Why Is the FDA Smothering Innovation in Lab Testing?

Recent actions against the trailblazing medical testing company Theranos only protect the status quo, drive up the cost of medicine, and thwart better treatments. Action Alert!

Natural medicine is said to stand on three legs: a natural diet, nutritional supplements, and integrative treatments. But testing is an essential fourth leg.

Some people are seriously deficient in a particular nutrient; others are not. This is one of many reasons why many food and supplement studies that try to assess the effect of nutrition on disease are often flawed. The only way to identify deficiencies is by testing. Yet now the FDA has shut down progress in reducing the cost and effectiveness of these tests.

For the past few weeks, the laboratory-developed testing startup company Theranos has been under close FDA scrutiny for its various testing technologies, and it recently was the subject of an FDA inspection. This inspection resulted in a warning that the company’s blood collection containers were unapproved medical devices. The FDA also told Theranos that it would have to resubmit data for a number of proprietary blood tests they are seeking approval for—that the previously submitted data was insufficient to determine the tests’ accuracy.

Although the FDA does not have the authority to regulate laboratory-developed testing (LDT), Theranos has agreed to comply with all of the FDA’s requests and has also agreed to pause the use of its blood collection containers while the FDA reviews them. This cooperation, however, has not stopped the mainstream media from pouncing.

Back-to-back front-page stories in the Wall Street Journal called into question the accuracy of Theranos’s tests. We suspect the information was leaked by FDA skeptics or by competitors. Other mainstream media outlets seem eager to deflate the enthusiasm over this innovating company: a New York Times headline reads, “The Narrative Frays for Theranos and Elizabeth Holmes”; and the Wall Street Journal writes that “Theranos has struggled behind the scenes to turn excitement over its technology into reality.”

As a result of both the FDA’s assault and the media mudslinging, famous people like Henry Kissinger and George Schultz have left Theranos’s board.

Why would the FDA attack a company that seeks to bring affordable, convenient testing to millions of Americans? We suspect that the agency is doing everything it can to throttle innovators in this area to protect large, established testing companies and hospitals, which have been funding their deficits, in part, by charging exorbitant prices for tests. It’s the old crony game again.

The same sort of attack happened with personal genetic testing company 23andMe. In 2013, the company received warning letters from the FDA to stop its inexpensive “do-it-yourself” genetic testing service for health screening and ancestry purposes, because consumers could be “misled” and harm themselves by “self-treating,” as we describe in a companion article in this week’s Pulse.

Let’s keep in mind that LDTs are the future of medicine. There are already new tests to spot cancers long before they manifest themselves otherwise. But these tests are very expensive and neither Medicare nor insurance companies will pay for them. Testing can also help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases.

LDTs are not only the future of general medicine—they are also the future of individualized medicine. Integrative doctors use these tests to gather information that aids them in identifying the root causes of their patients’ illnesses— information cannot be gathered and analyzed otherwise.

Action Alert! Write to the FDA and tell them to stop harassing Theranos, 23andMe, and other innovators in the LDT field. Please send your message immediately.

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

Stop Crony Nutritionists’ Power Grab

Want to Start a Wildly Innovative Gene Testing Company?

Are Prescription Drugs on Your Menu for Dinner?

from The Alliance for Natural Health http://ift.tt/1NbnOXg via Aloe for Health
from Tumblr http://ift.tt/1NbsZGr

Want to Start a Wildly Innovative Gene Testing Company?

In order to survive, you will need to make friends at the FDA. And to do that, you will apparently first need to make friends with giant drug companies. Action Alert!

Consider the personal genetic testing company 23andMe. Forbes reports that, after an injection of new investment from a variety of sources that include ten major pharmaceutical and biotech companies, 23andme.com is now valued at around $1.1 billion.

This is quite a stunning reversal of fortunes, considering that just a few years ago, 23andMe didn’t seem like it would survive at all. In 2013, the company received warning letters from the FDA to stop its inexpensive (then $99 per test, now $199) “do-it-yourself” genetic testing service for health screening and ancestry purposes, because consumers could be “misled” and harm themselves by “self-treating.”

At the time, we exposed this as a baseless attack—sparked, in part we thought, by UnitedHealth Group’s desire to keep genetic information in a place where insurers could access it, presumably to use the information (such as an inherited health risk) to deny coverage.

After the FDA’s attack, the company could no longer stay in business by offering cheap testing to its customers; instead, it led them to make deals with large pharmaceutical companies. The idea is to use the tests to help drug companies test new drugs. This will likely keep the FDA at bay, and possibly even make the FDA friendly—but it also ensures that future developments will be guided by the interests of Big Pharma, not the consumers who desperately need these tests.

The Forbes article makes another interesting observation:

Since it was founded in 2006, 23andMe has collected data from 800,000 customers and it sells its tests for $99 each [sic]. That means this single deal with one large drug company [Genentech] could generate almost as much revenue as doubling 23andMe’s customer base.

All of this is yet another major setback for innovative and lower cost testing technology—the future of medicine, as we describe in a companion article in this week’s Pulse.

The FDA seems to be sending a clear message to any would-be innovators in laboratory testing: threaten the status quo, and we’ll make it impossible for you to do business. The only way around it is to hire former FDA employees and especially make deals with large drug companies. If you lose your independence doing this—well, that’s the whole point!

Action Alert! If you haven’t done so already, urge the FDA to back off companies like Theranos and 23andme.com that are innovators in their field and the future of medicine. Please send your message immediately.

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

Stop Crony Nutritionists’ Power Grab

Why Is the FDA Smothering Innovation in Lab Testing?

Are Prescription Drugs on Your Menu for Dinner?

from The Alliance for Natural Health http://ift.tt/1NbnOX8 via Aloe for Health
from Tumblr http://ift.tt/1H40TQP

Are Prescription Drugs on Your Menu for Dinner?

No, we didn’t think so. But you might get them in your dinner anyway. Action Alert!

“Biosolids”—a euphemism for human waste—are being used by some farmers as cheap fertilizer, according the New York Times, but it is usually done very quietly. In most states and counties, details about where biosolids have been applied is intentionally concealed; they make it as hard as possible for the public to get that information.

Biosolids can be dangerous. They may be riddled with harmful Big Pharma drugs and also personal care products. A new study shows that the animal and human drugs typically found in biosolids may, even at very low levels, interfere with important hormones that help the plant defend itself against predators and diseases. River water, similarly contaminated with pharmaceuticals, has caused male fish to develop female anatomy.

At higher concentrations, the study found, even the vegetables themselves are harmed by the drugs in the fertilizer. Zucchini plants exposed to pharmaceutical drugs developed leaves with burnt edges and white spots, as well as stunted roots. Exposure also impaired the plants’ ability to perform photosynthesis, the process by which plants produce energy from sunlight.

Biosolids are not permitted in organic production, but in conventional farming they fall under the jurisdiction of the EPA. The agency’s regulations only place limits on the amount of heavy metal and certain pathogens that are permitted—they are completely silent on the presence of pharmaceutical drugs and personal care products.

The EPA has admitted that there is a need to address the presence of both pharmaceuticals and personal care products in biosolids, and is currently “studying” the matter. Let’s make sure they do the right thing and don’t just study it forever.

Action Alert! Write to the EPA and urge them to limit the amount of pharmaceutical drugs and personal care products that are permitted in biosolids. Please send your message immediately.

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

Stop Crony Nutritionists’ Power Grab

Why Is the FDA Smothering Innovation in Lab Testing?

Want to Start a Wildly Innovative Gene Testing Company?

from The Alliance for Natural Health http://ift.tt/1NbnO9s via Aloe for Health
from Tumblr http://ift.tt/1H40TQK

Action Alert: Tell the EPA to Act on Drugs in Biosolids

Related article: Are Prescription Drugs on Your Menu for Dinner?

Trouble Taking Action? Click here.

from The Alliance for Natural Health http://ift.tt/20rv1Mo via Aloe for Health
from Tumblr http://ift.tt/1iAZrK6

Action Alert: FDA Attacks Medical Innovators

Related article: Why Is the FDA Smothering Innovation in Lab Testing?

Trouble Taking Action? Click here.

from The Alliance for Natural Health http://ift.tt/20rv3E8 via Aloe for Health
from Tumblr http://ift.tt/1Npf3x2

FDA Attacking Supplements to Boost Alzheimer’s Drug Sales?

The Oregon Attorney General, the FDA, and Sen. Claire McCaskill are targeting two supplements, but they don’t have their facts straight. Action Alert!

You will recall how the New York AG went after some herbs claiming they weren’t actually in the supplements sold. He got considerable egg on his face when it was shown that he had used the wrong test when assessing the supplements, and that scientists almost unanimously agreed that his conclusion were utterly incorrect.

The Oregon AG apparently learned nothing from that fiasco. According to USA Today, she has now filed a lawsuit alleging that “GNC, one of the world’s largest retailers of supposedly all-natural dietary supplements, has knowingly sold products spiked with two synthetic drugs.”

Interestingly, it appears to us that the US Food and Drug Administration (FDA) is actually the instigator of this action, even though they have all the power they need to take action against GNC themselves. So what is going on here?

There are two substances involved, BMPEA and picamilon. They are different and should not be lumped together. While BMPEA is a powerful synthetic stimulant, picamilon isn’t synthetic at all. It is a combination of GABA (a completely natural substance made from the amino acid glutamine) with niacin (vitamin B3). The combination is much more effective in crossing the blood-brain barrier than GABA alone.

GABA is produced by our own bodies and is the natural way we calm ourselves. It is by far the best remedy for anxiety, but is rarely used by conventional doctors, who generally favor toxic and usually ineffective drugs, often with tragic results.

The AG’s lawsuit follows a recent call from Sen. Claire McCaskill (D-MO) to pull both picamilon and vinpocetine (a substance useful for the brain) from store shelves pending an investigation into whether they should be sold as prescription drugs rather than as dietary supplements. The FDA may well be behind this too.

Why is picamilon being targeted right now? It has no serious side effects, so it clearly isn’t a safety issue. We do know that a potential blockbuster drug for Alzheimer’s is in phase three of FDA trials, and if the drug is successful it has been estimated to bring in $7.6 billion in sales by 2024. Perhaps the FDA is trying to remove any natural substances that help the brain before this new drug is approved? That has happened before. For example, the agency banned the natural substance tryptophan, which is needed for our bodies to make serotonin, just before approving the first synthetic serotonin re-uptake inhibitor drug (SSRI) for depression. And we believe this is just the tip of the iceberg, as you’ll read in our related story.

We know the FDA is involved in all this because it submitted an affidavit to the Oregon AG saying that picamilon is not a dietary ingredient. This is a puzzling position, given the fact that if the FDA thought there was a safety issue, or any other concern with picamilon, it could take its own action to remove it from the market. If there was an issue with the ingredient in question, why should it be removed only in Oregon and not everywhere else?

Action Alerts! Tell the FDA (and if you’re in Oregon or Missouri, tell the Oregon AG and Sen. McCaskill too) that picamilon is not a synthetic drug but a combination of natural ingredients that must continue to be freely available to consumers. Please send your message immediately.

from The Alliance for Natural Health http://ift.tt/1Wh39Wx via Aloe for Health

from http://ift.tt/1GvTWYB

Is the Attack on a Key Brain Health Supplement the First Step in an Effort to Eliminate Thousands of Supplements?

The recent actions against picamilon provide plenty of reason to think so. Action Alerts!

As we revealed in our related story, the attack on picamilon (a natural and safe substance combining GABA with a B vitamin) spearheaded by the Attorney General of Oregon with the assistance of Sen. Claire McCaskill (D-MO) has likely been orchestrated by the US Food and Drug Administration. Since the FDA has full power to move against any supplement, what is going on here?

To get to the bottom of this, you have to know about the agency’s recent treatment of new dietary ingredients (NDIs) —or, in other words, new supplements. You can read our previous coverage for context, but this pertains to a section of the Dietary Supplement Health and Education Act (DSHEA) that deals with how the FDA is to treat NDIs. In DSHEA, “new” means a supplement or ingredient that appeared on the market after 1994.

A few years ago, the FDA released a very bad draft guidance that, if enacted, would have eliminated thousands of supplements from the market in the blink of an eye. Essentially, the agency wrote an extremely restrictive definition of what would be considered a “new” supplement, and created an onerous set of regulations—including something akin to a pre-approval system—for “new” supplements to be allowed.

Remember, too, that drug companies can gain market exclusivity on dietary ingredients by filing investigational new drug (IND) applications before an NDI is filed. A parallel FDA guidance will accelerate this process, making a bad situation even worse and eliminating consumer access to affordable nutrients. This has happened before, most recently in the case of the pyridoxamine form of vitamin B6.

The FDA agreed to revise this bad NDI draft guidance in 2012 after substantial pushback from ANH-USA members and others, and the agency has been working on a revised guidance ever since. This means that supplement companies are in the dark about how to comply properly with DSHEA’s NDI provision.

This is part of what makes the Oregon AG’s lawsuit so troubling—thousands of “new supplements” (that is, placed on the market after 1994) whose producers have not filed NDI notifications could potentially be considered illegal “drugs” or “unlawful dietary ingredients” despite the fact that the FDA won’t say how this can be prevented. If picamilon is declared an illegal drug and driven off the market, it could leave thousands of other products—products that consumers rely on—vulnerable to similar assaults.

Action Alerts! If you haven’t taken action already, click the button below to tell the Oregon AG, the FDA, and Sen. McCaskill that this lawsuit sets a very dangerous precedent. Please send your message immediately.

from The Alliance for Natural Health http://ift.tt/1Wh39Wl via Aloe for Health

from http://ift.tt/1GvTUjC