Published on August 15th, 2016 | by DeForest Rathbone0
Thalidomide: Why Marijuana Cannot Be Medicine without FDA Approval
As illustrated in the Obituary of pioneering FDA scientist, Frances Oldham Kelsey in The Washington Post 8/8/15.
THIS POST OBITUARY WAS A GODSEND, COMING JUST AS MANY POLITICAL LEADERS ARE BEGINNING A HEADLONG RUSH TO USURP FDA’S AUTHORITY TO APPROVE MARIJUANA-BASED MEDICINES IN FAVOR OF MONEY-CORRUPTED POLITICAL APPROVAL. THE ENDANGERED CITIZENRY, THEIR HEALTH PROFESSIONALS, POLITICAL LEADERS AND OBJECTIVE NEWS MEDIA JOURNALISTS MUST STRONGLY RESIST THIS MISGUIDED ACTION BY POLTICIANS WHO ARE BLINDLY IGNORING THE HORRIFIC THALIDOMIDE PRECEDENT.
Edited excerpts with commentary follow: The full article is available at the following link:
Frances Oldham Kelsey, FDA scientist who
kept thalidomide off U.S. market, dies at 101
In the annals of modern medicine, it was a horror story of international scope: thousands of babies dead in the womb and at least 10,000 others in 46 countries born with severe deformities… The cause, scientists discovered by late 1961, was thalidomide, a drug that, during four years of commercial sales… was marketed to pregnant women as a miracle cure for morning sickness and insomnia.
The tragedy was largely averted in the United States, with much credit due to Frances Oldham Kelsey, a medical officer at the Food and Drug Administration in Washington, who raised concerns about thalidomide before its effects were conclusively known. For a critical 19-month period, she fastidiously blocked its approval while drug company officials maligned her as a bureaucratic nitpicker…
The global thalidomide calamity precipitated legislation…in October 1962 that substantially strengthened the FDA’s authority over drug testing. The new regulations, still in force, required pharmaceutical companies to conduct phased clinical trials, obtain informed consent from participants in drug testing, and warn the FDA of adverse effects, and granted the FDA with important controls over prescription-drug advertising…
In Washington, (Kelsey) joined a corps of reform-minded scientists who, although not yet empowered by the 1962 law that required affirmative FDA approval of any new drug, demanded strong evidence of effectiveness before giving their imprimatur.
At the time, a drug could go on the market 60 days after the manufacturer filed an application with the FDA… Meanwhile, pharmaceutical drug companies commonly supplied doctors with new drugs and encouraged them to test the product on patients, an uncontrolled and dangerous practice that relied almost entirely on anecdotal evidence. NICAP note: Much like today’s treatment of “medical marijuana.”
Thalidomide, which was widely marketed as a sedative as well as a treatment for pregnancy-related nausea during the first trimester of pregnancy, had proven wildly popular in Europe and a boon for its German manufacturer. NICAP note: Much like pro-pot propaganda today has created “wildly popular” support among a fact-deprived public, and boom-times for the Big Marijuana industry.
By the fall of 1960, a Cincinnati-based drug company, William S. Merrell, had licensed the drug and began to distribute it under the trade name Kevadon to 1,200 U.S. doctors in advance of what executives anticipated would be its quick approval by the FDA. NICAP note: Today, illegal drug companies produce and market hundreds of uncontrolled marijuana products and distribute them to corrupt doctors willing to “recommend” such unapproved marijuana “medicines.”
The Merrell application landed on Dr. Kelsey’s desk within weeks of her arrival at the agency…Immediately the application alarmed her. Despite what she called the company’s “quite fulsome” claims, the absorption and toxicity studies were so incomplete as to be almost meaningless. NICAP note: Much like the “quite fulsome claims” for pot medicines are legion today, as is the dearth of valid studies verifying those claims. For the true documented scientific case against smoking weed as “medicine” see “The DEA Position on Marijuana” at link: www.justice.gov/dea/docs/marijuana_position_2011.pdf
Dr. Kelsey rejected the application numerous times and requested more data. Merrell representatives, who had large potential profits riding on the application, began to complain to her bosses and show up at her office, with respected clinical investigators in tow, to protest the hold-up. NICAP note: Much as the Pot Legalization Lobbyists and ACLU show up at any attempts to limit sales and use of marijuana—and for the same reason: “large potential profits.”
Another reason for her concern was that the company had apparently done no studies on pregnant animals. At the time, a prevailing view among doctors held that the placental barrier protected the fetus from (harms from) what Dr. Kelsey once called “the indiscretions of the mother,” such as abuse of alcohol, tobacco or illegal drugs. Earlier in her career, however, she had investigated the ways in which drugs did in fact pass through the placenta from mother to baby… NICAP note: Today there are numerous valid studies showing that both mental and physical defects in children can be caused by a pregnant mother’s use of marijuana and other illegal drugs.
While Dr. Kelsey stood her ground on Kevadon, infant deaths and deformities were occurring at an alarming rate in places where thalidomide had been sold… NICAP note: Today, drug addiction, drug-related permanent disabilities and overdose deaths are “occurring at an alarming rate,” nearly all of which began with a shared joint of marijuana from a schoolmate or friend.
Dr. Kelsey might have remained an anonymous bureaucrat if not for a (previous) front-page story in The Post. The newspaper had received a tip about her from staffers working for Sen. Estes Kefauver, a Tennessee Democrat who had been stalled in his years-long battle with the pharmaceutical industry to bolster the country’s drug laws.
The coverage of Dr. Kelsey gave her — and Kefauver — a lift. As thousands of grateful letters flowed in to Dr. Kelsey from the public, the proposed legislation became hard to ignore or to water down. The new law was widely known as the Kefauver-Harris Amendments.
“She had a huge effect on the regulations adopted in the 1960s to help create the modern clinical trial system,” said Daniel Carpenter, a professor of government at Harvard University and the author of “Reputation and Power,” a definitive history of the FDA. “She may have had a bigger effect after thalidomide than before.”…
For decades, Dr. Kelsey played a critical role at the agency in enforcing federal regulations for drug development— protocols that were credited with forcing more rigorous standards around the world…
In Chicago, she helped Geiling investigate the 107 deaths that occurred nationwide in 1937 from the newly marketed liquid form of sulfanilamide, a synthetic antibacterial drug used to treat streptococcal infections. In tablet form, it had been heralded as a wonder-drug of the age, but it tasted unpleasant.
Because the drug was not soluble in water or alcohol, the chief chemist of its manufacturer, S.E. Massengill Co. of Bristol, Tenn., dissolved the sulfanilamide with an industrial substance that was a chemical relative of antifreeze. He then added cherry flavoring and pink coloring to remedy the taste and appearance.
Massengill rushed the new elixir to market without adequately testing its safety. Many who took the medicine — including a high number of children — suffered an agonizing death.
At the time, the FDA’s chief mandate, stemming from an obsolete 1906 law, was food safety. At the agency’s request, Geiling joined the Elixir Sulfanilamide investigation and put Dr. Kelsey to work on animal testing of the drug. She recalled observing rats as they “shriveled up and died.”
Amid national outrage over Elixir Sulfanilamide, Congress passed the Federal Food, Drug and Cosmetic Act of 1938, legislation that vastly expanded federal regulatory oversight over drugs and set a new benchmark for drug safety before marketing… NICAP note: Today, pro-pot politicians are rushing headlong into a massive campaign to block that objective FDA approval process for drugs and instead substitute a money-driven political process that will create a new “Thalidomide” out of marijuana and destroy many more American lives and futures.
Babies who suffered from the effects of thalidomide and survived grew up with a range of impairments. Some required lifelong home care… NICAP note: Is this to be the legacy of current politicians whose corrupt abandonment of the nation’s premier drug approval system will create generations of children “who suffered from the effects of POLITICAL APPROVED “medical” marijuana and survived with a range of impairments, some requiring lifelong home care?”
DeForest Rathbone is Chairman of the National Institute of Citizen Anti-drug Policy (NICAP).