1,200 Indigenous Women in Canada Murdered or Gone Missing Since 1980s

Indigenous women are five times more likely to be murdered, and most attacks are from outside their communities, says Audrey Huntley of the No More Silence campaign in Canada.

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The Cheap Propaganda of the Pro-GMO Lobby

gmo-apple

The pro-GMO lobby always demands that its opponents produce scientific evidence to back up their claims. Parts of this lobby smear and attack people like Vandana Shiva, Professor G.E. Seralini and others for supposedly being incompetent, ‘liars’ or ideological/politically motivated (for example, read this piece on Shiva that calls her a liar, especially the part on farmer suicides – then see the evidence that Shiva provides to back up her claims here).

In its view, anti-GMO campaigners or certain scientists are ignorant, engage in bogus science or are ‘demagogues’ who use emotion and ideological rhetoric to sway opinion.

Let us address these accusations.

The pro-GMO lobby demands its opponents back up their (wild) claims with peer-reviewed studies.

Perhaps, just for a start, GMO supporters should read ‘An evidence-based examination of the claims made for the safety and efficacy of GM crops and food‘ and ‘Adverse impacts of transgenic crops/food: a compilation of scientific references with abstracts‘.

The pro-GMO lobby says the debate on GMOs is over because there is a scientific consensus on their efficacy among the ‘scientific community’.

Another bogus accusation. See here for evidence pertaining to a lack of consensus.

GMO supporters argue that GMOs can prevent hunger, while trendy ‘elitist’ activists are merely serving to steal the food from people’s mouths.

See here for the evidence that says GMOs are actually causing food insecurity, see here to discover that GMOs are not required to feed the hungry millions and see here to read that ‘eco farming’ is a much more suitable and sustainable strategy that could double food production within a decade. Also see this report based on the input of over 400 scientists that took four years to complete, which was twice peer reviewed, and states we must look to small-holder, traditional farming (not GMOs) to deliver food security in poorer countries through agri-ecological systems which are sustainable. Moreover, see here to read about the serious health impacts of GMO-driven agriculture and here to discover how GMO agribusiness is devastating communities and driving genocide and ecocide in South America.

The pro-GMO lobby asserts that it relies solely on peer-reviewed science and dispassionate reason.

While some contest the claims of Vandana Shiva pertaining to farmer suicides, which she supports with statistical evidence and correlations, they then call her a ‘liar’. A liar is someone who deliberately sets out to deceive. The evidence she supplies may or may not stack up, but that is open to ongoing debate and interpretation. But the same can be said of many of the studies that the pro-GMO lobby puts forward, which have been contested, see here and in this report here (go to section three of the report), on the basis of conclusions overstepping the evidence or inconvenient findings being dismissed as not significant when they are.

Aside from emotive name calling, where else does emotion, ideology or falsehood play a part in the pro-GMO lobby’s side of the debate? That’s clear to see if we look at this on Owen Patterson, this on Anne Glover and this on Kevin Folta. In fact, these aspects are quite commonplace.

On a more general level regarding ‘dispassionate reason’ informing the debate, see what former Monsanto boss in India said in this piece in India Today ‘Monsanto faked data for its approvals, claims ex-chief‘. See here to discover what method it used in Indonesia to force its products into that country. See here and here  to find out how the industry restricts access to its own research conducted on its products. See here to discover how it sidesteps science when its interests are threatened and to gain wider insight into how the GMO agritech sector is distorting scientific practice and debasing the ethos of science.

It seems to be a case of peer-reviewed science to support the anti-GMO case but ‘anything goes’, including science that is anything but open to public scrutiny or peer reviewed (see here), from GMO agritech.

And yet the onslaught by the GMO agritech industry and its mouthpieces against those who legitimately and scientifically contest the claims about the efficacy of GMOs is relentless.

Just ask Arpad Pusztai, P. M. Bhargava, Judy Carman, Terje Traavik, Andrés Carrasco, Ignacio Chapela, Allison Snow, Marc Lappé, Britt Bailey, Bela Darvas and G. E. Seralini. These scientists have all either been threatened, smeared or hindered in their work because their research called into question the safety and/or efficacy of GMOs or associated products (see this ‘GMO researchers attacked, evidence denied and apopulation at risk’).

Such tactics appear to come easy to the pro-GMO lobby. For instance, see here for a revealing description of how the GMO sector sets up front groups and fake identities with the sole aim of attacking scientists and activists or promoting its propaganda.

This is what happens to scientists who attempt to engage with the GMO issue on a scientific or rational level. The hypocrisy of those from the pro-GMO lobby who call for sound science to inform the debate on GMOs is glaringly obvious.

When GMO supporters mount personal attacks and accuse prominent anti-GMO campaigners of being liars, it is useful to ask what credibility they themselves have: for example, bearing in mind the attack on Vandana Shiva mentioned at the start, see this by Tom Philpott on the author of that particular smear piece.

When the GMO agritech sector and its supporters set out to attack others in the ways outlined here, it is a blatant tactic of psychological projection: a self-defence mechanism that denies the existence of such characteristics in itself, while attributing them to others. In other words, those who argue against GMOs are accused of not having science or facts on their side and of engaging in propaganda and lying, while it is clear the pro-GMO lobby that hurls such allegations is itself guilty of such things.

This diversionary tactic of projection goes hand in glove with a strident populist agenda whereby the pro-GMO lobby portrays itself as on the side of the people, while its opponents are ‘elitists’ and are ‘stealing food from the bellies of the poor’. This is a typical tactic of corporate propaganda.

Reality is being twisted to make opponents appear guilty of the things the pro-GMO lobby is engaging in, not least ‘elitism’ (for example, see this and this on how elite interests are seeking to control global agriculture).

Lace the tactics of projection and populism with an unhealthy dose of cheap, fallacious character assassination and you have the basis for a very transparent and predictable propaganda campaign.

CIA Looking Into Weather Modification As A Form of Warfare

cia

This week, a top American climate researcher – Professor Alan Robock from Rutgers – says that the CIA is looking into weather modification as a form of warfare.

The Independent reports:

A senior American climate scientist has spoken of the fear he experienced when US intelligence services apparently asked him about the possibility of weaponising the weather as a major report on geo-engineering is to be published this week.

Professor Alan Robock stated that three years ago, two men claiming to be from the CIA had called him to ask whether experts would be able to tell if hostile forces had begun manipulating the US’s weather, though he suspected the purpose of the call was to find out if American forces could meddle with other countries’ climates instead.

During a debate on the use of geo-engineering to combat climate change, at the annual meeting of the American Association for the Advancement of Science in San Jose, California, Prof Robock said: “I got a phone call from two men who said we work as consultants for the CIA and we’d like to know if some other country was controlling our climate, would we know about it?

”I told them, after thinking a little bit, that we probably would because if you put enough material in the atmosphere to reflect sunlight we would be able to detect it and see the equipment that was putting it up there.

“At the same time I thought they were probably also interested in if we could control somebody else’s climate, could they detect it?”

Professor Robock, who has investigated the potential risks and benefits of using stratospheric particles to simulate the climate-changing effects of volcanic eruptions, said he felt “scared” when the approach was made.

“I’d learned of lots of other things the CIA had done that haven’t followed the rules and I thought that wasn’t how I wanted my tax money spent. I think this research has to be in the open and international so there isn’t any question of it being used for hostile purposes.”

***

Professor Robock’s concerns come as a major report on geo-engineering is to be published this week by the US National Academy of Sciences. Among the report’s list of sponsors is the “US intelligence community”, which includes Nasa, the National Oceanic and Atmospheric Administration, and the US Department of Energy.

The professor alleges that the CIA told a colleague of his that it wanted to fund the report, but claimed that it did not want this fact to be too obvious – he added that the CIA is “a major funder” of the report which “makes me really worried about who is going to be in control”.

He claimed the US government had a proven history of using the weather in a hostile way, citing the action of seeding clouds during the Vietnam War to muddy the Ho Chi Minh foot-trail and attempt to cut it off, as it was used as a supply route but the north Vietnamese.

He claimed the CIA had also seeded clouds over Cuba “to make it rain and ruin the sugar harvest”.

Professor Robock may sound like a nutcase … but he’s actually sane, and his concerns are well-founded.

The Guardian reported in 2001:

During the Vietnam war, the Americans launched Project Popeye, a secret mission to seed the tops of monsoon clouds and trigger phenomenal downpours that would wash away the Ho Chi Minh Trail used for ferrying supplies.

For five years Vietnam, Cambodia and Laos were sprayed during the monsoons, and military intelligence claimed that rainfall was increased by a third in some places. It only came to an end in March 1971 when [Washington Post] journalist Jack Anderson exposed the project and caused such a public furor that the UN general assembly approved a universal treaty banning environmental warfare.

Interestingly, U.S. weather modification efforts during the Vietnam war were revealed as part of the Pentagon Papers.

The Washington Post reported on July 2, 1972:

Indochina – by the evidence of a long-ignored passage in the Pentagon Papers – has been a test battleground, the site of purposeful rain-making along the Ho Chi Minh trails.

***

Sen. Claiborne Pell (D-R.I.) is prominent among members of Congress who believe it has become a reality. “There is very little doubt in my mind,” he says. Rep. Gilbert Gude (R-Md.) states: “There’s no doubt in my mind that it’s going on in Vietnam.”

“I think there’s no doubt rain-making was used in Laos on the trail,” says a Senate committee aide well versed in defense affairs.

***

It is a “successful” pre-1967 use which is documented in the “senator Gravel” version of the Pentagon papers. In late February, 1967, this document discloses the Joint Chiefs of Staff prepared a list of “alternative strategies” for President Johnson.

One, titled “Laos Operations”, read:

“Continue at present plus Operation Pop Eye to reduce trafficability along infiltration routes … authorization required to implement phase of weather modification process previously successfully tested and evaluated in same area ….

In 1967 — according to columnist Jack Anderson, who published the first allegation of Indochina rain-making — U.S. forces started secret Project Intermediary Compatriot “to hamper enemy logistics” … (with) claimed success in creating man-made cloudbursts … and flooding conditions” along the Ho Chi Minh trails, “making them impassable.”

The Post makes clear that cloud-seeding wasn’t limited to the Vietnam war theater:

The Defense Department freely reports that it has “field capacities” for making rain. It used them in the Philippines in 1969, in a six-month “precipitation augmentation project” at the Philippines request; in India in 1967, at a similar invitation; over Okinawa and Midway Islands, and in June, July and August, 1971, over drought-stricken Texas, at the urgent request of Gov. Preston Smith.

***

Navy rain-makers are currently involved in two long-range California programs — one over the Pacific off Santa Barbara, an attempt to increase rainfall over a national forest; the other over the Central Sierras to try to increase the snow-pack for electric utilities that depend on water power.

The Post also quoted high-level scientists warning that enemies could modify weather as a direct form of warfare, for example, by flooding coastal areas where one’s enemy resided.  And – as the Post notes – even in 1972, the government was studying the affect of counter-measures to weather warfare:

ARPA Director Stephen J. Lukasik told the Senate Appropriations Committee in March: “Since it now appears highly probable that major world powers have the ability to create modifications of climate that might be seriously detrimental to the security of this country, Nile Blue [a computer simulation] was established in FY 70 to achieve a US capability to (1) evaluate all consequences of of a variety of possible actions … (2) detect trends in in the global circulation which foretell changes … and (3) determine if possible , means to counter potentially deleterious climatic changes …”

“What this means,” Lukasik explains, “is learning how much you have to tickle the atmosphere to perturb the earth’s climate. I guess we’d call it a threat assessment.”

The Boston Globe noted in 2005:

A few years ago, a team led by the late Edward Teller [the creator of the nuclear bomb] suggested creating a similar effect by launching a million tons of tiny aluminum balloons into the atmosphere.

***

The US military, unsurprisingly, was intrigued by the possibility of a godlike meteorological arsenal. According to Spencer Weart, a physicist and historian of science at the American Institute of Physics, the thinking in the Defense Department was “maybe we’ll give the Russians a real Cold War, or maybe they’ll give us one, so we should be ready.” Pentagon money funded much of the era’s climate research, helping to create the weather models we now use in forecasting. War gamers dreamed up climatological warfare scenarios like laying down a blanket of fog over an airfield or visiting drought upon an enemy’s breadbasket.

***

A 1996 Air Force report entitled “Weather as a Force Multiplier: Owning the Weather in 2025,” argued that “the tremendous military capabilities that could result from this field are ignored at our own peril.”

Here is a copy of the Air Force study “Weather as a Force Multiplier: Owning the Weather in 2025″.

The Technology Has Advanced Far Beyond Seeding Clouds With Silver Iodide

The technology has advanced a long way since the early 1970s.

For example, the Telegraph reported in 2011 that Abu Dhabi ‘creates man-made rainstorms’ by “using giant ionisers, shaped like giant lampshades, to generate fields of negatively charged particles, which create cloud formation.” “There are many applications,” Professor Hartmut Grassl, a former institute director, is quoted by the Daily Mail as saying. “One is getting water into a dry area. Maybe this is a most important point for mankind.”

The Guardian reported in 2001:

The US air force planners recently came up with new proposals to launch new weather weapons. Instead of silver-iodide, the idea is to shower fine particles of heat-absorbing carbon over clouds to trigger localised flooding and bog down troops and their equipment. Lasers on aircraft would also trigger lightning onto enemy aircraft, whilst other lasers could be fired at fog to clear a path over enemy targets on the ground.

Former secretary of defense William Cohen told a conference on terrorism on April 28, 1997:

Others are engaging even in an eco-type of terrorism whereby they can alter the climate, set off earthquakes, volcanoes remotely through the use of electromagnetic waves.

The American Institute of Physics (the organization mentioned above in the Boston Globe article)provides an interesting overview of the history of weather modification:

From 1945 into the 1970s, much effort went into studies of weather modification. American entrepreneurs tried cloud-seeding to enhance local rainfall, Russian scientists offered fabulous schemes of planetary engineering, and military agencies secretly explored “climatological warfare.”

***

At the close of the Second World War, a few American scientists brought up a troublesome idea. If it were true, as some claimed, that humans were inadvertently changing their local weather by cutting down forests and emitting pollution, why not try to modify the weather on purpose? For generations there had been proposals for rainmaking, based on folklore like the story that cannonades from big battles brought rain.

Now top experts began to take the question seriously…. At the end of 1945 a brilliant mathematician, John von Neumann, called other leading scientists to a meeting in Princeton, where they agreed that modifying weather deliberately might be possible. They expected that could make a great difference in the next war. Soviet harvests, for example, might be ruined by creating a drought. Some scientists suspected that alongside the race with the Soviet Union for ever more terrible nuclear weapons, they were entering an equally fateful race to control the weather. As the Cold War got underway, U.S. military agencies devoted significant funds to research on what came to be called “climatological warfare.”

***

In 1953 a President’s Advisory Committee on Weather Control was established to pursue the idea. In 1958, the U.S. Congress acted directly to fund expanded rainmaking research. Large-scale experimentation was also underway, less openly, in the Soviet Union.

Military agencies in the U.S. (and presumably in the Soviet Union) supported research not only on cloud seeding but on other ways that injecting materials into the atmosphere might alter weather. Although much of this was buried in secrecy, the public learned that climatological warfare might become possible. In a 1955 Fortune magazine article, von Neumann himself explained that “Microscopic layers of colored matter spread on an icy surface, or in the atmosphere above one, could inhibit the reflection-radiation process, melt the ice, and change the local climate.” The effects could be far-reaching, even world-wide. “What power over our environment, over all nature, is implied!” he exclaimed. Von Neumann foresaw “forms of climatic warfare as yet unimagined,” perhaps more dangerous than nuclear war itself. 

As such, it is vital that weather warfare not be allowed to spiral out of control.

NYU Professor Uncovers How the FDA Systematically Covers Up Fraud and Misconduct in Drug Trials

by Mike Krieger via Liberty Blitzkrieg blog,

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

From the Slate article: Are Your Medications Safe? 

In the past week or so, I’ve come across several important articles that will leave any rational observer increasingly skeptical of the entire medial industry in the U.S. This isn’t something I say lightly, and I think it’s an absolutely horrific development for our society.

Just last week, Liberty Blitzkrieg published an article titled, Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam, which expounded on why an erosion of trust in doctors is so troubling. If you missed that piece, I suggest going back and reading it. Here’s an excerpt:

Once the corruption reaches a certain level of societal saturation, you create a culture in which people simply stop trusting everyone and everything. For obvious reasons, this is a very dangerous development. There are people whom you need to trust for any civilization to function reasonably well. Police are one, but doctors are another. I can speak for myself when I say that I am not convinced that any medical professional I see has only my best interests at heart. I seriously wonder how he or she is balancing my health with the ability to earn more money. From conversations with friends and family, I have found that this is much more widespread than we would like to admit. This is incredibly bad and incredibly sad.

While that article was bad enough, it is nothing compared to what I just read by Charles Seife, a journalism professor at New York University. He and his students set out to research the FDA and how it deals with evidence of fraud and misconduct in pharmaceutical drug trials. What he found will shock and disturb even the most hardened cynic. If you are one of the 70% of Americans that take at least one prescription drug, brace yourself…

From Slate:

Agents of the Food and Drug Administration know better than anyone else just how bad scientific misbehavior can get. Reading the FDA’s inspection files feels almost like watching a highlights reel from a Scientists Gone Wildvideo. It’s a seemingly endless stream of lurid vignettes—each of which catches a medical researcher in an unguarded moment, succumbing to the temptation to do things he knows he really shouldn’t be doing. Faked X-ray reportsForged retinal scansPhony lab testsSecretly amputated limbs. All done in the name of science when researchers thought that nobody was watching.

That misconduct happens isn’t shocking. What is: When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary. For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.

We didn’t have to search very hard to find FDA burying evidence of research misconduct. Just look at any document related to an FDA inspection. As part of the new drug application process, or, more rarely, when the agency gets a tipoff of wrongdoing, the FDA sends a bunch of inspectors out to clinical sites to make sure that everything is done by the book. When there are problems, the FDA generates a lot of paperwork—what are called form 483s, Establishment Inspection Reports, and in the worst cases, what are known as Warning Letters. If you manage to get your hands on these documents, you’ll see that, most of the time, key portions are redacted: information that describes what drug the researcher was studying, the name of the study, and precisely how the misconduct affected the quality of the data are all blacked out. These redactions make it all but impossible to figure out which study is tainted. My students and I looked at FDA documents relating to roughly 600 clinical trials in which one of the researchers running the trial failed an FDA inspection. In only roughly 100 cases were we able to figure out which study, which drug, and which pharmaceutical company were involved. (We cracked a bunch of the redactions by cross-referencing the documents with clinical trials data, checking various other databases, and using carefully crafted Google searches.) For the other 500, the FDA was successfully able to shield the drugmaker (and the study sponsor) from public exposure.

Think about that. Despite all that digging, they were able to link questionable data to specific drugs in only 20% of the cases examined.

It’s not just the public that’s in the dark. It’s researchers, too. And your doctor. As I describe in the current issue of JAMA Internal Medicine, my students and I were able to track down some 78 scientific publications resulting from a tainted study—a clinical trial in which FDA inspectors found significant problems with the conduct of the trial, up to and including fraud. In only three cases did we find any hint in the peer-reviewed literature of problems found by the FDA inspection. The other publications were not retracted, corrected, or highlighted in any way. In other words, the FDA knows about dozens of scientific papers floating about whose data are questionable—and has said nothing, leaving physicians and medical researchers completely unaware. The silence is unbroken even when the FDA itself seems shocked at the degree of fraud and misconduct in a clinical trial.

Such was the case with the so-called RECORD 4 study. RECORD 4 was one of four large clinical trials that involved thousands of patients who were recruited at scores of clinical sites in more than a dozen countries around the world. The trial was used as evidence that a new anti-blood-clotting agent, rivaroxaban, was safe and effective. The FDA inspected or had access to external audits of 16 of the RECORD 4 sites. The trial was a fiasco. At Dr. Craig Loucks’ site in Colorado, the FDA found falsified data. At Dr. Ricardo Esquivel’s site in Mexico, there was “systematic discarding of medical records” that made it impossible to tell whether the study drug was given to the patients. At half of the sites that drew FDA scrutiny—eight out of 16—there was misconduct, fraud, fishy behavior, or other practices so objectionable that the data had to be thrown out. The problems were so bad and so widespread that, contrary to its usual practice, the FDA declared the entire study to be “unreliable.” Yet if you look in the medical journals, the results from RECORD 4 sit quietly in The Lancet without any hint in the literature about falsification, misconduct, or chaos behind the scenes. This means that physicians around the world are basing life-and-death medical decisions on a study that the FDA knows is simply not credible.

It’s not just one study, either. The FDA found major problems with sites involved in the other three clinical trials that were used to demonstrate rivaroxaban’s safety and effectiveness. RECORD 2, for example, was nearly as awful as RECORD 4: Four out of 10 sites that the FDA inspected showed evidence of misconduct, or other issues grave enough to render the site’s data worthless—including clear evidence of data falsification at one site. In aggregate, these problems raise serious doubts about the quality of all four key rivaroxaban studies—and, by extension, doubts about how seriously we should take the claim that rivaroxaban is safe and effective. The FDA is keeping mum, even as wrongful-death lawsuits begin to multiply.

In the decade since the Ketek affair, it’s hard to see any change in behavior by the agency. On occasion, the FDA has even actively approved and promoted statements about drugs that, according to its own inspectors, are based upon falsehoods. At the end of 2011, the FDA learned that an audit of a Chinese site involved in a key clinical trial of a different anti-clotting agent, apixaban, had turned up evidence of fraud: Personnel had apparently been fiddling with patient records. Worse yet, the fraud appeared to invalidate one key finding of the study. Just three months earlier, the researchers running the trial proudly announced in the New England Journal of Medicine that there was a “significant reduction in mortality” among patients who took apixaban compared with those who took the old standby, warfarin. Alas, the moment you exclude the data from the Chinese fraud site, as per standard FDA procedure, that statement went out the window. Yet look at the label for apixaban—the one approved by the FDA after the fraud was discovered—and you read that “treatment resulted in a significantly lower rate of all-cause death … than did treatment with warfarin,” backed up by the data set with the Chinese site included. In other words, the label is carrying a claim that the FDA knows is based upon fraud.In a written response to my questions on this subject, the FDA stated that, “The FDA extended the drug’s review period to address the concerns. However, the review team did conclude concluded [sic] that the data at that site and other sites in China did reflect meaningful clinical information; that was not what was considered unreliable.”

Again, this isn’t an isolated incident. I had previously encountered bogus data on FDA-approved labels when a colleague and I were looking into a massive case of scientific misconduct —a research firm named Cetero had been caught faking data from more than 1,400 drug trials. That suddenly worthless data had been used to establish the safety or effectiveness of roughly 100 drugs, mostly generics, that were being sold in the United States. But even after the agency exposed the problem, we found fraud-tainted data on FDA-approved drug labels. (The FDA still maintains its silence about the Cetero affair. To this day, the agency refuses to release the names of the 100-odd drugs whose approval data were undermined by fraud.)

The most common excuse the agency gives is that exposing the details about scientific wrongdoing—naming the trials that were undermined by research misconduct, or revealing which drugs’ approvals relied upon tainted data—would compromise “confidential commercial information” that would hurt drug companies if revealed. This claim falls apart under scrutiny. The courts have ruled that when information is provided by companies involuntarily, such as the information that an FDA inspector finds, “commercial confidential information” refers to proprietary material that causes substantial, specific harm when it falls into the hands of a competitor. It doesn’t cover embarrassing peccadilloes—or misconduct that might cause bad publicity when word gets out.

As usual, it’s all about protecting corporate profits. America’s new religion. 

The sworn purpose of the FDA is to protect the public health, to assure us that all the drugs on the market are proven safe and effective by reputable scientific trials. Yet, over and over again, the agency has proven itself willing to keep scientists, doctors, and the public in the dark about incidents when those scientific trials turn out to be less than reputable. It does so not only by passive silence, but by active deception. And despite being called out numerous times over the years for its bad behavior, including from some very pissed-off members of Congress, the agency is stubbornly resistant to change. It’s a sign that the FDA is deeply captured, drawn firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate. We can no longer hope that the situation will get better without firm action from the legislature.

For related articles, see:

First is a MUST WATCH hilarious video by John Oliver: Video of the Day – John Oliver on Pharma Company “Marketing to Doctors”

Fraud Alert: FDA Allowed Drugs with Fraudulent Testing to Remain on the Market

The FDA is Caught Spying on its Employees and Creating an “Enemies List”

Introducing “Physician Dispensing” – The Latest Troubling Medical Industry Scam

Geoengineering: First Do No Harm

The U.S. – and Presumably Russia – Have Researched Weather Modification As Warfare For Many Decades

Proposals to use geoengineering to fight global warming are in the news. But geoengineering has not always been thought of as a way to fight global warming

In the 1950s, 1960s and 1970s, presidents and scientists considered geoengineering to stop a new iceage and to create more warming.

On April 28, 1975, Newsweek wrote an article stating:

Climatologists are pessimistic that political leaders will take any positive action to compensate for the climatic change, or even to allay its effects. They concede that some of the more spectacular solutions proposed, such as melting the Arctic ice cap by covering it with black soot or diverting arctic rivers, might create problems far greater than those they solve. But the scientists see few signs that government leaders anywhere are even prepared to take the simple measures of stockpiling food or of introducing the variables of climatic uncertainty into economic projections of future food supplies. The longer the planners delay, the more difficult will they find it to cope with climatic change once the results become grim reality.

Here is a reprint of the article in the Washington Times, and here is a copy of the 1975 Newsweek article.

Why were scientists considering melting the arctic ice cap?

Because they were worried about a new ice age.

Newsweek discussed the 1975 article in 2006:

In April, 1975 … NEWSWEEK published a small back-page article about a very different kind of disaster. Citing “ominous signs that the earth’s weather patterns have begun to change dramatically,” the magazine warned of an impending “drastic decline in food production.” Political disruptions stemming from food shortages could affect “just about every nation on earth.” Scientists urged governments to consider emergency action to head off the terrible threat of . . . well, if you had been following the climate-change debates at the time, you’d have known that the threat was: global cooling…

Citizens can judge for themselves what constitutes a prudent response-which, indeed, is what occurred 30 years ago. All in all, it’s probably just as well that society elected not to follow one of the possible solutions mentioned in the NEWSWEEK article: to pour soot over the Arctic ice cap, to help it melt.

Obama’s senior science adviser – John Holdren – was one of those warning of a catastrophic ice age.

The Boston Globe reported in 2005:

The grandest climate engineering schemes came from the Soviet Union. The most Promethean among them was a late 1950s proposal to dam the Bering Strait and, by pumping water from the Arctic Ocean into the Pacific, draw warm water northward from the Atlantic to melt the polar ice pack, making the Arctic Ocean navigable and warming Siberia. The leading Soviet climatologist, Mikhail I. Budyko, cautioned against it, arguing that the ultimate effects were too difficult to predict (though he himself had played with the idea of warming the Arctic by covering it in soot to decrease its reflectivity). John F. Kennedy, as a presidential candidate, suggested the United States look into collaborating on the project. While the two countries continued desultory discussions of the Bering Strait plan into the 1970s, the American government was by then losing interest in the whole field of weather modification.

Similarly, the American Institute of Physics notes:

Around 1956, Soviet engineers began to speculate that they might be able to throw a dam across the Bering Strait and pump water from the Arctic Ocean into the Pacific. This would draw warm water up from the Atlantic. Their aim was to eliminate the ice pack, make the Arctic Ocean navigable, and warm up Siberia. The idea attracted some notice in the United States — presidential candidate John F. Kennedy remarked that the idea was worth exploring as a joint project with the Soviets, and the discussion continued into the 1970s.

Soot is a major cause of ice warming and melting in the Arctic and in the Himalayas.  As NASA’s Goddard Institute for Space Studies has shown, soot in the upper atmosphere ends up on the surface of ice sheets and glaciers, such as Arctic ice cap:

South Asia is estimated to have the largest industrial soot emissions in the world, and the meteorology in that region readily sweeps pollution into the upper atmosphere where it is easily transported to the North Pole.

If scientists had convinced policy-makers to pour soot over the Arctic ice cap in the 1970s, we might have had real problems. Damning the Bering Strait would have been disastrous.

First, Do No Harm

I have previously pointed out numerous decisions regarding the environment which have caused more harm than good, such as the government forcing a switch from one type of chemical to a chemical which turned out to be 4,470 times more potent as a greenhouse gas than carbon dioxide.

Here’s another one. The mongoose was introduced to Hawaii in order to control the rats (which were eating the sugar cane used to make rum). It didn’t work out very well – mongeese are daylight-loving creatures while rats are nocturnal – and the mongeese trashed the native species in Hawaii.

My whole point is that we should make sure that our actions do not cause more harm than good.  And see this.

High Rates of Mental Illness Actually Based on Sham Science?

The real purpose behind many of these statistics is to change our attitudes and political positions.

About one in five American adults (18.6%) has a mental illness in any given year, according to recent statistics from the National Institute of Mental Health. This statistic has been widely reported with alarm and concern. It’s been used to back up demands for more mental health screening in schools, more legislation to forcibly treat the unwilling, more workplace psychiatric interventions, and more funding for the mental health system. And of course, personally, whenever we or someone we know is having an emotional or psychological problem, we now wonder, is it a mental illness requiring treatment? If one in five of us have one….

But what NIMH quietly made disappear from its website is the fact that this number actually represented a dramatic drop. “An estimated 26.2 percent of Americans ages 18 and older — about one in four adults — suffer from a diagnosable mental disorder in a given year,” the NIMH website can still be found to say in Archive.org’s Wayback Machine. Way back, that is, in 2013.

A reduction in the prevalence of an illness by eight percent of America’s population—25 million fewer victims in one year—is extremely significant. So isn’t that the real story? And isn’t it also important that India recently reported that mental illnesses affect 6.5% of its population, a mere one-third the US rate?

Pharmaceutical companies fund the tests

First, that 18.6% is comprised of a smaller group who have “serious” mental illness and are functionally impaired (4.1%), and a much larger group who are “mildly to moderately” mentally ill and not functionally impaired by it­. Already, we have to wonder how significant a lot of these “mental illnesses” are, if they don’t at all impair someone’s functioning.

NIMH also doesn’t say how long these illnesses last. We only know that, sometime in the year, 18.6% of us met criteria for a mental illness of some duration. But if some depressions or anxieties ­last only a week or month, then it’s possible that at any time as few as 1-2% of the population are mentally ill. That’s a much less eye-popping number that, critics like Australian psychiatrist Jon Jureidini argue, is more accurate.

But even that number may be overblown. That’s because these national-level statistics come from surveys of the general population using mental health screening questionnaires that produce extremely high “false positive” rates.

Virtually all of the screening tools have been designed by people, institutions or companies that profit from providing mental health treatments. The Kutcher Adolescent Depression Scale, for example, will “find” mental illnesses wrongly about seven times as often as it finds them correctly. The screening tool’s author, psychiatrist Stan Kutcher, has taken money from over a dozen pharmaceutical companies. He also co-authored the massively influential study that promoted the antidepressant Paxil as safe and effective for depression in children – a study which, according to a $3 billion US Justice Department settlement with GlaxoSmithKlin­e, had actually secretly found that Paxil was ineffective and unsafe for children. ­Similarly, t­he widely used PHQ-9 and GAD-7 adult mental health questionnaires were created by the pharmaceutical company Pfizer.

This year’s NIMH numbers came from population surveys conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA) and National Survey on Drug Use, which included the Kessler-6 screening tool as a central component — the author of which, Ronald C. Kessler, has received funding from numerous pharmaceutical companies. How misleading is the Kessler-6? It has just six questions. “During the past 30 days, about how often did you feel: 1) nervous, 2) worthless, 3) hopeless, 4) restless or fidgety, 5) that nothing could cheer you up, or 6) that everything was an effort?” For each, responses range from “none of the time” to “all of the time.” If you answer that for “some of the time” over the past month you felt five of those six emotions, then that’s typically enough for a score of 15 and a diagnosis of mild to moderate mental illness. That may sound like the Kessler-6 is a fast way to diagnose as “mentally ill” a lot of ordinary people who are really just occasionally restless, nervous, despairing about the state of the world, and somewhat loose in how they define “some of the time” in a phone survey.

And indeed, that’s exactly what it is.

How 80% accuracy leads to 20 times as much mental illness

Under optimal conditions, the best mental health screening tools like the Kessler-6 have sometimes been rated at a sensitivity of 90% and specificity of 80%. Sensitivity is the rate at which people who have a disease are correctly identified as ill. Specificity is the rate at which people who don’t have a disease are correctly identified as disease-free. Many people assume 90% sensitivity and 80% specificity mean that a test will be wrong around 10-20% of the time. But the accuracy depends on the prevalence of the illness being screened for. So for example if you’re trying to find a few needles in a big haystack, and you can distinguish needles from hay with 90% accuracy, how many stalks of hay will you wrongly identify as needles?

The answer is: A lot of hay. With a 10% prevalence rate of mental illnesses among 1,000 people, any online screening tool calculator can be used to help show that of the 100 who are mentally ill, we will identify 90 of them. Not too bad. However, at 80% specificity, of the 900 who are well, 180 will be wrongly identified as mentally ill. Ultimately, then, our test will determine that 270 people out of 1,000 are mentally ill, nearly tripling the mental illness rates we started with to 27%. And if mental illnesses are less prevalent, the performance of the test is mathematically worse: ­When only 10 in 1,000 are mentally ill, our test will determine that over twenty times that many are.

Mental illness diagnosing is a scientific bottomless pit

This is a common problem with most medical screening tests. They are typically calibrated to miss as few ill people as possible, but consequently they also then scoop up a lot of healthy people who become anxious or ­depressed while getting subjected to lots of increasingly invasive follow-up tests or unnecessary, dangerous treatments. That’s why even comparably much more reliable tests like mammography, cholesterol measuring, annual “physicals,” and many other screening programs are coming under increasing criticism.

The designers of mental health screening tools acknowledge all this in the scientific literature, if not often openly to the general public. As explained deep in their report, SAMHSA tried to compensate for the Kessler-6’s false positive rates; however, the main method they used was to give a sub-sample of their participa­nts a Standard Clinical Interview for DSM Disorders (SCID).

SCID is the “gold standard” for diagnosing mental illnesses in accordance with the Diagnostic and Statistical Manual of Mental Disorders, SAMHSA stated. In fact, SCID simply employs a much larger number of highly subjective questions designed to divide people into more specific diagnoses. For example, the SCID asks if there’s ever been “anything that you have been afraid to do or felt uncomfortable doing in front of other people, like speaking, eating, or writing.” Answering “yes” puts you on a fast path to having anxiety disorder with social phobia. Have you ever felt “like checking something several times to make sure that you’d done it right?” You’re on your way to an obsessive compulsive disorder diagnosis.

That’s why SCID actually isn’t any more reliable than the Kessler-6, according to Ronald Kessler. He should know; Harvard University’s Kessler is author of the Kessler-6 and co-author of the World Health Organization’s popular screening survey, the World Mental Health Composite International Diagnostic Interview (WMH-CIDI). In their scientific report on the development of the WMH-CIDI, Kessler’s team explained that they simply abandoned the whole idea of trying to create a mental health screening tool that was “valid” or “accurate.”

The underlying problem, they wrote, is that, unlike with cancer, there’s no scientific way to definitively determine the absence of any mental illnesses and thereby verify the accuracy of a screening tool. “As no clinical gold standard assessment is available,” Kessler et al wrote, “we adopted the goal of calibration rather than validation; that is, we asked whether WMH-CIDI diagnoses are ‘consistent’ with diagnoses based on a state-of-the-art clinical research diagnostic interview [the SCID], rather than whether they are ‘correct’.” Essentially, creating an impression of scientific consensus between common screening and diagnostic tools was considered to be more important than achieving scientific accuracy with any one of them.

And where that “consensus” lies has shifted over time. Until the 1950s, it wasn’t uncommon to see studies finding that up to 80% of Americans were mentally ill. Throughout the ’90s, NIMH routinely assessed that 10% of Americans were mildly to seriously mentally ill. In 2000, the US Surgeon General’s report declared that the number was 20%, and the NIMH that year doubled its reported prevalence rates, too. In recent years, NIMH was steadily pushing its rate up to a high of 26.2%, but changed it several months ago to 18.6% to match the latest SAMHSA rate.

Suicide and mental illness and other influential sham statistics

Yet as a society we don’t seem to care that there’s a scientific bottomless pit at the heart of all mental illness statistics and diagnosing. One example which highlights how ridiculously overblown and yet influential such epidemiological statistics have become is the claim that, “Over 90% of people who commit suicide are mentally ill.” This number is frequently pumped by the National Alliance on Mental Illness, American Foundation for Suicide Prevention, American Psychiatric Association, and the National Institute of Mental Health, and it has dominated public policy discussions about suicide prevention for years.

The statistic comes from “psychological autopsy” studies. Psychological autopies involve getting friends or relatives of people who committed suicide to complete common mental health screening questionnaireson behalf of the dead people.

As researchers in the journal Death Studies in 2012 exhaustively detailed, psychological autopsies are even less reliable than mental health screening tests administered under normal conditions. Researchers doing psychological autopsies typically don’t factor in false positive rates. They don’t account for the fact that the questions about someone’s feelings and thoughts in the weeks leading up to suicide couldn’t possibly be reliably answered by someone else, and they ignore the extreme biases that would certainly exist in such answers coming from grieving friends and family. Finally, the studies often include suicidal thinking as itself a heavily weighted sign of mental illness—making these studies’ conclusions rarely more than tautology: “Suicidal thinking is a strong sign of mental illness, therefore people who committed suicide have a strong likelihood of having been mentally ill.”

Unfortunately, there is immense political significance to framing suicidal feelings and other psychological challenges this way, if not any substantive scientific significance. These alleged high rates of mental illness are becoming increasingly influential when we discuss policy questions with respect to issues as diverse as prison populations, troubled kids, pregnant and postpartum women, the homeless, gun violence, and the supposed vast numbers of untreated mentally ill. They draw attention, funding and resources into mental health services and treatments at the expense of many other, arguably more important factors in people’s overall psychological wellness that we could be working on, such as poverty, social services, fragmented communities, and declining opportunities for involvement with nature, the arts, or self-actualizing work. At the individual level, we all become more inclined to suspect we might need a therapist or pill for our troubles, where before we might have organized with others for political change.

And that reveals what the real purpose behind many of these statistics is: To change our attitudes and political positions. They are public relations efforts coming from extremely biased sources.

The politics of “mental illness”

Why is 18.6% the going rate of mental illnesses in America? SAMHSA’s report takes many pages to explain all the adjustments they made to arrive at the numbers they did. However, it’s easy to imagine why they’d avoid going much higher or lower. If SAMHSA scored 90% of us as mentally ill, how seriously would we take them? Conversely, imagine if they went with a cut-off score that determined only 0.3% were mentally ill, while the rest of us were just sometimes really, really upset. How would that affect public narratives on America’s mental health “crisis” and debates about the importance of expanding mental health programs?

However well-meaning, the professional mental health sector develops such statistics to create public concern and support for their positions, to steer people towards their services, and to coax money out of public coffers. These statistics are bluffs in a national game of political poker. The major players are always pushing the rates as high as possible, while being careful not to push them so high that others skeptically demand to see the cards they’re holding. This year, 18.6% is the bet.

The Pharma Drug That Is Bankrupting America

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How can Gilead Sciences charge $84,000 for a drug that costs less than $300 to produce?

America is the land of breakthrough science — and health care scams. The two seem to go hand in hand in the case of the new hepatitis C virus (HCV) cure named sofosbuvir, sold under the brand name Sovaldi by the drug company Gilead Sciences. There is no question that Solvadi is a godsend — a lifesaver for millions of Americans, and perhaps someday for hundreds of millions of people around the world infected by Hepatitis C. Yet Sovaldi is also the poster child of a U.S. health care system that is being bankrupted by greed, lobbying and indefensible policies on drug pricing.

The basic facts are these. In December 2013, the Food and Drug Administration approved Sovaldi, and another formulation, Harvoni, which is sofosbuvir used in combination with another drug. Gilead set the price for a 12-week treatment course of Sovaldi at $84,000, amounting to $1,000 per pill. Gilead set the price of Harvoni at $94,000.

According to researchers at Liverpool University, the actual production costs of Sovaldi for the 12-week course is in the range $68-$136. Indeed, generic sofosbuvir is currently being marketed in India at $300 per treatment course, after India refused to grant Gilead a patent for the Indian market. In other words, the U.S. price-cost markup is roughly 1,000-to-1!

How can Gilead Sciences charge $84,000 for a drug that costs less than $300 to produce? First, Gilead’s patent on sofosbuvir runs until 2028, giving it a monopoly in the U.S. market. Second, a range of Federal and state government programs will cover the $84,000 for a sizeable number of patients. For those not covered by government programs, some will be covered by private insurance, a few will pay out of pocket, and still others will likely die because they lack coverage and can’t afford the treatment.

In the first year of marketing, Sovaldi and Harvoni are already blockbusters, reaping a remarkable $12.4 billion of market sales in 2014, more in just one year than the $11.2 billion price that Gilead paid in January 2012 to buy sofosbuvir from a biotech start-up named Pharmasett.

The standard defense by the drug companies of these astronomical prices is that drug discovery is costly and their high profits reimburse the R&D costs. Here is where the story of Sovaldi gets even more interesting. The total private-sector outlays on R&D were perhaps $300 million, and almost surely under $500 million, meaning that the decade-long R&D outlays were likely recouped in a few weeks of drug sales.

Here is the background. Sofosbuvir was developed under the leadership of Prof. Raymond Schinazi, a brilliant professor of biochemistry at Emory University. The U.S. Government heavily funded Prof. Schinazi’s research, with major grants from the National Institutes of Health (NIH) and support from the Veterans Administration. Like many academic researchers, Schinazi has frequently parlayed his government grants into private companies to market his discoveries. He set up Pharmasset Inc. as a Delaware corporation in 2004 as his business to develop sofosbuvir and hold the patents on the new prospective drug.

Pharmasset raised around $45 million in a 2007 IPO and used those funds and others to supplement the R&D. According to the company’s SEC filings, the total Pharmasset R&D on sofosbuvir up through 2011 totaled around $62.4 million. In January 2012, with an eye on sofosbuvir, Gilead paid $11.2 billion to purchase Pharmasett. Schinazi pocketed an estimated $440 million for his shares in Pharmasett.

By the fall of 2011, sofosbuvir was ready for Phase 2 clinical trials, which were carried out between October 2011 and April 2012 by the NIH, which published the results in the Journal of the American Medical Association in 2013. Phase 3 trials were then carried out in mid-2013 and were paid by Gilead, at a cost of perhaps $50-$100 million for a two-month trial that covered around one thousand patients. (Gilead has not disclosed the exact costs of the Phase 3 trials).

We can therefore estimate that private investors spent perhaps $300 million in R&D outlays for sofosbuvir over the course of a decade, and perhaps well below that sum. Those R&D outlays were likely recouped in a few weeks of sales in 2014.

With a rational U.S. drug pricing system, private investors would expect to earn a reasonable multiple of their R&D for a highly successful drug, perhaps even 5 to 10 times the R&D outlays, in order to reflect the long time horizons and high uncertainties surrounding drug development. Yet at a treatment course of $84,000, the multiple for Sovaldi looks to be around 40 times or more.

With a rational drug pricing system, Gilead might have paid $1 billion rather than $11.2 billion for the drug, and Prof. Schinazi might have pocketed $40 million rather than $440 million. Sovaldi would most likely still have been developed and brought to market on the same timeline, but with taxpayers spared of perhaps $10 billion a year in outlays.

Gilead has worked the political system to protect its windfall by ramping up its lobbying activities. That soared to $2.2 million in 2013, the year of FDA approval, and $2.9 million in 2014, the first year of sales. The lobbying helped to smooth the way to the massive uptake of the drug and the substantial financing by the U.S. Government of Gilead’s inflated prices.

Sovaldi therefore represents the best and the worst of the U.S. health system. It represents the best of U.S. produced science, and the government’s support for it. Sofosbuvir is a remarkable, life-saving medicine at the cutting edge of science.

Yet Sovaldi also shows how publicly financed science easily turns into arbitrarily large private profits paid for by taxpayers. The challenge facing the U.S. is to adopt a rational drug pricing system that continues to spur excellent scientific breakthroughs while keeping greed in check. Big Pharma and the U.S. public are on a collision course when they should be partners for the advancement of health.

Jeffrey D. Sachs is a world-renowned professor of economics, leader in sustainable development, senior U.N. advisor, bestselling author, and syndicated columnist whose monthly newspaper columns appear in more than 100 countries. He has twice been named among Time Magazine’s 100 most influential world leaders. Professor Sachs serves as the Director of The Earth Institute, Quetelet Professor of Sustainable Development, and Professor of Health Policy and Management at Columbia University. Sachs has authored three New York Times bestsellers in the past seven years, including “The End of Poverty.” A native of Detroit, Michigan, Sachs received his B.A., M.A., and Ph.D. degrees at Harvard