Al­ter­na­tive medicines may face scru­tiny

Mak­ers of com­ple­men­tary medicines are fight­ing claims their prod­ucts face in­ad­e­quate reg­u­la­tion. Health ed­i­tor Adam Cress­well re­ports

The Weekend Australian - Travel - - Health -

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 Week­endHealth 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 coau­thors 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 as black co­hosh, which has been linked to liver that at­tempts are made to es­tab­lish what other fail­ure. Other herbal prepa­ra­tions can prove ev­i­dence ex­ists that would un­der­mine the dan­ger­ous, es­pe­cially when they in­ter­act with man­u­fac­tur­ers’ claims. pre­scribed med­i­ca­tions. As con­sumers imag-

While com­plaints pro­ce­dures do of­fer some ine that be­cause herbs are ‘‘ nat­u­ral’’ they mech­a­nism to stop com­pa­nies mak­ing du­bi­can­not cause harm, they of­ten do not tell their ous claims, Har­vey, Mar­ron and their colGP what com­ple­men­tary medicines they are leagues say th­ese are over­loaded, lack transtak­ing. parency, are rel­a­tively tooth­less and take ‘‘ The TGA claims th­ese prod­ucts are safe, months to achieve any­thing at all — al­low­ing but there is clearly no re­search to sup­port this the dis­puted pro­mo­tional be­hav­iour to con­claim,’’ Mar­ron says. tinue unchecked in the mean­time. As many ‘‘ While the TGA does not ask for proof of weight loss prod­ucts cost about $50 per bot­tle ef­fi­cacy they fail to pro­tect the pub­lic from for 60 tablets, and merely con­tain a con­cocherbal reme­dies that may cause harm.’’ tion of herbs such as bit­ter orange, gin­seng, As an ini­tial step, Har­vey and Mar­ron’s green tea and other ex­tracts, the in­dus­try is pa­per sug­gested in­clud­ing a state­ment on also be­lieved to be highly prof­itable. listed medicine la­bels that ‘‘ this medicine has

‘‘ The pub­lic con­tin­ues to think that a not been eval­u­ated by Aus­tralian health List­ing num­ber means the prod­uct works,’’ au­thor­i­ties for ef­fi­cacy’’. Mar­ron says. The CHC’s Tony Lewis says the pro­posal to ‘‘ Noth­ing could be fur­ther from the truth. scrap the list­ing process and as­sess com­ple‘‘ With mil­lions of dol­lars in rev­enue from men­tary medicines for ef­fi­cacy ‘‘ flies in the new and ex­ist­ing prod­ucts, the TGA has no face of sound, ef­fi­cient and eco­nomic riskmo­ti­va­tion to clean up its act. The TGA based reg­u­la­tory prac­tice’’, while the ASMI ap­pears to have a fo­cus on in­come rather than ‘‘ does not be­lieve that con­sumers would be pub­lic well-be­ing.’’ served well by putting dis­claimers on prod-

Mar­ron — who won the Skep­tic of the Year ucts’’. award from the Aus­tralian Skep­tics, in But Gov­ern­ment is clearly more in­ter­ested recog­ni­tion of her work to de­bunk bo­gus in th­ese ideas than its pre­de­ces­sor. med­i­cal claims — also chal­lenges one of the Sen­a­tor McLu­cas says the warn­ing statepil­lars of the com­ple­men­tary medicines in­dus­ment on la­bels ‘‘ seems a rea­son­able thing to try’s defence of the sta­tus quo, which is that say’’ but wants to take ad­vice be­fore rush­ing their listed prod­ucts, be­ing mainly herbs, to judg­ment. vi­ta­mins and min­er­als, are safe and can­not ‘‘ What I have asked the TGA to pro­vide me harm pa­tients. — I don’t want guff,’’ she says. ‘‘ I want a

Mar­ron points out there are many com­plere­sponse to th­ese pro­pos­als that’s se­ri­ous, and men­tary prod­ucts that can be harm­ful — such deals with the is­sues that are there.’’

Pic­ture: Lyn­don Mechielsen

An­other look: Sci­en­tist Loretta Mar­ron (left) and phar­ma­cist Sue Holzberger read the fine print on al­ter­na­tive medicines

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