Svær sak-FDA vil tvinge fram en NDA for Armour etc--hele nettet er fullt av meldinger

[nora]

sjekk: http://www.facebook.com/pages/Save-N...d/121680434089 samt alle engeskspråklige forums

Ifølge facebook-siden kan det være mulig at FDA gir seg og ikke krever en NDA (new drug application, noe som er velidg dyrt og tar halvannet år typisk) pga alle telefoner til FDA

EDIT/Mod: Government halting production of natural thyroid drugs

[nora]

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.
"
"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!"
--
"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

[Hansen]

Det er nok ei helvetes ryktesmie rundt hele saken. Mange trekker bastante konklusjoner på spinkle grunnlag og hammrer ut sannheter.

Noe ligger i bånn der, men er vel i bunn og grunn bare advokatmat rundt en lovfortokning ?

Fint å få en så konsentrert presentasjon Nora !
Hvilket inntrykk har du ?

[nora]

FDA sier ikke noe er på gang, og til andre som ringte sier de at noen må komme med en NDA, og noen postinger kommer inn på FDA hvor det er minst ett medlem som har hatkampanjer mot alle naturlige legemidler eller naturmidler....har hørt om det siste i årevis.

En NDA er bare positivt, synes jeg, men haken er at det er så lite penger i å lage de billigste Thyroid-tablettene at de firmaene ikke har råd.

Leser meldinger om at FDA ville ha krevd en NDA av alle Thyroid-USP-produsentene uansett. Merk at de har alllerede sendt ut slike krav så det er ikke løse rykter.

(NDA er New Drug Application.
Levothyroxin gikk aldri gjennom denne prosessen, forresten, og vi ble snytt for dobbelblindstudier av levothyroxin vs Thyroid USP. Levothyroxin gikk aldri engang gjennom kliniske forsøk dengangen, det ble hevdet at levothyroxin var helt identisk med Thyroid som jo var kjent som virksomt og pålitelig. Mer om dette på hjemmesiden min) (alle produsenter på levothyroxin måtte rundt år 2000 levere en NDA og Synthroid nektet men måtte allikevel. Det ble ikke gjort dobbelblindtester på virkningen, heller tester på hvor mye virkestoff det er i tablettene og hvor lenge de holder riktig dose)

[nora]

Sjekk denne, fra facebook-forumet, det er noe velidg drastisk på gang! FDA sier nå plutselig at Thyroid er ulovlig.
http://www.facebook.com/topic.php?ui...89&topic=10470

Det er imot alle gamle og vedtatte regler, som jo sier at midler som er brukt fra gammelt av og er kjente som virksomme og pålitelige skal være godkjente av den grunn, og er "godfathered in" dengang de begynte å kreve NDA på 50-eller 60-tallet.
Og det var nettopp begrunnelsen til synthroid for aldri å søke NDA, at det var identisk med den gamle og virksomme Thyroid USP. (mens det ikke var identisk, for det manglet for eksempel t3 og er ikke bundet til albumin, men natrium, og mangler kalsitonin, osv osv)

[nora]

Dawn svarer at det er en mengde andre gamle medisiner som er brukt daglig, det er ikke fair å kun gå etter Thyroid og ikke de andre, for eskempel Aspirin . Det er ulogisk. Noe muffens foregår. De vil vel ha alle oss på thyroxin . Skal være så bra fordi det nå er godkjent. (hadde som kjent ikke levert en søknad om godkjenning før etter 2000) (din norske lege har neppe hørt om dettemens det har vært i media utenlands i årevis)
"In the uk we have looked at other medication in current and oft prescribed use, that was also grandfathered in, such as aspirin and some of us have been lucky enough to then get NDT precribed on the NHS as they haven't been able to argue with that logic. It may be worth doing the same in your letters as if it's ok for one medication why not NDT's... Les mer.

If there is anything we can do over here to back you up then lmk, obviously we are battling our own problems with the RCP et al but if there is a shortage in the US then we don't get it over here so our powers that be a very happy.

have any of the producers indicated they would apply for license if forced to do so, in some respects if they do and get one it does stop the arguement that it is dodgy medication I suppose" Dawn

Mer forklaring her:
http://www.stopthethyroidmadness.com...da-has-spoken/

som forklarer om loven fra 1962 (amendment) og hvorfor de går løs på Major og time Caps (som offisielt har fått brev om å stoppe produksjonen av Thyroid, det er ikke bare et rykte), at de er "nye" fremstillere av Thyroid USP , mens Armour og RCL er "gode gamle" fremstillere.
Altså teknikaliteter om datoer og Grandfathered in og amendment av 1962.
Aha.
(men de ville likt å "ta" alle naturlige thyroxiner bare fordi det er et kjør på alt som er naturligt, vi har hørt om det i årevis)

[Hansen]

Ja, det er bare bra med en NDA, og krevd er den. Jeg forsto det sånn at man hadde juridiske stridigheter om lovligehten av kravet.
Men de må vel bøye seg ?

Det går nok utover mangfold og kan jo bli dyrere, men de kan jo bare gå tilbake til de gamle virkestoffene.
Noe taktikkeri er det vel ?

Jo, jeg merka meg at Thyroxin Natrium skifta navn til Levaxin og det var vel rundt 2000. Leste senere at det var fordi de hadde fått bedre kiralitet.
Men ante ikke - iallfall ikke den gangen - at de også fikk ny godkjenning.

Får iallfall håpe at de for swung på sakene snart......

------------

Det ser jo ekte ut.... meget betenkelig dette !

[Anisa]

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.

Både og.... på hjemmesiden International Hormone Society (IHS) findes et mindre men interessant Patientforum Thyroid, hvor i tråden "natural thyroid" er samlet nogle få interessante breve/artikler om netop FDAs rolle i de aktuelle forsyningsproblemer.

The International Hormone Society (IHS) er den endokrinolog-organisation, der helt og holdent står på patienternes side, hvorimod de fleste andre lægelige fagforsamlinger dyrker fremfor alt hinanden/sig selv og deres sponsorer: medicinalindustrien.

Den berømte, "patienternes læge" Thierry Hertoghe tilhører denne organisation = i min optik, den bedste anbefaling.

[nora]

Ja, det fins mange retninger innen legestanden, noe vi pleier å glemme her i skandinavia, legene her later som om de forvalter den ene sannhet.

Jeg pleier å få nyhetsbrev av Hotze og Pfannenstiel, som er de ledende legene for thyreodea i tyskland, og de skriver ut resepter på Armour osv, og skriver litt om det i nyhetsbrevene.

I USA er det en anne type legeutdanning også, de har D.O. i tittelen, og ikke M.D. De jobber helhetlig, og skriver ut Armour og natulig thyroxin, og ser ikke bare på TSH. De har egne legestudier, egne sykehus, osv. Nesten øredøvende taushet om at sånt fins her ifra skandinavia....

Mer om mangelen på Armour, her fra ht-mb forumet:
http://www.ht-mb.de/forum/showthread.php?t=1120725 har ikke lest tråden ferdig
jo, de nevner noen internasjonale apotek (svaret hører vel også hjemme i erfa-tråden) og tysklaget thyreoidea-ekstrakt (stopthethyroidmadness har en liste over naturligthyroxin i hele verden, og denne er laget i tskland)
fra http://www.ht-mb.de/forum/forumdisplay.php?f=4

en til tråd om mangelen http://www.ht-mb.de/forum/showthread.php?t=1121420
husk google translate men det er ikke så bra fra tysk til norsk
og http://www.ht-mb.de/forum/showthread...08#post1903608

Siste nytt fra Mary Shomon fra facebookgruppen:
"Save Natural Thyroid
For anyone who would like the story in one place, download the 6-page Save Natural Thyroid Coalition PDF -- "History of the Natural Thyroid Shortage"
http://www.savenaturalthyroid.com/do...id-summary.pdf Feel free to download,... and share copies with your doctors, and other thyroid patients who aren't online."

[Vigdis]

Link her til en seks siders sak om mangelen på naturlig tyroksin fra Mary Shoman.