Want to Save $62.4 billion? Enact Medical Liability Reform, AMA says

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Here’s a straightforward way for Congress’ Joint Select Committee on Deficit Reduction to save $62.4 billion over 10 years without cutting payments to healthcare providers: Institute meaningful medical liability reform.

That was what the American Medical Association (AMA), the American Academy of Family Physicians, the American College of Physicians, and more than 90 other state and specialty medical societies told the so-called “supercommittee” in essentially identical letters sent to Democratic and Republican co-chairs.

“Reforming the costly and inefficient medical liability system with proven solutions will save taxpayers money,” said AMA President Peter W. Carmel, MD “Comprehensive reforms that include a reasonable limit on non-economic damages would reduce the federal budget deficit by $62.4 billion over 10 years, according to the Congressional Budget Office.”

The reforms requested by the medical groups:

• a $250,000 cap on non-economic damages;
  
• a collateral source rule reform by allowing evidence of outside payments to be submitted in court, and a ban on subrogation by certain collateral sources;
  
• language from H.R. 816, the “Provider Shield Act of 2011,” that would prohibit new causes of action against physicians and other healthcare providers from the Patient Protection and Affordable Care Act (PPACA);
  
• liability protections for physicians and other healthcare providers so that payment issues related to programs such as Medicare or Medicaid would not be admissible in a liability claim;
  
• liability protections for physicians and other healthcare providers who provide emergency care or volunteer to treat victims of a disaster; and
  
• a requirement that an individual who serves as an expert witness in a liability case meet established standards of expertise and knowledge.

The AMA also urged the deficit committee to include language that allows individual states to maintain or enact their own reforms.

“Preserving quality and access in medicine while reducing unnecessary cost will require fairness in the civil justice system,” Carmel said. “Every dollar that government health programs spend on the broken medical liability system is money that cannot be used on healthcare.”

By: Brenda L. Mooney

California Bans Use of Tanning Beds by Minors

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LOS ANGELES (Reuters) Oct 10 - Minors in the state of California will no longer be allowed to use tanning beds after Governor Jerry Brown signed a bill on Sunday prohibiting anyone under the age of 18 from using ultraviolet tanning devices.

California is the first state in the nation to ban minors from using tanning beds, legislators said.

Previously, California had banned minors under the age of 14 from using tanning beds, but allowed those between 14 and 18 years of age to use tanning beds with parental consent.

The bill was part of a cluster of legislation signed on Sunday designed to "improve the health and well-being of Californians," according to a statement from the Governor's office.

"I praise Gov. Brown for his courage in taking this much-needed step to protect some of California's most vulnerable residents - our kids - from what the 'House of Medicine' has conclusively shown is lethally dangerous: ultraviolet-emitting radiation from tanning beds," the bill's sponsor, state Senator Ted Lieu, said in a statement.

"If everyone knew the true dangers of tanning beds, they'd be shocked. Skin cancer is a rising epidemic and the leading cause of cancer death for women between 25 and 29."

The law will go into effect on January 1, 2012, according to Lieu's office.

From Reuters Health Information

Solid Hyaluronic Acid Tailored to Fix Fine Wrinkles

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September 26, 2011 (Denver, Colorado) — The developer of an investigational thread-like solidified hyaluronic acid (HA) product that can be slipped under narrow facial wrinkles claims that it might one day simplify procedures for cosmetic surgeons who struggle to keep gel-based fillers within their intended boundaries.

Research presented here at Plastic Surgery 2011: American Society of Plastic Surgeons (ASPS) Annual Meeting demonstrates that solid-state HA is effective for treating crow's feet, transverse forehead wrinkles, and other facial wrinkles.

Lead investigator Geoffrey Gurtner, MD, professor of surgery at Stanford University School of Medicine in Palo Alto, California, told meeting attendees that it allows for instant procedural reversibility — an advantage not possible with injectables.

"Gel fillers usually follow the path of least resistance," Dr. Gurtner said. "Since wrinkles and folds are lines, it would be nice if we could put a cylinder underneath them to essentially buttress them. We think the solid-state HA is a new class of products that can improve predictability and precision in filling techniques."

Dr. Gurtner is founder of the TauTona Group, the California company that is developing the product. He and Stanford surgeon Mike Longaker, MD, recently collaborated on a single-center prospective 31-patient study of solid-state HA. Participating physicians reported that the HA strings resulted in greater predictability, greater ease of use, and quicker application than traditional fillers.

Solid HA threads were able to hydrate back to a gel state within a few hours, facilitating the effective treatment of tear troughs, nasolabial folds, and glabellar creases. The product was also effective in the contouring and volumizing of lips.

"We feel it is best suited for some specific areas, but clinical trials are necessary to statistically demonstrate where it is most effective," Dr. Gurtner told Medscape Medical News.

In preclinical studies, the researchers found that existing filler products, such as Juvéderm and Restalyne, can migrate up to 2 cm from the injection site. Solid-state HA does not spread and, if necessary, can be quickly extracted.

"This is a fundamental difference between the thread and the injectables," said Dr. Longaker. "Injectable fillers cannot be controlled in terms of where they go once injected into the body. The HA thread can be placed precisely where the physician desires and it does not appear to migrate. In addition to enhanced precision during placement, the thread avoids potential complications, such as injection into a blood vessel, causing an embolus. This is a concern when placing injectables around the eye."

According to Dr. Gurtner, the worst-case scenario occurs when a gel is mistakenly injected into a vessel and forced upstream, resulting in occlusion and tissue necrosis.

"There are even a few extremely unfortunate documented cases of blindness or a stroke, although the published incidence of such serious complications is less than 1 in 1000," he said. "Solid-state HA should reduce the occurrence of serious complications because it is not injected under pressure; it is threaded in a hair-like suture."

The study revealed that solid HA results in less pain than traditional dermal fillers. This benefit was demonstrated even though HA strands are pulled into place using a straight (Keith) needle as a guide.

Drs. Gurtner and Longaker said the mediation of pain with solid HA is largely attributable to the fact that injected fillers promote an uncomfortable hydrostatic dissection of tissue, whereas the HA thread does not. 

Moreover, when correcting nasolabial folds, it is common for physicians to inject a gel numerous times — a "string of pearls" technique — whereas the use of HA allows for fewer needle sticks, Dr. Gurtner said.

Several iterations were necessary to perfect a processing method by which HA could be transformed into a value-added investigational product by means of a very slow extrusion process.

According to Dr. Gurtner, manufacturing costs will allow solid HA to be priced similarly to existing products. However, some physicians might choose to charge premiums if they use it for sophisticated treatment methods that others cannot perform, he noted. For now, plans call for further studies with longer follow-up periods to test for product durability.

According to the ASPS, HA-based products are the most popular fillers used for soft-tissue defects, with more than 1.2 million procedures completed in 2010.

By: Rod Franklin

Ohio Researcher Aims at Developing Breast Implants using Nanotechnology

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Published in WIREs Nanomedicine and Nanobiotechnology, the review titled, “Breast implants: the good, the bad and the ugly. Can nanotechnology improve implants?” explains how nanotechnology can be used to develop safer implants.

Researchers at the University of Akron are currently developing a new material to develop safer breast implants using nanotechnology, which will minimize the complications associated with silicon rubber implants. 

Silicon rubber implants is the only option available to the 75% of post-mastectomy patients who undergo breast augmentation and reconstruction. Complications such as psychological disease, systemic disease and cancer attributed to breast implants using silicone rubber are high and these implants have a high failure rate of 20-30%.

The review’s lead author, Dr Judit E Puskas and her team of researchers have determined that by decreasing the components present in the nanostructured materials, it is possible to achieve certain properties. The researchers are developing a nanostructured material that can be used as an alternative to silicon rubber. 

Dr Puskas stated that the material could be used in developing implants capable of delivering drugs. Thus, apart from reducing complications, the distribution of cancer drugs could improve the treatment’s efficacy and reduce the side effects of chemotherapy. 

By: Cameron Chai

DEA Moves to Make 'Bath Salts' Illegal as Overdoses Rise

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September 7, 2011 ( UPDATED September 8, 2011 ) — In the wake of a growing number of overdose visits to emergency departments, the US Drug Enforcement Administration (DEA) has moved to make psychoactive "bath salts" (PABS) a controlled substance.

In a statement released today, the DEA announced it is using its emergency scheduling authority to temporarily control methylenedioxypyrovalerone and 2 other synthetic stimulants: mephedrone and methylone.

As of September 7, 2011, possessing and selling these chemicals or the products that contain them are both illegal in the United States for at least 1 year while the DEA and the US Department of Health and Human Services mull over whether the substances should be permanently controlled.

"This imminent action by the DEA demonstrates that there is no tolerance for those who manufacture, distribute, or sell these drugs anywhere in the country, and that those who do will be shut down, arrested, and prosecuted to the fullest extent of the law," DEA Administrator Michele M. Leonhart, said in a statement. "DEA has made it clear we will not hesitate to use our emergency scheduling authority to control these dangerous chemicals that pose a significant and growing threat to our nation."

In the last 6 months, the DEA has received increasing reports from poison centers, hospitals, and police involving one or more of the now-controlled substances.

Increasing Emergency Visits Related to Overdose

 

People who overdose on the bath salts are showing up in emergency departments with increasing frequency, concerned clinicians Edward A. Ross, MD, Mary Watson, MD, and Bruce Goldberger, PhD, from the University of Florida College of Medicine, Gainesville, write in a letter to the editor, that appears in the September 8 issue of the New England Journal of Medicine.

"Despite growing efforts to ban these products through legislation, [PABS] often skirt substance-control laws and are readily available at low cost," the authors write.

Until now easily obtained over the Internet, these bath salts, which have nothing to do with any hygiene product, go by such names as Ivory Wave and Vanilla Sky.

The main ingredient in PABS is methylenedioxypyrovalerone, which is structurally related to pyrovalerone and a-pyrrolidinophenone compounds that inhibit norepinephrine-dopamine reuptake and act as central nervous system stimulants.

Touted for giving a high similar to that of methamphetamine, PABS are also known as alertness enhancers or aphrodisiacs and are sometimes called "legal cocaine."

PABS are taken orally, intranasally, intravenously, or rectally, and doses as low as 3 to 5 mg will produce an effect. The average dose ranges from 5 to 20 mg, and the risk for overdose is high because packages can contain up to 500 mg. Taken orally, the bath salts are rapidly absorbed and produce a rush that peaks at 1.5 hours after ingestion and lasts for 3 to 4 hours.

The physical effects of PABS include tachycardia, hypertension, arrhythmias, hyperthermia, seizures, stroke, myocardial infarction, and even death. Behavioral and mental effects include panic attacks, anxiety, paranoia, hallucinations, psychosis, aggressive or violent behavior (such as self-mutilation, suicide attempts, and homicidal activity), insomnia, anorexia, and depression.

The consequences of a PABS overdose can be particularly nasty, and clinicians need to be aware of several issues, the authors warn.

Individuals who are experiencing symptoms of PABS overdose need to be cared for and monitored in the intensive care unit. In addition, routine drug screens are unable to detect bath salts. Bath salts also can be cut with other psychoactive substances, which can further confuse the clinical presentation, the authors write.

Overdose victims may also require physical restraints and high doses of sedatives to prevent harming themselves or others.

Treatment involves intravenous benzodiazepines to control seizures or for sedation and intravenous fluids for suspected rhabdomyolysis.

By: Fran Lowry