GNC Drops as U.S. to Announce Action on Supplement Makers


GNC Holdings Inc. and Vitamin Shoppe Inc. plunged Tuesday on plans by the Justice Department, the Food and Drug Administration and other U.S. agencies to announce criminal and civil enforcement actions over the advertising and sale of dietary supplements.

Source: GNC Drops as U.S. to Announce Action on Supplement Makers

Hot Startup Theranos Dials Back Lab Tests at FDA’s Behest – By JOHN CARREYROU Updated Oct. 16, 2015 3:17 p.m. ET


 Under pressure from regulators, laboratory firm Theranos has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests. WSJ's John Carreyrou explains on Lunch Break With Tanya Rivero. Photo: Martin E. Kilmek


Under pressure from regulators, laboratory firm Theranos has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests. WSJ’s John Carreyrou explains on Lunch Break With Tanya Rivero. Photo: Martin E. Kilmek

Under pressure from regulators, laboratory firm Theranos Inc. has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests, according to a person familiar with the matter, backing away from a method the company has touted as it rose to become one of Silicon Valley’s hottest startups.

The move is a setback to the Palo Alto, Calif., company’s ambition to revolutionize the blood-testing industry. As a result of the halt, Theranos is operating more like a traditional lab that draws blood with needles from patients’ arms. Theranos is valued at $9 billion, or about as much as each of the industry’s two largest companies in the U.S.

Food and Drug Administration inspectors recently showed up unannounced at Theranos, the person familiar with the matter said. The inspection was triggered by concerns the agency had about data Theranos had voluntarily submitted to the FDA in an effort to win approval for its proprietary testing methods, this person said.

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http://www.wsj.com/articles/hot-startup-theranos-dials-back-lab-tests-at-fdas-behest-1444961864

The Dangerous Rise of K2: America’s Cheapest High – Vice News Published on Oct 14, 2015


K2 — the street name for plant matter sprayed with synthetic chemicals, designed to mimic the effects of marijuana’s active ingredient — is currently America’s cheapest way to get high. The drug is often sold at corner stores, labeled as potpourri and unfit for human consumption. A bag of K2 sells for $5 to $10, while a joint goes for just $1.

But the drug’s dangerous side effects have taken a toll on a wide variety of communities across the country, particularly in New York City. US poison control centers received more than 6,000 K2 calls in the first nine months of 2015, around a quarter of those calls came from NYC.

VICE News gets a glimpse of the challenges New York City is facing with K2 through the lens of volunteer ambulance corps and harm reduction specialists in its outer boroughs.

Watch “Back from the Brink: Heroin’s Antidote” – http://bit.ly/1X0DX8W

California enacted the strictest law yet on antibiotic use in farms – Updated by Julia Belluz on October 11, 2015, 3:20 p.m. ET


Polarpx/Shutterstock

Antibiotic resistance is now considered a catastrophic threat to public health, as more and more deadly, drug-resistant bacteria have been appearing in our cities, farms, and hospitals. In theory, the solution should be simple: We need to stop overusing antibiotics. Yet nearly every attempt to do so thus far has failed.

Now California is taking drastic measures. This weekend, Gov. Jerry Brown signedthe toughest restrictions yet on antibiotic use in the United States, banning the state’s livestock producers from using certain antibiotics for routine disease prevention and growth promotion.

“The science is clear that the overuse of antibiotics in livestock has contributed to the spread of antibiotic resistance and the undermining of decades of lifesaving advances in medicine,” Brown said in a statement.

This is, potentially, a huge deal. Across the United States, more than 70 percent of medically important antibiotics are sold for use in animals, so curbing overuse in this area has always been a priority for public health reformers. And California’s new law could push other states to follow suit.

Why curbing antibiotic use on farms is so controversial

The science behind drug resistance is straightforward enough. The more we use antibiotics to kill off disease-causing bacteria, the more likely those bacteria are to evolve resistance, developing random mutations to outwit our drugs. And overuse has become a huge problem. In the United States alone, antibiotic-resistant infections are now associated with 23,000 deaths and 2 million illnesses every year.

So public health experts have been looking for places to curtail misuse. It would help, for instance, if doctors stopped prescribing unnecessary antibiotics. But another key place to look is on farms, where the vast majority of medically important antibiotics are sold.

Antibiotics on farms are typically used in three ways: to treat sick animals, to prevent infections, and to fatten up animals. The first use is uncontroversial: Everyone agrees that it’s okay to use antibiotics to treat animals that come down with disease. But public health experts have criticized the latter two uses. They argue that many livestock producers needlessly overuse antibiotics to prevent infections and promote growth — essentially relying on them as an alternative to hygiene and good nutrition. These are considered “nontherapeutic” uses.

And experts argue this overuse has real consequences. Both the Food and Drug Administration and the Centers for Disease Control and Prevention have told Congress that there’s a link between the routine, nontherapeutic use of antibiotics on farms and the superbug crisis in humans.

 

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http://www.vox.com/2015/10/10/9489849/california-antibiotic-resistance-sb27

2 new studies show the FDA is rushing more drugs to market based on shoddy evidence – Updated by Julia Belluz on September 24, 2015, 5:39 p.m. ET


There was a time when the Food and Drug Administration was so sluggish and conservative in approving new drugs that people who desperately needed access to medicines would die waiting.

But by the early 1990s, Congress had created four programs to expedite the development and approval process for new pharmaceuticals (the breakthrough drug designation, priority review, fast track and accelerated approval). These pathways were intended to push innovative new drugs — drugs to treat rare, serious, or life-threatening diseases — through the FDA more quickly.

Since these medicines were sorely needed, the idea was that rushing them through, often on the basis of more limited and preliminary clinical trials data, would help patients languishing with unmet medical needs.

fda jb

(Javier Zarracina)

 

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http://www.vox.com/2015/9/24/9387987/fda-expedited-drug-approvals

Nine Obama regulations to watch – By Lydia Wheeler – 09/06/15 02:31 PM EDT


The window is already closing on President Obama’s regulatory agenda, and agencies across the federal government are moving to crank out a slew of new rules before election year politics bring business in Washington to a virtual standstill.

Obama has made no bones about using the power of his office to accomplish his policy goals in lieu of congressional action, presiding over numerous controversial regulations in the energy, healthcare and financial sectors, among many others.

With more than a year left, the administration will continue to promulgate regulations until the clock runs out.

However, controversial rules in any administration tend to stall in election years. And proponents of stronger heath and safety protections fear that a GOP-controlled Congress could overturn rules issued at the tail end of the Obama administration, in the event that a Republican wins the White House next year.

They are instead hoping for a flurry of action this fall on regulations, many of which they see as long overdue.

Here are ten of the most highly anticipated rules likely to come down the pipeline in the remainder of 2015:

Tobacco: The Food and Drug Administration (FDA) is expected to finalize its tobacco “deeming rule” to regulate all tobacco products under the Tobacco Control Act, including electronic cigarettes and cigars.

Industry and advocacy groups have been pushing FDA to finalize the rule by the end of the summer, but with two weeks left in August all bets are now on September.

The agency has been slow from the start on issuing the rule, which would expand the FDA’s reach to a host of new products over which it has not previously asserted authority.
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Why President Obama and Congress turned their backs on food safety – By HELENA BOTTEMILLER EVICH July 2015


Congress passed a landmark law. Then everyone walked away.

Mario Wagner for Politico

Mario Wagner for Politico

The bacteria-tainted apple that probably killed Shirlee Frey traveled hundreds of miles from an orchard to a packinghouse and then to a factory that coated it in caramel. It never came anywhere close to being examined or tested by a food-safety inspector.

The California woman died in December, about a month after she ate some of the Halloween treats she bought for her grandchildren. At the end, her brain was so swollen she couldn’t breathe on her own. Frey, 81, was one of seven fatalities in a listeria outbreak caused by caramel apples that spread to 12 states. Common bacteria such as listeria, salmonella and E. coli kill several thousand people each year and sicken some 48 million Americans. Brad Frey believes his mother and hundreds of others might still be alive if a sweeping law hailed as a complete revamp of the nation’s broken food-safety system had been put into action.

“This didn’t have to happen,” Frey said.

He may well be right.

According to a POLITICO investigation, the Obama administration and Congress have all but squandered an opportunity to give the anemic Food and Drug Administration, which is responsible for the safety of 80 percent of the nation’s food supply, a level of oversight the public long assumed it already had.

On paper, the law that Congress passed in late 2010 — known as the Food Safety Modernization Act — was bigger than anything since Teddy Roosevelt cleaned up the meatpacking industry. The law mandated more inspections and much tougher anti-contamination standards for everything from peaches to imported pesto sauce, and it placed more emphasis on preventing outbreaks than on chasing them down after people become sick.

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http://www.politico.com/story/2015/07/sickness-in-the-system-120057.html?hp=t4_r

Unhealthy Fixation – By William Saletan JULY 15 2015 5:45 AM


1 They Want You to Be Overwhelmed

Is genetically engineered food dangerous? Many people seem to think it is. In the past five years, companies have submitted more than 27,000 productsto the Non-GMO Project, which certifies goods that are free of genetically modified organisms. Last year, sales of such products nearly tripled. Whole Foods will soon require labels on all GMOs in its stores. Abbott, the company that makes Similac baby formula, has created a non-GMO version to give parents “peace of mind.” Trader Joe’s has sworn off GMOs. So has Chipotle.

Some environmentalists and public interest groups want to go further. Hundreds of organizations, including Consumers Union, Friends of the Earth, Physicians for Social Responsibility, the Center for Food Safety, and the Union of Concerned Scientists, are demanding “mandatory labeling of genetically engineered foods.” Since 2013, Vermont, Maine, and Connecticut have passed laws to require GMO labels. Massachusetts could be next.

The central premise of these laws—and the main source of consumer anxiety, which has sparked corporate interest in GMO-free food—is concern about health. Last year, in a survey by the Pew Research Center, 57 percentof Americans said it’s generally “unsafe to eat genetically modified foods.” Vermont says the primary purpose of its labeling law is to help people “avoid potential health risks of food produced from genetic engineering.” Chipotle notes that 300 scientists have “signed a statement rejecting the claim that there is a scientific consensus on the safety of GMOs for human consumption.” Until more studies are conducted, Chipotle says, “We believe it is prudent to take a cautious approach toward GMOs.”

I’ve spent much of the past year digging into the evidence. Here’s what I’ve learned. First, it’s true that the issue is complicated. But the deeper you dig, the more fraud you find in the case against GMOs. It’s full of errors, fallacies, misconceptions, misrepresentations, and lies. The people who tell you that Monsanto is hiding the truth are themselves hiding evidence that their own allegations about GMOs are false. They’re counting on you to feel overwhelmed by the science and to accept, as a gut presumption, their message of distrust.

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http://www.slate.com/articles/health_and_science/science/2015/07/are_gmos_safe_yes_the_case_against_them_is_full_of_fraud_lies_and_errors.html

An FDA panel just backed the ‘female Viagra.’ Critics say it’s a mistake. – Updated by Julia Belluz on June 4, 2015, 7:21 p.m. ET


1) A panel of advisers to the Food and Drug Administration just recommended the agency approve a new drug designed to boost womens’ sex drives.

2) Flibanserin — a pill dubbed the ‘female Viagra’ — has already been rejected by the FDA twice since 2010 out of concerns that its harms outweigh its benefits.

3) The 18-6 vote is considered a “major victory” for the drug, since the FDA more often than not adopts the advice of the expert group and same panel voted unanimously against flibanserin in the past.

4) Critics have raised questions about the efficacy of flibanserin. They’ve also accused the pharmaceutical industry of inventing the medical condition— hypoactive sexual desire disorder — that the drug would supposedly treat.

American women may be one step closer to the ‘female Viagra’

female viagra

(El Nariz /Shutterstock

Flibanserin (pronounced fluh-BAN-ser-in) is a daily pill made by Sprout Pharmaceuticals designed to treat low libido in premenopausal women. To date, the FDA has not approved it for sale — but the pressure to do so is growing.

On Thursday, a government advisory panel voted 18 to 6 to recommend that the FDA approve the drug — on the condition that Sprout can figure out how to minimize the safety risks to patients. That might entail requiring medical professionals to take a training course before being allowed to prescribe the drug, or making women who want the pink pills sign an agreement saying they won’t use birth control or alcohol while on flibanserin (since these two behaviors increased the risk of side effects).

About one in five women who took the drug have experienced side effects: most commonly, low blood pressure, dizziness, and fainting, increasing the risk of injuries such as concussions.

While Viagra improves men’s sexual performance, by increasing blood flow, the pink pill works on women’s brains, raising dopamine levels.

It’s not clear that the FDA will take the panel’s advice, particularly since the agency has questioned the drug’s effectiveness and safety in the past. As the New York Times reports, the results of clinical trials for flibanserin have been lackluster:

Three clinical trials testing flibanserin were consistent in their results. The women who took part were having an average of two to three of what they defined as “sexually satisfying events” per month when the studies began. Once they started taking the drug, the number of such events increased, but by no more than one event per month more than for women in the trial who got a placebo.

At the advisory committee meeting, the FDA gave a scientific presentation against the drug, arguing that it only resulted in eight more sexually satisfying events per year (when compared to placebo) and that side effects were common.

But the room was also filled with emotional testimony by women who feel they would greatly benefit from the medication. Sprout claims nearly one-tenth of premenopausal women suffer hypoactive sexual desire disorder.

Article continues:

http://www.vox.com/2015/6/4/8732723/female-viagra-fda

Report: FBI investigating medical device that spread cancer in women – CBS NEWS May 27, 2015, 6:10 PM


The FBI reportedly is investigating a medical device that was withdrawn from the market last year after it was found to spread cancer in women. The Wall Street Journal reports investigators are looking into what Johnson & Johnson, the largest manufacturer of the device, knew about the problems.

Johnson & Johnson’s Ethicon division manufactured power morcellator devices which were withdrawn from the market after the FDA warned they could spread cancer. AP PHOTO/MEL EVANS

The device, known as a laparoscopic power morcellator, was used by surgeons during certain minimally-invasive hysterectomy procedures or to remove uterine fibroids. The morcellator ground up tissue so it could easily be removed through tiny incisions. But when the device was used on women who had undiscovered uterine sarcoma cancer, it had the effect of spreading cancerous tissue throughout the abdomen and pelvis.

The U.S. Food and Drug Administration issued a warning about the cancer risk in April 2014, saying morcellation could “significantly worsen…the patient’s likelihood of long-term survival.”In November, the FDA required a strong new warning on the product label.

Ethicon, a division of Johnson & Johnson that made the devices, advised doctors to stop using them and withdrew them from the market, although models made by other companies remain available.

Prior to that, about 60,000 such procedures were performed every year, estimated Dr. William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

Asked about the investigation, J&J/Ethicon told CBS News they have not been contacted by the FBI regarding morcellation devices.

But at least one of the affected patients has been interviewed by the FBI about her case. Dr. Amy Reed, an anesthesiologist and mother of six, became an outspoken critic of the devices after she underwent a hysterectomy with a morcellator at Boston’s Brigham and Women’s Hospital in 2013. Follow-up testing showed she had cancer that had spread through her abdomen.

Reed’s husband, Dr. Hooman Noorchashm, told CBS News the couple had reached out to the FBI starting in late 2013 and “finally, agents in New Jersey listened.” He said they were interviewed last October and again recently about their concerns.

http://www.cbsnews.com/news/fbi-investigating-medical-device-that-spread-cancer-in-women/