After the last brief post about this issue, readers may be interested in the details, (as far as an amateur blog writer like myself can establish), as to what occurred between SensaSlim, the TGA and Dr Ken Harvey.
[Note: Links have been added to the end of this post to keep readers up to date with the legal case and to provide further reading. Recently, this story has had significant coverage in the mainstream press.]
A whois search shows that the Sensaslim dot com web site was registered in February 2008.
A Queensland manager of a SensaSlim distribution operation says the company is owned by a Peter O’Brien.
The company was registered with the Australian Securities and Investments Commission (ASIC), on the 2nd of November 2009.
SensaSlim, as a product, was listed on the Australian Register of Therapeutic Goods (ARTG) on the 20th of September 2010. The ARTG product number is 176003. Only the sponsoring company is listed “SensaSlim Australia Pty Ltd” at a Sydney address, no individual’s names are shown.
As has been stated before on this site, listing on the ARTG simply means that the TGA considers the product not likely to be harmful. The TGA does not test whether the product is effective, whether supporting evidence for the claims made by the sponsor exists, or whether the claimed underlying scientific mechanisms are real.
The claims as shown on the register include:
….encourages the body’s natural fat burning processes.
….contains Camellia Sinensis (green tea) which is an antioxidant containing caffeine to assist with thermogenesis.
Thermogenesis being the nice technical term for the body’s ability to produce heat from digestion.
On the 16th of November 2010, Dr Matthew Capehorn, Clinical Director of the National Obesity Forum (UK), said he signed an agreement to provide “certain consultancy services” for SensaSlim. Dr Capehorn claims he signed this agreement with SensaSlim International, a Swiss-based parent company which he believes was started by Peter O’Brien and William Duffy.
Dr Capehorn, who lives in Rotherham in the UK, has good credentials which are further detailed here.
SensaSlim appears to have a high regard for Dr Capehorn, describing him on their web site as “Dr Matthew Capehorn, SensaSlim Research Director”.
Soon after signing the agreement with SensaSlim, Dr Capehorn began writing the “white paper”, which will be referred to later in this post.
Returning to events in Australia with a brief re-cap of the way the TGA operates.
Once a therapeutic product is listed on the ARTG by the TGA, the product can be legally sold in Australia. If a product is considered to be “low risk” by the TGA, its listing is a relatively automatic process. The TGA has the right to levy a fee for listing a product on the ARTG. Monies generated through listing fees have become a significant revenue source for the TGA.
The TGA has a division called the Complaints Resolution Panel (CRP). The CRP’s function is to deal with public complaints about products listed on the ARTG. The CRP can also check that products are being truthfully promoted.
The process for having the CRP re-assess a product or advisement for its suitability in the Australian marketplace is triggered by complaint to the CRP. Anyone may initiate a complaint which can be lodged via an on-line form. The CRP does not initiate its own investigations and it is possible to lodge a complaint anonymously.
26th of January 2011
The CRP received an anonymous complaint about SensaSlim.
14th of February 2011
Channel Seven’s news and current affairs show Today Tonight ran a four-minute SensaSlim advertorial. When I last checked, it could still be viewed on the SensaSlim web site here.
Dr Capehorn is shown talking about what the reporter described as “the SensaSlim trial”, saying:
….this a randomized, double-blind, placebo controlled trial. So it stands up to all of the scientific rigors of clinical trials. The only difference is that this one was based on the Internet.
10th of March 2011
The CRP met to consider the anonymous complaint lodged about SensaSlim. The determination of the CRP in relation to SensaSlim wasn’t favorable. The determination was to impose sanctions against SensaSlim. (See also “30th of March” below, this determination was briefly published.) However, it was felt by the CRP that, as SensaSlim had not responded to an email, they may not be aware that a complaint had been made. SensaSlim were given more time whilst the CRP made more of an effort contact them. Whilst efforts where being made to contact SensaSlim the determination was withheld from publication.
18th of March 2011
Dr Ken Harvey lodged a complaint with the CRP about SensaSlim.
Dr Harvey’s complaint indicated that Sensaslim has been vigorously promoting a weight loss product. Apart from testimonials from attractive models, there are bold but serious claims made by one Dr Capehorn, who holds important positions in two impressively-named research institutions. Sensaslim quote him as stating that the product is clinically proven and is the most effective slimming solution available in the world today.
Dr Harvey’s complaint went to the heart of these claims and the supposed clinical trial which Sensaslim claimed supported them. From Sensaslim’s summary of the clinical trial, Dr Harvey branded the results as “frankly unbelievable” and “most likely to have been fabricated”.
At the time, a copy of Dr Harvey’s CRP complaint is also forwarded to “Auspharm.net.au”, which is an organization that provides news tailored to a readership of Australian pharmacists. Auspharm subsequently published some of the details of Dr Harvey’s CRP complaint on their web site.
30th of March 2011
The CRP published their determination on the anonymous complaint (note, this is not Dr Harvey’s complaint), about SensaSlim on their website. The determination is removed from the CRP website within one hour. The CRP received representations from SensaSlim saying that they had not received an email inviting them to respond to the allegations of breaching Therapeutic Goods Regulations contained in the anonymous complaint.
To allow for procedural fairness the CRP decided to withdraw the determination and give SensaSlim time to respond.
31st of March 2011
In relation to the article written and published by Auspharm based on Dr Ken Harvey’s complaint, SensaSlim’s legal representatives wrote to Auspharm saying:
We therefore demand that this article be removed from the website immediately. Failure to do will result in us seeking injunctive relief in the Supreme Court of Tasmania. Should this action be necessary we will also seek a costs order against you.
AusPharm complied with the demand.
SensaSlim also wrote to Dr Ken Harvey stating:
It is also of major concern that you have a genuine bias against complementary healthcare and are driven by your interest in pharmaceutical prescribed medicines.
You are advised that should you make any further inaccurate or adverse comment against this company, it’s product SensaSlim, its agent, employees or Dr Matthew Capehorn, we will not hesitate to commence proceedings against you for defamation in the Supreme Court of Victoria.
If this company or its agents or employees suffer any loss as a result of your comments, we will be seeking damages from you personally, with said damages potentially running into the millions of dollars.
On the same day, Dr Ken Harvey replies to SensaSlim defending his reputation:
Finally, I dispute your statement that I have, “a genuine bias against complementary healthcare … driven by … interest in pharmaceutical prescribed medicines“.
My interest in ethical promotion comes from membership of the group of experts that produced the World Health Organization’s “Ethical Criteria for Medicinal Drug Promotion”, membership of the PHARM Committee that devised the Quality Use of Medicines plank of Australian Medicines Policy and membership of the Australian Government Working Group on Promotion of Therapeutic Products. I have also submitted a number of upheld complaints about the promotion of therapeutic goods to Medicines Australia (prescription medicines), the Australian Self Medication Industry Association (OTC medicines) and to other authorities concerning medical devices and in-vitro diagnostic tests as well as complementary medicines.
10 April 2011 (prior to)
There is evidence that SensaSlim entered into a commercial agreement with Channel Nine and Channel Ten. The agreement provides for the screening of four-minute infomercials. The infomercials are to be shown 27 times between the 10th of April and the 6th of May 2011. Some of the infomercials are to be run on Channel Nine’s “Mornings with Kerrie Anne”.
20th of April 2011
The Supreme Court of New South Wales acknowledged receipt of a Statement of Claim by SensaSlim Australia Pty Ltd. The claim states:
The plaintiff (SensaSlim) claims from the defendant (Dr Ken Harvey).
(a) General and punitive damages for libel in the sum of Eight Hundred Thousand Dollars ($800,000).
(b) The cost of this action.
(c) Such further and other relief as the court shall see fit.
One of the statements of claim by SensaSlim contends that:
On or about the 18th day of March 2011, the Defendant (Dr Ken Harvey) published or caused to be published a complaint delivered to the Complaints Resolution Panel, Therapeutic Goods Administration, and the Australian Competition and Consumer Commission (ACCC).
21st of April 2011
The CRP set aside making a determination on the Dr Ken Harvey complaint against SensaSlim. The CRP refered to the “Therapeutic Goods Regulations 1990”, in particular, regulation 42ZCAJ.
Part 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.
Thus the result of SensaSlim’s launching of libel action against Dr Harvey for an allegedly defamatory complaint is to halt the progression of the complaint to determination.
What about the anonymous complaint? If you recall, a determination had been made by the CRP, published then withdrawn (See 30th of March).
The commencement of court proceedings has the effect of also invoking part 1 of the same regulation, 42ZCAJ, it states:
Part 1; The Panel cannot deal with a complaint if a proceeding has begun in a court about the subject matter of the complaint and the proceeding has not been finally disposed of.
Therefore, the combined effect of the regulations and court action by SensaSlim stops progression on all complaints against SensaSlim.
There is nothing to stop the sale and marketing of the SensaSlim product whilst court action is ongoing. SensaSlim remains on the ARTG.
27th of April 2011
A recent newsletter (Number 42) from SensaSlim to its distributors discusses the legal action against Dr Harvey:
Peter O’Brien didn’t accept such a fate but together with his lawyers (by the way Robbinson Legal are the lawyers who acted for Paul Hogan in his case against the ATO, so they’re not frightened of a stoush either) found a way to defend the company. 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.
[Note that the exact publication date of this newsletter is not shown, however the date can be estimated based on the events discussed therein.]
27th of May 2011
Dr Matthew Capehorn, through his independent legal representative, wrote to Peter O’Brien of SensaSlim. The letter makes it clear that Dr Capehorn no longer wishes to be a representative for SensaSlim. Dr Capehorn also mentions in this letter the “white paper” that he authored for SensaSlim. In part, the letter to Peter O’Brien says:
….we are instructed to make our client’s position clear as follows:
1. Dr Capehorn was initially engaged by SensaSlim to provide certain external consultancy services.
2. SensaSlim induced Dr Capehorn to become involved with its product on the specific representation that extensive clinical tests had been undertaken on the SensaSlim products that conclusively proved the effectiveness claimed for those products by SensaSlim.
3. At no time, notwithstanding repeated requests made by Dr Capehorn, have those clinical tests ever been made available to him – if, indeed, they exist, or did take place and/or gave the results contended for them by SensaSlim.
4. Notwithstanding this, after signing an agreement dated 16th November 2010 (the “Agreement”) with our client SensaSlim International Limited, a Swiss company that we believe to be the ultimate parent of the SensaShm Group (sic), which Dr Capehorn believes to have been established by Williarn Duffy and yourself. After signing the Agreement, our client produced a so-called White Paper which, in essence, is a preliminary review of the SensaSlim product.
5. We are instructed that the White Paper was provided as a draft and strictly subject to and conditional upon our client being provided with the results of the putative clinical tests so that it might then have been completed. Nevertheless, our client made It clear to SensaSlim that the White Paper was not to have been used or quoted unless and/or until such time as the clinical results had been made available, thus enabling Dr Capehorn to produce a complete and effective set of conclusions.
6. In February 2011, following Dr Capehorn’s second visit to Australia in February 2011, it became apparent that SensaSlim (in whichever of its corporate guises) was fundamentally failing to comply with and observe its contractual obligations to Dr Capehorn in that:
(a) payments due were not made;
(b) written material was being issued without the contractual requirement of first obtaining our client’s written sign-off and which material supported and endorsed the SensaSlim products; and
(c) the clinical results were still not provided yet the White Paper was being quoted.
(….and so on, twelve points are made.)
It’s disappointing to see a former employee have a falling out with and employer, but it wouldn’t be the first time.
Whilst legal action continues, big gun lawyers are engaged, reputations are put on the line, the average skeptic still wonders if the scientific evidence to support the product will ever be published. -sigh- Simply showing the scientific evidence for the effectiveness of the product would completely halt the ongoing criticism of SensaSlim. I await further developments.
(With assistance from others, many thanks, you know who you are.)
More links, updates and further reading:
There is an excellent post by Dr Mick Vagg about the Dr Ken Harvey – SensaSlim libel case on the SkeptiBros website, which can be found here.
13th of June 2011, the case is covered by the British Medical Journal (BMJ), the extract can be found here.
17th of June 2011, the case is covered by the Sydney Morning Herald, Diet-aid firm’s law suit halts review of its ‘outlandish’ ads here.
17th of June 2011, the most recent changes in the case are covered in this post on the Australian Skeptics national site, found here.
18th of June 2011, Article in The Weekend Australian by Leigh Dayton, Disputed remedy in the dock: a defamation case highlights the need to tighten regulation of complementary medicines Read here.
18th of June 2011, Dr Ken Harvey explains the current situation on his own blog, here.
20th of June 2011, The Age newspaper, Whistleblower slams delays in spray case, here
21st of June 2011, The Age newspaper Slim chance of protection for dieters, here.
21st of June 2011, The Harvey/SensaSlim libel case is also mentioned in a number of Letters to the Age, here.
22nd of June 2011, The Age newspaper Dodgy websites push diet spray, This article has the news that SensaSlim’s assets have been frozen by the Federal Court here.
22nd of June 2011, The Coversation website SensaSlim goes SLAPP, public interest crusader cops a legal whack, here.
22nd of June 2011, Choice magazine SensaSlim puts TGA on hold, here.