Dawn MacKeen

The exact cause of Baez’s death will not be known until the official pathology report comes out. But Bruce Finzen, a Minneapolis attorney who is now representing the Baez estate in a wrongful death suit against St. Jude, says all evidence points to the manufacturer. “Her family holds the manufacturer responsible for her death,” he says. “Her surgeon and cardiologist believe the trauma of three open-heart surgeries in a year was a substantial factor in causing her death.”

What happened to Baez is a horrifying example of what can — and, increasingly, will — go wrong in an era in which it’s become normal to trade in your own defective body parts for those manufactured, assembled and sorted by machines. In this brave new world of medical technology, surgeons can place a computerized defibrillator next to your heart, ready to shock your ticker back into action should it falter. Countless lives are saved, or prolonged, each year because of inventions like this. And as new, improved body parts come rolling off the medical assembly line, it becomes easy to take them for granted: Only a scar seems to separate the mechanically altered from the rest of us.

That is, until there’s a glitch. As with anything mass-produced, not every batch is perfect. Flawed implants are rare, but sometimes they make it all the way from the factory to the surgeon’s table to a carved-out place inside of you. And unlike a station wagon, which can have a faulty transmission replaced in an afternoon at the garage, the only way to retrieve a defective implant, in many cases, is to cut open a human body. And since there are no guidelines on how to proceed when there’s an implant recall, whether a surgeon removes, or “ex-plants,” the device is largely a judgment call.

Since 1977, there have been 571 recalls of implants, according to ECRI, a nonprofit company that assesses medical devices and tracks the number of Food and Drug Administration-reported recalls. In 1999, there were 91 reports of recalls; in 2000, 55. (In 1985, when far fewer implants were in existence, there were only 10.) In many cases, each recall involved thousands of units of the particular product. (This figure does not correspond to the number of people who received the device or had to have it taken out.)

“If you don’t have implants, people will die or be crippled,” says Dr. Joel J. Nobel, president of ECRI. “If the question is, are some of these implants going to become defective over time, the answer is yes. That’s reality.”

Implants used in almost every part of the body have been recalled, from lifesaving devices like pacemakers to neuromuscular stimulators (used for pain remediation) to hip replacement devices to penis enlargement implants (one lot leaked hydraulic fluid) and implants used for breast enhancement (one company sent out unsterile implants). Although the FDA has the authority to order a recall for a product that is believed to threaten public health, it rarely comes to that. Most of the time, once a problem is documented, the recall is voluntarily made by the manufacturer. The company reports the problem to the FDA and then writes a letter to physicians detailing the severity of the problem. A product can be recalled not only for having bad wiring but also if it’s just incorrectly labeled.

“There are no guidelines that the FDA puts out,” says FDA spokeswoman Sharon Snider. “It really is up to the doctor who’s monitoring this individual patient to make those types of decisions because the patients’ conditions vary and not every single device is necessarily faulty.”

But for those who find themselves part of a manufacturer’s margin of error, with the wrong serial number implanted under their skin, the dilemma of what to do can be excruciating. The decision to ex-plant is a high-stakes gamble: Take it out and risk the complications of surgery and the possibility that the second procedure won’t be as effective, or leave it in and hope it’s not a time bomb waiting to go off.

Physicians say that as modern medicine progresses, we will be seeing more and more cases of patients living with faulty devices inside them, and the medical community will increasingly face the question of what to do each time a recall is announced. For example, the success of a hip replacement surgery depends on the quality of the bone that supports the prosthesis. And that quality can be greatly diminished by a second surgery.

Patients don’t decide whether to have the recalled implant removed; doctors do. Snider says most doctors, armed with the knowledge that only a small percentage of the recalled implants will actually fail, choose to leave them in. Still, the decision varies widely from patient to patient, largely depending on the person’s age, physical condition and whether there are clear signs — like those that Baez reportedly experienced prior to her final surgery — that the device is not working.

“Let’s say [problems] occur in 20 percent of people who have the implant,” says Dr. Joseph Zuckerman, chairman of New York University’s Hospital for Joint Diseases’ department of orthopedic surgery. “But look at the other side — 80 percent aren’t having problems. Why redo something that is going to be successful?” Zuckerman also adds that because FDA oversight is so effective, it rarely happens. In fact, after all his years as a surgeon, he has never had a product he’s implanted recalled.

But critics of the medical devices’ manufacturers contend that defective parts are making it past the normal screening process because companies are rushing their products to market without appropriate testing. (They also find it disturbing that most studies are funded and conducted by manufacturers.) They also charge that the companies are caving in to competitive pressures to “improve” devices that already had been proven to work over time in an effort to win new customers.

For example, the Silzone heart valve’s predecessor, the St. Jude artificial heart valve, was one of the most popular such devices for the past two decades and had very few complications. The main difference between the old St. Jude model and the new Silzone was the addition of silver around the sewing cuff fabric: The metal was supposed to reduce infection.

According to the FDA, the Silzone was approved as a supplement to its basic product in 1998. The FDA reviewed clinical data from patients in Europe who received the product, and it looked at animal studies. It was approved as “safe,” but its “effectiveness” — a more stringent requirement — was only required to be shown in a post-marketing study. (This is not an unusual practice; many products are approved this way.) It was the results of that post-marketing study that gave the impetus for the recall. Extrapolating data from 792 patients, the company found that the Silzone leaked in 2 percent of the patients, in comparison to 1 percent with its older product. (In this case, the somewhat murky distinction between “safe” and “effective” appears to have blurred to the point of unrecognizability: The Silzone presumably is not only less effective than the earlier model but less safe.)

“What we’re seeing is that harmful products, be they drugs or devices, are being approved, and then introduced into unwitting people who think they have been thoroughly tested for their safety when obviously they have not,” says Vera Sharav, president of Citizens for Responsible Care (CIRCARE), a human rights organization.

But Peter Gove, a spokesman for St. Jude, says that not only did the company meet FDA requirements, it went beyond them when applying for the pre-market supplemental approval. Clinical data was not required, he says, yet the company submitted it anyway. “We did all of the appropriate pre-clinical and animal testing,” says Gove. “If we did not, the FDA would not have approved this as a supplement. Any lawyer can Monday-morning quarterback this and say ‘I wish they would have done this and that,’ but the fact is the FDA wouldn’t have approved this, or even considered it, if we hadn’t met their requirements. It’s easy to say two or three years later, ‘They should have done more testing.’”

Gove also says only a “very few” patients had to undergo revision surgery as a result of the recall. (He would not comment specifically on the Baez case because of the legal proceedings.)

In contrast, approximately 351 people so far, or about 2 percent of the total number of patients, have had to go back under the knife for hip replacement surgery after Sulzer Medica issued a recall of its Inter-Op Acetabular Shell last December. An estimated 17,500 patients received the device. Many of the devices had residual mineral oil from the manufacturing process, which reportedly made it difficult for the pelvic bone to adhere to the prosthetic device.

Rhonda Silva was one of those recipients. The 48-year-old Oakland, Calif., resident first had the surgery last April because her arthritis had progressed to the point where she was popping painkillers just to stay out all day and walk around. She says she was told after the surgery that she would be laid up for just a matter of weeks and then could return to her normal life. But after the first Sulzer implant created slippage, her doctors — before the recall — put in another Sulzer implant. And now that, too, she says, is failing. Her third procedure is scheduled for this month.

“When one thinks of a recall, one thinks of a car, one thinks of tires, you don’t think of body parts,” says Silva. “You think, ‘This can’t possibly be happening to me.’ It’s really like living in a nightmare.”

That nightmare has manifested itself in many ways, most visibly on her left hip, where there is a purplish-black 14-inch-long incision that, she says, has become infected. But the public relations executive is most upset about the timing. She had her second surgery in November, two months after the company says it had received word from surgeons that there might be problems with the device. The company issued a recall on Dec. 5. In other words, not only did Silva receive the same defective hip implant twice, but when she received the second one the company already had reason to be suspicious of it. Silva decided to sue.

Sultzer spokesman Jim Moore says he believes that most of the people who will need revision surgery have already surfaced. Typically, he says, problems present themselves within two or three months of the operation, and it’s almost that time now. But, still, he says, this type of manufacturing malfunction rarely happens, and the company is doing some soul-searching as to how things went so very wrong.

“We feel worse than bad,” says Moore. “This is a company that has decades of success, improving the quality of life for hundreds of thousands of people each year. Everyone is profoundly disturbed by this failure. People are working 20 hours a day to help the people we have hurt, who we normally would have helped.”

Moore says that Sulzer is covering the costs of the revision surgery, the ensuing doctor visits and any out-of-pocket expenses. For those who have received the device but haven’t experienced any problems, the company isn’t paying for any additional follow-up, since Moore says it is typical postoperative protocol for the patient to be checked up on by his or her physician anyway.

However, many believe that is not enough. A class action suit was filed two weeks ago on behalf of all those patients who haven’t experienced any problems yet, but say they have to live with the day-to-day fear that it’s just a matter of time before the implant will fail. They want Sulzer to pay for additional monitoring by their physicians just in case something should go wrong.

But not all of those in the field think that implant recalls are a serious problem. “I don’t think the numbers that we’ve seen are a reason for public alarm at all,” says Mark Bruley, vice president for accident and forensic investigation at ECRI. Bruley says that we’re seeing more recalls because an aging population is using more implants. In addition, he says FDA’s MedWatch system, which ensures that manufacturers alert the public when recalls take place, is another safeguard.

Still, for those thousands of patients who ended up with a product that slipped past all the oversight, this type of explanation provides little solace. “I have constant sleepless nights because I’m in pain,” says Silva, the hip implant patient. “But the point is that it’s just not the physical pain — it’s constantly worrying whether I’m ever going to get well.”

“Are you looking for the El Sayeed family?” asks a man walking beside my car, which has slowed to a crawl. He leads me down a garbage-strewn alleyway, past kids playing, to the El Sayeeds’ modest apartment. A steady wail signals sundown — a time to pray.

On this particular evening, most of the El Sayeed family is crowded into one room waiting for me. Hamdy, the father, is present only in a framed picture on the wall. The 50-year-old man lies in a hospital bed on the outskirts of Cairo. His neighbors know why he isn’t at home. They also know why Hamdy’s cousin doesn’t show up at his clothing store on some days — probably feeling too weak — and why yet another cousin, Hamed Zayed, stayed in El Tod instead of moving to Saudi Arabia as he had planned. The reason? Zayed did not pass the blood test required to work in Saudi Arabia. Like those of many others in town, his came back positive.

The disease infecting the El Sayeeds isn’t AIDS. Their medical records tell the story of another blood-borne pathogen — the hepatitis C virus (HCV) — which has its grip on this region and 130 million to 170 million people worldwide. The virus is spread mainly by blood; everything from intravenous drug use to tattooing and body piercing is a common vehicle for transmission. Globally, HCV is three to four times as prevalent as HIV, and there is no vaccine to prevent it. Yet, perhaps because it is a benign companion for the majority of carriers, HCV has not received a great deal of attention as a major public health issue.

The number of people worldwide with this highly contagious virus will continue to climb until 2015 to 2035, according to estimates from the World Health Organization. And many cases have fatal consequences. In the United States, 8,000 to 10,000 victims of HCV die each year, and the number of Americans who are waiting for a liver transplant has increased almost sixfold over the last decade, according to the United Network for Organ Sharing. Unless organ donations increase drastically, the organization’s officials warn, there won’t be enough livers to go around when they are desperately needed. There aren’t enough even now.

“Hepatitis C still doesn’t have the pizazz of AIDS. It doesn’t drive countries to do something,” says Harvey J. Alter, chief of the infectious-disease section at the National Institutes of Health. “But in point of fact, it’s a huge global problem.”

Egypt, with 12 to 15 percent of its population estimated to carry the virus’s antibodies, hovers near the top of the global HCV chart. (In the United States the percentage is 1.8.) The El Sayeeds live in a region that lies at ground zero in the HCV crisis. Studies of villages in the Nile Delta show that about half of the residents older than 35 have the virus or have had it in the past.

“We heard about it two years ago,” explains Hamdy’s brother, Moawed El Sayeed. “We heard about it but didn’t see no one sick of it. Now many, many have hepatitis — I feel that if I do the test, most likely it’s positive.”

The viral time bomb is set to go off in Egypt — and the United States — in the next few years. And yet most people who are chronic carriers do not know they have it. In some cases, people in Egypt know they are ill but aren’t able to distinguish the virus they carry from the other alphabet of hepatitises — A, B, D and E.

Making matters worse are the prohibitive cost and limited effectiveness of treatment with the latest antivirals. In a dilemma similar to that caused by HIV, it is not possible in Egypt to provide the drugs to all who need them. A further complication is that liver transplants are basically not an option here. Procuring livers from the dead is culturally taboo in Egypt.

The country’s burden — in the sheer number of victims and the hurdles to treatment — makes Egypt a worst-case scenario worthy of global attention. Indeed, Egypt is a laboratory for the world’s HCV researchers: Epidemiologists are monitoring the largest group of patients here as they approach the time — decades after infection — when malignancies such as cirrhosis or liver cancer tend to occur.

But Egypt’s tragedy also has a unique aspect that other countries are unlikely to encounter: The virus is believed to have been spread here, unintentionally, through improperly sterilized syringes used by government health workers to treat millions for bilharzia, a debilitating illness that was sickening farmers and others who lived around the Nile. The government medical campaign, now thought to be largely responsible for the HCV epidemic, took place before hepatitis C was identified. Epidemiologists now contend that it may be the medical community’s largest transmission of a blood-borne pathogen in history.

Any outrage over the fact that this country’s misfortune can be attributed, in large part, to the actions of its government, has been largely absent among its citizens, most of whom see their plight as the will of Allah. And talking about the campaign against bilharzia, and its disastrous impact, makes Egyptian officials extremely uncomfortable; even those doctors researching the issue admit there’s a problem, but they play down any grave ramifications. The “healthy” are routinely pointed out to visitors; the “ill” are barely acknowledged. Liver specialists say they have been fearful of speaking out for fear of losing their jobs or seeing their programs eviscerated.

Researchers from the University of Maryland — who published a study three years ago in the Lancet linking the prevalence of hepatitis C in Egypt to actions of its government — worry about discussing the disease’s impact. The university has a Cairo-based hepatitis C prevention project, which has been examining the routes of transmission.

“When the paper originally came out, there were headlines saying, ‘Ministry of Health infected millions with hepatitis C and dirty needles,’” says Dr. George T. Strickland, the director of the University of Maryland’s international health division as well as a coauthor of the study. “It was embarrassing to them and unfair because it’s retrospectively looking at something that was meant to do great good and ended up harming. The sensationalism has made everybody fearful.”

Indeed, when a doctor who studies HCV learned that I met with patients suffering from the virus, he was panicked, and then tough. “Which hospital did you go to? Who let you in? You then went to the delta? Who did you go with?” he asked in a rush.

“People in Egypt don’t want to talk about problems,” says Dr. Frank J. Mahoney, director of the U.S. Naval Medical Research Unit No. 3′s office in Cairo. “No one has been willing to step forward like the way [former U.S. Surgeon General] C. Everett Koop did in the U.S. [for AIDS]. It wasn’t until Koop came in and said, ‘This isn’t a gay disease; it’s a disease of everyone in America’ that the debate changed.

“No one has done that here,” Mahoney continues. “Someone needs to stand up and do that.”

As Mahoney’s comments become increasingly bold, he is interrupted several times by a colleague who wants to make sure that he is fully cognizant of what he’s saying. He thinks about it and says he is.

“[Egypt] is the world’s laboratory for studying hepatitis C,” he says. “Unfortunately, it’s not the laboratory for prevention. And it’s frustrating because it should be.”

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The same waterways that give so much life to the verdant Nile Delta are also home to a parasitic worm called the schistosome. Its underwater attack on the El Sayeed family members occurred on the most blissful of days — when, as children, they would congregate at the Ferhashe canal for swimming and picnicking. The Ferhashe, which runs just outside town, is one of the only respites from temperatures that soar into triple digits.

The schistosome enters the body in the soft webbed area between the toes. It then infiltrates the bloodstream and lays eggs that settle in organs like the liver, bladder and intestines. A buildup of these eggs — which causes the disease called bilharzia, or schistosomiasis — can lead to bladder cancer and sometimes death. Bilharzia’s most famous victim is Abdel Halim Hafez, a beloved singer who died from complications from the disease in the 1970s. These days, his music, which still blares on the radios of passing cars, serves as one of the few reminders that the disease was once a scourge here.

At the time that bilharzia was a problem, Egypt was the hardest-hit country in the world, and in agricultural areas like the delta, where residents rely on water for farming, bilharzia had infected 70 percent of the residents of some communities. Many members of the El Sayeed family, including Hamdy, fell ill. It was in response to this epidemic that the government launched a national campaign to treat those with the illness and prevent others from suffering.

“Schistosomiasis killed people — they could not walk, they had bleeding from the mouth, they found really young people dying,” says Dr. Mohamed Abdel-Hamid, in his Cairo office of the University of Maryland School of Medicine’s Viral Hepatitis Reference Laboratory. “That’s why people started this campaign. During this time, they didn’t even know of something called HCV.” Hepatitis C wasn’t identified until 1989, at which time it was renamed, dropping the highly ambiguous “Non A, Non B Hepatitis.” Blood wasn’t adequately screened for HCV until three years after that.

When the government combated bilharzia, patients lined up to receive 10 to 12 shots of tartar emetic to kill the blood flukes. Although the anti-bilharzia campaign dates back to the 1920s, it ramped up in the 1960s. The delta’s high prevalence of HCV may be explained by the fact that the campaign lasted the longest here, until the mid-’80s, when oral medication replaced the intravenous.

“[The swimming] was nice, but if I would have known that it would have caused me this illness, I would have thought differently,” says Hamdy El Sayeed. The yellow cast of his skin and eyes, the result of cirrhosis, stands out in contrast to the white prayer cap and tunic that he wears in the hospital.

Hamdy first felt the pathogen’s effects 25 years ago. A fatigue descended on him and, like a shadow, followed him everywhere. Then the color of his eyes changed. Someone told him that sugarcane, marmalade and honey — whose healing properties are noted in the Quran — could cure these mysterious ailments. And it seemed to work. Hamdy repeated this regimen for years, until the day when all this sweetness couldn’t erase the ever darkening yellow of his limbs and torso. Simple activities like walking became a chore. When he finally sought medical attention and was tested for hepatitis C, it was positive. Three months later, he ended up at this Cairo hospital.

“What increases the death rate is people present themselves too late,” says Dr. Hesham Dabbous, assistant professor of tropical medicine and liver diseases at Ain-Shams University. “I see it every day. You have a perfectly healthy life with no signs of disease or symptoms. The liver is damaged silently and the patients come in with end-stage liver disease like cirrhosis, digestive bleeding, liver cancer and liver failure.”

Over the last decade, cirrhosis has increased substantially in Egypt, and liver cancer has risen in rank to be the third most common cancer. About six years ago, doctors at the Cancer Institute in Cairo used to see one case of liver cancer a week or every other week. Now they see one every day. By comparison, it is not even in the top 10 cancers in the United States.

For the majority of its carriers, the hepatitis C virus is not life threatening. Doctors don’t understand why an estimated 20 to 50 percent can rid themselves of HCV — with antibodies left in many as the virus’ sole calling card. They don’t understand why it leads to serious complications such as cirrhosis and end-stage liver disease in 20 percent of the patients. To those individuals, this virus can be just as crippling as AIDS, and some wither away to little more than skin and bones. And researchers are not even close to finding a vaccine.

“Is it frustrating?” asks Dr. Robert Purcell. The chief of the hepatitis viruses section at the National Institute of Allergy and Infectious Diseases, Purcell has been traveling to Egypt since 1997 to research the virus. “I have been involved in the development of a vaccine for hepatitis B, hepatitis A, hepatitis E. And all of them are a hell of a lot easier than hepatitis C. You do all the right things and still it doesn’t work. Just like HIV.”

In the United States, doctors commonly prescribe antivirals for their patients with HCV. The drugs peginterferon and ribavirin, taken over 48 weeks, can help 55 percent of the patients rid themselves of the virus for at least six months after treatment. But the therapy varies in effectiveness from genotype to genotype, and it is so expensive it may not be feasible for a country like Egypt to cover the costs for all of those in need.

Dabbous, of Ain-Shams University, says one of the most trying aspects of his job is witnessing the disease progress in those patients whom he cannot offer much more than unproven vitamins and Chinese herbs, or procedures to allay their pain temporarily. But antivirals — which are not as effective in the genotype most common in Egypt — cost $20,000 for a course of treatment. They tend to reach only a small circle of people who can afford to pay or whose insurance covers it. Beyond that, Egyptian officials say that perhaps more will be gained if the money is spent on prevention.

“I think everybody in Egypt knows there’s a problem with hepatitis C,” says Dr. Mohamed M. Zahran, professor of urology at Cairo University and chairman of health board of the opposition party, Al Wafd. “Their relatives or cousins have it. You can’t hide it. [The government] should face the facts by calling for financial aid. We need the help of other countries, like the United States and Europe, to treat our patients.”

Dr. Zahran says that Egypt needs the international community’s help in controlling this disease. He says there should be assistance to pay for medicine and organ transplants. This would ostensibly reduce both transmission and morbidity rates. But even officials from the World Health Organization contend that it’s not that simple. Besides the huge financial cost to a poor country like Egypt, where antivirals might work in about 50 percent of the cases where they can be used, the treatment has severe side effects, such as depression, personality changes, debilitating fatigue, nausea and weight loss.

And there are cultural and spiritual barriers to the effective prevention and treatment of HCV in Egypt. Ignorance about its origins and transmission is rife; fatalism about the chance of contracting it creates recklessness and a dangerous climate of resignation. And strict cultural ideas about transplants mean that survival for the hardest-hit victims is almost impossible, unless the person can travel abroad for the surgery.

Walking through the corridors of the liver unit of a public hospital on the outskirts of Cairo, it’s difficult to ignore the men, weak from the virus, sleeping in fetal position. It’s equally impossible to deny the virus’s impact while sitting by Talaat Hassan’s bedside and listening to the toll it’s had on his life.

“I am not in contact with my children because of fear of infecting them,” says the 54-year-old father of three, his eyes glassy. “I’m isolated in a different room and try to decrease hugging and kissing. I eat alone and live alone while the family is in the rest of the house.” As he speaks, a tube drains liquid from his distended belly into a Siwa water bottle. Too much fluid in the abdomen swells the midsection to the curves of a woman nine months pregnant. The drainage helps alleviate the pain for about one week.

Doctors have repeatedly informed Hassan that touching won’t transmit hepatitis — only blood-to-blood contact will — but the situation at home remains the same. He isolates himself from his loved ones despite the heartbreak that it causes everyone involved.

“Our communities aren’t very well educated,” says Dr. Soraya A. Sharaf, head of parasitology at the National Liver Institute and vice dean for environmental affairs at the Menoufeya University. “So you need to convey the message that it’s blood. They think it’s only major procedures that cause it.”

Hamdy’s cousin, Zayed, who couldn’t go to Saudi Arabia, believes he may have contracted HCV from dental surgery, though, like most people, he can’t say for sure. “I didn’t have any symptoms before the blood test,” Zayed says as he sits on a couch, squeezed in between his male cousins. “And I still don’t have any.”

Zayed is representative of another class of individuals with the virus. They didn’t contract it from the bilharzia-treatment campaign, but sometime after, once it took hold in the community and continued to spread. It’s almost impossible to trace the source of infection for these people, especially since many patients can go years without knowing they have it. And because so many practices inherent to village life involve shared blood, it is extremely difficult for doctors to identify specific risk factors. The possibilities are endless: Could families share toothbrushes? Go to the same community barber who doesn’t sterilize his equipment? Pass around the gouza, a water pipe, when some may have gingivitis? Have babies circumcised by nontraditional health practitioners?

“So you have this huge pool of infected people, living, aging, with HCV,” says Mahoney of the U.S. Naval Medical Research Unit. “[Say] you go to the barbershop and people have HCV, and you get a nick. Things that are low risk in a low-prevalence country become high risk.”

But the high potential for contracting the virus doesn’t create much anxiety; nor does having the virus create much anger or fear. Zayed is feeling fine, so — like many others who are antibody-positive — his only complaint is that he missed an economic opportunity by staying in El Tod. His acceptance is not particularly unusual. Even those who were most likely infected by their government’s medical campaign feel this way. “We believe it is all from Allah,” explains Moawed El Sayeed, Hamdy’s brother. “No one can prevent it.”

Public health officials say this belief makes their job — altering a population’s behavior because of a disease’s threat — that much more challenging.

“Usually Egyptians are fatalistic,” says Sharaf, the parasitology expert. “They may think, ‘I may catch this anyway.’ They are very religious but it makes them a little too fatalistic, so they’re not careful enough. This concept has to be passed on to them: Do your part, protect your family, your children, and then be fatalistic.” Protecting oneself can be as simple as not sharing needles for the administration of medication and using orally administered drugs as an alternative.

On the second floor of the National Liver Institute in Shibin El Kom, which sits in Minufiya at the heart of the delta, Dawood Faragiskander, a frail man who looks to be in his mid-50s, is slowly dying. He wears a red jogging suit that almost mocks the state he’s in, one in which he can barely talk. “In 1996, I would smoke and it would hurt in my abdomen,” says Faragiskander in a hushed tone that is more of a whisper. “[The doctors] didn’t discover hepatitis C until I started vomiting blood.”

His brother reveals Faragiskander’s I.D. card — he is pictured wearing a big cheeky smile, a bow tie and a dinner jacket. Now his skin looks more like a loose canopy tent, caving in where there are no bones to hold it up. The I.D. also shows how old he really is — only 39. “He’s been here since Sunday,” says his wife, Amal Aziz. “We came here because we heard this is the best place.”

Faragiskander has end-stage liver failure and has just waked up from a coma. Like most other people in the hospital here, he is not alone; his brother, and wife wait by his side.

“Can you do anything to help him?” asks his brother Samir, helpless, as he and the others start crying. “We are willing to give everything we have. We just want him cured somehow.”

The family knows that a transplant is the only thing that can possibly save him. Faragiskander came in too sick for doctors to do much more. But what the family doesn’t know is that the country’s largest liver institution doesn’t even perform them at this time. Same with the National Cancer Institute in Cairo.

Cultural and religious opposition to removing organs from the deceased has kept Egypt from recovering livers from cadavers. The only treatment option has been the partial liver transplant, in which doctors take a lobe from a healthy donor, and then place the reddish-brown organ into the person in need. But the surgery is prohibitively expensive — hundreds of thousands of dollars — and difficult to justify because it jeopardizes the healthy donor’s life. A healthy man died last year following surgery at New York’s Mount Sinai School of Medicine.

The partial transplant also doesn’t guarantee that the virus won’t invade the new liver, leading to failure once more. Nonetheless, doctors at both the Liver and Cancer Institutes say there are plans to begin split liver transplants in the near future. And some private hospitals have recently begun to do so as well.

It’s too late for Faragiskander. He died a few weeks after I visited. He leaves two little girls, a wife, and a family without their main breadwinner.

During that time I also visited Hamdy in the hospital, where he drifted in and out of sleep. He looked tired but happy and talked about how much he missed his daughter. Asked if he is angry about contracting the illness, he said nothing but pointed up, to the heavens. There was no talk of reparations, no demand of the government, no grievance with anyone. “It’s up to destiny,” Hamdy said. “It’s up to God if we should find treatment now.” Soon afterward, he died.

The first blow came when long-awaited results from the Parkinson’s study hit the media. The study involved 40 patients between the ages of 34 and 75 with Parkinson’s. Half of them received “sham” surgery, and the other half, the transplant of cells from the “substantia nigra.” After following the patients for one year, researchers found that there were devastating side effects in 15 percent of those who received the transplant.

Meanwhile, Nightlight Christian Adoptions and several couples interested in adopting embryos filed their lawsuit, which demands that the National Institutes of Health stop the grant application process and appropriation of money to scientists doing research with stem cells harvested from human embryos.

These developments have motivated anti-abortion groups to say that they are no longer pinning all their hopes on President Bush’s signing an executive order banning federal funding of this type of research. They believe that the new scientific evidence, and the impact of the lawsuit, could end the practice of controversial cell research without presidential intervention.

“The study took everybody by surprise,” says Scott Weinberg, spokesman for the American Life League, which supports the suit but is not named as a plaintiff. “This completely undercuts the scientific claims that this kind of research is necessary. We’ve always strongly opposed these unsubstantiated claims, and [the research] merely proves that this is deleterious not only for the patient but for the embryonic person.”

The groups listed as plaintiffs in the suit, along with Nightlight Christian Adoptions, which facilitates the adoption by infertile couples of unwanted frozen embryos stored at fertility clinics, include the Christian Medical Association; a woman from Arizona who is pregnant with an adopted embryo; and California and Colorado couples who want to adopt embryos and contend that stem cell research curtails the availability of embryos for adoption.

“We have an ethical alternative which is scientifically better than the embryonic stem cells,” says Dr. David Prentice, a professor of life sciences at Indiana State University and a plaintiff in the suit. “There is no reason to do this research that destroys human embryos and, especially, to use human tax dollars to fund that research.”

The current guidelines for stem cell research, which are at the center of the debate, were issued in August by the Clinton administration. While it is still illegal to use federal money to extract stem cells from discarded embryos, the regulations allow research with embryonic cells as long as they are obtained from and paid for by private sources.

The lawsuit alleges that these regulations are contrary to “ethical norms that protect human life from medical experimentation,” and that the government has ignored other viable sources from which stem cells can be derived, such as adult bone marrow.

Last week, Tommy Thompson, the newly appointed secretary of the Department of Health and Human Services, said that government scientists would evaluate the guidelines and issue a decision on their propriety sometime this summer. But the impetus for Thursday’s lawsuit was another statement by Thompson indicating that the NIH will continue to accept applications for grants in this area of research until March 15. Thompson, HHS, NIH and its acting director were all named in the suit. A spokesman for HHS said he could not comment on the complaint, and a call to the White House for comment was not returned.

A quick look at Thompson’s position on this issue shows how fractured the debate over stem cell research is, and how the sides are not necessarily drawn along political lines. Thompson is against abortion, yet has expressed his support for embryonic research in the past. And his latest announcement that he will accept grant applications has pushed critics of embryonic stem cell research over the edge. They say they can’t wait any longer for the president to overturn the regulations.

“We said, ‘No way, this is the fox guarding the henhouse,’ and we sprung into action and mobilized a grass-roots campaign urging the president to issue an executive order immediately,” says Weinberg of the American Life League. “In fact, [Bush] should have done this already. This [lawsuit] is a serious vote of no confidence in regards to the pro-life credentials of this administration.”

The issue of using embryos for research is emotionally charged, largely because it pits many patients with debilitating diseases like Parkinson’s, Alzheimer’s and diabetes against those who believe any tampering with embryos — which are destroyed during the cell extraction process — is unethical. Those who point to the promise of stem cells believe they can be manipulated to develop almost any type of tissue in the human body. (They are taken from the inner sphere of a fertilized egg.)

Many physicians, researchers and patients — including actor Christopher Reeve, who suffers from spinal cord injuries — believe that stem cell research will one day lead to a cure for their ailments, and they insist that the field of embryonic stem cell research needs time — and funding — in order to be successful. (While there is also great hope for adult stem cell research, those cells are considered to have less plasticity than cells from embryos.)

Sen. Patty Murray, D-Wash., is among those who strongly support stem cell research. She says she and her family have always hoped it might provide a cure for multiple sclerosis, a disease her father had until he passed away a few years ago. Thursday’s complaint by a “small extremist group,” she says, should not be allowed to thwart the progress in this area of medicine.

“This is not about destroying human lives, it’s about saving human lives,” says Sen. Murray. “I think it’s outrageous that they have gone to such extremes to stop research that is going on in the most bioethical way possible.” The senator also warns that if the federal government stops funding embryonic stem cell research, the field will become dependent on funding from private sources, which may not have the public’s best interest at heart.

But those who oppose the controversial extraction of cells from sources such as embryos and aborted fetuses were definitely in control of the debate as the details from the disastrous study on the fetal cell treatment for Parkinson’s disease came out.

In the double-blind study, led by Curt Freed from Denver’s Health Sciences Center, cells from aborted fetuses were transplanted into the brains of patients with the disease. While the study, published in the New England Journal of Medicine, found that there were benefits from the transplant of fetal tissue, horrifying side effects were also experienced by some of those who received the dopamine neurons. For example, some patients could not stop chewing or flexing their wrists. One even ended up on a feeding tube.

“It’s a nightmare,” said Dr. Paul Greene, one of the study’s researchers and a neurologist at Columbia University, in an interview with the New York Times. “And we can’t selectively turn it off.”

The publication of the results of the Parkinson’s study came as a shock — albeit a fortuitous one — to anti-abortion activists. For supporters of fetal tissue research like neurologist Dr. Jeffrey Kordower, it was a huge blow. A researcher in the midst of a study looking at the effects of transplanted fetal cells in Parkinson’s patients, Kordower is gravely concerned that critics will use the NEJM report as a political tool to halt all research using fetal tissue. He says that the techniques employed in the Parkinson’s study were unusual, including everything from where the cells were implanted (the forehead) to the small number of fetuses used to the way the tissue was prepared. (A researcher in the study did not return a call seeking comment.)

“They will use this study as a basis to prevent stem cell research and it’s inappropriate,” says Kordower, who works at Rush-Presbyterian-St. Luke’s Medical Center. “This is just one study.” In his research so far, he says, he has not encountered any serious side effects such as the ones experienced in the study reported in the NEJM. He hopes that the results of his study of 34 Parkinson’s patients, to be completed later this year, will somehow provide a fresh and convincing argument for research in his now fragile field of medicine.

“The economic impact of this is going to be horrendous,” says Dean Cliver, professor of food safety at the University of California at Davis and a member of the FDA’s transmissible spongiform encephalopathies advisory committee. “Especially superimposed on the problems they had to face in the aftermath of the mad cow thing, this is going to be a big, big blow to the economy in England.” Already, 37,000 animals are being killed, and that number could rise to 67,000. But so far only 40 animals have been documented as actually having the disease.

Indeed, the main fear with foot-and-mouth disease (FMD), besides the welfare of the animals, is financial. British farmers, barely recovering from the mad cow epidemic, may lose up to $73 million just on this weeklong ban of livestock, and even more if it continues. And animal health officials in the United States say if it ever reached this continent, it could significantly damage the $4.2 billion-a-year meat industry. Many countries halt importation of meat from countries where even a single case of FMD has been reported for at least a year.

Foot-and-mouth disease is among the most contagious of animal viruses. All cases in the U.K. can reportedly be linked to an outbreak at a single farm in Northumberland, England. Fortunately, unlike mad cow disease, FMD does not pose a risk for humans. But it is extremely virulent, and can be spread by almost anything — from cars, clothing, shoes and even, possibly, the wind. That’s why it can move through a continent like Europe and cause an infectious domino effect on countries there; it’s also why France and Ireland are particularly concerned about the disease’s possible infiltration and are taking extra precautions to keep it out. One farm in Ireland was quarantined because it was merely suspected that the animals had been in contact with sick animals at a farm in Northern Ireland.

Although it is rarely fatal to an adult animal, veterinarians say FMD is extremely painful and it can cause blisters on the tongue, muzzle, teats or feet of cloven-hooved animals like deer, pigs, cattle, goats and sheep, as well as spiking a fever. As the disease progresses, the skin of the tongue or feet can peel right off, making it excruciatingly painful for infected animals to eat, swallow or walk. FMD has a short incubation period — symptoms usually show up within a few days — so if an animal is quarantined for a week, and there are no telltale signs, chances are the disease is not present. Diseased animals rarely produce as much milk as they did before coming down with the condition. Though the cloven-hooved can eventually recover from the virus, the only way health officials believe they can control the disease is through eradication. And that has set the stage for mass slayings of cattle and other livestock across Britain. Many of the animals have not even been infected; they were merely exposed to foot-and-mouth.

The last case of foot-and-mouth disease on American soil was documented 72 years ago. Still, the recent outbreak in Europe has put American animal health officials on alert. “Foot and mouth is an old threat and has been of great concern for many years,” says Dr. James Roth, professor of immunology at Iowa State University’s College of Veterinary Medicine. “Having it present in England increases the threat a little bit. England has all the safeguards that we have in place and it got in there. We have to be aware that it could get in here. I think there’s a need to increase investment in prevention and detection.”

The disease has been particularly active in the last few years, moving through countries in Asia, South America and Europe. It has also been detected in the Middle East and Africa. And as countries in these areas have learned, no place — with even the best regulatory systems — is immune. Foot-and-mouth disease showed up in Japan last year, even though it hadn’t been present since 1908, and also in Korea, where it hadn’t been seen for almost as long. The 1997 outbreak in Taiwan dealt a crippling blow to that country’s meat industry, destroying its pig population and causing billions in estimated damages. Taiwain’s meat industry still hasn’t fully recovered.

But veterinarians say the United States may be less at risk because of bans already in place on all imported ruminants from the European Union. The U.S. banned ruminant imports from the United Kingdom in 1989 and the E.U. in 1997, following outbreaks of mad cow disease.

“We’re monitoring the situation in the E.U. and basically we have very strict regulations in place to protect us from foot-and-mouth disease,” says Kim Smith, spokeswoman for the United States Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS). “While it’s a concern, it’s not an extraordinary concern because our safeguarding measures are excellent,” she says.

In light of the British outbreak, the Department of Agriculture is asking ranchers to continue surveillance of animals to make sure that there are no signs of FMD in their herds. In Texas, on Wednesday, government officials urged livestock producers to step up observation procedures and to take extra precautionary hygienic measures, which include wiping off shoes with disinfectant and making sure that wastefood fed to swine is properly cooked. The state’s chief veterinarian also issued a warning to farmers: “If your livestock become lame or develop blisters or sores, call us … Our emergency response within the first 24 hours after the first signs of disease will affect our outcome over the next six months.”

Veterinarians and animal health officials believe that the growing international livestock trade is partly to blame for FMD’s resurgence. The outbreak of diseases like FMD can also highlight the dangers of free-trade and open-border agreements like those found in the European Union. “For the time being, [E.U.] commerce has gotten ahead of public health,” says Cliver. “This stuff moves around much more quickly than it used to, and some of it is stuff that has infectious disease agents in it.”

Although a vaccine exists, it’s difficult to immunize animals against the virus since seven sero-types of FMD exist, along with dozens of subtypes. Many times an animal will be given a vaccine that doesn’t protect it from other strains. Also, since it’s difficult to tell if an animal has the disease or is only vaccinated, many countries like the U.S. don’t import meat from places where vaccines are administered.

In the United States, there is only one place where the highly infectious foreign disease is researched. And that’s Plum Island, off the northeastern tip of Long Island, N.Y., where researchers are standing by in case infectious agents not present in the U.S. somehow make their way in. Of the 15 highly contagious diseases listed by the Office International Des Epizooties (World Organization for Animal Health), only three are present in the United States: bluetongue (a sheep and cattle virus disease), vesicular stomatitis (in cattle and horses) and New Castle disease (a viral poultry disease).

Marvin Grubman, a virologist who works with FMD, explains all the precautions he and the other researchers take just in order to work with the virus. They commute out every morning to the island, change into protective gear, and then shower before leaving. Since U.S. regulations prohibit the manufacture of the vaccine, the entire U.S. supply is imported. (Outbreaks in Europe have occurred in the past because the virus escaped out of the high-containment facilities where the vaccines were being manufactured.)

Grubman and his colleagues are working on developing a new vaccine that would be safer to produce and would produce immunity more quickly in animals. “We find that it can protect animals after they are vaccinated once; and when they are exposed, we can protect them from developing clinical signs of the disease,” says Grubman. “It seems to be working on a small scale.” The new vaccine also allows them to tell whether an animal is infected with the virus or has merely has been vaccinated. But still, Grubman says, any new and improved vaccine that could be used in case an outbreak occurs in the United States is probably several years away. If foot-and-mouth disease did make its way here, the United States would probably adopt the same disease eradication approach currently being used in the United Kingdom: the mass slaughter of animals, infected and uninfected.

According to a report issued last week by the United Nations Intergovernmental Panel on Climate Change (IPCC), the strange things going on at the Leopold Reserve are not isolated. Researchers found that more than 80 percent of the 500 species studied — including birds, amphibians, mammals, reptiles, plants, mollusks, insects and other invertebrates — are changing in response to rising temperatures. Some birds are migrating up to three weeks earlier now; other animals are migrating outside their natural habitat, edging closer to the poles and living at higher altitudes.

“There’s no doubt there will be extinction,” says Terry Root, the University of Michigan professor who led the research. “Because you have species that have small ranges, a lot of them won’t be able to move quickly [enough] since the temperature is rising so fast.”

The researchers who conducted the analysis of more than 44 studies on the topic say this can create a slew of problems since not all birds, for example, are changing their migration pattern. Some birds, previously thought to migrate in response to day length — the hours of light in a given day — are now believed to cue to temperature instead. Root says the ones still responding to day length may end up arriving at a habitat where other bird species have already set up shop. This could make it difficult for them to find a spot to nest, possibly setting off a whole set of other complications.

In January the IPCC released the first installment of its study, which focused on the science of global warming and predicted that the earth’s atmosphere could warm up by 10.4 degrees Fahrenheit during the next 100 years. But this latest report devotes many of its 1,000 pages to a hard look at the damage that global warming has already caused. For example, as ice packs break up, polar bears will have a more difficult time stalking their prey and feeding, since seals will no longer need breathing holes to get air. It also forecasts that, as temperatures rise, there will be more deaths from heat stress, as well as an increase in the number of people exposed to vector- and water-borne diseases like malaria and cholera. The report also predicts decreased water for those living in the subtropics, and more flooding in many low-lying areas, like Bangladesh, as sea levels continue to rise.

“What we’re seeing is movement into uncharted territory, into a warmer state that we have not known for the last 450,000 or perhaps up to a million years,” says James McCarthy, professor of oceanography at Harvard University and co-chairman of the IPCC panel that issued the report. “So it will take many organisms into a condition they haven’t been in.”

Researchers say that we can learn a lot about our own fate by studying global warming’s effect on different animal and plant species.

“It’s sort of an early warning system,” says Jeff Price, director of climate change impact studies at the American Bird Conservancy and co-author of the report. “You know the cliché of the canary in the coal mine — if the canary croaked, the miners knew to get out in a hurry. Plants and wildlife are barometers for the environment,” Price says.

In the Northern Hemisphere, satellite images show that spring is beginning about 11 days earlier than it did about 50 years ago. Warblers, Baltimore orioles and robins — spring-migrating birds — are procreating earlier than they did three decades ago. The clock is also moving up for other ecosystems as well — the time in which trees, like the cherry blossoms in Japan, bloom; when birds lay their eggs; when the aphid eggs hatch; and when the common toad breeds. Also, the coloration of the ladybird beetle has lightened, and the Edith’s checkerspot butterfly is moving farther north to cooler areas. All of these are almost meaningless events, Root says, unless looked at as a whole. And that picture depicts a world in which global warming is already leaving its imprint.

The work of Root and her colleagues is being heralded by numerous environmentalists as the “smoking gun” of the whole global warming debate, one that finally shows how large an effect even small changes in temperature can have on our biological systems.

“For the first time, it shows people in front of their very eyes what global warming is,” says Jennifer Morgan, director of World Wildlife Fund’s Climate Change Campaign. “What’s very interesting to me is it links everyday life with hard scientific data. We all have the conversations about how the flowers are blooming this year and the birds that are arriving early, and Root’s study provides the answer to the public. Is this global warming? The answer is yes.”

But those on the front lines of observation — birdwatchers — are not so sure. Since the data used to analyze many bird studies are gathered from birdwatchers, and the number of them perched out there has increased exponentially in recent years, critics say this may be one of the reasons why there has been a shift in recorded migration dates.

“I would be hesitant to go too far out on a limb,” says Eirik A.T. Blom, contributing editor to Bird Watcher’s Digest and former editor of Birding Magazine. “Everyone is in a frenzy. It’s easy to get hooked up on global warming and say this is part of it. But biologically it doesn’t necessarily make sense — [although] eventually it will have a big impact and over a long period of time, it’ll change the migratory patterns of birds.” But for something like this to occur, he says, will take many more years.

Peter Dunn, an assistant professor of biological sciences at the University of Wisconsin at Milwaukee, says he was initially skeptical, too. When he first read about the study on birds in the U.K. that showed they were laying their eggs earlier in response to temperature, he didn’t believe that this could be found on a wider scale. Dunn was already in the process of analyzing nest records of North American tree swallows, dating back to the 1950s, when he decided to take a peek at the temperature change during those years, too. His study, published in the Proceedings of the Royal Society two years ago, found that as temperatures have risen, these birds — one of the most common species in the United States — are laying their eggs up to nine days earlier.

“I thought I wouldn’t find as strong of a pattern because I was looking at the entire continent,” says Dunn. “But their food abundance is changing with the temperature. The food that they’re eating are aerial insects, and their abundance is directly correlated with air temperature. When it’s cold out, there are not as much insects; when it’s warm, the insects start to come out during spring and summer.”

While Dunn says he’s certain that it’s happening with birds like the tree swallow, he wonders whether or not birds that have different food sources — such as red-breasted robins, which eat worms — are being as drastically affected by temperature change. So far the swallow’s clutch size (the number of eggs it produces) has not changed, but he says it’s still too early to tell whether there are ramifications to breeding earlier. In fact, there may be some positive aspects. One, he says, is that these chicks may have a better chance of surviving since they will have longer to develop and will have a head start on life.

Critics of the U.N. report, such as University of Virginia environmental sciences professor Patrick Michaels, believe the IPCC report grossly exaggerates the inability of these species, and of humans, to adapt to temperature change.

“It’s science fiction,” says Michaels, who is also a senior fellow at the libertarian Cato Institute. “The reason for it is quite simple: The dire scenarios are based on assumptions that have extremely low probability. Of all the assumptions that are made, the lowest probability one is that people will sit idly by over the course of 100 years and not adapt to slowly evolving changes in their weather and climate.”

As for the butterflies like the Edith’s checkerspot, which is continuing to move north where it is cooler, Root says we will reach a point in which there is either nowhere farther north a species can move to, or they will run into different habitats, like cities, where they will be unable to settle. This specific species will run into San Diego, a certain roadblock to adaptation, she says.

Root says the solution is to start creating reserves that run north-south, so animals and other species can have room to adapt. And it’s better to start working on it now, she says, before conditions worsen. To those who doubt global warming’s effects, Root offers this analogy: “It’s like a court case: You may not have eyewitnesses, but you have circumstantial evidence, and it keeps on mounting, and all of it points to what we have been doing — and that’s humans ejecting greenhouse gases into the atmosphere.”