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Sunday, December 19, 2010

“FDA panel deliberates the health effects of mercury in dental fillings - USA Today” plus 1 more

“FDA panel deliberates the health effects of mercury in dental fillings - USA Today” plus 1 more


FDA panel deliberates the health effects of mercury in dental fillings - USA Today

Posted: 18 Dec 2010 08:34 PM PST

By Lee Howard

WATERFORD, Conn. — Amanda Just of Waterford has finally been able to speak directly to federal regulators looking into the health effects of mercury in dental fillings.

Just, who claims to have been made ill by mercury released during a botched dental procedure several years ago, had four minutes before a U.S. Food and Drug Administration panel this week in Gaithersburg, Md.

The panel, convened by the U.S. Food and Drug Administration to look into the safety of amalgam dental fillings containing mercury, advised the agency Wednesday to reevaluate the use of the material in children and pregnant women.

At the end of two days of hearings in Gaithersburg, Md., the advisory panel said new data brought to light Tuesday and Wednesday shows that some dental patients may experience medical problems related to amalgam, a mix of metals that generally contains about 50% mercury. Anti-mercury advocates say amalgam can lead to a variety of neurological disorders, such as Alzheimer's, Parkinson's, multiple sclerosis and Lou Gehrig's disease and may be a factor in a rise of kidney and periodontal disease.

"We need to see where the science is and if there are gaps," said panel Chairwoman Marjorie Jeffcoat, a University of Pennsylvania researcher and dental authority quoted by CNN.

Bob Reeves, a Lexington, Ky., attorney who has been fighting against amalgam for nearly 30 years, said the panel's findings, if accepted by the FDA, would likely require the agency to re-categorize amalgam as a Category 3 material, which is for substances considered most dangerous to human health. Category 3 requires manufacturers to prove amalgam is safe, which Reeves said would effectively end its use as a filling material.

"This was a big carving away of the myth of safety of mercury in fillings for all people," Reeves said in a phone interview immediately after the panel's consensus decision. "That myth was destroyed."

Just, an East Lyme Middle School teacher, said she was thrilled to have been part of the decision-making process.

"This is historic," she said in a phone interview after the panel's decision.

Just said she saw testifying as her responsibility to her students and children throughout America.

"Why is this poisonous element being drilled into the mouths of pregnant women and children?" she asked the FDA panel during her four-minute presentation. "I'm certain that any loving and caring teacher would protect children from exposure to mercury vapor ... and so would a government that cares about the future of its country."

The FDA ruled 18 months ago that amalgam was safe for children and women of childbearing age. But public pressure brought by citizens such as Just and organizations such as the International Academy of Oral Medicine and Toxicology led the FDA to convene a panel to re-examine the issue.

The FDA, which has about six months to respond to the panel's findings, does not have to accept its recommendations.

Reeves, the Kentucky attorney who has filed suits in the past to press the case against amalgam, called the panel "amazingly fair-handed," and predicted that the FDA would not be able to ignore this group, as it did a previous advisory body in 2006, partly because the mercury issue is getting so much more media attention this time around.

Still, Reeves said he was surprised at how quickly the panel moved to agree that subpopulations such as pregnant women, mercury-sensitive adults and children up to the age of 12 should receive special consideration in deciding whether amalgam is safe.

Dentists who testified before the FDA panel said they believe amalgam was safe. The panel said the FDA's decision to approve amalgam last year — after a short period when the agency temporarily recommended against its use in pregnant women and young children — had been based on the best information available at the time.

The FDA panel could not decide on one of the key issues before it: What level of exposure to the mercury vapors emitted by amalgam fillings would be considered safe for humans? The panel decided that not enough data existed to make a determination.

"This morning was highly, highly charged," said Just, the Waterford schoolteacher, who protested outside her hotel Tuesday wearing a hazardous-materials suit.

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Information from: The Day of New London, http://www.theday.com/

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Is Health Care Inflation Inevitable? What Are the Consequences? - Huffingtonpost.com

Posted: 17 Dec 2010 07:42 AM PST

Delivering the 2009 commencement address to the University of Chicago Medical School, Dr. Atul Gawande said:

Our country's health care is by far the most expensive in the world. It now consumes more than one of every six dollars we earn. The financial burden has damaged the global competitiveness of American businesses and bankrupted millions of families, even those with insurance. It's also devouring our government at every level -- squeezing out investments in education, our infrastructure, energy development, our future.

Lecturing the Stanford School of Medicine graduation in June of this year, Dr. Gawande said, "By the end of the decade, at the present rate of cost growth, the price of a family insurance plan will rise to $27,000. Health care will go from ten per cent to seventeen per cent of labor costs for business, and workers' wages will have to fall. State budgets will have to double to maintain current health programs."

Also in June of this year, the Commonwealth Fund, a foundation that focuses on health care, issued a report relating American health care to economically comparable countries:

Americans spend twice as much as residents of other developed countries on healthcare, but get lower quality, less efficiency and have the least equitable system. . . . The United States ranked last when compared to six other countries -- Britain, Canada, Germany, Netherlands, Australia and New Zealand, the Commonwealth Fund report found. "As an American it just bothers me that with all of our know-how, all of our wealth, that we are not assuring that people who need healthcare can get it," Commonwealth Fund president Karen Davis told reporters.

In September of this year, Hewitt Associates projected that 2011 will see the greatest rise in health care costs for businesses and employees in the last five years:

The average total health care premium per employee for large companies will be $9,800 in 2011, up from $9,000 in 2010... Average employee out-of-pocket costs, such as copayments, coinsurance and deductibles, are expected to be $2,200 in 2011 -- a 12.5 percent increase from 2010 ($1,900). These projections mean that in a decade, total health care premiums will have more than doubled, from $4,100 in 2001 to $9,800 in 2011. Employees' share of medical costs -- including employee contributions and out-of-pocket costs -- will have more than tripled, from $1,200 in 2001 to $4,400 in 2011. [figures rounded to nearest hundred]

How's our health doing?

In October of this year, two researchers at the Columbia University School of Public Health published their finding that "fifteen-year survival rates for forty-five-year-old U.S. white women were lower than in twelve comparison countries with populations of at least seven million and per capita gross domestic product (GDP) of at least 60 percent of US per capita GDP." [White women have the highest life expectancy (81) among Americans compared with black women (77), white men (76) and black men (70).]

The American health care system is not equitable --- who you are determines your access to health care -- even how long you live. American health care is not effective -- even those in relatively privileged social groups fare poorly in international comparisons. American health care is not cost effective -- our expenditures are enormous to produce such poor outcomes. American health care costs are uncontrollable -- they are accelerating even as we claim to be taking steps to restrain them.

Americans and their representatives don't understand (a) how our health care costs and performance compare to the rest of the world - although they are certainly aware that their personal medical bills are rising, (b) how the growing proportion of our GDP that medical costs comprise drains the American economy and weighs us down competitively worldwide, (c) what causes our health care system to be so costly and ineffective. The consequences of this ignorance are that -- even with health care reform -- we haven't addressed these things, don't know we need to, don't know how to, don't foresee the disaster for our health and our economy that our albatross of a system is.

The most popular cable news commentators regularly announce confidently that the United States has, "by far," the best health care system in the world, while Republicans are working -- successfully (including via court challenges of its Constitutionality) -- to make sure that any halting efforts to modify the health care system represented by the Obama health legislation are immediately and permanently sabotaged.

Bon santé!

 

 

 

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