Free Republic

“MY SPIRIT IS BROKEN” Will the New Statin Guidelines Do More Harm Than Good? Part 1: A $29-billion-dollar-a-year industryWhen he was nearing the end of his career, Henry Gadsden, then-CEO of pharmaceutical giant Merck, gave an interview to Fortune magazine in which he said that he regretted that he couldn’t sell drugs to healthy people. He said his dream was to be able to peddle his company’s wares to everybody, like chewing gum giant Wrigley’s. Mr. Gadsden’s dream soon began to come true. A few years earlier, Japanese biochemist Doctor Akira Endo surmised that a compound that could inhibit the...

Reforming health care is a signature issue with the current administration, but even the most ardent proponents of Obamacare would be reluctant to call it a success. Notwithstanding the well-publicized problems, of the countless billions spent on this program, precious little has gone into actual patient care. But really, what should we expect from a system designed by soulless bureaucrats such as “bioethicist” Ezekiel Emanuel and Donald Berwick, former Administrator of the Centers for Medicare and Medicaid Services? Emanuel infamously suggested that doctors take the Hippocratic Oath too seriously, while Berwick intoned that the federal government must step in between...

A Methodist church in West Virginia was stymied in its efforts to help the needy last week when the county health department told them their plan violated state health codes. The parishioners at First United Methodist Church had decided to install a large refrigerator outside their building that those in need could access at any time. Anticipating concerns about food safety, they planned to stock it with only prepackaged food, and built a cage around it to prevent small children from climbing inside. “We just wanted a way for more people to have access to food, along with some privacy...

Given the link between alcohol consumption during pregnancy and birth defects, should expectant mothers who drink be arrested for assault? If not, it is hard to see why Mallory Loyola is in jail. Loyola, who was arrested last week after giving birth to a baby girl who tested positive for amphetamine, is the first woman to be charged under a new Tennessee law that criminalizes drug consumption by pregnant women. The law, ostensibly aimed at protecting children, is really about punishing what its chief sponsor described as "the worst of the worst": women who not only use arbitrarily proscribed intoxicants...

The U.S. Food and Drug Administration is protecting consumer rights in a bold new way–by policing companies’ Facebook pages.Zarbee’s Naturals, a producer of “safe and effective natural [cough] remedies” for children, was sent a warning letter by the FDA for liking comments on its Facebook page implying that its products “are intended for use as drugs.”Zarbee’s products were designed specifically for children too young for FDA-approved medications and have not been reviewed by the FDA. Happy customers posted their approval on the company’s Facebook page, saying things like “Love Zarbee’s this is the only medicine we use for our 2...

The U.S. Food and Drug Administration has found that Alaska seafood is safe from Fukushima radiation, but a citizen’s group plans to conduct a separate study of the water in lower Cook Inlet using a crowdsource funding site. “The (FDA) results confirm information from federal, state and international agencies that seafood in the North Pacific and Alaska waters poses no radiation related health concerns to those who consume it,” said a statement released by state health and environmental officials. The FDA review was based on a sampling plan developed by the departments of Environmental Conservation and Health and Social Services,...

It’s called the “little pink pill,” a tiny tablet that could have a huge impact on treating female sexual dysfunction. If it’s approved, it would become the first drug of its kind on the market. But that’s a big IF. The drug Flibanserin is locked in a heated battle for approval from the U.S. Food and Drug Administration, raising controversial questions about why there are so many sexual enhancement drugs available for men and zero for women. Cindy Whitehead, the founder and COO of Sprout Pharmaceuticals, a Raleigh, North Carolina-based company focused on producing only Flibanserin, has been fighting for...

The public will have more time to weigh in on a federal proposal to regulate electronic cigarettes and other tobacco products. The Food and Drug Administration said Friday that the public comment period slated to end July 9 is being extended an additional 30 days to Aug. 8 after getting lots of input on how to regulate e-cigarettes. Those are battery-powered devices that heat a liquid nicotine solution, creating vapor that users inhale. The FDA also proposed extending its authority to regulate cigars, hookahs, nicotine gels and pipe tobacco.

I’m no cheese expert. But I know what I like. And I prefer “interesting” cheese to the mostly mass-produced product I see on supermarket shelves. Why? A failure of capitalism? No. Blame the FDA for today’s mediocrity in cheese. The milk product industry has been heavily regulated, subsidized, and managed since FDR’s time, at least. And it’s mostly gotten worse. Government, like cheese, ages to “perfection.” By which I mean, when it comes to government, perfectly foolish. The most famous “government cheese” problem (the government buying and storing huge quantities of the stuff to raise consumer prices and “therefore” stabilize...

Texas Gov. Rick Perry probably shouldn't have attempted to make the case that gay people can "decide not to" be gay despite genetic predisposition, he conceded Thursday, offering no semblance of an apology but trying instead to rally attention back to his message about jobs and the economy. "I got asked about an issue," Perry, a Republican, explained during a lunch hosted by the Christian Science Monitor. "And instead of saying, 'You know what? We need to be a really respectful and tolerant country - to everybody - and get back to talking about: Whether you're gay or straight, you...

The FDA, perhaps still smarting from the recent artisanal cheese kerfuffle, is setting its sights on a bigger target: salt.“The current level of [sodium] consumption is really higher than it should be,” said FDA commissioner Margaret Hamburg. That’s why they’re preparing “voluntary guidelines” for the food industry encouraging them to stay below certain salt levels.While the guidelines will initially be voluntary, health groups are lobbying for mandatory standards — lobbying that will only grow more intense if businesses refuse to comply once the standards are released. If businesses don’t go light on the salt “then FDA should start a process...

CNSNews.com has confirmed that Monica Metz, the FDA employee who wrote the letter that said "the use of wooden shelves... for cheese ripening does not conform to cGMP requirements," previously worked for Leprino Foods, the largest mozzarella producer in the world. In other words, Metz, a former employee of "big cheese," used her position at the FDA to write a letter that would have obliterated the artisanal cheese making industry (or "small cheese.") The FDA put at least one New York cheese maker out of business for "a 'repeat violation' involving aging cheese on wood," but the Agency now says...

It's been a weird few days for people who love good cheese, particularly wheels of American farmstead cheese aged on wooden boards: Last week, it seemed as if the FDA had moved to ban aging cheese on wood, a practice almost as old as coagulated dairy itself and the production aspect that turns Comté into, well, Comté. New York's Department of Agriculture got curious as to why the agency had all of a sudden cited several producers for doing something New York and practically every other state permit, so the FDA replied it was simply enforcing long-standing policy, not doing...

Darcy Olsen, president of the Arizona-based Goldwater Institute, and Richard Garr, president of Neuralstem, a biotech company, wrote "Right to Try experimental drugs" in USA Today (5/28/2014). They pointed out that "this year, more than 5,000 Americans will lose their battle with ALS, commonly known as Lou Gehrig's disease." Up until recently, there was no medicine on the market that significantly improved the lives of ALS patients. But now there is one in clinical trials that holds considerable promise, but it has not been granted Food and Drug Administration approval. The average amount of time it takes to get a...

The Federal Food and Drug Administration (FDA) announced Friday that it will not allow cheese makers use wooden boards to age their cheese - a ruling that would effectively wipe out artisanal cheeses.The FDA's ruling came to light after several cheese makers in New York were cited - despite state laws that allow the use of wood boards."Reports showed that the porous structure of wood made it susceptible to the colonization of bacteria on the surface and inside the wood," Monica Metz, the branch chief for the FDA's Center for Food Safety and Applied Nutrition's Dairy and Egg Branch, wrote...

Gabe Luddy, fourth-generation cheesemaker at Vella Cheese Co. in Sonoma, makes his Dry Jack the same way his grandfather and great-grandfather did - he rolls and presses curds into large wheels of cheese, then brines and coats the wheels before sliding them onto wooden racks. There they age, from seven months to several years. A U.S. Food & Drug Administration statement which became public last week puts this 83-year-old practice in doubt. In what the agency is calling a clarification, the FDA has declared that the wooden surfaces that cheesemakers around the world age cheeses on "cannot be adequately cleaned...

Old guy in the cell: What are you in for? New guy in the cell: I aged cheese on wooden boards. Old guy: Oh. (Moves away slowly.) From Walter Olson at Overlawyered, the FDA has interpreted the Food Safety Modernization Act to preclude the aging of cheese on wood boards. Much as you may not think this touches your life, it does if you happen to enjoy any better cheese than velveeta. From CheeseUnderground: A sense of disbelief and distress is quickly rippling through the U.S. artisan cheese community, as the federal Food and Drug Administration (FDA) this week announced...

The white-marble Rayburn House Office Building, in Washington DC, looks like a giant courts building or a central bank, fully intimidating and imposing in its hulking stony blockiness. And the US Congress, of course, is an institution best known for its tedium, albeit a tedium that is regularly punctuated by fiery partisan combat. On a typical day, the Rayburn building--acronymed as RHOB--is a place where politicos and bureaucrats struggle for and against some special interest, yea or nay, on regulation or appropriation. And the biggest single activity in RHOB, or in any of the other five office edifices on Capitol...

The latest bad news concerns one more of the ill-fated thiazolidinediones (TZDs). This class of drugs was introduced in the late 1990s, and includes Avandia, Actos, and Rezulin. TZDs are PPAR-gamma agonists, meaning that they activate peroxisome proliferator-activated receptors, especially the “gamma” receptor. Such activation affects certain metabolic processes, and among other things, insulin resistance is reduced. Rezulin—notoriously fast-tracked by FDA—was withdrawn from the market in 2000, in the wake of scores of liver failures and deaths. Pfizer, the manufacturer, was on the hook for upwards of $750 million in damages. At the time, Dr. Janet Woodcock, director of FDA’s...

For reasons passing understanding, the FDA announced recently that it was moving forward with invoking its authority to regulate cigars, along with other forms of tobacco. It’s a part of the Tobacco Control Act, signed into law in 2009, which gave the agency the option of casting its net down on cigars at the time of its choosing. In other words – it was only a matter of time before bureaucrats decided to be bureaucrats. It’s not set into stone, yet. Between now and July 9 the FDA will accept comments on its proposals, at which point it will the...