At one time, decades ago, penicillin, vitamin C, and many other prescription and over-the-counter products were manufactured in the United States. But now, antibiotics, antidepressants, birth control pills, blood pressure medicines, cancer drugs, among many others are made in China and sold in the United States. The result – millions of Americans are taking prescription drugs made in China and don’t know it. China makes essential ingredients for thousands of medicines found in American homes and used in hospital intensive care units and operating rooms. In China Rx: Exposing the Risks of America’s Dependence on China for Medicine (Prometheus Books, 2018), Rosemary Gibson and Janardan Prasad Singh argue that there are at least two major problems with the United States relying on China for its medicines.
Imagine a TV ad for a hip replacement device. Over scenes of the puppies and sunsets, a voiceover warns, “Hip replacements may cause tissue death, the destruction of muscles, bones and ligaments, nerve damage, mental changes, thyroid disorder, vision and hearing problems and heart failure.” Such ads may soon be part of primetime viewing, not just because the device industry is starting to advertise but because medical device side effects are as scary as, if not worse than, drug side effects. According to a chilling new book by Jeanne Lenzer, The Danger Within Us: America’s Untested, Unregulated Medical Device Industry and One Man’s Battle to Survive It, an estimated 6.7 million Americans a year––almost 70 million in a decade––are implanted with artificial knees, hips and shoulders, spinal hardware, pacemakers, stents, other cardiac devices and more that are woefully under-regulated and under-tested.
Disability Rights Activists Occupy Park Near FDA Chairman’s Home, Demand End To Electric Shock ‘Torture’
Washington, DC — A group of disability rights activists from around the country are urging the FDA to release new regulations that will permanently end Graduated Electronic Decelerator (GED) at the Judge Rotenberg Center (JRC) in Canton, Massachusetts, an education facility which specializes in habilitation of severely impaired persons. The activists have begun an indefinite occupation of a small park near FDA chairman Dr. Scott Gottlieb’s home, claiming he is delaying the release of regulations that would end the JRC practice of using GED shock therapy to discipline residents. About fifty people from the disability rights group ADAPTstarted the park’s occupation, which is being live-streamed across the Internet to thousands. They say they will not end their protest until the regulations ending GED are signed and enacted by Dr. Gottlieb.
By Martin A. Lee for Project CBD - The Food and Drug Administration (FDA), which defers to the DEA on cannabis-related matters, considers CBD to be an experimental pharmaceutical undergoing evaluation. In early November, the FDA sent letters to several companies selling hemp-derived CBD products warning that they were violating the Federal Food, Drug and Cosmetic Acts. This was the third time in recent years that the FDA has issued warnings to CBD manufacturers and retailers, which market hemp-derived CBD products as nutraceuticals or food supplements. The most recent round of FDA warning letters did not involve false statements about the source of the CBD extracts. Instead, the agency objected to unsubstantiated medical claims allegedly made by four CBD oil producers: Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and last but not least, the Stanley Brothers. Some of these unsubstantiated claims, according to the FDA, included patient testimonials and assertions that CBD “may be effective in treating tumors from cancer” and other diseases. Thus far, however, there have been no FDA-approved clinical trials that might validate preclinical studies and anecdotal accounts of CBD’s anti-cancer properties. Today one can easily purchase unregulated CBD products online and at some supermarkets and storefronts across the nation.
By Katherine Paul for Organic Consumers Association - Next month will mark one year since Congress obliterated Vermont’s GMO labeling law and replaced it with its own faux-labeling measure. The DARK Act was an outright attack on consumer and states’ rights. Still, then-President Obama refused to veto it. We lost the right to labels on GMO foods. But we never lost our determination to expose Monsanto’s corrupt manipulation of government agencies, or the truth about just how harmful Roundup herbicide is to humans and the environment. Fast forward to today. Monsanto is facing down scores of lawsuits by people, or their families, who were diagnosed with non-Hodgkin lymphoma after being exposed to Roundup. Those lawsuits have led to revelations about possible collusion between Monsanto employees and former U.S. Environmental Protection Agency (EPA) officials to bury evidence of Roundup’s carcinogenicity. Meanwhile the EPA, perhaps fearing consumer backlash, refuses to rule on whether to renew the license for glyphosate (the active ingredient in Roundup), even though we’re now nearly two years past the deadline.
By Charles Seife for Scientific American. It was a faustian bargain—and it certainly made editors at National Public Radio squirm. The deal was this: NPR, along with a select group of media outlets, would get a briefing about an upcoming announcement by the U.S. Food and Drug Administration a day before anyone else. But in exchange for the scoop, NPR would have to abandon its reportorial independence. The FDA would dictate whom NPR's reporter could and couldn't interview. “My editors are uncomfortable with the condition that we cannot seek reaction,” NPR reporter Rob Stein wrote back to the government officials offering the deal. Stein asked for a little bit of leeway to do some independent reporting but was turned down flat. Take the deal or leave it.
By David Kirby for RSN - Several environmental, consumer, and fishing groups filed suit on Thursday against the U.S. Food and Drug Administration over its approval of a lab-developed fish that combines genes from three fish species: Atlantic salmon, Chinook salmon, and Arctic eelpout. The lawsuit contends that the FDA ignored advice from federal fisheries and wildlife scientists to delay or deny the application and made the approval “without disclosing or analyzing the significant environmental effects from this foreseeable expansion.”
By Staff of Corporate Crime Reporter - A coalition of environmental, consumer, and commercial and recreational fishing organizations has sued the Food and Drug Administration (FDA) for approving the first-ever genetically engineered (GE) food animal, an Atlantic salmon engineered to grow quickly. The man-made salmon was created by AquaBounty Technologies, Inc. with DNA from three fish: Atlantic salmon, Pacific king salmon, and Arctic ocean eelpout.
By Staff of The Real News - Public Citizen's Dr. Michael Carome describes the thousands in consulting fees new FDA commissioner Dr. Robert Califf received from pharmaceutical manufacturers and why only four senators voted against his confirmation
By Abigail Abesamis for The Daily Meal - Just months after the US Food and Drug Administration (FDA) approved genetically engineered salmon for consumption, the FDA has issued a ban on the import and sale of so-called “Frankenfish” until the agency determines guidelines on how it should be labeled, according to The Washington Post. The ban was made in response to language in a federal spending bill recently passed by Congress instructing regulators to forbid the sale of genetically engineered salmon until labeling guidelines are in place. The Washington Post points out that this process could potentially take years.
By Just Label It for Nation of Change - The new GMO potato cleared this week by the U.S. Food and Drug Administration (FDA) for sale in the U.S. is yet another in the long list of reasons why consumers deserve an on-package, federal mandatory labeling system, according to Just Label It. The FDA’s decision means that the Idaho company responsible for the new GMO potato, J.R. Simplot, will be able to bring the product to market next year, assuming it gets final approval from the U.S. Environmental Protection Agency.
By Staff of Center for Food Safety - WASHINGTON, DC (November 19, 2015) – Center for Food Safety today announced plans to sue the Food and Drug Administration (FDA) to block the agency’s approval for sale and consumption of the genetically engineered AquaAdvantage® salmon developed by AquaBounty. The suit will be filed in coordination with other colleague plaintiffs. “The fallout from this decision will have enormous impact on the environment. Center for Food Safety has no choice but to file suit to stop the introduction of this dangerous contaminant,” said Andrew Kimbrell, executive director of Center for Food Safety.
By CREDO Action - Petition to the U.S. Senate: "Oppose the nomination of Dr. Robert Califf as head of the Food and Drug Administration. At a time of rising prescription drug prices and safety risks we need a champion for American families, not an insider so closely tied to the pharmaceutical industry." Americans pay the highest prices for prescription drugs of anywhere in the world – and the cost is going up, 12% on average in the last year and in some cases nearly 1,000%. We need an FDA chief with the guts to stand up to the pharmaceutical companies. But instead, President Obama has nominated Robert Califf, a doctor described as “the ultimate industry insider.” Sen. Bernie Sanders recently made waves by announcing he would oppose Califf’s nomination, and we need to demand the rest of the Senate follow his lead.
The agency has responded to comments from ANH-USA activists and other stakeholders. Here’s what they’re proposing now. Action Alert! In May we reported that the FDA is currently drafting rules that implement the 2011 Food Safety Modernization Act (FSMA). As we noted then, some of the rules that have been proposed so far have brought a deafening outcry from small farmers, prominent members of Congress, consumers, and even big business. This response presumably caused the FDA to backtrack considerably, and the agency addressed many of the concerns you raised. On September 19, the FDA released several revised rules. The public has an additional seventy-five days to comment.
The new guidelines, known as Final Guidance 213, were officially released two weeks ago, just in time for Christmas. “Two-thirteen is an early holiday gift to industry,” says Avinash Kar, a health attorney at the Natural Resources Defense Council. “The FDA has essentially followed a voluntary approach for more than 35 years, but use of these drugs to raise animals has increased. There’s no reason why voluntary recommendations will make a difference now, especially when FDA’s policy covers only some of the many uses of antibiotics on animals that are not sick.”