How much of a danger are the H1N1 vaccine side effects?
Posted using ShareThis
Sunday, December 13, 2009
Tuesday, November 24, 2009
Man Trapped In 23-Year 'Coma' Was Conscious
Yesterday, 09:32 am
© Sky News 2009
Top of Form
An engineering student thought to be in a coma for 23 years was actually conscious the whole time, it has emerged.Skip related content
RELATED PHOTOS / VIDEOS
Man Trapped In 23-Year 'Coma' Was ConsciousEnlarge photo
Rom Houben was misdiagnosed as being in a vegetative state after a car crash left him totally paralysed.
For the whole time, he was trapped in his own body with no way of letting friends and family know he could hear every word they were saying.
The 46-year-old, who can now tap out computerised messages and read books on a device above his hospital bed, has revealed: "I screamed, but there was nothing to hear.
"All that time I literally dreamed of a better life. Frustration is too small a word to describe what I felt.
"I shall never forget the day when they discovered what was truly wrong with me - it was my second birth.
"I want to read, talk with my friends via the computer and enjoy life now people know I am not dead."
His misdiagnosis was discovered by neurological expert Dr Steven Laureys, who fears there may be similar cases all over the world.
He looked at Mr Houben's case again at the University of Liege, Belgium, using state-of-the-art imaging that showed the patient was aware of what was happening around him even though he had lost control of his body.
Dr Laureys, who leads the Coma Science Group, was unavailable for comment when contacted by Sky News Online.
He told the Daily Telegraph: "In Germany alone each year some 100,000 people suffer from severe traumatic brain injury.
"About 20,000 are followed by a coma of three weeks or longer. Some of them die, others regain health.
"But an estimated 3,000 to 5,000 people a year, remain trapped in an intermediate stage: they go on living without ever coming back again."
Rom, a martial arts enthusiast who remains in constant care at a facility near Brussels, was repeatedly wrongly assessed in Zolder, Belgium, by doctors using technology available at the time.
They used the internationally accepted Glasgow Coma Scale to assess his eye, verbal and motor responses. But each time he was graded incorrectly.
The disclosure is likely to renew the right-to-die debate over whether people in comas are truly unconscious.
There have been several cases where people in deep comas have recovered.
Carrie Coons, 86, from New York, regained consciousness 20 years ago.
Days before her recovery, a judge had granted a request for the removal of her feeding tube which had been keeping her alive.
Tuesday, November 10, 2009
Three Killer Indicators Identified That Are Even Worse Than High Cholesterol
Three Killer Indicators Identified That Are Even Worse Than High Cholesterol
ScienceDaily (Nov. 4, 2009) —
Researchers at the University of Warwick have identified a particular combination of health problems that can double the risk of heart attack and cause a three-fold increase in the risk of mortality.
The team, led by Assistant Clinical Professor of Public Health at Warwick Medical School Dr Oscar Franco, has discovered that simultaneously having obesity, high blood pressure and high blood sugar are the most dangerous combination of health factors when developing metabolic syndrome.
Metabolic syndrome is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes.
The main five health problems normally associated with metabolic syndrome are abnormal levels of blood pressure, high cholesterol, high triglyceride levels (the chemical form in which fat exists in the body), too much sugar in the blood and central obesity (excess of fat around the waistline).
In his study, published in the American Heart Association journal Circulation, Dr Franco has identified the most dangerous combination of these conditions to be central obesity, high blood pressure and high blood sugar. People who have all three of these conditions are twice as likely to have a heart attack and three times more likely to die earlier than the general population.
His team looked at 3,078 people to track the prevalence and progress of metabolic syndrome as part of the Framingham Offspring Study.
He said: "Metabolic syndrome is a highly prevalent condition that is increasing dramatically and affects a large portion of the middle-age population. Not all individuals enter the syndrome with identical combination of factors. Certain combinations confer higher risks of incident cardiovascular disease and mortality."
Dr Franco said the combination of high blood pressure, central obesity and hyperglycemia (high blood sugar ) showed a significantly higher risk compared to the others.
He added: "Intense efforts are needed to identify populations with these particular combinations and to provide them with adequate treatment at the early stages of disease."
Three Killer Indicators Identified That Are Even Worse Than High Cholesterol
ScienceDaily (Nov. 4, 2009) —
Researchers at the University of Warwick have identified a particular combination of health problems that can double the risk of heart attack and cause a three-fold increase in the risk of mortality.
The team, led by Assistant Clinical Professor of Public Health at Warwick Medical School Dr Oscar Franco, has discovered that simultaneously having obesity, high blood pressure and high blood sugar are the most dangerous combination of health factors when developing metabolic syndrome.
Metabolic syndrome is a combination of medical disorders that increase the risk of developing cardiovascular disease and diabetes.
The main five health problems normally associated with metabolic syndrome are abnormal levels of blood pressure, high cholesterol, high triglyceride levels (the chemical form in which fat exists in the body), too much sugar in the blood and central obesity (excess of fat around the waistline).
In his study, published in the American Heart Association journal Circulation, Dr Franco has identified the most dangerous combination of these conditions to be central obesity, high blood pressure and high blood sugar. People who have all three of these conditions are twice as likely to have a heart attack and three times more likely to die earlier than the general population.
His team looked at 3,078 people to track the prevalence and progress of metabolic syndrome as part of the Framingham Offspring Study.
He said: "Metabolic syndrome is a highly prevalent condition that is increasing dramatically and affects a large portion of the middle-age population. Not all individuals enter the syndrome with identical combination of factors. Certain combinations confer higher risks of incident cardiovascular disease and mortality."
Dr Franco said the combination of high blood pressure, central obesity and hyperglycemia (high blood sugar ) showed a significantly higher risk compared to the others.
He added: "Intense efforts are needed to identify populations with these particular combinations and to provide them with adequate treatment at the early stages of disease."
Three Killer Indicators Identified That Are Even Worse Than High Cholesterol
Tuesday, October 13, 2009
Monday, September 28, 2009
Swine flu jab link to killer nerve disease: Leaked letter reveals concern of neurologists over 25 deaths in America
A warning that the new swine flu jab is linked to a deadly nerve disease has been sent by the Government to senior neurologists in a confidential letter.
The letter from the Health Protection Agency, the official body that oversees public health, has been leaked to The Mail on Sunday, leading to demands to know why the information has not been given to the public before the vaccination of millions of people, including children, begins.
It tells the neurologists that they must be alert for an increase in a brain disorder called Guillain-Barre Syndrome (GBS), which could be triggered by the vaccine.
GBS attacks the lining of the nerves, causing paralysis and inability to breathe, and can be fatal.
The letter, sent to about 600 neurologists on July 29, is the first sign that there is concern at the highest levels that the vaccine itself could cause serious complications.
It refers to the use of a similar swine flu vaccine in the United States in 1976 when:
- More people died from the vaccination than from swine flu.
- 500 cases of GBS were detected.
- The vaccine may have increased the risk of contracting GBS by eight times.
- The vaccine was withdrawn after just ten weeks when the link with GBS became clear.
- The US Government was forced to pay out millions of dollars to those affected.
Concerns have already been raised that the new vaccine has not been sufficiently tested and that the effects, especially on children, are unknown.
It is being developed by pharmaceutical companies and will be given to about 13million people during the first wave of immunisation, expected to start in October.
Top priority will be given to everyone aged six months to 65 with an underlying health problem, pregnant women and health professionals.
The British Neurological Surveillance Unit (BNSU), part of the British Association of Neurologists, has been asked to monitor closely any cases of GBS as the vaccine is rolled out.
One senior neurologist said last night: 'I would not have the swine
flu jab because of the GBS risk.'There are concerns that there could be a repeat of what became known as the '1976 debacle' in the US, where a swine flu vaccine killed 25 people – more than the virus itself.
A mass vaccination was given the go-ahead by President Gerald Ford because scientists believed that the swine flu strain was similar to the one responsible for the 1918-19 pandemic, which killed half a million Americans and 20million people worldwide.
Within days, symptoms of GBS were reported among those who had been immunised and 25 people died from respiratory failure after severe paralysis. One in 80,000 people came down with the condition. In contrast, just one person died of swine flu.
More than 40million Americans had received the vaccine by the time the programme was stopped after ten weeks. The US Government paid out millions of dollars in compensation to those affected.
The swine flu virus in the new vaccine is a slightly different strain from the 1976 virus, but the possibility of an increased incidence of GBS remains a concern.
Shadow health spokesman Mike Penning said last night: 'The last thing we want is secret letters handed around experts within the NHS. We need a vaccine but we also need to know about potential risks.
'Our job is to make sure that the public knows what's going on. Why
is the Government not being open about this? It's also very worrying if GPs, who will be administering the vaccine, aren't being warned.'Two letters were posted together to neurologists advising them of the concerns. The first, dated July 29, was written by Professor Elizabeth Miller, head of the HPA's Immunisation Department.
It says: 'The vaccines used to combat an expected swine influenza pandemic in 1976 were shown to be associated with GBS and were withdrawn from use.
'GBS has been identified as a condition needing enhanced surveillance when the swine flu vaccines are rolled out.
'Reporting every case of GBS irrespective of vaccination or disease history is essential for conducting robust epidemiological analyses capable of identifying whether there is an increased risk of GBS in defined time periods after vaccination, or after influenza itself, compared with the background risk.'
The second letter, dated July 27, is from the Association of British Neurologists and is written by Dr Rustam Al-Shahi Salman, chair of its surveillance unit, and Professor Patrick Chinnery, chair of its clinical research committee.
It says: 'Traditionally, the BNSU has monitored rare diseases for long periods of time. However, the swine influenza (H1N1) pandemic has overtaken us and we need every member's involvement with a new BNSU survey of Guillain-Barre Syndrome that will start on August 1 and run for approximately nine months.
'Following the 1976 programme of vaccination against swine influenza in the US, a retrospective study found a possible eight-fold increase in the incidence of GBS.
'Active prospective ascertainment of every case of GBS in the UK is required. Please tell BNSU about every case.
'You will have seen Press coverage describing the Government's concern about releasing a vaccine of unknown safety.'
If there are signs of a rise in GBS after the vaccination programme begins, the Government could decide to halt it.
GBS attacks the lining of the nerves, leaving them unable to transmit signals to muscles effectively.
It can cause partial paralysis and mostly affects the hands and feet. In serious cases, patients need to be kept on a ventilator, but it can be fatal.
Death is caused by paralysis of the respiratory system, causing the victim to suffocate.
It is not known exactly what causes GBS and research on the subject has been inconclusive.However, it is thought that one in a million people who have a seasonal flu vaccination could be at risk and it has also been linked to people recovering from a bout of flu of any sort.
The HPA said it was part of the Government's pandemic plan to monitor GBS cases in the event of a mass vaccination campaign, regardless of the strain of flu involved.
But vaccine experts warned that the letters proved the programme was a 'guinea-pig trial'.Dr Tom Jefferson, co-ordinator of the vaccines section of the influential Cochrane Collaboration, an independent group that reviews research, said: 'New vaccines never behave in the way you expect them to. It may be that there is a link to GBS, which is certainly not something I would wish on anybody.
'But it could end up being anything because one of the additives in one of the vaccines is a substance called squalene, and none of the studies we've extracted have any research on it at all.'
He said squalene, a naturally occurring enzyme, could potentially cause so-far-undiscovered side effects.
Jackie Fletcher, founder of vaccine support group Jabs, said: 'The Government would not be anticipating this if they didn't think there was a connection. What we've got is a massive guinea-pig trial.'
Professor Chinnery said: 'During the last swine flu pandemic, it was observed that there was an increased frequency of cases of GBS. No one knows whether it was the virus or the vaccine that caused this.
'The purpose of the survey is for us to assess rapidly whether there is an increase in the frequency of GBS when the vaccine is released in the UK. It also increases consultants' awareness of the condition.
'This is a belt-and-braces approach to safety and is not something people should be substantially worried about as it's a rare condition.'
If neurologists do identify a case of GBS, it will be logged on a central database.
Details about patients, including blood samples, will be collected and monitored by the HPA.
It is hoped this will help scientists establish why some people develop the condition and whether it is directly related to the vaccine.
But some question why there needs to be a vaccine, given the risks. Dr Richard Halvorsen, author of The Truth About Vaccines, said: 'For people with serious underlying health problems, the risk of dying from swine flu is probably greater than the risk of side effects from the vaccine.
'But it would be tragic if we repeated the US example and ended up with more casualties from the jabs.
'I applaud the Government for recognising the risk but in most cases this is a mild virus which needs a few days in bed. I'd question why we need a vaccine at all.'
Professor Miller at the HPA said: 'This monitoring system activates pandemic plans that have been in place for a number of years. We'll be able to get information on whether a patient has had a prior influenza illness and will look at whether influenza itself is linked to GBS.
'We are not expecting a link to the vaccine but a link to disease, which would make having the vaccine even more important.'
The UK's medicines watchdog, the Medicines and Healthcare Products Regulatory Agency, is already monitoring reported side effects from Tamiflu and Relenza and it is set to extend that surveillance to the vaccine.
A Department of Health spokesperson said: 'The European Medicines Agency has strict processes in place for licensing pandemic vaccines.
'In preparing for a pandemic, appropriate trials to assess safety and the immune responses have been carried out on vaccines very similar to the swine flu vaccine. The vaccines have been shown to have a good safety profile.
'It is extremely irresponsible to suggest that the UK would use a vaccine without careful consideration of safety issues. The UK has one of the most successful immunisation programmes in the world.'
I COULDN''T EAT OR SPEAK... IT WAS HORRENDOUS
But within hours, she was on a ventilator in intensive care after being diagnosed with Guillain-Barre Syndrome.
She spent three months in hospital and had to learn how to talk and walk again. But at times, when she was being fed through a drip and needed a tracheotomy just to breathe, she doubted whether she would survive.
The mother of two, 57, from Maryport, Cumbria, had been in good health until she developed a chest infection in March 2006. She gradually became so weak she could not walk downstairs.
Doctors did not diagnose Guillain-Barre until her condition worsened in hospital and tests showed her reflexes slowing down. It is impossible for doctors to know how she contracted the disorder, although it is thought to be linked to some infections.
Mrs Wilkinson said: 'It was very scary. I couldn't eat and I couldn't speak. My arms and feet had no strength and breathing was hard.
I was treated with immunoglobulin, which are proteins found in blood, to stop damage to my nerves. After ten days, I still couldn't speak and had to mime to nurses or my family.
'It was absolutely horrendous and I had no idea whether I would get through it. You reach very dark moments at such times and wonder how long it can last.
But I'm a very determined person and I had lots of support.'
After three weeks, she was transferred to a neurological ward, where she had an MRI scan and nerve tests to assess the extent of the damage.
Still unable to speak and in a wheelchair, Mrs Wilkinson eventually began gruelling physiotherapy to improve her muscle strength and movement but it was exhausting and painful.
Three years later, she is almost fully recovered. She can now walk for several miles at a time, has been abroad and carries out voluntary work for a GBS Support Group helpline.
She said: 'It makes me feel wary that the Government is rolling out this vaccine without any clear idea of the GBS risk, if any. I wouldn't wish it on anyone and it certainly changed my life.
'I'm frightened to have the swine flu vaccine if this might happen again – it's a frightening illness and I think more research needs to be done on the effect of the vaccine.'
Hotline staff given access to confidential records
Confidential NHS staff records and disciplinary complaints could be accessed by hundreds of workers manning the Government's special swine flu hotline.They were able to browse through a database of emails containing doctors' and nurses' National Insurance numbers, home addresses, dates of birth, mobile phone numbers and scanned passport pages – all details that could be used fraudulently.
And private and confidential complaints sent by hospitals about temporary medical staff – some of whom were named – were also made available to the call-centre workers, who were given a special password to log in to an internal NHS website.
It could be a breach of the Data Protection Act.
The hotline staff work for NHS Professionals, which was set up using taxpayers' money to employ temporary medical and administrative staff for the health service.
The not-for-profit company runs two of the Government's swine flu call centres – with 300 staff in Farnborough, Hampshire, and 900 in Watford, Hertfordshire.
Shadow Health Secretary Andrew Lansley described the revelations as 'disturbing'.
Anne Mitchell, a spokeswoman for Unison, said: 'There's no excuse for such a fundamental breach of personal security. Action needs to be taken as soon as possible to make sure this does not happen again.'
A spokeswoman for NHS Professionals would not confirm whether access to the confidential files had been granted.
Thursday, July 16, 2009
Glitch hits Visa users with more than $23 quadrillion charge
Glitch hits Visa users with more than $23 quadrillion charge
STORY HIGHLIGHTS
$23,148,855,308,184,500 charge is about 2,007 times the size of the national debt
Visa customer in New Hampshire, also hit with $15 overdraft fee, finds out online
Statement said he'd spent the big sum at gas station where he buys cigarettes
Card issuer strikes charge and fee, blames "temporary programming error"
July 15, 2009 -- Updated 1837 GMT (0237 HKT)
By Jason Kessler
CNN
NEW YORK (CNN) -- A technical snafu left some Visa prepaid cardholders stunned and horrified Monday to see a $23,148,855,308,184,500 charge on their statements.
Josh Muszynski noticed the 17-digit charge while making a routine balance inquiry.
That's about 2,007 times the size of the national debt.
Josh Muszynski, 22, of Manchester, New Hampshire, was one Visa customer aghast to find the 17-digit charge on his bill. Adding insult to injury, he had also been hit with a $15 overdraft fee.
He noticed that his debt exceeded the world GDP while making a routine balance inquiry on his online Bank of America account. According to his statement, he had spent the profound sum in one pop at a nearby Mobil gas station -- his regular stop for Camel cigarettes.
"Very, very panicked," he jumped in his car and sped to the station.
Had they perhaps noticed any "outrageous" charges come across their books recently, he inquired of the cashier there. She checked the records. They had not.
Muszynski wondered aloud what he might possibly have asked to purchase for such an astronomical price. "Can I buy Europe on pump 4?"
He next called Bank of America, the issuer of his Visa prepaid debit card. The bank kept him on hold for two hours, during which time he contemplated the impossibly bleak financial future that might await him. He also felt a stab of fear that he had saddled all his unborn grandchildren -- and their grandchildren -- with a lifetime of debt. "Down the generational line, nobody would have any money."
Finally, a bank representative told him that the $23 quadrillion charge -- and the $15 overdraft fee -- would be stricken from his account.
Muszynski compared the giant debt reprieve to receiving "an amazing Monopoly card that says, 'Bank error in your favor.' "
In a statement, Visa said the rogue charges affected "fewer than 13,000 prepaid transactions" and resulted from a "temporary programming error at Visa Debit Processing Services ... [which] caused some transactions to be inaccurately posted to a small number of Visa prepaid accounts."
The company assured customers that the problem has been fixed and that all falsely issued fees have been voided. "Erroneous postings have been removed ... this incident had no financial impact on Visa prepaid cardholders."
STORY HIGHLIGHTS
$23,148,855,308,184,500 charge is about 2,007 times the size of the national debt
Visa customer in New Hampshire, also hit with $15 overdraft fee, finds out online
Statement said he'd spent the big sum at gas station where he buys cigarettes
Card issuer strikes charge and fee, blames "temporary programming error"
July 15, 2009 -- Updated 1837 GMT (0237 HKT)
By Jason Kessler
CNN
NEW YORK (CNN) -- A technical snafu left some Visa prepaid cardholders stunned and horrified Monday to see a $23,148,855,308,184,500 charge on their statements.
Josh Muszynski noticed the 17-digit charge while making a routine balance inquiry.
That's about 2,007 times the size of the national debt.
Josh Muszynski, 22, of Manchester, New Hampshire, was one Visa customer aghast to find the 17-digit charge on his bill. Adding insult to injury, he had also been hit with a $15 overdraft fee.
He noticed that his debt exceeded the world GDP while making a routine balance inquiry on his online Bank of America account. According to his statement, he had spent the profound sum in one pop at a nearby Mobil gas station -- his regular stop for Camel cigarettes.
"Very, very panicked," he jumped in his car and sped to the station.
Had they perhaps noticed any "outrageous" charges come across their books recently, he inquired of the cashier there. She checked the records. They had not.
Muszynski wondered aloud what he might possibly have asked to purchase for such an astronomical price. "Can I buy Europe on pump 4?"
He next called Bank of America, the issuer of his Visa prepaid debit card. The bank kept him on hold for two hours, during which time he contemplated the impossibly bleak financial future that might await him. He also felt a stab of fear that he had saddled all his unborn grandchildren -- and their grandchildren -- with a lifetime of debt. "Down the generational line, nobody would have any money."
Finally, a bank representative told him that the $23 quadrillion charge -- and the $15 overdraft fee -- would be stricken from his account.
Muszynski compared the giant debt reprieve to receiving "an amazing Monopoly card that says, 'Bank error in your favor.' "
In a statement, Visa said the rogue charges affected "fewer than 13,000 prepaid transactions" and resulted from a "temporary programming error at Visa Debit Processing Services ... [which] caused some transactions to be inaccurately posted to a small number of Visa prepaid accounts."
The company assured customers that the problem has been fixed and that all falsely issued fees have been voided. "Erroneous postings have been removed ... this incident had no financial impact on Visa prepaid cardholders."
Wednesday, July 15, 2009
Experts dispute doctor's stem cell breakthrough claim
Experts dispute doctor's stem cell breakthrough claim
• STORY HIGHLIGHTS
• Florida cardiologist is administering stem cell therapy in Dominican Republic
• He claims he's had success in turning stem cells into cells from target organ
• "There is no such cell" as a "regenocyte," stem cell research expert says
• Therapy patient and her longtime physician say her improvement was significant
SANTIAGO, Dominican Republic (CNN) -- This Caribbean city already known for cigars, furniture, chocolate and coffee may become a magnet for Americans seeking controversial stem cell therapy for life-threatening illnesses if a Florida cardiologist has his way.
The Food and Drug Administration has not approved this stem cell therapy in the United States because no clinical trials to prove its effectiveness have been done. But Dr. Zannos Grekos says his company, Regenocyte Therapeutic, has successfully used adult stem cells to treat patients with heart and lung disease.
Grekos said he and his associates draw blood from a patient in Florida and then send it to a laboratory in Israel that produces what his company calls "regenocytes." The company defines regenocyte as "a stem cell that has been activated to become a target organ."
"These procedures work," he told CNN, standing inside a hospital room at the Clinica Union Medica del Norte in Santiago. "And it's substantiated by objective data that we are collecting."
But Grekos' procedures have not been reviewed by other researchers, and leading scientists involved in U.S. stem cell research efforts say Grekos is simply wrong. Dr. Irving Weissman, president-elect of the International Society for Stem Cell Research, told CNN, "There is no such cell. There is nothing called a 'regenocyte.' "
"As a stem cell scientist who works in the field of regenerative stem cells, I am disappointed and shocked that somebody would prey on a family that has an untreatable disease with the promise of a therapy that has no scientific or medical basis," Weissman said.
Grekos has a busy practice in Bonita Springs, Florida, outside Naples, and runs a company that promotes and administers stem cell therapies in Santiago, a noisy, crowded industrial city in the central Dominican Republic.
He told CNN that in the past 18 months, about 100 patients have received adult stem cell therapy at a Dominican hospital. Most of them have been patients with severe heart disease, while the rest have suffered from chronic lung illnesses, he said.
He said the Israeli laboratories can produce between 40 million and 80 million stem cells from a patient's blood sample.
"Then they also activate them and educate them to become the end organ to any tissues we are looking to regenerate," Grekos said.
Grekos said he makes no promise of results to his patients. He is collecting data from his procedures and has been in contact with a Florida hospital to independently review his findings, but that hasn't happened yet, he said.
He said he wants to present his data to the Food and Drug Administration by the end of 2009, then ask the federal agency to accelerate its approval process.
But Weissman said the FDA will not accept data from a physician if the doctor has a financial interest in the outcome. "It is simply not done," he said.
The procedure is costly. Grekos said he charges $64,500 -- none of it covered by insurance. He said the cost is driven by the expense of processing the stem cells, and providing clean rooms and couriers who hand-carry the cells to Israel and back.
A year ago, Barbara McKean of Naples, Florida, paid Regenocyte Therapeutic more than $54,000 for stem cell therapy in the Dominican Republic after suffering from chronic lung disease. She said she believes the therapy was worth the expense.
"Right away, the next morning, I felt a sense of well-being that I hadn't felt in a long, long time," McKean said.
"I know that I am living proof that this does work," she added. "I know that."
McKean's family physician, Dr. Robert Folsom, confirmed to CNN that she had been suffering for many years from an advanced state of COPD, an incurable lung disease. Folsom told CNN he was "quite incredulous" after seeing her condition improve.
The chief medical officer of the American Lung Association, Dr. Norman Edelman, said he does not doubt the sincerity of patients who believe they have been helped by stem cell therapy. But he added, "There's an enormous placebo effect in almost all of these cases."
"I have looked for the scientific efficacy of this approach, and can find none," Edelman said.
Folsom, who said he has been McKean's family physician for many years, disputed any suggestion that her apparent recovery stemmed from a "placebo effect" -- an improvement sometimes seen in patients who are given an inert substance in clinical trials.
"I know about the placebo effect, and her improvement does not seem to be a result of that," he said.
Grekos said his patients "are getting better" under his treatment, but he has not yet applied for clinical trials in the United States because of the high cost. He shrugs off the criticism from people who doubt his claims, saying he -- and not they -- are on medicine's cutting edge.
Stem cell experts who reject his methods "need to be better educated," he said.
• STORY HIGHLIGHTS
• Florida cardiologist is administering stem cell therapy in Dominican Republic
• He claims he's had success in turning stem cells into cells from target organ
• "There is no such cell" as a "regenocyte," stem cell research expert says
• Therapy patient and her longtime physician say her improvement was significant
SANTIAGO, Dominican Republic (CNN) -- This Caribbean city already known for cigars, furniture, chocolate and coffee may become a magnet for Americans seeking controversial stem cell therapy for life-threatening illnesses if a Florida cardiologist has his way.
The Food and Drug Administration has not approved this stem cell therapy in the United States because no clinical trials to prove its effectiveness have been done. But Dr. Zannos Grekos says his company, Regenocyte Therapeutic, has successfully used adult stem cells to treat patients with heart and lung disease.
Grekos said he and his associates draw blood from a patient in Florida and then send it to a laboratory in Israel that produces what his company calls "regenocytes." The company defines regenocyte as "a stem cell that has been activated to become a target organ."
"These procedures work," he told CNN, standing inside a hospital room at the Clinica Union Medica del Norte in Santiago. "And it's substantiated by objective data that we are collecting."
But Grekos' procedures have not been reviewed by other researchers, and leading scientists involved in U.S. stem cell research efforts say Grekos is simply wrong. Dr. Irving Weissman, president-elect of the International Society for Stem Cell Research, told CNN, "There is no such cell. There is nothing called a 'regenocyte.' "
"As a stem cell scientist who works in the field of regenerative stem cells, I am disappointed and shocked that somebody would prey on a family that has an untreatable disease with the promise of a therapy that has no scientific or medical basis," Weissman said.
Grekos has a busy practice in Bonita Springs, Florida, outside Naples, and runs a company that promotes and administers stem cell therapies in Santiago, a noisy, crowded industrial city in the central Dominican Republic.
He told CNN that in the past 18 months, about 100 patients have received adult stem cell therapy at a Dominican hospital. Most of them have been patients with severe heart disease, while the rest have suffered from chronic lung illnesses, he said.
He said the Israeli laboratories can produce between 40 million and 80 million stem cells from a patient's blood sample.
"Then they also activate them and educate them to become the end organ to any tissues we are looking to regenerate," Grekos said.
Grekos said he makes no promise of results to his patients. He is collecting data from his procedures and has been in contact with a Florida hospital to independently review his findings, but that hasn't happened yet, he said.
He said he wants to present his data to the Food and Drug Administration by the end of 2009, then ask the federal agency to accelerate its approval process.
But Weissman said the FDA will not accept data from a physician if the doctor has a financial interest in the outcome. "It is simply not done," he said.
The procedure is costly. Grekos said he charges $64,500 -- none of it covered by insurance. He said the cost is driven by the expense of processing the stem cells, and providing clean rooms and couriers who hand-carry the cells to Israel and back.
A year ago, Barbara McKean of Naples, Florida, paid Regenocyte Therapeutic more than $54,000 for stem cell therapy in the Dominican Republic after suffering from chronic lung disease. She said she believes the therapy was worth the expense.
"Right away, the next morning, I felt a sense of well-being that I hadn't felt in a long, long time," McKean said.
"I know that I am living proof that this does work," she added. "I know that."
McKean's family physician, Dr. Robert Folsom, confirmed to CNN that she had been suffering for many years from an advanced state of COPD, an incurable lung disease. Folsom told CNN he was "quite incredulous" after seeing her condition improve.
The chief medical officer of the American Lung Association, Dr. Norman Edelman, said he does not doubt the sincerity of patients who believe they have been helped by stem cell therapy. But he added, "There's an enormous placebo effect in almost all of these cases."
"I have looked for the scientific efficacy of this approach, and can find none," Edelman said.
Folsom, who said he has been McKean's family physician for many years, disputed any suggestion that her apparent recovery stemmed from a "placebo effect" -- an improvement sometimes seen in patients who are given an inert substance in clinical trials.
"I know about the placebo effect, and her improvement does not seem to be a result of that," he said.
Grekos said his patients "are getting better" under his treatment, but he has not yet applied for clinical trials in the United States because of the high cost. He shrugs off the criticism from people who doubt his claims, saying he -- and not they -- are on medicine's cutting edge.
Stem cell experts who reject his methods "need to be better educated," he said.
Subscribe to:
Posts (Atom)
