A top-rated hospital in New York, an unapproved treatment and an F.D.A. certificate. Warning
A visiting scholar at NewYork-Presbyterian/Weill Cornell Medical Center was surprised when he read the Food and Drug Administration's warning about a product that had been used in surgeries of the spine in prestigious Manhattan. hospital.
The liquid, derived from umbilical cord blood, has not been approved for such procedures, the agency warned, and its manufacturer Idaho was cited for possible contamination issues and a lack of effectiveness. screening of donors, making the product potentially dangerous.
But before this notice, approximately 40 patients at the hospital had received treatment with this liquid under the direction of Dr. Roger Hartl. , senior surgeon and professor at Weill Cornell, who is also a physician for the New York Giants. The surgeries were documented in a proposed study that Dr. Härtl and others, including the visiting scholar, intended to publish, on the effectiveness of the fluid in fusing delicate bones.
After seeing the F.D.A. After this announcement, the researcher, Dr. Pravesh Gadjradj, approached Dr. Härtl and told him that the liquid "has not yet been proven to be safe," according to a complaint filed at the hospital and reviewed by the New York Times. The liquid fell under a growing area of treatment known as regenerative medicine, which aims to replace or restore damaged cells through gene and stem cell therapies.
In the complaint, Dr. Gadjradj said that Dr. Härtl asked him to "delete" the research file on the project and "never bring up the subject again." The researcher expressed concern that Dr. Härtl failed to inform patients, according to the complaint, and instead “covered up the matter.”
The cited conversation The complaint dates back to the spring of last year, Dr. Gadjradj said in an interview. In January, after months of concern for patients — and believing that they had still not been warned — Dr. Gadjradj filed a complaint against his boss.
Dr. Senior surgeon Roger Härtl used this treatment before the F.D.A. warning, as did doctors at other hospitals.Credit...Sipa USA via APYet, he said, nothing was learned from the alarm regarding the concerns of his patients... .
A visiting scholar at NewYork-Presbyterian/Weill Cornell Medical Center was surprised when he read the Food and Drug Administration's warning about a product that had been used in surgeries of the spine in prestigious Manhattan. hospital.
The liquid, derived from umbilical cord blood, has not been approved for such procedures, the agency warned, and its manufacturer Idaho was cited for possible contamination issues and a lack of effectiveness. screening of donors, making the product potentially dangerous.
But before this notice, approximately 40 patients at the hospital had received treatment with this liquid under the direction of Dr. Roger Hartl. , senior surgeon and professor at Weill Cornell, who is also a physician for the New York Giants. The surgeries were documented in a proposed study that Dr. Härtl and others, including the visiting scholar, intended to publish, on the effectiveness of the fluid in fusing delicate bones.
After seeing the F.D.A. After this announcement, the researcher, Dr. Pravesh Gadjradj, approached Dr. Härtl and told him that the liquid "has not yet been proven to be safe," according to a complaint filed at the hospital and reviewed by the New York Times. The liquid fell under a growing area of treatment known as regenerative medicine, which aims to replace or restore damaged cells through gene and stem cell therapies.
In the complaint, Dr. Gadjradj said that Dr. Härtl asked him to "delete" the research file on the project and "never bring up the subject again." The researcher expressed concern that Dr. Härtl failed to inform patients, according to the complaint, and instead “covered up the matter.”
The cited conversation The complaint dates back to the spring of last year, Dr. Gadjradj said in an interview. In January, after months of concern for patients — and believing that they had still not been warned — Dr. Gadjradj filed a complaint against his boss.
Dr. Senior surgeon Roger Härtl used this treatment before the F.D.A. warning, as did doctors at other hospitals.Credit...Sipa USA via APYet, he said, nothing was learned from the alarm regarding the concerns of his patients... .
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