The Revolving Doors at the FDA has always been a serious subject, but in the past two years, it has gone from serious to catastrophic. How many people will suffer and die in 2019 as a result of the failed regulatory processes in the very agencies that were created to protect the American public? This ghastly imbroglio affects every single American plus other nations who still believe FDA is "so stringent"! What a cruel joke.

::::::::

The very vast subject of the Revolving Doors at the regulatory agencies, particularly the FDA, has always been a serious one, but in the past two years, it has gone from serious to catastrophic. How many people, indeed, will pass away in 2019 as a result of the failed regulatory processes in the agencies, particularly the FDA, the very agencies that were created to protect the American public?

Don't kid yourself: this ghastly imbroglio at the FDA affects every single living American, and much of the rest of the world to boot, at least those nations laboring under the premise that the United States FDA is the most stringent of them all....what a joke~

I will set aside considerations for the moment of the Environmental Protection Agency and the Centers for Disease Control. Stories about abusive manipulations pop up all of the time pertaining to them as well, but such would be the subject for a small book, and not for a precursory article that would lay the groundwork for future discussions among the few who actually care about such things.

This article is just as much about the varying coverages in the journalistic world, ranging from brilliant and accurate coverage to mere puff pieces by corporate hacks trying to please their sponsors. I have included less of the latter in this compilation.

On a far more optimistic note, please also see my recent article:

Monsanto's subpoena on Avaaz is Quashed by Manhattan Judge! by Avaaz's Ricken Patel

click here

Of all of the most visible officials going in and out of the revolving doors within the corporate world and within the regulatory world, none jumps out at me more than the example of Michael R. Taylor.

Who is Michael Taylor? Summarized from Wikipedia's very thorough and candid article on him:

After receiving his B.A. degree in political science from Davidson College and a law degree from the University of Virginia, Taylor passed the bar, and became a staff attorney at the FDA, in 1976, where he was executive assistant to the FDA Commissioner. He was in office in 1981 when Donald Rumsfeld forced through the FDA the approval for Aspartame, one of the dirtiest chapters in the long history of dirty deals at the FDA.

Taylor then worked in private law practice at King & Spalding in Atlanta from 1981 - 1991, one of whose clients was the biotechnology company Monsanto. He established and led the firm's food and drug law practice.

In 1988, he published an article entitled "The De Minimis Interpretation of the Delaney Clause: Legal and Policy Rationale" in the International Journal of Toxicology, which he had presented earlier in December 1986 at a symposium sponsored by International Life Sciences Institute Risk Science Institute, Society for Risk Analysis.

That particular paper was published during the midst of a debate and litigation over federal agencies' interpretation of the Delaney clause, a part of a 1958 federal law that prohibits any carcinogenic chemical from being added in any amount to processed food As analytical instrumentation increased in power and more agents were found to be carcinogenic even at very low levels, the agencies had developed a quantitative risk assessment approach to interpreting the Delaney Clause, which stated that if a carcinogen was present at levels less than 1 in 1,000,000 parts (1ppm), the risk of that carcinogen was "de minimis", and it could be allowed on the market, with absolutely no input or interference from the legislative branch.

In his article, Taylor presented arguments in favor of this approach. Advocates in favor of organic food have criticized Taylor for taking this stance while attributing the stance not to a good faith effort to reasonably regulate, but to an alleged (but very clear cut and obvious) desire to financially benefit Monsanto, which was at that point the #1 manufacturer of aspartame, among other poisons.

On July 17, 1991, Michael Taylor left King & Spalding for the FDA, accepting the newly created post of 'Deputy Commissioner for Policy.'

In 1992, he signed a guidance that milk from cows treated with Bovine Growth Hormone was not required to be labeled. His name is not on the FDA's May 1992 guidance on genetically modified plant foods, but he probably was a co-author.

Both documents are part of a regulatory framework developed since the 1980s under the Reagan and Bush Administrations to ensure the public's safety and development of the fledgling biotechnology industry "without overly burdensome regulation."

This "guidance" had three tenets:

"(1) U.S. policy would focus on the product of GM techniques, not the process itself,

(2) Only regulation grounded in verifiable scientific risks would be tolerated,

(3) GM products are on a continuum with existing products and, therefore, existing statutes are sufficient to review the products."

These tenets were initially presented in the 'Coordinated Framework for Regulation of Biotechnology', published by the President's Domestic Policy Council Working Group on Biotechnology through the Office of Science and Technology Policy in 1986.

The 1992 guidance treats "transferred genetic material and the intended expression product or products" in food derived from GM crops as food additives subject to existing food additive regulation, under which that material may be considered either generally recognized as safe (GRAS) or not GRAS, initially at the producer's determination.

If the food additive is not GRAS, the producer is required to submit data proving that the food additive does not "adulterate" the food - in other words, that the additive is not injurious to health.

With respect to GM food, the FDA retained its ability to take enforcement action any food it found to be "adulterated", which would make its producer "subject to the full range of enforcement measures under the act, including seizure, injunction, and criminal prosecution of those who fail to meet their statutory duty."

United States Department of Agriculture, 1994-1996

Between 1994 and 1996 Taylor moved to the United States Department of Agriculture (USDA), where he was Administrator of the Food Safety & Inspection Service. During that term he implemented a so-called "science-based approach" called Hazard analysis and critical control points (HACCP) to raising safety standards for meat and poultry production over the protests from industry, which food safety advocates have called "a truly heroic accomplishment".

In February, 1994 anti-biotechnology activist Jeremy Rifkin charged that Taylor had a conflict of interest with respect to the approval of rBST (recombinant Bovine somatotropin). The FDA replied that Taylor had recused himself from all but the final stages of the review.

The Washington Post reported that: "On March 15, FDA Commissioner David A. Kessler sent Rifkin a four-page letter stating that 'none of the activities of Mr. Taylor cited in your petition were in violation of any applicable law or regulation, or were otherwise inappropriate.... I believe that Mr. Taylor's behavior adhered to all applicable ethical standards.'

Kessler said that Taylor had not been 'intimately' involved in Monsanto's efforts to obtain approval, as Rifkin charged, and that he was involved in the FDA's bST policy only in the final stages of review. Kessler attached a nine-page memo by FDA ethics official Jack M. Kress supporting that position. Upon arriving at the FDA in the summer of 1991, Taylor recused himself for one year from taking part in any agency action dealing directly with Monsanto or any other King and Spalding clients."

It reported that "Some longtime agency critics found the charges against Taylor misplaced, like Sidney Wolfe, a physician who heads the Public Citizen Health Research Group and has filed complaints with the FDA about revolving-door ethics issues concerning other officials."

Monsanto, 1996 - 2000

Between 1996 and 2000, after briefly returning to King & Spalding, Taylor worked for Monsanto as a Vice President for Public Policy.

In 1999, a lawsuit (Alliance For Bio-Integrity v. Shalala, and a GAO report, as well, revealed considerable disagreement within the FDA concerning decisions about biotechnology products made during Taylor's tenure. The lawsuit and report also said that Taylor had recused himself from matters related to Monsanto's BGH and had "never sought to influence the thrust or content" of the agency's policies on Monsanto's products. (I don't believe any of those sanguine conclusions, not for two seconds!)

Center for Risk Management, 2000 - 2009

In June 2000, he joined the think tank Resources for the Future (RFF) in the position of Senior Fellow and Director of RFF's Center for Risk Management, where he published two documents on U.S. aid for African agriculture, both of which were funded by the Rockefeller Foundation.

During this time he was also a Director at 'Resolve', a nonprofit environmental and public health mediation and dispute resolution organization, and was an adjunct professor of law at Georgetown University Law Center.

During this time, Taylor made strong arguments for a more rigorous and unified approach to food safety, in which he argued for: "A single agency accountable for providing consistent and coordinated oversight of food safety, from farm to table. Institution of Pathogen Reduction: HACCP, with performance standards verified by pathogen testing, at every step of food production. Recall authority, access to records, and penalties for lapses in safety procedures. Standards for imported foods equivalent to those for domestic foods. Food safety to take precedence over commercial considerations in trade disputes."

Taylor has been a professor at the University of Maryland's School of Medicine. In 2007 he became a Research Professor of Health Policy at the George Washington University School of Public Health and Health Services.

FDA, 2009 - 2016

On July 7, 2009, Taylor returned to government as Senior Advisor to the FDA Commissioner. On January 13, 2010, at the order of President Obama, he was appointed to another newly created post at the FDA, Deputy Commissioner for Foods. On March 8, 2016, Taylor notified friends and colleagues that he would be departing the FDA as of June 1, 2016.

Other than an occasional appearance on news programs and a few speeches here and there, Taylor seems to have dropped out of official and unofficial view.

One relevant and notable quote from his speech at the Tokyo Global Food Safety Initiative, where he applauded the GFSI's ability to provide a stepping stone for emerging businesses like these to succeed. "This is a time for optimism, a remarkable time for food safety around the world. Private responsibility can't take the place of public oversight, and no amount of regulation can make food safe without the private sector taking responsibility."

>>>>>>>>>>>>

What is the Delaney Amendment? Food Additives Amendment, 1958; quoting from Amendment's text:

"An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety."

Signed into law by President Dwight Eisenhower on September 6, 1958

From Wikipedia:

The Food Additives Amendment of 1958 is a 1958 amendment to the United States' Food, Drugs, and Cosmetic Act of 1938. It was a response to concerns about the safety of new food additives. The amendment established an exemption from the "food additive" definition and requirements for substances "generally recognized as safe" by scientific experts in the field, based on long history of use before 1958 or based on scientific studies. New food additives would be subject to testing including by the "Delaney clause". The Delaney clause was a provision in the amendment which said that if a substance were found to cause cancer in man or animal, then it could not be used as a food additive.

More currently, from the now deceased Internist H.J. Roberts:

"Unfortunately, the Delaney clause was emasculated by the Senate's Comprehensive Regulatory Reform Act of July 19, l995. Without defining the terms "negligible" or "insignificant," it stated that a substance or product shall not be prohibited or refused approval when it "presents a negligible or insignificant foreseeable risk to human health."

Consumer Protection Attorney, Jim Turner:

"The National Food Processors Association, the scientific voice of the food industry, supports science-based FDA reform to permit companies to seek approval of food additives through qualified third-parties; TO REFORM THE DELANEY CLAUSE OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT; to improve the process for approval of health claims on food labels; and to establish national uniformity for food laws. While some of this can be done by the agency --such as the FDA's positive response to NFPA's petition on health claim and nutrient content claim policy -- the agency lacks authority to make a number of the reforms supported by the food industry. Therefore, FDA reform legislation is necessary. FDA reform bills, supported by NFPA and the food industry, are being considered by both the U.S. Senate and the House of Representatives."

>>>>>>>>>>>>>>>>>>>>>>>>>>.

Jim Turner, 2006:

"Aspartame/NutraSweet cripples the lives of thousands of people. When I tried to persuade the President of the Searle Drug company, manufactures of that chemical sweetener, to do the tests that would find any dangers it posed before It was marketed he blew me off. His name was Donald Rumsfeld (Iraq war architect). In exchanges about aspartame safety with him and his company, I learned how little he values human life."

>>>>>>>>>>>>>>>>

Jim Turner, 2005:

Delaney covers cancer in both man and animals. The Delaney clause in the Federal Food, Drug, and Cosmetic Act (FFDCA) provides that no additive including pesticides may be approved in processed food if it has been found to induce cancer in man or animals. EPA regulates pesticide residues in food under FFDCA and has interpreted the Delaney clause as subject to an exception for carcinogenic pesticides that pose only a negligible risk. This interpretation was adopted in 1988 upon the recommendation of the National Academy of Sciences.

>>>>>>>>>>>>>>>>>

Summarized rom a superb article in Farm Land Birds by Hunter Lewis:

click here

Monsanto's Friends in High Places - The remarkable revolving door career of Michael Taylor at the FDA and Monsanto

Many corporations send an employee into a government agency to influence regulation.

How much better if the employee can actually shape government regulation to promote and sell a specific product! Monsanto seems to have accomplished this -- and much more. Michael Taylor is among a number of people with Monsanto ties who have worked in government in recent years. He worked for the Reagan Food and Drug Administration in the 1970s, then became a lawyer representing Monsanto. In 1991, he returned to the FDA as Deputy Commissioner for Policy under George H. W. Bush, and helped secure approval for Monsanto's genetically engineered bovine (cow) growth hormone, despite it being banned in Canada, Europe, Japan, Australia, and New Zealand.

This was only a start for Taylor. He really did not like some producers advertising their milk as bovine-growth-hormone-free, thus putting Monsanto's product in an unfavorable light. Thus, in 1994 he wrote a guidance document from within the FDA requiring that any food label describing the product as bovine-growth-hormone-free must also include these words: "The FDA has determined ... no significant difference has been shown between milk derived from [BGH] and non-[BGH] supplemented cows." It did not bother Taylor one whit that this new pronouncement by the FDA was unsupported by either Monsanto or FDA studies. A private company making any such unsupported claim could have been charged with fraud. But because it came out of the FDA, milk producers would place themselves at legal risk by not printing it on their label.

Taylor then moved to the US Department of Agriculture in the mid-1990s, and he attempted to persuade the FDA and Federal Trade Commission to take a further step and make it illegal for dairies to make any claim to a bovine-growth-hormone-free product. This failed, so he reached out to state governments to make such a claim illegal at the state level. This was finally blocked by a court decision in Ohio that there was indeed a "compositional difference" between BGH and non-BGH-treated milk.

However, long before that 2010 ruling, Taylor had returned to Monsanto as a vice president, and then returned to President Obama's FDA, first as Senior Advisor on Food Safety and then Deputy Commissioner for Foods.

Taylor's story, however, is not just about milk, or even mainly about milk. During his second posting at the FDA, as Deputy Commissioner for Policy 1991--1994, Agency scientists were grappling with questions about the overall safety of genetically engineered foods (often labeled Genetically Modified Organisms). As Jeffrey Smith notes,

[Internal] memo after memo described toxins, new diseases, nutritional deficiencies, and hard to detect allergens. [Staff scientists] were adamant that the technology carried "serious health hazards," and required careful, long-term research, including human studies.

The Agency, under Taylor's and later under others' leadership, simply ignored these findings. No human studies were required. GMO foods were allowed to enter the food supply unregulated by the FDA and barely regulated by the USDA, which views them as an important US export product. By 2012, in the US, 90 percent of sugar beets (representing half of overall sugar production) was GMO, 85 percent of soybeans (which are to be found in 70 percent of all supermarket food products), and 85 percent of corn, including the corn used to make high fructose corn syrup, a sweetener used in most soft drinks and processed foods.

The few scientists trying to conduct independent research on GMO found their careers damaged. Most food research, conferences, and fellowships are funded by "Big Food" companies including Monsanto, with obviously a very negative and chilling effect. Even sympathetic colleagues may be reluctant to back those who dare speak out.

Those who persevered in conducting independent research, often abroad, reported worrisome findings. An Austrian study found that mice fed GMO corn seemed fine in the first and second generations, but by the third were sterile. A Russian study of hamsters fed GMO soybeans found a similar result.

Could human beings exhibit a similar, delayed response? No one knows. Another, unrelated study showed that the pesticide used in large quantities on engineered Roundup Ready crops is toxic to male testicle cells and threatens both testosterone synthesis and sperm count.

The FDA tries to remain as silent as possible about GMOs, while the US Department of Agriculture and other parts of the US government are doing everything they can to promote them. The USDA under both George W. Bush and Obama has sought to speed up the automatic rubberstamping for new GMO products, to "deregulate" them, and to provide immunity from lawsuits over the spread of GMO crops to adjoining organic farms. Immunity from lawsuit was quite ironic.

For decades, GMO producers had threatened, intimidated, sued, and in every imaginable way attempted to bully adjoining farmers. If any of the patented seeds drifted and were found on the neighboring farm, that farmer would be charged with "theft." The clear message: buy the patented seeds or face destruction through legal costs. Remarkably, courts were buying this specious argument. But finally the persecuted began to counter-sue successfully, at which point, the all-too-compliant USDA rushed to provide legal immunity to the GMO producers in the form of an insurance policy that organic farmers would have to buy; that would be their only available form of compensation.

Thus, our focus on the remarkable revolving door career of Michael Taylor at the FDA and Monsanto shows that it has potentially affected the future health of hundreds of millions of people; stories like his are not uncommon.

A Chicago Tribune article from 2012 is headlined: Chemical Firms Champion New EPA (Environmental Protection Agency) Expert. It describes how Todd Stedeford worked at the EPA from 2004--2007 under the George W. Bush administration, then joined chemical firm Albemarle Corp. While at Albemarle, which makes flame retardants, he defended chemicals used in many products and even suggested that the standard set by the EPA for flame retardants was 500 times too high. After returning to the EPA in 2011 under Obama, he was put "in charge of a ... program studying whether dozens of industrial chemicals, including flame retardants, are too dangerous." One must ask: what were the EPA and the President thinking when they made this appointment?

Bill Ruckelshaus, twice EPA head, once said that "at EPA you work for a cause that is beyond self-interest. ... You're not there for the money; you are there for something beyond yourself." However, after leaving the EPA, Ruckelshaus became a Monsanto director.

Meanwhile the Geneva-based Covalence group placed Monsanto dead last on a list of 581 global companies ranked by their reputation for ethics.

[Source: The Market Oracle, November 9, 2013 Author: Hunter Lewis

Hunter Lewis is cofounder of Against Crony Capitalism. He is the former CEO of Cambridge Associates and the author of six books. His most recent book is Where Keynes Went Wrong. He has served on boards and committees of 15 not-for-profit organizations, including environmental, teaching, research, and cultural organizations, as well as the World Bank.]

>>>>>>

Taylor's appointment by Obama incurred a lot of shock and dismay in those sections of the journalistic world who remain both conscious and cognizant:

You're Appointing Who? Please Obama, Say It's Not So! by Jeffrey Smith in a superb article in Huffington Post; I consider Jeffrey Smith to be THE BEST journalist in America writing about these matters!

[click here]

The person who may be responsible for more food-related illness and death than anyone in history has just been made the US food safety czar. When FDA scientists were asked to weigh in on what was to become the most radical and potentially dangerous change in our food supply -- the introduction of genetically modified (GM) foods --documents reveal that the experts were concerned. Memos described toxins, new diseases, nutritional deficiencies, and hard-to-detect allergens. They were adamant that the technology carried "serious health hazards," and required careful, long-term research, including human studies, before any genetically modified organisms could be safely released into the food supply.

But the biotech corporations had rigged the game so that neither science nor scientists would stand in their way. They had placed their own man (Michael Taylor) in charge of FDA policy and he wasn't going to be swayed by feeble arguments related to food safety. He was going to do what corporations had done for decades to get past these types of pesky concerns. He was going to lie.

When the FDA was constructing their GMO policy in 1991-2, their scientists were clear that gene-sliced foods were significantly different and could lead to "different risks" than conventional foods. However, no official policy declared the opposite, claiming that the FDA knew nothing of significant differences, and declared GMOs substantially equivalent.

This became the rationale for allowing GM foods on the market without any required safety studies! The determination of whether GM foods were safe to eat was placed in the hands of the companies that made them -- companies like Monsanto, which told us that the PCBs, DDT, and Agent Orange were safe.

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

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

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

Milk, Michael Taylor, and Human Disease

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

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

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

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

Will Monsanto's Wolff Also Guard the Chickens?

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

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

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

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

>>>>>>

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

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

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

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

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

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

"

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

"There are just so many checks and balances within the review process that it's really not up to one person by and large," said Sharfstein, now an associate dean at the Johns Hopkins Bloomberg School of Public Health in Baltimore. "Key regulatory decisions are looked at from many different angles. I think it would be very difficult for an individual to do something inappropriate and not have that caught. The revolving door is a fair topic to study, he said, but having former FDA officials on the pharmaceutical industry payroll can have a public health benefit. Former FDA employees with deep knowledge of the approval process can help make it go smoother by ensuring all the relevant research is complete and that the latest pathways to approval are understood.

FDA spokesman Jason Young said employees leave the government to work for industry at various agencies, not just the FDA. "The FDA has a strong set of rules in place to ensure that our employees are working in the public interest, not to advantage any company, organization or individual," he said, adding that these include protecting confidential information they learned at the FDA and a cooling-off requirement for senior officials before they can work for industry.

>>>>>>>>>>>>>>>>>>>

(In a kind of puff piece to please the corporations and perhaps the FDA, the author is Thomas Sullivan, President of Rockpointe Corporation, almost a gloss to cover up the research findings by Dr. Prasad and Dr. Bien?):

FDA "Revolving Door" Gets Slammed -- Policy & Medicine

click here

Several news outlets wrote recent articles about the "revolving door" at the United States Food and Drug Administration (FDA), stemming from a research letter published in the BMJ by Dr. Prasad and Dr. Bien. The bulk of the articles excoriated FDA employees who leave the FDA to go work for private companies in the pharmaceutical industry.

Prasad and Bien recognized that the "transition from regulator to advising companies seems logical, but it raises concern as to whether regulators indefatigably act in the public interest." The New York Times dubbed the revolving door kin to "appointing the fox to guard the henhouse" and asked for "Congress to enact conflict-of-interest laws forcing employees above a certain grade level at any agency to recuse themselves from official actions that affect a former employer or client, including trade associations and their members."

>>>>>>

Policy Med, in even more of a nonsensical apologist skewed logic corporate serving "analysis":

Is The Revolving Door Really That Bad? Aug 30, 2018 by Thomas Sullivan

While the revolving door may be a fair topic to study, having former FDA officials on the pharmaceutical industry payroll can have a true public health benefit. Former FDA employees with a deep working knowledge of the approval process can help make it go smoother by ensuring all relevant research is complete and that the latest pathways to approval are understood.

The FDA process can be Byzantine at times and having access to someone who previously worked at the FDA, now working in private practice to help guide applications can help avoid many serious errors in the application. Such expertise can lead to an early approval, saving considerable time and effort for both the companies and FDA by preventing submissions of product that have little chance of approval.

Similarly, why do football players become football coaches? Because they understand the game. The same holds true for scientists who worked at FDA as reviewers and now work for industry, they understand the game. The reason for this is the same for drug development as it is for football, if a company spends billions to develop a breakthrough therapy, the company may need some help understanding the nuances of the FDA submission process. This cuts both ways, first it helps companies with reasonably good therapies to get through the gauntlet of the FDA, second, it helps companies face reality, that perhaps their "drug" or "baby" may not be as good as they had lead themselves to believe. In either scenario, the usefulness of someone who has been on the other side of the table and understands their perspective is invaluable.

You can also look at district attorneys and their staff. More likely than not, if a study was done with respect to where they go after a few hours of working for the public, it would show that a vast majority end up working for legal defense firms, making several times their DA salary. Just because they switched from public to private, or from one side to the other, does not innately make them biased.

Andrew Powaleny, a spokesperson for the Pharmaceutical Research and Manufacturers of America (PhRMA), noted that "expertise in drug discovery, development and regulatory affairs gleaned from both government and the private sector experience can enhance shared knowledge. This knowledge can better inform scientific and medical research and enhance predictability for the benefit of patients."

>>>>>>>

Following is an important article and insight into which US Senators are willing to put their names on legislation as cosponsors, and not just the brief public relations soundbite you would see in the occasional confirmation hearing in the Senate. In addition to the bill sponsor, Tammy Baldwin of Wisconsin: They are Sens. Dianne Feinstein (Calif.), Kamala D. Harris (Calif.), Edward J. Markey (Mass.), Maggie Hassan (N.H.), Jeanne Shaheen (N.H.) and Tom Udall (N.M.)

Washington Post: Senators call for crackdown on pharmaceutical industry 'revolving door'

By Scott Higham and Lenny Bernstein November 2, 2017

click here

Seven Democratic U.S. senators introduced legislation designed to slow the "revolving door" between federal agencies such as the Drug Enforcement Administration and the pharmaceutical companies they regulate.

"The pharmaceutical industry has a deep-rooted and strong influence in Washington, and a revolving door between drug companies and government cannot undermine the safety of our communities. Patients, families and the public need to have trust that the DEA and FDA are working for them, not powerful Washington interests," Baldwin said.

"

The legislation would impose a two-year "cooling off" period on former officials from the DEA and the Food and Drug Administration, barring them from assisting pharmaceutical companies with lobbying efforts, as well as expands the definition of "lobbying contact" to include taking part in activities such as strategy sessions, and limits the issues pharmaceutical industry officials can handle if they join the federal government.

There are regulations designed to prevent potential conflicts of interest. The current restrictions include a lifetime ban on participating "personally and substantially" on a "particular matter" that the official had handled while working for the federal government. However, government ethics experts say some of those laws are easily skirted.

" "The bill could go further, but this is a nice step toward slowing the revolving door that is responsible for steering public policy in favor of the drug companies and distributors rather than in the favor of the public," said Scott Amey, general counsel for the Project on Government Oversight, a Washington watchdog group. The proposed legislation follows a joint Washington Post/"60 Minutes" investigation into the opioid industry and its influence in Washington. Companies that manufacture or distribute highly addictive pain pills have hired dozens of high-ranking officials from the DEA during the past decade, many of them from a division that regulates some of the same companies.

"

A decade ago, DEA investigators began to crack down on large drug companies they suspected of failing to report unusually large orders of painkillers, many of which were winding up in the hands of street dealers and users. Since then, drug companies and the law firms that represent them have hired at least 46 DEA officials -- 32 of them directly from the agency's division that regulates the industry.

One of those DEA officials left the agency and formed a law practice to represent opioid companies. He later helped to write a law that undercut the agency's enforcement efforts against large companies accused of violating federal drug laws, according to government documents and a legal analysis of the law by the DEA's chief administrative judge.

Baldwin said her proposed legislation would serve as a check on the power the pharmaceutical industry wields on Capitol Hill. She cited an investigation by the Associated Press and the Center for Public Integrity that found that the makers of prescription painkillers spent $880 million on campaign contributions and lobbying efforts between 2006 and 2015.

>>>>>>>>>>>>>>>>>>>>>>>>>

Regulatory Affairs Professionals Society is just down the same street from the FDA, and lo and behold, we find some strange arguments in this article by Zachary Brennan: FDA and Industry: How Dangerous is the Revolving Door?

click here

Earlier this week, a former deputy director of the US Food and Drug Administration's Office of Generic Drugs settled charges that he provided tips on drug approvals to three hedge fund managers that made tens of millions off the non-public information. The settlement raises some important questions on the so-called revolving door between industry and FDA, and what it means for patient safety. While the answers to those questions may never be fully answered, a recent flurry of employees moving between FDA and industry, as well as this latest settlement, have re-ignited the conversation around the connections between industry and the regulators that protect the public.

What many who complain about the coziness between industry and FDA do not realize is that both sides work together on a continual basis--from cooperating and offering advice on drug development plans to tracking adverse events to forging agreements on the various user fees that industry must pay to FDA for its services that ensure a structured review process for drugs and devices. In addition, FDA, which typically pays up to three times less than an industry salary, is struggling to fill more than 500 vacant positions and a lot of that needed expertise can come from within industry.

The uglier side of this revolving door can be seen in this week's settlement of Securities and Exchange Commission charges of insider trading against two hedge fund managers and their source, Gordon Johnston, who worked for a dozen years at FDA and later at the Generic Pharmaceutical Association. Johnston leaked approval information to two of the hedge fund managers, one of whom reaped unlawful profits of nearly $32 million. One of those hedge fund managers committed suicide in June and Johnston has pleaded guilty to multiple charges that carry possible prison terms and millions in fines.

>>>>>>>>>>>>>>>>>>>

(Leave it to the Canadians to arrive at serious and compelling facets of the truth about their next door neighbors, the larger overview". Not all Canadians are so naively accepting of the poisons and bad regulations in which we seem to wallow)

How Monsanto Invaded, Occupied and now CONTROLS Government Regulators

By Ethan A. Huff Global Research, July 12, 2016

[Ethan also writes for The Epoch Times and for Natural News] [Epoch Times is an independent, global news source, headquartered in New York, with a focus on uncensored China news, culture and science]

click here

If you've ever wondered why corporations seem to hold so much sway over our government, look no further than who's making all the decisions in Washington -- and more importantly, where many of these people worked before being handed comfy, high-level positions at top government agencies.

You might be surprised at the number of senior advisors, chiefs of staff, judges, commissioners and others employed at agencies like the Department of Justice, the Food and Drug Administration and the Environmental Protection Agency who all have one thing in common: they used to hold executive-level positions at multinational corporations like Monsanto, a revolving-door relationship between Monsanto and the federal government that dates back many decades. You'll probably recognize many of the names on the list, but chances are you had no idea these folks used to work for Monsanto or advocate for its interests before taking key positions of power on the taxpayer dime.

Both conservative and liberal politicians share history of affiliation with Monsanto. Donald Rumsfeld is one of the more prominent names that probably jumps out at you, as this former Secretary of Defense under both Gerald Ford and George W. Bush is remembered as one of the key Bush administration warmongers who helped propel forward the "War on Terror" following 9/11. Rumsfeld also was a former CEO for G.D. Searle, a pharmaceutical company that has since merged with Monsanto.

A prominent name on the list is Clarence Thomas, a U.S. Supreme Court justice who many conservatives respect for his supposedly far-right stances on most issues. Thomas is a former lawyer for Monsanto, who also cast the deciding vote to hand the contested 2000 election over to George W. Bush.

Michael Taylor, who recently resigned from his position as deputy commissioner of the FDA, is another former attorney for Monsanto who fought on behalf of the company's interests for seven years. Taylor also served as head of Monsanto's Washington, D.C., office, an obvious conflict of interest considering the FDA's job is to regulate the activities of corporations like Monsanto.

The very first Chief Administrator for the EPA, William D. Ruckelshaus, is another Monsanto hack who served on the company's Board of Directors. Ruckelshaus, who was appointed back in 1970, later went on to become the acting director of the Federal Bureau of Investigation (FBI), and even held the position of Deputy U.S. Attorney General.

Other key names include:

" Michael Kantor, a Monsanto lawyer and board member who served as campaign chair for the Clinton-Gore campaign in 1992, U.S. Trade Representative from 1993--1996, and U.S. Secretary of Commerce from 1996--1997.

" Margaret Miller, a top Monsanto scientist who oversaw getting the genetically-engineered growth hormone rBGH commercially approved despite a lack of evidence assuring its safety, and who in 1991 was appointed Deputy Director for the FDA.

" Islam Saddiqui, former vice president of CropLife America -- a Monsanto affiliate -- who was later appointed as Chief Agricultural Negotiator for the Office of the U.S. Trade Representative.

" Anne Veneman, a former board member for the Monsanto biotech subsidiary Calgene, who in 2001 was appointed as head of the U.S. Department of Agriculture.

" Rufus Yerxa, former Chief Counsel at Monsanto, who in 1993 was nominated as U.S. Deputy to the World Trade Organization.

" Richard J. Mahoney, former Monsanto CEO for 14 years, who served as Director of the U.S., Soviet, Japanese and Korean Trade Councils, as well as member of the U.S. Government Trade Policy Committee.

>>>>>>>>>>>>>>>>>>>

Another Canadian insight: Monsanto Controls Both the White House and the US Congress

click here

By Josh Sager Global Research, March 06, 2018

This article published one month before the November 2012 US presidential elections documents how Monsanto has cornered the US political system. Whoever gets in, Monsanto's interests will be served. Moreover, Monsanto also controls key appointments to the US Department of Agriculture (USDA) and the Food and Drug Administration (FDA)

In the 2012 presidential election, the American people chose between incumbent President Barack Obama (D) and Mitt Romney (R). With this choice, the American public determined who sets the tone for national policy and is given power over the executive branch of our government. There are many ways to look at candidates, but one is to look at their past actions and affiliations in order to predict how they will act in the future.

During Obama's four years as president, the federal government had several opportunities to pass legislation and executive initiatives which affect Monsanto. Of these federal initiatives, the 2010 African hunger plan and the 2012 Farm Bill present the most important examples of the Obama administration's friendly attitude towards Monsanto. In 2010, the Obama administration pushed a humanitarian initiative focused upon increasing the food supply of poor areas of Africa--while the ideals of this program are admirable, the execution presents an incredible opportunity to agro-business conglomerates like Monsanto. In order to solve the hunger problem in Africa, the Obama administration has partnered with large industrial farming and GMO operations, under the aegis that these organizations can produce large amounts of food quickly.

By giving several billion dollars to agro-businesses, one of which is Monsanto, the "Southern Africa FY 2010 Implementation Plan" intends to promote the expansion of these businesses into the provision of food for Africa. In focusing on promoting industrial, mono-crop farming and genetically modified goods rather than investing in local farms, the Obama administration created a situation where Monsanto is able to increase its profits. As a partner in the Obama administration's Africa program, Monsanto will be given subsidies to expand into the African farming market. This expansion is aimed at increasing food supplies in Africa, but it will have the unintended consequence of promoting Monsanto's takeover of the African food markets.

Once Monsanto gains a foothold in the African food market, they will crowd out local farmers and capture African food markets; Monsanto is able to supply more crops than any farmer and at a lower price, thus it will reduce the competitiveness of local farmers. Capturing the African food market by Monsanto means that more food will be available, but it will be supplied by Monsanto rather than small African farms and the local farmers of Africa will gradually begin to go out of business. Monsanto will crowd local African farmers out of the market and will make a profit that would be more beneficial in the hands of local African farmers.

Monsanto sees the Africa hunger plan as beneficial to its business, as Hugh Grant--the current Monsanto CEO--said this in response to the Africa initiative:

"I'm delighted to be here taking part in this conversation as I believe public and private sector commitment is necessary and able to support a transformation in African agriculture." The transformation that Grant envisions is one where large-scale industrial farming takes over from smaller, local farms, and provides mass-produced crops. In such a situation, hunger decreases, but it is multi-national corporations rather than local farmers which do this farming and garner most of the profits.

On the issue of GMO labeling, Obama was rhetorically supportive of mandating GMO products to be labeled, but his administration was silent on the issue. During the creation of the 2012 Farm Bill, there was a fight over mandating that genetically modified foods be labeled. Despite Obama's supposed support for such labeling, his administration was silent on the issue during this fight and, as a result, no mandate was passed. Currently, there is no federal regulation that ensures that all GMOs are labeled.

The "Farm Bill" includes several policy changes which are immensely advantageous to Monsanto. While this is an issue that primarily involves the Congress, rather than the Obama administration, the Obama Administration has been silent on the proposed policy changes. The Farm Bill was an immense boon to Monsanto, as it streamlined the approval process of its GMO crops and would limit the ability of the federal government to regulate its commerce to the Department of Agriculture.

Monsanto has control over a significant amount of the agro-business and genetically modified organism markets. Both the agricultural and GMO markets involve large public safety concerns, thus Monsanto is heavily affected upon federal regulations (or potential regulations) on its business--the largest of which come from the United States Department of Agriculture and the Food and Drug Administration. If regulations and labeling requirements are increased, Monsanto's profits are directly impacted; if such regulations are kept low, then corporations like Monsanto make a larger profit.

Due to the interest that Monsanto has in controlling regulation that affects its business, it has both donated to politicians and promoted the appointment of people who work for them to positions within the American government. Monsanto has been successful in keeping its regulatory burdens low and getting its representatives into positions within the US government. The infiltration of regulatory agencies by corporate actors that is referred to here is called the "regulatory revolving door". Individuals who work for industry go to work for the government, make public regulations, and then return to the private sector after leaving the public service.

While there are numerous points of overlap between Monsanto and the United States Government under the Obama administration, the three most important connections are that of Michael Taylor, Roger, Beachy, and Islam Siddiqui--all three of these Monsanto affiliates were appointed to high level positions within the government by the Obama administration.

The Obama administration appointed Michael Taylor, the previous vice president of Monsanto and a current Monsanto lobbyist, to a high level advisory role at the Food and Drug Administration [FDA]. It is virtually inarguable that this appointment constitutes a massive boon for Monsanto and an undeniable conflict of interest for Taylor. Given the fact that Taylor is a lobbyist for Monsanto and is being paid by the agro-giant, it is reasonable to assume that his advice to the FDA is focused upon helping his employer reduce its regulatory burden and improve its profitability.

Roger Beachy, the Director of the Danforth Plant Science Center (a Monsanto organization), was appointed by the Obama administration as the Director of the USDA's National Institute of Food and Agriculture. NIFA is a department of the USDA which focuses on funding research and innovation in the field of agriculture as well developing more efficient ways to produce food. As the major grant-writing division of the USDA, the NIFA department has the ability to grant or reject agricultural research grants. By giving Beachy the Directorship of the NIFA, the Obama administration gave a Monsanto associate the most powerful position in the organization which allocates agricultural research grants. This appointment is a great boon for Monsanto and bad news for any group which disagrees with the agri-business giant.

Islam Siddiqui, a Monsanto lobbyist, was appointed to the post of Agriculture Trade Representative by the Obama administration. Trade representative are tasked with promoting trade of goods within their appointed field (ex. Agricultural trade reps promote the export of American crops). As Monsanto has a controlling interest in American corn production, the appointment of a Monsanto lobbyist to the position of trade representative is a large boon for the corporation. Siddiqui's government job is to promote the export of American crops and his Monsanto job is to promote the sale of Monsanto crops--it is undeniable that these two jobs present a conflict of interest and will only lead to Siddiqui representing Monsanto's interests as though they are the interests of the United States.

Kagan and Monsanto

The justices that a president appoints to the Supreme Court is one of their most enduring and important contributions to the United States that every president gives the country. During his first term, President Obama appointed two Justices, one of whom was Elena Kagan, the former Solicitor General of the United States. During her time as the Solicitor General, Kagan filed a brief in support of Monsanto.

In 2007, Monsanto was brought to court by growers of alfalfa in California--these growers alleged that their crops were being cross-pollinated with, and thus contaminated by, Monsanto's GMO crops. After winning an initial legal victory and securing an injunction on Monsanto's planting of its modified alfalfa, Monsanto appealed the ruling and the case eventually reached the Supreme Court. Despite the fact that the United States government had no interest in the Monsanto alfalfa case, Kagan, the solicitor general wrote an "amicus" brief in favor of Monsanto's position.

Nobody knows why the Solicitor General's office decided to get involved in the Monsanto alfalfa case, but it was an unusual act by a supposedly neutral body; there was no rational reason for the US government to get involved in this case. While we don't know the reason for this brief, it does make many believe that Kagan may be sympathetic to Monsanto's corporate interests.

The Agricultural advisory Committee is staffed with numerous other agri-business supporters:

Chuck Connor -- The former leader of the Corn Refiners Association; this is the largest interest group for ethanol and corn syrup producers within the United States.

Bill Even -- The former head of the DuPont Chemical "high-tech seed" division, which manages DuPont's GMO seed business.

Chris Policinski -- The CEO of "Land O Lakes" and a party to the 2007 GMO alfalfa case in California.

Tom Nassif -- The leader of the Western Growers Association who has been the recipient of thousands of dollars in donations from the Monsanto Fund.

Tom Johanns -- A senator from Nebraska who has taken nearly $10,000 in campaign contributions from Monsanto and who advocated in favor of blocking GMO labeling during the early 2000s push by the EU to mandate disclosure.

Conclusion 2012 (How prescient these insights now seem in 2018!)

When all things have been considered, it is undeniable that Monsanto has significant influence over both major parties in the United States--the only real difference between the candidates is how deep this influence goes. Regardless of who becomes the next president, it appears that Monsanto will continue to have significant power in Washington politics and will retain extraordinary high levels of lobbying influence.

(Article changed on September 8, 2018 at 18:35)

Authors Website: https://www.facebook.com/groups/592985284186083/

Authors Bio:

Early in the 2016 Primary campaign, I started a Facebook group: Bernie Sanders: Advice and Strategies to Help Him Win! As the primary season advanced, we shifted the focus to advancing Bernie's legislation in the Senate, particularly the most critical one, to protect Oak Flat, sacred to the San Carlos Apaches, in the Tonto National Forest, from John McCain's efforts to privatize this national forest and turn it over to Rio Tinto Mining, an Australian mining company whose record by comparison makes Monsanto look like altar boys, to be developed as North America's largest copper mine. This is monstrous and despicable, and yet only Bernie's Save Oak Flat Act (S2242) stands in the way of this diabolical plan.

We added "2020" to the title.


I am an art gallery owner in Santa Fe since 1980 selling Native American painting and NM landscapes, specializing in modern Native Ledger Art.


I have always been intensely involved in politics, going back to the mid's 1970's, being a volunteer lobbyist in the US Senate for the Secretary General of the United Nations, then a "snowball-in-hell" campaign for US Senate in NM in the late 70's, and for the past 20 years have worked extensively to pressure the FDA to rescind its approval for aspartame, the neurotoxic artificial sweetener metabolized as formaldehyde. This may be becoming a reality to an extent in California, which, under Proposition 65, is considering requiring a mandatory Carcinogen label on all aspartame products, although all bureaucracies seem to stall under any kind of corporate pressure.


Bills to ban aspartame were in the State Senates of New Mexico and Hawaii, but were shut down by corporate lobbyists (particularly Monsanto lobbyists in Hawaii and Coca Cola lobbyists in New Mexico).


For several years, I was the editor of New Mexico Sun News, and my letters to the editor and op/eds in 2016 have appeared in NM, California, Wisconsin, New York, Maryland, the Christian Science Monitor, USA Today, and many international papers, on the subject of consumer protection. Our best issue was 10 days before Obama won in 2008, when we published a special early edition of the paper declaring that Obama Wins! This was the top story on CNN for many hours, way back then....


My highest accomplishments thus far are

1. a plan to create a UN Secretary General's Pandemic Board of Inquiry, a plan that is in the works and might be achieved even before the 75th UN General Assembly in September 2020.


2. Now history until the needs becomes clear to the powers who run the United Nations: a UN Resolution to create a new Undersecretary General for Nutrition and Consumer Protection, strongly supported ten years ago by India and 53 cosponsoring nations, but shut down by the US Mission to the UN in 2008. To read it, google UNITED NATIONS UNDERSECRETARY GENERAL FOR NUTRITION, please.


These are not easy battles, any of them, and they require a great deal of political and journalistic focus. OpEdNews is the perfect place for those who have a lot to say, so much that they exceed the limiting capacities of their local and regional newspapers. Trying to go beyond the regional papers seems to require some kind of "inside" credentials, as if you had to be in a club of corporate-accepted writers, and if not, you are "from somewhere else," a sad state of corporate induced xenophobia that should have no place in America in 2020!

This should be a goal for every author with something current to say: breaking through yet another glass ceiling, and get your say said in editorial pages all over America. Certainly, this was a tool that was essentially ignored in 2016, and cannot be ignored in the big elections of 2020.


In my capacity as Editor of the Santa Fe Sun News, Fox interviewed Mikhail Gorbachev: http://www.prlog.org/10064349-mikhail-gorbachev