May 20-26, 2004

cover story

The $45 Million Man

Illustration By: Hyacinth Hughes

In Philadelphia, the Silicon Valley of pharmaceuticals, your body is a valuable commodity.

by Amy L Webb

How much are you worth? Have you ever sat down with a pencil and calculated the value of your being? For right now, forget about your skills and your intellect and your sparkling personality. Look down at the skin on your forearms. Put your hand over your heart. Experience yourself breathing. After all, federal law classifies your body as property, and for the moment, it belongs to you.

So start by making a list. Are you in good health with a strong heart? Write down $57,000. Do you have a silky pair of lungs and fresh alveoli? Add $116,400. Any problems with urination or blood filtration? No? Tack on an extra $91,400 for your kidneys. How about your bone marrow? Do you have cancer, a communicable disease or another serious ailment? If not, that's an extra $23 million.

But don't post anything on eBay. In America, laws understandably prohibit anyone from harvesting his own body parts for money. There are loopholes, however. Do you have long, curly brown hair more than 16 inches long? Wig makers will pay you $30 an ounce. How's your plasma? As long as you haven't paid for sex with a prostitute lately, blood banks will pay you $20 for every donation. Lactating recently? Check the local classified sections of your newspapers. That could earn you $5 for an ounce of breast milk. Are you an attractive woman with an Ivy League pedigree? Infertile couples around the country have been soliciting egg donations in campus newspapers for as high as $100,000. All told, the medical industry estimates that the sum of your parts is worth about $45 million.

Now, consider the cost of maintenance. What if you lost or damaged part of your body? A surgeon opens you up to remove a tumor, and other vital tissue goes with it. In its place, he gives you processed human cadaver tissue that was made by a for-profit company. He's going to bill your insurance provider, and you're going to write a co-payment check to the hospital. The hospital is going to pay for that human tissue and for the medicines and sterile wraps it took to keep you alive. By the time you're feeling well, unthinkable sums of money will have exchanged hands dozens of times.

Like it or not, there is no such thing as nonprofit health care. At some point, everyone is either investing money, earning a salary or reaping in dividends for the sake of our own flesh. And the epicenter of that business is right here, in the Greater Philadelphia region. This area is one of the nation's biggest biotech and pharmaceutical corridors, the Silicon Valley of the life-sciences world. Here, there are hundreds of companies manufacturing and developing products to enhance life. The nation's most productive organ procurement organization is in Center City. And state lawmakers have streamlined a process to help hospitals legally procure your organs and tissues after brain death, a model that has become status quo across the country.

To be sure, the industry has been lambasted everywhere, for corruption and the appearance of wanting to profit off of our ailments or want of youthful skin. Pharmaceutical companies, hospitals, insurance companies and doctors in Philadelphia are making big money off of your $45 million body. Then again, could you refuse a new life-saving pill, a healthy heart or the chance to live without dialysis?

Right now, you're reading this story, which means that you're registering brain activity. By medical definitions, your body is still in your own possession. Once your brain activity stops, though, you no longer have a say in what happens to your body. That decision is left to your surviving family members, unless you've left behind instructions or entered into a binding agreement. And technically, if you signed an organ-donor card when you registered for your Pennsylvania driver's license, your parts are up for grabs.

The Pennsylvania legislature has helped catalyze the process of organ and tissue donations through a series of laws. One, called a legislative-consent law, allows tissue banks or organ-procurement organizations (OPOs), agencies that deal in the transport and transplant of human tissue, to harvest your corneas as long as a "reasonable attempt" has been made to contact one of your relatives. Doctors would then slice off the transparent tissue covering the colored part of your eye and attach it to someone who suffers from disease or infection.

And in 1994, a new state law backed by then-Governor Robert P. Casey, who underwent a rare heart-liver transplant the year earlier, required all hospitals to contact an OPO at the time of brain death. The idea behind the legislation was to increase the availability of organs for transplant, to make the process easier on the families -- and easier for the hospitals.

Some of that legislation became the model for a new federal law in 1998, which established 59 agencies and territories throughout the country to work with hospitals. Now, no matter where in the country you are, an OPO will pay a call on your family at the time of your brain death. What happens to your body now depends on any signed documents you may have left behind, the instructions you left with family members and the ability of an OPO to reach your next of kin at the time of your death.

"We do everything possible to reach families," says Howard Nathan, chief executive of Gift of Life, Philadelphia's OPO. "We're not here to disrespect peoples' wishes." Gift of Life, which has serviced this region for 30 years, has a main office in Center City and satellites all throughout the eastern half of the state, employing 103 people full time. Gift of Life is a nonprofit that receives federal funds and is the official OPO for 151 hospitals and 13 transplant centers -- and it is the most productive OPO in the country. Donations have increased 2 percent to 3 percent every year due to educational programs and cooperation from hospitals. According to a March 2004 study by the European Transplant Coordinators Organization, Gift of Life has an average of 35.1 donors per million, compared with 9.7 donors per million -- in the whole United Kingdom.

"The opportunity to donate only comes once," says Nathan. "We want to make sure people are informed. We've worked hard to make sure that hospitals trust us, to treat families with dignity and respect and to educate people about the benefits of organ donation. Human tissue is important, too, and is desperately needed to make new medicines and to do research on diseases and cures. We don't want anything to go to waste."

Still, 90,000 people across the country are waiting for organs. As of April 1, there were 2,486 people waiting for a kidney, 1,063 waiting for a liver, 323 waiting for a lung, 174 waiting for a pancreas and 126 waiting for a heart across the Philadelphia region. Last year, 350 local people died waiting for an organ. Part of the shortage has to do with finding the right match: to qualify as an organ donor, death must occur in a very specific way. It must be a sudden car accident or heart attack -- something that renders the body brain-dead but still functioning on life support. Blood must still be traveling to the organs.

At the same time, hundreds of companies, both for-profit and not, are vying for various human tissues. Universities and biotech firms need cell lines and tissues to run trials and develop new medical therapies. Eye banks need corneas for transplant. Blood banks need plasma for transfusions. Labs need skin to process. In all, it is estimated that 700 different products are currently being manufactured from the human body after death.

And while specific circumstances preclude many from donating organs, everyone can be a tissue donor. One donor can service 50 to 60 other people.

Still, many people in Philadelphia object to donation -- according to Gift of Life, only about half the families contacted at or before the time of death agree. Islamic leaders, Orthodox Jews and some fundamentalist Christians say that their religious beliefs prohibit them from damaging the human body before burial. Some people don't like the idea of a company profiting from their bodies. Others buy into the myth that if they agree to become organ donors, ambulance workers and doctors won't do enough to help save them.

"Ambulance drivers aren't checking driver's licenses for organ-donor status," Nathan says. "At that point, no one knows." Instead, he says, the process begins at the hospital, and only after someone has been declared brain dead, which is the medical definition for death. The body is being kept alive only by the use of ventilators and other machines, and the chances for recovery to consciousness are zero.

Within 24 hours, two tests are run to determine if the brain is functioning. If both tests come back negative, a Philadelphia hospital will make a phone call to Gift of Life.

The phone will ring at a call center, where three to four staff members sit at cubicles and work in 12-hour shifts. They've been trained as paramedics, emergency-room nurses or triage assistants, and they've learned how to work extremely fast under stressful conditions. On the walls hang large whiteboards with vital information -- one tracks the living dead. There are columns for the hospital's name; the name, age and sex of the potential donor; and the name of the transplant coordinator for that area.

The transplant coordinator then receives a call from the center. They are trained medical professionals, many of whom work out of satellite offices in their homes. Once the call comes, they must rush to the hospital to gather information. They check medical records, looking to see what the organ function is at different times. They consult with the attending physician to see if the vital organs are still viable. Once brain death has been established, they meet with the family.

"No one wants to talk about organ donation unless they think there's no hope," Nathan says. "We check the organ-donor registry to see if the patient was a donor. Then we introduce ourselves as an organization that helps with end-of-life decisions. We try to reaffirm that if the patient was an organ donor that he didn't change his mind. We act in a very caring and sensitive way -- the families are cared for regardless of what is on the license."

If the family agrees, the coordinator begins asking a series of 40 questions, many of which are the same asked when donating blood. Has there been any intravenous drug use? Has there ever been a positive result on an HIV test? Any history of communicable diseases? The families are presented with three consent forms to sign: one for organ donation, one for tissue transplant and one for research.

The transplant coordinator then begins a quick series of calls. The call center identifies recipient patients. The coordinator contacts their doctors and transplant surgeons and alerts them that a donor has become available. There's a call made to hospital schedulers to reserve a time for the operating room.

The coordinator collects plastic foam boxes, ice, sterile equipment and solutions in black Gift of Life duffel bags and arranges to either meet or pick up surgical teams from various locations. Everyone meets back at the donor hospital, typically in the middle of the night because of scheduling difficulties.

Within minutes, the process begins.

As many as four or five surgical teams wait in the operating room. The donor is given a syringe to stop the heart and then life support is removed. The heart is taken first and placed into an ice-cold solution because it is only good for three to four hours after removal. The lungs go second. Then the liver, pancreas and kidneys. Finally, various tissues are removed.

In a hospital less than three hours away, a recipient patient is in pre-op, ready for a new lease on life. Tissue banks begin processing what is recovered and store it for use in transplant surgeries, research and shipment to various companies.

Most people don't plan ahead for the decision. It takes a strong sense of acceptance to contemplate your own morbidity. Even stronger, perhaps, to think about the death of a loved one.

It never occurred to Diane Milbourne to think about life without her husband, Ed. They were both in their 40s, successful and had raised a family in the Reading area. On Nov. 8, 1997, the phone rang. "There's been an accident," a voice said from the other end. "Get to the hospital right away."

Diane didn't have the keys to the car, but at the moment, she couldn't drive anyway. Her friends Tom and Betty Ann rushed over to pick her up. As they drove to the hospital, Ed was laying on the operating table. Diane arrived in time to hear the kind of news no one ever expects: The impact of the car crash was bad. His head injuries were serious. The ventilators are keeping Ed alive. The doctors are recording brain activity, but there is little hope.

For 12 days, Diane waited for a sign. The flicker of an eyelid. A gentle squeeze from his hand. But none came. Ed would spend the rest of his life depending on machines for survival.

It was Diane who approached the doctors, asking about donation.

"I couldn't just let him die, I needed to do something," she says. "I spoke with a Gift of Life transplant coordinator, and we decided to help other people live. Ed was able to donate veins, tissue, corneas, his liver and his kidneys." A Philadelphia man received his liver, and a young woman from Reading received his right kidney.

"It is gratifying to know that I made the right decision," she says. "I feel like Ed is living on. I never felt pressured by Gift of Life -- they were wonderful to work with. And they've been a support for me since the accident."

Not everyone agrees to donate at first. Mary Sickel's husband suffered from a heart attack and died at the hospital. Gift of Life approached her shortly after his death, "but at that moment I was too upset to think about it," she says. "I was in a state of shock and wasn't able to give an answer. He was the oldest of four children, and I thought that everyone in the family should have a say. They called me later at home and by that time we'd decided to donate. They were very gracious and caring. I felt I was doing the right thing, and I had no reservations at that point."

Her husband was able to donate tissue and cornea because of the way he passed. "Tissue is just as important," she says. "The way we see it, he gave a gift to ensure that medicine moves forward, that we accomplish bigger and better things. It is an investment in the future." Today, Sickel is the chairperson of Gift of Life's donor family volunteer group.

Transplanting organs and procuring tissues isn't inexpensive -- the process costs enormous time and money. Transplant surgeries cost tens of thousands of dollars, while products manufactured from human tissues can cost upward of $100 depending on its use. No one at Gift of Life is getting rich off of organ donors. The organization is funded through federal money and various grants. But that isn't to say that at several stages of the process companies and individuals aren't making a profit.

When organs are harvested, that initial bill is footed by the OPO. After the recipient receives his or her new parts, the OPO bills the recipient's insurance company. Factor in the fees of personnel: transplant surgeons, medical personnel, hospital orderlies. Add in operating costs: medicines used, surgical supplies, facility overhead. And figure in the costs of sheltering and feeding you for the length of your stay.

The OPO likely has a contract with local tissue banks, which are regulated by both the Food and Drug Administration and in many cases the American Association of Tissue Banks (AATB). Banks pay initial costs to recover and store tissues. Depending on their relationship with the OPO and hospital, they may be getting money from the insurance companies, hospitals, biomedical companies and labs with which they work.

While the organs are used immediately, up to 20 bones and tendons, veins, corneas and 4 square feet of skin can be taken in the 24 hours after death. After it arrives at the tissue bank, there is little oversight into how that material is used at its next destination.

"The organ-procurement organization is only the first step," says Bob Rigney, chief executive officer of the AATB. "We retrieve tissue, we process it, we store it and we distribute it. The tissue may go to a for-profit hospital, it may go to a for-profit lab. It may be transplanted by a for-profit surgeon. A patient may be treated with drugs developed with donated tissue by a for-profit pharmaceutical. But we do not track the business side of tissue banks."

Instead, the AATB writes the standards for tissue banks and accredits them. They have a certification program to ensure quality and good ethics. It's not mandated that a tissue bank be certified through the AATB. Rigney estimates that there are between 150 and 200 tissue banks around the country, and notes that only 83 are accredited. "Most hospitals will only work with a bank that we certify," he says. "The ones who aren't typically don't have a relationship with hospitals or academic researchers."

Any lab, university or company working with human cells and tissues must, however, register with the FDA. In Philadelphia, there are more than 80 on the FDA's list -- and many of them are for-profit companies that purchase tissue from banks.

Philadelphia is a hub for the research, development and manufacturing of biological and medical products. There are 200 firms listed with the Pennsylvania Biotechnology Association, and more companies are relocating to the region every year. One of the world's largest, U.K.-based GlaxoSmithKline, has a U.S. office located in Center City at 16th and Franklin Plaza.

The region is also just 90 minutes away from New York City, where much of the venture capital is. And it is less than three hours away from Washington, D.C., where the regulators make decisions about new patents and medications.

"One of the things that supports the biotech industry here is the proximity to pharmaceutical companies and academic institutions," says John A. Skolas, chief financial officer at the Plymouth Meeting-based Genaera Corp. "People in this industry tend to move from one company to another, and as more companies consolidate, more qualified people are displaced. And a lot of startup companies spring from research done at universities. This is a hotbed of activity."

Genaera is working on a product that uses squalamine, a substance found in the stomach and liver of dogfish, to treat respiratory ailments, cystic fibrosis and asthma.

Eatontown, N.J.-based Osteotech was the first company to serve as a human bone broker and is now the nation's top producer of bone products. One includes a putty used in back and spinal surgeries. One application of the product costs $850. The company uses bones received from the Edison, N.J.-based Musculoskeletal Transplant Foundation, a nonprofit.

New Jersey's Branchburg-based LifeCell Corp. is the only company that manufactures replacement tissue from processed human skin. They start with cadaver dermal tissue, which is the layer of tissue just below the skin, and strip it of cells. Called AlloDerm, it is used on burn victims and cancer patients. Without it, surgeons would need to use a synthetic product. But AlloDerm helps in the regeneration of normal tissue. To date, LifeCell has shipped more than 500,000 tissue grafts to surgeons around the country.

"We deal with approximately 25 tissue banks around the country; some are in this area as well," says chief financial officer Steven T. Sobieski. "We go through all the medical screening and review the medical and social history to see that the potential tissue is safe. Then we put the tissue through a process to remove all the blood and cells, but in a way so as not to damage the collagen. Everything is done in a sterile environment. In the end, we take human tissue and package it so that a surgeon then can take it off the shelf, open the package and use it for transplant."

LifeCell spent several years in the red while trying to develop its product, because for research to start on an idea, a scientist needs $500,000 to $1 million of venture capital invested. It's an extremely risky bet -- experts estimate that less than 1 percent of the ideas conceived on paper yield a viable product. Once enough money is gathered, a team of researchers will begin working on a new treatment. They may reach a point and apply for a "new drug application" which allows them to work with humans. The first phase is testing for safety. The second phase works on correcting the drug doses. The third phase -- very few treatments reach this stage -- means large clinical trials and an eventual application for approval by the FDA.

This entire process takes at least six to 10 years. All that time, scientists were being paid a salary. Overhead fees had to be met. Tissue, samples and research materials had to be acquired. And the nervous venture capitalist waited by the sidelines, hoping that his initial investment would eventually turn into a usable product.

"Our company was founded in 1986, and it was only in 2001, which was 15 years later, that we turned profitable," Sobieski says. There have been $90 million invested in this company. Are there issues around donated tissue and for-profit companies making money? Sure there are. I understand when a family today might say, "Wow, I'm donating tissue and some stockholder is making money.' But if they really took the time to understand that people spent an incredible amount of money on research to develop the products that are enhancing their lives today, maybe that family wouldn't be so quick to criticize the stockholder."

Cephalon Inc. is a West Chester-based international biopharmaceutical company that manufactures and develops products for sleep disorders, cancer and pain. It does $1 billion annually in the sales of three patented products: Provigil, a drug to promote wakefulness, Actiq, a pain manager for cancer patients, and Gabitril, an anti-seizure medication. But it's not like the company hit profitability overnight.

"It is exceedingly difficult to develop a new drug," says Robert W. Grupp, vice president of corporate communications. "The true cost of medication is hidden from people. They make their copay at the hospital and pharmacy, but they don't realize that their $3 pill is actually a $100 pill that took $1 billion to research and eventually manufacture. That investment has to be recouped," Grupp says. "And it has to be recouped fast, because after a certain number of years, the patent expires on a drug. Then any company can copy a generic version of it."

Cephalon is working on new products. One, which aims to slow or halt Parkinson's disease, is only two years away from final testing. "We're pouring 25 percent of our profits back into research and development. Yes, some of that money has to go to shareholders. But why shouldn't it? Why should pharmaceuticals not make a profit, while every other industry in America can? Why should we be any different?"

To be sure, the pharmaceutical industry isn't doing all it can to keep the cost of prescription medicine within the reach of retired senior citizens or impoverished families. If that was the case, people wouldn't be driving en masse to Canada in search of cheap drugs. According to a 2000 study by AARP, a nonprofit group for people 50 and over, total prescription drug spending in the U.S. grew by 13 percent every year between 1993 and 2000 and is expected to grow by 12 percent every year until 2011. The reason we're paying more for prescription drugs? Price increases, the study says. And only 19 states have pharmacy-assistance programs to subsidize the cost of prescription drugs.

And when it comes to recovering tissue, not all is removed and processed without incident. In 1984, California businessman John Moore was in the hospital being treated for cancer. He later sued his doctor, the hospital and some pharmaceuticals for taking the cancerous tissue from his spleen to create a cell line which has generated an estimated $3 billion in profits. In 1991, Virginia Brown sued the Delaware Valley Transplant Program (which later became Gift of Life), the Brandywine Hospital and a host of doctors for harvesting her brother's heart and kidneys without her family's express consent. And last year, a woman filed charges against an organ-procurement organization in Indiana for forging the consent forms and harvesting her husband's heart without permission. Moore and Brown lost their cases, while the Indiana matter is still tied up in county court.

These stories, and their gruesome details, usually make the evening news. So do headlines about pharmaceuticals claiming huge profits.

"In all honesty, this industry is so misunderstood," says Elizabeth Treher, chief executive officer of the Washington Crossing-based The Learning Key, a firm that consults with pharmaceutical companies. "There is a lot of suspicion, and the media to a large extent has helped foster that. For one, people don't understand how drugs get developed. Chances are minuscule that a new drug will ever get on the shelf. How many people in sales would make 10,000 sales calls before they actually made a sale? How many would stick with it? None. People in research fail all the time in order to succeed."

Another problem is the sense of entitlement in America, she says. "Americans assume that they shouldn't have to pay for health care, but they're perfectly willing to spend thousands of dollars on computers, flat-screen televisions and expensive cars. They're willing to pay $4 for a cup of coffee at Starbucks, but ask them to pay that much for a pill that could lengthen their lives and they cry foul. We are a society of people who expect that things will be given to us for free. That's unfortunate."

And part of the misconception about the cost of drugs and time it takes to develop them is fostered within the industry itself. For that very reason, Treher, who worked on the radiopharma side of the business inventing imaging products, wrote a book called The Pharmaceutical Business From Drug Discovery Through Product Launch; she now works with various biotechs to help their employees their own companies. "Many researchers are so specialized that they don't see how the entire process works," she says. "It's such a complex business."

Adding to the difficulties is politics. Stem-cell research is costly now, but in the long run could save millions of dollars that would have been spent on long-term care for seriously ill people. The problem is that research depends to a large degree on obtaining embryonic stem cells, which are taken from a developing fetus. In Washington, debate is focused more on the beginning of life and the right to choose what to do with that embryo rather than how stem cells can generate medical therapy. "In addition to people wondering about the cost of their medicines, they're also listening to politicians argue about how and if to use stem cells," Treher says. "These politicians know very little about the technical aspects of stem cells, so they're arguing for or against a completely different issue. It's easy to get confused, and that's unfortunate."

While misunderstandings help fuel concern about the industry and the role human tissue plays, some lawyers are now saying that we should accept the fact that money is involved in the process of staying healthy, and rather than ignore or somehow outlaw the exchange, it should be regulated. "Despite all the misgivings expressed about commerce in human biological materials, no serious proposals to remove such materials from the market have been advanced," Julia D. Mahoney, an associate professor at the University of Virginia School of Law, wrote in the March 2000 Virginia Law Review. "The reasons for this conspicuous absence are not hard to fathom: Whatever sentiments of horror the thought of trafficking in human flesh may engender, the benefits of commercial activity in human tissue are enormous." She argues that biological materials should instead be regulated.

Indeed, our future medical health may depend on more and more tissue. Gene-based therapy will someday pinpoint disease so that a very specific drug can be created to treat your specific disorder. That could mean the end of cancer. The obliteration of debilitating genetic disorders. A world, possibly, without AIDS. There have been numerous gene-based therapy trials, some successful and many not. But as the idea advances, so will the need for human tissue for research and treatment.

To help ensure that there will always be enough tissue and organs available for transplant and research, some Pennsylvania lawmakers are again advocating for a new type of law. This time, they want to adopt something called "presumed consent," which means that rather than electing to be an organ donor, participation would be automatic. Instead, those who refused because of religious or other reasons would have to register on something like a "Do Not Take My Organs" list. The University of Pennsylvania Department of Medical Ethics was recently endowed with a grant from the U.S. Department of Health and Human Services to test drive a presumed-consent law. Researchers are working with OPOs in Minnesota, Pennsylvania and Washington, D.C., to determine if an "opt-out" system would yield more organ donations.

"Look, we need something on the books," says Samantha A. Wilcox, a Wellsboro-based lawyer and advocate for presumed consent. "People are living longer, they're getting older. Nobody wants a 96-year-old kidney. I'm not saying to take away choice. But why not increase the availability of organs and tissues? In this state, we managed to adopt a statute to allow hospitals to take our corneas without consent, and no one has launched any huge demonstrations against it. I think that if people considered presumed consent, it'd start to make sense to them. It may never pass because of political reasons, but the idea is a good one."