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NEWS & VIEWS

NIH SCIENTISTS HIRE LAW FIRM TO NEGOTIATE WITH AGENCY

NIH scientists added bite to their bark when they hired a law firm in April to convince the agency to re-evaluate changes to ethics rules that bar scientists' financial ties to industry.

The law firm, Arent Fox, filed a motion on behalf of the disgruntled scientists with the US Circuit Court of Appeals for the District of Columbia asking them to review the new conflicts-of-interest rules. According to the Los Angeles Times, the firm has ties to pharmaceutical and biotechnology companies that, in the past, hired NIH scientists as consultants.

Dissenting Scientists

One of the scientists, Ezekiel J. Emanuel, MD, PhD, Chair of the NIH Department of Clinical Bioethics, said his group wants to work with the Department of Health and Human Services (HHS), which oversees the NIH, and not against it.

A news brief in the May Neurology Today (page 50) discusses how the new rules have made many NIH staffers unhappy; one scientist claims that the changes have made it difficult to recruit new talent.

Dr. Emanuel told Neurology Today in a phone interview that the Assembly of Scientists, a group originally formed in 1959 to represent the interests of the intramural scientists at the NIH, are most concerned about the portion of the new rules that prohibit scientists from holding stock in any healthcare-related companies.

Response from the NIH

NIH Deputy Director Raynard Kington, MD, PhD, said the NIH is working with the HHS to change the stock prohibition, after both departments received an overwhelming amount of negative feedback within the 60-day window they gave to employees to respond. Any changes must ultimately be approved by the HHS.

“Our goal is to assure the public that our scientific information is without bias, but we also want the rule to be reasonable and fair to our employees,” he told Neurology Today in a phone interview.

Dr. Emanuel said that within the 60 days, his group also submitted to the NIH a detailed proposal that outlines “ideas for less onerous and intrusive regulations that get the job done.”

“The fundamental problem with the HHS regulations is that they try to bar every financial interest, suggesting that every financial interest is a conflict-of-interest, and that is just a fundamental misunderstanding,” he said. His group's proposal, he added, ties the prohibitions on consulting and stock ownership directly to the research in which a scientist is engaged. It also calls for the HHS to the rethink its ban on healthcare stocks that are part of financial portfolios that employees do not directly control, such as mutual funds.

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Dr. Raynard Kington said reviews suggest that NIH salaries are generally competitive at the junior and mid-career levels, but lag somewhat behind industry at senior levels.

“If you don't make a decision on it, how could it possibly influence you?” he said.

Salary Review to Come

In response to speculation that some NIH scientists perform outside consulting work to offset their salaries, which some say are not as competitive as those in industry, Dr. Kington said that his department is currently reviewing the salary structure of the agency. He said that reviews suggest that NIH salaries are generally competitive at the junior and mid-career levels, but lag behind industry at senior levels.

Dr. Kington said the new rules still allow scientists to interact with pharmaceutical and biotechnology companies and to give talks at academic institutions as part of their “official responsibilities,” meaning that they would be working on behalf of the NIH and would not receive outside compensation for those services. In addition, scientists may be compensated for CME-type lectures and teaching courses that are based on their general area of expertise, rather than on their specific research at the NIH.

Michael A Williams, MD, Chair of the AAN Ethics, Law and Humanities Committee and Assistant Professor of Neurology at Johns Hopkins University School of Medicine, said that the federal government originally mandated that the agency work with industry to transform its research into products that are useful to patients.

Dr. Williams said both sides can resolve the issue by establishing rules that “ensure the integrity of the NIH but also do not compromise the scientists ability to do what they need to do.”

NATIONAL ACADEMY OF SCIENCES ISSUES STEM CELL GUIDELINES

At a time when stem cell research is mired in political and scientific debate, the National Academy of Sciences (NAS) is recommending that oversight committees be established to ensure adherence to standard practices for deriving, storing, distributing, and using embryonic stem cell lines. The guidelines intend to enhance the integrity of privately funded human embryonic stem cell research, according to the committee that wrote the report, which was a joint project between the NAS National Research Council and Institute of Medicine.

The proposal, issued in late April, suggests that all institutions establish Embryonic Stem Cell Research Oversight (ESCRO) committees comprising stem cell investigators, legal and ethical experts, as well as representatives of the public. The committees would not replace existing institutional review boards, but would ensure adherence to standard research guidelines

New Guidelines

Among the guidelines, they state that donor consent must be obtained before a blastocyst is used to generate stem cells and that ESCRO committees should ensure that there are no conflicts-of-interest between researchers and donors. Investigators collecting stem cells, for example, would not be able to influence any decision involving fertility treatments. In addition, donors would not be allowed to receive payments for their contributions.

The guidelines also regulate research involving chimeras, animals made wholly or partly of human parts. Human organs grown from embryonic stem cells should be tested in animals only in cases where no other alternatives exist, the guidelines state. They specifically warn against experiments that test human brain and reproductive cells in animals.

Several stem cells scientists applaud the guidelines.

“It is not a bad idea to have the most respectable scientists make suggestions to help translate potentially controversial technology,” said Dennis Stiendler, PhD, Director of the Evelyn F. and William L. McKnight Brain Institute of the University of Florida. “If the goal is to generate just the stem cells that we need for research, we need standardization of protocol with a nice set of guidelines that will generate a better way to use the material wisely.”

Ping Wu, MD, PhD, Assistant Professor in the Department of Anatomy and Neuroscience at the University of Texas Medical Branch in Galveston, said in an e-mail to Neurology Today that ESCRO committees are helpful for setting clear policies for researchers and with facilitating communication between scientists and the public.

Paul Root Wolpe, PhD, Faculty Associate at the Center for Bioethics at the University of Pennsylvania, said in an e-mail that the previous lack of guidelines created a strange disconnect between the federal government, which banned most embryonic stem cell research, and private industry, which he says was working without a regulatory net.

“It is important to show that we are not talking about mad scientists secretly playing with life in the lab,” he said. “Scientists want to do this work ethically, and these guidelines will greatly enhance their ability to proceed with needed research in an ethical way.”

The AAN and American Neurological Association expressed support for expanded federal and state funding for embryonic stem cell research in a position paper issued in October 2004. It can be found at www.aan.com/advocacy/pdfs/stem_cell_statement.pdf.

The NAS has suggested the formation of a national independent body to review the guidelines periodically and to update them for any scientific advances and evolving public attitudes. The guidelines can be found at www.nap.edu.

STUDY FINDS CONSENT FORMS TOO CONFUSING

A new study confirms what many in the neurology community say is a common problem: research consent forms are often too difficult for the average person to understand.

An investigative team, led by Alan R. Tait, PhD, Professor of Anesthesiology and Director of Clinical Research at the University of Michigan, surveyed 305 parents of children scheduled for minor elective surgery.

The parents were given two different versions of a consent form and told to consider the forms as if their child were actually participating in the study. The first version was a standard consent form that was written at an eleventh-grade reading level. The second was modified to adapt to an eighth-grade reading level. Researchers also increased type size from 12 to 14 points, added boldfacing and underlining for emphasis, and bullets and diagrams to clarify the information.

Researchers reported that the parents who received the modified form had a much better understanding of the procedure than those who received the standard form. The parents were later shown both forms, and 81 percent preferred the modified form.

James C. Johnston, MD, JD, a neurologist and attorney who is Director of Legal Medicine Consultants, LLC, in San Antonio, TX, said the problem of incomprehensible consent forms extends to neurology studies. “It is not uncommon for neurology consent forms to be presented in a language, format or setting that is beyond the full comprehension of most patients,” he said in an e-mail to Neurology Today. Dr. Johnston said that this issue is especially critical in neurology trials because of the added burden of including patients with cognitive dysfunction.

“Some practitioners are unfamiliar with the informed consent process, and fail to adopt a consistent protocol,” he continued. “The result appears to be an increased number of informed consent claims against neurologists.”

Dr. Johnston suggests neurologists modify consent forms to the guidelines suggested by Dr. Tait and his colleagues. He also recommends that physicians document all discussions they have with their patients, whether or not a consent form is used.

The study is published in the April issue of the Archives of Pediatrics and Adolescent Medicine (2005;159(4):347–352).

PATIENTS SUE AMGEN FOR ACCESS TO PD DRUG

Two participants in an Amgen-sponsored Parkinson disease (PD) study are suing the company after it discontinued an experimental drug that they said greatly improved their quality of life, reported the New York Times in late April.

The trial studied the effects of GDNF (glial-cell line-derived neurotrophic factor). GDNF seemed promising in two phase I studies, which studied the treatment in animals and in a small open trial. However, the results of a randomized controlled Amgen-sponsored phase II trial suggested that the drug did not show a significant difference over the placebo and caused brain damage in studies done on monkeys, the company contends.

Amgen halted the distribution of the drug last year, but several investigators and patients urged the company to continue providing the drug, arguing that it worked and showed no dangerous side effects. The FDA had also ruled this January that the drug appeared safe and that the trial should continue. However, Amgen confirmed its earlier decision this February.

The whirlwind of controversy that followed the Amgen decision is discussed in the April issue of Neurology Today (page 4) in which investigators on both sides of the issue weigh in on the company's decision.

The plaintiffs filed their lawsuit in Federal District Court in Manhattan on April 26. The suit claims that Amgen “treated the patients as mere guinea pigs, as material to be discarded,” and had violated a legal and moral obligation to continue to supply the drug, the New York Times reports.

Robert Suthers of Greenlawn, NY and Niwana Martin of Harpers Ferry, W. VA, were both treated at New York University Medical Center. Their lawsuit also argues that the drug company and patients had, in effect, entered into a contract, in which the company promised to continue providing the drug as long as it proved to be safe and effective. The trial required surgery to deliver GDNF into the brain. According to the lawsuit, Mr. Suthers had a stroke after this surgery and had to have a second operation to correctly position a catheter that had come loose.

Mr. Suthers claims that the drug allowed him to walk two miles regularly. Since he has been deprived of the drug, his wife told the New York Times, he can barely walk a block.

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Dr. Don Gash said Amgen has a poor record in organizing clinical trials for Parkinson disease.

Don Gash, PhD, Professor and Chair of Anatomy and Neurobiology and Director of the MRI Center at the University of Kentucky, was a co-investigator on one of the phase I trials that were designed independently of Amgen. He said in an e-mail to Neurology Today that Amgen has a poor record in organizing clinical trials for PD and recommended that a team outside of Amgen organize the next trial for GDNF.

“It seems to me that they walked away from a promising drug that would help hundreds of thousands patients with Parkinson disease,” he said.

Alan C. Milstein, the lawyer representing the two patients, told the New York Times that more patients may participate in the suit, but that it was more efficient to start with two plaintiffs because the goal was to get the court to quickly order Amgen to provide the drug.

CANADA APPROVES CANNABIS-BASED PAINKILLER

The debate over medicinal marijuana took another turn last month when Canada became the first country in the world to approve a cannabis-based prescription painkiller for multiple sclerosis (MS) patients suffering from chronic pain.

Health Canada, the federal agency responsible for overseeing the country's health care system, approved the drug, which is made from extracts of Cannabis sativa L., cannabis plants that ease pain, according to a news statement from Health Canada.

The drug will be marketed by Bayer Healthcare under the brand name Sativex, and is expected to hit pharmacies by this summer. The British drug company GW Pharmaceuticals developed the drug, which can be sprayed under the tongue or inside the cheek.

Mark Ware, MD, Assistant Professor of Anesthesia and Family Medicine at McGill University in Montreal, co-authored a 2004 study that showed increased use of marijuana among Canadian MS patients to ease symptoms. He called the Health Canada development a “step in the right direction” (Neurology 2004;62:2095–2097).

“This opens the door to possibilities of exploring other modes of delivery combinations,” he said. However, he warned that there is a need for further research of medicinal marijuana and associated products.

Joseph I. Sirven, MD, Associate Professor of Neurology at the Mayo Clinic College of Medicine in Scottsdale, AZ, said in an e-mail to Neurology Today that neurologists should inform their patients that experts do not have enough information to determine the risks or benefits of this therapy. Dr. Sirven co-authored an editorial accompanying Dr. Ware's survey (Neurology 2004;62:1924–1925).

“We need more research on this topic so that either we can discourage people from cannabis use if it is not effective or harmful, or encourage regulatory agencies to explore cannabis as a therapy if indeed benefits are found,” he said.

The medicinal marijuana product was approved based on a double-blind, placebo-controlled four-week trial in MS patients suffering from neuropathic pain for at least three months. The study found that the drug reduced pain and decreased sleep disturbance.

Canada is also the first country to adopt a system regulating the medicinal use of marijuana for people suffering from terminal illnesses and chronic pain, a measure it passed in 2001.

In the US, medical marijuana is legal in 11 states, and the Supreme Court is currently considering a case involving the use of marijuana for medical purposes, according to the New York Times. The US federal government classifies marijuana as a dangerous drug and considers it illegal under the Controlled Substances Act, which supersedes any laws passed by the states.

According to a spokeswoman for Bayer, Inc. in Canada, medicinal marijuana will only be made available through pharmacies by prescription and cannot be ordered through the Internet.