http://www.wnd.com/?pageId=247833Former Alaska Gov. Sarah Palin last year created a nationwide furor when she predicted that Obamacare would lead to the creation of "death panels" that would decide who would receive life-saving treatments – or be allowed to die.
Now Obama's health policy team stealthily is moving forward with that idea, WND has learned.
And this development has nothing to do with proposed rules that would have called for doctors to have "end of life" discussions annually with senior citizens. Those plans were dropped from Obamacare because of public outrage, then slipped into administrative rules, then removed once more in just recent days when the public discovered what was going on.
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This new development involves Obama's political appointees at the powerful Food and Drug Administration, who appear to have started making life or death choices for Americans in 2010 using the cost of a therapy, apparently, as a primary criterion for acceptance or rejection, critics have told WND.
It was Sen. David Vitter, R-La., who said, "I shudder at the thought of a government panel assigning a value to a day of a person's life. It's sickening. I fear this is the beginning of a slippery slope leading to more and more rationing under the government takeover of health care."
"The FDA denies that cost had anything to do with the ultimate decision against approval," Greg Conko, a senior fellow who tracks the FDA at the Competitive Enterprise Institute, a free-market think tank in Washington, D.C., told WND.
"But many of us fear that FDA may in fact be slowly but covertly moving in that direction," he said.
According to statistics released by the FDA on its website, new drug approvals declined dramatically last year. Drugs with the potential to treat cancer and other maladies were not approved by Obama's regulators for mass marketing. FDA approved a mere 21 new drugs for sale in 2010, down from 25 in 2009.
"For a number of years, some public health activists – including Sidney Wolfe at Public Citizen's Health Research Group, former New England Journal of Health editor Marcia Angell and former Senator Tom Daschle," Conko said, "have been arguing that FDA should not approve new drugs that are very costly or that are no more effective that cheaper alternatives already on the market."
To be sure, the FDA disclaims that any big death panel operation is planned. FDA spokeswoman Sandy Walsh said there was "no change in how the FDA is approaching new drug approvals."
But it was just a few weeks ago, the Obama FDA announced it would seek to revoke the approval of Roche's cancer drug Avastin for use in breast cancer, saying the product didn't appear to help patients live longer at an affordable price.
The developer of the drug is appealing the move, which won't affect the use of Avastin in other kinds of cancer, and is claiming the cost of the drug is the motivating factor in the FDA's decision. Treatment for breast cancer using Avastin is estimated to be $70,000 per year.
The Obama FDA model seems to be countries that already are well advanced in the move into socialism.
"Many countries with socialized medicine, such as the U.K., France, Sweden, and Canada, won't pay for drugs unless they meet a rigid cost-effectiveness metric," said Conko. "The rationale is that, if government health programs (or even private insurers) are paying for medical care, they shouldn't have to pay for treatments that don't provide sufficient benefit for the price."
This clearly is a form of rationing of medical therapies, or, as former GOP vice presidential nominee Palin put it, "death panels."
There is nothing in the law which created the FDA, the Food, Drug and Cosmetic Act, which empowers the agency to object to drugs based on pricing data. The agency is supposed to eye pharmaceuticals for safety and efficacy; nothing more, experts said.
"The FDA does not [historically] approve or disapprove drugs based on cost," Roberta Tucker, a medical regulatory affairs expert, told WND. "They evaluate drugs based on risk/benefit (efficacy/safety). FDA does not set prices, companies set the price and if formularies think it is too high and there are other drugs available that are just as good, they don't put it on their hospital formulary or insurance company formularies."
But a company's intent and effort to develop new therapies cannot be unlinked from the government's authority to curtail their use, and therefore profitability.
In just the last months, the FDA also dramatically restricted the use of GlaxoSmithKline PLC's diabetes drug Avandia and removed painkillers Darvon and Darvocet from the market.
"The early Obamacare proposals would have instituted much stronger controls in Medicare and Medicaid, though the provisions were largely neutered in the final legislation," said Conko. "There's a way for them to come back in through the back door, which I think we need to keep an eye on."
Obama's FDA seems to have had no problem with drugs that are for quality-of-life enhancement, but which are unlikely ever to be life or death defining.
The new drug approvals from 2010 include:
Amgen Inc., which won approval for Prolia, a drug that is injected twice yearly to treat osteoporosis in postmenopausal women.
Roche Holding AG's biotechnology unit, Genentech, which won approval for Actemra, a drug that's administered intravenously to treat rheumatoid arthritis.
Those health policy activists who lean to the left long have advocated so-called "comparative effectiveness research" as the way to go for U.S. medical treatment, and have experimented on veterans with these delivery models. Under that idea, only drugs which are cost effective in the eyes of the bureaucrats are approved for use.
It's just one more way for the government to maintain control over treatments and expenses.
"If FDA ever does start considering cost-effectiveness in approval decisions, those treatments wouldn't even be available if patients were willing to spend their own money to pay for them," said Conko.
The so-called "death panels" highlighted by Palin in the original Obamacare comprehensive were removed because of the public outcry over their inclusion, but recently it was revealed that a revision of Medicare rules would call for doctors to have annual conversations about "end-of-life" planning with senior citizens.
It was Democratic Congressman Earl Bremenauer who issued a memo urging that supporters of the measure keep it a secret.
An administration official later said that the rule was being amended "to take voluntary advance care planning" out of the equation.
A commentary by Dan Calabrese at North Star Journal said the real problem is money spent on people during their last, and often, most health-troubled months of life.
"They (liberals) figure it would save a lot of money if we would just let them die," he wrote. "And the more thoroughly the government takes over health care, the more liberals want to see this because now it's costing the government money that could be wasted in places they would prefer to see it wasted.
"Sarah Palin, who is smart, warned that one of the dangers of government-run health care would be the prospect of senior citizens' having life or death decisions taken away from them and handed to government bureaucrats, who would care only about costs and not about the value of life," he continued.
He said Obama will "put it back in later when he thinks he can do so without anyone noticing."
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