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US states begin outlawing abortions, which have been practiced legally in most societies for thousands of years; at the time of the adoption of the US Constitution, abortions before “quickening” (i.e. birth) were commonly performed. In 2010, the National Abortion Federation will explain: “The motivations for anti-abortion laws varied from state to state. One of the reasons included fears that the population would be dominated by the children of newly arriving immigrants, whose birth rates were higher than those of ‘native’ Anglo-Saxon women.” As medical procedures were developed to increase the safety of both births and abortions, medical doctors began attempting to legally exclude practicioners such as homeopaths, midwives, and apothecaries from performing abortions, in part due to legitimate medical concerns and in part to ensure that they collected the fees paid by clients for abortions. In the late 1800s, the newly formed American Medical Association (AMA) argues that abortion is both immoral and dangerous. By 1910, all but one state has criminalized abortion except where necessary, in a doctor’s judgment, to save the woman’s life. “Back-alley,” or “criminal” abortions become commonplace, often performed by untrained “practitioners” in dangerous and unsanitary conditions or by the women themselves; many women are unnecessarily killed or injured during these procedures. Though in the mid-1960s some states will begin liberalizing their abortion laws, it will not be until 1973 that abortion becomes legal throughout the United States (see January 22, 1973). (National Abortion Federation 2010)
The American Medical Association (AMA) releases an 11-minute spoken-word album (LP) featuring actor and promising conservative politician Ronald Reagan. Reagan speaks against what he and the AMA call the “socialized medicine” of Medicare, currently being considered in Congress as part of legislation proposed by Democrats Cecil King and Clinton Anderson; many refer to the legislation as the King-Anderson bill. The AMA, along with most Congressional Republicans and a good number of Democrats, has been fighting the idea of government-provided health care since 1945 (see 1962).
Socialism Advancing under Cover of Liberal Policies - Reagan begins by warning that as far back as 1927, American socialists determined to advance their cause “under the name of liberalism.” King-Anderson is a major component of the secret socialist agenda, Reagan says. “One of the traditional methods of imposing statism or socialism on a people has been by way of medicine,” he says. “It’s very easy to disguise a medical program as a humanitarian project.” No real American wants socialized medicine, Reagan says, but Congress is attempting to fool the nation into adopting just such a program. It has already succeeded in imposing a socialist program on the country by creating and implementing Social Security, which was originally envisioned to bring “all people of Social Security age… under a program of compulsory health insurance.” Reagan, following the AMA’s position, says that the current “Eldercare” program, often called “Kerr-Mills” for its Congressional sponsors, is more than enough to cover elderly Americans’ medical needs. (Author Larry DeWitt notes that in 1965, Kerr-Mills will be superseded by Medicaid, the medical program for the poor. He will write, “So Reagan—on behalf of the AMA—was suggesting that the nation should be content with welfare benefits under a Medicaid-type program as the only form of government-provided health care coverage.”) King-Anderson is nothing more than “simply an excuse to bring about what [Democrats and liberals] wanted all the time: socialized medicine,” Reagan says. And once the Medicare proposal of King-Anderson is in place, he argues, the government will begin constructing an entire raft of socialist programs, and that, he says, will lead to the destruction of American democracy. “The doctor begins to lose freedom,” he warns. “First you decide that the doctor can have so many patients. They are equally divided among the various doctors by the government. But then doctors aren’t equally divided geographically. So a doctor decides he wants to practice in one town and the government has to say to him, you can’t live in that town. They already have enough doctors. You have to go someplace else. And from here it’s only a short step to dictating where he will go.… All of us can see what happens once you establish the precedent that the government can determine a man’s working place and his working methods, determine his employment. From here it’s a short step to all the rest of socialism, to determining his pay. And pretty soon your son won’t decide, when he’s in school, where he will go or what he will do for a living. He will wait for the government to tell him where he will go to work and what he will do.” DeWitt will note that this is far more extravagant than any of the Medicare proposals ever advanced by any lawmaker: “It was this more apocalyptic version of Medicare’s potential effects on the practice of medicine that Reagan used to scare his listeners.”
Advocating Letter-Writing Campaign - Reagan tells his listeners that they can head off the incipient socialization of America by engaging in a nationwide letter-writing campaign to flood Congress with their letters opposing King-Anderson. “You and I can do this,” he says. “The only way we can do it is by writing to our congressman even if we believe he’s on our side to begin with. Write to strengthen his hand. Give him the ability to stand before his colleagues in Congress and say, ‘I heard from my constituents and this is what they want.’”
Apocalypse - If the effort fails, if Medicare passes into law, the consequences will be dire beyond imagining, Reagan tells his audience: “And if you don’t do this and if I don’t do it, one of these days you and I are going to spend our sunset years telling our children, and our children’s children, what it once was like in America when men were free.” Reagan is followed up by an unidentified male announcer who reiterates Reagan’s points and gives “a little background on the subject of socialized medicine… that now threatens the free practice of medicine.” Reagan then makes a brief closing statement, promising that if his listeners do not write those letters, “this program I promise you will pass just as surely as the sun will come up tomorrow. And behind it will come other federal programs that will invade every area of freedom as we have known it in this country, until, one day… we will awake to find that we have socialism. And if you don’t do this, and if I don’t do it, one of these days, you and I are going to spend our sunset years telling our children, and our children’s children, what it once was like in America when men were free.” (Larry DeWitt 9/2004; Beutler 8/25/2009)
The American Medical Association (AMA), in conjunction with many Congressional Republicans and some Democrats, attempts to beat back attempts to create a new government-run program to provide medical care for the elderly, to be called “Medicare.” The AMA and its political allies have fought the idea of a government-provided health care program for senior citizens since 1945, when then-President Harry Truman first suggested universal health care for all Americans.
Minimal 'Eldercare' Considered Too Much - Currently, a modest health care program for senior citizens, called “Eldercare,” is the only government coverage American seniors have. It is based on a compromise proposal written by conservative Democratic Senator Robert Kerr (D-OK) and Representative Wilbur Mills (D-AR) and signed into law by President Dwight Eisenhower. Eldercare provides government benefits only for senior citizens who can demonstrate economic need, and states that choose not to participate in the program can opt out entirely. However, the AMA considers even this truncated program far too invasive, and fiercely opposes the more sweeping “Medicare” proposal, called King-Anderson after its main authors, Senator Clinton Anderson (D-NM) and Representative Cecil King (D-CA). The legislation is mired in Congressional committees. (Time 2/19/1965; Larry DeWitt 9/2004)
WHAM - The opposition to King-Anderson is led by the Women’s Auxilary of the AMA, which is given the task of coordinating the WHAM program—Women Help American Medicine. WHAM is directly dedicated to defeating the King-Anderson bill in Congress, “a bill which would provide a system of socialized medicine for our senior citizens and seriously curtail the quality of medical care in the United States.” The public campaign consists of the usual rallies and advertisements, most funded by corporate lobbyists working for the AMA and other health care firms. WHAM accuses King-Anderson proponents of being “socialists” and warns of federal bureaucrats violently invading “the privacy of the examination room.” WHAM coordinates an extensive grassroots effort under the rubric of “Operation Hometown,” enlisting local medical societies to speak out against King-Anderson, and providing pamphlets, reprints of press releases and articles, and talking points to local physicians.
Operation Coffeecup - Operation Coffeecup is a less visible, but just as important, element of the WHAM campaign. It centers around a series of “coffee klatches,” or “impromptu” get-togethers in kitchens and living rooms across America, hosted by WHAM members. WHAM members are told to downplay the significance of the events. One instruction tells them to portray the events as nothing more than “spontaneous” neighborhood get-togethers: “Drop a note—just say ‘Come for coffee at 10 a.m. on Wednesday. I want to play the Ronald Reagan record for you.’” The attendees are shown how to write equally “spontaneous” letters to members of Congress opposing the King-Anderson bill. The letters are carefully constructed to give the appearance of real, unsolicited missives written by concerned Americans, not the product of an orchestrated lobbying effort. Each WHAM member uses a 10-point checklist to ensure that the letters cover the points needed to make the argument against King-Anderson, and are not full of boilerplate, obviously copied-over material. The program is deliberately kept quiet, for fear that the media will portray it as an attempt to manipulate public opinion.
Reagan on Vinyl - The centerpiece of the Operation Coffeecup material is a vinyl LP entitled Ronald Reagan Speaks Out Against Socialized Medicine (see 1962). The album is a 19-minute recording featuring an 11-minute address by Reagan, followed by an eight-minute follow-up by an announcer. WHAM members are assured that Reagan’s work for the organization is unpaid and voluntary, though they are not told that his father is a top AMA executive. Instead, they are told Reagan is motivated entirely by his sincere political convictions. The hope is that Reagan’s message will inspire legions of housewives to write letters demanding that King-Anderson be defeated. The AMA claims that Operation Coffeecup prompts a “legion” of responses. (Larry DeWitt 9/2004)
Exposed - In June 1962, investigative reporter Drew Pearson exposes Operation Coffeecup in his newspaper column. Pearson writes: “Ronald Reagan of Hollywood has pitted his mellifluous voice against President Kennedy in the battle for medical aid for the elderly. As a result it looks as if the old folks would lose out. He has caused such a deluge of mail to swamp Congress that congressmen want to postpone action on the medical bill until 1962. What they don’t know, of course, is that Ron Reagan is behind the mail; also that the American Medical Association is paying for it.… Reagan is the handsome TV star for General Electric.… Just how this background qualifies him as an expert on medical care for the elderly remains a mystery. Nevertheless, thanks to a deal with the AMA, and the acquiescence of General Electric, Ronald may be able to outinfluence the president of the United States with Congress.” (Larry DeWitt 9/2004; Beutler 8/25/2009)
The Medical Care Act comes into law in Canada. The legislation provides for universal public coverage of hospital and doctors’ services to all Canadians. This follows the first public health insurance plan enacted in 1947 by the province of Saskatchewan, and the passage in 1957 of the federal Hospital Insurance and Diagnostics Services Act, which ensured universal coverage for in-hospital services in provinces that met certain criteria. By 1961, all Canada’s 10 provinces had signed on. In 1962, the government of Saskatchewan passed an act requiring doctors to collect fees solely through the government-run plan. In 1964, the Royal Commission on Health Services led by former Saskatchewan chief justice Emmett Hall recommended that a national plan covering all medical costs for all Canadians be established. (staff 8/2000; Government of Canada 5/4/2007)
During a campaign debate between President Jimmy Carter (D-GA) and his Republican challenger, Governor Ronald Reagan (R-CA), Carter lambasts Reagan for his decades-long opposition to Medicare (see 1962). “Governor Reagan, as a matter of fact, began his political career campaigning around this nation against Medicare,” Carter says. Reagan counters with what author Larry DeWitt calls “a deft quip and a blatant denial.” He says, “There you go again.” When the laughter subsides, Reagan continues: “When I opposed Medicare, there was another piece of legislation meeting the same problem before the Congress. I happened to favor the other piece of legislation and thought it would be better for the senior citizens and provide better care than the one that was finally passed. I was not opposing the principle of providing care for them. I was opposing one piece of legislation versus another.” Reagan is referring to a Republican alternative called “Bettercare” that was little more than a voluntary insurance program funded by Social Security. Carter also states that Reagan had, in his career, advocated making Social Security a voluntary program, which as Carter notes, “would, in effect, very quickly bankrupt it.” Reagan had frequently advocated such a position while supporting Senator Barry Goldwater’s 1964 presidential campaign, and as recently as 1975 during his unsuccessful primary campaign for the presidency, but Reagan now denies taking such a stance: “Now, again this statement that somehow I wanted to destroy it, and I just changed my tune, that I am for voluntary social security, which would mean the ruin of it, Mr. President, the voluntary thing that I suggested many years ago was that a young man, orphaned and raised by an aunt who died, his aunt was ineligible for Social Security insurance, because she was not his mother. And I suggested that if this was an insurance program, certainly the person who’s paying in should be able to name his own beneficiaries. And that’s the closest I’ve ever come to anything voluntary with Social Security.” Though Reagan’s claims are at odds with his previous positions, his denials go virtually unchallenged in the media. (Blevin 2001; Larry DeWitt 9/2004; American Presidency Project 2009)
Actor Rock Hudson, a close friend of Ronald and Nancy Reagan, dies of Acquired Immune Deficiency Syndrome (AIDS). The virus was identified in 1983, but until now has been ignored by the Reagan administration. With the death of Hudson, Reagan will call AIDS research a “top priority” for his administration. However, Reagan immediately proposes spending cuts that would slash funding for such research. (PBS 2000)
During this period, pharmaceutical companies begin hiring fewer and fewer universities to perform the clinical research studies for their drugs, contracting instead private research firms or conducting the studies themselves. In the early 1990s, roughly 75 percent of drug companies’ clinical research budgets went to universities. By 2000, this figure drops to only 34 percent. (Peterson 11/22/2002)
Neoconservative publisher and pundit William Kristol writes a five-page memo explaining why and how Republicans can ensure the Clinton administration’s health care proposal fails. The memo warns that if the Clinton health care plan is implemented, and actually improves the lives of Americans, the success of the program would badly damage the Republican Party by improving Americans’ relationship with government. Therefore, the plan must be stopped before it can begin. The memo’s strategy will be used in the powerful “Harry and Louise” media campaign, based on TV commercials featuring an older couple who worry that the program would destroy their relationships with their family doctor. Kristol writes in part: “Passage of the Clinton health care plan, in any form, would guarantee and likely make permanent an unprecedecented federal intrusion into and disruption of the American economy—and the establishment of the largest federal entitlement program since Social Security. It’s [sic] success would signal a rebirth of centralized welfare-state policy at the very moment we have begun rolling back that idea in other areas.… The long term political effects of a successful Clinton health care bill will be even worse—much worse. It will relegitimize middle-class dependency for ‘security’ on government spending and regulation. It will revive the reputation of the party that spends and regulates, the Democrats, as the generous protector of middle-class interests. And it will at the same time strike a punishing blow against Republican claims to defend the middle class by restraining government.… Its rejection by Congress and the public would be a monumental setback for the president, and an incontestable piece of evidence that Democratic welfare-state liberalism remains firmly in retreat.” In 2009, Washington Post columnist Greg Sargent will note: “Here’s what’s striking about this. Kristol repeatedly says defeating Clinton on health care would deal a death knell to something that at the time already appeared on its way towards extinction—the ‘welfare-state,’ or the idea that government can improve the lives of the middle class. Kristol describes this idea as ‘firmly in retreat,’ in the process of being ‘rolled back,’ in need of ‘re-legitimizing.’ At the time the defeat of health care was viewed as a potential final victory over liberalism.” (Plum Line 3/2/2009; Smith 3/2/2009; Sargent 3/2/2009)
Elizabeth “Betsy” McCaughey (R-NY), a lawyer and future lieutenant governor of New York, writes a scathing analysis of the Clinton administration’s health care reform plan. The article, “No Exit,” is published in the New Republic, and sparks not only a detailed rebuttal from the Clinton administration, but numerous editorials and responses praising the article and joining in the attack. Echoing McCaughey’s arguments, Newsweek writes, “The plan would reduce the quantity and quality of health care and medical technologies by vastly expanding government’s coercive role.” McCaughey and Newsweek question the proposed creation of a seven-member “National Health Board” which will, she claims, “guess the nation’s health care needs and decree how much the nation may spend meeting them.” According to Newsweek: “Everyone would be locked into one system of low-budget health plans picked by the government. Fifteen presidential appointees, the National Quality Management Council, not you and your doctor, would define the ‘medically necessary’ and ‘appropriate’ care a doctor could give you. Escaping government control to choose your doctor or buy other care would be virtually impossible. Doctors could be paid only by the government-approved plans, at rates set by the government. It would be illegal for doctors to accept money directly from patients, and there would be 15-year jail terms for people driven to bribery for care they feel they need but the government does not deem ‘necessary.’ Government would define a minimum level of care and herd people in particular regions into dependence on the lowest-cost organization able to deliver that level. Doctors would be driven into organizations in which they would be punished financially for giving more treatment than the organizations’ budget targets permit. The primary care physician assigned to you would be, McCaughey notes, a gatekeeper with an incentive to limit your access to specialists and high-tech medicine. The premise of the Clintons’ plan is not just that government knows best, but that government knows everything relevant, including how many specialists there should be no more than 45 percent of all doctors [sic]. McCaughey says many medical students will be told that the specialties they prefer are closed, or closed to them because they are not the right race or ethnicity. Yes, the plan subordinates medical values to ‘diversity.’” Prescription drug prices would be controlled through the Department of Health and Human Services, and, McCaughey and Newsweek claim, would “certainly suppress research” that might benefit patients of incurable diseases and disorders. (Newsweek 2/7/1994)
Refuting McCaughey - The Clinton administration details the “numerous factual inaccuracies and misleading statements” contained in McCaughey’s article. The administration’s response says that doctors and patients, not “government bureaucrats” or a board of governors, will decide what treatments are “necessary and appropriate.” The government will not decide what treatments are, and are not, provided: “If anything, the ‘necessary and appropriate’ care provision in the bill delegates authority to the medical profession—rather than imposing further government bureaucracy between the patient and the doctor.” The plan will not block Americans from opting into private health care plans just as they do now, nor will it block doctors and hospitals from accepting payments from “non-approved” health care plans. Nor does the plan require doctors and hospitals “to report your visit to a national data bank containing the medical histories of all Americans,” as McCaughey writes. And the so-called “National Health Board” will not “decide how much the nation can spend on health care beginning in 1996,” as McCaughey claims. The plan will not seek to reduce quality of care in the interest of saving money, and it does not contain price controls. (White House 1/31/1994) A year later, author and columnist James Fallows will call the article “a triumph of misinformation,” and refutes McCaughey’s (and others’) claims point by point. (Fallows 1/1995)
Instrumental in Derailing Reform - The article will later be cited by House Speaker Newt Gingrich (R-GA) as “the first decisive breaking point” in the plan’s initial support; the plan will never be implemented. The article itself will spark tremendous controversy, winning the National Magazine Award while being attacked for being fundamentally inaccurate. (In 2006, the new editor of the New Republic, Franklin Foer, will apologize for his magazine having run the article.) In 2009 McCaughey will be a fellow at the conservative Manhattan Institute and will soon join the equally conservative Hudson Institute. Both are heavily funded by health care corporations. (Sarlin 5/15/2009)
Warner-Lambert launches a new campaign to aggressively promote its epilepsy drug Neurontin. To boost the drug’s sales, the company begins marketing the drug for uses that have not been approved by the FDA. (While it is legal for doctors to write prescriptions for “off-label” uses, drug companies are prohibited from promoting such uses.) The company’s discreet campaign claims the drug can be used to treat pain, headaches, Lou Gehrig’s disease, attention deficit disorder, restless leg syndrome, drug and alcohol withdrawal seizures, bi-polar disorder, and other psychiatric illnesses. (Peterson 5/15/2002; Emery 8/8/2003) One marketing executive is recorded on tape telling a sales representative, “If we are going to market Neurontin effectively, we have to do it for monotherapy, for epilepsy, also for pain and bipolar and other psychiatric uses.” (Neurontin is only approved for use in conjunction with other drugs—it is not supposed to be used monotherapeutically.)
Independent studies later suggest that the drug is not an effective treatment for some of those unapproved uses, and in some cases, Neurontin may even make a patient’s condition worse. Furthermore, patients may suffer if a doctor takes them off an effective medication so they can take Neurontin instead. (Peterson 5/15/2002) The company’s marketing campaign is so effective that by 2003, 90 percent of the drug’s $2.7 billion in sales is for uses not approved by the FDA. (Harris 5/14/2004) In addition to the promotion of off-label use, the Warner-Lambert sale representatives are instructed to press doctors to prescribe the drug at levels higher than the FDA-approved dosage. (Peterson 5/15/2002)
Marketing tactics -
Paying doctors to write favorably about the drug. In one case the company reportedly pays $303,764 to publish a textbook on epilepsy written by Ilo Leppik, a professor at the University of Minnesota. Leppik later denies that the book was a marketing tool and says the book discussed other drugs beside Neurontin. (Peterson 3/30/2003; Emery 8/8/2003)
Hiring marketing firms to help write articles favorable of Neurontin. Doctors are paid to claim authorship for the articles, which are vetted by Warner-Lambert before being submitted to a journal for publication. In one case, Warner-Lambert agrees to pay a company $12,000 per article and $1,000 to any doctor agreeing to accept authorship. (Peterson 5/15/2002)
Rewarding dozens of doctors who write a high-volume of Neurontin prescriptions with consulting or speaking contracts worth tens of thousands of dollars. By 1997, Dr. B. J. Wilder, a former professor of neurology at the University of Florida, receives almost $308,000 for speeches he gives. Six other doctors get paid more than $100,000 each. And Dr. Steven C. Schachter, a neurologist at Beth Israel Deaconess Medical Center, earns $71,477 for speaking on the drug’s off-label uses. (Peterson 3/30/2003)
Paying doctors $350 a day or more to admit sales representatives into examining rooms to meet with patients, review their medical charts, and recommend treatment. This tactic, known as “shadowing,” involves approximately 75 to 100 doctors in several Northeast states. (Peterson 5/15/2002)
Instructing sales representatives to pressure doctors to write Neurontin prescriptions for unapproved uses (see April 1996-July 1996).
David Franklin later accuses drug company Parke-Davis of instructing its sales representatives to pressure doctors to prescribe the drug Neurontin for off-label uses. This marketing tactic is part of a larger effort aimed at increasing Neurontin prescriptions for uses not approved by the FDA (see 1996-2000). “I was trained to do things and did things that were blatantly illegal,” he says. “I knew my job was to falsely gain physicians’ trust and trade on my graduate degree.… I’d tell them we had physicians across the county, some involved in clinical trials, and others who had hundreds of patients on Neurontin, all getting an extraordinary response rate. We’d make them think everyone was using it but them.… [W]e were taking people who were moderately controlled on another drug and experimenting with Neurontin. We were gambling with people’s lives.” Franklin quits after two executives pressure him to get with the program. When Franklin tells one of them that he’s leaving, the executive warns, “I can’t guarantee what is going to happen to you or your career.” (Kowalczyk 3/12/2003)
David Franklin, a former salesman for Warner-Lambert drug company, files a lawsuit alleging that Warner-Lambert is illegally marketing its drug Neurontin for non-approved uses (see 1996-2000 and April 1996-July 1996). Franklin also says that the company’s illegal promotion of the drug is resulting in state Medicaid programs spending millions of dollars on Neurontin for non-approved uses. (Peterson 5/15/2002)
A Merck official writes a memo on the question of whether the company should conduct a trial to demonstrate that Vioxx is gentler on the stomach than other painkillers. The memo notes that such a study would likely show that “there is a substantial chance that significantly higher rates” of cardiovascular problems will occur among the patients taking Vioxx. (Mathews and Martinez 11/1/2004; Bradley 4/28/2005)
Investigative reporters Jane Akre and her husband Steve Wilson are hired by WTVT-TV, the Tampa, Florida, Fox News affiliate, to become part of its “Investigators” team. They soon begin filming a report on bovine growth hormone (BGH), a controversial substance manufactured by Monsanto. Their four-part report finds that BGH poses numerous health risks to milk consumers, including the threat of cancer, and that Florida supermarket chains routinely lie to their customers about not selling milk that contains BGH. Akre and Wilson will later recall that the local station is thrilled with the report. But after Monsanto complains to Fox News chief Roger Ailes about the report, the station’s general manager, David Boylan, tells Akre and Wilson to redo their film: to include statements from Monsanto that the filmmakers know to be false, and to make other revisions to the story that contradict the facts. According to Akre and Wilson, one Fox lawyer tells them that “it doesn’t matter if the facts are true,” what matters is the size of the lawsuit Monsanto might file against WTVT and Fox. Boylan tells the filmmakers that the position of Fox Television is: “We paid $3 billion for these television stations. We will decide what the news is. The news is what we tell you it is.” Akre and Wilson revise the story some 70 times, none of which passes muster with the station or with network officials. The couple is variously suspended without pay, suspended with pay, locked out of their workspace, and offered money to “just go away.” In late November 1997, when they threaten to inform the Federal Communications Commission (FCC) of the incident, WTVT fires them. They will file a lawsuit against WTVT and against Fox Television (see August 18, 2000). (Fairness and Accuracy in Reporting 6/1998; BGH Bulletin 2004; St. Louis Journalism Review 12/1/2007) Wilson later says: “Every editor has the right to kill a story and any honest reporter will tell you that happens from time to time when a news organization’s self interest wins out over the public interest. But when media managers who are not journalists have so little regard for the public trust that they actually order reporters to broadcast false information and slant the truth to curry the favor or avoid the wrath of special interests as happened here, that is the day any responsible reporter has to stand up and say, ‘No way!’ That is what Jane and I are saying with this lawsuit.… We set out to tell Florida consumers the truth a giant chemical company and a powerful dairy lobby clearly doesn’t want them to know. That used to be something investigative reporters won awards for. As we’ve learned the hard way, it’s something you can be fired for these days whenever a news organization places more value on its bottom line than on delivering the news to its viewers honestly.” Akre will add: “We are parents ourselves. It is not right for the station to withhold this important health information and solely as a matter of conscience we will not aid and abet their effort to cover this up any longer. Every parent and every consumer have the right to know what they’re pouring on their children’s morning cereal.” (BGH Bulletin 2004) Akre and Wilson will win the Goldman Environmental Prize for their original report in 2001. (Prize 2001)
Around 2004, FBI investigators will come to believe that a version of the Ames strain anthrax known as RMR-1029 was the anthrax used in the 2001 anthrax attacks (see October 5-November 21, 2001). RMR-1029 is first developed in 1997 by Bruce Ivins, a scientist at USAMRIID, the US Army’s top bioweapons laboratory. The FBI will later claim that Ivins was the sole custodian of RMR-1029, and only about 100 other people potentially had access to it. However, after the FBI makes this claim, the New York Times will report that beginning in 1997, RMR-1029 is not stored in USAMRIID’s Building 1425, where Ivins’s laboratory is, but in the adjacent Building 1412. The Times will report, “Former colleagues said that its storage in both buildings at different times from 1997 to 2001 might mean that the bureau’s estimate of 100 people with physical access to it was two or three times too low.” (Shane and Lichtblau 9/6/2008)
Merck official Briggs Morrison sends an e-mail warning that if the company conducts a proposed trial of the drug Vioxx (see also November 21, 1996), and the subjects do not take aspirin, there will be “more thrombotic events [i.e., more blood clots] and kill [the] drug.” In response, Merck scientist Alise Reicin laments that the company is in a “no-win situation.” She suggests that people with a high risk of cardiovascular problems be excluded from the study so the association between Vioxx and thrombotic events “would not be evident.” (Mathews and Martinez 11/1/2004)
A Merck clinical trial of Vioxx conducted on 978 patients suggests the drug substantially increases the risk of serious cardiovascular events, including heart attack and stroke. Patients who take Vioxx are six times as likely to suffer heart problems than patients taking an alternative painkiller or a placebo. The study, named Study 090, is never published. Merck later says this is because the sample size was not large enough to provide statistically significant data. (US Food and Drug Administration 2/1/2001, pp. 31-34 ; Topol 2004; Bradley 4/28/2005)
According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 6.1 percent in 1998 (Colliver 12/8/2003) compared to a 1.6 percent increase in the Consumer Price Index. (InflationDate(.com) 6/22/2006)
Abbott Laboratories, maker of the drug Hytrin, agrees to pay rival drug company Zenith Goldline Pharmaceuticals up to $42 million not to produce a generic version of Hytrin, a drug for high blood pressure and prostate enlargement. For three years Abbott, whose patent on Hytrin expired in 1995, has been fighting Zenith in court to prevent it from marketing a cheaper generic. Abbott currently earns about $500 million a year on the drug. After signing its agreement with Zenith, Abbott inks a similar deal with another rival, Geneva Pharmaceuticals, agreeing to pay that company as much as $101 million to keep its generic version of Hytrin off the market. Geneva and Abbott will abandon their agreement a year later when the federal government launches an antitrust investigation. Consumers will sue Abbott and Geneva charging that the companies’ agreement cost patients hundreds of millions dollars. (Stolberg and Gerth 7/23/2000)
Merck submits its New Drug Application (NDA 21-042) to the Food and Drug Administration (FDA) for Vioxx, which is intended to treat acute pain in adults, dysmenorrhea and osteoarthritis. The drug is supposed to cause fewer gastrointestinal problems than painkillers currently on the market. The NDA includes results from clinical studies that involved 5,400 subjects. (US Food and Drug Administration 2005)
According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 7.3 percent in 1999 (Colliver 12/8/2003) compared to a 2.2 percent increase in the Consumer Price Index. (InflationDate(.com) 6/22/2006)
Omnicom, one of the world’s largest advertising firms, pays $20 million for part-ownership of Scirex, a research firm that conducts clinical studies on drugs to determine their effectiveness and safety. Thomas L. Harrison, a top executive of the company, says he expects Scirex’s studies to provide positive results for its clients in the drug industry. “Our goal is to help ensure that all clinical studies and each patient accrued into a study can be assessed to support the NDA submission.” (Peterson 11/22/2002)
Merck begins the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, involving more than 8,076 subjects. The study is being carried out by a data and safety monitoring board (DSMB) that has been appointed by Merck. The Food and Drug Administration recommends the use of DSMBs but does not require them, nor does it require that the panels are put together by an independent party. Merck appoints Michael Weinblatt of Brigham & Women’s Hospital in Boston to lead the study. Weinblatt’s wife owns $73,000 in Merck stock, which according to doctors consulted by an NPR investigation, is enough to potentially influence Weinblatt’s judgment. Furthermore, during the course of the study, all the panel’s meetings will be attended by Merck employee Deborah Shapiro, who is present even during the panel’s private deliberations. She is also the notetaker for the meetings. (National Public Radio 6/8/2006) The VIGOR study is the largest clinical trial ever performed for the drug. Half the participants is given Vioxx, while the other half is given naproxen. The study is designed to determine whether Vioxx causes fewer digestive problems than naproxen, an older painkiller. The outcome of this study is important to Merck because Vioxx’s expected characteristic of being gentler on the stomach would be the drug’s only selling point since there is no evidence that it is a better painkiller than other drugs. The FDA currently requires Vioxx to have the same warning about gastrointestinal bleeding that is carried on the Naproxen label. (Rubin 10/12/2004; Bradley 4/28/2005; Prakash and Valentine 6/8/2006)
The Food and Drug Administration approves Vioxx as a treatment for acute pain, dysmenorrhea, and osteoarthritis in adults, making the drug the second Cox-2 inhibitor available by prescription in the United States. (US Food and Drug Administration 2005)
The VIGOR study’s safety panel has its first meeting. VIGOR, or the Vioxx Gastrointestinal Outcomes Research study, was designed to determine whether Vioxx causes fewer stomach problems than other painkillers on the market (see January 1999). Results as of October 1, 1999 suggest that patients taking Vioxx experience fewer ulcers and less gastrointestinal bleeding than those taking naproxen. (Prakash and Valentine 6/8/2006)
At the VIGOR safety panel’s second meeting (see also January 1999 and October 3 or 4, 1999), panel members discuss concerns over the “excess deaths and cardiovascular adverse experiences” observed among patients taking Vioxx. (US Food and Drug Administration 2/1/2001, pp. 5 ) As of November 1, 1999, 79 patients out of the 4,000 taking the drug have experienced serious heart problems or have died, compared with 41 patients taking naproxen. Minutes of the meeting note that “while the trends are disconcerting, the numbers of events are small.” (Prakash and Valentine 6/8/2006)
The VIGOR study’s safety panel meets for a third time and learns that as of December 1, 1999, the number of Vioxx patients who have experienced heart problems or have died is twice as high as those taking naproxen. The panelists are shown a chart with two lines—one showing the number of deaths in the Vioxx group; the other, deaths in the naproxen group. The chart shows that since the sixth week of the study, the line representing the Vioxx group has been going up at an increasingly brisk pace, while the naproxen group’s line rises slower and is relatively linear. (National Public Radio 6/8/2006) Some members suggest that diverging lines could be “due to cardioprotective effects of Treatment B,” i.e., that naproxen is somehow reducing the risk of heart problems. (US Food and Drug Administration 2/1/2001, pp. 6 ) The panel’s chairman, Michael Weinblatt, and Merck statistician Deborah Shapiro write a letter to Merck’s Alise Reicin advising that the company develop a plan to study the cardiovascular results before the VIGOR study is completed. When an investigation by NPR learns about this meeting, it asks three experts to comment on the chart and the panel’s decision. All three say that the study should have been called off immediately because the chart clearly showed that the risk of heart problems among those taking Vioxx increased with time. The panel, in a statement to NPR, claims that it did not cancel the study noting that it was not clear to the panelists at the time whether the different rates of heart problems and deaths were a result of Vioxx causing the cardiovascular problems, or naproxen preventing them. But no study has ever proven that naproxen is cardioprotective. (Prakash and Valentine 6/8/2006; National Public Radio 6/8/2006)
According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 8.1 percent in 2000 (Colliver 12/8/2003) compared to a 3.4 percent increase in the Consumer Price Index. (InflationDate(.com) 6/22/2006)
In 2000, the US begins a secret project to train its special forces how to detect and disarm mobile biological weapons factories. One real mobile biological weapons factory is built, but not actually used to make weapons. US Delta Force units will use this factory in their training in the months before the 2003 Iraq war. The designer of the factory is Steven Hatfill, who will later be named as a suspect in the 2001 anthrax attacks (see October 5-November 21, 2001) before being exonerated in 2008. Hatfill’s role in making the factory is one reason why he is later suspected in the anthrax attacks, even though there is no evidence the factory makes anthrax or any other kind of biological weapon, as the different components in it are never connected. Hatfill helps build the factory while working for Science Applications International Corporation (SAIC), a contractor for the US military and the CIA. He begins gathering parts to build it in 2000, and construction begins in September 2001, at a metalworking plant near Fort Detrick, Maryland. SAIC fires him in March 2002, after he fails to get a high-level security clearance and he comes under suspicion for the anthrax attacks. But Hatfill continues to work on the half-built factory on his own, for no pay, until it is finished later that year (see Autumn 2002). The factory is commissioned in 2000 apparently because US intelligence chooses to believe the claims of an Iraqi defector named Curveball, who falsely claims that Iraq has such mobile weapons factories (see January 2000-September 2001). (Broad, Johnston, and Miller 7/2/2003)
In 2000, US military personnel are being required under the threat of court-martial to be inoculated with an anthrax vaccine. But the vaccine, known as Anthrax Vaccine Absorbed (AVA), is not working very well and some soldiers are getting sick. This results in a loud public outcry lasting into 2001. One of the key scientists working on the vaccine is future anthrax attacks suspect Bruce Ivins.
Problems - The vaccine is being made by a company known as BioPort, but in 1998 the company’s sole manufacturing plant was shut down following the discovery of problems there. Ivins is working at USAMRIID, the US Army’s top bioweapons laboratory, and he and about six other USAMRIID scientists were assigned by the Defense Department to fix the problems with the vaccine so production could resume. In a June 2000 e-mail message, Ivins writes, “Unfortunately, since the BioPort people aren’t scientists, the task of solving their problem has fallen on us.” In a July 2000 e-mail message, he writes about the inoculation program, “think the sh_t is about to hit the fan… big time… It’s just a fine mess.”
Alleged Motive - After Ivins’s suicide in 2008, government officials will theorize that Ivins was stressed out due to the vaccine crisis and started having psychological problems. It is undisputed he was having problems at this time (see April-August 2000 and September-December 2001), but officials will further theorize he grew so upset that he was driven to launch the anthrax attacks to eliminate doubts about the vaccine. Investigators will cite Ivins’s e-mail messages from August 2001 regarding ABC News reporter Gary Matsumoto, who had been pressuring Ivins to turn over copies of his notebooks detailing experiments with the vaccine. Ivins complains about Matsumoto, “We’ve got better things to do than shine his shoes and pee on command. He’s gotten everything from me he will get.”
Criticism of FBI - However, Ivins’s colleagues will later criticize the FBI’s vaccine theory. They acknowledge that there was a real threat the AVA vaccine could be pulled from the market. But they also say that Ivins and others were working on a promising new vaccine that was considered safer and more effective. Ivins’s colleague Jeffrey Adamovicz will comment, “There was a lot of consternation, a lot of pressure to rescue this thing. But if AVA failed, he had his next vaccine candidate. It was well on its way to what looked to be a very bright future.” Colleague Gerry Andrews will similarly comment, “Nothing is unimaginable… But I would definitely say [the FBI’s AVA theory] is doubtful.” The Defense Department claims at the time that the vaccine is both safe and effective. But eventually Ivins’s notebooks will be made public and they will show Ivins thought the vaccine was making some test animals sick. (Lipton 8/8/2008)
Merck says it does not want to begin developing a plan to analyze the data on the large number of deaths from heart problems that has occurred during a clinical trial for its drug Vioxx (see December 22, 1999 and November 18, 1999). Michael Weinblatt, who is heading the study, sent a request to Merck the month before asking the company to develop such a plan (see December 22, 1999). Merck suggests that they wait and combine the cardiovascular results of this study with the results from other clinical studies for the drug. But Weinblatt is adamant that the company needs to begin analyzing the data immediately, and continues discussing the matter with Merck, which finally agrees to a plan the following month (see Early February 2000). (Prakash and Valentine 6/8/2006; National Public Radio 6/8/2006)
Merck finally agrees to analyze the data on deaths that have occurred during the clinical trials for its drug Vioxx (see December 22, 1999 and November 18, 1999). The analysis was requested by Michael Weinblatt, who is leading the Vioxx study (see December 22, 1999). But Merck says it will only analyze the deaths that take place before February 10, one month before the study ends. Any deaths that occur after this “cut-off” date will not be factored into the analysis. (Prakash and Valentine 6/8/2006; National Public Radio 6/8/2006)
The VIGOR study, a clinical trial for the drug Vioxx, comes to an end (see also January 1999). The goal of the study was to determine whether patients taking Vioxx experienced fewer gastrointestinal problems than subjects taking naproxen, another painkiller. The study’s results back Merck’s claim that Vioxx is gentler on the stomach. But it also seems to confirm the suspicions of some Merck scientists that it causes cardiovascular problems (see November 18, 1999 and December 22, 1999). During the course of the 12-month study, 20 of the patients taking Vioxx died, far more than the number of deaths among the group taking naproxen. (Prakash and Valentine 6/8/2006; National Public Radio 6/8/2006) Later analyses of the data from the study find that subjects taking Vioxx were five times more likely to suffer a heart attack. (Bradley 4/28/2005)
Edward Scolnick, head of Merck’s research labs, sends an e-mail to his colleagues noting that Vioxx’s anticipated cardiovascular side effects “are clearly there… It is a shame but it is a low incidence and it is mechanism based as we worried that it was.” (Mathews and Martinez 11/1/2004; Chustecka 11/1/2004)
Merck issues a press release announcing the results of the VIGOR study (see March 2000) and saying that the study showed patients taking Vioxx experienced fewer gastrointestinal problems than patients on naproxen. Merck also says that “significantly fewer thromboembolic events were observed in patients taking naproxen.” Merck asserts that this was due to “naproxen’s ability to block platelet aggregation,” (Merck 3/27/2000) a theory for which there is no conclusive evidence. (Peterson 5/22/2001)
According to an internal company document, Merck research chief Edward Scolnick discusses possible plans to reformulate Vioxx with the company’s in-house patent counsel. The new Vioxx would contain an anti-clotting agent to reduce the risk of cardiovascular problems. The document indicates that the company’s researchers believe the current Vioxx formula inhibits the production of a substance called prostacyclin which leads to blood vessel constriction and clotting. But Merck was alerted to this problem two years before by scientist Garrett FitzGerald, who had warned the company that all Cox-2 inhibitors would likely have this effect. Merck, eager to get its drug on the market, dismissed his research (see 1998). (Associated Press 6/22/2005)
The Sunday Times reports that an inquiry has been launched into the behavior of Bayer, after revelations in a British trial regarding the anthrax antibiotic drug Cipro. The drug has been tested on hundreds despite the company having conducted studies which showed it reacted badly with other drugs, seriously impairing its ability to kill bacteria. These results are kept secret. Nearly half of those on whom the drug was tested at one test center develop a variety of potentially life-threatening infections, while data at other test centers is unknown. (Sunday Times (London) 5/14/2000)
Merck submits the results of the VIGOR clinical trial for its drug Vioxx to the New England Journal of Medicine (NEJM) for publication. The data include only 17 of the 20 deaths that occurred among patients taking Vioxx (see March 2000). (Prakash and Valentine 6/8/2006) Data concerning the last three deaths were deleted two days before, according to Dr. Gregory Curfman, executive editor of the journal, who does not discover the missing data until December 2004. “When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says ‘Merck,’” Curfman later tells Forbes magazine. (Langreth and Herper 12/8/2005)
The authors of a paper on VIGOR, a clinical study on the drug Vioxx, submit two sets of corrections to the New England Journal of Science for the manuscript they submitted in May (see May 18, 2000). They do not correct the omission of three fatal heart attacks that occurred toward the end of the study (see March 2000) after a February 10 “cut-off” date (see Early February 2000). (Prakash and Valentine 6/8/2006)
In a memo to Merck scientist Alise Reicin, Merck statistician Deborah Shapiro includes a reference to the three Vioxx deaths that occurred during the last month of the VIGOR study (see March 2000). Those three deaths—numbers 18, 19, and 20—were not included in a paper submitted to the New England Journal of Medicine in which Reicin and Shapiro are listed as authors (see May 18, 2000). (Prakash and Valentine 6/8/2006)
The FDA endorses the use of Bayer’s Cipro drug to prevent inhalation anthrax. (Reuters 7/28/2000) An official recommendation like this is highly unusual for the FDA. A 1997 Pentagon study of anthrax in rhesus monkeys showed that several other drugs were as effective as Cipro. The reason given for only recommending Cipro is the government wants a weapon against anthrax should it come up against a strain resistant to drugs in the penicillin and tetracycline families of antibiotics. (Bumiller 10/21/2001) The pharmaceutical industry spent $177 million on lobbying in 1999 and 2000—more money than any other industry. The FDA has been accused of conflicts of interest with companies including Bayer. (Wayne and Petersen 11/4/2001)
The New England Journal of Medicine publishes the VIGOR paper (see May 18, 2000) summarizing the results of a clinical trial for the drug Vioxx. The paper’s main conclusion is that patients taking the drug experienced fewer gastrointestinal complications than patients taking naproxen, another painkiller. This conclusion is important to Merck, the maker of the drug, because this is Vioxx’s only selling point. There is no evidence that Vioxx is a more effective painkiller than any other drug available on the market. But the paper’s section on “General Safety” is misleading because the authors leave out the deaths of three Vioxx patients (see March 2000). The authors were aware of the fatal heart attacks and had at least two opportunities to correct these omissions (see July 2000-November 2000). Notwithstanding their knowledge of these deaths, the authors say there is no causal relationship between Vioxx and heart problems. (Bombardier et al. 2000; Prakash and Valentine 6/8/2006) When the Journal learns about the missing deaths, executive editor Dr. Gregory Curfman, demands a correction. He tells Forbes magazine, “I was somewhere between surprised and stunned. They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health.” (Langreth and Herper 12/8/2005)
HCA Inc., the largest for-profit hospital chain in the US, reaches a settlement with the Justice Department over allegations of having defrauded the government. HCA is owned by the family of Senate majority leader Bill Frist. As part of the agreement, the company pleads guilty to 14 criminal counts and agrees to pay more than $840 million in criminal fines, civil penalties, and damages. It is the largest fraud settlement in US history. The Justice Department’s investigation found that the company had employed a variety of schemes to falsely charge or overcharge for services provided to patients covered by federal health plans. HCA billed Medicare, Medicaid, and other federal health care programs for lab tests that were not medically necessary or ordered by physicians. It billed the government for non-reimbursable expenses by disguising them as reimbursable “community education” expenses or as “management fees.” Other violations included using incorrect diagnostic codes when billing the government in order to increase its revenue, billing for services rendered to patients who did not qualify to receive them, and billing for services that were never performed. Of the total amount settled upon, $95 million is for violations committed by two HCA subsidiaries, Columbia Homecare Group Inc. and Columbia Management Companies Inc. The two companies had engaged in cost report fraud, fraudulent billing, paying kickbacks to doctors for referrals, and paying kickbacks in connection with the purchase and sale of home health agencies. (CBS News 12/14/2000; US Department of Justice 12/14/2002) Not all of the Justice Department’s allegations are resolved in the settlement. In spring 2003, HCA will reach another settlement over allegations of fraudulent cost reporting and kickbacks to physicians for referrals (see June 26, 2003).
Merck’s sales force develops a flash-card game called “Dodge Ball Vioxx” to help train Merck sales representatives on how to respond to certain questions and concerns that doctors might have about Vioxx. (Ben-Yehuda 1/31/2005) The game includes a 12-page list of obstacles including some questions concerning the association between Vioxx and heart problems. One of them is, “I am concerned about the cardiovascular effects of Vioxx.” In the summer of 2005, a former Merck sales woman tells CBS 60 Minutes that when faced with that question, the company said representatives should say the drug does not cause heart problems. “We were supposed to tell the physician that Vioxx did not cause cardiovascular events; that instead, in the studies, Naproxen has aspirin-like characteristics which made Naproxen a heart-protecting type of drug where Vioxx did not have that heart-protecting side,” she said. According to the FDA, there is no evidence that Naproxen has such properties. (Bradley 4/28/2005)
Merck files a patent application with the US Patent Office for a drug that would contain a combination of Vioxx and an anti-clotting agent, or thromboxane inhibitor. The new drug would hopefully reduce the risk of cardiovascular problems while preserving Vioxx’s gastrointestinal benefits. Merck never develops the drug. Critics later note that Merck’s interest in this new drug contradicted its assertions that Vioxx was safe for the heart. (Associated Press 6/22/2005)
According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 11.2 percent in 2001 (Colliver 12/8/2003) compared to a 2.8 percent increase in the Consumer Price Index. (InflationDate(.com) 6/22/2006)
According to the US Census Bureau, between 2001 and 2004 the number of uninsured Americans increases by 5 million to 45.8 million, or 15.7 percent of the country’s total population. (US Department of Commerce 8/2005, pp. 16-17 ) The increase is blamed on a poor economy, budget cuts to the Medicaid program, and a more than 50 percent increase in insurance premiums. (Connolly 10/22/2004; Pugh 2/24/2005)
The Food and Drug Administration holds an advisory meeting on the VIGOR study, a clinical trial for the drug Vioxx, to assess whether there is a connection between the drug and heart problems. Unlike the VIGOR study published in the New England Journal of Medicine (see November 23, 2000), this group includes heart attacks 18, 19, and 20 (see March 2000) in their analysis. The meeting’s members conclude that there is not enough data to draw a solid conclusion. (US Food and Drug Administration 3/8/2001; Prakash and Valentine 6/8/2006) Notwithstanding, they do recommend that physicians be informed that the VIGOR study showed “an excess of cardiovascular events in comparison to naproxen.” (Office of Representative Henry A. Waxman 5/5/2005, pp. 21 ) On March 7, the agency publishes all of the VIGOR data on its website, as well as its analysis. (US Food and Drug Administration 3/8/2001)
Fearing increased public concern over the safety of Vioxx, Merck sends its sales representatives a bulletin instructing them in all capital letters: “Do not initiate discussions on the FDA Arthritis Advisory Committee… or the results of the… VIGOR study.” The previous day, an FDA panel (see February 8, 2001) reviewed the results of the VIGOR study and said physicians need to be informed that Vioxx appears to cause “an excess of cardiovascular events in comparison to naproxen.” The Merck bulletin provides a list of responses that its representatives are authorized to use in addressing physicians’ concerns. It emphasizes that these are the only responses they are allowed to use. If doctors ask about Vioxx’s effects on the heart, sales persons should say, “Because the study is not in the label, I cannot discuss the study with you.” However, as a report by Henry A. Waxman notes, drug company representatives are permitted by FDA regulations to discuss safety concerns even when those concerns are not on the label. The sales persons are also advised to tell physicians to submit their questions in writing to Merck’s medical services department. Merck says reps can also show the physicians the Cardiovascular Card, a pamphlet consisting of data that appears to show that Vioxx is safe (see April 28, 2000). The bulletin indicates that sales reps are not supposed to leave the pamphlet with the doctor. (Merck 2/9/2001 ; Office of Representative Henry A. Waxman 5/5/2005, pp. 22 )
In a 7 to 3 vote, an FDA advisory panel recommends approving the antibiotic Ketek, also known as telithromycin, for use in treating streptococcus pneumonia. But the panel does not recommend approving it for use against acute chronic bronchitis, sinusitis, or penicillin-resistant or erythromycin-resistant strep. The panel also recommends conducting additional clinical trials to “see if hints of concern… are real or not” about the drug’s potential side affects on the heart and liver. (Associated Press 4/26/2001)
The New York Times reports the results of the VIGOR study (see March 2000), which showed that Vioxx, marketed by Merck, increases the risk of heart attacks four-fold (later studies increase this to five-fold). The Times also reports Merck’s interpretation of the results—that the different number of heart attacks suffered by patients taking Vioxx compared to those using naproxen was due to the heart-protective properties of naproxen. But no studies have been done showing that naproxen prevents heart attacks, says Dr. Maria Lourdes Villalba, an FDA scientist who was interviewed by the newspaper. Another scientist, Dr. M. Michael Wolfe, chief of the gastroenterology section at the Boston University School of Medicine, says people need to know about these risks. “The marketing of these drugs is unbelievable. I’m sure there are many people out there who are taking these drugs that should not be,” he says. Another concern noted is that the very same people who are likely to take the drug—elderly people with arthritis—are the ones with the highest risk of having heart problems. (Peterson 5/22/2001)
Merck issues a press release titled “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx” asserting that there is no evidence that patients taking the prescribed dosage levels of Vioxx have an increased risk of having heart problems. It says that the higher number of heart troubles experienced by patients taking Vioxx compared to naproxen during the VIGOR study (see March 2000) was likely because naproxen has similar properties to aspirin, which is known to prevent heart attacks. (Merck 5/22/2001) The FDA later issues a warning to Merck calling this press release “simply incomprehensible, given the rate of MI and serious cardiovascular events compared to naproxen” (see September 17, 2001). (US Food and Drug Administration 9/17/2001, pp. 1-2 )
The same day the New York Times publishes an article (see May 22, 2001) raising questions about the safety of Vioxx, Merck sends a bulletin to its sales representatives instructing them in capital letters: “Do not initiate discussions on the results of the… VIGOR study, or any of the recent articles in the press on Vioxx.” The bulletin says that if physicians ask any questions about the cardiovascular safety of Vioxx, sales reps should refer to the “Cardiovascular Card” (a marketing pamphlet on the safety of Vioxx, see April 28, 2000), request that Merck’s “Medical Services” staff fax or Fedex additional information to the doctor, or respond appropriately “in accordance with the obstacle-handling guide.” (Merck 5/22/2001 )
The FDA informs Aventis that it will not approve the drug Ketek until the company has provided enough information to determine the drug’s safety profile. (Aventis 6/4/2001) In April, an FDA advisory board recommended additional clinical studies for the drug because of concerns about potential side effects on the heart and liver (see April 26, 2001).
Ann-Marie Lynch, deputy assistant secretary in the office of policy at the Department of Health and Human Services, allegedly blocks the release of several government reports that contradict claims made by the drug industry. One of them is a 2001 report stating that involvement of private health companies in Medicare’s prescription-drug benefit programs would lead to higher prices and would not work well in rural areas. (Mulkern 5/23/2004)
An new analysis of data from the VIGOR study (a clinical trial for Vioxx, see January 1999) along with data from a clinical trial of the drug Celebrex, and two smaller studies, raises concerns that COX-2 inhibitors may cause cardiovascular events. The study, published in the Journal of the American Medical Association, concludes that “it is mandatory to conduct a trial specifically assessing cardiovascular risk and benefit of these agents.” The authors are cardiologists Debabrata Mukherjee, Steven Nissen, and Eric Topol. (Mukherjee, Nissen, and Topol 2001; Prakash and Valentine 6/8/2006)
The Food and Drug Administration faxes a warning letter to Raymond Gilmartin, the CEO of Merck, accusing the company of conducting a deceptive promotional campaign for its drug Vioxx. The eight-page letter, referring mostly to events that took place between June 2000 and June 2001, states: “You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the VIOXX Gastrointestinal Outcomes Research (VIGOR) study (see March 2000), and thus, misrepresents the safety profile for VIOXX. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen).… You assert that Vioxx does not increase the risk of MIs and that the VIGOR finding is consistent with naproxen’s ability to block platelet aggregation like aspirin. That is a possible explanation, but you fail to disclose that your explanation is hypothetical, has not been demonstrated by substantial evidence, and that there is another reasonable explanation, that Vioxx may have pro-thrombotic properties [i.e., cause heart attacks]. You have also engaged in promotional activities that minimize the Vioxx/Coumadin (warfarin) drug interaction, omit important risk information, make unsubstantiated superiority claims against other NSAIDS, and promote Vioxx for unapproved uses and an unapproved dosing regimen.… Your minimizing these potential risks and misrepresenting the safety profile for Vioxx raise significant public health and safety concerns.” The letter also warns the company about a May 2001 press release (see May 22, 2001), which claimed the drug has a “favorable cardiovascular safety profile.” (US Food and Drug Administration 9/17/2001, pp. 1-2 )
An expert panel convened by the National Science Academy’s Institute of Medicine issues a report recommending a number of changes to how the FDA regulates the drug industry. The proposed changes are unanimously endorsed by the panel, comprised of 15 experts from academic and professional organizations. Some of the recommendations include:
The FDA should implement a moratorium on direct consumer advertising of recently approved classes of drugs until enough aggregate data is available to confirm the drugs’ safety. Packaging for such medications should have a special symbol imprinted on them alerting consumers to the higher risk associated with new medications.
The FDA should be required to reevaluate the safety and effectiveness of drugs at least once every five years after the drug has been approved. The agency’s current system for monitoring drug safety post-approval is far less effective than pre-approval testing. The report notes that there is a history of fierce disagreements between the FDA’s Office of Drug Safety and the agency’s Office of New Drugs.
The FDA should be given new powers to impose fines, injunctions, and withdrawals when drug companies fail to complete the required safety studies.
The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe.
The government should require drug companies to register all clinical trials they sponsor in a government-run database so patients and physicians can review all studies. Currently, only those studies published in medical journals are accessible to the public, and these tend to be the studies that produce the most favorable results for the drug being tested.
Expert advisory panels should not be loaded with industry-connected scientists. Most of the members making up these panels should be free of industry ties. “FDA’s credibility is its most crucial asset, and recent concerns about the independence of advisory committee members… have cast a shadow on the trustworthiness of the scientific advice received by the agency,” the report says. (Institute of Medicine 9/22/2006; Vedantam 9/23/2006; Harris 9/23/2006)
On September 22, 2001, an employee at the New York Post gets a blister on her finger. She will later test positive for cutaneous anthrax. Six others get sick from anthrax on September 26, 27, and 28, and October 1, including an assistant to NBC News anchor Tom Brokaw. But most of these cases their only visible symptoms are minor skin lesions. None of these cases are seen as anthrax infections at the time. On September 30, Robert Stevens, an employee at the tabloid The Sun, starts to feel ill. He will later die of the more serious inhalation anthrax (see October 4, 2001 and Shortly Afterwards and October 3, 2001). Only in the days right after his death will these earlier cases be properly diagnosed and linked to the anthrax letters. (South Florida Sun-Sentinel 12/8/2001)
The New York Times publishes an article by Sheryl Gay Stolberg entitled, “Some Experts Say US Is Vulnerable to a Germ Attack.” The article claims that the US “is inadequately prepared to confront bioterrorist attacks, according to a broad range of health experts and officials. The nation must develop new vaccines and treatments, they say, but it must also fortify its fragile public health infrastructure, the first line of defense in detecting and containing biological threats.” It further notes that since 9/11, “much of the discussion about bioterrorism has centered on a shortage of antibiotics and vaccines. But the bigger problem, officials agree, is a lack of basic public health infrastructure and preparedness that could thwart a terror attack or limit its effects. Doctors are poorly trained to recognize symptoms of infection with possible biological weapons, like plague and anthrax, which can resemble the flu.” Asha George, an expert on biological warfare, says, “We are not going to have a bomb fly out of the sky and land on somebody so that we can say, ‘Look, there’s a bomb, and we are all dying of anthrax.’ It is most likely going to be a covert release, and people will get sick and go to their hospitals, and the public health system will have to pick up on this.” Ironically, at the time this article is published, the 2001 anthrax attacks (see October 5-November 21, 2001) have already begun and some people have started to get sick but have not been properly identified as having anthrax infections (see September 22-October 2, 2001). The article notes that since shortly after 9/11, the Centers for Disease Control and Prevention have alerted state and local health departments to look for signs of illnesses that could be from a chemical or biological attack. The article also notes, “In the wake of the [9/11] attacks, some members of the public have developed intense fears of germ warfare, and are trying to stock up on their own supplies.” (Strolberg 9/30/2001)
Aventis contracts Pharmaceutical Product Development, Inc. to do a clinical trial for Ketek, an antibiotic designed to treat respiratory infections. The trial, named “Study 3014,” is being done because of FDA concerns (see Early June 2001) about possible links to heart and liver problems. The company pays doctors $400 for each patient they enroll in the study. Some of the doctors—a bit overzealous in recruiting patients—forge signatures, sign up family members, and invite patients into the study who do not have infections. There are also problems with the way some of the doctors collect and record their data. One doctor, who enrolls 251 patients, does not follow the study’s instructions and fails to report adverse drug reactions. Another physician, Dr. Maria Anne Kirkman-Campbell, who runs a weight-loss clinic, signs up 407 patients—but only 10 percent of them actually take the drug. These problems are discovered by FDA inspectors in fall 2002. (ABC 1/14/2006; Mathews 5/1/2006 )
After the October 2001 anthrax attacks (see October 5-November 21, 2001), government spending on bioweapons research skyrockets. For instance, the National Institutes of Health (NIH) spends $53 million on bioweapons research in 2001 and more than $1.6 billion in 2008. A total of more than $20 billion is spent on the field of research in the US from 2001 to 2008. When all projects underway in 2008 are completed, there will be ten times more space for working with the most dangerous substances, and thousands of additional scientists are working with deadly bioweapons agents. In 2008, research scholar Elisa Harris will comment that this surge in research using deadly germs “suggests that our biodefense program risks creating the very threat it is meant to fight.” (Harris 8/11/2008)
On October 2, 2001, Robert Stevens, a photo editor at the tabloid The Sun, arrived at a Florida hospital with a 102-degree fever and vomiting. He quickly got worse. The next day, doctors determine he has been infected with anthrax. He is put on a respirator. On October 4, Florida doctors and officials hold a press conference to confirm that a patient has anthrax, but that they believe it is an isolated case. On October 5, Stevens is pronounced dead, becoming the first person in the US to die from anthrax since 1976. One of Stevens’s coworkers, Ernesto Blanco, has been hospitalized with pneumonia since October 1, but it will not be discovered that Blanco also has anthrax until shortly after Stevens’s death. (South Florida Sun-Sentinel 12/8/2001) Health and Human Services Director Tommy Thompson tells reporters that the Stevens infection is “an isolated case” that is “not contagious.” Thompson reassures the public, “There is no terrorism” involved in Stevens’s infection. He also asserts that Stevens was infected from an environmental source, saying, “We do know that he drank water out of a stream when he was traveling to North Carolina last week.” It is unclear whether Thompson is misinformed or being deliberately deceptive. (Harnden and Fenton 10/5/2001; Rich 2006, pp. 34)
The Canadian government overrides Bayer’s patent for the anthrax antibiotic Cipro and orders a million tablets of a generic version from another company. The US government says it is not considering a similar move. Patent lawyers and politicians state that adjusting Bayer’s patent to allow other companies to produce Cipro is perfectly legal and necessary. (Harmon and Pear 10/19/2001) The New York Times notes that the White House seems “so avidly to be siding with the rights of drug companies to make profits rather than with consumers worried about their access to the antibiotic Cipro,” and points out huge recent contributions by Bayer to Republicans. (Bumiller 10/21/2001)
The Boston Globe reports that the FDA is considering the validity of the pharmaceutical industry’s argument that the agency’s regulation of drug advertisements violates manufacturers’ “free speech” rights. The inquiry is being led by FDA Chief Counsel Daniel E. Troy, who represented drug companies before being appointed to the FDA position in August 2001 (see August 2001). (Dembner 10/19/2002)
The Bayer Corporation, holders of the US patent on the anthrax antibiotic Cipro, agrees with the US to reduce the price of Cipro in the US from $1.83 to 95 cents. Analysts say the price reduction will reduce Bayer’s profit margin from 95% to 65%. This reduction applies only to sales to the US government, not sales to the public. (Wayne and Petersen 11/4/2001) Bayer has allowed no other companies to produce or import Cipro into the US. Other countries with less stringent patent laws sell Cipro for 1/30th the US price, and have offered to import large quantities into the US. (Bradsher 10/21/2001) Nevertheless, a class action suit by over one million Americans has been filed against Bayer and two other companies, alleging that Bayer has paid $200 million to two competitors to not make generic versions of Cipro. (Lieff Cabraser Heimann & Bernstein 10/25/2001) The profits from Cipro are considered a “lifesaver” for Bayer, which had been considering pulling out of pharmaceuticals altogether. (Kelso et al. 10/31/2001)
The New York Times reports that health officials and experts believe numerous other drugs are as effective as the antibiotic Cipro in combating anthrax. “Several generic antibiotics, including doxycycline, a kind of tetracycline, and various penicillins, are also effective against the disease,” and they all are in plentiful supply. (Abelson and Pollack 10/23/2001) A 1997 Pentagon study of anthrax in rhesus monkeys showed the other drugs to be equally effective. But Cipro remains the only drug officially recommended by the FDA (see July 27, 2000). (Bumiller 10/21/2001)
According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 14.7 percent in 2002 (Colliver 12/8/2003) compared to a 1.6 percent increase in the Consumer Price Index. (InflationDate(.com) 6/22/2006)
Mark Colombo, 57, is told by a heart specialist at Redding Medical Center in California, that he needs a double bypass surgery. When he asks a surgeon for a second opinion, he is told the problem is so severe that he shouldn’t go home until after it has been done. The following day, he undergoes surgery. But months later, a Sacramento cardiologist tells him the operation was probably not necessary. In 2004, Colombo, along with more than 769 other heart patients, will sue Tenet Healthcare Corp., which owns the hospital, and settle for $395 million (see December 21, 2004). The company had allegedly performed hundreds of unnecessary bypass surgeries and other medical procedures between 1992 and 2002. (Wallack 12/22/2004)
A training manual for Merck’s marketing force recommends that sales representatives think of people like Helen Keller, Martin Luther King, Tiger Woods, and George Washington when they are faced with a doctor who is a hard sell. “Martin Luther King could have laid low when his home was firebombed,” the manual states, suggesting that like MLK, the Vioxx sales representatives should never back down. (Merck 1/2002 )
Beginning no later than January 2002, Merck provides its sales staff with detailed information on the prescribing habits of individual doctors, or as they like to call them, “customers.” The data—purchased by Merck from an outside company—allows sales representatives to see how many prescriptions each of their customers writes for any given medication. The sales person can see which customers are prescribing large quantities of Merck drugs and which ones aren’t, indicating to the rep which customers need to be worked on the most. Furthermore, each doctor has a “Merck Potential,” which is a “dollar estimate of each prescriberÃÂ¢ÃÂÃÂs total prescribing volume that can realistically be converted to Merck prescriptions.” Bonuses for reps are based on the overall sales and Merck market shares for their respective sales territories. So the more Merck drugs their customers prescribe, the more money they make. (Merck 1/2002 ; Office of Representative Henry A. Waxman 5/5/2005, pp. 13-14 )
The Bush administration decides to drop its plan to nominate Dr. Alastair J. J. Wood as commissioner of the Food and Drug Administration. An article recently posted on the conservative National Review Online’s website warned that Wood is not friendly to industry interests. “The people I know in clinical pharmacology, in the research trenches, went berserk when they heard about Wood,” wrote Robert Goldberg, a senior fellow at New York’s Manhattan Institute, a free-market think tank. Goldberg said the doctor is overly obsessed with drug safety and asserts, falsely, that Wood is “a buddy of Senator Ted Kennedy.” The attack on Wood was continued in the editorial pages of the Wall Street Journal six days later in a piece titled “It’s Not Ted’s FDA.” Shortly after the publication of these articles, the White House calls Wood to inform him that the administration is no longer considering his nomination for commissioner, a post that has been vacant for more than a year. Republican Senator Bill Frist—the person who had recommended Wood’s nomination—tells the Boston Globe that the White House was concerned that Wood “put too much emphasis on the safety.” Wood’s track record was evidence that he might take an aggressive approach to regulating drugs. He previously called for an independent board to investigate potentially deadly drugs. The current policy is to allow the drug companies to do their own studies on adverse drug reactions and then provide these results to the FDA. Wood has also said that he believes the current FDA regulatory process has an inherent conflict of interest because the same department that approves drugs is also in charge of reviewing the safety of those drugs post-approval, a criticism that is shared by at least one FDA insider (see November 18, 2004). Furthermore, in May 2001, Wood supported making three allergy prescription drugs—Pfizer’s Zyrtec, Schering-Plough’s Claritin, and Aventis’s Allegra—available over-the-counter (OTC). The companies were opposed to the idea because OTC drugs are often sold at lower prices and are not typically covered by insurance. During a panel discussion on the issue, Wood had noted, “What we have today is an unseemly parade of people trying to protect their own financial interests.” (Kranish 5/27/2002)
After six months of negotiations, Merck and the FDA finally agree on the text for a warning about Vioxx’s cardiovascular side effects that will be added to the drug’s label. The FDA had wanted to include a clear message that Vioxx increases the risk of heart problems since the current version of the label includes no information about such risks. An excerpt from the FDA’s originally proposed text reads: “VIOXX should be used with caution in patients at risk of developing cardiovascular thrombotic events… . The risk of developing myocardial infarction in the VIGOR study was five-fold higher in patients treated with VIOXX 50 mg (0.5 percent) as compared to patients treated with naproxen (0.1 percent).…” The FDA also wanted to include a graph showing that the risk of heart problems increases with continued exposure to the drug. Merck objected to the FDA’s proposals. It insisted that a description of the cardiovascular risks be included in the “Precaution” section of the label, instead of the more severe “Warning” section, as proposed by the FDA. The company also wanted to include results from several disparate clinical studies that had been conducted prior to the drug’s release. These are the same tests that are cited in the “Cardiovascular Card” that Merck sales people show to doctors (see April 28, 2000). But the FDA objected, telling the company that the studies were “trials of different design, size, and duration, using different doses of VIOXX and different comparators” and therefore did not provide useful data for determining the drug’s cardiovascular risk. The FDA eventually concedes to several of Merck’s requests. The final text of the warning is included in the “Precaution” section of the label, as Merck wanted, and does not include the graph that had been requested by the FDA. The text of the cautionary statement is also watered down. The section summarizing the results of the VIGOR study (see March 2000) and two other studies states: “The significance of the cardiovascular findings from these 3 studies (VIGOR and 2 placebo-controlled studies) is unknown.” (Merck 2001; US Food and Drug Administration 1/30/2002 ; US Food and Drug Administration 2005; Office of Representative Henry A. Waxman 5/5/2005, pp. 16-19 )
The Journal of the American Dental Association publishes a study concluding that Bextra, a new drug manufactured by Pharmacia, offers relief to the acute pain patients feel after dental surgery. (Daniels et al. 2002) Just six months before, the FDA investigated the claim and found no evidence to support it. (Peterson 11/22/2002) Bextra is only approved to treat pain caused by arthritis or painful menstrual cycles. (US Food and Drug Administration 11/22/2002) During the three-month period following the article’s publication, Bextra sales increase by 60 percent. It is later learned that the authors of the article were not independent scientists, but rather employees of Scirex, a research company owned partially by Omnicom, one of the world’s largest advertising firms. When the New York Times asks three doctors to review the Scirex article, the doctors say its conclusions are not persuasive. “All three said that one of Scirex’s conclusions was insignificant: that one dose of Bextra worked longer than a single dose of a medicine containing oxycodone and acetaminophen, a combination often sold under the brand name Percocet. Patients rarely receive just one dose of that combination drug, the doctors said, because it wears off in four to six hours.” One of the doctors, Eric J. Topol, says the studies cited in the article make “a contrived comparison.” He notes that patients in the study had an average age of 23, which is not representative of the age group that would mostly likely use the drug. Judy Glova, a spokeswoman for Pharmacia, denies in a statement to the New York Times, that the article was an attempt to bypass the FDA regulation. And Pat Sloan of Omnicom insists the company has “nothing to do with the design of clinical studies.” (Peterson 11/22/2002)
Dr. Michael Podell, a medical researcher with Ohio State University, gives up his tenured position and a $1.7 million research project after being targeted for harassment by activists with the animal rights group People for the Ethical Treatment of Animals (PETA). Podell used cats in his research, which focused on why drug users succumb more quickly to AIDS. After PETA put Podell on its “action alert” list, PETA activists sent Podell almost a dozen death threats, including a photograph of a British scientist whose car had been bombed with the words, “You’re next,” scrawled across the top. (Beirich and Moser 9/2002)
The FDA begins blocking consumer lawsuits against drug manufacturers and asking attorneys working for drug companies to notify the agency of such lawsuits so it can intervene on their behalf. The agency’s chief counsel, Daniel E. Troy, asserts that consumers cannot sue drug companies over drugs that the agency has approved because FDA decisions on the safety of drugs are absolute and cannot be challenged by any state court. According to the FDA, allowing such lawsuits to proceed would “undermine public health” and disrupt the FDA’s regulation of drugs by encouraging “lay judges and juries to second-guess” FDA experts. Furthermore, the Bush administration argues, lawsuits “can harm the public health” because they may cause companies to remove products from the market or to overstate the risks, possibly resulting in the “underutilization of beneficial treatments.” The policy of prohibiting consumers from suing drug companies, according to the FDA, is meant to protect consumers. This policy differs sharply with the agency’s past practice, which allowed states to adopt stricter standards. But the FDA’s new claim that it has absolute jurisdiction over the question of drug safety preempts state involvement in the regulation over drugs. (Pear 7/25/2004) The Boston Globe notes that this policy allows the White House to “use its administrative and legal powers to change the regulatory terrain without taking the often arduous course of asking Congress to change the law.” (Kranish 12/22/2002; Pear 7/25/2004)
According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 10.1 percent in 2003 (Colliver 12/8/2003) compared to a 2.3 percent increase in the Consumer Price Index. (InflationDate(.com) 6/22/2006)
Aventis announces that the FDA has again declined to approve the company’s antibiotic drug Ketek, citing the need for additional analyses and information pertaining to Study 3014 (see October 2001-Fall 2002). (Aventis 1/27/2003)
CIA Deputy Director John McLaughlin’s executive assistant sends a memo to Tyler Drumheller requesting that he look into the whereabouts of Curveball. McLaughlin wants to be certain that Curveball won’t pop up after Colin Powell’s UN speech (see February 5, 2003) and say something to the press that would contradict the information presented by Powell. “[W]e want to take every precaution against unwelcome surprises that might emerge concerning the intel case; clearly, public statements by this emigre, press accounts of his reporting or credibility, or even direct press access to him would cause a number of potential concerns,” the memo states. (Isikoff and Corn 2006, pp. 183) Drumheller is astonished to learn that Powell’s presentation will include a claim that Iraq’s mobile bioweapons labs can create enough toxins “in a single month to kill thousands upon thousands of people.” Drumheller recognizes the claim as originating with the Iraqi defector Curveball (see November 1999). Drumheller meets with McLaughlin, who promises an immediate investigation. What McLaughlin does or does not do is unclear, but Powell never hears about Drumheller’s objections. UN weapons inspector David Kay will later note, “[A]ll the fine-grained stuff that might have caused [Powell] not to use it, he wasn’t given an opportunity to hear firsthand.” (McLaughlin will later deny that Drumheller ever warned him about the Curveball intelligence: “If someone had made these doubts clear to me, I would not have permitted the reporting to be used in Secretary Powell’s speech.”) (Unger 2007, pp. 281, 283)
James Haveman, a 60-year old social worker and the director of a faith-based international relief organization, is recommended by the former Republican governor of Michigan, John Engler, to run Iraq’s health care system. Haveman earned Engler’s approval by running a large Christian adoption agency in Michigan that pushed pregnant women not to have abortions. Engler recommends Haveman to Paul Wolfowitz, the deputy secretary of defense; Haveman is soon dispatched to Baghdad to oversee the rebuilding of Iraq’s health-care system.
Replacing the Expert with the 'Loyalist' - Wolfowitz orders the immediate firing of Dr. Frederick Burkle, who worked the issue during the invasion. Unlike Haveman, Burkle has extensive experience in such areas: he has multiple degrees in public health, taught disaster-response issues at Johns Hopkins University, and is currently a deputy assistant administrator for the US Agency for International Development (USAID), who sent him to Baghdad in the days after the invasion. Burkle has extensive experience working in postwar climates such as Kosovo, Somalia, and Iraq after the 1991 Persian Gulf War. A USAID colleague will call him the “single most talented and experienced post-conflict health specialist working for the United States government.” However, Burkle lacks the Republican political connections. A USAID official tells Burkle that the White House wants a “loyalist” in the job, and Haveman fits the bill.
Anti-Smoking Campaigns, Fee-Based Care - Haveman’s tenure is marked by voluble recitations of how well the reconstruction is going: he tells anyone who will listen about how many Iraqi hospitals have reopened and about the pay raises Iraqi doctors have received. He refuses to discuss how decrepit most Iraqi hospitals still are, or the fact that many of Iraq’s best doctors are fleeing the country. Haveman mounts an aggressive anti-smoking campaign (and appoints a closet smoker to head it), ignoring comments that Iraqis have far bigger dangers in their lives than tobacco and recommendations that CPA funds might better be spent trying to combat fatal maladies running rampant through Iraqi populations. Haveman, a conservative ideologue, is offended by the idea that health care in Iraq is free. He institutes a fee-based health care system instead. Most importantly, he allocates almost all of the Health Ministry’s share of US reconstruction funds—some $793 million—to renovating Iraqi maternity hospitals and building community medical clinics. He later explains that his goal is “to shift the mind-set of the Iraqis that you don’t get health care unless you go to a hospital.” Unfortunately, his decision means that no funds are available to reconstruct emergency rooms and operating theaters in Iraqi hospitals, which are being overrun with injuries from insurgent attacks.
Privatizing the Drug Supply Distribution Process - Haveman opposes the idea of state-based drug and medical supply distribution on ideological grounds. Instead, he decides to privatize the dysfunctional government firm that imports and distributes drugs and medical supplies to Iraqi hospitals. When he served as Michigan’s director of community health, he dramatically cut the amount of money Michigan spent on prescription drugs for poor citizens by limiting the medications doctors could prescribe to Medicaid patients. He instituted a short list of cheaper drugs that poor patients were limited to using. Haveman decides that the same approach will work in Iraq. Currently, Iraq has around 4,500 drugs on its formulary, and Haveman decides the list is much too long. Any private firm who wants to bid on the job of supplying drugs and medical supplies will not want to deal with such a long list. Haveman also wants to restrict the firm to buying American-made drugs and supplies—no more medicines from Iran, Syria, or Russia. The Pentagon sends Haveman three formulary experts to help him implement his plan, including Lieutenant Commander Theodore Briski, a Navy pharmacist. Haveman’s order, as Briski later recalls, is “Build us a formulary in two weeks and then go home.” Two days into his position, Briski decides that Haveman’s plan is untenable. The existing formulary works well enough, he believes. Haveman wants to redesign “the entire Iraqi pharmaceutical procurement and delivery system, and that was a complete change of scope—on a grand scale.” Most importantly, Briski recalls, Haveman and his advisers “really didn’t know what they were doing.” Others agree, including many on Haveman’s team. Rewriting the formulary is a major distraction, they argue, as is privatizing the pharmaceutical distribution process. Haveman ignores the immediate needs of the populace for his grandiose, ill-considered plans.
No Progress - When Haveman leaves Iraq, the hospitals are as decrepit and dysfunctional as they were when he arrived. Baghdad’s largest medical facility, Yarmouk Hospital, lacks basic equipment to monitor blood pressure and heart rate. Operating rooms lack essential surgical tools and sterilizers. Pharmacy shelves are bare. The Health Ministry estimates that of the 900 drugs it deems essential, hospitals lack 40 percent of them. Of the 32 medicines used in combating chronic diseases, 26 are unavailable. Health Minister Aladin Alwan asks the United Nations for help, asks neighboring nations for emergency donations, and throws out Haveman’s idea for a new formulary. “We didn’t need a new formulary,” he later says. “We needed drugs. But the Americans did not understand that.” (Chandrasekaran 9/17/2006)
HCA Inc. and the US Justice Department sign a settlement agreement, resolving allegations that the company paid kickbacks to physicians and submitted false cost reports and fraudulent bills to Medicare, Medicaid, and other federal health programs. Under the terms of the agreement, HCA, the country’s largest for-profit hospital chain, will pay the US government $631 million in civil penalties and damages. Additionally, under a separate agreement that was negotiated more than a year ago, HCA will pay the Centers for Medicare and Medicaid Services (CMS) $250 million to resolve “outstanding cost report issues.” Critics of that settlement have alleged that the CMS head—a former lobbyist for the hospital industry—cut the deal behind the Justice Department’s back saving HCA several hundred million dollars (see March 28, 2002-November 2002). (CBS News 12/18/2002; O'Harrow 12/19/2002; US Department of Justice 6/26/2003; Nashville Business Journal 6/26/2003; New York Times 6/27/2003) These amounts, when combined with the $840 million settlement reached in December of 2000 (see December 14, 2000), make this the government’s single largest fraud settlement in US history. The $1.7 billion settlement concludes a nine-year investigation that began when whistle-blower James Alderson, a former chief financial officer of one of its former hospitals, filed a lawsuit alleging that the company’s cost reports to the government were fraudulent. During the course of the investigation, authorities discovered a second set of books marked “confidential,” revealing that the company had inflated reimbursable costs billed to government health programs. (Phillips & Cohen 12/18/2002; Eichenwald 12/18/2002)
FDA medical officer Andrew D. Mosholder finds evidence that antidepressant drugs such as Paxil, Zoloft, and Effexor may increase the risk of suicidal thoughts in children. Agency officials praise his work but express a lack of confidence in the data. The FDA takes no action. (Vedantam 9/24/2004)
Britain’s Department of Health advises doctors treating depressed children to prescribe only Prozac. Other antidepressants like Zoloft, Paxil, Luvox, Effexor, Celexa, and Lexapro should be avoided, it warns, because of a potential link between these drugs and suicidal and hostile behavior. (BBC 12/10/2003; Goode 12/16/2003) The FDA takes no action in the US, and continues to sit on a study by one of its own scientists (see September 2003) that links the drugs to suicidal thoughts in children. (Vedantam 9/24/2004)
Thomas A. Scully resigns as head of the Centers for Medicare & Medicaid Services (CMS)(formerly called the Health Care Financing Administration (HCFA)). (Goldstein 12/3/2003) For the last six months Scully, a former lobbyist for the health care industry, has been shopping around for a job in the private sector hoping to find a firm that would hire him to advise clients affected by the new Medicare program that he helped draft (see June-December 2003). Shortly after resigning, Scully is hired by Alston & Bird LLP to help the law firm build a health practice in their Washington office. He also lands a second part-time job with Welsh, Carson, Anderson & Stowe, a New York investment firm specializing in telecommunications and health care. (Goldstein 1/14/2004)
In January 2004, an FDA safety officer determines from analysis of adverse event reports that there may be a link between sudden blindness and the impotency drug Viagra. She recommends that the agency warn doctors and patients about the drug’s possible side effect. FDA staffers generally agree that Viagra’s label needs to be updated with a warning. Two months later, a formal draft safety “consult” on the potential Viagra-blindness link is submitted, followed by a final report in April. The FDA approaches Pfizer, the maker of the drug, but the company “resist[s] the FDA’s initial request to update the Viagra label to include information about the NAION risks,” according to a letter that is later sent to the FDA by Senator Charles E. Grassley. The FDA does not issue a public notice or propose a change to the drug’s label until May 2005 when a study published in the Journal of Neuro-Ophthalmology reports seven cases of men experiencing sudden blindness within 36 hours of taking Viagra. (Kaufman 6/1/2005)
Russell Katz, director of the FDA’s division of neuropharmacological drug products, informs medical officer Andrew Mosholder that he will not be permitted to present his report on the suicidal side effects of Paxil, Zoloft, and certain other antidepressants. Mosholder—who believes the drugs may increase suicidal tendencies in children (see September 2003)—was scheduled to report his findings at an FDA advisory hearing on February 2. Katz reportedly tells Mosholder his report is biased. When the San Francisco Chronicle asks about this decision, Anne Trontell, deputy director of the agency’s Office of Drug Safety, says Mosholder can’t present the report because it has not yet been “finalized.” (Waters 2/1/2004)
New York Times reporter Robert Pear discovers that the Bush administration has employed two fake “reporters,” Karen Ryan and Alberto Garcia, who have appeared in administration-produced television “news” segments—“video news releases,” or VNRs—designed to promote the administration’s new Medicare prescription-drug policies. (Garcia primarily appeared in Spanish-language Medicare VNRs.) HHS had budgeted $124 million for the fake news segments, more than most real news organizations can provide. The segments are under investigation by the General Accounting Office (GAO) for possible violation of government statutes prohibiting the use of federal money to produce propaganda or partisan presentations. The Secretary for Health and Human Services (HHS), Tommy Thompson, appears in one of the segments, saying, “This is going to be the same Medicare system only with new benefits, more choices, more opportunities for enhanced benefits.” Several others show a crowd giving President Bush a standing ovation as he signs the new Medicare bill into law. Another segment shows a pharmacist talking to an elderly customer. The pharmacist says the new law “helps you better afford your medications,” and the customer says, “It sounds like a good idea.” The pharmacist agrees, “A very good idea.” The segments, professionally produced and ending with tag lines such as “In Washington, I’m Karen Ryan reporting,” were regularly aired by at least 50 local television news broadcasts in 40 cities around the country. The government also provides scripts that can be used by local news anchors to introduce, or “walk up,” the VNRs. One script suggested that anchors read the following: “In December, President Bush signed into law the first-ever prescription drug benefit for people with Medicare. Since then, there have been a lot of questions about how the law will help older Americans and people with disabilities. Reporter Karen Ryan helps sort through the details.” A VNR is then broadcast explaining how the new law benefits Medicare recipients.
'Infoganda' - Ryan is a freelance journalist, the administration claims, and using her for such fake news segments is perfectly acceptable. But cursory investigation reveals that she was once a freelance reporter, but has for years worked as a public relations consultant. Her most recent assignments include appearing in marketing videos and “infomercials” promoting a variety of pharmaceutical products, including the popular drugs FloMist and Excedrin. Perhaps the most telling reaction is from Comedy Central’s comedy-news program The Daily Show, where host Jon Stewart can’t seem to decide whether to be outraged or flattered by what Rich calls “government propaganda imitating his satiric art.” (Daily Show member Rob Corddry calls the HHS videos “infoganda.”) Administration officials also insist that the VNRs are real, objective news releases, but the company that produced the segments, Home Front Communications, confirms that it had hired Ryan to read a script prepared by government officials. The VNRs give a toll-free phone number for beneficiaries to call. To obtain recorded information about prescription drug benefits, the caller must speak the words, “Medicare improvement.” The Columbia Journalism Review writes, “The ‘reports’ were nothing more than a free advertisement for the legislation, posing as news.”
Legal? - GAO lawyers say that their initial investigations found that other fliers and advertisements disseminated by HHS to promote the new Medicare policies are legal, though they display “notable omissions and other weaknesses.” Administration officials claim the VNRs are also a legal, effective way to educate Medicare beneficiaries. The GAO is still investigating the VNRs. GAO investigators believe that they might violate the law in at least one aspect: misleading viewers by concealing their government origins. Federal law expressly forbids the use of federal money for “publicity or propaganda purposes” not authorized by Congress. Earlier investigations have found government-disseminated editorials and newspaper articles illegal if they did not identify themselves as coming from government officials. The GAO will find that the VNRs break two federal laws forbidding the use of federal money to produce propaganda (see May 19, 2004).
'Common Practice' - HHS spokesman Kevin Keane says the VNRs are well within legal guidelines; their only purpose, he says, is to inform citizens about changes in Medicare. “The use of video news releases is a common, routine practice in government and the private sector,” he says. “Anyone who has questions about this practice needs to do some research on modern public information tools.” Congressional Democrats disagree with Keane. “These materials are even more disturbing than the Medicare flier and advertisements,” says Senator Frank Lautenberg (D-NJ). “The distribution of these videos is a covert attempt to manipulate the press.” Lautenberg, fellow Senator Edward Kennedy (D-MA), and seven other members of Congress requested the GAO investigation. Keane is correct in one aspect: businesses have distributed VNRs to news stations as well as internally for years, and the pharmaceutical industry has been particularly successful in getting marketing videos that appear as “medical news” or “medical features” aired on local and even national news broadcasts. And government agencies have for years released informational films and videos on subjects such as teenage smoking and the dangers of using steroids. Bill Kovach, chairman of the Committee of Concerned Journalists, says HHS’s VNRs have gone far beyond what the government has previously provided. “Those to me are just the next thing to fraud,” he says. “It’s running a paid advertisement in the heart of a news program.” (Pear 3/15/2004; McDermott 3/15/2004; Rich 2006, pp. 164)
Media Responsibility - The Columbia Journalism Review’s Bill McDermott writes: “[F]or our money, the villains here aren’t the clever flacks at HHS—they’re supposed to be masters of deception. Nope, the dunce hats go to the local TV station editors willing to slap onto the air any video that drops in over the transom.” (McDermott 3/15/2004) Ryan is relatively insouciant about the controversy. “Stations are lazy,” she says. “If these things didn’t work, then the companies would stop putting them out.” (Pittsburgh Post-Gazette 3/20/2004)
The FDA’s Division of Scientific Investigations says in a memo that Aventis’s clinical study for the drug Ketek, study 3014 (see October 2001-Fall 2002), “uniformly failed to detect data integrity problems when they clearly existed.” The report notes that doctors participating in the study failed to comply with FDA regulations and were found to have engaged in “multiple instances of fraud.” (Mathews 5/1/2006 )
The FDA approves the drug Ketek for treatment of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia in patients age 18 and older. (Aventis 4/1/2004) The approval decision is made despite evidence that a 2001-2002 clinical trial for the drug, study 3014, was replete with fraudulent data (see October 2001-Fall 2002). The FDA says the approval is based on data submitted in 2000, other studies, and the drug’s safety record overseas where the drug has been in use for several years. (Mathews 5/1/2006 )
The Food and Drug Administration (FDA) announces that it will not permit pharmacies to sell the emergency contraception drug “Plan B” without a prescription. The drug is a “morning-after” birth-control drug that prevents fertilization and the implantation of the embryo. The agency explains to the manufacturer of the drug, Barr Pharmaceuticals, that the government is worried about the possibility that teenaged girls might not understand how to correctly use the drug without a doctor’s advice. The FDA’s decision is in direct contradiction of a federal advisory panel’s 23-4 decision to recommend approving the drug for over-the-counter sales, including to teenagers, without a doctor’s approval. The FDA’s staff recommended that the agency follow the panel’s recommendation. In 2007, author and reporter Charlie Savage will write, “Normally, agencies such as the FDA base their decisions on the information provided by their expert advisory panels—but, strangely, not this time.” A spokesman for the presidential campaign of John Kerry (D-MA) says: “By overruling a recommendation by an independent FDA review board, the White House is putting its own political interests ahead of sound medical policies that have broad support. This White House is more interested in appealing to its electoral base than it is in protecting women’s health.” James Trussell, director of the office of population research at Princeton University and a member of the advisory board, says, “The White House has now taken over the FDA.” Numerous women’s groups accuse the FDA’s political appointees of overruling the experts in order to please social conservatives who believe that the “Plan B” drug encourages promiscuity and is a form of abortion. In the following months, a lawsuit will be filed to have the FDA’s decision overturned (see January 21, 2005 and After). (Harris 3/7/2004; Savage 2007, pp. 300-301)
Pfizer pleads guilty and agrees to pay $430 million to settle criminal and civil charges that Warner-Lambert, a company it acquired in 2000, marketed its epilepsy drug, Neurontin, for non-approved uses (see 1996-2000, August 1996, and April 1996-July 1996). (Harris 5/14/2004)
The General Accounting Office (GAO) finds that the Bush administration broke two federal laws as part of its publicity campaign to promote its new Medicare prescription drug policies. The Department of Health and Human Services (HHS) illegally spent federal monies on what amounts to covert propaganda in producing and distributing “video news releases,” or VNRs, to local television news broadcasters around the country that were designed to look like objective news reports (see March 15, 2004). The GAO findings do not carry legal weight, because the GAO acts as an adviser to Congress. The viewers in the more than 40 cities who saw the reports did not know they were watching government-produced videos anchored by public relations “flacks” paid by HHS who were not real reporters. The VNRs have only fueled criticism of the Medicare prescription drug coverage program, which gives private health care firms and prescription drug companies a much larger role in providing and setting prices for Medicare recipients’ prescriptions. Democrats have long insisted that the law cripples Medicare beneficiaries’ ability to receive low-cost prescriptions in favor of funneling Medicare dollars into the pharmaceutical companies’ coffers; with the GAO findings, Democrats now say that the government used illegal propaganda tactics to “sell” the citizenry on the new program. The administration has already admitted that the program will cost hundreds of billions of dollars more than originally claimed. Democratic presidential candidate John Kerry (D-MA) calls the videos “another example of how this White House has misrepresented its Medicare plan.” Kerry’s Senate colleague, Edward Kennedy (D-MA), says: “The new GAO opinion is yet another indictment of the deception and dishonesty that has become business as usual for the Bush administration. It was bad enough to conceal the cost of the Medicare drug bill from the Congress and the American people. It is worse to use Medicare funds for illegal propaganda to try to turn this lemon of a bill into lemonade for the Bush campaign.” The Bush administration continues to insist that the VNR program is legal. “GAO opinions are not binding on the executive branch. That’s an opinion of the GAO. We don’t agree,” says HHS spokesman Bill Pierce, who justifies the VNR usage by pointing to their ubiquitous usage in corporate settings. Asked if he understands that a viewer might be angry at being led to believe that the VNRs were real news stories, Pierce replies, “If I’m a viewer, I’d be angry at my television station.” (Goldstein 5/20/2004; Kemper 5/20/2004)
FDA scientist David Graham has analyzed data on 1.4 million Kaiser Permanente patients who took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. Based on his findings, Graham believes there have been more than 27,000 heart attacks and sudden cardiac deaths in the US that would not have occurred had those patients been prescribed Celebrex instead of Vioxx. (Kaufman 10/8/2004) When the FDA reviews a summary of his study, which Graham will present in France on August 25 (see August 25, 2004), his conclusion triggers “an explosive response from the Office of New Drugs.” Graham later tells Congress, “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.” (US Congress 11/18/2004 ) In an August 12 e-mail, John Jenkins, director of the Office of New Drugs, suggests “watering down” the report’s conclusions because the FDA is “not contemplating” a warning against high-doses of Vioxx. In response, Graham says, “I’ve gone about as far as I can without compromising my deeply-held conclusions about this safety question.” In another e-mail, a different top official expresses concern about how the report might impact Merck. The person writes that the company should be warned beforehand “so they can be prepared for [the] extensive media attention that this will likely provoke.” (Mathews 10/8/2004; Kaufman 10/8/2004)
David Graham, associate science director for the FDA’s Office of Drug Safety, presents the findings of a study on Vioxx in a poster exhibit at an international medical conference in Bordeaux, France. According to Graham’s research, thousands of Americans have died from taking the drug. In his study, he analyzed data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. According to Graham’s analysis of the data, the risk of having a heart attack or dying from heart problems is 3.2 times higher for Vioxx patients than people who do not use painkillers, and twice as high for those using Celebrex. Based on these figures, Graham estimates that more than 27,000 Americans have had heart attacks or died from sudden cardiac deaths as a result of taking Vioxx instead of Celebrex. In response to Graham’s study, Merck, the maker of Vioxx, issues a statement insisting that its drug is safe. Alise Reicin, vice president of clinical research at Merck, claims that numerous studies comparing the drug to a dummy pill found “no difference in the risk of having a serious cardiovascular event.” FDA spokeswoman Laura Alvey says the FDA has no plans to ban the drug. “Removing the drug from the market is not on the table,” she says. (Johnson 8/26/2004) Prior to the event, FDA officials had pressured him to water down his conclusions (see Mid-August 2004).
Merck voluntarily withdraws Vioxx from the market after a long term colon-polyp prevention study, called APPROVe, appears to show that the drug doubles the risk of heart attacks or strokes when taken for 18 months or longer. (Merck 9/30/2004 ) Acting FDA Commissioner Dr. Lester M. Crawford praises Merck for “promptly reporting these finding” to the FDA. (US Food and Drug Administration 9/30/2004) An estimated 107 million people have used Vioxx since it was approved in 1998. A paper by FDA scientist David Graham, published in the British medical journal Lancet, will later suggest that 88,000-140,000 Americans may have suffered serious coronary heart disease as a result of taking the drug. (see January 25, 2005)
Raymond Gilmartin, Merck’s chairman and chief executive officer tells the Boston Globe he was “stunned” when he learned a Merck clinical trial had confirmed that Vioxx increased the risk of heart attacks and strokes. “It was totally out of the blue.… This was totally unexpected.” (Rowland 10/9/2004)
David Graham, associate science director for the FDA’s Office of Drug Safety, appears before the Senate Committee on Finance to testify on the agency’s ability to protect the American public from harmful drugs. Graham, a twenty-year veteran of the agency, tells the committee that “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” Graham was an early critic of Vioxx, a painkiller that was recalled in September (see September 30, 2004) because of its link to heart problems. Graham recounts how in August (see Mid-August 2004), the FDA tried to suppress a study he led which found that “nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.” He says the study’s findings were “extremely conservative” and that “a more realistic and likely… estimate ranges from 88,000 to 139,000 Americans” of which “30-40 percent [or 26,400-55,600] probably died.” He notes that this figure is the “rough equivalent of 500 to 900 aircraft dropping from the sky… [or] 2-4 aircraft every week, week in and week out, for the past 5 years.” (US Congress 11/18/2004 ) The remainder of Graham’s testimony focuses on problems within the FDA’s Office of Drug Safety (ODS). He makes the following points:
The Office of New Drugs (ONS), which approves all new drugs, is the same division that is responsible for taking regulatory action against those drugs after they have been released on the market. This is an inherent conflict of interest, he notes, because when a problem arises, recognizing it would require the ONS to acknowledge that it had made a mistake. Instead, the office’s “immediate reaction [to a problem] is almost always one of denial, rejection, and heat.” (US Congress 11/18/2004 )
The Office of Drug Safety (ODS) is subordinate to the Office of New Drugs, and consequently the management of the former sees its mission as pleasing the latter. (US Congress 11/18/2004 )
The culture of the FDA’s Center for Drug Evaluation and Research (CDER) “views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards, and disrespects drug safety.” (US Congress 11/18/2004 )
The Office of New Drugs refuses to take regulatory action on any drug unless it can be shown with 95 percent or greater certainty that it is unsafe. However “to demonstrate a safety problem with 95 percent certainty, extremely large studies are often needed… [and] those large studies cannot be done.” Graham suggests the 95 percent rule makes as much sense as a person with a 100-chamber pistol loaded with 90 bullets saying that the gun is safe. “Because there is only a 90 percent chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.” (US Congress 11/18/2004 )
Tenet Healthcare Corp. settles with more than 769 patients over allegations that one of its hospitals, Redding Medical Center in California, performed hundreds of unnecessary operations on its patients between 1992 and 2002. A 2002 FBI affidavit alleged that perhaps as many as 50 percent of the heart surgeries and tests performed by doctors at the hospital were not necessary. Of those, as many as a quarter did not even involve patients who had serious heart issues. According to Russell Reiner, the attorney who represented about half the patients, at least 20 patients died after undergoing unnecessary heart surgery at the hospital, while other patients suffered strokes, brain damage, or amputations. Under the terms of the settlement agreement, Tenet will pay the former patients $395 million. (Wallack 12/22/2004)
The Center for Reproductive Rights (CRR) files a lawsuit against the Food and Drug Administration (FDA) asking that the courts reverse a recent FDA decision not to allow the so-called “morning-after” birth-control drug “Plan B” to be sold without a prescription (see May 6, 2004 and After). The CRR says the FDA’s decision was made based on politics and not science. CCR president Nancy Northrup will say that the FDA’s decision “broke its own rules, held Plan B to a higher standard than other over-the-counter drugs, and [as a result,] women have suffered the consequences.” Testimony and depositions gathered indicate that the FDA indeed placed politics over science in its decision. One scientist says that a deputy FDA commissioner told her that the over-the-counter (OTC) application for Plan B had to be rejected “to appease the administration’s constituents,” and that it could later be quietly approved for adults only (see March 4, 2008). Another scientist testifies that he learned before the 2004 decision was issued that then-FDA commissioner Mark McClellan—the brother of White House press secretary Scott McClellan—had already decided to disapprove the drug even before the FDA’s advisory panel had completed its analysis. However, McClellan will deny the accusation. (Center for Reproductive Rights 11/14/2005; Savage 2007, pp. 301-302)
The British medical journal Lancet publishes a paper by FDA scientist David Graham suggesting that tens of thousands of Americans probably died from taking Vioxx, a painkiller that was recalled in September (see September 30, 2004). His study looked at data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. The data showed that the risk of having a heart attack or dying from heart problems was 1.6 times higher for patients taking standard-dose Vioxx compared with those using Celebrex. The risk was 3.6 times higher for those on high doses. Graham notes that Vioxx’s potential impact on the patient population was likely severe. Using the risk factors from Merck-sponsored randomized clinical trials, and extrapolating these to the estimated 106.7 million Vioxx patients, Graham says that the drug may have caused cardiovascular problems for 88,000-140,000 Americans. It is estimated that 44 percent of acute myocardial infarction’s are fatal. (Graham et al. 2005 ; London Times 1/25/2005) In November, Graham told Congress that senior managers at the FDA’s Office of Drug Safety had delayed giving Graham permission to publish this study, even after it had been accepted by Lancet. (US Congress 11/18/2004 )
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