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Doctors who want to ban the availability of saliva testing

Oh jolly.

Diane, a thyroid and adrenal patient, informed me of a recent visit to a local Endocrinologist.  The doc stated that she was on a committee that is working with the FDA to do away with saliva testing, strongly proposing that it’s not accurate testing and is “harming” people.

Well, let’s see. For a couple of years now, thyroid patients who strongly suspect they have adrenal fatigue by the reactions they have to desiccated thyroid have been using saliva testing…and lo and behold,  the results they receive nearly completely conform with how they feel! i.e. saliva testing, which tests one’s cortisol levels at four key times during a 24 hour period,  has worked beautifully in helping thyroid patients with adrenal fatigue identify their problem, in helping these patients doctors have a better understanding of their problem, and knowing better what might be their best treatment, which can range from using licorice root, to over-the-counter adrenal support, to hydrocortisone (HC).

Harmful?? Give me a break.

Could it be that medical school trained doctors just hate and despise any method which a patient might benefit from WITHOUT going to the doctor and paying big bucks??  hmmmm.  And once again, could it be that a method NOT taught in medical school just MIGHT be a good one (just as desiccated thyroid like Armour, Naturethroid, etc. is far, far better than Synthroid or Levoxyl, which ARE taught in medical school)?

The FDA approved saliva testing for AIDS in 2005. They approved saliva testing for ovulation in 2003. They approved saliva testing to detect if a woman is going into premature labor in 1998. And there’s many more they have approved.  So…perhaps this is all a gasp of a committee who hates to see patients have some control over their health (terrible, awful thing, isn’t it?) or the cry of a committee that only reveals its ignorance.

p.s. Dr. Best of San Antonio recently posted the following excellent article on saliva testing: http://besthealthandwellnessinfo.com/hormone-testing-i-spit-on-your-blood-test/

Order your own saliva cortisol test here.

2 replies

Oops. Let’s not blow this out of proportion!

A very overreactive rumor is being started as I type this about the FDA and Armour, and I think this whole topic needs to be leveled out. The rumor is as follows:

1) The FDA has stopped manufacture of all grandfathered drugs like Armour.
2) Armour will no longer be available at your local pharmacy

i.e. it’s being banned, discontinued, taken off the market, gotten rid off…you name it.

Now first let me clarify that all are totally and completely false. Forest Labs is still making Armour, and you can also find Armour at your local pharmacy, even if certain strengths are easier found than others.

Here is what is going on: In the January-February issue of the 2007 (i.e. a YEAR AGO) FDA Consumer Magazine, an article came out by Michelle Meadows titled The FDA Takes Action Against Unapproved Drugs. But this is NOT new news. This is based on the June 2006 release guidance by the FDA, called Marketed Unapproved Drugs–Compliance Policy Guide. What the FDA is doing is working to get unapproved drugs meet their approval guidelines.

What is an unapproved drug? For one, they are those drugs which were around before the FDA (Federal Drug Administration) came into existence in 1938, and these drugs were ‘grandfathered’ in with the subsequent FDA-approved drugs thereafter. (Armour is an example. Synthroid was too until it did what it took to be approved in 2002) Other examples, as explained in the January/February 2007 article, are when only one company may have approval to market a drug, but other companies are illegally marketing their versions of the drug without having gone through the FDA’s approval process. Another scenario is that a combination of ingredients is approved by the FDA, but a company is marketing a single ingredient without approval.

The article also clearly states: Before pursuing regulatory action against unapproved drugs, the FDA plans to consider the effects on the public health, including whether the product is medically necessary. The agency recognizes that some unapproved therapies offer benefits. An example is Phenobarbital, a drug used to control seizures. In some cases, FDA action requiring drug approvals will be gradual to avoid shortages of medically necessary products. In other words, whenever the day may come that Forest Labs is asked that Armour meet the regulations of the FDA, the process will be gradual and Forest will be given a fair deadline to do what it takes.

Kathy, a pharmacist with Forest Labs, reminds us that Armour has never been asked to go through that process (or they may not be admitting it yet so they can go through it in peace.). And if the day comes, they will do what it takes. Armour is a safe and life-giving product. And you bet your booties that even if it looked threatened some day, there would be a huge uprising from patients to stop it. But that’s not going to happen, just as it was for Synthroid where Abbott labs did what it took to be approved, and succeeded.

So, take heart: everything is fine. Armour is still being made. Your pharmacies still have it, even when some strengths are easier to come by than others. And I’ll keep you informed. And remember: I’ve always told you to stock up on your desiccated thyroid products anyway. 🙂

p.s. The root of the rumor comes from a recent recall by Forest Labs concerning its 3, 4 and 5 grain tablets, which had a 6-month potency problem, and a misunderstanding about it’s implications by individuals. Those tablets are currently scheduled to be out again by the end of January.

http://www.fda.gov/fdac/features/2007/107_drug.html
http://www.fda.gov/cder/guidance/6911fnl.pdf

***Want to spread the word and be your own thyroid patient advocate? Get your t-shirt here.

16 replies

The FDA is improving T4’s potency….but it won’t change one particular FACT…

Is this akin to “improving” cardboard?

The FDA announced today that they are tightening the potency specifications for levothyroxine sodium (aka Synthroid, Levoxyl, etc) “to ensure the drug retains its potency over its entire shelf life” rather than what often occurs with any T4 med: the deterioration of T4 before it’s expiration date. They state that this tightening will improve the quality of the product.

Cough.

Let me give you some history. After it was isolated, T4 was first produced as a treatment substance over 80 years ago. The T4 did result in some improvement in patients they tried it on at the time. But guess why they never gave it to patients beyond the early experiments? BECAUSE THEY KNEW IT WASN’T STABLE. They knew that fact 40+ years before it came back on the market in the 60’s due to the heavy and moronic pharmaceutical promotion.

And the irony of this so-called improvement is that it’s NOT going to stop the deterioration of T4. They are only attempting to stop it before “the expiration date”.

Sorry FDA. You can improve the tensile strength of cardboard, but you can’t improve the FACT that T4-only meds are about as effective as giving a hypothyroid patient CARDBOARD…whether it’s stable or not.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01717.html

(Thanks Stephanie)

7 replies