Showing posts with label stem cell Bahamas. Show all posts
Showing posts with label stem cell Bahamas. Show all posts

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

thenassauguardian

Friday, July 19, 2013

Matthew Feshbach, CEO of the Okyanos Heart Institute; the only stem cell facility to have received government approval to operate in in The Bahamas ...is in the midst of a court battle to have $3.8 million in debt to the Internal Revenue Service (IRS) discharged ...due to alleged inability to pay

Stem cell investor fights IRS debt

U.S. tax agency claims $3.8 million owed


Alison Lowe
Guardian Business Editor
alison@nasguard.com


The co-founder and key financial backer of a stem cell treatment facility in Grand Bahama is in the midst of a court battle to have $3.8 million in debt to the Internal Revenue Service (IRS) discharged due to alleged inability to pay.

As Parliament yesterday debated the Stem Cell Bill, which would put in place the legal framework to govern stem cell research and treatment in this country, it emerged that Matthew Feshbach, CEO of the Okyanos Heart Institute, declared bankruptcy in the Florida courts in June 2011.

Since this time, Feshbach and his wife have been seeking to have a $3.8 million debt relating to 2001 tax liabilities discharged, alleging that in 2011 their joint assets amounted to just $138,000, according to documents filed in the Middle District of Florida’s Tampa Division of the U.S. Bankruptcy Court.

A government minister, who declined to go on record, said yesterday that the Christie administration is unaware of Feshbach’s court battle with the IRS.

Okyanos Heart Institute is at present the only stem cell facility to have received government approval to operate in this country and was mentioned by name several times during yesterday’s parliamentary debate.

In an April 4, 2013, filing for a motion for a summary judgment on Feshbach’s desired discharging of the IRS debt, the Feshbachs’ attorneys describe the pair as “honest and unfortunate debtors” who cannot pay their creditors.

In a declaration dated November 12, 2011, Matthew Feshbach stated the “massive tax liability from 2001 arises from ‘phantom income’ triggered by changes in the tax code that affected some of the hedge fund positions I was managing”.

“We are not millionaires,” said Feshbach in the declaration to the court. “In fact, the very generous appraisal of our assets recently obtained by the Chapter 7 trustee in our case showed that all of our assets totaled $138,000.”

In support of his claim that he is unable to pay the IRS, Feshbach stated in court filings that he became “seriously ill with chronic pelvic pain syndrome” in 2008, “curtailing his ability to restart and investment business, interview for employment with an investment firm or otherwise engage in meaningful business opportunities.”

Court documents show a hearing took place on Tuesday relating to the motion for a summary judgment on the question of discharging Feshbach’s IRS liabilities. The outcome of that hearing is at present not clear. The matter was previously set down for trial on August 20, 2013.

Feshbach has stated that he has not sought to evade his debts and engaged in “numerous attempts to work with the IRS prior to seeking bankruptcy.” Court documents filed on his behalf state that he paid the IRS $5.62 million in principal taxes due, interest and penalties since 1999.

The former hedge fund manager has described the Okyanos Heart Institute, set to be based in Freeport, Grand Bahama, as offering “a new option, standard of care and quality of life to patients with coronary artery disease (CAD), utilizing cell therapy technology from the growing field of stem cell therapeutics.”

According to information on the Okyanos Heart Institute website, Feshbach co-founded the facility with Manuel Vianna, who lists Feshbach’s now defunct hedge fund operation – MLF Investments – as a former place of work on his LinkedIn profile.

MLF Investments was liquidated in 2008, according to Reuters news agency, after it “suffered a reversal of fortunes”. Prior to founding MLF Investments, Feshbach, the article notes, had been “one of the most famed short-sellers of the 1980s” gaining “praise and vilification” for his strategy of betting on stock declines.

In a statement to Guardian Business on Tuesday, Okyanos spokesperson Erika Mansur had described how Okyanos Heart Institute intends to undertake a hiring drive should the Stem Cell Research Bill be passed by the government.

Mangrum said that construction of the facility would be completed by “the end of the year.” Late last night the Bill was still being debated in the House of Assembly.

Contacted for comment yesterday Mangrum said she would supply a statement to Guardian Business today on the issue of Feshbach’s court case.

July 18, 2013

thenassauguardian