Stem Cell Clinics Promise Miracle Cures, but at What Cost to Patients?

These clinics offer shining testimonials. Yet, the technique has not been proven safe and effective. 

 

Stem cell clinics have popped up all over the country, promising vast improvements in serious conditions, and offering patient testimonials to back up their claims. At the same time, these clinics are skating a line, carefully warning that these are anecdotal statements and that such treatment “…is not a cure for any medical condition.” This particular legal statement comes from the website of StemGenex, of La Jolla, Calif., recently the focus of an exposé by the L.A. Times.  


Such clinics use direct marketing techniques to approach patients with serious conditions, hinting that an “intervention” will improve symptoms dramatically. Alzheimer’s patients and those who have children with autism are particularly targeted. According to one researcher, who attended an informational session at a clinic, “There were people in the audience suffering from various conditions that made them a fairly vulnerable population.” Some experts wonder whether the dramatic turnarounds patients claim in testimonials is not just the placebo effect or a short-term improvement, which may not last.

Over 500 stem cell clinics have opened their doors across the country with virtually no oversight, according to an FDA hearing in September. This fledgling sector is taking advantage of a regulatory loophole. They offer stem cell therapies which are virtually untested, and make unsubstantiated claims about helping patients overcome disease. Sports stars undergoing stem cell therapy have fueled interest. Angel’s pitchers Andrew Heaney and Garrett Richards, tennis star Rafael Nadal, and quarterback Peyton Manning are among them.

Such clinics use autologous stem cells, the kind that are extracted from the fat of a patient’s abdomen—known as adipose stem cells. Whether or not this particular kind offer any therapeutic benefit at all is something currently under debate. There are some clinics which provide umbilical cord or amniotic stem cells, along with documentation to prove their origin. Yet, the use of these remains controversial.

Stem cell therapy among sports stars has increased public interest in such treatments.

Another problem is, clinical trials have not cleared such practices for safety and effectiveness, according to a statement by the International Society for Stem Cell Research. Even so, for these clinics business is booming. Their services cost thousands, tens of thousands, or even $100,000. That’s an out-of-pocket expense. No health insurance company will cover such a procedure.

Meanwhile, stem cell researchers are worried that these clinics might sully legitimate research or therapies in the pipeline. Paul Knoepfler is one such researcher. He hails from the University of California, Davis. He and bioethicist Leigh Turner at the University of Minnesota, conducted a survey last year of “stem cell tourism.” 570 clinics across the US were identified. Some patients even travel to Mexico or the Caribbean to have a stem cell procedure done.

These researchers discovered a confluence of clinics in major cities including New York, L.A., Beverly Hills, and San Antonio, Texas. Knoepfler and Turner found clinics offering other treatments, unrelated to stem cell therapy, yet marketed as such. There was a lack of uniformity among clinics, and experts say that outcomes are often ambiguous. Imagine paying a small fortune for something and not knowing whether or not the treatment helped.

Knoepfler visited an informational seminar at one clinic, which he described in the journal Stem Cells Translational Medicine. He encountered “questionable medical claims,” gleaming testimonials, and an informational packet which included a credit application. Those with Parkinson’s, Autism, M.S., cerebral palsy, and Lou Gehrig’s disease are said to experience incredible improvements, according to the clinic’s literature. One of the claims he found dubious was, “90% of patients had a 50% or better improvement.”

Patient testimonials speak of sparking turnarounds. But experts wonder if this is just the placebo effect.

According to Knoepfler, this is a fledgling science still in the seminal stages. The idea of a simple injection improving one’s condition is an attractive one, especially for those with suffering from a serious medical condition. But at this stage, clinical trials are lacking, hence the absence of FDA approval.

In this case the speed of enterprise has outpaced regulation. The FDA is trying to catch up. It recently clamped down on topical cream distributors who claim to use stem cells in their formula. Some clinics in New York, California, and Miami have also received written warnings. Two so far, one in California and another in New York, have closed down as a result.

Since these clinics aren’t technically using a medical device or drug, the FDA doesn’t have a policy in place to regulate them. The procedure itself has also proven tricky to regulate. It uses the patient’s own cells. Since they don’t come from someone else and aren’t dramatically altered, the procedure isn’t technically considered a transplant. But this loophole allows stem cell clinics to posit unproven claims and rake in the cash, without having to undergo the lengthy and costly clinical trial process.

Cutting out access outright could block some patients from a treatment they may be benefiting from. That’s why the REGROW Act is moving through Congress which would allow some stem cell therapies to move quickly through the clinical trial process.

Yet, the editorial board for the journal Nature argues that doing so could undermine good science and prematurely adopt therapies, without knowing whether or not they work, or are safe. Other experts point out how slow and cumbersome the regulatory process is, and are calling on the FDA to streamline it, so companies don’t have to spend fortunes, and patients suffering on the sidelines can gain quicker access.

To learn about where we are in terms of stem cell therapy, click here:  

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Political division is nothing new. Throughout American history there have been numerous flare ups in which the political arena was more than just tense but incideniary. In a letter addressed to William Hamilton in 1800, Thomas Jefferson once lamented about how an emotional fervor had swept over the populace in regards to a certain political issue at the time. It disturbed him greatly to see how these political issues seemed to seep into every area of life and even affect people's interpersonal relationships. At one point in the letter he states:

"I never considered a difference of opinion in politics, in religion, in philosophy, as cause for withdrawing from a friend."

Today, we Americans find ourselves in a similar situation, with our political environment even more splintered due to a number of factors. The advent of mass digital media, siloed identity-driven political groups, and a societal lack of understanding of basic discursive fundamentals all contribute to the problem.

Civil discourse has fallen to an all time low.

The question that the American populace needs to ask itself now is: how do we fix it?


Discursive fundamentals need to be taught to preserve free expression

In a 2017 Free Speech and Tolerance Survey by Cato, it was found that 71% of Americans believe that political correctness had silenced important discussions necessary to our society. Many have pointed to draconian university policies regarding political correctness as a contributing factor to this phenomenon.

It's a great irony that, colleges, once true bastions of free-speech, counterculture and progressiveness, have now devolved into reactionary tribal politics.

Many years ago, one could count on the fact that universities would be the first places where you could espouse and debate any controversial idea without consequence. The decline of staple subjects that deal with the wisdom of the ancients, historical reference points, and civic discourse could be to blame for this exaggerated partisanship boiling on campuses.

Young people seeking an education are given a disservice when fed biased ideology, even if such ideology is presented with the best of intentions. Politics are but one small sliver for society and the human condition at large. Universities would do well to instead teach the principles of healthy discourse and engagement across the ideological spectrum.

The fundamentals of logic, debate and the rich artistic heritage of western civilization need to be the central focus of an education. They help to create a well-rounded citizen that can deal with controversial political issues.

It has been found that in the abstract, college students generally support and endorse the first amendment, but there's a catch when it comes to actually practicing it. This was explored in a Gallup survey titled: Free Expression on Campus: What college students think about First amendment issues.

In their findings the authors state:

"The vast majority say free speech is important to democracy and favor an open learning environment that promotes the airing of a wide variety of ideas. However, the actions of some students in recent years — from milder actions such as claiming to be threatened by messages written in chalk promoting Trump's candidacy to the most extreme acts of engaging in violence to stop attempted speeches — raise issues of just how committed college students are to
upholding First Amendment ideals.

Most college students do not condone more aggressive actions to squelch speech, like violence and shouting down speakers, although there are some who do. However, students do support many policies or actions that place limits on speech, including free speech zones, speech codes and campus prohibitions on hate speech, suggesting that their commitment to free speech has limits. As one example, barely a majority think handing out literature on controversial issues is "always acceptable."

With this in mind, the problems seen on college campuses are also being seen on a whole through other pockets of society and regular everyday civic discourse. Look no further than the dreaded and cliche prospect of political discussion at Thanksgiving dinner.

Talking politics at Thanksgiving dinner

As a result of this increased tribalization of views, it's becoming increasingly more difficult to engage in polite conversation with people possessing opposing viewpoints. The authors of a recent Hidden Tribes study broke down the political "tribes" in which many find themselves in:

  • Progressive Activists: younger, highly engaged, secular, cosmopolitan, angry.
  • Traditional Liberals: older, retired, open to compromise, rational, cautious.
  • Passive Liberals: unhappy, insecure, distrustful, disillusioned.
  • Politically Disengaged: young, low income, distrustful, detached, patriotic, conspiratorial
  • Moderates: engaged, civic-minded, middle-of-the-road, pessimistic, Protestant.
  • Traditional Conservatives: religious, middle class, patriotic, moralistic.
  • Devoted Conservatives: white, retired, highly engaged, uncompromising,
    Patriotic.

Understanding these different viewpoints and the hidden tribes we may belong to will be essential in having conversations with those we disagree with. This might just come to a head when it's Thanksgiving and you have a mix of many different personalities, ages, and viewpoints.

It's interesting to note the authors found that:

"Tribe membership shows strong reliability in predicting views across different political topics."

You'll find that depending on what group you identify with, that nearly 100 percent of the time you'll believe in the same way the rest of your group constituents do.

Here are some statistics on differing viewpoints according to political party:

  • 51% of staunch liberals say it's "morally acceptable" to punch Nazis.
  • 53% of Republicans favor stripping U.S. citizenship from people who burn the American flag.
  • 51% of Democrats support a law that requires Americans use transgender people's preferred gender pronouns.
  • 65% of Republicans say NFL players should be fired if they refuse to stand for the anthem.
  • 58% of Democrats say employers should punish employees for offensive Facebook posts.
  • 47% of Republicans favor bans on building new mosques.

Understanding the fact that tribal membership indicates what you believe, can help you return to the fundamentals for proper political engagement

Here are some guidelines for civic discourse that might come in handy:

  • Avoid logical fallacies. Essentially at the core, a logical fallacy is anything that detracts from the debate and seeks to attack the person rather than the idea and stray from the topic at hand.
  • Practice inclusion and listen to who you're speaking to.
  • Have the idea that there is nothing out of bounds for inquiry or conversation once you get down to an even stronger or new perspective of whatever you were discussing.
  • Keep in mind the maxim of : Do not listen with the intent to reply. But with the intent to understand.
  • We're not trying to proselytize nor shout others down with our rhetoric, but come to understand one another again.
  • If we're tied too closely to some in-group we no longer become an individual but a clone of someone else's ideology.

Civic discourse in the divisive age

Debate and civic discourse is inherently messy. Add into the mix an ignorance of history, rabid politicization and debased political discourse, you can see that it will be very difficult in mending this discursive staple of a functional civilization.

There is still hope that this great divide can be mended, because it has to be. The Hidden Tribes authors at one point state:

"In the era of social media and partisan news outlets, America's differences have become
dangerously tribal, fueled by a culture of outrage and taking offense. For the combatants,
the other side can no longer be tolerated, and no price is too high to defeat them.
These tensions are poisoning personal relationships, consuming our politics and
putting our democracy in peril.


Once a country has become tribalized, debates about contested issues from
immigration and trade to economic management, climate change and national security,
become shaped by larger tribal identities. Policy debate gives way to tribal conflicts.
Polarization and tribalism are self-reinforcing and will likely continue to accelerate.
The work of rebuilding our fragmented society needs to start now. It extends from
re-connecting people across the lines of division in local communities all the way to
building a renewed sense of national identity: a bigger story of us."

We need to start teaching people how to approach subjects from less of an emotional or baseless educational bias or identity, especially in the event that the subject matter could be construed to be controversial or uncomfortable.

This will be the beginning of a new era of understanding, inclusion and the defeat of regressive philosophies that threaten the core of our nation and civilization.