Author: WorkCompAcademy

Pfizer’s Senior Principal Scientist has quietly left the company, following allegations of data manipulation in several of her published papers.

Cancer researcher Min-Jean Yin was with Pfizer in LaJolla California for 13 years and published multiple scientific articles during that time. Now, the pharmaceutical giant is retracting five of them and correcting a sixth, after PubPeer raised suspicions of image duplication.

A private corporate inquiry found the images in Yin’s papers were in fact duplicates. Pfizer has recommended, along with the researcher herself, that the journals retract five of these articles on the efficiency of Pfizer’s own pharmacological enzyme inhibitors, and publish a correction to a sixth.

An article in Pharmaceutical Investing News says that this issue “image duplication” is rather prevalent in biomedical publications. In fact, recent research indicates that as much as 3.8 percent of them may contain inaccurate date. It’s an honest mistake most of the time – or at least in 50 percent of cases. Researchers accidentally replicate western blot images, for example – but they also deliberately splice and duplicate select, clinically promising, parts of a gel band.

The reported irregularities in Yin’s papers, according to watchdog blog For Better Science, included duplicated western blots and duplicated bands within western blots. The problem articles span a four year period, from 2010 to 2014.

Pfizer is keeping mum on the exact nature of the duplication and the circumstances around Yin’s departure. But while the company has only said that she is “no longer employed” at Pfizer, some suspect the researcher was let go – perhaps as a result of the image duplication incidents.

In September 2016, she joined Diagnologix, a small San Diego-based biotech startup. Once Pfizer’s Senior Principal Scientist, her business card now reads “general manager.”

C. Glenn Begley, former head of oncology and hematology research at Amgen, believes this latest example of flawed research is just the tip of the iceberg – not for industry specifically, but for all published science.

“These retractions appear to be intentional image duplication, but there’s an entire spectrum of flawed research published in journals at every tier,” Begley said in an interview last week.

While Big Pharma fraud attracts more attention, Begley said the incentives are far greater for academic scientists to exaggerate, “cherry-pick,” or deliberately bias their results. A 2013 study of 140 cancer research trainees found over 30 percent had felt pressure to confirm a mentor’s hypothesis, even when the science wasn’t there.

The Division of Workers’ Compensation has concluded its investigation into San Bernardino County’s handling of cases involving victims of the Dec. 2, 2015, terror attack at the Inland Regional Center, finding that denials for treatment have been rare and that delays were mainly attributed to doctors failing to submit the appropriate information.

State officials, in an eight-page report, concluded that a significant number of cases involved “a provider’s failure to provide an adequate clinical rationale or appropriate documentation to justify requests for extended or new prescriptions, extended or alternative therapies, or special equipment that veered away from standard medical treatment guidelines and limits.”

In a letter accompanying the report, addressed to Department of Industrial Relations Director Christine Baker from George Parisotto, acting administrative director for the Division of Workers’ Compensation, Parisotto noted that as claims matured, the county increased its scrutiny of treatment requests, leading to modifications and denials.

Until mid-April 2016, the county was routinely approving nearly all requests, according to the report.

“While the (independent medical review) decisions generally upheld the county’s actions, often because doctors failed to document or fully explain their requests, employees who were still suffering and expected their doctors’ recommendations to be followed were frustrated by the denials,” Parisotto wrote in his letter to Baker.

The report also stated that better documentation at the time requests were submitted might have reduced the number of denials and independent medical review requests.

State officials credited the county with hiring nurse case managers to facilitate treatment requests, according to a county news release.

In December, the Board of Supervisors allocated $100,000 to hire an outside firm to help expedite workers’ compensation claims by establishing the Workers’ Comp Claim Expediter Reserve fund.

Of the 2,146 requests for medical and psychological treatment and prescription medications for the 58 survivors, 2,000, or 90 percent, were approved, while two cases were neither approved nor denied, with one being classified as a “disputed liability” and another providing no information about the decision. Three percent of the requests received modified approval.

Among the 144 treatments that were denied, only nine were overturned on appeal – less than one percent of the total number of requests. In all, there were 68 appeals filed by 11 employees, according to the county’s news release.

The county denied claims of 25 employees alleging psychological injury from the terror attack, according to the report.

“According to the county, a common thread among these denials was that the employees were not present at the training center when the incident occurred,” the report states.

The report also noted that a large percentage of denied claims was concentrated among a relatively small number of providers, suggesting a “particular problem with certain providers and not typical or characteristic of interactions as a whole.”

Most people aren’t aware that surgeons are sometimes involved in multiple operations happening at the same time, and many patients might object to the practice if they knew about it.  The practice also raises questions about the correct payment formula under the Official Medical Fee Schedule.

In the study published in the Journal of the American College of Surgeons, researchers focused on what’s known as overlapping surgery, when a senior surgeon performs critical components of one operation at the same time that a trainee surgeon or physician assistant handles a non-critical portion of another procedure.

Only about 4 percent of the 1,454 people surveyed for the study had heard of overlapping surgery, the study found. Just 31 percent of them strongly supported the practice once it was explained, and nearly all of the participants thought patients should be told before surgery exactly what aspects of their operations might be handled by a senior surgeon or by a trainee, or resident, surgeon or an assistant.

“Surgeons should discuss overlapping surgery with patients beforehand and obtain their consent if this is part of their practice,” said lead study author Dr. Michael Kent of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston.

“Respondents understood that overlapping surgery allows surgeons to potentially perform more operations in a given day, so patients may not need to wait as long for their procedure,” Kent said. “They also understand that complications may occur when a surgeon’s attention is divided, and this may have an impact on patient safety.”

For the study, Kent and colleagues surveyed participants about their knowledge of overlapping surgery, their expectations regarding disclosure during the informed consent process and their willingness to have this type of surgery as a patient.

During the survey, researchers randomly selected one of three scenarios to illustrate what happens during overlapping surgery: a hip replacement, a procedure to remove a brain tumor or a heart valve replacement. All three scenarios offered similar descriptions of the roles filled by senior surgeons and assistants.

Overall, about 92 percent of respondents thought surgeons should document what portion of the operations they were present for, researchers report in the Journal of the American College of Surgeons.

After overlapping surgery was described, about 70 percent of participants thought the practice might be acceptable in certain circumstances, such as lower-risk procedures or in situations when an emergency occurred in another operating room.

The study focused on the more accepted practice of overlapping surgery, not situations, known as concurrent surgery, when one senior surgeon is in charge of crucial portions of two different operations at the same time.

Concurrent surgery, is rare and generally should be avoided unless there’s an urgent or unplanned situation, said Dr. Karl Bilimoria, director of the Surgical Outcomes and Quality Improvement Center at Northwestern University’s Feinberg School of Medicine in Chicago.

Overlapping surgeries, like the kind examined in the study, are more common and relatively safe, Bilimoria, who wasn’t involved in the study, added by email.

The Workers’ Compensation Appeals Board (WCAB) has adopted its final Rules of Practice and Procedure (Rules) implementing Senate Bill 1160 (SB 1160).

The Office of Administrative Law has filed the WCAB’s new Rules with the Secretary of State. The new Rules will become effective on March 26, 2017.

Any lien claimant who filed a lien before January 1, 2017 that was subject to a filing fee under Labor Code section 4903.05 is required to file a “Supplemental Lien Form and 4903.05(c) Declaration” on the form approved by the Appeals Board before July 1, 2017.

The Appeals Board has already approved the Supplemental Lien Form and 4903.05(c) Declaration for use as an e-form and lien claimants can use that form now. Lien claimants may wish to file this form in advance of the adoption of the rule requiring it and will not have to re-file the form once the rule goes into effect.

The Division of Workers’ Compensation (DWC) has posted frequently asked questions regarding the use of the lien form and Supplemental Lien Form and 4903.05(c) Declaration on its website.

As part of the regulatory process, the DWC held a public hearing on these proposed rules on January 4, and released a transcript of public comments made that day.

Steve Cattolica who represents the California Society of Industrial Medicine and Surgery, a couple other medical societies, as well as the California Workers’ Compensation Interpreters Association, and attorney Steve Rondeau who represents lien claimants both voiced concerns about retroactive requirements for lien documentation under the new rules. They said that some of the required information is not now available or known to the lien claimants since there was not previously a requirement that they collect this information.

Specifically they were concerned with the declaration requirement going forward under Labor Code Section 4903.05 ( c) ( 1) ( e). Lien claimants have to file a declaration under penalty of perjury stating that they have, documentation that treatment has been neglected or unreasonably refused and “many providers are having difficulty assembling this documentation.”

Pilar Garcia, the owner of Statewide Interpreters and Carolina Darond who works for the company both testified that the new requirements are running them out of the business after 19 years of providing interpreting services. Most their complains involve the inability to obtain pre-authorization for interpreting services from carriers and TPAs. Commissioner Sweeney probed their testimony and learned that most of their 315 interpreters are not certified as specified by SB 863.

Darond complained “It’s not fair whatever the rules are for interpreters. You’re putting it so difficult that we can’t do business anymore. And here comes — the other agencies are coming from the other states. Pilar was — it was the Statewide Interpreters for California back then. No, not anymore. Now we are requested by other agencies from the other states because they have the authorization. There’s no money difference between my rates and their rates. It’s the authorization what is changing the problem. They’re not giving it to us because they want to give it to One Call, and One Call is doing the monopoly of the business as you all — you all know that; right?”

The newly adopted Rules, and their related Final Statement of Reasons, are posted on the WCAB’s website.

A Washington lawyer at a prominent firm was arrested in a disguise while trying to sell a copy of a secret lawsuit involving a company that was under investigation by the U.S. Justice Department.

Jeffrey Wertkin was taken into custody in the lobby of the Hilton Garden Inn in Cupertino, California, where he believed he was about to collect $310,000 for selling a copy of the sealed whistle-blower lawsuit to the targeted company.

“My life is over,” Wertkin told the FBI agent. He was charged with Contempt of Court and Obstruction of Justice in violation of 18 U.S.C. § 401(3).

Attorney Wertkin had previously won a coveted job at the Justice Department in 2010. Working on cases related to health-care, he remained there until April 2016, when he left for a job at Akin Gump Strauss Hauer & Feld LLP in Washington. His government pay was about $150,000 per year. At a firm like Akin Gump, where Wertkin defended companies sued under the whistle-blower law, attorneys with his credentials earn as much as $600,000.

Wertkin believed he would hand a copy of a sealed federal Qui Tam complaint to an employee of the company, which was accused in the complaint by a whistle-blower of falsely billing the government. The Qui Tam civil matter was previously filed under seal in January, 2016, pursuant to 31 U.S.C. § 3730(b)(2) and pending before the Honorable Jacqueline Scott Corley in the San Francisco division of the United States District Court in the Northern District of California. Wertkin, who was wearing a wig and using the name of Dan, was met instead by an FBI agent, according to arrest documents unsealed on Feb. 6.

Prosecutors say Jeffrey Wertkin attempted to sell a whistle-blower’s confidential lawsuit against a Silicon Valley company. FBI agents want to know whether Wertkin, who left the government in April, got the lawsuit from someone inside the Justice Department and if he sold other secrets while working there, according to two people familiar with the matter who weren’t authorized to discuss it publicly.

Wertkin, who appeared in San Francisco federal court Feb. 1, was released on $750,000 bail, which was secured by real estate in Washington, D.C., located on 12th Street, Northwest, according to court filings.

The case began with an employee at an unidentified technology security company in Sunnyvale, California, getting a voice mail on Nov. 30. The caller left a phone number and said a sealed False Claims Act lawsuit had been filed against the company, according to the FBI.

When the employee dialed the number, the caller identified himself as Dan and said he could provide a copy of the complaint for a “consulting fee,” the FBI said. He mailed a redacted copy of the cover page to the employee, who notified the FBI. The agency verified that the case has been pending since January 2016.

The employee agreed to secretly record calls to Dan for the FBI. On Dec. 22, Dan said he would provide the full complaint for $300,000, the FBI said. Two weeks later, Dan suggested he get paid in untraceable bitcoins, and said buying the complaint would help the company “get out ahead of the investigation.” The employee unsuccessfully sought to negotiate a cheaper price for the sealed lawsuit, according to the court filings.

On Jan. 19, Dan outlined to the employee his plan to meet on Jan. 31 near Sunnyvale, boosting his price to $310,000 to cover his travel expenses, according to the filings. Five days later, the employee said a colleague named Bill would meet him with the money in a hotel lobby. Dan wanted Bill’s cell phone number to text the location. That proved his undoing.

Bill turned out to be FBI agent William Scanlon. As he had agreed, Scanlon wore a gray Titleist hat and carried a blue duffel bag into the lobby of the Hilton Garden Inn. Dan texted him to find the empty chair in the lobby graced with a newspaper, according to the filings.

The case is U.S. v. Wertkin, 17-70131, U.S. District Court, Northern District of California (San Francisco).