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 British National Health Service, Economic Issues, FDA, Health Insurance, Healthcare financing, outcomes, outcomes measurement, Patient Choice, Patient Safety, Policy Issues, Protocols, Quality, Technology, Uncategorized

Should access to life-saving medicines be determined by economic evaluations? | TheHill

“My opportunity finally came. In April 2018, I was one of a few hundred cystic fibrosis patients to dose in a pivotal phase III clinical trial to evaluate a new drug designed to correct CFTR, the dysfunctional protein responsible for CF. The medication, two pills in the morning, and one at night worked almost immediately.

Within a few hours, the viscosity of my usually thick, sticky mucus changed; within a week, the constant cough I had lived with for my entire life nearly vanished, and within a month, my pulmonary function tests skyrocketed. I could finally breathe.

Instead of heading towards end-stage illness, disability income, and an end to my fight with cystic fibrosis, Trikafta, as the drug came to be named, saved my life.

A disturbing trend is washing over the United States, though. Insurers are using economic analyses based on a discriminatory cost-effectiveness metric called Quality-Adjusted Life Years (QALY) as negotiating leverage to limit access to life-changing medications.

A 2018 article in Health Affairs said, “QALY calculations inherently privilege treatments that extend the lives of those who can be restored to perfect health, and disadvantage the many who seek life-extending treatments despite having a disability or chronic condition that is not curable.”

But, QALY is not adequately able to quantify what happened in my own life — my journey from near end-stage illness and no hope for a future to correctly managed CF and entrance into an elite graduate program. Living in a world where I would not have had the chance to dose Trikafta sends a shiver down my spine.

That world, however, has existed in countries where QALY has been used to justify not covering CFTR modulators for people with CF. In the United Kingdom, the National Institute for Health and Care Excellence (NICE) makes QALY calculations to determine which medications are covered by the nation’s National Healthcare Service. In 2016, NICE decided that Orkambi, a previous CFTR modulator iteration, was not cost-effective for its citizens.”

https://thehill.com/opinion/healthcare/477547-should-access-to-life-saving-medicines-be-determined-by-economic

Posted in American Presidents, Disease Prevention, Education, FDA, government incompetence, Government Regulations, Nutrition, outcomes, Patient Choice, Patient Safety, Policy Issues, Prevention, Quality, Uncategorized

Watch “How the Government Made You Fat” on YouTube

Or AKA…

Stay in Your Lane:  Why the government should not parent the citizenry.

Posted in Disease Prevention, FDA, Government Regulations, outcomes, Patient Safety, Policy Issues, Uncategorized, Unsettled Science

Is the Sunscreen Scare Legitimate?

But just because something gets into your body doesn’t mean it’s bad for you. I know these compounds have chemical names, but the assumption that artificial compounds are worse for you than all of the other stuff we put in our bodies is known as the “naturalistic fallacy.” By way of comparison, the average blood level of caffeine after a cup of coffee is 50 times higher than the peak concentration of oxybenzone seen in this study. But that oxybenzone level is about seven times higher than the blood nicotine level seen after smoking a cigarette.

In other words, the fact that you can measure something in the blood doesn’t tell you anything about whether it is bad for you. We simply don’t know what the risk is. And we need to find out.

Personally, I wouldn’t call for a freeze on chemical sunscreens. These drugs have been used for decades and there have been no strong epidemiologic signals of harm. Quite the opposite, they have probably prevented uncounted cases of skin cancer.

The problem with studies like these is that the fear they engender may do more harm than the good science that results from them. Nothing has changed about the harm of UV rays since the publication of this study in JAMA; you still don’t want your skin exposed to them.

https://www.medscape.com/viewarticle/913130

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/