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Fox News Analyst: Deadly Meningitis Outbreak Demonstrates Need For Less Government Regulation

Andrew Napolitano

On Fox News this afternoon, a conservative political analyst suggested the current outbreak of a rare strain of meningitis stemming from a Massachusetts-based compounding pharmacy’s contaminated steroid shots is the result of too much government regulation. Andrew Napolitano told host Neil Cavuto that the shots that exposed thousands of Americans to meningitis — and contributed to eight deaths — made it to the public market because insurance companies aren’t in charge of regulating drug production and distribution:

NAPOLITANO: It is well known that the state of Masachusetts is the most highly-regulated state in the union, with the government that is most in your face. It has a government that is physically present at the plants of the people and entities that they regulate…I don’t know if they have a person physically present in this facility, but they have the right to do so. So it is obvious that the state cannot keep its people — and others, when [the shots were] shipped outside the state — safe.

CAVUTO: So what’s the alternative?

NAPOLITANO: The alternative is to have insurance companies do the regulating because they would be on the hook.Hear me out. When someone is injured because the state drops the ball, the state can’t be sued. when someone is injured because an insurance company drops the ball, the insurance company can be sued. So you darn well believe that they are going to be certain that every batch of chemicals that is mixed in that facility is safe because if it is not, they are going to pay for it.

Watch it:

The root cause of the deadly meningitis outbreak was not too much regulation, it was too little.
The thousands of pharmacies across the country that practice compounding, a method of remixing medicines to cut down on prescription costs, are currently outside of the FDA’s regulatory power. If the FDA had the authority to oversee compounding pharmacies, the agency could ensure that compounded products — like the contaminated steroid shots that were produced in Massachusetts and shipped to over 20 states — adhered to the same safety guidelines they uphold for drug manufacturers’ products. But the pharmaceutical industry has resisted further regulation, even as health advocates have called for increased FDA oversight into a sector of the drug industry they say is ripe for a public health disaster.

Gains In HIV Treatment Remain Stratified By Race And Class

A new study published in the Archives of Internal Medicine journal yesterday finds significant variation in HIV death rates across racial and sociological lines. Although the death rate for Americans with higher levels of education has significantly declined since 1993, the death rate for those with less education — which the researchers used to extrapolate economic status — barely budged. Deaths among low-income black women did not decline at all during the same time period.

The study looked at the education levels of more than 90,000 adults between the ages of 25 to 64 who died from HIV infections between 1993 and 2007. Researchers were interested in determining whether new treatments for HIV, particularly the highly active antiretroviral therapies (HAART) medications that first became available in 1996, have helped reduce HIV death rates since their development. Although they found that overall death rates did drop across races after 1996 — African-Americans, who had the highest infection rates, saw the biggest drops — significant discrepancies emerged along socioeconomic lines:

Among black men with a college degree, HIV deaths for every 100,000 people in the population plummeted from 117 before HAART to 15 after those medications became available. For similarly educated white men, those numbers slid from 26 to two.

But when researchers looked just at men and women with less education — those who had gone no farther than high school — the numbers were alarming. Black women with no more than a high school diploma saw almost no change in death rates from HIV over 15 years of the study. From 1993 to 1995, about 30 black women for every 100,000 people in the general population died of AIDS. From 2005 to 2007, that number was about 27.

“This is very, very striking and probably one of the bellwether findings of the study,” says [Dr. Edgar P. Simard, a senior epidemiologist with the American Cancer Society].

The researchers pointed out that although HIV treatment is advancing, it isn’t reaching all racial or socioeconomic groups equally, and comparing death rates before and after the widespread availability of HAART drugs pinpoints those disparities. For example, the study found that less-educated black men died from HIV at a higher rate in the years after 1996 — once HAART drugs had been made available — than less-educated white men did in the early 1990s, even before advanced treatment had been developed.

Rates of HIV infection in cities across the country are disproportionately higher among low-income communities, which often lack public health resources. In the nation’s capital city, the infection rate for heterosexual African-American women in the city’s poorest neighborhoods nearly doubled over the past two years.

STUDY: Obamacare Reduces Costs For Small Businesses

One of the attacks leveled against Obamacare is that it will further hamper the already sluggish economy by imposing new costs on employers who want to hire. But a new study by the Urban Institute — modeling the effect of Obamacare’s various provisions on employer behavior had the law been in effect in 2012 — found the health care reform law would’ve only impose a modest increase of 2.2 percent on total employer spending. More strikingly, for small businesses of 100 employees or less, total spending would’ve actually decreased by 1.4 percent:

The drop in total spending for small firms was due to three factors. One, Obamacare exempts employers with 50 workers or less from penalties levied for not providing mandated coverage. Two, it provides a tax credit for two years to employers with 25 workers or less — and an average pay of $50,000 or less — in order to help with the costs of premiums. Third, Obamacare’s exchanges are expected to lower costs by providing a centralized marketplace in which both firms and individuals can comparative shop. On net, these factors completely overwhelm the new costs imposed on smaller businesses from Obamacare’s new coverage requirements.

Because larger businesses will still be subject to the new coverage requirements, but won’t enjoy the tax credits or the exemption for the smallest firms, their total spending increases under the model. For businesses of 101 to 1,000 employees, overall spending would increase 9.5 percent, mainly due to expanded enrollment. For businesses over 1,000 employees, the increase would be 4.3 percent. In both cases, those increases fall on larger firms more capable of absorbing the costs.

The findings from The Urban Institute’s model are also in line with real world results from the health care reform that was passed in Massachusetts. Like Obamacare, that reform imposed new requirements on businesses to cover their employees along with penalties for the firms that failed to comply. As a result, the percentage of small businesses offering coverage to their employees jumped from 70 percent to 77 percent, and employers saw their costs rise 9 percent between 2009 and 2010. At the same time, no evidence of reduced employment could be found.

Pepsi And Coke Will Post Calories On Vending Machines

The American Beverage Association is launching a new pilot effort called Calories Count to update PepsiCo and Coca-Cola vending machines to include lower-calorie drink options, as well as display the calorie counts for the available drinks. The new vending machines will appear in municipal buildings in Chicago and San Antonio early next year — as part of a broader wellness challenge between the two cities that will attempt to lower health care costs by encouraging municipal employees to set goals to improve their health — with the potential to expand the program to other cities in the future.

The beverage industry has become a central figure in the public health battle to combat obesity, as research has linked the consumption of sugary drinks to obesity and lawmakers like New York City Mayor Michael Bloomberg (I) have moved to ban large sizes of soda. But as the New York Times reports, soda critics are cautiously optimistic that the Calories Count initiative could help encourage Americans to choose lower calorie options:

“People tend to overconsume products with sugar and for these companies to be doing something that may decrease consumption of their sugared beverages surprises me,” said Kelly D. Brownell, director of the Rudd Center for Food Policy and Obesity at Yale University. “But it does seem to me to be a positive move.”

Sales of carbonated sodas have been declining for the last decade, as American consumers have embraced new choices of beverages and, more recently, become more aware of how much sugar they contain. Coke and Pepsi have greatly expanded their portfolios, adding bottled waters, juices and sports drinks that have helped reduce their reliance on their core brands, though they still defend them.

In a note Monday morning, John Sicher, the publisher of Beverage Digest, an influential trade publication, said he thought the new effort might be a way to get consumers to drink more of their low-calorie and no-calorie drinks.

The health care reform law will eventually require all chain restaurants — defined as those with more than 20 locations — to disclose calorie counts on their menus. Although that regulation has not yet gone into effect, PepsiCo and Coca-Cola are not the only companies to get a jump start on publicly posting calories for their products. Last month, fast food giant McDonald’s added calorie labels to its menus. One Harvard study estimated that the average American child consumes about 270 calories from sugary drinks each day.

Restricted Access To Death Records Hinders Essential Health Studies

In an effort to curb identity theft and preserve private information, the Social Security Administration (SSA) instituted new rules to limit access to death records in November, interpreting a 1983 law to mean that the Administration cannot divulge certain state records to the public. But the changes have made it significantly more difficult for public health officials to update their data on research topics ranging from transplant availability rates to cancer prevention research.

According to the New York Times, the new policy hampers the researchers who need to access public health data and don’t have many good alternatives — such as the federal agency that determines whether or not certain transplant programs are effective enough to merit federal funding, which is no longer receiving its data on time due to the added burden of verifying a patient’s death:

“It’s very critical that we have an objective way to measure deaths,” Dr. Schold said. “Otherwise we’re getting the data from the centers we’re measuring, and that’s problematic” because they cannot track all former patients until death.

Gary Chase, the senior project manager of the Nurses’ Health Study, a 36-year Harvard examination of cancer prevalence among more than 200,000 women, said the new policy had “thrown us back to the pre-Internet era, where you’d start looking in the phone book for someone with a similar name and sending out a bunch of letters.”

Greta Lee Splansky, the director of operations for the Framingham Heart Study, which is based at Boston University, said the withheld records meant “the loss of a very valuable tool.”

Over six decades, the study has examined the causes and effects of heart disease in three generations of subjects who were originally from the same town in Massachusetts. Many are dying off. “It just slows us down,” Ms. Splansky said. “It’s wasting research dollars.”

The SSA, however, says that its officials’ hands are tied. Mark Hinkle, a spokesperson for the SSA, told the New York Times that researchers will have to collect data from the states while the SSA follows the law to the best of its program’s ability. The conflict demonstrates that even in an era of electronic records, information-sharing policy has not quite caught up with massive technological advances.

“We are not going to be on time until this problem is corrected,” said Dr. Bertram L. Kasiske, a Minneapolis nephrologist who directs the Scientific Registry of Transplant Recipients research group. “It’s a big deal. A lot of people look for these reports and depend on them.”

Deadly Meningitis Outbreak Highlights The Need For Strengthened FDA Regulations

Potentially contaminated steroid injections that led to meningitis infections

On Monday, U.S. health officials warned that up to 13,000 Americans across 23 states could have been exposed to a strain of fungal meningitis that has been traced to contaminated steroid shots produced by a Massachusetts-based compounding pharmacy. The outbreak of meningitis — which causes a potentially fatal inflammation of the brain or central nervous system — has already resulted in over 100 cases and eight deaths.

Although more than half of the estimated 56,000 U.S. pharmacies across the country practice compounding — repackaging or recombining medications on a large scale, in an attempt to keep down the costs of filling prescriptions — the FDA cannot oversee this sector of the pharmaceutical industry. The FDA has authority over drug manufacturers, not pharmacies, so drugs that are compounded at pharmacies do not currently have to meet the agency’s guidelines to ensure they are safe or effective.

In order to mitigate potential public health risks stemming from compounded drugs, Democratic lawmakers and health advocates are calling on Congress to strengthen FDA’s regulatory oversight in the area:

“These compounding pharmacies are operating now on a scale where (regulation) should be a priority,” said Senator Richard Blumenthal, a member of the Senate Health, Education, Labor and Pensions Committee, who is urging hearings and an investigation in prelude to new legislation.

His concerns were echoed by U.S. Representative Edward Markey, another Democrat who sent a letter to the FDA asking whether agency rules ensure that compounded drugs meet the same safety standards as the products of major drug manufacturers. [...]

Disease outbreaks have been traced to compounding pharmacies repeatedly in the last decade, including other cases of meningitis and hepatitis C infections.

“If regulation doesn’t set a standard that seeks to prevent this, we can expect these outbreaks to keep happening,” said Dr. John Santa, director of the Health Ratings Center at the Consumers Union advocacy group.

Seventy five health facilities received the potentially contaminated steroid injections from the New England Compounding Center between July and September. The Massachusetts-area compounding pharmacy voluntarily recalled all of its products over the weekend following the FDA’s recommendations.

And the larger clash between the pharmaceutical industry’s interests and the FDA’s public health regulations could eventually make its way to the Supreme Court. Although repeated legal challenges have attempted to slowly chip away at the FDA’s authority over pharmacies practicing compounding, an appellate court in New Orleans sided with the FDA in 2008. But if a current case against the FDA that is set to be decided in Florida goes the other way, the Supreme Court could step in to arbitrate.

Former Republican Health Official: Romney’s Plan Won’t Cover The Uninsured

Republican presidential nominee Mitt Romney says that his national health care reform plan would offer coverage to uninsured Americans, emphatically repeating his claim during last week’s presidential debate. But a growing number of Romney surrogates and Republican health care economists are disputing Romney’s assertions.

Romney has committed to preventing insurance companies from discriminating against those who already have continuous coverage, such as the Americans who had employer-based health insurance before abruptly losing their jobs. As health economist and longtime GOP adviser Gail Wilensky admits in the Washington Post, Romney’s plan would barely make a dent in the nation’s uninsured population, not to mention leave out the millions of Americans who have not been continuously insured:

[Romney's] campaign has not spelled out details other than it would help people who have maintained continuous coverage. That involves making incremental changes to insurance laws and regulations, and may or may not whittle down the number of uninsured.

“It will solve some of the problems,” said health economist Gail Wilensky, a longtime adviser to Republicans. “It won’t solve the problem of people having gone for a long time without health insurance.”

By contrast, Obamacare prevents insurance companies from discriminating against all Americans with pre-existing conditions, regardless of whether or not they have been continuously covered. As individual insurance market expert Karen Pollitz explains, “The ACA just says insurance companies can’t discriminate against you, period. If you’ve been uninsured, you can come into this market on Jan. 1, 2014, no questions asked.” Combined with Obamacare’s proposed expansion of the Medicaid program, President Obama’s health care reform law could help insure up to 32 million Americans who currently lack health insurance — while an estimated 72 million will continue to go without health insurance under Romney’s plan.

Wilensky headed the Centers for Medicare & Medicaid Services under President George H. W. Bush.

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