From: THE ALLIANCE FOR HUMAN RESEARCH PROTECTION

Re: Opposition to AB 2328

To: Members of the California Health and Human Services Committee and Staff:

Senator Deborah Ortiz (Chair), Mr. John Miller
Senator Ray Haynes (Vice Chair), Ms. Debbie Rogers
Senator Jim Battin, Ms. Katie Tinney
Senator Wesley Chesbro, Ms. Peggy Collins
Senator Martha Escutia, Ms. Wendy Umino
Senator Liz Figueroa, Ms. Lisa Markey
Senator Sheila Kuehl, Ms. Carol Wallisch
Senator Bill Morrow, Ms. Jayme Chick
Senator Richard G. Polanco, Mr. Chris Slammer
Senator Gloria Romero, Ms. Rosie Escobar
Senator John Vasconcellos, Ms. Oanh Ho
Senator Edward Vincent, Ms.Carolyn Robinson

Dear Committee Members and Staff,

The Alliance for Human Research Protection opposes proposed amendment AB 2328 for a number of reasons.

REASONS FOR OPPOSITION:

Researchers would not be required to first try approved treatments, if any exist, before entering the patient into a medical experiment that may be "risky."

Researchers would not be required to consult with an independent medical expert, a non-researcher who would consider the patient's best medical interests as paramount.

Researchers would not be required to disclose their own professional and financial interests deriving from the experiment.

Researchers would not be required to fully disclose to the patient's family what happened to other patients who had already participated in the experiment.

Researchers would not be required to provide the patient's family with the research records that would show what happened to the patient while in the experiment.

Since half of the patients would receive placebo, no benefit would be possible for 50% of the patients. In fact, the patients receiving placebo might suffer and get worse because they are not receiving any treatment for their condition.

Finally, the research enterprise would not assume financial responsibility if an adverse outcome occurred leading to increased medical expenses. Medicare, Medi-Cal or other insurers would be required to pay increased medical costs. The research enterprise also bears no fiscal responsibility in the event of death.

In summary, this proposed legislation would not provide essential protections for vulnerable persons and their families.

Under the proposed amendment, consent may be obtained from relatives who may not even be familiar with or care about the beliefs of the patient expressed at a prior time when decision-making capacity was intact.

TIMING OF AMENDMENT:

Why has this proposed amendment been submitted to the legislature at this time?

We discussed this proposed amendment with an administrator at one of the research institutions that conducts research with persons who have lost their decision-making capacity. The administrator explained that in order to obtain proper consent from persons without decision-making capacity, researchers should have been obtaining consent through an advance health care directive, a durable power of attorney, or a conservatorship. Instead, the administrator explained that the researchers had routinely obtained the signature of a relative not properly qualified to provide "proxy consent."

We were told that attorneys for these research institutions decided to halt such research because the consents were not in compliance with the California Medical Experimentation Act. The advocate explained that AB 2328 was drafted so that such research can proceed.

When we asked to review consents from such research, our request was denied.

Without a review of such consents it is not possible to verify if such research had been conducted in violation of the Medical Experimentation Act.

If it is true that experiments have been taking place without legally valid informed consent under existing California law, it would seem that the research community, instead of choosing to comply with existing law is attempting to change the law.

Though adverse events often lead to a re-examination of informed consent procedures, the sponsor of the bill has not indicated whether any serious adverse event (s) or any death (s) have led to a much higher level of concern about the consents for experimentation with this vulnerable population.

It would be appropriate for the sponsor of the bill to inform the Committee if any complaints have been made to any of the involved institutions, if any government oversight has been initiated, or if any recent litigation has ensued pursuant to experiments with this vulnerable population.

HISTORY OF MEDICAL EXPERIMENTATION ACT

When the California legislature originally passed the Protection of Human Subjects in Medical Experimentation Act in 1978, the legislature stated that since the Nuremberg Code could not be enforced in California "The Legislature hereby finds and declares that medical experimentation on human subjects is vital for the benefit of mankind, however such experimentation shall be undertaken with due respect to the preciousness of human life and the right of individuals to determine what is done to their own bodies."

The Legislatures thoughtfully considered the Nuremberg Code in drafting the state law.

The first principle of the Nuremberg Code states: "The voluntary consent of the human subject is absolutely essential." The Nuremberg Trial judges decided that when a choice is to be made between medical science and the integrity of human subjects that choice should be made in favor of respect for the integrity of the individual. The Nuremberg Code provided uncompromising language protecting the inviolability of subjects in research.

AB 2328, if passed, will reverse the achievement of the Nuremberg Code and the California Medical Experimentation Act.

The Health and Human Services Committee is now asked to make a choice between the protection of individual inviolability of a vulnerable population, or allowing clinical trials sponsored by pharmaceutical companies to be conducted without thorough and independent protections for this particularly vulnerable population.

UNDESIGNATED PATIENT POPULATIONS:

AB 2328 does not identify those who may be included under this bill. By failing to designate targeted populations in the bill the researchers have cast as wide a net as possible. Prospective patient populations include those with AIDS, the developmentally disabled, those who are mentally ill (except while under a 5150 hold), victims of stroke or Alzheimer's Disease, and others.

Moreover, the bill sets no limits on the kinds of medical experiments that the researchers may conduct for drug companies or others.

For example, the Medical Experimentation Act currently requires that experimentation on conservatees maintain or improve their health. Now, the researchers are seeking human subjects who are at the level of conservatees without an assurance that the patient's health will stay the same or get better. Thus, the proposed amendment would degrade the legislation.

DRUG TRIALS DO NOT ALWAYS ADVANCE MEDICAL SCIENCE

We fully concur that it is vital to develop new medications that will benefit mankind. However, in this quest it is important for reviewers of AB 2328 to recognize that the process is not altruistic. Drug trials are first and foremost a commercial venture guided by commercial interests. The vast majority of drugs tested are never approved. The chance of a patient benefiting in a drug trial is statistically remote.

Conducting clinical trials does not necessarily lead to advancing medical science.

While pharmaceutical firms do develop medications of substantial benefit to society, they are sometimes also involved in practices found contrary to the public interest. One recent example involves litigation where AARP recently joined 29 states in litigation involving some pharmaceutical firms efforts to block access to generic cancer drugs. Peter Jennings recently presented (May 29^th) consumers with issues to consider in a program entitled "Bitter Medicine, Pills, Profit and the Public Health." Jennings focused on questions such as whether new medications are actually better than the ones they replace and how little we know about a drug's relative safety and effectiveness when it comes onto the market.

Clinical trials can hardly be viewed as primarily humanitarian efforts designed to advance medical science. Clinical trials are primarily designed to ultimately provide profit.

RECENT PROBLEMS IN RESEARCH:

In recent years oversight investigations have revealed gaping failures in medical ethics and scientific integrity at many great universities: Duke, Pennsylvania, Yale, Harvard, John Hopkins, the University of Oklahoma and other sites. The sponsor of this bill, the University of California, has also been the subject of federal investigations and Congressional hearings.

On April 21, 1999 the House Subcommittee on Oversight and Investigations held a hearing about the 1999 suspension of over 500 medical experiments at the West Los Angeles Veterans Affairs facility, staffed largely University of California at Los Angeles researchers.

The Director of the National Institute of Health's Office for Human Research Protection testified:

We know that the institutions are located across the street from each other. We knew we had problems at UCLA; we know many investigators had joint appointments at the VA and UCLA, so it had a certain gravity to it· We did a site visit, Dr. Puglisi led it, in 1995. It was marked by non-responsiveness by the institution through months and years.

At UCLA we identified, through the mid-1990s a culture of non-compliance with Federal human subject regulations and so labeled it.

That was April, 1999.

This is June, 2002.

There's a simple message here.

Medical science should advance carefully, respecting the integrity of each patient. There should be appropriate protections for vulnerable persons. The best medical interests of the patients should come well ahead of the commercial interests of the pharmaceuticals.

The mechanism of an advance health care directive already exists. It should be used.

Advance health care directives require appropriate planning and preclude informed consent from being granted in a hasty or casual manner, without appropriate consideration of all of the pertinent issues. For example, the Harvard Brain Bank is focused on speaking in advance with persons about donating their human brains many years in advance of their demise. This is a similar situation. Here, also, the researchers are asking for human subjects to donate their bodies to science. The researchers can appropriately achieve their goals with an advance directive.

AB 2328 is a proposed amendment that cannot promise benefit. Yet, those asked to provide "proxy consent" under AB 2328 will likely think that there is some possible benefit to their loved one.

We recently spoke with the manager of a Board and Care about this proposed legislation. She thought that a family member would have difficulty refusing to sign a "proxy consent" because of the guilt that would surface when a physician suggests that a clinical trial "might" help the patient. She felt that such circumstances would not be conducive for objective decision-making.

CONCLUSIONS:

We have been informed by the sponsor of this bill that the states of Missouri, Texas, Ilinois and Florida have laws permitting "proxy consent." We also know that New York and Maryland have rejected proposed amendments similar to AB 2328.

In 1978 the California legislators understood the significance of the Nuremberg Code when they drafted the California Medical Experimentation Act.

Consider the thoughts of bioethicist Jay Katz, M.D. J.D: "As medical professionals, we remain unconvinced that we should embrace the [Nuremberg] code's principles in the spirit in which they were promulgated. It remains my dream that we shall do so.

It may only be a dream, but it comforts my nightmares."

Remember the words of Martin Niemoller, the German pastor. He spoke simple words that resonate today. "Then they came for me. There was no one left to speak for me." AB 2328, if passed, places vulnerable human subjects on a "slippery slope."

Since AB 2328 does not provide important protections for this vulnerable population, we urge members of the Senate Committee on Health and Human Services to oppose this amendment and fully protect those who have lost their capacity to consent.

The existing Medical Experimentation Act does the job.

THE ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Bob Aller
1301 Brockton Ave. #9
LA CA 90025
(310) 479-5058

Vera Hassner Sharav
President, AHRP
548 Broadway, 3^rd floor
New York, NY 10012-3950

More information and documents relevant to AB 2328 are available at: http://www.mninter.net/~lbarry/Voices/