The Tribune

By LARRY SMITH

IN one of his now infamous “Sith Lord” videos posted online, fashion mogul Peter Nygard is shown injecting himself with a hypodermic needle while exclaiming to awed onlookers at his Lyford Cay pleasure dome: “Ah, it feels so good – and you can see it’s working.”

That minute or so of hilarity demonstrates precisely what opposition leader Dr Hubert Minnis was seeking to convey in the current stem cell debate. It is the type of “science” that could be attracted to the Bahamas rather than the object of that science which concerns the good doctor.

Unfortunately, the growing public confusion over this issue has been fuelled by Nygard’s in-your-face involvement, which has turned the whole affair into a political circus. And as a result, politicians are sending conflicting messages. It also takes a lot of effort to focus on the complexities of the subject, and most of us do not have the time or interest for that. So here’s the score.

By all accounts, there is big money to be made in stem cell medicine based on unproven junk science treatments that target desperate patients and thrive in a lax regulatory environment. For example, in his search for the fountain of youth Nygard claims that “anybody whose body is at 60 years can get back to 25 years”. And at one point he was talking about establishing a stem cell facility in China.

But that doesn’t mean there isn’t a lot of good work being done by reputable scientists, and that includes age-reversing research. Commenting on a lab study earlier this year, Professor Danica Chen of the University of California said: “The question is whether we can understand the process well enough so that we can actually develop a molecular fountain of youth. Can we actually reverse aging? This is something we’re hoping to understand and accomplish.”

The difference between Nygard’s claim and Chen’s comment on longevity is clear.

But research in other areas of stem cell medicine is much further along. Treatments in cardiology, orthopaedics and autoimmune diseases have demonstrated remarkable benefits that have been proven out in clinical trials, though scientists still do not know exactly how stem cells work.

According to Dr Minnis (who is a former minister of health), “Stem cell science holds tremendous potential. Hope for revolutionary treatments and cures for myriad conditions have been held out. Does this mean that The Bahamas ought to become involved in this advanced scientific work? I am not convinced.”

Minnis doesn’t believe we can monitor and police this work to international standards, which could result in a tremendous publicity backlash against the Bahamas. He is also concerned that the government appears to be fast-tracking legislation simply to satisfy a financial backer who is on record as wanting to establish an age-reversing stem cell facility at his Lyford Cay home.

But the reality is we have been moving in this direction for some time. The previous administration, of which Dr Minnis was a part, began looking at these issues early in its term, with a view to establishing niche markets for the Bahamas in the lucrative and growing medical tourism industry.

In a five-year-old position paper, Dr Duane Sands (who is now deputy chairman of the FNM) wrote that “The opportunity to allow rigidly controlled introduction of therapies vetted and approved in other mature jurisdictions – but not yet FDA approved – can potentially create a cottage industry for compassionate treatment, supported in part by pharmaceutical and device manufacturers, in conventional hospital and clinic environments owned and operated by Bahamians.”

In fact, it was health travel that originally gave rise to our tourist industry. As one visitor wrote in 1900: “Nassau is so situated as to be an almost ideal health resort. It is near to the continent and has recently been made quite easy of access from thence...and its advantages... cannot fail of producing happy results.”

Among the medical tourism markets considered feasible for us are treatments that have been authorised in some developed countries but are still awaiting approval in the US. A second niche covers treatments that require long periods of rehabilitation, for which our environment is attractive. And a third covers procedures that patients might prefer to have performed abroad, such as cosmetic surgeries combined with a recuperative vacation package.

Until now, proposals like these have been vetted for safety, ethics and efficacy by an expert committee that functions under the Chief Medical Officer. They must also be approved by the Investment Authority – a cabinet subcommittee which seeks the advice of the Ministry of Health. Once approved, projects must apply for business licenses and work permits.

Efforts over the years to strengthen this un-legislated system by passing an improved medical act, enhancing the CMO’s office, and adding teeth and capacity to the Hospitals and Healthcare Facilities Board were never accomplished. But the Christie administration appointed an expert task force last year (which included Dr Sands) to consider stem cell legislation.

The task force reviewed regulations from other countries, and most of its recommendations were incorporated into the stem cell research and therapy act passed by the House of Assembly last week.

This law will set up a national committee chaired by the minister of health with members experienced in science, medicine, commerce and law. Proposals must be reviewed by subsidiary science and ethics committees, and facilities must then be licensed by the Hospitals and Healthcare Facilities Board. The review committees will base their decisions on an extended set of regulations contained in the new act.

These regulations require all clinical use of stem cells for research or therapy to take place in properly licensed facilities. Only autologous cells (from a patient’s own body) can be used, and proposed therapies must be backed by peer-reviewed published studies and clinical trial data. In addition, stem cells and their derivatives must be certified to have been handled according to strict medical safety rules.

“These regulations are rigorous,” one industry observer told me. “They are much tougher than those which apply in Panama, Mexico or even China, for example. That’s because the Bahamas doesn’t want to position itself as a place where any therapy goes. The best way to regulate this industry is to prevent bad actors from coming in the first place.”

The first stem cell therapy approved in the Bahamas was proposed in 2005, although no patients were ever treated. This was a cardiac procedure that is now available in the US. Several other cardiac stem cell procedures are awaiting enactment of the new law, including proposals by Dr Conville Brown and a proposal by Freeport’s Okyanos Heart Institute, approved in principle under the previous government. These procedures are undergoing FDA-approved clinical trials.

There are clinics around the world that will provide stem cell procedures for almost every intractable condition, targeting desperate people and charging tens of thousands of dollars for unproven treatments. In some cases, patients have developed tumours from injections of unpurified stem cells, and people have been injected with cells taken from animals.

But not every stem cell clinic is predatory, experts say. As noted earlier, procedures can be approved in the European Union while still undergoing lengthy trials in the US, and countries like the Bahamas can “play the spread” between the two. The US Food and Drug Administration requires that all stem-cell procedures undergo clinical trials for safety and efficacy before companies begin selling them in the US as therapies.

The Okyanos Heart Institute was attracted to Freeport by its medical tourism investment initiative. The clinic bills itself as “the first healthcare provider to offer cardiac cell therapy in a state-of-the-art clinical setting, using a European Union-approved cell processing device.” Plans are to start treating patients next year. Okyanos’ chief medical officer is a trustee of the American College of Cardiology.

Stem cells have the ability to divide and produce a range of different cell types, so they may be able to help the body regenerate damaged or lost tissue. But according to the International Society for Stem Cell Research, the range of diseases where such treatments have been shown to be beneficial in clinical trials is still limited.

“The best defined and most extensively used is blood stem cell transplantation to treat diseases and conditions of the blood and immune system, or to restore the blood system after treatments for specific cancers,” the ISSCR says. “Some bone, skin and corneal diseases or injuries can be treated with grafting of tissue that depends upon stem cells from these organs. These therapies are also generally accepted as safe and effective by the medical community.”

According to Dr Robin Roberts (director of the UWI School of Clinical Medicine and also a member of the stem cell task force), “Is there merit in the Bahamas being involved in stem cell medicine? The answer is a resounding ‘yes’. The centre of the stem cell debate today is not its scientific merit or economic value, it is setting the parameters of stem cell science as the new medical commodity. I believe that the task force accomplished its mission with distinction.”

However, he also points out that many proposed therapies are still speculative, with a potential for staggering profits. “This is the dark side of stem cell medicine – patients are receiving costly and unproven therapies that put lives at risk. The big question is whether the government can regulate so that stem cell therapies are safe and effective and the manufacturing processes are of the highest quality standards, as with traditional drugs.”

So the upshot seems to be that our current legislation is in keeping with work that was started years ago under previous governments, and extends the oversight system that already exists by formalising a set of well-considered regulations for cutting edge research and therapy. And specific proposals will be vetted by expert review committees.

But unfortunately Peter Nygard’s megalomania has intervened in this debate.

The video of his self-treatment described at the beginning of this article is a promotional sideshow that belies the rigorous standards provided in the act. And Nygard’s involvement has sparked a huge political row, leading the government to shut down our parliament and gag the leader of the opposition – an unprecedented and most unfortunate action.

The key to maintaining the nation’s reputation as a potential medical tourism destination is to avoid those who want to peddle snake oil to desperate patients for huge profits. By all accounts, the new legislation can do this if properly applied.

The key to avoiding unproductive political rows over foreign investors and paymasters is to implement campaign financing laws. I mean, who is Peter Nygard to be setting our political agenda? We only have so much capacity to begin with.

Do you think Perry Christie would be able to fast-track that legislation?

• What do you think? Send comments to larry@tribunemedia.net or visit www.bahamapundit.com.