The French Way (7 page)

The deadly AIDS epidemic, which emerged during the early 1980s among Americans, threatened to envelop Europe and spurred researchers in both France and the United States to find its cause. A team of virologists at the Pasteur Institute in Paris led by Dr. Luc Montagnier and another at the National Cancer Institute in Maryland under Dr. Robert Gallo claimed almost simultaneously, between 1983 and 1984, the discovery of the culprit, what later became known as the human immunodeficiency virus, or HIV. At first there was transatlantic scientific cooperation: the Pasteur team provided the Americans with specimens and research data, which the latter used to isolate and reproduce the virus. Identification of the virus led to research for techniques to curb
the disease and especially for a test that would screen blood supplies and donors. Patent rights for such a test, given a viral outbreak that could become a pandemic, had the potential of generating revenues on a global scale. The French and the Americans soon became embroiled in a controversy—which lasted almost a decade—over who had discovered HIV and who deserved the patent rights. In 1984 the U.S. Patent Office ignored a request by the Pasteur Institute for rights to a prototype diagnostic test, which it had licensed to a Seattle company, and instead awarded a patent to the Gallo team on behalf of the U.S. government. At stake were not only millions of dollars in royalties but also the scientific prestige of discovery—which was keenly felt by the Pasteur Institute because its reputation had been eclipsed. Some speculated (correctly, as it turned out) that a Nobel Prize might even be awarded the researchers.

The transatlantic rivalry inflected the way France confronted the AIDS epidemic in three ways: patent rights, blood transfusions (i.e., treatment with heated versus unheated blood products), and testing blood donors and stocks. In the latter two cases the contest had deleterious consequences for hundreds of French patients.

Administrative control of the blood supply in France was complicated. This bureaucratic tangle played an important part in this sad affair because it hampered communication and clouded responsibility. The Centre National de Transfusion Sanguine, or CNTS (National Blood Transfusion Center), was “national” in only a limited sense: it monopolized the import of all blood products from abroad, represented France internationally, and acted as the principal technical adviser to the government. As a major fractionating, or separation, center it also supplied plasma and concentrated blood products for Paris and much of northern and western France. But the CNTS had no authority over either 160 other transfusion centers, which also collected blood from donors and distributed products to users like physicians and hospitals, or the several regional fractionating centers like the one at Lille, which sometimes cooperated with, and sometimes competed against, the CNTS. The CNTS itself was divided into two sections: one for production and
distribution and another for research. It received advice from numerous consultative boards composed of hematologists and other medical researchers, and in turn reported through various bureaucratic routes to the Ministry of Health and, above all, the Ministry of Social Affairs, which subsidized the CNTS, set prices for products, and bore the ultimate responsibility for the national blood supply. The point person for the administration was the director of health, a post held at the time by Jacques Roux.

At first, French officials regarded AIDS as a sexually transmitted infectious disease confined mainly to American homosexuals; it was not long, however, before cases appeared among those receiving transfusions in both countries, suggesting that blood could be a carrier. French authorities were confident that their blood stocks were “pure,” certainly compared to those in the United States. Blood donations in France were given freely, without reimbursement, and were thus presumably less likely to carry disease than donations enticed by payment from marginal members of the populace. The best protection then appeared to be stopping the importation of blood products from the United States.

If recipients of transfusions were in danger, hemophiliacs were even more vulnerable because they needed regular treatment with anticoagulants that were especially susceptible to HIV contamination. Anticoagulants derived from blood lots donated by thousands of donors multiplied the risk of contamination. If blood could transmit HIV, then donors required screening and blood needed treatment before it could be used. France relied entirely on unheated blood products, but over the course of 1983-84 studies showed that heating blood products reduced the possibility of contamination. Preliminary findings, reported at an international conference held in Munich in the summer of 1984, tentatively confirmed the effectiveness of heating blood products and testing donors. When an American company, Travenol-Hyland Laboratories, offered to sell heated products to the CNTS in early 1984, the center ignored the proposal on the grounds that imports would cause a panic among French users who would think that they had been exposed to
infection by the use of unheated products.
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Confidence in the safety of the French blood bank precluded American imports.

By then France—and Paris, in particular—was in the grip of the AIDS epidemic and it was becoming increasingly clear that one of its target populations was that of hemophiliacs. But the CNTS, which was directed by Dr. Michel Garretta after October 1984, harbored doubts about the effectiveness of heated products in deactivating both HIV and a certain type of hepatitis. There was also the fear of incurring huge financial loss from the unsold French blood bank and causing a panic, especially among those dependent on regular transfusions.
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Garretta elected to continue using unheated concentrates, including Factor VIII, which was one of the anticoagulants used by hemophiliacs that were easily contaminated by the dreaded virus. Dr. Garretta, who was under pressure from the Ministry of Health to make France self-sufficient in blood products—in part to avoid imports that might be contaminated—accelerated the production of Factor VIII without waiting for the development of heating techniques and without increasing imports of heated products from outside sources like the United States. But the director of the CNTS did take precautions: he signed a contract with an Austrian firm to use its heating technology in a new plant that would come on line in 1985.

By early 1985, evidence gathered by French researchers demonstrated that the national blood supply was probably contaminated and that there was a grave risk of infection from the use of unheated products. Meanwhile, Dr. Montagnier's team confirmed that heating blood concentrates deactivated the virus. Those responsible for the blood supply had to choose: they could recall previously distributed products, destroy the rest, and turn to the Americans or other suppliers for heated products, or they could continue monitoring the situation and depend on the Pasteur Institute, which was on the verge of perfecting its own heating process, and wait for the opening of the new CNTS plant that would rely on Austrian technology. They chose to wait. Opting for a recall and turning to American or other suppliers of heated blood products
would incur heavy financial loss for the CNTS, which was under instructions from the Fabius government to control costs. Moreover, foreign laboratories, principally American, would most likely replace French suppliers. There was a third alternative, but because of rivalries among the transfusion centers the CNTS also rejected turning to local fractionating plants like the center at Strasbourg, which Travenol-Hyland Laboratories was assisting in developing its heating process, and the center at Lille, which had designed its own technique. In April, Dr. Garretta attended an AIDS medical convention in Atlanta; he later admitted that he should have begun purchasing American products then: “I should have bought massive amounts of heat-treated blood from abroad. I didn't do it. It was a mistake.”
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Advisers to the CNTS in the spring of 1985 were giving contradictory advice: some recommended that “the stock of ‘contaminated' products be distributed entirely before proposing the substitution of heated products”; this might mean, they acknowledged, selling their stores at discount on the French market or exporting them.
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Others urged that all stocks be recalled immediately and destroyed. At a fateful meeting of the CNTS on May 29, Dr. Garetta acknowledged that all the Paris center's stocks were, at least in a statistical sense, contaminated. One scientist in attendance estimated the probability of any lot of CNTS blood being safe was 1 in 22,000. Nevertheless, Dr. Garretta cited administrative, judicial, and practical obstacles for a recall, especially noting “serious economic consequences.”
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Estimated losses for halting the distribution of Factor VIII alone were over a million dollars a month while destroying the large store of unheated blood and importing concentrates would cost $10 million or more. Dr. Garretta chose to continue the current practice of distributing unheated supplies and passed responsibility, including the financial losses, for changing course to the ministries.
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But recommendations to the ministries from the CNTS about modifying existing policy were often ambivalent: they cited costs and uncertainties about obtaining supplies and managing a recall, and these reports, once forwarded, seemed to get lost in the
bureaucracy. Without intervention by the supervisory ministries, the practice of depleting the unheated stores continued throughout the summer and early autumn of 1985. Budgetary constraints, bureaucratic fumbling, and holding off the Americans trumped medical ethics and safety.

Meanwhile, inquisitive and often critical articles in medical journals and the press urged the government to act promptly to secure the blood supply. But Dr. Garretta received no instructions from the ministries to recall or destroy existing blood stocks. On June 26 he informed his colleagues in charge of transfusion that sufficient heated blood products from domestic providers would not be available for at least a month, and concluded, “The distribution of nonheated products remains the normal procedure, so long as they are in stock.”
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He later argued that he had to wait on French suppliers because available imports were inadequate, but this argument has been challenged: it seems foreign suppliers, like the Americans, were willing and able to meet French needs.
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Moreover, the regional fractionating center at Lille, which had acquired the technology, claimed it could fill much of the demand itself.
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As a precaution the CNTS, which now was fully aware of the risk of contamination, urged using remaining unheated French products for those already infected with HIV and reserving the heated supply for patients without HIV. Yet without readily available screening tests, it was impossible to know which patients were HIV-positive.

Screening tests were a second missed opportunity that turned on the rivalry with America. Until 1985 there was no reliable way to check donors or the blood supply for HIV. Researchers at the Pasteur Institute were working on such a technique when in February 1985 the Americans perfected a process and offered it to the French. Abbott Laboratories, which marketed the test, contacted the CNTS and sent representatives to local French transfusion centers selling their technology. Thus the Americans forced another decision on the CNTS and the responsible ministries: importing the Abbott test would rob the Pasteur Institute of its French market valued at $II million and possibly its global market.
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In early May, at a meeting of representatives of the ministries, the scientist representing the prime minister's office decided to delay licensing the Abbott test, even though it was less costly and simpler to use, in order to protect the French market for the Pasteur Institute.
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The American rival was on their minds. Officials were told to do what they could to save the national market, which was “already in large part captured by the American test,” for the Pasteur test.
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As Jacques Roux, a key official in the health administration, stated later, “It appeared utterly normal that they tried to help Pasteur whose financial weakness handicapped it industrially and commercially compared to an American industrial giant.”
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A month later, on June 18, 1985, Dr. Montagnier confirmed that the Pasteur Institute had perfected its screening technique; the next day Prime Minister Fabius promised the National Assembly he would make checking for HIV mandatory for blood donations. The Pasteur test was immediately licensed while the Abbott test did not receive its certification until the end of July. During the intervening weeks the principal transfusion centers equipped themselves with the Pasteur test. The Fabius government continued to dally. It was not until July 23 that the Ministries of Health and Social Affairs ordered mandatory tests, but they postponed the start date until October 1 and did not require the destruction of existing blood stocks.

Together, hesitant and divided officials from the CNTS and the ministries delayed introducing screening tests and continued providing unheated products, which were most likely contaminated, during the spring and summer of 1985 to anyone who would buy them; this deadly practice continued until October. The CNTS and the supervisory government officials had passed up importing American heated products and the Abbott test in order to avoid financial losses and to protect the French from dependence on the United States. They did not want to undermine confidence in French medicine and medical research, to give an advantage to the Americans in the competition for medical markets including France itself, especially in patenting and selling the tests and treatment that might control the epidemic, or to boost their
transatlantic rivals' claim in the legal contest over who discovered HIV. But this unseemly rivalry had its costs. Between April and August 1985, when the risk of communicating the virus was obvious, over a million units of unheated factor VIII alone were sold and, it has been calculated, over 1,000 recipients—mainly hemophiliacs—were infected with AIDS.
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France continued distributing unscreened blood products for more than six months after the United States, Canada, and several other countries had stopped the practice. The transatlantic rivalry was more than a battle of words and policies; in this case it cost hundreds of lives.