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The TGA Need Public Help in Reporting Adverse Drug Reactions in Australia
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| As I have noted elsewhere (see Pan
Crisis), there is currently a world wide campaign to encourage
consumers to report the slightest adverse reaction to alternative
medicines, regardless of actual cause (1,2,3,4,5,6,7,8
- see also Dietary
Supplements). The TGA has again recently emphasised the need to report
suspected reactions to "complementary medicines" (10)
and these alleged safety concerns have been utilised to justify (see Pan
Crisis) the TGA's crackdown on alternative medicines (12).
The TGA's persistent determination to emphasise reactions to
"complementary medicines" and downplay reactions to
"drugs" or "all medicines", should be noted,
especially in view of the fact that the TGA considers complementary
medicines to be (11)
"low risk", a fact which was confirmed by Professor Dwyer
who describes such medicines as (13) "usually harmless".
Since "low risk" is a relative term it is abundantly
clear that there are also other medicines which are "high risk".
These of course, are the pharmaceutical drugs, the medicines which the TGA
seems to show least interest in.
The safety of alternative medicine has been further stressed by the bible of sceptics and scepticism, the Skeptics Dictionary (14):
Since, not surprisingly, adverse reactions to high risk pharmaceutical drugs outnumber reactions to alternative medicines by around 98 to 2 ( see Response to the Report of the Expert Committee, Holistic Medicine Sets the Standard for Safety), this concern about low risk alternative medicines is clearly not motivated by public health considerations. If our concerns are confined to public health considerations then we should consider first those products which pose the greatest risk. Pharmaceutical drugs of course, unlike low risk alternative medicines, are classified under the Poisons Schedule. Sudden concerns about the safety of low risk alternative medicines, while not related to public health, do correlate very strongly with moves to justify a takeover of the industry by the medico-pharmaceutical juggernaut (see Pan Crisis). According to Geraldine Moses of the Pharmaceutical Society of Australia, changes to the alternative medicine industry are usually brought about by complaints and adverse reaction reports (2):
One can appreciate the considerable dilemma facing those with a vested interest in the drug industry and their political servants. Since changes only result from adverse reaction reports, how can they possibly justify a financial takeover of products which, at their worst, are hundreds of times safer than the drugs which they peddle everyday? The answer is simple. Convince consumers that all adverse reactions are due to the lowest risk and most harmless products. In the rush to convince consumers of the dangerous nature of low risk usually harmless alternative medicines it has been declared that the precise cause of any apparent adverse reaction is unimportant (see Pan Crisis):
Given the current medical obsession with reporting adverse reactions to low risk usually harmless alternative medicines, and in view of the infinitely greater risks posed by the use of high risk pharmaceutical drugs (see Holistic Medicine Sets the Standard for Safety), it is vitally important that we concentrate first and foremost on these much more dangerous and toxic pharmaceutical products. Since 90%-99% of adverse drug reactions are never reported (see Holistic Medicine Sets the Standard for Safety) it is abundantly clear that the current reporting system is an abject failure, a fact which clearly gives public health authorities a very dangerous and disturbing false impression about the dangers of pharmaceutical drugs. Since doctors are very reluctant to report adverse drug reactions (see Holistic Medicine Sets the Standard for Safety), public health authorities such as the TGA can only be correctly informed about drug reactions if there is widespread consumer participation in the reporting process. As I have stated elsewhere (see Pan Crisis):
Recently I had an opportunity to assess first hand the effectiveness of the adverse drug reactions reporting system in Australia. After taking the blood pressure drug candesartan for some time, suddenly, and quite dramatically, my elderly mother experienced acute swelling around the face and mouth. An urgent trip to the local GP resulted in a diagnosis of angioedema due to candesartan, a reaction which, according to the GP is not too uncommon. Amazingly, according to the doctor, this type of reaction to candesartan commonly continues for six months or more after the medication is discontinued, a fact which was subsequently confirmed by various other doctors.
After administering further drugs to counter this adverse reaction and advising her to immediately discontinue candesartan, the doctor gave us specific instructions to immediately attend hospital if there was any deterioration, especially swelling in the throat. About one hour later the throat did begin to swell and necessitated a trip to hospital. The swelling soon began to subside however, and she was discharged a few hours later. Doctors at the hospital confirmed the initial diagnosis. Two weeks after discontinuing the drug she experienced the same reaction and was taken to hospital again with the same diagnosis and result. A further three weeks later, or five weeks after discontinuing the drug, she experienced yet another reaction and was rushed to a different hospital. This third reaction was by far the worst with extensive internal swelling in the throat which made talking and swallowing virtually impossible and breathing was impeded to the degree that oxygen and adrenalin had to be administered. The diagnosis was the same. Considering my responsibility to report this reaction, especially given the current environment regarding reporting of reactions to low risk alternative medicines, I decided to report this matter to the Adverse Drug Reactions Unit of the TGA. One of the advantages of reporting this reaction would be that it would give me the opportunity to observe first hand the effectiveness of the TGA's drug monitoring and safety system. I would be able to assess how effective the reporting system actually is when it comes to life threatening reactions to drugs as distinct from reactions to low risk alternative medicines. I initially reported these reactions using the TGA's online reporting system followed up by facsimile reports. During my subsequent communication with the Adverse Drug Reactions Unit (ADRU) of the TGA some rather surprising and disturbing facts began to emerge. Firstly, I found it rather difficult to obtain definite statements from the ADRU regarding whether or not the various doctors and hospitals involved in my mother's case had actually submitted adverse reaction reports. At first this question was completely ignored. In a subsequent communication I made the following response to the TGA:
I received the following response to this query from the ADRU:
This incredible reluctance to provide a specific answer to my query is of course an answer in itself. The TGA's drug reaction reporting system is obviously a complete sham and is in keeping with estimates that up to 99% of drug reactions, even life threatening reactions, are unreported. What is most disturbing however, is the obvious evasiveness of our national drug regulatory body and public health watchdog, the TGA. Why would they seek to conceal whether or not an incident had been reported? What do they feel is to be gained by such evasiveness? Are not public health and drug safety the primary considerations? But perhaps even more disturbing is the fact that the ADRU found my query to be so difficult to cope with that they terminated any further correspondence about the matter. According to the ADRU:
This really is absolutely astonishing. Our national regulatory authority and public health watchdog is so incapable or unwilling to respond to queries about adverse drug reaction reports that they simply refuse point blank to communicate. This surely is the absolute height of evasiveness. But why? Are we expected to believe that members of ADRAC are so emotionally hypersensitive that they cannot cope with simple queries about adverse reaction reports. Or is there a more sinister motive for their response? Are they attempting to conceal the fact that the whole adverse drug reaction reporting system is a sham, a fact which would also mean that the TGA has absolutely no idea of the true extent of adverse reactions in Australia? I should not be surprised. As I have noted elsewhere (see Pan Crisis):
What is most insulting about the attitude of the TGA and the government is that they apparently believe that the intelligence of the general community is such that they may be persuaded that they must be urgently protected from the safest or lowest risk medicines on the market. When drugs such as hyoscine hydrobromide in Travacalm are shown to be toxic (see Pan Crisis), we are expected to believe that we must be urgently protected from the sale of 'dangerous' vitamins and nutritional supplements, the clear inference being that this will protect us from dangerous pharmaceutical drugs. It is all for our own good. As medical experts (who increasingly take supplements themselves) increasingly confirm that those who do not take nutritional supplements are increasing their risk of suffering serious or fatal chronic diseases (see Health News and Links, Alternative Medicine Inquiry, Pan Crisis), the TGA expects the community to believe they must be protected from these dangerous lifesaving supplements. They really do have an amazingly low opinion of the intelligence of the general public and the alternative health community. It is also astonishing that our public health watchdog and regulatory authority is asking the alternative health industry, and the wider community, to accept blanket reforms to a complete heterogenous group of products as though they are one and as though the 'scientific evidence' applies equally and identically to all of them. Never before has the public been treated with such contempt. Do the authorities intend in future to take action against ALL pain killers or ALL anti-inflammatories? Or will ALL drugs be banned when a serious adverse reaction is reported? Or perhaps a radically different set of rules apply to highly profitable high risk pharmaceutical drugs. The more profit, the fewer rules? It is difficult indeed to imagine a more preposterous double standard and insult to the collective intelligence of the community. This is simply a deliberate move to deceive the public by manufacturing false public health concerns to justify legislative changes aimed at enabling drug companies to take financial control of the alternative medicine industry. It is a clear abandonment of honesty, integrity and public health in the interests of profit. If public authorities are permitted to successfully perpetrate this incredible fraud then clearly their future behaviour can be expected to degenerate to an even lower level. It is abundantly clear that if our current adverse reaction reporting system is to be even remotely effective then it will depend very heavily indeed on extensive public participation in the reporting process. Unless this occurs, then clearly, regulatory and public health authorities will remain blissfully unaware of the myriad of adverse reactions which are experienced everyday. Appropriate health care reforms cannot occur in such a situation of ignorance. Since our health care system is strongly dependent upon public participation in the reporting process I urge everyone to report any and all adverse drug reactions to the Adverse Drug Reactions Unit of the TGA. As is emphasised by the TGA, the monitoring of drug safety in Australia can only be carried out effectively if all significant adverse reactions are reported (9).
The TGA emphasises that all suspected adverse reactions should be reported, including reactions to prescription drugs although they avoid any specific mention of these (10):
To report adverse reactions follow the guidelines provided by the TGA (10):
If you wish to maximise the efficiency of Australia's drug monitoring system then make sure you double check with the ADRU to ensure that the doctors and/or hospitals involved in your particular case also submitted reports along the same lines. As is so often stated in regard to politics, we get the system we deserve. The same also holds true for our health care system. Unless we all actively participate we will continue to get the health care system we deserve. |
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| References
1. http://www.ama.com.au/web.nsf/doc/SHED-5FK4YN/$file/healths_gd_p
See: AMA Position Statement on Complementary Medicine, 2002.
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