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10 NATURE MEDICINE VOLUME 6 NUMBER 1 JANUARY 2000 NEWS Opposition to new marijuana research rules Dozens of scientists, lawmakers, enter- tainers and patients have protested to the Clinton administration that its new guidelines for medical research involv- ing marijuana are too cumbersome, and will only delay studies seeking to find out whether the illegal drug is valuable for pain relief, nausea and other thera- peutic uses. The administration announced last May that it would ease the restrictions on “research grade” marijuana, making it available to research scientists (Nature Med. 5, 721; 1999). Research protocols require the oversight of the National Institute on Drug Abuse (NIDA), the Food and Drug Administration and the Drug Enforcement Administration— which the complainants argue is a com- plicated and bureaucratic procedure that will keep the research from moving forward “as expeditiously as possible.” Thus, in a letter to Health and Human Services Secretary Donna Shalala, nearly three dozen members of Congress, ac- tress Susan Sarandon, comedian Richard Pryor, scientist Stephen Jay Gould and former Surgeon General Joycelyn Elders, among others, calling themselves the Marijuana Policy Project, complained that the new rules, which came into ef- fect on 1 December 1999, “place a much greater burden on medicinal mar- ijuana researchers than on drug compa- nies that develop and study newly synthesized pharmaceuticals.” But NIDA Director Alan Leshner told Nature Medicine that the new rules were designed to streamline the process— not hamper it—and described the pol- icy as “nothing compared to trying to get a [typical] grant from NIH.” He adds, ”The policy decision was made to expand research opportunities. Some might find the process cumbersome. Do I think it’s cumbersome? No. Do I think we haven’t got it smoothly oper- ating yet? Absolutely. There is no ques- tion we will smooth out the process as it goes.” Leshner admits that since changing the policy there have only been two seri- ous research inquiries: “We expected substantially more interest, but it seems clear there is relatively little interest in the scientific community.” Marlene Cimons, Washington, D.C. Biomedical research in Australia is char- acterized by poor job security, low salaries and a gloomy outlook, a new survey has found. The Australian Society for Medical Research (ASMR) Workplace Survey, which attracted 266 responses, including 32 from Australians based overseas, revealed concern over lack of research funds and poor career prospects. The study showed that more than one-third of Australia’s biomedical re- searchers were planning to change posi- tions in the next year, at home or abroad, in quest of more stable employment and funding. Most Australian researchers seeking overseas work said they wanted to broaden their scientific experience, find a career path and learn new research techniques—priorities ahead of boosting their pay packet. But once a position overseas has been secured, the higher for- eign salaries make it difficult to leave, ac- cording to the convenor of the annual ASMR conference, Jason Smythe: that is why one-quarter of those overseas have been away from home for five years or more. Most overseas researchers are based in either the UK or the US, with a small number in Canada and Germany. The survey revealed that nearly half the researchers within Australia had an an- nual salary range of A$40,000–60,000 (US$25,000–40,000) and only 28% exceeded A$60,000. The opposite is true of those overseas: 53% are earning A$60,000 or more. Not only is the money better overseas, but also there is a better prospect of its continuing to flow. According to Smythe, security in research is diminish- ing in Australia, with tenured positions becoming hard to come by as universities switch to agreements that require ratifi- cation every few years. Most researchers in Australia are on government-funded grants of three or fewer years, with no guarantee of re- newal, compared with the more com- monplace five-year grants in the US and UK. The ASMR hopes that the Australian Government’s promise to double med- ical research spending over the next five years will stop the ‘brain drain’. Rada Rouse, Brisbane Survey shows Australian scientists’ discontent Investigators wishing to carry out clini- cal trials of xenotransplantation in the UK will have to wait until after June this year to receive approval from UKXIRA (the United Kingdom Xenotransplantation Interim Regulatory Authority), George Griffin, professor of infectious diseases at St Georges Hospital, London, and head of the UKXIRA’s Infection Surveillance sub- committee, told attendees last month at a press conference to launch the group’s second annual report. Furthermore, Griffin advised inter- ested parties to submit any applications before this time, in order to engage in discussions with the UKXIRA panel. But because some aspects of the approval system remain unresolved—namely, the involvement of the Public Health Laboratory Service (PHSL) in disease sur- veillance—many believe that the UKXIRA will not be ready even by mid- year. Griffin was less than forthcoming when one researcher, eager to begin tri- als, pressed him on how likely it is that the necessary monitoring systems will be in place by then, and would only comment that “discussions are under- way” with the PHSL on whether they can take on the responsibility. The subcommittee’s draft document on surveillance attracted media atten- tion recently, since it contains the pro- posal that women xenotransplant recipients must agree not to have chil- dren. The final report is due out in June, and Griffin made it clear that any patients chosen for trials will be care- fully selected. He told Nature Medicine that the first ideal candidates are likely to be young healthy males, unlikely to have children, with a desire to comply with surveillance programs and thereby advance the knowledge of medical science. The UKXIRA is the first level of regula- tion that must be passed before a trial application is handed to the Medicines Control Agency and then to local ethical review boards. So far, the UKXIRA has re- ceived three trial applications; the first was withdrawn and the other two were returned to the investigators because of “insufficient supporting evidence.” A copy of the annual report is available at http://www.doh.gov.uk/ukxira.htm Karen Birmingham, London UKXIRA delays potential xenotransplant trial approvals © 2000 Nature America Inc. • http://medicine.nature.com © 2000 Nature America Inc. • http://medicine.nature.com

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10 NATURE MEDICINE • VOLUME 6 • NUMBER 1 • JANUARY 2000

NEWS

Opposition to new marijuanaresearch rulesDozens of scientists, lawmakers, enter-tainers and patients have protested tothe Clinton administration that its newguidelines for medical research involv-ing marijuana are too cumbersome, andwill only delay studies seeking to findout whether the illegal drug is valuablefor pain relief, nausea and other thera-peutic uses.

The administration announced lastMay that it would ease the restrictionson “research grade” marijuana, makingit available to research scientists (NatureMed. 5, 721; 1999). Research protocolsrequire the oversight of the NationalInstitute on Drug Abuse (NIDA), theFood and Drug Administration and theDrug Enforcement Administration—which the complainants argue is a com-plicated and bureaucratic procedurethat will keep the research from movingforward “as expeditiously as possible.”

Thus, in a letter to Health and HumanServices Secretary Donna Shalala, nearlythree dozen members of Congress, ac-tress Susan Sarandon, comedian RichardPryor, scientist Stephen Jay Gould andformer Surgeon General Joycelyn Elders,among others, calling themselves theMarijuana Policy Project, complainedthat the new rules, which came into ef-fect on 1 December 1999, “place amuch greater burden on medicinal mar-ijuana researchers than on drug compa-nies that develop and study newlysynthesized pharmaceuticals.”

But NIDA Director Alan Leshner toldNature Medicine that the new rules weredesigned to streamline the process—not hamper it—and described the pol-icy as “nothing compared to trying toget a [typical] grant from NIH.” Headds, ”The policy decision was made toexpand research opportunities. Somemight find the process cumbersome.Do I think it’s cumbersome? No. Do Ithink we haven’t got it smoothly oper-ating yet? Absolutely. There is no ques-tion we will smooth out the process as itgoes.”

Leshner admits that since changingthe policy there have only been two seri-ous research inquiries: “We expectedsubstantially more interest, but it seemsclear there is relatively little interest inthe scientific community.”

Marlene Cimons, Washington, D.C.

Biomedical research in Australia is char-acterized by poor job security, lowsalaries and a gloomy outlook, a newsurvey has found. The Australian Societyfor Medical Research (ASMR) WorkplaceSurvey, which attracted 266 responses,including 32 from Australians basedoverseas, revealed concern over lack ofresearch funds and poor career prospects.

The study showed that more than one-third of Australia’s biomedical re-searchers were planning to change posi-tions in the next year, at home or abroad,in quest of more stable employment andfunding.

Most Australian researchers seekingoverseas work said they wanted tobroaden their scientific experience, find acareer path and learn new researchtechniques—priorities ahead of boostingtheir pay packet. But once a positionoverseas has been secured, the higher for-eign salaries make it difficult to leave, ac-cording to the convenor of the annualASMR conference, Jason Smythe: that iswhy one-quarter of those overseas havebeen away from home for five years ormore.

Most overseas researchers are based ineither the UK or the US, with a smallnumber in Canada and Germany. Thesurvey revealed that nearly half theresearchers within Australia had an an-nual salary range of A$40,000–60,000(US$25,000–40,000) and only 28%exceeded A$60,000. The opposite is trueof those overseas: 53% are earningA$60,000 or more.

Not only is the money better overseas,but also there is a better prospect of itscontinuing to flow. According toSmythe, security in research is diminish-ing in Australia, with tenured positionsbecoming hard to come by as universitiesswitch to agreements that require ratifi-cation every few years.

Most researchers in Australia are ongovernment-funded grants of three orfewer years, with no guarantee of re-newal, compared with the more com-monplace five-year grants in the US andUK. The ASMR hopes that the AustralianGovernment’s promise to double med-ical research spending over the next fiveyears will stop the ‘brain drain’.

Rada Rouse, Brisbane

Survey shows Australian scientists’ discontent

Investigators wishing to carry out clini-cal trials of xenotransplantation in theUK will have to wait until after June this year to receive approval fromUKXIRA (the United KingdomXenotransplantation Interim RegulatoryAuthority), George Griffin, professor ofinfectious diseases at St GeorgesHospital, London, and head of theUKXIRA’s Infection Surveillance sub-committee, told attendees last month ata press conference to launch the group’ssecond annual report.

Furthermore, Griffin advised inter-ested parties to submit any applicationsbefore this time, in order to engage indiscussions with the UKXIRA panel. Butbecause some aspects of the approvalsystem remain unresolved—namely, theinvolvement of the Public HealthLaboratory Service (PHSL) in disease sur-veillance—many believe that theUKXIRA will not be ready even by mid-year. Griffin was less than forthcomingwhen one researcher, eager to begin tri-als, pressed him on how likely it is thatthe necessary monitoring systems willbe in place by then, and would onlycomment that “discussions are under-

way” with the PHSL on whether theycan take on the responsibility.

The subcommittee’s draft documenton surveillance attracted media atten-tion recently, since it contains the pro-posal that women xenotransplantrecipients must agree not to have chil-dren. The final report is due out in June,and Griffin made it clear that anypatients chosen for trials will be care-fully selected. He told Nature Medicinethat the first ideal candidates are likelyto be young healthy males, unlikely tohave children, with a desire to complywith surveillance programs and therebyadvance the knowledge of medicalscience.

The UKXIRA is the first level of regula-tion that must be passed before a trialapplication is handed to the MedicinesControl Agency and then to local ethicalreview boards. So far, the UKXIRA has re-ceived three trial applications; the firstwas withdrawn and the other two werereturned to the investigators because of“insufficient supporting evidence.” Acopy of the annual report is available athttp://www.doh.gov.uk/ukxira.htm

Karen Birmingham, London

UKXIRA delays potential xenotransplant trial approvals

© 2000 Nature America Inc. • http://medicine.nature.com©

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