Polio – Unconditional Surrender (1956)

From The National Foundation for Infantile Paralysis, Unconditional Surrender looks more closely at the steps involved in making the polio vaccine.

The makers of this movie seek to educate how important the vaccine manufacture protocol, thus safety and efficacy, is. Following production comes testing and retesting. And cute bunnies. Then off to The National Institutes for Health complex where the protocol is examined. Samples from every batch end up in the labs of the NIH, tested for sterility, tissue culture, incubation tests, monkey tests… all designed to ensure safety and efficacy. Many are repeats of those done during manufacture.

In that wonderful victorious lilt of 1950’s narration viewers were held in confidence by such turns of phrase as “man’s enemy becomes his servant”. Of course, the unstated purpose was also to maintain confidence following The Cutter Incident named after Cutter Laboratories – the first lab to unwittingly dispense live virus vaccines instead of killed. This resulted in infections, and still later it became plain not only Cutter lab’s were struggling with Salk’s protocol.

It resulted in a suspension of only one fortnight. A good deal of Paul Offit’s book The Cutter Incident can be found at Google Books.

Unconditional Surrender

 

NPS urges independent advice as Blackmores deal may contravene legislation

Already the myth that the AMA is critical of Blackmores scam to push woo woo at point of sale because of profit jealousy has emerged.

Whilst there are justified criticisms of medical and pharmaceutical industry cooperation, it is frequently blown up to conspiratorial levels. Or misunderstood as being a negative influence on doctors in total. There’s no evidence doctors are immune to incentives – none of us are – but regulations and guidelines exist for a reason. Also, the strongest push to place ethics before the benefits of pharmacy marketing comes from doctors themselves.

Quite frankly though, it also has zip to do with this new problem lapping around the ankles of patients visiting pharmacies to have scripts filled. Drugs work. In the vast majority of cases the consumer can choose a cheaper brand at point of purchase. Alternative products may loosely be said to not so much work, as to carry almost no risk. And this lack of risk, if you pause and think, by definition in the vast majority of cases brings a lack of efficacy. That is, after all, the basis by which they make it onto shelves. That is what differentiates a listed product from a regulated product.

You may have noticed there’s no black market in echinacea. “Naturopath shopping” due to a high tolerance of spirulina or glucosamine isn’t a problem. Clandestine labs aren’t employing criminals to smurf homeopathic tablets so the latest ATS can continue to be supplied. Pharmacies aren’t ram raided in the dead of night so the probiotic fridge or magnesium supplements can be carried off. No cries in emergency departments of “Quick nurse… two teaspoons of Ethical Nutrients fish oil… No – make that Cod Liver Oil. And no fruity flavour Godammit!”.

Alternative medicines have been shown to not work reliably over and again. Those with demonstrable effect suffer from unpredictable results, varying concentration and drug interaction. If Blackmores’ hanky panky does anything well, it’s interferring with the expected effect of real medication. Being not customised per patient needs, it’s impossible to claim one size fits all immediately after claiming it is for something so difficult to quantify as “nutritional deficiency”. A deficiency that may or may not exist at all and if so, demands individual follow up and perhaps a pathology test.

Yet side stepping this final step in patient specificity is exactly what Blackmores seeks to do in mass managing highly specific, and very rare, potential eventualities.

Which brings us back to the grandiose sell being pushed in Blackmores promotion. Claims made in advertising are frequently not backed by evidence. 80 of 82 complaints pertaining to the relevant Advertising Code this year were upheld by the TGA. The two failed complaints were specific to competing companies.

Yet presently there’s no way to follow through and prosecute for non compliance with TGA demands to address false advertising claims. Readers may remember crook and homeopath Fran Sheffield smirking at TGA demands to publish a retraction of outrageous claims on her website. It is simply not cost effective to prosecute, according to the TGA. Indeed it is so cost ineffective, it is not judged to be in the public interest. Pages 130-131 of The Auditor Generals Report into the TGA and Complimentary Medicines, includes;

The TGA’s Advertising Unit is not aware of having successfully used the full range of sanctions, such as seeking a prosecution for breaches:

Due to the very low financial penalties currently available (a maximum of $6600 for individuals and $33 000 for corporations) for advertising offences in the Act and other investigative priorities for the TGA, it is not cost‐effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence for consideration of prosecution by the Director of Prosecutions …

It has never been cost‐ effective for the TGA to initiate a formal investigation of an advertising breach with a view to preparing a brief of evidence.

The size of penalties attached to criminal offences may also mean that it is seen as not in the public interest to proceed. This view is consistent with legal advice provided to the Advertising Unit about specific breaches.

The TGA has also observed that “prosecution is currently the only available option where administrative requests fail to achieve compliance”. There have never been any cases that have been referred for prosecution action and accepted.

In 2010 a DoHA review found 90% of products reviewed were found to be non-compliant with regulatory requirements. The infamous 31 products selected at random yielded 68 breaches;

20 medicines had labelling issues such as non‐compliance with labelling requirements and/or breaches which may mislead consumers.
12 included incomplete and/or inappropriate information on the Australian Register of Therapeutic Goods (ARTG).
22 were found to have manufacturing and/or quality issues.
14 did not have adequate evidence to substantiate claims made about the medicines.

It is into this highly unsatisfactory environment the Blackmores Beast is born. Ken Harvey has written an excellent summary in addition to his Fairfax piece noted in the last post. Pharmacies to push supplements as fries and Coke to prescriptions is hosted on The Conversation.

In a change from Pharmacy Guild president Kos Sciavos being “personally thrilled” to announce the deal, it now also emerges;

The National President of the Pharmaceutical Society of Australia, Grant Kardachi, is meeting Blackmores this week and will seek an apology for the damaging and denigrating comments made about the profession of pharmacy.

Mr Kardachi said the “coke and fries‟ comment by Blackmores‟ Chief Executive was more than unfortunate and ill-considered.

One can only await further developments with interest.

In other news…

 The NPS have come out against the deal:

Whilst contravention of legislation has also been raised:

Guild & Blackmores “naive money-grubbing action”

Today’s Letters to the Editor in Fairfax’s The Age offer ample criticism and no praise for the Blackmores scam (see PDF below) outlined here recently. Pharmacist and health store proprietor, Ian Collins writes;

AS A pharmacist and health store proprietor, I find the guild’s action of linking with one company a most naive and money-grubbing action. To be forced to recommend one company bringing out a new range of products, whose composition has not been widely discussed and has no track record, is beyond belief. To attempt to give all people with blood-pressure problems, no matter what the cause, one formula, ignoring all other health factors, is incomprehensible.

There are so many other products from different brands that may be more effective, products with a history of being useful; why pick this small range of untried products? Maybe the answer is that complementary medicine is basically ignored in pharmacy degrees and very few pharmacists have the knowledge to discuss or ask the relevant questions regarding complementary products.
How embarrassing for pharmacists to be caught with their hand in the till.

Prominent Mornington skeptic Graeme Hannigan writes;

I AM a health consumer and am disgusted at this agreement. If it wasn’t enough that pharmacies credulously offer such quackery as ear candles and the good old magic water of homeopathy, the agreement with Big Quacka means that any lingering vestiges of trust in pharmacies has vanished. Pharmacies are putting financial objectives well ahead of the ethical treatment of customers.
All guild pharmacies should come with a health warning and advice to customers to wash off the snake oil after visiting their pharmacy. I trust the guild will also make available the results of the peer-reviewed randomised double-blinded clinical trials of Blackmores Companion preparations so customers can make informed choices.

In a comprehensive Opinion article, Dr. Ken Harvey digs for some evidence to back this caper, finding little more than a business deal. He writes in part;

So what is the evidence to support the use of Blackmores Companions products?

Its Biotic Companion contains the probiotic strain Lactobacillus reuteri, which is claimed to reduce antibiotic-associated bloating, flatulence and diarrhoea. The risk of suffering these side-effects is relatively low. There is some evidence certain probiotics may reduce the incidence of antibiotic-associated diarrhoea in some populations, but routine use is not recommended by medical authorities. In immune-compromised patients, occasional cases have been reported where probiotic organisms have caused serious blood-stream infection.

Anti-HT Companion contains zinc gluconate to complement use of antihypertensive therapy. There are occasional reports that such therapy may lower zinc levels, but I am unaware of any independent medical authority that recommends routine zinc supplements with antihypertensive drugs.

Stat Companion contains coenzyme Q10 and vitamin D3 allegedly to support statin use. Muscle pain occurs in about one to two patients in 1000 receiving statins, especially if a high dose is used. The evidence that coenzyme Q10 and vitamin D3 can relieve statin-associated muscle pain is not clear-cut and the evidence that taking these ingredients together with statins prevents muscle symptoms is even less clear. As a result, the routine use of CoQ10 and vitamin D in statin-treated patients is not recommended.

PPI Companion contains magnesium to aid use of proton pump inhibitors. There are only occasional reports of clinically significant magnesium deficiency occurring in the many patients receiving PPI therapy. If this rare problem is diagnosed, the recommended management is to stop the PPI. Routine supplementation with magnesium for all patients on PPIs is not recommended.
The fine print of the material Blackmores provides about its products states that if a nutritional deficiency is suspected, pharmacists should refer customers to their GPs for further investigations. I agree.

When the rare person develops a nutrient deficiency on a prescription drug, the evidence-based approach is to confirm the diagnosis objectively with a blood test, case by case, and then treat accordingly. Sometimes that might mean prescribing a supplement. There is some evidence to support that.

But what the Pharmacy Guild-Blackmores arrangement implies is supplementation en masse, in the hope nutrient depletion will be prevented. I am unaware of any good evidence to support that. More importantly, this deal unnecessarily adds to the ”medication burden” and financial cost that many elderly patients already struggle with when taking multiple drugs.

Debate over the lack of evidence to justify the move as patient, not profit oriented, was also reported in Pharmacy News. CEO of APESMA, Chris Walton observed;

We are deeply concerned that pharmacists are increasingly being asked to put their expertise and professional ethics aside by pharmacy owners more interested in making money than doing what is in the best interests of their patients

Blackmores promotional material

Blackmores’ black heart: Would you like lies with that?

One can be forgiven for wondering exactly how pharmacist members of The Pharmacy Guild of Australia, will keep a straight face when giving advice about medication.

Not that they don’t have the training to do so. Far from it. Which is what makes the money spinning deal to push Blackmores’ “companion products” to certain medications particularly galling. By it’s very nature this “Coke and fries” (to use Blackmores term) deal is predicated on pharmacists pre-empting doctors and making on the run diagnoses. Diagnoses that they aren’t equipped to make and that may also prove deleterious.

The scam works like this. Blackmores have identified key prescription medicines and isolated potential “nutritional consequences”. They’ve proposed a “companion product” to the prescription with scant regard to the fact that no standing recommendations exist. More so, research into this approach to supplements is both ambiguous and has revealed negative effects.

The four areas you should be terrified about are:

  • Proton pump inhibitors and magnesium deficiency with muscle cramps, vertigo, hyper-irritability, excitability and the inevitable poor concentration. But if you can remember where you’re going for long enough you can limp to the chemist, stagger from wall to wall and unleash your hyper-rage upon stock to ensure a swift diagnosis.
  • Antibiotic treatment, upset GI microflora and the need for probiotics helped along by icky stories of bloating, farting and diarrhoea. Fear not you gaseous, smelly, splattering assault upon polite society, for they have just the probiotic for you.
  • Anti-hypertensives and zinc deficiency along with poor immunity, poor appetite, impaired sense of taste and smell. Topped off with poor skin health (delayed wound healing), GI tract issues with the inevitable diarrhoea which compounds zinc deficiency. Can’t eat, can’t heal, can’t taste, can’t smell and you’re stuck in the toilet. There’s a plus in there somewhere but no doubt you need a zinc supplement.
  • Statins (cholesterol lowering drugs) and myalgia plus (get this) “muscle soreness”. Along with cramping, weakness and fatigue, you clearly need Coenzyme Q 10 and vitamin D3. What a pity you’re already too shattered to get out of bed.

Of course dealing with the nutritional consequences, may have… er, consequences. For example Blackmores go on to tell consumers, CoQ10 may:

• Have hypotensive effects in patients with hypertension and may have additive effects on antihypertensive medications

• Interfere with some types of chemotherapeutic agents. Use with caution

• Decrease the anticoagulant effect of warfarin

• Decrease blood glucose levels in people on hypoglycaemic therapy

Vitamin D3 may theoretically cause hypercalcaemia if taken with thiazide diuretics. Caution is advised in those with hyperparathyroidism, malignancies that increase serum calcium levels or other risk factors for hypercalcaemia. Zinc may decrease absorption and blood levels of tetracycline and quinolone antibiotics unless doses are separated by at least 2 hours.

Magnesium may decrease the absorption and efficacy of tetracycline and quinolone antibiotics, bisphosphonates and chlorpromazine unless doses are separated by at least 2 hours. If using [Blackmores’ probiotic] with antibiotics to which [Blackmores’ probiotic] is sensitive, separate doses by at least two hours.

This is enough to make you pause and think about chatting at length with your doctor. There’s a few other useless spooky observations that the (s)CAM industry simply rock at pulling off. Such as vitamin D deficiency being widespread and associated with poor CV health. Magnesium contributes to healthy teeth, bones, muscle/nerve function, electrolyte balance and normal energy metabolism. Myalgia is one of the most common reported adverse effect of statin use.

Many patients – particularly older ones – may already have poor nutrient intake… 1/3 of Aussies over 18 don’t get the RDI of magnesium. My favourite is the veiled suggestion GP’s aren’t capable of doing their job: “…the TGA have advised prescribers to be alert to hypomagnesaemia in people taking PPIs”. To which I can easily imagine Professor Farnsworth from Futurama saying, “Why yes… which is exactly why cowboy’s like you should stay the hell away from grown up science”.

With the help of Dr. Ken Harvey, who we know here from the SensaSlim saga, we can pin down the extent of frivolity being advanced by this joint venture. The statin claims are particularly bold, given side effects. Also, noting Wyman et al;

Some small clinical trials seem to show that coenzyme Q10 supplements can be used to lower blood pressure and to treat or prevent myalgia caused by hydroxymethylglutaryl coenzyme A reductase inhibitors (statins). However, larger trials are needed to determine if they are truly effective for these purposes.

On the topic of probiotics, The March 2011 issue of Therapeutic Guidelines Antibiotic, states;

There is some evidence that prophylactic probiotics reduce the incidence of antibiotic-associated diarrhoea but the appropriate combination of agents has not been established, so probiotics cannot be recommended for routine use. In immune-compromised patients, occasional cases of probiotic-associated bacteraemia have occurred

Regarding zinc and magnesium supplementation there is no standing recommendation for use with anti-hypertensive therapy and PPI use respectively. As Farnsworth just reminded us, being on the lookout for symptoms is for trained health professionals. Blackmores’ hijacking of professional guidelines is just another trick for selling for the sake of it.

Consumers Health Forum of Australia chief Carol Bennett claims in Fairfax that the entire caper is unethical and urges consumers to demand evidence and report pharmacists who lean on fears. Geraldine Moses, who is a drug safety researcher reminds us of the folic acid related seizures epileptics sustained after taking a supplement to combat the reduction in folate specific to epilepsy medication.

Today The Age reported;

PHARMACISTS have been accused of putting money ahead of patients’ interests after striking a controversial deal to market dietary supplements with prescription medicines.

The Pharmacy Guild of Australia, which represents 94 per cent of Australia’s 5200 pharmacies, has agreed to start recommending a range of Blackmores products to patients when they pick up prescriptions for anti-biotics, blood pressure drugs, cholesterol medicine and proton pump inhibitors.

Last week, Blackmores chief executive Christine Holgate told Pharmacy News the deal meant they could provide ”the Coke and fries” with prescription drugs while providing pharmacies with ”a new and important revenue stream”.

Her comments prompted sharp criticism from doctors and consumer advocates who said it risked turning pharmacies into McDonald’s-like businesses that push products onto patients who do not need them. Under the deal, when a prescription is filled, a prompt in the pharmacist’s computer system will remind them to discuss a particular Blackmores product that has been designed to offset possible side-effects of their prescription drug.

[……]

Australian Medical Association president Steve Hambleton said the move was outrageous and smacked of commercial interest rather than clinical need.

He said he did not know of any solid evidence backing the combination of dietary supplements with the prescriptions included in the deal. ”I think the evidence for Coke and fries is about the same as the evidence for these products,” he said. Dr Hambleton said the recommendations had the potential to confuse patients, who should trust their doctors to prescribe them what they need without any conflicts of interest.

Geraldine Moses, a drug safety researcher and pharmacist based at Brisbane’s Mater Hospital, said she was concerned about the deal because of good evidence that the more drugs a person took, the more likely they were to have adverse reactions and interactions. She said while Blackmores may have evidence showing that prescription drugs reduce particular nutrient levels and that their supplements increase those nutrient levels, it was incorrect to presume that replenishing those levels was the right thing to do.

Outrageous, unethical and potentially dangerous according to experts. This is undoubtedly a grab for money targetting a demographic that is unable to afford trumped up scams with potential risks. Given the appalling performance of the alternative product industry in the recent Auditor General’s Report and concerns raised about regulation of same in the TGA Transparency Review in July, the Pharmacy Guild should be ashamed of itself.

I wish Professor Farnsworth could get a piece of them.

The Polio Crusade

For an American citizen, Meryl Dorey, president of The Australian Vaccination Network pays scant attention to her homelands recent history.

The tragedies caused by polio were fierce and unrelenting. ‘‘It was an atmosphere of grief, terror, and helpless rage,’’ remembered a nurse who worked on the medical wards at a Pittsburgh hospital. ‘‘It was horrible. I remember a high school boy weeping because he was completely paralyzed and couldn’t move a hand to kill himself. I remember paralyzed women in iron lungs giving birth to normal babies.’’ [….]

Four of the boys got polio that summer. One day no one could find our head counselor, Bill Lilly. He took what happened to those boys pretty hard. The police were called and, after they searched all around the lake, they found that Bill had hung himself from a tree – hung himself. We were all huddled around the beach when the police came to tell us. I’ll never forget it.’’ [Source]

As is plain in the video below by 1950 33,000 polio cases in which 50% affected children under 10 were reported. Whilst it was uncommon to catch, remote to be injured by, and extremely rare to die from polio, Americans feared it almost as much as the atomic bomb. As one who claims vaccination had no impact on polio at all – personal hygiene, public sanitation, clean water and mama’s apple pie eliminated vaccine preventable diseases – this video holds a surprise for Meryl Dorey.

In the post war years clean water and public sanitation meant less prevalence of a milder, wild type of polio virus. Previously maternal antibodies and/or exposure to this wild type from very young ages had equipped the young with sufficient immunity. Polio is taken in orally and water or vapour are it’s most common mode of infection. In a more prosperous America exposure was occurring later in life, particularly during summer months. The virus itself was more virulent and within a few seasons was also striking adults severely.

In a nutshell, as described by eloquently by Dr. Paul Offit, as sanitation improved exposure occurred later and cases rose. And so pfft! goes another well worn antivaccination lie, recently peddled by Viera Scheibner on Sunrise TV.

Of course today, anti-vaxxers carry the burning Stupid as a beacon to light their way and tend to blame almost any outbreak on vaccination. Indeed only a day or so before the video below aired, Meryl Dorey refers to this viral polio outbreak in China as “vaccine associated polio”, blaming the vaccine. Even worse, she linked to the same article as here, which kinda informs the reader by paragraph two. Even worse… well no, actually so incredibly stupid it hurts to comprehend, Dorey thinks the file picture is an account of it’s own as to what’s happening. I shag you not. She writes;

What type of vaccine do they use in China – is it oral or injected? The picture looks like someone getting oral in which case, that is most likely where the outbreak is coming from

That’s our girl! “Australia’s leading expert on vaccines” looked at the picture.

A member of her Facebook page decided to point this out. The brave Emma Hill was banned, her comment deleted to make room for vaccine blaming and business briskly resumed. Meryl hates suppression of dissent or impinging on free speech as she often opines. She just has a unique way of showing it.

Pre Ban Hammer

Post Ban Hammer

As Emma notes the outbreak is caused by WPV1 spreading from Pakistan. But in defence of Meryl, we’re now getting into facts and that just won’t do. So, back to 1950’s America.

This doco looks at the impact of increasingly devastating outbreaks, infantile paralysis, the quest for a vaccine under Jonas Salk and the development of government quality control following the Cutter Incident. As documented well, also by Dr. Paul Offit poor quality control led to live virus vaccines being distributed and consequent infection in some cases.  Program centres around Wytheville in the US.

Enjoy…

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