Posted in Access to healthcare, CDC, Disease Prevention, Education, Evidence-based Medicine, FDA, News From Washington, outcomes, outcomes measurement, Patient Choice, Patient Safety, Uncategorized, Unsettled Science

FDA to Study Hydroxychloroquine for COVID-19 | MedPage Today

The drug is currently approved for malaria and also for rheumatoid arthritis and systemic lupus erythematosus, which is its main use in the U.S. It’s therefore available to be prescribed off-label, and some clinicians have already said they’re using it on COVID-19 patients. But neither Hahn nor other task force members addressed whether enough hydroxychloroquine is on hand to treat large numbers of coronavirus cases. Convalescent plasma is another treatment the FDA is considering for COVID-19, said FDA Commissioner Stephen Hahn, MD.

Convalescent plasma and the immune globulin that it contains is another possible treatment the agency is considering, Hahn added. “FDA’s been working for some time on this,” he said. “If you’ve been exposed to coronavirus and you’re better — you don’t have the virus in your blood — we could collect the blood, concentrate that and have the ability, once it’s pathogen-free, to give that to other patients, and the immune response could potentially provide a benefit to patients. That’s another thing we’re looking at; over the next couple of weeks, we’ll have information and we’re really pushing hard to try to accelerate that.” Such treatments have been effective in Ebola, for example.

Source: FDA to Study Hydroxychloroquine for COVID-19 | MedPage Today

Posted in Education, FDA, Government Regulations, Medical Costs, Patient Safety, Policy Issues, Technology, U.S. Security, Uncategorized

Is that a Centipede I See in My Capsule?? | MedPage Today

Eban: They knew I was coming. They had let me come in, but I saw a very different world within these plants through whistleblowers. I worked with a lot of whistleblowers who had contacted me — or I had made contact with them — who were showing me documents, showing me photographs, giving me really the sort of gory details of what was happening in these plants and the kinds of crazy decisions that were being made like failing drugs, drugs that had glass particles in them were being approved to be dispensed. Broken down, rusted equipment that was leaving metallic fragments in pills. Those were being dispensed.

Illicit use of ingredients. You can’t just swap ingredients. But they had drugs that were dissolving improperly, so they just haphazardly changed things up to try to get better data to show the FDA. All of this was taking place in a kind of lawless regulatory environment. They’re not afraid of their own regulators. They’re afraid of the FDA, but what they have built is an elaborate system to trick the FDA. Our FDA has all but volunteered to be tricked because we announce our inspections in advance overseas. We give 3 months’ notice. They send in data fabrication teams.

https://www.medpagetoday.com/podcasts/anamnesis/84501

Posted in Capers, Disease Prevention, FDA, Government Regulations, Patient Safety, Policy Issues, Protocols, Uncategorized

Stem cell clinics co-opt clinicaltrials.gov to push unproven therapies – STAT

When a judge ruled last week that the FDA could stop the work of U.S. Stem Cell, the firm’s trials remained on clinicaltrials.gov; the postings were no longer actively enlisting patients, but they didn’t mention that the company’s injections had blinded at least four people, either.

Nor did a listing of a completed study sponsored by Cell Surgical Network include any indication that the FDA is seeking an injunction against that company, too.

Nor did the five entriesfrom StemGenex say anywhere that regulators had found the clinic’s marketing to be illegal in 2018.

What worries bioethicists and biologists is not just the crossing of governmental wires. It’s also these companies’ co-opting of a taxpayer-funded database to market therapies without proof of safety or regulatory review. To let such dubious vendors post on a federal website, the critics say, is to lend them an air of legitimacy they don’t deserve.

https://www.statnews.com/2019/06/11/stem-cell-clinics-clinical-trials-dot-gov/

Posted in Economic Issues, Education, Evidence-based Medicine, FDA, government incompetence, Government Regulations, Medical conditions and illness, Patient Safety, Policy Issues, Prevention, primary care, State Medical Boards, Uncategorized, War on Drugs

The Harmful Campaign Against Vaping and E-Cigarettes | International Liberty

At some point in the future, observers may joke that one side is willing to accept more smoking if one teenager forgoes vaping while the other side is willing to have lots of vapers if it means one less smoker.

https://danieljmitchell.wordpress.com/2018/11/12/the-harmful-campaign-against-vaping-and-e-cigarettes/

Posted in Education, FDA, News From Washington, Patient Safety, Prevention, Uncategorized

Kratom Now an Opioid, FDA Says

FDA scientists analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid analgesics, such as morphine derivatives. They also found that compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.

“Based on the data we now have, we feel confident in calling these compounds opioids,” Dr Gottlieb said.

https://www.medscape.com/viewarticle/892375