Archive for March 15th, 2010|Daily archive page

Boston Scientific Corp. (BSX) suspend sales of medical devices that restore normal heart rhythm and manage heart failure

In BUSINESS OF STEM CELLS on March 15, 2010 at 8:01 pm

Pharma can’t seem to do anything right these days.  Falsified clinical trials, political agendas, now this. – dg

3rd UPDATE: Boston Scientific Slides On Halt Of ICD Sales

MARCH 15, 2010, 11:40 A.M. ET

Boston Scientific Corp. (BSX) suspended sales of medical devices that restore normal heart rhythm and manage heart failure, saying it failed to submit for U.S. regulatory approval certain changes in the way it makes the products.

The news sent Boston Scientific shares plunging 16% to $6.51 in recent trading. A big portion of the products affected–implantable cardioverter difibrillators, or ICDs, in the U.S.–represented about 15% of total company sales last year, and it’s not clear how long sales of the products will be suspended.

The documentation snafu is the latest setback for the Natick, Mass., company’s ICD business. Boston Scientific acquired Guidant in 2006 after reports of safety problems with Guidant’s ICDs, and Boston Scientific suffered years of negative fallout over the issue.

The news could also damage the credibility of the company’s new management team in the eyes of investors. “The announcement will weaken quality perception of a company that was on the brink of recovery,” Morgan Stanley analyst David Lewis wrote in a note.

On Monday, Boston Scientific said it stopped shipment and is retrieving inventory of all ICDs, as well as its cardiac resynchronization therapy defibrillators, or CRT-Ds. The company said it had found two instances of manufacturing changes that, while successfully validated, weren’t submitted to the U.S. Food and Drug Administration.

The errors put the company’s ICD devices out of compliance with FDA regulations, according to an analyst note from Bernstein Research. Boston Scientific said it plans to work closely with the FDA to resolve the situation, while saying it had no indications the manufacturing-process changes poses a risk to patients and it is not recommending that implanted devices be taken out…


Grinstead Still Grinning – 2 Years afterwards Adult Stem Cell Therapy

In ALL ARTICLES on March 15, 2010 at 7:59 pm

Grinstead Still Grinning – 2 Years afterwards Adult Stem Cell Therapy

Monday, March 15, 2010 – Seventeen years ago Bob Grinstead, now 71, from Roswell, Georgia, had his first massive heart attack. After a series of grafts he continued working as a salesman for five years until told to retire as he was in and out of hospital having stents inserted – and then having to have them cleaned out.

In 2003 he had another bypass, this time with three grafts and a short while later he needed three medicated stents. After all this he still went on the next year to have four more heart attacks and yet another bypass was proposed. His specialist at Emory University, not surprisingly, told him his heart was not strong enough to undergo further surgery, so he investigated a laser procedure that would have cut away a part of his heart. Declining this offer his family searched for some real help.

A son read about a man who had had his own adult stem cells injected and was now active, so Bob searched to see if he could get on a clinical trial. His fear that if accepted he might end up in a placebo group sent his family scuttling back to the internet and eventually they found Theravitae, an Israeli-Thai company at the forefront of research and development into adult stem cells for heart failure, ischemic heart disease and cardiomyopathy. Bob read about patients’ successful outcomes and came to believe that adult stem cell therapy represented his best chance.

By the end of 2004 Bob was taking a daily tablet of nitro and gobbling up more every time he exerted himself. The least activity proved painful, and to travel, as he did in December of that year, entailed a wheelchair at every airport. In March 2005 he went to Bangkok, still needing an airport wheelchair and entered Chao Phaya Hospital under the care of renowned cardiologist Dr. Suphachai. After a simple blood draw which was flown to Israel to the laboratory for harvesting of the stem cells he needed, he had to wait a few days until the enriched supply of millions of his adult stem cells were reintroduced into his heart by catheter.

His experience of the hospital and care on Bangkok was simply, “Fantastic. The hospital was spotless and I received the most thorough physical examination I had ever had. The nurses, too, were just wonderful.”

Returning home Bob continued with his nitro tablets the first week but despite being more active, walking further and feeling better within four weeks he was experiencing no chest pain at all, so dispensed with his nitro. He continues to improve to this day and notes that his EF (a measure of the heart’s effectiveness at pumping blood) has risen from 30 to 46.

Two years later Bob is feeling great. He does what he wants to do. He can walk for half an hour and use a treadmill. Living without chest pain alone has been fantastic enough for him to volunteer his time to talk to people contemplating receiving adult stem cell therapy and to share his story.

Bob could have sat on his decking and read a book until he died but instead he and his wife have been to London (where they walked everywhere), the British Virgin Islands and he has skippered a 47-foot catamaran for a week. He is so busy traveling around catching up with his family that in the last year he has spent only six months at home.

The cost? “Not a waste for two years of life. I reckon it was a pretty good buy. It’s a far better option than a bypass,” he said.

Theravitae- makers of Vescell have now helped over 200 end-stage heart patients. Their clinical trial results have demonstrated that over 75 percent of heart failure, ischemic heart disease and cardiomyopathy patients can expect to regain a far better quality of life, be more active and pain free. Further clinical trails are planned and recently the company received Thailand’s Board of Investment approval. The future looks bright for being able to claim that most patients not only gain a better quality of life, but a considerably longer life than they might have expected.

via invacare wheelchair: Grinstead Still Grinning – 2 Years afterwards Adult Stem Cell Therapy.


In BUSINESS OF STEM CELLS on March 15, 2010 at 2:04 pm
Central Figure in CDC Vaccine Cover-Up Absconds With $2M

// A central figure behind the Center for Disease Control’s (CDC) claims disputing the link between vaccines and autism and other neurological disorders has disappeared after officials discovered massive fraud involving the theft of millions in taxpayer dollars. Danish police are investigating Dr. Poul Thorsen, who has vanished along with almost $2 million that he had supposedly spent on research.

Thorsen was a leading member of a Danish research group that wrote several key studies supporting CDC’s claims that the MMR vaccine and mercury-laden vaccines were safe for children. Thorsen’s 2003 Danish study reported a 20-fold increase in autism in Denmark after that country banned mercury based preservatives in its vaccines. His study concluded that mercury could therefore not be the culprit behind the autism epidemic.

His study has long been criticized as fraudulent since it failed to disclose that the increase was an artifact of new mandates requiring, for the first time, that autism cases be reported on the national registry. This new law and the opening of a clinic dedicated to autism treatment in Copenhagen accounted for the sudden rise in reported cases rather than, as Thorsen seemed to suggest, the removal of mercury from vaccines. Despite this obvious chicanery, CDC has long touted the study as the principal proof that mercury-laced vaccines are safe for infants and young children. Mainstream media, particularly the New York Times, has relied on this study as the basis for its public assurances that it is safe to inject young children with mercury — a potent neurotoxin — at concentrations hundreds of times over the U.S. safety limits.

Thorsen, who was a psychiatrist and not a research scientist or toxicologist, parlayed that study into a long-term relationship with CDC. He built a research empire called the North Atlantic Epidemiology Alliances (NANEA) that advertised its close association with the CDC autism team, a relationship that had the agency paying Thorsen and his research staff millions of dollars to churn out research papers, many of them assuring the public on the issue of vaccine safety.

The discovery of Thorsen’s fraud came as the result of an investigation by Aarhus University and CDC which discovered that Thorsen had falsified documents and, in violation of university rules, was accepting salaries from both the Danish university and Emory University in Atlanta — near CDC headquarters — where he led research efforts to defend the role of vaccines in causing autism and other brain disorders. Thorsen’s center has received $14.6 million from CDC since 2002.

Thorsen’s partner Kreesten Madsen recently came under fierce criticism after damning e-mails surfaced showing Madsen in cahoots with CDC officials intent on fraudulently cherry picking facts to prove vaccine safety.

Leading independent scientists have accused CDC of concealing the clear link between the dramatic increases in mercury-laced child vaccinations beginning in 1989 and the epidemic of autism, neurological disorders and other illnesses affecting every generation of American children since. Questions about Thorsens’s scientific integrity may finally force CDC to rethink the vaccine protocols since most of the other key pro vaccine studies cited by CDC rely on the findings of Thorsen’s research group. These include oft referenced research articles published by the Journal of the American Medical Association, the American Journal of Preventive Medicine, the American Academy of Pediatrics, the New England Journal of Medicine and others. The validity of all these studies is now in question.

1. http://www.cphpost.dk/news/international/89-international/48229-researcher-accused-of-cheating-uni-out-of-millions.html
2. http://www.safeminds.org/news/pressroom/press_releases/20040518_AutismAuthorsNetwork.pdf
3. http://www.nytimes.com/2010/02/06/opinion/06sat3.html
4. http://www.huffingtonpost.com/robert-f-kennedy-jr/time-for-cdc-to-come-clea_b_16550.html
5. http://www.ageofautism.com/2010/03/poul-thorsens-mutating-resume.html
6. http://www.rescuepost.com/files/thorsen-aarhus.pdf
7. http://www.cphpost.dk/news/international/89-international/48229-researcher-accused-of-cheating-uni-out-of-millions.html

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