There is a tension inherent in the drug approval process between the desire to approve new drugs rapidly in order to treat suffering people and the need to be cautious, to make sure that new drugs are safe and effective before they are approved for sale. This weighing of the risks of too-rapid approval of drugs that doesn’t work (or doesn’t work well) and might cause harm versus the harm that can be caused by delaying approval of an effective drug that might help millions longer than necessary is complex, as is balancing the benefits of rapidly approving effective drugs …
Tag: fda
Will the Medical Board of California crack down on the stem cell hard sell?
For-profit stem cell clinics selling unproven and downright quacky stem cell therapies have proliferated over the last several years, with federal and state law seemingly powerless to stop them. Recently, the FDA and FTC have shown signs of acting to crack down on them. Now, the Medical Board of California is forming a task force to determine how to regulate physicians offering these unproven therapies. Will it matter?
Burzynski’s old lawyer Richard Jaffe throws a quack stem cell clinic under the bus
Richard Jaffe was Dr. Stanislaw Burzynski's lawyer. For nearly two decades, Jaffe defended this cancer quack from the FDA, Texas Medical Board, and the government in the name of "health freedom" and even invented Burzynski's business model of having over 70 clinical trials open that allow him to treat any cancer patient he wants. More recently, he's been a defender of for-profit quack stem cell clinics. Last week, he shocked me by finding one stem cell clinic so quacky that he thinks the government should shut it down, even going so far as to use criminal prosecution if necessary. Basically, …
The cruel sham that is federal right-to-try has passed. Let patients beware!
“Right-to-try” laws are a cruel sham that purport to allow terminally ill patients access to promising experimental drugs. In reality, they strip away many protections and leave vulnerable patients on their own. After four years and a number of toothless state laws, a federal version of “right-to-try” has passed Congress and is poised to become law. Once President Trump signs the bill this week, this federal version of “right-to-try” will leave terminally ill patients on their own and will likely be the first step in returning the FDA to its pre-thalidomide state, in which it only required evidence of safety, …
The FDA brings the hammer down on two quack stem cell clinics
Last year, the FDA announced a regulatory framework for stem cell clinics, and hopes were raised that it would finally crack down on the hundreds of quack stem cell clinics in the US. Yesterday, the FDA dropped the hammer on two clinics, seeking injunctions in federal court to stop them. Is this the beginning of a real (and long overdue) crackdown on these clinics?
The cruel sham that is “right-to-try” will be up for a vote in the House tomorrow
It's finally happened. A "right-to-try" bill is coming up for a vote in the House of Representatives. It's been slightly modified from the version that passed the Senate last year to make it less patient-hostile, but it's still the same cruel sham that right-to-try has always been.
Will 2018 be the year that the FDA finally regulates homeopathic remedies as drugs?
Earlier this week, the FDA issued draft guidance that would, if adopted, allow it to regulate homeopathic remedies as drugs. Will 2018 be the year that the FDA finally stops deferring to homeopaths and regulating homeopathic remedies as drugs?
Robert F. Kennedy, Jr. and his World Mercury Project: Antivaccine, NOT “fiercely pro-vaccine”
Robert F. Kennedy, Jr. claims that he is "fiercely pro-vaccine." His words and actions say otherwise, for instance his Indiegogo campaign to raise money to promote antivaccine misinformation.
The FDA cracks down on quack stem cell clinics…or does it?
Last week, the FDA released final regulatory guidance regarding freestanding stem cell clinics. The new regulatory framework appears custom-made to allow the FDA to crack down on quack stem cell clinics. But will it?
“Right To Choose Medicine”: The free market fundamentalist assault on the FDA continues
Yesterday, I wrote about how right-to-try and an unethical offshore vaccine trial are part of free market fundamentalists' attack on the FDA. Here's another example, the "right to choose medicine."