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FDA vs Adult Stem Cells – another view

Posted Aug 17 2010 12:00am

More ObamaCare Cutbacks: Denver Clinic Must Stop Stem Cell Treatments

Obamacare has landed in Denver, where doctors at a pain-management clinic have been told they must stop treating patients with a successful process that extracts their own adult stem cells, cultivates them and then reinjects them to stimulate growth in damaged limbs. The word of the dispute comes from Dr. Christopher Centano of the Centano Schultz clinic, whose Regenexx, or Regenerative Sciences Inc., has been successfully treating patients with the process for several years.

Centano confirms his work provides a much less costly and significantly more convenient alternative to knee or hip joint replacement surgeries, which sometimes require a year or more of recuperation.

But the Food and Drug Administration, in the wake of the adoption of President Obama’s plan to nationalize health-care decision making, has ordered the company to halt, because the federal agency views the process as making “drugs.”

The FDA announced Aug. 6 that it wanted an injunction in federal court against the company, alleging “violations of current good manufacturing practice.”

“Regenerative Sciences’ cultured cell product is not approved by the FDA, and no adequate and well-controlled studies have been done to demonstrate its safety or effectiveness for any indication,” the federal agency announced.

Karen Midthun, acting director for the FDA’s Center for Biologics Evaluation and Research, said in the announcement, “FDA recognizes the importance of the development of novel and promising new therapies. However, when companies like Regenerative Sciences fail to comply with FDA laws and regulations, they put the public’s health at risk.”

An FDA spokeswoman provided the announcement to WND but did not elaborate.

The agency, in a 2008 letter to the company, said, “In order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug application in effect as specified by FDA regulations. … The mesenchymal stem cells utilized in your Regenexx™ procedure are not the subject of an approved biologics license application (BLA) nor is there an investigational new drug application (IND) in effect. Therefore, your implantation of the mesenchymal stem cells for which a valid license or IND is not in effect appears to violate the Act and the PHS Act and may result in FDA seeking relief as provided by law.”

Centano told WND that despite the company’s repeated efforts to obtain a resolution in the disagreement, the FDA continually declined to respond – until Obamacare was adopted.

Now the federal agency has moved to “enjoin” the company’s operations, and Centano told WND his company will fight.

“I think what we’re seeing is a massive federalist move here,” he told WND. “I think this represents that [for] Obamacare to work there has to be strict federal control over medicine.”

A video has been posted in which Centano describes his work:

To see the video: http://www.youtube.com/watch?v=1qpkxK89T7U&feature=player_embedded

He said that until now, medicine has been provided by doctors and regulated at the state level.

“That’s not going to work under Obamacare,” he said. “The government is trying to get more and more positive control over what your doctor does or doesn’t do.”

Centano said the process he uses doesn’t create a drug, as the FDA claims. It’s not more complicated than the “blood-doping” process that athletes sometimes in the past have attempted to improve their performance.

And under the guidance offered by the FDA, a doctor who treats knee pain with a steroid and a painkiller should go through the process of acknowledging he or she is making a “drug” because of the combination of medications, he suggested.

In fact, labs that do in vitro fertilization “do pretty much identical to what we were doing in our lab.”

This, he said, is what “all physicians, regardless of what they do, can expect if the FDA has authority over the practice of medicine.”

“This is opening a Pandora’s box that will never be closed,” he warned. “It means that some bureaucrat sitting in Maryland has the ability to tell the doctor what he can and can’t do to you.

“The FDA action here clearly is an infringement of states’ rights; it infringes on the doctor-patient relationship. In order to make Obamacare work, there’s going to have to be a lot of infringement. They cannot control costs without it,” he said.

Centano explained the process his clinic has used: Stem cells are extracted from the back of the hip, they are isolated in the lab and cultivated to obtain a bigger number. They then are injected into the knee as an alternative for knee replacement surgery.

The doctor said only 4 percent of his patients end up eventually having knee replacement surgery after his treatments, leaving more than nine of 10 able to avoid the surgical costs, hospitalization costs and dangers, rehabilitation time and costs and pain of a joint replacement.

“Many of our patients are self-employed,” Centano said. “They just cannot afford a knee replacement and to take three to six months off work.”

The company also points out that stem cells from the body can be regenerated and reinjected to treat heart disease, COPD and other auto immune diseases.

He said that he’s looking forward to getting the case into court.

“The FDA will finally answer our questions, in court, about their claims and jurisdiction as opposed to doing everything in their power to avoid the issue that we are not a drug manufacturer, but simply a medical practice,” he said.

The clinic has been using its patients’ stem cells to treat orthopedic conditions since 2005 and first got a letter from the FDA in 2008 claiming its medical procedure was creating a new biologic drug. The FDA inspected Regenerative Science’s facility in 2009 and found, at that time, it was not compliant with drug mass manufacture guidelines but failed to take any action.

In the meantime, Regenerative Sciences had filed several lawsuits against the FDA to resolve the issue. It most recently has sought a temporary restraining order demanding the agency take “final” action or leave the medical clinic alone.

Adult stem cells are found throughout a patient’s body. Medical studies increasingly are indicating they have as much – or more – clinical promise than the controversial embryonic stem cells, which are derived from embryos that must be destroyed in the process.

Yet the Obama administration has been on a headlong pursuit to fund research using embryonic cells, while cracking down through the FDA on adult stem cell processes that work, he noted.

Customers, however, are thoroughly behind Centano’s work.

“I want the whole world – especially seniors – to know that injuries such as femoral, hip and pelvic fractures don’t have to diminish your quality of life,” wrote patient “J.A.” on behalf of the company. “You can be healthy and moving forward again with this procedure.”

While a long list of lawsuits are pending against Obamacare, most challenging its underlying constitutionality and seeking to cancel the entire concept, WND also has reported that more than three-quarters of the needed members of the U.S. House of Representatives have signed on to a measure to have a new vote on Obamacare that essentially would allow the chamber to withdraw its approval of the law and begin the process of banishing it.

August 16, 2010: 
Dr.  Donald Berwick , the death panel doctor approved by President Obama in a recess appointment without the approval of Congress now begins his sordid work.  This will kill women, pure and simple.
“Obama Stopping Some Drugs for Ovarian Cancer Patients”

Ovarian Cancer National Alliance, 8/12/10

Washington D.C. August 12, 2010.
The Ovarian Cancer National Alliance (OCNA) and Susan G. Komen for the Cure today urged the U.S. Food and Drug Administration to continue to allow the use of the drug bevacizumab, commonly known as Avastin, for metastatic breast cancer patients, noting that it is effective for many individuals.
In a joint letter sent to the FDA and key Congressional lawmakers Thursday, OCNA and Komen for the Cure wrote we are particularly concerned about patients who are presently receiving bevacizumab and the message that this decision sends about drug development for women with advanced breast cancer.
OCNA is concerned that an FDA label change will further restrict access to Avastin for ovarian cancer patients. Many women with ovarian cancer are receiving and benefitting from Avastin, although its use for ovarian cancer is off label. These women face another worry: Medicare has already rejected some requests for Avastin, one of the worlds most expensive but widely used cancer drugs. OCNA argues that Medicare and its contractors should pay for anti-cancer drugs that are listed on the approved compendia for Avastin.
There is a fundamental fairness problem when the law is not being enforced equally, says Karen Orloff Kaplan, CEO of the Ovarian Cancer National Alliance. Medicare is obliged to pay for the costs of off label anti-cancer drugs listed on the approved compendia. We are concerned that a label change may create another barrier for treatment.
Many doctors report patients taking Avastin enjoy better than modest results according to the joint OCNA-Komen letter to the FDA. In addition, a large scale Phase III trial showed an increase in progression free survival in women who used Avastin in combination with chemotherapy and as maintenance therapy for ovarian cancer.
The decision to use Avastin should be made between a woman and her doctor after a thoughtful conversation that carefully considers its benefits and risks. OCNA believes that women who have the potential to benefit from this drug should have access to it.
The Ovarian Cancer National Alliance is the foremost advocate for women with ovarian cancer in the United States. To advance the interests of women with ovarian cancer, the organization advocates at a national level for increases in research funding for the development of an early detection test, improved health care practices, and life-saving treatment protocols.  The Ovarian Cancer National Alliance educates health care professionals and raises public awareness of the signs and symptoms of ovarian cancer. The Ovarian Cancer National Alliance is a 501 (c) (3) organization established in 1997.

via More ObamaCare Cutbacks: Denver Clinic Must Stop Stem Cell Treatments .

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