The Helsinki Declaration

To some the story of the inexpensive, effective and safe anticancer drug hydrazine sulfate and its suppression by the National Cancer Institute (NCI)--this country's top federal cancer agency--presented in this blog-series, may remind one of the "legendary carburetor" of the 1940s and 1950s, which reportedly got 100 miles to the gallon but which the Detroit automobile manufacturers were burying because of the interests of the oil companies. Is hydrazine sulfate in the same boat as the magic carburetor--that it is as ineffective as the carburetor is non-existent, as the NCI and the auto makers affirm? Or is hydrazine sulfate different--that it is a remarkably effective, safe and extremely inexpensive drug, which is being put down by the NCI only in the interest of the pharmaceutical companies? "Yeah...sure." The Helsinki Declaration presents continuing evidence that in the case of hydrazine sulfate, the drug is real, the controlled clinical trials that have demonstrated its safety and effectiveness are real, and the NCI's power to suppress or approve any medication it wishes--over and above the authority of the Helsinki Declaration--is real.

How many of you have heard of the Helsinki Declaration? Sounds like an international treaty, you might think. Well it is...something like the Geneva Convention. But unlike the Geneva Convention, which is largely ineffective, the Helsinki Declaration, pertaining to the safe and allowable conduct of medical studies involving human beings, is extremely effective and underlies all experimental human research. The Declaration in fact requires all published human studies to state: "This study was conducted in conformity to the Helsinki Declaration."

The Helsinki Declaration is a multinational ratification of principles governing human biomedical research studies, first adopted by the World Medical Assembly, in Helsinki, Finland, June 1964, and thereupon amended by this organization in 1975, 1983 and 1989. This document, to which the United States is a principal signatory, lies at the very heart of internationally accepted standards for biomedical research.

The Declaration, an outgrowth of the Nuremberg Trials (Doctors Trial) following World War II which uncovered in detail the hideous human medical "experiments" inflicted on helpless human beings by the Nazis, was put in place to guarantee that no harmful procedures be used in patients undergoing experimental medical treatment--and is at the very core of all clinical trials and informed consent.

Principle 1 of this Declaration affirms: "Biomedical research involving human subjects must conform to generally accepted scientific principles and...[be] based on a thorough knowledge of the scientific literature." Perhaps most important of generally accepted scientific principles in the conduct of human biomedical research is that no incompatible agents (medications) be used in a drug trial. Why? Because such use can result in the grave illness--or death--of a patient, as well as can cause a negative drug study. For this reason use of an incompatible agent--or one even suspected of incompatibility--is virtually unknown in human biomedical testing.

Principle 1 of the Helsinki Declaration also requires experimental studies to be based on a "thorough knowledge of the scientific literature." In the case of NCI's sponsoring of the hydrazine sulfate studies, is it possible that the NCI did not know hydrazine sulfate was an MAO inhibitor, as so described throughout the medical literature? Is it possible that the scientists responsible for the hydrazine sulfate sponsored studies were not conversant with even the most basic pharmacology textbooks, which for three decades prior to these studies had indicated hydrazine sulfate to be an "irreversible"--powerful--MAO inhibitor? Is it possible that the sponsors of these studies--administrators and scientists--were unfamiliar with the multiple warnings throughout the scientific literature that use of tranquilizers, barbiturates and alcohol was incompatible with MAO inhibitors such as hydrazine sulfate and would result in "sicker patients" and negative studies? The NCI's PDQ publication of October 25, 1999, suggests that NCI was well aware hydrazine sulfate was an MAO inhibitor.

In view of the Helsinki Declaration's prohibition of biomedical studies not in conformity with internationally accepted standards, why did NCI use incompatible agents with a test drug in the sponsored trials of hydrazine sulfate? As indicated in our previous blog, only two reasons underlie such usage: incompetence and deliberateness.

Given the level of scientific expertise available to the NCI, it is hardly likely that NCI did not know hydrazine sulfate was an MAO inhibitor and therefore that incompetence was the reason for NCI's going ahead with its sponsored studies. Was it deliberateness? Knowing full well an incompatible agent in the presence of a test drug acts to produce a negative study, did NCI have reason to deliberately go ahead with its sponsored studies? NCI's twenty-five-year-long adversarial orientation--if not antipathy--to hydrazine sulfate ("We throw away better drugs than hydrazine sulfate"), may well speak to this question.

But NCI's violation of the Helsinki Declaration was not limited solely to Principle 1. Principle 8 of the Declaration states: "Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication." Principle 8 specifies that the NCI-sponsored studies--in their failure to conform to Principle 1 (accepted scientific standards)--should never have been presented for publication in the first place, no less arranged by NCI for sequential publication in the same journal issue (Journal of Clinical Oncology, June 1994). NCI further violated Principle 8 by publishing the results of its studies on the Internet for the public --while at the same time juxtaposing to them false statements on hydrazine sulfate: "There is only limited evidence from animal studies [i.e., no human studies] that hydrazine sulfate has anticancer activity....Hydrazine sulfate has shown no anticancer activity in randomized clinical trials [the "gold-standard" of clinical trials]." (Whereas the truth was that up to the time of the NCI Internet publication, there were ten controlled human studies published in the peer-reviewed medical literature, all known to the NCI since 1975, all showing anticancer activity; and of five Harbor-UCLA studies published in the peer-reviewed medical literature, four were randomized clinical trials, all showing anticancer activity and all known to the NCI.)

The Helsinki Declaration is the international standard for the performance and acceptance of human experimental biomedical research. It has been ratified literally by all nations which participate in human clinical testing, including the United States.

However, in its sponsored studies of hydrazine sulfate the NCI seems to have lost sight of the Helsinki Declaration, of the fact that the United States was a sponsoring signatory to this Declaration, and that this Declaration in regard to human biomedical experimental research is the international "law of the land." This Declaration in fact requires all published human biomedical research to contain a statement of compliance with principles enunciated in the Declaration. But nowhere in the research protocols or in the published NCI-sponsored trials of hydrazine sulfate is there such a statement.

The Helsinki Declaration asserts that by virtue of use of an incompatible medication in the presence of a test drug, a study is in violation of internationally accepted standards of medical conduct. The Helsinki Declaration states that the NCI studies, in violation of Principle 1 and Principle 8, thus have no ethical, scientific or legal standing among the international medical community, that in effect the NCI had no ethical or scientific right to engage in its sponsored studies of hydrazine sulfate as performed, or be a party to their publication.

By NCI's ongoing Internet publication and publicity of the results of its non-conformant hydrazine sulfate studies, by its lack of compliance with Helsinki Declaration directives in these studies, NCI on its part indicates that it can defy any international agreement which this country endorses--to which the United States has given its name--that when it is in its interests, NCI alone is the 'law of the land.'