By Joseph Jankowski
Researchers at Iowa State University are moving forward with a long-delayed project in which a dozen students will be paid to eat genetically modified bananas.
According to The Des Moines Register, the bananas were created by a Australian scientist and contain a gene that is supposed to help people living in Africa make vitamin A.
The project, funded by Bill and Melinda Gates, would pay each student $900.
Food-science professor Wendy White, who is leading the ISU end of the trial, says the project will take place sometime this year after approximately two years of delay.
From The Des Moines Register:
In the summer of 2014, White’s team sent an email to ISU students seeking a dozen female volunteers for the study. White said that the volunteers would be paid $900 to eat the equivalent of three bananas each. Just one of the bananas would be the genetically modified type.
The participants were to eat a diet, including the bananas, for four days during each of three study periods, then have their blood tested. White said more than 500 women responded to the query, and 12 were to be selected.
White said in 2014 that the goal of her research was to help people in Africa increase their production of vitamin A.
Earlier this week, activists delivered a petition against the project to University officials and to the Seattle headquarters of the Bill and Melinda Gates Foundation. According to the activists more then 57,000 people have signed the petition that warns the trial may be unsafe.
“ISU students are being asked to be the first to consume a product of unknown safety,” the activists said in a prepared statement. “The study is not being conducted in a transparent manner, and concerned ISU community members have not been able to receive answers about the research design, risks, nature of the informed consent given by the subjects and the generalizability of the study.”
According to the researchers the new type of banana includes a gene taken from another banana species, which naturally produces large amounts of beta-carotene.
“In Uganda and other African countries, vitamin A deficiency is a major contributor to deaths in childhood from infectious diseases,” Wendy White wrote in a statement released by the university in 2014. “Wouldn’t it be great if these bananas could prevent preschool kids from dying from diarrhea, malaria or measles?”
There has been no prior animal testing of the banana, and the study is one of the first ever GMO human feeding trials. There is no telling what kind of adverse health effects may occur from eating the genetically altered fruit.
By Carey Gillam
Former University of Illinois food science professor Bruce Chassy is known for his academic gravitas. Now retired nearly four years, Chassy still writes and speaks often about food safety issues, identifying himself with the full weight of the decades of experience earned at the public university and as a researcher at the National Institutes of Health. Chassy tells audiences that before he retired in 2012, he worked “full time” doing research and teaching.
What Chassy doesn’t talk much about is the other work he did while at the University of Illinois — promoting the interests of Monsanto Co., which has been trying to overcome mounting public concerns about the genetically engineered crops and chemicals the company sells. He also doesn’t talk much about the hundreds of thousands of dollars Monsanto donated to the university as Chassy was helping promote GMOs, or Monsanto’s secretive role in helping Chassy set up a nonprofit group and website to criticize individuals and organizations who raise questions about GMOs.
But emails released through Freedom of Information Act requests show that Chassy was an active member of a group of U.S. academics who have been quietly collaborating with Monsanto on strategies aimed at not just promoting biotech crop products, but also rolling back regulation of these products and fending off industry critics. The emails show money flowing into the university from Monsanto as Chassy collaborated on multiple projects with Monsanto to counter public concerns about genetically modified crops (GMOs) – all while representing himself as an independent academic for a public institution.
A New York Times article by Eric Lipton published last September laid bare the campaign crafted by Monsanto and other industry players to use the credibility of prominent academics to push the industry’s political agenda. That Times article focused primarily on University of Florida academic Kevin Folta, chairman of the university’s Horticultural Sciences Department, and Folta’s work on behalf of Monsanto. But an examination of recently released email exchanges between Monsanto and Chassy show new depths to the industry efforts.[...]
Chassy has said he did nothing unethical or improper in his work supporting Monsanto and the biotech crop industry. “As a public-sector research scientist, it was expected... that I collaborate with and solicit the engagement of those working in my field of expertise,” Chassy has stated.
[...]
In a November 2010 email, Monsanto chief of global scientific affairs Eric Sachs tells Chassy that Monsanto has just sent a “gift of $10,000” to the university “so the funds should be there.” He then tells Chassy he is working on a plan for Monsanto and others in the agribusiness industry to support an “academics review” website that Chassy can use to counter concerns and allegations raised by critics of GMOs. “From my perspective the problem is one of expert engagement and that could be solved by paying experts to provide responses,” Sachs wrote. “The key will be keeping Monsanto in the background so as not to harm the credibility of the information.”
In a separate 2010 exchange, Jay Byrne, president of the v-Fluence public relations firm and former head of corporate communications for Monsanto, tells Chassy he is trying to move the Academics Review project forward. He suggests “we work on the money (for all of us).” Byrne says that he has a list of GMO critics for Academics Review to target. He tells Chassy that the topic areas “mean money for a range of well-heeled corporations.”
'We have got a 50-50 chance of salvaging the most important antibiotics
but we need to stop agriculture from ruining it again,' says UK health
expert.
UK scientists found the latest antibiotic-resistant gene in E. coli from
two pig farms, in samples from a pig and two separate patients. (Photo:
NIAID/flickr/cc)
By Deirdre Fulton
Following the discovery in the UK of bacteria that resist the most common antibiotic of last resort, a leading British expert is warning it is "almost too late" to stop a global superbug crisis.
News outlets reported Monday that UK government scientists have found a gene, known as mcr-1, that gives bacteria resistance to colistin, often used by doctors when other antibiotics fail. Such resistance was first discovered last month in China, and in the past few weeks, the resistance gene has also been found in Denmark, France, the Netherlands, Portugal, and in several Asian and African countries.
The rise of the so-called post-antibiotic era is widely linked to over- and misuse of antibiotics in industrial agriculture.
Public Health England found colistin-resistance in 15 of the 24,000 bacterial samples it keeps on record from cases between 2012 and 2015, including samples of Salmonella and E. Coli.
According to the Soil Association's Alliance to Save Our Antibiotics campaign, scientists found the mcr-1 gene in E. coli from two pig farms, in samples from a pig and two separate patients. The E. coli from the human patients were also resistant to the critically important cephalosporin antibiotics, the Alliance noted. Meanwhile, the colistin gene was also found in 10 human Salmonella infections and in Salmonella from an imported sample of poultry meat.
The gene is reportedly found on mobile pieces of DNA, which means it can jump from farm-animal bacteria into bacteria causing human infections.
As the BBC wrote, "The concern is that colistin-resistance will now find its way into other superbugs to create infections that doctors cannot treat."
Indeed, Antibiotic Research UK director David Brown told the Press Association on Tuesday: "It is almost too late. We needed to start research 10 years ago and we still have no global monitoring system in place."
"I think we have got a 50-50 chance of salvaging the most important antibiotics but we need to stop agriculture from ruining it again," he said.
The Alliance to Save our Antibiotics echoed that call, with the group's scientific adviser Cóilín Nunan demanding the UK government "respond urgently" to the crisis.
"The routine preventative use in farming of colistin, and all antibiotics important in human medicine, needs to be banned immediately," Nunan declared.
But Brown said it would take more than legislation to turn the tide. "When the public start demanding meat that has not seen antibiotics—because they understand that the meat may contain antibiotic resistant bacteria—only then will real progress be made," he argued. "We need education about the threat."
Meanwhile, in the United States, superbugs kill at least 23,000 Americans every year, "and the problem is only getting worse," wrote Anya Vanecek, public health digital campaigner for U.S. PIRG, in a blog post on Monday.
As the U.S. Food and Drug Administration's (FDA) own accounting showed in a report (pdf) issued earlier this month, the sale and use of antibiotics for food-producing animals is actually on the rise, despite decades of warnings from scientists and health experts and the FDA's imposition of voluntary guidelines meant to lower the use of antibiotics on livestock and poultry.
Calling on the agency to "set a stronger, more meaningful plan to combat antibiotic resistance at one of its primary origins," PIRG's antibiotics program director Bill Wenzel wrote: "We now have definitive evidence that as long as producers are permitted to use antibiotics for disease prevention in animals that are not sick, antibiotics misuse on farms will continue."
"More must be done," he concluded. "Nothing less than a ban on the routine and unnecessary use of antibiotics on livestock and poultry will halt this trend, and ensure that our life-saving medicines can remain effective for generations to come."
At the Time Jim Jones Was Calling Dan Mitrione His "Close Friend" Mitrione Was Teaching Latin American Dictatorships Torture Techniques. Mitrione is depicted by an actor in the classic film, "State of Siege." He was eventually kidnapped and executed by Tupamaro Guerrillas.
_____________
Jonestown "Death Tape"
(FBI File No. Q042)
Recorded November 18, 1978
Source: Internet Archive
_______________
LT. COL. JAMES “BO” GRITZ AND JONESTOWN: "All The Niggers Are Dead" (Excerpt)
By "Gunny G"
The officer in charge of all U.S. Army Special Forces
for Latin America at the time of the Jonestown holocaust was Lt. Col.
James “Bo” Gritz. Gritz was the original soldier after which the movie
character “Rambo” was patterned. Gritz was the most decorated soldier to
come out of the Vietnam war.
The Guyana massacre was carried out by Bo Gritz’ men (along with British SAS troops). *Flatland* (#10) magazine, in an interview with Gritz, asked him:
Question: You trained Special Forces that went into Jonestown? What was the precise nature of the operation?
“I
don’t know precisely because it was a compartmentalized operation. The
only thing that I do know for certain is what the Sergeant I quote
coming out of Jonestown, he was insistent because he was disgusted, on
writing this book. He was, without compromise, going to call it *All the
Niggers Are Dead.* I asked him, ‘Why would you want to entitle anything
such an offensive way?’ ‘It doesn’t make a difference what your color,
your creed, your sex,’ he said, ‘when you are treated the way they were,
that’s what you are; you’re a nigger, you’re nothing else.’ I think
that those soldiers saw things that affected them and made them very
angry. I’ve seen other things like that in combat where there have been
abuses. I wrote about one of them in my book where the Captain tortured
the young severely and the young Sergeant put on a swastika and said,
“If I’m going to act like a Nazi I’m going to look like one.’ I think
that the same kind of negative impact occurred in Jonestown.”
Gritz
has more about Jonestown in his autobiography, *Called to Serve.*
Perhaps you simply cannot believe what I am telling you. Will you
believe it if told to you by the Green Beret officer in charge of the
men who did the killing? He admits that the information was
“compartmentalized” and it was not until later that he learned what his
men were actually doing. The following information is from pages 584-587
of his book:
“The true story of the Jonestown camp in
Guyana has been brought to light through an extensive investigation
conducted by John Judge, from Philadelphia and Washington, D.C., and
other dedicated researchers and investigators. The truth, which was
thoroughly suppressed by the American media, is that it was actually a
slave-labor camp run by Jones with the assistance of the CIA.
Most of the information which follows is from John Judge’s summary of
the investigation, supplemented with information provided by Special
Forces teams I had earlier trained and commanded, who were sent in to
‘clean up the remains of Jonestown.’
“Most of the
black and Hispanic poor people and social activists who became the
inmates of the camp were brought there either by force or coercion, or
lured under false pretenses, where extensive experiments of drug-induced
mind control were performed on them. Even before they were moved to
Guyana, reports of beatings, kidnappings, sexual abuse and mysterious
deaths had leaked out to the press about the earlier Peoples’ Temple in Ukiah, California.
“Jim Jones had a very interesting past which was overlooked by the media: During the time his friend Dan Mitrione
was teaching torture techniques to the Brazilian and Argentineans,
Jones was also sent to Brazil where his house, transportation and
groceries were provided to him by the U.S. Embassy, and he frequently
traveled to Belo Horizonte, the CIA headquarters in Brazil.
“Jones
had been contacted in Ukiah by ‘Christian missionaries’ from World
Vision (World Vision is a CIA controlled front operation), an
evangelical order which had performed espionage work for the CIA in
Southeast Asia. Most of Jones’ top lieutenants were from wealthy,
educated backgrounds, many with connections to the military or
intelligence agencies. These were the people who were involved in
setting up the bank accounts, complex legal transactions and financial
agreements which put people under the control of the Peoples’ Temple.
“Some of Jones’ Lieutenants were: Dr. Lawrence Layton was chief of Chemical and Biological Warfare Research at Dugway Proving Grounds
in Utah for many years and later worked as Director of Missile and
Satellite Development at the Navy Propellant Division at Indian Head,
Maryland. His wife, Lisa, was the daughter of Hugo Phillips, who had
represented the huge Nazi manufacturing cartel, I.G. Farben, as a
stockbroker. Their daughter, Debbie, met and married George Philip
Blakey, whose parents had extensive stock holdings in Solve Drugs, a
division of I.G. Farben.
“Blakey was reputed to be
training mercenaries in Jonestown who were sent to work with CIA-backed
UNITA forces in Angola. Terri Buford’s father, Admiral Charles T.
Buford, worked with Naval Intelligence. Marie Katsaris’ father was
minister with the Greek Orthodox Church, thought to be a conduit of CIA
funding, and she claimed she had proof he was a CIA agent. The ‘official
survivors’ were represented upon their return to the U.S. by Joseph
Blatchford, an attorney who had been named in a prior scandal involving
CIA infiltration of the Peace Corps.
“The people who
were taken from San Francisco to begin their ‘new life’ in Guyana were
bussed to Florida and arrived in Guyana bound and gagged, where they
were forced to work 16 hours or more daily, and were fed on minimum
rations. As more and more rumors began to filter back to the United
States of druggings, beatings, torture, sexual humiliations and coercion
at the Guyana site, Congressman Leo Ryan decided to go to Guyana and
verify the situation for himself.
“Ryan had challenged
the CIA’s overseas operations before, as a member of the House
Committee responsible for oversight on intelligence. He was co-author of
the controversial Hughes-Ryan Amendment, which would have required
advance CIA disclosure to the congressional committees of all planned
covert operations. The amendment would be defeated shortly after his
death in Jonestown.
“With Ryan on the way to
Jonestown, the secrecy surrounding the camp would be broken and
desperate measures would need to be taken to keep the truth from
escaping, much less the inmates. In a futile attempt to test their
conditioning methods, the leaders at Jonestown apparently tried to
implement an actual suicide drill, but it was obviously ignored.
Official stories first numbered the victims at 408, but later revised
the toll upward to 913. It was claimed that some 505 bodies had been
covered by those of the first 408 who had fallen directly on top of
them, confusing those who had been counting from aerial photographs. – a
blatant and ridiculous attempt at cover-up.
“However,
the first reports were true – 408 had died, and 700 fled to the jungle
where British Black Watch troops and American Special Forces were
conducting ‘training exercises.’ Of the 700, 505 who had been
deliberately shot in the jungle were added to the count of those who had
supposedly committed suicide by drinking cyanide-laced Kool Aid.
Was There A CIA Conspiracy to Destroy Jonestown? (Excerpt)
By Laurie Efrein-Kahalas, San Diego State University
The last person to leave the scene alive, Stanley Clayton, told the coroner’s jury in Matthews Ridge (an adjoining town) that when he left, only 100-200 people were still alive, and that although the scene was gruesome, it was peaceful, with Marceline Jones hugging people saying "I’ll see you in your next life." Indeed, there was an explicit final letter left at Jonestown (see FINAL WITNESS), which is specific about people passing on in a peaceful, if grief-laden procession.
So who was it who desecrated the bodies at Jonestown in such a gruesome manner? First, what might be the motive? One motive is clear: Make Jim Jones look like a brutal murderer of his own people, to bolster the claim that he had "ordered" the assassination of the Congressman. That would deflect investigation of the facts, much less consideration of a frame. Surely Jim Jones was responsible for everything. Case closed.
Who was responsible for the desecration? Who arrived at Jonestown before the coroner; before, indeed, anyone else arrived "officially"? Had forces arrived clandestinely, and if so, who were they, and how much time did they have to make the scene appear as they wanted?
The answer to these two questions appears to be, respectively, "Yes" and "A lot of time." First, the tragedy happened the night of Saturday, November 18th. The first team brought in "officially" was the Guyanese Defense Force, along with survivors from Jonestown brought back to identify bodies. That did not happen until Monday morning, November 20th. For the entire day of Sunday, November 19th, presumably no one was at Jonestown at all.
Yet two completely separate sources confirm that U.S. Special Forces (Green Berets) were in Jonestown within five or six hours. The first was a source from within the U.S. military, one Charles Huff from the U.S. Army Special Forces in Panama. According to FREEDOM Magazine, he was "one of the Green Berets who were the first American troops on the scene following the massacre." He said they were into Jonestown within about five hours. Indeed, Clayton told the coroner’s jury of the community falling completely silent following the deaths for 45 minutes, and that then, suddenly, there was a chorus of shouts, as well as gunfire. The source of the sounds and the gunfire, has never been identified.
Huff elaborated that "’We saw many bullet wounds as well as wounds from crossbow bolts." Huff noted that those with fatal bullet or bolt wounds appeared to have been running towards the jungle that surrounded Jonestown. Huff said that the adults who had not been shot had been killed by injections between the shoulder blades." Then enigmatically, "The killers escaped before the arrival of Huff and his team." Huff also claims that of the troops early into Jonestown, sixteen of them later "committed suicide." Given that only two Peoples Temple survivors committed suicide in the wake of the tragedy, sixteen "suicides" amongst trained combat personnel defies believability. But sixteen "suspicious deaths" is indeed a high figure, which compels investigation.
Who desecrated the bodies? Nearly no one "escaped" from Jonestown except for the tiny handful of people who ran into the jungle, and who were surely not responsible for any carnage. How could one not suspect that it was the Green Beret force itself who inflicted the purported damage?
An unexpected confirmation of U.S. troops clandestinely on site just showed up recently in a Russian book called "The Jonestown Carnage: A CIA Crime" printed by Progress Press in Moscow. Their claim was that "At about 18.00 [that’s 6 p.m. on November 18th], several S-141 military transport planes took off from military bases in Panama and Dover [Delaware] and headed for Guyana. The estimated time of flight was 3 hours 40 minutes. … Two hours later, without notifying the local authorities in the area of Venezuela where the Americans had their private missions (which served as a front for C.I.A. secret operations), three helicopters took off in the direction of Jonestown, which was 1 hour 10 minutes away."
What is startling in the Russian account, is that both their account and the American account of the arrival of Green Berets, designate the country of origin as Panama. The two independent reports tally with each other perfectly.
Equally ominous, the A & E special this past November, called "Jonestown: Mystery of a Massacre" revealed that the deaths at Jonestown were originally confirmed via a CIA radio channel, NOIWON, at 3:29 a.m. on the morning of Sunday, November 19th. The producer speculated that Richard Dwyer, the alleged C.I.A. plant in the State Department who had accompanied the Congressman to Jonestown, was the only one on site who could have made this call. But now we can see that it could have just as easily been made by U.S. Green Berets already on site, and undoubtedly under the control of the C.I.A.
What were Green Berets doing at Jonestown in the middle of the night? The C-141 MEDEVAC plane to assist the survivors of the airport shooting, according to official State Department records, did not even arrive at Georgetown from Charleston, SC until 7:55 a.m.! The Green Berets, meanwhile, were flown in immediately, before the situation at Jonestown had even been officially ascertained. They arrived in the middle of the night, but not to assist medically – rather for secret, classified work specifically at Jonestown, leaving the injured at an airstrip only seven miles away, completely unattended. Meanwhile, the MEDEVAC plane shows up on the official State Department log, but the Green Berets do not.
Was there any real concern for the people of Jonestown – their deaths, rapid evacuation of the bodies, possible survivors? Medical personnel such as the Guyanese coroner, were not sent into Jonestown for two more days! This bizarre reversal of priorities, involving moreover clandestine forces under separate command, is unsettling if not appalling, and requires investigation. Even the fact that confirmation of the suicides was received at 3:29 a.m. on the morning of the 19th, yet the incoming MEDEVAC personnel were not sent to investigate the death of over 900 people a mere seven miles away, implies not just lack of coordination between open and secret military commands, but utter disregard for human life.
Lastly, retired U.S. Air Force Colonel L. Fletcher Prouty (also uncovered by Freedom Magazine), claimed that "The Joint Chiefs of Staff had prepared air shipments of hundreds of body bags. … Within hours, they began to shuttle them down to Georgetown, the main city. They couldn’t possibly have done that without prior knowledge that it was going to happen. It shows that there was prior planning."
Not content with having created over 1,000 hybrid mice with different heads, some a different colour from their bodies, controversial doctor Xiaoping Ren next wants to perform pioneering transplants on primates.
Shadowing him during a 10-hour operation, the Wall Street Journal witnessed a mouse with a new head move and breathe on its own following the procedure, even opening its eyes and drinking.
That being said, none of Dr Ren's transplanted mice have as yet lived longer than a few minutes.
He claims to be perfecting the procedure however, using tiny tubes to carry oxygenated blood from the brains to their new bodies, and will next try it out on primates (there are already plans for it up on his wall).
The US now officially admits to conducting human experiments with mustard gas and other chemical weapons on 60,000 African Americans, as well as Japanese and Puerto Rican people. This is in addition to other human experiments the US carried out on African Americans, Guatemalans, Marshall Islanders, whom mainstream US culture referred to as “savages.“
Rollins Edwards is a young soldier in 1945 at Clark Air Force
Base in the Philippines. (Courtesy Rollins Edwards)
By Caitlin Dickerson
As a young U.S. Army soldier during World War II, Rollins Edwards knew better than to refuse an assignment.
When officers led him and a dozen others into a wooden gas chamber and locked the door, he didn't complain. None of them did. Then, a mixture of mustard gas and a similar agent called lewisite was piped inside.
"It felt like you were on fire," recalls Edwards, now 93 years old. "Guys started screaming and hollering and trying to break out. And then some of the guys fainted. And finally they opened the door and let us out, and the guys were just, they were in bad shape."
Edwards was one of 60,000 enlisted men enrolled in a once-secret government program — formally declassified in 1993 — to test mustard gas and other chemical agents on American troops. But there was a specific reason he was chosen: Edwards is African-American.
"They said we were being tested to see what effect these gases would have on black skins," Edwards says.
An NPR investigation has found evidence that Edwards' experience was not unique. While the Pentagon admitted decades ago that it used American troops as test subjects in experiments with mustard gas, until now, officials have never spoken about the tests that grouped subjects by race.
For the first time, NPR tracked down some of the men used in the race-based experiments. And it wasn't just African-Americans. Japanese-Americans were used as test subjects, serving as proxies for the enemy so scientists could explore how mustard gas and other chemicals might affect Japanese troops. Puerto Rican soldiers were also singled out.
White enlisted men were used as scientific control groups. Their reactions were used to establish what was "normal," and then compared to the minority troops.
All of the World War II experiments with mustard gas were done in secret and weren't recorded on the subjects' official military records. Most do not have proof of what they went through. They received no follow-up health care or monitoring of any kind. And they were sworn to secrecy about the tests under threat of dishonorable discharge and military prison time, leaving some unable to receive adequate medical treatment for their injuries, because they couldn't tell doctors what happened to them.
By Ari LeVaux
We know foods like donuts and soda can make you fat, but the effects of sugar on the liver and brain are less well-known. Dietary sugar can fry your liver in much the same way alcohol can. This in turn can hurt your brain, leaving you with dementia-like symptoms decades too soon.
Most people associate liver disease with alcohol abuse or hepatitis. But another type, non-alcoholic fatty liver disease, which barely existed three decades ago, has quickly become the most common liver disease in America. NAFLD isn’t caused by booze or a nasty virus, but dietary sugar, which causes a buildup of fat in your liver. Overweight people are likely candidates for NAFLD. Memory loss and diminished cognitive function are often the first symptoms, as the liver loses its ability to filter toxins that compromise the brain.
According to the American Liver Foundation, at least a quarter of the U.S. population now suffers from NAFLD, and that number is expected to swell to 40 percent by 2030, apace with an accompanying swelling of the American body, thanks to the insatiable American sweet tooth and the corporate interests that feed it. A study published March 25 further solidified the connection between sugar and NAFLD, finding that even moderate amounts of sugary drinkswill stimulate the production of enzymes that deposit fat in the liver.
By Wenonah Hauter
You may have heard that popular scientist Bill Nye has mysteriously revised his outlook on genetically modified organisms (GMOs). Several years ago, the children’s show host advocated for the labeling of genetically modified foods, citing concerns about what GMOs could do to ecosystems. But now his position on the controversial technology has flipped. This development is the latest in a trend spearheaded by agribusiness giants to discredit the GMO labeling movement, and it’s especially hard to disassociate his reversal from this PR blitz since it coincided with Nye’s recent trip to Monsanto’s headquarters.
We’ll never know what actually went down during Nye’s visit, as Tom Philpott at Mother Jones notes, but we do know that Monsanto has poured millions of dollars into public relation efforts to sell the public on GMOs. Because that’s what you do when you are a corporation with deep coffers and a product that the public is wisely skeptical of.
Does this mean that it’s game over for the GMO labeling movement or that we should trust Monsanto’s word? Of course not. In fact, it means we should be more suspicious than ever.
We’ll never know what actually went down during Nye’s visit, as Tom Philpott at Mother Jones notes, but we do know that Monsanto has poured millions of dollars into public relation efforts to sell the public on GMOs. Because that’s what you do when you are a corporation with deep coffers and a product that the public is wisely skeptical of.
Does this mean that it’s game over for the GMO labeling movement or that we should trust Monsanto’s word? Of course not. In fact, it means we should be more suspicious than ever.
While more numerous than the critically endangered northern white
rhinoceros, the southern white rhino is under withering assault from
poachers. Photo by Flickr user Elizabeth Haslam. CC-BY-NC-SA 2.0
This post by Adam Welz was originally published on Ensia.com, a magazine that highlights international environmental solutions in action, and is republished according to a content-sharing agreement.
By Ensia
In 1909, after completing his second term as U.S. president, Theodore Roosevelt led an ambitious expedition across east Africa to shoot specimens for America’s most famous museums. Along with his son Kermit and a handful of naturalists, he collected thousands of animals — everything from elephants to shrews, large raptors to tiny songbirds. The expedition’s bounty was preserved in 4 tons of salt and carried across vast savannas by large crews of African porters, some of whom died along the way.
The ultimate prize of Roosevelt’s epic scientific safari was the Nile rhinoceros, a mysterious type of square-lipped rhino found along the Upper Nile in the regions today called southern South Sudan and northern Uganda. Zoologists noted that it was remarkably similar to the so-called white rhinoceros of southern Africa but smaller, and that it was separated from the southern white by thousands of miles. Were Nile and white rhinos the same species? Experts couldn’t agree.
Teddy and Kermit shot only nine Nile rhinos between them, though they saw tens more. “Too little is known about these northern square-mouthed rhino for us to be sure that they are not lingering slowly towards extinction,” wrote Roosevelt. “We were not willing to kill any merely for trophies.”
We’re charging headlong into an era in which new technology may allow us to save species once considered doomed, but also in which threats come in previously unimaginable forms. Roosevelt’s caution was warranted: The Nile rhino, having suffered decades of trophy hunting and poaching, is on the very edge of extinction. Now often called the northern white rhino, it has only five individuals left, all in captivity, and none able to breed. The southern white rhino is under withering assault by poachers — although it’s the most numerous of the world’s rhino species, with perhaps 20,000 remaining, conservationists conservatively estimate that if killing continues to increase at current rates, all wild southern whites could be gone within 12 years.
The high-profile plight of these closely related species has brought forth a bewildering array of proposed solutions, many of which trigger serious ethical dilemmas, risk unintended and troubling consequences, or rely on unproven technology. We’re charging headlong into an era in which new technology may allow us to save species once considered doomed, but also in which threats come in previously unimaginable forms that mainstream wildlife protectors cannot handle.
Cryo Conservation
In Teddy Roosevelt’s time, saving a species involved little more than declaring it illegal to hunt and protecting a place where it could live. This either worked, as with the American bison, or didn’t, as with the heath hen, a ground-dwelling North American bird whose 1932 extinction resulted from a cascade of factors (including genetic problems from inbreeding) that conservationists didn’t have the knowledge or tools to deal with at the time.
Among the cryopreserved cells stored in the the San Diego Zoo Institute
for
Conservation Research’s “Frozen Zoo” are samples from 12 Nile
(northern
white) rhinos. Photo courtesy of San Diego Zoo.
Had the Nile rhino been in its current predicament a century ago, it certainly would have gone extinct. But today’s conservationists think they can save it by stretching the bounds of reproductive science.
Three of the remaining five Nile rhinos, two females and a male, live at Ol Pejeta Conservancy in Kenya. These animals have thus far failed to breed due to various reproductive problems. German and South African researchers will now pioneer artificial insemination techniques on a group of southern whites in South Africa that will be applied as soon as possible to the Nile rhinos in Kenya in a last-ditch attempt to breed from them.
The San Diego Zoo Institute for Conservation Research houses a “Frozen Zoo” where cells of many threatened animals, including 12 individual Nile rhinos, are deep-frozen in liquid nitrogen. Working in parallel with the German/South African effort, Frozen Zoo staff plan to use a technique developed at the Scripps Research Institute to transform the cryopreserved Nile rhino cells into stem cells, which can then theoretically be used to make embryos that can be incubated in the zoo’s southern white rhinos. Many pieces of the puzzle remain to be figured out, but the San Diego team has just received a grant to map the genetic differences between Nile and southern white rhinos, a vital part of the process.
Some conservationists fear that if scientists figure out how to make new animals from preserved cells cheaply stored in a bottle, so to speak, tax money will be directed away from conservation and into things that are more immediately popular. There are also fears that young Nile rhinos raised by captive southern whites may not learn behaviors vital for their survival in the wild. Can we really say we’ve saved the Nile rhino if it acts like a zoo-dwelling southern white? How important is learned “culture” to the makeup of a species, and how do we revive that? Moving Experience
The steps being taken to save southern white rhinos from the relentless onslaught of ever more organized poachers and traffickers — who sell their horns for extraordinary sums in Asia to consumers who believe that rhino horn cures cancer and other ailments and businesspeople seeking status symbols — are no less fraught with uncertainty.
Large-scale translocation projects are now moving hundreds of rhino from Kruger and other at-risk preserves to other parks.The largest population of southern white rhinos, perhaps 7,000 animals, resides in South Africa’s Kruger National Park. It’s the epicenter of world rhino poaching: 827 carcasses were found there in 2014, and the actual number poached may have been over 1,000. Despite reinforcing park rangers with military units and gathering extensive intelligence on poaching gangs, park authorities have been unable to stem the slaughter.
Large-scale translocation projects are now moving hundreds of rhino from Kruger and other at-risk preserves to other parks across South Africa and even to neighboring countries like Botswana — their exact destinations shrouded in secrecy because poaching gangs have even been known to hijack relocation trucks to kill the rhinos in them. One plan even calls for establishing populations of African rhinos in Australia.
But many South African conservationists are wary of large-scale rhino translocations because they’re expensive and poachers are extremely mobile, now using low-flying helicopters and night vision equipment to find rhinos in remote areas. Large translocated populations might become new “poaching magnets,” attracting poachers to previously untroubled places. National pride also comes into play; by sending rhinos to other countries, some South Africans feel like they’re admitting defeat.
Carefully designed translocations are a proven part of conservation practice, and have been used to boost rhino populations and save many other species in the past. Clearly, the expense of rhino translocation must be weighed in context and the possibility of creating new poaching magnets should be considered (both these problems can be solved by only moving small, carefully chosen groups of animals). Misplaced national pride was the downfall of the last wild population of Nile rhinos, which lived in Garamba National Park in the Democratic Republic of the Congo. In the early 2000s conservationists planned to transfer some of the remaining 30 or so animals to Kenya to create an insurance population. Nationalist Congolese politicians stalled the transfer, poaching intensified, and a 2008 survey found none remaining there.
Altered Appeal
Others aim to save rhinos by making their horns less appealing and valuable.
One group of South African rhino lovers has started injecting brightly colored poison into the horns of live rhinos. Their goal: to make the horns useless to poachers and at least a little dangerous to consumers. The approach is legally controversial, as horn-poisoners might be found liable for harm to consumers, even if the latter are acting illegally. And some scientists say the toxic mixture doesn’t actually saturate the horn, and so is a waste of time.
An influential group of South African wildlife ranchers are taking the opposite tack. If Asian consumers won’t stop paying absurd prices for poached, illegally traded rhino horn, perhaps Africans should change international wildlife trade laws and create a legal trade in horn from farmed rhinos, they say. (Rhino horns can be carefully cut off every few years without harm to the animal; they eventually regrow.) Their idea is to flood the market with legal horn, drive criminals out of business and generate revenue for rhino conservation.
International opposition to a legal horn trade is intense, making it exceedingly unlikely that international treaties could be altered within a timescale that’s meaningful to rhinos.The reasoning is superficially appealing. What’s not to like about generating dollars for rhinos’ welfare without killing them? But critics who understand Asian markets say that legal trade in high-value wildlife products boosts demand by legitimizing them in the eyes of consumers, and creates channels through which to launder poached products. This is evident from the currently legal trade in elephant ivory and farmed tiger products in China. Far from reducing pressure on wild elephants and tigers, legal ivory and tiger parts have made these commodities more visible and desirable in Chinese society, driving poaching to new heights. There’s usually no way of telling poached and legally farmed wildlife products apart, making it easy for illegal material to be sold in legal marketplaces; poached and legally harvested rhino horns look identical, making law enforcement very difficult.
It would also be very difficult, perhaps impossible, for rhino farmers to meet the twin goals of generating large profits to fund conservation and flooding the market to drive horn traffickers out of business. Making money for conservation means maximizing the price of horn. Undercutting the wildlife crime industry means selling horn cheaply. How does one do both at the same time?
In any case, international opposition to a legal horn trade is intense, making it exceedingly unlikely that international treaties could be altered within a timescale that’s meaningful to rhinos.
Military-Grade Solutions
Rhino poaching often takes place in massive, rugged, hard-to-police areas: the Kruger Park, for example, is roughly the size of Israel, and other African parks are even larger. But a few new companies are re-purposing military surveillance technology to boost conservationists’ ability to monitor such expanses. A dizzying array of drones, long-range cameras, hypersensitive microphones, cell phone monitoring stations and cutting-edge software are being packaged with the specific purpose of finding poachers before they strike.
Understaffed anti-poaching squads, desperate for help, are in favor of the military-tech approach. However, some critics balk at the expense of this hardware, pointing out that billions spent on similar gear has failed to stop people and illegal drugs flowing across America’s borders. Others wonder if tourists will visit parks that increasingly resemble military camps.
Grow Your Own
If all that consumers care about is the horn part of the rhino, why not leave the animals in peace by growing horn in a lab? A Seattle-based company, Pembient, aims to grow nature-identical rhino horn (and ultimately other wildlife products) using cutting-edge biotechnology and a hefty dose of Silicon Valley techno-optimism.
Critics are worried that, just as with selling legally farmed horn, this approach may backfire horribly. It may disassociate horn from the gruesome business of poaching in the mind of some consumers, making its use more socially acceptable. And it could counter-productively increase demand for poached horn in other consumers, as “real” horn may be seen as more genuine or potent.
This already has happened with American ginseng, a plant that grows wild on forest floors across much of the northeastern U.S. and is highly desired in China for medicinal use. The creation of a large cultivated ginseng industry has made wild ginseng root appear better and more desirable, driving prices up and increasing pressure on wild populations. Ginseng collecting has gone from a small seasonal occupation to a big money spinner in places like Appalachia. Illegal harvesting is rife and violent conflicts now occur over natural ginseng patches in formerly peaceful rural communities.
Dropping Demand
The ultimate solution to poaching and the illegal trade in wildlife products is, of course, to persuade people not to buy them — an approach known as “demand reduction.” Most conservation groups paid little attention to this in the past, but organizations like the one I represent, WildAid, have made measurable progress in shifting public attitudes against wildlife products and driving down consumption using techniques pioneered by Hollywood and the advertising industry.
There’s always a risk of a campaign having unintended consequences. For example, WildAid partnered with Chinese basketball superstar Yao Ming and other celebrities to campaign against the cruel and wasteful killing of sharks for shark fin soup, a status item whose consumption was skyrocketing in China with that country’s growing wealth. The campaign’s TV ads and billboards have been seen by hundreds of millions in China, and last year 85 percent of respondents to a public survey said they’d stopped consuming shark fin in the previous three years, the most common reason cited being anti-shark fin public awareness campaigns. Chinese wholesalers report massive declines in sales, and fishermen across Asia are getting out of the shark fin business because prices are too low.
A range of wildlife groups are now rolling out word-of-mouth, broadcast media and cell phone campaigns against ivory and rhino horn in Asia, and surveys reveal that public attitudes have begun to shift against these products as well. Much needs to be learned, however, in today’s ever-evolving media landscape, and there’s always a risk of a campaign having unintended consequences. Many conservation groups refuse to put a number on the sky-high street prices of rhino horn, for example, for fear of encouraging more trafficking.
Beyond Imagination
In the recent past, conservation was mainly about understanding the biology of endangered species, protecting and managing their habitats, and lobbying for new laws. Today, saving high-value species like rhinos and elephants means outmaneuvering nimble poaching and trafficking networks, which are surprisingly well-funded, able to exploit cutting-edge technology and unencumbered by tedious legal processes and governing committees.
Wildlife protectors, for their part, have to become expert gene manipulators, criminologists, military technologists and marketers. They must deal with practical and ethical problems that previous generations could not have imagined.
There is clearly no silver-bullet solution. Conservationists have no choice but to grasp the future and grapple with its risky technologies if rhinos — and thousands of other species — are to continue to exist in any condition resembling their wild, ancient way.
Adam Welz is a writer/filmmaker, longtime naturalist, addicted birder and inveterate debater. He's the South African representative of WildAid, a nonprofit that focuses on ending the demand for illegal wildlife products. He tweets from @AdamWelz and @WildAid_SA.
By RTT
You are wrong if you thought diet soda was healthier as they use artificial sweeteners. A new study found that people who regularly drink diet soda gain about triple the abdominal fat compared to non-drinkers.
According to a study published in the Journal of the American Geriatrics Society, people who daily drank diet soda for about 10 years gained almost triple the abdominal fat than those who did not drink diet soda.
The waist circumferences of diet soda drinkers gained about 2.11 centimeters, while non-users gained 0.77 centimeters around the waist. Daily consumers gained a whopping 3.04 centimeters, while occasional users' waist increased 1.76 cm.
By Lenny Bernstein
A team of prominent researchers suggested Thursday that limited airborne transmission of the Ebola virus is "very likely," a hypothesis that could reignite the debate that started last fall after one of the scientists offered the same opinion.
"It is very likely that at least some degree of Ebola virus transmission currently occurs via infectious aerosols generated from the gastrointestinal tract, the respiratory tract, or medical procedures, although this has been difficult to definitively demonstrate or rule out, since those exposed to infectious aerosols also are most likely to be in close proximity to, and in direct contact with, an infected case," the scientists wrote. Their peer-reviewed analysis was published in mBio, a journal of the American Society of Microbiology.
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RELATED STORIES: While big media was insisting that Ebola could not be transferred through the air, these are some of the facts they ignored:
The paper's lead author, Michael T. Osterholm, an epidemiologist at the Center for Infectious Disease Research and Policy at the University of Minnesota, touched off a small furor and was condemned by some experts last Sept. 11 when he raised the same possibility in an op-ed piece in the New York Times as concern over the spread of the deadly disease was increasing rapidly.
Less than a month later, Thomas Eric Duncan, a Liberian infected with Ebola in his home country, died in a Dallas hospital, but not before two nurses who treated him became infected, sparking fears about how prepared U.S. hospitals were to handle the disease. Public health authorities reassured Americans they were in no danger of contracting the hemorrhagic disease from casual contact with others. Ebola is transmitted by contact with infected body fluids -- mainly blood, feces and vomit -- experts around the world have said. This is why health care workers and people who had contact with victims were most likely to become infected in the current epidemic, they said.
"There was almost a rush to ensure the public that we knew a lot more than we did," Osterholm said in an interview Wednesday night, repeating a theme he has raised many times before. "But we're saying you can’t rule out respiratory transmission."
By Ronald David Jackson
The following "Mercury in Medicine" report was added to the Congressional Record on May 20, 2003. The report was prepared by the staff of the Subcommittee on Human Rights and Wellness, Committee on Government Reform. The report is the result of a three-year investigation initiated in the Committee on Government Reform. The key findings of the investigation are highlighted with black outlines and in some cases with black and yellow outlines. Some of the key findings include:
1) No one knows for sure if vaccines are safe or unsafe because while there are studies comparing health outcomes in those who did and did not get the vaccine (epidemiological studies) - the vaccines themselves (and more importantly, the various ingredients in the vaccines) have never been thoroughly tested for safety in humans. Specifically: "The FDA [Food and Drug Administration] has never required manufacturers to conduct adequate safety testing on thimerosal and ethylmercury compounds."
2) As the rate of autism has grown at epidemic proportions during the last two decades, the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold.
3) The Institute of Medicine (an American non-profit, non-governmental organization founded in 1970) determined that a relationship between autism, attention deficit hyperactive disorder, and speech or language delay, and the increased use of thimerosal in vaccines is plausible and deserves more scrutiny (even though there was not enough evidence to support or reject this hypothesis).
4) In 1998, the FDA finalized a rule requiring that ethylmercury be removed from over-the-counter products like topical ointments and skin creams (suggesting that ethylmercury—used as a preservative in many vaccines—could be hazardous to health) . Yet it took the FDA 18 years to get around to doing this, even though an advisory committee determined that ethylmercury was unsalfe in these products in 1980.
5) The FDA and the CDC [Center for Disease Control] failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule. When the Hepatitis B and Haemophilus Influenzae Type B vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled.
6) The amount of ethylmercury to which children were exposed through vaccines exceeded the safety thresholds established by the Federal government for a closely related substance methylmercury, "experts agree that the methylmercury guidelines are a good substitute."
7) Federal health officials have conceded that the amount of thimerosal in vaccines exceeded the EPA threshold of 0.1 micrograms per kilogram of bodyweight. "In fact, the amount of mercury in one dose of DTaP or Hepatitis B vaccines (25 micrograms each) exceeded this threshold many times over.
8) The FDA has: a) Failed to require the pharmaceutical industry to conduct extensive safety studies on thimerosal or ethylmercury. b) Failed to require the pharmaceutical industry to conduct adequate testing to determine how thimerosal is metabolized. c) Failed to require the pharmaceutical industry to determine the maximum safe exposure level to thimerosal.
9) Over the course of two decades the FDA slowly removed ethylmercury from many medicinal products - WHY?
10) In June of 2000, the CDC's Advisory Committe on Immunization Practice met in Atlanta. One of the key factors that weighed against a recommendation for a preference for thimerosal-free vaccines was the financial health of the vaccine industry. A recommendation for thimerosal-free vaccine had "the potential for financial losses of existing inventories", "could harm one or more manufacturers and may then decreased the number of suppliers", and "could entail financial losses for all existing stocks of vaccines that contain thimerosal."
It appears that protecting the industry's profits took precedent over protecting children from mercury damage.
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."
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Related stories: Read more patient safety coverage by Marshall Allen and Olga Pierce.
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