Is Your Stem Cell Treatment Safe-Addressing the Proliferation of Unapproved Stem Cell Products

Proliferation of Unapproved Stem Cell Therapy as a Cure-all

Stem cell therapy, drawn from infant umbilical cord blood or from an adults’s own cells is the new snake oil cure-all. In the United States the only FDA approved use of stem cell therapy is for treatment of blood disorders like leukemia or hemophilia. (US Food and Drug Administration, n.d.) Here is the link to approved stem cell products in the US. https://www.fda.gov/biologicsbloodvaccines/cellulargenetherapyproducts/approvedproducts/default.htm  Any other use is experimental and has not received the rigor of the Federal Drug Agency investigation for patient safety and efficacy. Unfortunately, thanks to unscrupulous direct-to-consumer marketing, stem cell therapy is nearly as ubiquitous as Botox treatment. This article highlights some of the dangers of unapproved treatment, what the FDA has done to protect consumers, and resources for further investigation.

Are Stem Cell Treatments Drugs?

The FDA considers stem cell treatment to be an injectable drug therapy and as such is under the purview of the agency. Many of these high profit stem cell clinics offering the treatment disagree with the FDA classification and have been flouting the rules.

Risks of Stem Cell Treatment

1.  Stem cell products are being manufactured in facilities that are not inspected or run by FDA patient safety standards. Injectables that are created in an unsterile environment run a high risk of infection for patients. Timothy Lunceford of Texas was injected with stem cells for joint pain and was hospitalized for 58 days with a blood infection and E. coli. (McGinley, 2019)
2.  Nonscientists are creating stem cell products which means they do not assess, test, or control for unintended consequences the way a controlled scientific experiment does. Three people lost their sight after being injected with stem cells as a treatment for macular degeneration. (alpha1.org, 2018)
3.  Umbilical cord blood containing stem cells, billed as the miracle of life, can have different reactions in people. At least 17 people have been hospitalized after being injected with products containing umbilical cord blood. (McGinley, 2019)
4.  Site infections from injection of stem cell products is also common and can require hospitalization. John Herzog, MD injected himself as a test of safety before he would recommend the product to his patients and he ended up in the hospital with a bone infection and a blood clot. (McGinley, 2019)
5.  People promoting stem cell treatments often have no scientific or medical background and their only motive is to make money. Liveyon products sold as stem cell therapy were tested by Lisa Fortier, a Cornell University regenerative medicine researcher and she found that nine of the products did not contain stem cells or even a single live cell. (McGinley, 2019)
6.  Two people died in Florida after receiving stem cell injections in 2012. (McGinley, 2019)

Regulatory Actions Taken By the US

Centers for Disease Control and Prevention tested and found that bacterial contamination occurred at the manufacturing level prior to clinical use of the stem cell products distributed by Liveyon of Yorba Linda, California. A product recall for Liveyon ReGen treatment vials occurred 4 months after the company’s product tested positive for e coli. Most worrisome is Liveyon has opened an operation in Cancun, Mexico so American patients can receive treatment without the oversight of the FDA. (McGinley, 2019)

The FDA has the authority to regulate drug, cosmetic, and scientific treatments in the US. New drugs or treatments are supposed to apply for an Investigational New Drug (IND)application. The agency has reviewed 5,322 stem cell products in clinical trials. To learn more about stem cell products which have been reviewed in a clinical trial follow this link: https://clinicaltrials.gov/ct2/results?term=stem+cell+therapies

The FDA sued the US Stem Cell Clinic, LLC in Florida for failure to respond to their inspection concerns. The agency also took action against StemImmune, Inc in California to prevent the use of a dangerous and unproven treatment. In 2017, US marshals seized vials of smallpox which were being used to create stem cells and given to cancer patients in California. In November 2017, the FDA published 4 guidance documents on risk and regulatory compliance for regenerative medicine products. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585345.htm

So, it’s quite simple you should not be using any stem cell therapy which has not been in a clinical trial under the auspices of the FDA. And you should definitely avoid companies which promote stem cell treatments despite being found to have contaminated products by the CDC. These opportunists do not sign a hippocratic oath like physicians for patient care.

This is the healthpolicymaven signing off encouraging you not to sign blanket release forms when you check into a treatment center. Do specify that for why you consent and that for which you decline.

Roberta Winter is a freelance journalist and health policy analyst whom has published under the trademark healthpolicymaven since 2007. This article does not give medical advice, but is an advisory on health policy. She is the author of Unraveling U.S. Healthcare-A Personal Guide, published in 2013.

https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

References

alpha1.org. (2018, May 16). FDA Files Lawsuits to Stop Unapproved Stem Cell Therapies. alpha1.org. Retrieved March 24, 2019, from https://www.alpha1.org/Alphas-Friends-Family/Resources/News/ArtMID/5952/ArticleID/7860/FDA-files-lawsuits-to-stop-unapproved-stem-cell-therapies

McGinley, W. W. (2019, February 27). Miraculous Stem Cell Therapy Has Sickened People in Five States. The Washington Post, pp. 1-10. Retrieved March 9, 2019, from https://www.washingtonpost.com/national/health-science/miraculous-stem-cell-therapy-has-sickened-people-in-five-states/2019/02/26/c04b23a4-3539-11e9-854a-7a14d7fec96a_story.html?utm_term=.0a2ea7b69b72

US Food and Drug Administration. (n.d.). FDA Consumer Updates. doi:ucm286155

Addressing Vaccine Fears Proactively

Washington State, is in the midst of a measles epidemic because of a high rate of unvaccinated children in Vancouver, Washington, a city just across the mighty Columbia River from Portland, Oregon. There have been multiple cases of measles in eleven other states this year. This article suggests ways to bridge the gap between the vaccinated and the unvaccinated populations.

Facts About Measles

• Measles is highly contagious-Entering a room within two hours after an infected person has left can transmit the disease
•  Measles can cause permanent hearing loss and brain damage
•  People die from Measles and it remains the leading cause of vaccine preventable death in the world; approximately 1 to 2% of those exposed to Measles die and 110,000 people died from exposure to the disease in 2017 alone
•  People with impaired immune systems are more likely to have complications from Measles

Why the Hysteria About Vaccines?

Parents have two main fears regarding vaccines, one is the mercury in the vaccine from thimerosal, a preservative and the other is a belief that exposure to vaccines will trigger autoimmune responses leading to other health conditions. Let’s look at the scientific studies on the mercury in vaccines to determine if there is any harm from this stabilizing component. The American Academy of Pediatricians published this document which is a meta-analysis of available high-quality studies on vaccine safety to address parental concerns about vaccines. After analysis of credible studies on vaccine safety this august body of physicians made the following conclusions:

1.   Increased exposure to antibody stimulating proteins is not associated with autism (DeStefano F, 2013)
2. On-time first year vaccines did not harm neurological development (C, 2010)
3. A 14-year study found no link to autism or inflammatory bowel disease and vaccinations (Peltola H, 1998)

 Here is a link to scientific studies which showed no harm in the organic compound thimerosal in vaccines. https://www.fda.gov/biologicsbloodvaccines/safetyavailability/vaccinesafety/ucm096228#bib

Addressing Vaccine Fear

Mercury Exposure

Parents are concerned about injecting thimerosal, which contains mercury and is used as a vaccine preservative into their children.

Solution-Give your child a vaccine without the thimerosal component

Too Much Too Soon

Solution-Provide parents information on these multi-national studies which involved thousands of children over an extended period of time and demonstrated no link to neurological conditions. Vaccines are not profitable for drug companies to manufacture so there are no customize-able versions for parents who want to break up the Measles, Mumps, and Rubella vaccine. Individual doses of Measles, Mumps, and Rubella vaccines were discontinued in 2009. (Control, 2009) Presently in the United States the combined MMR vaccine is the only option.

Seizure Risk

Solution-Explain to concerned parents that the risk of a child getting a seizure from a vaccine is extremely rare, approximately 30 children out of 100,000 who received the MMR vaccine may have a febrile seizure, which is related to the fever. The involuntary shaking should last no more than two minutes and usually does not cause any long-term damage. These seizures can occur at any time throughout childhood as a result of any fever. However, if the fever and risk of seizure is a concern, parents may wish to avoid the combined Measles, Mumps, Rubella, and Varicella vaccine as it has been shown to have an increased risk for seizure versus the MMR. Choose the lower risk MMR vaccine. (Control C. f., 2019)

Safety of the Vaccine Manufacturing Process

There have been cases were faulty vaccines were sold and these are usually in India and China, but this is extremely rare in the U.S. The Centers for Disease  monitors vaccine safety and publishes alerts if a recall is necessary. Your clinician would receive notice of the recall and alert patients.

However, it is in our best interest to increase the efficacy of vaccines, not to curb them. A biologist friend of mine recently suggested a solution to increase vaccine safety through testing. Essentially, we would require the vaccine's supplier to perform a random and routine assay test for antibodies in the vaccines. This would be a simple and cost-effective method to assure that the vaccines were real.

Population or Herd Immunity

Preventing the spread of preventable diseases is a public health obligation and the best way to do that is through vaccines. A community needs a vaccination rate of 90% to assure adequate immunity from the disease for a population, which means not your house, but your county, your region. Clark County had a 78% vaccination rate for MMR, which is below the threshold to prevent an outbreak.

Vaccine Exemptions

Washington State is one of 17 states which allow philosophical exemptions for vaccines. In February, Washington passed a House bill to ban philosophical exceptions for vaccines and there have been demonstrations in the state capitol since. Vaccines are proven to prevent disease and the actions of a few individuals should not be allowed to endanger everyone else. This is why we have drivers license testing, speed limits, and background checks for the purchase of weapons. Public safety trumps the individual needs. If parents willfully choose not to vaccinate their children they should not be allowed to enroll in public school. However, the community health risk for everyone else is only partially mitigated by limiting school exposure, because participation in any public activity, such as swimming in the local pool, using the play fields, or public transportation could expose you to preventable disease. Wearing those surgical masks, the Chinese sport everywhere doesn’t seem so odd now.

And this is the healthpolicymaven signing off encouraging you to read good science, make informed decisions, and prudently get your vaccinations. A healthy diet is not going to prevent Measles, Mumps, or Rubella.

This article was written by Roberta E. Winter, author of Unraveling U.S. Healthcare-A Personal Guide, which ranked vaccination rates by state as evidence of public health, and was published by Rowman and Littlefield in 2013. https://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972

References

C, S. M. (2010). On-time Vaccination Receipt In The First Year Does Not Adversely Affect Neuropyschological Outcomes. American Journal of Pediatrics, 125(6), 1134-41. Retrieved March 6, 2019, from http://pediatrics.aappublications.org/cgi/content/abstract/125/6/1134

Control, C. f. (2009, October 21). Monovalent M-M-R Vaccines. Retrieved March 6, 2019, from Centers for Disease Control: https://www.cdc.gov/vaccines/hcp/clinical-resources/mmr-faq-12-17-08.html

Control, C. f. (2019, March 6). Vaccine Options Fact Sheet. Retrieved from Centers for Disease Control.gov/Vaccines: https://www.cdc.gov/vaccines/vpd/mmr/hcp/vacopt-factsheet-hcp.html

DeStefano F, P. C. (2013). Case Control Study on Frequency of Vaccines and Risk for Autism. Journal of Pediatrics. Retrieved March 6, 2019

Peltola H, e. a. (1998). No Evidence for Measles, Mumps, and Rubella Vaccine Associated with Autism or Inflammatory Bowel Disease. Lancet, 351, 1327-28.