681THE LANCET

NEW S

Washington PerspectiveFDA’s Kessler stays, NIH’s Healy goesTwo dramas of biomedical politics have played out here

in recent weeks, enriching the precept that too much carecannot be invested in the selection of enemies. One starredDr Bernadine Healy, a Bush appointee who candidly wishedto continue in the Clinton administration as director of theNational Institutes of Health, a post she has held for nearly 2years. The other drama featured Dr David Kessler, anotherBush recruit, similarly desirous of continuing as

Commissioner of the Food and Drug Administration,which he has headed for 2t years. The denouement in bothinstances came on Feb 26 with the announcement that

Healy is to go and Kessler is to stay, by edict of the WhiteHouse, which has absolute authority in these matters.

Kessler and Healy both inherited troubled organisationsthat had long drifted under interim chiefs when they tookoffice. FDA, routinely underfinanced and accused ofinexcusable rushing or delaying the approval of new drugs,was deep in criminal scandal over payoffs from generic drugmakers. Harried by consumer groups, Congress, the

pharmaceutical industry, and the press, FDA was also avictim of the anti-regulatory zeal of the Bush administration.Perhaps out of fear of a pharmacological Chernobyl, orunaware of what it was getting, the Bush White Houseoffered the job to Kessler, who possessed sterling credentialsand experience: degrees in medicine and law, the

directorship of a major hospital in New York, membershipon a government committee conducting an inquest intoFDA’s woes, and prior service on the staff of Senator OrrinHatch, a conservative Utah Republican long involved inhealth-related legislation.

Familiar with Capitol Hill, and taking over an agency thatwas generally regarded as dysfunctional, Kessler boldly andsuccessfully campaigned against pharmaceutical fraud,deceptive food labels, and other shortcomings out of favourwith politics and the public. In quick order, he revived FDAwhile holding the support of the many warringconstituencies that surround the agency. There was no

surprise when the Clinton administration asked him to stayon, nor was there any when Healy announced that same dayshe would leave NIH by June 30.When Healy took office in April, 1991, NIH had been

headed by an acting director for 20 months-a hiatus arisingfrom the Bush administration’s initial insistence that anyprospective appointee must pass an abortion "litmus test".After several candidates declined the honour, the abortionhurdle was disavowed as never having existed. Healy, headof research at the Cleveland Clinic, then accepted theappointment, but from the first she was enmeshed in publiccontroversy, a rarity for NIH directors, who normally passunnoticed outside of biomedical circles.As a member of an advisory panel during the Reagan

administration, Healy had supported the use of aborted fetaltissue for transplantation experiments. Reagan, however,banned federal funds for such research on the grounds that

beneficial use of the tissue would be an inducement toabortion, and Bush affirmed the ban. Asked where she stoodon this issue, the newly installed NIH director offendedboth camps by replying that her personal and professionalopinion remained unchanged but that she would conform tothe policy of the Government she served.

Shortly afterwards, Healy committed the unforgivableerror of openly clashing with Rep John Dingell, an irasciblebaron of Capitol Hill who chairs a committee with extensivepower over NIH affairs. The issue was scientificmisconduct, much in the news then because of several casesinvolving well-known scientists. Dingell insisted that Healyand company were soft on scientific crime and indifferentcustodians of the taxpayers’ research money. Citingpersonnel upheavals that Healy had ordered at NIH’s Officeof Scientific Integrity, Dingell linked them to an ongoinginvestigation of a misconduct case at the Cleveland Clinic.Healy scoffed at the accusations as insulting and

preposterous. Thereafter, the NIH director and the

congressman were linked by mutual antagonism. Dingell,employing a favourite tactic, engaged the services of an NIHmisconduct investigator whom Healy had removed from thecelebrated case of Robert Gallo, the AIDS researcher longunder investigation at NIH.

Healy also had a highly publicised run-in with thetart-tongued Nobelist James Watson, who was

simultaneously serving as director of NIH’s NationalCenter for Human Genome Research and director of the

non-governmental Cold Spring Harbor Laboratory whenshe became director of NIH. "Sheer lunacy" is how Watsondescribed Healy’s efforts to have NIH take patent positionsin genome research. Healy raised questions of conflicts ofinterest between Watson’s financial holdings and his role atNIH. Watson, something of a scientific folk hero, quit NIH,complaining of outrageous abuse by Healy.While these skirmishes raged, Healy was also having

difficulty with her superiors in the Department of Healthand Human Services. Her attempts to devise a long-termstrategic plan for NIH were suspiciously regarded as abudget-busting ploy aimed at embarrassing the Bush WhiteHouse into increasing spending for biomedical research.Drafts of the plan disappeared into the Department, only toemerge months later with requests for revisions and moredetails. When the Bush Administration checked out, the

plan, 2 years in preparation, was still in limbo. Meanwhile,Healy’s nominations of senior NIH staff were similarly lostin the recesses of departmental headquarters.

Healy’s strong championship of expanded research onwomen’s health issues evoked a great volume of favourable

press and TV coverage. But many in the biomedicalresearch community regarded this cause as grandstanding.Ironically, when several Congresswomen backed legislationto put sex quotas on clinical research supported by NIH,Healy offended them by arguing that research protocolsshould not be bound by inflexible rules. When the Clintonadministration took office, Healy was on the outs with manymembers of Congress whose opinions count in biomedicalaffairs.

682 THE LANCET

Dingell, courted by the newly inaugurated PresidentClinton, made it clear that he wanted Healy to go. On Feb 3,Dingell carried his vendetta to an unusual length, appearingas the first witness when one of his own subcommitteescommenced hearings on NIH legislation. Present, too, werethe newly installed Secretary of Health and HumanServices, Donna Shalala, and Healy.Welcoming Shalala to her new position, Dingell noted

that he had presided over "a number of hearings which haveraised questions about the adequacy of NIH mechanisms toguard against scientific misconduct. This has caused anunfortunate stress between this committee and the NationalInstitutes of Health", he said. Dingell went on to express thehope that "those stresses will be removed during youradministration".

Healy was the first to announce her departure. In agracious statement, she said, "My announcement today willhelp ensure that there is time for an orderly transitionwithout the abrupt changes that sometimes challengegovernment agencies". She also said she is confident thatShalala will support the strategic plan, the women’s healthinitiative, and other programmes associated with the Healyregime. Healy said nothing, however, about reports fromOhio that she plans a run there for the Republicannomination for the US Senate in 1994.

Daniel S. Greenberg

Round the World

USA: Health task force draws fire

President Clinton’s Task Force on National Health CareReform has begun to draw fire from health-industry andconsumer groups who complain that they are being shut outof the health-reform process. So far, most of the work of thetask force has been conducted behind closed doors, andPresident Clinton has rejected demands that the group openits meetings to the public.The controversy was highlighted last week when the

280 000-member American Medical Association asked to beincluded more directly in the task force’s work, and waspromptly turned down by the White House. In a letter to thePresident’s senior domestic policy adviser, Ira Magaziner,AMA executive vice-president Dr James S. Todd wrote,"Bring us into the process, we can help make it work". Toddsaid that the AMA would be willing to go along with aNational Health Board to review prices and practices, alarger role for managed-care organisations, and negotiatedhealth-care spending limits-policies that would have beenanathema to the conservative organisation only a few yearsago. "We know the status quo must go", said Todd. He alsowarned the administration that "any reform of the healthcare system will fail without the support of the medical

profession". However, a White House spokesman said thatalthough the administration wanted to hear the views of allhealth-care-industry and consumer groups, it wouldcontinue to exclude such "special interest" groups from thetask force’s day-to-day deliberations.To compel the task force to open its meetings, the

3500-member Tucson-based Association of American

Physicians and Surgeons has sued the administration inFederal District Court, citing a 1972 law that requiresfederal advisory committees to conduct their business inpublic. Dr Jane M. Orient, executive director of the

association, which supports a free-market solution to the UShealth-care crisis, said open debate on the reforms must startnow, otherwise the president will ram his "stealth" packagethrough Congress before effective opposition can bemounted.

Michael McCarthy

India: Proposed new drug policyA revision of the existing drug policy is to be debated in

the current parliamentary session. One of the main reasonsfor the revision is the price control on several drugs, whichmanufacturers say has forced them to reduce or stopproduction of those that are not remunerative enough.Phenytoin sodium, produced and marketed here by Parke-Davis as Dilantin, is a case in point, Parke-Davis stopped theproduction of Dilantin, alleging that the Government didnot allow it to recover its cost price. The Government,however, maintains that the company was importing thisdrug in bulk at a high price despite its availabilityindigenously and more cheaply. The deadlock continues.Although locally produced generic preparations of

phenytoin sodium are available, doctors tell of patients whowere being maintained on Dilantin who have hadrecurrences of epileptic fits on switching to another brand. Apaediatric syrup formulation of Dilantin is also no longeravailable.The existing drug policy, adopted in 1986, was intended

to make essential drugs available to a large section of thegeneral population at an affordable price, while

simultaneously encouraging the indigenous pharmaceuticalindustry to modernise and to broaden its base. The DrugPrice Control Order (DPCO) issued in August, 1987, covers143 drugs-21 category I drugs deemed necessary fornational health programmes, and 122 category II or essential

drugs identified by an expert committee (KelkarCommittee) from a basket of 418 drugs-which todayaccount for nearly 72% of the turnover of the organisedsector. Manufacturers cannot sell these drugs at a pricehigher than that fixed by the Government, calculated toallow a reasonable profit. Although a company can apply tohave the price revised after three years to account for factorssuch as increased costs of raw materials, the reasonableprofits promised by the DPCO have seldom translated intoreality, partly because the pricing policy does not alwayscapture all the actual costs incurred and the process ofrevision is so cumbersome and slow. According to a studyconducted by the Organisation of PharmaceuticalProducers of India, the average pre-tax profit from the homemarket was only 1% of sales in 1991-92, hence manycompanies subsidise their domestic business by exports andnon-pharmaceutical products such as food, agrochemicals,and consumer products.

Satyendra Nath Chattopadhyay, of the Ministry ofIndustry’s Bureau of Industrial Costs and Prices, whichrecommends prices and price revisions for drugs, does notdeny that the system should be flexible enough to giveadequate and timely price increases since costs of productionare increasing continuously. "However, if a manufacturer isimporting raw material which is available indigenously, andthe imports constitute less than two-thirds of the total

consumption of that drug by the industry, we can only allowthe domestic price", he adds. In the case of Dilantin theimported raw material costs twice locally produced rawmaterial. Parke-Davis argues that domestic supply is oftenerratic and that it was importing phenytoin sodium (for