Medical Ethics and Personhood

By Jon Russell, National Coordinator of Medical Students for Life of America

Human person at the point of fertilization.

After all the advancements in medical science, which show us that human life definitely begins at fertilization, abortion advocates and some in the pro-life movement struggle with the issue of personhood. They ask the question: “when does personhood begin?” While those who advocate for the legality of abortion often admit that they don’t know or care to know when the personhood of a human begins, some will acknowledge that the human embryo or fetus has personhood rights but then claim the rights of the mother carrying the child trump the rights of the child. While I’m looking forward to addressing this logically fallible argument in a future article, it’s not the subject for the day.

I want to address the small minority of pro-lifers who claim that the human embryo(s) created for in vitro fertilization (IVF) or used in embryonic stem cell research may not be persons because they were not conceived through sexual intercourse. Some of these pro-lifers such as well-known pro-life physician Dr. Paul Byrne have made the case that these human embryos, made outside of sexual intercourse, are soulless and therefore cannot be considered persons. This line of “soulless” thinking beckons the question, What if a child is born as a result of IVF? Does that “soulless” child have a right to life? This dangerous line of reasoning condemns every human created through in vitro fertilization and destroyed through embryonic stem cell research to be beyond the realm of our concern for persons.

Setting aside the deep ethical concerns many of us have about IVF or our disdain for the unproven science of embryonic stem cell research, if we accept the argument that we must defend every human beings life from “conception/fertilization to its natural end” but cannot state that personhood rights also begin with conception, then we will stand with our hands tied beside Dr. Byrne (and Planned Parenthood). Our premise of our entire human rights movement falls quickly apart. This is the very logical fallacy that abortion advocates suffer from; they don’t believe in determining when personhood begins for humans and therefor anyone can say rights begin at any time most convenient to them. This fallacy is what drives some philosophers to even claim that children may be “put to death” or “left to die” after birth until a random point in time when it is determined they have value, are conscience, or can have the mental capacity to want to live.

So why is having the discussion of personhood rights important? It is important because as science continues to advance, the human embryo will increasingly be the object of destruction. If we allow for and tolerate the destruction of any human embryo, we have lost the entire argument of the intrinsic value of every human person starting at the point of fertilization. To this point there can be no compromise.


Why Don’t Patients Stay in the U.S. for Stem Cell Treatments?

by Rebecca Taylor | Washington, DC | | 8/1/12 3:08 PM

The United States has arguably the most advanced health care in the world. Which is why many Americans are surprised at how many of our fellow citizens are going abroad for stem cell treatments using their own adult stem cells. This is called an autologous stem cell transplant. So why is this autologous stem cell tourism happening and why are these stem cell treatments we keep hearing about not available in the United States?

Progressives often wrongly imply that it has to do with Bush’s restrictions on the funding of embryonic stem cell research. And since there is so much misinformation surrounding stem cell research, the public often believes that this is the case. In reality, this kind of stem cell tourism has absolutely nothing to do with that because these are autologous adult stem cell transplants not embryonic stem cell transplants.

The real reason is more complex than simple funding restrictions. It is because of the U.S. Food and Drug Administration or FDA. The FDA has categorized an autologous stem cell transplant as it would a drug and therefore autologous stem cell transplants must go through the same rigorous phase trials that a new drug would. From the FDA Regulation of Stem-Cell–Based Therapies in theNew England Journal of Medicine:

Any stem-cell–based product that contains cells or tissues that “are highly processed, are used for other than their normal function, are combined with non-tissue components, or are used for metabolic purposes” — and that includes most, if not all, of them — would also be subject to the Public Health Safety Act, Section 351, which regulates the licensing of biologic products and requires the submission of an investigational new drug application to the FDA before studies involving humans are initiated.

So because stem cells would be removed from the body and “processed” with components not from the patient to get them to grow, the FDA has ruled that an autologous stem cell transplant is like a drug.

Others disagree with this assessment basically taking the stance that because the stem cells come from the patient, they should not be considered a drug. From a press release from the former American Stem Cell Therapy Association (ASCTA) which changed its name to The International Cellular Medicine Society (ICMS):

“Many patients are dying or suffering daily with incurable diseases or problems that require major surgery. These patients should have access to basic adult stem cell therapy now.” stated Christopher J. Centeno, M.D, an ASCTA physician member. “ASCTA is establishing guidelines which will allow the safe use of the patient’s own adult stem cells under the supervision of doctors.” continued Centeno. Another ASCTA physician member, Frank Falco, M.D. stated, “The FDA’s position against someone using their own stem cells is taking it too far. We are talking about a person using their own tissue to treat a degenerative disorder or process safely without the use of medications or surgery. Although we agree that oversight and standards are necessary, this should be provided through a physician organization such as ASCTA rather than by a government agency.”

A U.S. District Court has now ruled that the FDA has the authority to regulate clinics in the U.S. that are offering autologous stem cell transplants. From New Scientist:

It’s official: stem cells are drugs. At least, that’s the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies.

Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice – not regulated by the US government. But if the cells are subjected to more than “minimal manipulation”, the FDA maintains that the therapy becomes a “drug”, which must be specifically approved for use.

It was on this basis that in 2008 the FDA began moves to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx.

Regenerative Sciences challenged the FDA’s authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court’s ruling.

Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. “This is really round one,” he says. “Our position remains that a patient’s cells are not drugs.”

I am not a doctor and am not qualified to comment on whether the FDA policy is reasonable or whether the court made the correct ruling, but I can say that this is an important decision. On one hand, it may prevent charlatans with too-good-to-be-true claims from preying on sick Americans. On the other hand, it means that autologous stem cell transplants with potential to help patients will have to go through years of trials, just like drugs, to get FDA approval.

If nothing else, readers should be aware of the FDA policy so that next time someone wrongly states that Americans are going elsewhere for stem cell treatments because of Bush’s funding restrictions on embryonic stem cell research, you can correct them.

Two Men HIV-Free After New Adult Stem Cell Breakthrough

by Andrew Bair | Washington, DC | | 7/30/12 10:50 AM

Adult stem cells are responsible for another incredible scientific breakthrough.

On Thursday at the AIDS 2012 Conference in Washington, DC, researchers unveiled that two HIV-positive men have been found to be HIV-free following bone marrow transplants. Researchers believe giving bone marrow transplants, which by nature involve the use of adult stem cells, to patients undergoing anti-retroviral therapy could potentially cure the AIDS-causing virus.

“We expected HIV to vanish from the patients’ plasma, but it is surprising that we can’t find any traces of HIV in their cells,” said Dr. Timothy Henrich, one of the researchers studying the two men. “It suggests that under the cover of anti-retroviral therapy, the cells that repopulated the patient’s immune system appear to be protected from becoming re-infected with HIV.”

Only time will tell if the two men have been permanently cured of the virus. “Studies over time including biopsies of lymphatic tissue would be required,” said Dr. Michael Saag, an infectious disease expert from University of Alabama at Birmingham.

The breakthrough bears similarities to the case of Timothy Ray Brown, known as “the Berlin patient,”who says he continues to be cured of HIV after receiving a transplant of cells found to have a genetic mutations making them HIV-resistant.

Bone marrow transplants mark one of the earliest uses of adult stem cells. The first successful one was performed in 1968. Today, they are used to treat a host of blood and bone marrow diseases, blood cancers, and immune disorders. Beyond their use in bone marrow transplants, adult stem cells are used to cure or treat nearly 80 diseases. In contrast to the widely successful adult stem cells, embryonic stem cell research requires taking the life of a living human embryo and has produced no success stories.

Recently, former Republican presidential candidate Rick Santorum announced he would be a national spokesman for Give Cures- The John Paul II Stem Cell Research Institute, an organization committed to advancing ethical adult stem cell research.

Santorum said, “It’s exciting to be a part of innovative research that uses cutting-edge, disease-specific adult stem cells to find treatments for rare diseases and cancer. Human life at the earliest stage is still a life- valued, loved, and created by God, and I believe to use and kill a human embryo for research is wrong. Creating ethical stem cell lines for people with rare diseases is ethical and innovative.”

Stem Cell Bank Closes as Embryonic Research Dies Off

Stem Cell Bank Closes as Embryonic Research Dies Off

by Gene Tarne | Bos | | 7/24/12 10:20 AM

It would seem that the California Institute for Regenerative Medicine (CIRM) is not alone as it increasingly moves away from human embryonic stem cell research (hESCR) and towards adult and other non-embryonic avenues of stem cell research.

As a recent Lozier Institute study reported, over the years since it was founded to provide financial support for hESCR, CIRM has instead been awarding more and more grants to adult stem cell research.  CIRM’s current strategic plan has as its goal moving projects as quickly as possible to the clinical trial phase, and its pattern of awarding more and more grants to adult stem cell research would indicate that hESCR is falling far short of achieving this goal.

Enter the University of Massachusetts Stem Cell Bank.

Or, rather, exit the University ofMassachusetts Stem Cell Bank.

According to news reports, the stem cell bank will run out of money at the end of the year and, when it does, state officials and officials at the University of Massachusetts have agreed to just let it close.

This was not how things were supposed to turn out.

As was the case with CIRM, the University of Massachusetts Stem Cell Bank was conceived as push-back against President Bush’s policy of limited federal funding for hESCR.

“Originally, the bank was seen as a repository for embryonic stem cell lines that were being created but were not eligible for federal funding under Bush-era restrictions,” according to the Boston Globe.

When it first opened, the bank was “absolutely state of the art,” said Susan Windham-Bannister, president of the Massachusetts Life Sciences Center.  Such a bank housing hESC lines was to be “a marquee piece of Governor Deval Patrick’s effort to bolster the life sciences industry” in Massachusetts.  Towards that end, the state provided just under $8 million to launch the project.

Yet today, “the bank receives one to two requests a week,” Terence Flotte, dean of University of Massachusetts Medical School, told the Globe.  The most reasonable explanation for this unanticipated development would seem to be that scientists hoping to turn research into cures are losing interest in working with hESCs.

Or, as the Globe succinctly put it, the bank has “become obsolete.”

Taken together with CIRM’s favoring of adult/non-embryonic stem cell research, the University of Massachusetts Stem Cell Bank’s closure provides yet more evidence that the therapeutic promise of hESCs – so hyped in the past — is becoming obsolete as well.