How safe is stem cell therapy?INQUIRER.net 12:50 am | Thursday, July 26th, 2012

Gene Probes- Fluorescent In-Situ Hybridization (FISH)

MANILA, Philippines – Stem cell therapy is getting a lot of buzz nowadays thanks to stories from the media about how Filipino celebrities, including politicians, are availing of its benefits. This treatment, which involves injecting stem cells into the human body, is being offered as a treatment for cancer, heart disease and other serious illnesses. It’s also being used to counter the signs of aging: making skin healthier and wrinkle-free and rejuvenating the body’s organs for more youthful vitality.

There are several sources for the stem cells that are being used to treat patients. These include bone marrow and peripheral blood—usually taken from the patient himself or herself—and from umbilical cords. All of these, the bone marrow, blood and umbilical cords, are taken from  human sources.

However, there are also cell therapy treatments that use, believe it or not, animal cells.

Proponents of this therapy claim that these animal cells are “purified” and are therefore safe for injection into human patients. These sources of cells or stem cells, however, are still controversial. In short, they do not have a track record of safety or effectiveness when it comes to treating human illnesses or the signs of aging.

Recently, Department of Health Secretary Enrique Ona gave out a warning related to the use of cell therapy. According to him, not all sources of stem cells are equal: there are those that still have no evidence of being safe or effective for use in patients.

Secretary Ona said that there are only three sources of stem cells that have a record of proven safety and effectiveness: human bone marrow, human peripheral blood; and humanumbilical cords.

“We already know today that the safest and most effective cellular preparations are those that use the patient’s own cells—called autologous human cells. Thousands of patients worldwide have been treated over several decades with autologous human cells and their safety and efficacy is well established, especially those derived from bone marrow and peripheral blood. Umbilical cord stem cells also have a long track record of safety and efficacy,” he said.

All other sources besides these, according to him, must be treated with caution:

“In the meantime, the public should be careful about receiving cell preparations that are being offered in the Philippines and elsewhere, such as embryonic, aborted fetal, genetically altered, and especially animal stem cells,” he said.

Secretary Ona also said that these sources of stem cells “still need strict regulatory assessment before they are allowed for human use in the Philippines” and that he has formed a special task force to develop guidelines on the regulation and use of stem cell therapy in the country.

Other doctors have also warned against the use of animal cells for the treatment of human diseases.

In its website, The American Cancer Society says that the use of animal cells in humans carries a lot of risks.

“Cell therapy may be dangerous, and several patient deaths linked to the therapy have been reported in the medical literature.

“Patients can contract bacterial and viral infections carried by the animal cells, and some have had life-threatening and even fatal allergic reactions. Other reports list complications such as brain swelling or the immune system attacking blood vessels or nerves following cellular treatment.  Serious immune system reactions resulting in death have also been reported.

“Women who are pregnant or breast-feeding should not use this method, as its possible effects on a fetus are unknown.”

The American Cancer Society also differentiates between the use of animal cell therapy from the use of human cell therapy: “It is important to distinguish between this alternative method involving animal cells and mainstream cancer treatments that use human cells, such as bone marrow transplantation.” Furthermore, the American Cancer Society says there is still no solid evidence that the use of animal cells in humans is actually effective.

“None of the therapeutic success claimed by cell therapists has been documented through scientific testing and published in peer-reviewed medical journals. Claims of the therapy’s success take the form of individual cases, testimonials, and publicity issued by practitioners of the  therapy. Even supporters of cell therapy admit they do not know how cell therapy works in the body. No reliable evidence has been published in medical journals to support the claims of cell therapy.”

All told, it is very important for every patient to distinguish between animal stem cell therapy and human stem cell therapy because only the latter is recommended for use in the Philippines because of its proven safety and benefits.

Medical Malpractice Lawsuit Following Death of Stem Cell Recipient by Leigh Turner • November 27, 2012 • 3 Comments

Henry Young, a researcher who specializes in study of adult stem cells and is Professor of Anatomy at Mercer University, and Bioregenesis Institute, Nevada-based clinic marketing stem cell procedures for variety of illnesses, are being sued following the death of a patient, Karen Allison Hones. The lawsuit, Hones v. Young et al., was filed August 20, 2012, in the District Court of the State of Nevada. Plaintiff is Edward P. Hones, Karen Hones’ husband.

According to the lawsuit, Michigan resident Karen Hones suffered for many years from asthma and thyroid disease. In October 2006 her health deteriorated and she began experiencing shortness of breath. Later that year she was diagnosed with idiopathic bronchiectasis. Her symptoms worsened and by 2009 her pulmonologist suggested that lung transplantation should be considered as a treatment option. Hones was subsequently referred to transplant physicians. Instead of undergoing lung transplantation Hones learned of stem cell procedures marketed by Bioregenesis Institute. According to the lawsuit, Bioregenesis Institute claims that it conducts “therapeutic cellular research for a variety of difficult diseases and ailments.” The lawsuit alleges that despite claims about engaging in “therapeutics research” Bioregenesis Institute “was not operating under IRB guidelines.”

When Hones began undergoing stem cell interventions allegedly provided by Henry Young and his colleagues at the Bioregenesis Institute, she weighed approximately ninety pounds. Given her frail status it is surprising that part of her treatment regimen reportedly included having 400 ml of blood withdrawn every few months. The lawsuit states, “such practice could have been detrimental given Ms. Hones’s low body weight.”

Karen Hones died August 31, 2011. According to the lawsuit, “The treatment rendered by Young was not FDA approved, was not subject to a human research protocol, and was not reviewed by any Institutional Review Board.” Plaintiffs allege that Hones was “treated with a proprietary stem cell therapy designed by Young.”

In May 2012, Henry Young and Bioregenesis Institute were asked to provide all medical records and bills related to Hones’ treatment. The lawsuit states that to date Young and Bioregenesis Institute have not provided records related to stem cell procedures Hones underwent.

According to the counts listed in the lawsuit, Edward Hones is suing Henry Young and Bioregenesis Institute for negligence, breach of fiduciary duty (for this count Bioregenesis Institute is not listed), lack of informed consent, loss of consortium, fraud-intentional misrepresentation, and negligent representation of fact. The lawsuit alleges, “As a Ph.D. without a medical degree or license, Young’s actions constitute the unlawful practice of medicine.” In addition, it alleges, “all conduct undertaken at Young’s direction, whether by licensed physicians or staff, also constitutes the unlawful practice of medicine.” The lawsuit asserts that “Young was at all times charged with the professional responsibility of conducting an ethical experiment where risks did not exceed benefits, of determining the universe of harm through proper preclinical animal studies, of properly conducting the informed consent process, of rendering proper care and treatment to Ms. Hones, of properly and carefully designing and administering the experiment’s protocol in a careful and prudent fashion, of assuring that proper care and attention were provided during all periods of time during which she remained under his care and treatment, and of candidly and honestly advising her of the results and consequences of the experiment.” Plaintiff alleges, “Young breached his obligations and duties under these regulations” and administered to Hones an experimental stem cell intervention that “carries a high probability of causing harm.” According to the lawsuit, “As a result of the careless, negligent and reckless conduct of the Young (sic), Ms. Hones was caused to suffer excruciating and agonizing pain and discomfort.”

The lawsuit filed by Edward Hones alleges a series of negligent acts by Henry Young and Bioregenesis Institute. The list includes:

1. failing to conduct an ethical experiment in accordance with the standards and guidelines governing human subjects research;

2. failing to determine the universe of harm through preclinical animal studies;3. failing to properly conduct the informed consent process;4. failing to disclose the conflicts of interest inherent in the experiment;5. failing to provide a subject advocate;

6. failing to properly and adequately treat and care for her condition;7. failing to perform proper care and careful research practices and procedures in accordance with the

standards prevailing in the community;8. caring for Ms. Hones in a negligent and improper manner;9. failing to properly monitor her condition both prior to and subsequent to the delivery of the experiment’s

therapies;10. failing to inform Ms. Hones of all the risks of the experiment so as to afford her with the opportunity to make

an informed decision as to whether to participate;11. failing to properly and timely observe, discover, diagnose, treat and care for her condition;12. failing to exercise reasonable care under all of the circumstances, in accordance with the accepted practices

and procedures in the community;13. failing to design, implement and monitor an experiment in accordance with the ethical standards for such

experiments;14. failing to warn Ms. Hones regarding the risks of the study;15. failing to perform the study in a careful and prudent manner;16. failing to treat Ms. Hones with respect for her human dignity as a human subject; and17. practicing medicine without a license.

The lawsuit proceeds to allege, “As a direct and proximate result of the carelessness, negligence, gross negligence, recklessness and willful and wanton conduct of Young and Bioregenesis Institute…Ms. Hones was caused to sustain serious and debilitating personal injuries. As a direct and proximate result of the misrepresentations of Young, Ms. Hones decided to forgo other therapies. Even if the procedures performed on Ms. Hones did not directly cause her death, her failure to seek proper medical treatment at the urging of defendants certainly contributed to her death.” Plaintiff further alleges that as result of stem cell interventions Ms. Hones received, “She was caused to suffer agonizing aches, pains and mental anguish; she sustained loss of enjoyment of life and loss of life’s pleasures, and she suffered dignitary harm, and, ultimately, death.” Plaintiff seeks “compensatory damages, pre-and post-judgment interest, dignitary damages, and allowable costs of suit.” Henry Young has until February 19, 2013 to file a response to the allegations in the lawsuit.

This lawsuit, much like ongoing lawsuit by clients of RNL Bio and Human Biostar (the latter business was formerly known as RNL Life Science), draws attention to risks related to individuals reportedly undergoing stem cell interventions that are of unknown safety and efficacy and provided outside framework of FDA and IRB oversight. Claims made in Hones v. Young et al. constitute allegations that have not been established in court. Nonetheless, the lawsuit raises disturbing questions about marketing of purported stem cell interventions by clinics located in the US, reported failure to balance risks and benefits by individuals allegedly marketing and providing stem cell procedures, safety of stem cell intervention allegedly provided by Henry Young and Bioregenesis Institute, disclosure of risks and adequacy of informed consent processes in Karen Hones’ case and in other instances in which ill individuals allegedly undergo stem cell procedures, quality of care in treatment of individuals receiving stem cell interventions that are not subject of investigational new drug applications or approved biologics applications, provision of stem cell “therapies” as “research” performed without oversight by IRBs and FDA, and alleged involvement of nonphysician stem cell researcher in practice of medicine. This lawsuit merits close attention by individuals who are concerned with domestic and international proliferation of clinics marketing stem cell-based interventions that are not provided in context of rigorously designed and conducted clinical studies reviewed and approved by both FDA and qualified, competent institutional review boards.

What we should know about stem cell treatment in the PH

By Totel V. de Jesus |INQUIRER.net 10:35 pm | Wednesday, January 30th, 2013

Doctor-lawyer Samuel Bernal, an expert in regenerative medicine, believes in the true worth of the Filipinos. CONTRIBUTED PHOTO

MANILA, Philippines—In recent years, it’s common to hear beauty doctors in the Philippines offering stem cell therapy as if a new-found medical fountain of youth, the answer to all medical worries.

In various media platform, there are bombardment of advertisements from various hospitals and clinics packaging stem cell therapy as “cure-all” remedy.

With such medical breakthrough, it begs the question on how equipped we are in offering such services. We can’t help but ask the parameters on distinguishing the real experts from seemingly fly-by-night clinics and medical centers.

Filipino-American doctor-lawyer Samuel Bernal, an expert in the fields of regenerative medicine and regulatory law, said the public should take a lot of precautions.

“Be careful. Number one, stem-cell therapy is not a ‘cure-all’ (medical procedure),” he said in an interview with the INQUIRER a few weeks after receiving the 2012 Presidential Award for Filipino Individuals and Organizations Overseas at the Malacañang Palace.

“The goal of stem-cell therapy is not a longevity-anti-aging program. Stem cell therapy is actually trying to allow the body to heal itself,” he said.

Educated at Johns Hopkins’ and Harvard Medical School, Dr. Bernal is currently Professor Emeritus of Medicine at the University of California-Los Angeles, member of American Association of Clinical Oncologists, the American Association of Cancer Researchers and a recognized cancer investigator with the US National Institutes of Health.

As a lawyer, his legal expertise includes cases on medical malpractice, medical product liability as well as Federal Drug Administration (FDA) and Federal Trade Commission’s (FTC) regulations in the testing, approval, advertising and marketing of health products.

He explained stem cell treatment requires “analyzing at the molecular level what is causing the problem or (what could be done) to prevent the problem.”

“Stem cells are just a small part of molecular approach to medicine. When someone is just collecting and injecting cells, that is really missing the point,” Dr. Bernal emphasized.

“So be careful, especially with any service that offers embryonic stem cells from aborted fetus, or genetically altered sources and most especially from animal cells,” he said.

Not in any clinic

“Number two precaution, you can’t really get this (stem cell therapy) in any clinic somewhere. Like in a hotel or a mall,” he said.

He added one needs a major health or medical center. In the Philippines, he cites the Medical City, St. Luke’s Medical Center “which is focused more on the eye,” and the Lung Center of the Philippines, which is obviously focused on the lungs, among others. “These are legitimate medical centers (that can perform the stem cell treatment),” he said.

Though educated and trained abroad, since 1992 Dr. Beltran has been consultant director at the regenerative medicine department of Medical City in Pasig City and has been visiting professor at the Ateneo de Manila University School of Science and Engineering.

As an example, he explained how they do it in the Medical City.

He emphasized having physicians around is not the only requirement to perform the stem cell treatment.

Dr. Bernal accepting the 2012 Presidential Award for Filipino Individuals and Organizations Overseas at the Malacañang Palace. CONTRIBUTED PHOTO

“You need an army of basic scientists in molecular biology, biochemistry and biochemical engineering,” he said.

“And that’s what we (at the Medical City) have. We have a group from the Ateneo School of Science and Engineering. We have a group from UST. All are brought together to be able to develop this very complex program to accelerate the body’s own ability to heal,” he said.

“Receiving this treatment in some clinic, you’re better not doing it at all.”

Each patient is unique

He said that even though “each day we have new discoveries” in the field of regenerative medicine, one thing is certain: Every patient is unique, very different from the other.

That’s why the existing standards, guidelines and “one-size fits all” approach don’t work.

“It applies to drugs but not to stem cell therapy. Model in clinical trials in drugs doesn’t apply to stem cell therapy. You cannot randomize clinical trials. That, maybe, is appropriate for drugs but not for stem cell therapy.”

He explained why data from one patient does not apply to another.

“First step is to understand what is unique about that patient. Gathering information from other people may give you the clue but it doesn’t give you the full information for each patient,” he said.

Dr. Bernal explained why stem cells can’t work by itself.

“It’s not an easy thing, na you just collect stem cells from the bone marrow and you inject to a patient with heart disease and he will be healed,” he said.

“Stem cells need other components. Remember we are not just a bag of cells. We need the components of maturation factors and growth factors.

“Third, there’s the dimensional architecture, composed of molecules. Fourth, there’s electrical energy and signaling, which are all very critical.

“Our brains, hearts, our eyes, livers, bones, all are electrical.

“That’s why stem cells by themselves don’t work. It’s only part of molecular medicine and it’s not a cure-all remedy.”

Philippines among the best

Dr. Bernal delivering his acceptance speech in Malacañang Palace on December 5, 2012. CONTRIBUTED PHOTO

The good news is, Dr. Bernal assured the Philippines already has the capability to perform the treatment and the medical institutions offering it are among the best in the world.

“The best, most advanced, customized services are right here in the Philippine. There’s no reason for Filipinos to travel abroad. Not even to US or Germany and definitely not to Singapore,” he said.

“In fact, it’s not a matter of theory but actual practice. We have gained competitive advantage so that Filipinos don’t have to travel to US or Europe. Yet most of our fellow Filipinos don’t know this.”

When we pointed out it has something to do with colonial mentality, Dr. Bernal agreed.

He said he knows there are cases when patients from North America “who could not be treated anymore there come here in the Philippines.”

“We have patients from Germany, Norway, Indonesia, Malaysia, Canada and Singapore. I wonder why are Filipino patients flying abroad?”

 

Filipino diaspora

This is one of the major concerns being addressed by the organization of accomplished overseas Filipinos he co-founded.

Together with Filipino-American businesswoman-philanthropist-social activist Loida Nicolas Lewis and INQUIRER.net contributing columnist lawyer Ted Laguatan, Dr. Bernal is founding member of the Global Filipino Diaspora Council.

The non-profit, non-governmental organization was founded during the “First Global Summit of Filipinos in the Diaspora” held in the Philippines in September in 2011.

Based on a May, 2012 article on INQUIRER.net, the organization aims to articulate “the Filipino migrant community’s concerns and desire to help in the development both of their host and home countries.”

The council also drew “a framework for Filipino communities to interact and work with multi-sectoral groups of both host and home countries in addressing issues, empowering migrants and strengthening their capacity to re-engage with the Motherland.”

Dr. Bernal’s focus, he said, is on health and science.

“We’d like to open opportunities not only in scientific field like molecular biology. We’d like to focus also on stem cell research’s contribution to the Philippines,”

On the business side, he said the council’s purpose is to increase the competitiveness of our Philippine hospitals, doctors and scientists.

“Instead of exporting our health professionals abroad, we’d like to open opportunities here. We are trying to develop the industry here by involving legitimate services.”

He added: “The legitimacy has something to do with providing technologies related to molecular biology of cells, in order to provide appropriate treatment that is designed, customized for each patient.”

Sterling career

Dr. Bernal graduated with a degree in Chemistry in 1969 from the University of Illinois. From 1966 to 1969, he conducted research in the area of Synthetic Organic Chemistry. From 1969 to 1974 he continued his research in Protein Synthesis at the University of Chicago, earning a Ph.D. degree in Biochemical Pathology in 1974.

In 1975, he completed his medical studies and obtained an M.D. degree from the University of Chicago. Early in his career, Dr. Bernal conducted experiments in nanotechnology involving protein synthesis in vitro and stem cell growth and differentiation.

At the Johns Hopkins Hospital, while continuing his research in the Human Biochemistry, he underwent medical specialty training in Internal Medicine from 1976 to 1979.

Dr. Bernal is Board Certified in Internal Medicine and is a Diplomate of the American Board of Internal Medicine.

In 1979, he continued his training as fellow in Internal Medicine at Harvard Medical School, and as fellow in Medicine at the Peter Bent Brigham Hospital in Boston. From 1979 to 1981, he underwent medical subspecialty training in Oncology (Cancer Medicine) at the Dana-Farber Cancer Institute at Harvard.

Dr. Bernal is Board Certified in Medical Oncology and is a Diplomate of the American Board of Cancer Specialists. From 1981 to 1983, he was a post-doctoral research fellow in Cancer Biochemistry, while appointed as Instructor at Harvard Medical School.

From 1983 to 1989, he was Assistant Professor of Medicine at Harvard Medical School, where he was conducting research in the differentiation and maturation of human cancer cells.

From 1989 to 1992 he was Associate Professor of Medicine at Boston University, where he examined Drug Resistance of Cancer Cells. Dr. Bernal transferred to University of California, Los Angeles in 1992, where he was Professor of Medicine, Director of the Cancer Center of the Greater Los Angeles VA Health Care System, and Attending Physician at Cedars-Sinai Medical Center. He is currently Professor Emeritus of Medicine at UCLA San Fernando. He has an active clinical practice, treating patients with new biotherapies including stem cells.

Dr. Bernal completed his Doctor of Jurisprudence degree in 1997 at the Loyola University Law School in Los Angeles. He specializes in Regulatory Law, particularly FDA and FTC regulations and in Medical Malpractice. He also completed a program in Comparative and International Law in Trinity College, Cambridge University, England. He is a licensed attorney in California State Courts and the U.S. Federal Courts.

He is currently in the senior lawyer program of the Center for International Business Law in Salzburg, Austria. Dr. Bernal completed his M.B.A. degree in a business program for company presidents at Pepperdine University, in Malibu, California, specializing in biotechnology business strategies. He is a founder and chair-man of LA-Boston Bioresearch Fund, a biotechnology research and consulting organization based in California, and GlobeTekPro International technology services and products.

Dr. Bernal published numerous scientific journal articles and several books including one on Lung Cancer Differentiation and Drug Resistance in Oncology. He is a member of the American Association of Clinical Oncologists, the American Association of Cancer Researchers, and a recognized cancer investigator with the U.S. National Institutes of Health.

He is a also member of the Board of Directors of several business organizations and foundations. Dr. Bernal’s legal practice includes Medical Malpractice, Medical Product Liability, and FDA and FTC regulations in the testing, approval, advertising and marketing of health products. He has served as consultant and panel presenter for FDA and FTC cases involving medical devices, nutritional supplements and pharmaceuticals.

His laboratory continues to create advances in cancer and stem cell growth and differentiation.

Stem cell ‘doctor’ faces more raps for Ateneo grad’s death By Sheila Crisostomo (The Philippine Star) | Updated April 20, 2014 - 12:00am

Katherine Grace Tan poses while undergoing treatment for Hodgkin’s lymphoma, in an undated photo provided by her father, Bernard.

MANILA, Philippines - A businessman has updated the charges he filed with the National Bureau of Investigation (NBI) against a wellness center operator who allegedly caused the death of his daughter, a cum laude graduate of Ateneo de Manila University, last year.

Bernard Tan added the illegal practice of medicine to the charges of estafa and reckless imprudence resulting in homicide he filed in October 2013 against Antonia Carandang-Park, her husband Young Joe Park and some center personnel over the death of his daughter Katherine Grace, 23, on July 4, 2013.

Tan based the additional charge on a certification issued in August 2013 by the Professional Regulation Commission showing that Park “does not appear in the database of physicians, which contains the names of those duly authorized to practice medicine in the Philippines.”

In an interview, Tan said Kate allegedly underwent stem cell treatment for Hodgkin’s lymphoma, a type of cancer, at the Green and Young Health and Wellness Center owned by Park in Tagaytay City during the last quarter of 2012.

“We went to her clinic and she told us that she already treated a similar case and it would only take three months to treat my daughter… We did not know that she is not a doctor,” he said.

According to Tan, his daughter was in remission but she no longer wanted to undergo the pain of cancer treatments like chemotherapy and radiation.

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“She also did not want to miss classes because she was graduating cum laude in March 2013.  So when we heard about Park, we went to her clinic in Tagaytay,” he said.

Tan said Park had promised his family that she could cure Kate within three months, provided that she will not receive any complimentary treatment from other doctors.  She assured the family that she already treated a similar case in the past.

Tan said Park had injected “embryonic stem cells” into his daughter several times and Kate was fed only bananas and vegetable juices for three months.

“Three months passed but my daughter’s condition was not improving.  She started to lose weight. She was deteriorating so we brought her to (conventional doctors),” he said.

Kate died on July 4, 2013.

No such treatment

The wellness center, in a statement published by www.interaksyon.com earlier this month, said Tan’s daughter “was never given stem cell treatment” by the center or Park.

The center’s lawyer, Stephen Cascolan, said Tan brought his daughter to “many other physicians” long after she visited the center. He said all hospitals where Kate was admitted and all doctors who treated her before she died “should be investigated.”

Cascolan also said Park never stated she was a licensed physician in the Philippines and her center is “assisted by… competent medical practitioners who are licensed in the Philippines.”

Previous charge

Earlier this month, the NBI filed a medical malpractice charge with a Tagaytay City court against Park, known for administering stem cell therapy on former President Gloria Macapagal-Arroyo.

Park “misrepresented herself as a licensed physician on several occasions,” according to an investigation by the NBI.

These incidents include the issuance of an official statement on July 25, 2012 regarding Arroyo’s treatment.

Park stated that she diagnosed Arroyo, now a Pampanga representative, and that “stem cell therapy is contemplated and strong considered for the latter’s condition. She even signed the same as ‘Dra. Antonia Park, M.D.’” the NBI said.

The malpractice charge was filed by Dr. Eunice Salazar-Abad, a physician who worked for wellness center. Abad alleged that she discovered that Park was using her name and doctor’s license number.

The NBI said Park “admitted that she did not take the licensure examination in medicine in the Philippines due to various preoccupations and that the wellness center she owns is not engaged in the practice of medicine.”

House panel trains sights on unregulated stem-cell therapy in PHBy: InterAksyon.comAugust 9, 2013 10:02 AM

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InterAksyon.comThe online news portal of TV5

MANILA, Philippines - The controversy over unregulated stem cell procedures in the country, including the role of unlicensed foreign doctors, has reached Congress, from where several alleged victims of malpractice came. The vice chairman of the House blue-ribbon panel is set to deliver a privileged speech Monday ahead of hearings on the current state of things in the stem cell therapy practice in the country, where experts warned earlier the "fad-like" atmosphere poses serious threat to public health and safety.

Rep. Doy Leachon of Oriental Mindoro is expected to train his sights on, among others: the unethical practice of stem cell therapy without Food and Drug Administration (FDA) approval and on unapproved indications; the charging of exorbitant fees for still-experimental procedures; the criminal liabilities of doctors who prey on the miseries of desperate sick patients; a review of the potential conflict of interest, unethical conduct of self-promotion and violation of FDA rules in pushing stem cell therapy and charging of fees involving the Philippine Medical Association (PMA) and Philippine Society for Stem Cell Medicine (PSSCM).

Leachon wants the academe, ethics experts and the Philippine College of Physicians to shed light on the multidimensional controversy.

The House inquiry may also focus on the deaths of two congressmen who allegedly died after undergoing stem cell therapy; and the case of Dangerous Drugs Board chairman Antonio Villar, who developed adverse reactions.

Expected to be summoned to the House hearings, besides representatives of the PMA and PSSCM are officials of the FDA, Department of Health, PRC, Securities and Exchange Commission,   Bureau of Immigration, Bureau of Internal Revenue and  other stakeholders.

Earlier this week, the Professional Regulations Commission (PRC) served notice it would require special permits from foreign doctors who conduct stem cell procedures in the country. It warned that those failing to do so, as well as their local partners, face criminals charges for medical malpractice.

For his part, Leachon--saying a class suit is possible against doctors in cases where the stem cell therapy was found to have caused deaths and adverse reactions--encouraged patients victimized by "unscrupulous con artists and who developed side effects" to report to his office.

Leachon, a lawyer, was a TOYM awardee in public service in 2011.