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Weetman/Ross attempt to patent slow release T3

Slow Release T3 Patent Application

Many of you will be delighted to learn that patents have been applied for by the Company Diurnal Ltd. of Cardiff in the UK, for a new drug combination designed to treat hypothyroidsim.

The drug is named Tri4 Combi and it comprises of 6 mcg slow release T3 combined with 100 mcg of T4. The Diurnal website announces:

Tri4CombiGoal: to be the best-in-class thyroid hormone replacement treatment for patients with hypothyroidism.”

They also state:

“Despite conventional thyroxine replacement being widely available, more than 25% of patients with hypothyroidism report significantly impaired quality of life with medical and social economic consequences. Commercially available combination products of T3 and T4 do not provide physiological replacement and at best are titrated empirically (by the physician) based on symptomatic responses.”

http://tpauk.com/images/bank/richard-ross.jpgThe Inventors/Applicants are Professor Richard Ross and Dr. Hiep Huatan . In their International Application published under The Patient Coorperation Treaty they wrote:

“Individuals who suffer from hypothyroidism are typically prescribed Thyroxine (T4) as replacement therapy. It is well recognised that a large proportion of patients persist with specific symptoms and a failure to regain a normal sense of well-being despite thyroxine replacement. For example, recent studies (show that) it is estimated that between 30% and 50% of patients reported dissatisfaction with their treatment”. and

It is apparent that current recent regimes for hypothyroidism do not adequately control the condition and alternative improved treatments are needed that do not have the side effects associated with T4 treatment.”

Am I alone in finding such a patent application in the present thyroid treatment climate very useful in illustrating the level of hypocrisy in medicine. The application appears to use the graphs from the paper Professor Ross and Professor Weetman et al. authored. The circadian rhythm is the basis for the technology, sustained release, that they are trying to patent, not only for cortisol but for thyroid also.

This is the company that was formed to market the technology http://www.diurnal.co.uk/. It looks like they have had the most success with the infant cortisol, the adult version will probably follow later. The thyroid product is mentioned.

However, an interesting and somewhat ironic point about this patent application is that as stated above, they are planning to use 100mcg T4 to 6mcg T3. 200mcg T4 to 20mcg T3. This is approximately a 17 to 1 and a 10 to 1 ratio.

But, we have seen this before haven’t we and researchers have proved already that it doesn’t work. This can be seen in those studies that showed therapy using T4/T3 combination -v- T4-monotherapy to be ineffective.

Those patients being treated with natural desiccated thyroid (NDT), which has 38mcg T4 and 9mcg T3 or a 4 to 1 ratio, know that this combination works well. NDT has enough T3 to work with the Circadian T3 Method (CT3M). Will Tri4Combi have enough T3 in it to be effective in the circadian rhythm arena?

The British Thyroid Association (BTA) and the Royal College of Physicians (RCP) are fond of stating that the T3 content in NDT is too high and therefore could be dangerous, producing hyperthyhroid symptoms in some people. Yet, I personally have never heard of such a complaint from the 4,600 plus members of our support forum, many of whom are taking NDT safely and successfully.

Could this new product be strictly a marketing ploy? http://tpauk.com/images/bank/prof-weetman.jpg

Especially as there are links between Prof. Richard Ross and Prof. Antony Weetman , former President of the BTA,member of the RCP and a Chair of the General Medical Council Fitness to Practice Panel. The link is that they are both alumni of Sheffield University and they jointly contributed to a paper written in 2008, about the circadian rhythm of free T3 and cortisol.

Under the auspices of Professor Weetman, the British Thyroid Association (BTA) in their 2008 statement on thyroid disease, announced that:

Overwhelming evidence supports the use of Thyroxine (T4) alone in the treatment of hypothyroidism. Thyroxine is usually prescribed as levothyroxine. We do not recommend the prescribing of additional Tri-iodothyronine (T3) in any presently available formulation”

He also announced in his paper “Whose Thyroid Hormone Replacement is it Anyway” that

“Nothing seems more straightforward than treatment of hypothyroidism. We have robust assays to diagnose the condition and an effective replacement in the form of synthetic thyroxine.”

Is it any wonder that endocrinology doesn’t know which way to turn when their patients continue to complain of symptoms of hypothyroidism when they have ‘normal’ thyroid function test results and who are already being treated with this so called wonder drug called levothyroxine?

Could the Tri4 Combi change the view of the BTA, the RCP and Endocrinology as a whole, eventually giving better health to the 30% to 50% of patients who are reporting “dissatisfaction with their treatment” on T4-monotherapy? Will the slow release T3, as set out above, make any difference to these 30% to 50% left suffering. Do the Inventors of the Tri4 Combi believethey may benefit financially given the $800,000,000 market? We can only wait and see.

As the amount of T3 in the combi tablet is small at 6mcg only, we are hoping that the Applicants will cite studies that prove the effect of the slow release will compensate for the lack of active hormone. ?

You can read further information about theRoss European Application, which has been refused. No appeal against the refusal has been filed, so it is now dead. It was deemed to lack inventive level over the prior art.

The US patent application (20100136109) has now been abandoned. Usually people don’t reply to an Office Action when the objections raised are difficult to rebut.

The following link provides info on directorships for Diurnal: . You may need to register to view it it doesn’t cost anything to register.

I can find no sign of Professor Weetman being a Director or Shareholder of Diurnal and his CV makes no reference.

In contrast, Professor Ross’s entry does refer to Diurnal. Interestingly, Professor Ross gives an extensive list of professional activities whereas Weetman gives none.

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