Dr. Ken Harvey is an adjunct senior lecturer in the School of Public Health, La Trobe University, well known for his ethical stance against unproven and grandiose claims that often accompany alternative medicines and bizarre therapies. In fact on December 6th last year “Pharma in Focus” revealed that “up to 90% of complementary medicines reviewed by the TGA do not comply with regulatory requirements”. He has also carved a niche for himself through educating skeptics and advocates of evidence based medicine as to what are arguably shortfalls of current regulatory guidelines.
On March 18, 2011 I submitted my first complaint about the promotion of SensaSlim to appropriate authorities; the Complaint Resolution Panel (CRP) who hear complaints about alleged breaches of the Therapeutic Goods Advertising Code 2007, the Therapeutic Goods Administration (TGA), who administer the Therapeutic Goods Act 1989 and the Australian Competition and Consumer Commission (ACCC) who administer the Competition and Consumer Act 2010.
This complaint, and at least six others sent to the CRP by other people, alleged that the promotion of SensaSlim on the Internet, TV and in shops breached numerous sections of the above regulations.
My initial complaint had been worked up with the help of several pharmacists. In addition, specific promotion was directed at pharmacists to encourage them to stock and sell this product. Thus, on March 31, 2011 AusPharm published a brief but accurate account of the complaint detailing concerns about the claims made.
Later that day both AusPharm and I received a letter from the SensaSlim Australia Pty. Ltd, titled, “Notice of Intention to Commence Proceedings”. This, and subsequent communications from SensaSlim Australia Pty Ltd, threatened legal action against AusPharm and myself; initially aimed at removing the material on AusPharm, but subsequently (after AusPharm complied) threatening both my university and me with legal action unless my complaint was withdrawn.
My university could not be joined in the threatened legal action because the conditions of my Adjunct appointment were clear,
“During the period of this appointment you will receive no remuneration from La Trobe University. Nothing in this offer creates or implies an employment relationship between you and the University”.
I declined to withdraw my complaint. Whereupon, on April 19, 2011 a “Statement of claim” was issued against me in the NSW Supreme Court alleging that my complaint was defamatory and claiming “general and punitive damages for libel in the sum of $800,000.00”, plus costs.
This action had the effect of stopping the CRP from hearing all complaints about SensaSlim due to Therapeutic Goods Regulations 1990 42ZCAJ (2),
“If, after a complaint has been made to the Panel, a proceeding begins in a court about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding is finally disposed of”.
I have now learnt that the CRP did make a determination about the promotion of SensaSlim in response to an anonymous complaint submitted in late January, 2011. The CRP agreed that the SensaSlim promotion breached multiple provisions of the Therapeutic Goods Advertising Code. The determination was posted on http://www.tgacrp.com.au on March 30, 2011 for less than one hour before it was taken down in response to a representation from SensaSlim Australia Pty Ltd. However, this determination was downloaded during this time and can be found here.
I have also been made aware of SensaSlim Newsletter No. 42 from Adam T. Adams which states in relation to the above,
“Last week Peter O’Brien was at his desk until 11pm the night before the CRP were to reconsider the matter, and back at 5 a.m., drafting, redrafting and writing a 9 page submission. With the assistance of his legal team and SensaSlim in London’s lawyers a very comprehensive submission was written stating that the CRP had absolutely no justification at law in adjudicating on the matter since the company had filed an $800,000.00 defamation lawsuit against Dr. Ken Harvey. You see, it is written in Law that if the subject matter of the complaint is currently the subject of court proceedings, then the CRP are unable to adjudicate”.
“This defamation action, which could be in the courts for a year or two or even longer, basically gives an iron clad protection that nobody can raise a complaint against SensaSlim to the CRP and hurt us. There are nine complaints that were received in a three day period two weeks ago. These were not complaints by members of the public, but clever legal crafted arguments by people acting on behalf of our competitors and big pharmaceutical companies. These are the same people who have written to the CHC [Complementary HealthCare Council] to delay and hinder our progress and having our advertisements approved. And they also wrote to the TGA. But let me say this. We will not allow their dirty tactics defeat us. We had a very big win this week with the determination by the CRP that they cannot adjudicate on any matters pertaining to SensaSlim.”
My own lawyers filed a notice of motion in the NSW Supreme Court seeking orders to have the SensaSlim claim struck out and the proceedings dismissed because they disclose no reasonable cause for the action. In addition, my lawyers asked for an order that the plaintiff pay the defendants’ costs. These matters are now before the Court.
Meanwhile, the issues raised have been ventilated by the ABC “Health Report“, the “Croaky Health blog“, the Australian Skeptics and, last night, Channel SEVEN’s “todaytonight” and Channel NINE’s, “A Current Affair“.
The Medical Research Director of SensaSlim, Dr Matthew Capehorn, has now resigned. He stated,
“Despite requests, I have never seen evidence of the original clinical trial, and it has never been published in a peer reviewed medical journal. Therefore, the White Paper holds no scientific relevance, until that original trial is published”. “It has not been published at the European Congress of Obesity in Istanbul as suggested recently” and “video interviews were put on the SensaSlim website, without my approval or opportunity to review the content”.
As of today, SensaSlim is still listed on the TGA’s Australian Register of Therapeutic Goods (no: 1760039) which allows it to continue to be legally sold, it’s still actively promoted on numerous Australian Internet sites and Dr Capehorn is still featured spruiking the product.
There are a number of lessons that need to be drawn from this case study.
First, one might have hoped that university trained health professionals (Dr Capehorn and numerous Australian pharmacists) would have been more discerning in their assessment of the evidence for this ‘dietary aid’; but perhaps the return on investment offered was more compelling?
Second, one might have expected that the TGA would have responded to previous calls to look more rigorously at complementary medicines before they are listed on the Australian Register of Therapeutic Goods (ARTG).
Failing that, on receipt of well documented complaints, surely the TGA could have rapidly removed this product from the ARTG which would have made continued sales illegal? Ironically, the TGA have yet to respond to queries and complaints about this product that were sent to them direct. Perhaps the Pan Pharmaceutical class action has made the TGA more cautious about taking such action?
Finally, we are left with the ACCC, whom I understand have been investigating this matter for some time but are not yet ready to inform us of their findings.
It seems a sad reflection on the regulators that we are dependent upon complainants, investigative journalists, blogs, skeptics and pharmacy web sites to get the message out.
Written by Dr. Ken Harvey June 5th, 2011 and initially published on Medreach. Republished here with permission.
You can help Dr. Ken Harvey navigate this challenge by emailing Australian Skeptics, who have begun a programme to assist Dr. Harvey meet the financial burden. Simply email supportken [at] skeptics [dot] com [dot] au with a phone number and your pledge.
There is also a Facebook page run by supporters of Ken Harvey where you can find out more on this topic and have a look at the unique management of SensaSlim members who ask probing questions on Facebook.