Stem Cell Clinics & the FDA

When any business over-promises and under-delivers, it is well on its way to failure.   Does this principle also hold true in the world of stem-cells?  In the last few months the promise of stem cell treatment has met the reality of government oversight.

Does the government have the responsibility to rein in the larger-than-life claims of stem cell treatment clinics? In a letter dated August 24, 2017 to US Stem Cell of Sunrise, Florida, the FDA cited at least 14 failures relating to the facility’s compliance with federal regulations. It is a powerful letter that makes one wonder what is happening in some of these clinics throughout the country. US Stem Cell responded quickly, re-asserting their claim that they were simply treating consenting patients with their own cells and not subject to the same sorts of regulations that drug manufacturers are.

Is there a place for government oversight over stem cell clinics? At the very least, it could easily be argued that some of their claims are over-the-top and should be subject to false advertising laws.  Michael Joyce makes this point clearly.  He cites the concerns of stem cell researchers Paul Knoepfler and Jeanne Loring. Dr Loring puts it bluntly: “[Stem cell clinics] don’t want to talk to real scientists . . . Because 99 percent of them know they’re pulling the wool over people’s eyes. This is marketing, not science.”

Joyce makes an important point. There are real people with real physical problems who are turning to stem cell clinics as a last resort. If one buys a faulty product from the mall, one has the opportunity to return it for a refund. However, if one receives a faulty medical procedure, how can they be repaid for their loss? In these cases, shouldn’t stem cell clinics be held accountable for misleading the public?

The New York Times describes what happened to some unfortunate individuals who suffered at the hands of US Stem Cell: “The women had macular degeneration, an eye disease that causes vision loss, and they paid $5,000 each to receive stem-cell injections in 2015 . . . Staff members there used liposuction to suck fat out of the women’s bellies, and then extracted stem cells from the fat to inject into the women’s eyes.” They “suffered severe, permanent eye damage…”

Desperate people will try desperate things in order to receive desirable results. It is my opinion that the FDA is acting properly by providing at least a level of protection from those who would exploit the desperation of suffering people.

Spiritual Pain

Recently, I’ve been thinking about spiritual pain. Given our current circumstances, it seems like it is more prevalent than we may have imagined.

In a 2006 article in the Journal of Palliative Medicine, spiritual pain was defined as ‘a deep pain in your being … in your soul, that is not physical’ (Mako, Glek, & Poppito). I must admit that seemed a bit nebulous to me, but it has been repeated in several other articles since which have dealt with this topic. Hospice innovator Cicely Saunders brought this concept to the front of people’s thinking with her talk of ‘total pain.’

In several studies on spiritual pain, cancer patients were asked if they had it, and presented with the definition above. Many said that they did. These studies have concluded that medical teams should take spiritual pain seriously as they seek to treat the “whole person,” not just a collection of miscellaneous symptoms. The thought being that, if someone’s spirit is being addressed, then perhaps the body would respond more positively. Or at the very least, perhaps relief in the spiritual area might mitigate some of the physical symptoms they are facing.

As a hospital chaplain, this seems quite reasonable to me. There are many patients whose very presence in the hospital (for any reason) leads them to experience spiritual pain. “Why am I here?” they ask. Or, “I thought God was on my side—how could this happen?” The sense of pain, although not measurable with medical devices, is absolutely real. It is something akin to what the prophet Jeremiah cried out to God in the Hebrew Bible: “Why is my pain unending and my wound grievous and incurable? You are to me like a deceptive brook, like a spring that fails” (Jer. 15:18).

In light of recent events—earthquakes, hurricanes, and horrific shootings—we must not only tend to the obvious physical needs of the hurting, but also to the spiritual pain they are facing. Last week I spent a day in Marathon in the Florida Keys talking to several people who had lost everything they owned in Hurricane Irma. Obviously, their physical needs are many; however, they also have a need to speak of what they lost and whether they will have the spiritual strength to carry on. It was my honor to hear what they had to say.

Treating the “whole person” entails listening to their struggles and offering meaningful support. This is more necessary than ever before. Let’s make progress in easing spiritual pain.

Happy Labor Day

As we enjoy the unofficial end of summer on this Labor Day, it’s good to remember those who do their difficult jobs well with little fanfare and in some cases, with some risk involved. One recent example is the case of Alex Wubbles, a Utah nurse who was arrested in July for simply following the basics of patient care when she stopped a police officer from taking blood from an unconscious patient without any warrant or consent.

If you have seen the troubling body-cam video of the incident, you can see the nurse calmly explain to the officer why she could not allow him to draw blood from the patient. During the confrontation, she spoke to her supervisor on the phone, who was able to confirm the correctness of her actions. Even this did not stop the officer from dramatically taking her into custody.

Clearly, this was an extraordinary occasion. However, we mustn’t miss an important point: Alex Wubbles put her patient’s rights first. By demonstrating patient-centered care, she valued the patient as a human being. This is medical care (and, by extension, bioethics) at its best. Even in the best of times, being a patient in the hospital can be a wearying and disorienting experience—all of the professionals coming in and out of the room, the strange sounding terminology, accompanied by the uneasy feeling that no one is listening to you. In the midst of it all, it is important to remember that the rights of the most vulnerable are as important as those of the most powerful.

We owe a debt of gratitude to the many in the medical field who watch out for their patients—in both small and large ways.

The NFL & CTEs, again

Channel surfing last week, I was shocked to see that there was an NFL preseason game on TV already. With the arrival of the NFL season comes a report from The New York Times on a study published in The Journal of the American Medical Association. 

The convenience study included the brains of 111 former NFL players, 110 of which were found to have evidence of chronic traumatic encephalopathy (CTE). Acknowledging the limitations of a convenience study, the authors conclude, “… CTE may be related to prior participation in football.” Putting it more bluntly, the Times quotes Dr. Ann McKee, who has studied the brains of 202 football players: “It is no longer debatable whether or not there is a problem in football—there is a problem.”

Thankfully, the NFL has come a long way since the publication of League of Denial by Mark Fainaru-Wada and Steve Fainaru in 2013. After years of denial, it now acknowledges a link and according to the Times “… has begun to steer children away from playing the sport in its regular form…” Indeed, there is much more emphasis on concussion protocol than ever before. But will it be enough?

Those who for one reason or another deny the linkage between playing football and CTE complain that the study is not a representative sample.   Fair enough. But still, the Times notes: “About 1,300 former players have died since the B.U. group began examining brains. So even if every one of the other 1,200 players had tested negative — which even the heartiest skeptics would agree could not possibly be the case — the minimum C.T.E. prevalence would be close to 9 percent, vastly higher than in the general population.”

Put more simply, evidence is mounting that shows that repetitively banging your head in a contact sport is dangerous to your health.

 

Buck v Bell at 90 years old

Last month marked the 90th anniversary of Buck v Bell. Justice Oliver Wendell Holmes wrote the Supreme Court decision that ruled that Virginia’s sterilization law was constitutional and infamously stated regarding the litigant Carrie Buck, “Three generations of imbeciles are enough.”

In his 2016 book Imbeciles: The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck (Penguin), Adam Cohen goes over the facts of the case as seen through its main characters. The picture that Cohen paints is grim. In his telling, by the time Carrie Buck’s case reached the Supreme Court, she did not have a chance to prevail. The system from top to bottom was wired against her. She was merely a trial case to establish the legality of state-sanctioned sterilization for the ‘feeble-minded,” leading to the sterilization of between 60,000-70,000 people.

Cohen’s book has received mixed reviews on stylistic grounds, some saying it spends too much time on one part of the story and not enough time on other parts. That said, none of the reviews I read suggests that he gets the story wrong.   Given the role that eugenics plays throughout Carrie’s story, this is especially chilling, because the book is more than history, it is a warning to those who want to remake humanity in their own image.

Cohen, a graduate of Harvard Law, states at the outset, “Another reason Buck v. Bell cannot be left in the past is that unlike so many of the Supreme Court’s worst rulings it has never been over-turned . . . In the twenty-first century, federal courts are still ruling that the government has the right to forcibly sterilize—and citing Buck v. Bell” (12).   While we would like to think something like this will never happen again, history does not allow us that luxury.

For those of us interested in bioethics, Cohen puts the matter plainly: “… Buck v. Bell remains critically important because its deepest subject is a timeless one: power, and how those who have it use it against those who do not” (12). If we devalue a person simply because they do not meet our standard of what a person should be, we are all devalued.   The story of Carrie Buck needs to be told and retold, and I am grateful to Cohen for retelling it.

 

 

 

Health care as a right

Reports on President Trump’s first 100 days have dominated the news lately.   Some have argued that he has not been able to deliver on his promises, while others have pointed out that he is slowly but surely keeping them. No matter what your political perspective, you will be able to find a cable news channel or some other media outlet that validates what you have been thinking.

Perhaps you have been keeping track of the ongoing debate over the Affordable Care Act (aka “Obamacare”). Seemingly all of the Republican candidates for president last year spoke of how they would “repeal and replace” Obamacare. And when Trump was elected, many assumed that the days of Obamacare were numbered.   However, an amazing thing happened along the way: it appears that Obamacare is more difficult to repeal and replace than first imagined. Even President Trump expressed this frustration when he said, “Now, I have to tell you, it’s an unbelievably complex subject. Nobody knew health care could be so complicated.”

The reasons for this complexity are too numerous to elaborate here. It is noteworthy that the Republicans had been campaigning against Obamacare since it was signed into law, but when given the opportunity to repeal and replace it after gaining control of the White House and both houses of Congress, there was no popular ready-made replacement to be found.

That said, the recent discussion on health care and the future of Obamacare raises an important question: Is health care a constitutional right? In a pivotal 1991 senatorial election, unknown candidate Harris Wofford defeated a former two-term governor of the state, Richard Thornburgh, by arguing that if the United States Constitution guarantees the right to an attorney, then by extension it guarantees the right to a doctor. Gov. Thornburgh never really rebutted the logic of that argument, and when it resonated with many unemployed Pennsylvanians, his easy path to victory was lost. The momentum of Wofford’s win was part of the rocket fuel that boosted Bill Clinton to victory in 1992 and inspired a national debate on health care insurance during the first years of his presidency.

Fast forward 25 years. Obamacare passed in 2010 and since then the Supreme Court has upheld its basic constitutionality. What Trump is now facing is the reality that it is very difficult, if not impossible, to repeal an entitlement, something that is considered by many to be a right. In an address to the Florida Bioethics Network last month, Rep. Debbie Wasserman Schultz not only defended the positive elements of Obamacare, she also revisited the basic argument of Senator Wofford. The message of her talk was that health care is a right for all Americans. She argued that taking health care away from anyone, as the replacement plan offered by the GOP is said to do, must be resisted.

It’s not clear what the next 100 days will bring, but it might be wise to revisit the “health care as right” discussion. At the very least, it could clarify what the next legislative steps should be.

On Slippery Slopes

In a recent commentary ethicist Arthur Caplan discusses the difference between physician-assisted dying (which he finds morally permissible) and physician-assisted suicide (which he finds troubling). He notes that “there are some very disturbing developments” in Belgium and Holland. Instead of having a terminal illness as a trigger, these countries have a different standard: “Are you suffering and is it irremediable?”

Caplan notes, “During the past year, people in Belgium and Holland have been given access to lethal doses of medication by doctors for things like a bitter divorce, losing their job, going blind, and very severe depression. People who are not dying and healthy persons are requesting help in dying from a doctor—and getting it—on the grounds that their life has lost meaning or that they do not want to go on because of their suffering.”

Caplan correctly finds this troubling. I wholeheartedly agree with his warning about the potential slippery slope that America is facing. If the past is any indication of the future, it will not be long before a seriously depressed person files suit challenging a state’s assisted-suicide law, arguing that they too have the “right to die.” Interestingly, however, he offers no solutions to prevent this from happening. Perhaps that is because slippery slopes seldom have off-ramps.

Indeed, those who have argued against all physician-assisted suicide (whether for terminal diseases or deep depression) have often utilized the ‘slippery slope’ argument that Caplan now employs. Opponents of PAD have consistently argued that once physicians move away from their role as healers to the role of assisting in suicide, slippery slopes are bound to follow.  Is there any way to reverse a slippery slope?

On Cuba’s Birth Rate

Last month The Washington Post reported that “Cuba is giving parental leave to the grandparents of newborns, the country’s latest attempt to reverse its sagging birthrate and defuse a demographic time bomb.” Upon closer look, the low Cuban birth rate has been a cause of concern for years. Of course, fewer babies spell demographic trouble. The population on the island country is aging and if things continue, there will not be enough people to replace them when they die. The problem becomes even worse when one considers that there are many who flee the country every year. It makes better sense for those people to have children after they leave the country, not before.

Explaining this potential crisis, one website notes that “Cuba’s low birth rate is largely attributable to three factors: the sluggish economy, emigration of women of child-bearing age, and the fact that over 70% of the labor force is professional women (who tend to delay childbirth while they pursue careers).” On a personal note, someone I know was visiting the country recently and was told by a young couple, “Why would we want to bring children into this situation?”

Additionally, when The New York Times reported on the Cuban birth rate issues two years ago, it noted the island’s high abortion rate:

“There is another factor that alters the equation in Cuba: Abortion is legal, free and commonly practiced. There is no stigma attached to the procedure, helping to make Cuba’s reported abortion rates among the highest in the world. In many respects, abortion is viewed as another manner of birth control.

“By the numbers, the country exhibits a rate of nearly 30 abortions for every 1,000 women of childbearing age, according to 2010 data compiled by the United Nations United Nations. Among countries that permit abortion, only Russia had a higher rate. In the United States, 2011 figures show a rate of about 17.”

While The Times article thinks the Cuban abortion rate is more a result of the bad economy than the cause of the low birth rate, it is difficult to ignore such a high rate.

One further factor comes to mind. In his 2013 Erasmus Lecture to the Institute on Religion and Public Life, Rabbi Jonathan Sacks addresses the possibility of believers establishing “creative minorities” in cultures that are not necessarily friendly toward religion. As he outlines his proposal, he interacts with a 2004 lecture from then Cardinal Ratzinger in which he discusses the population decline in Europe. Sacks remarks, “Though he [Ratzinger] did not use these words, he implied that when a civilization loses faith in God, it ultimately loses faith in itself.” These words might also be applied to Cuba’s population growth problem. Stated another way, faith in God ought to lead to greater faith in humanity, because faith is able to see that humans are created in the image of God. It ought to inspire a culture of life, where hope and love are in abundance.

Bioethics & SCOTUS Appointment

Some of us had hoped that bioethics would have been an issue in the presidential election of 2016, but that was not to be. Now, less than three weeks into the Trump presidency, bioethics appears to have resurfaced in the nomination of Judge Neil Gorsuch to be an associate justice on the Supreme Court.

Amidst all the media coverage of his appointment, The Washington Post, among others, made note of the fact that Judge Gorsuch has published a book arguing against euthanasia and physician assisted suicide. The Future of Assisted Suicide and Euthanasia is temporarily out of stock on Amazon , but the Post writer offers a summary of the 2006 publication, calling it “exhaustive, but evenhanded, treating respectfully the positions of those who disagree with him.” The premise of Gorusch’s argument is that “. . . [A]ll human beings are intrinsically valuable and the intentional taking of human life by private persons is always wrong.”

During the nomination process, Judge Gorsuch will be asked all kinds of questions on any number of important legal issues. In light of the recent activity in the United States on physician-assisted suicide laws, I am hoping that at least one senator will ask him how his views on PAS and euthanasia may have changed in the past decade.

Happy New Year!

As I sit to write this blog, 2016 is nearing its end. It seems like many people are quite happy about this prospect. I must admit, the year became rather wearying at points with all of its ups and downs.

I took a few moments to reflect upon my blogs from the past year. Zika, physician-assisted death, and pharmaceutical prices were some of things I blogged about in 2016. Undoubtedly, each of those, along with many others, will continue to be issues in 2017.

At the beginning of 2017, with all of the things that are rapidly changing around us, there is one thing that remains constant: the intrinsic value of a human life. As we approach 2017, let us remember that this value is not an economic number, based on an individual’s contribution to the national GDP. Neither is the value of a human life based on intellectual ability, tied to a person’s IQ. Too often, humanity’s measurements of a person’s value—physical strength, intelligence, or buying power—all miss the point. Those from a Judeo-Christian perspective understand that each and every human is made in the image of God; therefore, each deserves to be treated with honor and dignity. Bioethics is at its best when it recognizes this unchangeable reality.

Have a great 2017!