Consumer Health Digest #18-22
Your Weekly Update of News and Reviews
June 3, 2018
Consumer Health Digest is a free weekly e-mail newsletter edited by William M. London, Ed.D., M.P.H., with help from Stephen Barrett, M.D. It summarizes scientific reports; legislative developments; enforcement actions; news reports; Web site evaluations; recommended and nonrecommended books; and other information relevant to consumer protection and consumer decision-making. Its primary focus is on health, but occasionally it includes non-health scams and practical tips.
Federal "right to try" law enacted. 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]
Naturopath found guilty of manslaughter. Montreal naturopath Mitra Javanmardi has been found guilty of manslaughter after the Quebec Court of Appeal overturned her 2015 acquittal in the death of 84-year old Roger Matern, whom she illegally injected with magnesium. The Court also ordered her to be tried on a separate charge of criminal negligence causing death. The Quebec College of Physicians has fined her three times for practicing without a license, which had included administering injections. [Montreal naturopath found guilty of manslaughter after acquittal overturned. CTV News, June 1, 2018]
Vision loss following chiropractic neck manipulation reported. A case report describes what happened to a 46-year-old man who came to an emergency department with left-sided body weakness after having fainted and who was found to have newly developed right eye blindness that was eventually judged to be permanent. The patient had previously been healthy except for having chronic musculoskeletal pain. He had been frequently treated over a seven-year period with chiropractic neck manipulation. He was most recently manipulated one month before his emergency department visit. A week later, he developed a headache, his two pupils differed in size, and his right upper eyelid drooped. This appears to be the first reported case of blindness due to ophthalmic artery blockage resulting from internal carotid artery dissection that is plausibly attributable to chiropractic neck manipulation. [Regan KA and others. Ophthalmic artery occlusion after chiropractic neck manipulation. Acta Ophthalmologica, May 31, 2018] Previously reported eye problems, including vision loss, following chiropractic neck manipulation have not involved ophthalmic artery blockage. [Ernst E. Ophthalmological adverse effects of (chiropractic) upper spinal manipulation: Evidence from recent case reports. Acta Ophthalmologica 83:581-585, 2005]
"Functional neurology" chiropractor sentenced. James Joseph Martin of West Sacramento, California has been sentenced to one year in jail and five years of probation after pleading no contest to three felony counts of practicing medicine without a license, four felony counts of grand theft, and two misdemeanor counts of improperly using the titles "Dr." and "physician." He was also ordered to:
- stop portraying himself as practicing functional or pastoral medicine
- surrender his chiropractic license (which currently has the status of denied)
- pay $67,934 in restitution to his victims
Martin did business as "Dr. James Martin, D.PSc." and appeared on Sacramento morning news shows telling patients that he was a "thyroid and diabetic specialist" and that he practiced "functional neurology and metabolic medicine." Many of his patients thought he was a medical doctor, and some paid thousands of dollars for his treatments. He also used titles such as "Head Physician" and "Lic. MD (P)" to misrepresent himself. At the sentencing, five of his victims made statements to the court. "D.PSc." stands for "doctor of pastoral science," a designation issued by the Pastoral Medical Association, which claims to license "spiritually minded health professionals." [Case update: chiropractor sentenced after claiming to be a physician. California Department of Consumer Affairs news release, June 1, 2018] Casewatch has additional information about Martin's activities.
This page was posted on June 4, 2018