Friday, March 30, 2012

With the fate of Obamacare in the hands of the Supreme Court, healthcare reform will continue regardless of its decision as alternatives are already being discussed (unfortunately no one appears to be discussing insurance reform).

ACA Alternatives Waiting in the Wings


WASHINGTON -- As the fate of the Affordable Care Act (ACA) is debated privately by Supreme Court justices over the upcoming weeks, bills containing "Obamacare" alternatives are waiting and ready in Congress, regardless of what the Supreme Court decides.

Following 3 days of oral arguments on Obama's healthcare reform law, legal and healthcare policy experts are combing through the court transcripts and looking for clues as to how the court will rule. Many say the pointed and at times surprising questioning from the justices indicates a deep skepticism of the law, while others say oral arguments are not indicative of how individual justices will ultimately rule.

Whether the law is overturned or upheld, or pieces of it are stripped away, several members of Congress have their healthcare reform alternatives ready to go.

On Thursday, the House approved a budget proposal from Rep. Paul Ryan (R-Wis.), which would eliminate Obama's healthcare reform law and structure Medicare in a manner similar to Medicare Advantage plans. Medicare beneficiaries could choose between traditional fee-for-service Medicare and several private insurance plans once they become eligible for coverage.

Once a beneficiary chooses a plan, the government would send that plan a "premium support" payment in an amount that would cover a basic health insurance plan. Beneficiaries who wanted a more generous plan would pay the difference.

The Ryan budget proposal is almost certain to be defeated in the Democratic-controlled Senate.
Rep. Paul Broun, MD (R-Ga.), has a proposal he's calling the Patient OPTION bill, which would repeal the ACA and transform Medicare from what he calls "socialized medicine" into a premium support system, which people would have a choice of opting out of.

The bill would also make healthcare expenditures -- including health insurance -- fully tax deductible, and it would create tax incentives for physicians who provide free care to needy patients.

"Americans have loudly voiced that they want a do-over on Obamacare," Broun wrote in an opinion column published in the Washington Times. "My OPTION Act is just that, providing access to the affordable care that so many people need, while adhering to the Constitution and strengthening the free market. It completely removes government from the doctor-patient relationship. It is also the only bill to give the patient full control of their coverage -- even if they are on Medicare."

Senate Majority Leader Mitch McConnell (R-Ky.) -- who was in the Supreme Court for Tuesday's oral arguments on the individual mandate -- took to the Senate floor later in the week and reiterated that Republicans fully plan to repeal and replace the law. He didn't mention that the Supreme Court might decide to repeal the whole law.

"It should be replaced with common-sense reforms that lower costs and that Americans actually want -- reforms that protect jobs and state budgets, reduce the deficit, reform entitlements, and strengthen Medicare, " McConnell said.

While Republicans are crafting limited-government alternatives to the Affordable Care Act (ACA), some on the other side of the political spectrum are trumpeting a single-payer, government-run system as the preferred alternative to the ACA.

Early in the healthcare reform debate, many Democrats wanted a government-run plan -- referred to as the "public option" -- included in the ACA. A House committee even passed a version of the ACA that contained a Medicare-for-all type plan. However, the public option wasn't politically popular with some Democrats, and it was wildly unpopular among Republicans, so that provision was eventually removed.

What passed instead was a healthcare system that continues to rely on the private insurance industry as well as public insurance programs -- like Medicare and Medicaid -- in their current forms.

The irony is that while the public option wasn't popular enough to pass, no one disputes the Supreme Court wouldn't be considering the case if a single-payer plan had passed, because expanding Medicare and taxing everyone more would have been well within the powers of Congress.

Rep. Dennis Kucinich (D-Ohio), a single-payer advocate, is calling for a Medicare-for-all system regardless of how the Supreme Court votes in June.

"Whether the Supreme Court upholds the law or strikes it down, single-payer is the only alternative that can meet our nation's needs," Kucinich said in a press release.

Kucinich's bill, titled "Medicare for All," would "cover everyone in the U.S. for all medically necessary services with no copayments, premiums, or deductibles, for the same amount we currently pay for healthcare."

Saturday, March 24, 2012

With the FDA now looking at stopping the addition of antibiotics to meat following a recent story about how your local grocery store is now considering to stop adding "pink slime" to it's ground beef offerings, maybe we'll reach a point where meat will be safe to eat. Still, the over-processing of foods with additives and preservatives, along with unlabeled ingredients, will continue until the consumer demands it be stopped.

FDA Told to Move on Antibiotic Use in Livestock




A federal judge in New York City has ordered the FDA to start proceedings to revoke approvals for the use of antibiotics in livestock, a practice blamed for the spread of antibiotic-resistant "superbug" bacteria.

In a case brought by five environmental and consumer advocacy groups, Judge Theodore Katz of the Southern District of New York ruled that the FDA had violated its own regulations when, in 1977, it identified risks to human health from widespread antibiotic treatment of livestock but then failed for nearly 35 years to take action.

The lead plaintiff, the Natural Resources Defense Council (NRDC), applauded the ruling. "Today, we take a long overdue step toward ensuring that we preserve these life-saving medicines for those who need them most – people," said the group's health attorney, Avinash Kar, in a statement.

In 1977, the FDA officially concluded that low doses of penicillin and tetracycline antibiotics -- commonly used to promote weight gain in chickens, hogs, and other livestock, rather than to treat infections -- may foster emergence of antibiotic-resistant bacterial strains.

The agency issued notices at that time that it intended to withdraw approvals of the agents for this purpose. But, said Judge Katz in an opinion released late Thursday, "[a]lthough the notices were properly promulgated and over twenty drug sponsors requested hearings on the matter, the FDA never held hearings or took any further action on the proposed withdrawals."

He also noted the evidence that widespread antibiotic dosing in farm animals was creating a threat to human health that had only increased in the intervening years, "and there is no evidence that the FDA has changed its position that such uses are not shown to be safe."

Environmental groups filed so-called citizen petitions with the FDA seeking to spur action, but the agency did not respond.

Last May, the NRDC and four other groups (Public Citizen, the Union of Concerned Scientists, the Center for Science in the Public Interest, and Food Animal Concerns Trust) filed the suit in federal court in another attempt to force the FDA's hand.

In response, the FDA formally withdrew the 1977 notices and argued to the court that the suit was now moot.

Katz rejected that argument and directed the agency to begin the proceedings specified in the notices.

"Specifically, the Commissioner of the FDA or the Director of the CVM [the FDA's Center for Veterinary Medicine] must reissue a notice of the proposed withdrawals (which may be updated) and provide an opportunity for a hearing to the relevant drug sponsors; if drug sponsors timely request hearings and raise a genuine and substantial issue of fact, the FDA must hold a public evidentiary hearing. If, at the hearing, the drug sponsors fail to show that use of the drugs is safe, the Commissioner must issue a withdrawal order," according to Katz's ruling.

The judge stressed that he was not ordering the FDA to actually withdraw the approvals at this time.
"If the drug sponsors demonstrate that the subtherapeutic use of penicillin and/or tetracyclines is safe, then the Commissioner cannot withdraw approval," he wrote.

The FDA was planning to issue nonbinding guidance next week calling on the livestock industry to use antibiotics in livestock only to treat infections.

Prophylactic use of cephalosporins in animals was already formally barred in an order scheduled to take effect in April.

Tuesday, March 20, 2012

New study indicates that antioxidants may be of no help in treating Alzheimer's Disease. But the study may be flawed and misleading while comments about the study indicate some of the study faults. As the study results reach the mainstream media, readers would be well advised not to jump on its bandwagon as further research is certainly needed.


Antioxidants Appear No Help for Alzheimer's


The combination of vitamin E, vitamin C, and alpha-lipoic acid did not lower levels of the amyloid and tau proteins that make up the plaques and tangles seen in the brain with Alzheimer's disease, Douglas R. Galasko, MD, of the University of California San Diego, and colleagues found.

The combination did reduce CSF levels of the oxidative stress biomarker F2-isoprostane by 19% but raised a safety concern with faster decline in cognitive scores, they reported online in the Archives of Neurology.

The popular antioxidant coenzyme Q (CoQ) had no significant impact on any CSF measures in the Alzheimer's Disease Cooperative Study antioxidant biomarker trial.

Oxidative damage is widespread in the brain in Alzheimer's disease and contributes to neuronal damage, Galasko's group explained.

Some prior observational evidence has pointed to lower Alzheimer's risk with an antioxidant-rich diet, although prevention trials with supplements have had mixed results, they noted.

Their study included 78 adults with mild to moderate Alzheimer's randomly assigned to double-blind treatment over 16 weeks with the combination of 800 IU vitamin E, 500 mg vitamin C, and 900 mg of alpha-lipoic acid once a day; CoQ alone at a dose of 400 mg three times a day; or placebo.

Vitamins C and E act as antioxidants by controlling dangerous free radicals produced when oxygen reacts with certain molecules, while alpha-lipoic acid spurs production of many antioxidant enzymes in the body. CoQ is an antioxidant that helps protect mitochondria from oxidation.

Serial CSF specimens collected from 66 of the participants showed only small changes from baseline.

Beta-amyloid 42, which accumulates to forms plaques in the Alzheimer's brain, declined by 8 pg/mL from a baseline of 190 pg/mL with the antioxidant combination and by 15 pg/mL from a baseline of 185 in the CoQ group, but neither was a significant difference from placebo.

Tau protein, which forms neurofibrillary tangles in the brain with Alzheimer's, fell by 23 pg/mL with the antioxidant combination from a baseline of 123 and by 9 pg/mL from a baseline of 109 in the CoQ group, but again neither differed from changes with placebo.

Levels of tau phosphorylated at a specific site (P-tau181) likewise declined slightly over the study period for the two antioxidant groups but without a significant difference from placebo.

The one significant change was in CSF levels of the oxidative marker F2-isoprostane, which is stable oxidized arachidonic acid.

The vitamin C and E plus alpha-lipoic acid group saw a 7 pg/mL reduction in F2-isoprostane from a baseline of 38 over the 16 weeks of treatment (P=0.04). The other groups showed no change.

"It is unclear whether the relatively small reduction in CSF F2-isoprostane level seen in this study may lead to clinical benefits in Alzheimer disease," the group cautioned.

Cognition, measured with the Mini-Mental State Examination, didn't improve in any of the groups. In fact, the decline in scores appeared accelerated in the antioxidant combination group, with a change of -4.6 points over the 16 weeks compared with -2.3 to -2.4 in the other two groups.

The researchers highlighted that as a potential safety concern that needs further careful assessment if longer-term trials are considered. The antioxidants were otherwise well tolerated.

Function, as measured on the Alzheimer's Disease Cooperative Study Activities of Daily Living Scale, didn't change in any group.

The study was supported by a National Institute on Aging grant.

The researchers reported having no conflicts of interest regarding the study; the specific antioxidants studied or the company that makes them, Vitaline, which supplied both study drugs and placebo; or the CSF assays that were measured.

Galasko reported serving as editor of Alzheimer's Disease Research and Treatment, serving on data safety monitoring boards for Elan and Janssen, being an investigator in clinical trials sponsored by Eli Lilly and Avid, and receiving research support from National Institutes of Health grants.

Primary source: Archives of Neurology
Source reference:
Galasko D, et al "Antioxidants for Alzheimer disease: a randomized clinical trial with cerebrospinal fluid biomarker measures" Arch Neurol 2012; DOI:10.1001/archneurol.2012.85.

Comments:
Colenso
Big pharma, little pharma - it makes no difference. Wellness is not to be found in a bottle..

Robert Haile MD
During an acute MI a statin would be of little benefit at all although statins have shown clear primary prevention benefit. Only long term preventative research on antioxidants would be useful to predict if antioxidants would be of benefit in preventing Alzheimer's disease. At this time no prevention use of antioxidants can be made..

Nicholas Pokoluk
The choice of supplement is important to this discussion. To say "antioxidants" is unfair as these antioxidants do not encompass the totality of antioxidants. All antioxidants are not created equal and have different mechanisms of action. Plus antioxidants that also have anti-inflammatory action such as those of curcumin, grape seed extract and EGCG work in totally different ways and have shown to be good candidates for affecting Alzheimer's. This is a dangerous article and can have a very deleterious affect on the public perspective on antioxidants be they in the form of supplements or from natural sources such as vegetables, berries and other botanical sources. This is what is wrong with the reporting of scientific with such bold and disingenuous headlines!.

Ian Biner
What forms of the anti-oxidants were used? This is especially important in the case of alpha lipoic acid and coq10. If the trial was conducted with synthetic ALA, then then entire study is worthless. Similarly, if the study was conducted with ubiquinone, then the 25% of the population who lack the gene SNP to convert it to ubiquinol would have skewed the test results. Given the relative costs of synthetic v natural and ubiquinone v ubiquinol, I would put money on the cheaper supplements being used. I also agree with Jim Brockman's comments re Vitamins E and C. The dose was too low, and if the form of the E was the synthetic, or if the form was the common alpha tocopherol, then once again, the study is worthless..

Jim Brockman
The doses of Vitamin C and Vitamin E used in the study are far too low to give us useful data in regards to their efficacy here especially when compared to the doses of alpha-lipoic acid and Coenzyme Q10. Score another one for the propaganda machine of big pharma I guess. The form of Vitamin E also makes a difference in regards to it's effectiveness as well. Was the typical synthetic alpha-tocopherol version used in this study?.

Thursday, March 15, 2012

It appears that a TENS unit, a small electronic device that many doctors prescribe to help patients block low back pain throughout the day, will no longer be covered by Medicare due to conflicting efficacy reports. Is this the Federal government saving money at the patient's expense?

Medicare Says 'No' to TENS for Low Back Pain


Medicare is set to withdraw most coverage of transcutaneous electrical nerve stimulation (TENS) for chronic low back pain, the Centers for Medicare and Medicaid Services indicated Tuesday.

Reimbursements for this indication would be available only when patients are participating in a randomized, controlled trial of the technology's clinical effectiveness, according to a proposed decision memo from CMS.

Currently, Medicare pays for FDA-approved TENS equipment and supplies when prescribed by a physician for chronic intractable pain, and reimburses physicians and physical therapists for evaluating patients' suitability for the treatment, which is typically used at home.

CMS decided on its own to review its coverage of TENS for chronic low back pain in the wake of a 2010 report by an American Academy of Neurology panel that found the treatment was not effective.

The panel had conducted a systematic review of published studies of TENS. "The review concluded that there was conflicting evidence for the use of TENS in the treatment of chronic low back pain and that TENS should be deemed ineffective for this purpose," the CMS memo said.

CMS also cited a series of other reviews that failed to find clear support for the technology's efficacy. On the other hand, some individual studies had shown that it can reduce pain and improve patients' physical function.

The memo also noted that the National Institute of Neurological Disorders and Stroke has listed TENS as a "possible treatment option" for lower back pain that has not responded to conventional therapies.

But in the absence of consistent evidence of TENS's efficacy in this indication, CMS plans to withhold coverage except in the context of randomized trials.

Patients in such trials must have been suffering for low back pain for at least three months, with the pain not resulting from conditions such as inflammatory autoimmune disease or metastatic spinal tumors. The trials must also directly address TENS's clinical efficacy and be designed and powered to yield clear-cut answers. Listing on the Clinicaltrials.gov website is mandatory.

CMS emphasized that Medicare will continue to reimburse for TENS when prescribed for chronic, treatment-refractory pain indications other than low back pain, such as for patients with chronic or severe post-operative pain.

CMS is accepting public comments on the proposed decision through April 12, after which it will issue a final determination.

Monday, March 12, 2012

If you're a parent, grandparent or guardian, this study is a reminder to be ever vigilant of a young child, particularly around stairs. Records indicate that one child is treated every six minutes at the ER for stair related injuries.


Injury Rates from Stairs Tumble but Kids Still at Risk


Although stair-related injuries among young children have become less frequent, they are still a common source of injury in the U.S., researchers found.

Over a recent 10-year period, a child younger than 5 was treated in an emergency department for a stair-related injury every six minutes, on average, according to Gary Smith, MD, DrPH, of the Research Institute at Nationwide Children's Hospital in Columbus, Ohio, and colleagues.

In 2008, which were the most recent year data, an estimated 89,619 young children were treated for such an injury, the researchers reported online ahead of the March issue of Pediatrics.

"Increased prevention efforts are needed, including parental education and improved stairway design, to decrease stair-related injuries among young children," they wrote.

Until the mid-1990s, most stair-related injuries in young children involved baby walkers. That changed as walkers were increasingly cast aside for stationary activity centers, and the American Society for Testing and Materials released a new voluntary infant walker standard in 1997.

To provide a look at the patterns of stair-related injuries after the change, Smith and colleagues retrospectively examined data from the National Electronic Injury Surveillance System of the U.S. Consumer Product Safety Commission for 1999 through 2008.

During that 10-year period, an estimated 931,886 children younger than 5 were treated in an emergency department for a stair-related injury.

The total number of injuries dropped by 11.6% during the study period (P=0.011). The annual rate declined also -- from 53 to 42.4 per 10,000 population (P<0.001) -- even after excluding the baby walker cases.
Some of the other findings:
  • The largest percentage of injuries occurred in 1-year-old kids (32.4%).
  • Injuries were more common in boys at all ages than in girls (56.9% versus 43.1%).
  • About one-third of the injuries were soft tissue injuries (34.6%) and most occurred to the head and neck (76.3%).
  • The vast majority of the injuries were not serious, and only 2.7% required hospitalization. That rate was highest in children less than 1 (5.2%).
One-quarter of the infant injuries occurred when the caregiver was carrying the child. Babies hurt in this way were about three times more likely to be hospitalized as those injured in other ways (RR 3.10, 95% CI 2.41 to 3.99).

"Caretakers should minimize stair use while carrying children by placing the child in a safe place instead of bringing the child with them if possible," the authors wrote. "Child caretakers can also reduce injuries by keeping the stairs well maintained and free of objects that could result in tripping."

To continue the overall trend of declining stair-related injuries, Smith and colleagues suggested improving the design and construction of stairs, discouraging children from playing on or carrying objects down the stairs, not using baby walkers, and using, but not relying on, safety gates.

The study was limited, they said, by the inclusion of cases treated in the emergency department only, the lack of information on possible cases of abuse, and the difficulty in determining the mechanism of the fall for a large number of cases.

The study was supported by the National Center for Injury Prevention and Control at the CDC, which provided a student research stipend for one of the study authors while she worked on the study.
The authors reported that they had no conflicts of interest.

Primary source: Pediatrics
Source reference:
Zielinski A, et al "Stair-related injuries to young children treated in U.S. emergency departments, 1999-2008" Pediatrics 2012; DOI:10.1542/peds.2011-2314.

Saturday, March 3, 2012

With sugar accounting for 16% of the caloric intake of children, the quickest and easiest way to begin reducing obesity in America is for parents to be mindful of their children's diet and help them by reducing the amount of sugar they eat.

 From Heartwire

Kids Still Eating Too Much Added Sugar

Michael O'Riordan


 
February 29, 2012 (Atlanta, Georgia) — US children and adolescents consumed an average of 16% of their daily caloric intake from added sugars, according to a new report from the Centers for Disease Control and Prevention (CDC) [1]. Boys tend to consume more absolute calories from sugar than girls, but the intakes did not differ when the amount of sugar was expressed as a percentage of daily caloric intake, report investigators.

The report, a National Center for Health Statistics (NCHS) brief using National Health and Nutrition Examination Survey (NHANES) data from 2005 to 2008 and authored by Dr Bethene Ervin and colleagues, notes that boys consumed 362 calories from added sugars while girls consumed 262 calories from sugar. In both boys and girls, caloric intake from added sugars increased linearly with age, with adolescent boys (ages 12–19 years) consuming 442 calories from sugar and adolescent girls consuming 314 calories from added sugars. When analyzed as a percentage of recommended daily caloric intake, added sugar consumption still increased linearly with age.

Non-Hispanic white children consumed significantly more calories from added sugar than Mexican American children, with non-Hispanic white males and females consuming 17.2% and 16.1% of daily calories from added sugar, respectively, compared with Mexican American males and females, who consumed 14.8% and 14.0% of their daily calories from added sugars (p < 0.05 for the comparison between ethnicities in boys and girls). Non-Hispanic black males and females both consumed 15.9% of their daily calories from added sugar, but their consumption was not significantly different from non-Hispanic whites or Mexican Americans. An analysis of economic status revealed that added sugar consumption did not vary when stratified by the poverty income ratio.

Overall, food, rather than soft drinks, contributed more to the addition of sugar calories. In total, 59% of the added sugar calories came from foods, whereas 41% of the additional calories were derived from soft drinks. Most of the added sugar calories were consumed in the home (65%), report Ervin and colleagues.

The researchers note that the 2010 Dietary Guidelines recommend limiting the total intake of discretionary calories, which includes added sugars and solid fats, to 5% to 15% of daily caloric intake, but most Americans exceed these levels. If children and adolescents lower their intake of added sugars, the effect will be to reduce the overall daily calories consumed. "This strategy could play an important role in reducing the high prevalence of obesity in the United States without compromising adequate nutrition," conclude Ervin et al.