Harriet Washington previously wrote Medical Apartheid where she reviewed the history of using African Americans for medical research going back to when slavery was still legal; she has followed this up with Deadly Monopolies which exposes how big pharmaceutical companies are finding more sophisticated ways to use people without their consent in the most extreme cases this leads to what she calls investigative servitude, which essentially means slavery for research purposes.
Both religion and our political system claim to reward good behavior and punish bad behavior; whether they call it ethics, as most scientists do or morality, as religions do. Religions have often accepted arbitrary morals like stoning people to death for working on the Sabbath is acceptable; and there is even one case where they did this, in the Book of Numbers, because someone was collecting sticks on the Sabbath.
In practice both religions and secular ethics, when controlled by a centralized authoritarian government routinely reward those in power, often at the expense of the innocent, or relatively innocent, sometimes after entrapping them, instead of rewarding good behavior. This often means that it is the guilty that pass judgement over the innocent. When it comes to research it is generally those with the least political power that get used as research subjects and those with the most that get all the benefit.
In a democracy this is supposed to be prevented but when those in power control the propaganda and the best research is only available to a few, it fails to do so, indicating that this country isn't nearly as democratic as it pretends to be.
In science ethics are supposed to stand up to peer review and it is hard to imaging that many religious sets of morality would do so; however Harriet Washington has shown that secular ethics can be corrupted just as easily when those with political power cater to powerful special interests. The original intent of patent laws was to reward innovation by giving inventors monopoly rights for a limited time to provide a financial incentive to develop new technology while enabling it to be shared after that patent was up so that society could benefit from competition and add new ideas to old.
This has never worked as well as it was planned; however it is becoming increasingly obvious that they're not even trying to make it work right. Unfortunately the best critical review of the current system isn't reported widely; however Harriet Washington and other academics that the majority of the public have demonstrated that the current system is often doing the opposite of what was intended!
She's demonstrated that the vast majority of the benefits from drug research goes to a small percentage of people with political connections and in at least a couple cases the innovators that they're supposed to protect have actually been charged with theft of the technology they helped develop by powerful institutions that control the patents.
Harriet Washington traces the decline of the legal system to the "Bayh-Dole Act," which was one of the laws that enabled private corporations to profit from research financed by the government as she describes in the following excerpt:
As a result, American technological innovation was stifled, according to Senator Birch Bayh, an Indiana Democrat, who complained that the vast majority of twenty-eight thousand patented discoveries made in universities with $30 billion dollars in taxpayers’ dollars were “lying there, collecting dust”: only 5 percent of these patented items were being developed into commercial products with public utility. Kansas Republican Bob Dole agreed, and together in 1980 they sponsored the Government Patent Policy Act of 1980, commonly known as the Bayh-Dole Act, to foster the commercialization of inventions based on university-held patents financed by government grants.
Not everyone approved of this proposed marriage of academia and industry. Dissenters including the influential Admiral Hyman Rickover, “Father of the Nuclear Navy,” who voiced his unambiguous, strident, and frequent objections on the grounds that corporate ownership of university innovation would spawn ungovernable monopolies: “In my opinion, government contractors – including small businesses and universities – should not be given title to inventions developed at government expense. That is the gist of my testimony. These inventions are paid for by the public and therefore should be available for any citizen to use or not use as he sees fit.”
The powerful Senator Russell Long of Louisiana, a Democrat, agreed. On September 24, he proclaimed to Congress, “I am adamantly opposed to the House Bill. I urge you to join with me in taking what ever steps are necessary to prevent this monopolistic provision from being included in the final form of any patent policy legislation.” In private, he railed to Bayh’s staff that “this is the worst bill I have seen in my life.” The Carter administration agreed, Congress was convinced, and the Bayh-Dole bill dies in the regular sessions of the Ninety-sixth Congress.
By December, however, Jimmy Carter was a lame duck, and when Congress was briefly revived for a necessary budget session, Bayh wanted the bill slipped in for another vote and another chance at passage. But Bayh had lost the election, too, and so wielded even less political clout than earlier. Long had the power to withhold the bill from consideration during the budgetary session.
However, good ol’ boy sentiment trumped congressional fears of renegade monopolies. Russell Long, in a farewell act of respect for the departing Bayh called him to say, “Birch, take that patent bill, you’re entitled to it. You’ve earned it.” Long released the bill for consideration and withdrew his opposition; following his lead, so did other representatives.
Thus Bayh-Dole became law on December 12, in the last hour of the last congressional session during the waning days of 1980, reversing more than three decades of public policy that reserved to universities the sole right to own inventions that resulted from federally funded research.
Moreover, not only could colleges now sell and license the patents developed with taxpayers’ dollars to private companies, they could do so without publicly disclosing the deals. .... Harriet Washington "Deadly Monopolies" 2011 p.40-1
Not everyone approved of this proposed marriage of academia and industry. Dissenters including the influential Admiral Hyman Rickover, “Father of the Nuclear Navy,” who voiced his unambiguous, strident, and frequent objections on the grounds that corporate ownership of university innovation would spawn ungovernable monopolies: “In my opinion, government contractors – including small businesses and universities – should not be given title to inventions developed at government expense. That is the gist of my testimony. These inventions are paid for by the public and therefore should be available for any citizen to use or not use as he sees fit.”
The powerful Senator Russell Long of Louisiana, a Democrat, agreed. On September 24, he proclaimed to Congress, “I am adamantly opposed to the House Bill. I urge you to join with me in taking what ever steps are necessary to prevent this monopolistic provision from being included in the final form of any patent policy legislation.” In private, he railed to Bayh’s staff that “this is the worst bill I have seen in my life.” The Carter administration agreed, Congress was convinced, and the Bayh-Dole bill dies in the regular sessions of the Ninety-sixth Congress.
By December, however, Jimmy Carter was a lame duck, and when Congress was briefly revived for a necessary budget session, Bayh wanted the bill slipped in for another vote and another chance at passage. But Bayh had lost the election, too, and so wielded even less political clout than earlier. Long had the power to withhold the bill from consideration during the budgetary session.
However, good ol’ boy sentiment trumped congressional fears of renegade monopolies. Russell Long, in a farewell act of respect for the departing Bayh called him to say, “Birch, take that patent bill, you’re entitled to it. You’ve earned it.” Long released the bill for consideration and withdrew his opposition; following his lead, so did other representatives.
Thus Bayh-Dole became law on December 12, in the last hour of the last congressional session during the waning days of 1980, reversing more than three decades of public policy that reserved to universities the sole right to own inventions that resulted from federally funded research.
Moreover, not only could colleges now sell and license the patents developed with taxpayers’ dollars to private companies, they could do so without publicly disclosing the deals. .... Harriet Washington "Deadly Monopolies" 2011 p.40-1
The claims from both Bayh and Dole were probably dubious at the time, as Hyman Rickover, Russell Long and the Carter administration seemed to recognize; and before the election they clearly thought it was in their own political interests not to support this bill. It is incredibly ironic and suspicious that the opposition to this bill, which turned out to be right in hindsight caved after the election, whether they won that election or not.
That is simply not the way the democratic process is supposed to work!
I don't recall much if any reporting on this bill or numerous other bills that are mentioned in her book while they were being passed, which is a major part of the problem. Researchers like Harriet Washington explore the details of these bills, often before they're passed, but tehy have little or no chance to explain problems to the majority of the public through the traditional media. Instead they're often able to explain it to relatively small percentage of the public in the academic world or involved in community groups that try to keep up with this.
There is little or no doubt that if the majority of the public was better informed about these bills, and from grassroots candidates that aren't catering to corporate interests, that they would stop reelecting politicians, that are far more concerned about serving the interests of their campaign donors and creating propaganda to distract the public, than serving the public's interests.
As Harriet Washington, and some of her sources including, Marcia Angell author of "The Truth About the Drug Companies," explain this bill enabled a massive subsidy to the pharmaceutical by financing the majority of the research done to develop most drugs then handing the patents over with little or no protection for the public from price gouging or, in many cases safe drugs or medical care. The vast majority of research is done in the first three phases of medical trials, and the drug companies don't step in with much if any financing until most of this is done with government financing. They don't take many if any risks until they know that it will be a profitable drug they're investing in.
They're required by law to invest in additional Phase four drug trials after the drugs are approved to study long term effects for people that are on the drug on a much larger scale; however they often drag their feet on this research since if problems do come up on a profitable drug they would have to take it off the market, so they prefer not to know.
This is essentially theft of what they call "intellectual property," from the taxpayer, which foots the bill for the majority of the research including most if not all research that doesn't turn out profitable drugs. The justification for outrageous prices on drugs, according to pharmaceutical companies, is that they have to take enormous risks, but clearly the risk isn't taken by them at all but by the taxpayer!
This is just one of many examples where their right to this so called "intellectual property" is blatant theft as described in the following exerpt where they take advantage of knowledge from native people from other countries without giving them credit for their discoveries:
Researchers travel to parts of the world rich in biodiversity to acquire and patent plants with medicinal value. They learn of these plants from native healers and guides who tell them where to gather them and how to use them as medicines. When they return home, these scientists determine the plants’ chemical structures, extract their active ingredients, and obtain patents. They do not offer to share credit or profits with the natives who determined the medicinal uses of the plants, and the new patents actually block the organism’s use by natives and require the country of origin to pay for access to its own plant medicines.
Environmental activists such as India’s Vandana Shiva, PhD, of the International Forum on Globalization, as well as many indigenous advocacy groups, call these exploitive policies “biopiracy” or “biocolonialism” in a parallel of the economic policies that deplete the resources and reinforce the poverty of the Third World denizens while enriching their Western guests. Washington "Deadly Monopolies" p.266
Environmental activists such as India’s Vandana Shiva, PhD, of the International Forum on Globalization, as well as many indigenous advocacy groups, call these exploitive policies “biopiracy” or “biocolonialism” in a parallel of the economic policies that deplete the resources and reinforce the poverty of the Third World denizens while enriching their Western guests. Washington "Deadly Monopolies" p.266
This isn't a new practice; aspirin was patented in the nineteenth century by Bayer which helped them become a pharmaceutical giant; however this was widely used by ancient Egyptians thousands of years ago. Patents are supposed to be for new discoveries! Patents, in practice aren't a reflection of inventiveness at all, but of political power to gain competitive advantages.
However even though the government isn't inclined to protect the public from price gouging by mutinational corporations or protect native healers from theft of so-called intellectual property when the multinational corporations they're often quick to protect the multinational corporations when they claim they're the victim, sometimes even at the expense of the researchers that patent laws are supposed to defend as indicated in the following excerpts:
Some cell lines retain the characteristics of and produce substances that are peculiar to their cells of origin. Royston was working on a cell line that he hoped would treat cancers by producing antibodies that attack cancer cells. Hagiwara suggested that he use lymph cells from his sick mother, and Royston did so, fusing Hagiwara's mother's cells to the line. UCSD researchers soon agreed that this particular cell line possessed unique cancer-fighting properties, so Royston patented the promising cells. Hagiwara then returned to Japan, surreptitiously taking with him a sample of the cell line, which he used to treat his mother, who rallied but ultimately succumbed to her cancer.
Months later, Hagiwara gave the cell line to his father, Dr. Yoshide Hagiwara, who was also a biomedical researcher, for use in the family firm, the Hagiwara Institute of Health in Osaka. He claimed patent rights to the cell line and the antibodies it produced because it emanated from his mother's body, entitling his family, he said, to a financial interest in the cell lines. The U.S. Office of Technology Assessment disagreed and sued Hagiwara fils for taking the patented cells without permission. Hagiwara argued that despite the UCSD patent, the fact that the cell line had originated with his mother's tissues gave his family rights to the cells as well.
Hagiwara won these rights in a 1983 settlement with the university that gave the Hagiwaras the sole license to the patent throughout Asia. Patented entities can be licensed in an exclusive or a nonexclusive manner, and they can be licensed for specific geographic regions, and even for specific uses. In this case, the Hagiwaras' agreement with UCSD permitted them to use the line in research, but not to license it commercially elsewhere.
Twenty years later, another family affair was handled quite differently when FBI agents tracked down, arrested, and jailed Dr. Jiangyu Zhu, thirty, of China and Dr. Kayoko Kimbara, thirty-two, of Japan on June 19, 2002, in La Jolla, California.
The married couple were former fellows of Harvard Medical School who had resigned to pursue new research positions. But their time at Harvard had been very fruitful: from November 1998 through September 1999, Kimbara identified two genes that block the action of calcineurin, an enzyme that signals the immune system to reject transplanted organs. This was a potentially lucrative discovery that could transform organ transplantation by leading to immunosuppressive drugs, medicines that drastically lower the risks of organ rejection. It also was a potential treatment for several diseases that affect the cardiovascular, immune, and nervous systems, which multiplied its commercial potential. Then, on October 22, 1999, Harvard filed a provisional patent on the two genes and their products.
.....
Harvard officials angrily accused Zhu and Kimbara of violating the terms of their agreement by sneaking into the lab in the wee hours to remove contested material, and of lying about having done so. The duo denied this, and the facts were never established in court. But according to the university's complaint, the Japanese company did succeed in producing antibodies against two of the three genes and then shipped them to Zhu at the University of Texas, where he now ran his own lab.
....
Because any attempt to develop drugs from the pair's Harvard discovery threatened Harvard's own ability to patent calcineurin and sell the rights to a biotechnology company or corporation, this was a turf battle between Harvard and Medical and Biological Laboratories as well as between it and its erstwhile fellows. Unlike UCSD, Harvard did not seem inclined to share patent rights with the Japanese firm. The school and the FBI's public statements, however, focused on Zhu and Kimbara.
"Prosecuting people who steal the intellectual property of individuals and institutions is a very high priority for the Department of Justice," declared U.S. attorney Michael J. Sullivan. "Congress has enacted a series of laws to assure that innovators get credit for their inventions and if people steal the ideas that belong to someone else and try to use those ideas for their own economic benefit, they will be prosecuted. Protecting cutting-edge ideas is crucial to the creation of new products and our economy as a whole." Complete Chapter for additional details
Months later, Hagiwara gave the cell line to his father, Dr. Yoshide Hagiwara, who was also a biomedical researcher, for use in the family firm, the Hagiwara Institute of Health in Osaka. He claimed patent rights to the cell line and the antibodies it produced because it emanated from his mother's body, entitling his family, he said, to a financial interest in the cell lines. The U.S. Office of Technology Assessment disagreed and sued Hagiwara fils for taking the patented cells without permission. Hagiwara argued that despite the UCSD patent, the fact that the cell line had originated with his mother's tissues gave his family rights to the cells as well.
Hagiwara won these rights in a 1983 settlement with the university that gave the Hagiwaras the sole license to the patent throughout Asia. Patented entities can be licensed in an exclusive or a nonexclusive manner, and they can be licensed for specific geographic regions, and even for specific uses. In this case, the Hagiwaras' agreement with UCSD permitted them to use the line in research, but not to license it commercially elsewhere.
Twenty years later, another family affair was handled quite differently when FBI agents tracked down, arrested, and jailed Dr. Jiangyu Zhu, thirty, of China and Dr. Kayoko Kimbara, thirty-two, of Japan on June 19, 2002, in La Jolla, California.
The married couple were former fellows of Harvard Medical School who had resigned to pursue new research positions. But their time at Harvard had been very fruitful: from November 1998 through September 1999, Kimbara identified two genes that block the action of calcineurin, an enzyme that signals the immune system to reject transplanted organs. This was a potentially lucrative discovery that could transform organ transplantation by leading to immunosuppressive drugs, medicines that drastically lower the risks of organ rejection. It also was a potential treatment for several diseases that affect the cardiovascular, immune, and nervous systems, which multiplied its commercial potential. Then, on October 22, 1999, Harvard filed a provisional patent on the two genes and their products.
.....
Harvard officials angrily accused Zhu and Kimbara of violating the terms of their agreement by sneaking into the lab in the wee hours to remove contested material, and of lying about having done so. The duo denied this, and the facts were never established in court. But according to the university's complaint, the Japanese company did succeed in producing antibodies against two of the three genes and then shipped them to Zhu at the University of Texas, where he now ran his own lab.
....
Because any attempt to develop drugs from the pair's Harvard discovery threatened Harvard's own ability to patent calcineurin and sell the rights to a biotechnology company or corporation, this was a turf battle between Harvard and Medical and Biological Laboratories as well as between it and its erstwhile fellows. Unlike UCSD, Harvard did not seem inclined to share patent rights with the Japanese firm. The school and the FBI's public statements, however, focused on Zhu and Kimbara.
"Prosecuting people who steal the intellectual property of individuals and institutions is a very high priority for the Department of Justice," declared U.S. attorney Michael J. Sullivan. "Congress has enacted a series of laws to assure that innovators get credit for their inventions and if people steal the ideas that belong to someone else and try to use those ideas for their own economic benefit, they will be prosecuted. Protecting cutting-edge ideas is crucial to the creation of new products and our economy as a whole." Complete Chapter for additional details
These patent laws are designed to reward innovation; however the advantage has shifted to large corporations that have lawyers and lobbyists. Innovators in medical research often aren't inclined to pay as much attention to patent laws as they are their own field. If researchers have to worry about being prosecuted for developing new technology complex patent laws could do the opposite of what they're intended to.
The government that is often quick to defend their large corporations that donate to campaigns, isn't nearly so quick to defend research subjects when they're the victim of unethical research without full consent when the victims are foreign children or veterans that agreed to defend our country, and were coerced into participating in research projects against their will as indicated in the next few stories:
The newcomers infused their expertise, energy and even a new medicine, Pfizer’s Trovan (floxacin), into the situation, and terrified parents, desperate for medical attention, lined up to grasp at Trovan’s straw.
Among them were the parents of patient 6587-0069. She was ten years old, and because of a shortly after the time of her treatment many research records were lost, accounts of her story use her number. A number was what she was to Pfizer because she, like the other children whose parents sought help from them in the new clinic, was an experimental subject. Trovan was an experimental drug that had not been FDA-approved, and although Pfizer hoped it would become the firm’s next $1 billion blockbuster, its approval depended on the results the new doctors would have with the medication so patient 6587-0069 was given 56 mg of Trovan.
But 6587-0069 was not getting the results she needed. As her fever soared and she slipped deeper into unconsciousness, her strength disapated and an eye froze in place. In response to this, the staff noted that “the dose was continued unchanged.” If she had been in an ethically conducted U.S. trial, she would have been switched from the experimental drug to one that was known to work, such as chloramphenicol that was given to the control group. But she was not in Connecticut; she was in Kano, and because testing Trovan was the priority, she was given no other drug throughout her steady decline, and she later died.
….
By the time the experiment nded, two hundred children were left deaf, lame, blind, seizure-ridden, disoriented, and with other severe disabilities. Eleven were dead. Although the epidemic continued, the Pfizer doctors were gone, having flown out after they had doled out their doses and collected their data, which took just three weeks.
In 2001, at least Nigerian parents sued New York-based Pfizer, alleging that non-FDA-approved experiments had killed their children; that Pfizer failed to obtain the requisite prior approval from local leaders; and that the pharmaceutical giant failed to administer standard therapies with proven efficacy, such as Pfizer’s own ceftriaxone, to those children who, like 6587-0069, continued to deteriorate and be given Trovan.
…….
But documenting what patients had been told of the drug’s experimental status and determining Trovan’s effects on their patients for the lawsuit would prove difficult; the medical records of 350 meningitis patients treated between April and June 1996 have disappeared from the hospital, as the records of research studies that are accused of cutting legal and ethical corners so often seem to do.
“It could be considered murder,” said Dr. Evariste Lodi, supervising physician for the Doctors Without Borders treatment clinic in Kano, adding, “If I had the power I would take away their medical licenses.” The victims’ $6 billion suit against Pfizer was bounced from continent to continent, having been conducted at various times in both Kano and Manhattan, and Pfizer was accused of unsavory political machinations in an attempt to dissuade Nigerian officials from pursuing the case of the Kano children.
A secret State Department cable discovered and released by Wikileaks, alleges that Pfizer levied corruption accusations against the Nigerian attorney general, Michael Aondokaa, in an attempt to get him to drop the case. ….. However, the same 2006 State Department cable also correctly describes the terms of a settlement for $75 million that Pfizer reached with the Kano families. ….. But some of the Nigerian parents insisted that justice had not been served, and sought to invalidate the settlement and reopen a criminal case against Pfizer. See additional details at Washington "Deadly Monopolies" p.300-4
Among them were the parents of patient 6587-0069. She was ten years old, and because of a shortly after the time of her treatment many research records were lost, accounts of her story use her number. A number was what she was to Pfizer because she, like the other children whose parents sought help from them in the new clinic, was an experimental subject. Trovan was an experimental drug that had not been FDA-approved, and although Pfizer hoped it would become the firm’s next $1 billion blockbuster, its approval depended on the results the new doctors would have with the medication so patient 6587-0069 was given 56 mg of Trovan.
But 6587-0069 was not getting the results she needed. As her fever soared and she slipped deeper into unconsciousness, her strength disapated and an eye froze in place. In response to this, the staff noted that “the dose was continued unchanged.” If she had been in an ethically conducted U.S. trial, she would have been switched from the experimental drug to one that was known to work, such as chloramphenicol that was given to the control group. But she was not in Connecticut; she was in Kano, and because testing Trovan was the priority, she was given no other drug throughout her steady decline, and she later died.
….
By the time the experiment nded, two hundred children were left deaf, lame, blind, seizure-ridden, disoriented, and with other severe disabilities. Eleven were dead. Although the epidemic continued, the Pfizer doctors were gone, having flown out after they had doled out their doses and collected their data, which took just three weeks.
In 2001, at least Nigerian parents sued New York-based Pfizer, alleging that non-FDA-approved experiments had killed their children; that Pfizer failed to obtain the requisite prior approval from local leaders; and that the pharmaceutical giant failed to administer standard therapies with proven efficacy, such as Pfizer’s own ceftriaxone, to those children who, like 6587-0069, continued to deteriorate and be given Trovan.
…….
But documenting what patients had been told of the drug’s experimental status and determining Trovan’s effects on their patients for the lawsuit would prove difficult; the medical records of 350 meningitis patients treated between April and June 1996 have disappeared from the hospital, as the records of research studies that are accused of cutting legal and ethical corners so often seem to do.
“It could be considered murder,” said Dr. Evariste Lodi, supervising physician for the Doctors Without Borders treatment clinic in Kano, adding, “If I had the power I would take away their medical licenses.” The victims’ $6 billion suit against Pfizer was bounced from continent to continent, having been conducted at various times in both Kano and Manhattan, and Pfizer was accused of unsavory political machinations in an attempt to dissuade Nigerian officials from pursuing the case of the Kano children.
A secret State Department cable discovered and released by Wikileaks, alleges that Pfizer levied corruption accusations against the Nigerian attorney general, Michael Aondokaa, in an attempt to get him to drop the case. ….. However, the same 2006 State Department cable also correctly describes the terms of a settlement for $75 million that Pfizer reached with the Kano families. ….. But some of the Nigerian parents insisted that justice had not been served, and sought to invalidate the settlement and reopen a criminal case against Pfizer. See additional details at Washington "Deadly Monopolies" p.300-4
When ethical guideline in the United States prevent them from doing some of their riskiest research they often go abroad where there are less ethical guidelines and governments are less inclined to protect their own citizens. In many cases the governments are as corrupt as the pharmaceutical companies. Clearly they're more concerned with maximizing profits than with the Hippocratic Oath, "first do no harm," and when they're not held accountable they do what they can to avoid any accountability. The clear implication is that if they could have avoided any lawsuit the families would have gotten no compensation at all; and if they had done the same thing in the United States then the settlement would almost certainly have been much higher and there might have been calls for criminal charges putting some of the people responsible for this in jail!
When they have a hard time convincing one group of people, whether it is African's in Kano that learn from past abuses or African Americans that become suspicious from past experiments as Harriet Washington described in Medical Apartheid, they apparently seek people that are more willing to go along, often because they're less informed and indicated in the following excerpt:
The Los Angeles Times also recounts how Rezulin’s maker focused its marketing on doctors with many Hispanic patients, who have a high incidence of diabetes. Spanish-speaking doctors in Miami, for example, were enlightened by drug reps’ talking points that stressed “differences between Hispanics and American patients,” such as:
“The Hispanic patient is less informed and educated about medicines,” “The Hispanic patient is less disciplined,” and “The Hispanic patient is easy to intimidate because they are afraid of having to go on insulin.” In addition to targeting Latinos, Warner-Lambert paid doctors up to $350 each to switch diabetic patients from safer drugs to Rezulin. In 1999, it even took the suspiciously prescient step of “offering to indemnify doctors nationwide if they were sued for prescribing Rezulin.”
By the time Rezulin was pulled from the U.S. market in 2000, it had been implicated in ninety known liver failures and sixty-three deaths. It ahd also garnered U.S. sales totaling $1.8 billion. According to the Wall Street Journal, and FDA epidemiologist estimated that liver failure was afflicting twenty additional patients who took Rizulin every month. By 2003, Pfizer (which acquired Warner-Lambert in June 2000) was facing thousands of lawsuits from Rezulin victims or their survivors. See additional details at Washington "Deadly Monopolies" p.142
“The Hispanic patient is less informed and educated about medicines,” “The Hispanic patient is less disciplined,” and “The Hispanic patient is easy to intimidate because they are afraid of having to go on insulin.” In addition to targeting Latinos, Warner-Lambert paid doctors up to $350 each to switch diabetic patients from safer drugs to Rezulin. In 1999, it even took the suspiciously prescient step of “offering to indemnify doctors nationwide if they were sued for prescribing Rezulin.”
By the time Rezulin was pulled from the U.S. market in 2000, it had been implicated in ninety known liver failures and sixty-three deaths. It ahd also garnered U.S. sales totaling $1.8 billion. According to the Wall Street Journal, and FDA epidemiologist estimated that liver failure was afflicting twenty additional patients who took Rizulin every month. By 2003, Pfizer (which acquired Warner-Lambert in June 2000) was facing thousands of lawsuits from Rezulin victims or their survivors. See additional details at Washington "Deadly Monopolies" p.142
They also seek to use people for research in institutions where people are committed to either prisons or the military and they have less choice, or legal defense if they object, in the matter.
Amazingly our own government has a long history of providing veterans that they claim to respect so much for research subjects without permission. This is especially outrageous since most if not all military activities since World War II have been based partly or entirely on lies including the weapons of mass destruction that weren't there and they have often incited the attacks used to justify invasions of other countries like 9/11.
The military has used veterans for research with Mustard gas during WWII, nuclear fallout in the fifties, Agent Orange during the Vietnam war and again for and anthrax vaccine during recent wars. These are often exposed after the fact and laws passed to prevent them from happening again; however these laws are often overturned one way or another when people aren't paying attention so even though, once again they had a favorable court ruling to prevent the following situation from happening; veterans will have to be vigilant to be sure:
Wartime military expediency has often escalated the erosion of human rights in research, and recent events have proved no exception. The military fired the first modern legal salvo against informed consent in the shadow of the impending Gulf War and subsequent Middle Eastern hostilities – and besides the military, at least one private drug maker, then called BioPort, stood to profit.
The Department of Defense (DOD) sought and secured the FDA’s permission to dispense with informed consent as it forced 2.4 million soldiers to accept injection with an experimental anthrax vaccine, a patented product of BioPort Laboratories, via its 2000-2005 Anthrax Immunization Program (AVIP). So, just four decades after the army had overseen the Nuremburg trials of twenty Nazi physicians on charges of conducting experiments upon the powerless without their consent, the DOD opted to experiment on its own soldiers without their consent.
This odyssey into research without consent proved a medical and legal disaster that eroded many soldiers’ trust in medical research. Soldiers suffered miscarriages and were maimed, blinded and killed, all of which they blame on experimental anthrax vaccines. The Washington Post raised questions about the safety and quality of the vaccine and alerted the public that the factory in which it was manufactured had been the subject of repeated FDA evaluations, which found substandard hygienic and production conditions.
By a conservative estimate, ... They literally had no recourse, because the Feres Doctrine stipulates that soldiers on active duty cannot sue the U.S. government for personal injuries experienced in the performance of their duties, and their families cannot sue for wrongful death.
...
But the army did not need Barber’s permission. Barber tried to resolve the issue through legal means and requested a transfer to a unit where she would not need to submit to the injections, but she says her commanding officer blocked it, intending to “make and example” of her, and that he encouraged others to harangue her into compliance.
“I was bothered by the blatant disrespect of the men around me, who were pushing me as they shouted at me to take the shot.” She relates being physically assaulted, followed by confinement to a barracks until the day she jumped out of the second-story window because “I learned that I was being detained in a building where a gang rape had taken on the same floor just two weeks earlier.”
In the end, demoralized and suffering from PTSD, Jamekia accepted the proffered “Chapter 10” resignation from the army in lieu of a court-martial because, she says, she was assured that she would not receive anything less than an honorable discharge. But on May 11, 2000, a less-than-honorable “administrative discharge” was exactly what she received. She unsuccessfully appealed the decision in 2003, by which time her husband had also been released with an administrative discharge.
Later that year, Judge Emmet G. Sullivan of the United States District Court in Washington, D.C., ruled to end the forced experimentation. The FDA responded by rapidly elevating the anthrax vaccine from a questionable investigational drug to an approved therapeutic, which allowed the DOD to sidestep the intent of the law and force the medications on soldiers as part of fitness-for-battle measures.
This move returned U.S. soldiers to a state of investigative servitude – “investigative” because the data collection and evaluation of the anthrax vaccine risks, including death, continued. In rapidly approving the vaccine, the FDA had violated not only the intent of Sullivan’s ruling but also its own regulations by failing to hold the required public hearings.
in 2004, half a dozen unnamed soldiers filed a class-action suit protesting the vaccinations. Judge Sullivan, again presiding, finally drove a stake through the heart of this probellum experimentation with a decision that read in part, “The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy. Absent in informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.”
Between 2004 and 2011, more legal cases were brought by soldiers who had been forced into the vaccination program while the DOD attempted, on several occasions and with limited success, to restore mandatory vaccinations. The FDA issued a string of actions against the vaccine manufacturer, which were triggered by quality issues such as failed potency tests and unapproved changes in manufacturing as well as the soldiers’ injury lawsuits. The vaccinations are currently voluntary, but will the remain so? Currently, Emergent BioSolutions, now the parent company of BioPort, has committed to preparing 1.45 million doses of anthrax vaccine by 2011.
After Sullivan’s decisions ended forced research on soldiers, Barber renewed her appeal and won an honorable discharge. But the price of her vindication was high; she and her husband divorced. Although she remarried and she and her ex-husband ramin friends, Barber attributes the breakdown of their marriage to the strain of fighting the DOD. “Sometimes I wonder what our lives would have been like without ‘the shot.’ But I don’t allow myself to dwell on it. For additional excerpts see Washington "Deadly Monopolies" p.208-13)
The Department of Defense (DOD) sought and secured the FDA’s permission to dispense with informed consent as it forced 2.4 million soldiers to accept injection with an experimental anthrax vaccine, a patented product of BioPort Laboratories, via its 2000-2005 Anthrax Immunization Program (AVIP). So, just four decades after the army had overseen the Nuremburg trials of twenty Nazi physicians on charges of conducting experiments upon the powerless without their consent, the DOD opted to experiment on its own soldiers without their consent.
This odyssey into research without consent proved a medical and legal disaster that eroded many soldiers’ trust in medical research. Soldiers suffered miscarriages and were maimed, blinded and killed, all of which they blame on experimental anthrax vaccines. The Washington Post raised questions about the safety and quality of the vaccine and alerted the public that the factory in which it was manufactured had been the subject of repeated FDA evaluations, which found substandard hygienic and production conditions.
By a conservative estimate, ... They literally had no recourse, because the Feres Doctrine stipulates that soldiers on active duty cannot sue the U.S. government for personal injuries experienced in the performance of their duties, and their families cannot sue for wrongful death.
...
But the army did not need Barber’s permission. Barber tried to resolve the issue through legal means and requested a transfer to a unit where she would not need to submit to the injections, but she says her commanding officer blocked it, intending to “make and example” of her, and that he encouraged others to harangue her into compliance.
“I was bothered by the blatant disrespect of the men around me, who were pushing me as they shouted at me to take the shot.” She relates being physically assaulted, followed by confinement to a barracks until the day she jumped out of the second-story window because “I learned that I was being detained in a building where a gang rape had taken on the same floor just two weeks earlier.”
In the end, demoralized and suffering from PTSD, Jamekia accepted the proffered “Chapter 10” resignation from the army in lieu of a court-martial because, she says, she was assured that she would not receive anything less than an honorable discharge. But on May 11, 2000, a less-than-honorable “administrative discharge” was exactly what she received. She unsuccessfully appealed the decision in 2003, by which time her husband had also been released with an administrative discharge.
Later that year, Judge Emmet G. Sullivan of the United States District Court in Washington, D.C., ruled to end the forced experimentation. The FDA responded by rapidly elevating the anthrax vaccine from a questionable investigational drug to an approved therapeutic, which allowed the DOD to sidestep the intent of the law and force the medications on soldiers as part of fitness-for-battle measures.
This move returned U.S. soldiers to a state of investigative servitude – “investigative” because the data collection and evaluation of the anthrax vaccine risks, including death, continued. In rapidly approving the vaccine, the FDA had violated not only the intent of Sullivan’s ruling but also its own regulations by failing to hold the required public hearings.
in 2004, half a dozen unnamed soldiers filed a class-action suit protesting the vaccinations. Judge Sullivan, again presiding, finally drove a stake through the heart of this probellum experimentation with a decision that read in part, “The women and men of our armed forces put their lives on the line every day to preserve and safeguard the freedoms that all Americans cherish and enjoy. Absent in informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs.”
Between 2004 and 2011, more legal cases were brought by soldiers who had been forced into the vaccination program while the DOD attempted, on several occasions and with limited success, to restore mandatory vaccinations. The FDA issued a string of actions against the vaccine manufacturer, which were triggered by quality issues such as failed potency tests and unapproved changes in manufacturing as well as the soldiers’ injury lawsuits. The vaccinations are currently voluntary, but will the remain so? Currently, Emergent BioSolutions, now the parent company of BioPort, has committed to preparing 1.45 million doses of anthrax vaccine by 2011.
After Sullivan’s decisions ended forced research on soldiers, Barber renewed her appeal and won an honorable discharge. But the price of her vindication was high; she and her husband divorced. Although she remarried and she and her ex-husband ramin friends, Barber attributes the breakdown of their marriage to the strain of fighting the DOD. “Sometimes I wonder what our lives would have been like without ‘the shot.’ But I don’t allow myself to dwell on it. For additional excerpts see Washington "Deadly Monopolies" p.208-13)
The government spend an enormous amount of money on propaganda glorifying veterans; however when it comes to actually respecting their rights and fulfilling their promises to them they rarely ever live up to that propaganda! They pay their military contractors, most of whom donate an enormous amount to political campaigns, and are often involved in an enormous amount of corruption, on time without any problem but when veterans need care after returning from wars based on lies they often get long waiting lines and they also ahve to deal with an enormous amount of intimidation requiring them to participate in these experiments.
In addition to that, in some cases like Abu Ghraib they face potential criminal charges for following orders while the people that give the orders aren't held accountable; and in other cases if they refuse to obey illegal orders like those to invade a country based on lies without authorization from the UN they face criminal charges for refusing to obey.
They did "Obedience to Authority" experiments decades ago claiming that they were trying to avoid blind obedience that took place in Nazi Germany; However as I explained in Philip Zimbardo, Lucifer Effect, Stanford Prison Experiment and Eli Roth’s Milgram/Obedience experiment much more extensive than most people realize these experiments clearly seem to have been designed to do the opposite. they could do what they claimed they were teaching people to stand up to authority and in some cases, they do when they teach the full perspective of these experiments; however the people that learn about these experiments are mostly college educated people that aren't inclined to join the military, unless it's those preparing for command that study how to indoctrinate their troops.
the majority of the troops that are recruited never learn about the psychological manipulation until it is used against them. This indoctrination is designed to turn soldiers into complaint people that obey without question, and they're often put in a no win situation when the same commanders that glorify veterans force them into lose-lose situations where they abandon their own freedom based on false promises and propaganda.
Whether it is the third world people used for research, veterans, minorities prisoners, or any other low income people that participate in research experiments they rarely ever get the best medical care and the drugs these pharmaceutical companies try to develop the most aren't necessarily the ones that improve health for the majority the most; they're the ones that are the most profitable for pharmaceutical companies.
Even though they use children from third world countries for their research when it serves their purposes they don't do much if any research into some of the diseases that impact them the most like tropical diseases that kill far more than the diseases that are common in the United States. In some cases even when it is cheap to manufacture vaccines for third world people to save a large number of people they refuse to do it.
Even people in the United States should be concerned about their practices. Harriet Washington, Marcia Angell and others have also reported on how they often ghost write many papers that are favorable to them; fail to disclose all the research from their drugs when it isn't favorable; the people doing their reviews often have financial ties to the industry and on at least one occasion when a reviewer wrote something that was critical of the pharmaceutical industry Joseph Herman, the editor who wanted to print it wrote, “unfortunately, I have been overruled by our marketing department with regard to publishing your editorial. The publication of your editorial would, in fact, not be accepted in some quarters . . . and apparently went beyond what our marketing department was willing to accommodate.” This letter exposed their blatant corruption but many people forgot it after a relatively short period of time and they may have simply learned to be more subtle when censoring research that they don't like.
Washington reports on a survey of doctors that were in charge of reviewing drugs and “Nineteen Medical officers identified a total of 27 approved new drugs in the past three years that they reviewed that they thought should not have been approved.” One medical evaluator wrote, “My feeling after more than 20 years at FDA is that unless drugs can be shown to kill patients outright then they will be approved with revised labels and box warning.”
Clearly research has been severely tainted by profit motives and this could be endangering many people health.
Even on the rare occasion where they actually prosecute and convict someone in the pharmaceutical industry or the government working with the pharmaceutical industry the accountability is very limited. In one example Dr. Pearson “Trey” Sunderland III a NIH employee was exposed for conflicts of interests when he "took the fifth rather than testify about receiving consulting fees from Pfizer. He was later exposed taking money and giving them samples collected by the NIH and according to Washington:
.... “Will a criminal conviction for conflict of interest be enough to get someone fired from the NIH?” asked Representative John Dingell (D-MI).
Apparently not. In the end, Sunderland was allowed to plead guilty to a misdemeanor for which he received two years of probation and four hundred hours of community service at a geriatric psychology service. He also agreed to pay the government $300,000, about half his compensation from Pfizer.
Thus it was that Pfizer, which denies any ethical breaches, acquired samples that cost the government $6.4 million and fifteen years to collect for the bargain basement price of Sunderland’s approximately $600,000 in fees. The samples enabled refinement of Pfizer’s patented Alzheimer’s drug Aricept, which is now the top-selling Alzheimer’s drug in the world, with $2 billion in sales during 2011 alone.
In the end, the government received nothing for its investment in the embezzled samples. And worst of all, Molchan’s quest to characterize and treat Alzheimer’s disease at an earlier stage, before irreversible loss sets in, has been derailed after taking a backseat to greed. Washington "Deadly Monopolies" 2011 p.256-9)
Apparently not. In the end, Sunderland was allowed to plead guilty to a misdemeanor for which he received two years of probation and four hundred hours of community service at a geriatric psychology service. He also agreed to pay the government $300,000, about half his compensation from Pfizer.
Thus it was that Pfizer, which denies any ethical breaches, acquired samples that cost the government $6.4 million and fifteen years to collect for the bargain basement price of Sunderland’s approximately $600,000 in fees. The samples enabled refinement of Pfizer’s patented Alzheimer’s drug Aricept, which is now the top-selling Alzheimer’s drug in the world, with $2 billion in sales during 2011 alone.
In the end, the government received nothing for its investment in the embezzled samples. And worst of all, Molchan’s quest to characterize and treat Alzheimer’s disease at an earlier stage, before irreversible loss sets in, has been derailed after taking a backseat to greed. Washington "Deadly Monopolies" 2011 p.256-9)
Theft of so-called intellectual property from the government or indigenous people or even ordinary Americans by the pharmaceutical companies is routine; however prosecution and accountability seems very limited in one direction and is pushed to bizarre extremes in the other direction when people are accused of stealing from them. The coverage on this in the mainstream media is typically very limited; and if they report it once briefly they quickly forget it. Until we get major media reform it is up to alternative media and good researchers like Marcia Angell and Harriet Washington to report it.
On at least one other occasion the use of patents has done the opposite of what it was intended when a drug company came to the conclusion that a drug wouldn't be profitable, instead of doing the research to develop that drug they stopped it and prevented their own researcher from going elsewhere to continue his work. Harriet Washington writes, "Then, abruptly, Progen shut down the trials, voicing concerns about factors 'that impacted the commercial return' of PI-88, including the successful joint launch of Nexavar (sorafenib), a competing drug, by the Bayer and Onyx pharmaceutical companies. …… So the drug maker simply pulled the plug on PI-88, Parish’s lifework, and on the hopes of imperiled liver-cancer patients. Because Progen holds the patent on PI-88, Parish cannot go elsewhere to conduct the Phase III trial and pursue its approval." Washington "Deadly Monopolies" p.96
Harriet Washington and Marcia Angell both come up with some of their own ideas about how to reform this; however they both also admit that their ideas won't go far enough and it will take an enormous effort from the grassroots, reform of the media so that honest candidates can be covered and electing candidates that have previously been unable to get any name recognition to reform this industry and many other multinational corporations involved in other epidemic levels of fraud.
One of the most important thing that Harriet Washington recommends is the repeal of Bayh-Dole and other bills that never should have passed in the first place, but as I implied this is unlikely without major efforts to stop reelecting crooks taking virtual bribes thinly disguised as campaign contributions.
Even though their recommendations are far better than anything the political establishment comes up with limiting ourselves to their recommendations would be a mistake, and they agree. Marcia Angell wrote, "I propose that an Institute for Prescription Drugs Trials be established within the National Institute of Health (NIH) to administer clinical trials of prescription drugs." This would be part of an effort to restore government participation in the accountability process. As it stands the pharmaceutical industry has more control of their own accountability than the government does which Angell agrees is outrageous. But just a couple pages later she writes, (Here I’m assuming there is no National Institute for Prescription Drugs Trials,) implying that she's a realist and that in the current political environment it is virtually impossible to increase participation from government. Marcia Angell The "Truth About Drug Companies: How They Deceive Us and What to Do About It" p. 245,248
Many people re so accustomed to hearing from the media how incompetent the government is, and it is often true; however the reason for that is that is that we're constantly hearing about people like Grover Norquist say that he wants to "shrink the size of government so that it is small enough that he can drown it in a bathtub;" and the opposition presented by the media is led by the party of Bill Clinton, who once said that "The are of big government is over." This is misleading in a few ways and it puts people that want to dismantle a functioning government in a position of power so that they can make it incompetent justifying their claims.
We've been electing people that want to dismantle government accountable to the public for decades, partly because they're the only candidates that get media coverage and name recognition is the first requirement to be a viable candidate. This isn't actually dismantling government at all it is a transfer of power to the corporate board rooms!
As it stand now not only can't we get much if any reporting on how the pharmaceutical companies are gouging consumers and endangering research subjects and even the rest of the public when the FDA approves drugs based on selective research but we can't get coverage of the fundamental basics of insurance which would enable most people to understand how single Payer is already working much better in other countries.
If the a poor person were to pollute or poison and murder a rich person there would be quick prosecution but if the energy companies do it to the poor all the time there is little or no accountability and instead of arresting those responsible the police routinely arrest protesters.
If multinational corporations outsource manufacturing to countries that oppress their workers and add to pollution destroying the environment by forcing cheap disposable goods to be shipped half way around the world scamming consumers instead of arresting CEOs responsible for dangerous working conditions and in some cases products as well the police arrest protesters.
Now instead of arresting the lobbyists and CEOs of the pharmaceutical companies that are endangering our health care system the police are arresting handicapped people that want to participate in the democratic process.
Stanley Milgram did research into how far people would go when obeying orders without question. As i said in the previous articles about him and Philip Zimbardo their research could just as well have been done to obtain obedience rather than to prevent it when it goes to bizarre extremes. this training has often been used to obtain blind obedience from cadets when they're sent to war. When we fight one war after another based on lies about weapons of mass destruction, babies being taken out of incubators or the Gulf of Tonkin incident, blind obedience is what they need.
The same boot camp indoctrination is also used when training police as you can see, they obey orders without question when dragging out handicapped people that want to participate in their own government.
How far will they go?
I know there are a lot of good cops that don't sign up for this but one way or another they're not the ones that are responsible for removing protesters. with all the complaints about the war on cops who are trying to "protect us" they need to think about whether or not they're protecting us or aiding and abetting the epidemic levels of fraud by our own government.
I'm not calling for violence against police or politicians any more than I have in the past; however as I have repeatedly said when the government refuses to respond to the will of the people; the media refuses to report on the most important news that impacts society and the police routinely arrest people for trying to participate in their own government occasionally oppressed people that have no hope or opportunity because the corporations are getting away with so much fraud are going to go off the deep end like the veterans that were trained to kill by the government and returned to the country to realize the government wasn't protecting abandoned inner cities and killed cops in Baton rouge and Dallas or the baseball shootings.
It's not critics like me that are inciting this violence; it is the people controlling the government that aren't responding to their own citizens.
The government has turned into an insane satire where they hardly even pretend they're representing the people with people like Tom Price who brazenly Intervened on Rule That Would Hurt Drug Profits, the Same Day He Acquired Drug Stock as a congressman and still was approved as head of the Department of Health and Human Services. and the rest of Congress is full of politicians that have been catering to drug companies. The research done by more sincere academics like Harriet Washington and Marcia Angell clearly indicates that the current system isn't protecting the public; nor is it developing the best medicine for the majority of the public.
This should raise one other major question that hardly anyone is taking about; if they're using intellectual property laws to prevent the free exchange of ideas by shrouding everything in secrecy how can they develop some of the best technology they've been developing, not just in the medical industry but in many other industries?
Many of the claims by pharmaceutical ads as well as many other ads for other products are clearly fraudulent; but there is still an enormous amount of scientific advancement going on since the computer age escalated in the past thirty or forty years.
Epidemic levels of secrecy should have made this much more difficult if not impossible.
Regardless of how they managed this there is still no justification for all this secrecy or refusing to cover the best research in the traditional media!
[PDF]a new lease on life - Edward Reid Engineering First Chapter
