Dubious Stem Cell Creations

We’ve no doubt that this is how Captain Trips came about…

Food and Drug Administration just put dubious stem cell clinics on notice.

The agency announced plans on Monday for new policies and enforcement efforts to stamp out what it called “unscrupulous actors” peddling unproven, potentially dangerous, and often expensive stem cell therapies—including a bizarre and troubling instance involving smallpox vaccine.

As an initial demonstration of its harder stance, the agency today posted information on two enforcement efforts. One was a warning letter to a Florida stem cell clinic that had posed as legitimate clinical research andended up blinding three patients after injecting stem cells directly into their eyeballs. The other was a concerning announcement that the agency had seized five vials of smallpox vaccine from stem cell clinics in California.

The clinics, run by StemImmune Inc., were said to be mixing the dangerous vaccine with stem cells for an unproven, unapproved, and potentially harmful cancer treatment that was injected intravenously into patients or directly into their tumors. Though the injection of stem cells alone lacks safety and efficacy data, the vaccine is known to be dangerous. The vaccine contains a live poxvirus, similar but less harmful than smallpox. When it’s injected into patients with weakened immune systems—such as many cancer patients—the vaccine can cause life-threatening side effects, such as swelling of the heart.

Dubious Stem Cell Creations

Robin Williams and LBD

As you may know, my husband Robin Williams had the little-known but deadly Lewy body disease (LBD). He died from suicide in 2014 at the end of an intense, confusing, and relatively swift persecution at the hand of this disease’s symptoms and pathology. He was not alone in his traumatic experience with this neurologic disease. As you may know, almost 1.5 million nationwide are suffering similarly right now.

Although not alone, his case was extreme. Not until the coroner’s report, 3 months after his death, would I learn that it was diffuse LBD that took him. All 4 of the doctors I met with afterwards and who had reviewed his records indicated his was one of the worst pathologies they had seen. He had about 40% loss of dopamine neurons and almost no neurons were free of Lewy bodies throughout the entire brain and brainstem.

Robin is and will always be a larger-than-life spirit who was inside the body of a normal man with a human brain. He just happened to be that 1 in 6 who is affected by brain disease.

Not only did I lose my husband to LBD, I lost my best friend. Robin and I had in each other a safe harbor of unconditional love that we had both always longed for. For 7 years together, we got to tell each other our greatest hopes and fears without any judgment, just safety. As we said often to one another, we were each other’s anchor and mojo: that magical elixir of feeling grounded and inspired at the same time by each other’s presence.

Click through – it’s well worth the full read…

Robin Williams and LBD

No More Alzheimer\’s

Amyloid-β (Aβ) peptide has been implicated in the pathogenesis of Alzheimer’s disease (AD). We present a nonpharmacological approach for removing Aβ and restoring memory function in a mouse model of AD in which Aβ is deposited in the brain. We used repeated scanning ultrasound (SUS) treatments of the mouse brain to remove Aβ, without the need for any additional therapeutic agent such as anti-Aβ antibody. Spinning disk confocal microscopy and high-resolution three-dimensional reconstruction revealed extensive internalization of Aβ into the lysosomes of activated microglia in mouse brains subjected to SUS, with no concomitant increase observed in the number of microglia. Plaque burden was reduced in SUS-treated AD mice compared to sham-treated animals, and cleared plaques were observed in 75% of SUS-treated mice. Treated AD mice also displayed improved performance on three memory tasks: the Y-maze, the novel object recognition test, and the active place avoidance task. Our findings suggest that repeated SUS is useful for removing Aβ in the mouse brain without causing overt damage, and should be explored further as a noninvasive method with therapeutic potential in AD.

Or…in much plainer English:

Publishing in Science Translational Medicine, the team describes the technique as using a particular type of ultrasound called a focused therapeutic ultrasound, which non-invasively beams sound waves into the brain tissue. By oscillating super-fast, these sound waves are able to gently open up the blood-brain barrier, which is a layer that protects the brain against bacteria, and stimulate the brain’s microglial cells to activate. Microglila cells are basically waste-removal cells, so they’re able to clear out the toxic beta-amyloid clumps that are responsible for the worst symptoms of Alzheimer’s.

The team reports fully restoring the memory function of 75 percent of the mice they tested it on, with zero damage to the surrounding brain tissue. They found that the treated mice displayed improved performance in three memory tasks – a maze, a test to get them to recognise new objects, and one to get them to remember the places they should avoid.

Trans-Pacific Partnership

Fever

Flu-like symptoms in the 1950s were cause for consternation: polio was mostly under control, but a proven vaccine for smallpox wasn’t available until my high school years. Thus parents were justifiably worried a fever might mean the paralysis or death of their child; though now ‘eradicated’, smallpox killed nearly half a billion people in the 20th century.

Asta was ill yesterday and stayed home from classes. By the early afternoon she was running a fever of just under 102. Because of school, violin, brass instruments and guitar lessons, ballet and AP classes, Asta has yet to receive her annual flu vaccination. The rest of our little household have all been inoculated. 1 Of course as Asta’s ill she will have to further wait to be inoculated.

So naturally my first thought yesterday was: Fever = Ebola.

Which was stupid.

And also perfectly (as a parent) logical.

Though certainly a far cry away from being a pandemic, by almost any measure the risk from Ebola in America is certainly greater than the official news organs would allow – wouldn’t want to cause a panic now, n’est-ce pas? But where one Liberian managed to enter the U.S. infected with Ebola, more are sure to follow. If indeed they haven’t already; this time next month will undoubtedly see anywhere from 10 to 20 new cases in the United States. From there math will inexorably take over. We still have what? 50 million people uninsured, people living in the streets , or under bridges, in cardboard boxes, who are out and about in public every day; should one person in that demographic become infected the vectors would be nightmarish.

Worse, Ebola appears to be running rampant in Africa with little chance of being reined in: too many infection points there milling willy-nilly about, creating new infection points, and so on and so on. The African nations involved unfortunately have neither the personnel resources or an administrative infrastructure to effectively contain the virus.

Which is why the president deployed boots on the African ground. However in spite of  thousands of our troops sent to assist it is probably a matter of too little too late. The truth of that is reflected in the current international community’s ad hoc thinking: use Ebola survivors as primary care givers in these community centers.

Fever

This could have been the U.S. in the 50s and 60s had the medical community not made the decision to step in and do what it took to eradicate polio and smallpox…and still 500 million people died. Africa’s chance at stemming this particular blood tide occurred in the 70s but was (some say) deliberately thwarted by the IMF and the western world’s financial engines (including the good ol’ U.S. of A.) in yet another attempt at ‘nation building.’ So, no – there are not enough medical professionals, not enough government oversight and infrastructure, and certainly too little faith in the west’s medicine to be effective in and of themselves.

And the soon-to-be epidemic has not just flown through our doors; some of the EU states — themselves in the midst of draconian downsizing (due to that pesky world-wide recession Shrub and Company kicked off by meddling in the Middle East on someone else’s dime)– are hardly in much better shape than the African nations. Remember Greece? Really, really broke-ass Greece that is so down on its luck it was willing to throw its citizenry to the wolves if only Germany would loan it more money (it has no hope in hell of repaying)? The Greece that, like Blanche,  is only getting by due to the kindness of strangers? Do you really believe the Greeks are up to Ebola? For that matter Spain is still in a wait-and-see mode after fumbling their first known case. And hell, the ‘Stans could all morph into even more of the living hells than they already are should the virus spread there…

Closer to home? Mexico. The country is just a holey fence and some midnight illegal alien crossings away from swamping Sheriff Joe Arpaio’s county with an unprecedented medical emergency. Or do you really believe the drug gangs America’s insane War on Drugs has engendered are going to provide adequate triage and treatment?

Fever

If we are very, very lucky this mutation – different from the 70’s version – will not again mutate. However the more people who become infected, the more chance for mutation. So far the virus has remained non communicable when the individual is asymptomatic, but should that change, or if it alters so that it passes airborne, well…let’s not go there.

Where we should go in the future is toward a common good.

We should not sit back and decide that a deadly virus in a god-forsaken corner of the world should be left alone because 1) it only affects the ancestral home of our traditional field hands; besides it 2) moves through the population so fast it has no time to infect a broader population, burning itself out (and its hosts) in a matter of days, a few weeks at most.

Instead we need to lead the effort to expunge the world of such horrors, no matter who they bedevil; your fever is my fever and vice versa. Of course, truth be known, it was always ever thus.

Ebola has finally proven there are no more islands, geography be damned. What we do or don’t do will surely catch up with us from this point forward.

Fever

Show 1 footnote

  1. Though separately: my office no longer offers flu shots so three weeks ago I strolled down to the Brookside CVS and let the nice gentleman in the pharmacy there stick me in the arm, after first assuring him that his lack of medicine prepared for the ‘elderly’ (65 and up) would not be a hindrance to our mutual cause. Nora received her dose at the end of a normal hospital workaday. And Asta Jr. had her nasal passages invaded by the appropriate mist a couple of weeks ago during a routine Girl Scout checkup.