TRENDS IN DRUG USE BY YVETTE FARNSWORTH BAKER, ESQ.
Toxic Marijuana and Tainted Tylenol: Who Pays the Price?
The FDA requires that manufacturers of drugs and medical devices prove they are safe and effective. The FDA also oversees warning labels, writes consumer guides that accompany some medications, sends out public health advisories about drug risks, and investigates potential drug problems. Marijuana is subject to none of this.
T
ylenol made news recently by settling lawsuits filed by 42 states and the District of Columbia for
false or misleading labeling, and for distributing drugs that did not meet regulatory standards. Tylenol will pay $33 million in settlement. Allegations included reports of foreign material, particulate matter, or contamination in some of the medication. Of course, this also brings to mind the cyanide-laced Tylenol deaths of the 1980s, after which the company spent millions recalling medication from the shelves, and later paid undisclosed sums of money to victims’ families. Similarly, University of California,
Davis researchers discovered potentially lethal bacteria and mold on samples of medical marijuana from 20 California growers and dispensaries. Concerns began at UC Davis aſter a blood cancer specialist there began to see rare infections in the lungs of his cancer patients. Aſter one patient died from a lung infection, the doctor developed a hypothesis that inhalation of medical marijuana may have been the cause, and he built a team to study soil-borne pathogens in medical marijuana. Te study discovered “surprisingly”
large numbers of bacteria and mold, including some that can lead to a deadly infection known as Mucor. Patients with compromised immune systems, such as those undergoing cancer treatments or suffering from AIDS or leukemia, are at particular risk for serious infection. “Tere’s a misconception by people
who think that because it’s from a dispensary, then it must be safe. Tat’s not the case,” said UC Davis’ Dr. Joseph Tuscano. “Tis is potentially a direct
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inoculation into the lungs of these contaminated organisms, especially if you use a bong or vaporization technique.” While both stories involve negligence on the part of those producing medication, this is where the similarities end. Why? Aren’t marijuana dispensers subject to the same scrutiny that Johnson & Johnson was? Te simple answer is no. While Tylenol, along with all other over-the-counter and prescription drugs in the United States, is highly regulated by the Food and Drug Administration (FDA) as well as state regulators, medical marijuana still inhabits a no-man’s land of regulation. Even when states such as California “legalize” medical marijuana, marijuana remains illegal under federal law. Tus, the FDA takes no part in overseeing medical marijuana, because in its view it is an illegal drug and not a medicine or supplement. Even as recently as October 2016, the FDA advised the Drug Enforcement Agency (DEA) that marijuana should remain a Schedule I substance, keeping it illegal with no approved medical use. The FDA requires that manufacturers
of drugs and medical devices prove they are safe and effective. The FDA also oversees warning labels, writes consumer guides that accompany some medications, sends out public health advisories about drug risks, and investigates potential drug problems. Marijuana is subject to none of this. Without FDA enforcement, what checks
exist on the quality and safety of medical marijuana? It is leſt to state regulation, and possibly private litigation. Medical marijuana may be subject to product liability litigation, which requires that products not pose unreasonable dangers to
fall 2017
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