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Tag: stem cell

Stem Cell Research: Are California’s Priorities in the Right Place?

Written by on Tuesday, January 20th, 2009

As the State of California sinks into a deep economic crisis, California’s Stem Cell Agency is so well-financed that it gave out $19 million dollars last month and is in the process of giving out another $66 million this month. 

David Jensen of the California Stem Cell Report raises the timely question: are California’s priorities in the right place?

Clearly, California voters believed in the value of stem cell research when they voted for Proposition 71, and there is little doubt that stem cell research has the potential to be tremendously beneficial to the state’s biotech community, but did the voters really intend to fund stem cell research with state taxpayer money in lieu of everything else? 

The problem with research, of course, is that it can take years to bear fruit. So, while investing in stem cell research today can easily be viewed as an investment in the future, that future may be years down the road.  Meanwhile, the state is out of money and that reality is having an immediate effect today across the board on a variety of programs as well as the overall operation of the state.  While California can certainly raise taxes, in this economy where so many residents are losing their jobs and their homes, raising taxes is probably not going to fix the states’s economic problems. 

Jensen addresses the situation as follows:

No one – except for those congenitally opposed to hESC work — is contending that all these millions are going to unworthy scientists or to dubious research. But the CIRM giveaways stand in marked contrast to what is happening to the rest of the state in the light of its $40 billion budget crisis. . . .

The disparity raises major public policy issues about the use of ballot initiatives to promote and protect various causes. Should the elderly and poor see their much-needed assistance and medical care cut while cash flows unimpeded, in this case, to researchers, some of whom are already exceedingly well funded?

In my opinion, Jensen’s point is well-taken.  As a transplant from the South–not Southern California, but the "real" South–I have always been uncomfortable with California’s ballot initiatives for the simple reason that I always felt like I was missing some critical information to making a decision: the budget.  I have run my law firm now for five years, and I can assure you that while I made some mistakes early on, I quickly learned that a business owner cannot make any spending decision without carefully reviewing the budget that will finance such spending.  I serve on a nonprofit board of directors, and the same is true in making spending decisions for that organization.

Yet, as a California voter, I am somehow expected to make a decision on a ballot initiative without being able to see the overall financial picture of the state.

Does this really make sense?

In the case at hand, I doubt that the current funding imbalance is going to turn Californians against stem cell research.  By and large, I think people support the research and recognize its potential.  On the other hand, it should make us all stop and think about our state’s priorities in this economic crisis.  Are they invested in the right place?

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Biotech Industry Begins to Assess Likely Impact of New Administration

Written by on Monday, November 10th, 2008

The biotech industry is beginning to assess what the impact of the new Obama administration is likely to mean for individual biotech companies.

A key concern for the industry is the likely financial implications of the Obama presidency on biotech companies, according to an article by SFGate

What financial concerns are at issue?

While biotech companies are definitely concerned about the bad economy and the credit crisis, they are also  concerned about an anticipated push for cheaper drug prices, which could potentially have a very detrimental impact on biotech companies, since any such increase could negatively affect the profits that biotech companies could potentially achieve on their drugs and would perhaps impact companies’ valuations as well.

Another concern for the industry is what will happen to the Food and Drug Administration under an Obama presidency, accoding to the SFGateDuring the Bush Administration, Congress criticized the Administration for how the Food and Rug Administration was run–in particular, they viewed it to be "underfunded" and "ineffective." As Adam Feuerstein of the Street.com reported: "The agency is in turmoil. Morale is low, resources are scarce and too many drug approvals have been delayed at best, or worst, have become politicized."  President-Elect Obama will presumably sink some money into the organization and try to take it in a new direction, which he may begin by choosing new leadership.  According to SFGate and  Feuerstein, a few of the names being considered include: Dr. Steven Nissen, a cardiologist for the Cleveland Clinic;  Dr. Scott Gottlieb, who worked directly under Mark McClellan when he was FDA commissioner; and Janet Woodcock, a veteran agency official who is the favored choice of drug manufacturers.

One highly anticipated change by the new administration is the likely adoption of a new view on stem cell research, reported Yahoo News, which reported that  Obama’s Transition Chief John Podesta indicated this weekend that Obama is currently reviewing President Bush’s executive order on stem cell research and may reverse that order fairly quickly.

As for other changes that might be in the works which would affect the industry, the Patent Baristas have provided an extended list of potential changes that we may see under the new administration, including but not limited to doubling federal funding for basic research over the next ten years, making the research and development tax credit permanent, and reforming the Patent and Trademark Office.

All in all, it seems clear that the new administration will bring "change" to the biotech industry; however, the jury is still out as to whether any such "change" will be for the better or for the worse.   The industry is hoping–like the majority of Americans that voted for Obama on election day–that the "change" Obama will bring will be for the better.

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San Diego Consortium for Regenerative Medicine to Build $115 Million Stem Cell Research Facility in San Diego

Written by on Tuesday, April 22nd, 2008

The San Diego Consortium for Regenerative Medicine has announced its plans to build a $115 million stem cell research facility in San Diego, according to the Associated Press

The Associated Press reported as follows:

The facility would be located on more than 7 acres owned by the University of California at San Diego in the Torrey Pines area biotechnology cluster. . . . The state is expected to provide a large portion of the facility’s funding. Californians in 2004 approved a measure creating a $3 billion stem cell research agency.

A panel for the state agency has determined the San Diego consortium is eligible for $43 million. A condition to receive the state funds is that the building be completed by 2010.

Consortium officials estimate they would need to raise at least an additional $72 million to complete the center’s funding. They said an out-of-state donor whom they decline to name has agreed to contribute $30 million.

It will be interesting to see how the plans for this new center compare to the California Institute of Regenerative Medicine ("CIRM") facility.  We will keep you posted. 

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USPTO Upholds WARF Stem Cell Patent Claim

Written by on Thursday, February 28th, 2008

The USPTO has upheld a key WARF stem cell patent, which as the California Biotech Law Blog reported in April 2007, is considered one of the most significant patents on stem cells.

According to Bill Novak, reporter for Madison.com:

The patent for the primate and human embryonic stem cell known as 913 was one of three under review by the patent office, following challenges brought by the New York-based Public Patent Foundation and the California-based Foundation for Taxpayer and Consumer Rights.

The 913 decision was the first in the review process, with the patent office also re-examining the patents by WARF for stem cells 780 and 806.

Novak reports that decisions are still pending on the two remaining patents under review: the 780 and 606 patents.  We will keep you posted on the status of those patents as we hear of any new developments.

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Stem Cell Companies Looking Ahead to New Administration

Written by on Wednesday, February 27th, 2008

Stem cell biotech companies are looking forward to the next presidential administration, reports CNN MoneyAll three of the leading presidential candidates–Senator John McCain, Senator Barack Obama, and Senator Hillary Clinton–have expressed a more tolerant view toward stem cell research than has the current President Bush. 

CNN Money reported:

Bush has twice vetoed legislative attempts to expand the funding, including those backed by McCain, Clinton and Obama. In reference to Bush’s policies, Obama has said, "Stymieing embryonic stem cell research is a step in the wrong direction." Clinton has called for funding for "additional cell lines in order to pursue the promising avenues for research." McCain has said "stem cell research has the potential to give us a better understanding of deadly diseases and spinal cord injuries affecting millions of Americans."

Following his second veto in 2007, Bush said the legislation "would compel American taxpayers – for the first time in our history – to support the deliberate destruction of human embryos." Instead, the president touted the therapeutic potential of stem cells taken from adult tissue.

Given the support by President Bush of the concept of taking taking stem cells from adult tissue and umbilical cords, the companies that have utilized this methodology such as Aastrom, Cytori Therapeutics , Stemcell, and Osiris Therapeutics have been somewhat shielded by the ongoing controversy, reported CNN Money. In contrast, the companies using the methodology of deriving stem cells from human embryos such as Geron, Advanced Cell Technology, Novocell and Neuralstem have found themselves right in the middle.

CNN Money predicts, however, that the new administration will benefit all of these companies, regardless of the methodology used, since investors will have a more positive view about the political climate for these companies and the funding is likely to be made available to them. 

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California’s Stem Cell Priorities: Is the State Ahead of its Time or Was the Vote a Reactionary Political Decision?

Written by on Monday, August 13th, 2007

In his blog Secondhand Smoke, J. Wesley Smith makes an interesting argument that California’s stem cell priorities have been misplaced.  Wesley points to an article in today’s San Francisco Chronicle as evidence for his argument.  The Chronicle article is a human  interest story on State Senator Carole Migden’s push for a state system to collect and store umbilical cord blood.

J. Wesley Smith writes as follows:

This story illustrates how politics has twisted the proper pursuit of regenerative medicine in California. During the last six years or so, the legislature went GA-GA over ESCR and human cloning. It passed a state law explicitly permitting human cloning research. And then, under a $35 million propaganda barrage, state voters agreed to an initiative (Proposition 71) that created a constitutional amendment to permit human cloning research and to fund SCNT and ESCR to the tune of $3 billion over ten years using borrowed money–meaning the actual cost will be about $7 billion. And all to pursue utterly unproven and ethically contentious approaches to regenerative medicine–and to supposedly “defy Bush,” even though Bush has done nothing to prevent state jurisdictions from funding whatever they want.

And yet, the legislature is only now getting around to creating an umbilical cord blood banking policy

Smith certainly makes a strong argument that California’s priorities have been misplaced.  The question for those of us in California: is he right?

Certainly, there is evidence that State taxpayers’ decision to fund stem cell research was a purely political one.  It is no secret that President Bush will not go down in the record books as the most adored President in this state.  One can absolutely make the argument that the decision to fund stem cell research was in part a reaction to the President’s repeated opposition for stem cell legislation, particularly since stem cell research is such a popular issue in this state.

Of course, a counter-argument could also be made that this State’s economy will be supported by the investment into stem cell research, since the investment will go largely toward hiring people to conduct the studies.  Many jobs will likely be created by the investment, which will trickle down to the economy at large.

However, one cannot help but wonder if the money couldn’t have been better spent elsewhere, even if you are a supporter of the biotech industry and of the concept of the research generally.  Our schools, health care, keeping drugs off the street, illegal immigration, crime, overcrowded prisons, and terrorism are just some of the many issues facing this state that could have also been better funded with the same money.  Did we as taxpayers make a good decision when we voted to use the funds instead on stem cell research?

It’s a thought-provoking question that all Californians should  consider.

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California Stem Cell Agency Funds Controlled By Conflicts of Interest

Written by on Tuesday, July 10th, 2007

California Stem Cell Report provided more enlightening coverage today on how funds are being disbursed at the California Stem Cell Agency.

California Stem Cell Report reported as follows:

About ninety percent of the $209 million handed out so far by the California stem cell agency has gone to institutions that have “representatives” on the board that approves the funding. . . .

The group that approves the money is the 29-member Oversight Committee. Fourteen members of that committee have close links to the institutions that have received about $190 million in grants.

None of this is illegal but it illuminates the nature of the built-in conflicts of interest on the board. Prop. 71 created the situation. Nearly all the institutions in California that could be suitable recipients of stem cell research have some sort of representation on the decision-making board. The measure spelled out, for example, that five executive officers from University of California medical schools have seats on the board. It also stipulated that four executive officers from California research institutions sit on the Oversight Committee. . . .

Isn’t it comforting to know that millions of California’s taxpayer dollars have been entrusted to an entity, which is plagued by so many conflicts of interests?   Did voters unknowingly create just another bloated bureaucracy when they voted in favor of Proposition 71?  It is difficult not to think that this is exactly what has happened when you read these reports.

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Victory for Stem Cell Research in California

Written by on Wednesday, February 28th, 2007

Supporters for California’s Stem Cell Research Program won a victory this week when a state appeals court upheld a lower court’s decision that the program does not violate laws concerning state spending, the structure of ballot initiatives, or rules regarding conflicts of interest.

The New York Times reported that Robert N. Klein, chairman of the board overseeing the stem cell program, hailed the court’s decision as “one huge step for California,” and also stated that:

Mr. Klein said the decision was so strong that he thought the California Supreme Court would decline to hear the case if the ruling were to be appealed. If the Supreme Court turned away the case, he said, the state could begin issuing bonds as soon as 120 days from now.

According to The New York Times, a lawyer representing opponents of the program indicated that they would likely appeal, but that no definitive decision had been made on the issue.

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