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.
If there is a violation, the FDA classifies it in one of two ways: Voluntary action indicated (VAI) means the inspectors have found violations, but the problems aren’t serious enough to require sanction. Official action indicated (OAI) means that the inspectors have found violations significant enough to warrant official action.
Siefe and his assistants used the Freedom of Information Act to request information from the FDA, and supplemented that data with Google searches of the FDA database. They found 57 clinical trials that were directly linked to an OAI inspection.
The misconduct identified by the FDA in these cases included:
Falsification or submission of false information
Underreporting of adverse events
Failure to follow the investigational plan or other violations of protocol
Inadequate record keeping
Failure to protect the rights, safety, and welfare of patients
Use of experimental compounds in patients not enrolled in trials
Failure to supervise clinical investigations properlyThe 57 trials Seife identified were in turn linked to 78 research articles published in the peer-reviewed scientific literature. 96 percent of these articles failed to mention the violations identified by the FDA inspection—despite the fact that in the majority of cases the inspection was completed at least 6 months before the article was published.
Unsurprisingly, older Americans believe that children should be vaccinated against diseases like measles, mumps and whopping cough, by a 73 percent to 21 percent margin. Americans 18-29, by contrast, believe by a 43 percent to 42 percent plurality that government should not mandate such vaccinations.
That’s because young people don’t remember a time when such diseases claimed lives. They don’t remember a time when the vast majority of Americans weren’t vaccinated. Older people do. Many of them lost loved ones to polio and measles and mumps and rubella. In 1952, over 3,000 Americans died of polio and well over 21,000 were left with mild or severe paralysis. Thanks to Dr. Jonas Salk’s vaccine, there have been zero cases of natural polio in the United States since 1979.
The same is true of measles. According to Dr. Mark Papania of the Centers for Disease Control and Prevention, more than 90 percent of Americans suffered from the measles by age 15 before widespread vaccination beginning in 1962. From 1956 to 1960, he reports, “an average of 542,000 cases were reported annually.” That included 450 deaths per year, as well as 150,000 cases of respiratory complications and 4,000 cases of consequent encephalitis per year, many of which resulted in later death. Then mandatory vaccination kicked in. Until a major upswing in 2014, we averaged less than 100 cases of measles per year in the United States since 2000.
The point of mandatory vaccinations is not merely to protect those who are vaccinated. When it comes to measles, mumps and rubella, for example, children cannot be vaccinated until 1 year of age. The only way to prevent them from getting diseases is to ensure that those who surround them do not have those diseases. The same is true for children with diseases like leukemia, as well as pregnant women. Herd immunity is designed to protect third parties.
But Americans have short memories and enormous confidence in junk science. Parents will ignore vaccinations but ensure that their kids are stocked up with the latest homeopathic remedies, Kabbalah bracelets and crystals. St. John’s wort, red string and crystals all existed before 1962. They didn’t stop the measles. Vaccination did.
It is true that spending for the CDC has dipped ever so slightly since 2011, but the cuts followed years of massive increases. Overall, since 2000, CDC outlays have almost doubled, from $3.5 billion to $6.8 billion in 2014 constant dollars. Moreover, in January, the Republican-controlled House actually passed legislation that increased CDC spending for 2014 by $567 million — $300 million more than was requested by President Obama.
It’s not that the CDC hasn’t had money, it’s that the money has been spent on things that have little or nothing to do with the agency’s mission of protecting Americans from health threats.
As the agency’s mission statement says in part, “Whether diseases start at home or abroad, are chronic or acute, curable or preventable, human error or deliberate attack, CDC fights disease and supports communities and citizens to do the same.” Seems straightforward enough. There is, after all, a reason for the disease in the CDC’s name.
Yet, while the agency still might not have been prepared for an Ebola outbreak, President Obama did restart its push for gun control. Over the last decade, in fact, the CDC has spent much of its time — and money — studying seat-belt use, infant car seats, and obesity. These may or may not be worthy topics, but this focus makes it somewhat harder for Democrats to turn around and blame budget cutting for a lack of attention to the things that the CDC is actually supposed to do — like protect us from contagious diseases.
Constitution-defending Conservative Christian Texan Physician Patient Survivor Mother of 4 daughters Small business owner on a mission to get government out of medicine. I have read The Patient Protection and Affordable Care Act (Obamacare), tweeted it and studied it. I will not implement, comply with it or let my patients live or die by it. Co-Founder AmericanDoctors4Truth.org
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