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Portia Wynona G. Soriano

123741

En12 – S02

October 9, 2013

Unproven Stem Cell Therapies, Available in Countries Near You: A Call For Stem Cell Tourism

International Regulation

Stem cell therapies are considered the “holy grail” in the field of medicine because stem

cells have the ability to self-renew and replace damaged or diseased areas in a body. As a result,

this kind of therapies have gained popularity and provided hope to patients with rare diseases.

However, other people saw it as an opportunity for business. According to Lesley DeRenzo,

through the internet, private-owned clinics advertise stem cell therapies directly to patients

without valid supports for their treatment. With this kind of market, these clinics lure patients

who have rare diseases to travel and try unproven stem cell therapies they are offering (888-9).

Thus, the practice of travelling overseas to try unproven stem cell-based therapies, which is

called stem cell tourism, became popular. Since treatments are unproven and untested, stem cell

tourism is dangerous. Furthermore, since stem cell tourism involves two countries, local

regulation is insufficient. Therefore, integrated international regulation of stem cell tourism

among countries is needed to avoid unwanted results.

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Risks of Stem Cell Tourism

According to Jill Hodges, Leigh Turner, and Ann Marie Kimball, risks of stem cell

tourism include significant financial burden, lack of therapeutic benefit, complications and

disqualification to participate in legitimate treatments under clinical trials.

Despite the fact they are unproven and untested, these treatments are very expensive. The

price ranges from USD 5,000 to USD 50,000 (Caulfield, et al. 255). By adding travel expenses

such as plane tickets, the patient needs a lot of money to undergo such treatments. Thus, stem

cell tourism causes significant financial burden to the patient. In connection to that, the treatment

having no therapeutic benefit also heightens the financial burden of the patient. The patient’s

money is just put to waste. One example of this is Barabara Pineu, a Canadian who spent USD

30,000 to receive stem cells for her atrophy in Shenyang, China. Carolyn Brown reported in the

Canadian Medical Association Journal (CMAJ) that Pineu’s multiple system atrophy continues

to progress despite the therapy (122).

From the same article of Carolyn Brown, one case involved a boy who developed spinal

and brain tumors after being injected with fetal neural stem cells in Russia (122). Also, another

instance was in Beijing, China where 400 patients were injected stem cells. Researchers found

out that most of the patients developed meningitis after the treatment (DeRenzo 889). Another

case includes a patient with lupus nephritis, a disease that attacks a patient’s kidney. After

undergoing stem cell therapy in Thailand, the patient developed lesions in his kidney (Cyranoski

997). Stem cell tourism can cause a lot of complications. Even though there are no systematic

reporting, complications from unproven and untested stem cell-based therapies include tumor

formation, cancer, meningitis, lesions and death (Caulfield, et al 255).

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Lastly, patients who underwent such treatments are consequently disqualified to

participate in legitimate treatments under clinical trial. According to Krista Conger of Stanford

University, the reason for this is stem cells used by these fraudulent clinics are hard to identify.

Krista Conger also stated that Irvin Weissman, MD, director of Stanford Institute for Stem Cell

Biology and Regenerative Medicine and immediate president of International Society for Stem

Cell Research (ISSR) said, “Failures of these unproven treatments will undoubtedly affect the

public and private support of legitimate stem cell science.” As a result, patients are disqualified.

Why is Local Regulation Insufficient?

Regulations are needed because they have the ability to set the standards in the society

and guarantee patients’ safety by encouraging them to avoid fraudulent clinics (McMahon &

Thorsteinsdottir, 35). Countries have set regulations regarding unproven and untested stem cell

therapies in their own boundaries while others don’t. Such countries that set regulations include

USA, Canada, and surprisingly, China. According to Insoo Hyun, patients seek these kinds of

treatments overseas because these treatments are not allowed in their home countries due to

political and religious reasons (188-9). Those statements show the gaps and cultural differences

among countries especially the degree of how much they are developed. As a result, patients who

were taken advantage of will have a hard time pursuing legal actions against the fraudulent

clinics from the other country with just local regulations.

From these cultural differences, it can be concluded that the kinds of stem cell used in

these therapies vary among countries. For instance, recently, it was reported three Filipino

politicians died and the Philippine Medical Association allegedly blamed this incident on the

stem cell therapy the politicians got from the same clinic in Germany where the use of animal
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stem cells is allowed. Unlike here in the Philippines, animal stem cells are not allowed. Local

regulations cannot void these differences.

Another problem with local regulations is they are not enough since stem cell tourism

involves two countries, the patient’s country and the country which offers the treatment. From

the start, patients travel to another country for these treatments because such treatments are not

allowed in their home countries. Carmel Shalev in her article “Stem Cell Tourism—A Challenge

for Trans-National Governance” states that “This [Stem Cell Tourism] is not simple, since the

wrongs occur outside the territorial jurisdiction of the state, so that creative forms of

transnational governance need to be developed (41).”

In “Stem Cell Tourism and Future Stem Cell Tourists: Policy and Ethical Implications,”

Edna Einsiedel and Hannah Adamson argue that another challenge is that some ministries under

the same government might have different goals and aims. One example that they cited is India.

India’s Council of Medical Research set thorough guidelines for stem cell therapies and on how

to register in clinical trials. According to Einsiedel and Adamson the ironic thing here is the

guidelines they set are in conflict with their goal to be a hub of medical tourism (43). That

statement shows local regulation can’t answer most of the problems posted by stem cell tourism.

It might be helpful but legal actions which the patients can take are limited.

The Need for International Regulation

Stem cell tourism’s kind of market has made it hard to be regulated by legal operations

(Caulfield et al 256). Through the internet, private-owned clinics advertise stem cell therapies

directly to patients without valid supports for their treatment (DeRenzo 888-9). Carmel Shalev

also asserts that:

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The market crosses national borders, and being private it can elude the

governance of internationally accepted medical ethics. The private market is not

conducive to the transparency and accountability that are required for oversight of

research ethics in the case of clinical trials or of patient care ethics in the case of

medical innovation (41).

With that statement, stem cell tourism calls for an international regulation to strengthen the

enforcement of internationally accepted medical ethics since regulations have the ability to set

the standards of the society.

Furthermore, scientists find stem cell research hard to regulate because of its

multijurisdictional nature. One study showed that the main reason why accepted standards based

on Science fail is the lack of international actions to check for the accountability, transparency

and ethical oversight (DeRenzo 895). This argument from DeRenzo supports and expresses the

need for not just local regulation but international regulation.

In her paper, “Stem Cell Tourism: The Challenges and Promise of International

Regulation of Embryonic Stem Cell-Based Therapies, Lesley DeRenzo concluded:

Further research should apply lessons learned from trade regulations and explore

ways that international trade and commerce laws can reward model stem cell

clinics and penalize rogue clinics that violate international regulations. Specific

areas to advance include: strengthening enforcement mechanisms, enhancing

border control techniques, establishing an international accreditation process, and

imposing sanctions on countries that detract from the promise of hESC-based

therapies (912).
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That statement not only applies to hESC-based therapies but to all stem cell-based therapies.

DeRenzo illustrates what international regulations can do and other points the community should

improve on. By implementing international regulations, fraudulent clinics can be easily avoided.

Moreover, having an international regulation has many other advantages. By having an

international integrated joint regulation, the gaps from legal, political, social, and cultural

differences among countries could be settled (Shalev 42). Other than that, it will be easier for the

patients who were taken advantage of and exploited to find legal assistance (DeRenzo 892). Data

gathering regarding these treatments would also be systematic. As a result, stem cell research

would accelerate and innovations will be made faster than before.

But who should set up and enforce these regulations? According to McMahon and

Thorsteinsdottir, the safety of the patients is the responsibility of the governments of countries

that offer these unproven stem cell-based therapies and also the doctors who should clarify what

benefits these treatments can give (35). By parallel reasoning, the governments and the doctors

should enforce these regulations (36).

Last June 25, 2013, there was a gathering in University of Sussex where countries such as

Russia, India and China discussed what could be done to stem cell tourism. This convention is

the first step forward of stem cell tourism’s international regulation. From the site of the

university, it was reported that Adrian Ely, lecturer in the Science Policy Research Unit of the

University of Sussex and chair of the debate, said that:

The discussions [among the countries] show that – despite their different

perspectives – there is clear agreement across a range of stakeholders that the

current state of affairs does not adequately provide for safe, just and mutually
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profitable exchanges in this area.  Bringing diverse groups together like this allows

us to explore potential ways forward.

As a whole, international regulation answers the problems with local regulation. In the

first place, stem cell tourism is an international concern so why solve it with local regulation?

Therefore, by having integrated regulation among countries, there will be fewer cases of

accident. In that integrated regulation, countries can agree on certain guidelines on when to

consider the treatment is safe and efficacious. As Insoo Hyun suggested, regulations should be

flexible and sensitive to the field it is governing. Regulations should allow innovations without

tolerating the malpractices in the said field (189-190).