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Tuesday, September 3, 2019

Death Certificate Project Accuses 64 Calif. Doctors

The so-called Death Certificate Project initiated by the Medical Board of California that began in 2015 has now resulted in formal accusals of wrongdoing filed against 64 physicians related to their drug prescribing, primarily involving opioids, newly updated records show.
Five of the 64 have surrendered their licenses; six others were put on probation, and eight received public reprimands.
These are out of a total of 469 physicians investigated for excessive prescribing because of patients’ overdose deaths in 2012 or 2013.
Two of the 64 accusations were withdrawn, according to statistics released by the board last week.
The remaining 43 physicans of the 64 accused still await final decisions; half of these have been hanging more than 7 months and five for nearly a year.
Beyond the 64 doctors against whom an accusation had been filed, another 11 of the 469 are still under investigation. It remains to be seen whether a round orange gavel signifying a disciplinary action will mark any of their profile pages.
The agency’s investigators continue to prowl the state Department of Justice’s prescription drug database to identify doctors who prescribed opioids to a patient who, according to a death certificate, fatally overdosed in 2012 or 2013, even as long as three years after that doctor wrote that script, and not necessarily from the same drug the doctor prescribed.
Separate investigations were conducted of 72 nurse practitioners, physician assistants, and osteopathic physicians — who are governed by different state boards — but the results of those were not immediately available.
In the next leg of the investigation, the medical board, which licenses some 140,000 physicians, will scrutinize practices of doctors whose patients fatally overdosed in 2016 and 2017, when presumably far more conservative opioid prescribing had replaced more liberal practices and as the extent of addiction potential and lethality of these drugs was better understood.
‘Witch-hunt’
The project is intended to stop overdoses and save lives. But it has been harshly lambasted by some doctors as a “witch hunt.” It also has disrupted practices by many physicians who — prior to 2014 — were abiding by the now outdated mantra that patients’ pain complaints should be aggressively treated with whatever it takes.
Many representatives of organized physician groups said the project is now hurting patients in pain trying to get relief. Pain specialists’ waiting lists have backed up and increasing numbers of primary care providers refuse to prescribe opioids in fear that years later, a patient death — even by suicide — may put their licenses under public scrutiny as well.
But Kimberly Kirchmeyer, the medical board’s executive director, defended the project. In an e-mailed statement, she said it “is helping the board meet its mission of consumer protection in a proactive way.” She added that her agency “will continue to find ways to improve this process.”
In remarks to the board during its January meeting, Kirchmeyer gave more detail. She said expert reviewers looked for high-dose opioid prescribing patterns that included morphine equivalencies greater than 90 mg, opioids in combination with sedating drugs like benzodiazepines, Soma, sleeping pills, and other unsafe combinations of medications. Additionally, the reviewers zeroed in on doctors who prescribed dangerous drugs frequently, “and other red flags.”
A welcome change?
Perhaps not surprisingly, consumer advocates have applauded the Death Certificate Project for calling out doctors with reckless prescribing habits.
Carmen Balber, executive director of Consumer Watchdog, spoke from “the injured patient’s perspective,” saying, “Doctors in this state are accustomed to weak or non-existent regulatory oversight. For patient safety, it’s about time that the medical board started acting to proactively investigate the opioid crisis.”
In many accusations she’s read, dangerous prescribing practices are obvious. “Patients are not getting medical exams. Doctors are not confirming the injuries the patients came forward with. Doctors are prescribing wildly excessive doses of medications. Even to a lay person it seems blatantly obvious that action should have been taken,” Balber said.
Patient safety activist Eric Andrist of Los Angeles, who started the newer Patient Safety League which posts stories about medical harm and patient experiences, travels around the state to every medical board meeting to complain that the agency is too soft, allowing hundreds of dangerous doctors to get off with no more than a slap on the wrist. He said he’s pleasantly surprised the board tackled the opioid issue in the first place.
“They’ve always said that they don’t and won’t look for cases themselves … and only act on complaints brought to them,” he said. Without this initiative, these doctors would never have been punished or called out. He also praised the yield of 19 accusations resulting in disciplinary action to date — even with 43 more to go — because by his count the agency’s average is much lower.
Five licenses surrendered
Among the most egregious cases, those that prompted five physicians to surrender their licenses, departure from the standard of care was especially well documented.
In the longest accusation, a 63-page petition to revoke the license of Frank D. Gilman, MD, of San Diego, the board listed hundreds of prescriptions written for four patients. He prescribed 370 prescriptions for one of them, and of those more than 200 were for oxycodone. Two of his patients died from overdoses. Gilman was accused of gross negligence, repeated negligent acts, incompetence, repeated acts of clearly excessive prescribing, and failure to maintain adequate and accurate medical records.
John Winthrop Pierce, MD, of San Francisco, surrendered his license after one of his patients died of an overdose of hydrocodone. The board’s 28-page accusation said that he had prescribed a long-acting combination of fentanyl and morphine for another patient who had exhibited suicide ideation, and overall prescribing behavior that constituted gross negligence and repeated negligent acts.
Robert M. Littman, MD, of San Diego, also surrendered his license after the board’s accusation said that his treatment of a patient, who was found dead at her home from “carisoprodol, lorazepam, oxycodone, zolpidem and trazodone toxicity” with traces of amphetamines and clonazepam, constituted “gross negligence.” The patient had received prescriptions from multiple doctors, and “doctor shopped,” but Littman had failed to conduct toxicology screenings and had not checked the prescription database to see what other prescriptions she had been getting.
Philipp Leo Bannwart, MD, of Zermatt, Switzerland, surrendered his license after the board found fault with his treatment of a patient in Concord, near San Francisco. She died of “acute methadone intoxication.” The board accusation says that Bannwart wrote combination prescriptions for her, including methadone, Percocet, Norco, and promethazine-codeine syrup, constituting what the board called “gross negligence, repeated negligent acts/incompetence/improper prescribing without an appropriate prior examination and medical indication.”
Daniel George Clark, MD, of Auburn, surrendered his license after the agency found that a patient died after Clark increased dosages of fentanyl, which it labeled “gross negligence.”
Probation and public reprimand
Six accused physicians were placed on probation for periods of 3-7 years: Ashmead Ali, MD, of California City; Jay Milton Beams, MD, of Susanville; Harold Budhram, MD, of Shasta Lake; William Lee Matzner, MD, of Simi Valley; Michelle Anne Orengo-McFarlane, MD, of Martinez; and Ilona Sylvester, MD, of Thousand Oaks.
Another eight physicians were formally reprimanded and ordered to take courses on prescribing practices and, in most cases, medical record-keeping: Alyn Gary Anderson, MD, of Huntington Beach; Michael S. Basch, MD, of Temecula; Jose Rosendo Cesena, MD, of El Cajon; Vorakiat Charuvastra, MD, of Los Angeles; Moshe Miller Lewis, MD, of San Francisco; Diana Maria Prince, MD, of Rohnert Park; Charles Yang, MD, of Huntington Beach; and Tahir Yaqub, MD, of Atwater.
Still-pending accusations against the remaining 43 physicians can be read here.
The California Medical Association did not respond to a request for comment about the current status of the Death Certificate Project. But in an interview late last year, David Aizuss, MD, CMA president and an ophthalmologist from Encino, criticized the board for going after doctors because of how they prescribed controlled substances before 2014. “I don’t think it’s appropriate to apply our current clinical guidelines to what was going on six or seven years ago,” he said then.
Asked why the investigations take so long, medical board spokesman Carlos Villatoro replied that for the latest fiscal year ending June 30, 2018, it took an average of 322 days after an accusation was filed for the case to conclude without compromising due process. He added that the process involves the Attorney General’s office and the office of administrative hearings, both of which are outside the board’s control, he said.

Orphan Drug Tag to Puma Bio Med for Breast Cancer with Brain Metastases

Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to NERLYNX® (neratinib) for the treatment of breast cancer patients with brain metastases.
“Receiving Orphan Drug Designation from the FDA signifies our continued progress and commitment to developing treatments for patients with HER2-positive breast cancer,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “Despite expanded treatment options for HER2-positive breast cancer, brain metastases in these patients represent a significant clinical challenge, as well as sources of morbidity and mortality for most of these patients. The blood-tumor penetrability of NERLYNX represents a potential treatment option for these underserved patients.”
The FDA Orphan Drug Designation program grants orphan designation to investigational drugs designed to treat, prevent, or diagnose rare medical diseases or conditions that affect fewer than 200,000 individuals in the United States. Orphan designation qualifies sponsors for several key benefits and incentives, including opportunities for grant funding towards clinical trial costs, tax credits, user fee waivers, and the potential for a seven-year period of marketing exclusivity upon FDA approval of the investigational drug for the indication for which it has orphan designation.

Castle Biosciences EPS misses by $0.57, beats on revenue

Castle Biosciences (NASDAQ:CSTL): Q2 GAAP EPS of -$1.05 misses by $0.57.
Revenue of $10.74M (+169.2% Y/Y) beats by $3.26M.

China says has only ‘limited’ cooperation with U.S. on fentanyl

China and the United States have only “limited” cooperation in stopping fentanyl smuggling, a Chinese narcotics official was quoted as saying on Tuesday, after complaints China isn’t doing enough to help fight an opioid crisis in the United States.
U.S. officials say China is the main source of illicit fentanyl and fentanyl-related substances that are trafficked into the United States, much of it through international mail. China denies that most of the illicit fentanyl entering the United States originates in China.
U.S. President Donald Trump last month accused Chinese President Xi Jinping of failing to meet his promises to crack down on the deluge of fentanyl and fentanyl analogues flowing into the United States. China labeled that “blatant slander”.
Fentanyl is a cheap, relatively easy-to-synthesize opioid painkiller 50 times more potent than heroin that has played a major role in a devastating U.S. opioid crisis.
Liu Yuejin, Vice Commissioner of the China National Narcotics Control Commission, told a news conference that China was cracking down on illicit fentanyl production, state television reported.
“The National Narcotics Control report states that looking at cases, counter-narcotics law enforcement departments from China and the United States have for many years maintained a good cooperative relationship,” the report cited Liu as saying.
“But cooperation on investigating and prosecuting fentanyl-related substances is extremely limited.”
Since 2012, the United States has only reported “clues” on six fentanyl-related smuggling cases to China, with only three of these cases successfully cracked, the report added.
Since May 1 of this year, when China tightened controls on fentanyl-related substances, China has not yet discovered a single fentanyl-related smuggling case, Liu said.
Liu reiterated previous government denials that China is the source of most of the fentanyl smuggled into the United States.
China has told the United States it needs to get its house in order when it comes to tackling fentanyl abuse, and should do more to reduce demand.
The U.S. Treasury last month imposed sanctions on three Chinese men accused of illegally trafficking fentanyl, acting three weeks after Trump accused China of reneging on pledges to stem the flood of the highly addictive synthetic opioid into the United States.
The National Institute of Drug Abuse reported earlier this year that 130 people die every day in the United State after overdosing on opioids, which include prescription pain relievers, heroin and synthetic drugs like fentanyl.
The dispute over fentanyl comes as the United States is in the middle of a major trade dispute with China.

ShockWave Medical down 10% on bearish Cliffside report, lockup expiration

ShockWave Medical (SWAV -10.4%) is down on a 7x surge in volume in apparent response to a report from Cliffside Research that rates the stock a Strong Sell with a $23 (39% downside risk) price target citing its  heady valuation and the expiration of the lockup period today.

Zealand Pharma advances BI 456906 to mid-stage clinical test in obesity/diabetes

Boehringer Ingelheim plans to initiate Phase 2 development of the GLP-1/glucagon dual agonist BI 456906, which was in-licensed from Zealand Pharma (NASDAQ:ZEAL).
The dual agonist BI 456906 is a part of Boehringer Ingelheim’s pipeline portfolio in the obesity and diabetes disease areas.
The Phase 2 trial for BI 456906 is expected to be initiated in late 2019 and will trigger a €20M milestone payment to Zealand Pharma out of total outstanding potential milestone payments of €365M and high single to low double digit royalties on future sales.

Amarin up as European CV groups include Vascepa in practice guidelines

The European Society of Cardiology and European Atherosclerosis Society have updated their clinical practice guidelines for managing dyslipidemias to include finding from the REDUCE-IT study, including the recommendation that Amarin’s (NASDAQ:AMRN) Vascepa (icosapent ethyl), 2g twice daily, be considered for high-risk patients with cardiovascular (CV) disease with triglyceride levels between 135 mg/dL and 499 mg/dL despite treatment with statins.