Blog Archives

Stem Cells Part I

1/28/2018

“Wild fire.” That was how Dr. Paul Knoepler—a well-known American cell and molecular biologist—phrased the up swell` of direct-to-consumer stem cell clinics. In less than nine years, the number of new stem cell clinics has gone from two to about 600, with new clinics more than doubling every year. Here’s a youtube video showing how the map has changed over time: https://www.youtube.com/watch?v=7U-WMKr1K3w .
*Direct-to-consumer means patients see advertisements of different treatments for themselves, like seeing an ad banner online, rather than hearing about it from their doctor during a regular office visit.

These private clinics cater to a growing market of patients—ranging from curious to desperate—who often seek stem cell treatment for joint disease, pain, and nerve damage. They use stem cell products that are neither FDA-approved nor approved for a special status that allows doctors to use them for possibly life-saving treatment. So, then, why do these clinics continue to crop up and use unapproved products? Most likely because no one told them it was wrong.

Since 2009, less than one warning letter per year has been issued from the Food and Drug Administration (FDA), the organization responsible to monitoring drug and biologic product safety. This inaction, according to Dr. Knoepler, may have “inadvertently enabled the US commercial space for unproven stem cell interventions.” However, the FDA may be starting to pick up the pace on its review of clinics and stem cell manufacturers. Just this past month a major warning letter was sent to a company in New Jersey. Many of the complaints were related to the processing of the stem cell product, which is derived from a patient’s own fat tissue and currently the most popular non-FDA approved stem cell product in the market. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm . It’s unclear yet what the consequences will be for not complying the letter, but the tone suggests that the FDA’s patience has run out.

But why go through all this trouble? So many doctors are using stem cells. Shouldn’t it be safe? What is a stem cell, anyhow? And if stem cells are retrieved from one’s own body, what harm is there in injecting them back into the same body? More on this next.

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1
https://ipscell.com/2018/01/animated-map-video-shows-wildfire-spread-of-us-stem-cell-clinics-lacking-fda-approval/
2
https://www.futuremedicine.com/doi/10.2217/rme-2017-0115
3
https://www.nytimes.com/2017/08/28/health/fda-stem-cell.html?rref=collection%2Ftimestopic%2FFood%20and%20Drug%20Administration&action=click&contentCollection=timestopics&region=stream&module=stream_unit&version=latest&contentPlacement=16&pgtype=collection

The Shutdown

1/27/2018

It’s happening. The federal government is partially shutting-down. And though there are endless summaries of what will happen, the truth is no one can really predict it. That’s because each federal agency has it’s own contingency plan. And these plans, just like any plan you might make for, say, an unpredicted house fire or bad weather, can be adjusted by the leadership of each agency as deemed prudent.

For example, if part of an employee’s work is deemed essential but another part is not, can that employee still do the other nonessential work? According to page 9 of the official memorandum by the White House Budget Office ( https://www.whitehouse.gov/wp-content/uploads/2017/11/m-18-05-Final.pdf ), it seems like the answer to this is “yes” as long as it is completed within a day. However, what constitutes essential and nonessential work also varies between agencies. So, in order to help you better understand what might happen, or what has happened, or what should have happened, is your very own official guide on the “Causes, Processes and Effects” of a government shut down: https://fas.org/sgp/crs/misc/RL34680.pdf. This official publication by the Congressional Research Service outlines in detail the history of recent shutdowns (there have been 18!), the specific order of furloughs and the multiple unresolved issues related to federal grants and national security.

But why does the government even have to shut down? Well, it turns out that there is a law called the Antideficiency Act that states an agency must cease operations if there are no appropriations (planned budget) for the year, except in certain situations when law authorizes continued activity. The idea is that this would help the government run responsibly. A summary of some things that might change during a partial shut down can be found here: https://www.voanews.com/a/during-government-shutdown-what-closed-who-affected/4216433.html/

In healthcare, the big federal entities that see immediate changes are the National Institutes of Health Clinical Center, which has to stop accepting new patients for clinical studies (https://cc.nih.gov/), and the Centers for Disease Control and Prevention, which has to stop surveillance activities including answering their disease hotline. The VA should operate as normal, and clinics and hospitals expecting reimbursements from Medicare and Medicaid should still see payments made on time. However, because employees who help answer billing questions might be furloughed, there might be delays in solving payment problems or correcting billing errors.

If you haven’t tired of yet another piece on the federal shut-down, then here are additional links to writings on what has happened ( https://www.natlawreview.com/article/effect-government-shutdown-medicare-medicaid-and-other-affordable-care-act-aca-relat ) and what might happen https://www.whitehouse.gov/omb/agency-contingency-plans/

Angelie Singh

Photo used under Creative Commons from lena_lozhkina