Aloe Vera Health Benefits

Tuesday, March 1, 2016

More Supplements Face the Axe

…At the next meeting of the FDA’s Pharmacy Compounding Advisory Committee. If recent history is any indication, the outlook is not good—unless we push back. Action Alert!

The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA in writing new rules regarding what supplements and drugs can be made individually for patients with specific needs by compounding pharmacies. It will meet for the fourth time, on March 8 and 9, to discuss whether to continue to allow a new group of supplements and drugs from being made for individuals. Here are some of the substances being considered:

Boswellia (Indian frankincense) is a tree resin that has been used for thousands of years to treat a variety of conditions, and recently has been shown to have anti-inflammatory properties. It also can be used to treat arthritis and osteoarthritis. Drug companies no doubt see this potent herb as a major threat to current or future drugs.
Aloe vera, 200:1 freeze dried. Aloe vera leaves have been used medicinally as far back as the 16th century BCE. It is widely used in natural and traditional medicine for a variety of conditions, treating everything from burns to constipation, psoriasis, and herpes simplex virus.
D-ribose is a natural ingredient for increasing energy (ATP) production. Evidence indicates that d-ribose can rejuvenate heart muscles after a heart attack or other cardiac events.
Chondroitin sulfate is a structural component of the cartilage in joints. It stimulates the production of cartilage, improves blood circulation to the joints, and is used to treat osteoarthritis, among other things.
Acetyl-L-carnitine is naturally produced by the body, functions as an antioxidant, and promotes the production of glutathione in cells. It is used for Alzheimer’s disease, age-related memory problems, and a wide range of other conditions.

These are, of course, supplements. As such they are commonly available. Yet the committee seems to think that everyday supplements should be banned from compounding. This is completely illogical. You can buy them in stores! Yet your doctor cannot include them in personalized medicine he prescribes?

Despite this crazy illogic, we doubt that any of these supplements will get a fair hearing. Last year, remember, PCAC voted to ban curcumin, which is widely used for its well-documented anti-inflammatory properties, among many other health benefits.

The elimination of supplements from compounding has far-reaching implications for natural medicine. Sometimes patients don’t even have the option of using any form other than the compounded one. Supplements are compounded for all types of patients—such as those with environmental sensitivities who cannot have supplements with preservatives, autistic children and other patients for whom swallowing pills is extremely difficult, or patients suffering from depression who rely on compounded amino acid solutions to manage their mood. All of these types of patients, and many more, will suffer if the PCAC continues to ban supplements from compounding.

The PCAC only makes recommendations to the FDA, but the committee has almost always followed the agency’s lead, or else the agency has arranged the verdict in advance—it is often hard to tell. We noted early last year that the PCAC seems to be a stacked deck, and developments have proved this observation correct. It has long been our suspicion that the end goal is to eliminate the compounding industry altogether, and this is a clever way to do it—whittle away what ingredients are allowed to be compounded, and it’s “death by a thousands cuts” for compounding pharmacies.

We must send a clear message to the PCAC to maintain patient access to compounded supplements—some of our most vulnerable patients rely on them!

Action Alert! Send a message to the PCAC urging them to approve the ingredients that have been nominated to the Bulk Ingredient List—and send a copy to Congress as well. Your legislators need to see what is happening to their compounding law! Please send your message immediately.

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

Bad Trade Deal Gets Worse

Crony FDA Chief Approved by Senate

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Bad Trade Deal Gets Worse

An underhanded maneuver could make the Trans-Pacific Partnership (TPP) even worse than it was originally. Action Alert!

The Electronic Frontier Foundation (EFF) picked up on an almost imperceptible but vitally important change in the TPP text.

It was widely understood that the text had been completed and finally made public after years of hyper-secrecy when we covered this late last year. According to the EFF, however, the final document has been going through a “legal scrubbing” phase in which lawyers, translators, and trade ministers go over the deal and ensure there are no “errors,” and that everything is legally consistent.

Briefly put, one word was changed (“paragraph” became “subparagraph”) in a section relating to copyright infringement. But this one-word substitution drastically changes the substance of the document. Before, the language exempted states from applying certain criminal penalties in cases of copyright infringement when there was no market or economic impact on the copyright holder. The one-word substitution now means that most criminal penalties in these cases must apply even if there was no discernible impact on the copyright holder.

This maneuver could have dire consequences, especially in how information gets around the Internet. Will articles with links to other content—like the kind contained in this newsletter—become illegal and subject to draconian criminal penalties? The ramifications of this sleight-of-hand trick could be far-reaching. Will links to other articles become illegal in the US because a foreign government could object to them under the trade agreement?

Especially troubling is the apparent lack of concern in the two major political parties and the mainstream media about this deal. The issue has been mostly ignored in the presidential campaign so far, and coverage in the media has been scant.

This is only the newest issue to arise out of the TPP. Our other concerns—the ones we raised when the text was finally revealed after months of secrecy—remain. We noted in our coverage last year that TPP undermines the safety of the food supply in sections that treat stringent standards as “barriers” to international trade; it extends generous patent privileges to Big Pharma that keep drug prices in the stratosphere; and it also protects biotech seed companies with stringent intellectual property provisions.

None of this is hypothetical. The World Trade Organization just voided an Indian plan to build solar power to reduce pollution on the grounds that it violated international trade law. Who brought the complaint? The same Obama administration that touted the need for global environmentalism recently in Paris.

Action Alert! Write to your members of Congress and urge them to oppose the TPP deal, which undermines consumers and farmers, extends monopoly rights of Big Pharma, and will undoubtedly be used to “harmonize” international law in ways that will limit or even extinguish our natural health rights. Please send your message immediately.

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

More Supplements Face the Axe

Crony FDA Chief Approved by Senate

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Crony FDA Chief Approved by Senate

Do your senators support crony medicine?

Last week, the Senate voted overwhelmingly to approve the nomination of Dr. Robert Califf as FDA Commissioner.

The final tally was 89 “yea” votes, seven abstentions—and only four “no” votes. The four were Kelly Ayotte (R-NH), Richard Blumenthal (D-CT), Joe Manchin (D-WV), and Ed Markey (D-MA).

Presidential candidates Ted Cruz (R-TX), Marco Rubio (R-FL), and Bernie Sanders (I-VT) did not vote, nor did Bob Corker (R-TN), Ron Johnson (R-WI), Claire McCaskill (D-MO), or Mark Warner (D-VA).

Califf’s ties to the pharmaceutical industry are well documented. He ran a clinical research center at Duke University that received the majority of its multimillion dollar budget from Big Pharma. According to financial disclosures from last year, Dr. Califf received money for consulting with at least seven drug and medical device companies, and six other companies supported his university salary including Merck, Novartis, and Eli Lilly. The conflict-of-interest section of a paper he wrote for the European Heart Journal last year lists financial support from more than twenty companies.

The importance of this decision cannot be understated. According to the New York Times, the FDA regulates a quarter of every dollar spent in the United States—and now Big Pharma has its person in this immensely powerful position. It is a great victory for crony medicine—and a major setback for everyone else.

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

More Supplements Face the Axe

Bad Trade Deal Gets Worse

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