California voters soundly rejected two hotly contested propositions Tuesday night — one that claims it would have halted excessive health care insurance rates and another that would have raised the state’s 39-year-old cap on medical malpractice damage awards.

Proposition 45 would have given the state insurance commissioner the power to reject health insurance rate hikes for about six million Californians who buy their own policies or who work for small businesses. The measure would have required health insurance companies to publicly disclose rate changes and allowed California’s insurance commissioner to control rates. Supporters said the initiative would stem skyrocketing healthcare costs. It failed to pass by a wide margin. Insurance Commissioner Dave Jones won reelection Tuesday, but he’s left with no real power over health insurance rates. Jones had invested significant political capital in campaigning for Proposition 45 and drew the ire of fellow Democrats at times for his criticism of Covered California. The commissioner called Tuesday’s vote a major setback. “Health insurers flooded Californians with $57 million worth of false television commercials, radio ads and slick mailers,” Jones said. “Our consumer coalition simply could not compete with that.” Jones’ backers see the fight returning to Sacramento. “We expect the rate regulation debate to return to the Legislature, possibly with more momentum,” said Anthony Wright, executive director of Health Access. “We will continue to advocate the simple point that patients shouldn’t have to pay premiums deemed unreasonable by regulators.”

“Prop. 45 was an ill-conceived measure that would have been a step backwards against the progress made by the Affordable Care Act and our state’s health exchange, by giving a politician power over health care decisions that should have involved doctors and their patients,” Dr. John Maa of the San Francisco Medical Society, said in a statement. “California voters saw through this deceptive measure motivated by self-interest, and opposed it wholesale.”

The Los Angeles Times laments the loss as a “boon for health insurers.” The Times went to to say that “California’s biggest health plans, led by Anthem Blue Cross and Kaiser Permanente, spent millions of dollars on ads portraying Proposition 45’s rate regulation as a threat to implementation of the health law. In a lopsided result, 60% of voters joined the industry in opposition.” Despite the stinging loss, supporters of rate regulation vowed to keep fighting on behalf of consumers in the courts, state Legislature and possibly again at the ballot box.

“It’s incredible that an industry that’s so unpopular could do so well in this election,” said Robert Laszewski, a healthcare consultant who has closely tracked California’s implementation of the health law. “Pro-Obamacare forces and anti-regulation folks formed a 60% coalition. It was a strange set of bedfellows.”

Proposition 46, which would have raised the state’s 39-year-old cap on medical malpractice damage awards, would have also required doctors to take random drug tests and mandate use of a database designed to reduce prescription drug abuse. It was a wide-ranging initiative that included raising the limit on pain and suffering damages in medical malpractice lawsuits. This proposition was also defeated Tuesday by a wide margin. Supporters had said the proposition would have detected and deterred medical negligence, over-prescribing of prescription drugs and drug and alcohol abuse by doctors and promoted justice for people who don’t have an income — including retirees, children and stay-at-home parents — who are victims of medical malpractice.

“This was a battle worth fighting. But the battle doesn’t stop here,” Bob Pack, author of Proposition 46, said in a statement released late Tuesday night. He and his wife, Carmen, lost their two children Troy and Alana as a result of medical negligence. “Our coalition will continue to press for changes to end that cycle of preventable death, to put a dent in prescription drug abuse, ensure our doctors aren’t operating under the influence and give malpractice victims a better shot at justice,” Pack said.

The defeat of Proposition 46 came after a cascade of negative advertising financed by insurance and physician groups. They warned the change would send medical costs soaring and drive doctors from the state. “In this health care environment, undermining California’s long-standing malpractice cap is a political poison pill,” Dustin Corcoran, chief executive of the California Medical Association and chairman of the No on 46 campaign, said in a statement. “Increasing payouts in medical lawsuits would have increased health care costs.” Insurance companies, hospitals and physician groups depicted the proposal as a sugar-coated pill that’s really about fattening attorneys’ wallets.

A new Northwestern Medicine® study has found that smokers are three times more likely than nonsmokers to develop chronic back pain, and dropping the habit may cut chances of developing this often debilitating condition. Since apportionment of permanent disability can be based upon causation, this study may be of interest to the workers’ compensation community.

“Smoking affects the brain,” said Bogdan Petre, lead author of the study and a technical scientist at Northwestern University Feinberg School of Medicine. “We found that it affects the way the brain responds to back pain and seems to make individuals less resilient to an episode of pain.” This is the first evidence to link smoking and chronic pain with the part of the brain associated with addiction and reward. The study was published online in the journal Human Brain Mapping.

The results come from a longitudinal observational study of 160 adults with new cases of back pain. At five different times throughout the course of a year they were given MRI brain scans and were asked to rate the intensity of their back pain and fill out a questionnaire which asked about smoking status and other health issues. Thirty-five healthy control participants and 32 participants with chronic back pain were similarly monitored.

Scientists analyzed MRI activity between two brain areas (nucleus accumbens and medial prefrontal cortex, NAc-mPFC), which are involved in addictive behavior, and motivated learning. This circuitry is critical in development of chronic pain, the scientists found. These two regions of the brain “talk” to one another and scientists discovered that the strength of that connection helps determine who will become a chronic pain patient. By showing how a part of the brain involved in motivated learning allows tobacco addiction to interface with pain chronification, the findings hint at a potentially more general link between addiction and pain. “That circuit was very strong and active in the brain’s of smokers,” Petre said. “But we saw a dramatic drop in this circuit’s activity in smokers who — of their own will — quit smoking during the study, so when they stopped smoking, their vulnerably to chronic pain also decreased.”

Medication, such as anti-inflammatory drugs, did help study participants manage pain, but it didn’t change the activity of the brain circuitry. In the future, behavioral interventions, such as smoking cessation programs, could be used to manipulate brain mechanisms as an effective strategy for chronic pain prevention and relief.

Opioids are potent respiratory depressants, and overdose is a leading cause of death among people who use them. Worldwide, an estimated 69 000 people die from opioid overdose each year. Among people who inject drugs, opioid overdose is the second most common cause of mortality after HIV/AIDS. A recent rise in opioid-overdose deaths in a number of countries is associated with an increase in the prescribing of opioids for chronic pain. In 2010, an estimated 16 651 people died from an overdose of prescription opioids in the United States of America alone.

New World Health Organization (WHO) guidelines, released this month aim to reduce the number of deaths from opioid overdose globally by providing evidence-based recommendations on the availability of naloxone for people likely to witness an opioid overdose along with advice on the resuscitation and post-resuscitation care of opioid overdose in the community. The guidelines recommend countries expand naloxone access to people likely to witness an overdose in their community, such as friends, family members, partners of people who use drugs, and social workers. In most countries, naloxone is currently accessible only through hospitals and ambulance crews who may not manage to get help to the people who need it fast enough

According to the Guideline, people dependent on opioids are the group most likely to experience an overdose. The incidence of fatal opioid overdose among opioid-dependent individuals is estimated at 0.65 per 100 person years. Non-fatal opioid overdoses are several times more common than fatal ones.Although people taking prescribed opioids are at lower risk of overdose than people using unprescribed opioids. The high number of people receiving prescribed opioids in many countries mean that they constitute a significant proportion of opioid overdose deaths, if not the majority. Risk factors for overdose in people taking prescribed opioids include higher prescribed dosage, male gender, older age, multiple prescriptions (including benzodiazepines), mental health disorders and lower socioeconomic status. The risk of overdose is significantly higher where the prescribed dose is 100 mg morphine equivalents daily or greater.

Opioids depress the respiratory drive and overdose is characterized by apnoea, myosis and stupor. A severely reduced respiration rate results in hypoxaemia, leading to cerebral hypoxia and impaired consciousness. Cardiac arrest is a late complication of opioid overdose and secondary to respiratory arrest and hypoventilation. Prolonged cerebral hypoxia is the mechanism for brain injury and death in opioid overdose, resulting from apnoea or cardiac dysrhythmias and cardiac arrest.

The Guideline concluded that death in opioid-overdose can be averted by emergency basic life support resuscitation and/or the timely administration of an opioid antagonist such as naloxone. Most opioid overdoses occur in private homes, and most of these are witnessed. Close friends, a partner or family members are most likely to witness an opioid overdose. The other key group of individuals likely to witness overdoses are people working with people who use drugs. They include trained health professionals and first responders, such as ambulance, police, fire and drug-treatment workers as well as outreach workers. Naloxone has been used in the management of opioid overdose for more than 40 years. It is a safe drug with a low risk of serious side effects. Any adult capable of learning basic life support can also learn to recognize an opioid overdose, and administer naloxone in time to save lives.

Naloxone is a prescription medicine in almost all countries. In recent years, several countries in different regions have started distributing naloxone to people likely to witness an opioid overdose, initially in pilot programs, but now also in some cases state or national policy, demonstrating the feasibility of this approach and prompting calls for widespread adoption of this approach.

The California legislature passed Assembly Bill No. 1535 this year and it was signed by the Governor on September 15, 2014. The new law adds Section 4052.01 to the Business and Professions Code, relating to pharmacists. Existing law, generally, authorizes a California pharmacist to dispense or furnish drugs only pursuant to a valid prescription except for nicotine replacement products and emergency contraceptives and hormonal contraceptives. The new law would now also authorize a pharmacist to furnish naloxone hydrochloride in accordance with standardized procedures or protocols developed and approved by both the Pharmacy Board and the Medical Board of California, in consultation with specified entities. The new law would authorize the California State Board of Pharmacy to adopt emergency regulations to establish the standardized procedures or protocols that would remain in effect until the earlier of 180 days following their effective date or the effective date of regulations adopted as described above. California therefore will provide non prescription access to naloxone and will be on the forefront of these new WHO Guidelines. Claim examiners may wish to take advantage of this new law in cases where risk factors are high for overdose.

Lab-grown tissues could one day provide new treatments for injuries and damage to the joints, including articular cartilage, tendons and ligaments. Cartilage, for example, is a hard material that caps the ends of bones and allows joints to work smoothly. UC Davis biomedical engineers, exploring ways to toughen up engineered cartilage and keep natural tissues strong outside the body, report new developments in the journal Proceedings of the National Academy of Sciences.

“The problem with engineered tissue is that the mechanical properties are far from those of native tissue,” said Eleftherios Makris, a postdoctoral researcher at the UC Davis Department of Biomedical Engineering and first author on the paper. Makris is working under the supervision of Professor Kyriacos A. Athanasiou, a distinguished professor of biomedical engineering and orthopedic surgery, and chair of the Department of Biomedical Engineering.

While engineered cartilage has yet to be tested or approved for use in humans, a current method for treating serious joint problems is with transplants of native cartilage. But it is well known that this method is not sufficient as a long-term clinical solution, Makris said.

The major component of cartilage is a protein called collagen, which also provides strength and flexibility to the majority of our tissues, including ligaments, tendons, skin and bones. Collagen is produced by the cells and made up of long fibers that can be cross-linked together.

Researchers in the Athanasiou group have been maintaining native cartilage in the lab and culturing cartilage cells, or chondrocytes, to produce engineered cartilage. “In engineered tissues the cells produce initially an immature matrix, and the maturation process makes it tougher,” Makris said.

Knee joints are normally low in oxygen, so the researchers looked at the effect of depriving native or engineered cartilage of oxygen. In both cases, low oxygen led to more cross-linking and stronger material. They also found that an enzyme called lysyl oxidase, which is triggered by low oxygen levels, promoted cross-linking and made the material stronger.

“The ramifications of the work presented in the PNAS paper are tremendous with respect to tissue grafts used in surgery, as well as new tissues fabricated using the principles of tissue engineering,” Athanasiou said. Grafts such as cadaveric cartilage, tendons or ligaments – notorious for losing their mechanical characteristics in storage – can now be treated with the processes developed at UC Davis to make them stronger and fully functional, he said. Athanasiou also envisions that many tissue engineering methods will now be altered to take advantage of this strengthening technique.

The plethora of medical developments on the horizon pose a mixed dilemma for workers’ compensation claims administrators when reserving long term medical costs and settlements.  On one hand, the cost of exotic medical care will no doubt drive higher reserve estimates for these procedures in the future.  On the other hand, if these treatments are successful, costs should at some point be reduced to the extent of less effective care that is no longer needed.  An accurate reserve estimate may be somewhat difficult to establish between these forces.

Spinal Solutions founder. Roger Williams spent 16 years in the orthopedic sales business with his father before he went out on his own. He started Spinal Solutions in 1999 and launched a firm selling knee and hip implants three years later. From nothing, he built an $18 million-a-year business based in Murrieta, California. Williams and his wife had a BMW, a Mercedes-Benz, a yacht named “Spare Change” and a 6,300-square-foot Murrieta home, according to court records and interviews. He ordered his seven-seat jet painted with stripes of Lakers purple and gold, and he and his wife sat courtside among celebrities at Laker games, according to interviews with former employees.

But Spinal Solutions also racked up big debts with hardware manufacturers and then refused to pay, according to industry executives and lawsuit allegations.The company increasingly relied on Lenders Funding LLC, a firm that fronted cash at an interest rate of 35 percent. By 2013, the company owed the lender about $35,000 per month – solely in interest payments – and imploded in debt.

Spinal Solutions could not have raked in millions or spread its products across the U.S. if not for doctors eager to do business. Roger Williams allegedly lured them with private plane rides, generous consulting contracts and even cash. Williams made it clear the consulting deals and free flights were tools to keep doctors hooked on his products, said Quin Rudin, a businessman who poured money into the company when it hit a cash crunch in 2012. “He said that many times. ‘In order to do business with these guys, I gotta take care of them,’ ” Rudin recalled from behind thick glass in a downtown Oakland jail, where he landed after pleading guilty in an unrelated fraud case.

Although the true extent of the caper remains buried in the necks and backs of people scattered around the U.S., it began to unravel in 2009 when evidence of the scheme landed in the receiving room of Ortho Sol, a surgical supply firm in South Africa. Ortho Sol makes precision screws for the most delicate of construction projects: spinal fusion. The company had repossessed some of its screws after Spinal Solutions LLC stopped paying its bills. Nestled with the returns, the brighter yellow luster of a few screws caught Richard Walker’s eye. Testing confirmed his fears. Some were not made of his firm’s medical-grade titanium. Their uneven threads showed potential for backing out or breaking, he said. He feared the laser-etched markings intended to make them look authentic could be toxic to patients.

More evidence – Derika Moses hefted a case of 2-liter soda bottles while setting up a grocery store display in 2007. Nothing helped. In desperation, Moses opted for spinal fusion surgery.The procedure offered little relief. Five years later, she had most of her spinal hardware removed, convinced that the erector set of metal in her spine was the source of ongoing problems. Attorneys contacted Moses after finding her name among Spinal Solutions’ sales records. CIR showed photos of Moses’ hardware to U and I, the South Korean company whose logo was etched on it. Company engineers noted the finishes and lot numbers on some of Moses’ screws and connectors did not match their product. But the dead giveaway was the logo, they said, which lacks the firm’s signature forward-leaning font. During an interview at the company’s U.S. office in Orange County, California, General Manager Sung Hwang identified three of Moses’ four screws as fakes. “This is obviously not what we did,” Hwang said. “I feel sorry because (patients) got the surgery with improper devices, so they might suffer from it.”

The screws, real or fake, all funneled into what lawsuits claim was a larger scheme to bilk California’s workers’ compensation system. Some hospitals billed insurance carriers as much as $12,500 a screw before a 2012 change in state law shut down the astronomical markups. From that, Spinal Solutions stood to reap several thousand dollars from the sale of a single screw.

The source of the counterfeits, plaintiffs’ attorneys allege, was 85-year-old machinist William Crowder. He owns a small office park machine shop in Southern California’s Inland Empire. He had experience working on parts for boats, planes and, it appears, the human body. In an interview with CIR, Crowder said Spinal Solutions’ operations manager, Jeff Fields, gave him professional-looking medical screws and asked for exact copies. “He might want 50 of this size and 40 of these,” said Crowder, who has been named as a defendant in dozens of lawsuits. Plaintiffs’ attorneys believe that thousands of counterfeit screws went into unsuspecting patients, though Crowder testified in a recent deposition to making “maybe 500.” Crowder also said he didn’t etch anything on the screws he made for Spinal Solutions. Instead, that trail seems to lead to another Spinal Solutions contractor, Ryan Zavilenski. On his YouTube page, Zavilenski boasts of owning a laser engraver. He also posted photos of spinal implants on his photo-sharing website. From behind the screen door of his Santa Rosa, California, apartment, Zavilenski confirmed to CIR that he did laser engraving for Spinal Solutions several years ago. He said he engraved only a few screws, however, which he called prototypes.