Thanks to Australian Doctor for sharing a most informative Ministerial brief on the Government’s response to recent reviews recommending reforms of the TGA (it can be downloaded here, and is worth reading for many reasons, not least for the insights it gives into government processes and communications, as well as regulatory complexities and challenges).
Over at The Conversation, public health advocate Dr Ken Harvey analyses the Government’s response – and says it is so disappointing that he has resigned from the Labor Party. He writes:
Like the Curate’s egg, the government’s reform blueprint appears to be good in parts. But it also displays a timidity to grapple with key issues, such as therapeutic goods advertising reform, and that seems to be a common failing of this Labor government.
I’ve been a card carrying member of the Labor Party for some time. I worked hard to get rid of the Howard government and get Labor elected and I’ve sat on a number of the working parties and consultations that have made the recommendations outlined above.
But I can no longer be a member of the party when a Labor government fails to implement unanimous recommendations from its own working parties, and continues to procrastinate after a decade of calls for effective sanctions on advertising violations. I have today submitted my resignation.
Meanwhile, public health advocate, Rebecca Johnson, examines in the article below what lessons the public health community can learn from Ken Harvey’s battles with SensaSlim. She makes many useful points that merit consideration, from individuals as well as organisations and public health leaders.
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The SensaSlim saga: what have we learnt?
Rebecca Johnson writes:
Many readers have followed Dr Ken Harvey’s recent legal ordeal with the company peddling the discredited weight loss spray SensaSlim.
For those that haven’t: earlier this year, Ken was hit with a SLAPP suit by SensaSlim after he complained about the company’s outlandish advertising claims to the Therapeutic Goods Advertising Complaints Resolution Panel.
The action, which was thrown out of the NSW court, cost Ken time, energy and $42,000 in legal fees – which were thankfully covered by donations from members of the public health, skeptics and consumer communities. SensaSlim has since lodged a similar action in QLD, for which Ken is being defended pro bono.
It is a sticky, complex ordeal that sprung from a valid complaint made through an appropriate channel. So – what can we, the public health community, learn from Ken’s experiences with SensaSlim?
One question immediately stands out: even where we are unshakably confident in our own actions as public health practitioners, do we have the confidence that our colleagues and peers will back us up?
The question applies to the everyday actions of many health-based organizations, not just those that challenge products or practices that are on the fringe. If your statement, action or position is challenged, do you have a ‘SWAT team’ of colleagues/organizations that you can call upon for support? Do you have a way of reaching them quickly and effectively?
In Ken’s case, his links with the Skeptics networks, consumer organizations such as Choice and social media tools such as Croakey were invaluable in helping him raise awareness of the legal action, invoke ire about the issues, and – although not at his request – raise dollars to assist with his costs.
Ken’s experience invites us to examine our own professional and organizational networks, and to set about improving their strength and reliability. It may also invite us to create new networks, and to engage with tools like social media and the blogosphere, that can make the connections happen.
Thinking about confidence leads us to consider the extent to which we’d stand by our professional actions if they are challenged. Ken’s perfectly legitimate complaint was met with a legal challenge to the tune of $800,000. It’s possible that if he’d quietly withdrawn the complaint the legal suit might have gone away – but he didn’t.
Any practitioner or organization offering health information that potentially undermines a commercial interest – and there are likely to be many – could find themselves subject to a similar suit. Should we therefore watch our backs and cover our arses, or should we stick up for our work?
Ken’s experience encourages us to consider what we would risk in contexts where our legitimate professional actions face opposition, legal or otherwise. It makes us consider the cultures in the organizations we work in, and whether they’d face a challenge or shy away from one. It also makes us think about how strongly we feel about our own work, how invested we are, and the lengths we’d go to defend it.
On a less introspective note, the SensaSlim case reveals the need for the public health community to step up its scrutiny of both the therapeutic goods regulator and the complementary and alternative medicine (CAM) industry.
About half of the Australian population uses CAM, much of which is advertised using spurious health claims. Therapeutic goods, particularly those that are as widely used as CAM products, are obviously a population health issue. So are the problems with the regulator, which have been well and truly revealed in a series of recent inquiries and reviews.
The Therapeutic Goods Administration does not ensure the claims associated with complementary products can be substantiated before it allows them to be legally sold in Australia. Nor does it act swiftly upon issues when they are raised; indeed, it failed to de-list SensaSlim from the Australian Register of Therapeutic Goods for nearly a year after Ken’s initial complaint, allowing it to continue to be purchased by thousands of unsuspecting consumers.
As public health professionals, we possess health literacy that is considerably more advanced than Joe Public’s. It is our responsibility to step further into this space and demand transparency, honesty, and substantiation of health claims on therapeutic products.
Currently, a few individuals and organizations do the vast majority of the advocacy, and take the hits for it. Is that right?
In today’s world, where words like ‘collaborative’ and ‘cross-sectoral’ roll off our tongues, we should ask ourselves – what can we do to pull together better on issues like this?
Turning outwards, Ken’s experience should invite rigorous debate in the public health community about SLAPP litigation and legal protections. Making a legitimate complaint about shonky advertising claims should not expose a complainant to legal action that is designed to silence and intimidate. The case has exposed some important systemic flaws that are overdue for action.
We should call for comprehensive protections to be built into our legal systems to ensure that SLAPP actions do not chill public participation, or the SensaSlim case will be repeated. This is very real issue for the public health community; SLAPP actions threaten our ability – indeed our responsibility – to keep things honest where commercial interests tangle with population health.
There are several valuable lessons to be learned from Ken Harvey’s SensaSlim experience, about confidence in our positions on issues and in our networks, about the importance of better scrutiny of the regulation of therapeutic goods and CAM, and about how legal intimidation can erode our ability to ensure health information does not mislead or deceive.
Ken’s experience also raises a lot of important questions. Reflecting on those questions and applying the lessons could help make us, the public health community, better networked, supported and informed, and better able to stand up for our work.
• Rebecca Johnson is Policy Advisor, Cancer Council WA (This post does not necessarily reflect the views of Cancer Council WA)
• Here are more Croakey articles on the SensaSlim case
Rather than dividing medicines arbitrarily into ‘medicines’ and ‘complementary medicines’, with different requirements for evidence of the safety and effectiveness of the medicines in each group, the most logical approach would be to have only one category of ‘medicines’, with the same requirements for the manufacturer or promoter of each medicine to show evidence of the safety and the effectiveness of that medicine. Then the listing for each medicine could say something like:
“Proposed indication(s): X
Evidence of safety: Y
Evidence of effectiveness for each proposed indication: Z”
Nice piece Rebecca. I contributed to Ken’s costs, but I’ve got a decent income so could afford it. But the challenge will be to get lots of people willing to contribute a modest amount to such incidents. Getting a sandwich and a coffee usually takes you past $10 these days, and is never missed. But there needs to be some painless mechanism (like Get Up) within public health, for 1000s in the community and the health professions who admire the guts of people like Ken and would be privately horrified at seeing people like him ruined by having the courage he has SLAPPED. I was hoping your piece was going to outline the architecture & governance for something like that … it would be great if a few peopel might suggest some ideas