FDA vs Experimental Stem Cell Drug lawsuits, investigations, and online ads

President Trump’s choice for FDA Commissioner was Dr. Scott Gottlieb. He was no stranger to FDA nor the inner workings of the field of medicine having acted in several capacities over the years in the field and in government. His qualifications were impressive as well as extensive and involved government work as well, not even the liberals could object to much about him.

According to MedCity News on December 26,2017 the man hit the office at high-speed to help get the backlog and procedures out of stasis to process applications faster and improve investigative procedures.

“Dr. Gottlieb’s first year as FDA Commissioner, he has chaperoned the agency through a blockbuster 2017 with 46 novel drug approvals to date. The final tally is the highest seen this century, surpassing the previous record holder 2015, which clocked in at 45. Both were more than double 2016’s sad tally of 22 new molecular entities (NMEs) approved.”

So is it that this is just “politics” or is there actually a sound basis for having FDA approve new drugs and oversee all? Overall, it isn’t about politics but about safety and procedures. Part of the problem has always been the length of time required to get a drug to market. Apparently Dr. Gottlieb now has a handle on that process and is making progress far beyond those of the last eight years.

One area of expertise for Dr. Gottlieb is stem cell research. In November, the FDA released new guidelines, asserting its authority over clinics, and says it will begin cracking down on those selling dangerous stem cell treatments.

Stem cell research has been around since 1968. Since that time stem cell research, trials, production, therapy, and results have been moving forward in many ways. Some have been well-documented and some research has been faked by seemingly qualified research analysis. Stem cell research has now progressed dramatically and there are countless research studies published each year in scientific journals.

Adult stem cells are already being used to treat many conditions such as heart disease and leukaemia. Researchers still have a long way to go before they completely control the regulation of stem cells. The potential is overwhelmingly positive and with continued support and research, scientists will ideally be able to harness the full power of stem cells. However, rogue groups continue to test the boundary between clinically FDA certified and experimental with no safeguards and unapproved methodology.

Back in July 2012, in the case of United States of America v. Regenerative Sciences, LLC the DC Court of Appeals ruled that their stem cell “therapy” was to be considered a product and therefore required FDA approval. Their product, Regenexx-C, was for the treatment of arthritis and orthopedic injury that involved extraction and culture of mesenchymal stem cells from the same patient which were later reinjected. After the decision the makers of Regenexx-C moved out of the U.S. to a more lenient country and placed a ban on being purchased for US markets.

Was it the right choice for the health of the patient? According to the company making Regenexx their success rate is good. This may force those wealthy enough or willing to go into deep debt to travel to their location for treatment. It also might deny solutions to other patients who don’t have the same resources here in the states.

This isn’t the only instance nor will it be the last where FDA and companies wanting to “make money” off their products clash. More than a few companies had moved out of the US over the years over issues of approval. Some have found a good market in the new country, others have bilked desperate people out of millions of dollars. In the reverse, there have been occasions when FDA approved some drug but other countries have banned the same product. Which has people questioning what they know versus what FDA approves.

The thing is leadership of FDA is a key factor in decision-making as in any government agency. And, like any other agency, it has been afflicted at times with bias and with politics. Overall though the purpose of FDA is important to insure that quality, qualifications, and procedures used will actually benefit the vulnerable patients. There have been miscalculations and recalls even with drugs that took years waiting for approval. So FDA is not foolproof but then no agency of government ever is. However, even if it is only right some of the time, it does provide a measure of relief to know that a drug has met the minimum of standards.

In April 2018, the FDA after months of warnings had DoJ issue formal complaints in Florida and California on several defendants manufacture of “stromal vascular fraction” (SVF) products from patient adipose (fat) tissue, which the companies then market as stem cell-based treatments for a host of serious conditions and diseases. Desperate people, mostly elderly, have flocked to those locations to try to get relief or get cured.

Sun Sentinel in Florida had done an investigative report back in the first days of December 2017 on the use of the product. They just released a new article on May 10th which details further what they discovered. Their investigation resulted in some serious issues not just for drug approval but for its online aspects as well:

— Some of these clinics’ medical procedures are questionable, experts say, such as injecting patients with experimental stem cell solutions in both eyes at the same time, risking blindness.

— Florida clinics use online seminars, high-tech websites and listings in the federal database ClinicalTrials.gov to market their treatments to patients. They tout Florida sunshine and tourist attractions such as fine hotels, beaches and unique shopping districts.

— Some stem cell clinics use hard-sell tactics and lead patients to rake together thousands of dollars, as insurance doesn’t cover stem cell treatments.

— State and federal regulators rarely have stepped in to stop these advertising and medical practices.

Sun’s efforts may have paid off as the DoJ and FDA have focused complaints on US Stem Cell Clinic LLC, of Sunrise, Florida, US Stem Cell, Inc., and company officers Kristin Comella and Theodore Gradel.  A separate complaint was filed the same day in the Central District of California against California Stem Cell Treatment Center Inc., of Rancho Mirage and Beverly Hills, California, Cell Surgical Network Corporation, and company owners Elliot Lander, M.D. and Mark Berman, M.D.

LA Times on April 24, 2018 ran an article about Kristin Comella. They described her this way:

“Comella, 41, who is the founder and president of the academy — crowd-pleasing, shot through with what sounded like serious science, delivered with the superficial credibility of a PhD from an unaccredited offshore university. Her pitch has made her a sought-after speaker at health industry conferences and gatherings of .longevity enthusiasts such as the annual Revolution against Aging and Death Festival, or RAADFest.

The biotech firm, Florida-based U.S. Stem Cell Inc., disclosed earlier this month that the Securities and Exchange Commission subpoenaed its financial records and other documents in connection with what the company says is a formal “fact-finding inquiry.” U.S. Stem Cell declined to provide any further details of the probe, and the SEC declined to comment.

Regulatory scrutiny of this entire field is long overdue. The FDA has been signaling for nearly a year that it takes its responsibility seriously. FDA Commissioner Scott Gottlieb and agency official Peter Marks wrote last month in an article for the New England Journal of Medicine that giving patients these treatments risks “serious adverse events” and warned of the drawbacks of “propagating products with dubious clinical efficacy and possible risks.”

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It could be that Trump’s choice for FDA Commissioner is proving to be a good one who intends to put action to ideas rather than mouth off and make promises. It could be these people were already under review by DoJ and that FDA was acting quickly and efficiently to shut down the companies (for a government agency).  It might be only coincidental that the Sun article ran the first week in December, but hey good investigative reporting can help speed actions along once in a while.

I wonder if the FDA has a way to analyze prior companies turned down to see if their products did move overseas and if they did finally prove through their efforts that their products were worth bringing back into the US? Also, one that questions why foreign countries have actually banned things that the FDA approved and move to get them off our markets as well if they find the reasoning sound.

It’s a shame that the same level of investigative journalism isn’t still available on the MSM these days instead of just Anti-Trump canned rhetoric.

–Uriel–

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