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It's begun: Obamacare shutters pain treatment
Posted By Bob Unruh On 08/16/2010 @ 9:13 pm In Front Page | Comments Disabled
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 Centeno of the Centeno Schultz clinic,
whose Regenexx, or Regenerative Sciences Inc., has been successfully treating patients with the process for several years.
Centeno 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.”
Centeno 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 Centeno 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 Centeno describes his work:
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.”
Centeno 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.
Centeno 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,” Centeno 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 Centeno’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.
Under the provisions of the discharge procedures in the House, such a move is required to have the support of 218 members, a majority, of the 435-member chamber before moving forward.
But since it requires a majority, it is virtually assured of approval.
The proposal states: “Pursuant to clause 2 of rule XV, I, Steve King of Iowa, move to discharge the Committees on Energy and Commerce, Ways and Means, Education and Labor, the Judiciary, Natural Resources, Rules, House Administration and Appropriations from the consideration of the bill (H.R. 4972) to repeal the Patient Protection and Affordable Care Act, which was referred to said committees on March 25, 2010, in support of which motion the undersigned Members of the House of Representatives affix their signatures.”
Its target is the $940 billion, or greater, bill adopted by the Democrat-controlled Congress in March.
Advocates say constituents need to call their representatives to tell them to get on board right away so that the petition is positioned to move forward whether or not the GOP becomes the majority in the House after the 2010 fall elections.
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