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Issue 1 - Jan 01, 2001

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CONTENTS
Dr Christiano interviewed on the Bald Truth Show Dutasteride Update
Generic 5% Extra Strength Rogaine available now Transplant Marketing Scams
Consumer Alert - Beware of Dermal Retention Consumer Survey
Hollywood does Hair Loss! - New Movie Expert Advice
Help Fund Hair Loss research Message Boards Upgrade
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Dutasteride Update


Just over a year ago Dr Marty Sawaya announced some shocking news on the Bald Truth Show. Dr Sawaya had been testing a new hair loss drug code-named GI198745 or otherwise known as Dutasteride. She said the results were so dramatic that researchers could easily see which person was getting the placebo and which person was getting the active ingredient. In fact the results were so impressive they were better than she had seen with any other drug she had ever tested.

What shocked Dr Sawaya
was the decision by Glaxo Welcome, the company who owned the drug, to suddenly pull the plug on the Phase 3 trials. They did so without warning and in spite of the excellent results that were being seen. According to Dr Sawaya, she received a letter from Glaxo stating the Phase 3 trials were on hold and they requested that all equipment be sent back to Glaxo.

This sudden cancellation of the drug's trial has led to a lot of speculation as to why Glaxo pulled the plug. It has been theorized that Glaxo felt that because of Propecia's lackluster sales, Dutasteride would not be a moneymaker for them. Another possible reason floated is that Glaxo had been involved in a merger with SmithKline Beecham that was recently finalized on Dec 27, 2000. It is possible that Smith Kline did not want to enter into the hair loss market or may have been concerned because of scrutiny by the U.S. Federal Trade Commission who were worried about market dominance of certain therapeutic areas resulting from the merger.

Whatever the reason for the withdrawal there still is a way that you may be able to obtain Dutasteride. Glaxo was simultaneously testing the same drug for both BPH, Benign Prostatic Hyperplasia and for hair loss. Glaxo did complete Phase 3 trials for the Prostate version and it is believed that they are in the process of submitting it to the FDA for approval. This information was reported by our resident expert Dr Richard Lee:

"I called Glaxo-Wellcome in regards to dutasteride (GI198745) and was told that dutasteride has 'just completed' Phase 3 clinical trials and will be submitted to the FDA as an NDA (New Drug Application) for the treatment of benign prostatic hyperplasia 'soon'. The spokesperson's estimate as to when dutasteride would be available as a prescription medication is '6 to 12 months' hence.

If Dutasteride is available you will be able obtain it if your physician will write you a prescription for it. As Dr Lee explains, "The medical profession has always been accepting of using a drug for purposes other than that for which it has been approved by the FDA (e.g. taking aspirin for prevention of heart disease). This practice is referred to as "off-label prescribing". It was the method in which I prescribed finasteride before Propecia was available."

We have also heard word that there is a drug company outside the USA that will be selling a generic Dutasteride as soon as April 2001. While we don't want to give out any info until its been validated, we do feel that there is a very good chance that Dutasteride will be available to some people sometime in 2001.

This is good news for all hair loss sufferers as Dutasteride is a lot more effective than Propecia since it eliminates almost all the DHT produced in the body. We will keep you informed of the latest news about Dutasteride through the Hair Loss News Update.

 

 

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