Harriet Washington Deadly Monopolies

Now universities sell and license patents developed with taxpayer dollars to privately held firms, including biotechnology and pharmaceutical companies, which underwrite the cost of drug research and development. (Harriet Washington "Deadly Monopolies" 2011 p.2-5)

We shall see how often sick, medically desperate people of the Third World are used as the laboratory subjects of the West as Pharmaceutical companies .....

Leaving aside for the moment the moral unacceptability of withholding medicine from poor people in order to maximize profits for one of the world’s most profitable industries, we must consider the global extent of drug makers’ control over our medical fates.

Most discussions treat Third World medical-access issues as if they were completely separate from those of developed nations. (Harriet Washington "Deadly Monopolies" 2011 p.8-9)

Chapter One A NEW LEASE ON LIFE: The Patent in American Medical Culture How does it feel to be patented? There was a sense of betrayal. I mean, they owned a part of me that I could never recover. I certainly have no objection to scientific research . . . but it was like a rape. In a sense, you've been violated, for dollars. My genetic essence is held captive. -John Moore, the subject of u.s. patent no. 4,438,032 (Harriet Washington "Deadly Monopolies" 2011 excerpts

(Harriet Washington "Deadly Monopolies" 2011 First Chapter

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.4 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.5 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.6 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.

On December 13, 1999, Zhu and Kimbara accepted university research positions at the Institute of Biotechnology at the University of Texas, San Antonio, and when they left Harvard, they took some materials and notes with them, as researchers are wont to do. They were to begin on January 15, and by early January 2000 they shipped some additional materials from Harvard to their new lab.

But the university's complaint says that in direct violation of the participation agreement signed by both Zhu and Kimbara, Zhu emailed Medical and Biological Laboratories of Nagoya, a biochemical company in Japan,7 indicating that he intended to collaborate with a researcher there to commercialize the antibodies suggested by his Harvard gene research after he left Boston. Harvard says that Zhu also sent three other genes to Japan without its knowledge.

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.

Removing materials is not a crime and is certainly not prosecuted unless the materials are alleged to be the property of the university, not the researcher. Even removing university property is acceptable if the amounts are not excessive and the researcher has appropriate permission. If the accusations of having lied about the removal of large quantities of university property are true, the couple become less sympathetic.

But it is important to evaluate such actions in the context of research culture: researchers typically remove materials from their laboratories when they leave for other institutions and sometimes do not ask permission to do so. There is no question that Heideaki Hagiwara, for example, had violated the spirit and the letter of the agreements he signed, yet he and UCSD were able to come to an amicable arrangement that recognized his contribution and shared the rights in the contested cell line. Therefore, many in the research community felt that Harvard overreacted when the university decided to play hardball.

Moreover, given that they were sued by Harvard, an academic behemoth of sterling reputation, it is also easy to overlook that Zhu and Kimbara steadfastly denied having taken disputed materials with them and that Harvard's very public accusations of theft were never publicly backed up with copies of agreements or evidence of wrongdoing.

The school brought criminal charges, and the two were charged with conspiracy, theft, theft of trade secrets, and (since they had left Texas and were now ensconced in new labs in San Diego) interstate transportation of stolen property.8 The case was investigated by the Federal Bureau of Investigation in New England.

The Department of Justice press release, titled "Pair Charged with Theft of Trade Secrets from Harvard Medical School," focused on the fear of corporate competition, speculating that the two shared an "intention of profiting from such information by collaborating with a Japanese company in the creation and sale of related and derivative products."

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." (Harriet Washington "Deadly Monopolies" 2011 p.12-3)

Golde surreptitiously moved Moore’s spleen to a research wing of the hospital, establishing a lab where he used it and other of Moore’s tissues (Harriet Washington "Deadly Monopolies" 2011 p.36-43)

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)

Unlike researchers and the university, the taxpayers, whose dollars funded discoveries made and patented in academia and commercialized by drug makers, receive nothing except the presumption that they-we-will benefit down the line from an increases number of medical advances. (Harriet Washington "Deadly Monopolies" 2011 p.47)

Does it really cost more than $800 million to create a new drug? In 2001, Joseph A. DiMasi, now Director of Economic Analyses at the Tufts University Center for the Study of Drug Development, partnered with the University of Rochester to calculate the answer: Each new drug for the US market takes 12 to 15 years and costs $802 million, a price that had doubled since 1987.

.....

PhRMA praised DiMasi’s study and verified the accuracy of its findings, constantly citing the $802 million figure — often rounded down to $800 million — in its publications and in interviews that defended high drug prices. .....
In fact, a US government study just the year before had determined that a new drug took from 10 to 12 years to come to market at a cost of $359 million — less than half that alleged by the Tufts study.

From the beginning, independent expert analysts had wished to scrutinize the DiMasi study’s data, but ….. The individual pharmaceutical companies that had supplied its figures insisted that their numbers were proprietary — industry secrets — and over the next year, they successfully fought their release to independent evaluators.

Over the next year, the $800 million figure remained unchallenged as analysts unsuccessfully sought to force the release of the proprietary data on which it was based. During this time the report’s numbers were widely accepted and had gained currency among the public as well: a surprising number of people can cite $800 million estimate.

Drug makers certainly can: The mammoth price tag, which was recently revised upwardly, to as much as $2 billion per new drug, forms the backbone of their rationale for high prices. (Harriet Washington "Deadly Monopolies" 2011 p.60-9)

John Stuart Mill introduced the concept of an opportunity cost as the cost of what one surrenders in one direction in order to pursue and investment in another. These deaths are directly related to Patent protection, because were the patent holders willing to allow licensing of low-cost or generic versions of their protected medications, which they do only rarely, more people would live. (Harriet Washington "Deadly Monopolies" 2011 p.69)

(Harriet Washington "Deadly Monopolies" 2011 p.64-5)

(Harriet Washington "Deadly Monopolies" 2011 This is an adaption from “Deadly Monopolies” Harriet A. Washington’s new book from approximately p.55-69 with numerous changes often subtle

The industry's stirring commercials feature earnest young researchers who recount how the ailments of family members or cherished patients sent them on a personal mission to save others from a medical killer. Soaring anthems trumpet the company's humanitarian mission of ameliorating human health at home and abroad. Yet Pharmaceutical Companies seem driven by motives that they decline to trumpet, for the drug industry does far more than recoup IT'S COSTS: IT'S ANNUAL SALES OF $400-600 BILLION SPEAKS FOR THEMSELVES, ELOQUENTLY ANNOUNCING THAT PHARMACEUTICAL MAKERS ARE LIVING LARGE. THE INDUSTRY'S PROFITS, NEARLY 10 PERCENT OF ITS GROSS INCOME, EXCEEDED $65.2 BILLION IN 2008 ALONE. FOR APPROXIMATELY TWENTY YEARS PHARMACEUTICAL COMPANIES ENJOYED THE HIGHEST PROFITS OF ANY U.S. INDUSTRY. IN 2002 THE COMBINED PROFITS OF THE TEN DRUG COMPANIES IN THE FORTUNE 5000 ($35.9 BILLION) EXCEEDED THE PROFITS OF THE OTHER 490 BUSINESSES PUT TOGETHER ($33.7 BILLION). If the R&D costs are so high, and if, as http://www.phrma.org/ claims, five to ten thousand candidate drugs are investigated for every one that ultimately finds its way to the medicine cabinet, HOW CAN AN INDUSTRY BURDENED WITH WITH SUCH ASTRONOMICAL COSTS SEE ANY PROFIT, TO SAY NOTHING OF HAVING BECOME THE MOST PROFITABLE INDUSTRY ON THE PLANET? It’s simple, Drug companies don’t pay for most of their R&D you do. University research is typically subsidized by your tax dollars. Whether the university research (Harriet Washington "Deadly Monopolies" 2011 p.80-1)

(Harriet Washington "Deadly Monopolies" 2011 excerpts in CAPS

So we return to the key question: If research and development costs are more often borne by the government than by the large drug firms and if these companies deftly employ various stratagems to ward off patent expiration -- and do all this so well that their profits consistently place them at the global corporate apex – why do medications cost so much?

The prices are high because the structure of the U.S. patent system leaves us no choice but to meet their demands. (Harriet Washington "Deadly Monopolies" 2011 p.86-7)

PI-88 had been shown to work against cancer and now was ready for Phase III clinical trials, the last stage before approval and availability to the public.5

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, (Harriet Washington "Deadly Monopolies" 2011 p.96-7)

Armed with its FDA approval, KV Pharmaceutical set about recouping its investment by setting Makena’s price at $1500 a shot, ten times the price of the costliest (Harriet Washington "Deadly Monopolies" 2011 p.122-3)

example, Biederman initially reported to Harvard that he had received no payments from Johnson & Johnson in 2001, but when confronted by Grassley, he admitted having received $3,500. Johnson & Johnson, however, says that it paid him $58,169 that year. Biederman earned at least $1.6 million in consulting fees from drug makers between 2000 and 2007, but reported only about $200,000 to the university. Wilens also earned $1.6 million, but admitted this only after being apprised of Grassley's accusations.

Much more than money is at stake here. The mental health of the nation’s children hangs in the balance, because Biederman medications to young children like the thirteen-year-old son of Liza Ortiz. (Harriet Washington "Deadly Monopolies" 2011 p.128-31)

Goodwin’s defense was startling. Instead of denying that he is bankrolled by pharmaceutical companies, he claimed that he was paid by so many different drug makers—a New York Times account lists nine, including Pfizer and Novartis"—that their competing interests canceled out any bias in his promotions. This logic is obviously faulty, especially because accepting funds from pharmaceutical companies incentivizes experts to discount nondrug therapies such as the talk therapy, family therapy, and behavior modification that helped Kyle Warren far better than psychoactive pills he was subscribed. Accepting pharmaceutical company funding also tempts doctors to favor newer drugs that are still profiting under patent protection over older medications that have gone generic and become inexpensive. (Harriet Washington "Deadly Monopolies" 2011 p.134-5)

And no wonder: as you will read below, physicians who question the safety and ...

.... survey of physicians who evaluated medications for the FDA, more than a third expressed a belief that standards had dropped since 1995. ....

“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.”

The complaint of yet another evaluator is especially chilling: “In the last two years, I recommended that two drugs not be approved. They were both approved without consulting me.

“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.” (Harriet Washington "Deadly Monopolies" 2011 p.140-3)

(Harriet Washington "Deadly Monopolies" Threats to Safe (and Effective) FDA Regulation of Products Survey of CDER Reviewing Medical Officers

(Harriet Washington "Deadly Monopolies" Does $760m a year of industry funding affect the FDA’s drug approval process?

Even more significant, a close reading of the settlement reveals that Pfizer paid the fine, but only its subsidiary Pharmacia & Upjohn pleaded guilty to one criminal count of violating the U.S. Food, Drug, and Cosmetic Act by its illegal promotion (Harriet Washington "Deadly Monopolies" 2011 p.148-9)

The practice of being a medical reviewer in the pay of drug makers has grown so widespread that it has become normal. By June 2002, conflicts of interest had grown so rife that the NEIM gave up its ….

Ghostwritten (Harriet Washington "Deadly Monopolies" 2011 p.152-3)

Some medical data, however, suggested links between HRT and cancer, so Wyeth chimed in to counteract these using ghostwriters who promulgated the companies sales messages in medical journal articles. Wyeth sponsored dozens of ...

The ghostwritten articles by DesignWrite scribes followed Wyth’s instructions to “Mitigate perceived risks of hormone-associated breast cancer,” to “Promote unproven, off-label uses, including prevention of dementia, Parkinson’s disease, …. (Harriet Washington "Deadly Monopolies" 2011 p.153)

In the case of BiDil, the expiring time limit on a patent, not a negative racial animus, encouraged shabbily conducted science that greased the slippery slope into (Harriet Washington "Deadly Monopolies" 2011 p.162-3)

Pharmaceutical advertising impinges heavily on the editorial sphere of medical journals, sometimes with surprising brazenness. The drug epoetin is widely accepted for its role in prolonging survival in people with end-stage renal disease: Medicare alone spent $7.5 billion on the drug in the decade preceding 2002. Dennis Cotter is president of a nonprofit institute that scrutinizes conventional medical wisdom, and his group’s analysis suggested that epoetin’s benefits for people with end-stage renal disease were largely chimerical, based on flawed logic. In 2003, Cotter submitted an editorial that detailed his questioning of epoetin’s role to Transplantation and Dialysis, whose editor and peer reviewers agreed that it should be published. However, as the British Medical Journal reported in January 2004, Joseph Herman, Transplantation and Dialysis’s editor, rejected the piece because “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.”

After a hue and cry was raised in the medical press, the journal reversed itself and offered to publish Cotter’s work, but he demurred, preferring a less commercial venue.

Medical journals are utterly dependent upon pharmaceutical advertising, which can provide between 97 and 99 percent of their advertising revenue. By 2005, some major journals, including Consultant, Geriatrics, and American Family Physician, carried more advertising than editorial pages and glossy, full-color inserts that were longer than the journal’s longest article. This explains why medical journals themselves advertise to drugmakers, flooding the pages of pharmaceutical-industry publications such as Medical Marketing and Media to vie for the attentions of Big Pharma. The Journal of the American Medical Association (JAMA) bills itself in advertising as “a priceless audience at a price you can afford,” while the Annals boasts: “With an audience of more than 90,000 internists (93 percent of whom are actively practicing physicians), Annals has always been a smart buy.”

Pharma’s journal ads tout not only products but also its hundreds of thousands of subsidized “educational opportunities.” Drug and medical-device makers spend $2 billion annually for more than 300,000 seminars and training opportunities, often held in the Bahamas or the Caribbean. The wolfed-on-the-run free pizza for harried medical residents that the industry has so sanctimoniously forsworn bears little resemblance to the sumptuous feasts, flowing wines, chartered flights, cruises, luxurious lodgings, golfing, snorkeling, and remarkably attractive sales reps that characterize these island educational junkets.

“There’s a lot of bribery involved—the kids get pizza, the grownups get trips to Hawaii,” observed Marcia Angell, MD, professor of social medicine at the Harvard Medical School, former editor-in-chief of the New England Journal of Medicine (NEJM), and the author in 2004 of The Truth About the Drug Companies: How They Deceive Us and What to Do About It. These pedagogic playdates familiarize doctors with pharmaceutical companies’ patented products to the exclusion of cheaper and sometimes safer and more effective alternatives.

By 2000, drugmakers were paying physicians a total of $6 billion a year for trinkets, island “educational opportunities,” and financial grants for their pet projects, from golfing jaunts to clinics; this doesn’t include the speaking and consulting fees that the pharmaceutical industry pays influential and “high-prescribing” clinicians to discuss its products. “Drug companies have moved their gift-giving from drug reps to hiring ‘thought leaders’—the best drug reps of all,” says Angell. “They send experienced physicians out to give talks and ensconce them on well-paid speakers’ bureaus. Then they claim that this is education, not marketing.” (Harriet Washington "Deadly Monopolies" 2011 p.168-9)

(Harriet Washington "Deadly Monopolies" 2011 variation cited in her article "Flacking for Big Pharma Drugmakers don’t just compromise doctors; they also undermine top medical journals and skew medical research"

Business, Science Clash at Medical Journal 02/07/2004

Despite the history of flu pandemics, some Americans are wary of the flu vaccine, largely because of the swine-flu fiasco of 1976. On February 5, 1976, Private David Lewis contracted the flu at the army’s Fort Dix, New Jersey, boot camp, and within twenty-four hours he was dead.When government epidemiologists revealed that Lewis had died of a swine-flu strain and that five hundred other Fort Dix soldiers were infected,the Centers for Disease Control feared another worldwide scourge, so it advocated for mass immunizations across the nation and warned that all 220 million Americans must take the vaccine to avoid a possible pandemic, at a cost of at least $135 million.

“When lives are at stake, it is better to err on the side of overreaction than underreaction,” wrote Dr. David J. Sencer, who was then CDC director, in 2006. President Gerald Ford also wished to err on the side of caution, so he recruited Albert Sabin and Jonas Salk to lobby for rapid mass production of a treatment that the pharmaceutical manufacturers, who had an obvious financial interest in selling doses of their sera and vaccines, were happy to supply. Public service announcements and unquestioning news stories urged all Americans to immunize themselves and their families against swine flu. Yet at the October deadline, drug makers proffered not the coveted vaccines, but an ultimatum: They would sell them to the federal government only if it first indemnified the companies against any legal claims arising from the vaccines’ adverse effects. The suspicious nature of this requirement led some to wonder what might be wrong with the vaccines, but the government, its back against the wall, caved; on October 1, just eight months after Lewis’s death, vaccines were urged on Americans at doctors’ offices, places of employment, schools, firehouses, and medical centers.

But within two weeks, people began dying from heart attacks within mere hours of immunization. After inoculating 40 million people, so many had developed heart problems that the government suspended the program. No swine epidemic ever emerged, and, in fact, Lewis, was the only casualty – unless you count the people who died after developing chronic illnesses from the vaccine. They or their survivors sued the government, and faith evaporated in the government’s ability to predict pandemics and to provide a safe vaccine. (Harriet Washington "Deadly Monopolies" 2011 p.173)

Between 2003 and 2006, 720 trauma victims at thirty-two U.S. medical centers were “enrolled” in a research study to determine the efficacy of Polyheme, a patented blood substitute manufactured by Northfield Laboratories. …..

… Chief among these were “the vast and vaguely defined discretion granted to IRBs in administering these fateful regulations” and his fear that the affected communities would be duped regarding the true nature of the research into which they were conscripted. “The informed-consent dialogue in research with competent patient-subjects,” he wrote, “must be stripped of the ‘therapeutic illusion,’ which misleads patient-subjects into believing that they are receiving the most advanced and beneficial treatments available, when instead they are being asked to serve the interests of science.”

That same yeaqr Adil Shampoo, PhD, a University of Maryland professor and the editor of Accountability in Research, wrote that there may be a limited role for nonconsensual research but warned, “In ten years we’ll have abuses and people will start rethinking the rules.”

Commerce versus Consent

In this chapter I focus on the PolyHeme study as an example of the pitfalls and ethical failings of 50.24 research, but it is far from the only recent episode of investigative servitude for patients unwittingly conscripted into the studies that are often conducted in order to make or to save money for corporations.

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.

There have been many more recent instances of U.S. citizens conscripted into medical research without their knowledge of consent. In a 2001 Maryland appeals court decision, Judge Cathell condemned a Kennedy Krieger Institute study of lead levels in children whose parents were urged by staff to rent homes that the institute, which serves children with pediatric developmental disabilities, knew to be tainted with lead. The study had been approved by the IRB of John Hopkins University, with which the KKI is associated, but its design was unethical because the KKI researchers told families with young children that they would help them find lead-free housing, then referred the families to housing that they knew to be imbued with lead. The motivation was financial: the KKI was trying to determine the cheapest way to reduce the homes’ lead, and the bodies of the children were used to tritate the resultant lead exposure. Predictably, some of the children’s lead levels rose, and they were visited by a Pandora’s box of ills, including mental retardation. The court found the KKI guilty of using black Baltimore children like “canaries in a coal mine” in a veiled experiment to test lead levels.

In 1995, black and Hispanic children in Los angeles were given experimental measles vaccines without their parents’ knowledge, and that year the Medical University of South Carolina was accused of illegal human experimentation when it enrolled pregnant women in North Carolina, most of them black, in a drug-treatment research study without their knowledge, and then reported them to police as drug abusers. A year later, three New York City research institutions gave six-to–eleven-year-old black boys the cardiotoxic drug fenfluramine as part of research into genetically mediated violence.

As early as 1996, a report by the Cleveland Plain-Dealer determined that 4,154 FDA inspections of new drugs have been conducted since 1977 uncovered a dramatically broad abandonment of informed consent. The article noted, “More than half the researchers were cited by FDA inspectors for failing to clearly disclose the experimental nature of their work.” (Harriet Washington "Deadly Monopolies" 2011 p.208-13)

With millions in taxpayers’ dollars at stake, the House Energy and Commerce Committee determined to trace the fate of this fortune in tissues. But at the ensuing two-day congressional hearing to which he was summoned, Sunderland became the first NIH official ever to “take the Fifth.” After Sunderland invoked his right not to testify, the startled committee asked twenty-one drug manufacturers to supply information about their transactions with NIH researchers. In this way the committee learned of pharmaceutical-company payments to scores of NIH researchers who had not reported them as required by law.

One of these was Sunderland. An NIH ethics officer had earlier asked him whether he ahd outside consulting arrangements, and he had replied, “No.” Now the NIH was shocked to discover that Sunderland was actually under contract to Pfizer, which had paid him a total of $596,000 in fees, lectures, and travel expenses over the years.

Sunderland gave Pfizer something in return: nearly all the missing tissue samples, accompanied by their clinical data.

Perhaps “gave” is not the right verb. After he bestowed the samples on Pfizer, Sunderland is said to have received $285,000 and definitely was named coinventor of a patent titled “Nuclic Acid Molecules, Polypeptides and Uses Therfor, Including Diagnosis and Treatment of Alzheimer’s Disease.” He assigned the patent rights to Pfizer, as his contract with them required. ...

.... “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 ..

In the end, the government received nothing for its investment in the embezzled samples. …. In 2005 the NIH had adopted ethics regulations that barred all its employees from consulting for outside entities and prohibited their owning stock worth more than $15,000. Many NIH scientists took exception to the new rules, and influential scholar Richard A. Epstein, professor of law at the University of Chicago, wrote, “If the protests sound to you like the howls of a greedy biomedical elite, consider that the NIH’s policy is likely to drive qualified physicians and scientists out of the national labs where they’re most needed – and slow the pace at which treatment and cures come to market.” But his consequentialist argument ignores the chilling effect of greed such as Sunderland’s, which is what really threatens the pace of medical innovation. The case of the missing alzheimer’s samples offers the most powerful evidence that the policy is sorely needed and, if anything, overdue. We should never forget this. (Harriet Washington "Deadly Monopolies" 2011 p.258-9)

(Harriet Washington "Deadly Monopolies" 2011 p.259 incomplete)

Furthermore, their model, in which researchers and affected patients share the patents, can temper the drive for profit with the prominent interests of patients whose sacrifice made the gene discovery possible.

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. .... The United States and Europe have bred crops by selecting for traits that will maximize market performance such as hardiness, disease resistance, long shelf life, and even for shapes that ease stacking and storage, such as square tomatoes and watermelons. (Harriet Washington "Deadly Monopolies" 2011 p.264-71)

(Harriet Washington "Deadly Monopolies" 2011 p.266 not 268)

The United States and Europe have bred crops by selecting for traits that will maximize market performance such as hardiness, disease resistance, long shelf life, and even for shapes that ease stacking and storage, such as square tomatoes and watermelons. When a French naturalist named Pierre Belon drew European attention to the widespread opium use among Turk. Today, the U.N. estimates that drugs derived from plants are worth $16 billion.

The intellectual property of the Third World included medical techniques as well, as when Cotton Mather’s slave Onesimus instructed him in the method of smallpox prevention through the African practice of inserting a bit of matter from an infected person into an incision. This procedure induced mild illness, fever, and permanent immunity. Mather in turn told Dr. Zabdiel Boylston, who proved that the technique worked during the Boston smallpox epidemic of 1721, and who was praised at home and abroad as the originator of smallpox variolation. Onesimus’s name, and the role of African healers, was forgotten.

Through the 1950s, major pharmaceutical companies still sold many plant-based medicaines in tablet, liquid, and ointment form, and plants continue to provide the basis for 40 percent of the U.S. medicines in use today.

For all its storied biological diversity, Brazil, like most developing nations, has never patented a new drug. Its cultural heritage does not include monopolistic claims on living things for profit, and it lacks the technological basis for turning its biodiversity into pharmaceuticals.

But the West has mastered that technology. According to the World Intellectual Property Organization (WIPO) the growth of patents worldwide increased by 5 percent a year between 1990 and 2000. Biotechnology patents rose even more quickly, at triple this rate within the United States and by 10 percent in Europe during the same period. But the growth of these biotech patents is “highly concentrated,” because 74 percent are granted to the United States, Europe, Japan, south Korea, and China. In response to the 1980 Chakrabarty decision, nations such as as Brazil had passed laws to protect their traditional knowledge and natural resources by limiting access to their flora, but researchers often flout such laws.

A concentration of biotechnology expertise and a lust for biotech patents drive industrialized nations, while a proliferation of biological resources and a technology vacuum characterize most developing countries. This variance has set these nations on a collision course that is typified by a hallucinogenic plant that ahs been coveted by everyone from scientists to Sting.

.....

Vandana Shiva of the International Forum on Globalization writes that U.S., Japanese, and European corporations joined to design TRIPS,” which validates the rights of outsiders such as Miller who seize and patent the plants, animals, and processes of the developing world. It does not provide benefits to developing nations, because patenting is not part of the culture and practices of such technologically limited countries. Poor countries face immediate challenges to survival that tend to make blocking questionable patent claims a low priority. In short, the developing world is ill-equipped to defend its intellectual property and resources and is now bound to respect Westerns monopolies on that very property. TRIPS also makes it harder for developing countries to surmount the hurdle of the patents on expensive Western pharmaceuticals that they need. Before 1996, developing countries such as Brazil and Ecuador had the option of legally opposing patents by exercising various march-in powers. (Harriet Washington "Deadly Monopolies" 2011 p.271)

A quarter million homes collapsed in the wake of the hurricane that hit Haiti in January 2010, leaving a million people homeless. The lives of three million Haitians would never be the same. (Harriet Washington "Deadly Monopolies" 2011 p.276-9)

Between 1997 and 2003, the first seven years during which the increase in Indian farmers’ suicides was documented, there were 113,872 farm suicides, an average of 16,267 a year.

Into this natural disaster stepped Monsanto. In a 1970 partnership with the Indian government and international aid organizations, the company first encouraged (Harriet Washington "Deadly Monopolies" 2011 p.282-3)

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 (Harriet Washington "Deadly Monopolies" 2011 p.300-5)

“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 .... (Harriet Washington "Deadly Monopolies" 2011 p.302)

A lawsuit filed by the Trovan Victims Forum led the Nigerian Abuja High Court to issue an injunction halting the screening process. But the Emir of Kano persuaded the victims to drop their suit, thus paving the way for DNA testing, which resumed in April 2011. Yvonne Ndedge of Al Jazeera points out that “the subjects are poor and illiterate. They don’t understand what DNA testing is and fear it is another attempt by Pfizer to make them guinea pigs in a new drug trial.” Accordingly, some victims abandoned their claim when DNA testing was introduced as a condition of receiving payment. The abuses of the Trovan trial are inexcusable. Africa most certainly does need new and better medication, however, and some Westerners have tried to provide them. However, people in the developing world are also dying from a lack of medicines that are cheap and easy to administer. The 25 percent of sub-Saharan children who do not receive vaccines are deprived of drugs that cost a few cents a dose and are easy to deliver because they require no tests or diagnoses. Michael Kremer, PhD, the Gates Professor of Developing Societies at Harvard University, brought this inattention into sharp focus when he noted that of the 1,233 drugs licensed (Harriet Washington "Deadly Monopolies" 2011 p.304-5)

(Harriet Washington "Deadly Monopolies" 2011 p.304 not 305)

Drs. Peter Lurie and Sidney Wolfe of Public Citizen best summarized the arguments of those who disagreed. Babies lives might have been saved by using an effective medication in the comparisons, they maintained. Other critics believe that some participants in the trials may not have been given informed consent. Wendy K. Mariner of Boston University pointed out that trials such as these can be ethical only if the protocol includes a plan from the beginning to make the tested treatment available to the local population should it prove effective. But there was not, and the successful treatment was withheld after the study’s end. Yohanda J. S. Mashalla, MD, vice president of the Medical Association of Tanzania, told Scientific American that the studies sought to demonstrate in developing countries the value of a therapy that was adopted only in developed ones, compounding their exploitative nature.

Dr. Marcia Angell criticized the study’s lack of equipoise, a term that refers to the fact that because it is unethical to give a research subject a treatment that is known to be inferior to the accepted standard of care, a researcher must have genuine uncertainty about whether the substance he is testing is better or worse than the standard of care that he is using in control groups. Obviously these investigators in the African and Thai arms of the study knew the subclinical doses were not better than the clinical standard.

The Declaration of Helsinki demands that “only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo … Instead, subjects in the control group of the study must receive the best known treatment.”

In an editorial, Angell pointedly observed that the “local” treatment standard for medical research “could result in widespread exploitation of vulnerable Third World populations for research programs that could not be carried out in the sponsoring country.” She went on to compare the antiretroviral trials with the Tuskegee syphilis experiment, in which 399 black men with syphilis were tricked into a research study by being promised treatment for their “bad blood.” But they were not treated and instead were studied for forty years in an attempt to characterize the disease more extensively. She wrote,

The fact remains that many studies are done in the Third World that simply could not be done in the countries sponsoring the work. Clinical trials have become a big business, with many of the same imperatives. To survive, it is necessary to get the work done as quickly as possible, with a minimum of obstacles. When these considerations prevail, it seems as if we have not come very far from Tuskegee after all. (Harriet Washington "Deadly Monopolies" 2011 p.318-9)

(Harriet Washington "Deadly Monopolies" 2011 The Ethics of Clinical Research in the Third World

(Harriet Washington "Deadly Monopolies" 2011 Bibliography Harriet Washington Flacking for Big Pharma: Big Pharmaceutical companies don’t Just Compromise Doctors They also Undermine the Top Medical ”Harvesting Organs from Silence.” Vital Signs Emerge Magazine

Stop Poisoning Our Troops with Untested Vaccines 9 min On October 16, 2006, the Department of Defense announced that it will resume its previously court-halted anthrax vaccine.

Flacking for Big Pharma: Drugmakers don’t just compromise doctors; they also undermine top medical journals and skew medical research Harriet Washington June 3, 2011

Rand Corporation: Waiving Informed Consent: Military Use of Non-FDA--Approved Drugs in Combat

Patents Against People: How Drug Companies Price Patients out of Survival Fall 2013

Vaccines and Medical Experiments on Children, Minorities, Woman and Inmates (1845 - 2007) 12/14/2007

Non-Consenting Adults The Nuremberg Code, set up to protect the human subjects of research, is being routinely ignored. By Harriet A. Washington 01/22/2012

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