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zee
10-12-2010, 07:03 AM
The moral argument against Embryonic Stem cells continues. What you don't hear in the news is that embryonic stem cells can now be made from scratch. They don't have to start out with an egg. Regardless of where they came from, a few noisy and powerful obstructionists have been able to create political interference to stop it. Below is an article from the world stem cell summit and suggestions for a political remedy.
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by: Don C. Reed
Sponsor, California?s Roman Reed Spinal Cord Injury Research Act of 1999
Posted: October 6, 2010 10:22 AM

To Steal a Dream: Anger Builds at World Stem Cell Summit

Last night as I sat in the beautiful Detroit Marriot Renaissance Hotel, listening to speakers at the World Stem Cell Summit, I was torn between joy, agony, and rage.

Joy as the scientists detailed the step by step progress they had made toward cure of chronic disease and disability;

Agony because a million Americans are still imprisoned in wheelchairs, while their families live in desperate exhaustion trying to protect them;

And rage because our hope for cure may be stolen by political interference.

I could feel the mood of the conference change. At first, the hundreds of us were caught up in seeing old friends and making new ones, going from booth to booth seeing the latest advances -- oh, they can use magnets to sort stem cells, that looks cool -- but then the conversation would shift, inevitably, to the Sherley vs. Sebelius case, which may cut off federal funding for embryonic stem cell research.

Everyone was trying to be polite about it: hoping that reason and justice would prevail in the courts.

One lawyer friend pointed out an error I had made in a previous column about Judge Royce Lamberth, who disqualified the patient advocate group CAMR from participation in the trial, on the grounds of insufficient time for the plaintiffs (the people suing to shut down the research) to respond, saying the Judge was absolutely right in that point.

So, on the slim chance Judge Lamberth is reading this, my apologies, sir, for that misinterpretation of your action.

But that changes nothing, if the research which offers hope of cure is shut down for political reasons.

People are starting to get angry.

Laura Jackson, a beautiful young lady in a power wheelchair, received the World Stem Cell Summit Inspiration Award. She spoke briefly, thanking the scientists for their hard work, and for Bernie Siegel's organizing the event. She smiled at us, and cheerfully rejoined her family.

But as the father of a paralyzed young man, it broke my heart to see all the machinery she has to wear just to keep breathing, and to move. And it made my fists clench.

If we can cure her, with the use of microscopic tissues that would otherwise be thrown away, should we not do that? Are we not morally obligated to do so?

And Detroit, magnificent Detroit, struggling up from a grim recession, is doing everything right as they switch from being Cartown USA to a globally respected stem cell research "corridor", as they call it, three great colleges--Michigan State, Wayne University, and the University of Michigan, working together--building a new industry.

This revitalization began in 2008, when Michigan patient advocates overthrew some of the cruelest anti-research laws in the nation, when scientists could literally have been thrown in jail for ten years and fined ten million dollars for advanced stem cell research.

Today, Michigan is moving toward a new and sustainable economy, based on biomedicine.

That too is at risk.

Embryonic stem cell research is the foundation of the biomedical economy. It is already being used to test the toxicity of new drugs. Instead of injecting a new drug into a person, and just seeing what happens, pharmacologists can use a dish of salt water and stem cells.

New breakthroughs? Fine, we welcome them. But just as adult stem cells were studied for more than half a century and we still don't know everything they can do, even so it will take time for the latest version of stem cells to be tested--and they will always need to be tested against embryonic stem cells.

What if we can regenerate healing of wounded soldiers? Should we not do so?

My wife Gloria and I are still waiting for the biopsy results on her possible breast cancer; if embryonic stem cells offer us a cure for cancer, are we going to turn it down?

If Republican activist judges declare federal funding of embryonic stem cell research to be illegal, and Republicans in the House and Senate follow through on their 2008 platform promise to ban all embryonic stem cell research, public or private, we will all pay the price.

In personal terms, for sixteen years I have worked to find a cure for my paralyzed son, Roman Reed.

A law named after him (the Roman Reed Spinal Cord Injury Research Act of 1999) provided initial funding for the treatment Geron is taking to human trials. At the Summit, Geron CEO Tom Okarma showed a slide of the 28,000 pages of documentation provided to the FDA during the ten year struggle to prove embryonic stem cells were safe enough to try.

Now, at last, the human trials of embryonic stem cells have begun.

We are so close.

But unless we in the patient advocacy community can encourage Congress to pass a stem cell research protection act the dream will have been stolen.

The "lame duck" session after the election may be our only chance to pass such a bill.

It will be difficult, of course, like everything of value.

But it is worth the doing.

Congress passed such a bill twice before, and a Republican president vetoed it.

Probably Republicans will filibuster a bill brought by cancer-surviver Arlen Specter, or the Castle-DeGette bill, or Tom Harkin's bill, whatever is chosen.

But it must be done, if America's leadership in stem cell research is to be allowed.

California and the few other states that fund research cannot fill the void. Proposition 71 was developed because of exactly this situation, that politics could block research. But the problem of chronic disease and disability is too huge; last year America spent more on chronic illness ($1.65 trillion) than on all federal income taxes ($1.2 trillion) combined. Cure is the only real way to lower medical costs.

And if the anti-science element in the Republican party succeeds?

I will keep trying, of course, no matter what, until the end of my days. I have been studying Chinese for several years, preparing for exactly this eventuality. If America gives up its stem cell leadership because Republicans would rather win political points than heal people, I will still hope for the cure to come from elsewhere, most likely China.

But what a loss that would be. Without America's entrepreneurial genius, the world's quest for cure will basically lose a generation.

Eventually, research in other countries will make the cures happen, and America will play catch-up ball, and future generations look back on ours as an age of ignorance.

The Republican war against embryonic stem cell research will be remembered as a thing of shame--how many people will have suffered, and prematurely died, needlessly?

I am 65 now, and if I make it to my father's age, (he is still playing tennis at 87) I fully expect to see my son walk before I leave this earth.

But I do not think that will happen, if embryonic stem cell research is denied us.

It is not right to steal a dream of hope.

Follow Don C. Reed on Twitter: www.twitter.com/diverdonreed

Kaye
10-12-2010, 10:03 AM
Nobody is stopping research. They want taxpayers to pay for it. I am always shocked when people start discussing this as if Congress has approved/disapproved ALL research on embryonic stem cells. It's all about the MONEY! Adult stem cells doctors want more MONEY too. The media is all about controversy - not health. NOW THE FDA WANTS 25 MILLION MORE! The FDA chief Margaret Hamburg actually said this:

"FDA also wants to disperse the $25 million among a range of other projects: Linking specific ingredients in cigarettes to smoking-associated diseases; developing new chemical tests to assess the safety of fish caught for food in the Gulf of Mexico, following the April oil spill there; and developing better methods to characterize stem cells that might be given to patients."

"Billions of dollars have been invested in biomedical research," and those have led to major advances, Hamburg said yesterday in her talk. "But right now we lack the ability to effectively translate these developments into vital products for those who need them."

I posted the two comments, one of which was mine. I took the name off the other comment because I didn't have permission. I hope everybody reads this and replys at the bottom. We need to get the message out. They have wasted BILLIONS of dollars and "lack the ability to effectively translate these developments into vital products for those who need them" according to their chief. What good is research if it never treats anybody? Unbelieveable!

http://news.sciencemag.org/scienceinsider/2010/10/fdas-25-million-pitch-for-improving.html


FDA's $25 Million Pitch for Improving Drug Regulation
by Jennifer Couzin-Frankel on 7 October 2010, 3:17 PM

The U.S. Food and Drug Administration (FDA) is pressing for a big funding boost for "regulatory science"?research that can help it evaluate new treatments better and faster. Yesterday, FDA chief Margaret Hamburg laid out her case for regulatory research at the National Press Club while FDA released a report on the subject. The agency wants to devote $25 million next year to regulatory science, a small slice of the $4 billion President Barack Obama's Administration has requested for the agency in 2011. Congress has not yet approved that request.

FDA is trying to move forward nevertheless, in part by linking up with more flush agencies. Last week, in conjunction with the National Institutes of Health (NIH), it announced four sizable grants, totaling $9.4 million, in regulatory science. (FDA contributed just under $1 million and NIH gave the rest.) They include support for a heart-lung system that can test potential drugs and an effort to dramatically streamline clinical trials.

"Our current approach [to trials] is horribly inefficient, and we need to do something better," says Roger Lewis, an emergency medicine physician at Harbor-University of California, Los Angeles, Medical Center. Lewis helps advise a company called Berry Consultants founded by Donald Berry, a biostatistician at M.D. Anderson Cancer Center in Houston, Texas. He and Berry, along with emergency medicine physician William Barsan at the University of Michigan, will be studying whether "adaptive" trial designs that incorporate new information in midcourse can answer medical questions. They also want to learn what concerns researchers might have about this approach. Adaptive designs examine how patients are responding to treatment as a trial runs and adjust how people are assigned to a new therapy accordingly. The three, led by Barsan, will be testing this approach in neurological studies such as stroke and cardiac arrest. The goal, says Barsan, is to use an existing neurological trials network as a laboratory to examine this strategy for improving trials.

FDA also wants to disperse the $25 million among a range of other projects: Linking specific ingredients in cigarettes to smoking-associated diseases; developing new chemical tests to assess the safety of fish caught for food in the Gulf of Mexico, following the April oil spill there; and developing better methods to characterize stem cells that might be given to patients.

"Billions of dollars have been invested in biomedical research," and those have led to major advances, Hamburg said yesterday in her talk. "But right now we lack the ability to effectively translate these developments into vital products for those who need them."

Does the FDA really think more money will make their meddling into the practice of medicine any more palatable to doctors or to long suffering patients who have had treatment denied them with their own stem cells because of the FDA? The FDA has tried to hinder autologous stem cell therapy in every way they can. How about only allowing a one day gravity separation of stem cells from peripheral blood when it takes 2 days to do this and yet blood banks because they are licensed can store blood for 30 days or more. It is stupid types of over regulation and interference like that which is thwarting good doctors from practicing medicine based on good science that could be used now to treat patients instead of rodents. I am sick of research projects that are no more than research projects. The FDA needs a complete overhaul and this little dabble isn't going to do it. Today, 1:03:38

Kaye
"But right now we lack the ability to effectively translate these developments into vital products for those who need them." Don't you think that the FDA should have thought about that before they WASTED BILLIONS OF DOLLARS! Research is research. Treatment is treatment. The FDA should get their nose out of the "practice of medicine" by trying to regulate a person's own stem cells. A doctor in the US can't use a person's OWN stem cells if they are multiplied in number and returned to that SAME person. The FDA has determined this to be a "drug." Smells of BIG PHARMA and BIG GOVERNMENT. That "BILLIONS OF DOLLARS" was an absolute waste except to the people that got the jobs and the patents at taxpayers' expense.

zee
10-12-2010, 10:38 AM
I am in 100% agreement. I don't think congress or the NIH should be giving anything to anyone unless such organizations agree to commence human trials within 6 months of determining that a study demonstrates efficacy. I am wondering if it would be practical for the government to require that these organizations pay the money back if human studies are not started within 6 months or a reasonable period following proof of concept in animal models?

We all witnessed how research dollars are squandered. This is one of the biggest money grabs anyone has ever seen.

Zee

Kaye
10-12-2010, 11:23 AM
Sorry. I did not mean to take my frustrations out on you! It just looks like the IDIOTS are in controll and I don't mean Democrat or Republican. The FDA has wasted sooooo much money and many need treatment. The FDA has spent BILLIONS of dollars and now have the audacity to say they need 25 million more in order to somehow find the "ability to effectively translate these developments into vital products for those who need them." Are we to believe that 25 million more will somehow give her the intelligence she needs to do the job? What system is in place - none. A percent of the money needs to be set-aside for use in trials. Common sense seems to have flown out the window.

barbara
10-12-2010, 11:43 AM
Don Reed and a few other political lobbyists are strictly out for themselves. I asked Don to help with an adult stem cell awareness campaign one time and he said no because he didn't want any focus taken off of embryonic stem cell research. My complaint is that he and his lobbyist cronies and much of the media have turned this into a political game claiming that all research has been cut off, when in fact it is just federal funding for the NEVER ENDING EMBRYONIC RESEARCH that is the focus of the court case. Research is still going on at this moment because the court is allowing it. A strict time frame for moving the research into a clinical trial is the only answer, but you can bet these people won't see it this way.

I don't really feel like paying the salaries of researchers who only research. These are tax dollars being used and there needs to be more accountability.

I am not convinced that Don and others aren't using this as strictly a political platform to get candidates of their choice elected by trying to scare the public into believing that all stem cell research has come to an end. Representative DeGette from my home state certainly has no problem telling that story. Don's narrow mindedness totally turned me away from his campaign. I just don't see that throwing more money at this will change things unless the politics can be removed and time limits enforced. That will not happen with the FDA, I can almost guarantee it.

Kaye
10-12-2010, 02:06 PM
I think this is exactly what is going on with research. Greed! It's all about money in their pockets, not treatment for us. Even if it wasn't mostly taxpayer funds in one way or another, it would still be GREED!

http://www.consumerwatchdog.org/patients/articles/?storyId=34415


In the media ? May 23, 2010

Legal Challenge Between Palo Alto Company, Orange County Hospital Halts Stem Cell Research
By Lisa M. Krieger, SAN JOSE MERCURY NEWS

When a child dies of brain disease at Children's Hospital of Orange County, Philip H. Schwartz meets with the parents, explains his research and asks them to donate their child's brain to his quest for a cure.
"These are not easy conversations to have," he said. "There are expectations by parents that if they allow us to do that to their child, it will serve a useful purpose."

But for three years, the cells derived from many of those children's brains have been suspended in limbo, frozen in Thermos bottles. The nonprofit Southern California hospital has shut down the research, intimidated by a patent claim from the Palo Alto biotech company StemCells. The company's co-founder is esteemed Stanford stem cell scientist Dr. Irving Weissman, one of the world's most passionate advocates for giving scientists access to a field entangled by politics, ethics ? and now money.
The standoff over Schwartz's 50 cell cultures illustrates how the commercialization of stem-cell science is creating roadblocks to this red-hot field, even while spurring much-needed investment. It's a classic clash between business and science, and similar battles are being waged over access to embryonic stem cells, genes, biotech tools and other scientific discoveries.

"The landscape is messy,'' said Gregory D. Graff, a patent expert at Colorado State University. "It is a complex situation where you have research interests intermingling with commercial interests. They are both legitimate purposes, but can be in conflict with each other.''

Schwartz, who spoke at length last year to the Mercury News, is no longer publicly discussing the dispute but stood by his previous unpublished interview.

With his research stymied, "all the money has shifted from the lab to the lawyers," said Schwartz, who said he believes the cells may hold deep secrets to such devastating conditions as autism, brain cancer and neurological disease.

The dispute comes down to access to a technique that Schwartz helped develop at the Salk Institute but the institute failed to patent. StemCells did.

In January 2007, the company sent Schwartz a letter saying it owned rights to the technology that he used to extract the cells at his Neural Stem Cell Repository. The hospital attorneys told him to halt his research and stop shipping the cells to dozens of other academic scientists, who also are conducting brain research.

"It's a disservice to families who allowed us to'' use their children's brains, he said. "It's hard to talk about without getting angry.

"There's been a stranglehold put on the field because of this. The access to the science community to cells like this for basic scientific study is virtually nil," he said.

Weissman has had little to say about this dispute. In an e-mail to the Mercury News, he wrote that StemCells "has been prompt and diligent in discussing the issues" with the hospital, but referred further questions to company attorneys, saying "they know the situation, and I do not."

Negotiations are still inching forward, and the two sides have stayed out of court. Neither the hospital nor the company would offer official comment.

Weissman, the director of the Stem Cell Biology and Regenerative Medicine Institute at Stanford, is a champion of stem-cell science, expounding to legislators and laymen alike the promise of stem cells for treating disease and why it is wrong to restrict their use for ideological reasons. With a formidable team of scientists, the goal of StemCells is to transplant healthy cells into damaged brains, offering relief and recovery.

Schwartz said his nonprofit hospital has no intention of commercializing its discoveries or stealing profits from StemCells.

"We're a small clinical institution whose primary purpose is caring for kids," he said. "We're unwilling to risk this mission by bumping heads with StemCells Inc."

The U.S. Patent Act permits exclusive control of any "process, machine, manufacturer, or composition of matter" to a patent holder. StemCells holds exclusive rights to 55 U.S. patents and 200 non-U.S. patents and has launched clinical trials of treatments for several novel brain diseases. It is the leading private company in the neural stem cell field.

Patents can stimulate research because they attract private capital investment and assure investors that a company's products are protected, experts say.

"Research and development is very expensive and there are a lot of failures ? and the successes need to support the experimental trials, and the failures, so we can have successful and safe products on the market for everyone," said patent attorney Antoinette Konski of the Palo Alto law firm Foley & Lardner. Once the 20-year patent expires, the public has full access to it, she added.

But others say exemptions should be made for universities and nonprofit research teams. This noncommercial research can enhance the value of a company's patent if new discoveries are made, they say.

UC San Francisco and Stanford University require no license from academics to use their patent inventions and materials for noncommercial research purposes, according to Joel Kirschbaum of UCSF's Office of Technology Management and Katharine Ku of Stanford's Office of Technology Licensing.

"Behavior like this is repulsive and unacceptable, and the leadership of the company should be called to task,'' said Dan Ravicher, executive director of the Public Patent Foundation, a nonprofit group that urges limits on patent protections in life sciences.

John Simpson of the Los Angeles-based Consumer Watchdog, who is closely watching the case, called it "an egregious assertion of overreaching patent rights. Even if StemCells Inc. can technically assert the patent, I think it is wrongheaded for them to do it. You don't want to freeze that sort of research."

The roots of the conflict go back several years. While at Salk Institute, Schwartz created a new application out of an existing technique: deriving neural stem cells from post-mortem brains, then growing them in culture. At the same time, StemCells was doing similar things.

Neural stem cells, the immature precursors to brain cells, offer huge insights. They allow researchers a way to study cells as they grow and look for ways to interrupt diseases.

"You can create the battle in a culture dish," said Schwartz, saying it could also benefit research into diseases like Alzheimer's and Parkinson's. "Autism ? we don't even have a blood test. We don't understand what it is. In metabolic diseases that affect the brain, what is the sequence of events? What kills them?

"These cells can be used to help us get an idea."

Contact Lisa M. Krieger at 408-920-5565 or lkrieger@mercurynews.com

barbara
10-12-2010, 02:23 PM
If this doesn't say it all, then nothing does. I urge each and everyone of you to get this link out whenever you post comments or discuss stem cell research. This is the most appalling example of greed that I have heard about in a long time and to think it is all about Irv Weissman, past president of the "prestigious"
ISSCR.

Excellent post Kaye. You are awarded the Gold Star.