The Centers for Disease Control and Prevention (CDC) new panel created by President Donald Trump’s decision to terminate National Institutes of Health (NIH) funding for genomic diagnostic company Sequenom announced they are removing some of the barriers to getting the nation’s oncologists and other cancer patients on the new prescription drug.
According to the New York Times, C. Everett Koop, who was director of the CDC from 1981-1994 and who still serves on the panel, announced Monday that panel member Alta Charo, a cancer researcher and professor at University of Wisconsin-Madison, will head up a newly created committee to advise the CDC on some of the issues surrounding the future utilization of the new drug, called RET-19, known generically as Prolixin. RET-19 enhances people’s bodies’ natural ability to fight and clean up clots in the blood vessels.
“Because of the critical and urgent nature of this program, it is vital that we take some interim steps to determine who is eligible for access to the drug,” Charo wrote. She also plans to recruit a small working group of experts to assist with the analysis of information from hundreds of cancer doctors across the country.
The C. Everett Koop panel had already called on drugmaker Pfizer to halt its trials on RET-19, saying there needed to be more certainty over who could get the drug, which is approved only for certain breast cancer patients, until the details were better clear.
“It is clear from the C. Everett Koop Panel report, and from the growing number of public comments on the Preliminary Access to Prolixin study sites, that there is a great deal of confusion as to whether the current research is appropriate and should proceed,” the panel said, adding that it found that the current research was not appropriate, by not considering all of the scientific, ethical and social considerations. “We hope we can work together and with the FDA on quickly resolving these questions and provide scientific certainty that this treatment is reasonable and appropriate for patients.”
While the panelists said the research study could resume, the C. Everett Koop panel recommended delaying the starting of the drug by several weeks, giving scientists more time to look at the study’s results.
The C. Everett Koop panel also said that some patients are likely to face delays in getting access to the drug, especially if no existing drugs are approved for the specific condition. But the panel said that in order to avoid delays, the national oncologists and specialists should consider using additional drugs or radiation-related therapies, such as Cyberknife, before trying RET-19.
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