Healthy Skepticism Library item: 3069
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Harris G.
F.D.A. Bars Imaging Drug After Deaths
New York Times 2005 Dec 20
http://www.nytimes.com/2005/12/20/politics/20drug.html
Keywords:
NeutroSpec
Notes:
Ralph Faggotter’s Comments:
Here we have a dangerous test looking for a disease to diagnose.
It found appendicitis, but unfortunately it turned out that the position was already taken.
Appendicitis is usually diagnosed by taking a good history and doing some low-tech tummy poking.
Sometimes a white cell count or ultrasound are helpful for diagnosis.
But NeutroSpec is entirely unnecessary and is a good example of technology for the sake of technology- making doctors feel clever but profiting no-one except the manufacturer and distributor.
Full text:
http://www.nytimes.com/2005/12/20/politics/20drug.html
THE NEW YORK TIMES
December 20, 2005
F.D.A. Bars Imaging Drug After Deaths
By GARDINER HARRIS
WASHINGTON, Dec. 19 – Federal drug regulators on Monday removed from the market a radiological drug called NeutroSpec after 2 people died and 20 others became gravely ill moments after receiving it.
NeutroSpec is injected and used to find internal infections, like appendicitis. Palatin Technologies, the drug’s maker, had hoped that changing its label and sending a Dec. 5 letter to physicians alerting them to the deaths would be enough to satisfy the Food and Drug Administration, said Carney Duntsch, a company spokeswoman.
But F.D.A. officials insisted on a withdrawal, and Palatin and its marketing partner, Mallinckrodt, agreed to suspend sales. Stocks of the drug should be returned to Palatin, the agency said.
Besides the 2 deaths and 20 serious reactions, 46 other patients experienced “similar but less severe events,” said Sandra Kweder, deputy director of the agency’s new-drug office. In most cases, patients suffered cardiovascular problems like a heart attack or a sudden drop in blood pressure.
Those who were most severely affected in most cases already had heart problems, Dr. Kweder said. Neither the F.D.A. nor the company knows why the drug caused these problems, they say. Eleven thousand patients have received the drug, Dr. Kweder said.
Before the drug was approved, Palatin completed a clinical trial in 523 patients. While some of those patients experienced mild shortness of breath and a brief drop in blood pressure, there were no significant problems reported, Dr. Kweder said. “We will be working closely with Palatin to try to understand what is causing these events,” she said.
NeutroSpec is likely to still be available to patients enrolled in a clinical trial, Dr. Kweder said. The drug was approved in 2004 exclusively for use in diagnosing appendicitis. But physical exams and standard imaging tests are normally adequate in diagnosing that infection.
So NeutroSpec is most commonly used by physicians to diagnose other infections like those in bones. The medicine is a monoclonal antibody with a small radioactive signaler attached. When placed into patients’ bloodstreams, the medicine attaches itself to white blood cells, which are immune agents that fight infections. X-rays can then be used to uncover gatherings of white blood cells, showing where an infection is located in the body.
Monoclonal antibodies were discovered decades ago, and researchers once hoped they would become the key to curing many diseases, including cancer.
Copyright 2005The New York Times Company
