A Report from the Liaison Committee with Government Agencies and the Pharmaceutical Industry
The ACNP Liaison Committee with Government Agencies and the Pharmaceutical Industry is focusing on a number of issues in 2004. Committee members led by Dean Wong, Linda Brady, and Robert Innis are discussing strategies for facilitating the joint development of radiotracers by academic and industry scientists. Strategies for improving collaboration will be discussed in a Study Group at the 2004 Annual Meeting.
The Committee also supports the creation of a publicly available clinical trials registry. A subcommittee chaired by Donald Robinson and including College members from academia and industry is investigating the various proposals for implementing such a registry, and is developing a position paper that will be submitted to Council in December.
The Committee is also concerned about the impact of recent FDA guidelines on the support of professional education by industry. These issues will be discussed with both the Education and Training and Ethics Committees during the Annual Meeting. The chairs and co-chairs of these three committees are already discussing the impact of recent changes that have led to cutbacks on unrestricted grants for CME activities, and plan a joint discussion during the annual meeting that may lead to specific proposals to Council for action by the ACNP.
The Committee also believes that collaborations with industry will be improved if more industry scientists participated in the College as members. The Committee will communicate with the Credentials Committee regarding strategies for encouraging applications by industry scientists and issues in evaluating those applications.
In April 2004 the ACNP Executive Committee appointed a journal task force to address several issues. The task force was co-chaired by Sam Enna and Daniel Casey. Other task force members were John Kane, James Meador-Woodruff, Kenneth Moore, John Newcomer, and Elaine Sanders-Bush. The task force was asked to address the following issues:
The Task Force issued a report to Council that was considered during the Council conference call on October 6. The recommendations of the task force were centered around the creation of a Publications Committee to have responsibility for all College publications, including the journal, the scientific website, the Generations of Progress Books, and any other publications the College may develop. It was recommended that the College create such a committee, to be composed of six members and a chair. The members should be equally divided to represent both pre-clinical and clinical science, and should serve three-year terms on the committee, with the possibility of appointment for one additional term. The chair would be appointed by the President, but would require confirmation by Council, and would also serve a three-year term. However, no member of the committee may serve more than a combined total of nine years as a committee member and chair. The Task Force recommended that other issues, such as performance criteria and editorial board expectations should be deferred to this committee to both develop policies and to implement and monitor them. Council endorsed this recommendation of the Task Force, and will recommend that the College By-laws by amended to create such a committee. Council has named Sam Enna to serve as the first chair of this new committee, and will appoint other committee members by the annual meeting.
The Task Force report also recommended preliminary guidelines for a Conflict of Interest policy. Council appointed a sub-committee of Council members to further develop these conflict of interest guidelines into a policy statement. This policy will then be presented to the Publications Committee for their review and recommendations since they will be responsible to both implement and monitor the policy.
This Task Force report will be presented in full to the membership at the business meeting in December.
FDA's Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee Recommends "Black Box" Warning
Following two days of testimony and discussion at the September joint meeting of FDA's Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee, the panel voted 15 to 8 in favor of adding a "black box" label to all antidepressants warning of potential dangers associated with antidepressants for pediatric off-label use. FDA has not yet announced it will follow the panel's recommendation, but indicated it would "probably" do so shortly. The issue has been the topic of discussion for several months at FDA, the Senate Finance Committee, and the House Energy & Commerce's subcommittee on oversight & investigations. Given all the attention it has garnered, a strong warning label seemed inevitable.
Although the FDA advisory committee refrained from recommending a contraindication for the use of these drugs, the recommendation to add a black box warning to antidepressants may make prescribing such drugs to children and adolescents more difficult. A number of parents and health care providers testified saying that tools to help treat adolescents suffering from depression are already limited. One doctor on the FDA panel said he would be reluctant to prescribe a drug if he saw a black box warning. Other panelists pointed out that in the current litigious atmosphere, doctors would be wary of prescribing antidepressants for off-label use. Recent news articles have confirmed that many doctors are now referring patients to physicians who specialize in treating depression and other mental illnesses. This has brought another issue to light, the lack of mental health specialists trained to care for children and adolescents.
The House Energy & Commerce's subcommittee on oversight & investigations held a number of hearings on the efficacy of these drugs and the risk involved in prescribing drugs not approved nor marketed for pediatric use. At the most recent hearing in September, the subcommittee examined the Food & Drug Administration's (FDA) role in this issue. Among its concerns, some subcommittee members expressed alarmed when told FDA prevented a pharmaceutical company from voluntarily adding a warning label that indicated increased "suicidality" was found in clinical trials using these drugs. (FDA defines suicidality to include "suicide behavior, preparatory behavior and ideation.) FDA asked the company to replace its warning with one similar to FDA's March warning urging doctors to monitor patients of all ages taking antidepressants. This is consistent, FDA argued, with findings that suicidality often increases in the first weeks of treatment.
Also of concern to the subcommittee was FDA's decision not to allow Dr. Andrew Mosholder, an epidemiologist in the FDA's Office of Drug Safety, to discuss his analysis of clinical trials for these drugs; Mosholder found a possible link between antidepressants and suicidation. At the previous FDA advisory committee meeting held in February, the agency revealed the data Mosholder reviewed, but did not allow him to present his conclusion. FDA had commissioned Columbia University to review and reclassify the data to determine if examples of suicidation were uniformly classified. It was waiting for the reclassification before allowing Mosholder to present his conclusion. Columbia presented its reclassification of the data at FDA's September meeting and Mosholder was permitted to present his analysis.
In Columbia's review of the clinical trial data, it was determined studies were not uniform, making combined analysis difficult. Some studies included family history but did not include subjects with previous suicide attempts, while others did not gather information on family history of mental illness but allowed subjects with a prior suicide attempt. One panel member pointed out it is difficult to separate the symptoms of the disease from the side effects of the treatment, something inherent in many trials, but particularly so in trials involving major depression disorder (MDD). Columbia will work with FDA to help develop an improved method of adverse event reporting and a more specific and consistent classification coding for future trials.
OHRP Advisory Committee Discusses Research Involving Children
Throughout the House subcommittee's hearings and the FDA's advisory meetings, it was clear more research in this area is needed. This brings another controversial issue to the surface, research involving children, and specifically, research involving "well" children. The Office for Human Research Protections (OHRP) Secretary's Advisory Committee on Human Research Protections (SACHRP) met recently to discuss regulations and policies for research involving children. Topics included the definition of minimal risk, increments of increased risk and conducting studies on well children in order to have a basis for comparison. Current regulations include different levels of risk for children participating in research that will yield direct benefit, research that will yield information about the general illness, and research that yields information about an unrelated condition. An appointed subcommittee within SACHRP will continue to review these issues over the next year.
As reported in the September 2004 Bulletin, Council has led an effort this year to create an ACNP strategic plan. A final draft of that plan is near completion. The plan is currently being reviewed by four focus groups. Two groups of twenty members and fellows each were selected at random and asked to review the plan and make comments on it. One group of ten associate members selected at random was asked to do the same. The fourth and final group is made up of all committee chairs and co-chairs. The input from these groups will be collected and compiled by the end of October. Any suggestions for substantive changes in the plan will, at that time, be referred back to Council for consideration. A revised draft will then be sent to all members of the College. One additional opportunity for questions and discussion will be offered at the annual meeting. On Tuesday, December 14 from 7:30 - 8:30 AM Council members will host a town hall style question and answer session. All members are encouraged to attend that session. The College should then be ready to enter the new year with the plan complete and with implementation as the primary goal.
PICKWICK POSTDOCTORAL FELLOWSHIP
Deadline: December 1, 2004
The National Sleep Foundation supports and encourages sleep research by offering the Pickwick Postdoctoral Fellowship to persons interested in pursuing basic, clinical and applied sleep research. NSF Pickwick Postdoctoral fellows receive funding based on NIH guidelines from $35,568-45,048 plus a benefits allowance for two years; the second year contingent upon satisfactory progress. The deadline for the application is:
December 1, 2004
Applicants can be international citizens, but must conduct their research under the tutelage of a sleep mentor at an established American or Canadian lab.
You are encouraged to inform potential candidates of this award, your colleagues and/or other people you think might be interested.
For more information, visit the website at www.sleepfoundation.org .
ICGP 4th Annual Meeting
ACNP 43rd Annual Meeting
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The Annual Meeting registration packet was mailed to the membership in mid-June. If you haven't already completed your meeting registration and hotel forms, do it soon. The deadline for early registration is NOVEMBER 19th . The deadline for reserving a room at the convention rate is NOVEMBER 5th.