From the August 1997 Newsletter:
Note: This article is only relevant to Australian government pharmaceutical policies.
Recently, one of our male members decided it was time he had a bone density test and was shocked to find he had Osteoporosis. He was even more upset to find as a male he did not qualify for "free" list to obtain Rocaltrol or Fosamax. Instead of the usual $20.00 for a 100 tablet bottle of Rocaltrol, because he was a male with Osteoporosis, he had to pay $80.00! He decided to take the issue further and contacted the Therapeutic Goods Administration (T.G.A.) which are the division of the Commonwealth Department of Health and Family Services that has overall responsibility for ensuring the safety,. quality and efficacy of therapeutic goods - both devises and pharmaceuticals. Put simply, among other things, the T.G.A. is responsible for drug evaluation. He was advised that probably in August 1997, the situation regarding Rocaltrol would be changing.
We have followed this matter up and are happy to report that Rocaltrol is no longer a gender issue. As of the 1st August 1997 both male and female patients with Osteoporosis have an equal chance to obtain Rocaltrol at the reduced government sponsored rate. Of course there is a qualifying condition; Rocaltrol is only available on the ‘free list’ to established osteoporosis patients with fracture due to minimal trauma.
Wendy Duke from the Pharmaceutical Benefits Advisory Committee explained how the seemingly unfair situation against male patients with osteoporosis has arisen. Drug companies have to submit research data and evidence to the T.G.A. to get their drugs approved for release and use in Australia. Female patients are more prevalent than males with osteoporosis, so it is easier for the drug companies simply not to present the T.G.A. with data concerning male patients with osteoporosis. The T.G.A. can only evaluate a drug on the evidence it is given, so if there is no evidence they can not recommend the drug for male patients.
Roche Products, the manufacturers of Rocaltrol were quick to realise their mistake and have submitted evidence and research data concerning the benefits of Rocaltrol to male patients with Osteoporosis, which resulted in Rocaltrol now being available on the ‘free list’ to male patients. On the other hand, Merck Sharp and Dohme, the manufacturers of Fosamax have still not submitted data relating to male patients so it may be some time before Fosamax is available to males with osteoporosis at the reduced government funded rate.
Wendy Duke reported there have been considerable break-throughs in the treatment of osteoporosis and more drugs will be available in the next 18 months.