May 24, 2000

Fines Proposed for Violations of Human Research Rules
By SHERYL GAY STOLBERG

WASHINGTON, May 23 -- Responding to widely publicized lapses in medical experiments, the Clinton administration announced today that it would seek authority from Congress to levy fines of up to $250,000 on scientists who violate federal rules for human research and $1 million on the universities that employ them. 

The proposed fines are part of a broad plan, unveiled this morning by Donna E. Shalala, the secretary of health and human services, to better protect the thousands of patients who each year volunteer for medical experiments, including tests of new drugs and cutting-edge treatments like gene therapy. It comes two days before officials are to testify at a Senate hearing on patient safety. 

Under the plan, which President Clinton described today as "a critical first step" toward improving patient safety, the government will require bioethics training for clinical researchers and will lay down clear conflict-of-interest guidelines for doctors who have financial stakes in their studies. 

There will be new requirements for monitoring small clinical experiments, which are not subjected to the same intense regulatory scrutiny as larger studies. And, Dr. Shalala said, research institutions will now be required to audit records for proof that patients have truly given their "informed consent" to participate. 

"This is a clear message that we intend to get serious," Dr. Shalala said. Saying she is concerned about maintaining public confidence in medical research, she added, "We have to make sure that the entire enterprise is rigorous and has enormous integrity." 

With the exception of the move to assess fines, which requires Congressional action, Dr. Shalala said the initiatives outlined today would take effect immediately. Her announcement brought praise from Dr. Nils Hasselmo, president of the American Association of Universities, who called it a "constructive action." 

But punishing scientists with fines is bound to be controversial, and may face trouble on Capitol Hill. Senator Bill Frist, the Tennessee Republican who has been leading a Congressional examination of federal research protections, said today that the idea struck him as "somewhat premature." And it provoked a strong reaction in some academic quarters. 

"It's radical and it's inappropriate," said Dr. Gerald S. Levey, dean of the medical school at the University of California at Los Angeles. He added, "It will drive people out of doing clinical research and, I think, cause a great deal of chaos." 

At a morning press briefing to make the plan public, Dr. Shalala was flanked by Dr. Jane E. Henney, who heads the Food and Drug Administration, and Dr. Ruth Kirschstein, acting director of the National Institutes of Health. Both agencies have come under criticism for lax oversight of gene therapy experiments, particularly after the death of an 18-year-old patient, Jesse Gelsinger, at the University of Pennsylvania last fall. 

An F.D.A. inspection cited a litany of deficiencies in the way that experiment was run, and the agency has since shut down all gene therapy trials at Penn, as well as certain other gene therapy studies. But the tactic of shutting down an entire research program is draconian; some scientists call it "the atomic bomb of research regulation." In explaining the rationale for using fines, Dr. Henney said that while fines might sound harsh, they would actually be an intermediate step. 

Dr. George Rupp, president of Columbia University, put it this way, in a telephone interview: "The federal government doesn't have any intermediate actions between dropping the atomic bomb and a wrist slap. This is clearly an effort to look for a more focused and discriminating level of penalty." 

While much of the public attention has focused on gene therapy, gene research is not the government's only safety concern. The biomedical revolution of the last 20 years has produced countless medicines and therapies that have allowed patients to live healthier, longer lives. But the scientific boom has brought with it complications, Dr. Shalala said, that stretch across the spectrum of science. 

In part, this is because novel technologies like gene therapy pose new risks. At the same time, the changing relationship between academic scientists and industry is posing new conflict of interest problems. In addition, the sheer volume of clinical studies makes keeping tabs on them difficult. 

The patient safety infrastructure depends on hospital committees, institutional review boards, that evaluate and approve human experiments. In a report two years ago, the Inspector General of the Department of Health and Human Services found that those committees are overloaded and may spend no more than a few minutes reviewing each study. 

Dr. LeRoy H. Walters, a bioethicist at Georgetown University, cautioned that without more money to beef up the committees, the government's new initiatives will be of little use. 

"The institutional review board system is really strained almost to its limit," Dr. Walters said, adding that without money to help with "high quality research review," today's announcement "may feel to local institutions like it's the whip being cracked once again." 

Is it possible that Donna E. Shalala is a hypocrite of immense proportions???

By definition, every vaccine batch produced is an experiment without long term active surveillance large cohort scientifically controlled safety testing.

Current vaccination policy and the entire medical-industrial-government vaccine complex are in gross egregious violation of each and every point that this new plan ostensibly seeks to thwart. If Ms. Shalala is serious about rigorous informed consent and an enterprise with enormous integrity she should immediately halt production of all vaccines and massively fine the co-conspiring parties, starting with the manufacturers and their paid physician/researcher cronies! 

Don’t miss Shalala’s priceless quote about informed consent. Why not start auditing all the vaccinator’s records for informed consent starting today!

Dr. Doug Hertford, MD, MEng  <dehertf@med.cornell.edu>
 

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