Healthy Skepticism Library item: 13690
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Blackmores defends itself (plus Harvey's response to Blackmores)
Pharmacy Daily (Australia) - registration required 2008 May 19
http://www.pharmacydaily.com.au
Notes:
See below for Dr Harvey’s letter to Blackmores re alleged inaccuracies
Full text:
BLACKMORES has denied ever ignoring a determination from the Complaint Review Panel (CRP), saying there are “several inaccuracies” in a presentation made by La Trobe University’s Ken Harvey at the National Medicines Symposium (PD Fri).
Harvey used the example of Blackmores’ Weight Loss Accelerate product to highlight what he says are deficiencies in the way complementary medicines are regulated.
Blackmores R&D director Philip Daffy said Harvey had exaggerated the timings of complaints to emphasise his point – the complaints were made over an 18 month period from Dec 06-Jan 08, not “several years” – and also said the complaints system allows sponsors “to defend their products in response to complaints made and to appeal decisions.”
Daffy said that because Weight Loss Accelerate is supported by a clinical trial, and contains an ingredient which is the subject of a number of clinical trials, “there was an ongoing debate on the relevance and merits of the science available.”
He said Blackmores continues to have confidence in Weight Loss Accelerate and has “valid evidence to support our product’s efficacy.
“Anyone has the right to submit a complaint on a therapeutic product, and companies are also well within their right to lawfully defend their products and intellectual property,” Daffy said.
Harvey told PD on Sat that he and Daffy had had a “frank exchange of views” about his NMS presentation and had agreed to discuss the matters further.
He conceded that Blackmores had ‘legally’ complied with the CRP determination but continued to maintain that claims made for Weight Loss Accelerate were based on a “discredited 30 patient Indian study that lacked statistical validity.”
Harvey said: “I believe that the complementary medicine industry has much to contribute to Australia’s quality use of medicine policy and I hope that my interaction with Blackmores might stimulate this process.”
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Body of message from Dr Harvey to Blackmores:
Philip Daffy made contact with me on Thursday night before my presentation on, ‘Complementary Medicine Reform’ to the NPS National Medicines Symposium, 2008.
We discussed the ‘alleged’ inaccuracies (appended below) in my presentation. My response follows.
1. The complaints were made from December 2006 – January 2008, not “several years”.
The first complaint (57-1106) was made in November 2006, more followed in 2007 (1-0107, 6-0207, 6-0407) and more in 2008 (2008/02/005) by myself and another in May, 2008 by CHOICE.
Clearly, this period spans several years. However, in response to Mr Daffy’s concerns I changed the words in my actual presentation to, “5 complaints made over 18 months” (slide 11 attached).
2. Blackmores has never ignored a CRP determination.
I accept that CRP determinations can be legally challenged and ‘due process’ can be used to avoid compliance with CRP ‘requests’ until such time as the CRP requests the delegate of the Secretary of the Department to ‘order’ the product sponsor to comply. Some companies appear to have made such delaying tactics an art form. Meanwhile, misleading promotion and sales continue.
In response to Mr Daffy’s concerns I changed the words in my actual presentation to, “CRP determinations ignored?” (slides 7-9 attached).
I went on to point out that the ‘disclaimer’ on the Blackmores web home page does not mention the product unless you click through it, see:
http://www.blackmores.com.au/
In addition, there is no mention of a disclaimer on their ‘weight management’ page or on the specific product page, see:
http://www.blackmores.com.au/Products/GroupListing.aspx?GroupId=13
&
http://www.blackmores.com.au/Products/Detail.aspx?ProductId=2073
I also noted that in my complaint 2008/02/005, I pointed out that all the other claims (Reduce fat stores! Enhance fat oxidation (burning)!
Reduce appetite! Reduce body mass index! Help maintain normal cholesterol levels!) were based on the same discredited, 30 patient Indian study that lacked statistical validity.
These claims continue to made and no doubt Blackmores will keep on doing so until complaint 2008/02/005 works its way through appeals.
In addition, Blackmores continue to make the ’3* greater’ claim on the pack and pharmacy bin displays (one of which is my own shopping centre street)! So yet another complaint has recently been sent off (attached)!
So have Blackmores complied with the CRP determination?
My answer was legally perhaps. Morally NO!
I expressed regret to Mr Daffy that Blackmores did not attend the NPS conference which had a keynote presentation on complementary medicines and quality use of medicines by Margaret Williamson. She also presented NPS research on the CM information needs of consumers and health professionals. My own presentation was attended by the CEOs of Medicines Australia and the ASMI but, regrettably, not the CHC.
Mr Daffy invited me to come to Blackmores to discuss these matters further. I suggested that his company (and other CHC members) might appreciate a presentation I have given a number of times to other audiences on behalf of the NPS titled, “Evidence versus hype” (suitably modified to include complementary medicine examples. I have also mentioned this possibility to Dr. Lynn Weekes, CEO, NPS.
In conclusion, Mr Duffy and I have had a frank exchange of views about my presentation and we have agreed to discuss these matters further, hopefully under NPS auspices. I believe that the complementary medicine industry has much to contribute to Australia’s quality use of medicine policy and I hope that my interaction with Blackmores might stimulate this process.
With best wishes,
Ken
—
Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University http://www.medreach.com.au
