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Vulnerable to coercion or undue influence

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
and
Why Are Dope-Addicted, Disgraced Doctors Running Our Drug Trials?
posted by Joe in Australia on Aug 5, 2014 - 28 comments

The Pills of Last Resort

How Dying Patients Get Access to Experimental Drugs
posted by Blazecock Pileon on Nov 1, 2013 - 16 comments

"We’re giving just enough to prevent them from dying."

Because of nationwide shortages, Washington hospitals are rationing, hoarding, and bartering critical nutrients premature babies and other patients need to survive. Doctors are reporting conditions normally seen only in developing countries, and there have been deaths. How could this be allowed to happen?
[more inside]
posted by the man of twists and turns on Jun 23, 2013 - 113 comments

Even better than the real thing?

Widespread fraud has been discovered in the case of an Indian generic drug manufacturer that makes generic Lipitor (atorvastatin calcium) and many other drugs. Ranbaxy has "pleaded guilty to seven federal criminal counts of selling adulterated drugs with intent to defraud." [more inside]
posted by fiercecupcake on May 18, 2013 - 28 comments

In the Public Interest....

Earlier this year, six scientists and doctors filed a lawsuit against the US Food and Drug Administration alleging that the FDA had secretly monitored their personal e-mail accounts after they (legally) warned Congress that the "agency was approving medical devices that they believed posed unacceptable risks to patients." The agency said it had done so to "investigate allegations that the employees had leaked confidential information to the public." At the time, the FDA indicated their computer monitoring was limited to five scientists. But now, the New York Times is reporting that "what began as a narrow investigation" "quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process.". [more inside]
posted by zarq on Jul 15, 2012 - 29 comments

Premature birth-preventing drug faces cost spike

Progesterone caproate 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]
posted by disillusioned on Mar 9, 2011 - 63 comments

The Ban on Blood Donation

Are the Rules That Determine Who Can Donate Blood Discriminatory? Canadian AIDS researchers Dr. Mark Wainberg and Dr. Norbert Gilmore say that while the ban on blood donation from men who have sex with other men may have been ethically and scientifically justified in the 1980's, it no longer makes sense. (CMAJ.) Even though the US FDA reaffirmed their long-standing ban in 2007, they plan to revisit the policy in June. [more inside]
posted by zarq on May 26, 2010 - 69 comments

Defying the FDA, Doctors in Colorado Offer Stem Cell Therapies for Joint Diseases

The FDA has yet to approve stem cell therapies for general use in medicine, but that hasn’t stopped doctors in Colorado from providing them anyway. [more inside]
posted by zarq on Mar 17, 2010 - 50 comments

Mother's Little Helper was only in trouble if it was mislabeled

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.
posted by Asparagirl on Apr 6, 2009 - 28 comments

We've Replaced The Patient's Blood With PolyHeme. Let's See If They Notice.

The blood substitute PolyHeme has been previously discussed on MetaFilter, but new evidence shows that PolyHeme actually raises the chances of death by nearly 30%. PolyHeme was notable mostly for the reaction to its clinical trials, which, controversially, did not require patient consent.
posted by scrump on Apr 29, 2008 - 19 comments

No Need for a Plan B for Plan B

[NewsFilter] A partial victory for public health over politics. Amazingly, the FDA has finally, after 3 years of wrangling, approved over-the-counter sale of Plan B, an emergency contraceptive pill. The victory is partial because you need to be 18 or older to purchase it without a doctor's note. If you're under 18, you need to still have documentation from your physician (or nurse practitioner). The politics behind the approval process were laid bare in this (sincerely) fascinating GAO report [note: links to .pdf file]. I also hope that OTC approval will avoid this.

Plan B previously discussed on MeFi here.
posted by scblackman on Aug 24, 2006 - 65 comments

FDA halts adult stem cell procedure

The FDA has put the brakes on clinical trials of a promising form of stem cell therapy which uses the body's own stem cells to heal dammage. The procedure was used earlier this year to heal the heart of a teenager who was shot in the heart by a nail gun. Other research is being done with the body's own stem cells on the heart and the spinal cord, and new ways to produce large numbers of adult stem cells have been discovered by MIT and the British company TriStem. With the controversy over embryonic stem cells, I'm glad that adult stem cell therapy is showing promise. [Some links via FuturePundit, who is rather annoyed with the FDA.]
posted by homunculus on Nov 29, 2003 - 11 comments

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