This blog begins PWA's campaign to reform Australia's inept drug safety regulator (the TGA) and Freedom of Information and Political Donation Disclosure laws.
by Dr Martin Whitely - 8 May 2019 (This blog draws on the work of Dr Belinda Edwards regarding political donations, Dr Stephen Duckett regarding the PBS, and Peter Timmins regarding Freedom of Information law.)
Australia is nearing the end of another federal election campaign. Given past practice, it is very likely that drug companies have donated generously to our major political parties.[1] Because of Australia’s incredibly lax political donation laws, we will probably never know the full extent of drug company donations. The little we are allowed to know, won't be revealed until at least February 2020.[2]
Drug companies aren't benevolent institutions. They don’t donate to encourage democracy.
Drug companies are multinational corporations that donate to Australian political parties to curry favour, and influence government decisions that have an enormous effect on their profitability. By donating to both potential governments - Liberal/National and Labor - they ensure they are on the winning side, and don’t offend the losing side, knowing that eventually their time in government will come.
Drug company political donations, although substantial from the perspective of cash strapped political parties, are a tiny fraction of the money coming back to drug companies from whoever wins government. The Australian Government, and their agencies, make decisions about the approval and regulation of new drugs and medical devices, and control an annual $12.7 Billion Pharmaceutical Benefits Scheme (PBS) budget. Most of this $12.7 Billion is given directly to drug manufacturers, as part payment, for their PBS subsidised products.
In Australia drug companies make extraordinary profits because successive Commonwealth Governments have allowed their agencies to negotiate terrible drug deals.
As a result Australians pay far too much, both in taxes and at the pharmacist for medications, with prices "more than twice as high as in the UK and more than three times higher than in New Zealand".[5] As detailed by the Grattan Institute in 2013[3], 2015[4] and again in 2017[5], Australians "would pay less if the Federal Government made some simple changes to the way prices are set under the Pharmaceutical Benefits Scheme".[5]
It is our taxes that fund the PBS, and our bodies that ingest the drugs. However, because drug companies are regarded as legal 'persons', the documents they provide to the Commonwealth Government health regulators and agencies have the same exemption as patient records from Freedom of Information (FOI) requirements under section 135A of the National Health Act 1953. (see Appendix 1 below)
Therefore, we are not allowed see the safety and efficacy evidence used to persuade our government to licence and subsidise drugs.
This denies the media and the public the chance to evaluate these products, and scrutinise the work of our government, and its agencies.
Occasionally, there are spectacular regulatory failures causing deaths or destroying lives that become so obvious that even Australia's limp regulator, the Therapeutic Goods Administration (TGA), has to admit it stuffed up. (e.g. Vioxx[6], Pradaxa[7], metal hips[8], transvaginal mesh[9] and PIP breast implants[10]) However, most regulatory failures are less clear-cut. More often the TGA extends a considerable benefit of doubt to questionable treatments, like ADHD drug Strattera. (see Appendix 2 below)
Adding to this industry first, consumers last, approach is the fact that in Australia adverse event reporting for drugs and medical devices is voluntary. As a result only a fraction of incidents are reported to the TGA.[11]
This leads to an unrealistically, favourable perception of the safety of many drugs and devices that is rarely, if ever, challenged by the TGA.
These are key reasons that drug companies (and medical device manufacturers) have been able to masterfully game our hidden, industry friendly, system. Without reform, of Freedom of Information, adverse event reporting, and political donation disclosure laws, Australians will stay in the dark. Getting a sensible, considered, response from political parties on detailed policy issues, this close to an election, is not going to happen. However, after the election, PsychWatch Australia will quiz the new, or retained, government on its plans for reform (or not) and report their response.
Real progress will require at least one of our major political parties, to put the welfare of ‘people’, ahead of the privacy and profits of corporate ‘faux persons’.
PsychWatch Australia will recommend the following four reforms:
Remove corporations from entitlements to Freedom of Information exemptions allowed to patients via section 135A of the Health Act 1953. This could be done in isolation, or as part of a series of transparency reforms designed to lift Australia's poor Global Right to Information Rating of 65th out of 123 nations assessed.[12]
Commit to full public disclosure on a website of all safety and efficacy data provided to the Commonwealth Government.
Require mandatory reporting by medical practitioners, hospitals, pharmacists etc. of a specified range of serious suspected adverse effects (suicides, self-harm, strokes, heart attacks, psychosis etc.).
Ideally ban political donations from pharmaceutical companies and medical device manufacturers, or, failing that, commit to legislating for immediate (real time) public disclosure of all political donations.
Note: For more details of these and other proposed reforms, see two submissions to Australian Senate Inquiries prepared by Dr Whitely on behalf of the Health Consumers’ Council (WA), in 2014 and 2017, in regards to the licencing and subsidisation of pharmaceuticals, and the Transvaginal Mesh scandal.[13][14]
Appendix 1 - Freedom of Information Exemption - In 2010, a Freedom of Information case - Whitely and Department of Health and Ageing [2010] AATA 338 - adjudicated by the Administrative Appeals Tribunal (AAT), established a legal precedent that prevents public scrutiny of documents provided by corporations to the Commonwealth Department of Health and Ageing (DoHA).[15][16]
I (Martin Whitely) was the unsuccessful plaintiff in the AAT case. Citing public interest provisions of Commonwealth Freedom of Information legislation, I requested copies of all safety and efficacy data provided to DoHA by drug company Eli Lily supporting its application to get ADHD drug Strattera (atomoxetine hydrochloride) subsidised via the Pharmaceutical Benefits Scheme (PBS).
DoHA had originally recognised 11 documents as being relevant. Eli Lily opposed the release of eight of these documents to me. The DoHA decided to release two documents to me in full, and provided me with heavily redacted (virtually unreadable) copies of seven documents, and denied me any access to the two other documents. I appealed this decision, and asked for access to all documents, with appropriate redactions for commercially sensitive information about production costs and pricing. (I was only interested in safety and efficacy data).
The AAT were convinced by lawyers acting for Eli Lily and DoHA that for the purpose of the National Health Act (1953) all corporations are 'persons', and therefore under Section 135A their documents have the same privacy protections as a patient's medical records (and were therefore exempt from FOI requests). My appeal was a spectacular failure, in that I lost the ability to publicise disturbing elements of the documents I already had. The AAT determined I was not entitled to access to any of the eleven documents. I took this to mean I was forbidden from publicising any of the contents of the documents I had already been given copies of.
Section 135A is one of more than 65 secrecy provisions from over 28 Acts listed as being exempt from FOI requirements under Section 38(1) of the Australian FOI Act.[16] It states:
135A(1) - A person shall not, directly or indirectly, except in the performance of duties, or in the exercise of powers or functions, under this Act or for the purpose of enabling a person to perform functions under the Medicare Australia Act 1973 or the medical indemnity legislation, and while the person is, or after the person ceases to be, an officer, divulge or communicate to any person, any information with respect to the affairs of a third person acquired by the first-mentioned person in the performance of duties, or in the exercise of powers or functions, under this Act. Penalty: $5,000 or imprisonment for 2 years, or both.
From a public policy and transparency perspective my case was a disastrous outcome, however, given current Australian law the AAT had no option but to find as it did.
For legal purposes corporations are persons and therefore in regards to 135(A) are a “third person” whose privacy is protected. Therefore safety and efficacy data provided by drug companies to regulators responsible for protecting the public, like the documents on Strattera provided by Eli Lily to the Commonwealth Department of Health and Ageing (DoHA), must remain hidden.
Appendix 2 - ADHD drug Strattera (Atomoxetine Hydrochloride) is a rebranded and repurposed, failed antidepressant. Strattera was fist subsidised via the PBS in 2007 and up until January 2019, Eli Lily received $74.5 million in taxpayer funds. It carries the highest possible ‘boxed warning’ for increasing the risk of suicidal thoughts and behaviours as well as warnings for increased risk of cardiovascular events and potentially fatal liver damage.[17]
Since it first came on the market in 2004, there have been 155 adverse events reported to the TGA for consumers using Strattera. These include 50 reports of suicidal/homicidal thoughts, 10 suicide attempts (including a 7 year old girl) and 3 completed suicides (including a 9 year old boy).[18] Adverse event reporting is voluntary and most events are not reported to the TGA so we will never know the actual number of suicide attempts and completed suicides of patients taking Strattera.[8]
It is worth bearing in mind that:
Children taking Strattera risk suicidality, liver and cardiovascular damage in order to manage ADHD.
The diagnostic criteria of ADHD are behaviours including fidgetting, avoiding homework, losing things, interrupting, playing loudly and talking, running about and climbing excessively. (A full list of the diagnostic criteria of ADHD is available by clicking here).
Eli Lily's FOI exemption means that how the drug company convinced the Commonwealth Government and its agencies, that the benefits, outweigh the risks (suicide etc.) of Strattera, will always be a mystery.
Conflict of Interest Declaration: Dr Martin Whitely was a Labor Member of the Western Australian State Parliament from 2001 until 2013. He is currently an ordinary (but inactive) member of the WA Labor Party.
References
[1] Knaus C. Evershed N, Pharmaceutical industry donates millions to both Australian political parties. Guardian Australia. Available at
https://www.theguardian.com/business/2018/sep/25/pharmaceutical-industry-donates-millions-to-both-australian-political-parties (accessed 14 March 2019)
[2] Edwards B, The truth about political donations: there is so much we don’t know The Conversation February 2, 2018 Available at https://theconversation.com/the-truth-about-political-donations-there-is-so-much-we-dont-know-91003 (accessed 14 March 2019)
[3] Duckett, S.J., P. Breadon et al (2013), Australia’s bad drug deal: high pharmaceutical prices, Grattan Institute, Melbourne, p.2. Available at https://grattan.edu.au/report/australias-bad-drug-deal/ (accessed 25 June 2013).
[4] Duckett, S. and Breadon, P., 2015, Premium Policy? Fixing the policy for switching drugs, Grattan Institute. Available at https://grattan.edu.au/wp-content/uploads/2015/06/823-Premium-Policy4.pdf (accessed 30 April 2019)
[5] Duckett, S. and Banerjee, P. (2017). Cutting a better drug deal. Grattan Institute. Available at https://grattan.edu.au/report/cutting-a-better-drug-deal/ (accessed 30 April 2019)
[6] M Rout, “Vioxx maker Merck and Co drew up doctor hit list” The Australian 1 April 2009. Available at https://www.news.com.au/news/drug-company-drew-up-doctor-hit-list/news-story/eb55ca36e081d497730629e6c8559abf?sv=1f029b17d33bdbde184dbc4c4fed7126
(accessed 14 March 2019).
[7] Sophie Scott and Alison Branley, ‘Makers of blood-thinning drug Pradaxa “put marketing ahead of safety”, British Medical Journal finds’, ABC News, 4 August 2014. Available at http://www.abc.net.au/news/2014-08-04/study-finds-information-on-anti-clotting-drug-pradaxa-withheld/5642436?WT.mc_id=Innovation_News%7CMakersOfBloodThinningDrugPradaxaPutMarketingAheadOfSafety,BritishMedicalJournalFinds_FBP%7Cabc
[8] Quentin McDermott and Karen Michelmore, Patients Reveal Agony of Toxic Hip Implants, ABC Online Updated 16 May 2011, 9:20am http://www.abc.net.au/news/2011-05-16/patients-reveal-agony-of-toxic-hip-implants/2694656 (accessed 14 March 2019)
[9] Sophie Scott and Alison Branley, Pelvic mesh implants 'one of the biggest medical scandals' involving Australian women. ABC News. Updated 28 Mar 2018. Available at https://www.abc.net.au/news/2018-03-28/pelvic-mesh-implants-only-used-as-last-resort-senate-report/9592384 (accessed 14 March 2019)
[10] Australian Government Response to Senate Community Affairs References Committee Report on The role of the Therapeutic Goods Administration regarding medical devices, particularly Poly Implant Prothèse (PIP) breast implants. July 2013. Available at https://www.health.gov.au/internet/main/publishing.nsf/Content/B1ABE3987E9644F6CA257BF0001A34D9/$File/PIP%20breast%20implants.pdf (accessed 14 March 2019)
[11] A 2008 study by Curtin University pharmacologist Con Berbatis identified that for the prescription of all drugs by Australian General Practitioners only two percent of adverse events are reported to the TGA. Con Berbatis (2008), ‘Primary care and Pharmacy: 4. Large contributions to national adverse reaction reporting by pharmacists in Australia’, i2P E-Magazine, Issue 72, June 2008.
[12] Centre for Law and Democracy (Toronto Canada), Global Right to Information Rating - analyses the quality of the world’s access to information laws 65th out of 123 nations Available at https://www.rti-rating.org/country-data/ (accessed 1 May 2019).
[13] Whitely M, Licensing and Subsidising Pharmaceuticals in Australia - Reforms needed to deliver Transparency, Safety and Value for Money, Health Consumers’ Council submission to The Senate Select Committee on Health September 2014 https://www.aph.gov.au/DocumentStore.ashx?hearingid=2531&submissions=true
[14] Whitely M, Submission to the Senate Inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters, Joint submission by Health Consumers Councils across Australia: Health Issues Centre (Vic), Health Consumers Queensland, Health Consumers’ Council (WA), Health Consumers Alliance of SA, Health Care Consumers Association (ACT), Health Consumers New South Wales, 31 May 2017. Available at https://www.hconc.org.au/wp-content/uploads/2017/07/Combined-Australian-State-HCCs-Final-Report-Transvaginal-Mesh-Senate-Inquiry-31052017.pdf (accessed 14 March 2019)
[15] Administrative Appeals Tribunal of Australia Website. Whitely and Department of Health and Ageing [2010] AATA 338 (7 May 2010) http://www8.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/AATA/2010/338.html (accessed 14 March 2019)
[16] Timmins P. Blog - Drug secrecy law trumps FOI. 1 June 2010. Available at
http://foi-privacy.blogspot.com/2010/06/drug-secrecy-law-trumps-foi.html#.XIj0xSIzbIU (accessed 14 March 2019)
[17] See http://www.speedupsitstill.com/strattera/ (accessed 14 March 2019)
[18] Whitely M. Self generated report generated in March 2019 from the TGA DAEN website. Copy available upon request to psychwatchaustralia@gmail.com
This blog was first published on 8 May 2019