seneste nytt: FDA nekter for at noe foregår http://thyroid.about.com/b/2009/08/2...ed-thyroid.htm
og på facebookgruppen så skriver noen at RCL labs sa at det hele er at det er en mangel på Thyroid fordi pasienter og leger tømmer markedet for alternativer for armour Thyroid som har reformulert tablettene sine (ingrediensene, hjelpestoffene) og hundrevis av pasienter klaget jo på forumen om at de ikke virket lenger.
..."I just received a call from Steven Lang of the FDA. He mentioned that the article written by "that lady" has created a lot of chaos, but that there are no reports of desiccated thyroid production being halted. He said that Armour and RLC&...#039;s backorder issues are not because of anything he's aware of. He was polite. He just kept stating that there are no reports of FDA taking action on desiccated thyroid and that it would be posted on the FDA site if there was such a thing happening.
I don't know what to make of all this. Calling the FDA seems like a good idea, but then I wonder if all the hubbub about the problematic Armour reformulation has made the FDA take notice of desiccated thyroid when they might not have been paying attention to it before ......)
...."how can he say there are no reports of desiccated thyroid extract production being halted when Time Caps and Major Pharm have been shut down?......."
...and another thing...why didn't they tell that to Mary a couple phone calls ago? nope...something changed...
I agree... I saw the letter which is available online that the FDA sent to Time-Cap Labs and I spoke to them personally and they told me the FDA shut down their thyroid production.
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"Mixed messages from the FDA: I've done a quick review of all the posts over the past two days on the Yahoo Save Thyroid forum and on this forum, and came up with reports from four different people who had talked with the FDA. Two said the perso...n they spoke to said that the FDA is pulling the products from the market, one person (later on in the process) talked with someone who denied a stop production was taking place, and then there were Mary's interactions with her contacts, who have not given her consistent information. To me this says something was brewing, they've been surprised by the reaction, and are retrenching for a moment. All the more reason to keep up the polite pressure over the next few weeks as they make a final decision. "
"My Pharmacist had this opinion. Armour may have started this with the FDA when they changed their formula and it stopped working for many of us. The FDA had a lot of complaints as to how and why Forrest Labs could do this. Sure Abbot could be the bad... guy, but sometimes things can become a mess by any company that thinks they can just make a change.....there are always consequences. I for one stopped using Armour even though I have been on it for 52 years. No company should make major changes that will affect so many people."
"My phone call to the FDA (There is some possible good news at the end of this so keep reading): Spoke to a woman named "Sadhna". She said that they're asking all drug companies to do "safety studies" since this was Grandfathe...red in prior to the FDA's existence, and that so far the only let......ter to be sent out requesting this "study" was to Time Cap Labs. I then asked her if it would be available to the public while their "safety studies" were being conducted I got put on hold. She came back said that there would be "Lag time" period where the drug in question is sometimes still available, sometimes not. What she did say is that there has been "no action yet" (even though she told me a letter was sent out to Time Cap Labs - so to me, that means SOME action has been taken) and that she would know more by the end of the day and she would call me back (took my name and number) - continued below......"
"Actually called me back just now and said that there has been "no official action" yet and that there was "no comment" as of now (She did say she'd call me back by the end of the day if there was - and since she called me back once, maybe that will happen). However, and this may be good news; she DID say that when the public "REACTS", it can often ... Les merchange the decision. So, CALL, HAVE YOUR MOM CALL, HAVE YOUR NEIGHBOR CALL, HAVE YOUR DOG CALL - KEEP THE CALLS GOING - 888-463-6332 - CALL CALL CALL!!!!!"...
"My fear of losing Nature-Throid is overwhelming. I just went through the battle of the change if formula with Armour and all the symptons coming back, and I am finally feeling better and taking off the 10 lbs that came with the change of the Armour f...ormula. I can't go through this again! It makes me want to stock pile Nature-Throid and hide it in a safe some where. "
"Is anyone suspicious of the timing of the thyroid shortage with the imminent swine flu "pandemic"?"
"Once the info on what the FDA is doing is pinned down, it probably would also be helpful to get more info on who, how, and why the decision was made. For example, a poster on Mary's About thyroid blog describes what sounds to me like incredible... conflicts of interest in the FDA: Doesn't Abbott labs make Synthroid?:
"All of the following comes from the FDA, ATA, & AACE websites:

The Chair of the FDA endocrinologic and metabolic drugs advisory committe is Dr. Kenneth Burman. He is the president of the American Thyroid Association, has info on The American Association of Clinical Endocrinologists’ website, and has a relationship with Abbott labs (speaker/advisor/received research funding). This committe votes and helps make decisions affecting all of us.

In their 2008 tax return, ATA documents $704,739 in contributions from Abbott (the next highest contributor was genzyme with $198,500). AACE also reports Abbott and Forest as contributors.""
"This has been going on for years -- Whoever owned Synthroid -- Abbott, before that Knoll, and BASF, etc. -- have ALWAYS been major funding sources for ALL the endocrinologist organizations -- AACE, ATA, Endocrine Society -- as groups, AND individually. When they're in med school, Synthroid's reps come and bring lunch to starving ... Les merpoor interns to do "educational sessions". Once they've got an MD, they go to a thyroid meeting, and the cocktail parties, dinner cruises, golf outings -- all paid for by SYNTHROID. Most of the personally endos have accepted honoraria, travel grants, research grants, "unrestricted grants," trips, lunches, etc. from Synthroid. They get samples, script pads, mugs, pens, patient literature, posters, and their drug reps, many who look like swimsuit models, come to the offices weekly with lovely catered lunch trays for the whole staff. These guys are so in bed with Synthroid they couldn't see straight if they tried.-- Mary"
"And why haven't any NDA letters from the FDA to all the desiccated manufacturers been findable online? Seems like every other thing they do is."
"When I spoke to Naturethroid last week, I was told that is the only product they make...if they are told to stop, they will close down. Seems a HUGE double standard if that were a requirement.....Synthroid didn't go off the market during that time! Who's palms are being padded at FDA if that is the case?:( "
"Okay, I called and talked to a Misu. She said that the FDA has taken no action yet against the companies that make natural desiccated thyroid drugs and that at this time they are still able to produce those drugs. The companies have known for some time that they need to submit an "application" and should do so immediately as it is their ... Les merresponsiblity to submit the application not FDAs. She further said there is no timetable on when the FDA would take action against these companies - it could be tomorrow or it could be 10 years!"
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"Why is the FDA unable to provide clear, specific answers to thyroid patients about this critical issue?

And let's face it, we have a very troubling situation at present:

* Weeks ago, a major "big pharma" insider, Medco, sent a nationwide notice to doctors declaring that the FDA was taking all natural desiccated thyroid drugs off the market, and that doctors should switch patients to levothyroxine drugs
* We currently have an unexplained nationwide unavailability of Thyroid USP, the raw material that is used to manufacture natural thyroid drugs.
* Since the spring, production of three different natural desiccated thyroid drugs -- Biotech, TimeCapLabs and Major -- have been shut down. We know that TimeCapLabs was shut down in response to a publicly available notification letter they received from the FDA. The second-hand information is that Biotech and Major were also shut down by the FDA.
* We have the actual letter the FDA sent to TimeCapLabs, stating that natural desiccated thyroid requires a new drug application (NDA).
* Throughout the U.S., we have dwindling to non-existent supplies of Armour, Nature-Throid and Westhroid on the market, and most patients are now unable to get new or refilled prescriptions for these medications. Given the nationwide shortage of raw material, compounded capsules of natural desiccated thyroid is also unavailable to most patients.
* RLC is saying that it will be at least 90 days before they have any new product (Nature-Throid/Westhroid) to ship.
* Forest, which makes Armour, the most prescribed brand of natural desiccated thyroid, will provide no estimate whatsoever regarding when they expect to have any product available to ship.

And now, we have the FDA responding in a vague manner to a very specific request for information that affects millions of thyroid patients, patients who rely on natural desiccated thyroid drugs to treat a life-threatening health condition."
fra thyroid.about.com