By Keir Liddle
The Burzynski clinic has been receiving a great deal of attention from skeptics of late due in no small part to the actions of a purported representitive of the Burzynski clinic Mark Stephens. Stephens has been threatening bloggers with legal action for their posting of their doubts about the efficacy of antineoplasteon therapy and their ethical qualms about the substantial amounts of money the clinic charges patients to undergo treatment.
Stephens would do well to consider that the questions raised over his legal threats in the context of Texas Law (where it is a third degree felony to impersonate a lawyer) and in the wider context of various states legislation relating to SLAPP (Strategic lawsuit against public participation) which while this doesn’t seem to now apply in Texas there might be those looking for a test case to introduce it…
Rather than silencing criticism this has had exactly the opposite effect and prompted a Streisand effect with numerous skeptical and medical bloggers now exploring various aspects of the clinics practices and the lack of credible evidence supporting the efficacy of antineoplasteon therapy. It has also prompted a skeptic letter writing campaign to the Observer newspaper for uncritically publicising Burzynski.
One of the best posts to emerge critically examines the claims made in the Burznski movie and is highly recommended reading. While another blog lists the tragic outcome for many of those who fought long and hard against cancer and to raise funds to undergo treatment at the clinic.
Stephens actions have prompted many skeptical bloggers to weight in on the subject of Burzynski and we at the 21st Floor are also playing our part by analysing Burzynskis available published research and petitioning the clinic to release all the anonymous data it has gathered in it’s thirty plus years of activity.
However on top of all this activity one tweeter last night raised the possibility that Burzynski, or at least those promoting his treatment in the UK, might fall foul of UK legislation.
The Burzyski Clinic would not be able to claim to treat people using antineoplasteons in the UK under the Cancer Act (1939) which prohibits the advertising of such claims (though the act as published online is still being updated). It is not entirely clear whether the rash of recent charity websites that support the claims made by the clinic fall under the remit of this act.
However they may well fall under the remit of The Medicines (Advertising) Regulations 1994 particularly those claims made uncritically in newspapers in support of these charitable campaigns. While I would be very wary of the impact and stress caused by taking the charities themselves to task over this (I can see little justification in causing potentially great amounts of psychological harm to vulnerable families and patients over this) the act might be useful to quote in correspondence with newspapers running stories on the clinic and antineoplasteon therapy.
The act came into force in 1994 and section nine states:
9.—(1) Subject to regulation 11, no person shall issue an advertisement relating to any relevant medicinal product which contains any material which—
(b)suggests that the effects of taking the medicinal product are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another identifiable treatment or medicinal product,
(c)suggests that health can be enhanced by taking the medicinal product,
(e)is directed exclusively or principally at children,
(h)suggests that the safety or efficacy of the medicinal product is due to the fact that it is natural,
(l)mentions that the medicinal product has been granted a product licence.
Now if it is adjudged that the websites and articles relating to the clinic and antineoplasteon therapy qualify as adverts than the above section in the act (at least) poses some difficult question for those regurgitating the clinics claims.
The Medical Health Regulatory Agency (MHRA) offers the following advice for journalists and patient groups:
There are a number of legal safeguards on advertising medicines intended to protect public health. These apply to materials which fall within the definition of an ‘advertisement’, which broadly speaking is anything “designed to promote the prescription, supply, sale or consumption” of a medicine.
The safeguards include a ban on advertising medicines which have not been granted a marketing authorisation and on advertising prescription only medicines to the public. They also state that advertisements must present medicines objectively, without exaggerating their properties and that advertisements must not be misleading.
The key point is that these controls (and the penalties for breaches) apply to any person who promotes a medicine – not just the manufacturer. This can potentially include newspaper or magazine articles or information disseminated by a patient organisation.
The European Court has ruled on whether a third party organisation or individual who disseminates such materials falls under the remit of the law:
The Court held that under European law “dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising …, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product”.
The Court reaffirmed that any person could be viewed as promoting a medicine and proof of a commercial link to the sale of the product was not required. The Court went on to advise that the national courts were best placed to decide on individual cases, balancing the right to free speech against the potential for damage to public health that the law is designed to protect.
The practical implications of this? Journalists should not actively encourage readers to seek a particular product from their healthcare provider and must take care not to exaggerate the potential benefits and the advice further states that:
Articles discussing healthcare issues, particularly medicines, ought to be factual, well balanced and accurate. Readers who may be suffering from a distressing and disabling condition are entitled to balanced and accurate information that does not raise false hopes or unnecessary worries about their treatment.
We should perhaps reappraise coverage of the Burzynski clinic and antineoplasteon therapy in light of the above information.