Friday 11 May 2012

PIP Inquiry Rejects DES Story

Yesterday was the Senate Inquiry Hearing about the Poly Implant Prosthese (PIP) breast implant scandal. But the Senate did not want to hear organisation DES Action Australia-NSW's submission. This submission was about the Therapeutic Goods Administration's (TGA) mismanagement of the DES drug disaster and how this correlates to the TGA's current handling of the PIP scandal. In fact the Senate sent the submission back to the organisation, refusing to publish it online and deeming it irrelevant and not addressing the terms of reference.

Here are some excerpts from the 9 page submission:

"The monitoring and follow-up of the DES drug disaster by the TGA has been found wanting, with its initial delay in response and inefficiencies in administering DES cancer reports, sometimes with practices that would appear unorthodox (ie, the non-acceptance of data from 1983-2001). Lack of interest in investigating and acceptance of its own flawed and incomplete data has meant no further concerted action in continuous monitoring of the DES problem both in Australia and overseas by the TGA. Even where possibilities have existed to improve its own database, the TGA asserts there are restrictions in its role, eg, it is not in its role to cross-check the International DES cancer Registry. There is no feasible explanation for the misleading and inaccurate media release that was issued to the public (and for the government) in 2004. The reliability of its information sources for the 2004 media release should be questioned, including its available resource, RANZCOG, with its specific representative for DES health matters. The TGA's media release in 2004 provides evidence of failure to consult with USA experts in the DES field of research, some of whom are world renowned. Therefore, the TGA's procedures in risk assessment of DES exposed Australians could not be considered comprehensive and effective when only Australian consultative bodies have been used. If the TGA has any procedures in place to communicate with general public in relation to DES, then these have ensured that the Australian public has remained uninformed, ill-informed or has been issued accurate information ineffectively. 

In summary, by its actions and inactions, the TGA has stymied the availability of data to the Department of Health and Ageing in relation to the magnitude of the DES problem in Australia. By its actions and inactions, the TGA has stymied the likelihood of the Australian public receiving accurate information about DES. The TGA's response to the DES exposure problem has had an overall effect of decreasing government attention to the DES exposure problem - to the detriment of DES exposed Australians."

"The TGA response to the PIP disaster has been similar to the DES disaster response with self-imposed limitations in the acquisition of risk-assessment information. There has been limited focus on activities by overseas regulators and limited access to available international data in relation to PIP implant rupture rates. Similar to the DES problem, unbalanced and poor quality information to the government has resulted in sub-standard assistance to PIP breast implant recipients. Once again, the TGA's advice regarding a dangerous "therapeutic" good is grossly inadequate and not in line with overseas regulatory bodies and governments. Appropriate government response has been further impeded where there are ongoing problems, eg, surgery difficulties and arising complications when removing ruptured implants, substance leakage even in implants not ruptured. Just as PIP breast implant recipients have been deserted by the TGA and government with "time bombs" in their bodies, DES exposed Australians have similarly been disenfranchised with the "time bomb" effect of DES. Indeed, there may be DES daughters who have succumbed to DES related breast cancer and subsequently become PIP breast implant recipients. These women would have in effect, fallen foul to TGA inefficiency twice over."

"The fact that the TGA is fully funded by fees from the pharmaceutical industry provides explanation for its poor and inhumane responses to serious drug/medical device adverse events. This very obvious conflict of interest and the increase in reported incidents should signal the need for government legislation to ensure that specialist task forces independent of the TGA (with role of consulting with affected stakeholders), are set up to respond to medical device/drug disasters."

Without due consideration of this submission as part of this Inquiry, the shortfalls in TGA responses to any drug/medical device disaster will not be recognised. This is tragic for PIP recipients and all other victims of drug/medical device disasters. 

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