The Dirty War Over Medical Weed: Fear & Loathing in Pharmaland

20 Jan 2017: ($) Billions of reasons why drug companies love and hate cannabis

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Far from being permitted in Australia, medical cannabis is now, thanks to some pretty duplicitous moves by the Government, even harder to come by (legally) than ever, as discussed on this website here,  here, and here.

Among the most daunting adversaries faced by those fighting for access to the drug however are large corporations bent on stopping the ‘botanical’ herb or its extracts from finding so much as a toe-hold among patients or the healthcare professions.

Simply, were this to happen, many businesses would see their bottom lines clobbered – and clobbered hard – based on data now trickling in from abroad while others view cannabis as an excellent chance to boost spoils.

Either way, it comes down to cash and depends on control of the market: ‘Big Pharma’, it seems, will stop at little to maintain its hold over both.

To better understand how this works and what gets campaigners so riled, we looked at a selection of newspaper reports and other documents, some recent, some historical, from this country and overseas – and what we found had us slightly concerned.

First of all, some background. The pharmaceutical trade is big in Australia – nearly $23 billion big in fact, and rising – a good chunk of that from government spending on drugs subsidised through the Pharmaceutical Benefits Scheme. This in itself isn’t news, though the Industry’s sheer size means executives get to move in – or come from – high places, spending a fortune on lobbying and political donations as the Sydney Morning Herald revealed in a piece back in 2010.

At the time, readers learned, ‘Big Pharma spends millions every year buying influence in Canberra’ but slightly more recently, in 2013, the ABC’s Ray Moynihan found himself equally troubled. It was ‘the unhealthy alliance between drug companies and regulators’, that bothered him as he called into question ‘secretive relationships’ between them and advisors to Therapeutic Goods Administration (the body that oversees the regulation of medical cannabis) daring the public to ‘imagine if the defendants being tried in our courts were directly funding our judges’.

Then, in 2014, the consumer group ‘Choice’ wondered ‘is your prescribed medicine really the best option?’ when it looked at the influence drug companies had on GPs. This was based on a survey it had done some years prior, and suggested firms spent more on marketing their products through ‘multiple channels’ than they did on research and development and that ‘drug marketing is known to influence prescribing.’

Their misgivings, it turned out, weren’t unfounded, since, after recent revisions to the Industry’s Code of Conduct it was widely reported in the Spring of 2016 ‘Drug companies paying doctors millions‘ with such spending unlikely to have been out of charity.

The story was derived from Medicines Australia, the powerful pharmaceutical trade and lobbying organisation which speaks on behalf of the country’s biggest drug outfits and, of necessity, works at the highest reaches in Government.

That same organisation, back in 2015, objected to the Regulator of Medicinal Cannabis Bill in a Submission to the Senate’s Legal and Constitutional Affairs Legislation Committee which was considering the matter. Had that Bill been enacted, as the Committee would later recommend, medicinal cannabis would have been overseen by a specialist body dedicated to regulating that drug alone, as seen in countries elsewhere. And it would have by-passed ‘normal’ procedures conducted by the Government’s existing medical regulator the Therapeutic Goods Administration mentioned earlier which experts had argued was completely unfit to look after something like weed, due to the plant’s composition. As it was though the Turnbull Government ignored such advice as well as the Senate Committee’s suggestion so it is indeed with the TGA medical cannabis now uncomfortably sits in what is becoming for many a policy farce. The reason is simple: the TGA and its frameworks, ideal for big Pharmabusiness are uniquely unsuited to cannabis which requires a sui generis approach – something Medicines Australia would have known all too well when the organisation said it:

Does not see a need for, and therefore does not support, the introduction of the Regulator of Medicinal Cannabis Bill 2014 to establish a Regulator of Medicinal Cannabis and a system of regulating medicinal cannabis that is entirely separate from the TGA,’ adding: ‘Pharmaceutical manufacturers of prescription medicines are subject to a strict regulatory regime to ensure medicines made available to the Australian public are safe, effective and of a high quality.’

Which is management-speak for ‘don’t try and play on our turf’.

But if all that provides the backdrop, when we get to specifics and the behaviour of particular firms things acquire a still darker hue.

Take Purdue and its ‘international wing’ Mundipharma.

In case you didn’t know, that’s the company that invented one of the world’s favourite prescription narcotics, OxyContin, credited as having played a major part in America’s current ‘opioid epidemic’, the worst in its history, which kills tens of thousands a year according to official statistics.

In 2014 the New York Times chirruped the below, in relation both to Australia’s hugely successful opium poppy trade and the drug which has grossed its owners around US$35 BILLION since its launch in 1995, even as thousands were dying as a result of using it or similar concoctions:

Nearly a half-century of assiduous plant breeding, a gentle climate and tight regulations have given Tasmania a hammerlock on production of one of the pharmaceutical industry’s most important raw materials,’ said the Times, continuing: ‘Tasmania, which is about the size of West Virginia, grows about 85 percent of the world’s thebaine, an opium poppy extract used to make OxyContin and a family of similarly powerful prescription drugs that have transformed pain management over the last two decades.’

Hold onto that thought, and bear in mind it was Australia’s compliance, or otherwise, to the UN Single Convention on Drugs which groups cannabis with substances like cocaine and heroin that provided the Government with another reason to hold back on making the plant available through a specialist, stand-alone regulator. Non-compliance with the Treaty may (they said – possibly) have had an adverse effect on its poppy straw trade, which, as the NYT says, is without any doubt the world’s largest.

Fast forward now to late 2016 when that paper’s namesake, the LA Times, blisteringly said about Purdue, a company that in 2007 was fined over US$634 million for lying to doctors and the public about the dangers of OxyContin, among the worlds most abused pharmaceuticals:

Prescriptions for OxyContin have fallen nearly 40% since 2010, meaning billions in lost revenue for its Connecticut manufacturer.’

And it continued:

So the company’s owners, the Sackler family, are pursuing a new strategy: Put the painkiller that set off the U.S. opioid crisis into medicine cabinets around the world.

A network of international companies owned by the family is moving rapidly into Latin America, Asia, the Middle East, Africa and other regions, and pushing for broad use of painkillers in places ill-prepared to deal with the ravages of opioid abuse and addiction.

That ‘network of international companies’ is called Mundipharma which has offices here in Australia.

They, and companies like them, spend millions fighting laws that would limit the availability of their powerful drugs as this article from Vice in September 2016 explains. And cannabis hasn’t killed anyone in its 5,000 years of known use.

All very nasty you may think, but poppy sales aside and ignoring the fact this country has, according to the LA Times article ‘seen U.S.-style problems, including criminal trafficking, addiction and death’ related to OxyContin, what’s the involvement with weed?

The answer, it turns out: quite a big one.

Purdue and others, you see, are frightened.

Why?

Because in the US, States where medical pot has been legalised, prescriptions for opioids are dropping. This isn’t ‘anecdotal’, its is based on 3 years’-worth of figures and was published in the American journal Health Affairs which also found further links between medical cannabis use and a drop in prescriptions for antidepressants, seizure medication, sleeping pills, anxiety medication and anti-nausea drugs.

So to fight back, Purdue and other similar companies fund anti-cannabis campaigns all over the US in an effort to stem legalisation, which, says The Nation, ‘threatens the bottom line of these special interests, which reap significant monetary advantages from pot prohibition that are rarely acknowledged in the public debate‘.

But trying to keep the herb on the statute books by funding anti-drug organisations (which tend tend to have little or nothing to say about addiction or death from prescribed medicines) isn’t the only way businesses go about thwarting the march toward accessing it.

As the article from Choice mentioned earlier points out, many drug companies, including Purdue/Mundipharma, also throw lots of money at patient groups that, says Choice, ‘can compromise the independence of the group and the information it provides.’

Which is interesting, since a look at Mundipharma’s Australian website reveals no fewer than 18 such groups (that it owns up to) or professional bodies in receipt of its benefaction. Of these nearly half either made Submissions to the Senate’s Public Inquiry into the Regulator of Medicinal Cannabis Bill in 2015 coming out strongly against it or have similarly positioned themselves in relation to cannabis use as a medicine.

One of them, PainAustralia – among several ‘cannabis-sceptical’ pain-related groups bankrolled by Mundipharma – even managed to annoy one of its board members by its outright hostility, causing the Honorouble David Ipp, a former High Court Judge, to write separately to the Senate Committee complaining about the fact.

But Mundipharma is by no means alone in this battle against patients accessing pot.

Insys, another major culprit in the opioid epidemic, is the purveyor of Fentanyl, the synthetic painkiller 100 times stronger than morphine and beloved of heroin addicts. The drug has made company founder Dr John Kapoor a billionaire but delinquents of some former executives (including its CEO) who were arrested in December 2016 for ‘conspiring to bribe doctors to prescribe a mouth-spray version of Fentanyl unnecessarily, potentially harming patients and defrauding insurers,’ according to Forbes magazine.

Insys, like Purdue, has been busy in the campaigning business as well, but with a twist all of its own: the company is working on various cannabinoid pharmaceuticals and has admitted legalising weed ‘poses a direct threat to its plans to cash in on a synthetic cannabis product they have developed,’ The Intercept reported in September 2013.

Its story discusses how the company donated US$500,00 to a group called Arizonans for Responsible Drug Policy which was trying to defeat a ballot to legalise pot in that State.

Though Insys said it made the contribution – the group’s biggest – to protect children, The Intercept found a disclosure statement filed with the US Securities and Exchange Commission which suggested something quite different.

If marijuana or non-synthetic cannabinoids were legalized in the United States, the market for product sales would likely be significantly reduced and our ability to generate revenue and our business prospects would be materially adversely affected,’ the company said in its filing.

For those interested, the synthetic cannabinoid medicines (Dronabinol and Cannabidiol) currently under development by Insys can be found here.

And a further story, this one about its partnership with the Victorian Government in clinical trials among children with seizures is on the State Premier’s website – no doubt greatly reassuring activists and patients who may now rest secure in knowledge the Administration is tucked up with such principled individuals as these.

The Guardian too did an exposé on such shenanigans, taking look ‘Inside big pharma’s fight to block recreational marijuana’ at the end of October 2016 and finding, like The Intercept, ‘Pharma and alcohol companies have been quietly bankrolling the opposition to legal marijuana, raising questions about threats to market share.’

But companies like Insys aren’t the only ones with designs on the market as a quick trawl round websites like Drug Discovery & Development and New Cannabis Ventures reveals – literally $ millions are now being thrown at what the smart money sees as a widening opportunity.

Among the world leaders in ‘cannabinoid therapeutics’ is the British firm GW Pharmaceuticals, makers of Sativex, the only approved cannabis-derived medicine in Australia and a company that, according to its website, wants to be ‘the global leader in prescription cannabinoid medicines, developing and commercializing pharmaceutical products which address clear unmet needs.’

GW is currently testing out (either successfully or unsuccessfully depending on which paper you read) another drug, Epidiolex – in essence a pharmaceutical-grade hemp oil, rich in CBD, the non-psychoactive ingredient of cannabis which has shown great promise treating epilepsy.

The drug has already annoyed some campaigners because, according to Associated Press, it is ‘complicating the medical marijuana debate in hospitals and (US) Statehouses‘.

GW is deeply embedded in Australia, having supplied bucketfuls of Sativex to researchers at Sydney University and involved itself in the much-vaunted NSW Clinical Trials of various cannabis medicines.

Unfortunately it has also been heavily mixed up in another trial, this one for cannabis addiction using its drug to offset withdrawal which is being run by a team from the Government’s main anti-weed organisation the National Cannabis Prevention and Information Centre. Upon the Centre closing its doors in late 2016, staff were quickly re-deployed to run another Government project, ‘Cannabis and cannabinoids for medicinal purposes: Reviewing the evidence’, covered here, which has enlisted some of the countries most prominent cannabis critics to write guidelines for doctors considering its use.

Not only that, over the last couple of decades GW has been extremely busy creating what New Cannabis Ventures calls a ‘Powerful Patent Portfolio‘, quoting the company as claiming its intellectual property includes:

60 patent families with issued and/or pending claims directed to plants, plant extracts, extraction technology, pharmaceutical formulations, drug delivery and the therapeutic uses of cannabinoids, as well as plant variety rights, know-how and trade secrets,’ from which it derives ‘353 pending patent applications worldwide.’

According to the Internet, the company has also done deals with drug giant Bayer which is trying to merge with Monsanto – a titan of GMO crops – causing much fluttering of fans among activists. ‘Signs Point to a Corporate Takeover of the Marijuana Industry by Bayer, Monsanto’ one breathy headline reads. Other more paranoid sites even fear the pro-cannabis stance of George Soros has more to do with his major stake in the latter company than it does his liberal ideas, though a deep and meaningful relationship with the Government of Uruguay where the herb is now permitted seems plausible.

The prospect of GMO cannabis was certainly disconcerting to the pressure group Drug Policy Australia which, in April last year warned the country had legislated for ‘100% GMO Biotech Cannabis not Marijuanaand spoke of ‘an Australian delegation traveling to Asia to look at GMO Cannabis with no THC, and in mid-2016 bringing the who’s who of the GMO Biotech Cannabis community to NSW for a conference.

However you dice it though, GW’s efforts to ‘own’ what could easily be grown in the yard requires, even demands, as ‘alternative’ author Ellen Brown puts it, that ‘the plant would need to be legalized but still tightly enough controlled that it could be captured by big corporate interests‘.

Which might sound familiar to anyone who’s looked at what Australia has done about cannabis.

Such a thought was, in any case, enough to prompt Vice magazine (again) to ask in 2016 ‘Is Big Pharma Out to Stop — Or Take Over — Marijuana Legalization?‘ with a piece that opens with a potted profile of GW’s founder, Geoffrey Guy – the ‘G’ in the company name.

Corporate interests were certainly in play though if we return for a moment to out friends at the NCPIC. The whole kit and kaboodle, according to the noted drug reform group Unharm came into being after staff at NDARC, the Government’s think tank on drugs, got together with Pfizer Australia, one of the biggest of Big Pharma concerns to create a Health Report which looked at the dangers of weed.

The Centre was Canberra’s response, but as the Wikipedia page on the matter puts it: ‘Many in the Australian community are concerned that this collaboration and NCPIC involvement with GW Pharmaceutical and Sativex places NDARC and NCPIC in a position of conflicted interests.

And the Medical Cannabis Users Association of Australia pressure group lists some of Pfizer’s many political donations and its funding of patient groups which, like Mundipharma, include various pain-related organisations and those dealing with arthritis – another condition for which cannabis has been found to be useful.

As if all of that wasn’t enough, hemp oil is being attacked too. The CBD-rich product, until lately believed perfectly permissible in many if not most parts of the globe, has recently been targeted by the American Drug Enforcement Agency which claims it’s an extract of marijuana – a ruling that looks set to be challenged in court, hemp growers insisting the Agency has overstepped its authority.

The DEA of course is informed of what should and should not be permitted by the Food and Drug Administration, a set-up notorious for being under the corporate thumb. Indeed, in a damning 2013 report from Harvard University, solid evidence was provided ‘to show that the FDA is nothing more than a pay-for-play front group that caters strictly to the interests of the pharmaceutical industry,’ according to the Natural News website.

Meanwhile, in Australia, CBD has been re-classified as a Schedule 4 drug, meaning it’s more difficult than ever to obtain. And Australian companies like Ecofibre have shifted operations to the US after the Government’s new medical cannabis regulations stopped it from growing its crops here – something it had been cheerfully engaged in for over 15 years. Stateside, the company freely makes its oil under a law known as the Farm Bill which they say protects it from the DEA but the Australian Government sees differently and and won’t let the stuff into the country, citing the Agency’s stand as its reason.

In contrast to all this, shares in Australian company Zelda Therapeutics ‘went nuts’ after it reported favourable results using cannabis oil to treat breast cancer. Shortly afterwards the firm announced further trials into the pancreatic variety, saying it would source its raw materials from AusCann, another Australian business with ties to the huge Canopy Growth Corps of Canada. Both companies – Zelda and AusCann – will operate under and comply with licences obtained from the Government’s Office of Drug Control set up to regulate the cultivation and import of medical cannabis as well as manufacture and research into products made from it.

This particular enterprise, naturally, is one that should be applauded – highly specialist drugs for illnesses such as cancer cannot come fast enough and seeing them developed in Australia is a good thing for all concerned.

But the fact the companies are able to move forward is an excellent illustration of what the Government actually meant when it said it had legalised medical pot – as opposed to what campaigners and the general public were led to believe they had got.

The Authorities, it seems, are more than happy to suck spoons with the likes of Insys and GW Pharmaceuticals and let firms like Zelda undertake research into cannabis medicines.  But they will not, under any circumstances, allow cannabis itself – raw, ‘botanical’ so-called ‘full spectrum’ weed or its extracts, replete with their hundreds of chemicals – anywhere near to the patient.

So campaigners are in something of a David and Goliath situation in which overwhelming public support and a sympathetic media are undoubtedly going to be of much help.  Are they enough though to overcome the might of a $ multi-billion industry with its eye on complete domination and not above dirty tricks?

PS (21st Jan 2017) We’re not drawing any conclusions here other than ‘what a small world’ but as one site user pointed out just after the above piece was posted, the Australian Prime Minister’s wife, Lucy Turnbull is Chairman of a biomed concern known as Prima. In 2015, the Company, which is ‘working primarily in the field of cancer immunotherapy’ according to its Wikipedia page, received ‘an undisclosed clinical milestone payment from its collaboration and licensing agreement with Novartis in relation to its antibody for cancer.’

And Novartis, a ginormous multinational referred to by Mrs Turnbull as ‘our partner in this space’ also, as luck would have it, happens to hold a licence from GW to sell Sativex. Just saying.

Such a ‘coincidence’ proves nothing of course and may have no meaning at all, still though, one can’t help but wonder what gets discussed during cocktail nights at the Turnbulls’ when ‘partners’ or ‘partners of partners’ hit town.

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