How should we regulate stem cell treatment?

South Africa’s inability to enforce its laws that govern stem cell treatments has resulted in a proliferation of bogus and unproven stem cell treatments being offered to many vulnerable citizens.

Stem cell treatment uses stem cells to repair and replace a patient’s damaged cells or tissues. There are treatments such as bone marrow transplants recognised to be safe and effective to treat blood or immunological disorderslike leukemia, myeloma and aplastic anemia. These have been performed for more than five decades.

But South Africa is one of several countries that has seen a sharp increase in the number of patients receiving unproven stem cell-based treatments. The medical community has raised concerns that these widely advertised treatments are potentially harmful, unproven and often fraudulent.

Many of these treatments are still experimental, which means there is no evidence that they are safe. The so-called success of these therapies is anecdotal or is based on self-reports from patients.

Stem cell tourism destinations

In the early 2000s South Africa was at the centre of a bogus stem cell treatment scandal, which drew international headlines. Biomark International, also known as Advanced Cell Therapeutics, claimed to be able to cure many diseases including spinal cord injury, multiple sclerosis and amyotropic lateral sclerosis.

More than 800 people allegedly paid exorbitant fees for largely unproven treatments. The case had legs in the US, the Netherlands and South Africa. One of the alleged perpetrators, Steven van Rooyen, who fled the US and continued his fraudulent activities in South Africa, is still on the list of most wanted fugitives of the US’s Food and Drug Administration’s Office of Criminal Investigations.

By 2012, researchers estimated that there were more than 700 clinics offering bogus treatments operating
mostly in developing countries such as Costa Rica, Argentina, China, India, Russia and South Africa.

These clinics had lured patients from industrialised countries, desperate to find treatments for their non-curable diseases. Other popular destinations for stem cell tourism included the Bahamas, Singapore, Mexico, Korea, Thailand, Barbados, Hungary, Malaysia, Japan and Thailand.

Success stories

Globally, the failure to contain bogus stem cell providers and enforce legislation is compounded by inaction and some complicity from governments and medical establishments.

The US, Netherlands and Ireland have, however, been effective in addressing the problem. This is largely because of strict regulations and protective measures which shield vulnerable patients from these operators.

Although most countries have legislation that governs research on human subjects, medical malpractice and licensing laws, some guidelines are not specific to stem cell therapy. While international agreements may help close this regulatory gap, some countries don’t accept or abide by these.

Media reports do, however, play an important part in addressing the problem. For example, a BBC documentary series several years ago revealed a lucrative trade in human fetuses. The fetuses were sourced from the Ukraine and sold to stem cell clinics in the Caribbean. This led to one of the major clinics, the Institute for Regenerative Medicine in Barbados being closed down.

Local enforcement lacking

South Africa has laws that govern the regulation and registration of human tissue, medicines, health professions and medical malpractice.

The National Department of Health provides guidelines on ethics in health research. This stipulates that all health research must be approved by a registered and accredited research ethics committee before the study begins.

In addition, the legal requirements to register medicines is governed by the provisions of the Medicines and Related Substances Control Act. Under this act, some types of stem cell therapy can be classified as biological medicine. This means that these products must be registered and undergo safety and quality tests before they can be used. This may include pre-clinical studies in relevant animal models.

But, in some cases, the prescripts of these laws are not exercised by practitioners and there is no enforcement. Stem cells are not registered as biological medicines and the treatments are not subjected to clinical trials or peer review by ethics committees.

Unproven stem cell therapies generally fail to comply with minimal legal, ethical, scientific and medical standards of safety and efficacy, which clinical trials set out to determine.

There is no national watchdog or regulatory body to monitor activities in the field, including patient safety and the ethical standards of healthcare practitioners.

The medical risks

As a result, patient safety is compromised. Patients who undergo bogus treatments face several risks. These include:

• not giving informed consent for the stem cell samples, which could then be used unethically without their knowledge;
• expensive therapy despite the accepted norm that experimental treatments should be free;
• no post-treatment care or follow-up monitoring to deal with adverse events;
• absence of patient registries;
• associated medical risks such tumour growth, immunological reactions or unknown long-term health consequences.

Patients should not be afraid to seek remedy if they are harmed. Registered healthcare providers who provide bogus treatments could face disciplinary action from their respective professional bodies. And disclaimers in contracts signed with bogus providers do not necessarily exonerate these providers from the harm they cause.

If South Africa’s laws and regulations governing the use of human tissue are not amended to close the regulatory gap that has arisen, stem cell tourism will flourish and legitimate stem cell research and its clinical translation will be jeopardised.

This article  based on a paper published in a special South African Medical Research Council Flagship edition of the South African Journal of Bioethics and Law.

This article is published in collaboration with The Conversation. Publication does not imply endorsement of views by the World Economic Forum.

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Author: Melodie Slabbert is Deputy Executive Dean and Professor of Law, College of Law at University of South Africa and Michael Sean Pepper is Director of the Institute for Cellular and Molecular Medicine at University of Pretoria.