Senator Boxer calls for FDA Accountabilty For Medical Devices

Some of you maybe remember the great post on the Beauty and the Breast blog Supreme Court Rules You Can’t Sue Medical Device Makers Because the FDA Does Such a Great Job Assessing Safety?

In response to the ruling, Senator Barbara Boxer (D-CA) introduced a bill last week that would bring greater accountability and transparency to the Food and Drug Administration’s (FDA) regulation of all medical devices. Millions of Americans are implanted with devices ranging from pacemakers to breast implants, yet don’t realize that medical devices are not rigorously approved like pharmaceuticals. The bill (S.3020), the Food and Drug Administration Accountability and Transparency Act, will provide the FDA with several tools to help ensure the safety of these devices.

Because of less stringent safety approval mechanisms, the FDA allows manufacturers to conduct post-approval studies. But in many cases these studies are altered or not completed and consumers are left in the dark about safety problems.

“The FDA has been charged with a central role in safeguarding the health of our nation. Since the creation of this agency more than 100 years ago, the role of the FDA has expanded to ensuring the safety of foods, drugs, medical devices, and even cosmetics. Too often, however, the FDA lacks the authority or the resources to safeguard the health of our nation….[this act] would give the FDA several tools to ensure the safety of medical devices, including larger fines to hold these companies accountable,” Senator Boxer said.

Medical device manufacturing is a $75 billion industry, with considerable lobbying power, which enables them to secretly waive or alter post-approval agreements with the FDA, without informing consumers. This bill would end this practice by requiring such changes to be placed in the Federal Register.

Senator Boxer also stated: “If the Secretary of Health and Human Services determines that a manufacturer’s failure to conduct post-market surveillance is a risk to public health, this legislation give the Secretary the authority to notify health professionals that have been using these devices about any safety concerns.”

Sybil Niden-Goldrich, a long-time advocate of the breast-implant issue, applauded Senator Boxer: “More than 360,000 women received breast implants last year—a 40% increase over the last five years. Yet none of these women knew silicone implants were approved on the basis of post-approval studies that subsequently were watered down by FDA and aren’t being conducted. Senator Boxer’s bill would correct these grave injustices.”

Shortcomings of Compassion

Dispatches from the Culture Wars reports on a lesbian couple who were denied visitation rights and a chance to provide medical information when one woman fell ill and was taken to a hospital. The woman died shortly afterward, and the state of Florida refused to provide a copy of the death certificate so the surviving partner and their children could obtain survivor's benefits.

Rather than point to the legal failures to provide recourse for these and other people in such tragic circumstances, I'd like to focus on the shortcomings of the hospital. While it is certainly important to respect patient privacy, does the Hippocratic Oath and the physician's humanity not demand that all reasonable measures be taken to obtain information that could save a patient's life? There was no conflict here, other than possibly with an administrative policy barring non-family from seeing a patient or providing information for the protection of the patient, but when weighed against the chance of saving a patient's life and the opportunity to act with a certain level of compassion, I don't see how any physician could look him or herself in the mirror after such a failure as this.

As I am not a part of the medical community, I am unfamiliar with the professional perspective on this. It is my hope, however, that if there is not yet consensus by the medical community on how to humanely address cases like these in a consistent fashion (because they are not going away and will become more prevalent) that some can be reached to demonstrate that the medical community can and will rise to a higher standard of humanity than what is dictated by the law.

Update: Alicia Ouellette has provided a link with information on the lawsuit being filed on the patient's behalf by Lamda Legal.

Happy New Year: A Celebration of Hope

A very Happy New Year to all of our readers from all of us here at the Women's Bioethics Blog -- I love ringing in the new year, it always hold so much promise. For what can we hope to make it a healthier, more ethical New Year? A few things come to mind:

- Transparency -- I just learned this phrase I had not heard before: "Sunlight is the best disinfectant" and for just about every profession, from academia to health care to the justice system, the metaphor holds true.

- Accountability -- a corollary to the above concept -- as a fellow blogger over at the Healthcare blog notes: "The main value of transparency is not necessarily to enable easier consumer choice or to give a hospital a competitive edge. It is to provide creative tension within hospitals so that they hold themselves accountable. This accountability is what will drive doctors, nurses, and administrators to seek constant improvements in the quality and safety of patient care."

- A step towards healing our broken health care system in the US. (as Art notes in his editorial cited below).

-- Tell us, what do you hope for in 2008?