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Tag: 2013 News

Drugmaker Ends Payments to Doctors for Promoting Products

The British drug maker GlaxoSmithKline will no longer pay doctors to promote its products and will stop tying compensation of sales representatives to the number of prescriptions doctors write, its chief executive said Monday, effectively ending two common industry practices that critics have long assailed as troublesome conflicts of interest. According to the story in the New York Times, the announcement appears to be a first for a major drug company – although others may be considering similar moves – and it comes at a particularly sensitive time for Glaxo. It is the subject of a bribery investigation in China, where authorities contend the company funneled illegal payments to doctors and government officials in an effort to lift drug sales. Glaxo is among the largest drug companies in the world, reporting global third-quarter sales of 6.51 billion pounds, or $10.1 billion, a 1 percent rise from the same period a year ago. Sales fell markedly in China as the investigation proceeded.

Andrew Witty, Glaxo’s chief executive, said in a telephone interview Monday that its proposed changes were unrelated to the investigation in China, and were part of a yearslong effort “to try and make sure we stay in step with how the world is changing,” he said. “We keep asking ourselves, are there different ways, more effective ways of operating than perhaps the ways we as an industry have been operating over the last 30, 40 years?”

For decades, pharmaceutical companies have paid doctors to speak on their behalf at conferences and other meetings of medical professionals, on the assumption that the doctors are most likely to value the advice of trusted peers. But the practice has also been criticized by those who question whether it unduly influences the information doctors give each other and can lead them to prescribe drugs inappropriately to patients. All such payments by pharmaceutical companies are to be made public next year under requirements of the Obama administration’s health care law.

Under the plan, which Glaxo said would be completed worldwide by 2016, the company will no longer pay health care professionals to speak on its behalf about its products or the diseases they treat “to audiences who can prescribe or influence prescribing,” it said in a statement. It will also stop providing financial support directly to doctors to attend medical conferences, a practice that is prohibited in the United States through an industry-imposed ethics code but that still occurs in other countries. In China, the authorities have said Glaxo compensated doctors for travel to conferences and lectures that never took place. Mr. Witty declined to comment on the investigation because he said it was still underway.

Glaxo will continue to pay doctors consulting fees for market research because Mr. Witty said it was necessary for the company to gain insight from doctors about their products, but he said that activity would be limited in scope. A Glaxo spokesman said that each year the company spends “tens of millions” of dollars globally on the practices that it was ending, but declined to be more specific.

The move won qualified praise from Dr. Jerry Avorn, a professor at Harvard Medical School who has written critically about the industry’s marketing practices. “It’s a modest acknowledgment of the fact that learning from a doctor who is paid by a drug company to give a talk about its products isn’t the best way for doctors to learn about those products,” Dr. Avorn said. But he noted that Glaxo would continue to provide what the company described in a statement as “unsolicited, independent educational grants” to continue educating doctors about their products. He said that in the past the grants had often been provided to for-profit companies that rely on such payments from drug companies, raising questions about whether they were providing truly independent information. Mr. Witty said while the details were still being worked out, the company intended to provide such grants to respected educational institutions and medical societies. “I’d like to look for those sorts of partners, and I do not envision these partners being companies or pseudocompanies,” he said.

Glaxo is first among its peers to announce a plan to end paid-speaker programs, but it is not the only one considering such a move, said Pratap Khedkar, who oversees the pharmaceutical practice at ZS Associates, a global sales and marketing firm. He said a handful of drug makers were weighing similar actions for several reasons, including concerns about the reaction to the required disclosure of such payments that will begin next fall under a provision of the health care law. Glaxo and several other major companies already report many such payments, but Mr. Khedkar said the new requirements may go farther than what some companies are reporting, and will be accessible on a searchable government website. Previously, “It wasn’t really made public in some big, splashy way,” he said.

Jeff Francer, vice president and senior counsel at the Pharmaceutical Research and Manufacturers of America, the industry trade group, said many other companies were looking for ways to better reach increasingly busy doctors – who may not have time to travel to a conference in the first place – and Glaxo’s actions represent just one example. “Of course all of our companies are looking for ways in which they can refine their relationship with physicians to make sure they’re making the best use of physicians’ time,” he said.

NFL to Fund $14 Million for Brain Injury Research

U.S. researchers on Monday unveiled a $14 million series of research projects aimed at diagnosing and treating brain injuries in football players and others who have suffered multiple head injuries or concussions. According to the story in Reuters Health, the projects, partly funded by the National Football League, are aimed at chronic traumatic encephalopathy, or CTE, a condition linked to the loss of decision-making control, aggression and dementia. The condition is allegedly tied to repeated hits to the head, such as those experienced by football players, hockey players and boxers. The condition currently can be diagnosed only by examining a person’s brain after their death. But researchers with the National Institutes of Health aim to develop tests to detect and treat CTE while the patient is alive.

“This is a public health problem,” said Walter Koroshetz, deputy director of the NIH’s National Institute of Neurological Disorders and Stroke. “We don’t know the mechanics of the head injuries that lead to this, the number and severity that is required to get this. We don’t know whether certain people based on their genes are more susceptible or not. There are a lot of questions to be answered.”

The NFL in August agreed to pay up to $765 million to settle a lawsuit brought by thousands of former players, many suffering from dementia and other health problems, who accused the league of covering up the risks of brain injury. Many of these players have also filed for workers’ compensation benefits in California. The league is paying $12 million of the allocated $14 million in research, the rest of which will be funded by the NIH. The $14 million comes from $30 million in research funding the NFL made available to the NIH in 2012.

The research is not focused just on football players, but any people who engage in activities in which they suffered head injury. Researchers say they also hope to better understand the potential relationship between traumatic brain injury and late-life neurodegenerative disorders, especially Alzheimer’s disease. Two of the new research projects will focus on defining the long-term changes that occur in the brain years after a head injury or after multiple concussions. Ten neuropathologists from eight universities will work to describe the chronic effects of head injury in tissue taken from hundreds of individuals as they try to develop standards for diagnosis. Six pilot projects will aim to identify potential biomarkers that can be used to track a person’s recovery from concussion. One of the pilot projects will focus on sports concussions in adolescents. Researchers will examine the effects of sports-related concussions on brain structure and function one month following injury in adolescents who have been cleared to resume playing their chosen sports.

CHSWC Safety and Health Training Program Gains National Recognition

The Commission on Health and Safety and Workers’ Compensation (CHSWC) has released the 2013 WOSHTEP Advisory Board Annual Report. WOSHTEP, the Worker Occupational Safety and Health Training and Education Program, is a statewide effort aimed at reducing job-related injuries and illnesses among California workers. This program was created as part of workers’ compensation reform and is administered by CHSWC through inter-agency agreements with the Labor Occupational Health Program (LOHP) at the University of California, Berkeley, the Western Center for Agricultural Health and Safety (WCAHS) at the University of California, Davis, and the Labor Occupational Safety and Health Program (LOSH) at the University of California, Los Angeles.

The WOSHTEP labor-management Advisory Board guides the development of all activities, broadens partnerships with the employer, worker and insurance communities, and evaluates the program. In addition, the Advisory Board prepares an annual written report evaluating the use and impact of the programs developed.

From its inception in 2003 through 2013, WOSHTEP has served about 11,950 workers and about 1,150 employers, through close to 5,650 hours of instruction. In addition, participants in WOSHTEP trainings often provide training and resources to workers at their workplaces, thereby significantly broadening the program’s reach.

Pursuant to Labor Code Section 6354.7(a), insurance carriers who are authorized to write workers’ compensation insurance in California are assessed $100 or .0286 percent of paid workers’ compensation indemnity amounts, whichever is greater, for claims reported for the previous calendar year to the Workers’ Compensation Insurance Rating Bureau (WCIRB). This assessment is then deposited into WOSHEF. CHSWC uses these funds each year to develop and implement WOSHTEP through interagency agreements with the Labor Occupational Health Program (LOHP) at the University of California (UC), Berkeley, and the Labor Occupational Safety and Health Program (LOSH) at the University of California, Los Angeles (UCLA). LOHP provides a subcontract to the University of California, Davis Western Center for Agricultural Health and Safety (WCAHS) to operate WOSHTEP’s Central Valley Resource Center.

To date, WOSHTEP has provided health and safety information and/or training to numerous industries including: janitorial; construction; small manufacturers; corrections and rehabilitation; health care; telecommunications; food service or restaurant; laundry; agriculture; transportation; schools; refineries; warehousing; garment; meat packing; recycling; and state and local government. WOSHTEP is gaining national recognition through CHSWC, LOHP and LOSH presentations at national and state conferences, such as the International Association of Industrial Accident Boards and Commissions (IAIABC), the National Institute for Occupational Safety and Health (NIOSH), the American Society of Safety Professionals, and the American Public Health Association, the National Council for Occupational Safety and Health, and the Annual Conference of the California Community Health Workers Network, as well as through articles written for publications such as the IAIABC Journal, Public Health Reports, the Bureau of National Affairs SafetyNet monthly newsletter, New Solutions; a Journal of Environmental and Occupational Health Policy, and the quarterly magazine for Foodservice Consultants Society International (FCSI).

Angie Wei Appointed CHSWC Chair for 2014

The California Commission on Health and Safety and Workers’ Compensation (CHSWC) announced the unanimous election of Commissioner Angie Wei as the Chair of the Commission for 2014. Ms. Wei, appointed by the Senate Rules Committee to represent labor, is the legislative director of the California Labor Federation, the state AFL-CIO Federation. Previously Ms. Wei was a program associate for PolicyLine of Oakland, California, and advocated for the California Immigrant Welfare Collaborative, a coalition of four immigrant rights groups that came together to respond to cuts in public benefits for immigrants as a result of the 1996 federal welfare reform law.

Angie was also one of the architects of SB 863. She negotiated provisions of the new law jointly with employer representatives.

CHSWC, created by the workers’ compensation reform legislation of 1993, is charged with examining the health and safety and workers’ compensation systems in California and recommending administrative or legislative modifications to improve their operation. CHSWC was established to conduct a continuing examination of the workers’ compensation system and of the state’s activities to prevent industrial injuries and occupational diseases and to examine those programs in other states.

States Seek Removal of New Drug 5 to 10 Times More Potent Than Hydrocodone

Attorneys general from 28 U.S. states have asked the Food and Drug Administration to reconsider its approval of the powerful painkiller Zohydro ER, which Kentucky’s top law enforcement official said could start an epidemic of abuse. The drug, manufactured by Zogenix Inc of San Diego, was approved by the FDA in October.

The article in Reuters Health reports that a panel of outside experts convened In December 2012, by the agency had voted 11-2 against the drug’s approval, citing its potential to cause addiction.

Kentucky Attorney General Jack Conway said his state had been hurt by abuse of prescription painkillers, especially OxyContin, and he feared more problems with Zohydro ER. “The approval of this very potent drug is troubling because, unlike extended-release opioids containing abuse-deterrent properties, there is nothing that would prevent someone from easily crushing or injecting Zohydro ER to get high,” Conway said.

Conway joined attorneys general from 27 states and the U.S. territory of Guam in signing a letter to FDA Commissioner Margaret Hamburg, dated Tuesday, asking that approval of Zohydro be reconsidered or that the drug be reformulated with chemical deterrents to abuse. “State attorneys general do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed,” the letter said.

The attorneys general said Zohydro reportedly is five to 10 times more potent than standard hydrocodone products.

The FDA approved the drug for daily, long-term treatment for which other options were inadequate. FDA spokeswoman Morgan Liscinsky said the agency would review the attorneys generals’ letter and respond.

Abuse of OxyContin became so widespread that manufacturer Purdue Pharma changed its formula in 2010 so that the drug could not be injected or snorted as easily.

Insurance Agent Arrested for Fake Comp Policies

Rodger Edward Winkler, 64, a property and casualty agent was arrested by Shasta County District Attorney investigators and charged with numerous felonies including grand theft, insurance fraud and petty theft, for allegedly collecting insurance premiums from clients and issuing bogus insurance certificates. The California Department of Insurance urges anyone who purchased insurance from Winkler to contact their insurance company and verify coverage.

“Winkler’s crimes are particularly offensive because he potentially victimized consumers twice,” said Insurance Commissioner Dave Jones. “When Winkler stole premiums from consumers and issued bogus insurance certificates, he left them vulnerable to additional loss because they actually did not have coverage for their car, home or business.”

The department received several requests for assistance from consumers who claimed that after paying Winkler for insurance coverage they did not receive the coverage promised. Two of the consumers contacted the insurance companies when they did not receive their policies and were told the policies were canceled for non-payment of premium. Other consumers who paid Winkler and received insurance certificates found out the certificates were allegedly fraudulent after the insurance companies confirmed the policy information on the certificates was bogus.

Investigators found that Winkler collected more than $6,000 from clients for workers’ compensation, general liability, and commercial automobile insurance coverage and allegedly failed to forward the premium exposing his clients to the risk of uncovered loss.

The Department of Insurance is taking enforcement action to suspend Winkler’s agent license and prohibit him from transacting insurance business. The department is also asking anyone that purchased insurance from Winkler and find they do not have legitimate coverage to contact the Consumer Hotline at 800-927-4357.

Winkler is currently out on $50,000 bail and is scheduled for arraignment in Shasta County Superior Court on January 6, 2014.

Court of Appeal Reverses Death Benefits Award

In 2008, Brandon Clark suffered back, head, neck and chest injuries when he fell from a roof while working for South Coast Framing. Brandon’s workers’ compensation physician prescribed amitriptyline, gabapentin (Neurontin) and hyrdrocodone (Vicodin) for his injuries. Brandon was also taking Xanax and Ambien, which were prescribed by his personal physician in January 2009. Xanax was prescribed for “ongoing anxiety,” and Ambien was prescribed for sleeping difficulties. Brandon’s personal physician noted that Brandon was “having problems sleeping. This [was] occurring at least 3 or 4 times a week . . . . During these times, [Brandon was] not aware of anxiety or . . . pain.”

In July 2009, Brandon died from the combined effects of amitriptyline, gabapentin, Xanax and Ambien, and associated early pneumonia. Brandon’s wife, Jovelyn Clark, and their three minor children filed a claim for death benefits alleging the death was the result of the injury and industrially prescribed medications.

The claimant supported her claim with the report of Dr. Bressler who concluded that “[Brandon’s] death was secondary to an accidental overdose.” In reaching this conclusion, Dr. Bressler stated, “[t]he specific combination of medicines [Brandon] was on, which included Xanax, Ambien, Flexeril, Neurontin, amitriptyline, and hydrocodone, all separately and in combination had the capacity to induce respiratory depression, and even respiratory arrest.” Thus there was a mixed cause of both industrial and non-industrially prescribed medications.

However the agreed medical examiner, Dr. Thomas C. Bruff, had a more detailed analysis of the interaction of the industrial and non-industrial drugs. “While there is some difference of opinion on therapeutic and toxic levels of the medications in this particular case, several conclusions can be made. While [Brandon] was prescribed a number of medications only amitriptyline, zolpidem, alprazolam, gabapentin, and acetaminophen were found in peripheral blood specimen. Gastric specimens showed both alprazolam and zolpidem. It is my opinion that gabapentin did not have a role in this particular case. Amitriptyline was prescribed in such low dose, and bloods levels show that the medication was likely taken as prescribed. However, zolpidem [(Ambien)] and alprazolam [(Xanax)] was found in excess of what would be normally considered peripheral blood concentrations. Both these medications work in a similar fashion and would be considered at least additive in their effects. It is my opinion in the case of [Brandon] that it is just this additive effect of zolpidem and alprazolam that caused sedation significant enough to result in the events leading to his death.”

“For clarity, it is my opinion that [Brandon] passed away as a result of the additive drug interaction between zolpidem and alprazolam. The two additional medications present in the bloodstream, gabapentin and amitriptyline, were not high enough to result in any coincident drug interaction.”

During his deposition Dr. Bruff recognized the limitations of toxicology by noting that mixtures of drugs are difficult to quantify. After repeatedly being pushed to calculate the percentage of amitriptyline’s contribution to Brandon’s death, Dr. Bruff stressed that no medical person could offer a precise percentage because “it would be closing your eyes and throwing a dart at a dartboard.”

A workers’ compensation judge concluded that Brandon Clark died as a result of medications he took after suffering an industrial injury. South Coast and its insurance carrier, Redwood Fire and Casualty Company administered by Berkshire Hathaway Homestate Companies petitioned for writ of review after the Workers’ Compensation Appeals Board denied reconsideration of the WCJ’s decision in favor of Brandon’s wife and children.  The Court of Appeal in the unpublished case of South Coast Framing v WCAB (Clark) concluded that the Board erred in denying reconsideration because the WCJ’s decision was not supported by substantial evidence. A physician’s report and testimony must demonstrate his opinion is based on “reasonable medical probability.” The Court supported the reversal on the following analysis.

“Here, Dr. Bruff admitted that it is difficult to make a “reasonable medical analysis” regarding amitriptyline’s precise contribution to Brandon’s death. He also stated that making that kind of determination ‘really gets to be speculative.’  Liberally construing Dr. Bruff’s testimony and report in its totality, we conclude the evidence did not establish industrial causation. Rather, the evidence demonstrates that if amitriptyline played a role at all, it was not significant such that it constituted a material factor contributing to Brandon’s death.”

“Lastly, we note that there is some dispute regarding whether Brandon was taking Ambien due to his industrial injury. Jovelyn testified that Brandon had trouble sleeping before his industrial injury and used Tylenol PM to help him sleep. However, the Tylenol PM was not working. In January 2009, Brandon’s personal physician prescribed him Ambien for his sleeping difficulties. The physician noted that Brandon was not experiencing pain during the times he had trouble sleeping. Brandon’s medical record indicates that around the same time, he used “pain medication mostly at night to help him get comfortable for sleep.” Based on our review of the record, the evidence is insufficient to establish that Brandon used Ambien as a result of pain from his industrial injury.”

Accordingly, the order denying reconsideration was annulled and the matter is remanded to the Board with directions to enter a new order denying the claim.

LAPD Police Officers Arrested for Comp Fraud

Two veteran Los Angeles Police Department officers were arrested this week after an investigation by the department’s Workers’ Compensation Fraud Unit. The story in the Daily News claims that investigators working with the Los Angeles County District Attorney’s Office determined that the officers had provided false testimony during depositions related to their industrial injury claims.

One of the police officers who was arrested was Jonathan Hall, a 19-year- old veteran last assigned to the Emergency Services Division. He surrendered Wednesday in response to an arrest warrant listing four felony counts of workers compensation fraud, insurance fraud, grand theft and attempted perjury, police said. Bail for the 45-year-old officer was set at $80,000. He is assigned to home pending the outcome of the criminal and administrative investigators.

Also arrested was Ralph Mendoza, a 13-year veteran, last assigned to the Hollenbeck Division patrol. He surrendered on an arrest warrant listing two felony counts of workers’ compensation fraud and grand theft. Mendoza, 44, who lives in San Bernardino County, was held on $40,000 bail. He has been relieved of duty pending the outcome of an investigation.

“Public trust is at the very core of the police profession, and when that trust is violated we must employ every measure to restore it,” said LAPD Chief Charlie Beck. “I am troubled whenever our officers are accused of violating that trust. As the chief, it is my duty to ensure that we fully investigate these cases of alleged misconduct and to take appropriate action when the misconduct is found to be true.”

Anyone with information related to this or any other case was asked to call the LAPD’s Special Operations Division at (213) 473-5672.

Lien Activation Fee Injunction Case Continued to January 16.

The PACER information on the Angelotti Chirporactic case reflects that the plaintiffs have appealed to the 9th Circuit Court of Appeals with respect to the two (of the three) causes of actions that were dismissed. The transcripts are being prepared. Surprisingly, there not yet any effort on behalf of the DWC to appeal the adverse ruling on the one cause of action that was favorable to the lien claimants. Plaintiffs are far more responsive and aggressive in the litigation thus far than is the DWC.

With respect to the hearing in December, here is the current docket entry. “The Court, on its own motion, CONTINUES the Status Conference previously scheduled for 12/23/2013 to 1/16/2014 at 08:30 AM before Judge George H. Wu.”

Thus the December 23 hearing will now take place on January 16. Nothing earth shattering will take place at a status conference. It operates much as it is named, except you must file a status documentation ahead of time. At the status conference, Judge Wu will remove frivolous planned activities, and cut to the chase. Essentially, there is likely no need for an evidentiary trial, as there is no significant factual dispute. If there is a factual dispute, Wu will likely order the parties to take depositions, or get affidavits of any potential witness, and will ultimately gear this case up for decision by way of summary judgment.

Thus, either at this status conference, or the next, the conclusion will likely be that there is nothing left to do to decide the case, and that the decision can be accomplished by way of summary judgment, and the case will simply be submitted

Meanwhile the dismissal of two of the three causes of action will be argued before the 9th Circuit Court of Appeals, It is not yet clear if the DWC will appeal the rruling granting a preliminary injunction precluding enforcement of the lien activation fee in January.

More Doctors Moving to Fee for Services Mode

A small but growing number of physicians are not accepting government insurance, such as Medicare and Medicaid, and are even refusing to accept patients’ private insurance, according to Dr. Jane Orient, executive director of the American Association of Physicians and Surgeons (AAPS). Orient says the transition to a business model in which patients agree to pay doctors directly for the health care services they provide started before Obamacare was passed, but that the new law has accelerated the trend, especially among AAPS’ 4,000 or so members. AAPS is the conservative alternative to the much larger American Medical Association (AMA), which endorsed Obamacare while AAPS opposed it.

“They like the freedom,” Orient, a Tucson-based internist, told CNSNews.com. “They don’t like third parties telling them why they can’t do what’s best for their patients. They’re tired of the constant threats of audits and prosecution, and they don’t like being owed money by government programs and many insurance programs. But the biggest complaint I hear is that they are tired of fighting people who don’t have a clue, and don’t even know how to spell the procedure they want to perform,” Orient added.”It just devours time and sometimes puts the patient’s life at risk.”

Some physicians never signed up with managed care insurance plans in the first place because the reimbursement levels didn’t cover their costs, she said. But now even doctors who “agreed to accept the crumbs, whatever compensation the government or the insurance companies decide to send them,” are having second thoughts as the costs of practicing medicine continues to climb and government regulations become even more onerous. “I get several calls a week from doctors seeking advice on how to opt out,” Orient told CNSNews.com. “They tell me that they either have to go out of business or go back to the old-fashioned practice of charging for their services.”

At least 100 physicians attend workshops and seminars AAPS sponsors twice a year on the subject. Former AAPS president Dr. Juliette Madrigal-Dersch, who started her cash-only practice in Texas 11 years ago, tells fellow physicians that she has more time and flexibility to spend with patients and is actually better compensated for it, even after offering a discount for “teachers and preachers” and free care for cancer patients. “I see billionaires and migrant workers, and everybody gets the same care,” she says. She charges $15 for a CBC (complete blood count), while the tax-subsidized “charity hospital” down the street charges $79. Medicare reimbursement is just $3.50 for the same test.

Madrigal-Dersch says that by not having to deal with third-party payers, she is able to establish “a true doctor-patient relationship,” enabling her to provide better care. For example, she says one of her patients would probably have died waiting for the Veteran’s Administration to approve an MRI for her brain tumor.

Doctors who stop accepting insurance typically lose patients and experience a drop in income, Orient said. Some never recover the revenue, but because they don’t have to pay people to process insurance claims, their overhead costs also decrease. “Before too long, they often find the move very positive financially as well as professionally because they are working less and making more money,” she pointed out.

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