Dr. Hooman Noorchashm calls for FDA Deputy Director resignation over power morcellation conflicts

 American Recall Center
Oct. 30, 2014

Dr. Hooman Noorchashm, an outspoken critic of the use of power morcellators in gynecological operations, recently published an open letter calling for the resignation of Dr. William Maisel, the deputy director and chief scientist at the FDA’s Center for Devices and Radiological Health (CDRH). Dr. Noorchashm, a cardiothoracic surgeon at Brigham & Women’s Hospital and surgical lecturer at Harvard University, accuses Dr. Maisel of a conflict of interest.

As it pertains to the deadly hazard of gynecological morcellators in the United States and abroad, your primary stated mission as a strong industry advocate represents a clear conflict of ethical interest in guaranteeing patient safety. Under your leadership, the CDRH has failed to call for a ban on power morcellators, nearly two months after the data was clearly delineated and the victims presented at the FDA advisory – nearly one year after we raised an alarm from Boston, MA.¹

Dr. Noorchashm has been a central figure in the fight to ban power morcellation. When the FDA issued a safety communication recommending that patients talk with their doctors about power morcellation, Dr. Noorchashm criticized the FDA for not going far enough, arguing that a forced recall of power morcellators should be issued rather than simply advising people to talk with their doctors. To date the FDA has not issued such a mandatory recall, although Johnson & Johnson did voluntarily withdraw its Ethicon morcellation devices from the market, and several insurance providers have stopped covering morcellators as a surgical tool.
In his latest communication, Dr. Noorchashm accused the FDA of deliberately dragging its feet on a potential power morcellator ban.

It is now our understanding that the FDA may be delaying a final statement. This delay in a ban on power morcellators by the FDA is occurring despite the overwhelming evidence of deadly hazard. And many industry advocates appear to have been assured that FDA will not be banning the power morcellators from market.
[It seems] increasingly clear that this lethargy in FDA action to protect the public is directly related to industry lobby to which you, as a CDRH leader, have clearly stated your loyalty in the press.

Dr. Noochashm has called for Dr. Maisel “to do right by all those women harmed, resign from the CDRH and relinquish the responsibility to protect the public’s health to those of your colleagues at FDA with capacity and patient safety foremost in their highest priority.” The letter appeared as part of Dr. Noorchashm’s larger effort to build awareness about health risks related to power morcellation, which includes a petition on Change.org.
For Dr. Noorchashm, the power morcellation issue is both a matter of public health and one of personal interest. His wife, Amy Reed, an anesthesiologist at Beth Israel Hospital in Boston, received a morcellator-assisted hysterectomy in October 2013. A few days later, Dr. Reed learned that she had leiomyosarcoma, a rare form of soft-tissue cancer, and that the morcellation procedure may have worsened her prognosis. Since then, Dr. Noorchashm has been on a campaign to ban the use of power morcellators altogether.
Although it’s hard to predict how the FDA will respond to Dr. Nooschashm’s latest call for Dr. Maisel’s resignation—if the agency responds at all—the letter does seem to have drawn some attention to this important issue. Power morcellation has been discussed in recent days on popular shows like The Dr. Oz Show, and a number of articles have appeared in reputable publications like The Wall Street Journal and various health news outlets. Even if Dr. Maisel does not resign as Dr. Noorchashm wishes, at least more people are now talking about the potential problems of power morcellators.

UCSD doctor concealed six-figure pay from medical device company and used that company's products on his patient did nothing wrong; UCSD says he did nothing wrong

Dr. William Taylor, UCSD, implanted screws from a company that paid him a six-figure income and in which he owned hundreds of thousands of dollars in stock options. UCSD paid for his legal defense, saying he did nothing wrong. UCSD paid $1.75 million settlement to avoid trial.

It took longer to uncover some critical details that Dr. William Taylor, the surgeon, had not told the retired special education teacher or the university: He owned stock options worth hundreds of thousands of dollars in the company selling the spinal devices and had also collected six-figure annual fees from the same firm, the lawsuit said. Disclosure of such corporate payments is required by state law and university policy.

A lawyer for UCSD said Taylor did nothing wrong and denied that any patients were harmed. But the university last year paid Kitrosser $1.75 million to settle the case.

Dr. William Taylor got his medical degree from UCLA, whose medical school seems have particular problems with conflicts of interest.

UC system struggles with professors' outside earnings
Failing to report compensation from other sources leads to concerns about conflicts.
BY MELODY PETERSEN
OC Register
May 25, 2014

Doctors eventually solved the mystery of why Brenda Kitrosser suffered from unrelenting pain after her back surgery at a University of California hospital in San Diego.

A UCSD surgeon had implanted experimental screws and other hardware into her back, promising this would relieve her pain. Instead the devices pressed on her nerves endlessly, according to a lawsuit she filed later.

It took longer to uncover some critical details that Dr. William Taylor, the surgeon, had not told the retired special education teacher or the university: He owned stock options worth hundreds of thousands of dollars in the company selling the spinal devices and had also collected six-figure annual fees from the same firm, the lawsuit said. Disclosure of such corporate payments is required by state law and university policy.

A lawyer for UCSD said Taylor did nothing wrong and denied that any patients were harmed. But the university last year paid Kitrosser $1.75 million to settle the case.

The controversy over Taylor’s undisclosed compensation is not an isolated case. The University of California has repeatedly failed to discipline medical professors who did not disclose payments from drugmakers and medical companies.

Last month, after UCLA paid $10 million to settle a lawsuit that centered on undisclosed corporate compensation, the non-profit group Consumer Watchdog called on state Attorney General Kamala Harris to investigate how widespread the unreported payments have become.

In a letter to Harris, the Santa Monica-based consumer group said that evidence presented in the case had shown that the university’s policies were “either inadequate or unenforced.”

“Patients in UC hospitals deserve the most reliable surgical devices and medication,” the group wrote, “and they shouldn’t be treated as subjects in expensive experiments.”

Officials at UCLA and UCI said they have recently increased efforts to make sure professors comply with the rules. UCLA doubled its compliance staff and hired a chief compliance officer. UCI’s chancellor directed all medical faculty to certify they were in compliance with reporting requirements and not engaging in unauthorized outside activities.

Those changes came after a series of undisclosed compensation cases involving professors from across the UC system. In each case, the professors who received the payments were involved in promoting or encouraging the use of a company’s product at the same time they were treating patients. In all the cases except one, it was people from outside the university who discovered the undisclosed payments.

• In a Los Angeles courtroom last month, Dr. Robert Pedowitz, the former chair of UCLA’s orthopedic surgery department, testified that administrators retaliated against him after he tried to get surgeons to report their corporate payments – including one doctor who said he had received $250,000 from a device maker for just 20 days of work. Just before closing arguments, UCLA agreed to pay Pedowitz $10 million to settle the case. The university said administrators did nothing wrong.


Dr. Thomas Ahlering
FILE PHOTO: MARK RIGHTMIRE, ORANGE COUNTY REGISTER

• At UC Irvine, Dr. Thomas Ahlering received more than $100,000 since 2002 from a company selling a surgical robot, but put most of that money in his nonprofit foundation without disclosing it, the Register reported last year. University officials say they have since required Ahlering to turn over $4,000 of that money to the school.

• An investigation by U.S. Sen. Charles Grassley in 2009 found that UCLA spinal surgeon Dr. Jeffrey Wang had failed to report almost a half million dollars in compensation he had received from several companies. UCLA officials say Wang was required to turn over an undisclosed portion of that to the university.

Although some of the professors were required to return a portion of their undisclosed pay to the university, it’s not clear whether the universities disciplined them in any other way.

In Oakland, UC administrators said they have an obligation to encourage faculty to work with companies to develop new medicines and medical devices that can help the public. And they pointed to the policies that the university has long had in place to require faculty to disclose payments.

“We also recognize that more can be done to increase transparency and oversight,” said Steve Montiel, a spokesperson at UC’s Office of the President, “and we are reviewing our policies to determine how best to achieve these goals.”

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Under state law, UC faculty who are leading research must disclose publicly any payments or gifts they receive from the companies or other parties involved in those studies. They must also disclose how much stock or stock options they hold in that company.

According to university policy, all faculty also must disclose on internal annual reports how much time they are spending on outside activities, as well as how much they were paid for that work.