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

[Rufus]

Diskusjonen om FDA og NDA er jo amerikansk. Om FDA ikke lar naturlig thyroxin være på markedet mens en ny NDA behandles, vil vel ikke det påvirke eksepmelvis Erfa som er kanadisk? De kan vel fortsette som før? Bør ikke norske leger i stedet begynne å skrive ut naturlig thyroxin fra Erfa og ikke produktene til Forest og RCL? Er det en spesiell grunn til at det skrives ut Armour, Nature-Throid og Westroid og ikke Erfas thyyroxin, f.eks?

[nora]

Ja, erfas Thyroid er godkjent og registrert i Kanada, og har ingen problemer, og de ryktes å komme til å søke om godkjenning i USA. (og da vil de være eneste FDA-godkjente Thyroid...)
erfa er mye billigere enn Armour thyroid også.
Pasientene har vært bakstreverske og kun bedt om Armour.
Forest har aldri vurdert å søke om godkjenning i Europa.
RLC og Erfa har søkt om sentral godkjenning i europa.
Er ikke så vanskelig, all den tid det danske thyreoideum er godkjent, både i Danmark og Holland, og de har Thyreogland som er av tyskopphav i tyskland, og et italiensk Thyroid antageligvis laget i italia.
Jeg antar at de baserer seg på gamle dokumentasjoner om bruk fra sent 1800-tallet...burde være rikelig dokumentasjon.

En gang til: Be om Erfa Thyroid. Fins på lager i europa, noen fikk svar fra et av de mange internasjonale apotek i tyskland. De trenger hvit resept i tyskland, vi trenger vel søknad om registreringsfritak (som er norsk for named-patient programme) men mon tro om en hvit resept til tyskland vil gjelde også, det er jo lov å importere medisin. Bare grubler.
Her står det i en av postingene at alle leger i tyskland kan skrive et privatresept (i motsetning til kassaresept, tilsvarer vårt blåresept) og at apoteket så får det fra et internasjonalt apotek, og det er flere av dem i tyskland. http://intlhormonesociety.org/forum/...hp?topic=650.0

[Rufus]

"Von: Onlinebestellung Internationale Apotheke STGT <bestellung@internationale-apotheke-stuttgart.de>
An: ........@arcor.de
Datum/Uhrzeit: 25.09.2009 / 17:17 (Empfang)

Sehr geehrte Frau ....

vielen Dank für Ihre Anfrage.

Thyroid aus Kanada ist erhältlich.

Thyroid 30 mg 500 Tab für ca. 77,05 €
----------- 60 mg------------ für ca. 98,00 €
-----------125 mg------------für ca. 129,00 €

Internationale Apotheke OHG
Dr. Bernd Miller Herr Nikolaus Kondraschov
Königstr. 70
70173 Stuttgart
Telefon: 0711/22478-20
Telefax: 0711/22478-32
E-Mail: apotheke@interapo.com
Homepage: www.interapo.com
"
merk de hyggelige prisene

Takk for tipset, Nora!

Jeg kontaktet det samme apoteket og fikk lignende mail tilbake (de samme prisene). De oppgav at frakt til Norge koster 28 Euro.

Jeg spurte om framgangsmåten. Svaret var: "At first you may send us your prescription and your credit card details afterwards we will follow your order".

Så i dag fikk jeg resept på Thyroid (Erfa Canada) av legen min. Så sender jeg den til Tyskland. Da burde det vel gå bra!?

Rufus

[nora]

jepp, men du er prøvekaninen vår her....det var vel vanlig hvit resept dere prøver?

Hvis pasientene og leger blir vant til Erfa Thyroid, kan de kanskje gidde å registrere det her i Norge, jeg fikk en forespørsel en gang fra dem hor de spør hvordan. Men jeg er ikek sikker på at en historisk/bibliografisk søknad holder (den er mye billigere enn en vanlig søknad) men jeg er redd det koster en stor avgift å ha medisin registrert og ha markesdføringstillatelse hvert år her....nesten naboen til Adenbukta og Kongo.

[Rufus]

.det var vel vanlig hvit resept dere prøver?

Nei, ikke vanlig resept, men den som jeg har fått før for legemidler på Registreringsfritak (Statens legemiddelverk). Var det dumt?

[nora]

De i tyskland trenger bare privatrezept så du kunne prøvd dette, ville vært interessant, for hvis det går så er flere norske leger interesserte i å skrive resept siden de ikke må anstrenge seg så mye...
men det du sendte er resept på named patient programme og det må da duge. Erfa og IDIS nevner jo dette.

[nora]

Her fra facebookgruppa, posting av Mary Shomon:
"
Save Natural Thyroid Coalition/Conference Call Summary Report
Del
I dag klokken 07:45
On Thursday, September 24, 2009, from 8 – 10 p.m. Eastern, we held a telephone conference call, kicking off the Steering/Strategy Committee for the Save Natural Thyroid Coalition, to discuss the future of natural desiccated thyroid (NDT) drugs.

The following is a brief recap of the call’s highlights, along with action points.

PARTICIPANTS & AFFILIATIONS

In addition to a number of patient advocates, the following individuals participated on the conference call (Note: I’m combining a bit of their own introductions of themselves, along with some of their additional accomplishments and credentials. These notes are, however, by no means inclusive of all their affiliations, publications, and accomplishments!)

Gretchen DuBeau, Washington DC – Gretchen is the director of the American Association for Health Freedom (AAHF), a membership-based organization that promotes access to integrative medicine

Robban Sica, MD, Orange, CT – Robban is a doctor, practicing almost 25 years in Orange, CT. The Broda Barnes Foundation was referring patients to her since 1987. She uses natural thyroid in her practice, and has about 3,000 patients on natural desiccated thyroid. She is a Secretary of the American Association for Health Freedom, President of the International College of Integrative Medicine, and represents ICIM to the Integrative Medicine Consortium (whose combined organizations of integrative physicians have some 4,000 doctors who prescribe natural thyroid).

Jim Turner, Washington, DC – Jim is an attorney in Washington, DC, chairman of Citizens for Health, a consumer activist group since 1993, and the group that was responsible for getting 2.5 million letters sent that helped get the Dietary Supplements Health Education Act (DSHEA) passed. Jim is now working on integrative wellness, and food and water safety. He participated in the compounding pharmacy campaigns, and is concerned about the FDA’s authority to limit individual decisions to make healthful choices.

David Brownstein, MD, Michigan – David is a family practitioner in Michigan, and author of a number of books on thyroid disease, iodine, and bioidentical hormones.

Dr. John Lowe – John is a clinical researcher and educator, focusing on basic and clinical thyroidology. He has 25 years of working in multidisciplinary research, studying synthetic T3, natural desiccated thyroid, etc. For the last four years, he has been editor in chief of the open access journal Thyroid Science, doing clinical studies, dose response studies with NDT.

Kent Holtorf, MD, Torrance CA – Kent has been practicing for 10 years, and is particularly interested in thyroid issues, as he finds that they are poorly treated with standard model used. He is a strong advocate of using T4/T3 combination treatments.

Theodore Friedman, MD, Los Angeles, CA – Theodore is chairman of medicine and chief of endocrinology at Charles Drew Medical School, an affiliate of UCLA. He sees many of patients with thyroid problems, and says “desiccated thyroid is an important option, there shouldn’t just be one treatment for thyroid.” He is author of The Everything Health Guide for Thyroid Disease.

Pat Barber – Pat is the patient educator at the American Autoimmune Related Diseases Association (AARDA), and their mission is to bring awareness and more research dollars to autoimmunity, and get it known as a category of disease. Pat said: “we hear from too many patients who have had great results with natural thyroid not to get involved in this issue.”

Jacob Teitelbaum, MD, Hawaii – Jacob is medical director of the Fibromyalgia and Fatigue Centers nationwide, and an internal medicine physician who specializes in fibromyalgia and chronic fatigue. He is author of From Fatigued to Fantastic. His recent efforts have also focused on helping to heal the health care system itself. He is also active in the media, and was a recent guest on the Dr. Oz show.

Dai Jinn and Rick Cox, Cave Creek, AZ, RLC Labs – Dai is Chief Science Officer at RLC, and Rick is the owner of this manufacturer of Nature-Throid and Westhroid. Rick said: “I believe in NDT, not because I own a business, but because I am a patient!”

Jim Rock, Washington, DC – Jim is with Parry, Romani, DeConcini & Symms, a lobbying firm, and he lobbies for AAHF. He has also worked representing compounding pharmacies, and currently represents 4 of the larger compounding pharmacies. He is also an Armour patient himself.

Donna Hurlock, MD, Alexandria, VA -- Donna is a gynecologist who, she said “learned to do thyroid correctly back in 1998 when my hair was falling out and Alan Gaby enlightened me!” Donna has several thousand patients on Armour, but says “I also use the synthetics. I use whatever makes my patient well!”

Richard Shames, MD, San Francisco Bay Area, CA – Rich has been practicing for 35 years, has several thousand thyroid patients, many who only do well on Armour. His wife and daughter are also thyroid patients. Rich is also author of

Joseph Mercola, DO, Hoffman Estates, IL – Joe is trained as a family physician, his site is the most visited natural health site in world with millions of page views weekly, and he hopes to leverage that exposure to help the natural thyroid issue. Dr. Mercola is also author of a number of popular books on health, wellness, and diet.

Erika Schwartz, MD, New York City –Erika was unable to be on the call but Gene from her office participated in the call, and explained that Dr. Schwartz is a patient health advocate, one of the leading experts on bioidentical hormones, has been using natural thyroid and bioidentical hormones with patients for years. Dr. Schwartz is also one of the founding directors of the Bioidentical Hormone Initiative.

Ken Woliner, MD, Boca Raton, FL – Ken is a family physician who has been using natural thyroid with his thyroid patients successfully.

DISCUSSION REGARDING FDA

We discussed the following issues:

• FDA has made it clear that natural desiccated thyroid is an unapproved drug
• FDA is running an “Unapproved Drug Campaign”
• Desiccated thyroid will eventually need to go through the approval process – the question is how and when
• Time-Cap Labs received an enforcement letter that shut them down – but they were not specifically targeted due to their manufacture of natural desiccated thyroid
• Biotech had shut down in the past, and Major recently shut down their NDT production – claiming FDA involvement (but no enforcement letter is on the record)

We are in a position to set up a meeting with FDA officials at the highest levels, and discussed the message to be delivered in this meeting, specifically, that we many patients take NDT, that many doctors are prescribing it, and that we have an active and engaged Coalition of patients and practitioners who have an interest in the drug remaining on the market, having an expedited drug application for NDT, and for NDT to remain on the market during any drug application process that might take place.

DISCUSSION REGARDING APPROVALS PROCESS

The Coalition understands that a drug approval process is really the only way to make the drug, but that there’s a need for concern. In particular, issues with NDT, including recalls, efficacy issues, raw material shortages, etc., have put NDT in a difficult place vis a vis the FDA and the professional organizations. We must focus our efforts on helping to make NDT a viable, valid therapy for hypothyroidism, and help ensure that NDT as a category of medications remains viable.

Ultimately, we all agreed that the FDA still needs to be convinced of the validity of NDT, and part of our work will be to establish the validity and necessity of NDT with the endocrine panel at the FDA, and well as professional organizations like ATA, AACE, etc.

Rick Cox of RLC indicated that his company intends to cooperate and work within FDA guidelines – and does not support efforts to do things outside the bounds of the FDA and the government.

DISCUSSION OF NDT STUDIES/RESEARCH

Dr. John Lowe discussed the hundreds of studies, going back 100 years, that discuss the efficacy of NDT, and will be leading an effort to coordinate additional studies, case studies, and research summaries.

FOREST PHARMACEUTICALS

A panel of practitioners will be contacting Forest for a meeting, in the hopes that Forest’s commitment – or lack thereof -- to the NDT market, as well as patients and practitioners who use NDT -- can be assessed.

PATIENT/PRACTITIONER/PROFESSIONAL OUTREACH

A number of support materials are in production, including

Fact Sheet for Patients

Fact Sheet for Doctors/Practitioners

Research Summary Paper

Case Study Program:
• Guidelines on how to write a case study
• A sample case study

These materials will be available for download, and patients will be encouraged to share the Fact Sheets and Research Summary with your practitioners.

Our Coalition experts are putting together guidelines on how to write a case study, along with a sample case study, and once those are ready, we’ll ask that you get these in the hands of your practitioners, and ask them to submit case studies for as many thyroid patients on NDT as possible.

YouTube Save Natural Thyroid Channel

We’ve created the Save Natural Thyroid YouTube channel at
http://www.youtube.com/user/SaveNaturalThyroid and you are encouraged to create videos supporting natural thyroid. You may also want to film your practitioners talking about the use of natural thyroid.

You may also want to create spoof advertising videos for possible viral dissemination (i.e., Moveon.org’s viral Will Ferrell “Help the Health Insurance Industry” parody advertisement video – see this video at http://www.funnyordie.com/videos/041...-companies-psa )

Ultimately, video testimonials from patients and doctors may be edited into online PSAs or presentations for use with members of Congress, the FDA, the media, or practitioners.

I’ll have more details on this next week, but in the meantime, start filming yourself, friends, family, doctors, or think about funny ways to make the case for natural thyroid!

Professional/Practitioner Outreach

Save Natural Thyroid Coalition Steering Committee members will be writing articles, letters, editorials for journals and professional websites, and making presentations at medical meetings.
"
kopiert og limt inn fra http://www.facebook.com/note.php?not...2828833&ref=mf

[Vigdis]

NB! Nederst på siden Nora har sakset fra Save Natural Thyroid står det at de vil gjerne ha videoer ut på youtube.

Små snutter som støtter saken, om hvordan livet har forandret seg etter naturlig tyroksin, samtale med deg og legen din etc.

Hadde vært fint med noe fra Norge eller Danmark?

Legg ut filmen din her

[nora]

Siste rykter om Forest (som eier Armour) fra facebookgruppen: http://news.moneycentral.msn.com/pro...02&id=10445104 at et annet firm skal overta en del av Forest sin portefølge

[Hansen]

Spørs hva de vil sitte igjen med da ?
Det kan vise seg at markedssituasjonen har en mangesidig årsak.

Lave priser skaper lavt overkudd og liten interesse for investeringer.
Høye priser gir god avkasning og fare for oppkjøp og diverse ordninger.

Da jeg begynte med Levaxin kostet den sånn omtrent 5kr. (100 100)
noe som vel skulle bety omtrent 50 idag.
Men, den koster jo endel mer da.......

Det er liksom ikke OSS de tenker på først.......