Oriented to Thoracic Transplant Recipients -- April 1996

The UPBEAT! Archive


1100 Boulders Parkway, Suite 500

Richmond, Virginia 23225

March 20, 1996


Forbes, Inc.

60 Fifth Avenue

New York, NY 10011

Dear Sir:

Today more than 45,000 candidates await life-sustaining organ transplants. And this year approximately nine patients per day are expected to die while waiting. Nearly twice as many new patients are listed for transplants each month as there are transplants being performed. The scarcity of available organs is distressing to all who wait.

In "Why people die waiting for transplants" (March 11, 1996), Forbes readers were told that the organ supply is kept artificially low by a government monopoly. In reality the organ shortage is primarily due to lack of donor and donor family consent.

Rather than becoming entrapped in a government monopoly, transplantation is the only segment of the entire health care community that is self-governed, serving as an important model for government deregulation in this country and around the world. Transplantation policies are designed - by consensus - by the patients, professionals and institutions that must live by them.

The United Network for Organ Sharing is a democratic forum where members of the transplant community, including patients, converge to develop policies for the organ procurement and transplantation network and the 45,000 people awaiting transplants.

Fairly allocating a scant supply of organs to the thousands of patients waiting is a complex process that is constantly evolving. UNOS members are grappling with a very slow increase in donor organs and - thanks to continued scientific advancements - a rapidly growing list of patients waiting.

As the organ scarcity intensifies, prioritizing patients becomes more difficult. The only way out of this distress is to double or triple the number of donors, avoiding the current wastage of a valuable national resource.

We hope in future features, Forbes will join those interested in addressing the crux of the problem in organ transplantation - the organ supply.


Bruce A. Lucas, M.D.

President, United Network for Organ Sharing

Director, Kidney Transplant Program, Dept. Of Surgery,

University of Kentucky Medical School

Professor, University of Kentucky College of Medicine


March 17, 1996

Dear To Whom It May Concern:

Brigid McMenamin's article on organ transplantation errs when she suggests that policies denying transplanting scarce organs to patients with some preexisting conditions (cancer for example) are designed to "keeping a lid on demand," or jack up prices. Those policies recognize the lower survival rates of people with such conditions and are an attempt to assure that scarce organs go to those with the best chance of survival. It is called "good stewardship."

Equally curious is her unsupported assertion that the "obvious solution" to scarcity would be to dismantle UNOS, the federal system designed to assure fair allocation of available organs. nonce doctors and hospitals could harvest organ for their own patients," she insists, "there would be added incentive for doctors and hospitals to solicit for them." This assumes, erroneously, that doctors and hospital and procurement coordinators do not currently recommend organ donation. It also implies that there would be greater contributions under private stewardship.

Incentives, she later explains, means money for body parts. "If they could offer money and other economic incentives, more families might agree to donate." Readers should ask themselves how willing they might be to sell a kidney, lung, or heart to the highest bedside bidder if their spouse or child were deathly ill and in a hospital's ICU.

Treating useable body parts as just another commodity to be bought and sold is a solution rejected as abhorrent by every nation in the world, with the possible exception of China. Whether organ stewardship is private or public, financial compensation for useable body parts would be a gross violation of US laws. Privatization would not change this fact, or allow the "incentives" she glibly suggests a "free market" must necessarily allow.

I very much doubt whether Forbes Magazine staff, its publisher Steve Forbes, or readers seriously wish to endorse turning Emergency Rooms and the Intensive Care Units of U.S. hospitals into commodity trading floors. Nor, I suspect, will they be cavalier in recommending, as McMenamin seems to be doing, a policy-the richest get to buy the parts, whatever their medical condition-which is not only inequitable but often medically counterproductive and morally abhorrent.

What is most surprising is that Forbes both ran an article which will likely be condemned by public and private sectors alike, and then promoted it in one of its electronic forums.

Tom Koch and Dave Thomasma

- Loyala U. Medical Humanities

Posted on Translist-Internet

The editor of UpBeat had never seen this report until very recently, although it is now somewhat dated. If one accepts the logic and conclusions in totality, the UpBeat plan for organ donation offered forth a month or so ago, hits the big, eternal, circular file. Oh well! DM


A Report of the UNOS Ethics Subcommittee

James F. Burdick, M.D., Chairman

Alexander M. Capron, LLB

Francis L. Delmonico, M.D.

Mark D. Ravenscraft, M.D.

Craig R. Reckard, M.D.

Michael Shapiro, M.D.

June 30, 1993

NOTE: This report is circulated for informational purposes and to stimulate discussion of a very important subject. The report has been presented to the UNOS Board of Directors. It has not been adopted as UNOS policy.

Summary of the Concept.

The concept of preferred status involves the rewarding of organ donors by providing them with a modest but definite recognition, in kind, for their willingness to participate in the system. A precedent to some degree is credit to blood donors should they need blood in the future.

Individuals who have signified their intention to be organ/tissue donors, or perhaps, to a lesser degree, first degree relatives of those who have signed up or have actually been donors, would receive points or other value that would somewhat facilitate their likelihood of receiving an organ, should they need it in the future. Preferred status has been viewed as a reasonable approach to increasing fairness in the system and potentiating organ donation by some but with abhorrence by at least one critic.

Ethical Essence.
At least two ethical issues are important in considering Preferred status: If preferred status were instituted, what would be the balance between intrinsic ethical good and bad; and, as an independent utilitarian ethical issue, what would be the impact on the system? In other words, it is necessary to consider both whether the process is intrinsically justified ethically, and whether it would actually help or harm organ donation. The impact on the system would depend strongly on the perception of society an d the transplant community as to the ethical worth of preferred status, and this would involve mainly the degree to which the process was deemed to be fair. A net ethical good from this point of view would accrue from an increased perception that organ donation is important to all, transplants are successful, and the system works without barriers to the disadvantaged segments of society.

The net ethical worth of preferred status is partly an issue of justice. Is it fair for an individual who is willing to participate in the system of transplantation to not receive an organ while another medically similar individual who was unwilling to participate receives a transplant? On the other hand, it may be framed in terms of autonomy. Intrinsic to the present approach to organ donation is the autonomy of each person to decide. Any policy change in the direction of inducement to donation may be cons trued as impinging on that autonomy.

The altruism involved in different approaches to encouraging organ donation might be put on a relative scale from most to least altruistic as follows: the present system; presumed consent; routine retrieval; preferred status; and payment (in some form) in exchange for organs. There is a clear distinction between the implications of opting in for preferred status, and receiving payment.

Prospective Benefits.
One of the most important aspects of the preferred status concept is its potential to provide recognition for those opting into the system without the unfairness and tawdriness intrinsic to any form of financial incentive or recognition. If the definition of a modest but definite benefit is optimal, preferred status has the potential to maximize fairness in the system, in excess of that at present.

In general, the value or points awarded should be sufficient to be tie-breakers. The value should probably not be sufficient to place an elective case with a short time on the list ahead of one who is about to die, or who has been waiting for years. Given this aim, it seems possible that preferred status would help facilitate a change from the present general sense of personal un-involvement to a majority that agree to opt in.

As a corollary to this, those in society that are disadvantaged in general, and therefore in terms of access to medical care, would be dealt with most fairly by the possibility of preferred status. Because the life-giving organ represents a benefit that transcends money, its value is the same to a very poor disadvantaged person as to a wealthy one, unlike a monetary consideration. It would be hoped that the disadvantaged, now particularly likely to view organ donation and transplantation with suspicion, mig ht realize a sense of democracy in their rightful access to the same option (that of preferred status) as any other citizen. This could be particularly important in the case of kidneys for Blacks, who have a particular need at present, in view of their higher incidence of kidney failure, since it would encourage donation by this segment of the population that is particularly likely to also need the availability of a transplant.

With regard to impact on the system it would be hoped that many who had not found it important to consider the issue of organ donation would be encouraged think about it and agree to participate, thereby eventually increasing the number of registered organ donors substantially. However this might not produce enrollment of sufficient numbers to directly increase organ donation much, at least initially. More likely to be important in the short run would be the indirect benefit of complimentary discussion in s ociety, which would foster increased awareness of the success of transplantation, the appropriateness of organ donation, and the importance that society places on this process.

Potential Harms.
Some possibilities by which preferred status might produce harm are derived from negative speculations on its potential for good. The primary objection is that there are two sides to the issue of fairness. Consider the scenario of two medically similar patients, for whom preferred status would be the tie-breaker. One patient has signed an organ donor card, but has had a life of doing harm to society, robbing and beating others. The other patient has lived an exemplary life, has contributed financially and p ersonally to medical causes including transplantation, and therefore has directly benefited many other people, but has not felt comfortable with agreeing to organ donation. Is there justice in the former person receiving the organ, allowing the one arbitrary fact of opting into the system to override all the other comparative points, which would tend the choice toward the latter. One objects that in fact such judgments are not made now. In fact opting in is not envisioned as a determinant of moral worth but rather a social contract, a sort of insurance that everyone has a right to if they wish to make the deposit. However it would be disingenuous to argue that there is not an imprimatur of worth connected to the concept of preferred status. If one factor, preferred status, were to be instituted, might that start the system down a slippery slope of increasing calculations of worth that have so far been avoided?

Another danger is that the hoped-for amelioration of suspicion of the system on the part of the disadvantaged would not result, but rather it would be viewed as another scheme by the establishment, this time to obtain more organs for others. Some people express willingness to be an organ donor, but would not carry a donor card out of fear that their terminal care would be compromised to obtain their organs. This possibility is potentiated by the lack of access to extra-renal, and to some degree, renal, tran splantation, for the disadvantaged. The increased access to an organ that preferred status could provide would not be valuable if reimbursement for the necessary medical care were not available.

In addition, in spite of attempts to provide equal access to the information, equality of the system over disparate socioeconomic status would be imperfect. As is generally the case with anything, those who are well-read and living above the survival level would be more likely to benefit, since they would be better informed about the option and have better medical care underlying the possibility.

Perhaps the most important negative aspect of the idea of preferred status is one that it shares with all other forms of inducement: it is likely to be seen by some as inherently compromising the altruism that is a key ingredient of the present voluntary system in which organs are donated as gifts.

Another proposed problem is shared with all approaches such as required response to the driver' s license donation question, which is that, given results of public opinion polls, the process is likely to have the undesired outcome of forcing a large fraction of negative responses, which might decrease donation in fact. This is a difficult ethical issue, since this might be an intrinsic good, increasing as it does the individual's autonomy. However it could impair the system that potential organ recipients a re relying upon.

As noted above, the value or number of points is critical since it should represent a meaningful but not overpowering advantage. This may be impossible to achieve in practice. A serious drawback is that the system may suffer on the one hand if the value of the preference is quite large, since it could be interpreted as proof that the system is not fair and can be manipulated. On the other hand, if the help represented is too minimal, the proposal would appear to be dis-ingenuous, as not really meaningful.

Money and personnel resources would be required and it would be necessary to estimate these. Implementation of preferred status should not detract from present conventional organ donor efforts.

Aside from ethical worth, how practical is such a system? It is not the purpose here to invent a detailed system. As envisioned, a national registry, perhaps managed by HCFA on the basis of Social Security Numbers, would list all individuals who declared either their intention to be a donor, or their wish not to be. This would be accessible across the country essentially instantaneously. It is likely that security of confidentiality would be maximized but not guaranteed. Individuals could register at or aft er age 18. People with known disease threatening the relevant organ would not be eligible. A one year waiting period would be invoked to avoid seriously ill patients signing up for immediate benefit. Beyond this, no attempt would be made to determine prior knowledge of disease that might require organ transplantation. A registrant could change their mind at any point and redesignate their category.

Education of the public about the system would be a major effort. Perhaps focus groups and town meetings could be used to attempt to democratize the availability of the information as much as possible.

The benefit might be a few points on the waiting list. The number of points would have to be computer-modeled based on the waiting list to establish an appropriate (see above) benefit and might require ongoing reanalysis as patterns of transplantation changed. Different organs would probably need slightly different treatment. It might be appropriate to also provide a fraction of the points to first-degree relatives and spouses. This might greatly extend the potential benefit, although if the fundamental ben efit were calculated appropriately, the fractional benefit might not be substantive. Perhaps one could accrue points from two or more relatives, but never to the same point as if one gave permission for donation personally.

It is argued that the chances of needing a transplant are, in fact sufficiently small that the preferred status would be unlikely to benefit any particular person by actually becoming needed. However it might still be accepted if viewed as intrinsically fair, and could still have a powerful benefit by heightening public awareness and acceptance of organ donation.

There are a series of imaginable ways this system could be "gamed" and the most obvious would have to be addressed, but the overall impact of improving acceptance of organ donation and establishing communication of its value to all would not be impacted.

Possibly the system might best be implemented only for kidneys: this would benefit Blacks particularly, and avoid problems stemming from reimbursement not being generally available. Unfortunately with regard to kidneys it is unlikely to improve access for high PRA patients, regardless of the magnitude of the preference. Individuals could nor in this case sign up if they had known kidney disease; violation of this would most efficiently be monitored by analysis of the situation at the time the patient was li sted as a potential recipient.

Ultimately, if organ donation were being agreed to by the vast majority of potential donors, the system might wither and become meaningless, a most optimal outcome.

Advantages of preferred status over other approaches to facilitation of organ retrieval include intrinsic fairness with regard to "opting in," the fact that the special priceless organ does not represent financial payment, and that it would be equitable across strata of society. A trial could be implemented without requiring any alteration in existing legislation, unlike other mechanisms under discussion.

The major detractions include that it still represents compensation akin to purchase, that it might raise suspicion rather than increase acceptance of organ donation, that there is no ethical justification for attaching unique moral worth to willingness to give, and that the implementation would be troublesome.

In balance, the recommendation is for wider societal discussion before considering concrete plans for implementation.


By Stuart Auerbach

After lagging behind the rest of the nation for decades, America's ethnic minorities have stepped up donations of vital organs for transplants to the point where their donations now nearly equal their share of the population.

According to the latest annual report of the U.S. Scientific registry of Transplant Recipients and the Organ Procurement and Transplantation Registry, released here last week, the number of black donors increased 29 percent between 1988 and 1994.

Blacks gave 11.5 percent of the 5,100 organs that were donated in 1994. That is slightly less than their 12.1 percent of the population.

Donations by Hispanics and Asians also increased, according to the registry. Hispanic donations increased 32 percent to 8.2 percent of all donations.

The increase in minority donations is critical because the chance of success in transplants is enhanced by a close genetic match between the recipient and the donor, and transplant scientists said this is more likely to occur between members of the same ethnic and racial group. Blacks made up more than one-third of all Americans on the waiting list for kidneys for transplant at the end of 1994. More than one fourth of all kidney transplant recipients that year were black.

As a result, the U.S. Department of Health and Human Service's Division of Organ Transplantation said that "a shortage of organs donated by minorities can contribute to death and longer waiting periods for transplants for minorities."

Minorities are more prone than whites to many diseases that lead to transplants. For example, government figures show that blacks, Hispanics and Asians are three times more likely to suffer from end-stage kidney disease than whites.

Lawrence G. Hunsicker, professor of internal medicine at the University of Iowa and a specialist in organ donation, added that blacks and Hispanics make up "a disproportionate high percentage" of patients in end-stage heart disease.

The donation report came at a meeting in Washington of the United Network for Organ Sharing (UNOS). UNOS links the different segments of the organ procurement, transplantation and tissue typing community to promote transplantation and develop an equitable system for allocating scarce organs. Under contract with the federal government, it runs the national organ procurement and transplantation network and the scientific registry for organ transplantation.

Transplant specialists at the UNOS meeting also reported that patients are surviving longer with transplanted organs. As many as 94.3 percent of them live three years with a transplanted kidney and 74.4 percent live three years with a transplanted heart.

The longer survival times are due largely to better use of drugs that dampen the body's natural immune system defenses against foreign bodies such as transplanted organs and to better skills in genetically matching patient and donor so the chances of rejection are lessened.

But the supply of organs for transplants has failed to keep up with a growing demand as surgeons are becoming more successful in transplanting kidneys, hearts, lungs, livers and other organs and the number of patients demanding transplants has increased.

As a result, the waiting list of the sick and dying is increasing at a much faster rate than organs being donated.

"The number one problem in transplants is the shortage of donor organs," said Judith B. Braslow, Director of the Division of Organ transplantation.

UNOS statistics showed that transplants increased by almost 50 percent from 1988 through 1994, when they totaled 18,270.

But organ donations increased by just 37 percent- from 5,908 to 8,114- causing the number of patients on the waiting list to more than double. According to UNOS, there were more than 44,000 patients on the waiting list as of 2/15/1996.

As a consequence of the shortage of donated organs, 3,072 patients died waiting for transplant organs in 1994.

"These are patients who most likely would be alive today if only there had been enough organs to go around. We desperately need donors," said O. Patrick Daily, assistant executive director of operations for UNOS.

Most of the patients - 31,286 - were waiting for kidney transplants, the procedure with the greatest success rate.

At the current rate of kidney transplants - more than 10,000 a year - it would take three years just to clear the backlog without adding new patients.

Patients receiving transplanted kidneys from a living donor - usually relatives who agreed to give up one of their two healthy kidneys to save a life - ran a 94.3 percent chance of living three years. The results with kidneys from cadavers were slightly lower an 87.4 percent three-year survival rate.

There were 5,784 patients waiting for liver transplants as of 2/15/1996. There were 3,652 liver transplants performed in 1994 and the three-year survival rate was 72.7 percent.

Heart transplants, which created a great media frenzy when they were first performed almost three decades ago, have lessened in popularity as other surgical and medical means have been developed to treat serious heart ailments.

Still, 3,465 patients were waiting for a donated heart on 2/15/1996, a thousand more that the number of transplants that were performed in 1994. Heart transplants have a 74.4 percent three-year survival rate.

In an effort to overcome the shortage of human organ donations for transplants, scientists are working to develop special animal species whose organs can be placed into humans. These xenotransplants "address the crying need....of the tremendous shortage of donor organs," said Fritz H. Bach, a leading transplant scientist and director of the Sandoz Center for Immunobiology at Harvard medical School.

Transplants of animal organs, however, remain in the experimental stage. Washington Post 2/27/96 Contributed by Myrna Porter, Woodbridge, VA


Quips from the recent Gridiron Banquet in DC:

As for Clinton's GOP opponent for the White House, an actor playing the 72-year-old Dole sang:

"Younger than Thurmond, am I." If he wins another Senate term, Thurmond would be 100 years old when he completes it.

Senate Majority Whip Trent Lott, RMiss., also joked about Thurmond's age. He said that when freshman Sen. Bill Frist, R-Tenn., a (transplant) surgeon, started an organ donor drive among senators, "Strom listed a couple of body parts they don't even make anymore."

OK folks, now it has been told! Sandimmune does stink, and thus could well be an excellent insect repellent! A conversation with a highly placed Sandoz technical person reveals that the new Neoral uses "the same basic chemical agent (as Sandimmune), which is the apparent source of the smell, and in conjunction with ethanol is unchanged. The pills still have that skunky smell, and occasional people will smell like garlic."

This is presently an UpBeat exclusive and is factually reported as heard. It is doubtful that either Sandoz or the American Garlic Foundation will pursue patents in the area of our now famous Cyclo-Repel. Keep popping those capsules and quit wondering why your deodorant always fails.


By Arthur H. Rotstein - Associated Press Writer

TUCSON, Ariz. (AP 4/8/96) -- An artificial heart used to snatch patients from death's door has been brought back from the brink itself by scientists who believe in how well it works.

A researcher says the U.S. Food and Drug Administration will be asked to approve broader use after trials have shown that the device keeps most dying patients alive long enough to have successful heart transplants.

"The numbers speak for themselves," says Richard Smith, biomedical engineer at the University of Arizona's University Heart Center who heads the CardloWest artificial heart program.

Its current FDA-authorized investigational study is designed to prove that the heart replacement device works as a temporary bridge to transplant in dying heart patients whom other heart-assist devices can't save. The study involves medical centers in Chicago, Pittsburgh, Milwaukee, San Antonio and Salt Lake City, two in Paris and one in Ottawa, Canada.

"There's enthusiasm out there. There's need out there," Smith said, adding that he gets inquiries weekly from heart surgeons.

Of 2,000 Americans who get transplants every year, about 25 percent to 35 percent need some mechanical assistance to stay alive beforehand. Most devices in use support only the heart's left ventricle, its main pumping chamber.

When both sides of the heart are in failure, nothing else works as well as a total artificial heart, Smith said. Since the first CardioWest heart pump was implanted in Sharoyn Loughran's chest in January 1993, 69 have been used worldwide, including 25 in the United States.

The device kept Loughran alive for 186 days before she got a transplant. Counting her, 65 patients met all criteria for the study. Of that number, 47 went on to receive transplants, and all but five are still alive.

Loughran, 49, thinks the device is great.

"It kept me alive, so I have to appreciate that," she said from her home in Scottsdale. "But if anybody wants to break that record, they're free to."

Of the 25 CardioWest implants in the United States, 19 met all criteria for the study, and 17 of them are alive after subsequent heart transplant.

Smith said that means an artificial heart implant offers transplant candidates with two-sided heart failure "a 90 percent chance that you'll go home with a transplanted heart. And that's good news."

In each study case, he said, medical teams must show why other devices would not suffice. Dr. Howard Frazier of Houston's Texas Heart Institute, a transplant specialist not involved in the study, has said the CardioWest fills a void, and that "it's good they've made this effort."

The FDA counts only the study's domestic cases but tracks adverse events, from bleeding to death, in the foreign cases, Smith said.

The two-chambered CardioWest plastic pump is a direct descendant and improved version of the Jarvik heart. It replaces a patient's own failing heart, handling the pumping chores of both the left and right ventricles.

As with the Jarvik, the CardioWest patient is tethered to a washing machine-sized, 500 pound air-powered console. Smith hopes to have a purse-sized portable drive unit within two years so patients awaiting transplant can go home The once-promising Jarvik heart appeared to reach a disastrous end by 1991. Less than a decade earlier, a University of Utah team riveted the world's attention by implanting it in dentist Dr. Barney Clark as a permanent replacement heart in 1982. Clark died after 112 days.

Starting in 1985, attention focused on using the Jarvik as a temporary bridge to transplant, a technique pioneered by University of Arizona heart surgeon Dr. Jack Copeland.

By late 1990, 198 of the Jarvik hearts, marketed under the name Symbion, were implanted worldwide. Of those, 144 patients, or 73 percent, later received human heart transplants, and 85 survived, or 43 percent. But the FDA ordered it off the market in 1991 because of record-keeping and quality control problems.

A joint venture between Arizona's University Medical Center and the University of Utah's Medforte Foundation created CardioWest, took over the technology rights and convinced the FDA to approve a new study. Smith said the ongoing study compared CardioWest patients to 17 in a control group who would have received total artificial hearts had they been available.

Eight of them received transplants, of whom seven were sent home and six are still alive -- 35 percent. The rest died.

"We have shown ... that statistically we can do good work," he said.

CardioWest probably will apply for pre-market approval within six months. If granted, the heart would sell for about $32,500. A label would list all the possible side effects. Smith said the heart ultimately would be of use to about 100 centers worldwide -- including about 50 in this country, he said.


By Paul Majendie

LONDON (Reuter 3/25/96) - The world's first patient to receive a permanent electric heart has died in Britain, 30 hours after doctors removed the revolutionary device, a hospital said Monday.

After five months, surgeons took out the battery-powered heart from 64-year-old Abel Goodman Saturday when his own heart appeared to be strong enough to work independently. Bleeding around the device had also caused concern.

The former film producer died at the John Radcliffe Hospital in Oxford, west of London, Sunday. His wife and son were with him at his death. Doctors acknowledged Goodman's death was a setback but vowed to continue with the pioneer surgery.

"It's not fair to say the removal of the heart caused his death. Mr Goodman was a very sick man and it certainly extended his life," said hospital spokesman Martin Leaver.

He said its removal had been on the cards for some time as this type of artificial heart was leaving him prone to other infections because it needs to be powered by leads which run into and out of the body.

Surgeon Stephen Westaby said: "He developed a sudden and unpredictable change of heart rhythm and could not be rescuscitated."

He was the first patient to receive a permanent device. At least six people in Australia, the United States and Germany have since undergone similar operations.

Given just six months to live when he had the pioneering surgery, Goodman said then: "I weighed up the options. My life was seriously at risk and this seemed the only way forward."

"Life is good. It is worth living," he said this month as he underwent extensive physiotherapy to rebuild his muscles.

"Without it I might not have lasted the winter and it is very comforting to feel that I am a pioneer for this work. I hope others will benefit from it in the future," he said.

Doctors had hoped the process would revolutionize heart surgery. Half a million Britons suffer from heart disease and few can hope for a transplant with a real heart because of the chronic shortage of donors.

Since the operation last October, Goodman had worn a harness carrying the two 1.5 pound batteries that operated the heart. These had to be changed every eight hours. The electric heart, stitched into the left ventricle of Goodman' s own heart, gave off a just-audible whiff as it pumped oxygenated blood around the body. The device, about the size of a grapefruit, cost about $100,000.

Westaby implanted a second battery operated heart into another British patient last week. He is also 64. The electric heart was developed by scientists at the Texas Heart Institute. Goodman was its first permanent recipient.

Air-driven versions of the device had been fitted in more than 400 patients in Britain and the United States as a temporary measure while they awaited donor organs.

The Texas Institute had been unable to carry out the operation in the U.S. because the device had not been approved by the Food and Drug Administration.


By Neil Winton, Science and Technology Correspondent

LONDON, March 15 (Reuter 3/15/96) - If Volkswagen or Ford spent half a billion dollars developing a new car, worked on it for 10 years and failed to come up with anything, shareholders would be outraged and executive heads would roll.

But that's the kind of risky investment path faced by the world's biggest pharmaceuticals companies as they strive to develop innovative new medicines.

It takes thousands of new chemical discoveries to come up with one marketable product which patients can buy.

Shareholders of Sandoz and Ciba-Geigy will be hoping that the proposed merger of their companies into Novartis, announced last week, will provide an efficient, inside track to successful new drugs.

"The whole thing is a lottery. The more you spend the more likely you are to come up with successful drugs, but there' s always the quirk of fate; you might spend vast amounts and get nowhere," said Margaret Sharp, senior research fellow at Sussex University's Science Policy Research Unit.

Sharp says the ranking list of the world' s biggest spenders on research shows spending doesn't guarantee success.

Merck and Co. of the United States spent $980 million or just over 11 percent of its sales revenue on research in 1993 and had six products in the world's Top 50 Selling Brands. Switzerland's Roche Holding spent $1.2 billion or 23.2 percent and had only one product on it, said Sharp.

"There's lots of serendipity in drug research, any scientist will tell you that. If you get it right the payoff is big, but a lot of potential products fall by the wayside," said Janet Dyson, pharmaceuticals analyst at stockbroker Merrill Lynch.

"The pharmaceutical business is phenomenally risky," said Sue Stansfield, executive consultant at chartered accountants KPMG. "It takes 10,000 chemical discoveries to get one drug on the market, and even then, its profitability is uncertain."

The process begins in the laboratory with the discovery of a new compound which looks worth patenting.

"Then the conveyor belt starts which can last from 10 to 15 years, with basic research, animal research, then into man for the first time," says Stansfield.

In "phase 1" trials the drug is tried on people, usually volunteers, to study basic data on its efficacy, and how humans handle possible side effects. If the drug jumps this hurdle, "phase 2" tests increase the potential patients exposed to the drug and test dosage.

"Phase 3" again increases numbers, and enters a more general patient profile with age restraints relaxed. This stage will establish compatibility with other drugs, and confirm the benefit gained from taking the drug. The new drug can then be registered with licensing authorities, and the marketing process can begin.

Novartis says it would spend about $1.4 billion or 17 percent of its sales revenue on research and development, and has more than 90 drugs in various stages of development. Experts say it must be ruthless in streamlining them.

"The Novartis drug pipeline will have to be whittled down," says Stansfield.

"It's important that they focus on what they can market profitably and target innovative disease areas where solutions are still lacking."

Sandoz's main strength has been in immunology -- with drugs like the antitransplant rejection agent Sandimmune -dermatology, and anti-fungal drugs.

Ciba has been prominent in cardiovascular treatments, high blood pressure and arthritis drugs. Merrill Lynch's Dyson also says Novartis must make cuts.

"I can't see them having time to develop all that. British companies have been good at cutting back the number of research projects and concentrating on winners. This is something the new group will have to do, and Ciba's been very good at this in the past," Dyson said.

Novartis is expected to become a powerhouse in the new science of developing biotechnology drugs. Sandoz, through its takeover last year of Genetic Therapy and Ciba with its 49.9 percent stake in Chiron Corp have shown a firm commitment to this area.

This avenue for drug development usually involves small, startup ventures which gain speculative funding from bigger companies which see the possibility of a "blockbuster" drug.

But biotechnology, where scientists manipulate living organisms to seek new cures for diseases, is at least as risky as more traditional methods. "Many biotech companies had products that looked extremely hopeful but failed at the last phase," said Sharp.

The pharmaceutical industry is facing tougher times making profits. In the 1980s, profit margins were high as new drugs commanded easy premiums. In the 1990s, governments in Europe and health care providers in north America are determined to rein in spiraling costs as budget deficits are pared. Drug costs are a prime target. Lehman Brothers summed up this quandary in a recent report.

"The pharmaceutical industry is now spending around 15 percent of its sales on R&D, and looking to get a satisfactory return on that spend in a world market growing at around five percent per annum. Compare this with the 1980s; at the start of the decade, the industry was spending only around half that level...and got its return in a market which was growing at double digits."


BOSTON, (Reuter 3/27/96) - A growth hormone now given to abnormally small children may help reverse a form of heart disease in adults, according to a study to be published on Thursday.

The only long-lasting treatment for the condition, where one of the pumping chambers of the heart becomes increasingly large and the muscle walls become dangerously thin, currently is a heart transplant.

An Italian team led by Dr. Serafino Fazio of Federico University in Naples gave the growth hormone for three months to seven adult volunteers who suffered from the condition known as idiopathic dilated cardiomyopathy. They found that the hormone sold under the brand name Genotropin by Pharmacia AB increased the amount of heart muscle, made the heart work better and improved the patients' ability to perform exercise.

The amount of stress on the heart wall declined by an average of 41 percent and the efficiency of the heart more than doubled. But the results, in the New England Journal of Medicine, were greeted with caution because only a few people were tested, the treatment lasted for only three months and there was no control group.

In addition, the improvements might be only temporary or may have been a fluke, the result of the placebo effect.

There could also be dangerous side effects with long-term used of the hormone as a treatment for the heart condition; Drs. Evan Loh and Judith Swain of the University of Pennsylvania warned in an editorial in the Journal.

While the Fazio team's findings "are exciting and dramatic, our optimism must continue to be cautious" until larger, long-term studies are done, Lob and Swain said.


SAN FRANCISCO (AP 4/1/96) -- Scientists largely blocked an immune system reaction by human blood cells that mimics a potentially fatal side effect of bone marrow transplants, possibly offering a clue for a new treatment.

They worked with mice that lacked their own immune system but were injected with the immune system cells from people. Normally, those cells will attack mouse tissue because it is foreign.

That resembles graft-versus-host disease, in which transplanted marrow cells recognize the transplant recipient's tissues as foreign and launch an attack.

In the mice, researchers found the attack could be largely prevented by administering an antibody that blocked a particular structure on the surface of some immune: system cells. So that structure, called a protease receptor, might be a useful target for treating graft-versus-host disease.

Scientists have not yet tried the strategy to try stopping the attack after it has begun, said Dr. Michel Duchosal, a researcher at the University Hospital of Lausanne in Switzerland.

It will take more work to see if the new approach would work any better than current treatments for graft-versus-host disease, he said in a telephone interview.

The mouse work appears in the March 28 issue of the journal Nature. Duchosal did the work with scientists at Yale University and elsewhere.

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