I was gonna make a coronavirus treatments thread, but I think I'll wait for a study or two to be released, there should be a couple coming out soon. Here are the kinds of things that would be posted there though, along with basic scientific information that will inform those interested. Treatments are coming soon, indeed convalescent plasma is being used now, while trials are underway for covid -19 efficacy and it will most likely be the first effective treatment deployed this summer,
we await proper studies and clinical trials. Why you might see this treatment deployed first is that there are no real ethical issues with using it any more than giving a patient a regular plasma transfusion and that happens everyday.
More public policy and science, scientists should be making the calls and not psycho politicians, con men, syncopaths, or greed driven CEO's.
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A Yale researcher poised to start a crucial clinical trial received an ominous email from a pharmaceutical company. “There is undoubtedly a financial motivation,” he said—and there could be millions on the line.
www.vanityfair.com
“I Take That as a Threat”: Big Pharma Is Meddling in the Race for a COVID-19 Treatment
A Yale researcher poised to start a crucial clinical trial received an ominous email from a pharmaceutical company. “There is undoubtedly a financial motivation,” he said—and there could be millions on the line.
BY
DIANA FALZONE
APRIL 24, 2020
The race to develop a COVID-19 vaccine is well underway, but given its extended timeline—12 to 18 months—the search for an existing drug to treat the virus is almost equally pressing. For many on the right, including the president, the method of choice was hydroxychloroquine, a malaria drug initially thought to combat the infection. But with a damning study out showing the drug is basically ineffective, and in fact may lead to increased death rates, even Fox News has quietly dispensed with that theory.
In New Haven, meanwhile, Dr. Joseph Vinetz, an infectious disease doctor at Yale School of Medicine, is seeking to launch a clinical study of the drug camostat mesylate, a generic medication approved in Japan to treat chronic pancreatitis that he hopes can be approved and marketed to treat COVID-19. If the trial succeeds, he said, this could be ”a total game changer.” But the process is proving fraught. Within hours of registering his trial on a National Institutes of Health website on April 20, he received an email from a large U.S. pharmaceutical company. “They are trying to take my project and engulf it for their proprietary [financial] gain,” Vinetz told me. “I take that email as a threat.”
Unlike hydroxychloroquine, camostat is a drug researchers believe may have promising effects on COVID-19. It’s also being studied in countries including Germany and Denmark. “The virus that causes COVID-19 requires a protein to get inside of the cells that line the respiratory tract,” Vinetz explained. In test tubes and in mice, he said, camostat has been shown to inhibit an enzyme that allows the virus to enter those cells. Another published experiment showed that camostat prevented mice from dying of the SARS virus. As of yet, there’s no data that shows how it could impact the novel coronavirus in humans. But if Vinetz’s study is successful, he hopes camostat can be administered both to infected COVID-19 patients and as a preventative.
The drug is manufactured in Japan; Ono Pharmaceutical, a massive company headquartered in Osaka, has committed to providing enough camostat pills for 300 patients over the course of Vinetz’s study. All he needs is FDA approval for the trial and his staff can begin testing. “We will be enrolling patients to come in daily for a swab test, receive medication, provide a symptom survey to ensure safety, and to look at any improvement [or lack thereof] after the drug or placebo is given,” he explained. “We will be closely following all participants, including looking at their oxygen levels by pulse oximeter to make sure that they do not need to be hospitalized.”
The email Vinetz received on April 20, after he registered the trial, threatened to throw a wrench in proceedings. In the email, a copy of which was reviewed by the Hive, a representative for a large pharmaceutical company wrote that the company was itself “exploring the opportunity with BARDA,” the Biomedical Advanced Research and Development Authority, “and others to conduct clinical trials testing camostat mesylate in COVID-19,” and noted that it has an “open IND,” essentially a permission slip from the FDA to conduct a clinical trial. The email proposed that Vinetz, who has applied for an IND but has not yet received it, would need access to data the company has received through its IND, and that he’d need a letter of authorization from the company to get it. “We would appreciate gaining a better understanding of your study,” the email continued, proposing a call to discuss the matter.
Vinetz said he interpreted the email to mean “you have to go through us.” “They seem to want me to have to work under their authorization,” he said. “I viewed it as a threatening email,” he reiterated. “There is undoubtedly a financial motivation.” He theorized that the company might be hoping to get camostat designated as an orphan drug. The Orphan Drug Act, which Congress passed in 1983, uses financial incentives to encourage the development of drugs that treat rare diseases. Among other things, said Dr. Marion Mass, a Philadelphia-based pediatrician and cofounder of Practicing Physicians of America, the act gives drug makers seven-year market exclusivity (meaning no other company can advertise the same version of the drug), a 50% tax credit on the cost of conducting clinical testing, and access to grants to conduct that testing.
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