FDA Relying on Medical Fraud to Promote Devices
March 2, 2010
Natural News
By Ethan A. Huff
The Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) have both published papers criticizing the way in which the Food and Drug Administration (FDA) approves medical devices. Citing a lack of legitimate safety and effectiveness studies, the papers allege that the FDA is approving medical devices without proper scientific evidence proving that they work and will not harm patients.
Researchers from the University of California, San Francisco, pored over seven years worth of FDA public summaries concerning approved medical devices. Researchers from Beth Israel Deaconess Medical Center in Boston wrote the AJT piece, concluding that the FDA’s safety and effectiveness data for medical devices is inconsistent and unreliable. William Maisel, one of the researchers, indicated that the FDA needs to improve its clinical trial standards for medical devices.
When drugs are approved, they typically go through a series of studies prior to even being evaluated by the FDA. A medical device, however, can be approved based on the results of a single study which may or may not contain important specifics such as who participated in the study. Critics note that, since a medical device is usually a permanent addition to someone’s body, it deserves even more intense scrutiny than prescription drugs which can be discontinued if found to be harmful. This is especially true with heart devices that are necessary in order to keep a person alive.
Dr. Jeffrey Shuren, acting director of the FDA’s device division and co-author of one of the studies, conceded that the FDA’s process for evaluating medical devices is inadequate. He explained that the FDA is working on creating stronger standards for evaluation and approval but that device manufacturers need to work more closely with them to establish study goals.
Janet Trunzo, an executive vice president of AdvaMed, an advocacy group for the medical device industry, defended the FDA’s current approach to approving medical devices. She expressed that device manufacturers submit extensive data to the FDA who spends 1,200 hours reviewing it all prior to approving a device.
Many approved medical devices have been recalled over the years for safety reasons. The FDA maintains a list of the most serious medical device recalls for which the products in question may cause “serious health problems or death.” There are over 30 devices on the list from 2009 alone. Since 2004, there have been 137 medical devices recalled by the FDA.
Click here for the full report.
GlaxoSmithKline Knew of Drug Dangers
February 23, 2010
Natural News
By Mike Adams
GlaxoSmithKline, maker of the diabetes drug Avandia, knew the drug was linked to tens of thousands of heart attacks but went out of its way to hide this information from the public, says a 334-page report just released by the Senate Finance Committee. (http://finance.senate.gov/press/Gpr…)
This report also accuses the FDA of betraying the public trust, explaining that FDA bureaucrats intentionally dismissed safety concerns found by the agency’s own scientists.
The report says that Big Pharma’s drugs “put public safety at risk because the FDA has been too cozy with drug makers and has been regularly outmaneuvered by companies that have a financial interest in downplaying or under-exploring potential safety risks.” Sales of Avandia were $3.2 billion (yes, billion) in 2006.
According to a statistical analysis in the report, if all the diabetics currently taking Avandia were put on a “safer” drug, it would avert 500 heart attacks and 300 cases of heart failure every month in the United States alone. Presently, hundreds of thousands of Americans are still taking this drug, and hundreds will continue to die each month as a result, according to the report estimates.
This report, championed by U.S. Senators Grassley and Baucus, is the result of investigators pouring through more than 250,000 pages of documentation gathered from GlaxoSmithKline and the FDA. The document reveals some rather startling facts about the dangers of Avandia, including evidence from the FDA’s own scientists who concluded that Avandia was associated with 83,000 heart attacks.
GlaxoSmithKline intimidates scientists
This investigative report also reveals that GSK engaged in the intimidation of physicians, saying: “GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”
“Patients trust drug companies with their health and their lives, and GlaxoSmithKline abused that trust.” said Sen. Baucus. (Gee, really? Is anyone really surprised that GSK put its own financial interests ahead of a few thousand human lives?)
A separate letter sent to FDA Commissioner Margaret Hamburg by Senators Baucus and Grassley added, “the totality of evidence suggests that GSK was aware of the possible cardiac risks associated with Avandia years before such evidence became public.”
The FDA’s own research also showed Avandia to be associated with a significant increase in heart attack risk, yet the FDA did nothing to protect the public. The agency’s own scientists wrote in 2008, “There is strong evidence that rosiglitazone [Avandia] confers an increased risk of [heart attacks] and heart failure compared to pioglitazone [a rival drug on market].” This evidence went completely ignored at the FDA.
The FDA’s famous Dr David Graham — the key whistleblower on the Vioxx scandal — concluded from his own research, “Rosiglitazone should be removed from the market.”
Even the American Medical Association — a long-time defender of Big Pharma’s drugs — admitted Avandia was dangerous. Its journal, JAMA, wrote in 2007: “Among patients with impaired glucose tolerance or type 2 diabetes, rosiglitazone use for at least 12 months is associated with a significantly increased risk of myocardial infarction and heart failure, without a significantly increased risk of cardiovascular mortality.”
The New England Journal of Medicine also warned about the safety of the drug in an article published in 2007.
Despite these multiple warnings, an FDA panel voted 22 – 1 in favor of keeping Avandia on the market. This is no surprise, of course, to those who know how the FDA really operates (and where its priorities really lie).
To continue reading this report, click here.
Mayo Clinic To Stop Treating Some Medicare Patients in Arizona
January 6, 2010
Bloomberg.com
By David Olmos
The Mayo Clinic, praised by President Barack Obama as a national model for efficient health care, will stop accepting Medicare patients as of tomorrow at one of its primary-care clinics in Arizona, saying the U.S. government pays too little.
More than 3,000 patients eligible for Medicare, the government’s largest health-insurance program, will be forced to pay cash if they want to continue seeing their doctors at a Mayo family clinic in Glendale, northwest of Phoenix, said Michael Yardley, a Mayo spokesman. The decision, which Yardley called a two-year pilot project, won’t affect other Mayo facilities in Arizona, Florida and Minnesota.
Obama in June cited the nonprofit Rochester, Minnesota-based Mayo Clinic and the Cleveland Clinic in Ohio for offering “the highest quality care at costs well below the national norm.” Mayo’s move to drop Medicare patients may be copied by family doctors, some of whom have stopped accepting new patients from the program, said Lori Heim, president of the American Academy of Family Physicians, in a telephone interview yesterday.
“Many physicians have said, ‘I simply cannot afford to keep taking care of Medicare patients,’” said Heim, a family doctor who practices in Laurinburg, North Carolina. “If you truly know your business costs and you are losing money, it doesn’t make sense to do more of it.”
Medicare Loss
The Mayo organization had 3,700 staff physicians and scientists and treated 526,000 patients in 2008. It lost $840 million last year on Medicare, the government’s health program for the disabled and those 65 and older, Mayo spokeswoman Lynn Closway said.
Mayo’s hospital and four clinics in Arizona, including the Glendale facility, lost $120 million on Medicare patients last year, Yardley said. The program’s payments cover about 50 percent of the cost of treating elderly primary-care patients at the Glendale clinic, he said.
“We firmly believe that Medicare needs to be reformed,” Yardley said in a Dec. 23 e-mail. “It has been true for many years that Medicare payments no longer reflect the increasing cost of providing services for patients.”
Mayo will assess the financial effect of the decision in Glendale to drop Medicare patients “to see if it could have implications beyond Arizona,” he said.
Nationwide, doctors made about 20 percent less for treating Medicare patients than they did caring for privately insured patients in 2007, a payment gap that has remained stable during the last decade, according to a March report by the Medicare Payment Advisory Commission, a panel that advises Congress on Medicare issues. Congress last week postponed for two months a 21.5 percent cut in Medicare reimbursements for doctors.
National Participation
Medicare covered an estimated 45 million Americans at the end of 2008, according to the Centers for Medicare & Medicaid Services, the agency in charge of the programs. While 92 percent of U.S. family doctors participate in Medicare, only 73 percent of those are accepting new patients under the program, said Heim of the national physicians’ group, citing surveys by the Leawood, Kansas-based organization.
Greater access to primary care is a goal of the broad overhaul supported by Obama that would provide health insurance to about 31 million more Americans. More family doctors are needed to help reduce medical costs by encouraging prevention and early treatment, Obama said in a June 15 speech to the American Medical Association meeting in Chicago.
Reid Cherlin, a White House spokesman for health care, declined comment on Mayo’s decision to drop Medicare primary care patients at its Glendale clinic.
Medicare Costs
Mayo’s Medicare losses in Arizona may be worse than typical for doctors across the U.S., Heim said. Physician costs vary depending on business expenses such as office rent and payroll. “It is very common that we hear that Medicare is below costs or barely covering costs,” Heim said.
Mayo will continue to accept Medicare as payment for laboratory services and specialist care such as cardiology and neurology, Yardley said.
Robert Berenson, a fellow at the Urban Institute’s Health Policy Center in Washington, D.C., said physicians’ claims of inadequate reimbursement are overstated. Rather, the program faces a lack of medical providers because not enough new doctors are becoming family doctors, internists and pediatricians who oversee patients’ primary care.
“Some primary care doctors don’t have to see Medicare patients because there is an unlimited demand for their services,” Berenson said. When patients with private insurance can be treated at 50 percent to 100 percent higher fees, “then Medicare does indeed look like a poor payer,” he said.
Annual Costs
A Medicare patient who chooses to stay at Mayo’s Glendale clinic will pay about $1,500 a year for an annual physical and three other doctor visits, according to an October letter from the facility. Each patient also will be assessed a $250 annual administrative fee, according to the letter. Medicare patients at the Glendale clinic won’t be allowed to switch to a primary care doctor at another Mayo facility.
A few hundred of the clinic’s Medicare patients have decided to pay cash to continue seeing their primary care doctors, Yardley said. Mayo is helping other patients find new physicians who will accept Medicare.
“We’ve had many patients call us and express their unhappiness,” he said. “It’s not been a pleasant experience.”
Mayo’s decision may herald similar moves by other Phoenix- area doctors who cite inadequate Medicare fees as a reason to curtail treatment of the elderly, said John Rivers, chief executive of the Phoenix-based Arizona Hospital and Healthcare Association.
“We’ve got doctors who are saying we are not going to deal with Medicare patients in the hospital” because they consider the fees too low, Rivers said. “Or they are saying we are not going to take new ones in our practice.”
Click here for the full report.
Soy Beneficial for Breast Cancer Survivors
December 9, 2009
Web MD Health News
By Kathleen Doheny
Moderate intake of soy foods by breast cancer survivors appears to be not only safe but beneficial, according to a new study.
”Women who had a higher soy intake had a lower mortality and lower risk of relapse [than women with a low intake],” says researcher Xiao Ou Shu, MD, PhD, professor of medicine at Vanderbilt University Medical Center in Nashville, Tenn.
Previous research has yielded conflicting findings, with some studies finding that soy foods reduce breast cancer risk but others finding that genistein, an estrogen-like compound known as an isoflavone in soy, helps breast cancer cells grow in the lab and promotes tumor growth in animals.
“Some papers say it’s safe for women [with breast cancer] to eat some form of soy, others say [these] women should be cautious,” Shu tells WebMD. Her findings, she says, should be reassuring to breast cancer survivors.
But the new study isn’t the final word, says an expert who co-authored an editorial accompanying the study, both published in the Journal of the American Medical Association. She cites a relatively short follow-up of four years, along with differences in soy consumption habits of women in the U.S. and women in the study, who were from China.
American Medical Association’s Fight for Medicinal Marijuana
November 16, 2009
NaturalNews
By E. Huff
The nation’s largest physician organization, the American Medical Association, has reversed its position on marijuana and now supports investigation and clinical research on the plant for medicinal use. The group urged the federal government on Tuesday to reassess its Schedule I controlled substance categorization of marijuana that wrongly vilifies it with some of the most dangerous narcotics in existence like heroin and LSD.
Dr. Edward Langston, an AMA board member, points out that only a minimal number of randomized, controlled trials have ever been conducted on smoked marijuana despite clinical research that spans more than 30 years. The group is now encouraging further research into marijuana’s efficacy despite its support since 1997 for Schedule I classification of the plant.
The Obama administration also this year ordered federal narcotics agents to cease prosecution of medical-marijuana users in states that allow for its usage, indicating a change of course from previous administrations’ strict opposition to usage and enforcement of violations, even in legal states. Currently thirteen states legally allow the usage of medicinal marijuana and another twelve or so have begun to consider allowing it.
The AMA is interested in research that considers alternative delivery methods for marijuana aside from smoking it therapeutically. Advocates for medicinal marijuana cite other useful ways of utilizing the plant medicinally, including the extraction of tetrahydrocannabinol(THC)-rich hemp oil that some claim is capable of curing cancer.
Federal government reaction to the AMA’s position has been largely silent despite relaxed federal enforcement of marijuana usage. The Drug Enforcement Administration (DEA) reiterated marijuana’s status as a Schedule I drug and the Food and Drug Administration (FDA) declined to comment on the development.
The AMA was one of the only organizations to oppose the first federal restrictions on marijuana that were enacted in 1937; it continues to reject the arbitrary notion that marijuana serves no medicinal purpose, despite its past support of classification as a Schedule I narcotic. The group even opposed a proposed amendment that would have established its organizational policies in opposition to smoked marijuana as a safe delivery method for medicinal therapy.
Marijuana advocacy groups are ecstatic about the AMA’s new position and the widespread shift in attitude towards medicinal marijuana. While federal policy still opposes the legalization of marijuana, citing the FDA judgment in opposition to its safe usage as medicine, popular opinion continues to sway in favor of continued research and medicinal usage.
The American College of Physicians, the second-largest physician group, last year expressed similar support for increased research and reconsideration of medicinal marijuana. The California Medical Association also passed its own resolutions that articulated the criminalization of marijuana as a “failed public health policy”.
The tides are shifting towards honest inquiry into the health benefits of marijuana. The beckoning for further evidence-based research by reputable medical organizations is a step in the right direction towards legalizing marijuana for safe, legitimate medical purposes.
Click here for the full report.
Doctors’ Deal With Coke Creates Uproar
November 9, 2009
Associated Press
By Lindsey Tanner
Advice about soft drinks and health from one of the nation’s largest doctors groups will soon be brought to you by Coke.
The American Academy of Family Physicians has prompted outcry and lost members over its new six-figure alliance with the Coca-Cola Co. The deal will fund educational materials about soft drinks for the academy’s consumer health and wellness Web site, http://www.FamilyDoctor.org.
Academy CEO Dr. Douglas Henley said Wednesday that the deal won’t influence the group’s public health messages, and that the company will have no control over editorial content. He said the new online information will include research linking soft drinks with obesity and will focus on sugar-free alternatives.
But critics say the Coke deal will water down the advice.
“Coca-Cola, like other sodas, causes enormous suffering and premature death by increasing the risks of obesity, diabetes, heart attacks, gout, and cavities,” Harvard University nutrition expert Dr. Walter Willett said in an e-mail.
He said the academy “should be a loud critic of these products and practices, but by signing with Coke their voice has almost surely been muzzled.”
Dr. Henry Blackburn, a University of Minnesota public health specialist, said the deal “will inevitably have a chilling effect on the focus of their message in regards to sweet drinks.”
Coca-Cola spokeswoman Diana Garza Ciarlante said that kind of criticism “misses the point of the partnership which is to provide education based on sound science.”
Dr. William Walker, public health officer for Contra Costa County near San Francisco, likened the alliance with ads decades ago in which physicians said mild cigarettes are safe,
Walker has been a member of the academy for 25 years but quit last week. He said 20 other doctors who work with his local medical practice also quit because of the Coke deal.
In an announcement last month, the academy, based in suburban Kansas City, Kan., said the new Coca-Cola-funded educational material will be posted online in January.
The idea is “to develop educational materials to help consumers make informed decisions so they can include the products they love in a balanced diet and healthy lifestyle,” the academy’s president-elect, Dr. Lori Heim, said at the time.
The American Academy of Pediatrics received similar criticism seven years ago when it allowed an infant formula maker’s logo to appear on copies of that group’s breast-feeding guide.
And the American Medical Association faced harsh reaction more than a decade ago with a plan to endorse Sunbeam appliances without testing them. Criticism forced the AMA to abandon that deal.
The Coke deal is not the only corporate alliance for the family physicians group. In 2005 it received funding from McDonalds for a fitness program. And its consumer Web site includes advertising for a variety of products, including deli meats and air freshener.
Henley said the Coke deal is worth six figures but he and a Coca-Cola spokeswoman declined to elaborate.
In a protest letter to Henley, 22 health specialists and activists questioned the safety of artificial sweeteners and urged the academy to abandon the deal and speak out against sugary drinks “in the strongest language.”
Henley said the academy regrets the resignations and hopes other members will not “rush to judgment” before seeing the new content.
Coca-Cola is among several corporate contributors to the American Academy of Family Physicians Foundation, a separate philanthropic group. These contributors include many drug companies, McDonalds, PepsiCo and a beef industry group. Henley said the academy is in talks with other foundation contributors to fund other materials for the group, but he declined to say which ones.
Click here for the full report.
Lobbyists Spend Millions to Influence Health Care
July 21, 2009
Washington Post
By Dan Eggen
Drugmakers, hospitals and insurers continued to pour millions of dollars into lobbying during the second quarter of this year, hoping to limit the damage to their bottom line as lawmakers and the Obama administration wrangle over landmark health-care legislation.
New disclosure reports that began arriving Monday in Congress showed familiar players at the top of the health-care influence heap, including $6.2 million in lobbying by the dominant Pharmaceutical Research and Manufacturers of America (PhRMA) and $4 million by the American Medical Association.
Many health companies and associations increased their first-quarter lobbying expenditures, sometimes dramatically. The Blue Cross and Blue Shield Association upped its lobbying expenditures by a full million, to 2.8 million dollars in the second quarter; GlaxoSmithKline’s spending jumped from $1.8 million to $2.3 million; Novartis grew from $1.4 million to $1.8 million; and Metlife Group reported $1.7 million, up nearly 50 percent. Allstate, which spent less than $900,000 on lobbying through March, boosted its spending to more than $1.5 million from April to June.
Others simply kept up the pace, including Johnson & Johnson at $1.6 million and America’s Health Insurance Plans and Bayer Corp. both approaching $2 million in spending from April to June. The AMA has spent a total of $8.2 million on lobbying through June of this year.
Final aggregate numbers are likely a day or two away as reports continue to trickle in and get tallied by journalists and watchdog groups. But the data so far suggest that the second quarter has a good chance of reaching a new high for the health-care lobby. The industry already set records from January to March, when health-care firms and their lobbyists spent money at the rate of $1.4 million a day.
There were a few surprising examples of declines, however, most notably PhRMA, which reported spending about $700,000 less than it did in the first quarter. But consider that PhRMA spent $8.6 million in the first half of 2008 — just two thirds of what they’ve spent so far this year.
Click here to read the full report from the Washington Post.
FDA Approval of Antipsychotics for Children Mirrors Bayer, AMA Approvals of Heroin as Cough Medicine for Children
June 11, 2009
NaturalNews.com
by Mike Adams
(NaturalNews) Today an FDA advisory panel approved the prescribing of powerful mind-altering chemicals for children. Seroquel, Zyprexa and Goedon have now been approved by the advisory panel to be prescribed to children as young as 10 years old to treat a fictitious disease invented by psychiatrists and given the name “bipolar disorder.” (There is no such thing as a bipolar disorder disease. It is merely a name assigned to children demonstrating the predictable side effects of correctable dietary imbalances.)
In light of this disturbing decision, it is instructive to remember the history of pharmaceutical medicine and children. One hundred and ten years ago, Bayer marketed heroin to children as a non-addictive alternative to morphine. Did I say “non-addictive?” Yes, it’s right from the company’s own marketing materials. It just goes to show you that drug companies have been lying to the public (and poisoning the children) for well over one hundred years.
Much like the FDA’s present-day endorsement of antipsychotic drugs for children, the American Medical Association endorsed Bayer Heroin for kids, touting its ability to ease coughs. Heroin definitely eases coughs. And so does smoking meth! In offering this endorsement, the AMA apparently borrowed some of the FDA’s screwy logic, which claims “The benefits outweigh the risks.”
This means, of course, that the benefits to the drug companies outweigh the risks to the children!
During all this, of course, the AMA utterly failed to inform parents that heroin was a highly addictive narcotic drug. So parents were dosing their babies with heroin — all with the full approval of the American Medical Association!
Today, the FDA spearheads the promotion of drugs to children, doing its best to promote toxic synthetic chemicals that artificially alter brain chemistry while outlawing any mention of natural remedies that work much better (like omega-3 oils, which are natural brain chemistry stabilizers). The FDA also utterly fails to ban toxic chemical food ingredients known to destroy healthy brain chemistry (like MSG and artificial food coloring).
Thus, in one hundred and ten years, western medicine has learned nothing! It still poisons the children with the full approval of “health authorities” all while enriching the powerful drug companies.
Big Pharma’s ties to Nazi Germany
In remembering the endorsement by the AMA of heroin treatments for children, it’s helpful to consider a bit more of the history of Big Pharma:
The name Heroin comes from the German word heroisch, which means “heroic.” Take enough heroin, and you might feel heroic, too. (At least until the high is gone.)
Bayer, of course, is a German pharmaceutical company with all sorts of interesting ties to Nazi Germany and the medical experiments conducted on Jewish prisoners during World War II. In 1956, for example, Fritz ter Meer became the chairman of Bayer. What’s so interesting about that? This was after he served seven years in prison for carrying out experiments on Jewish prisoners at Auschwitz.
One minute you’re committing crimes against humanity, and the next minute you’re the Chairman of Bayer. Amazing, isn’t it? (Amazing how deep the criminal backgrounds go for these Big Pharma people, it seems…)
More recently, Bayer has been found contaminating the U.S. rice crop with genetically engineered rice seeds.
There’s a lot more you probably didn’t know about the true history of Big Pharma’s dangerous experiments on humans.
Pushing narcotics for children – the Big Pharma way!
Bayer eventually pulled its heroin from the market in 1910, by the way. In 1914, the U.S. Congress passed the Harrison Narcotics Tax Act, which allowed heroin to continue to be prescribed as a medicine. In wasn’t until 1924 that the U.S. Congress banned heroin sales outright.
Interestingly, 85 years later, narcotics are routinely prescribed to U.S. schoolchildren as “ADHD medications” (they are actually amphetamine drugs). And now, with the help of the FDA, drugs like Seroquel and Zyprexa can be legally prescribed to children by doctors.
And yet even that is just a hodge-podge of FDA theater, because in reality, doctors have been illegally prescribing these drugs to children for well over a decade, and not one doctor has ever been arrested or fined for engaging in this “off-label prescribing” of dangerous, mind-altering chemicals. In fact, the FDA’s decision today isn’t really about medical science at all: It’s about sweeping under the rug the routine crimes of America’s psychiatrists who have been poisoning children’s minds with dangerous drugs for years on end.
And rather than enforcing existing medical laws that forbid off-label prescribing of drugs, the FDA apparently finds it more convenient to simply legalize the criminal behavior of psychiatrists via a politically-motivated vote.
A hundred and ten years from now, this decision will be viewed with the same disbelief that we now evoke when looking back at the AMA’s endorsement of heroin cough syrup for children. Future citizens of our world will look back and ask themselves, “Were these people on drugs?”
And the answer, of course, is yes, the decision makers are all on drugs. They’re taking drugs, pushing drugs and profiting from drugs. And now they’re going after the children with those same drugs because there’s more profit to be found by expanding the age range of victims who can be targeted for financial exploitation by the pharmaceutical industry. Children are simply the next target on the corporate profits priority list.
Let’s be honest here: These are crimes against our children. And those FDA advisory panel members who voted to whitewash these crimes are, themselves, guilty of crimes against humanity (and should be arrested and tried accordingly).
The Nazis gassed Jewish children with Zyklon B. America now openly drugs its own children with Zyprexa.
Both chemicals, not coincidentally, were invented and manufactured by the same industry: The pharmaceutical industry.
Click here to read the full story and get all the links from NaturalNews.com.
