Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, November 2, 2012

High Standards for FDA leaders?

                Police & Fire
William Maisel is one of three men who pleaded guilty to charges of soliciting prostitution during a sting carried out by the Howard County Police Department.
                By Brian Hooks
                September 25, 2012

Dr. William Maisel, the cardiologist and Food and Drug Administration (FDA) official charged by the Howard County Police Department in July with soliciting a prostitute, recently pleaded guilty in district court.

Maisel is the deputy director of the Center for Devices and Radiological Health (CDRH), which has become embroiled in an employee-spying scandal. He received one day of probation and paid $257.50 in fees and courts costs, according to T. Wayne Kirwan, spokesperson for the Howard County State's Attorney's Office.

Maisel's one day of probation ended on Friday, Sept. 21, according to Kirwan.  

According to charging documents from district court, an undercover female police officer approached Maisel at a restaurant on Route 1 in Jessup and asked him if he wanted "a date." Maisel agreed and asked how much it would cost for sex.
Three of the other men arrested in the prostitution sting also pleaded guilty and received probation, according to Kirwan, but only one faces probation longer than two days. Five additional men charged are still facing court dates.  

In a matter unrelated to Maisel's arrest, the National Whistleblower Center (NWC) is asking whether the charges against him are indicative of his involvement in the FDA surveillance activity, reports The Washington Post.  

According to the NWC, Maisel was responsible for firing Ewa Czerska–one of the FDA employees observed in the surveillance–and the whistleblowers are asking whether Maisel's work will be investigated, reports The Post.  

FDA spokesperson Erica Jefferson told The Post that the administration considers the solicitation charges "a personal matter" that would not affect his work.

Larry Husten, Contributor to Forbes
PHARMA & HEALTHCARE | 8/01/2012 @ 3:34PM
Cardiologist William Maisel, the deputy director for science at the FDA Center of Devices and Radiological Health, was arrested on prostitution charges after being caught in an undercover sting operation in North Laurel, Maryland. Maisel was one of 10 men arrested on July 13.
The Savage-Guilford Patch reported that Maisel ”approached a plain-clothed female police officer and offered money for sex.” He is scheduled to appear in Howard County District Court on Sept. 20.
According to Pharmalot, the news ”was greeted with a mixture of shock and sadness inside the FDA, which is treating the incident as a personal matter, according to an FDA spokeswoman. The arrest, she tells us, ‘has nothing to do with the work he is doing here.’” Maisel did not respond to a request for comment from Pharmalot.
Prior to joining the FDA Maisel had been the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School. Maisel was a vocal advocate for better safety measures and FDA reform in the wake of the recall of the Sprint Fidelis ICD lead recall.

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