Archive for November, 2009

The War on Cheerios

November 13th, 2009 | No Comments | Source: Washington Post

As Washington watchers remain transfixed by the 3-ring circus masquerading as a health reform debate, several Obama appointees have stealthily begun to revitalize the nation’s vast regulatory bureaucracy which had been eviscerated by the Bush administration.

cheeriosThe FDA fired the first shot when it told General Mills it crossed a line with claims that Cheerios lowers cholesterol.

GM was, the FDA said, in effect claiming that Cheerios was a drug, and that it would have to submit clinical trials showing efficacy to the FDA before it could make such assertions.

GM eventually scrubbed the claim from its Web site.

zicamThe FDA subsequently went after dietary supplements containing “steroid-like” chemicals and advised consumers to stop using Zicam nasal products after consumers reported it caused them to lose their sense of smell.

The agency knew about both matters during the Bush administration, but didn’t act.

Meanwhile, the new chairman of the Consumer Product Safety Commission, Inez Moore Tenenbaum, has lobbied for a law to cut lead levels in children’s products and drafted new safety standards for ATVs.

And over at the Occupational Safety and Health Administration, acting head Jordan Barab wants to create rules that protect workers from repetitive-motion injuries, which cause 60% percent of all workplace injuries.

Longarmofthelaw“The law says that employers are responsible for workplace safety and health,” he told the Washington Post. “And there’s a new sheriff in town to enforce the law.”

Alas, many of these initiatives are not done deals.  Businesses will argue that they will stifle our nation’s economic recovery. 

Their “argument is going to be that this is going to hurt jobs,” said Michael Livermore, who directs the Institute for the Study of Regulation at NYY Law School.
“That has resonance on the Hill and within the public. That’s the one big challenge.”



Health Care M&A on the Rise

November 12th, 2009 | No Comments | Source: Wall Street Journal

One would think that the continuous tumult caused by Big O’s effort to overhaul health care would give deal makers pause for thought, or that the festering recession might dampen M & A activity in health care, as it has in other sectors of the economy.

itsajungleoutthereBut that’s not the case, not by a long shot.

In fact, health care M & A activity is more robust this year than it has ever been, according to Dealogic.

Driven by Pfizer’s mega-acquisition of Wyeth and Merck’s deal for the Plough, the health care sector has accounted for about 30% of all mergers and acquisitions in the US this year based on dollar value. That’s 3 times normal.

And that doesn’t even account for several tech sector deals, such as Dell Inc.’s acquisition of Perot Systems, which have a distinctly health care-oriented subtext, or the recent $4.2 billion LBO of health data mining company IMS Health.

Several things have driven the frenzy.

In the health information technology arena, the Big O’s Economic Hail Mary set aside $30 billion to encourage providers to adopt electronic health records and that has driven up the value of a raft of EHR companies, both public and private.

Meanwhile, Big Pharma has decided that acquiring new drugs is cheaper and less risky than growing their own.

For their part, lenders remain confident that health care is destined to grow, no matter what happens in Congress.

To be sure, the health reform debate has been lethal for M&A activity among providers and Big Insurers, 2 areas that had been hot beds of such activity in years past. And most small- and medium-sized life sciences and biotech companies are on life support, having proven largely unable to secure financing for their risky bets on future drugs.

Nevertheless, Dealogic reports there have been 707 deals in the sector so far this year, a bit higher than last year. Other perennially strong sectors like energy, tech and telecommunications have experienced substantial drops over the same period.

And in the food and beverage sector–which has been plagued by US consumers’ quirky new tendency to save money–deal volume is off 82% compared to a year ago.



Postponing Doctor Visits

November 11th, 2009 | No Comments | Source: HealthDay

The Great Economic Crisis may not make front-page news with the regularity it did a year ago, but it continues to have a pernicious effect on the health of Americans, according to a survey carried out by the American Optometric Association.

outofpocketThe nationally representative survey of 1,000 adults showed that recession-related financial problems have prompted 36% of US citizens to cut back on doctor visits.

Sixty-three percent of the survey respondents have foregone visits to the dentist, whereas 59% and 52% have done the same for primary care physicians and eye doctors, respectively. Only 8% claimed they hadn’t changed their routine health-maintenance schedules at all.

The poor economy has hit Hispanics disproportionately, according to the survey. Nearly half (49 percent) of them said they’ve cut back on doctor visits, whereas 36% of blacks and 33% of whites had done the same.

Nearly 2/3 of Hispanics had bagged one or more dental visits, and 53% said they had been to see an eye doctor less often.

Women (38%) were more likely than men (32%) to forego a visit.

In rural areas, nearly 2/3 of respondents said they had reduced eye doctor visits, whereas only half of urban and suburban respondents had done so.

The survey findings “are very worrisome,” said David Cockrell, an optometrist and a trustee with the Association. “We know that many eye and vision problems have no obvious signs or symptoms, so early diagnosis and treatment are critical. This is true beyond just eye care. Health issues of any kind are not things that Americans should ignore.”

“The longer patients go between doctor visits, the greater the opportunity for additional health problems that ultimately can be much more expensive than routine checkups and early-stage treatment,” he added.


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What to do about Meth Labs?

November 10th, 2009 | No Comments | Source: Wall Street Journal

A recent spike in illegal methamphetamine use and an associated proliferation of meth labs has prompted lawmakers to consider implementing a home-grown version of an Oregon law requiring that people who wish to purchase certain cold remedies must have a doctor’s prescription.

MethMakerMeth labs use pseudoephedrine—an ingredient in many cold elixirs—to make the highly addictive stimulant.

Federal laws enacted 4 years ago limit the amount of pseudoephedrine-containing compounds that a person can purchase per month and per store visit. They also require pharmacies to track and report such purchases and to keep the drugs behind counters or in locked cabinets.

These laws cut meth utilization for 2 years, but meth producers have learned to circumvent them by deploying groups of people to purchase their limit and pooling the stash. And the number of meth labs nationwide has jumped from 3,000 in 2007 to 3,600 in 2008, authorities claim.

The same year that the Federal law went into effect, Oregon passed one of its own requiring a doctor’s prescription for drugs containing pseudoephedrine. Since then, meth-related arrests have dropped 43% and meth labs have nearly vanished in the state.

Those results prompted two cities in Missouri, Washington and Union, to pass ordinances modeled after Oregon’s law.

“To me, [what Oregon did] is the answer,” Richard Stratman, Washington’s mayor told the Wall Street Journal. “If you can tie up the pseudoephedrine and make it difficult to obtain, you can get the job maybe not completely done, but you can put a pretty good dent in those labs.”

More recently, lawmakers in Missouri and California introduced similar legislation and nationally, Oregon Senator Ron Wyden is planning to do the same later this year.

Companies that produce the cold remedies aren’t too keen on the proposals. The laws would “put a great burden not only on consumers but on the health-care system as well,” said Andrew Fish, who is the general counsel for a trade group representing the drug makers.



H1N1 Vaccine Shortage Sparks Rumors of Foul Play

November 9th, 2009 | No Comments | Source: Washington Post

Amid growing public clamor for the H1N1 flu vaccine, the CDC’s top sheriff charged his posse to be on the lookout for instances in which people who don’t qualify for the woefully scarce resource are jumping the queue.

CDCbossmeansbusiness“Any vaccine distribution decisions that appear to direct vaccine to people outside the identified priority groups (can) undermine the credibility of the program,” Thomas Frieden warned state and local health departments in an email.

The call to action was prompted by reports that Wall Street bank employees and other well-heeled types were scoring the jab even as most of the 159 million people on the CDC’s priority groups couldn’t do the same.

Last Friday, some health officials denied that such transgressions had occurred. “Our system is designed to make the vaccine available to the priority groups established by CDC,” New York City’s health commissioner Thomas Farley told the Washington Post.

At the same time, the Wall Street bankers, who have truly endeared themselves to average citizens over the last year, were busy explaining they were providing the vaccines to qualified employees. 

The Feds own the entire H1N1 vaccine supply. They have contracted with McKesson to distribute the vaccines, as directed by city and state health departments, to 150,000 qualified providers including hospitals, clinics, physicians’ offices, pharmacies and the medical departments of corporations and schools.

CDC official Anne Schuchat said the rumors may have been sparked by legitimate deliveries to corporations, and that workplace medical departments are excellent venues to reach target groups like pregnant women and adults with chronic illnesses.

“When vaccine is shipped to an employer-based clinic, we expect it is being given to the target population,” she said.


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Study Clears Mercury-Containing H1N1 Vaccine

November 6th, 2009 | No Comments | Source: Pediatrics, PRNewswire

In a recent survey, only 67% of US citizens said they believed the H1N1 vaccine is safe, and only 22% claimed they were “very” confident it is safe. Among the respondents who said they were not confident in its safety, only 6% planned to take the spike.

what,meworry?One concern about the injectible H1N1 vaccine is that it contains thimerosol, a mercury-based preservative that is also found in the MMR vaccine. Many believe thimerosol causes autism, although there is no scientific evidence to support this belief.

With H1N1 spreading rapidly and scary (though still relatively rare) reports of fatal complications in previously healthy individuals stricken with the infection, officials know it is critical to prove, if possible, that the vaccine is safe.

A report in Pediatrics has provided some heartening news in this regard, at least as it relates to thimerosol.

In the report, Michael Pichichero and colleagues from the Rochester General Research Institute measured mercury levels in the blood of the smallest children — low birth weight neonates and prematurely born babies after they received a thimerosol-containing vaccine.

They found blood mercury levels in these patients to be exceedingly low.

“We found that blood mercury levels before vaccination were often detectable…at a level similar to many children after the vaccination,” Pichichero said in a press release. After the babies were given vaccines containing thimerosol, “their blood levels of mercury did rise to very low levels and then fell rapidly to baseline levels by day ten after the vaccination.”

Thimerosol has been largely removed from vaccines in the US since 2001, so the study of 72 newborn infants was conducted at a hospital in Argentina. Argentina and many other countries purchase vaccines through sources supported by the WHO, which has rejected the assertion that thimerosol is unsafe in vaccines.

“The H1N1 vaccine is safe and should be given to those at risk as recommended by the US Centers for Disease Control,” concluded Pichichero.



Stores Sell Calories on the Cheap

November 5th, 2009 | No Comments | Source: MedPageToday

Just days after a CDC report showed that schools across the nation had drastically reduced on-site sales of calorie-leaden snacks, a new study has revealed that kids have responded by trotting over to nearby convenience stores where they load up on goodies to their hearts’ content.

doritosAccording to Temple University’s Kelley Borradaile and colleagues, Philadelphia school children spend an average of $1.07 per day on snacks at such corner stores and get 357 calories for their money.

To reach these conclusions, Borradaile’s group surveyed 833 students from 10 urban elementary and middle schools during 2008.

Most of the students were black (54%) or Hispanic/Latino (23%).

More than half (53%) the students in the study reported visiting the convenience store every day. An additional 22% reported doing so 2-4 times per week.

fanta“For the most frequent shoppers, those who shopped both before and after school, five times per week, this would amount to about 712 calories per day, or 3,560 calories per week,” the researchers told MedPageToday.

About 30% of the purchased calories were derived from fat, 66% from carbohydrates and 23% from protein.

Chips were purchased most frequently, accounting for nearly 40% of all purchases. Candy came in second.

spriteAccording to Borradaile, simply switching from fried to baked chips could reduce the kids’ caloric intake by 14%, and drinking water rather than sugar-laced drinks could cut about 60 calories per store visit.

Alas, the war on childhood obesity is being fought in many theaters. Winning the war requires a concerted effort both inside the schools and out.

The write-up is in Pediatrics.



Schools Bag Snacks

November 4th, 2009 | No Comments | Source: Wall Street Journal

The CDC tells us that nearly 2/3 of American school children are overweight or obese.

And although the 20 year rise childhood obesity had begun to slow recently, the extended economic downturn seemed likely to force poorer folks to buy cheaper foods like soda and salty snacks, a phenomenon that threatened obliterate the recently favorable trend.

TheseDoritosareheavyBut thankfully, that may not be the case after all thanks to some positive steps taken in public school systems across the country.

According to a new CDC  report, US middle schools and high schools have begun a serious campaign to stop making available salty snacks and candy to their students.

The report compared results from 2006 and 2008 and was based on a survey of public schools in 34 states. According to the report, the percentage of secondary schools that offered calorie rich, nutrient poor snacks fell from 54% to 36% in that 2 year period.

Similarly, the percentage of schools selling artificially sweetened fruit drinks and regular soda dropped from 62% to 37%.

Schools in southern states were the biggest offenders in 2006 and made the biggest improvements during the survey period. In Mississippi for example, the proportion of schools selling soda dropped from 78% to 25%, and there was a similarly impressive reduction in sales of salty snacks and candy.

“Efforts to improve the school nutrition environment are working,” Howell Wechsler, director of CDC’s Division of Adolescent and School Health, told the Wall Street Journal.

Clyde Yancy, the President of the American Heart Association, hailed the news and credited tough legislation and policy changes at the local school-board level.

“What kids do in school in large measure dictates what they do away from school,” he said.



Obama and State Secrets

November 3rd, 2009 | No Comments | Source: Washington Post

The Obama administration has announced a new policy that makes it harder for the government to claim “state secrets”—a phrase we thought had become George W. Bush’s middle name—in an effort to hide shady national security tactics like rendition and warrantless wiretapping from the public. 

NotellingsecretsinmycourtThe new policy requires the CIA, FBI, NSA and the US military to convince the attorney general and a team of lawyers at Justice that the release of information regarding such tactics presents a significant risk to “national defense or foreign relations,” according to the Washington Post.

The legislation raises the standard for “state secrets” to instances when the release of material “would be reasonably likely to cause significant harm to the national defense or the diplomatic relations of the United States.”

Under Bush, a claim of “state secrets” required approval of a mid-level official using a much lower standard of proof that disclosure would harm national security.

Bush asserted “state secrets” dozens of times, according to legal scholars.

“What we’re trying to do is . . . improve public confidence that this privilege is invoked very rarely and only when it’s well supported,” a senior department official confided to the Post. “We’re not following a ‘just trust us’ approach.”

Gary Bass, executive director of OMB Watch, a nonprofit that promotes government transparency welcomed the change. It is “enormously consistent with open-government recommendations” that he and other advocates have made for years.

Last February, in anticipation of the policy shift, Justice began reviewing about a dozen cases in which “state secrets” had been invoked.

Surprisingly, it reversed course in just one instance—a bizarre case in which a former DEA operative has accused the CIA and the State Department of wiretapping his home.


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Is Autism Becoming More Prevalent?

November 2nd, 2009 | No Comments | Source: CNN, Pediatrics

A recent study in Pediatrics suggests that about 1% of US children have autism or a related disorder. That’s nearly 50% higher than previous estimates.

isthatamisprintTo determine the prevalence of the condition among US children aged 3 to 17 years, Michael Kogan and colleagues at the Health Resources and Services Administration and the CDC queried data from the 2007 National Survey of Children’s Health, which involved outbound calls to more than 78,000 parents.

In the Survey, parents were asked whether a health care provider had ever told them their child had autism, Asperger’s disorder, or pervasive developmental disorder, which are the 3 behavioral conditions that comprise Autism spectrum disorder, or ASD.

Parents who said yes were then asked whether their child had the condition at the time of the call.

The scientists found that 673,000 children had ASD, which equates to a prevalence just above 1%. The odds of having ASD were 4 times higher in boys than in girls. Non-Hispanic black and multiracial children had lower odds of ASD than white children.

Interestingly, parents reported that 40% of all children who were once labeled as having ASD did not currently have it, a finding that suggests over-diagnosis of the condition since there is no known cure.

The reported 1% prevalence is higher than that cited by the previous gold-standard study on the subject, which was published in 2003. It said the prevalence was 1 in 150.

But many urged caution about the apparent change in prevalence. “We don’t know whether the change over time is a result of the change in the actual condition or due to the fact that the condition is being recognized differently,” the CDC’s Ileana Arias told CNN.

The study raises “a lot of questions about how we are preparing in terms of housing, employment, social support — all the issues that many of these people are going to need,” added Tom Insel, who directs the National Institute of Mental Health.



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