E-DRUG: TGA draft guidelines for evidence to support claims for weight loss
-------------------------------------------------------
Draft Guideline for Levels and Kinds of Evidence for Listed Medicines
with Indications and Claims for Weight Loss
[released Feb 9, 2009; comments to TGA by COB March 20, 2009]
http://www.tga.gov.au/cm/consult/drweightloss.htm
Comment by Dr. Ken Harvey, School of Public Health, La Trobe University
The Australian Therapeutic Goods Administration (TGA) said, "This
guideline will .... give consumers confidence in the medicines they
choose for self-care".
I don't think so! In my opinion, this document provides yet another
example of how the TGA is focused on industry, not consumer, protection.
This document was first conceived in 2007, stimulated by the increasing
number of complaints about complementary medicines promoted for weight
loss. These products included Cat Media's "Xantrax High Potency Weight
Loss Formula", "Fat Blaster" and "Fat Magnet" and Blackmores "Weight
Loss Accelerate" and "Sugar Balance".
My colleagues and I found more than 1000 of these products had been
listed on the Australian Register of Therapeutic Goods (ARTG), their
numbers were increasing exponentially, no evidence of their efficacy was
assessed routinely by the TGA, and the complaint system was ineffective,
being overloaded, under-resourced and lacking effective sanctions. [1]
Initially, it was my understanding that the TGA planned to review the
evidence about the limited number of herbal and other ingredients used
in listed weight loss products; none of which have convincing evidence
of efficacy, either alone or in combination [2-5]. It was hoped that
such up-stream evaluation would reduce the need for down-stream
complaints (and better protect consumers) by proscribing the use of
ingredients that lacked evidence of efficacy.
However, allegedly in response to industry concerns, the topic of the
TGA review was changed to the current, "Draft Guideline for Levels and
Kinds of Evidence for Listed Medicines with Indications and Claims for
Weight Loss". In addition, although a consultant's report was received
in November 2007, the release of the draft Guidelines was delayed for 14
months; this procrastination is hard to understand given the anodyne
nature of what has just been released.
The "Guidelines" state that, "Clinical trials, particularly randomised
and blinded trials provide the most robust information regarding the
potential effects of an intervention". They go on to provide useful
information about how such trials should be conducted, including the
number and types of patients needed to achieve statistical power,
outcome measures and the study duration.
Ironically, the "Guidelines" then allow "medium" level (non-randomised
trials) or "traditional" evidence to be used in making claims. They also
say nothing about the acceptability of product names making their own
implicit claims, such as "Fat Magnet" and "Weight loss Accelerate".
In my opinion, refining "Guidelines for evidence to support claims for
weight loss" merely perpetuates the current situation where the onus
remains on the public and health professionals to submit complaints
about individual products to an already overloaded and ineffectual
system.
This has led sponsors such as Blackmores to challenge complaint
resolution panel findings and draw out proceedings for months and years
through appeals to the TGA. Whereupon the complaints disappear into the
TGA black hole! Although the TGA say they sometimes take action, the
details are "commercial-in-confidence". Months or years may elapse,
complainants are told nothing and the TGA publicises nothing, all very
convenient for industry!
The only way that these "Guidelines" might have some impact would be if
the TGA used them to undertake a post-market review of ALL listed
weight-loss product; in short insisting that ALL sponsors of these
products submit the evidence (according to the new Guidelines) that
substantiates their efficacy.
Is the TGA likely to do this; on their current form, I don't think so!
In August 2008, Parliamentary secretary Jan McLucas said there was a
real sense of urgency about reforming the complaints process and
available information on weight-loss pills, vitamins, herbal remedies
and other complementary medicines on which Australians spend more than
$2 billion a year. [6]
I believe that's it time Senator McLucas held the TGA to account! Or
perhaps others might do so at the forthcoming Senate Estimates
Committee?
Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
http://www.medreach.com.au
VOIP: 03 9029 0634; Mobile 04 1918 1910
k.harvey@medreach.com.au
References
1. http://www.mja.com.au/public/issues/188_01_070108/har10522_fm.html
2. http://www.racgp.org.au/afp/200801/29029
3. http://www.medscape.com/viewprogram/12613_pnt
4. http://www.nutraingredients-usa.com/Industry/Why-weight-loss-supplements-don-t-work-according-to-GSK
5. http://www.bmj.com/cgi/content/full/337/nov25_2/a2408
6. http://www.theage.com.au/national/alternative-remedies-face-review-20080731-3nzu.html