Tag: 2013 News

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.

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).

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.

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.

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.