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“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

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

Heat waves steal headlines for their deadly spikes, but, globally, more deaths are caused by the cold than heat. When it comes to heat, our bodies do a pretty good job of regulating our core temperature without any help. But when the temperature drops, even to a mild 60 degrees F, our bodies rely on heaters and extra clothes. This human weakness is especially dangerous in subzero temperatures, where a few minutes in wet clothing or little clothing can cause severe hypothermia or even death if left untreated. Tragically, this past week nine Wisconsinites lost their lives to hypothermia.

HYPOTHERMIA
Doctors divide hypothermia into three stages: mild, moderate, and severe. But what we call mild hypothermia is a already drop in the body temperature below 95 degrees F (normal body temperature is about 98.6) and not actually very “mild.”

Unlike heat stroke or other problems with high temperature, mild hypothermia has more subtle symptoms. You might just feel off or slow, have some memory loss and confusion, or feel angry and become combative. You also might notice the skin on your belly or inner thigh feeling cooler, and even if you don’t notice this, your brain will detect the low temperature and start sending signals to make heat by shivering.

Shivering jacks up your metabolism 4 to 6 times, so it costs a lot of energy and isn’t a good long-term solution. Your breathing and heart rate speed up to help fuel the shivering and also to make sure the rest of your organs are getting enough oxygen. But once the core body temperature gets below 91.5 degrees F, your brain starts to malfunction. This is known as the “transition zone.” Everything starts to slow down, including your heartbeat and breathing. This is a time when arrhythmias—abnormal heart beating that could lead to death—are likely to occur. It’s a very dangerous emergency that could require intensive care in the hospital.

WATCHING FOR SIGNS AND PREVENTION
If you or someone you know has been outside or in wet clothes and appears confused, is slowing down mentally and physically, and/or is shivering, take a temperature. If the temperature reads 95 degrees F or below, GET EMERGENCY HELP immediately. While you wait for help, or if the temperature is above 95, take off any wet clothing and wrap the person in warm, dry blankets. Prioritize keeping the core warm rather than the arms and legs. Do not take a hot bath as this might actually cause the temperature to drop further (known as the “after drop”). If the person is talkative or interactive, encourage drinking fluids. Do not force any drinks down if the person is losing consciousness.

For older adults, a slight decrease in temperature can be even more problematic because the body’s shivering mechanism is weaker, and the perception of cold may be less sensitive. In addition, older adults are more likely to have other medical problems that are exacerbated by slight fluctuations in temperature.

Here are three non-commercial websites with more information about hypothermia prevention and care.

For all age groups: https://www.cdc.gov/disasters/winter/staysafe/hypothermia.html
https://medlineplus.gov/ency/article/000038.htm

For older adults:
https://www.nia.nih.gov/health/cold-weather-safety-older-adults

TREATING FROST BITE
Frostbite is when the skin or another part of the body temperature reaches 32 degrees F, literally freezing. Unlike hypothermia, frostbite should be rewarmed with warm water (99 to 104 F). Rewarming a frost bitten hand can be very painful as sensation returns to the hand.

HYPOTHERMIA AND CHRONIC PAIN
Some patients with chronic pain sense that things are worse when there is a sudden temperature change. And in the winter they seem to be extra sensitive to cold air. Well, a research team in Australia was interested in looking at this topic and asked the question: do chronic back pain suffers have a lower threshold for pain from cold or heat than other people without low back pain?

Turns out that pain sensitivity from cold stimulation may be worse in those patients with chronic low back pain when compared with patients with no chronic pain. By using a cold stimulus that gradually got colder, a thermometer, and a button, subjects would push when they wanted the pain to stop, researchers measured the difference in cold pain tolerability. When the cold stimulus was on their arm, subjects with chronic back pain asked to stop the cold stimulus at 57 degrees F, on average, while subjects without low back pain averaged at 46 degrees F. And this difference was statistically significant.

DISCLAIMER:

The above does not constitute professional medical advice. Please contact your doctor or health care provider for personal medical attention. Seek immediate medical help for anyone with suspected hypothermia or frostbite. Call 911 if you suspect severe hypothermia or notice any change in mental alertness.

Angelie Singh, MD, MPH, MS

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