England's first year of health

NEWS the board dismissed three of ORI’s findings against Gallo on grounds of lack of End of the Gallo evidence, leaving two intact-that he misrepresented the French accomplishment in Science and that he withThe prolonged and acrimonious mis- 1 to finish the Gallo report. In April, held reagents from other researchers. conduct case against Robert C Gallo 1991, Bernadine Healy stormed into Following the Popovic dismissal, collapsed last week when the agency1 NIH as director, and uprooted OSI, ORI that had branded him guilty of scien- 1 accusing it of press leaks and undue requested a one-week delay. On Nov 12, ORI’s Bivens announced tific misdeeds declined to contest an friendliness towards "whistleblowwithdrawal of the Gallo findings, sayappeal by the renowned and reviled1 ers". Rejecting Healy’s orders to AIDS researcher. Gallo triumphantly1 ing that the board "applies different soften the Gallo report, Hadley quit claimed exoneration, asserting that1 standards from those applied by" his tormentor, the Office of Research the case. Soon afterwards she reapORI, adding that the board’s stanIntegrity (ORI), realised it would fail1 peared on the misconduct circuit-as 1 dards "reflect a fundamental disan independent review. ORI con- 1 an aide to Congressman Dingell. agreement with ORI as to the OSI’s rewritten Gallo report, isceded as much, and slunk away in1 of clarity, accuracy, and rout, leaving behind a mess of scien- 1 sued in September, 1991, censured 1 importance in science". and debris honesty tific and unrejudicial Gallo for unbridled self-aggrandiseGallo said he would now be able to solved questions about the canons of1 ment, belittlement of Pasteur’s contri1 concentrate in behaviour the conduct of on AIDS research. 1 butions, and other unpleasant 1 personal research. As the case played out over 1 When I spoke to Bivens about the characteristics. The chairman of an 1 nearly a decade, it illuminated the OSI board standards a few weeks appeals advisory panel, Frederic M strange linkages and interactions that1 he ago, glumly noted that ORI had have developed between the once1 Richards, professor of molecular 1 voluntarily signed on with the board. autonomous enclave of science and1 physics and biochemistry at Yale, 1 "We did it to ourselves", he said. the public and politicians that are its charged that Gallo’s hoarding of1 ORI now plans to amend the misconindispensable patrons. reagents had seriously impeded AIDS duct criteria to read that misconduct Gallo and his colleagues’ isolation1 research. Nonetheless, OSI conof the AIDS virus quickly led to a1 cluded that Gallo’s tactics did not rise 1 can be established if a scientist "eiblood test for antibodies to the virus. 1 to misconduct, tops on the scale of ther knew or should have known" It also brought a challenge from the scientific sin. A token "sanction" of i that that behaviour was not permissible. Pasteur Institute, which claimed pri- 1 close surveillance was recommended. From Dingell’s camp, the word is ority and accused Gallo of understat- 1 Healy declared Gallo "exonerated". that their man is not through with the ing its achievement to glorify his own. 1 Dingell called it a whitewash and the Gallo case. Legal artillery was being unlimbered1 Department of Health and Human for a fight over lucrative patent royal- 1 Services (DHHS) accepted his deties, when the dispute was resolved by mands for a new investigation, asDaniel S Greenberg an agreement between President1 signing the task to a new creation, the Office of Research Integrity (ORI). Reagan and French premier Chirac Headed by Lyle Bivens, the new that scientific credit and royalties be1 first year of ! office was sensitive to charges of lack the two countries. shared equally by of due in of scienuntil the All was relatively quiet i process pursuit health tific delinquency. To correct this, in November, 1989, when the Chicago Tribune published an extraordinary November, 1992, it voluntarily added Health secretary Virginia Bottomley an appeals process. Henceforth, aparticle by John Crewdson suggesting launched the first annual report on the that Gallo had robbed the French of Health of the Nation strategy this week. peals could be made to the DHHS Board. their virus and rightful credit, though However, most of the data in the thick, Appeals The board instituted two it cautiously concluded that Gallo’s glossy, multicoloured document predated promptly or overlapped with the introduction of the claims of discovery were based on legal standards for establishing misstrategy. Data in each of the five key areas conduct-intent and materiality. ORI "either an accident or a theft". The of coronary heart disease and stroke, canhad assumed that a prima facie case of article was embraced by Rep John cers, mental illness, HIV/AIDS and sexual Dingell, a legislative overseer of NIH misconduct existed if it could be health, and accidents were presented. Of and proponent of the thesis that scishown that a scientist had engaged in the 19 sets of data in these areas that were ence is soft on crime. NIH ordered "fabrication, falsification, plagiarism available, 16 were felt to be already movan investigation by the or other practices that seriously deviOffice of ing towards the targets set last year. Scientific Integrity (OSI), recently esate from those that are commonly acExamples included a 9% reduction in actablished in response to Dingell’s alcidental deaths since 1990 among chilcepted in the scientific community", dren aged less than 15 years (the target but the board insisted that ORI legations. Serving as chief investigator of the Gallo case was OSI’s acting dibeing a 33% fall by 2005) and a 4-8% would have to prove intent to deceive drop since 1990 in the death rate from and serious consequences from the rector, Suzanne Hadley. By early

opening day approached,

WASHINGTON PERSPECTIVE

case—maybe

’

England’s

coronary heart disease in people aged under 65 years (the target being at least 40% by 2000). According to the report, these early successes, although not attributable to the strategy, indicate that the targets have been set in areas that offer scope for

1991, Hadley was drafting a damning report against Gallo and one of his Mikulas principal associates,

deception. Using that standard, the board dismissed all of ORI’s findings against Popovic, when a full-fledged director Popovic, whose case was heard before for OSI was appointed. Hadley then Gallo’s appeal, due to open on Nov moved elsewhere in NIH, but agreed 8, and to run for at least 3 weeks. As

,

progress.

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The targets where the data are not already moving in the right direction are reductions in the percentage of obese people, in overall suicide rate, and in prevalence of smoking among 11-15 year olds. The last target would seem the most pressing since the original aim was to reduce smoking in this age group by at least 33% by the end of 1994. In fact smoking rates in this age group have remained static between 1990 and 1992. The document pointed out new steps that have been taken, which will not have had time to affect the data available, such as recent

Abortion foes’

new

claim

Anti-abortion activists in the US have launched a publicity campaign claiming that epidemiological evidence linking abortion to breast cancer is now strong enough for women to be warned of the danger. The medical establishment, they charge, is concealing the evidence because of its "pro-choice bias". Proponents of the view cite the work of two men, Scott Somerville, a lawyer and anti-abortion activist, and Joel Brind, PhD, a professor of biology and chemistry at Baruch College, City University of New York, who holds faculty appointments at New York’s Mount Sinai School of Medicine and Beth Israel Medical Center. Both men have gone public with their own independent reviews of the medical literature. In his review’ Brind concludes that an abortion in absence of a full-term pregnancy may increase a woman’s relative risk of breast cancer to 1-5. "If we v then assume an average lifetime risk in the absence of abortion of 10% then we can expect abortion to be responsible for at least 40 000 excess cases of breast cancer every year, by the time the cohort of American women who were in their twenties in 1973 reach their eighties in 2023." Somerville’s conclusions are even more dire. Brind said he arrived at his conclusion by carefully re-analysing data in published studies. According to Brind, re-analysis was necessary because in many of the papers he reviewed "the researchers showed a pro-abortion bias in designing their studies or presenting their data in ways that would minimise or eliminate the evidence of an increased risk of cancer due to abortion". Brind maintains that the better designed studies all tend to support the association. "I was frankly surprised and amazed with the consistency with which an elevated risk was found". But some epidemiologists whose work Brind cites in his critique disagreed with his methods of analysis and findings. "It is epidemiologically illiterate", said Nancy Krieger, director of research at the Kaiser Research Institute in Foundation Oakland, California. "The lack of epi-

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sales of tobacco to uneducation campaign aimed at parents in the north of England. But those who feel that a ban on tobacco advertising would greatly help the achievement of the target in children’s smoking will find themselves once more at odds with the government. Mrs Bottomley’s evasiveness when questioned directly about such a move at the document’s launch indicated that the UK government’s opposition to such a ban remains firm.

legislation

on

der-16s, and

Prions and

illegal a

placentas

new

1

Official disquiet about the risks of disease transmitted (notably by prions Creutzfeldt-Jakob) has taken on a new dimension in France. A group of scientific and medical experts convened by the Agence du Medicament (the French equivalent of the US Food and Drugs has asked for an urgent 1 Administration) review of the industrial processes of the Societe Pasteur Merieux Serums et Vaccins (Rhône Poulenc group), one of Sarah Ramsay the largest producers of blood products in the world. The firm has specialised for 20 years in collecting placentas from materis demiological knowledge profound." nity units in some 40 countries for the was critical of Brind’s final Krieger sharply production of albumin, immunoglobulins, risk estimate of 1-5. Such a conclusion and collagen, which are sold worldwide. would require meta-analysis, Krieger said. The problem, which came to light re"It’s beyond irresponsible to simply eyecently in France, concerns the origin of ball relative risks for a variety of studies the placentas, which often come from and conclude that one can come up with countries where AIDS is common, and an overall risk." Krieger said the hypothethe facts that history of disease in the sis that abortion may increase breast canwomen is not sought and that placentas cer certainly warrants discussion, "but this are not tested serologically. However paper goes much further than this. They thorough the processing is later on, the assert it should be accepted as a French experts think that there is a potenrisk factor, when, in fact, the data are not tial risk of transmission of prion diseases. in to resolve this question". They fear, in particular, that among the raw material used by the French firm Lynn Rosenberg of the Slone Epidemiology Unit of Boston University there may be placentas from women in School of Medicine, another researcher whom Creutzfeldt-Jakob disease is not cited by Brind, agreed. "There just aren’t recognised or is incubating. Of particular concern is the possibility that placentas very many studies on breast cancer and abortion, and the studies that there have may be obtained from women who have been are all over the place. They certainly been treated with growth hormone made don’t indicate that there is an independent from cadaver pituitaries. The experts have effect of abortion beyond the effect of a called on the French health authorities to ensure that Pasteur Merieux stops using delayed pregnancy." Brind says he intends to prepare a metaplacentas from women known to be at risk analysis for submission to a peer-reviewed (those who have had growth hormone treatment or have a family history of journal but felt it was important to get his views to the public quickly. neurodegenerative disease) and that it According to National Abortion substantially improves standards of colFederation spokeswoman Pat Anderson, lecting placentas from the 44 countries abortion rights advocates welcome any concerned. The experts also recommend studies on abortion-related that the same measures be taken with good-faith health issues, but that they doubted the donors of placentas as are taken with of the reanti-abortionist blood donors. sincerity searchers. "Nothing we’ve seen shows that Revelations by a daily newspaper, Le they have a leg to stand on", Anderson Monde, of the confidential conclusions of said. Abortion foes are trying to cast the group of experts in virus safety has doubts on the safety of abortions because deeply embarrassed the French government in view of the industrial and ecothey took a drubbing in last year’s election, nomic troubles of the Societe Pasteur losing the White House and a number of Merieux Serums et Vaccins, and also by congressional seats, Anderson said. But antiabortion activist Scott the fact that Rhone Poulenc, up to now a Somerville said the abortion-breast cancer public company, is in the process of being link should be treated seriously. "I don’t privatised. For many observers this claim to have proven that abortion causes episode exemplified the difficulties in calbreast cancer, but women who are decidculating the risk of the medical use of human tissue. However, after the dramas of ing today to have an abortion have the contaminated blood and of growth horright to know there is a controversy." mone infected with Creutzfeldt-Jakob prion, the French public cannot underMichael McCarthy stand why the government authorities have been so slow to learn lessons from the past. 1 Brind J. Induced abortion as an independent

known

risk factor for breast cancer. Association for Interdisciplinary Research in Values and Social Change, 1993; 5 (3).

Jean-Yves Nau