C'è sul New York Times Magazine un interessante articolo che fa
il punto sulla sorte dei tessuti prelevati (anche senza consenso) e
poi usati a scopi commerciali, persino contro il volere dei
ricercatori che li hanno raccolti e studiati.
Ecco un brano, su un fatto stranamente passato finora sotto
silenzio anche negli Stati Uniti:
L'articolo completo è disponibile (credo solo per qualche
giorno) all'indirizzo http://tinyurl.com/r8o9o .
William
Catalona is undeniably one of the top prostate surgeons in the world.
He is surgeon to sheiks, to Stan Musial and Joe Torre, as well as
thousands of other men. But he's also a researcher. Which is why he
and his patients ended up in a federal courtroom in St. Louis a year
ago, in the first case to bring together all the biggest tissue
issues: ownership, consent, control and a patient's right to withdraw
from tissue research.
Catalona started collecting prostate-cancer samples in the late 80's. Today, the collection - one of the largest in the world - fills more than a dozen industrial freezers. It has resulted in some of the most important prostate-cancer advances (among other things, he used it to show that the P.S.A. test can predict most prostate cancer). The collection is vast: more than 4,000 prostate samples and 250,000 blood samples from 36,000 men. Some of these men came to him through newspaper and radio ads he placed seeking donors. Some came from other doctors. But many were his patients.
Catalona was committed to informing his patients: he provided detailed consent forms explaining the research and its risks, and his consent forms said, "Your participation is voluntary, and you may choose not to participate in this research study or withdraw your consent at any time." He even sent a quarterly newsletter updating them on the studies. The problem was, Catalona and his patients saw things differently from his employer - Washington University.
Several years ago, Washington University took possession of the samples. The collection could be worth more than $15 million. In letters that surfaced in court, a Washington University official complained that Catalona gave free tissue samples to collaborators at a biotech company and that all the university gained in exchange for its support of Catalona was "the potential for Catalona to get a publication," which it saw as "unacceptable." (Catalona isn't business savvy: he never tried to patent his specific use of the P.S.A. test, which could have made millions.) The university invested millions of dollars in developing that collection, it said: money for freezers, lab technicians, the building where he stored them. Some of that money came from multimillion-dollar federal research grants that Catalona brought into the university; some came from his patients. But the university paid Catalona's salary and his health, malpractice and liability insurance; his contract said it owned his intellectual property. Therefore, the university argued, it owned those tissue samples.
Catalona started collecting prostate-cancer samples in the late 80's. Today, the collection - one of the largest in the world - fills more than a dozen industrial freezers. It has resulted in some of the most important prostate-cancer advances (among other things, he used it to show that the P.S.A. test can predict most prostate cancer). The collection is vast: more than 4,000 prostate samples and 250,000 blood samples from 36,000 men. Some of these men came to him through newspaper and radio ads he placed seeking donors. Some came from other doctors. But many were his patients.
Catalona was committed to informing his patients: he provided detailed consent forms explaining the research and its risks, and his consent forms said, "Your participation is voluntary, and you may choose not to participate in this research study or withdraw your consent at any time." He even sent a quarterly newsletter updating them on the studies. The problem was, Catalona and his patients saw things differently from his employer - Washington University.
Several years ago, Washington University took possession of the samples. The collection could be worth more than $15 million. In letters that surfaced in court, a Washington University official complained that Catalona gave free tissue samples to collaborators at a biotech company and that all the university gained in exchange for its support of Catalona was "the potential for Catalona to get a publication," which it saw as "unacceptable." (Catalona isn't business savvy: he never tried to patent his specific use of the P.S.A. test, which could have made millions.) The university invested millions of dollars in developing that collection, it said: money for freezers, lab technicians, the building where he stored them. Some of that money came from multimillion-dollar federal research grants that Catalona brought into the university; some came from his patients. But the university paid Catalona's salary and his health, malpractice and liability insurance; his contract said it owned his intellectual property. Therefore, the university argued, it owned those tissue samples.
So Catalona
quit. He moved his lab to Northwestern University in Chicago and then
sent letters to 10,000 patients, saying, "You have entrusted me
with your samples, and I have used them for collaborative research
that will help in your future medical care and in the care of others
for years to come." To continue this work, he wrote, "I need
your assistance and your permission." He enclosed a form for them
to sign that said: "Please release all of my samples to Dr.
Catalona at Northwestern University upon his request. I have entrusted
these samples to Dr. Catalona to be used only at his direction and
with his express consent for research purposes." Within weeks,
6,000 patients signed and returned those forms. But Washington
University denied their requests. The university, it turned out, had
distributed samples to scientists for research that the patients
didn't know about.
Confesso la
mia ignoranza sulle regole vigenti in materia in Europa: qualcuno ne
sa qualcosa?
Fabio
Turone
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