By Lisa Seachrist

Washington Editor

WASHINGTON — With federal legislation to ban cloning stalled following Senate Majority Leader Trent Lott's (R-Miss.) failure to break a Democratic filibuster and bring a cloning ban to the floor for a vote, the states have stepped in with their own efforts to ban the creation of a human clone.

At the present time there are 50 bills pending in 25 state legislatures, with Michigan ready to pass a cloning ban and New Hampshire just entering the fray. The potential problem with these efforts to ban human cloning is that they are imprecisely worded and may inadvertently ban legitimate biomedical research.

Should the plethora of bills become state laws, biotechnology and pharmaceutical companies conducting research could be subject to a patchwork of bans and penalties across the country that vary depending on how the laws are worded.

As a result, the Pharmaceutical Research and Manufacturers Association (PhRMA), the Biotechnology Industry Organization (BIO), and the American Association of Medical Colleges (AAMC) have been monitoring and lobbying state legislatures to prevent restrictive laws from going into place, and encouraging the states to send resolutions to Congress instead of enacting state legislation.

"Our primary concern with these laws is that they are state laws and they would not be in effect across the nation," said PhRMA media spokesperson Jeff Trewhitt. "We concede to the point that the American people may want legislation of some sort; but we think that if there is a law — and that is a big if — it should be a federal law extended uniformly to all 50 states centered around the authority of the FDA."

Industry Lobbies Say FDA Has Jurisdiction

Both BIO and PhRMA have urged caution to legislators at the federal and state levels noting that the FDA has jurisdiction over attempts to create a cloned human.

In an April 9 letter to BIO President Carl Feldbaum, Health and Human Services Secretary Donna Shalala assured Feldbaum that not only does the agency have jurisdiction over attempts to clone humans, but that the agency is prepared to exercise that jurisdiction.

Shalala said the "FDA's authority does not address the larger question of whether or not creating a human being using cloning technology should be prohibited altogether, but this authority will help ensure that such experimentation does not proceed until basic questions about safety are answered."

During the interim, BIO and PhRMA argue the nation as a whole has time to discuss how far this technology should be allowed to proceed.

"We've got plenty of time for this discussion," Trewhitt said. "There is no need to go stampeding toward legislation."

Even so, state legislatures have proceeded to introduce bills to ban cloning. However, industry concerns are being heard in some states. In Ohio, the Senate adopted industry supported language protecting biomedical research before pulling its anti-cloning measures from the agenda. Indiana had two measures that died when the legislature adjourned without taking action on either bill.

Nevertheless, Michigan stands poised to enact three bills that would revoke the licenses of doctors attempting cloning, enact a $10 million fine for human cloning and prevent any state funds from being used in human cloning experimentation.

Patrick Kelly, manager of state government relations at BIO, noted the Michigan bills carry such imprecise language they may restrict research into cloning human tissues, cells and organs.

"This is essentially the same language we saw in the (U.S.) Senate bill," Kelly said. "They basically are saying that they don't want to see the creation of any embryos using somatic cell nuclear transfer. It really seems like they are trying to ban embryo research and are using a cloning bill to get at that."

In addition, Trewhitt pointed out the bill simply bans the technology — removing the nucleus from an egg and replacing it with the nucleus of a somatic cell — which may not prevent someone from creating a human clone.

"There are several different methods that could potentially be employed to create a cloned human being," Trewhitt said. "The Michigan legislation will do nothing to address other methods."

Both Trewhitt and Kelly predict the Michigan bill will become law as early as next week despite efforts by BIO, PhRMA and the AAMC.

Trewhitt said the New Hampshire legislation that is set for a hearing this week calls only for an advisory panel to delve into the issues surrounding cloning.

"New Hampshire is at an early stage and its legislation is less problematic," Trewhitt said. "But we would still rather not see a patchwork set up." *

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