Elected officials play an important role in determing the future of medical research.  They set government budgets that create funding priorities and that provide a source of research funds.  They use eligibility for government funding as a carrot in order to encourage compliance with ethical guidelines.  And, sometimes they use the blunt weapon of criminal sanctions in order to place certain types of research off limits.

It is important for the state legislature to work with the medical research community in partnership, and not to become an adversary of the research community.  A partnership with the medical community requires a good faith effort by the legislature to inform itself about the science that it regulates and to listen to the concerns of researchers, just as it listens to the concerns of faith-based groups and other constituents.  In this regard, we here in Wisconsin need look no further than to our neighbor across the lake for an example of what happens when elected officials become the adversaries of medical research.

As reported by reporter Juliana Keeping at the website AnnArbor.com:

“A preeminent figure in embryonic stem cell research is leaving the state.

And Sean Morrison, director of the Center for Stem Cell Biology at the University of Michigan, isn’t mincing words on his way out the door.

Since news broke of his pending departure to lead a new pediatric research initiative at University of Texas Southwestern Medical School in Dallas, he’s accused the state Legislature and faith-based groups of harassing stem cell researchers — threatening Michigan’s potential for stem cell research and a thriving life sciences industry.

‘There are a small number of faith-based special interest groups that are attacking relentlessly. Relentlessly looking for ways to block these forms of medical research most people in the country feel should be supported,’ he said. ‘They’re well-enough organized and sophisticated and have deep-enough pockets. What that means is we are constantly under attack.’
. . .

According to an MLive.com report, both the House and Senate spending plans for the state’s 15 public universities require that schools engaging in embryonic stem cell research file a report on those activities with the state Department of Community Health.

The reports have to include the number of human embryos and human embryo stem cell lines received by the university in the current fiscal year, the number of embryos utilized for research, the number of stem cell lines created, the number of embryos held in storage and the number of research projects underway, MLive.com reports.

State Rep. Bob Genetski, R-Saugatuck, who supports the reporting requirements, told the Holland Sentinel in April he wants to bring transparency to stem cell research through provisions in the higher education budget.

‘It is important to know where the human embryonic stem cells are coming from and where they’re being generated,’ he told the Sentinel. ‘We want to make sure the embryos are legal — that they didn’t come to us through the black market.’

Morrison calls that fear-mongering.

Gov. Rick Snyder’s legal counsel told GOP leaders Friday that the reporting requirements are unconstitutional.

‘There are already multiple forms of regulation that would prevent a black market, including the state Constitution, which makes it illegal to buy or sell a human embryo,’ Morrison said.

. . .

Morrison’s loss will be felt, said Alan Saltiel, director of the Life Sciences Institute, the parent entity of the Center for Stem Cell Biology.

Morrison’s lab — and the millions of dollars his work brought to U-M — will go with him to Texas, along with at least 10 of 20 staff members so far. The center — which was an intellectual rather than a brick-and-mortar home for stem cell scientists — will continue. But it’s not yet clear if and when a new director will be hired, Saltiel said Friday.
. . .

Morrison points out that Texas and California have recently each made a $3 billion investment in stem cell research, creating an outstanding environment for science in spite of budget troubles.

‘Michigan needs to decide whether it wants to compete in the life sciences or not,’ he said. ‘If it doesn’t, fine. U-M will do the best it can without any help from the Legislature.

‘You don’t compete by looking for ways to put stem cell biologists in jail.’

The entire story can be read at the following link:  http://www.annarbor.com/news/departing-stem-cell-researcher-sean-morrison-to-gop-to-gop-you-dont-compete-by-looking-for-ways-to-p/

This week, Wisconsin Stem Cell Now sent the following letter to Governor Scott Walker and to every member of the Wisconsin State Senate and the State Assembly:

Since 2004, the organization Wisconsin Stem Cell Now, Inc. has worked to educate the public about the science and ethics of stem cell research.  As you know, many of our nation’s leading stem cell scientists are affiliated with the University of Wisconsin and with the Medical College of Wisconsin.  Their efforts at increasing our understanding of the human body support a growing biotechnology industry in Wisconsin, while simultaneously providing hope for the thousands of Wisconsin families that struggle daily with disease and chronic injury.

Because our elected officials are often called upon to make important decisions that impact this crucial research, we believe that it is important for all policymakers in Wisconsin to have access to accurate and up to date information about stem cell research.  For that reason, we are forwarding to you a forthcoming article that will appear in the Marquette Elder’s Advisor journal, a publication of the Marquette University Law School.  I am the author of the article, entitled “Funding Stem Cell Research: The Convergence of Science, Religion & Politics in the Formation of Public Health Policy.”

This article provides a clear and detailed discussion of the science of stem cell research, the religious and ethical perspectives relating to stem cell research, and the issues that policymakers face in relation to the funding and support of stem cell research.  We hope that you will find this information useful.  More information about the subject is available at our website: www.wistemcellnow.org .  In addition, I hope that you will feel free to contact me directly if I can answer any questions or provide any data concerning stem cell research.

We urge you to support the important work of the stem cell scientists in our state and to stay informed of new developments in this fast paced field.

Enclosed with the letter was a copy of the article, which can be read online by clicking on the download button at:   http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1747802

Contact your state representatives, and urge them to be responsible stewards of medical research in Wisconsin.

A second patient with a recent spinal cord injury has been treated with human embryonic stem cells as part of Geron Corporation’s clinical trial.  This trial seeks to restore damaged nerves and improve muscle control and sensation in paralyzed patients.  The treatment took place this week in Chicago at Northwestern Memorial Hospital.  More information is available here: http://www.reuters.com/article/2011/05/10/us-spinal-cord-idUSTRE74970X20110510 .

Stem Cell researchers in Wisconsin and around the nation are breathing a little easier today.

This morning, the United States Court of Appeals for the District of Columbia Circuit vacated the preliminary injunction that was previously granted by the District Court in the case of Sherley v. Sebelius.  That injunction, ordering the National Institutes of Health to stop funding embryonic stem cell research under guidelines adopted by the Obama Administration, sent shock waves throughout the stem cell research community.  Now the preliminary injunction has been vacated.

While it is still possible that the United States Supreme Court might consider an appeal, and re-instate the injunction, for the time being the result of today’s Court of Appeals ruling is to allow the N.I.H. to use federal dollars to make grants supporting embryonic stem cell research.  The underlying litigation will still continue, but the immediate threat of a disruption of the federal funding stream has been averted.

In an article to be published in the Marquette Elder’s Advisor, entitled Funding Stem Cell Research: The Convergence of Science, Religion & Politics in the Formation of Public Health Policy, I criticized the lower court decision granting the preliminary injuction:

Judge Lamberth’s ruling can be criticized on several fronts.  First of all, his interpretation of the “unambiguous” language of the Dickey-Wicker Amendment is contrary to the interpretation adopted by three separate presidential administrations.  This suggests that the contrary interpretation is at least a permissible reading of the statutory language and that therefore the federal courts should defer to the agency interpretation.  Second, under Judge Lamberth’s interpretation of the Dickey-Wicker Amendment, even the Bush administration’s 2001 funding guidelines are unlawful.  At no time during the Bush administration did Congress express such understanding of the law.  Finally, by granting a preliminary injunction, Judge Lamberth necessarily found that the plaintiffs would suffer irreparable harm if the NIH guidelines were not immediately enjoined.  However, as discussed above, there is absolutely no evidence that the availability of federal funds for embryonic stem cell research has limited or detracted from the availability of funds for research using adult stem cells or iPS cells.  The federal government currently funds far more research using adult stem cells than embryonic stem cells, and to date the primary financial support for embryonic stem cell research has come from state governments.

In its decision vacating Judge Lamberth’s ruling, the Court of Appeals essentially agreed with these arguments.

Today’s decision is important, because it creates precedent supporting the legal interpretation relied upon by President Obama and the N.I.H. when authorizing the use of federal funds for embryonic stem cell research. 

More on the case and the legal issues involved can be found here:

http://chronicle.com/article/Embryonic-Stem-Cell-Research/127349/

The Court of Appeals opinion can be found in its entirety here:

http://www.cadc.uscourts.gov/internet/opinions.nsf/DF210F382F98EBAC852578810051B18C/$file/10-5287-1305585.pdf

A draft of my article, Funding Stem Cell Research: The Convergence of Science, Religion & Politics in the Formation of Public Health Policy, can be downloaded here:

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1747802

A recent press release from the University of Wisconsin highlights several start up companies that have spun off of the biomedical research underway at the UW System.  Research focusing on stem cells and regenerative medicine are an important part of this effort.  The release notes that 35% of the University’s professors work in the field of life sciences, a concentration that fosters collaboration and business formation.  As put by Professor Emeritus Richard Burgess:

“We are unique because we have colleges of medicine and agriculture, and schools of pharmacy, veterinary medicine and nursing. The college of engineering has a significant biological focus. Because we have strengths in all the major disciplines, brainstorming here can lead to fundamentally new ideas and research collaborations[.]“

Six Wisconsin biomedical companies are profiled in the release: Flugen, Third Wave Technologies, Stratatech Corporation, Cellular Dynamics International, Conjugon, Inc., and Isomark.  The University estimates that the total annual benefit to the Wisconsin economy from private companies building off of University-related scientific research (biomedical as well as other fields) is $2 billion.

The press release can be viewed here:

http://www.news.wisc.edu/19280

Columnist David Wessel, writing today in the Wall Street Journal, notes that the current debate over the federal budget has uncovered one area of bi-partisan agreement, and a corresponding fissure within the Republican party.  Newt Gingrich calls it “research & development,” while President Obama calls it “investment,” but many policy leaders in both political parties understand that the federal government has a vital role in funding scientific research.  This is one area where dollars spent today will pay huge dividends in the future.  Medical research in general, and stem cell research in particular, are examples of federal spending outlays that lead to increased economic growth and job creation.  However, some Republicans in Congress want to mindlessly shrink the federal budget.  This wing of the Party needs to be reminded that all federal spending is not equal.   

Here is Wessel comparing the views of Gingrich and Obama:

In making the case for more government investment in research, [Gingrich] sounds like Barack Obama.

Here’s Mr. Gingrich at Brookings: The “biggest budget mistake” he made as speaker was “not tripling the National Science Foundation budget (from a much smaller base) while doubling the National Institutes of Health .” When tightening their belts, companies “always distinguish between research and investment, which are essential to their survival, and spending.” Governments should, too. Americans “will support a smart effort to get to a balanced budget, but not a cheap effort [that] will sell out the future in favor of current interest groups.”

Here’s Mr. Obama, in his State of the Union: “This is our generation’s Sputnik moment. Two years ago, I said that we needed to reach a level of research and development we haven’t seen since the height of the Space Race….We’ll invest in biomedical research, information technology, and especially clean energy technology….”

And in the president’s recent attack on Mr. Ryan’s budget: “We have to live within our means….And we have to do it in a way that…protects the investments we need to grow, creates jobs, and helps us win the future.”

It’s true that one politician’s “investment” is another’s “wasteful spending,” that economists differ on how big a return public investments generate and that Washington could do R&D and infrastructure investing more efficiently.

But ponder these facts: Federal spending on payments for individuals (everything from housing subsidies to health care) has doubled over the past 30 years, as a share of the economy. Defense spending fell when the Cold War ended, but has been climbing for a decade.

Yet everything else—including all spending intended to pay off in the future—has been flat, setting aside the temporary Obama fiscal stimulus. Of the $3.5 trillion the federal government spent in 2010, only 1.6% went to non-defense physical capital, R&D, education and training, the White House budget office says. That’s half the size of the share for this spending in the early 1970s.

There is, and should be, debate over how much taxpayer money should go for benefit programs, how much defense spending is enough, how vigorously government should resist market forces widening the gap between economic winners and losers, and about how big government should be.

Mr. Gingrich and Mr. Obama come down on different sides of those issues (although Mr. Gingrich calls himself “a hawk, but a cheap hawk.”) But on the question of whether government should spend more on things that could raise living standards, Mr. Gingrich and Mr. Obama agree.

It’s a reminder that in the debate over government-spending priorities, the differences aren’t exclusively between the two parties, but sometimes within them.

Many corporate executives side with Messrs. Gingrich and Obama. Along with calling for lower taxes and less regulation, they’ve been arguing—to quote a recent statement signed by the Business Roundtable, a group of CEOs—for “federal investment to prepare our children with world-class educations and to support the scientific and technology research and innovation infrastructure that enable the private sector to create jobs.”

The debate over the balance between tax increases and spending cuts to reduce the deficit is loud. And it should be. But it threatens to distract us from something also important. What will matter to our children and grandchildren isn’t only how much of our money the government spends, but on what it spends that money.

The entire article can be found here:

http://online.wsj.com/article/SB10001424052748703367004576288641058989166.html?mod=WSJ_Election_RightTopCarousel_1