US Health Care System

The cover to the AMA album featuring Ronald Reagan. [Source: Larry DeWitt]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 (Author Larry DeWitt notes that in 1965, Kerr-Mills will be superseded by Medicaid, the medical program for the poor.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; TPMDC, 8/25/2009]

Entity Tags: Cecil King, Ronald Reagan, American Medical Association, Larry DeWitt, Clinton Anderson, Medicare

Timeline Tags: Domestic Propaganda

Category Tags: History of US Health Care System, US Health Care Polls

American Medical Association logo. [Source: American Medical Association]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; TPMDC, 8/25/2009]

Entity Tags: American Medical Association, Cecil King, Clinton Anderson, Operation Coffeecup, Drew Pearson, Women’s Auxilary of the AMA, Operation Hometown, Ronald Reagan, Women Help American Medicine, Medicare

Timeline Tags: Domestic Propaganda

Category Tags: History of US Health Care System, US Health Care Costs, US Health Care Polls

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. [CBC News, 8/2000; Government of Canada, 5/4/2007]

Entity Tags: Medical Care Act (Canada, 1966), Emmett Hall, Royal Commission on Health Services (Canada), Canada

Category Tags: Other health care systems

President Carter and Ronald Reagan shake hands during the 1980 presidential debate. [Source: PBS]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]

Entity Tags: Ronald Reagan, James Earl “Jimmy” Carter, Jr., Larry DeWitt, Medicare

Category Tags: History of US Health Care System

Rock Hudson shortly before his death. [Source: Southern Voice]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]

Entity Tags: Ronald Reagan, Reagan administration, Rock Hudson, Nancy Reagan

Category Tags: Disregard for Public Safety

For 16 available health indicators, the US ranks on average 12th out of 13 industrial countries. Ranking first is Japan followed by Sweden, Canada, France, Australia, Spain, Finland, the Netherlands, the United Kingdom, Denmark, Belgium, the United States, and Germany. For three of the indicators, the US ranks dead last: low-birth-weight percentages, overall neonatal and infant mortality, and years of potential life lost. Life expectancy in the US appears to improve with age. While the country ranks 11th and 12th for female and male one-year-olds, respectively, it ranks a high 3rd for life expectancy among 80-year-olds of both sexes. [Starfield, 1998; Starfield, 2000 ]

Entity Tags: United States

Category Tags: Studies-Academic

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. [New York Times, 11/22/2002]

Category Tags: Clinical drug studies

A still from the original ‘Harry and Louise’ TV commercial. [Source: American Environics]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; Politico, 3/2/2009; Plum Line, 3/2/2009]

Entity Tags: William Kristol, Clinton administration, Greg Sargent

Category Tags: HCA - Inflated Costs

Betsy McCaughey. [Source: Newsday / Gawker (.com)]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. [Atlantic Monthly, 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. [Daily Beast, 5/15/2009]

Entity Tags: Newt Gingrich, Franklin Foer, Elizabeth (“Betsy”) McCaughey, Clinton administration, James Fallows, US Department of Health and Human Services, Hudson Institute, Manhattan Institute

Timeline Tags: Domestic Propaganda

Category Tags: Defense of corporate interests, Clinton Health Care Reform

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. [New York Times, 5/15/2002; Associated Press, 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. [New York Times, 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. [New York Times, 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. [New York Times, 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. [New York Times, 3/30/2003; Associated Press, 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. [New York Times, 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. [New York Times, 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. [New York Times, 5/15/2002]
Instructing sales representatives to pressure doctors to write Neurontin prescriptions for unapproved uses (see April 1996-July 1996).

Entity Tags: Parke-Davis

Category Tags: Marketing

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.” [Boston Globe, 3/12/2003]

Entity Tags: Pfizer, David Franklin, Parke-Davis

Category Tags: Marketing

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. [New York Times, 5/15/2002]

Entity Tags: David Franklin, Parke-Davis

Category Tags: Marketing

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. [Wall Street Journal, 11/1/2004; CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

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.” [Wall Street Journal, 11/1/2004]

Entity Tags: Briggs Morrison, Alise Reicin

Category Tags: Disregard for Public Safety, Manipulation of data, Vioxx

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; CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Clinical drug studies, Manipulation of data, Vioxx

According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 6.1 percent in 1998 [San Francisco Chronicle, 12/8/2003] compared to a 1.6 percent increase in the Consumer Price Index. [InflationDate(.com), 6/22/2006]

Category Tags: Health Care Cost

Research done by Dr. Garrett FitzGerald suggests that COX-2 inhibiting drugs, like Vioxx and Celebrex, increase the risk of cardiovascular problems. FitzGerald believes that COX-2 inhibitors block the production of a substance called prostacyclin, which leads to blood vessel constriction and clotting. His research is dismissed by Merck, the maker of Vioxx. Vioxx’s only selling point is that it causes fewer gastrointestinal problems than other pain killers on the market. But according to FitzGerald, the mechanism that makes the drug gentler on the stomach is also responsible for causing the cardiovascular problems. [MSNBC, 10/6/2004] FitzGerald’s research is later published in two studies, one in 1999 and another in 2001. [Associated Press, 6/22/2005]

Entity Tags: Merck, Garrett FitzGerald

Category Tags: Disregard for Public Safety, Vioxx

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. [New York Times, 7/23/2000]

Entity Tags: Zenith Goldline Pharmaceuticals, Geneva Pharmaceuticals, Abbott Laboratories

Category Tags: Disregard for Public Safety

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]

Entity Tags: US Food and Drug Administration, Merck

Category Tags: Vioxx

According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 7.3 percent in 1999 [San Francisco Chronicle, 12/8/2003] compared to a 2.2 percent increase in the Consumer Price Index. [InflationDate(.com), 6/22/2006]

Category Tags: Studies-Academic

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.” [New York Times, 11/22/2002]

Entity Tags: Omnicom, Scirex, Thomas L. Harrison

Category Tags: Clinical drug studies

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. [USA Today, 10/12/2004; CBS News, 4/28/2005; National Public Radio, 6/8/2006]

Entity Tags: Michael Weinblatt, Deborah Shapiro, Merck

Category Tags: Clinical drug studies, Vioxx

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]

Entity Tags: US Food and Drug Administration

Category Tags: Vioxx

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. [National Public Radio, 6/8/2006]

Entity Tags: Merck

Category Tags: Vioxx

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.” [National Public Radio, 6/8/2006]

Entity Tags: Merck

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

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. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Alise Reicin, Michael Weinblatt, Merck, Deborah Shapiro

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 8.1 percent in 2000 [San Francisco Chronicle, 12/8/2003] compared to a 3.4 percent increase in the Consumer Price Index. [InflationDate(.com), 6/22/2006]

Category Tags: Health Care Cost

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). [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Merck

Category Tags: Clinical drug studies, Disregard for Public Safety, Vioxx

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. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Merck

Category Tags: Clinical drug studies, Manipulation of data, Vioxx

Merck offers Michael Weinblatt, who is heading a clinical trial (see December 22, 1999 and November 18, 1999) for the company’s drug Vioxx, $5,000 a day to sit on a Merck advisory board for 12 days over the next two years. He accepts the offer and signs the contract a few weeks later on March 6. Merck pays him $15,000 up front. [National Public Radio, 6/8/2006; National Public Radio, 6/8/2006]

Entity Tags: Merck, Michael Weinblatt

Category Tags: Clinical drug studies, Vioxx

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. [National Public Radio, 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. [CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Clinical drug studies, Vioxx

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.” [Wall Street Journal, 11/1/2004; HeartWire, 11/1/2004]

Entity Tags: Merck, Edward Scolnick

Category Tags: Disregard for Public Safety, Vioxx

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. [New York Times, 5/22/2001]

Entity Tags: Merck

Category Tags: Vioxx

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]

Entity Tags: Edward Scolnick, Merck

Category Tags: Vioxx

Merck sends all of its sales representatives a “Cardiovascular Card,” a tri-fold pamphlet on the safety of Vioxx, so they “are well prepared to respond to questions about the cardiovascular effects of Vioxx.” Since the announcement (see March 27, 2000) of the VIGOR study results, physicians have been asking the representatives whether Vioxx causes heart problems. The pamphlet contains a table of data appearing to indicate that patients on Vioxx are 11 times less likely to die than patients on standard anti-inflammatory drugs, and 8 times less likely to die from heart attacks and strokes. Another section displays data showing that Vioxx patients are half as likely to suffer heart attacks as patients who receive a placebo. The risk for patients on other anti-inflammatory drugs appears to be identical. [Merck, 4/28/2000 ] But the pamphlet is based on the combined data of several disparate studies, conducted before the drug’s approval. None of the studies were designed to test the cardiovascular safety of the drug. An FDA medical reviewer later tells the staff of a congressional committee that the relevance of those studies to the question of Vioxx’s effects on the heart is “nonexistent.” Furthermore, the reviewer says it would be “ridiculous” and “scientifically inappropriate” to use the pamphlet as evidence of the drug’s safety. [Office of Representative Henry A. Waxman, 5/5/2005, pp. 16-19 ]

Entity Tags: Merck, VIGOR

Category Tags: Vioxx, Marketing

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). [National Public Radio, 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. [Forbes, 12/8/2005]

Entity Tags: Merck

Category Tags: Suppression of data, Vioxx

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). [National Public Radio, 6/8/2006]

Category Tags: Fraud, Manipulation of data, Vioxx, Studies-Academic

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). [National Public Radio, 6/8/2006]

Entity Tags: Alise Reicin, Deborah Shapiro

Category Tags: Suppression of data, Vioxx

Merck informs the FDA about three fatal heart attacks (deaths 18, 19, and 20) that occurred toward the end of VIGOR, the clinical trial for its drug Vioxx that ended last March (see March 2000). These three deaths were initially left out because they had taken place after a February 10 “cut-off” that had been set at the company’s insistence (see Early February 2000) [National Public Radio, 6/8/2006]

Entity Tags: US Food and Drug Administration, Merck

Category Tags: Vioxx

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; National Public Radio, 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.” [Forbes, 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).

Entity Tags: US Department of Justice, HCA, Inc.

Category Tags: HCA - Inflated Costs

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. [Daily Journal Extra, 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. [CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

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]

Entity Tags: Merck

Category Tags: Vioxx

According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 11.2 percent in 2001 [San Francisco Chronicle, 12/8/2003] compared to a 2.8 percent increase in the Consumer Price Index. [InflationDate(.com), 6/22/2006]

Category Tags: Health Care Cost

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. [Washington Post, 10/22/2004; Knight Ridder, 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; National Public Radio, 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]

Entity Tags: US Food and Drug Administration

Category Tags: Vioxx

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 ]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

A new Merck training manual instructs company sales representives on how to use reprints of medical journal articles in their sales pitches to doctors. The company has divided the reprints into two categories, “approved” and “background.” The “approved” category includes articles that “provide solid evidence as to why [doctors] should prescribe Merck products for their appropriate patients.” Only these articles can be used or cited by Merck sales people. Background articles, on the other hand, cannot be used or even referenced. Doing so would be “a clear violation of Company Policy,” the document says. If a physician has any questions about studies not in the “approved” category, the sales representive should refer the individual to Merck’s medical services department. [Merck, 3/2001 ; Office of Representative Henry A. Waxman, 5/5/2005, pp. 12-13 ]

Entity Tags: Merck

Category Tags: Marketing, Vioxx

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]

Category Tags: Ketek

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. [New York Times, 5/22/2001]

Entity Tags: VIGOR, Merck

Category Tags: Vioxx

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 ]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

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 ]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

Thomas A. Scully is sworn in as head of the Health Care Financing Administration (HCFA), a division of the US Department of Health and Human Services. Prior to joining the Bush administration, Scully served as president and chief executive officer of the Federation of American Hospitals, a trade association that lobbies on behalf of 1,700 privately-owned and managed community hospitals and health systems. He held that position for six years [Healthcare Financial Management, 7/2001; US Department of Health and Human Services, 11/10/2003] and was making $675,000 a year when he left. As the administrator of HCFA, he will be paid a salary of $134,000 a year. [New York Times, 12/3/2003] During his confirmation hearings, Scully promised the Senate Finance Committee that he would “aggressively enforc[e] the fraud statutes.” Under the Clinton administration, the Justice Department had brought a number of lawsuits against hospitals alleging that they had over billed Medicare, Medicaid, and other federal heath programs. [Iglehart, 12/27/2001]

Entity Tags: Thomas A. Scully

Category Tags: Political appointments

President Bush appoints Ann-Marie Lynch as deputy assistant secretary in the office of policy at the Department of Health and Human Services. [US Congress, 7/25/2002, pp. 86 ; Denver Post, 5/23/2004] One of Lynch’s responsibilities is to decide which topics are researched and which reports are released. She previously worked as a lobbyist for the drug- company trade group Pharmaceutical Research and Manufacturers of America where she fought congressional efforts to implement price controls on prescription drugs. She had argued that price caps would discourage medical innovation. [Denver Post, 5/23/2004] During her tenure at DHHS, Lynch’s division will publish a report praising brand-name drugs and warning that “restrictions on the coverage of new drugs could put the future of medical innovation at risk and may retard advances in treatment” (see July 2002). She will also block the release of several completed research reports that challenge drug-company claims (see (Between July 2001 and May 2004)).

Entity Tags: Ann-Marie Lynch, George W. Bush

Category Tags: Political appointments

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).

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Ketek

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. [Denver Post, 5/23/2004]

Entity Tags: Ann-Marie Lynch

Category Tags: Suppression of data

Thomas A. Scully, administrator of the Centers for Medicare & Medicaid Services (CMS), tells Congress that he believes only a third of the estimated $12 billion in improper payments to health care providers is fraudulent. He says “the rest is probably billing mistakes.” Scully, a former lobbyist for the health industry, admits the inspector general would probably disagree with his estimate. [US Congress, 7/26/2001, pp. 27 ]

Entity Tags: Thomas A. Scully

Category Tags: Defense of corporate interests

President Bush appoints Daniel E. Troy as the FDA’s chief counsel. [Financial Times, 8/14/2001] Before taking the position, Troy was a partner at the law firm Wiley Rein & Fielding, where he sued the FDA several times on behalf of drug companies, including pharmaceutical giant Pfizer. He has repeatedly argued that the agency has only limited authority to regulate drug companies. Troy is mostly known for his involvement in the landmark Supreme Court case that ruled the FDA does not have the authority to regulate tobacco. [Boston Globe, 12/22/2002; Denver Post, 5/23/2004] As chief counsel, Troy will help the FDA commissioner, a post that is currently vacant, to draft policy and enforcement provisions. The commissioner’s post will remain vacant until October 2002. So far, Bush has considered two people for the position—Michael Astrue, senior vice-president at Transkaryotic Therapies, a British biotech company, and Eve Slater, Merck’s senior vice-president. In both cases the Senate made it clear that their nominations would be rejected because of their involvement in FDA-regulated industries. [Financial Times, 8/14/2001]

Entity Tags: Daniel E. Troy, George W. Bush

Category Tags: Political appointments

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; National Public Radio, 6/8/2006]

Entity Tags: Steven Nissen, Eric Topol, Debabrata Mukherjee

Category Tags: Vioxx, Studies-Academic

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 ]

Entity Tags: Raymond Gilmartin, Merck

Category Tags: Disregard for Public Safety, Manipulation of data, Marketing, Vioxx

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; Washington Post, 9/23/2006; New York Times, 9/23/2006]

Entity Tags: US Food and Drug Administration, Institute of Medicine

Category Tags: Clinical drug studies, FDA advisory panels, Studies-Academic

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; Wall Street Journal, 5/1/2006 ]

Entity Tags: Pharmaceutical Product Development, Inc., Aventis, Maria Anne Kirkman-Campbell

The US Department of Health and Human Services implements a new policy requiring that all enforcement letters to drug companies potentially engaged in false advertising be pre-screened by FDA Chief Counsel Daniel E. Troy. Prior to the policy change, the FDA’s drug-marketing division and district offices were free to determine when an enforcement letter was warranted. After the policy change, the number of enforcement letters sent annually drops by two-thirds. [Boston Globe, 10/19/2002; Boston Globe, 12/22/2002; Denver Post, 5/23/2004] In October 2002, the General Accounting Office (GAO) finds that the FDA is taking so long to review the letters that “misleading advertisements may have completed their broadcast life cycle before FDA issued the letters.” [Boston Globe, 12/22/2002] Fifteen months later, another report by the GAO finds that the review process is still slow, with the average approval time being six months. [Boston Globe, 1/30/2004]

Entity Tags: Daniel E. Troy, US Department of Health and Human Services

Category Tags: Defense of corporate interests

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). [Boston Globe, 10/19/2002]

Entity Tags: Daniel E. Troy

Category Tags: Defense of corporate interests

According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 14.7 percent in 2002 [San Francisco Chronicle, 12/8/2003] compared to a 1.6 percent increase in the Consumer Price Index. [InflationDate(.com), 6/22/2006]

Category Tags: Health Care Cost

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. [San Francisco Chronicle, 12/22/2004]

Entity Tags: Tenet Healthcare Corp.

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 prescriber’s 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 ]

Entity Tags: Merck

Category Tags: Marketing, Vioxx

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 ]

Entity Tags: Merck

Category Tags: Marketing, Vioxx

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.” [Boston Globe, 5/27/2002]

Entity Tags: Robert Goldberg, Bush administration, Alastair J. J. Wood

Category Tags: Political appointments, Disregard for Public Safety

HCA, the country’s largest for-profit hospital chain, announces that it has struck a deal with the Centers for Medicare & Medicaid Services (CMS) over unaudited Medicare and Medicaid billings. The company—which paid more than $840 million in criminal fines, civil penalties, and damages in 2000 for fraudulent reportings to Medicare (see December 14, 2000), and which is still being investigated—will pay CMS $250 million to zero out its account with the agency. [Associated Press, 3/28/2002] But according to numerous government whistle-blowers, the amount is far too low. In a letter to the Department of Health and Human Services, Senator Charles E. Grassley (R-IA) will later accuse Medicare officials of “seeking to allow HCA to resolve more than $1 billion of liability to the Medicare program for only $250 million, based on little to no evidence supporting this low figure.” Even more troubling, notes the Senator, Medicare has agreed not to audit the company’s cost reports that have been piling up since 1997 when the agency stopped processing HCA bills because of the lawsuit. “One would expect a company with such a track record to be subjected to heightened scrutiny.… [Instead,] the Centers for Medicare and Medicaid Services is proposing to excuse HCA from an even routine review of thousands of Medicare cost reports,” Grassley writes. He says the deal is “too lenient.” John R. Phillips, one of the attorneys involved in the lawsuit against HCA, later says the deal was quietly arranged between HCA and CMS head Thomas A. Scully. “The $250 million was a total sellout by Scully, who totally negotiated it behind Justice’s back,” he says. [New York Times, 11/19/2002] Similarly, Grassley, in a June 25 letter to a Justice Department lawyer, says comments by Scully “have given me great concern that there is an active, ongoing effort underway to change or modify enforcement [on Medicare fraud] policy that in my view could significantly undermine the [law].” [Office of Senator Charles Grassley, 7/25/2002] Scully, during his confirmation hearings, had pledged he would “aggressively enforc[e] the fraud statutes” (see May 29, 2001).

Entity Tags: HCA, Inc., Thomas A. Scully, Charles Grassley, Centers for Medicare & Medicaid Services

Category Tags: HCA - Inflated Costs

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 ]

Entity Tags: US Food and Drug Administration, VIGOR, Merck

Category Tags: Manipulation of data, Vioxx

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. [New York Times, 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.” [New York Times, 11/22/2002]

Entity Tags: Pharmacia & Upjohn Inc, Eric Topol, Omnicom, Scirex

Category Tags: Published studies

The Office of Policy at the US Department of Health and Human Services (DHHS) releases a report concluding that the US government should not impose price caps on prescription drugs. According to the report, doing so “could put the future of medical innovation at risk and may retard advances in treatment.” [US Department of Health and Human Services, 7/2002, pp. 2 ] The deputy assistant secretary of the division, Ann-Marie Lynch, had used the same argument when she was a drug industry lobbyist (see June 2001) fighting against congressional efforts to cap drug prices. [Denver Post, 5/23/2004] Critics of the report say its conclusions are contradicted by the experiences of other countries that have remained innovative despite price controls. DHHS officials “haven’t taken as seriously their job of making medicines affordable to all Americans,” says Gail Shearer, director of health policy analysis for Consumers Union. According to critics, the report plays a role in the passing of Bush’s Medicare drug plan that prohibits the government from using its buying power to negotiate lower prices from the drug companies.

Entity Tags: Ann-Marie Lynch, US Department of Health and Human Services

Category Tags: Defense of corporate interests

Pfizer attorney Malcolm Wheeler calls FDA chief counsel Daniel E. Troy requesting that the agency intervene in a lawsuit filed against the company. The lawsuit alleges that Zoloft, an antidepressant drug manufactured by Pfizer, caused Victor Motus of California to kill himself on November 12, 1998. It also says that the drug company should have warned physicians that Zoloft might cause suicidal thoughts in some people. On September 3, the FDA files a brief stating that the agency’s scientists have found no evidence that antidepressants cause suicidal thoughts. Furthermore, the FDA argues, if Pfizer had warned doctors of such a link, it would have been a violation of the law because all warnings must first be vetted by the FDA. According to Troy, the agency has “absolute control over the label.” This position, notes one of the plaintiff attorneys in the Pfizer case, contradicts arguments that Troy made when he was practicing in the private sector. Before he had argued that the agency’s rulings were arbitrary and capricious. [Boston Globe, 12/22/2002]

Entity Tags: Daniel E. Troy, Pfizer, Malcolm Wheeler

Category Tags: Defense of corporate interests

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. [New York Times, 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.” [Boston Globe, 12/22/2002; New York Times, 7/25/2004]

Category Tags: Defense of corporate interests

According to the Mercer National Survey of Employer-Sponsored Health Plans, the average total health benefit cost rises 10.1 percent in 2003 [San Francisco Chronicle, 12/8/2003] compared to a 2.3 percent increase in the Consumer Price Index. [InflationDate(.com), 6/22/2006]

Category Tags: Health Care Cost

After reviewing results of clinical study 3014 for the antibiotic Ketek, an FDA advisory panel recommends that the drug be approved. [Aventis, 1/9/2003] The panel makes the decision completely unaware that the FDA had discovered problems with the study only a few months before. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 ] In October, an FDA examiner found that some doctors were reporting fraudulent results. For example, some doctors had failed to record the data properly while others had invited patients into the study who did not meet the necessary qualifications. In one case, several patients who were enrolled in the study were not actually taking the drug (see October 2001-Fall 2002).

Entity Tags: US Food and Drug Administration

Category Tags: Clinical drug studies, Ketek

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]

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Ketek

Thomas A. Scully, administrator of the Centers for Medicare & Medicaid Services (CMS), warns Richard S. Foster, the agency’s top expert on Medicare costs, that he will be fired if he responds to Congress’s request for a cost estimate on the drug plan favored by the administration. Foster estimates that the plan will cost $534 billion over the next 10 years. This amount is roughly a third more than the $400 billion estimate that was provided to legislators by the Congressional Budget Office. The White House knows about Foster’s cost estimate but fears that if Congress obtains this information, it will not pass the drug plan. Several conservative House Republicans have said they will not vote for the bill if it exceeds $400 billion. Foster’s estimates are shared with Doug Badger, the president’s special assistant for health policy, and with James C. Capretta, associate director of the White House Office of Management and Budget. Scully instructs Foster that all cost estimates must first be submitted to him so he can decide whether they should be released. “More than once, Tom said he was just following orders,” Foster later tells the Washington Post, adding that he suspects the orders were coming directly from the White House, probably from Badger. On other occasions, when Foster is talking to lawmakers over the phone, White House officials are routinely on the line monitoring his comments and in some instances they instruct Foster not to respond to lawmakers’ questions, according to an unnamed congressional Democratic aide. It is not until January 2004, after the drug bill is passed, that the White House finally releases Foster’s estimates. [Knight Ridder, 3/12/2004; Washington Post, 3/13/2004; New York Times, 3/25/2004; US Department of Health and Human Services, 7/6/2004 ; New York Times, 7/7/2004] Several Republicans later say they would not have voted for the program had they known its true cost. [Savage, 2007, pp. 116]

Entity Tags: Doug Badger, Richard S. Foster, Thomas A. Scully, James C. Capretta

Category Tags: Suppression of data

At the same time top Medicare official Thomas A. Scully is working with Congress to draft new Medicare legislation, he is looking for a private sector job that will pay him to advise clients affected by the very same Medicare program he is helping to draft. The fact that Scully’s job search is taking place at the same time he is working on legislation, raises concerns that his contributions to the bill are potentially being influenced by his own private interests. Scully insists however that he is complying with all federal ethics regulations and says he has a waiver from the department’s general counsel permitting him to seek work in the private sector. By December he has narrowed his list of prospective employers to five companies: Alston & Bird; Baker, Donelson, Bearman, Caldwell & Berkowitz; Ropes & Gray; Welsh, Carson, Anderson & Stowe; and Texas Pacific Group. All of the companies have clients in the health care industry. Scully, who made $675,000 a year as a lobbyist before taking his current position in the government at $134,000 a year, is expected to make a hefty salary in the private sector with his insider knowledge of the new Medicare program. “His exhaustive knowledge of the Medicare program and the intricacies of the legislation, approved by Congress last week, would make him a prize catch for any law firm or private equity firm,” notes the New York Times. Scully will resign on December 16, less than a month after Congress passes the Medicare bill. [Washington Post, 12/3/2003; New York Times, 12/3/2003]

Entity Tags: Thomas A. Scully

Category Tags: Political appointments

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; Washington Post, 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; New York Times, 12/18/2002]

Entity Tags: US Department of Justice, HCA, Inc.

Category Tags: HCA - Inflated Costs

FDA chief counsel Daniel E. Troy intervenes in a lawsuit against Glaxo SmithKline, the manufacturer of the drug Paxil. The FDA says it disagrees with the judge’s temporary order that the phrase “not habit-forming” be removed from the company’s advertisements promoting Paxil. The plaintiffs in the case alleged that the phrase is misleading because they experienced withdrawal symptoms after they stopped taking the drug. The judge agreed saying, “It is difficult to imagine that the FDA would object to the removal of the reference that ‘Paxil is not habit-forming.’” But Troy does object. The FDA, taking the side of Glaxo SmithKline, says the product is not habit-forming and contend that the symptoms experienced by patients were not withdrawal symptoms, but rather symptoms of “discontinuation syndrome.” According to Troy, the FDA has absolute authority on the content of drug labels. Following the FDA’s intervention, the judge lifts her temporary order. [Boston Globe, 12/22/2002]

Entity Tags: Daniel E. Troy, Glaxo SmithKline

Category Tags: Defense of corporate interests

A study conducted by Harvard University and the Canadian Institute for Health Information finds that administrative costs in America’s health care system are almost twice that of Canada. The study, published in the New England Journal of Medicine, reports that the US health bureaucracy consumes 31 percent of total health care spending. By comparison, Canada’s administrative expenses amount to only 16.7 percent. Steffie Woolhandler of Harvard, who led the team, says if the US were to adopt a single-payer health care system like Canada, the funds saved would be enough to provide insurance for the more than 41 million uninsured Americans. [Woolhandler, Campbell, and Himmelstein, 2003; Toronto Star, 8/21/2003]

Category Tags: Studies-Academic

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. [Washington Post, 9/24/2004]

Entity Tags: Andrew Mosholder, US Food and Drug Administration

Category Tags: Dismissal of data, Paxil, Zoloft

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; New York Times, 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. [Washington Post, 9/24/2004]

Entity Tags: US Food and Drug Administration

Category Tags: Suppression of data, Paxil, Zoloft

Thomas A. Scully resigns as head of the Centers for Medicare & Medicaid Services (CMS)(formerly called the Health Care Financing Administration (HCFA)). [Washington Post, 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. [Washington Post, 1/14/2004]

Entity Tags: Thomas A. Scully

Category Tags: Political appointments

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. [New York Times, 6/1/2005]

Entity Tags: Pfizer, US Food and Drug Administration

Category Tags: Suppression of data

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.” [San Francisco Chronicle, 2/1/2004]

Entity Tags: Anne Trontell, Russell Katz, Andrew Mosholder

Category Tags: Suppression of data

The National Academy of Sciences issues a report calling for universal health insurance coverage by 2010. “It is time for our nation to extend coverage to everyone,” the report says. “Universal insurance coverage is an important and achievable goal for the country.” The report was drafted by a panel of 15 experts and is the product of three years of work.
Sampling of report's conclusions -
People without insurance receive about half the medical care of those who have it. Consequently, they are on average sicker and tend to die sooner.
Roughly 18,000 people die each year because they do not have insurance.
In 2001, only half of uninsured children in the US visited a physician during 2001, compared with three-quarters of privately insured children.
In 2001, taxpayers spent roughly $30 billion in unreimbursed medical care for uninsured Americans.
The poorer health and premature deaths of uninsured people cost taxpayers between $65 billion to $130 billion a year.
Reaction in US government - Republican Senate majority leader Bill Frist of Tennessee—whose family owns HCA Inc., the largest for-profit hospital chain in the US—expresses concern that “the report may not focus enough on the reasons why health care costs continue to rise and how to pay for any reform.” Democratic Senator Tom Daschle of South Dakota supports the call. “It’s doable,” he says. “It’s essential. This is, I believe, the single most important domestic issue facing our country.” Tommy G. Thompson, secretary of health and human services, tells reporters the proposal is “not realistic.” [Institute of Medicine, 2004; National Academies, 1/14/2004; New York Times, 1/15/2004]

Category Tags: Studies-Academic

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.” [Wall Street Journal, 5/1/2006 ]

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Clinical drug studies

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. [Wall Street Journal, 5/1/2006 ]

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Ketek

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). [New York Times, 3/7/2004; Savage, 2007, pp. 300-301]

Entity Tags: Charlie Savage, Barr Pharmaceuticals, Bush administration, James Trussell, John Kerry, Food and Drug Administration

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

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). [New York Times, 5/14/2004]

Entity Tags: Pfizer, US Department of Justice

Category Tags: Marketing

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. [Washington Post, 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.” [Wall Street Journal, 10/8/2004; Washington Post, 10/8/2004]

Entity Tags: John Jenkins, David Graham

Category Tags: Defense of corporate interests, Suppression of data, Vioxx

The Food and Drug administration approves Vioxx for children who are over the age of 2 and have symptoms of rheumatoid arthritis. [US Food and Drug Administration, 6/1/2005 ] The approval is announced on September 8. [United Press International, 9/8/2004; Medical News Today, 9/9/2004]

Entity Tags: US Food and Drug Administration

Category Tags: Vioxx

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. [Associated Press, 8/26/2004] Prior to the event, FDA officials had pressured him to water down his conclusions (see Mid-August 2004).

Entity Tags: Laura Alvey, Alise Reicin, David Graham, Merck

Category Tags: Vioxx

At a meeting attended by several officials and managers of the reviewing office of the FDA, David Graham, who recently presented a paper linking Vioxx to the deaths of more than 27,000 Americans, is asked by the director of the FDA reviewing office why he “even thought to study Vioxx and heart attacks because FDA had made its labeling change and nothing more needed to be done,” according to Graham’s later testimony to Congress. Also during the meeting, a senior manager from the Office of Drug Safety refers to Graham’s study as “a scientific rumor.” [US Congress, 11/18/2004 ]

Entity Tags: David Graham, US Food and Drug Administration

Category Tags: Vioxx

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)

Entity Tags: Lester M. Crawford

Category Tags: Vioxx

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.” [Boston Globe, 10/9/2004]

Entity Tags: Raymond Gilmartin

Category Tags: Vioxx

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 ]

Entity Tags: David Graham

Category Tags: Defense of corporate interests, Defense of corporate interests, Vioxx