Tuesday, December 7, 2010

Syntes Surgeons Test Bone Cement on Spinal Surgery Patients W/O Consent

Synthes Incorporated and its subsidiary, Norian Corporation are responsible for orchestrating a series of “unauthorized tests of its bone cement on about 200 spinal surgery patients” that resulted in a few deaths. The use of bone cement had already been approved to be used in the arm, but had not yet been approved to be used in the spine. Synthes “had trained surgeons to use it ‘off-label’ so the company could gather data to support its expanded use.” Company members pleaded guilty and are reportedly aware of the unlawfulness of their actions. Apparently Synthes company members and surgeons had been warned previously that the tests they were performing were considered “human experimentation.” Although the surgery was not the cause of the deaths of the patients- it was most definitely a contributing factor. “The patients who died suffered severe hypotension, or low blood pressure, following injections of Norian bone cement,” which leads one to believe that perhaps the injection of bone cement was a primary instigator of death. What other medical observers, such as Dr. Kassirer, professor of medical ethics at Tufts University Medical School find absurd is that not only is it unusual that the Synthes employees immediately pled guilty and sought jail time, but also that with this “off-label marketing…companies view these settlements of $300 million, $400 million, even…$1 billion, as almost spare change.” Rather than paying off expensive fines for illegal and immoral surgeries, this money could be invested wisely such as in cancer research or something of the sort. What’s startling to believe is that these surgeries were conducted from 2002 to 2004 and they are just now being brought to justice. I believe it was guilt that forced the Synthes employees and surgeons to immediately plead guilty—I imagine it’s a terrible feeling to know that you caused another’s death. If there’s one thing I have observed from the medical and scientific world, it’s that patience does indeed pay off and it’s especially important to respect this law when one’s health is at hand.

And so if companies are so willing to pay off their fines and hardly sweat at doing so, is this proper punishment? There must be a way to firmly bring ill-acting companies to justices so that they learn that putting patients’ lives in danger for the sake of experiment is absolutely not okay. Human experimentation, especially human experimentation without consent is never acceptable—and these larger companies must learn this in a way that truly makes an impact.

http://www.latimes.com/business/nationworld/wire/sns-ap-us-medical-devices-fraud,0,6267730.story

1 comment:

Lauren said...

I definitely agree that a fine does not seem enough of a punishment for such an unethical crime. The classic problem when dealing with large corporations in relation to ethical dilemmas is the phenomenon of diffusion of responsibility - somehow, because the crime was committed by an organization, specific individuals, at least in the eyes of the law, can be absolved from guilt. Big businesses are thus a big problem when it comes to matters of ethical justice, because there is a disconnect between the weight of the crime versus the punishment felt by the guilty individuals. It is shocking that such dangerous experimentation could have occurred in this day and age, so either some better punishment needs to be devised as a deterrent, or the government needs to regulate and monitor the activities of such businesses in the health care field much more thoroughly.


Obviously, it would be very hard to figure out the key individuals from the corporation who initiated the spinal surgery testing in this specific case - however, just because it would be an extensive and difficult process that should not allow them to escape more personal punishment. If not, people will inevitably feel unhindered in continuing to bypass ethical standards in the pursuit of advancement, greater personal gain and, of course, the all important capitalist profit. There is a little tension here, because obviously advancement is desirable in the long run and could prevent much suffering. But this specific example certainly overstepped the line by robbing their patients of their rights and experimenting upon them without consent.