2012年2月5日日曜日

What Does Usp Nf Stand For

what does usp nf stand for

Should Your Charity Dollars Be Given to a For-Profit Drug Company? | Welcome to the Alliance for Natural Health

The National Multiple Sclerosis Society has given a $5 million grant to a pharmaceutical manufacturer to help create a new drug for MS. No matter that the drug's key ingredient is readily available at a lower cost elsewhere. Or that good natural health alternatives are largely ignored.

The National MS Society, which funds scientific research on multiple sclerosis, says that it receives 95% of its income from special events like Bike MS and from individual donors, 5% from drug companies. It has an annual budget of $200 million.

Adeona Pharmaceuticals (formerly Pipex) makes a drug called Trimesta, whose active ingredient is the kind of estriol found in the human body. During pregnancy, women experience a shift in their immune system: instead of cells protecting them from disease, antibodies take on that role. Scientists think estriol—one of the three main estrogens produced by the human body, and which is only produced in significant amounts during pregnancy—is responsible for that change in the immune response. MS patients' cells secrete proteins that trigger an autoimmune response, so a substance that can halt that response might help.


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The irony here is that bioidentical estriol is already readily available with a doctor's prescription at relatively low cost from many compounding pharmacies. This remains true although another giant drug company, Wyeth (now owned by Pfizer), petitioned the FDA to ban it. Why? Because it was interfering with the sales of Wyeth's own synthetic hormones, which have been shown to be dangerous.

The FDA responded favorably to Wyeth's petition and moved to stop the sale of bio-identical estriol, but has been slowed down by our campaign to save bioidentical hormones and by a federal court judge. (We will give you a complete update on where all this stands in a future edition of this newsletter).

In the meantime, if Trimesta is approved for MS, it will be available for MS treatment only, not for other conditions that derive benefit from estriol—as is always the case when natural substances are turned into synthetic drugs with limited FDA approval. In addition, Trimesta is not pure estriol; it has other drug ingredients designed to give it patent protection. And it is expected to cost much more than compounded estriol.


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The MS Society tried to justify its grant by citing the apparent lack of incentive for drug companies to develop MS–beneficial drugs. This is a weak argument, since MS affects as many as 1.5 people per 1,000 worldwide—there's clearly a market for the medicine. Anyway, it seems outrageous for a charity to give away its members' contributions to a pharmaceutical manufacturer. The drug company also received grant money from the National Institutes of Health, which may well be a misuse of the Orphan Drug program.

Since the MS Society is so thick with drug companies, one might ask whether it has considered any natural health therapies. The website's take on "alternative" medicine reads as if it were written by a drug company. For example, one of the resources offered on the MS Society website is a PDF called "Clear Thinking About Alternative Strategies," in which writer Virginia Foster states:

Alternative treatments may have no clear relation to what medical science knows about the cause of a particular disease or its symptoms. Advocates of alternative therapies sometimes claim that conventional medicine is ignoring or suppressing treatments that can alleviate symptoms or even cure some diseases…. Unfortunately, there is plenty to lose. Health, money, hopes—even one's life. That's why we've prepared this booklet.


The rest of the Society's website isn't much better. It has several articles that mention the benefits of vitamin D for MS patients, but there is no hint the Society accepts vitamin D therapy as a serious tool in MS prevention or symptom alleviation. And its scientific research dollars certainly go toward developing new drugs rather than exploring natural health alternatives that may do far greater good.

Like estriol, vitamin D is a non-lucrative, inexpensive, readily available approach to MS—which is why big research institutes, funded by drug companies, don't study it: there's nothing patentable, so no profit. Yet recent studies have demonstrated how powerful vitamin D can be for MS:


  • One Australian study found that low vitamin D levels in expectant mothers are clearly linked to a higher risk of MS in their children. Experts suspect that mother's lack of exposure to sunlight—the main source of vitamin D—may affect the fetus's central nervous system or immune system, predisposing it to developing MS later in life.
  • A US study showed that low vitamin D blood levels are associated with a significantly higher risk of relapse attacks in MS patients.
  • Neurologists at the University at Buffalo have found that low vitamin D levels may be associated with more advanced physical disability and cognitive impairment in persons with MS.
  • And Dr. Colleen Hayes's research shows that MS does not occur below a certain latitude—where direct sunlight is much more prevalent—and that many cases of MS may be undiagnosed vitamin D deficiency. The Society mentions the latitude connection  on its website but ties it to sunlight rather than vitamin D.

Other natural treatments may benefit multiple sclerosis as well. For example, fish oil and other anti-inflammatories may help. In addition, studies indicate that acupuncture can bring relief from MS symptoms within ten treatments—with great improvements in balance, vision, sleep, muscle spasms, and weakness. And there is evidence that acupuncture brings vast improvement even to patients with Progressive–Relapsing MS who have found conventional medical treatments ineffective.


The Society might also want to look harder at some older, off-patent drugs, despite their lack of glamor. Famed integrative doctor Julian Whitaker, M.D. has been an advocate for low-dose naltrexone (LDN) for MS for many years now. At least the Society lists some research on this drug on its website.



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