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Policy

Letters

October 18, 2004 | A version of this story appeared in Volume 82, Issue 42

Harmful assumptions

I just read "In Harm's Way," and I would like to commend Bethany Halford for writing such a fine article (C&EN, Aug. 30, page 31). The issue she raises concerning worker's compensation is extremely important, especially to graduate students in the sciences.

I was a union organizer two years ago at Cornell University, and, ironically, the Ph.D. students in the physical sciences (such as chemistry and physics) were among the most antiunion at Cornell. Our efforts at organizing our fellow students were unsuccessful due in large part to students in the sciences' naive belief that their rights and safety in the lab were already protected by law. Thank you for pointing out that, while this is the case in New York, in many other states these decisions are made on a case-by-case basis.

Neil Bettez
Ithaca, N.Y.

 

A name for all seasons

John Stanks thinks that C&EN should readopt "global warming" and abandon the term "climate change" (C&EN, Aug. 30, page 2).

My opinion is that "climate change" is better for two reasons: One, as a description of how mankind is going to be affected by the increase of greenhouse gases in the atmosphere, climate change is a more accurate description from a scientific viewpoint. The most thorough study of predicted effects has been made by the Intergovernmental Panel on Climate Change (IPCC), which predicted the likelihood, in varying degrees, of rising seas, droughts, heavy precipitation, spread of diseases, water scarcity, and the intensification of tropical storms--all as effects of global warming.

Second, "climate change" is a term that is useful in alerting the public of the necessity to pressure politicians to take action. I feel that a description of expected damages is more apt to get attention than is the term "global warming," and the catastrophe from the recent hurricanes in Florida can be seen as warning signs of the IPCC prediction that it is very likely that "more intensive precipitation events" may occur in many areas in the Northern Hemisphere.

John J. Burton
Washington, N.J.

 

Medical device woes

Barry M. Jacobson makes valid points in his letter advocating government regulation of dietary supplements (C&EN, Sept. 6, page 6). I would counter that the size of the industry does not support regulation. In fact, the sheer size of the market is a fundamental problem that the Food & Drug Administration must face in a call to regulate; the economic impact to FDA's current and already underfunded missions could be disastrous.

While some supplements are known to pose potential threats, and others may pose more subtle risks, the myriad dangers in modern society suggest that the cost-benefit ratio of FDA regulation for supplements may not be economically sound. Put simply, there are bigger fish to fry, and the measure of those fish is the number of deaths and serious injuries that result, not the fiscal size of the market.

For example, until 1976, FDA did not have authority to regulate medical devices. The Medical Device Amendments of 1976 gave FDA some limited authority over this sizable industry, but only after the Cooper Commission noted that more than 700 deaths and 10,000 injuries were associated with medical devices. Additional authority over medical devices did not come until 1997; but even now, unsafe medical devices likely cause death or injury on a daily basis in the U.S.

Huge gaps remain in FDA's authority over these devices--devices that most U.S. citizens assume are completely under government control. Loopholes in the regulations exempt device manufacturers from any scrutiny if they manufacture "under contract" for a registered (regulated) company, placing the burden of ensuring that Good Manufacturing Practices are maintained on the contracting company.

In some areas, where costly equipment, such as surgical lasers, is offered on a fee-per-case basis to hospitals, there is zero regulation. Medical rental companies need not register with FDA and, as such, need not be compliant in providing devices that have been tested for safety and efficacy, such as the fiber-optic devices that deliver laser energy to target tissues within the body. Many of these devices are intended for single use, but in practice may be reprocessed and resterilized 100 times or more without any validation of continuing safety and efficacy. In fact, the indicator of art for when it is time to retire such a device is the failure of that device in surgery.

If FDA lacks the funds to regulate devices that deliver 100 W of laser energy inside your body, or even to establish performance and safety standards for such devices (there are zero), the acquisition of funds necessary to regulate dietary supplements is likely not forthcoming.

Steve Griffin
Phoenix

ACS ELECTION BALLOTS

Ballots for the American Chemical Society's fall 2004 national election were mailed to members on Sept. 27. If your ballot (mailed in a gold envelope) has not arrived yet, you may request that a duplicate ballot be sent to you by calling (800) 227-5558 no later than Nov. 5. Deadline for receipt of all voted ballots is Nov. 12. Election information on all candidates can be found at http://chemistry.org/election.

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