Dr Glen Warner, Oncologist

In an editorial on 19 September 2014, Business Day warned against dealing emotionally with the Medical Innovation Bill (MIB) which seeks to allow practitioners to innovate when treating diseases like Cancer. Doubt was expressed on the need for the Bill.

Cancer certainly evokes powerful emotions, not just from those of us who have it. 101 000 South Africans are diagnosed with Cancer each year. 60 000 of them die. One can neither disparage nor discount the emotion, pain and suffering of their families.

 

But the heroic parliamentary performances of the dying Dr Mario Ambrosini, the initiator of the MIB, attest to selfless courage, high-minded ideals and the fact that he did not wallow in emotionalism. This is not an emotional Bill.

 

It was birthed by the dialogue of two dying men. In February 2014, Mario and I made a Valentinian pact to use what was left of our lives to save others, where we could not save ourselves. Our quest struck a chord with South Africans. Echoing the public response in England to Lord Saatchi’s Bill, 92% of those canvassed support the MIB.

 

Around the world, the field of Cancer treatment is moving too fast for regulators. South Africa’s Medicines Act, which allows practitioners to apply for exemption to prescribe as yet unregistered treatments, is fifty years old. It harks to an era in which everything was prohibited, except that which was specifically permitted.

 

Exemptions, valid for six months only, must be approved and renewed in writing. In most cases, there is insufficient time. Already the Medicines Control Council is battling a backlog of some 3 000 pending applications. And the Council is soon to be superseded by the South African Health Products Regulatory Agency, which is dominated by commercial interest and intent on hegemony.

 

Compare this to the European Medicines Agency, which began evaluating 79 applications in 2013 and 95 in 2012. All EU Regulators have 210 days to make a marketing authorisation recommendation on a new drug. Dread indications such as Cancer, Ebola and HIV are fast-tracked. There is 25 – 40% reflection rate.

 

 

Without innovation, the status quo fails patients. Even with its massive National Health Service, England proves this point. Overwhelming public support for the Saatchi Bill is in part because the total number of patients with rare Cancers exceeds the number of new cases of top 4 Cancers in the UK every year. There are few new treatments and a dearth of clinical trials.

 

For rare diseases there are few if any randomised trials. We have exhausted the standard treatments of an already exhausted paradigm. The three ugly sisters of radiotherapy, chemotherapy and surgery are out-dated and unaffordable.

 

Yet we ignore the financial orphans of evidence-based medicine, such as stem cell therapy, TCM, Vitamin C, sodium bicarbonate, ketogenic diet, Gerson regime, dendritic cell therapy and others. Some 300 innovative treatments have been vilified, banned and made illegal, yet show signs of success. Laetrile is a good example.

 

The MIB proposes innovation while retaining scientific integrity. The electronic age enables instantly shared open-sourced and transparent data collection, in which innovative interventions can be registered. This kind of repository has been undertaken by Oxford University in respect of Saatchi. It could be done at any South African university.

 

Based on the apartheid paradigm, the Medicines Act of 1965 calculatedly excludes the majority of South African patients and healers. It has spawned a cascading cacophony of contested regulations, each with its own stultifying effect on innovation, reinforcing the unequal distribution of power and marginalising traditional healing and traditional medicines.

 

The Supreme Court of Appeal has affirmed that traditional healers and conventional physicians rank equally at law. Yet the current legal framework discriminates against traditional pharmacopeia. Moreover, the latest raft of regulations restrain the rights of our friends in the BRICS countries, depriving us of the massive ancient pharmacopoeias of China, India and Brazil. This violates bilateral treaties and constitutional prohibitions against discrimination.

 

In practice, there is no integration or innovation adopting traditional pharmacopoeias. Traditional healers have been left out of the debate entirely, in obeisance to a system that Linus Pauling described as not being science at all, but “based on science”.

 

Jonathan Yan explains the Western technique of producing synthetic or inorganic compounds to treat illness. Trial-and-error screenings and clinical experiments eliminate compounds based on their efficacy and side-effects. Yet they fail to eliminate unpredictable long-term side-effects, and often eliminate safe and effective compounds because results were not sufficiently spectacular. The problem, says Yan, is “the absence of a fundamental theory for relating the ideas in the head of a chemist to natural principles”.

 

Dr Ambrosini used Cannabis oil because of its extraordinary efficacy in lung cancer. The American Association for Cancer Research published recent research from Harvard University showing 60% reduction in tumour size using cannabinoids in rodents. This is remarkable by any measure.

 

The MIB affirms our Constitutional right to that last bastion of individual sovereignty: our bodies. Logically this must include the manner of our death. Healing has its origin in the Paracelsian patient/physician paradigm, which in Europe has been affirmed through the courts as inviolable.

 

If the worldwide trend towards legalization of Cannabis is not adopted in South Africa, its prohibition will be constitutionally challenged in litigation next year. It cannot rationally be argued that it is justifiable in an open and democratic society to prohibit Cannabis, which does a great deal of good, when alcohol and tobacco are legal fuel to the flames of crime and disease all over the world.

 

Legalisation of Cannabis diminishes crime, as proven in Uruguay. In Mexico legalisation in certain American states has reduced the price from $250/kg to $25/kg.

 

Criminalization simply drives up prices.

 

From legalisation in January 2014 to May 2014, Colorado recreational Cannabis sales were about R1bn and medical Cannabis sales closer to R2bn. First year sales are expected at over R10bn yielding tax of R1.5bn.

 

In South Africa, legalisation would generate regional economic upliftment, as neighbouring states follow suit. Crime would drop. Trafficking would cease. Rural prosperity, employment and tax revenue would increase. But if the nettle is not grasped, these benefits will go by default to other countries.

 

Industrially, Cannabis is a wonder product, native to South Africa. A multiplicity of fabrications abound, from bricks to blouses. Right now it is considered superior to graphene as a micro-thin conductor for supercomputers. Graphene won the Nobel Prize a year ago.

 

With 14 million people contracting cancer each year, the foreign revenue prospects for a producer country like South Africa are enormous. Furthermore the cost is blessedly miniscule compared to the cost of chemo. It is simply a bonanza in the offing. Its legalisation should certainly be based on evidence and not emotion. Parliament is rightly alert to the mood of the nation.

 

The scandalous cost to health of evergreening aged patented products was graphically demonstrated in the recent Supreme Court case in India of Novartis, where the court came down for health over wealth. The generic cancer drug is $177 – $266, whereas the patented product is $2 666.00. South Africa has a barely nascent generic industry, for want of innovation.

 

Viable rural-based models for a national Cannabis grower plan can readily be drawn from the Zimbabwe tobacco auction floors and the Dutch flower markets. Dollar denominated international markets would create employment via strong grading and application skills as well as secondary industries, scientific capacity and technology.

 

Legalised, a Cannabis industry could largely be regulated like the wine industry. Minimal State involvement is called for and this would incept largely at the level of tax collection where regulation and enforcement actually make money. The 99% of drug enforcement budget presently applied to Cannabis prosecution could be redeployed to combat dangerous drugs.

 

South Africa cannot afford a National Health System whilst ignoring innovation. Without innovation there cannot be integration of conventional Western and traditional medicine. Without this, there can be no National Health System even at the primary care level. What we have now continues to serve only the same narrow interests as the apartheid-based 1965 Act.

 

Even in England, whose NHS is considered the world’s third largest institution after the Chinese Army and Indian Railways, innovative steps have been found to be necessary. In Mali, there are 14 000 Chinese clinicians deployed to develop community health systems incorporating TCM.

 

Lord Saatchi’s Bill, supported by over 18 000 doctors and patients, creates a central open-sourced data repository which is accessible to doctors and patients alike. The MIB takes the same path. In this system a novel hypotheses for new studies incorporating traditional healing practices will herald a paradigm shift towards integration that might even improve Randomized Controlled Trials and provide a balance between evidence-based medicine and responsible innovation.

 

Sir Austin Bradford Hill, a godfather of clinical trials, said in 1966, “Any belief that the random controlled trial is the only way would mean that not only had the pendulum swung too far but that it had come right off its hook”.

 

Supporting Saatchi’s Bill, Lord Chief Justice Woolf MR said, “Doctors are frightened to try something not yet fully tested even when their patients give consent and even when… they face certain death if standard procedure is all that is on offer. It can take 15 years and £1bn to approve one drug. The patient as the person most affected must decide”.

 

Another supporter of Saatchi’s Bill is Professor Michael Rawlins, President of the Royal Society of Medicine and head of the National Institute for Clinical Excellence.

 

The MIB proposes a recalibration of the entrenched culture of defensive medicine by permitting safe and responsible innovation in a simple way. This should, of course, incorporate other great healing traditions of the world without creating new bureaucratic burdens on an already incapacitated health infrastructure.

 

Business Day’s 19 September editorial was unjust. There was ample opportunity to challenge Dr Ambrosini before his death. The Bill was tabled on 18 February 2014 and over 1 900 submissions were received, predominantly supportive.

 

Why present your readers now with a deductive argument, wherein the truth of a premise equals the truth of the conclusion, on a matter as important as this? It is intellectually unfair to presume upon the cognitive capacity of readers in this fashion.

 

Your opening premise is common sense; that emotion is a bad reason to make law. But this proceeds to an untenable, and frankly insulting, false premise that Parliament is legislating to foster an emotional legacy. That is far from the truth.

 

In the words of Voltaire, “Don’t let the best be the enemy of the good”. Back the Bill.