'Our federal regulators have again unlawfully bowed to the chemical industry,' says Center for Food Safety
A new lawsuit is challenging the EPA's approval of herbicides, with key
ingredients found
in Agent Orange and Monsanto's Roundup, on farms in 15
states nationwide. (Photo: Mike Mozart/flickr/cc)
By Nadia Prupis
A coalition of health and environmental organizations on Monday challenged the U.S. Environmental Protection Agency's (EPA) decision to expand the use of a new herbicide in nine states, which the groups say could endanger wildlife and public health.
The lawsuit (pdf) is the most recent step in a fight to push back against the use of the weed killer, Dow's Enlist Duo, which combines glyphosate, found in Monsanto's Roundup, and 2,4-D, the key ingredient in the infamous warfare herbicide Agent Orange.
As the coalition points out in a press release following its lawsuit, 2,4-D "has been linked to serious illnesses like Parkinson's disease, non-Hodgkin's lymphoma and reproductive problems. It also threatens endangered species that reside in the approved states, like the whooping crane, the Louisiana black bear, and the Indiana bat."
In March, the research arm of the World Health Organization declared that glyphosate was a "probable" source of cancer in humans and should be considered a carcinogen.
The EPA first approved use of Enlist Duo in six states in October, but recently widened that list to include an additional nine. The 15 total states where Enlist Duo may now be used are Arkansas, Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota, Missouri, Mississippi, Nebraska, North Dakota, Ohio, Oklahoma, South Dakota, and Wisconsin.
"Our federal regulators have again unlawfully bowed to the chemical industry, rather than protect our communities, land, and farms," said George Kimbrell, senior attorney for the Center for Food Safety, one of the groups challenging the EPA's decision. "We will continue to defend them vigorously."
Also in the coalition are Earthjustice, the Center for Biological Diversity, and Pesticide Action Network North America. The groups initially sued the EPA in October in response to its first approval, charging that the agency violated the Endangered Species Act by allowing the use of those chemicals, but the case was dismissed.
"In expanding its approval for this super-toxic chemical cocktail, EPA has shown an utter disregard for human health, our drinking water, and endangered species like the iconic whooping crane," said Lori Ann Burd, environmental health director at the Center for Biological Diversity, on Monday. "EPA has left us with no choice but to go to court."
As the coalition points out, the EPA approved Enlist Duo to address the rash of glyphosate-resistant "super weeds" infesting tens of millions of acres of U.S. farmland. But using 2,4-D to kill the weeds is nothing more than a "quick fix," the coalition said.
"Independent and USDA scientists... predict that the Enlist Duo 'crop system' will only foster resistance to 2,4-D in addition to glyphosate, continuing the GE crop pesticide treadmill," the Center for Food Safety said in a statement.
Marcia Ishii-Eiteman, senior scientist at the Pesticide Action Network North America, added, "Rural communities rely on EPA to take its job seriously... Communities across the Midwest are furious, knowing that they now face unprecedented levels of 2,4-D drift each summer."
Here's the Cliffs Notes version from NPR's Elise Hu:
"Net neutrality is the concept that your Internet provider should be a neutral gateway to everything on the Internet, not a gatekeeper deciding to load some sites slower than others or impose fees for faster service."
In other words, it's a concept in which Internet service providers (ISPs) don't discriminate when it comes to Internet traffic.
The Federal Communications Commission is voting on whether to reclassify broadband access as a "telecommunications service under Title II."
In layman's terms, the FCC is looking to reclassify broadband as a utility, which would give the commission more regulatory power over Internet providers.
The proposed rules are pretty lengthy, but from an FCC fact sheet, here are the three things that the rules would ban that matter most to consumers:
"No Blocking: broadband providers may not block access to legal content, applications, services, or non-harmful devices.
"No Throttling: broadband providers may not impair or degrade lawful Internet traffic on the basis of content, applications, services, or non-harmful devices.
"No Paid Prioritization: broadband providers may not favor some lawful Internet traffic over other lawful traffic in exchange for consideration — in other words, no 'fast lanes.' This rule also bans ISPs from prioritizing content and services of their affiliates."
Global Research Editor’s note: We bring to the attention of our readers this incisive and carefully documented 2005 article by Robert F. Kennedy Jr. published by Rolling Stone, first posted on Global Research in July 2009. The article sheds light on the collusion between Big Pharma and the US government and the dangers associated with vaccines produced by major pharmaceutical companies. In 2009 this article was of particular relevance to the debate on the H1N1 swine flu virus and plans by the WHO, The Obama Administration and Big Pharma to develop a swine flu vaccine.
By Robert F. Kennedy Jr; Rollingstone.com 20 July 2005
In June 2000, a group of top government scientists and health officials gathered for a meeting at the isolated Simpsonwood conference center in Norcross, Georgia. Convened by the Centers for Disease Control and Prevention, the meeting was held at this Methodist retreat center, nestled in wooded farmland next to the Chattahoochee River, to ensure complete secrecy. The agency had issued no public announcement of the session — only private invitations to fifty-two attendees. There were high-level officials from the CDC and the Food and Drug Administration, the top vaccine specialist from the World Health Organization in Geneva and representatives of every major vaccine manufacturer, including GlaxoSmithKline, Merck, Wyeth and Aventis Pasteur. All of the scientific data under discussion, CDC officials repeatedly reminded the participants, was strictly “embargoed.” There would be no making photocopies of documents, no taking papers with them when they left.
The federal officials and industry representatives had assembled to discuss a disturbing new study that raised alarming questions about the safety of a host of common childhood vaccines administered to infants and young children. According to a CDC epidemiologist named Tom Verstraeten, who had analyzed the agency’s massive database containing the medical records of 100,000 children, a mercury-based preservative in the vaccines — thimerosal — appeared to be responsible for a dramatic increase in autism and a host of other neurological disorders among children. “I was actually stunned by what I saw,” Verstraeten told those assembled at Simpsonwood, citing the staggering number of earlier studies that indicate a link between thimerosal and speech delays, attention-deficit disorder, hyperactivity and autism. Since 1991, when the CDC and the FDA had recommended that three additional vaccines laced with the preservative be given to extremely young infants — in one case, within hours of birth — the estimated number of cases of autism had increased fifteenfold, from one in every 2,500 children to one in 166 children.
Robert F. Kennedy, Jr.: The number of public figures with his level of integrity is quickly
dwindling to zero. (Photography by Mark Sutton)
Even for scientists and doctors accustomed to confronting issues of life and death, the findings were frightening. “You can play with this all you want,” Dr. Bill Weil, a consultant for the American Academy of Pediatrics, told the group. The results “are statistically significant.” Dr. Richard Johnston, an immunologist and pediatrician from the University of Colorado whose grandson had been born early on the morning of the meeting’s first day, was even more alarmed. “My gut feeling?” he said. “Forgive this personal comment — I do not want my grandson to get a thimerosal-containing vaccine until we know better what is going on.”
Unapproved, But Used In Surgery:Firm sold 18,000 knee-replacement tools before the government called a halt.
By Marshall Allen and Olga Pierce ProPublica This story was co-published with the New York Times.
Carla Muss-Jacobs didn't give much thought to the tools her surgeon would use to replace her knee. Like most patients, she just wanted to feel better and trusted that any devices in the operating room would be safe.
In her case, the surgeon sliced open her leg and positioned special cutting guides, like carpentry jigs, over her thigh and shin bones to line up his bone saw precisely. The device, called the OtisKnee, was supposed to speed the surgery and the recovery.
Muss-Jacobs' recovery was not speedy. In terrible pain after the operation, she eventually underwent a second knee replacement.
As it turned out, the OtisMed Corporation, the maker of the OtisKnee, did not seek clearance from the Food and Drug Administration for its OtisKnee guides before it started selling them. When the company did apply for FDA review, its application was rejected because, the agency said, the company failed to show that the product was safe and effective.
In December, OtisMed and its former chief executive pleaded guilty in Federal District Court in Newark to criminal charges of distributing adulterated medical devices. The Justice Department said the company sold and distributed 18,000 of its OtisKnee devices from 2006 to 2009 without FDA approval.
No one can say with certainty if the OtisKnee device caused Muss-Jacobs' problems, but in announcing an $80 million settlement of criminal and civil charges against OtisMed, United States Attorney Paul J. Fishman said patients "should be entitled to trust that the devices their doctors are using are safe, effective, tested and approved."
An examination of the OtisKnee case shows how easily that trust can be violated in the rapidly evolving world of medical devices, a thriving $110 billion-a-year industry. If not for a whistle-blower, the public might never have learned about the widespread use of a potentially dangerous device that sidestepped regulation.
About 700,000 knee replacements are performed every year, making it the most common elective surgery in the country. An aging population is increasing demand, creating opportunity for companies that make orthopedic devices and the accessories used to implant them.
OtisMed was an Alameda, Calif., start-up that saw an opening in that growing market. The company's guides worked with knee replacement components made by other medical device makers. The idea was to use magnetic resonance imaging and three-dimensional software to create guides at an OtisMed facility that were then shipped to the hospitals. The guides directed the angle of the surgeon's cuts so the artificial knee would be properly aligned. In theory, the method helped surgeons tailor bone cuts to a patient's anatomy.
Experts say the cutting blocks were a good idea, and similar devices are made by other companies. But the FDA trusts manufacturers to properly classify their devices, effectively giving them say over whether safety studies are required before they are sold. That can allow some products that should receive closer scrutiny to slip by.
Dr. Steven B. Haas, chief of knee service at the Hospital for Special Surgery in Manhattan, said OtisMed pioneered the use of disposable, patient-specific surgical instruments. The problem was that research hadn't demonstrated that the OtisMed alignment method was effective.
"OtisMed got it half right," Dr. Haas said.
Feeling Like a Guinea Pig
In 2008, Muss-Jacobs, a real estate agent in Beaverton, Ore., had a terrible pain in her left knee. Years earlier, she had a knee operation, but things were getting worse, so she went to see Dr. Ronald Teed, an orthopedic surgeon.
Teed told her many doctors were using the OtisKnee device for custom knee replacements, with faster recoveries and reports of less pain, she said.
Teed performed the surgery in May 2008 at Tuality Community Hospital in nearby Hillsboro. Muss-Jacobs, now 56, said she awoke with so much pain she couldn't stop crying. She knew immediately that something was wrong. Hospital records she provided document her persistent complaints about pain.
Muss-Jacobs said she had to hobble around with a walker and for several months was unable to show any homes to real estate clients. Six months later, she went to another surgeon, Dr. Ira Weintraub, in Portland, who said the new knee had failed and was misaligned. Dr. Weintraub performed a complex revision surgery, and Muss-Jacobs said she could walk the next day, though she still had a long, painful recovery. Teed said pain after a knee replacement could last up to a year and that Dr. Weintraub's revision surgery wasn't necessary. Dr. Weintraub and Tuality Community Hospital declined to comment.
Muss-Jacobs lived alone. Because she was unable to work, her bills mounted and, in 2009, she declared bankruptcy. When she couldn't persuade a lawyer that a malpractice case was worthwhile, she sued Teed on her own, but the case was dismissed. (In an interview, Teed said Muss-Jacobs had refused to comply with her rehabilitation plan. "She didn't do what she was told," Teed said, "and she ends up with a bad outcome.")
While Muss-Jacobs was preparing her lawsuit, she learned that there were complaints about the OtisKnee. She found news reports and OtisMed promotional materials and read medical device bulletin boards online. She discovered that some surgeons questioned whether the device was safe and that it had not been approved by the FDA.
The revelation made her feel like she'd been a "guinea pig," she said.
Promoting the OtisKnee
Like other medical device makers, OtisMed marketed directly to providers. And it had a powerful message for them: The OtisKnee would simplify surgery and bring in extra revenue from additional MRI scans, according to Justice Department case filings.
The company made its pitch to doctors over dinner and during cocktail parties at meetings of the American Academy of Orthopedic Surgeons. The OtisKnee was supposed to preserve more of a patient's bone and ligaments, improving fit and longevity. But none of the promotional claims had been evaluated by the FDA, the Justice Department said.
The company's public relations efforts worked. According to a case study in PR Week, the number of surgeons adopting the OtisKnee doubled each month in 2007.
Among the converts was Teed.
He endorsed the OtisKnee to a gathering of potential patients in an informational video obtained by Muss-Jacobs. The surgery is a "piece of cake," Teed tells the audience. "It doesn't take me a lot of effort."
Teed explained that operating room efficiency is crucial to reducing the risk of infections and other complications. He said he had been able to do as many as 12 knee replacements a day by bouncing among two or three operating rooms. Then OtisMed approached him and said that with the OtisKnee, he could work even faster.
"And of course, you can catch my attention with that," Teed says in the video. "It's like, 'Well, that sounds good to me, let's sit down and talk.'"
Eventually, though, Teed said, he found problems. He said he had taken part in an OtisMed study and was one of the first surgeons to discover that the procedures were not always working as hoped. "Some did. Some didn't," he said. "They weren't perfect."
During some surgeries, he could see that alignments weren't right. In a few cases he had to revert to the standard knee replacement method and redo the operation on the spot, he said.
He said he had visited the company's headquarters and "they seemed like they couldn't figure it out." Later, Teed said, he heard that OtisMed had changed the materials used to make the cutting guides, which might have led to them warping when they were sterilized before surgery.
The FDA should have been sterilizing "the crud" out of those things to test them, Teed said.
Faulty cutting guides were not a problem in Muss-Jacobs' case, Teed maintained. Nonetheless, he said he had learned a valuable lesson from the OtisKnee: "Don't jump on the bandwagon too early."
A Regulatory Bypass
The FDA regulates medical devices by classes, and each is treated differently.
Class III devices, like pacemakers, require extensive testing because they are implanted or sustain or support life and could put patients at serious risk.
Class II devices, like powered wheelchairs or pregnancy tests, are approved if companies assure that they are similar to other devices on the market.
Class I devices — bandages, dental floss, forceps and the like — must be registered but don't require premarket review because they present a low risk. They can be sold without any other FDA involvement.
The FDA gives companies some freedom in classifying their devices. And in the case of the OtisKnee, OtisMed officials told doctors and hospitals that its cutting guides were a Class I device and didn't need FDA approval or clearance, the Justice Department said.
According to the agency's legal filings, OtisMed worked closely with Stryker, a $9 billion medical device company based in Kalamazoo, Mich., to market the OtisKnee. Stryker made knee replacement components that worked with the OtisKnee. Stryker became interested in buying OtisMed, according to the Justice Department case, and requested that the start-up apply for FDA clearance to market the OtisKnee, which it did in October 2008.
Nearly a year later, in September 2009, Stryker was prepared to acquire OtisMed for $100 million when the FDA notified OtisMed that it had not demonstrated that the guides were safe. The notice said that the OtisKnee was a Class III device and that OtisMed's submission was missing data about how patients had fared, raising concerns about failure rates. The notice expressly warned against distributing the devices, according to the Justice Department.
The OtisMed board voted unanimously to halt shipments, the Justice Department said in court filings. But Charlie Chi, who was then the company's chief executive, directed employees to ship a batch of guides that had been held up since the FDA denial. OtisMed sent out 218 of the devices to surgeons, the Justice Department filings state.
Stryker executives were unaware of the shipment, the filings say. Stryker's acquisition of OtisMed went through in November 2009.
On Oct. 2, 2009, Richard Adrian, who worked in sales for Stryker, filed a whistle-blower case, accusing OtisMed of selling unapproved devices. Mr. Adrian received about $7 million as part of the resolution of the case. Mr. Adrian's lawyer said he declined to comment.
In settling the case, OtisMed paid $80 million in criminal and civil fines. Mr. Chi is to be sentenced on March 18 and faces up to three years in prison and $300,000 in fines. Stryker was not charged with wrongdoing and agreed to audit its other devices to ensure they had proper FDA approvals.
Representatives from OtisMed, including Mr. Chi, declined to comment for this article. Stryker said in a statement that the criminal conduct occurred before it acquired OtisMed and without its previous knowledge, and that the company "is committed to conducting its affairs ethically and lawfully."
Malfunction Reports
OtisMed sold $27 million worth of its cutting guides before the FDA rejected them. Problems began showing up as early as November 2007, according to a ProPublica review of injuries and side effects reported to the FDA.
There were 11 reports that month alone and 58 overall by the end of 2009, most classified as malfunctions: "Femoral guide does not fit, rocks freely." "Too much anterior slope in the tibia cut." "Femur and tibia guides would not seat correctly. Both slid around freely."
There were warning signs in the medical community, too. A January 2008 study in The Journal of Arthroplasty examined four cases: "The potential for malalignment with this system places implants at high risk of early failure," the study said.
No one knows how many patients might have been harmed by the device. Lawyers for the Justice Department said finding a number wasn't part of the agency's case.
Stacie Bilek, who directs premarket compliance at the FDA's Center for Devices and Radiological Health, would not discuss the OtisKnee case because it had been the subject of a criminal investigation. But there are so many Class I medical devices on the market that the agency generally does not check to see if they are properly classified, she said.
"It's based on voluntary compliance," Ms. Bilek said, noting that the FDA will sometimes investigate complaints. "We presume companies know the rules and regulations."
An FDA spokesman said the agency learned in late 2007 that the OtisKnee was being sold without proper clearance. An investigation was opened, then dropped after OtisMed sought approval in 2008.
Diana Zuckerman, president of the National Center for Health Research, an FDA watchdog group, said the agency wasn't doing enough to keep patients safe.
The FDA's "surveillance system is so flawed and so weak and so subjective and so inadequate," Ms. Zuckerman said, "that there are no automatic red flags going up when something happens."
As for Muss-Jacobs, December's settlement was bittersweet. While she is happy that OtisMed paid a price, she was disappointed that no medical provider was taken to account in her case.
"What happens to all the patients who had this device used on them?" Muss-Jacobs asked. "We're so marginalized. It's like we're not even in the equation in all of this."
__________
Related stories: Read more patient safety coverage by Marshall Allen and Olga Pierce.
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FCC chairman likely to support strict net neutrality protections after backing off from pro-industry initiatives
After months of pressure from grassroots groups, FCC chairman Tom
Wheeler is
likely to introduce strong net neutrality protections.
(Photo: ALA Washington Office/
flickr/cc)
By Nadia Prupis
Following a months-long campaign by consumer advocacy groups that pushed for strict protection of the internet, Federal Communications Commissioner Tom Wheeler appears to be ready to introduce some of the strongest regulations possible on Thursday ahead of the FCC's final net neutrality vote on February 26, according to reports.
Those regulations include redefining broadband as a public utility under Title II of the Communications Act, a policy change that has been touted by internet watchdog groups as one of the most important net neutrality protections available.
Once a lobbyist for the cable and telecommunications industries, Wheeler initially supported lax regulations that critics said would open the door to controversial paid-prioritization policies, known as "fast lanes," allowing internet service providers to charge higher fees for speedier website loading times.
According to reporting by Politico on Monday, "interviews with FCC officials, industry executives and representatives of public interest groups reveal the origins of his dramatic pivot on this issue: an intense and relatively brief grass-roots lobbying campaign that targeted two people — him and President Barack Obama."
Pressure from digital rights groups like the Electronic Frontier Foundation and Free Press, which galvanized support from consumers and progressive media figures, saw Wheeler steadily backpedaling on his initiatives last year. His shift appeared near-complete after President Barack Obama spoke out in favor of strict net neutrality regulations on November 10.
Wheeler proposed in April new rules that would allow ISPs to create fast lane deals with internet companies as long as they were "commercially reasonable."
In response, a coalition of internet watchdogs and consumer advocacy groups launched a months-long series of campaigns against the chairman's proposals, while protesters camped out in front of FCC headquarters. On June 1, Last Week Tonight host John Oliver ridiculed Wheeler and his proposed rules in a segment that quickly went viral, sending hundreds of thousands of consumers to the FCC website to comment in favor of stronger net neutrality regulations. Within months, four million emails and comments had come in, breaking FCC records.
Wheeler then moved towards a hybrid proposal that would impose Title II rules on parts of the internet, but not all of it. That, too, was met with disapproval by watchdogs and tech companies alike.
Meanwhile, Obama had also been under pressure from internet advocacy groups, who urged him to speak out in favor of stricter regulations. On November 10, he did just that, issuing a statement that called for using a Title II reclassification to safeguard the internet, "one of the most significant democratizing influences the world has ever known."
Earlier this month, Wheeler indicated support for reclassification of the internet as a public utility under Title II, bringing praise from Free Press president and CEO Craig Aaron who said, "Chairman Wheeler appears to have heard the demands of the millions of Internet users who have called for real net neutrality protections."
