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NEWS & VIEWS

FDA APPOINTS NEUROLOGIST AS NEW DIRECTOR OF DRUG SAFETY

The Food and Drug Administration (FDA) has chosen a neurologist, Gerald J. Dal Pan, MD, to serve as its new Director for the Office of Drug Safety, which monitors the safety of approved drugs. Dr. Dal Pan, who will fill a position that has been vacant for two years, is certain to encounter some controversy, as some question whether the office should continue to operate under the Center for Drug Evaluation and Research, since the center is responsible for approving new drugs and could potentially interfere with post-market evaluations.

Dr. Dal Pan is a part-time Assistant Professor of Neurology at Johns Hopkins University School of Medicine and is currently the Director of the Division of Surveillance, Research, and Communication Support at the Office of Drug Safety. He joined the agency in 2000 as a medical reviewer in the Division of Anesthetic Critical Care and Addiction Drug Products.

Dr. Dal Pan said in an e-mail to Neurology Today that he plans to work more closely with public and private healthcare organizations to identify new adverse drug reactions as soon as possible. He said he will also expand the FDA's use of databases that link pharmacy information to clinical information in order to spot and quantify drug-related risks.

Senator Charles Grassley (R-IA), Chairman of the Senate Finance Committee, introduced a bill in March that would have created an independent office to review the safety of drugs on the market. “If you want accountability, it doesn't make sense to have the office that reviews the safety of drugs to be under the thumb of the office that puts the drug on the market in the first place,” he said during a Senate Finance Committee hearing last November, which examined FDA drug safety issues.

On the other hand, Patricia K. Coyle, MD, Professor and Acting Chair in the Department of Neurology at the State University of New York at Stony Brook, said she is “not sure creating another bureaucracy is the best way to go. … If they are serious about this and give individuals appropriate funding and support, then I believe this may be as effective or even more effective than starting a brand new office that's completely outside the FDA.”

Dr. Coyle previously served on the FDA Peripheral and Central Nervous System Advisory Committee. She added that in order to restore the FDA's credibility as a public interest agency, the new director should maintain a high profile and be widely accessible to the public as well as to investigators and physicians working outside of the FDA.

TERRI SCHIAVO-LIKE CASE IN ENGLAND HIGHLIGHTS ISSUES FACED BY NEUROLOGISTS

A woman with incurable mitochondria cytopathy who was at the center of a right-to-die case in England, died in late November. An English judge had ruled two weeks earlier that she should be allowed to die “peacefully and with dignity,” despite requests from her family that she be kept alive by all means, according to British Broadcasting Corp. News. This case underscored the importance of thorough clinical examinations, according to one expert, and drew several parallels with the case of Terri Schiavo, the 41-year-old woman believed to have been in the persistent vegetative state (PVS) after suffering a heart attack that temporarily cut off oxygen to her brain 13 years ago. Ms. Schiavo died in March after a court ordered that her feeding tube be removed. Her parents and siblings had been engaged in a long-running legal battle to keep her alive.

In the case of Eileen Doran, 31, her family maintained that she had shown signs of awareness even though neurologists at the Walton Centre for Neurology and Neurosurgery in Liverpool, England, have determined she was in the PVS. The High Court in London upheld a decision allowing doctors not to resuscitate her if she stopped breathing, according to BBC News.

Ms. Doran's brother died from the same disease two years ago.

James L. Bernat, MD, Professor of Medicine (Neurology) at Dartmouth Medical School in Hanover, NH, said in an e-mail to Neurology Today that in such cases, neurologists could invite the family to demonstrate their evidence for responsiveness. Neurologists should explain the basis for their diagnosis to the family and can conduct ancillary tests such as brain MRI, functional MRI, EEG, and cortical evoked potential testing to show evidence of profound brain damage.

Neurologists should make the diagnosis of the PVS only when there is no evidence of awareness after a thorough evaluation, Dr. Bernat said. “We need to understand that loving family members want to see signs of awareness and may interpret random responses as evidence of awareness,” he said. “We should respond compassionately but maintain a scientifically accurate assessment.”

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Dr. James L. Bernat: “We should understand that loving family members want to see signs of awareness and may interpret random responses as evidence of awareness. We need to respond compassionately but maintain a scientifically accurate assessment.”

LATEST ROFECOXIB CASE COULD AFFECT FUTURE RULINGS

A court found that Merck & Co., Inc. had provided adequate warning to doctors about the health risks associated with its Cox-2 inhibitor, rofecoxib (Vioxx), in the latest case filed by a patient against the drugmaker. A legal expert told Neurology Today that this decision may be indicative of future court rulings.

Merck voluntarily pulled rofecoxib from the market in September 2004, after a study showed that it increased the risk of cardiovascular complications in patients who took the drug regularly for at least 18 months. The plaintiff in the latest case, 60-year-old Frederick Humeston, blames his 2001 heart attack on the medication, claiming that Merck had hidden the drug's risks.

In the first trial, which took place in Texas in July and August, a jury decided in favor of the family of a patient who died from a heart attack after taking Vioxx for eight months and found that the company had misrepresented the dangers of the drug.

Henry Allen, Esq., a health law attorney and partner with Holland & Knight in Chicago, said the verdict was probably different this time around because the plaintiff had only taken the drug for about two months. In addition, a juror told Reuters that a major deciding factor was that Mr. Humeston had suffered from other health issues prior to taking the drug.

Mr. Allen added that this case highlights how difficult it will be for future plaintiffs to prove that Merck was at fault, especially for those who took the drug for less than 18 months. The first federal rofecoxib case was scheduled to go to trial last month in Houston and Mr. Allen said that the US District Court Judge presiding over that case will most likely base the formula for future rofecoxib settlements on the “scorecard” of past cases.

NEW JERSEY TO HOUSE BLOOD BANK FOR STEM CELL RESEARCH

New Jersey Acting Gov. Richard J. Codey signed an executive order in October that will create a public umbilical cord and placental blood bank for use in stem cell research. Investigators in the state said that they welcome any new effort to expand the various avenues for stem cell research.

“More often than not, this rich stem cell source is discarded as medical waste after childbirth. But this holds too much promise to simply destroy,” said Gov. Codey in a published news statement.

According to a news release, New Jersey is the first state in the nation to create such a bank with public support. The order will create two pilot programs to allow expectant mothers to donate placental and umbilical cord blood following childbirth, which will then be stored and processed for research. Two nonprofit cord blood banks, the Elie Katz Umbilical Cord Blood Program in Paramus and the New Jersey Coriell Institute for Medical Research in Camden, will work with state health officials in running the program. The order also directs state health officials to educate healthcare providers about the value of such research so that they will inform expectant mothers about donating.

Ira M. Black, MD, Founding Director of the Stem Cell Institute of New Jersey, said since stem cell research is still in its early stages, equal attention should be paid to studying embryonic, adult, or organ cells. “We're really at the very beginning of deciding which stem cells, of any, may be most appropriate for which disease and in that sense, the larger the source we have, the better off we are,” he said. Determining the most promising approach would include examining and comparing stem cells for their ability to grow, differentiate, and self-renew, he added. Dr. Black is also Chair of the Department of Neuroscience and Cell Biology and Director of the Stem Cell Research Center at the University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School.

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Dr. Ira M. Black: “Were really at the very beginning of deciding which stem cells, of any, may be most appropriate for which disease and in that sense, the larger the source we have, the better off we are.”

“I am in favor of putting as much money into stem cell research as possible for New Jersey and support the initiative,” added Kateri A. Moore, PhD, Senior Research Molecular Biologist at Princeton University, in an e-mail to Neurology Today. Dr. Moore works with hematopoietic stem cells.