WASHINGTON (May 24) -- Almost half of the 500 most popular sunscreen products may actually increase the speed at which malignant cells develop and spread skin cancer because they contain vitamin A or its derivatives, according to an evaluation of those products released today.
AOL News also has learned through documents and interviews that the Food and Drug Administration has known of the potential danger for as long as a decade without alerting the public, which the FDA denies.
The study was released with Memorial Day weekend approaching. Store shelves throughout the country are already crammed with tubes, jars, bottles and spray cans of sunscreen.
The white goop, creams and ointments might prevent sunburn. But don't count on them to keep the ultraviolet light from destroying your skin cells and causing tumors and lesions, according to researchers at Environmental Working Group.
In their annual report to consumers on sunscreen, they say that only 39 of the 500 products they examined were considered safe and effective to use.
The report cites these problems with bogus sun protection factor (SPF) numbers:
-The use of the hormone-disrupting chemical oxybenzone, which penetrates the skin and enters the bloodstream.
-Overstated claims about performance.
-The lack of needed regulations and oversight by the Food and Drug Administration.
But the most alarming disclosure in this year's report is the finding that vitamin A and its derivatives, retinol and retinyl palmitate, may speed up the cancer that sunscreen is used to prevent.
A dangerous additive
The industry includes vitamin A in its sunscreen formulations because it is an anti-oxidant that slows skin aging.
But the EWG researchers found the initial findings of an FDA study of vitamin A's photocarcinogenic properties, meaning the possibility that it results in cancerous tumors when used on skin exposed to sunlight.
"In that yearlong study, tumors and lesions developed up to 21 percent faster in lab animals coated in a vitamin A-laced cream than animals treated with a vitamin-free cream," the report said.
The conclusion came from EWG's analysis of initial findings released last fall by the FDA and the National Toxicology Program, the federal government's principle evaluator of substances that raise public health concerns.
EWG's conclusions were subsequently scrutinized by outside toxicologists.
Based on the strength of the findings by FDA's own scientists, many in the public health community say they can't believe nor understand why the agency hasn't already notified the public of the possible danger.
"There was enough evidence 10 years ago for FDA to caution consumers against the use of vitamin A in sunscreens," Jane Houlihan, EWG's senior vice president for research, told AOL News.
"FDA launched this one-year study, completed their research and now 10 years later, they say nothing about it, just silence."
On Friday, the FDA said the allegations are not true.
"We have thoroughly checked and are not aware of any studies," an FDA spokesperson told AOL News. She said she checked with bosses throughout the agency and found no one who knew of the vitamin A sunscreen research being done by or on behalf of the agency.
But documents from the FDA and the National Toxicology Program showed that the agency had done the research.
"Retinyl palmitate was selected by (FDA's) Center for Food Safety and Applied Nutrition for photo-toxicity and photocarcinogenicity testing based on the increasingly widespread use of this compound in cosmetic retail products for use on sun-exposed skin," said an October 2000 report by the National Toxicology Program.
FDA's own website said the animal studies were done at its National Center for Toxicological Research in Jefferson, Ark. And it was scientists from the FDA center and National Toxicology Program who posted the study data last fall.
Monday, May 24, 2010
Wednesday, May 12, 2010
Vertebroplasty No Better Than Sham For Painful Osteoperotic Fractures
At least that's what the New England Journal Of Medicine is reporting. This randomized double blind, placebo controlled study took participants with one or two painful osteoperotic fractures unhealed and less than 12 months old by MRI and randomized them to either vertebroplasty or sham.
For the nonmedical types out there, vertebroplasty and kyphoplasty involves the injection or balloon expansion of a compressed vertebrae, the theory being that this action will decrease the back pain associated with fractures. The only indication to have one, that I'm aware of, is to treat uncontrolled pain.
Interestingly, 5 years ago we didn't have such a procedure. Patients with compression fractures got pain meds and Miacalcin and told to wait it out. They were told that as the bone healed the pain would improve. We would use moist heat and ultrasound to hasten the healing, then soft tissue adjustments.
Today, just about every acute compression fracture with associated pain gets an MRI and then gets evaluated by either an interventional radiologist or an orthopedic spinal surgeon for evaluation for vertebroplasty or kyphoplasty.
In the study above the primary outcome being measure was pain. Using the primary outcome of pain at 1 month, 3 months and 6 months the study showed no difference between the treatment group and the sham (placebo) group.
This is huge. HUGE. Granted, the study was small, but it appears to be well designed.
This is the second clinical study showing that vertebroplasties are worthless. And the studies were performed by spinal surgeons themselves!
People believe that invasive means better. It's engrained in the American culture where you have to be a specialist that does something to be worth your time and money. Why get pain medication or chiropactic care when you can get needles and cement at 1000 times the cost..... that must work.
This study is a fascinating example of the power of special interest groups infiltrated into clinical medicine. Early studies indicated the vertobroplaties and kyphoplasties may have clinical benefit. The key word is "may". They get approved by the Medicare National Bank as showing benefit over placebo and then everything gets paid for at enourmous cost to the MNB.
I would like to know how these procedures ever made it into mainstream medicine without strong scientific evidence to its efficacy, especially considering their cost to the public Treasury. Chiropractors are constantly ridiculed as being "unscientific", yet we have more clinical studies that show what we do works than most surgical procedures do!
Situations like this tend to weaken the standards of Western medicine which are supposed to be science based, but are looking more and more like they are financial based. Get a bunch of device manufacturers to back a less than optimal study design, gain favor from the radiological and orthopedic societies, which have direct finanical interests in the matter, and spread your position statements out to the world. And make it the gold standard.
Medicine is killing us....and you are paying for it!
For the nonmedical types out there, vertebroplasty and kyphoplasty involves the injection or balloon expansion of a compressed vertebrae, the theory being that this action will decrease the back pain associated with fractures. The only indication to have one, that I'm aware of, is to treat uncontrolled pain.
Interestingly, 5 years ago we didn't have such a procedure. Patients with compression fractures got pain meds and Miacalcin and told to wait it out. They were told that as the bone healed the pain would improve. We would use moist heat and ultrasound to hasten the healing, then soft tissue adjustments.
Today, just about every acute compression fracture with associated pain gets an MRI and then gets evaluated by either an interventional radiologist or an orthopedic spinal surgeon for evaluation for vertebroplasty or kyphoplasty.
In the study above the primary outcome being measure was pain. Using the primary outcome of pain at 1 month, 3 months and 6 months the study showed no difference between the treatment group and the sham (placebo) group.
This is huge. HUGE. Granted, the study was small, but it appears to be well designed.
This is the second clinical study showing that vertebroplasties are worthless. And the studies were performed by spinal surgeons themselves!
People believe that invasive means better. It's engrained in the American culture where you have to be a specialist that does something to be worth your time and money. Why get pain medication or chiropactic care when you can get needles and cement at 1000 times the cost..... that must work.
This study is a fascinating example of the power of special interest groups infiltrated into clinical medicine. Early studies indicated the vertobroplaties and kyphoplasties may have clinical benefit. The key word is "may". They get approved by the Medicare National Bank as showing benefit over placebo and then everything gets paid for at enourmous cost to the MNB.
I would like to know how these procedures ever made it into mainstream medicine without strong scientific evidence to its efficacy, especially considering their cost to the public Treasury. Chiropractors are constantly ridiculed as being "unscientific", yet we have more clinical studies that show what we do works than most surgical procedures do!
Situations like this tend to weaken the standards of Western medicine which are supposed to be science based, but are looking more and more like they are financial based. Get a bunch of device manufacturers to back a less than optimal study design, gain favor from the radiological and orthopedic societies, which have direct finanical interests in the matter, and spread your position statements out to the world. And make it the gold standard.
Medicine is killing us....and you are paying for it!
Saturday, May 8, 2010
Drugs Are Not The Solution-They Are The Problem!
Every day Americans are subjected to a barrage of advertising by the pharmaceutical industry. Mixed in with the pitches for a particular drug—usually featuring beautiful people enjoying themselves in the great outdoors—is a more general message.
Boiled down to its essentials, it is this: “Yes, prescription drugs are expensive, but that shows how valuable they are. Besides, our research and development costs are enormous, and we need to cover them somehow. As ‘research-based’ companies, we turn out a steady stream of innovative medicines that lengthen life, enhance its quality, and avert more expensive medical care.
You are the beneficiaries of this ongoing achievement of the American free enterprise system, so be grateful, quit whining, and pay up.” More prosaically, what the industry is saying is that you get what you pay for.
Is any of this true? Well, the first part certainly is. Prescription drug costs are indeed high—and rising fast. Americans now spend a staggering $500 billion a year on prescription drugs, and that figure is growing at a rate of about 12 percent a year (down from a high of 18 percent in 1999).1 Drugs are the fastest-growing part of the health care bill—which itself is rising at an alarming rate. (And I don't mean the Obama Care Bill).
The increase in drug spending reflects, in almost equal parts, the facts that people are taking a lot more drugs than they used to, that those drugs are more likely to be expensive new ones instead of older, cheaper ones, and that the prices of the most heavily prescribed drugs are routinely jacked up, sometimes several times a year.
Over the past 3 decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)
If prescription drugs were like ordinary consumer goods, all this might not matter very much. But drugs are different. People depend on them for their health and even their lives. In the words of Senator Debbie Stabenow (D-Mich.), “It’s not like buying a car or tennis shoes or peanut butter.” People need to know that there are some checks and balances on this industry, so that its quest for profits doesn’t push every other consideration aside. But there aren’t such checks and balances.
Boiled down to its essentials, it is this: “Yes, prescription drugs are expensive, but that shows how valuable they are. Besides, our research and development costs are enormous, and we need to cover them somehow. As ‘research-based’ companies, we turn out a steady stream of innovative medicines that lengthen life, enhance its quality, and avert more expensive medical care.
You are the beneficiaries of this ongoing achievement of the American free enterprise system, so be grateful, quit whining, and pay up.” More prosaically, what the industry is saying is that you get what you pay for.
Is any of this true? Well, the first part certainly is. Prescription drug costs are indeed high—and rising fast. Americans now spend a staggering $500 billion a year on prescription drugs, and that figure is growing at a rate of about 12 percent a year (down from a high of 18 percent in 1999).1 Drugs are the fastest-growing part of the health care bill—which itself is rising at an alarming rate. (And I don't mean the Obama Care Bill).
The increase in drug spending reflects, in almost equal parts, the facts that people are taking a lot more drugs than they used to, that those drugs are more likely to be expensive new ones instead of older, cheaper ones, and that the prices of the most heavily prescribed drugs are routinely jacked up, sometimes several times a year.
Over the past 3 decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)
If prescription drugs were like ordinary consumer goods, all this might not matter very much. But drugs are different. People depend on them for their health and even their lives. In the words of Senator Debbie Stabenow (D-Mich.), “It’s not like buying a car or tennis shoes or peanut butter.” People need to know that there are some checks and balances on this industry, so that its quest for profits doesn’t push every other consideration aside. But there aren’t such checks and balances.
Wednesday, April 21, 2010
Anoher Reason to Avoid the Cow!
Breast-feeding Could Save Lives and Money
A cost analysis published in the journal Pediatrics, estimates that the lives of 900 babies per year would be saved, along with billions of dollars, if 90 percent of U.S. women fed their babies breast milk for the first 6 months of life.
The findings suggests that there are hundreds of deaths and costly illnesses each year from health problems that breast feeding may help prevent. These include stomach viruses, ear infections, asthma, juvenile diabetes. Sudden Infant Death Syndrome and even childhood leukemia.
Breast milk contains antibodies that help babies fight infections, and can affect insulin levels in the blood, which may make breast-fed babies less likely to develop diabetes and obesity.
The analysis studied 10 common childhood illnesses, costs of treating those illnesses, including hospitalization, and the level of disease protection other studies have linked with breastfeeding. The $13 billion in estimated losses due to the low breast-feeding rate includes an economists' calculation partly based on lost potential lifetime wages - $10.56 million per death.
A cost analysis published in the journal Pediatrics, estimates that the lives of 900 babies per year would be saved, along with billions of dollars, if 90 percent of U.S. women fed their babies breast milk for the first 6 months of life.
The findings suggests that there are hundreds of deaths and costly illnesses each year from health problems that breast feeding may help prevent. These include stomach viruses, ear infections, asthma, juvenile diabetes. Sudden Infant Death Syndrome and even childhood leukemia.
Breast milk contains antibodies that help babies fight infections, and can affect insulin levels in the blood, which may make breast-fed babies less likely to develop diabetes and obesity.
The analysis studied 10 common childhood illnesses, costs of treating those illnesses, including hospitalization, and the level of disease protection other studies have linked with breastfeeding. The $13 billion in estimated losses due to the low breast-feeding rate includes an economists' calculation partly based on lost potential lifetime wages - $10.56 million per death.
Wednesday, February 24, 2010
Soy may benefit breast cancer survivors, study says
Women with breast cancer who eat more soy are less likely to die or have a recurrence of cancer than women who eat few or no soy products, according to a new study.
In the past, physicians have often warned breast cancer patients not to eat soy. The new research represents "a complete turnaround" from the previous understanding about the link between soy consumption and breast cancer, says Sally Scroggs, a registered dietician and senior health education specialist at M.D. Anderson's Cancer Prevention Center in Houston, Texas.
"We have gone from saying, 'No soy for breast cancer survivors' to, 'It's not going to hurt,'" Scroggs says. "Now it looks like we can say, 'It may help.'"
The study looked at more than 5,000 women in China who had undergone a mastectomy; they were followed for about four years. The women who consumed the most soy protein (about 15 grams or more a day) had a 29 percent lower risk of dying and a 32 percent decreased risk of breast cancer recurrence compared to the women who consumed less than about 5 grams of soy protein a day, according to the study, which appears in the December 9 issue of the Journal of the American Medical Association. The National Cancer Institute and the U.S. Department of Defense's Breast Cancer Research Program funded the study.
Women who ate between 9.5 and 15 grams of soy protein saw nearly the same decrease in risk as the women who ate more than 15 grams. In fact, the researchers found no additional benefits to eating more than 11 grams of soy protein a day. (An 8-ounce glass of soy milk and a cup of shelled edamame contain about 7 and 14 grams of soy protein, respectively.)
In all, 534 women had a breast cancer recurrence or died from breast cancer during the study period.
Soy foods--such as milk, tofu, and edamame--are rich in naturally occurring estrogens (especially isoflavones) that can mimic the effects of estrogen in the female body. Because the most common types of breast cancer depend on estrogen to grow, experts once feared that soy isoflavones could stimulate the estrogen receptors in breast-cancer cells, even though the estrogens in soy are much weaker than those produced by the body
The current study suggests the exact opposite: Soy may actually reduce the amount of estrogen that's available to the body.
"Soy isoflavones may compete with estrogens produced by the body. Soy isoflavones may also reduce the body's production of estrogen, and increase clearance of these hormones from the circulation--all of which together reduce the overall amount of estrogen in the body," says the lead author of the study, Dr. Xiao Ou Shu, M.D., Ph.D., a cancer epidemiologist at the Vanderbilt-Ingram Cancer Center of Vanderbilt University Medical Center in Nashville, Tennessee.
Shu says, however, that factors beyond estrogen may be at work. Other components of soy foods, such as folate, protein, calcium, or fiber (or some combination thereof) may also be responsible for the health benefits reported in the study, she says.
More studies are needed to confirm these findings, especially as they apply to women with estrogen-sensitive breast cancer or those who take drugs such as tamoxifen to keep breast cancer at bay, say Ballard-Barbash and Neuhouser. Still, they say, "Patients with breast cancer can be assured that enjoying a soy latte or indulging in pad thai with tofu causes no harm, and when consumed in plentiful amounts may reduce risk of disease recurrence."
In the past, physicians have often warned breast cancer patients not to eat soy. The new research represents "a complete turnaround" from the previous understanding about the link between soy consumption and breast cancer, says Sally Scroggs, a registered dietician and senior health education specialist at M.D. Anderson's Cancer Prevention Center in Houston, Texas.
"We have gone from saying, 'No soy for breast cancer survivors' to, 'It's not going to hurt,'" Scroggs says. "Now it looks like we can say, 'It may help.'"
The study looked at more than 5,000 women in China who had undergone a mastectomy; they were followed for about four years. The women who consumed the most soy protein (about 15 grams or more a day) had a 29 percent lower risk of dying and a 32 percent decreased risk of breast cancer recurrence compared to the women who consumed less than about 5 grams of soy protein a day, according to the study, which appears in the December 9 issue of the Journal of the American Medical Association. The National Cancer Institute and the U.S. Department of Defense's Breast Cancer Research Program funded the study.
Women who ate between 9.5 and 15 grams of soy protein saw nearly the same decrease in risk as the women who ate more than 15 grams. In fact, the researchers found no additional benefits to eating more than 11 grams of soy protein a day. (An 8-ounce glass of soy milk and a cup of shelled edamame contain about 7 and 14 grams of soy protein, respectively.)
In all, 534 women had a breast cancer recurrence or died from breast cancer during the study period.
Soy foods--such as milk, tofu, and edamame--are rich in naturally occurring estrogens (especially isoflavones) that can mimic the effects of estrogen in the female body. Because the most common types of breast cancer depend on estrogen to grow, experts once feared that soy isoflavones could stimulate the estrogen receptors in breast-cancer cells, even though the estrogens in soy are much weaker than those produced by the body
The current study suggests the exact opposite: Soy may actually reduce the amount of estrogen that's available to the body.
"Soy isoflavones may compete with estrogens produced by the body. Soy isoflavones may also reduce the body's production of estrogen, and increase clearance of these hormones from the circulation--all of which together reduce the overall amount of estrogen in the body," says the lead author of the study, Dr. Xiao Ou Shu, M.D., Ph.D., a cancer epidemiologist at the Vanderbilt-Ingram Cancer Center of Vanderbilt University Medical Center in Nashville, Tennessee.
Shu says, however, that factors beyond estrogen may be at work. Other components of soy foods, such as folate, protein, calcium, or fiber (or some combination thereof) may also be responsible for the health benefits reported in the study, she says.
More studies are needed to confirm these findings, especially as they apply to women with estrogen-sensitive breast cancer or those who take drugs such as tamoxifen to keep breast cancer at bay, say Ballard-Barbash and Neuhouser. Still, they say, "Patients with breast cancer can be assured that enjoying a soy latte or indulging in pad thai with tofu causes no harm, and when consumed in plentiful amounts may reduce risk of disease recurrence."
Wednesday, December 16, 2009
Toddler & Infant H1N1 Vaccine DEFECTIVE!!
DON'T SAY I DIDN'T WARN YOU!!
Concerns Over Swine Flu:
Potential Life-Threatening Allergies
Updated: Tuesday, 24 Nov 2009, 11:10 AM EST
Published : Tuesday, 24 Nov 2009, 8:19 AM EST
LONDON - The pharmaceutical company GlaxoSmithKline says it has advised medical staff in Canada to not use one batch of swine flu vaccine for fear it may trigger life-threatening allergies.
Fox 5 News spoke with a GlaxoSmithKline official who says the batch is on a 'voluntary hold' and does not affect the United States.
Spokeswoman Gwenan White said Tuesday the company issued the advice after reports that one batch of the swine flu vaccine might have caused more allergic reactions than normal.
She says the affected batch contains 172,000 doses of the vaccine. She declined to say how many doses had been administered before the advice to stop using them was given.
White says GlaxoSmithKline wrote to Canadian healthcare professionals advising them to stop using the batch on Nov. 18. She says a total of 7.5 million doses of the vaccine have been distributed in Canada.
Update On Swine Flu Vaccine Recall
Medical Headlines
Updated: Wednesday, 16 Dec 2009, 7:58 AM EST
Published : Wednesday, 16 Dec 2009, 7:58 AM EST
MYFOXNY.COM - Medical headlines for Wednesday, December 16.
Text of Dr. Sapna Parikh's report:
SWIN FLU VACCINE RECALL: Thousands of swine flu shots for children are recalled. I spoke with officials at the FDA and the Director of Immunizations at the CDC. Here's the deal-- this is not a safety issue. The issue is the vaccine's strength. Routine testing of the vaccines showed that the strength or potency of the vaccines had fallen slightly below required levels. The shots were made by Sanofi Pasteur and were distributed across the country including some in New York city and Nassau County.
All the doses are for kids-- aged 6 months to three years. What does this mean? Parents- if your child received the recalled vaccine, top health officials say nothing else needs to be done. The vaccine still works and kids who got it are still protected against the swine flu. Doctors who still have these recalled vaccines are being told to stop giving them. There is one important issue-- all the recalled vaccines were Thimerosol free. These are sought after by many parents who are concerned about links to autism. After this recall, there will be no Thimerosol- free vaccine option for kids under the age of two.
Concerns Over Swine Flu:
Potential Life-Threatening Allergies
Updated: Tuesday, 24 Nov 2009, 11:10 AM EST
Published : Tuesday, 24 Nov 2009, 8:19 AM EST
LONDON - The pharmaceutical company GlaxoSmithKline says it has advised medical staff in Canada to not use one batch of swine flu vaccine for fear it may trigger life-threatening allergies.
Fox 5 News spoke with a GlaxoSmithKline official who says the batch is on a 'voluntary hold' and does not affect the United States.
Spokeswoman Gwenan White said Tuesday the company issued the advice after reports that one batch of the swine flu vaccine might have caused more allergic reactions than normal.
She says the affected batch contains 172,000 doses of the vaccine. She declined to say how many doses had been administered before the advice to stop using them was given.
White says GlaxoSmithKline wrote to Canadian healthcare professionals advising them to stop using the batch on Nov. 18. She says a total of 7.5 million doses of the vaccine have been distributed in Canada.
Update On Swine Flu Vaccine Recall
Medical Headlines
Updated: Wednesday, 16 Dec 2009, 7:58 AM EST
Published : Wednesday, 16 Dec 2009, 7:58 AM EST
MYFOXNY.COM - Medical headlines for Wednesday, December 16.
Text of Dr. Sapna Parikh's report:
SWIN FLU VACCINE RECALL: Thousands of swine flu shots for children are recalled. I spoke with officials at the FDA and the Director of Immunizations at the CDC. Here's the deal-- this is not a safety issue. The issue is the vaccine's strength. Routine testing of the vaccines showed that the strength or potency of the vaccines had fallen slightly below required levels. The shots were made by Sanofi Pasteur and were distributed across the country including some in New York city and Nassau County.
All the doses are for kids-- aged 6 months to three years. What does this mean? Parents- if your child received the recalled vaccine, top health officials say nothing else needs to be done. The vaccine still works and kids who got it are still protected against the swine flu. Doctors who still have these recalled vaccines are being told to stop giving them. There is one important issue-- all the recalled vaccines were Thimerosol free. These are sought after by many parents who are concerned about links to autism. After this recall, there will be no Thimerosol- free vaccine option for kids under the age of two.
Friday, December 4, 2009
DRX 9000 a Hoax??!
As I have been telling patients for years......
AG: Firm fleeced docs for $100M
By Carol Gentry
12/1/2009 © Health News Florida
Florida’s Attorney General’s office has filed suit against a Tampa firm that it says made and sold more than 1,000 pricey back-pain therapy machines to physicians nationwide through “false, deceptive or misleading advertising.” Most of the doctors were chiropractors.
Defendants are Axiom Worldwide, President and CEO James J. Gibson Jr. and Vice President Nicholas Exarhos. The complaint says they co-founded the company and both participated in unlawful sales practices.
Among other misleading statements, the complaint filed Nov. 19 in Hillsborough Circuit Court says, Axiom called its DRX 9000 spinal decompression system “the eighth wonder of the world.”
Atty. Gen. Bill McCollum seeks an injunction barring Axiom from continuing to market the machine under false pretenses and also seeks a court order forcing almost $100 million in repayment to consumers and the state – the amount that Axiom received for the machine in 2005 and ’06.
Gibson told Health News Florida this morning that he cannot comment on the suit because the company hasn't received it yet.
The DRX 9000 package that is at issue in the suit cost $95,000, or $125,000 if a neck attachment is included, the complaint says.
Among the false statements, the complaint says, were that Axiom had a patent on DRX 9000, that the system was “approved” by FDA, and that NASA engineers developed it through “space age technology.”
The chiropractors who bought the system were led to believe that Medicare and private insurers would cover the treatments, when the defendants knew claims were being denied, the complaint says.
Also, it says, Axiom falsely led doctors to believe there were scientific trials showing an 86 percent success rate for the DRX 9000 in treatment of degenerative disc disease, disc herniations, sciatica and post-surgical pain.
The price included materials the doctors could use in marketing the system to the public through brochures and ads. So far, the complaint says, 12 chiropractors who used the Axiom marketing materials have been accused of false advertising by the state health department.
The company’s Web site, https://axiomworldwide.com, was not in operation today, but a lot of information was available on a related site, www.AxiomPainSolutions.com.
There, the system was said to “provide relief of pain and symptoms associated with herniated discs, bulging or protruding …discs, degenerative disc disease, posterior facet syndrome, and sciatica.”
The site also offers videos of patient testimonials and a map of practitioners who use the DRX system. In Florida, there are 68 listed.
In July 2006, North American Medical Corp. sued Axiom for trademark infringement regarding DRX 9000, but Axiom kept making false claims, the attorney general’s complaint says.
AG: Firm fleeced docs for $100M
By Carol Gentry
12/1/2009 © Health News Florida
Florida’s Attorney General’s office has filed suit against a Tampa firm that it says made and sold more than 1,000 pricey back-pain therapy machines to physicians nationwide through “false, deceptive or misleading advertising.” Most of the doctors were chiropractors.
Defendants are Axiom Worldwide, President and CEO James J. Gibson Jr. and Vice President Nicholas Exarhos. The complaint says they co-founded the company and both participated in unlawful sales practices.
Among other misleading statements, the complaint filed Nov. 19 in Hillsborough Circuit Court says, Axiom called its DRX 9000 spinal decompression system “the eighth wonder of the world.”
Atty. Gen. Bill McCollum seeks an injunction barring Axiom from continuing to market the machine under false pretenses and also seeks a court order forcing almost $100 million in repayment to consumers and the state – the amount that Axiom received for the machine in 2005 and ’06.
Gibson told Health News Florida this morning that he cannot comment on the suit because the company hasn't received it yet.
The DRX 9000 package that is at issue in the suit cost $95,000, or $125,000 if a neck attachment is included, the complaint says.
Among the false statements, the complaint says, were that Axiom had a patent on DRX 9000, that the system was “approved” by FDA, and that NASA engineers developed it through “space age technology.”
The chiropractors who bought the system were led to believe that Medicare and private insurers would cover the treatments, when the defendants knew claims were being denied, the complaint says.
Also, it says, Axiom falsely led doctors to believe there were scientific trials showing an 86 percent success rate for the DRX 9000 in treatment of degenerative disc disease, disc herniations, sciatica and post-surgical pain.
The price included materials the doctors could use in marketing the system to the public through brochures and ads. So far, the complaint says, 12 chiropractors who used the Axiom marketing materials have been accused of false advertising by the state health department.
The company’s Web site, https://axiomworldwide.com, was not in operation today, but a lot of information was available on a related site, www.AxiomPainSolutions.com.
There, the system was said to “provide relief of pain and symptoms associated with herniated discs, bulging or protruding …discs, degenerative disc disease, posterior facet syndrome, and sciatica.”
The site also offers videos of patient testimonials and a map of practitioners who use the DRX system. In Florida, there are 68 listed.
In July 2006, North American Medical Corp. sued Axiom for trademark infringement regarding DRX 9000, but Axiom kept making false claims, the attorney general’s complaint says.
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