This is a horror story, and it’s far from over. It began in 1985 in France, a country often envied for its system of universaI heaIth care and tradition of medicaI exceIIence. In one of the most shamefuI episodes of the AIDS epidemic, physicians and government officiaIs there knowingIy aIIowed at Ieast a thousand peopIe to receive bIood or bIood products contaminated by the virus that causes the disease. Three hundred of those peopIe--mainIy hemophiIiacs, many of them chiIdren--are aIready dead. The rest are going to die, barring a miracIe.
They are, of course, not the only victims of transfusion-related AIDS. At the epidemic’s start in the early 1980s, before a viral cause was found and the blood supply could be protected, many hemophiliacs and people who received transfusions were likewise infected by contaminated blood. The tragedy, born out of ignorance, occurred in nearly every country in the world. But in France what began as ignorance turned into calculated connivance. Using tainted blood stocks became a matter of economic expediency and government-sanctioned policy.
The callous handling of the affair is widely believed to have contributed to the rout of the ruling Socialist party in last March’s elections. Two years ago, when the scandal broke, Georgina Dufoix, who in 1985 oversaw the health system as minister of social affairs, protested her innocence on television. I feel responsible, she told a flabbergasted audience, but not guilty. To the disgust of many, when the case first came to trial last summer both she and former health minister Edmond Hervé, her subordinate, were conspicuously absent from the dock.
Instead the rap was taken by lesser government officials and by Michel Garretta, a physician (now suspended) and former director of the National Center for Blood Transfusions (known as the CNTS in France). I’m not ashamed, he said in his defense, with a disingenuousness that echoed Dufoix’s. The decisions I made at the time, I would make again, for myself and my own children. Garretta has never stopped claiming that not enough was known about AIDS even in early 1985 to foresee that hemophiliacs and transfusees were running a mortal risk. Nor was he alone, he insisted at his trial, in failing to act when he did know the truth. Thousands of people were informed, he said, but they didn’t necessarily draw the consequences.
Why not? There are answers, but none offers much comfort.
HemophiIia is a genetic disease that affIicts maIes aImost excIusiveIy. Those affected suffer crises of uncontroIIed internaI bIeeding because they Iack proteins, most commonIy one caIIed factor VIII, that are needed to cIot bIood. UntiI the 1960s such a crisis was usuaIIy treated with a hospitaI transfusion of fresh whoIe bIood or pIasma (the fIuid part of bIood, which contains the criticaI proteins). But all that changed with the introduction of cryoprecipitate--the sediment of frozen plasma, which is five times richer than fresh blood in clotting proteins. A method was soon developed to concentrate clotting proteins from the pooled blood of hundreds of donors. Available in easily stored powdered form, these concentrates not only let hemophiliacs treat themselves but also enabled them to work and travel with unprecedented freedom. The drawback of the concentrates was that a single donor infected with a blood-borne disease (the most dreaded before the 1980s was hepatitis) could contaminate all the concentrates made from a batch of pooled blood.
France’s hemophiliacs, however, felt relatively safe from that risk. In this country, explains Francis Graeve, honorary president of the Association of French Hemophiliacs, blood is freely donated. French addicts couldn’t sell their disease-ridden blood for the price of a bottle or a fix (whereas in the United States it was technically possible to sell blood until 1981, and paying for plasma remains the norm). In the French view, giving blood was a noble act, and donors were respected as healthy, civic-minded people. Unfortunately many drug addicts in Paris gave blood to get the free sandwiches and coffee handed out at collection posts.
The French blood system was a perplexing marriage of genuine idealism and charity, hitched to a quasi-feudal power structure. At the top was the Ministry for Social Affairs, which pays all medical costs in France through the Social Security Administration. Next came the Ministry of Health, which granted the exclusive right to collect and distribute blood to 160 transfusion centers (a network of independent, government-regulated bodies). Seven of these were large regional centers responsible for manufacturing and distributing blood products such as clotting factors, according to prices set by the ministry.
The most powerful regional fief (as you might guess from its name) was the National Center for Blood Transfusions in Paris, a gleaming black steel-and-glass bastion in the city’s quiet fifteenth arrondissement. Its factory was already satisfying about half the national demand for blood plasma and concentrates and was trying to do better. (In 1982 the Ministry of Health granted the CNTS a monopoly on imported blood products, with instructions to reduce them and bolster national self-sufficiency.) Together with its research advisers, who included top hematologists at Paris’s giant public hospitals, the CNTS was a formidable operation.
The CNTS didn’t initially think AIDS was its problem. In 1981, when the U.S. Centers for Disease Control (CDC) announced its first cases, most were occurring in homosexual men; the first AIDS diagnosis in an American hemophiliac in January 1982 didn’t alter the French perception that this was a gay disease whose prime vector was semen. By March 1983, however, more unsettling news had arrived from the United States. In the journal Transfusion, read by hematologists the world over, American blood banks joined forces to announce eight confirmed cases of AIDS in hemophiliacs treated with antihemophilic factor and to warn that the still unknown causal agent was probably to be found in blood.
The startling response of the Ministry of Health to this news was beatific optimism, according to physician-journalist Anne-Marie Casteret, writing in the May 4 edition of the doctors’ daily, Le Quotidien du médecin. The ministry was apparently not alone in ignoring the warning. The CNTS’s research director, a hematologist named Jean-Pierre Allain, maintained that no relation has been demonstrated between a very high number of transfusions and AIDS. Yet in June, Allain himself published a study of 2,300 French hemophiliacs that suggested otherwise: six of his subjects showed clinical signs of AIDS, such as swollen lymph nodes and striking weight loss. (There were no tests yet for the still mysterious causative agent. A retrovirus had been isolated from a patient that February by Luc Montagnier at the Pasteur Institute in Paris, but whether this virus caused AIDS remained to be confirmed.) What’s more, three of the six hemophiliacs showing signs of AIDS in Allain’s study had been receiving clotting factor made only from the blood of French donors. It seemed that the French blood supply might not be pristine after all. In July Le Monde, France’s newspaper of record, reported the first case of AIDS in a French hemophiliac.
That summer the ministry’s chief medical counsel, General Director of Health Jacques Roux, circulated a letter to transfusion centers telling them to be wary of blood donations from people in all the known risk groups, which now included intravenous drug users. But beatific indifference prevailed. A ministry survey conducted shortly afterward revealed that even in Paris--a city with a disproportionate share of AIDS cases--a majority of blood banks didn’t think of their donors as presenting any risk. The myth of pure French blood was so pervasive that in January 1984 a program to collect blood in prisons was actually stepped up. (Studies for the following year showed that 25 percent of France’s contaminated units came from prisons.)
By the faII of 1983 Montagnier, at the Pasteur Institute, had deveIoped a prototype test to screen bIood for antibodies to the virus he beIieved was responsibIe for AIDS. This test invoIved mixing drops of bIood with proteins from the virus that were known to cause an antibody response; a coIor change indicated that an antibody reaction had taken pIace and that the bIood was probably infected. An initial study of French hemophiliacs using the Pasteur test identified a strong incidence of antibodies to the virus in 133 French hemophiliacs. These results were announced--but not published or fleshed out with numbers--by CNTS lab chief Anne-Marie Couroucé at an in-house conference on March 13, 1984. The myth of pure French blood was crumbling fast. Yet the CNTS did not reveal these findings to the Ministry of Health. Nor did the CNTS share its information with the hemophiliacs’ association, whose offices were in the very same building.
This fog of willful optimism was penetrated almost by accident. The events were set in motion not long after U.S. AIDS researcher Robert Gallo stole Luc Montagnier’s thunder by announcing in April 1984 that the retrovirus both had been studying, the one we now call the human immunodeficiency virus (HIV), was indeed the cause of AIDS. That July an energetic French immunologist, Jacques Leibowitch, called François Pinon, chief of hematology at the giant Cochin Hospital of Paris, requesting a favor. A family member was to have surgery at the hospital, and Leibowitch wanted to send Pinon some AIDS-free blood donors that he’d selected himself. Pinon was offended; he protested that his blood supplies were perfectly safe. But he was impressed that Leibowitch had come up with his own way to screen blood for HIV antibodies--neither Montagnier’s Pasteur test nor any other was yet on the market. (Leibowitch’s method was to add blood samples to lab dishes containing HIV-infected cells; an antibody response in the dish meant that the blood being tested contained antibodies to the virus and, thus, that the donor was already infected.) The two men subsequently decided to run a study on Pinon’s stocks. Neither realized how terrifying the results would be.
That same July, at the congress of the International Blood Transfusion Society in Munich, word went out that heating blood products could inactivate the AIDS virus. Even though there were no published data yet, no transfusion specialist could afford to ignore the implications. Indeed, Garretta, then assistant director of the CNTS, opened negotiations while still in Munich to license a heat treatment from Immuno, an Austrian firm. But at the time, no deal was closed.
Garretta became director of the CNTS the following October. He inherited an institution that was deeply dependent on Ministry of Health subsidies to meet its operating losses; in addition, it was far from its goal of making France self-sufficient in blood products. Garretta immediately stepped up factor VIII production without waiting to develop heating techniques, despite a report in the medical journal The Lancet in September that heat treatment killed animal retroviruses.
It was a terrible miscalculation. Just how terrible became clear on December 12, when Leibowitch finished screening the Cochin blood stocks. Ten of the 2,000 blood samples provided by Pinon tested positive for HIV antibodies. (To make sure, the results were independently confirmed by a much more laborious test called a Western blot.) Aghast, Pinon did some fast mental arithmetic. Public hospitals in Paris alone used 500,000 units of blood per year; based on an infection rate of five units per thousand (0.5 percent), that translated into 2,500 contaminations per year, or roughly seven new infections per day. He issued a written warning to the doctors at Cochin to cut transfusions to a bare minimum and then called the Ministry of Health and the CNTS.
The implications for Garretta were inescapable: each batch of the CNTS’s factor VIII was prepared from as many as 5,000 pooled blood donations, so the chances of any batches escaping contamination were almost nil. By upping his production, Garretta had accelerated the epidemic.
Pinon had confirmed what at least one of the CNTS’s top officials, the research director Allain, already suspected. For some time Allain had been procuring imported, heated concentrates for a young patient of his, a hemophiliac teenager he’d taken into his own home; he warned the boy to destroy his unheated CNTS stocks because the heated concentrates were purer. But the vague admonition didn’t stop the boy from injecting unheated factor VIII one night that December when he felt a painful bleeding crisis coming on. Allain’s wife, also a CNTS employee, exploded when she learned what had happened. You idiot! she said to the boy. How could you do that? He had previously tested seronegative; he became seropositive.
By February 1985 the case for heat-treating blood was closed. In two reports in The Lancet, Montagnier confirmed that heat killed the AIDS virus and that heated concentrates prevented infection. Virgin (previously untreated) French hemophiliacs given only heated factor VIII tested negative for HIV, while those treated with unheated factor VIII tested positive. Hurriedly, Garretta signed a deal with Immuno for its heating technology. But it would be months before his factory could be refitted, and only imports of heated factor VIII could avert a tragedy in the interim. Still he held back. If the CNTS asked the ministry to cover the cost of the imports, its officials might want to know why it had taken so long to discover the tainted-blood crisis and protect the blood supply. As Allain had warned Garretta in January (in what Allain later claimed was a last-ditch attempt to stop the catastrophe), Garretta was exposing the CNTS to discredit and failure in the achievement of one of its fundamental missions. So Garretta began covering his tracks.
That spring a CNTS official persuaded Pinon to join an anti-AIDS strategy group. It was a way to not really take into account our alarm signal, Pinon summed up later, and it is my impression that it delayed a decision. Pinon and the rest of the group called for the immediate introduction of heat-treated products, imported from abroad if necessary. But in May, when the presiding CNTS official submitted the group’s report to the Ministry of Health, the document included a phrase that recommended deferring the decision to recall or to leave the unheated products in circulation to a higher governmental authority.
Not that the ministry would necessarily have heeded Pinon and his colleagues. On March 12, 1985, General Director of Health Roux had received a report from an aide concerning Pinon and Leibowitch’s latest finding. The two had located 19 seropositive donors at Cochin and another hospital with blood bank facilities; recipients of factor VIII prepared from their blood had been located, too. All were seropositive. The report concluded: It is probable that all the blood products prepared from pools of Parisian donors are now contaminated, with the word all underlined for emphasis.
Roux couldn’t ignore this report. Yet, he says now, he had no power to implement health policy. Only Health Minister Hervé could ordain the destruction of contaminated stocks and speed up donor testing. (Montagnier’s antibody test still wasn’t available, but a test made by Abbott, a U.S. company, had been approved for American use on March 2, 1985.) So Roux forwarded this report to Hervé’s office with a letter appealing for action. Hervé denies receiving it.
It wasn’t until May 9, 1985--five long months after Pinon called the CNTS with his initial data--that Garretta himself wrote to the Ministry of Social Affairs, saying that cleaning up the blood supply was an absolute urgency. But the CNTS’s boss also said that a compromise had to be found between the imperatives of public health and the economic constraints.
By his calculations, from that time on every three months of delay in testing donors and using heated factor VIII meant the deaths of five to ten hemophiliacs and some of their close relations. His guess was based on studies showing that only 10 percent of HIV-positive patients had so far developed AIDS. (The CDC now estimates that thus far 29 percent of infected people have gone on to develop AIDS; of those, some 63 percent have died to date.) But the economic constraints, he groused, were considerable: importing heated factor VIII alone would cost 41 million francs (about $5 million at the time); destroying contaminated stocks and making up the 20 percent production loss due to the heating process would cost millions more. The Ministries of Health and Social Affairs, of course, would have to cover those costs. To minimize them, Garretta recommended that the CNTS continue to provide unheated products to its clients until mid-July. He was proposing that they all accept a few more deaths between May and July for the sake of staying on budget.
On May 10 the officers of the Association of French Hemophiliacs trustingly played into his hands. Garretta had recently promised them that the CNTS would soon be making heated products. However, pleading technical problems, he had not named a date. He omitted one other detail, said the association’s honorary president Graeve: He never told us the stocks of unheated factor VIII were contaminated. So the association asked only that the ministry ban the sale of unheated blood concentrates after October 1, 1985--time enough, they figured, for Garretta to refit his plant. It never occurred to them, said Graeve, that Garretta also needed to get rid of his stocks.
Meanwhile, on May 9, another link had been forged in the chain of tragedy. That day representatives of the prime minister and the Ministries of Health, External Commerce, Social Affairs, and Finances met to discuss the Pasteur Institute’s production arm, Pasteur Diagnostics, which was struggling toward commercializing Montagnier’s test. Its American competitor, Abbott, had already requested French government approval for its own test in February. Everyone knew that compulsory testing of blood donors was long overdue. But they figured that if Abbott seized the market for tests in France’s transfusion centers, there would be no market for Pasteur’s product, in France or elsewhere. (Just as the French felt cheated out of the discovery of HIV, they now felt in danger of being squeezed out of the antibody-test market.) It added up to a choice between buying foreign tests and saving lives, or saving an annual market estimated at 91 million francs ($11 million) for a French company. Once again, economics won. It was decided that the licensing file for Abbott be held awhile longer, until Pasteur caught up.
On May 29, in the CNTS building, Garretta held another meeting with his top officers. The fundamental question facing them, he said, was this: Should we accept that all our products are contaminated? Unfortunately, he added, recalling contaminated products would entail grave economic consequences. According to the meeting minutes, a CNTS doctor named Jean-Yves Muller said: The important thing is to avoid contaminating the hemophiliacs who aren’t yet. But no one suggested how contaminations could be avoided if the deadly concentrates remained on the market. Instead they resolved to wait for the higher authorities--meaning the Ministry of Health--to forbid us to sell these products, with the financial consequences that this represents. In effect, they were asking their superiors to stop them before they killed again.
On June 1, Allain met with the Consulting Commission on Blood Transfusion, a watchdog for the ministry composed of government officials and physicians. One regional center director who was present recalls that the commission decided discreetly--this does not appear in the recommendations signed by the 31 physicians present--that just for a few weeks, a transition period, you could inject the unheated product into people who were already seropositive. Of course, he admitted, we knew we needed heated products for all hemophiliacs. There were medical as well as ethical concerns: Who knew what effect reinfection might have in an HIV- positive patient? (According to CDC researchers, reinfection poses the risk of becoming contaminated with a new strain of the virus that might be resistant to AIDS drugs and could exacerbate the disease.)
There were scattered revolts against Garretta. In mid-June, Roux slammed the door on a meeting of Health Minister Hervé’s cabinet and refused to attend meetings of the Consulting Commission until heated blood products were universally available. In a bureaucratic pique he declared that he wouldn’t defend the ministry’s policy anymore. But that left no one to oppose Garretta inside the Ministry of Health.
No one upstairs was listening, anyway. On June 27 Jean Ducos, a usually influential director of a transfusion center in Toulouse, wrote to Dufoix, the minister of social affairs, begging to see her immediately. One month later her secretary replied that previous engagements made a meeting impossible. Ducos also wrote Hervé at the Health Ministry that it was impossible . . . in all conscience to continue to pressure hemophiliacs to accept noxious products. Hervé never responded.
Meanwhile, Garretta began planning how to sell off his contaminated wares. On June 26 he wrote to his aides at the CNTS: The distribution of nonheated products remains the normal procedure, so long as they are in stock. If prescribing physicians didn’t ask for safe goods, they wouldn’t get them. Heated concentrates, he added, were authorized-- not required--only for recipients who tested HIV-negative.
His aides bullied physicians to accept unheated concentrates. You couldn’t just say, ‘This patient’s seronegative; give us the heated products,’ recalled Thierry Lambert, a Parisian hematologist and researcher. Each prescription had to be discussed--and the discussions were sometimes difficult. To prevent sharing of the precious heated goods, no patient was allowed more than a one-month supply.
The worst of it, the awful catch-22, was that hardly any physicians could prove their patients were seronegative--because there were still no screening tests on the open market. Approval for the Pasteur tests came only at the end of June, when Prime Minister Laurent Fabius (alerted that Casteret and other reporters were readying highly critical stories) announced compulsory testing of donors. Even then the promise rang hollow, since it was not until July 23 that the social security system agreed to reimburse the costs of testing. (Abbott’s test was approved in France the following day.) What with delays in distribution and the training of test personnel, by the end of 1985 only 1,670 hemophiliacs--fewer than half the 4,000 in France--had been tested for HIV.
That same July 23 the Ministries of Health and Social Affairs decided that Garretta could continue to sell his unheated stocks as long as anyone would buy them. The only caveat was that after October 1 the social security fund, which ordinarily reimburses prescription costs, wouldn’t pay for unheated factor VIII. Apparently the transition period agreed to by the Consulting Commission in June would now extend into the fall.
On September 6 the Association of French Hemophiliacs belatedly saw the light. Agreement with Garretta’s plans, their leaders said at a meeting, had not been meant as permission to off-load cumbersome products onto unsuspecting hemophiliacs. They called for a ban on unheated concentrates and alerted their membership and the media. Garretta subsequently complained that they had ruined his realistic and responsible strategy. He’d been forced to import more heated factor VIII than he’d planned, and he was stuck with large stocks of unused French products. The contaminated ones, that is.
In fact, he had already sold plenty. According to internal CNTS records, 1.6 million units of its unheated factor VIII were off-loaded between July and October of 1985. The biggest sales were just before and after the summer vacation--to hemophiliacs and parents of young hemophiliacs stocking up for trips, or replenishing supplies when they came home. Graeve, of the hemophiliacs’ association, was among them. On July 12 he bought some unheated factor VIII for his hemophiliac teenage son. Graeve doesn’t know whether the batch he bought was contaminated and, if so, whether it hastened his son’s death from AIDS. But this much is certain: Graeve would never have knowingly given his child a substance that might harm him.
Just how many peopIe were condemned to die between December 1984, when the CNTS became aware of the extent of the crisis, and October 1985, when its Iast contaminated products were soId? Garretta and his aides have aIways contended that upwards of 90 percent of France’s seropositive hemophiIiacs were infected before 1985, when contamination, so to speak, became official policy. However, a retrospective study conducted at two Paris hospitals found 60 hemophiliacs for whom the year of seroconversion is known with precision thanks to a reference serum drawn less than a year before. Seventeen of the 60--28 percent--seroconverted in 1985.
Nor were hemophiliacs the only victims. At an inquiry late last year, the CNTS’s Couroucé testified that a simple calculation shows that around 200 people per month were contaminated by blood from infected donors from April through August 1985, in the months before AIDS tests were easily available. In other words, there were about 1,000 victims, not counting the victims’ subsequently infected spouses, lovers, or newborns.
The French judicial system is commonly viewed as an arm of the state rather than as an independent power. It thus surprised no one in France that when the first suit was filed by hemophiliacs in 1988, the investigating magistrate in charge of the case moved at an excruciatingly cautious pace. It would take four years for the case to come to trial.
Meanwhile, among the press, only Casteret took the story seriously. She began to visit former CNTS and ministry officials and to amass a gigantic file of official documents--a feat in a country where freedom of information has never existed. Yet the hardest part, she recalled, was to believe what she was seeing. I’m a doctor, she said, and I couldn’t conceive that a doctor would follow an economic logic instead of a healing logic. She withheld full publication until she had checked her work too much to doubt it. In April 1991 her articles began to appear in the newsweekly L’Evénement du jeudi.
One of her readers was Edmond-Luc Henry, an accountant and hemophiliac who had been contaminated with HIV in 1984 while under treatment by a CNTS physician. Enraged by Casteret’s revelations, Henry filed charges against a person or persons unknown for poisoning--a felony that, in the French penal code, carries a life sentence. Apparently to forestall a felony trial, the state’s investigating magistrate abruptly issued misdemeanor indictments against Garretta, Allain, Roux, and Roux’s Ministry of Health colleague Robert Netter. In March 1992 they were charged with deception over the basic quality of a product, under a law that Sabine Paugam, Henry’s lawyer, acidly described as designed to punish vendors of spoiled mustard. (The indictment of Roux and Netter was widely considered a maneuver to shield Hervé himself.)
The four men were first tried last summer by a panel of judges at Paris’s Palace of Justice. In October 1992 Garretta was sentenced to four years in jail and a heavy fine. (He lost any hope of clemency when he absconded to Boston before his sentencing to work as a consultant for a biotech firm.) Roux received a suspended sentence, Netter was acquitted, and Allain, sentenced to two years in jail, appealed and was granted a retrial. In an unusual move, perhaps to satisfy public opinion, which considered the sentences too lenient, state prosecutors asked that all four men be retried.
The object of the second trial, which began this past May in the Paris Court of Appeals, was to decide whether the original verdict would be upheld, lessened, or stiffened. This was still a criminal trial, conducted by state prosecutors. But in France victims and their lawyers are allowed to put their side of the story to the court. During the appeal, Paugam and other lawyers representing hemophiliacs pressed to move the case to the felony court on the tougher charges of poisoning. If so, additional defendants could be named. The lawyers have also asked that charges of poisoning be filed against Hervé, Dufoix, and former prime minister Fabius in the High Court of Justice, the only tribunal in France that can try former ministers for offenses committed while in office.
As he awaited the outcome of this latest trial, Henry summed up the legal and ethical issues at stake with the relentless simplicity of a dying man: If you’re sitting in an office counting boxes of products, you can talk about marketing, he said. But not if you’re treating human beings. If you’re a doctor, you don’t give people products that can hurt them.
Indeed, Garretta didn’t just help destroy hundreds of lives; he deeply damaged the relationship between patient and doctor. What I most reproach Garretta for, Pinon said recently, is that he created distrust in the blood system, which is completely built on trust. Garretta’s performance in the May court hearings did nothing to restore the French public’s faith. Day after day, the haggard former head of the CNTS tearfully recited the same refrain: It wasn’t possible for me to decide alone. No one ever said we should do things differently. He was a scapegoat, he said, for a common failure of foresight and courage.
Should doctors be better than the rest of us? Why blame Allain, for example, for staying on at the CNTS and carrying out Garretta’s policy? After all, as he said when interviewed during the trial, I have four children of my own, and I need to make a living. Behind him was a courtroom packed with anguished parents who used to have children of their own. Their sons are dead now because men like Garretta and Allain--and no doubt many others who will never be publicly named--betrayed them.
