Bernard M. Jaffe, MD Professor of Surgery Department of Surgery Tulane University School of Medicine New Orleans, LA

We live in a crazy world. In order to ensure the free will of the American people, everyone and everything has his, her, or its rights. The Army Corps of Engineers has the right to make atrocious levee design errors and foolish mistakes without repercussion (except to New Orleans). FEMA has the right to waste billions of dollars while not providing for the essential needs of flood victims with its director’s resignation as the only consequence. The African-American mayor of New Orleans is allowed to call for a “chocolate city” with no legal repercussion or unanimous political rebuke. Foreign-born terrorists have protection from eavesdropping, even if the information collected would save American lives and property. A large segment of our population believes on religious grounds that embryos also have undeniable rights. I thought I had heard it all until I read a fascinating article in The New York Times Sunday Magazine about the rights of American citizens to direct the use of removed blood samples and tissue specimens.*

As surgeons, when we resect tissue and submit it for histologic examination, we don’t inquire as to its ultimate disposition. I have always assumed that operative specimens are destroyed, because on those occasions when I wanted further analysis of material from my hospital or from another institution, I was told that only paraffin-embedded blocks were available. Similarly, when blood samples are collected for electrolyte determination, hemogram, and particularly type and crossmatch, I have always assumed that the unused serum is discarded. It is probably the same at your hospital: if more blood is needed, the blood bank requires another specimen before it can crossmatch more units. Perhaps in naivety, I never imagined that such specimens were preserved and banked.

On the other hand, oncologists and infectious disease specialists have long made a practice of freezing specimens for later identification of genetic markers, antigens, cellular reactants, etc, and use in developing antisera and immunizations. Among many other benefits, these banked specimens have resulted in the development of serologic tests for HIV, hepatitis, and prostate cancer; immunizations for such infectious diseases as polio, measles, and smallpox; and effective new therapeutic agents against a variety of malignancies.

Despite the incredible successes and global benefits derived from specimens relinquished voluntarily, an increasing number of people have expressed serious concerns about the outcome and use of their biologic products. They have become the nucleus of a new tissue rights movement.

While lots of questions remain, courts have decided that patients do not own or have property claims for specimens once they have been removed. This was determined in a case involving John Moore, a patient cured of hairy-cell leukemia by splenectomy. Moore unsuccessfully sued Dr. David Golde, a UCLA cancer researcher, for ownership of Mr. Moore’s serum samples. Ultimately deciding in favor of Dr. Golde, the California Supreme Court declared that giving patients ownership of their removed specimens would “hinder research by restricting access to the necessary raw materials.”*

While it has now been acknowledged that patients do not own the specimens, it is far from clear who does: the research scientist or the institution. Dr. William Catalona is a brilliant prostate cancer scientist (and former neighbor). While at Washington University in St. Louis, he did pioneering work on the use of PSA screening for prostate cancer and banked 4,000 tissue and 250,000 serum samples from patients. When he provided a commercial venture with samples free of charge in order to further his research, the university took possession of the material, fully recognizing its potential economic value. Washington University claimed that it owned the intellectual property of its faculty members and sued Dr. Catalona (by then at Northwestern University) for ownership of the biological material. The ongoing battle has been extremely contentious. Dr. Catalona wrote his patients and pointed out that the consent forms they had signed directed donation to him and not the university. He urged them to release their specimens to Northwestern for his use, and many thousands did so. Nonetheless, Washington University has refused to acquiesce, and this matter will have to be decided by the courts. The decision will have important long-lasting implications on the use of biological material in medical research.

Although many patients do not seem to object that their specimens are banked for future use in medical research, an increasing number do. The two primary concerns expressed are privacy issues and financial gain.

Americans are becoming progressively more suspicious that the government and large institutions are invading their privacy and, in essence, spying on them. That’s the topic of Tracy Letts’ marvelous play Bugs, in which two strangers meet and rapidly have an affair in a tawdry Oklahoma motel. Soon thereafter, the couple feel themselves to be besieged by bugs and, try as they may, they can’t exterminate the imaginary creatures. Of course, the word “bug” is used as a double entendre, and the couple so intensely imagines they are being spied upon by the government that they resort to self-immolation as their only option for escape. This theater piece effectively uses dramatic license to make its point, but more people are becoming truly concerned about protecting their privacy. Wiretapping and other forms of surveillance were major obstacles to overcome in the passage of the Patriot Act. Identity theft is a real and critical concern to all citizens; Social Security numbers, fingerprints, and DNA are all important private possessions worthy of protection. Since all donated specimens contain such markers as DNA and tissue antigens, patients are increasingly reluctant to have them stored in readily identifiable formats.

Another concern is financial. Who should receive profits derived from harvested patient samples—the investigators? Their universities? Private companies that make investments? How about the patients? John Moore, whose plight I described, initiated his lawsuit when he heard that Dr. Golde made a lucrative financial arrangement with a biotech company using Mr. Moore’s stored biological samples. Ted Slavin, a hemophiliac with a high titer of antibody to hepatitis B, made a fortune selling his blood as a source of valuable antibody. An effective entrepreneur, he developed a company that sold blood from other hepatitis-immune patients as well. There is no question but that specific biological specimens have substantial economic value, and donors feel that they are entitled to at least share in the windfall. Some unfortunate individuals are so obsessed about this issue that it seriously clouds their judgment. Tom Pollock, an incredibly valuable Downstate faculty member, was murdered by a demented individual who imagined that Kings County Hospital earned a fortune from a discovery made during his successful bronchial sleeve resection for massive hemoptysis but did not cut him in on the take.

Handled correctly, there are adequate biological resources for patients, research scientists, institutions, and biotech companies to share. It is important to reconcile this conflict because it is the general public that benefits the most from diagnostic and therapeutic advances.

Tissue rights activism is really just beginning. As a result, we should all expect more aggressive and restrictive demands for sharing profits, as well as the institution of specific and restrictive consent forms for venopuncture and biopsy, registration and institutional coding of patient samples, heightened confidentiality requirements that go beyond even the current outrageous HIPAA guidelines, and an explosion of legal bickering. The title of The New York Times Sunday Magazine article “Taking the Least of You,” is misnamed. Tissue rights advocacy certainly isn’t taking the least from us.

Reference
*Skloot R. Taking the least of you. The New York Times Sunday Magazine. April 16, 2006:38.