Tuesday, January 10, 2017

Here We Go Again: FDA Defies Congress

And hobbles your doctor. Action Alert!

In the waning days of 2016, the US Food and Drug Administration (FDA) ignored the expressed will of Congress. The agency completed a “guidance” document that prohibits traditional compounding pharmacies from stocking doctors’ offices with custom drugs.

In December 2015, Congress included a provision in an end-of-the-year spending bill ordering the FDA to issue a guidance document clarifying how physicians and compounding pharmacists could continue the “office use” of drugs. These are custom drugs that a doctor keeps on hand for immediate treatment use. Congress could not have been clearer: the agency was not to forbid office use. The FDA has now answered—by ignoring it.

The FDA now wants the doctor to have to prescribe the drug—to have it compounded separately for each patient, and then administered on follow up visit. This is not only dangerous for patients who need immediate treatment. It also vastly increases the cost of the drug, wastes patient and doctor time, and is gross interference with the practice of medicine, which is supposed to be regulated by the states, not the federal government.

It’s increasingly obvious the FDA is a rogue agency unaccountable to the American people and the elected officials chosen to represent them. The FDA’s action is the latest evidence to support our long-held contention that the agency’s real goal is to eliminate traditional compounding pharmacies altogether. We think the agency wants to force all traditional facilities to register as outsourcing facilities, because under recent legislation, what can be compounded at outsourcing facilities is completely at the FDA’s whim, and can also be very narrowly defined. We can also expect the surviving pharmacies to be owned by Big Pharma.

We must not let the agency get away with this.

Action Alert! Write to Congress and voice your disapproval of the FDA’s thumbing its nose at Congress—and offer your support for compounding pharamacies.

Take-Action

Other articles in this week’s Pulse of Natural Health:

Worse than Zika, but Ignored. Why?

Mumps Outbreak: The Real Cause



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Worse than Zika, but Ignored. Why?

This is a virus that most of us are exposed to—one that is likely to shorten your life, and that can destroy it. But you may not even have heard of it.

Between 20,000 and 40,000 infants are born with cytomegalovirus (CMV) each year, and the virus kills 400 of those infants annually. These numbers compare with 1,600 babies exposed to Zika in the continental US in 2016. Twenty percent of infants born with CMV develop permanent disabilities such as hearing loss, microcephaly (a condition where the baby’s head is significantly smaller than expected), vision abnormalities, and intellectual deficits. It is the most common congenital viral infection and the leading non-genetic cause of deafness in children.

If you don’t get this virus in utero, you are lucky, but you are not out of the woods. Half of adults have been exposed by age 40. Like all viruses, it remains inside the body even after the illness has passed. Like other herpes viruses, it tries to come back, and challenges the immune system in order to do so. Because it is such a big and damaging virus, all the challenges over the years eventually take their toll. Eventually the immune system is worn down by the constant challenge. It has been estimated that the lives of those exposed are shortened on average by four years.

As bad as this is for adults, the risks for babies is much greater. Conventional doctors are way behind the ball in warning women about the dangers  of obstetrician-gynecologists tell pregnant patients how to mitigate the risks of CMV, which include hand-washing after diaper-changing, not sharing utensils with children in daycare, and other such measures. Could this negligence be due to the fact that there is no vaccine or drug to treat the virus? You might ask, “If there is no drug to treat it, why bother?” Yet studies have shown that a simple discussion about CMV resulted in fewer women contracting the virus.

It should surprise no one that some in the public health community are recommending antiviral drugs for infected infants. A study in the New England Journal of Medicine seems to endorse that view, finding that infants who took antiviral drugs for six months had “moderately better” hearing than newborns who took the drugs for just six weeks. The CMV antiviral drug, of course, comes with a host of nasty side effects: tremors, nausea, and diarrhea are among those acknowledged. Why let a few nasty side effects and a moderate benefit get in the way of selling more drugs, right? And of course there has been no testing of such drugs on children.

There are natural ways of dealing with CMV and other viruses, including silver and ozone, and also natural supplements to deal with the associated inflammation—which may ultimately be what kills the patient, as it was in the famous Spanish flu epidemic. These include fish oil, resveratrol, curcumin, cherry extract, green tea extract, and many others. Of course, these therapies don’t make money for the drug companies, so don’t expect conventional doctors to discuss them with you.

Other articles in this week’s Pulse of Natural Health:

Here We Go Again: FDA Defies Congress

Mumps Outbreak: The Real Cause



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Mumps Outbreak: The Real Cause

Surprise! It wasn’t unvaccinated kids. Action Alert!

A recent article in Scientific American upends the conventional wisdom about what caused the recent spike in mumps in the US. In 2016 there were about 4,000 cases across the US; in 2010, there were about 2,000.

If you followed the mainstream press and a number of opportunistic politicians, the answer was clear: unvaccinated kids were the cause. Parents who didn’t vaccinate their kids according to the government’s schedule were vilified and derided in the opinion columns of newspapers and magazines, and state politicians like Sen. Richard Pan of California used the hysteria to enact legislation (SB 277) that eliminated parents’ right to decide whether and how to vaccinate their children.

The idea that unvaccinated kids was the cause of the uptick in mumps cases doesn’t hold up. According even to the Centers for Disease Control and Prevention (CDC), a staunch supporter of the government vaccination schedule, most mumps patients said they had received both shots of the MMR (measles, mumps, and rubella) vaccine. The states with the most cases of mumps had vaccination rates of 90% or higher—a threshold where herd immunity should exist if it is ever going to exist. (The herd immunity hypothesis states that a very high percentage of a community must be vaccinated in order to protect everyone (the herd) from a disease. This is supposed to work because there are not enough vulnerable individuals to allow the disease to spread. The hypothesis does not hold up.

Mumps has occurred in schools that have a 98% vaccination rate. It is also spreading among vaccinated kids on college campuses. At the University of Missouri, there were 193 reported cases of mumps, and all patients treated by the university had received two MMR shots.

If it wasn’t unvaccinated kids spreading mumps, then what caused the outbreak? Some scientists—including Dr. Paul Offit, who wants to expand the government schedule of vaccines even more and who has a notorious conflict of interest—are suggesting that the reason for the increase in mumps cases is due to the waning effectiveness of the vaccine. Some think that the vaccine may not fit the current strain of mumps. Of course, those who think, like Offit, that kids could get 10,000 vaccines at once and be perfectly fine will see this evidence and suggest that kids should get an additional MMR shot! Note that the MMR has been considered perhaps the second riskiest shot. Note also that the mumps vaccine might be safer if it weren’t combined with the others, but no one in the medical establishment wants to acknowledge that point.

Without the false herd immunity argument, the case for forcing all kids to get vaccinated collapses. If the underlying assumption is false, then there’s no rationale for removing non-medical exemptions to vaccination—unless the true goal is not to increase public safety, but to guarantee profits for the vaccine industry!

Action Alert! Write to your state legislators and ask them to protect important vaccine exemptions. Please send your message immediately.

Take-Action

Other articles in this week’s Pulse of Natural Health:

Here We Go Again: FDA Defies Congress

Worse than Zika, but Ignored. Why?



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