Kieron Andrew
08-17-2006, 10:30 AM
Sex Hormone Licensed for Treatment Of Trans Men
Report by Christine Burns
Weds 16th August 2006
=========================
In what is believed to be the first such move of its kind, pharmaceuticals giant Akzo Nobel has obtained a license variation enabling the male hormone "Sustanon" to be officially prescribed for female to male transsexual people.
In a letter to Dr Lynne Jones MP, the company's Head of Regulatory affairs writes,
"I am pleased to inform you that our product license
for Sustanon in the UK has been updated to include use
in female to male transsexual patients. Section 4.1 of
the Summary of Product Characteristics (SPC) states that
'Testosterone administration may also be used as
supportive therapy for female to male transsexuals.' "
Before any drug can be officially prescribed by a doctor it must go through extensive tests for what is called "Regulatory Approval". Part of that process also involves defining the circumstances in which the drug is intended for use. Until now, drugs like "Sustanon" (a form of testosterone), the whole family of Oestrogen replacements, and other products such as drugs used to block hormone receptors, have been licensed for their originally conceived uses, but not for helping people to transition from one sex to the other or maintain appropriate hormone levels once there.
This lack of approval has meant that, for decades, doctors treating transsexual people have always effectively been out on a limb when prescribing. The risk was that if anything ever went wrong (if a trans woman had a blood clot, for instance), the doctor who prescribed the drugs in question would have no defence for their actions.
The way in which doctors have sought to cover themselves in these circumstances has been to rely on the authority of someone else to authorise them to write a prescription -- a GIC specialist or endocrinologist, for instance. Some GPs have simply refused to take the risk at all, however. The risks involved have also created a strong desire to lean on so-called Standards of Care as a further source of defence.
Over the last year, the chair of the UK's Parliamentary Forum on Transsexualism, Dr Lynne Jones MP, has had meetings with representatives from many of the companies who manufacture the products that trans people use. It was generally thought that the costs for any of those companies to justify a license variation of this kind would be prohibitive. Normally such a process involves extensive testing and analysis of results from controlled trials. This first-of-a-kind move is therefore EXTREMELY significant -- showing that IT CAN BE DONE.
Akzo-Nobel has supplied a copy of the updated Summary of Product Characteristics (RA 1440 UK S2 (ref 2.0)). They have also supplied a copy of the updated patient information leaflet for Sustanon 100 / 250.
We aim to have these documents loaded on the PFC web site as soon as possible for easy reference.
In the meantime all the necessary information can be obtained online from the Electronic Medicines Compendium at emc.medicines.org.uk.
Simply enter the keyword "Sustanon" in the Quick Search box and then select either the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SPC).
This license change only applies to the UK and, as yet, there is no indication yet of where other companies may be in terms of following suit. Each pharmaceutical company needs to go through a similar license variation process for the individual products they manufacture in order to achieve these changes. Akzo Nobel's Head of Regulatory affairs has indicated, however, that "we would be happy to share our experience of the process with other companies".
Someone had to be the first to do it though. And now it has happened it is a lot harder to justify holding back for other common drugs such as Ethinyl Oestradiol, widely used by trans women.
Christine Burns
Note: The updated product information leaflet (PIL) and SPC details for Sustanon 250 are now available on the PFC Web Site at
www.pfc.org.uk/node/613#drugs (http://www.pfc.org.uk/node/613#drugs)
Report by Christine Burns
Weds 16th August 2006
=========================
In what is believed to be the first such move of its kind, pharmaceuticals giant Akzo Nobel has obtained a license variation enabling the male hormone "Sustanon" to be officially prescribed for female to male transsexual people.
In a letter to Dr Lynne Jones MP, the company's Head of Regulatory affairs writes,
"I am pleased to inform you that our product license
for Sustanon in the UK has been updated to include use
in female to male transsexual patients. Section 4.1 of
the Summary of Product Characteristics (SPC) states that
'Testosterone administration may also be used as
supportive therapy for female to male transsexuals.' "
Before any drug can be officially prescribed by a doctor it must go through extensive tests for what is called "Regulatory Approval". Part of that process also involves defining the circumstances in which the drug is intended for use. Until now, drugs like "Sustanon" (a form of testosterone), the whole family of Oestrogen replacements, and other products such as drugs used to block hormone receptors, have been licensed for their originally conceived uses, but not for helping people to transition from one sex to the other or maintain appropriate hormone levels once there.
This lack of approval has meant that, for decades, doctors treating transsexual people have always effectively been out on a limb when prescribing. The risk was that if anything ever went wrong (if a trans woman had a blood clot, for instance), the doctor who prescribed the drugs in question would have no defence for their actions.
The way in which doctors have sought to cover themselves in these circumstances has been to rely on the authority of someone else to authorise them to write a prescription -- a GIC specialist or endocrinologist, for instance. Some GPs have simply refused to take the risk at all, however. The risks involved have also created a strong desire to lean on so-called Standards of Care as a further source of defence.
Over the last year, the chair of the UK's Parliamentary Forum on Transsexualism, Dr Lynne Jones MP, has had meetings with representatives from many of the companies who manufacture the products that trans people use. It was generally thought that the costs for any of those companies to justify a license variation of this kind would be prohibitive. Normally such a process involves extensive testing and analysis of results from controlled trials. This first-of-a-kind move is therefore EXTREMELY significant -- showing that IT CAN BE DONE.
Akzo-Nobel has supplied a copy of the updated Summary of Product Characteristics (RA 1440 UK S2 (ref 2.0)). They have also supplied a copy of the updated patient information leaflet for Sustanon 100 / 250.
We aim to have these documents loaded on the PFC web site as soon as possible for easy reference.
In the meantime all the necessary information can be obtained online from the Electronic Medicines Compendium at emc.medicines.org.uk.
Simply enter the keyword "Sustanon" in the Quick Search box and then select either the Patient Information Leaflet (PIL) or the Summary of Product Characteristics (SPC).
This license change only applies to the UK and, as yet, there is no indication yet of where other companies may be in terms of following suit. Each pharmaceutical company needs to go through a similar license variation process for the individual products they manufacture in order to achieve these changes. Akzo Nobel's Head of Regulatory affairs has indicated, however, that "we would be happy to share our experience of the process with other companies".
Someone had to be the first to do it though. And now it has happened it is a lot harder to justify holding back for other common drugs such as Ethinyl Oestradiol, widely used by trans women.
Christine Burns
Note: The updated product information leaflet (PIL) and SPC details for Sustanon 250 are now available on the PFC Web Site at
www.pfc.org.uk/node/613#drugs (http://www.pfc.org.uk/node/613#drugs)