Public Health

What Does The TGA Think It’s Doing?

You have to wonder what is going on at the Therapeutic Goods Administration, whence bizarre edicts are emerging in recent profusion. Take ivermectin, for instance, which a goodly body of evidence and opinion asserts is useful in preventing and treating COVID-19 infections. Last month, Health Minister Greg Hunt went on the record as saying doctors were free to prescribe the cheap, off-patent medication. Here is what he wrote:

“I acknowledge some physicians are prescribing ivermectin off-label. As you would know, the practice of prescribing medications outside of their approved indications is not regulated nor controlled by the Therapeutic Goods Administration, as it is at the discretion of the prescribing official.”

On Friday, directly countermanding the minister, the TGA’s bureaucrats banned ivermectin for anything other than standard uses, chiefly the the treatment of roundworm infestations. This followed the Pharmaceutical Society of Australia telling High Street chemists not to fill lawfully written prescriptions.

Does Minister Hunt oversee policy or do bureaucrats oversee the minister?

Then there is the looming ban on vaping other than when nicotine-infused “juice” is prescribed by a doctor and obtained from a chemist.

That vaping ban prompted Dr Gilbert Berdine to wonder what sort of minds and agendas are shaping TGA policy. — rf

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THERE is very little doubt that vaping – the use of electronic cigarettes or e-cigarettes – poses fewer health risks than cigarette smoking. Public perception, however, is that e-cigarettes are at least as harmful as smoking. This error of public perception is likely due to the following combination of errors:

♦ association of risk of smoking with nicotine rather than combustion products;

♦ conflation of nicotine addiction with the harmful effects of smoking; and

♦ misunderstanding of the importance of nicotine addiction to failure of smoking cessation efforts.

The discussion below will try to correct the above errors of perception. This discussion is based on my own professional experience as a medical doctor (MD) in treating smokers for over 40 years as well as two United Kingdom (UK) reports claiming that vaping e-cigarettes is “less harmful” than smoking cigarettes:

♦  E-cigarettes and heated tobacco products: evidence review by Public Health England (6 February 2018) which states “vaping is at least 95 per cent less harmful than smoking”; and

♦  Nicotine without smoke: Tobacco harm reduction by the Royal College of Physicians (28 April 2016) which states “e-cigarettes [are] unlikely to exceed 5 per cent of the harm from smoking tobacco”.

 

Harmful Effects of Cigarette Smoking

There is unanimity of opinion in the medical community that cigarette smoking is an important risk factor for chronic cardiovascular and lung disease including stroke, myocardial infarction (or heart attack), and chronic obstructive pulmonary disease (COPD). For COPD, smoking dwarfs all other risk factors combined. Death is more likely caused by these chronic diseases than by cancer, yet the public associates smoking with cancer rather than chronic disease. Unlike hypertension, which is generally not a choice, smoking is a behavior that can be eliminated. Smoking causes these chronic diseases (and cancer) by exposure to toxic substances in the cigarette smoke.

Although nicotine is a substance in the cigarette smoke, and nicotine has harmful effects – including addiction – products of combustion, such as tar, are the causative agents for disease. By eliminating these products of combustion, e-cigarettes offer a means to satisfy nicotine craving (including addiction) without the toxic products of combustion. Whether this potential will be realized largely depends on whether government regulation of e-cigarettes will lead to black markets supplied by criminals who have very little concern about quality or safety.

 

Harmful Effects of Vaping

There has been much recent press emphasizing the risks of vaping. Vaping may be associated with decreases in pulmonary function. Vaping may be associated with heart disease. These associations are weak, however, compared to the risks of cigarette smoking. Air pollution from factories and motor vehicles are associated with decreases in pulmonary function and increased prevalence of asthma. Nobody is suggesting that we ban cars and factories to solve this problem, because the effect is minor compared to the benefits of motor vehicles and factories. In fact, motor vehicles and factories raise our standard of living and lead to longer lifespans by making important things such as food and health care more accessible.

Prior to COVID-19 dominating the health care news, there was a great deal of concern about e-cigarette or vaping associated lung injury (EVALI). There were calls for more regulation, and some jurisdictions proposed bans on vaping. It turns out, however, that the regulation of vaping was responsible for EVALI. It should have been curious that vaping existed as a growing industry for over ten years without any cases of EVALI. As if by magic, there was a new illness associated with vaping that suddenly appeared in 2018-19. We now know that EVALI is mostly caused by the use of vitamin E acetate as a thickening agent. The use of vitamin E acetate appeared because regulation led to black markets supplied by illicit operators who used it as a cheap way to cut the product much like illicit heroin suppliers use talc. In the absence of government interference, there would have been no EVALI.

In 1914, deaths from motor vehicle accidents were over 33 deaths per 10,000 vehicles in use. That number is now less than 2. The market leads to improved quality of product over time. We might have banned cars in 1914 to deal with the tragedy of deaths by motor vehicle accident. Had we done so our lives would be worse today with shorter life expectancy. The market mechanism creates incentives for manufacturers of e-cigarettes to improve their product over time. These improvements include learning what impurities are causing adverse side effects and eliminating them. The suppliers also have incentives to provide the delivery of nicotine in a manner that users of e-cigarettes demand.

 

Smoking is More than Just Nicotine Addiction

Government and the medical profession have recently demonized nicotine. There is considerable irony here given the past histories of government and the medical profession. The US military provided free or low-cost cigarettes as a recruiting tool. There was a time during the 1930’s when physicians were used in advertisements for cigarette smoking. Smoking cessation is very difficult for most people. Both government and the medical profession have oversimplified the problem by creating an image that the difficulties of smoking cessation are entirely due to nicotine addiction. This is clearly not true. If smoking cessation were merely a matter of dealing with nicotine addiction, then previous systems of nicotine replacement therapies would have worked so well that there would be no market for e-cigarettes. Despite approval of nicotine replacement therapy by the American medical establishment, nicotine gum and nicotine patches fail by 80 per cent or more.

There is more to smoking cessation than nicotine. Smokers who are hospitalized are not permitted to smoke. In my experience, there is rarely a problem keeping patients smoke-free in the hospital. After two weeks, any physical addiction is no longer an issue. Yet, the first thing these patients do when they return home is smoke a cigarette. There are reasons why people smoke. Smoking fulfills some need. Contrary to what the government may claim, the problem is more than patients not understanding the risks of smoking. As a medical student at Harvard University School of Medicine in 1974, the professor who taught first year pathology had a ritual of pointing to a slide of lung cancer using a lit cigarette as a pointer. The professor was making an exclamation point with this gesture: I know all about the hazards of smoking, but I am going to smoke anyway.

Nicotine binds to receptors that exist in everyone. The same is true for opioids. Prior to the discovery of endorphins, it was a mystery why we had receptors for addictive opioids that seemed to have no functional purpose. Now we at least partially understand the importance of opioid receptors. Nicotine serves a purpose. Otherwise, the receptors would not exist. Unfortunately, the current paradigm of solving medical problems by breaking biochemical pathways is so dominant, that we do not even seem interested in understanding why things are the way they are. E-cigarettes have the potential to serve as a platform for carefully controlled delivery of nicotine to those who want it. We already recognize that different groups of nicotine consumers exist: some want a rapid onset to a high peak level; some want to maintain a minimum trough level; and some want steady delivery. Government generally creates a one-size fits all standard based on an average for the entire population that does not serve any individual well.

 

Conclusions

There are likely to be adverse effects of vaping. We should not encourage people to take up vaping as a habit.

However, we should recognise that vaping does help some people quit smoking. Given that the hazards of smoking are much greater than the hazards of vaping, if even a small number of smokers successfully quit smoking using e-cigarettes as a bridge therapy, then it is a victory. The market will allow manufacturers to discover any harmful effects and eliminate them over time. Demonizing vaping will only lead to black markets with more dangerous products available and no means to legally correct the problems. This has already occurred with EVALI. We need to stop repeating the same mistakes.

 

Dr Gilbert Berdine MD is an associate professor of internal medicine at the Texas Tech University Health Sciences Center (TTUHSC) and a faculty affiliate with the Free Market Institute. Dr Berdine earned his undergraduate science degree in chemistry and life sciences from the Massachusetts Institute of Technology in Boston and his graduate medical degree from Harvard University School of Medicine in Boston. He completed both his residency in internal medicine and fellowship in pulmonary diseases at the Peter Bent Brigham Hospital (now called Brigham and Women’s Hospital) in Boston. He regularly writes for both the American Institute for Economic Research and Mises Institute.

 

21 comments
  • Doubting Thomas

    As a very heavy smoker (up to 60 a day) from age 17 to 53, I tried many times to quit smoking. Several times over the years I managed to break the habit for some months. However, on all but the last occasion (3/3/1993), overconfidence led me to believe that “one won’t hurt me”, and nor did it. But the inevitable happened very quickly, and away we went again.
    The one irrefutable lesson I learnt over the years is that it is virtually impossible to quit smoking unless one genuinely wishes to do so. Another more arguable lesson is that smoking is not an addiction to anything. It is a habit, and nothing more – more like a form of OCD. Once the obsessive compulsion is interrupted, the rest is easy.

  • Daffy

    I’ve often wondered the age at which one’s probability of years to death is indifferent to taking up smoking. I asked the Cancer Council. They declined to answer. Just the occasional cigar, that’s all!

  • Daffy

    The photo of Skerritt and the minister reminds me Sir Humphrey watching his minister. Oh the horror of it.

  • Peter Marriott

    Good piece Gilbert and good comments. I think Daffy’s are spot on….both have occurred to me as well, especially the eagle eyed look of Professor Skerritt. The Government should have the power to pull them into line surely, even if they have to find different Professors who know the science equally well and can bypass Skerritt in the manner of disagreeing. Our own personal doctors should be able to prescribe the easiest, quickest readily available over the counter treatment and that has been shown to include ivermectin with the right protocols.

  • Stephen Due

    Maybe we need a large randomised double-blind placebo-controlled trial to see whether vaping cures (or protects from) Covid-19? It could be funded by the government and run by a coalition of corporations that manufacture and distribute vaping equipment and supplies.

  • Ian MacKenzie

    In considering ivermectin as a drug in general, the most important factor should be the benefits vs side effects equation. As it has been prescribed previously to treat unpleasant but non-fatal conditions such as head lice and scabies, it would be reasonable to conclude that side effects are rare and mild, and that is indeed the case. Known side effects, although uncommon, include fever, itching, and skin rash when taken by mouth, and red eyes, dry skin, and burning skin when used topically for head lice. Given this spectrum of uncommon, mild side effects, one would imagine that prescribing ivermectin off-label for something that could prove fatal should not be a particular concern for a regulatory organization. Unfortunately President Trump is on record as suggesting it might be efficacious for Covid19 infections and, according to the principles of Trump derangement syndrome, it must therefore be banned. This, added to the fact that pharmaceutical companies are making large profits for much more expensive alternative anti-viral medications, probably tells you all you need to know about TGA policy.
    .
    What then to do? As ivermectin is still approved for parasite control, anyone wishing to obtain it must first obtain the parasite. Usually this would be simple, but as schools are closed, I suspect the incidence of head lice is much reduced. Perhaps there is an opening for an enterprising capitalist to provide a supply by mail, much as some provide parasitic wasps and aggressive fungi by mail to control common garden pests.
    .
    What to do about the TGA for its disregard for Ministerial oversight and sign up to leftwing syndromes and Big Pharma profits? Well the only cure for infected Government bodies is to remove the members and introduce uninfected replacements.

  • Lewis P Buckingham

    ‘illicit operators who used it as a cheap way to cut the product much like illicit heroin suppliers use talc.’
    Just as a point of information white powders are also cut with glucose powder giving the user a sugar hit.
    There have been cases of the use of Ajax powder also.
    Cigarette addiction is harder to beat than opioids.
    This tragedy occurred to a fairly close relative in a nursing home.
    She ended up there, fiercely independent, having been resuscitated after 36 hours lying on a laundry floor.
    It was impossible to get a stent into her as she was so sclerotic.
    I recall being advised by the nurse manager that if she were caught smoking again she would be ‘asked to leave’ because of the fire risk and cigarette burns on the carpet.
    After discussion I pointed the above addictive fact out and the nurse manager actually broke down and said she had tried for years to give up but could not.
    Some years before a cigarette marketing person of my acquaintance was commenting of the banning of cigarette advertising in Australia.
    For her that was OK as she was off to New Guinea to sell them.
    The government was happy with the royalties. Tobacco smoking (2011 New Guinea
    Males
    54.9% Females 30.7%
    https://www.who.int/cancer/country-profiles/png_en.pdf
    The marketing was successful.
    Another relative close to me documented all her activities.
    We now know she finally gave up cigarette smoking 36 hours before she died of emphysema.
    With the opioids people just go onto the methadone program, go to the green door and get their ‘take away.’
    They are still addicted.
    They are still incompetent.
    Individuals are less likely to revert to petty crime.
    If vaping is a lesser evil and can be made a pathway to cure, then why not adopt the methadone analogy.
    Methadone is a dangerous drug, but it is dished out all the time.
    People still sell it or hand it to friends.
    Its hardly risk free, no ‘safe to do’ caveat here.
    The TGA could take another look at this whole thing.
    Ivermectin.
    According to Yesterdays Sydney Telegraph there is another trial going on in the UK on ivermectin.
    As I have expressed on these pages, its not clear to me that it will work, except in some countries with a history of mass endemic diseases such as SARS and poor sanitation with concomitant parasite loads.
    However I would love to be wrong.
    There are always problems with trials and those, such as the TGA, presumably want to make the right call, despite the expert advice that they should look again, now.
    https://acmedsci.ac.uk/viewFile/56314e40aac61.pdf
    One way of cutting through the debate would be simply publish the data from the Australian trial already contracted for at Monash. Researchers are always slow to publish negative data as in Pg 5 of the reference.
    ‘Why bother it did not show significance’.
    However this would clear the air for me and the correspondents and experts here.
    It would also allow an independent analysis of the statistical design and null hypotheses trialed.

  • Occidental

    The good old TGA. One of the reasons I left Australia was the decision by the TGA to require a prescription for codeine medications. It wasn’t the last straw but just another indication to me that Australia had moved on, and somehow left me behind. In my household, Mum Dad and myself would take maybe 10 aspalgin tablets (6mg codeine and 300mg) between us a year. But codeine can be very handy. My Mum who had advanced dementia got an attack of shingles. The GP prescribed a drug the name of which escapes me, but it was meant to reduce nervous pain, as well as the usual suspect paracetamol. Both were absolutely useless. At midnight with my Mum whimpering in pain, and at my whits end I get on the internet and find out how to precipitate the aspirin out and give mum 60mg (10 tablets). Worked a treat. A year or two later my father nearly 90 gets severe diarrhea, GP prescribes water and soft drink. I prescribe 32 mg of codeine, again problem solved. During this time I get a shoulder injury doing some fence repairs to a paddock and develop radiculopathy. GP prescribes paracetamol and ibuprofen. To get some sleep I go back to codeine. Used when you need it, and increasing the dose way beyond what the gate keepers permit it was a marvelous first aid kit. But to show they care about dickheads, the TGA basically prevented me from accessing the drug, and using it as it should be used. The control freaks in Australia just got too much for me.

  • rabel111

    The broader problem of the public service becoming politicised to push particular social agendas, or evangalised social engineering is a growing problem that needs to be addressed to preserve democratic gevernment and faith is so call evidence based government instruments. These agendas are often thinly disguised by catch names, like “quality use of medicines” and used by ruthless ideologues operating outside the statutory powers of authorities like the TGA, to force public compliance to ideologlical rather than evidence based exercise of powers.

  • John Michelmore

    Parliamentary petitions for Ivermectin EN3141 and EN3214. Please sign and pass on information to others.

  • pbw

    IIRC, in the leadup to the 2013 election, Tony Abbott, anxious to snooker feminist complaints about his 2005 refusal to approve RU-486, an abortifacient effective up to 10 weeks into pregnancy, announced that, if elected, he would remove ministerial discretion over decisions of the TGA. Peta Credlin may have had a role in this.

    If my memory has served me correctly, and if this policy was indeed carried out, it was a signal abrogation of Ministerial responsibility and of the principle of democratic governance.

    If this is the case, now is the time for Greg (Great Reset?) Hunt to re-assert Ministerial authority.

  • pbw

    The situation wrt Ivermectin is even more absurd. The TGA passes the ball to the ACMS.

    “Today the TGA, acting on the advice of the Advisory Committee for (sic) Medicines Scheduling, has place new restrictions on the prescribing of oral ivermectin.”

    Not only does the Minister wash his hands of the decision (if indeed he has), but the TGA punts the ball to a sub-committee. “We’re just following the science.”

    https://www.tga.gov.au/committee/advisory-committee-medicines-scheduling-acms

  • talldad

    Does Minister Hunt oversee policy or do bureaucrats oversee the minister?

    Daffy, you have just answered this question.

  • talldad

    PBW linked to a page which declares:

    The ACMS was established to advise and make recommendations to the Secretary of the Department of Health (or delegate) on the level of access required for medicines and in some instances chemicals.

    Since this is within the TGA pages, I ask: is the TGA an appointed delegate of the Department Secretary?

    Does the TGA invariably accept the advice of the ACMS? Or does it avoid thinking for itself at all (to misquote Sir Joseph Porter KCB)?

    And how does the ACMS receive requests to advise on chemical scheduling?

  • nfw

    Ivermectin bad; experimental drugs okay. Makes sense.

  • vickisanderson

    I may be wrong, but I have felt for some time that Greg Hunt was not always on the same page as Morrison and others in relation to the treatment of COVID.

    His earlier advice by letter to Dr. Mark Hobart that the TGA did not have jurisdiction over off label prescription of Ivermectin was surprising. But now that it appears such prescriptions by various GPs of the drug are increasing, the lords of the TGA are overruling the Minister. There is also anecdotal evidence that GPs have been warned, & pharmacies are also being told not to fill prescriptions for Ivermectin.

    Greg Hunt is a good man and a good Minister. He has diligently sought (& ordered) alternate vaccines (like conventional vaccine, Novavax) and now the anti-viral drugs being urgently developed in the USA. The latter will probably be no better than Ivermectin, but will not be obstructed by a medical autocracy of dubious worth.

  • STD

    What’s going on? The managerial elites have perfected the art of their individual survival – backside covering.
    They are in charge of their own little fiefdoms- a fall from manipulative grace in the business / corporate world is akin to peer suicide and one’s very reason for living- self absorbed cultural adulation.
    Lacking any semblance of humility, obstinance flies in the face of common sense.
    These types of people represent the scum of common sense.

  • pbw

    I haven’t yet found anything specific about Tony Abbott’s pre-election promises, but at the time of the RU-486 controversy, a private Senator’s Bill was proposed that removed the Ministerial oversight of “restricted goods” in this context.

    https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Completed_inquiries/2004-07/ru486/report/c01

  • STD

    @Stephen Due, in regard to your comments on vaping, I believe that down the track this method of delivery will see all sorts of illicit drugs being made available in legalised metered dosages. Another revenue stream for big business and government. The adverse effect, further cultural erosions , no doubt.

  • David_Blake

    I find it interesting that the TGA has avoided the great searchlight of a Royal Commission. It certainly needs one now since Hunt is a truly hapless Minister.
    As with many departments and agencies, the causes of failure to follow evidence in favour of the taxpaying public’s welfare, and the public’s will, are likely to be a mix of greed, hubris, arrogance, incompetence, laziness, pockets of corruption, groupthink, agency sclerosis, the capture of Ministers, and ideology.
    A second Royal Commision would examine how the pathology industry denies the widespread dispersion of rapid, cheap, point of care testing devices to Australians. There are home grown Aussie companies which market their POC devices overseas but not here, because of the highly biased rules which control collection and analysis.
    Rapid POC devices are especially relevant to the management of respiratory infections.

  • STD

    @pbw, “ Where just following the science”.
    Just like the climate no doubt – the political science- the fraud..

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