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OpEdNews Op Eds    H2'ed 9/6/18

How Many Innocent and Unsuspecting People in 2019 Will Die Because of the FDA's Revolving Doors?

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Stephen Fox
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GMOs were rushed onto our plates in 1996. Over the next nine years, multiple chronic illnesses in the US nearly doubled -- from 7% to 13%. Allergy-related emergency room visits doubled between 1997 and 2002 while food allergies, especially among children, skyrocketed. We also witnessed a dramatic rise in asthma, autism, obesity, diabetes, digestive disorders, and certain cancers. In January of this year, Dr. P. M. Bhargava, one of the world's top biologists, stated that after reviewing 600 scientific journals, he concluded that the GM foods in the US are largely responsible for the increase in many serious diseases.

The American Academy of Environmental Medicine concluded that animal studies have demonstrated a causal relationship between GM foods and infertility, accelerated aging, dysfunctional insulin regulation, changes in major organs and the gastrointestinal system, and immune problems such as asthma, allergies, and inflammation, followed by a report by eight international experts determined that the flimsy and superficial evaluations of GMOs by both regulators and GM companies "systematically overlook the side effects" and significantly underestimate "the initial signs of diseases like cancer and diseases of the hormonal, immune, nervous and reproductive systems, among others."

GMOs are responsible for massive sickness and death, and the person overseeing the FDA policy that facilitated their introduction holds a uniquely infamous role in human history: Michael Taylor. He had been Monsanto's attorney before becoming policy chief at the FDA. Soon after, he became Monsanto's vice president and chief lobbyist. Then Obama appointed Michael Taylor as the senior advisor to the commissioner of the FDA. He is now America's food safety czar.

Milk, Michael Taylor, and Human Disease

The milk from injected cows has more pus, more antibiotics, more bovine growth hormone, and most importantly, more insulin-like growth factor 1. IGF-1 is a huge risk factor for common cancers and its high levels in this drugged milk is why so many medical organizations and hospitals have taken stands against rbGH. A former Monsanto scientist stated that when three of his Monsanto colleagues evaluated rbGH safety and discovered the elevated IGF-1 levels, even they refused to drink any more milk -- unless it was organic and therefore untreated.

Government scientists from Canada evaluated the FDA's approval of rbGH and concluded that it was a dangerous facade. The drug was banned in Canada, as well as Europe, Japan, Australia and New Zealand. But it was approved in the US while Michael Taylor was in charge. His drugged milk might have caused a significant rise in US cancer rates.

Taylor determined that milk from injected cows should not require any special labeling. As a gift to his future employer Monsanto, he wrote a paper suggesting that if companies ever had the audacity to label their products as not using rbGH, they should also include a disclaimer stating that according to the FDA, there is no difference between milk from treated and untreated cows.

This was a lie. Monsanto's own studies and FDA scientists officially acknowledged differences in the drugged milk. Yet Monsanto used Taylor's paper as the basis to successfully sue dairies that labeled their products as rbGH-free.

Will Monsanto's Wolff Also Guard the Chickens?

As consumers learned that rbGH was dangerous, they refused to buy the milk. To keep their customers, a tidal wave of companies has publicly committed to not use the drug and to label their products as such. Monsanto tried unsuccessfully to convince the FDA and FTC to make it illegal for dairies to make rbGH-free claims, so they went to their special friend in Pennsylvania -- Dennis Wolff. As state secretary of agriculture, Wolff declared that labeling products rbGH-free was illegal, and that all such labels must be removed henceforth from shelves statewide. This would eliminate the label from all national brands, because they were not able to afford separate packaging for just one state.

Consumer demand forced Pennsylvania's Governor Ed Rendell to step in and stop Wolff's madness. But Rendell allowed Wolff to take a compromised position that now requires rbGH-free claims to also be accompanied by Taylor's FDA disclaimer on the package.

Ohio not only followed Pennsylvania's lead by requiring Taylor's FDA disclaimer on packaging; they went a step further, declaring that dairies must place that disclaimer on the same panel where rbGH-free claims are made. This would force national brands to re-design their labels and may ultimately dissuade them from making rbGH-free claims at all. The Organic Trade Association and the International Dairy Foods Association filed a lawsuit against Ohio. Although they lost the first court battle, upon appeal, the judge ordered a mediation session that takes place today. Thousands of Ohio citizens have flooded Governor Strickland's office with urgent requests to withdraw the state's pro-corporate labeling requirements.

Jeffrey M. Smith is the author of Seeds of Deception: Exposing Industry and Government Lies About the Safety of the Genetically Engineered Foods You're Eating and Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods from Chelsea Green Publishing. Smith worked at a GMO detection laboratory, founded the Institute for Responsible Technology. He currently lives in Iowa--surrounded by genetically modified corn and soybeans.

>>>>>>

How The Revolving Door Spins From FDA To Industry by Sydney Lupkin in Kaiser Health News

A job reviewing drug applications at the Food and Drug Administration can be the springboard for a career in industry. More than a quarter of the Food and Drug Administration employees who approved cancer and hematology drugs from 2001 through 2010 left the agency and now work or consult for pharmaceutical companies, according to research published by a prominent medical journal Tuesday.

Dr. Vinay Prasad, a hematologist-oncologist and assistant professor at Oregon Health and Science University, sought to understand the so-called "revolving door" between the FDA and the pharmaceutical industry, which he said is often discussed but hadn't been quantified.

"We all know about these anecdotal cases" of a person who was "often a major player at the FDA, someone in an important role -- and then they leave the FDA and go and work for industry," Prasad said, but he couldn't find anyone who knew whether this happened "5 percent or 60 percent" of the time. If you know in the back of your mind that your career goal may be to someday work on the other side of the table, I wonder whether that changes the way you regulate. Are you more likely to give [companies] the benefit of the doubt? Are you less likely to beat them up hard over [using bad comparisons in drug studies]?"

Prasad and Dr. Jeffrey Bien, an internal medicine resident also at OHSU, tracked 55 FDA reviewers in the hematology-oncology field from 2001 through 2010, and found that of the 26 reviewers who left the FDA during this period, 15 of them, or 57 percent, later worked or consulted for the biopharmaceutical industry. Put another way, about 27 percent of the total number of reviewers left their federal oversight posts to work for the industry they previously regulated. Prasad and Bien published their findings as a research letter in The BMJ, formerly The British Medical Journal.

"There's a lot of room for interpretation in deciding whether or not a cancer drug should be approved, because so many studies of cancer drugs rely on what's called a "surrogate endpoint," meaning that something other than survival or quality of life was measured to determine whether a drug worked. For example, shrinking a tumor may be a stand-in for survival. But there isn't always evidence that surrogate endpoints are linked to better health outcomes for patients, suggesting that some approved drugs aren't as beneficial as they appear. Sometimes, the public needs [the FDA reviewers] to be firm. If they're not, no one else in the health care sector is going to be. Once the agency approves a drug, the Centers for Medicare & Medicaid Services have to cover it and can't negotiate prices under current laws. The FDA is often the only real wall between ineffective, harmful drugs and patients."
"

Although Prasad said FDA reviewers have a lot of power over approvals, Dr. Joshua Sharfstein, the FDA's principal deputy commissioner until 2011, disagreed.

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