Showing posts with label Stem Cell Research and Therapy. Show all posts
Showing posts with label Stem Cell Research and Therapy. Show all posts

Thursday, August 8, 2013

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


Wednesday, July 24, 2013

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

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Wednesday, July 17, 2013

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

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