Advocacy Committee Meeting on April 9, 2003 at 10:00 a.m. in the Wyndham City Center Hotel - Georgetown Room.

The Advocacy Committee will meet in Washington, DC on April 9 in conjunction with the Academic Consortium efforts to make the case for mental health research funding. Our meeting will precede the Academic Consortium briefing, reception and lobbying efforts.

In addition to the usual discussion of mutual interests of ACNP members and ACNP Advocacy Affiliates, the focus of our committee meeting will be on the effects of the new HIPAA regulations on clinical research. Our guest speaker will be Dennis Swanson, Director of the Institutional Review Board at the University of Pittsburgh.

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James H. Meador-Woodruff

The ACNP Website has seen rapid growth over the past three years, with a number of features related to the annual meeting and multiple aspects of membership most recently being placed online. More important for the College's scientific presence is the highly visited scientific content that we have made available on the website, which includes the entire text of the Fourth Generation of Progress book (through three electronic revisions) as well as the rapid publication site for our journal, Neuropsychopharmacology. In large part due to this high quality scientific content, we experienced nearly one and a half million hits to the website in 2002.

Quite exciting for those of us who work with the website is that we were ranked number one in the Google Page Rank Index for the Google list of websites of psychiatric and related organizations. The Google Page Rank is an innovative metric to assess the quality of a given website. This ranking does not depend on the sheer volume of hits to a website, but rather on the quality of the hits, especially in terms of how efficiently sought information was retrieved, as well as the quality and importance of referring websites. In essence, more important pages (as Google defines them) weigh more heavily if they are the referring source to a given website. Of note, our first place ranking is in a pool of websites that includes those of the American Psychiatric Association, The American Academy of Child and Adolescent Psychiatry, The World Psychiatric Association, and other notable organizations. We are quite pleased with this recognition for the quality of our website. I suspect that this ranking is in large part due to the high quality scientific content that we make available on our website. I expect that the volume of traffic that we receive to our website, as well as our high ranking amongst websites of comparable organizations, will continue when we make the Fifth Generation of Progress content publicly available on the website in the near future.

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Report from NABR Annual Meeting

Anthony Grace

The National Association for Biomedical Research (NABR) held their 2003 annual meeting February 23-25 in Washington, DC. The meeting was attended by 150 members, who are representatives of national organizations, universities, research groups, pharmaceutical companies, and similar entities. As many of you know, NABR is an organization dedicated to representing scientists in defense of the use of animals in biomedical research. The purpose of this meeting was to update the member organizations on the state of animal research in the United States, how it is under attack, and the most effective means for ensuring that the future of animals in biomedical research may be preserved.

One of the major issues discussed regards the developing trend to establish legal rights for animals. Unfortunately, the animal rights groups have begun to make significant strides in this direction. As an initial step, there has been a focus on changing the legal definition of the relationship between humans and their pets from ownership to guardianship. Such a change in definition has already taken place in several major cities and in the state of Rhode Island. This is viewed as an attempt to change the legal definition of pets from property to entities with legal rights, similar to the type of guardianship that may be legally established for humans that do not have the capacity to represent themselves. Such an argument is clearly being used in an attempt to blur the line between humans and non-humans. The argument is that a chimpanzee has the capacity to communicate with symbolic language and possesses cognitive skills and therefore should be assigned the same legal rights as disabled children. And animal rights groups are seeking legal standing in court. It is further argued that the USDA is not sufficiently staffed to adequately represent the interests of animals under the Animal Welfare Act.

While animal rights activists like to equate their efforts to the civil rights movment, there are several arguments that can be made as to why civil rights arguments do not apply to animals, but many believe scientific arguments will not be effective with respect to the cognitive differences between disabled humans and chimpanzees. An argument based on human needs is a possibility, but the question of who has the legal standing to sue on behalf of medical progress is an issue. Based on philosophical or religious reasoning regarding lack of moral judgement by animals, equating rights with responsibilities, and that personhood does not equal cognitive ability but instead relates to the unique quality of being human, is considered by legal experts as the most effective strategy.

Another topic addressed was that of changing attitudes within the general public. There are two ways in which legislation and attitudes converge; one is that social attitudes change, and the laws follow. The other is that legislation drives changes in social attitudes. The animal rights groups believe that they can use the courts to change social attitudes the way the civil rights movement did. In fact, the comparison between animal rights and civil rights is employed quite often in these arguments. The concept upon which this is built is domination; i.e., men over women, whites over blacks, masters over slaves, and extending the analogy to humans over nonhumans.

There are also several current trends that are alarming. Germany has recently included animal rights in their constitution, the full implications of which remain to be determined. Another is the fact that in more than 25 law schools in the U.S., animal rights law is now part of the curriculum. This continues the educational objective of the animal rights movement, by spreading their doctrine first in primary schools, then in high schools, and now in postgraduate education, including law schools and medical schools.

One of the most informative and instructive topics of the conference involved the proper way to prepare and respond to actions by an animal rights infiltrator. One case in particular was the incident at the University of North Carolina at Chapel Hill. In this instance, a member of PETA took a job as an animal care technician, and over a 6-month period used video cameras to methodically document alleged abuse of laboratory rats and mice. The timing of this announcement by PETA was done to coincide with and attempt to defeat the Helms amendment, that sought to exclude rats, mice and birds from the Animal Welfare Act statute. However, as a result of quick and decisive action by the university officials, this situation was effectively diffused. It is clear that the largest public outcry typically does not arise from the act itself, but instead is often a consequence of the perceived attempt by the institution to minimize or cover-up the occurrence. In this case, UNC contacted NABR, and devised an effective response strategy based on full disclosure, including opening records, inviting the press to tour the facilities, an investigating and reporting on every aspect of the allegations. Thus, without a hint of a cover-up, the issue quickly resolved. NABR pointed out that a critical component of a response is to create an institutional crisis management team before a crisis develops, and to seek assistance from NABR to aid in establishing such a unit.

NABR also unveiled a new media campaign in support of biomedical research. This is the "Survivors" campaign. Dr. Terry Fossum, a prominent clinician and professor of small animal medicine and surgery at Texas A&M University's College of Veterinary Medicine, has generously agreed to serve as spokesperson, thereby lending professional credibility to the campaign message. The campaign is based on market research data that revealed that more people support biomedical research with animals for the sake of animal health than they do for human health. In the Survivors campaign, the issue is powerfully presented and emphasizes that animal research saves animals, too! It is believed that such an approach will not only be effective with the general public, but will be exceptionally difficult for animal rights groups to respond to negatively. A clever and poignant 30-second commercial is currently being aired as a public service announcement; however, to be maximally effective it will need to be aired during times when it can attract the most attention, and this will require substantial financial support. By the way, financial contributions of any amount are gratefully appreciated to support this campaign.

When it comes to Congress, biomedical research has not had a loud enough voice. The biomedical research community is notorious for not writing to express their views to Congress. However, it's a fact of life that, to a certain extent, Congressmen respond to numbers, and for each letter written in support of animal research, there is a deluge written in opposition. Being "right" bears little meaning when elected officials feel the need to represent the majority of their constituents. Furthermore, within the past couple of years, the animal rights movement has become much more sophisticated politically. Recently, a consortium of animal rights groups have founded a political action committee (PAC) and are now committing $100,000 - $300,000 per election cycle to political candidates. NABR is one of the few avenues that we have supporting us on Capitol Hill and dedicated to fighting our battles with animal rights activists. Yet, the financial commitment on the part of those who depend upon animal research is negligible. This must be changed, since NABR is one of the few avenues that corporations and universities will be able to support in the battle against animal rights. It has become common knowledge that investments of thousands of dollars today will help to circumvent millions of dollars of response in the future. NABR believes that they can have an effective political action committee with only $25,000-$35,000 per election cycle.

As members of the ACNP, we all are eligible for access to the NABR web page. This is an extremely valuable resource, listing upcoming legislation regarding animal research and pending issues, as well as to whom we should write letters. To access this site, go to www.nabr.org. If you'd like access to the Members Only part of the site, contact Sandra Boyd at sboyd@nabr.org to set up a password.

It is clear that Frankie Trull and NABR have been working valiantly on our behalf, and it is our responsibility to do all we can to garner support for NABR. Individual contributions, contributions by companies that depend on biomedical research, and participation in letter writing campaigns are an absolute necessity if we are to be able to continue to successfully practice our profession and improve the health and welfare of people.

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Human Subjects in Research
March 11, 2003

ACNP held its third Congressional Breakfast and Briefing on Tuesday, March 11, in the Capitol. The topic, "Human Subjects in Research: Special Challenges for People with Brain Disorders," was of particular interest to Congressman Chris Van Hollen (D-MD), the Congressional representative for the National Institutes of Health (NIH). Mr. Van Hollen sponsored the educational breakfast briefing where ACNP President-Elect Carol Tamminga, M.D served as moderator.

Scott Y. H. Kim, M.D., Ph.D., Assistant Professor of Psychiatry and Medical Humanities and Director of the Program in Clinical Ethics at the University of Rochester School of Medicine and Dentistry, and William T. Carpenter M.D., Professor of Psychiatry and Pharmacology at the University of Maryland School of Medicine, each spoke from a researcher's perspective on the issue of informed consent among individuals with brain diseases. Lydia Lewis, President of the Depression and Bipolar Support Alliance (DBSA) spoke from the perspective of patients and research subjects.

Providing this type of educational service to Congressional staff is an important contribution from the ACNP to the legislative process. It not only helps to educate those staff members who play a critical role in preparing and writing legislation, but it also continues to build the image of the ACNP as a leading source of cutting edge information in the areas of the brain, behavior, and psychotropic drug research. A videotape of the entire program is available on the ACNP Website at www.acnp.org.

In his remarks, Will Carpenter discussed the foundation of ethical human research as based in scientific merit, respect for person, justice, reasonable risks in proportion to benefits, and the voluntary participation of informed subjects. Using schizophrenia for illustration, he explained how some patients are not competent to provide informed consent and how screening procedures can exclude these patients from studies. In the main, however, the problem is that patients are decisionally challenged based on cognitive impairments. Informed consent, conducted as an educational process, can usually result in valid informed consent. Straightforward testing of consent information can document that valid consent was obtained prior to subject entry.

In addition, he described work by Laura Roberts which shows that mentally ill persons and non-ill control subjects are similar in evaluating risks and benefits of protocols, and making research participation decisions.

Scott Kim spoke to the ethics of involving decisionally incapable adults in research. This issue will continue to grow in importance as more research is conducted with this population in a climate of heightened ethical scrutiny of clinical research. Despite a wave of initiatives in the late 1990's to clarify policy, surrogate consent for research continues to be a murky legal area. There is evidence that conservative risk-management strategies by institutional review boards and their institutions may severely restrict research with decisionally impaired subjects. A passive approach to this problem may no longer be feasible. A recent Federal advisory report and a legislative initiative in California could begin to provide a blueprint for future policymaking. It is imperative that the scientific community, patients and their advocates, and policymakers at all levels establish a constructive dialogue to clarify the ethical and legal standards in this area.

Dr. Kim provided the following handout:

Surrogate Consent for Clinical Research: Need for Better Policy
Scott Kim, University of Rochester (scott_kim@urmc.rochester.edu)
March 11, 2003

• Definition: When an adult research subject is too brain-impaired to give his or her own informed consent, a third party (legally authorized representative, or LAR) gives permission in the subject's place.
• Is this an esoteric topic that affects only a few? No. Surrogate consent for research involves some of the biggest public health problems in the US (e.g., Alzheimer's disease, schizophrenia, AIDS with neuropsychiatric complications, severely ill medical patients).
  Example: Alzheimer's disease affects 4 million Americans currently, 1/10 of those over 65, nearly ½ of those over 85, and costs society $100 billion annually.
• What is the current policy? Two main policy domains:
  o Who can serve as legally authorized representative?
         .Currently left up to the states to define-a big, confusing mess!
         .Result: Major institutions halting ALL research involving surrogate consent (UCLA, Vanderbilt, Mt. Sinai); other institutions struggling to formulate policies
  o Even if LAR gives permission, should there be special protections for decisionally incapable persons in research? For example, amount of risk that should be permitted, or more rigorous process of IRB review, etc.
         .No specific provisions in Federal regulations.
• Why now?
  o Science has progressed; more research possible than 25 years ago (new drugs, gene therapy, stem cell therapy, vaccines, etc).
  o Research ethics now a major societal focus: more demand for accountability-major institutions are being publicly disciplined for research ethics violations.
• What can the Federal government do?
  o Promulgate specific regulations regarding surrogate consent for research.
  o Examine whether Federal government can define LAR for research consent rather than leaving this to the states?
• What will Federal action accomplish?
  o Provide specific protections to a vulnerable group.
  o Give researchers, IRBs, and institutions clear legal guidance and umbrella under which important research can occur.
  o Even if the Federal government does not solve the LAR issue, providing specific regulations for surrogate consent for research will make it easier for the states to address the LAR issue.
• What is likely to happen without policy reform? Idiosyncratic risk-management decisions will drive the practice of research with incompetent adults-to the detriment of both research volunteers and clinical science.

In her comments Lydia Lewis outlined appropriate safeguards that should be in place for people with mental illnesses. She also stressed that a "one-size-fits-all" approach to obtaining informed consent is discriminatory and does not work. She said, "One of the worst outcomes imaginable is to establish so many bureaucratic levels to human research protections that scientists choose to stop research -- research that may someday cure or eliminate diseases like depression and bipolar disorder. We believe as long as safeguards are in place, research into novel treatments and cures must increase."

Congressman Chris Van Hollen welcomes the group to the Capitol.

Carol Tamminga, moderator of the ACNP breakfast briefing

Lydia Lewis, Scott Kim, and William Carpenter

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Table of Contents

• Advocacy Committee Meeting
• ACNP Website Update
• Report from NABR Annual Meeting 
• ACNP Congressional Briefing
• Report From Washington
• ACNP Taskforce on Geriatric Neuropsychopharmacology
• Deadlines