A two-part series on problems in the clinical trials industry, from Medium.com:
The Best-Selling, Billion-Dollar Pills Tested on Homeless People
How the destitute and the mentally ill are being used as human lab rats
Why Are Dope-Addicted, Disgraced Doctors Running Our Drug Trials?
injections have been used to reduce the likelihood of premature births in at-risk pregnant women for years. Up until now, the drug was custom-compounded by wholesale and specialist pharmacies, legally, but without federal approval. These injections cost between $5 and $15 a dose and were regularly reimbursed by insurance companies and Medicaid.
Last month, the FDA announced their approval
of a commercially produced version of the compound, to be marketed under the brand name Makena by a company called KV Pharmaceuticals.
No stranger to controversy and trouble, KV barely survived a rash round of layoffs and wrongful termination lawsuits
. Their former chief executive now faces criminal charges
surrounding the company's failure to notify the FDA that they were producing oversized morphine tablets. (He could also do for a shave, it appears.)
Now, KV has announced that the new drug will be available at a cost of $1,500 per dose
, bringing the total pregnancy term cost of treatment to $25,000-$30,000
, from its former cost of $250-$300, a 100-fold increase
—but it gets worse... [more inside]
You may know it as acetaminophen, paracetamol, APAP, or ... Tylenol. Today an FDA advisory panel recommended banning prescription drugs that contain acetaminophen, such as vicodin and percocet.
The panel of experts also voted to give acetaminophen a black box warning
, and reduce the maximum dosage of over-the-counter formulations. Acetaminophen is a popular painkiller by itself and, in combination with opiates, is the most commonly prescribed medication
in the US. [more inside]
The US Food and Drug Administration
started regulating the labeling of food, beverages, and medicines after the passage of the 1906 Pure Food and Drug Act
, and added food coloring and cosmetics with the 1938 Food, Drug, and Cosmetic Act
. They have just released a new website, the FDA Notices of Judgment Collection, 1906-1963
, containing data from thousands of cases of mislabeled or misadvertised products and drugs, available in multiple forms (text, PDF, metadata XML, .TIF image, etc.), with searchable archives. Poking around in the data will yield information on cases ranging from misbranding methamphetamine tablets
, to quack "Film-O-Sonic" devices
, to bacteria-laden unproven abortifacients sold over the counter
, to purported "4-way" cures for baldness
, to hunks of radium sold for putting in your drinking water
to "stimulate the sex organs" (judged against for stating an unproven use, not for actual danger of product). Organized by the FDA's history office
, the new database is a fascinating resource for historians, public safety advocates, researchers, and librarians.
Towards responsible use of cognitive-enhancing drugs by the healthy
- a commentary in Nature that says, "we call for a presumption that mentally competent adults should be able to engage in cognitive enhancement using drugs
". Farkesque debate here
. [more inside]
Dying for Lifesaving Drugs
: Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments?Reason Magazine
Ecstasy approved by the FDA
Well not exactly but I thought it would grab people's attention a lot better than the original title of the article.
My only question is: Does seeing my fat, hairy, aunt naked qualify me as suffering from post-traumatic shock syndrome?
Why is everybody so happy?
This Thursday, U.S. regulators approved numerous copycat versions of Prozac. I wonder how long it will be until Bayer makes Flinstones Chewable Prozac for teens.