Healthy Skepticism Library item: 12410

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Publication type: news

Cresswell A.
Alternative medicines may face scrutiny
The Australian 2008 Jan 12
http://www.theaustralian.news.com.au/story/0,25197,23035005-23289,00.html

Full text:

TOUGHER oversight of complementary medicines is on the cards after the federal Government asked the national drug regulator to address allegations that the present system is too lax.

Senator Jan McLucas, parliamentary secretary to Health Minister Nicola Roxon, has asked the Therapeutic Goods Administration to provide a formal response to recommendations published in the Medical Journal of Australia this week, that outline ways to tighten the rules that now apply to herbal and other alternative medicines.

The study’s lead author, Ken Harvey, a longstanding campaigner for tighter regulation of complementary medicines, says the study “highlights the fact that there’s a big problem in regulation”.

Harvey, an adjunct senior research fellow at the school of public health at La Trobe University, wrote that in the authors’ opinion, the claims made for the weight-loss products the team identified “were often not in accord with the limited scientific evidence available”.

The paper made half a dozen recommendations, including compulsory statements on medicine labels stating that they have not been assessed for efficacy by the TGA, and streamlining and strengthening complaint procedures and penalties for inappropriate or misleading advertising.

It also called on the TGA to do more to check the composition of herbal products and the claims made for them more thoroughly. The paper also said that in the long term the dual system that allows complementary products a quicker and cheaper approvals process – ducking the more stringent scrutiny that applies to prescription or pharmaceutical drugs – should be scrapped altogether.

The proposals have already infuriated the alternative medicines industry, whose leaders have rejected the need for change.

Tony Lewis, executive director of the Complementary Healthcare Council of Australia, said in a statement that Harvey “appears to lack understanding of the checks and balances built into the system” and accused him of misrepresenting the situation.

“Sponsors of complementary medicines are required to hold evidence of their efficacy and certify so at the time of listing,” Lewis said.

The Australian Self-Medication Industry also weighed in, saying tighter regulation was not justified – although it did agree there should be “better enforcement of the existing system”.

But Senator McLucas told Weekend Health the MJA article (2008;188:21-25) was “a welcome and timely contribution to the discussion about regulation of CAMs” (complementary and alternative medicines).

“I have requested the TGA provide me a formal response to the solutions proposed by Dr Harvey et al,” Senator McLucas said.

“In particular, I am seeking from the TGA an analysis of the current process of approval of advertising material to ensure that consumers are being protected from misleading claims or claims that are unable to be substantiated.

“Consumers have a right to be able to easily access accurate information about products that they may wish to use.”

The Government’s line is in stark contrast to that of the former Coalition Government, which showed little interest in the issue despite concerns rumbling for well over a year.

In the MJA paper, Harvey and colleagues outlined the difficulties created by the present two-tier system, under which pharmaceutical products are required to be “registered” – a process costing the sponsor company some $170,000, plus annual ongoing fees of $3030 – while alternative products, mainly herbs, minerals and vitamins, are allowed the cheaper option of being “listed” – which costs just $540, plus an annual $690.

The rationale for this is that herbs and vitamins are generally fairly safe, and that products that have been merely listed cannot make claims about curing, treating, managing or preventing any condition or disease. They may instead only make claims related to symptoms and to “health maintenance and health enhancement”.

But the MJA paper raises the question of whether this restriction is any significant hindrance, given the apparent popularity of this “registration-lite” option. Between 1996 and 2006, over 1000 complementary medicines claiming to help with weight loss were listed by the TGA – 100 times the nine pharmaceutical medicines that were registered for the same purpose. New listings have grown significantly, from 45 in 1996 to 144 in 2006.

As well as the vastly reduced fees, companies derive other benefits from listing, in terms of a greatly simplified process. Using an online computer-based system called ELF (electronic listing facility), sponsors enter the ingredients of their product, and the purpose for which it is to be used. Although the purpose can be selected from a list (such as “may aid or assist weight loss…”), applicants can also type in their own wording as free text. They then confirm they hold evidence to back up the efficacy of their product in treating the identified symptom, and pay the applicable fee – which automatically generates an AUST-L listing number and certificate of listing.

Not surprisingly, the process is likened by critics to a vending machine entirely inadequate for the serious business of regulating medicines. The MJA paper says the two-tier system should eventually be scrapped and listed medicines “assessed for efficacy and delisted if the evidence is lacking”.

Currently, while companies are supposed to hold evidence supporting the claims made for their complementary listed products, whether they have this is only checked in 20 per cent of cases selected for random TGA audit at the time of listing.

But critics say even being audited in this way rarely means much.

“Sponsor ‘evidence’ could be a trial with two rats and a guinea pig – it does not have to be peer-reviewed,” says Queensland scientist Loretta Marron, one of Harvey’s co-authors on the MJA paper. Harvey says the checking process often means simply verifying that a study has been cited – not that the study indeed backs the claims (which given the complex nature of scientific evidence, would often be a complicated judgment), nor that attempts are made to establish what other evidence exists that would undermine the manufacturers’ claims.

While complaints procedures do offer some mechanism to stop companies making dubious claims, Harvey, Marron and their colleagues say these are overloaded, lack transparency, are relatively toothless and take months to achieve anything at all – allowing the disputed promotional behaviour to continue unchecked in the meantime. As many weight loss products cost about $50 per bottle for 60 tablets, and merely contain a concoction of herbs such as bitter orange, ginseng, green tea and other extracts, the industry is also believed to be highly profitable.

“The public continues to think that a Listing number means the product works,” Marron says.

“Nothing could be further from the truth.

“With millions of dollars in revenue from new and existing products, the TGA has no motivation to clean up its act. The TGA appears to have a focus on income rather than public well-being.”

Marron – who won the Skeptic of the Year award from the Australian Skeptics, in recognition of her work to debunk bogus medical claims – also challenges one of the pillars of the complementary medicines industry’s defence of the status quo, which is that their listed products, being mainly herbs, vitamins and minerals, are safe and cannot harm patients.

Marron points out there are many complementary products that can be harmful – such as black cohosh, which has been linked to liver failure. Other herbal preparations can prove dangerous, especially when they interact with prescribed medications. As consumers imagine that because herbs are “natural” they cannot cause harm, they often do not tell their GP what complementary medicines they are taking.

“The TGA claims these products are safe, but there is clearly no research to support this claim,” Marron says.

“While the TGA does not ask for proof of efficacy they fail to protect the public from herbal remedies that may cause harm.”

As an initial step, Harvey and Marron’s paper suggested including a statement on listed medicine labels that “this medicine has not been evaluated by Australian health authorities for efficacy”.

The CHC’s Tony Lewis says the proposal to scrap the listing process and assess complementary medicines for efficacy “flies in the face of sound, efficient and economic risk-based regulatory practice”, while the ASMI “does not believe that consumers would be served well by putting disclaimers on products”.

But Government is clearly more interested in these ideas than its predecessor.

Senator McLucas says the warning statement on labels “seems a reasonable thing to say” but wants to take advice before rushing to judgment.

“What I have asked the TGA to provide me – I don’t want guff,” she says. “I want a response to these proposals that’s serious, and deals with the issues that are there.”