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shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act." Section 902(c) of the Federal Food, Drug, and Cosmetic Act contains a comparable statement with respect to its effect on the Public Health Service Act. Biological products and the manufacturers of such products are therefore subject to both section 351 of the Public Health Service Act and the human drug provisions of the Federal Food, Drug, and Cosmetic Act.
Responsibility for the enforcement of these statutory provisions is vested by law in the Secretary of Health, Education, and Welfare. With respect to section 351 of the Public Health Service Act, this authority, except for the revocation of licenses, has been delegated to the Assistant Secretary for Health and Scientific Affairs, who in turn has made a delegation to the Director, National Institutes of Health. The Secretary's authority over biological products pursuant to the Fed. eral Food, Drug, and Cosmetic Act has contemporaneously with this memorandum been delegated concurrently to the Commissioner of Food and Drugs and to the Director, National Institutes of Health.
Purpose. The purpose of this Memorandum of Understanding is to establish the Department's policy to be followed by FDA and DBS concerning authority to enforce provisions of the Federal Food, Drug, and Cosmetic Act with respect to biological products which will foster the utmost public protection.
Agreement. It is agreed by both agencies that:
1. DBS, in addition to establishing standards designed to insure the continued safety, purity and potency of biological products pursuant to section 351 of the Public Health Service Act, has primary responsibility for enforcing all applicable provisions of the Federal Food, Drug, and Cosmetic Act with respect to a biological product, except for sections 302 and 304 of that Act.
2. In emergency situations involving protection of the public against a biological product which may be dangerous to life or health that cannot adequately be handled through section 351, DBS will request FDA to take appropriate enforcement action to remove the product from the market.
3. FDA will not enforce any provisions of the Federal Food, Drug and Cosmetic Act with respect to a biological product unless requested to do so by DBS.
4. If either agency, through inspection or otherwise, becomes aware of any information which indicates that a drug subject to the jurisdiction of the other agency may be in violation of the law, it will report that information to the other agency.
5. Any complaints or reports received by either agency with respect to a drug subject to the jurisdiction of the other agency will be reported to that agency.
6. All regulations promulgated by FDA under the provisions of the Federal Food, Drug, and Cosmetic Act with respect to all human drugs will be applicable to biological products. Regulations issued under the authority of the Federal Food, Drug and Cosmetic Act pertaining only to human drugs which are biological products will be promulgated by DBS after approval of FDA.
7. DBS and FDA will each appoint one liaison representative and one alternate to facilitate carrying out the above provisions. Dated: February 18, 1972.
CHARLES C. EDWARDS,
Commissioner of Food and Drugs. Dated: February 18, 1972.
ROBERT Q. MARSTON,
Director, National Institutes of Health. [FR Doc. 72-2769 Filed 2-24-72; 8:49 a.m.)
(Reprinted from Ramparts)
Most people in the United States take immunizing vaccines as a matter of course. Recently, however, doctors have begun raising questions as to whether in some cases vaccines are not as dangerous as the diseases they purport to prevent. Influenza vaccine, among the more suspect, is now under investigation by Senator Abraham Ribicoff's Subcommittee on Executive Reorganization and Government
Research. In addition, doctors at the National Institutes of Health’s Division of Biologics Standards, which licenses drugs for release to the public, are seeking to limit the vaccine's distribution pending more conclusive determination of its worth.
Flu vaccine was first prepared just before 1940 and is now widely manufactured and distributed. As early as 1944, however, clinical studies had begun to indicate that the vaccine might not result in reduced susceptibility to flu virus infection. In that year, one group of volunteers tested the vaccine by inhaling flu virus in a laboratory experiment. thereby contracting the disease. One third of those people became ill with flu again within four months. Many other experiments have been conducted showing that flu can be acquired twice within one year. If the disease itself does not confer immunity on those who contract it, no vaccine can give such protection.
Many scientists believe flu vaccine has little immunizing value, since it does not produce antibodies in the specific organs which influenza attacks. Furthermore, the vaccine might be dangerous. It contains antigens which, when injected into humans, induce the formation of specific anti-bodies directed against that antigen. Tests suggest that in pregnant women this can result in fetal damage. Although pregnant women are not now advised to take flu vaccine, they were not warned of its dangers in the past.
The vaccine's drawbacks have been suspected for almost 30 years; yet attempts to publicize them often have been suppressed. An epidemiologist at the National Communicable Disease Center in Atlanta published his reservations concerning the vaccine in 1964 and was severely criticized by the medical community for doing so. Administrative officers at NIH's Division of Biologics Standards (ĎBS) were first notified of the drug's limitations and possible dangers in 1963 but claimed there was not enough evidence to take action. By 1966, doctors at the DBS had produced clearer evidence against the vaccine's efficacy, but when one of these men, Dr. J. Anthony Morris, brought his documentation to the attention of the Division's Director, Roderick Murray, he was relieved of all activities concerning further research into the vaccine. Dr. Murray removed all Dr. Morris'e records, sera, viruses, and books concerning flu vaccine. According to Dr. Morris, Murray sought to prevent his efforts to publish his research, and delayed for over three years the appearance of Morris' findings in scientific literature. He also blocked efforts to begin collaborative studies among scientists at NIH, other government agencies, and universities aimed at improving the vaccine. Finally, Dr. Morris turned to James Turner, a public interest lawyer who is representing him in a Civil Service grievance proceeding which has broadened into a government examination of the Division of Biologics Standards. The Division is under investigation not only by Senator Ribicoff's Subcommittee, but also by the General Accounting Office, by a committee of outside advisors to DBS, and by an NIH management group. Alexis Shelokov, the DBS official in charge of flu vaccine from 1963 until 1968, who did nothing during that time to prevent wide public distribution of the vaccine, testified before the DBS grievance committee, "for many years, I have not taken influenza vaccine myself or given it to my family * * * I am not satisfied with its potency."
Other vaccines are also being called into question. Smallpox vaccine was once invaluable, but many scientists assert that smallpox has now been eradicated throughout most of the world. They say there is more danger now of people contracting a serious virus infection from the vaccine than of their contracting smallpox. Cholera vaccine is virtually useless. Rather than preventing the disease, it suppresses it, allowing people to carry cholera in their blood and excrete cholera bacteria, thus spreading it. Many doctors say a far more effective way of fighting cholera is to replace the salty fluids that cholera victims have lost. Last year, the US Surgeon General announced, “There is clear evidence that cholera vaccine is of little use in preventing spread of cholera * * * the only effective method for preventing the spread of the disease is improvement of environmental sanitation.” Yet numerous medical professionals still do not acknowledge or advise their patients of the vaccine's drawbacks. The current cholera epidemics in Egypt and in India are being fought with the vaccine.
Pertussis (whooping cough) vaccine, given to infants, is a necessary vaccination, but it can cause brain damage in some percentage of the infants who receive it. Acer
to a study in the British journal, Medical Officer, 23 infants suffer brain
f every 1000 vaccinated. In the worst cases, infants suffer severe, ige. More often, they simply develop temporary fever, twitching ely minor disturbances. Some physicians charge that these
reactions could be prevented if a more concerted effort were made to purify the vaccine. They assert that experiments on methods of purification were stymied at NIH for years. NIH officials, however, deny the charge.
(From the Congressional Record, Oct. 20, 1971)
GAO REPORT ON TUBERCULOSIS DRUG Mr. RIBICOFF. Mr. President, the results of a GAO investigation I am releasing today reveal that the Federal Food and Drug Administration and the Public Health Service's Center for Disease Control have failed to supervise properly the development and use of isoniazid, a drug for treating and preventing tuberculosis. As a result, several patients have died and the health of numerous others have been threatened. In addition, this study raises serious questions about the adequacy of Federal programs for the use of investigational drugs. Since 1952, doctors have used isoniazid to treat patients who have tuberculosis. Isoniazid has also been given, since 1955, to people who do not yet have tuberculosis to help prevent its onset.
Early in 1970 several cases of tuberculosis were discovered among workers in congressional cafeterias and restaurants. The Communicable Disease CenterCDC—is part of the Public Health Service in the Department of Health, Educa. tion, and Welfare. As part of its responsibility to treat and prevent communicable diseases, the CDC decided to undertake a preventive isoniazid program among congressional employees. Skin tests were given. Those with positive results were given isoniazid in 300-milligram tablets even though very few of those who show positive results on the skin test actually have tuberculosis. Statistics show, in fact, that only one out of every 1,400 people who has a positive reaction actually has this disease.
The Capitol Hill program was a disaster. More than twenty persons treated with isoniazid developed hepatitis. Two of those treated, Timothy Bleck, a reporter for the St. Louis Post-Dispatch, and Robert Stuckey, a television newsman, died of hepatitis after taking isoniazid.
As a result of this incident, I asked the GAO to investigate the manner in which the 300-milligram isoniazid tablet was developed. They found a shocking example of neglect, a total and knowing failure by Federal agencies to abide by legal requirements and a permissive attitude about the use of people as the subjects for medical experiments.
According to the GAO, isoniazid was originally given to patients three times a day in 100-milligram tablets. Doctors at the Communicable Disease Center, searching for an easier way to administer the drug, began to have patients swallow the three 100-milligram tablets all at once every day.
The Public Health Service doctors next sought to develop a single 300-milligram tablet that could be used in preventive programs. In order to experiment on people with a 300-milligram tablet the doctors needed an FDA exemption for the investigational use of this drug on human beings. The FDA exemption was required regardless of the fact that the smaller 100-milligram tablet was already in use. When the dosage of a drug is increased, FDA regulations treat the larger dosage as a new drug and require separate approval.
In November 1964, officials at the Communicable Disease Center-CDCasked for permission to start investigational use of a 300-milligram tablet. The FDA informed the CDC what information would be required before experi. mental use of the drug on people could begin, including all available data de rived from animal tests as well as from clinical studies and experience with the drug. An outline of the planned investigation was also required.
CDC supplied virtually none of this required information to the FDA. Instead, CDC doctors started an accelerated experimental program on a wide range of human subjects-over 6,000 people—between 1964 and 1970.
FDA regulations divide investigational testing procedures into three phases. Phase 1 covers the first trial in man to determine human toxicity and other reactions. Phase 2 covers pharmacological trials on a limited number of patients for purposes of specific disease control. Finally, the investigators may move to phase 3 where the drug is used on a group of patients to evaluate the drug's safety and effectiveness.
Contrary to those established procedures, CDC skipped the first two phases altogether and moved immediately to tests on groups of patients. FDA never knew what happened to the 6,000 people CDC was experimenting with-even though the agency is required by law to evaluate the results of all testing programs—because CDC never told the FDA anything about its results. This failure is all the more disturbing in view of the fact that on two occasions the FDA requested such information and the CDC promised to supply it.
The FDA's own records contain ample evidence that the agency was fully aware of the inadequacies of the data CDA had submitted. For example, an FDA chemist's evaluation dated December 28, 1970_more than 6 years after CDC had started investigational use of the 300-milligram tablet and more than a month after Bleck and Stuckey had died-contained the following evaluation :
Stability-unsatisfactory. Even with this report, FDA had not moved either to obtain the missing information from CDC or to stop the investigational programs.
The FDA Division Director told GAO investigators that the FDA had been unable to give appropriate attention to the isoniazid application at the time of the CDC request for exemption in 1964 because of the heavy work load resulting from the 1962 drug amendments. No reason was given to explain why the FDA had still not collected the required information more than 6 years later.
FDA officials also stated to the GAO that the failure of CDC to submit the data amounted only to a "technical violation.” Even if there had been reports to the FDA of hepatitis or jaundice in experimental programs, the FDA officials said they would not have been concerned because hepatitis and jaundice were well-known dangers even in small doses and could be expected to occur at least as frequently with the experimental larger tablet. Apparently, the greater the likelihood of danger, the less the FDA was concerned with protecting the public.
Even the FDA's negligence is exceeded, however, by the CDC's disregard for the human subjects of its medical experiments. As noted, the CDC ignored its statutory obligations and disregarded the FDA's requests for information about its treatment programs. Had it reported on those treatment programs, it would have had to admit that, even before the Capitol Hill test, two patients treated with the 300-milligram tablet had died of hepatitis.
Perhaps most surprising, however, was the manner in which CDC conducted the Capitol Hill program. Many persons who were given the drug were told by CDC doctors there would be no side effects. One patient remembers a CDC official describing the drug with the phrase, “as safe as aspirin.” Another patient described an orientation session at which a CDC doctor refused to answer questions about side effects, stating if he described them then “everyone might come down with them."
Attempts to monitor results were haphazard and inept to the extent they existed at all. CDC officials seem to have behaved as if they were unaware that they were dealing with a potentially dangerous drug.
Throughout the program, the rights of the patient were ignored. A patient who actuallly has tuberculosis may be willing to run certain risks of side effects from a drug which can help cure him. But a patient who merely has a positive reaction to a test which only establishes that he has 1 chance in 1,400 of actually having tuberculosis may well decide that the risks of using the same drug may be excessive. At the very least, a patient should know what risks he is running and be able to make this choice.
The FDA and the CDC have committed appalling mistakes in the use and the regulation of isoniazid. I am concerned that what we have discovered about isoniazid may be only the tip of a massive iceberg of bureaucratic neglect. I am therefore asking the GAO to undertake a comprehensive investigation of all drugs approved by the FDA for investigational use, with special attention to be given to drugs approved for such use in 1964 and 1965.
We urgently need to test and develop new drugs. At the same time, there is an equally pressing need to be sure that drugs used on human beings-especially investigational drugs—are safe. The fact that a drug is approved only for investigational use is no assurance that it is not being widely distributed and used.
Those taking an investigational drug have a right to be protected; they are not rats in an experimental lab. We have to depend for much of this protection on Federal agencies charged with that task. The very least we can ask of these agencies is that they observe the regulations they themselves have established.
AMERICAN MEDICAL ASSOCIATION,
May 4, 1972. Hon. ABRAHAM A. RibicoFF, Chairman, Committee on Government Operations, Subcommittee on Executive Reor
ganization and Government Research, U.S. Senate, Washington, D.C. DEAR SENATOR RibicoFF: Pending before your Committee is S. 3419, the "Consumer Safety Act of 1972," which among other provisions, establishes an independent Consumer Safety Agency that would assume many of the present responsibilities of the Food and Drug Administration.
The AMA's Council on Drugs will be meeting on May 5, at which time it has scheduled consideration of S. 3419. The following weekend, May 12-14, the AMA Council on Legislation will meet and also consider this bill. In attendance at the latter meeting will be representatives from many of the major medical specialty societies.
Because this legislation is of major significance, we would like to be able to submit our recommendations to you after these Councils have reviewed this bill. In this way we believe we can be most helpful to the Committee in its consideration of this legislation.
Accordingly, we will appreciate an opportunity to comment on this legislation following the meetings of our Councils, and respectfully request that our comments be included in the record of the hearings on S. 3419. Thank you for your consideration of this request. Sincerely,
ERNEST B. HOWARD, M.D.
AMERICAN MEDICAL ASSOCIATION,
Chicago, I., May 19, 1972. Hon. John L. MCCLELLAN, Chairman, Government Operations Committee, U.S. Senate, Washington, D.C.
DEAR SENATOR MCCLELLAN : We would like to take this opportunity to express the views of the American Medical Association regarding S. 3419, the Consumer Safety Act of 1972, which is now pending before your Committee.
This bill would create a new independent Agency, within the Executive Branch, charged with protecting consumers against accidental harm from consumer products. Three Commissions (a Commission of Foods and Nutrition, a Commission of Drugs, and a Commission of Product Safety) would function under the general supervision of the Agency Administrator. Functions of the Food and Drug Administration would be transferred to the new Agency.
One of the important effects of S. 3419 would be the elimination of the Food and Drug Administration, and the removal from the Department of Health, Education, and Welfare of FDA activities, including its present regulatory authority over drugs. The American Medical Association does not believe that the proposed transfer of drug evaluation and regulation represents a sound course of action. We would urge your Committee to reject any proposal which would isolate the testing, evaluation and regulation of drugs from the Department of government bearing the principal responsibility for the health of our people.
We are concerned that in any agency oriented primarily toward consumer and product safety the therapeutic benefits resulting from risk-bearing drugs may not be given appropriate recognition. Pharmaceuticals are unique and should not be described as "consumer products" within the common understanding of that term. Ideally all products reaching consumers should be safe. But, by their nature, all drugs carry some risk, and they all have the potential for misuse and abuse. The risks of administration for therapeutic purposes must always be balanced with the need, a judgment to be made by the physician. The entire process of developing, evaluating, and prescribing of medication is a continuing exercise