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July 2010
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September 2010

Bone-fusion protein raises questions about doctors' financial stakes

Some question whether doctors should be allowed to do clinical trial research involving products that might enrich them or the company they work for.

By John Fauber of the Journal Sentinel

Aug. 28, 2010

In January 2002, a group of Food and Drug Administration advisers met on whether to approve a powerful new biological agent that promised to revolutionize back surgery.

The product was like nothing the burgeoning field of spinal fusion surgery had seen before. If used properly, it essentially turned whatever it touched into bone. This was a good thing if it could be confined to the tiny space between vertebrae, but potentially calamitous if it leaked out.

One of the FDA advisers at the meeting raised a concern about nine of the doctors whose research on the product had been submitted to the FDA: The doctorsall had a financial stake in the product, and their test results with it were nearly twice as good as the doctors who did not have a financial interest.

The concern by the FDA advisory panel member was laughed off with a joke, according to a transcript of the hearing, and the panel ultimately deferred to Medtronic, a company that stood to get billions in sales as the maker of the product known as Infuse.

What has happened since is no laughing matter.

Full stroy.

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Ruling shuts down $70 million in stem cell projects

Decision draws praise, criticism

By Mark Johnson and Kathleen Gallagher of the Journal Sentinel

Aug. 24, 2010

A day after a U.S. district judge halted federal funding of all research involving embryonic stem cells, the government froze about $70 million for projects that were either up for renewal or well along in the approval process, effectively shutting down one of President Barack Obama's top scientific priorities.

In Wisconsin, the temporary injunction triggered praise from opponents of the research and anxiety from scientists who have dozens of projects and millions in federal money at stake. The ruling put at risk hundreds of millions of dollars in royalties the Wisconsin Alumni Research Foundation could potentially reap from its three key embryonic stem cell patents. And in the space of 24 hours, the court action thrust the issue of embryonic stem cell research into an already heated campaign for governor.

Full story.

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Judge blocks federal stem cell research funding

By Mark Johnson of the Journal Sentinel

Aug. 23, 2010

A federal judge on Monday temporarily blocked guidelines set down by the Obama administration expanding human embryonic stem cell research, throwing into doubt studies at the University of Wisconsin-Madison and other major universities across the nation.

"It's broad and could have dramatic impact if the court upholds this for all funding of embryonic stem cell research," said Timothy Kamp, director of UW's Stem Cell & Regenerative Medicine Center.

Kamp said the ruling appears to go beyond the restrictions in place under former President George W. Bush by prohibiting federal funding not only for the derivation of embryonic stem cells, but for research that involves existing cells derived with private funds.

"I don't know what that means," Kamp said. "Does that mean money already given out for existing NIH research, we now have to cease and desist?"

He added that UW will wait for instructions from the National Institutes of Health regarding the ruling.

Full story.

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Tosa biotech company acquired by California firm

By Kathleen Gallagher of the Journal Sentinel

Aug. 17, 2010

Zystor Therapeutics Inc. has been acquired by BioMarin Pharmaceutical Inc., a Novato, Calif., biopharmaceutical company, a deal that could attract investors for other Midwestern companies and venture funds.

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Mayo's 'smart' adult stem cells repair hearts

Mayo's 'smart' adult stem cells repair hearts

'Landmark work' moves beyond the bench

ROCHESTER, Minn. -- Mayo Clinic investigators, with Belgian collaborators, have demonstrated that rationally "guided" human adult stem cells can effectively heal, repair and regenerate damaged heart tissue. The findings -- called "landmark work" in an accompanying editorial -- appear in today's Journal of the American College of Cardiology.

Stem cells isolated from patients have normally a limited capacity to repair the heart. This innovative technology boosts the regenerative benefit by programming adult stem cells to acquire a cardiac-like profile. Primed by a cocktail of recombinant cardiogenic growth factors, mesenchymal stem cells (MSCs) harvested from the bone marrow of a cohort of patients with coronary artery disease showed "superior functional and structural benefit without adverse side effects" over a 1-year follow-up in a model of heart failure according to the study.

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Cloned beef causing uproar in Britain traced to Wisconsin cow

Oxford dairy farmer harvested DNA from champion Holstein in 2000

By Karen Herzog of the Journal Sentinel Aug. 14, 2010

Mark Rueth's Holstein cow Paradise had just been crowned supreme champion of the World Dairy Expo in Madison in 2000 when a biotechnology company salesman approached him ringside and offered a cut-rate deal to clone Paradise so she could "live forever," and make his farm more profitable.

The Oxford dairy farmer and cattle breeder agreed, and the salesman immediately pricked the prize cow's ear to harvest DNA.

The world of cloning hasn't exactly been paradise for Rueth in the decade since, and especially during the past two weeks. Recent headlines in the British press screamed that two male offspring of a Paradise clone were slaughtered for beef that entered the food chain. Milk from a daughter of a Paradise clone also was traced to the British food supply, setting off consumer fears about food safety.

"The English people get in an uproar about stuff," Rueth said last week, noting that a British reporter and photographer showed up unannounced at his farm. "It's not like you're manipulating or changing the DNA. Half of the DNA from the clone's offspring is from the father."

In the U.S., the Food and Drug Administration doesn't regulate milk or meat from offspring of cloned animals, and doesn't require labeling. Two years after the agency concluded those food products were safe, they're in the American food supply.

However, the U.S. Department of Agriculture requests that the industry continue a voluntary moratorium on placing products from original clones in the food supply to allow trade partners in other countries to pursue their own regulations.

Full story.

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