacobs concluded that "the future looks very bright for alternative medicine." In fact, his main fear for the OAM, he said, "is the tremendous expectations placed upon it." His intention of "holding on to the middle ground," he said, "will surely advance the cause for advocates of complementary medicine."
Since, in his view, the office by itself cannot meet the expectations put upon it, "we must include the cooperation of the rest of the NIH, the other agencies of the Public Health Service, other departments of the Federal government and the conventional medical educational institutions of the Nation, working with the alternative medicine community."
Dr. Jacobs declared himself "awestruck by the sincerity of the support," especially from conventional medicine. His support from Senator Harkin, however, may be less than awesome. Harkin interrogated Jacobs closely on two important issues:
What happened to the $750,000 which OAM gave to NCI to buy and evaluate Dr. Burzynski¼s antineoplastons?
And why hasn¼t the OAM hired the five scientific evaluators that Sens. Harkin
and Specter requested back in January, 1992?
In the end, the Senator told Jacobs that he intended to call new hearings
in September, to check on the progress of the office. Jacobs was given
three months to make some concrete progress on the evaluation of actual
alternatives --or, as Harkin put it in his low-keyed but determined
way, "you will hear from me."
See also the dialogue between Senator
Harkin and Joe Jacobs.
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