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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

National Gay Blood Drive

Today is the National Gay Blood Drive, a campaign dedicated to bringing attention to the fact that the FDA still bans any men who have had sex with other men (MSM), at any time since 1977 from becoming blood donors.
posted by roomthreeseventeen on Jul 11, 2014 - 98 comments

First they came for your raw milk, then your Parmigiano Reggiano

This week the FDA announced it will not permit American cheesemakers to age cheese on wooden boards, potentially destroying the ability to make or import a wide variety of artisanal cheeses. Despite being legal in the various cheese making states and having been used for hundreds of years, the FDA is cracking down under the Food Safety Modernization Act. A sampling of cheeses impacted: Pleasant Ridge Reserve, Cabot Clothbound, Marieke Feonegreek, Bleu Mont Bandaged Cheddar, along with parmesan, aged cheddar and the only American produced Limburger. [more inside]
posted by Muddler on Jun 10, 2014 - 354 comments

Warfarin Phased Out by Next Generation Agents?

Warfarin, for decades the standard of care for stroke prevention in patient with atrial fibrillation, has met its match! Novel oral anticoagulants are the new standard of care, with a favorable efficacy:safety profile compared with warfarin. And what’s more, they don’t require regular monitoring like warfarin. [more inside]
posted by Mister_A on Mar 5, 2014 - 33 comments

You, and me, and parent number three

FDA weighs risks of 3-person embryo fertilization, making "designer babies". This is explored with the goal of preventing mothers from passing on debilitating genetic diseases to their children. Daily Mail says 30 GM human babies have already been born in the United states. Half of them developed defects so the FDA stepped in.
posted by dabitch on Feb 24, 2014 - 61 comments

It's not paranoia if....

“He’s treating them like street punks, and they view themselves as captains of industry.” The most exciting article you will read all year about frog genitals, the FDA, and an eccentric, larger-than-life UC Berkeley scientist navigating class and culture issues while being psychologically profiled and pursued by a pesticide giant he's locked himself into mortal combat with for the last decade. Previously.
posted by blue suede stockings on Feb 5, 2014 - 52 comments

Is the Contraceptive NuvaRing Killing Thousands?

"Danger in the Ring." According to Karen, a doctor in the emergency room asked her over the phone: “Was your daughter using birth control?” Karen said, “Yes, NuvaRing.” He removed the device and said, “I thought so, because she’s having a pulmonary embolism.” [more inside]
posted by blue suede stockings on Dec 28, 2013 - 103 comments

FDA to Require Proof That Antibacterial Soaps Are Safe

F.D.A. to Require Proof That Antibacterial Soaps Are Safe - SLNYT
posted by Evilspork on Dec 16, 2013 - 96 comments

FDA Cheese Ban: Mite vs. Right

Despite the cries of "Save the Mimolette!", the FDA has decided to ban the sale of the French cheese Mimolette over mites used in the rind. [more inside]
posted by Room 641-A on Nov 6, 2013 - 50 comments

The Pills of Last Resort

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

There are no Z-Rays

Help stamp out quackery.
posted by nadawi on Sep 2, 2013 - 37 comments

Xanax and Zantac

Why are pharmaceutical names so goofy?
posted by Chrysostom on Aug 29, 2013 - 135 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

Nutrition Attrition

"Don't forget to take your vitamins!" Or not. Some say it could kill you. Will there ever be any definitive answers when it comes to nutrition?
posted by kidkilowatt on Jun 11, 2013 - 63 comments

Can I eat this?

How to ensure food and drink water safety during a flood or other natural disaster, courtesy of the FDA and the USDA.
posted by MartinWisse on May 20, 2013 - 12 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

According to FDA standards, the sauce is technically not “cheese"

The history of baseball stadium nachos.
posted by Chrysostom on May 13, 2013 - 58 comments

An investigative reporter investigates

Did my wife's cosmetics give her breast cancer? During her first round of chemo in 2009, some volunteers at the hospital came calling with a little red bag [from the Look Good Feel Better program] that contained products from Clinique, Estée Lauder, and Del Laboratories. Upon reviewing the contents of her bag, she realized that several of the products contained parabens — chemicals that mimic estrogen and that according to the Campaign for Safe Cosmetics are linked to cancer. (previously, previouslier, previousliest in AskMe)
posted by spamandkimchi on May 11, 2013 - 38 comments

The Embedded Dangers of Untested Stem Cell Cosmetics

Six and a half hours of surgery later, he and his colleagues had dug out small chunks of bone from the woman's eyelid and tissue surrounding her eye, which was scratched but largely intact. The clicks she heard were the bone fragments grinding against one another.
posted by latkes on Dec 17, 2012 - 51 comments

"Especially with the country in great need of donation, science should speak louder than stigma in determining who can help."

Tainted: Why Gay Men Still Can't Donate Blood - "Since 1983, Food and Drug Administration (FDA) guidelines have disqualified men who have ever had sex with men (MSM) from donating blood... Uneven application of exclusion to at-risk individuals suggests that risk aversion disproportionately impacts MSMs. For example, a non-MSM individual who has had sexual contact with a commercial sex worker or HIV-positive partner is deferred for only twelve months... The fact that the U.S. upholds a lifetime ban on MSM donation while Australian policy allows MSM individuals to donate a year or less after contact reveals a glaring discrepancy. Both ethics and science point to a flaw in FDA policy. That I could have had sex with 365 partners this year and be a perfectly fine candidate for donating blood, while the MSM next to me wouldn't qualify, betrays a faulty line of logic." [more inside]
posted by flex on Nov 12, 2012 - 104 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

FDA Moves to Reduce Antibiotic Use in Livestock

Worried about the widespread use of antibiotics used in the raising of steer, pigs and poultry, and fearing the rise of antibiotic-resistant illness, the U.S. Food and Drug Administration began the process of withdrawing its approval for the non-medical use of penicillin and tetracyclines (scribd, posted by Wired magazine's Maryn McKenna in conjunction with one of her posts on this issue). That was in 1977. The FDA stopped pursuing the process, and antibiotics have continued to be given in feed. But a recent court order may allow the FDA to oversee a major change to the system. [more inside]
posted by MonkeyToes on Jun 26, 2012 - 32 comments

Re: Docket No. FDA-2010-P-0149

FDA Rules Corn Syrup Can't Change Its Name To Corn Sugar [more inside]
posted by TangerineGurl on May 30, 2012 - 100 comments

"It's OK to eat cooked meat that's been glued."

What's inside your filet minion could kill you. -- Well, it probably won't, but would you order that $15 steak if you knew it was restructured out of glued-together stew meat?
posted by empath on May 1, 2012 - 85 comments

Psychotropic medication efficacy and publication bias

Antipsychotics: "The magnitude of publication bias found for antipsychotics was less than that found previously for antidepressants, possibly because antipsychotics demonstrate superiority to placebo more consistently."
Antidepressants: "We found a bias toward the publication of positive results. Not only were positive results more likely to be published, but studies that were not positive, in our opinion, were often published in a way that conveyed a positive outcome. [...] Using both approaches, we found that the efficacy of this drug class is less than would be gleaned from an examination of the published literature alone. According to the published literature, the results of nearly all of the trials of antidepressants were positive. In contrast, FDA analysis of the trial data showed that roughly half of the trials had positive results." Previously [more inside]
posted by OmieWise on Apr 3, 2012 - 34 comments

How Corporations Corrupt Science at the Public's Expense

How Corporations Corrupt Science at the Public's Expense: Report looks at methods of corporate abuse, suggests steps toward reform [Full Report (PDF)] [Executive Summary (PDF)] [more inside]
posted by Blasdelb on Mar 11, 2012 - 27 comments

Secretary Sebelius Makes History

For the first time ever, the Health and Human Services secretary publicly overruled the Food and Drug Administration, refusing Wednesday to allow emergency contraceptives to be sold over the counter, including to young teenagers. [more inside]
posted by DWRoelands on Dec 8, 2011 - 323 comments

"Rice Pudding. Milk. Bread and Butter. Tea. Coffee. A Little Borax."

But beyond the disgust element was another more important question concerning borax: was it actually safe to eat? This troubling issue was the reason why squad members were imbibing the compound at Christmas, the reason for the Poison Squad experiments themselves. Established by a famously outspoken, crusading chemist from the U.S. Department of Agriculture, Harvey Washington Wiley, the squads were also meant to answer another, larger question: were manufacturers actually poisoning the food supply?
posted by liketitanic on Jul 12, 2011 - 19 comments

Avastin and the power of hope

Based on a lack of evidence for efficacy, "an FDA panel unanimously voted to revoke its approval of Avastin (bevacizumab) for breast cancer. The decision evoked cheers from some groups and jeers from others. At least one group derided the decision as the work of a 'death panel'". An interesting article on the withdrawal of a "miracle" drug from a section of the market, explaining the reasoning behind the decision and discussing the reaction from patients, many of whom believe -- despite the evidence -- that the drug was actually helping them. [more inside]
posted by metaBugs on Jul 1, 2011 - 11 comments

The Problem with Tamiflu, Relenza, Swine Flu, GSK, and the FDA.

Flu Warning: Beware the Drug Companies! (snyrbl)
posted by Sticherbeast on May 10, 2011 - 42 comments

Please Support Genetic Freedom

Should you be allowed unrestricted knowledge of your own genetic makeup? Or should your doctor be the one to decide how much you can know about your own genes? Currently direct-to-consumer (DTC) genetic testing companies (such as 23andMe) allow consumers to discover which genes they have inherited. But some influential people are arguing that the general public is harmed by the ability to freely access this type of information. The American Medical Association is urging the FDA to make it so that genomic information is only available to a person through a personal physician or medical counselor. As a counterpoint the geneticists at the Genomes Unzipped website provide a six point statement on why People Have A Right To Access Their Own Genetic Information. [more inside]
posted by Jason Malloy on Mar 13, 2011 - 98 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

There is excessive lead in the nuclear sludge

Toxic Waste is toxic.
posted by ardgedee on Jan 14, 2011 - 43 comments

Warning: Cigarettes are addictive.

The FDA has unveiled new graphic warnings for cigarette packages, including for the first time images that might depict dead bodies, cancer patients and diseased lungs. You can see all 36 new images here. (13MB PDF). [more inside]
posted by Mister Fabulous on Nov 10, 2010 - 190 comments

Wasting Taxpayer Resources to Persecute the Pomegranate, or Pom Not-So-Wonderful?

POM Wonderful may not be so wonderful, but that might not be so surprising, given the history of Stewart and Lynda Resnick. The couple are involved with much more than pomegranate juice: they own Fiji Water, pesticide manufacturer Suterra, Paramount Agribusiness (source of citris, well-known pistachios and other nuts), and former owners of the Franklin Mint. This round with the Resnicks started in February 2010, with a warning from the FDA, which lead to a confusing bit of restraining order requested, then soon after requested to be withdrawn (with fears of pushing the First Amendment too far). That phase is past, but POM Wonderful is now stating they believe "very strongly in its first amendment rights to communicate the promising results," results which look similar to placebos taken by control subjects. The FTC is not impressed.
posted by filthy light thief on Sep 28, 2010 - 29 comments

Olive Oil in the U.S. - A Smeared Reputation

A lack of federal rules has made the nation the dumping ground for cheap, adulterated and even dangerous oils. With many consumers in the U.S. becoming ill after consuming "olive oil", the USDA is finally moving to create standards defining what is "virgin olive oil". These are supposed to come out in the fall. Except 'the new rules are voluntary — not mandatory — so the prospect of more slick shenanigans continues'. Meanwhile, the FDA 'which oversees most food-label accuracy issues, said the agency does not regularly test olive oils for adulteration, and that it relies on tips about problems from the public, trade groups and others'. [more inside]
posted by VikingSword on Jul 8, 2010 - 74 comments

Personally, I'm Holding Out for the "Sauron" Lens

The New York Times reports that anime-style "Circle" (or "Big Eye") lenses are currently gaining in popularity, thanks to Lady Gaga's Bad Romance video. [more inside]
posted by zarq on Jul 3, 2010 - 59 comments

Should we test drugs on pregnant women?

Should we start doing medical research on pregnant women? In the wake of the H1N1 epidemic, in which pregnant women had a disproportionately higher risk of death, the question of including pregnant women in clinical trials has begun to be tentatively breached. [more inside]
posted by KathrynT on Jun 21, 2010 - 22 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

Would You Want to Know?

"Starting Friday, Walgreens' shoppers can buy an over-the-counter genetics test from Pathway Genomics at 7,500 stores across the country. Priced at $20 to $30, the kit claims to offer information on users' possibility of developing conditions like Alzheimer's disease, breast cancer, or diabetes. Access to the scientific analysis online, however, costs another $79 to $179"* [video | 02:31]. "But doctors and geneticists fear the worst for this new over-the-counter access to genetic testing. With no physician to interpret the results of the test, and no FDA regulation of how results are processed or delivered, there is the potential for consumers to misinterpret what their risk really means for their health and their lifestyle."* [more inside]
posted by ericb on May 11, 2010 - 47 comments

21st. Century Snake Oil

"Con men used to travel town to town hawking medical remedies said to be made of Chinese snakes. Snake oil was useless and dangerous. So the FDA was created to put a stop to it and other food and drug scams. But, today, quack medicine has never been bigger. In the 21st century, snake oil has been replaced by bogus therapies using stem cells. Stem cells may offer cures one day, but medical charlatans on the Internet are making outrageous claims that they can reverse the incurable, from autism to multiple sclerosis to every kind of cancer."* Video Part 1 [13:15] || Part 2 [11:49]. [more inside]
posted by ericb on Apr 18, 2010 - 33 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

It's what's for dinner

Ammonia-injected centerfuged fatty trimmings = pink slime + E. Coli. Eight years ago, federal officials were struggling to remove potentially deadly E. coli from hamburgers when an entrepreneurial company from South Dakota came up with a novel idea: injecting beef with ammonia.
posted by cytherea on Jan 1, 2010 - 90 comments

Got Real (?) Milk?

Raw Milk is milk that has not been pasteurized or homogenized. Raw milk is legal in England, but not in Scotland. Similarly, it's legal in South Carolina and illegal in Georgia. Enter MeFi's Own® ewagoner of Athens Locally Grown. [more inside]
posted by Medieval Maven on Nov 2, 2009 - 144 comments

A new scare?

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]
posted by borborygmi on Jun 30, 2009 - 117 comments

Henry Waxman and his band of Merry Mad Men

The House passed H.R. 1256, the Family Smoking Prevention and Tobacco Control Act a few days ago. The bill would put regulation of tobacco under the jurisdiction of the F.D.A. Some are critical of this bill, pointing out that Philip Morris is behind it. But the bill does contain many positive elements. Manufacturers would be required to disclose product ingredients to the F.D.A. and marketing to children would be further restricted. [more inside]
posted by formless on Apr 7, 2009 - 35 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

Economic policy in a squeeze bottle

"Libertarians Are Dumb, or Why We Eat Heinz Ketchup"
posted by expriest on Mar 16, 2009 - 180 comments

Is There Nothing Lobbyists Can't Do?

FDA says your company's medical device isn't safe to market? No problem. Just hire a lobbyist. Afraid of being sued? Don't worry. The Supreme Court says you are immune.
posted by expriest on Mar 6, 2009 - 40 comments

Don't Worry, Be Hungry.

Foodies, gourmands, and gluttons! Courtesy of those muckrakers at the New York Times, consider this recent op-ed piece. For those still pissed about the Times cheerleading us into Iraq, skip it and just dig this handbook from your federal watchdogs to determine just how much rat shit may have been in those beanie-weenies you enjoyed cold from the can last night at 1:34a.m. Handy alphabetization makes finding your favorite processed foods easy as pie.
posted by barrett caulk on Feb 14, 2009 - 23 comments

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