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Netflix’s “The Bleeding Edge” Exposes the Horrors the FDA Approves From Medical Device Makers

Continuing their legacy of equally infuriating and enlightening documentaries, the producer-director team of Amy Ziering and Kirby Dick poke into the archaic and futile FDA approval systems for medical devices with their film The Bleeding Edge. Prepare to be scared shitless of vaginal mesh or high-tech surgery robots. Through a series of personal stories from both qualified medical professionals and laypeople, the film explores just what exactly the word complications means on a device’s warnings. In the cases Dick investigates, those complications become a ripple effect of lives ruined by untested but FDA-approved devices.

The film, which premieres on Netflix on July 27, traverses the spectrum of medical devices but opens and closes on one particular item, Essure, a metal coil that’s inserted into the fallopian tubes for sterilization purposes. We meet a mail carrier from upstate New York whose doctor sold her on Essure years ago. As the documentary jumps around to different people, devices and experts, we return again and again to the horrifying story of this mail carrier, who came to find that her body was rejecting the coil, which led her to nearly bleed to death. Another woman, a Latina account executive with four children, relays a frighteningly similar story, only with the added layer of racism; her doctor told her he assumed Latinas just bled more than white women did. Neither woman’s story takes a turn for the better, but it’s the Latina woman whose entire life — and the lives of her daughters — get smashed all because of one doctor not taking her concerns seriously.

Dick seems to anticipate that viewers — just like doctors — may be conditioned to think women overexaggerate their pain, so at the fifteen-minute mark of the film he jumps into the story of a respected older white male doctor who got a cobalt hip joint and began suffering from neurological issues. These were so severe that he had a complete mental breakdown in a hotel room, smashing things and scrawling cryptic messages on the walls. He begins questioning established medicine’s embrace of cobalt implants; upon the removal of his, every neurological issue he had developed disappeared. If a completely healthy man with medical training can go so quickly from zero to delusional, what of the millions of other Americans with cobalt in their bodies? What of the injured vets already fighting PTSD who live with an implant that could be poisoning them? What are the metal plates and screws in my own ankle made of, and why didn’t I know to ask?

The director backs up all these anecdotes with some hard facts about the FDA approval process for medical devices, which — even according to a former head of the department — is a broken system. The medical device industry is the least understood and regulated in the FDA umbrella. Dick exposes so much that I yelled, “Oh, my God!” multiple times while watching. There is nothing more upsetting than listening to a charming Southern woman say the words, “My colon’s falling out!” Worse yet are the profit-hungry companies that have been able to slide by unnoticed for so long. Here’s hoping The Bleeding Edge gets the right attention on a decidedly unsexy topic.

The Bleeding Edge
Directed by Kirby Dick
Netflix
Opens July 27, IFC Center
Premieres on Netflix on July 27

 

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FOOD ARCHIVES NYC ARCHIVES

Seafood Fraud on the Loose, Especially in NYC

Dining at even expensive seafood restaurants won’t guarantee that you’ll get the fish you ordered. Red Snapper? Could be tilapia. A study released today by Oceana revealed that seafood fraud is rampant, especially in New York City.

Thirty-nine percent of 142 seafood samples in grocery stores, restaurants and sushi spots in New York were mislabeled, according to FDA guidelines. Three in five retail outlets nationwide sold mislabeled fish. Surprisingly, the study showed that you’re most likely to get properly labeled fish at national supermarket chains.

Even more disturbing: 100 percent of the sushi bars tested nationwide — there were 16 — sold mislabeled fish. Even tilefish, which has documented high levels of mercury, was substituted for red snapper. Turns out 13 different types of fish pose as red snapper on a regular basis, and venues often serve less valuable fish in its place: tilapia, white bass, goldbanded jobfish, porgy/seabream, ocean perch, and others. All good. Just not what you ordered, and those fish cost way less than red snapper.

“I think the real issue is that seafood lovers have to demand better accountability and a full traceability system,” said Kimberly Warner, one of the study’s authors and a chief scientist at Oceana. “Some people who sell fish don’t want to call it a ‘goldbanded jobfish’ so they will call it a red snapper.”

Over the summer, Oceana examined 142 samples of fish from 81 outlets in Manhattan, Queens, Brooklyn, and a few surrounding suburbs. Of the 13 fish studied, only four were found to be the actual fish that was on the menu. DNA samples of salmon, snapper, tuna, cod, sole, halibut, striped bass, grouper, and blackfish all contained fraudulent fish.

Tuna was impersonated the most. Ninety-four percent of tuna samples in New York were found guilty of seafood substitution, according to the study. “They just call it white tuna,” Warner said, and added that chefs might just throw a sauce on it.

To combat seafood fraud, consumers can try to be educated about what an honest price for a dish like tuna should be. “If the price is too good to be true, it probably is,” she said.

Correction: An earlier version of this post stated tilefish was on the FDA’s do-not-eat list. Tilefish is only on the do-not-eat list for women who are pregnant or nursing and young children.

 

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NEWS & POLITICS ARCHIVES THE FRONT ARCHIVES

Your Peanut Butter From Trader Joe’s Might Have Salmonella in It

You heard that right.

Since early June, 29 people in 18 states across the country have had cases of the nausea-inducing virus and the FDA/CDC is pointing its fingers at the most innocent item in the room: the Creamy Salted Valencia Peanut Butter from Your Neighborhood Grocery Store, Trader Joe’s. After this conclusion was made, the agencies sat down the big chiefs at the trendy grocery store chain on Thursday so they could make the proper decision.
And they have: The Creamy Salted Valencia Peanut Butter is no more. In a statement, Trader Joe’s spokespeople said, “Out of an abundance of caution, we have removed all Trader Joe’s Creamy Salted Valencia Peanut Butter from sale, due to pending health-related inquiries.”
About three-fourths of the cases involved children under the age of 18. And, as of now, the FDA will not release which states these cases occurred in. The only thing that is known is the actual individual cases: salmonella popped up in Massachusetts, Rhode Island, and North Carolina.
Because of this, anyone can go to Union Square or wherever and get their refund, which amounts to a little less than $5. This goes to prove the overused expression: Not everyone is perfect.
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FOOD ARCHIVES NYC ARCHIVES

Raw Milk Products Accused of Causing Disease Outbreaks

The Centers for Disease Control and Prevention recently published a study with stats that might give raw-milk supporters pause. The CDC report states that the rate of disease outbreaks caused by raw milk and products related to it is 150 times greater than outbreaks linked to pasteurized milk.

For the study, which was published in the CDC journal Emerging Infectious Diseases, researchers reviewed 121 dairy-related outbreaks that took place from 1993 to 2006 in all 50 states, and determined that 60 percent of them were caused by raw milk products. They also found that the raw milk outbreaks disproportionately affected people under the age of 20.

The CDC study caused a stir at the Weston A. Price Foundation, a vocal supporter of raw milk consumption, which quickly published a press release accusing the government agency of cherry-picking data “to make raw milk look dangerous and to dismiss the same dangers associated with pasteurized milk.”

Both the CDC and the FDA have strongly advised against buying and consuming raw milk products. Nevertheless, raw dairy has continued to be popular with the farm-share set, many of whom believe that raw milk has beneficial and even healing properties missing in its pasteurized state. But until they can convince the government that they are right, raw milk will be considered too perilous to be on grocery-store shelves.

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FDA Monitoring Orange Juice for Fungicide

The Food and Drug Administration thinks that a sketchy foreign fungicide might have contaminated Brazilian orange juice — so FDA officials might start turning away OJ imports from there, according to NJ.com.

Fears that carbendazim — a chemical not approved for use in the U.S. — slipped into American OJ surfaced earlier this week, when Minute Maid parent company Coca-Cola announced that some of its Brazilian growers had sprayed trees with the substance.

Most orange juice in the U.S. features juices from many countries, including Brazil.

No juice has been recalled, but the FDA is going to start testing shipments to Port Newark — through which one-third of the country’s imported OJ travels. If the juices test positive, the FDA won’t let them into the U.S.

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Food Industry Wants to Keep Dioxins in Your Dinner: Report

It’s always good to know that the people who raise the nation’s livestock and sow the country’s crops really want to put health first. Or not.

A group of top U.S. food producers has recently protested the Food and Drug Administration’s upcoming demands for tougher dioxin limits in nutritional staples, according to Food Safety News. Dioxins and similar chemicals have been linked to reproductive problems and cancer in lab animals.

Though some dioxins occur naturally, they can enter the environment through industrial activities such as trash incineration, the website reports. Research indicates that humans get most of their dioxin exposure from food.

The group of U.S. food giants worries that the soon-to-come FDA guidelines — which might set the “safe” level of dioxin exposure at 0.7 picograms daily, compared with the World Health Organization’s 1-4 recommended daily picograms — would make most agricultural products in the country “unfit for consumption.”

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FDA Says ‘No’ to Drugged Up Livestock

Cows, chickens, and pigs in America are on lots of drugs — and even account for 80 percent of the country’s antibiotic consumption, Time reports.

But now, Food and Drug Administration officials have called on the ag industry to limit antibiotic use in livestock, as they think it might lead to the growth of deadly, drug-resistant bacteria: On January 4, the FDA banned farmers from using a class of these medicines in excess or for preventative reasons.

This particular group of antibiotics, cephalosporins, gets used frequently in humans to treat strep throat and bronchitis, Time notes.

The livestock industry commonly doses animals with antibiotics before they get sick, though they are not intended to prevent disease.

About 100,000 Americans die each year from infections related to drug-resistant bacteria, Time reports, and many fear that the situation will only worsen if animals routinely ingest antibiotics in their food and water.

This is not the first time the FDA has moved to enact such a rule.

In 2008, the administration tried establishing a similar regulation, but got too much flack from the über-wealthy ag lobby.

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Licorice Is Tasty, But It Just Might Kill You

Here’s some depressing news from Food Consumer, just in time for Halloween: Licorice can cause irregular heart rhythm or arrhythmia, and now the FDA encourages only moderate consumption of the jet-black candy.

According to the FDA report, if you’re 40 or older, eating two ounces of black licorice a day for at least two weeks could land you in the hospital. However, many licorice-flavored candies are “licorice flavor” sweets produced here that don’t actually contain the dangerous compound glycyrrhizin. Instead, they are made with anise oil, which has the same smell and taste. You can still gorge on them (though your dentist might say otherwise).

With Halloween around the corner, the FDA offers these words of advice: “No matter what your age, don’t eat large amounts of black licorice at one time.” So don’t go and give out black licorice to all the trick-or-treaters, OK? In addition to potentially killing them, you’ll be the lame person who thought only of herself by doling out a candy that tastes good to, oh, one out of 10 children.

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DOH Cracks Down On Dogs In Bars; Michelin Tweets About Closed Resto

Afternoones Restaurant on Staten Island was heavily damaged during Hurricane Irene, to the tune of at least $75,000. Unfortunately, the owner isn’t eligible for hurricane relief funds, which are only being allotted to eight counties upstate.
[CBS News]

The FDA is preparing strict new standards for food items labeled “gluten-free,” which until now have not been regulated and can still contain some gluten.
[CBS News]

A Dutch aquaculturalist has developed a revolutionary eight-tiered system of tanks in which to raise fish that keeps disease at bay and recycles waste.
[AP]

The Health Department, in its latest misguided effort, is cracking down on bars that allow dogs, because beer, wine, and spirits are classified as food.
[Atlantic]

The food blogosphere is still atwitter about Michelin tweeting this yesterday: “What an incredible dinner at Le Bernardin last night.” Le Bernardin is closed this month. Oops!
[Atlantic]

The Waffle House food truck is known for being the first business to open after a hurricane. Even FEMA uses it to gauge the seriousness of weather damage to an area.
[Wall Street Journal]

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FDA Gets Into Gluten-Free; Food Is the New Rock

New research suggests that babies develop their palates in the womb and that what a woman eats while pregnant could affect her child’s tastes later in life.
[NPR]

The FDA will soon start to regulate gluten-free foods. Currently, a gluten-free label doesn’t necessarily ensure that a product actually contains no gluten.
[Boston Globe]

A new study shows that the brain cells responsible for controlling hunger start to consume small parts of themselves when the body has gone without food for several hours. Yikes!
[ThirdAge]

James Murphy of LCD Soundsystem is now a chef; Fat Mike of NOFX is a restaurateur; Les Claypool of Primus is a winemaker. Looks like gastronomy really is the new rock.
[NY Post]