Stem Cell Therapy Industry Launched in The Bahamas

NASSAU, The Bahamas -- Prime Minister, the Right Hon. Perry G. Christie, delivers a speech during a ceremony marking the official launch of the Stem Cell Therapy Industry in The Bahamas. The event was held on Wednesday evening, January 14, at Melia Nassau Beach Resort.  In 2013 the government passed the Stem Cell Research and Therapy Act 2013; and in 2014 the Stem Cell Research and Therapy Regulations were officially brought into force.  

According to the Prime Minister, the experts involved in the newly introduced industry will ensure the highest professional standards and best practices in this highly sophisticated biotechnology industry. Mr. Christie said that it is expected that with the introduction of this industry, The Bahamas would attract clients (patients) from many different geographical territories with the potential development of a significant associated Medical Tourism component.  (BIS Photo/Peter Ramsay)

January 15, 2015

Bahamas.gov.bs

The Free National Movement (FNM), Peter Nygard, stem cell and the stem cell legislation

FNM Focused on Stem Cell, Not Nygard

By The Bahama Journal

Free National Movement (FNM) Chairman Darron Cash doesn’t believe the party focused more on the controversy surrounding Peter Nygard, instead of the actual stem cell legislation.

The chairman said this while speaking to Jones and Co. host Wendall Jones during his appearance on the programme.

Mr. Cash said despite people only seeing the ‘blow-up’ over Canadian fashion designer Peter Nygard’s interest in stem cell research being done in The Bahamas, FNM Leader Dr. Hubert Minnis actually gave detailed reasons as to why the party disagrees with passing legislation for the medical practice.

“In reality, the leader of the opposition essentially said it is supported. But what he did was speak to the question of how to educate people,” he said.

“He spoke to the fact that there are many deficiencies, in terms of how to oversee the structure, how to answer the broader questions like The Bahamas’ position in the international community as a good, safe and reputable place for researchers to do business. He said he’s not comfortable that that structure had already existed.”

“So the government ought to facilitate a broader discussion and analysis. Bring the bill forward and put it to a committee so that they can be an appropriate framework for all of these questions to be answered.”

The FNM leader was suspended from the House of Assembly for two sittings on August 7th after he refused to apologize and withdraw a statement he made concerning Mr. Nygard’s and the prime minister’s relationship.

Since then, members of the government have taken the Opposition to task over the debacle surrounding Mr. Nygard.

Both the FNM’s deputy leader and chairman have openly supported the legislation, which was eventually passed that same day.

FNM Deputy Chairman Brensil Rolle defended the party saying that they never brought Mr. Nygard in the discussion, but that he allowed the PLP government to drag him in it.

“The FNM never deflected to Nygard,” he said.

“Mr. Nygard himself and the PLP government allowed Mr. Nygard to inject himself into the discussion.”

“The FNM doesn’t have any difficulty with stem cell or stem cell legislation. What the FNM and hundreds of Bahamians were offended by was the fact that a non-Bahamian was giving an impression to people that this was for him.”

Mr. Christie made the announcement that Mr. Nygard was helping the government with bringing stem cell researchers to The Bahamas while making remarks at the Jones Communication Network’s ’40 Under 40’ awards.

19 August, 2013

Jones Bahamas

Caribbean Blog International

The governing majority has failed us on the Stem Cell Research and Therapy debate ...and so has the official opposition

Talking Sense: Political Hyperbole On The Medical Frontier

By NOELLE NICOLLS

khalilanicolls@gmail.com

WHEN politicians train to be politicians, one of the first lessons they learn is about the use of hyperbole, the art of using obvious and intentional exaggeration to make a point. It is a political tool that Bahamian politicians are very familiar with and use with great frequency (Full disclosure: the media profession is no novice when it comes to the art either)!

With true hyperbole, however, the extravagant statements are not intended to be taken literally; they are intended to make a point.

Trouble is, listening ears often miss the point, and instead come away believing the exaggeration. While talking heads, on the other hand, sometimes buy into their own hype, and use intentional exaggeration to get away with spreading outright lies. Too much hyperbole can really create one messy affair.

Needless to say, one has to be astute to weed through the mess. Let us take, for example, the Stem Cell Research and Therapy Bill, currently being debated in the House of Assembly, which has been painted as “revolutionary” by its proponents.

Much has been said about the benefits that stem cell research will bring to the Bahamas: $100 million annually, new jobs, spillover effects on all areas of the economy, lead scientists who will relocate to the Bahamas and create institutions and centres of excellence, and new medical treatments for Bahamians. The impressive list goes on.

The way in which this adventure is being trumped up has certainly made me weary. For one simple reason: Our politicians have a knack for trumpeting revolutionary projects that never live up to their promise. And I would hate for us to venture into another one of those limp experiments at the expense of matters of real national importance.

Let us not forget, a few years ago, telemedicine was the revolutionary technology that was supposed to transform health care in the Bahamas, “bridging the islands of the Bahamas medically”. The Bahamas was supposed to become a nerve centre for the Caribbean, using the success of connecting the Family Islands as the launch pad for a worldwide breakthrough in the developing world.

The Free National Movement government launched a tele-radiology pilot project in two community-based clinics: The South Beach Clinic in New Providence and Eight-Mile Rock Clinic in Grand Bahama. Radiologists at Princess Margaret Hospital or Rand Memorial Hospital consulted regularly with technicians and patients at the two clinics. They used a Picture Archiving and Communication System (PACS) to store, share and archive imaging data.

The idea was to link the entire Bahamas into the PACS system. International partners could also be plugged in, so a doctor in Nassau would be able to consult with a radiologist at the University of Miami. The government was hoping to use the technology to provide other long-distance services like pre-natal ultrasounds.

The government also launched a virtual skin clinic in Abaco, which treated 42 patients in its first month of operation. The government eventually rolled out the programme in Andros, and had plans to replicate the skin clinic model with paediatric clinics.

The government made some positive inroads with telemedicine, but whatever happened to the promised renaissance?

Recently, a $100,000 telemedicine lecture lab was launched in the oncology centre of PMH thanks to a donation from the Bahamas Telecommunications Company, evidence that the telemedicine dream is still alive, but not evidence of a revolution.

When telemedicine was the hot topic, Dr Hubert Minnis, the Minister of Health at the time, promoted it as a forward thinking project by a visionary government.

“(Telemedicine) is extremely futuristic; that is what this Government is all about. It is not just about today, but it is about tomorrow and tomorrow we will be able to expand that so that not only will we be taking the Emergency Room to the Family Islands, but we will be able to expand the service so that we will be in a position to also take Intensive Care Unit and other facilities to the Family Islands,” said Dr Minnis in 2007, on the occasion of the pilot project launch.

Unsurprisingly, the Progressive Liberal Party government is now framing its interest in stem cell research in the same light, as catching the wave of the future.

Oncologist Dr Arthur Porter, former head of the government’s stem cell task force, predicted a global “renaissance” in the use of stem cell therapy “over the next ten years”. He positioned the government as being forward thinking by getting ahead of the curve.

However, Dr Porter did not predict he would be embroiled in an international scandal just six months after his stem cell prophesy. He is currently being held on an international arrest warrant in connection with an alleged million dollar kickback scheme in Canada, where he faces charges of fraud, conspiracy to commit government fraud, abuse of trust, secret commissions and laundering the proceeds of a crime. Dr Porter denies all of the charges against him.

Nowadays it is hard to take the government seriously, when political leaders have such a loaded track record of rhetorical dishonesty. And it is almost impossible to take the government at its word, when it keeps dangling carrot sticks of some awe-inspiring future that is likely to have no impact whatsoever on the quality of life for the average Bahamian.

During debates in the House, Minister of Health Dr Perry Gomez boasted about the story of an infant born in Italy, who was recently treated successfully using stem cell therapy. What Dr Gomez did not say is that tracheomalacia, the condition that afflicted the child causing her to need a new trachea, is a very rare condition. The story is touching, but how relevant is it for the average Bahamian?

Bahamians are afflicted with common diseases such as diabetes, cancer, heart disease, kidney disease. All of these are top contenders for potential stem cell therapies. However, stem cell medicine is still in its infancy, from commercial and scientific points of view.

In 2011, the company that conducted the world’s first Federal Drug Administration approved clinical trial using human embryonic stem cells on spinal cord patients aborted the experiment and left the stem cell business entirely. Geron, the leading Silicon Valley biotech company in question, directed its resources towards experimental cancer drugs, which were much more advanced in their development.

The company was awarded a $25 million loan from the California Institute for Regenerative Medicine for the trail, but it returned the money: $6.5 million, the amount it had borrowed so far, plus interest.

The company determined it did not have sufficient financing to continue its experiments with stem cells and cancer treatments at the same time. And despite having spent $150 million over 15 years investing in its stem cell treatments, it chose to go with its cancer research.

There may obviously be other factors at play here, but one conclusion that can be drawn at face value is that stem cell medicine is a bad bet for Bahamians hoping for a cancer treatment in this generation.

At best, researchers “estimate that the time lag between research expenditure and eventual health benefits is around 17 years”, according to a report by the Welcome Trust, a UK based biomedical research and the medical humanities firm.

Of course, anything is possible. At the end of the day, treatment is not the same as a cure. The promise of stem cell therapy is a cure for disease.

Either way, stem cell medicine is a highly specialised niche market in the medical field and will likely be so for years to come. It seems doubtful that stem cell treatments for common conditions will become mass market in the near future, based on reports about the industry. At some point, they will be available to an exclusive few by virtue of their cost. And now, they are available to an exclusive few because patients have to meet “a very strict set of criteria” to qualify for treatment, based on rigid clinical research trial protocols.

Last year, when the Bahamas Heart Centre (BHC) in conjunction with Advanced Innovative Medicine Inc of Orlando, Florida, conducted the Bahamas’ first cardiac stem cell implantation, Dr Conville Brown, BHC director and CEO said: “The expansion of the patient’s stem cells is a procedure that generally attracts a price in the region of $20-30,000 just for the cells. And nobody has put them in yet and nobody has taken them from the patient yet, so the general price is somewhere easily around the $40-50,000 range.”

The 62-year-old cardiac patient, who was a medical tourist, had advanced coronary artery disease. He had already undergone bypass surgery on a number of occasions, after his first heart attack in 1989. The stem cell treatment was considered a “last option” before considering a heart transplant.

Stem cell research is not your average field of study. It would be irresponsible to mislead people by hyper inflating the benefits they are likely to reap with rosy portraits of an uncertain possible future.

There is another important aspect of the stem cell debate that needs to be explored. Let us look at our national healthcare needs. If the Bahamas was to aspire to global dominance in any area of medical research, it would seem more prudent to fix our eyes on area of medicine that was a) of great relevance to the Bahamian people, and b) best served by our natural resources, national infrastructure and areas of technical expertise.

An obvious example comes to mind: breast cancer research, considering Bahamian women suffer from the disease at disproportional rates to the rest of the world.

In the government’s speech from the throne, which established its legislative agenda, it committed itself to “facilitating the Public Hospital Authority’s acquisition of new cancer screening technology to ensure that Bahamian women have access to-state-of the art mammogram machines”. Makes sense.

Telemedicine is another good example. It was in fact a good idea (even if oversold), considering we desperately need ways to bring basic and advanced medical services to the remote corners of our archipelago.

Let us examine another healthcare example, an overlooked area of need. There are two main government entities responsible for delivering health care services in the Bahamas: the Public Hospital Authority (PHA), which manages the hospitals and the Department of Public Health (DPH), which manages a network of 55 health centres and 59 satellite clinics across the archipelago.

Every year, we have a flood of young doctors graduating from institutions such as the University of the West Indies (UWI) entering the professional ranks in the Bahamas. And yet, the Department of Public Health is still chronically short on doctors. It has to import doctors from around the world to work in the Bahamas.

How is it that we have so many people entering the medical profession in the Bahamas and yet we still have to import doctors? Here is a problem the government might want to invest some time and money into solving.

Junior doctors, particularly those coming out of the UWI system, are required to participate in a mandatory internship programme with the PHA. Many of them are scooped up by the PHA at the end of their internships and choose to remain in the hospital system, because they are able to continue understudying experienced doctors and develop new skills in areas of specialisation.

If they were employed to the DPH, they would be limited to practising general medicine, for the most part, and have to take up Family Island posts, where they would serve as resident experts unto their own.

Here is a problem that affects the day-to-day lives of Bahamians in an area of critical need. Our medical professionals, particularly young professionals, need greater access to training and more incentives to enter the Department of Public Health’s system.

There, government has a buffet of healthcare needs to choose from: a shortage of doctors in public health, a shortage of surgeons and specialists in the medical profession generally, a breast cancer rate that is out of control, high rates of prostate cancer in our male population, and a long awaited national health insurance scheme, among other immediate concerns. A responsible government would channel its resources and build human resource capacity in areas of true need for its people.

Sadly, none of this logic seems to matter because stem cell research in the Bahamas has a celebrity champion with money to spend.

I am reminded of the research I did last year about the funeral services industry. For decades, the government has failed to enact regulations to bring the industry in order. It is the wild wild west in funeral services in the Bahamas.

The lax regulation of sanitation standards, for example, is having a serious impact on public health. The nonexistent regulation of funeral service practitioners has given birth to players who employ embalming and burial practices that dishonour the dead.

The government has turned a blind eye. Meanwhile, families, according to members of the industry itself, are “being bamboozled” by the system, and our dead are being habitually dishonoured. The government has no shortage of excuses for its failure to act. Apparently, it is waiting on the industry to come forward with its own draft regulations.

The whole matter forces us to ask serious questions about how the government establishes its legislative priorities. Perhaps the funeral services industry needs to get itself a celebrity backer. Because stem cell medicine, a priority only for a few private medical companies prior to 2012, has managed to become a front burner issue for the government when it was never on the legislative agenda to begin with.

When the Stem Cell Research and Therapy Bill becomes law, the obvious question will be how is the government going to set its budgetary priorities in the health sector?

The government recently announced a possible new partnership with the University of Miami, who might help the government with its regulation of the industry. I am curious to know what kind of government resources will be allocated to the regulation and oversight of this industry, and sustaining a relationship with the University of Miami. Will the taxes associated with the industry sufficiently cover all of the government’s incurred expenses?

What frustrates me about how the stem cell debate has evolved is that our foray into the industry could have gone down without much fanfare or controversy, with sobriety and restraint, had it been a side project for which the government was only obligated to get involved in from a regulatory point of view to ensure public safety and the rule of law.

But no, the project has become a side show, having been trumpeted as “ground zero” for the next medical revolution in the Bahamas, based on claims that have not been sufficiently substantiated.

Stem cell technology might be revolutionary in the field of medical science, but it is not at this juncture the revolutionary answer to our healthcare needs or our economic woes.

The governing majority has failed us in this debate and so has the opposition. Both have wasted the people’s time overplaying their hands, proffering base arguments that have caused more confusion than clarity, more petty squabbling than true debate.

I hope discussion ends on this bill quickly, so the government can proceed to matters of true concern. And I hope any expense incurred by the people on this stem cell adventure is offset by fees and taxes paid by those who have the real vested interests.

• Noelle Nicolls is the Tribune’s Features Editor. She is also a travel writer, women’s activist and entrepreneur. Follow her on Twitter @noelle_elleon. For questions or comments, email khalilanicolls@gmail.com.

August 06, 2013

Tribune 242 

Caribbean Blog International

The Stem Cell debate has been hijacked by talk about Peter Nygard ...who is very interested in the use of stem cells for anti-aging treatments...

Talking Sense: The Economics Of Stem Cells

by NOELLE NICOLLS

khalilanicolls@gmail.com

IMAGINE living in a world where a drug-free fix for HIV/AIDS existed, or a cure for cancer, blindness, Parkinson’s, diabetes, heart disease, even Lou Gehrig’s disease. Advocates of stem cell research are driven by this vision. They say the promise of stem cell therapy is the birth of a new medical paradigm more revolutionary than the advent of the internet.

Some even believe stem cell therapy is the key to immortality. As a result, those pursuing medical breakthroughs in the field are often driven by an age old obsession to find the magical elixir of life.

However, it is not just anti-aging obsessives who support stem cell research. Legitimate, professional medical researchers have sound reasons to be optimistic about the positive impact stem cell treatments could have on public health.

There are also investors who want to cash in on new medical breakthroughs. There are also patients suffering from incurable diseases or chronic disorders praying for stem cell therapy to be their miracle cure.

Debate on The Bahamas’ potential foray into the world of stem cell research and regenerative medicine has touched on some of the moral and ethical issues, but there has been virtually no debate of the economics of stem cell research. The government’s economic claims have gone unchallenged.

For the most part conversation has been hijacked by talk about a millionaire fashion designer who is very interested in the use of stem cells for anti-aging treatments and happens to be an investor in the Bahamas. When debate resumes in the House of Assembly next week, I hope it will turn to more substantive issues.

Despite all of the reasons that make stem cell research an important area of medical study, it remains controversial. ‘Frankenstein’ scenarios aside (as stem cells could unlock the key to human cloning) the primary reason for controversy is concern over the harvesting of human embryonic stem cells, which are highly favoured among all types of stem cells.

Embryonic stem cells are harvested from human embryos when they are only days old. These embryos are usually destroyed as the cells are extracted. Most religious institutions have strong moral objections to the harvesting of embryonic stem cells, arguing for the sanctity of life, even at the embryonic stage. However, many support the use of adult stem cells and amniotic stem cells, which come from umbilical cord tissue.

In countries that allow the harvesting of embryonic stem cells - Finland, France, Greece, the Netherlands, Sweden, Italy and the United Kingdom - these cells are obtained from surplus embryos at in vitro fertilisation (IVF) clinics.

Last year, the government’s task force took a stand against the use of controversial embryonic stem cells in the Bahamas, while sanctioning the use of adult and amniotic stem cells.

Although the committee first reported its findings late last year, debate reignited when the government tabled a Stem Cell Research and Therapy Bill along with draft regulations in the House of Assembly in April.

The new law will create a regulatory framework covering all aspects of stem cell research, including clinical and pre-clinical research, the use of non-human animal research subjects; and therapeutic uses in people.

The opposition’s main argument against supporting stem cell research in the Bahamas is concern over the proper enforcement of laws governing the industry. In our country of lax government regulation, the concern is valid; perhaps not sufficient to sabotage the government’s efforts, but valid nonetheless, given the high risks posed by the industry.

It is certainly plausible that one of the reasons the Bahamas is perceived as a favourable destination for stem cell research, when it does not have competitive infrastructure to supporting an industry of medical research, is its lax regulatory environment. It is certainly plausible that unscrupulous researchers, investors or medical practitioners could prey on the Bahamas while advancing their own personal agendas.

We all know a little too well that having a law on the books in the Bahamas is not the same as having a strong regulatory environment with robust systems of oversight. But the illusion of a legal framework could provide the prefect cover for unethical players.

The economics of medical research

If we put concerns about government oversight aside for the moment, and questions of morality and ethics; if we take the government at its word that its interest in stem cell research is not some kind of political payback, or at least a political nod, to Mr Nygard for alleged political contributions, there is still one glaring issue that has gone unchallenged.

It is the economics of medical research and the economics of stem cell medicine.

The Stem Cell Research Bill has been called “revolutionary”. It has been portrayed as having the power to “catapult the health sector” in the Bahamas and revolutionise medicine. When Prime Minister Perry Christie tabled the bill, he said stem cell projects “promise to attract leading scientists” who will relocate to the Bahamas and “conduct research, establish institutions and centres of excellence”. Mr Christie said many young Bahamian scientists and physicians will gain new skills and new opportunities. That the industry will generate new jobs at many levels, and will fuel accelerated growth in the economy. The industry will have spillover effects on all areas in the economy, including the tourism industry.

“Our young Bahamian scientists and doctors will be able to establish thriving professional lives right here in The Bahamas. They will then be able to contribute back to our community in the years to come, as well as to the international community,” said Mr Christie.

The government has boasted that stem cell research could inject more than $100 million into the Bahamian economy annually. Peter Nygard has touted the idea that a stem cell centre in the Bahamas could raise to the status of the Mayo Clinic in Rochester, which caters to thousands of people around the world and employs some 50,000 people.

In the context of a stagnant economy, these words sound like to me a Junkanoo orchestra: sweet to the ears. Rhetorically, it is easy to connect the dots between stem cell research, regenerative medicine, medical tourism and economic development for the Bahamian people. At the rhetorical level, the relationship between these four elements represents a magic formula for pandering to populist sentiment.

Who wouldn’t want to be associated with a medical breakthrough that could cure all of the world’s ills? Who doesn’t like the sound of an economic stimulus that requires no investment on the part of the government, only the simple passage of a new bill?

In reality, sweet words do not make for sound economic policy.

There are deep, uncharted chasms between each step on the trajectory from private investment in stem cell research to economic profit for the Bahamas as a whole.

I am bewildered by the level of hype being generated around the issue, when the evidence does not seem to support many of claims being made, and our national needs do not justify them.

Let us unpack the economic issues first.

In the United States, studies show medical research has a positive economic impact. However, much of that success is attributed to a private/public sector funding partnership. Government funding accounts for approximately 36% of total research funding, according to some estimates. In 2003, for example, the National Institute of Health (NIH), the largest federal agency of medical research, was responsible for 28% (about US$26.4 billion) of the total biomedical research funding spent annually in the US. In 2009, the NIH injected $15.6 billion research dollars into medical schools and teaching hospitals alone. In places where medical research is highly successful from an economic impact point of view, there is a large sum of government money being spent. Unless I missed it, I have not heard the Bahamian government talking about investing in stem cell research or regenerative medicine, only legislating it.

The Association of American Medical Colleges (AAMC) published a 2009 report, summarising the economic and employment impact from federal and state funded research in the 25 states (plus the District of Colombia). Number one on the list: California (population 38 million). The total direct and indirect economic impact of the medical research industry for California from the AAMC network was $5,360 million (as in $5.3 billion). The employment impact on the other hand was only 35,734. Number 25 on the list was Iowa. With a population of 3 million people, the economic impact on Iowa was $400 million; while the employment impact was 2,719 jobs.

If our government is projecting a $100 million industry for the Bahamas (with a population of 0.4 million), where does that really place us in the grand scheme of things? $100 million sounds like a large number at first glance, but further analysis is required to assess its true value. Does $100 million reflect a projection of total spending, total revenue, total tax revenue, all of the above? And how many permanent jobs would an industry of this size actually produce? Is the $100 million projection speaking specifically to stem cell research or also stem cell therapy, because research and clinical treatment are two different things. Stem cell research is still in its infancy, which means stem cell treatment is still in a state of trial; it is not practiced widely at the clinical level. So I ask again, what exactly is the economic model?

In California, $1.5 billion in committed research grants to the California Institute for Regenerative Medicine is generating $286 million in new tax revenue for the state and local governments through 2014, according to a study conducted by Emeryville-based global consulting firm Berkley Research Group. CIRM was established by the state government in 2004 with the passage of the California Stem Cell Research and Cures Act.

It released an independently produced economic impact study measuring the stem cell agency’s financial impact on the state. The study found that the same grants will generate an estimated $530 million in tax revenue for the federal government.

There are models of success out there, but it goes without saying, California’s success, for example, is not a blueprint for the Bahamas. The markets are completely different. For one, California has the infrastructure to support a medical research industry: legal framework, sources of funding, technical expertise, supply chain, demand for services. Without the infrastructure or “risk-sharing partnerships”, any high risk industry will likely operate at 100 times the cost with 100 times the liability.

In the Bahamas, a few private ventures that represent isolated pockets in a global industry (no matter how world class they may be) will not automatically propel the Bahamas into global dominance. We should have learned that lesson from the tourism industry.

Bahamas Heart Centre

As a case study, let us look at the Bahamas Heart Centre (BHC), which entered the record books last year by performing the Bahamas’ first cardiac stem cell implantation in conjunction with Advanced Innovative Medicine Inc of Orlando, Florida. A very advanced team of doctors treated a 62-year-old cardiac patient who had advanced coronary artery disease by implanting some of the patient’s own stem cells into his heart. The patient, a ‘medical tourist’, had already undergone by-pass surgery on a number of occasions, after his first heart attack in 1989. The stem cell treatment was considered a “last option” before considering a heart transplant. He was eligible for this experimental treatment after meeting “a very strict set of criteria” to qualify, based on rigid clinical research trial protocols.

I congratulate the Bahamas Heart Centre on this successful treatment, and should they be able to save more lives with their stem cell therapy I support them doing so. However, I would be interested in speaking with the BHC’s chief financial officer. I highly doubt the medical facility has plans to change its business model to invest everything it has in stem cell treatment.

For not-so-sinister business reasons, offshore clinical trials are being promoted in places like China by leading centres of stem cell research for the same reasons corporate America outsources many of its business processes. In fact, China has picked up traction in the stem cell research race. So perhaps the Bahamas could become a hub for offshore clinical trials if it could help businesses lower their development costs. In this light, the BHC’s work can also be seen as a success.

Nonetheless, stem cell treatment for the foreseeable future is likely to be a small line item in the centre’s over revenue model, I would suggest.

Big Pharma

It might be the star player in the BHC’s research and development or clinical trials department, but it is not likely to be the foundation of their business model. Simply put, “the stem cell and regenerative medicine market is still in its commercial infancy” despite the scope of opportunities that exist. This, according to the Stem Cell Network (SCN), a Canadian not-for-profit corporation that funds applied stem cell research and facilitates collaboration between universities, industry, government and non-governmental organisation.

According to the SCN, Big Pharma is not even on board with stem cell medicine, because the economics are too uncertain.

“Cell-based biologic products represent both new technology and a business model that remains largely unknown, but is certainly different from traditional drug or device development. Drug and device companies are proceeding cautiously, and waiting to see who emerges from the 100 or more stem cell companies now operating around the world, most of which tend to lack the critical mass and the clinical, regulatory and manufacturing capabilities to establish a sustainable product portfolio and technology pipeline,” states SCN.

Former Fortune senior editor Jeffrey M. O’Brien publish a 2012 article investigating the stem cell business. His research showed that “shares in almost any public stem cell company can be had for less than $1. One of the highest fliers, Stem Cells Inc. (STEM), reached $171 a share once upon a time. In mid-September it was trading at 95�.”

The first-ever clinical trial for embryonic-stem-cell therapy approved by the Federal Drug Administration (FDA) in the United States was conducted by Geron, a leading Silicon Valley biotech company. Geron injected four spinal-cord patients with its stem-cell therapy. The treatment had previous success enabling paraplegic rats to walk. The company shut down its clinical stem cell trial months after it began, blaming difficult economic conditions. Reports indicated “the treatment did not show the immediate promise many had hoped”. The company, however, said it wanted to concentrate resources on two new and promising cancer drugs”.

Advanced Cell Technology (ACTC), another biotech company, picked up the slack. Its chief scientist Robert Lanza has made substantial progress in treating a type of blindness (macular degeneration), a condition that affects tens of millions of people, where spinal-cord injuries only represent a market of tens of thousands. ACTC has not figured out the economic model either. One report said ACT “has been scratching and clawing to survive for years”, dealing with a range of problems from raising venture funding to settling patent-infringement lawsuits.

When ACTC received FDA approval to commence clinical trials in 2010, it had already “spent upwards of $100 million on research”, according to reports.

No matter which way you spin it, the economics do not seem to be there - at the moment. For the Bahamas, stem cell medicine could be a hyped-up experiment with an empty payoff or it could be a forward thinking move by a bold government. Either way, it is a matter that could have been handled with much less fanfare and controversy.

Dangers of distraction

Debate about the stem cell bill has become a colossal national distraction, not because discussing stem cell medicine itself is a waste of time; but its advocates seem incapable of presenting sober arguments that tell the full picture; and they seem motivated by the hype. Debate has degraded into political squabbling, dreams of immortality and ‘Frankenstein’ science.

There is no doubt that advanced breakthroughs in clinical stem cell therapy could transform the Bahamas and the world. There is hardly anything to debate when it comes to the medical possibilities; they are bewildering and awe-inspiring.

But what is most relevant to the debate at this time is not the dream of a brave new world where incurable diseases are as obsolete as floppy disks, it is the notion that stem cell research and regenerative medicine can provide a viable economic stimulus for the Bahamas. It would be good if our leaders could sit across the aisle like adults and debate serious issues with competence, restraint and intellectual honesty.

As if the economics of stem cell medicine were not enough to fully explore the matter, there is also the matter of establishing our national health priorities. Next time, I plan to look at how our vigorous push for stem cell medicine contends with our national health priorities and the treatment opportunities that will open up for Bahamians in the near and long-term future.

I will also look at the government’s obsession with “revolutionary” projects that never live up to their promise. Remember the former government’s telemedicine project, which was also supposed to be a revolutionary technology that would transform health care in the Bahamas and put us on the map?

I support stem cell research in theory, and if we are to venture into the area (as private companies have already done in the Bahamas), there should be government regulation. But I do not support stem cell research becoming a national distraction. When debate resumes in the House of Assembly next week, I caution the government, as the old people say, when you lie with dogs you catch fleas. My advice to the government is to approach the conclusion of this stem cell debate with sobriety and restraint. Not everyone in the Bahamas deals in dreams. Some of us deal in fact.

Noelle Nicolls is the Tribune’s Features Editor. She is also a travel writer, women’s activist and entrepreneur. Follow her on Twitter @noelle_elleon. For questions or comments, email khalilanicolls@gmail.com

August 01, 2013 

Tribune 242 

Caribbean Blog International

The debate on the regulation of stem cell research and therapy

Consider this: The stem cell debate

By Philip C. Galanis
pgalanis@gmail.com

“Stem cell science is evolving rapidly and carries the promise of bringing us therapies that will revolutionize medicine.”

– Prime Minister Perry Christie

 

This week, the debate on the regulation of stem cell research and therapy in The Bahamas began in Parliament. The heated parliamentary debate was eclipsed by a certain mesmerizingly colorful personality, whose insinuation into the debate unfortunately distracted from the essence of the potential benefits and challenges of this controversial science. Therefore this week, we would like to Consider This... should we be concerned with regulating stem cell research and use for medical purposes in The Bahamas?

 

Stem cells

Stem cells are biological cells found in all multi-cellular organisms that can divide and self-renew in order to produce more stem cells. The importance of stem cells is that they can significantly regenerate or restore degenerating human cells, thereby contributing to the quality and longevity of human life. There are two broad types of stem cells: adult and embryonic stem cells.

Adult applications

In adults, stem cells act as a repair system for the body in order to replenish degenerating adult tissues. There are generally three sources of adult stem cells in humans:

1. Bone marrow – which requires extraction by harvesting, or drilling into bone.

2. Adipose, or fatty, tissue – which requires extraction by liposuction.

3. Blood – which requires extraction with blood being drawn from the donor passed through a machine that extracts the stem cells and returns other portions of the blood to the donor.

Adult stem cells are currently routinely used in medical therapies such as bone marrow transplantation. Stem cells can now be artificially grown through cell culture and transformed into specialized cell types with characteristics consistent with cells of various tissues such as muscles or nerves.

Of all stem cell types, harvesting involves the least risk. Cells are obtained from one’s body, just as a person can “bank” his own blood for elective surgical procedures.

Adult stem cell treatments have been successfully used for many years to treat leukemia and related bone or blood cancers. Additionally, in instances where adult stem cells are obtained from the intended recipient, the risk of rejection is essentially non-existent and the outcome much better for the patient. Consequently, considerable funding has been provided for adult stem cell research.

The use of adult stem cells in research and therapy is not as controversial as the use of embryonic or fetal stem cells because the production of adult stem cells does not require the destruction of an embryo or fetus.

Embryonic applications

In a developing embryo, stem cells can maintain the regenerative organs, such as blood, skin or intestinal tissues. Embryonic stem cell lines are cultures of cells derived from early stage embryos. Stem cells can also be taken from umbilical cord blood just after birth.

There are currently no approved treatments using embryonic stem cells in the United States. The first human trial was approved by the U.S. Food and Drug Administration (FDA) in January 2009, although human trial was initiated on October 13, 2010 in Atlanta for spinal injury victims. Because of their abilities for unlimited expansion, embryonic stem cells remain theoretically a potential source for regenerative medicine and tissue replacement after injury or disease.

Fetal and amniotic fluid stem cells

The primitive stem cells located in the organs of fetuses are referred to as fetal stem cells. The Roman Catholic Church forbids the use of embryonic stem cells in experimentation and medical application, primarily because the embryo or fetus has to be destroyed in order to access the stem cells for medical research or therapeutic applications. Stem cells are also found in amniotic fluid. Use of stem cells from amniotic fluid overcomes the ethical objections to using human embryos as a source of cells.

The stem cell act

On April 10, 2013, the prime minister introduced “A Bill for an Act to Regulate Stem Cell Research and Therapy in The Bahamas.” In presenting this bill, the prime minister admonished Parliament that “The Bahamas has an opportunity to become a world leader among nations in this field. This legislation is designed to help achieve that goal.” He also noted that the “act would create a strict oversight regime to ensure that no prohibited procedures occur in The Bahamas... and that every person who conducts research or provides treatment using stem cells must secure review by a Scientific Review Committee and an Ethics Committee, which must ensure that a sound scientific basis exists for permitting the proposed research or therapy to proceed.”

The official opposition’s objections

The official opposition has once again flip-flopped on its position regarding stem cell research and therapy. It has proven to be duplicitous and simply opposing for the sake of so doing, particularly since, while it was in office, the FNM government supported and allowed the establishment of stem cell operations in The Bahamas. In addition, prior to the debate, the opposition confirmed its support for this cutting edge medical procedure. In fact, while serving as the minister of health in the Ingraham administration, the current leader of the opposition strongly supported stem cell research in The Bahamas and, at that time, without the benefit of any regulations whatsoever. That the opposition and its leader have now reversed their position for a more regulated regime is the height of hypocrisy.

It is therefore commendable that The Bahamas government has sought to regulate stem cell research and therapy. The government has clearly indicated that it will not support embryonic stem cell research and therapy and will scrupulously regulate medical practitioners working in this field to ensure they do not stray into this prohibited area of stem cell research. This is extremely important because any support of embryonic or fetal stem cell application could greatly contribute to abortions in order to access embryonic or fetal stem cells.

Parenthetically, it is wholly unfortunate that a serious debate on this noble initiative was foiled by one whose fetish for flamboyance was featured in our local dailies for an entire week. But more about that in a future column.

Implications for The Bahamas

There is no mistake that, apart from progressive medical advancements that are likely to ensue from the legalization and regulation of this science, there is a tremendous financial windfall that will accrue for medical practitioners who engage in medical stem cell procedures.

Stem cell therapy also offers substantial medical tourism potential for The Bahamas. Medical tourists tend to travel in large groups, stay for long periods of time and spend considerable sums in many sectors of the society as they obtain the treatment that they are unable to access in their home countries. It is well known that the FDA tends to move at the pace of a snail wading in molasses to approve cutting-edge medical procedures and pharmaceuticals. As most of our tourists hail from the United States, that country will likely provide a plethora of patients in pursuit of stem cell medical treatments.

Conclusion

It is critically important for the government to focus its attention on redirecting and reframing the debate on this important development in medical science, so that Bahamians will fully appreciate the advantages that will accrue to The Bahamas, to Bahamians and to people from all over the world by the passage of this legislation and the accompanying regulations. It is now time to silence, not muzzle, stem cell detractors from what will undoubtedly positively contribute to the development of our country’s future.

• Philip C. Galanis is the managing partner of HLB Galanis & Co., Chartered Accountants, Forensic & Litigation Support Services. He served 15 years in Parliament. Please send your comments to pgalanis@gmail.com.

July 22, 2013

thenassauguardian

Caribbean Blog International

Peter Nygard and his Stem Cell Concept ...to introduce an Anti-aging Treatment Facility using Stem Cells

Nygard Talks Of His Stem Cell Centre

Tribune 242 Editorial



AT a press conference at his Lyford- Nygard Cay home last Monday Peter Nygard called The Tribune “silly” to think that he would create a stem cell centre in his own backyard.

In fact Mr Nygard expressed it in far more colourful language, so here goes – Nygard at his best:

“Stem cell facility here...there is another silly thing The Tribune wrote as if we are going to do a stem cell facility here as if there is a secret agreement...my goodness how can you stoop to such stupidity who in hell would ever even conceive that – it doesn’t make any sense at all to fabricate such a silly story if a stem cell facility and medical facility (will be built) it’s going to be a grand facility that will be a centre core to attract everyone else to it and it has to be a substantial business that would attract some of the smartest people in the industry but it needs to be the trophy of the Bahamas.”

So that is settled. This statement from the great man himself will obviously allow many Lyford Cay residents, who believed he had plans for an international youth rejuvenating centre at Nygard Cay, to sleep more peacefully tonight.

As a matter of fact, the only thing that makes The Tribune “silly” is that it believed Mr Nygard at all — and we even question whether we should believe him now. You see on June 19th last year, it was Mr Nygard himself who said that his spa was planned for Nygard Cay. He is recorded as having told the Bahamas Investment Authority: “The original concept is to house this facility in the same location as Nygard Cay, but to change the look and feel of some of the buildings.”

Are we to now believe that he has had a mind change? We hope so.

At least one Lyford Cay resident was also greatly relieved to learn that Mr Nygard is not a Bahamian, despite the assurances given in the House of Assembly last week by none other than MICAL MP V Alfred Gray that he was.

“Mr Nygard is a Bahamian,” Mr Gray told parliamentarians, “he is a philanthropist, and I think he has given more to this country than many other Bahamians – including those who criticize him.”

That was surely a mouthful from the cocky, little Mr Gray.

However, before the Assembly adjourned to this morning Mr Nygard’s Immigration file was pulled and the public was assured that Mr Nygard was in fact a permanent resident —not a Bahamian citizen. He had no more rights than any other permanent resident.

The Tribune, hearing the complaints of Lyford Cay residents, believed what it had been told about the location of the stem cell centre — which had been confirmed last year by none other than Mr Nygard. The argument was that the area was zoned as residential and private. Many a resident’s convenants would have been breached if the gates had been thrown open. There was much chatter of law suits if the area were commercialised.

The problem that residents faced was that the security, peace and quiet of Lyford Cay was about to be changed — a possibility that its Canadian developer EP Taylor could not have conceived in 1948.

Apparently, in developing Lyford Cay, Mr Taylor carved out for himself what is now Nygard Cay, minus all the restrictive covenants required of those buying property in Lyford Cay.

Mr Taylor also retained for himself, family and staff all the easement rights over the road and pathways in Lyford Cay, which led to his home. Mr Taylor could never have anticipated a Peter Nygard who would want to change all of that.

In June last year, Mr Nygard met with the Bahamas Investment Authority, headed by Sir Baltron Bethel, government’s senior policy adviser, to discuss his plans to restore parts of Nygard Cay damaged by fire. Also his proposal for a Medical Spa that would specialise in stem cell research and treatment.

Mr Nygard told the meeting that he planned to invest about $50 million in all — $29 to $30 million to restore Nygard Cay and $26 to $30 million invested in building a medical spa.

The whole concept seemed to be planned as one large unit at Nygard Cay. In fact that is what Mr Nygard told the Investment Authority last year. Obviously in view of last week’s statement when Mr Nygard virtually told The Tribune it was “silly” to believe his first statement, he has now changed his mind. If there is ever to be a stem cell centre it will not be at Nygard Cay.

It is understood that his stem cell concept was to introduce an anti-aging treatment facility using stem cells.

He said his vision “would be to put together an environment where the Bahamas can practice the most advanced medicine in the world, and do it within the regulatory lines of the government.”

The only problem is that we understand that there is another developer, whose plans have already been approved in principle by the Ingraham government. He has already invested millions into preparing a facility in Freeport and was just waiting for the legislation to be passed to proceed with his plans. We understand that his plans have also been approved by the medical ethics authority.

We shall now see if our legislators are in a position to objectively decide which plans will be best for the future of this country and its people.

July 22, 2013

Tribune 242 

Caribbean Blog International

Peter Nygard on Stem Cell Research and Therapy in The Bahamas

‘No personal interest in stem cell bill’

By Taneka Thompson
Guardian Senior Reporter
taneka@nasguard.com

Canadian fashion designer Peter Nygard yesterday said he has no self-serving interests in the government passing a law to govern stem cell research and therapy in The Bahamas.

Nygard said any advice Prime Minister Perry Christie has sought from him on stem cell research is due to his knowledge of the science and well-placed contacts within the international medical community.

Nygard, who said he uses stem cell therapy to slow the aging process, told reporters that the prime minister should be congratulated for advancing such “historic” legislation.

The Lyford Cay resident said he has given advice to numerous world leaders and helped set up laws in St. Kitts, the Turks and Caicos Islands and Panama.

Nygard said Christie approached him two years ago and asked his advice on possible opportunities for medical tourism in the country.

He said he told Christie that a stem cell research and therapy industry would make The Bahamas a world leader in the science.

“I said this will be a big coup for you if you could do it,” Nygard told reporters at his compound shortly after announcing his financial support of the upcoming Acklins regatta.

“I don’t know why anybody would paint that as doing it for me. I think he is doing for [Bahamian] people, for The Bahamas. If I can help and I will then that’s a whole different issue. There is nothing in it for me. This is not a money venture for me at all.

“There’s no promise to me. The promise that I made to him (Christie) is that I will do everything that I can to spur and bring like-minded people like myself to invest in this place to be the leading edge, to be the catalyst [to bring investments] here.”

On Friday, Christie confirmed that Nygard promised to bring experts in stem cell therapy and research to The Bahamas if the government passes legislation to govern the sector.

Christie said that Nygard approached him two years ago, while he was then leader of the opposition, and told him of his problems trying to find reputable stem cell treatment for his sick mother.

That ordeal prompted Nygard to pledge to bring top doctors and researchers in stem cell therapy to the country once there were laws in place, the prime minister said.

Two weeks ago, during the House of Assembly’s debate on a stem cell bill, Opposition Leader Dr. Hubert Minnis accused the government of “rushing” the law to appease Nygard.

However, this claim angered several government MPs who denied it.

Minnis said on Sunday the prime minister’s comments validated his concerns on the stem cell legislation.

“I was very shocked,” he told The Nassau Guardian. “What he (Christie) said is open for interpretation.”

Debate on the legislation is expected to resume when the House meets on Wednesday.

July 16, 2013

thenassauguardian

Caribbean Blog International

Ethical stem cell research and therapy “holds tremendous potential for The Bahamas”, says Free National Movement's deputy chairman - Dr. Duane Sands

Sands backs stem cell bill

Calls proposed law ‘progressive’

By Taneka Thompson
Guardian Senior Reporter
taneka@nasguard.com

A day after Free National Movement (FNM) Leader Dr. Hubert Minnis blasted the government for “rushing” stem cell legislation through Parliament, his party’s deputy chairman Dr. Duane Sands said the proposed law is “progressive”.

Sands stressed that he was not trying to publically disagree with Minnis. He said Minnis had questioned whether the country could properly enforce laws governing stem cell research and therapy.

Sands added that ethical stem cell research and therapy “holds tremendous potential for The Bahamas”.

Sands was a member of a government-appointed task force that reviewed the stem cell issue and presented recommendations on how the procedures could be developed in the country. Those recommendations were instrumental in the drafting of the law.

“I think that what Dr. Minnis was suggesting was that he had no issues with stem cell work, but he wanted to express his concerns that the

enforcement of laws in the country be upgraded accordingly,” said Sands said when asked yesterday what he thought of Minnis’ opposition to the stem cell bill in the House of Assembly on Wednesday.

“I guess in his view, he thought this was equivalent to opening a Pandora’s box. As a member of the task force, I think that we sought to make recommendations to the government to minimize any potential exposure or risk to The Bahamas and the position of the task force was a very comprehensive, very considered position.”

On Wednesday, Minnis cautioned the government against “rushing” forward with the law.

“I ask the government, if they truly believe in this Bahamas, to not embark on this ill-advised adventure into stem cell research where we know we do not have the enforcement,” Minnis said.

He said the country could face being blacklisted or be targeted by unscrupulous scientists who would take advantage of The Bahamas’ lack of experience and inability to stringently enforce laws, even minor ones.

“I do not believe that we are yet in a position to adequately police this research and to ensure the maintenance of international standards,” Minnis said.

The argument drew criticism from several MPs from the government’s side, who berated Minnis for opposing the bill.

Minnis also suggested that the government was pushing the law to appease Canadian fashion mogul Peter Nygard, who he claimed is a financial backer for some members of the Progressive Liberal Party (PLP).

Some government MPs also strongly denied these claims.

There have been some concerns expressed that stem cell research and therapy would be hijacked by mad scientists with unscrupulous motives and should not be allowed.

Sands downplayed that concern and said it should not deter the country from benefiting from medical tourism brought on by stem cell research and therapy.

“There will always be charlatans, snake oil salesmen trying to take advantage of anything,” Sands said.

“If there is somebody who is interested in cloning somebody, they are not going be stopped by legislation. There are laws against murder, there are laws against car theft, there are laws against incest. Legislation will not stop people from doing things.

“This legislation is intended to strengthen the controls in The Bahamas for this particular area of medicine.”

During debate on the bill on Wednesday, Minister of Health Dr. Perry Gomez said the bill would place strict limitations on the practice to prevent human reproduction.

July 05, 2013

thenassauguardian

Caribbean Blog International