The Peddlar, the Minister and the Inspector

Justice Zondi’s careful and deliberate judgment in the Cape High Court case brought by the Treatment Action Campaign (TAC) and South African Medical Association (SAMA) against Dr Matthias Rath and others, has several interesting consequences.

The main issues in the case were whether or not Dr Rath had been conducting unauthorised clinical trials, whether or not he was selling a medicine (or a foodstuff), and whether or not he had been publishing misleading or false advertisements.

The results: Dr Rath and others had been conducting an unauthorised clinical trial and were interdicted from carrying out studies in South Africa; they were selling a medicine and not a foodstuff as they had claimed (and were “selling” it as defined by the Medicines Act); and that the Medicines Control Council (MCC) would have to assess the advertising claims of Dr Rath’s Vitacell product.

There are gaps that were not and could not have been addressed by the judgment. The first of these is why the Department of Health Inspector, Lionel Snyman, was prematurely pulled off the job of inspecting Dr Rath and his activities. Speculation that he had recommended that Dr Rath be arrested, or that he had uncovered possibly embarrassing information, is not unreasonable.

André du Toit, a manager and co coordinator of law enforcement activities amongst other duties for the national department of health, was apparently appointed in Snyman’s place. Judge Zondi found du Toit to have not “sufficiently” investigated the matter of Dr Rath’s carrying out unauthorised clinical trials. Inspectors from the Department of Health are appointed by the Director General in terms of the Medicines Act and answer directly to the DG. An anomaly is that these inspectors are seemingly not obliged to report to the MCC itself. Judge Zondi’s judgment states that neither the DG nor Mr du Toit furnished information as to the nature and extent of the investigation carried out by du Toit. This is rather disturbing.

Towards the end of 2005 the then Registrar of the MCC, Dr Humphrey Zokufa, had promised to make the results of the investigation into Dr Rath’s activities available to the media within six weeks following a request which had been made for them. I do not know if this ever happened. However as the DG was the senior official, the promise made by the Registrar may well have not been honoured.

There are several complementary medicine products on the market that have been tested on human beings in South Africa seemingly without obtaining the required authorisation. Judge Zondi referred to a definition of clinical trial that was used in the Supreme Court of Zimbabwe in 2002. He did not accept that a “clinical pilot study” was not a clinical trial, but indicated that in characterising it as such, Dr Rath and others appeared to have been attempting to escape liability for their own widely proclaimed conduct.

The Minister of Health wrote that she would “only distance myself from Dr Rath if it can be demonstrated that the vitamin supplements that he is prescribing are poisonous for people infected with HIV.” She was probably using the word “prescribing” generically as it appears Dr Rath is not registered to practice in South Africa, and may therefore not prescribe medicines here. Poison(ous) is a word which has previously been used in South Africa to describe antiretroviral medications. I can find no record of anyone making assertions that Dr Rath’s vitamin supplements were “poisonous”. But by then there were already allegations of his conducting an illegal clinical study, and of undermining government’s own HIV and Aids comprehensive care, management and treatment plan, which includes the provision of antiretroviral therapy to the public sector. Will the Minister now distance herself from Dr Rath, seeing that he has been found by a court of law to have unlawfully been conducting a clinical trial?

The judgment has determined that the vitamin supplements referred to are a medicine (and not a foodstuff) in terms of the Medicines Act, and that the claims made for them are to be assessed by the MCC before they can be advertised. The judgment leaves it up to the MCC to decide whether or not Dr Rath’s products should be registered, and/or whether they should be scheduled.

Although guidelines are not law, the MCC’s own published guidelines (www.mccza.com) state that any product containing a scheduled substance is liable for registration. The judgment confirmed that Dr Rath’s product Vitacell contains a scheduled substance: N-acetylcysteine, which is a Schedule 2 substance. This means that it cannot be made available in an open shop, but only in a pharmacy or a registered health facility. The MCC should not have much difficulty deciding that Dr Rath’s Vitacell is liable for registration according to its own guidelines, even though Judge Zondi does not think it needs to be registered.

Judge Zondi however does not distinguish between a medicine and a “substance”. Individual substances are scheduled; medicines fall within a schedule according to the substances contained in them. Most medicines contain combinations of active and inactive ingredients or substances, some of which may be scheduled. Scheduling determines where a medicine may be sold, whether or not a doctor’s prescription is required, whether a substance is subject to special controls, or whether a substance may not be made available at all (“banned”).

The MCC may well have to reconsider its 2002 Complementary Medicines “call up” and issue another call up of products that are liable for registration, possibly based on their purported “use”, as Judge Zondi makes explicit. After six years there appears to have been little progress in either auditing or registering complementary medicines. There has instead been an explosion of products onto the market — and, as previously pointed out, no one is independently checking even the quality of these products, let alone the claims made. If what’s in a product is unknown, then clearly no statements can be made about its safety or efficacy. The medicines regulatory system in South Africa has unfortunately been an abysmal failure in controlling complementary medicines. According to Judge Zondi’s judgment, the MCC does not decide what is or is not a medicine. This is laid down in law. If someone is selling what they call a “nutritional supplement” which has any claimed medicinal use, and if they do not want it to be considered a medicine, they will have to go to court for a decision.

As far as the registration of complementary medicines goes, the DG seemingly pre-empted the judgment and the MCC’s decisions in November last year by telling the health portfolio committee that complementary medicines do not require registration.

What is the fuss about registration all about anyway? It’s really quite simple. It means that, in order to protect the public, an applicant who wants to register a medicine has to show that it meets requirements for quality, safety and efficacy. In other words evidence must be provided that the medicine contains only what the applicants claim it contains; that it has been shown to be safe in human beings at least in small scale studies; and that the medicine does what it is claimed it does. Just because a product is sold in a pharmacy or in a health shop does not necessarily mean that anyone has checked that the product meets any of these criteria. Registration also means that the scheduling, packaging, labelling, package insert, patient information leaflet and pricing all conform to the requirements in the Act.

If the judgment is taken to its logical conclusion and applied to the market, it surely means that every complementary medicine which makes any kind of medicinal claim in its advertising must now submit these claims to the MCC for review. The definition of “advertisement” would be that found in the Medicines Act. The judgment could also mean that the Advertising Standards Authority (ASA) does not in fact have the authority to make decisions about medicines’ advertising, as it is a function of the MCC in law. The ASA does not anyway have the medical or scientific capacity to assess claims made in medicines’ or health products’ advertising, so this ruling (if my interpretation is correct) should be welcomed.

The confounding factor in all this is that the Medicines and Related Substances Amendment Bill was introduced into parliament on 17 June 2008. If accepted, the MCC would be abolished and in its place a “health products regulatory authority” created. The amendment could possibly wipe the slate clean for the new regulatory authority by removing the accumulated six year backlog of tens of thousands of complementary medicines, the claims of which have not been reviewed. This is where Judge Zondi’s judgment may hold particular relevance. Does he, by implication, hold Minister Tshabalala-Msimang and DG Mseleku responsible for ensuring that advertising claims made for all medicines are submitted to the MCC for review? Is this possible in the MCC’s remaining lifespan, should the proposed amendment be passed? Could a concerted effort to determine the registrability of the complementary medicines on the market, and sufficient review of their claims, be the last great task (dying gasp?) of the MCC?

One of the most important changes of the amendment bill is that it would incorporate and regulate those foodstuffs and cosmetics that make “medicinal” or “health” claims. The proposed definition of a (health) product in the amendment bill appears to merely replace the word “medicine” with “product”. This broader definition would include “nutritional/dietary supplements” that make any health claim. The public should then benefit by knowing that any health claims made will have been reviewed to ensure that they are not false or misleading, and (finally!) be able to make an informed choice about their purchases. This is not the case at present, as no one is independently or proactively checking that all advertising claims for complementary medicines are neither false nor misleading.

It seems that all peddlars (unscrupulous or otherwise) of health products (dubious or otherwise) should in the mean time produce evidence for the claims made for their products and submit these to the MCC for review. The Minister should expedite this process. This could mean appointing assessors trained to scientifically evaluate the claims made, and who would then present their recommendations to the MCC. (This presupposes that for many products on the market such evidence even exists.) In addition, inspectors should be enabled to seize products that make advertising claims where these claims have not yet been reviewed by the MCC. If so, would ensuring this also be part of the Minister’s or DG’s responsibilities?

In summary, what is clear to me from the judgment is that authorisation is required in order to conduct a clinical trial; the definition of a medicine as stated in the Medicines Act cannot be decided by the MCC or anyone else but can only be disputed in court; and advertising claims of medicinal products should be reviewed by the MCC.

It is possible that Judge Zondi has done the citizens of our country a huge favour in tightening up the implementation of controls over medicines. Peddlars, no matter how smooth-talking, Ministers, DGs and inspectors are not above the law.

But a glaring unanswered question lingers — why was Lionel Snyman taken off the Rath case?

(These are my personal views and I do not speak for my present employers or as a former member of the Medicines Control Council. I have no working relationship with “Health-e news” whose excellent records I have drawn on, nor TAC who provided access to the judgment on their website, and I do not have any specific relationship with any part of the pharmaceutical industry.)