This is not going to help anyone. In fact, it very likely will hurt people who are dying. While the idea behind this seems to the uninformed to be an interesting idea, the possibility of dying people taking drugs that may cause greater suffering to them is very real. The Trump Administration attempt to undermine the FDA is clearly underway. The beneficiaries of this are large drug companies.
President Donald Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017, which had been opposed by a coalition of more than 100 non-governmental organizations. The law permits terminally ill patients who have exhausted approved treatment options and who are unable to participate in a clinical trial of an investigational new drug to receive the drug after it has passed only the first of three phases of testing required for marketing approval. Phase 1 testing requires only 20 to 80 healthy volunteers to determine a drug’s most frequent side effects and how it is metabolized or excreted. While it can reveal unacceptable toxicity, Phase 1 does not establish effectiveness. Most drugs that move past Phase I testing do not get approved for marketing because they are found to be unsafe and/or ineffective.
The Food and Drug Administration (FDA) already has “compassionate use” programs with safeguards that enable people with serious and life-threatening diseases to receive investigational medical devices, drugs, and biologics outside of clinical trials. The agency sometimes requires dosing and safety improvements but grants 99% of requests it receives and enables treatment to begin within 30 days (or five working days after emergency requests). The new law removes FDA’s consultative role in ensuring safety and fails to ensure informed consent requirements. It also “limits the liability of a sponsor, manufacturer, prescriber, or dispenser that provides, or declines to provide, an eligible investigational drug to an eligible patient in accordance with the bill.”
Senator Ron Johnson, who sponsored the legislation, said recently that its goal was to “diminish the FDA’s power over people’s lives, not increase it.” It was based on a model bill drafted by the Goldwater Institute, a libertarian think tank that opposes the FDA’s regulatory power. The Koch brothers-associated, right-wing groups Freedom Partners and Americans for Prosperity lobbied for the legislation. Similar legislation has already been enacted in 38 states. David Gorski, M.D., Ph.D. recently wrote:
Right-to-try is only a little about helping patients. It’s far more about dismantling the FDA and giving drug and device manufacturers more freedom to market drugs and devices with much less testing. [Gorski D. The very worst version of the sham known as “right-to-try” is poised to become law. Science-Based Medicine, May 21, 2018]
Having been in the room with my late wife at a fake stem cell facility in Mexico, I highly suggest you take this information into consideration before considering doing this therapy in this way. Feel free to contact me for more information on what we experienced.
An investigation of 368 Web sites found through Google with search terms combining stem cell with various buzzwords and practitioner names associated with “complementary and alternative medicine” has revealed:
- 243 sites marketed stem cell therapies and 116 marketed other interventions where stem cells were mentioned in the description of the treatment or its effects. The other interventions included platelet-rich plasma injections (88), prolotherapy (19) and others (9).
- The cells used for transplantation were said to be derived from adipose (fatty) tissue (112 sites), bone marrow (100 sites), blood (28 sites), umbilical cord (26 sites), and other sources [e.g., placenta, amniotic sac, amniotic fluid, embryonic stem cells] (35 sites).
- 20 sites advertised plant cell-based treatments and products (e.g., skin creams).
- The most common advertised treatment targets were: bone, joint, and muscle pain/injury (182 sites); diseases or maladies (82 sites); cosmetic concerns (52 sites); non-cosmetic aging (44 sites); and sexual enhancement (18 sites).
- 80% of the sites were for clinics in the USA; the rest were located in 17 other countries.
- The practitioner types mentioned on the 368 sites included medical doctors (161), naturopaths (63), chiropractors (61), acupuncturists (36), midwives (33), homeopaths (27) and massage therapists (13). Some sites mentioned more than one and some sites listed none.
- Hyperbolic language was found on 32% of the sites.
- Only 31% of the sites mentioned the regulatory status of the intervention, and only 33% noted that the therapy was unproven.
- Only 19% of the sites stated there was limited evidence of efficacy of the intervention and 13% said there was evidence of inefficacy.
- Only 25% of the sites mentioned general risks of the interventions.
The investigators concluded:
Many clinics seem to be engaging in scienceploitation, which can seriously obfuscate public discourse, mislead the public and make it difficult to discern real science from marketing claims that merely reference scientific sounding terminology. The marketing of unproven stem cell therapies has the potential to harm patients and to harm the reputation of stem cell science. It is incumbent on regulators and policymakers to take a proactive approach to managing the risks associated with the growing private market for stem cell-related interventions, and addressing misleading marketing practices is an important part of this strategy.
[Murdoch B and others. Exploiting science? A systematic analysis of complementary and alternative medicine clinic websites’ marketing of stem cell therapies. BMJ Open 8(2), March 2, 2018]
Interesting story on Homeopathy. There is no science behind homeopathy and this review of it by a noted association, gets to the core of the issue.
The British Veterinary Association’s journal has published two articles that place homeopathy in historical and scientific perspective. Although the articles concern veterinary practices, their conclusions are equally relevant to human drugs. The first article notes that, “For many drugs the mechanism of action is proven, and for most drugs without proven mechanisms of action, scientifically plausible mechanisms exist.” [Lees P and others. Comparison of veterinary drugs and veterinary homeopathy: Part 1. Veterinary Record, Aug 12, 2017] In contrast, the second article notes that “Homeopathy . . . is top down and faith-based; governed by arbitrary laws, invented by the founder, Hahnemann, which are immutable. As such, homeopathy is not just unscientific, it is a genuinely mystical belief system.” [Lees P and others. Comparison of veterinary drugs and veterinary homeopathy: Part 2. Veterinary Record, Aug 19/26, 2017]
A fascinating website that I was not aware of, in which the FDA lists the products that they have tested to have been shown to be tainted with chemicals that are not listed on the package label. If you were taking supplements or other Internet advertised products, you may want to look them up on this list to make sure they’re not listed here.
“The controversies regarding the combination of synthetic therapeutic substances and traditional Chinese medicines without adequate labeling should be resolved through regulatory actions for better safety of drug use.”
Proprietary Chinese medicines (pCMs) and health products, generally believed to be natural and safe, are gaining popularity worldwide. However, the safety of pCMs and health products has been severely compromised by the practice of adulteration. The current study aimed to examine the problem of adulteration of pCMs and health products in Hong Kong.
The rise of use of Chinese traditional remedies has been going on for sometime here on the West Coast in particular. My late wife tried many substances in a vain attempt to save her life. It always made me wonder as to who was overseeing the possible abuse of these remedies, and many of them are available on the Internet with no regulation at all.