This is a tale of two drugs, and how politics and ideology affect Australia’s drug approval process.
The abortion drug RU486 has been approved for clinical use in Australia but the Therapeutic Goods Administration seems reluctant to allow doctors to use it except for a narrowly defined range of circumstances.
Implants of anti-heroin addiction drug Naltrexone, by contrast, have not been approved for any purpose in Australia. They have not even been evaluated for safety and efficacy. Yet, as Crikey has previously reported, Dr George O’Neill, a gynaecologist in Perth has been able to implant a device of his own manufacture (and on which he has a patent) into at least 1,000 by using a named patient provision of the TGA Act. This enables him to use an unapproved treatment to allegedly save the lives of high risk patients.
Health Minister Tony Abbott has given his implicit approval for this process on national TV (Channel 7 last Monday night). He has also provided Dr O’Neill’s private company (GO Medical) with $1M of public money to do the research needed to get the drug approved for clinical trials.
Is this a case of double standards — with the Minister restricting access to RU486 allegedly on the grounds of protecting women’s health while tacitly allowing the use of an unapproved and untested drug on heroin addicts?
Is it simply a coincidence that the non-use of RU486 and the use of the naltrexone implants just happen to accord with the Minister’s personal moral views on abortion and addiction? It would not be the first such coincidence. Mr Abbott gave $22m of public money to fund an adult stem cell research at Griffith University, a decision made outside the usual NHMRC process of peer reviewed allocation of research funding.
If the Minister’s position is that these two regulatory processes are different, then it suggests a way is open for medical practitioners who wish to make more liberal use of RU486. They can follow Dr O’Neill’s example by using the special access scheme to prescribe the drug to any patient whom they adjudge to be at “high risk”.