A Natural Miracle, a Legal Morass, by Joel Havemann

November 2010 Monthly Message
 
- New Clinical Trial Begins for Treatment of Parkinson's Disease
- Policy Focus
- A Natural Miracle, a Legal Morass, by Joel Havemann
- Highlights of Recent Parkinson's in the Media

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Joel HavemannA Natural Miracle, a Legal Morass, by Joel Havemann

You have been hearing an awful lot lately about the legal controversy surrounding human embryonic stem cell research, with news of various court decisions flying back and forth.  Understanding the medical significance of stem cells is difficult enough without having to negotiate your way through the legal morass that stem cells are caught up in.  So I hope the following question-and-answer session I put together will help you make sense of it all.

    Question:  What’s the history of stem cell research as it pertains to Parkinson’s?
    Answer:  A newly fertilized human egg is tiny. It has no bone cells or heart cells or hair cells. Somehow it has to grow into all the wonderful diversity of a human being.  In the 1990s, fetal tissue transplants looked as if they might hold the key to curing Parkinson’s disease.  Parkinson’s was thought to result from the death of certain kinds of brain cells that made a key chemical called dopamine.  Maybe vibrant dopamine-producing cells from a fetus could be transplanted to the Parkinson’s brain and thrive there, making the brain as good as new.

Researchers knew how difficult the procedure would be from a scientific standpoint, and the issue was more difficult as a matter of public policy because the fetal cells were harvested from aborted fetuses.

Then in 1998, scientists discovered the cells in embryos that could develop into just about any kind of cell in the body.  Embryonic stem cells, they were called.  For certain maladies, they held the promise of being able to develop into healthy cells that could replace diseased ones.  Parkinson’s was one of those diseases.

With the discovery of embryonic stem cells, scientists breathed a sigh of relief.  With the parents’ consent, embryonic stem cell lines could be developed from surplus embryos in fertility clinics.  These excess embryos, just a few cells in size, would have wound up in the trash if they were not put to good medical use.

Yet, embryonic stem cells have aroused just as many political hornets as fetal tissue transplants.  Most recently, a federal judge ordered a temporary ban on federal funding of human embryonic stem cell research.  While a higher court is allowing funding to continue, this field of research remains at risk.

    Q:  How did stem cell research get tangled up in the news?
    A:  You may remember that President George W. Bush, in the first nationally-televised speech of his presidency, announced that he was effectively banning research on embryonic stem cell lines from all but those derived before August 9, 2001.

    Q:  How long did that policy last under President Barack Obama?
    A:  A month and a half.  President Obama issued an Executive Order on March 9, 2009, lifting the prior administration’s restrictions on federal funding of embryonic stem cell research.  Later that year, the National Institutes of Health issued new guidelines that expanded the number of stem cell lines that would be eligible for research.  But the National Institutes of Health’s new stem cell guidelines were challenged in federal court.  The administration, defending its policy, argued that the individuals had no “standing” in court—that they couldn’t sue because they weren’t personally injured by the new policy.  Two researchers among the group, Drs. James L. Sherley and Theresa Deisher, responded that their ability to get grants for their research on adult stem cells would suffer from competition with applications for grants for embryonic stem cell research and, therefore, they were granted standing to sue.

    Q:  Who won?
    A:  Nobody yet; the fight hasn’t gone the full 12 rounds.  Sherley and Deisher took the first round when Judge Royce C. Lamberth of the federal District Court for the District of Columbia issued a temporary injunction on August 23, temporarily halting all federal funding of the research.  The Federal Court of Appeals has since issued a “stay” on the injunction, allowing the government to, at least temporarily, continue funding embryonic stem cell research.

    Q:  Weren’t embryonic stem-cell researchers feeling whiplash?
    A:  You bet.  Research centers went to work on stem cells under the Obama administration’s new guidelines.  Lamberth made them stop while the courts sorted out the muddle.  Now they didn’t know whether to wait for the clouds to part or to go into another field of biomedical research.

    Q:  Couldn’t Congress resolve the matter?
    A:  It could, but it’s not so easy for legislation to get passed in this Congress.  In 1996, during the Clinton administration, Congress attached to a bill a prohibition against using federal funds to create or destroy human embryos for research purposes.  The Clinton administration later determined that this provision, named the Dickey-Wicker amendment after its two chief authors, did not apply to human embryonic stem cell lines that are derived using private funds.  Federal funds could be used for research on the stem cell lines after they were derived with private funds.  The Bush administration never challenged this determination.  And more than a decade later, the Obama administration also agreed.

    Q:  Isn’t that interpretation splitting hairs?
A:  Judge Lamberth thought so.  Deriving human embryonic stem cells cannot be separated from performing research on them, he held.  Nor, he said, can the Obama administration assert with certainty that stem cells contain a cure for such diseases as Alzheimer’s and Parkinson’s.

    Q:  What did Parkinson’s researchers think of that?
    A:  To researchers and disease-fighting advocates, those are fighting words.  “For 10 years, Dickey-Wicker has been interpreted to allow embryonic stem cell research to proceed if done properly,” said Parkinson’s Action Network CEO Amy Comstock Rick.

Stem cells may not turn out to be a cure, but right now they are a very promising area of research.  The Obama administration went back to court to seek a delay of Lamberth’s order to temporarily set aside its new stem cell research guidelines.  The Coalition for the Advancement of Medical Research, which includes PAN among its 100 members, filed a brief in support of the administration’s position.

    Q:  Any luck?
    A:  So far, so good for the Parkinson’s advocates.  The U.S. Court of Appeals for the District of Columbia Circuit overturned Judge Lamberth’s temporary injunction quickly enough that researchers who had begun work on stem cell projects could continue.  But, both Judge Lamberth and the appeals court are still hearing legal arguments, and the outcome is far from assured.

    Q:  If the legal obstacles shrivel, the research moves ahead at full speed and stem cells fulfill their clinical promise, when might they become a real therapeutic option for Parkinson’s patients?
    A: Under the best of circumstances, it can take 15-20 years to get a treatment to market, a period when the potential treatment is exhaustively tested on animals and then humans.  And we’re still a ways from having a treatment to test.  Thorny questions remain:  How many dopamine-producing cells derived from stem cells are enough but not too much?  How do you get them to the brain?  What about the dopamine outside the brain's substantia nigra that is also affected by Parkinson’s?

And in my not-very-sophisticated understanding of Parkinson’s, the most serious problem of all:  How do you stop whatever is killing or crippling the original dopamine cells from doing the same to the stem cell derived cells?

These questions may prove insurmountable.  But this much seems sure:  If research is stopped in its tracks, we’ll never be able to answer them.