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Plunging Headlong into Madness

From Animal Issues, Volume 29, Number 2, Summer 1998

Plunging Headlong into Madness

By Alan Berger & Gil Lamont

More than at any time in history, many of us today have the opportunity to live longer and healthier lives. Significant advances in immunosuppression and other techniques have greatly increased the success of human-to-human transplants ("allografts") to replace worn-out body organs. Too bad there aren't enough body parts to go around.

Despite encouraging organ donors -- even the Department of Health and Human Services has a web site devoted to the issue at http://www.organdonor.gov -- the number of waiting recipients is climbing steadily. In 1988, the United Network for Organ Sharing (UNOS) listed 16,026 registrants waiting for transplants. Today the list numbers nearly 55,000.

The number of donor organs, although increasing, has not kept pace. The pesky lack of donors has the medical community looking longingly at xenografts (animal-to-human transplants) as the perfect answer.

Good for Industry

Even when we put aside the serious ethical considerations of using animals as walking containers of spare parts, there are serious financial and health consequences to xenografts.

The wholesale adoption of xenotransplants, using organs from genetically altered pigs, will generate enormous profits for the pharmaceutical industry, for the bioengineering firms that supply the pigs, and for the medical professionals involved.

"Xenotransplantation," reports one story, " could become a $3 billion to $5 billion a year business within the next dozen years."1

Good for industry, bad for the consumer. Already 40 million Americans are uninsured, increasing to 48 million -- by 20% -- by the year 2000.2 Another 29 million are underinsured.3

Meanwhile, health care costs are skyrocketing. We spend $425 billion a year -- about two-thirds of all medical expenditures -- to treat the six leading chronic diseases that cause nearly three-quarters of all deaths: heart disease, cancer, stroke, diabetes, chronic obstructive pulmonary disease, and liver disease.4

Current transplant costs range from $116,000 for a kidney to more than $300,000 for a liver. Factoring in five years of follow-up charges puts the costs at nearly $400,000 for a liver transplants, with heart, heart-lung, and lung transplants totaling more than $300,000 each.5 Adding xenografts to allografts will boost annual transplant expenditures from nearly $3 billion to $20.3 billion.6 And it can only rise from there.

Dwindling Confidence, Dwindling Coverage

Meanwhile, people's confidence in our health care system is dwindling. In a National Coalition on Health Care poll, 80% believe something is "seriously wrong" with the system and 87% that the quality of care needs to be improved. Eight of 10 blamed the profit motive for compromising quality.7

"In these times of managed care and a nationwide glut of hospital beds," reported The Wall Street Journal on the reluctance of state officials to authorize $300 million to overhaul an aging hospital in Brooklyn, "reviving [these ailing medical centers] may make little economic sense. Experts say it is time for a better way: lean clinics that provide out-patient and primary care."8

But when health care management takes services away from poorer neighborhoods, the "nationwide glut of hospital beds" is not available to the people who need them most, as revealed in a new study by the Harvard University School of Public Health. There's virtually no access to health care for native Americans on reservations, for urban blacks, for the poor concentrated anywhere. For them, health is poorer, life is shorter. Health care access can vary life expectancies by as much as 15 years between areas as little apart as 12 miles.9

In a 1993 Kaiser/Commonwealth Fund health insurance survey, 34% of the uninsured reported that they failed to receive needed care, and 71% postponed needed care.10 And the uninsured who have chronic illnesses "are least likely to receive proper maintenance and continuous care, with the result that untreated conditions such as hypertension or diabetes can lead to serious health consequences."11

Problem? What Problem?

Instead of allocating health costs to providing care to the millions who can't get it, our "baby boomer" bias concentrates on keeping that aging population bulge alive. Xenotransplant proponents have already begun a carefully orchestrated education of the public to accept xenografts, as evidenced by a recent press release: "Nearly all Americans (94%) are aware of the shortage of available organs for transplant and most (62%) accept the concept of xenotransplantation, or animal-to-human transplantation, as a viable option." And "nearly 75 percent of people in all the groups surveyed would consider a xenotransplant for a loved one if the organ or tissue were unavailable from a human."12

Evidently these people don't have all the facts. Certain diseases jump from animals to humans (zoonosis). The best known example is probably AIDS, which even Centers for Disease Control (CDC) scientists now acknowledge "resulted from the adaptation of simian retroviruses introduced across species lines into humans."13 The historically best known example is that of the 1918 influenza epidemic, which killed more than 20 million people worldwide and is now believed to have been a mutated swine virus carried to Europe by U.S. troops.14

Nor are these isolated examples. Recently health officials in Honk Kong destroyed millions of chickens after a virus, A(H5N1), jumped directly from the birds to humans.15 And lately there has been much publicity over the occurrence of Creutzfeldt-Jakob disease (CJD), a fatal brain-wasting illness that has claimed a number of British humans' lives and which has been linked to mad cow disease (bovine spongiform encephalopathy).16

No Getting Away from Viruses

The animal of choice for supplying xenotransplant organs will be the pig. The transgenic pigs will be raised in a sterile environment, but pigs bring a whole new set of problems to the issue of xenosis (viruses transmitted during xenotransplants) .

Recent findings by London researchers -- at the Institute of Cancer Research and the National Institute of Medical Research (NIMR) -- suggest that breeding virus-free pigs will be extremely difficult, if not impossible.

Sensitive molecular probes searched pigs from a range of breeds for copies of two inherited retroviruses, PERV-A and PERV-B (porcine endogenous proviruses), which can infect human cells.17 All the pigs tested possessed multiple copies of the viruses, 10-23 copies of the PERV-A genes and 7-12 copies of PERV-B genes.18

"The existence of 20 to 30 copies per cell will make it very much harder to remove the viruses from pig cells," said Dr. Jonathan P. Stoye of the NIMR, who led the research. "It may actually be impossible."19

In the lab both viruses infect human cells, but nobody will commit to whether they will cause disease in people. Dr. Stoye, who wants further investigation before proceeding with pig-to-human xenotransplants, says, "We ought to know more about the pathogenic potential of these viruses."20

We do know that humans can already acquire approximately 25 diseases from pigs, including anthrax, influenza, scabies, rabies, leptospirosis (which produces liver and kidney damage) and erysipelas (a skin infection).21

Forging Ahead

Despite the above recognition that the dangers are unknown; despite the federal government's own assessment that the risk of infection cannot be quantified ("unequivocally greater than zero" was the official position22); despite the requests of leading scientists that a moratorium be imposed on clinical xenotransplantation "in the public interest";23 the government is committed to xenotransplantation.

At a December 1997 meeting, the Xenotransplant Advisory Subcommittee of the U.S. Food and Drug Administration (FDA) recommended that the FDA approve "limited" human clinical trials for xenotransplantation.24

"Developing U.S. Public Health Service [PHS] Policy in Xenotransplantation," a January 1998 government-sponsored conference announced the imminent release of final PHS Guidelines for Xenotransplantation to Protect Against Infectious Diseases. The oversight agency for xenotransplantation will be the FDA.25

The government intends to protect the public through cumbersome procedures that include screening donor animals for known viruses, constant surveillance of xenotransplant recipients and their contacts, maintaining tissue and blood samples from donor animals and human recipients, and establishing national and local registries of xenograft patients.26

Given the scope of xenotransplantation expected, the number of patients will, most likely, quickly outstrip the capabilities of the database that must be necessarily maintained. As for screening for known viruses, what about the unknown ones? In February 1998, Australian scientists discovered an unknown virus in pigs. The virus apparently came from a colony of fruitbats that lived nearby. Once it hit the piggery the virus attacked pig fetuses, which were either stillborn or had defects in the spinal cord and brain. It also infected two human workers, who recovered. "You can't screen for disease agents that you don't know about," said Virologist Peter Kirkland.27

And after the virus is discovered, what can we really do about it? HIV has been known for decades, yet worldwide the AIDS epidemic is getting worse.28

A Better Way

Would xenografts even be an option if enough human donor organs were available? Recent advances point the way to greater compatibility of organ and recipient. The discoverer of a "facilitating cell" that helps stem cells engraft says that "universal organ transplants may be possible, which may alleviate the chronic shortage of organs."29

That "chronic shortage" may also be reduced by a new National Organ and Tissue Donor Initiative,30 and new policies in several states. Beginning in 1995, Pennsylvania hospitals are required to notify the regional organ procurement organization upon each patient's death to determine potential for organ or tissue donation. This immediately increased referrals tenfold. An aggressive education program has also increased public awareness of the need for donors, especially for people renewing their driver licenses; in the first year, more than 820,000 drivers chose to have "organ donor" printed on the front of their licenses beneath their photograph.31 Similar legislation has been enacted or is being considered in New Jersey, Maryland, and other states.

While applauding all efforts to encourage more people to become organ donors, API supports enacting a national Presumed Consent Law, which supports a growing majority of Americans who have expressed a willingness to donate their organs at death. This law would assume that, unless expressed otherwise before death, everyone is a potential organ donor upon his or her demise. (Provisions for minors and the infirm require parental or guardian consent.) An opposite wish may simply be communicated in writing.

The Best of All

While transplants may offer longer and healthier lives to the chronically ill, one form of "medicine" reigns supreme. "I really don't think transplantation is going to be the answer," says Charles Porter, a Missouri cardiologist. "It's going to rehabilitation and prevention."32 Rep. Jim Moran, D-Va., agrees, pointing out that the nation spends far too much on curing illnesses and not enough trying to prevent them. "Prevention," he says, "is much less expensive and far more effective."33

Indeed, most illnesses are preventable. Studies show that changes in diet and increasing exercise can reduce high blood pressure,34 heart attacks,35 and cancer.36 Yet most people behave as if their bodies are machines to be worn out, or that the medical community sees transgenic pigs as the mobile warehouses for spare parts. Of the enormous numbers of dollars spent on health care, only a fraction goes to prevention and control efforts -- about 3% of most state public health departments' budgets. In 1994, over $287 million was spent at the state level on prevention efforts aimed at the six leading chronic diseases (heart disease, cancer, stroke, diabetes, chronic obstructive pulmonary disease, and chronic liver disease). This was approximately 0.07% of the estimated $425 billion spent annually to treat those same diseases, according to a CDC study.37

Xenotransplantation is not the answer, despite all the rosy pictures overoptimistic researchers, genetic engineers, and pharmaceutical companies, paint of readily available organs. Since 1994, API has been saying exactly that, in a series of position papers, arguments, and at government-sponsored conferences. We cannot continue to cure human lives by the wholesale taking of animal lives. We cannot continue to deny health care to others simply because where they live prevents that health care from being "cost effective." We must learn to take better care of each other, by becoming organ donors, and better care of ourselves, through diet and exercise.


The Campaign for Responsible Transplantation (CRT) is the first broad-based coalition to counter the irresponsible rush to transplant animal organs into people. CRT is composed of scientists, health care professionals, and public interest groups such as the Physicians Committee for Responsible Medicine (PCRM) and the Medical Research Modernization Committee (MRMC). Representing animal advocacy organizations, API has taken a lead role in fighting xenotransplantation.

CRT is calling for the government to halt animal-to-human transplants. You can help. Contact API for a CRT petition that when filled will be sent to the appropriate government officials, urging them to stop xenotransplantation, or go directly to CRT's online version.


Notes:

1. Judith Graham. "Risks, rewards of new transplants." Chicago Tribune, July 27, 1997.

2. Lucette Lagnado. "Inner-City Hospital Begs for Life Support." The Wall Street Journal, February 12, 1997.

3. Karen Donelan, ScD, et al. "Whatever Happened to the Health Insurance Crisis in the United States?" JAMA, Volume 276 (1996), 1346-1350.

4. "Chronic Disease Costs Could Soar." San Francisco Chronicle, April 4, 1997.

5. Richard H. Hauboldt, F.S.A. Cost Implications of Human Organ and Tissue Transplantations, An Update: 1996. Minneapolis, MN: Milliman and Robertson, Inc., 1996.

6. Institute of Medicine. Xenotransplantation: Science, Ethics, and Public Policy. Washington, DC: National Academy Press, 1996.

7. Edwin Chen. "Distress Over Health System Seen Growing." Los Angeles Times, January 24, 1997.

8. Lagnado.

9. Steve Sternberg. "Study shows yawning gaps in U.S. health care." USA Today, December 4, 1997.

10. Karen Davis. "1996 AHSR Presidential Address: Uninsured in an Era or Managed Care." Health Services Research, Volume 31 (1997), 641-649.

11. Davis.

12. "Americans Recognize Organ Shortage, Support Animal-to-Human Transplants, New Survey Says." The National Kidney Foundation, January 21, 1998.

13. Louisa A. Chapman, M.D., et al. "Sounding Board: Xenotransplantation and Xenogeneic Infections." The New England Journal of Medicine, Volume 333 (1995), 1498-1501.

14. Alix Fano, M.A., et al. Of Pigs, Primates, and Plagues: A Layperson's Guide to the Problems with Animal-to-Human Organ Transplants. New York: Medical Research Modernization Committee, n.d.

15. Dr. Murry J. Cohen and Alix Fano. "'Bird flu' a warning to stop animal-organ transplants." The Houston Chronicle, January 15, 1998.

16. Alicia Ault. "Brain grafts could pass on disease - U.S. panel." Reuters, October 6, 1977.

17. Clive Patience, et al. "Infection of human cells by an endogenous retrovirus of pigs." Nature Medicine, Volume 3 (1997), 282-286.

18. Associated Press. "Pig Organs May Bring Viral Risks." The New York Times, October 21, 1997.

19. Michael Day. "Tainted transplants." New Scientist, October 18, 1997.

20. Day.

21. Fano.

22. Xenotransplantation.

23. F. H. Bach, et al. "Uncertainty in xenotransplantation: Individual benefit versus collective risk." Nature Medicine, Volume 4 (1998), 141-144.

24. Animal Protection Institute. "Limited Xenotransplant Trials OK'd." Bulletin, Volume 5, Number 2, 1998.

25. Animal Protection Institute.

26. Xenotransplantation.

27. Reuters. "Pig virus sparks fears about animal transplants." February 25, 1998.

28. Associated Press. "AIDS epidemic worsening, UN says." The Globe and Mail, November 27, 1997.

29. "Chimeric Therapies Attempts Organ Transplants Involving Mismatched Donors, Recipients." NewsEdge, February 27, 1998.

30. Donna E. Shalala. "Letter from Secretary of Health and Human Services to Members of Congress." February 26, 1998.

31. "Organ Donations Experience Record Increase." PRNewswire, October 9, 1996.

32. Alan Bavley. "Doctors pump life into new ideas for healing heart failure patients." San Francisco Chronicle, December 1, 1996.

33. Sternberg.

34. Thomas H. Maugh II. "Study: Eat right, cut blood pressure." The Sacramento Bee, April 17, 1997.

35. Geoffrey Cowley. "The Heart Attackers." Newsweek, August 11, 1997.

36. Brigid Schulte. "Cancer study says bad food is not key; diet, exercise are." Contra Costa Times, October 12, 1997.

37. "Chronic Disease Costs."




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