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Rock Hudson shortly before his death.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, HIV/AIDS Epidemic

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 -
bullet 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]
bullet 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]
bullet 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]
bullet 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]
bullet 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, Medicaid

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

Jane Akre.Jane Akre. [Source: Injury Board (.com)]Investigative reporters Jane Akre and her husband Steve Wilson are hired by WTVT-TV, the Tampa, Florida, Fox News affiliate, to become part of its “Investigators” team. They soon begin filming a report on bovine growth hormone (BGH), a controversial substance manufactured by Monsanto. Their four-part report finds that BGH poses numerous health risks to milk consumers, including the threat of cancer, and that Florida supermarket chains routinely lie to their customers about not selling milk that contains BGH. Akre and Wilson will later recall that the local station is thrilled with the report. But after Monsanto complains to Fox News chief Roger Ailes about the report, the station’s general manager, David Boylan, tells Akre and Wilson to redo their film: to include statements from Monsanto that the filmmakers know to be false, and to make other revisions to the story that contradict the facts. According to Akre and Wilson, one Fox lawyer tells them that “it doesn’t matter if the facts are true,” what matters is the size of the lawsuit Monsanto might file against WTVT and Fox. Boylan tells the filmmakers that the position of Fox Television is: “We paid $3 billion for these television stations. We will decide what the news is. The news is what we tell you it is.” Akre and Wilson revise the story some 70 times, none of which passes muster with the station or with network officials. The couple is variously suspended without pay, suspended with pay, locked out of their workspace, and offered money to “just go away.” In late November 1997, when they threaten to inform the Federal Communications Commission (FCC) of the incident, WTVT fires them. They will file a lawsuit against WTVT and against Fox Television (see August 18, 2000). [Fairness and Accuracy in Reporting, 6/1998; BGH Bulletin, 2004; St. Louis Journalism Review, 12/1/2007] Wilson later says: “Every editor has the right to kill a story and any honest reporter will tell you that happens from time to time when a news organization’s self interest wins out over the public interest. But when media managers who are not journalists have so little regard for the public trust that they actually order reporters to broadcast false information and slant the truth to curry the favor or avoid the wrath of special interests as happened here, that is the day any responsible reporter has to stand up and say, ‘No way!’ That is what Jane and I are saying with this lawsuit.… We set out to tell Florida consumers the truth a giant chemical company and a powerful dairy lobby clearly doesn’t want them to know. That used to be something investigative reporters won awards for. As we’ve learned the hard way, it’s something you can be fired for these days whenever a news organization places more value on its bottom line than on delivering the news to its viewers honestly.” Akre will add: “We are parents ourselves. It is not right for the station to withhold this important health information and solely as a matter of conscience we will not aid and abet their effort to cover this up any longer. Every parent and every consumer have the right to know what they’re pouring on their children’s morning cereal.” [BGH Bulletin, 2004] Akre and Wilson will win the Goldman Environmental Prize for their original report in 2001. [Prize, 2001]

Entity Tags: Fox Broadcasting Company, Federal Communications Commission, David Boylan, Roger Ailes, Jane Akre, Monsanto, Steve Wilson, WTVT-TV, Fox News

Category Tags: Disregard for Public Safety, Manipulation of data

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

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

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 pdf file; Topol, 2004; CBS News, 4/28/2005]

Entity Tags: Merck

Category Tags: Clinical drug studies, Manipulation of data, 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

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 pdf file] 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 pdf file] 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

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

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 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 pdf file] 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 pdf file]

Entity Tags: Merck, VIGOR

Category Tags: Vioxx, Marketing

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

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

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 pdf file; Office of Representative Henry A. Waxman, 5/5/2005, pp. 22 pdf file]

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 pdf file; Office of Representative Henry A. Waxman, 5/5/2005, pp. 12-13 pdf file]

Entity Tags: Merck

Category Tags: Marketing, 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 pdf file]

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 pdf file]

Entity Tags: Merck

Category Tags: Manipulation of data, Marketing, Vioxx

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 pdf file]

Entity Tags: Raymond Gilmartin, Merck

Category Tags: Disregard for Public Safety, Manipulation of data, 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 pdf file]

Entity Tags: Merck

Category Tags: Marketing, Vioxx

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 pdf file; Office of Representative Henry A. Waxman, 5/5/2005, pp. 13-14 pdf file]

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 (43), Alastair J. J. Wood

Category Tags: Political appointments, Disregard for Public Safety

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 pdf file; US Food and Drug Administration, 2005; Office of Representative Henry A. Waxman, 5/5/2005, pp. 16-19 pdf file]

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

Category Tags: Manipulation of data, Vioxx

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

Dr. Jonathan Fishbein.Dr. Jonathan Fishbein. [Source: unknown]Government whistleblower Dr. Jonathan Fishbein, in testimony before a panel at the Institute of Medicine, says that federal officials involved in a US-funded study in Uganda endangered the lives of hundreds of patients testing an AIDS drug because of careless and negligent research practices. Fishbein says officials at the National Institutes of Health (NIH) ignored problems with the way the study was being conducted on the AIDS drug, nevirapine, which is used to protect babies in Africa from HIV infection during birth. The consequences of their failure had “grave and sometimes fatal implications for the lives of real patients,” Fishbein tells the panel. Fishbein does not allege that the drug is dangerous or ineffective. Instead, he discusses problems with the researchers involved, citing shoddy data collection, record-keeping and quality control issues. Because of those concerns, he says, the results of the study cannot be trusted. “We can ill afford to entrust the lives of people to invalid data,” he says. NIH has acknowledged that the Uganda research failed to meet required US standards. But it maintains that hundreds of thousands of African babies have been saved by using single doses of the drug to block the AIDS virus and that it can be done safely with those single doses. Nevirapine is an antiretroviral drug used since the 1990s to treat adult AIDS patients and is known to have potentially lethal side effects like liver damage when taken in multiple doses over time. Concerns have been raised over the possibility that the drug may cause long-term resistance in patients to further AIDS treatments. It is marketed in the United States as Viramune. Fishbein says that top officials at NIH became “so heavily invested in the trial’s outcome” that they could not be objective. “The old adage ‘garbage in, garbage out’ is apt,” he says. In 2003, Fishbein helped halt the study for 15 months after auditors, medical experts, and others disclosed problems with the project. But the concerns were dismissed by NIH officials, and the study began again. Documents show NIH knew of problems with the study in early 2002, but did not tell the White House before President Bush launched a $500 million plan that summer to use nevirapine throughout Africa. NIH is attempting to fire Fishbein for what it calls poor performance issues; Fishbein says the firing is retaliation for his speaking out. [Associated Press, 1/4/2005]

Entity Tags: Institute of Medicine, United States National Institutes of Health, Jonathan Fishbein

Category Tags: Suppression of data, Dismissal of data, Disregard for Public Safety, Manipulation of data, HIV/AIDS Epidemic

A survey of 483 physicians by GfK Market Measures finds that one-third feel drug company sales representatives are “too aggressive or pushy.” Roughly an equal percentage says that many reps are “not knowledgeable.” One general practitioner tells GfK, “It’s silly that a highly trained sales force does not know what their product is used for and they have to ask me.” According to the survey, drug companies Pfizer and Merck are considered by doctors to have the most effective marketing teams. Abbott Laboratories’ sales force is rated as the least effective. [CNN, 9/14/2005]

Entity Tags: GfK Market Measures, Merck, Abbott Laboratories, Pfizer

Category Tags: Marketing

The New York Times publishes an article suggesting that pharmaceutical companies are using sex to sell their drugs. Physicians interviewed in the article indicate that the sexual marketing of drugs is widespread. “There’s a saying that you’ll never meet an ugly drug rep,” says Dr. Thomas Carli of the University of Michigan. T. Lynn Williamson, a cheering advisor at the University of Kentucky, tells the Times that recruiters from pharmaceutical companies routinely call him looking for prospective sales representatives. “They watch to see who’s graduating,” he explains. “They don’t ask what the major is. Exaggerated motions, exaggerated smiles, exaggerated enthusiasm—they learn those things, and they can get people to do what they want.” He says approximately two dozen cheerleaders from the university, mostly women but also some men, have gone on to work for the drug industry. The newspaper also interviews Gregory C. Webb, the owner of Spirited Sales Leaders, a company that helps former cheerleaders find work in the sales industry. “I’ve had people who are going right out, maybe they’ve been out of school for a year, and get a car and make up to $50,000, $60,000 with bonuses, if they do well,” he explains. His company’s website boasts that a “large number of former Varsity employees have secured sales positions and built successful careers in various fields, such as pharmaceutical and medical sales.” The website’s header combines a large photo of a hospital room with a photo of a cheerleader. [New York Times, 11/28/2005; Spirited Sales Leaders, 7/23/2006]

Entity Tags: T. Lynn Williamson, Gregory C. Webb, Spirited Sales, Thomas Carli

Category Tags: Marketing

Dr. Susan Molchan testifies before Congress.Dr. Susan Molchan testifies before Congress. [Source: CBS News]Dr. Susan Molchan, a former clinical researcher for the National Institutes of Health (NIH), testifies before Congress that her supervisor at NIH made a secret deal with the pharmaceutical company Pfizer that involved human tissue samples supposedly collected for the public good, but were instead used for Pfizer’s own research and garnered the company millions in profit. [CBS News, 6/14/2006] Molchan testifies before the House Energy and Commerce Subcommittee on Oversight and Investigations [The Scientist, 6/14/2006] that a collection of unused spinal fluid samples, which CBS News describes as a "a treasure trove of biological material, many painfully given up by Alzheimer’s patients" disappeared without a trace from her laboratory freezer at NIH. The samples were slated to be used for NIH studies on Alzheimer’s disease. Molchan says she was told that some of the samples were lost due to freezer malfunctions, but, "nothing solid, nothing that made sense. I never got a handle on what happened to them." [CBS News, 6/14/2006] Procuring the tissue samples alone cost the government $6.4 million, say committee staffers, who spent a year investigating the matter. "It would really be a shame if we find out that the National Institutes of Health has more control over its paper clips and trash cans than it has over its human tissue samples," says committee member Joe Barton (R-TX). [The Scientist, 6/14/2006] Molchan’s testimony, and other data gathered by Congressional investigators, prove that Molchan’s immediate supervisor, Dr. Trey Sunderland, a well-known psychiatric researcher, cut a secret deal with Pfizer at the same time Pfizer was launching and refining a new Alzheimer’s drug. "If individual scientists are making use of that tissue for their own personal gain, that’s something we need to know about it. It’s not the right thing," says House Energy subcommittee chairman Ed Whitfield (R-KY). Sunderland provided Pfizer "access" to 3,200 tubes of spinal fluid, costing the NIH and, as a result, taxpayers, an estimated $6 million. In exchange, Sunderland reportedly received $285,000 in personal compensation. Pfizer’s drug Aricept is now the top-selling drug in the world for treating Alzheimer’s, generating $1.6 billion in sales in 2004. "The more tissue samples you can collect these days and extract genetic information about risk and benefit, that’s the future of drug development around the world," says Dr. Art Caplan, a bio-ethicist at the University of Pennsylvania. The House committee finds that Pfizer itself broke no NIH rules or knew of any wrongdoing by Sunderland, who does not testify before Congress, instead invoking his Fifth Amendment right against self-incrimination. [CBS News, 6/14/2006] Sunderland himself received more than $600,000 in outside consulting and speaking fees from Pfizer from 1998 to 2004 without prior government disclosure or approval. A review by NIH’s Office of Management Assessment found that Sunderland "engaged in serious misconduct, in violation of HHS ethics rules and Federal law and regulation," the report stated. In December 2006, Sunderland will accept a plea bargain in regards to his accepting payments from Pfizer (see December 11, 2006). [The Scientist, 6/14/2006]

Entity Tags: Susan Molcher, Pfizer, Joe Barton, Pearson (“Trey”) Sunderland III, Art Capland, Ed Whitfield, United States National Institutes of Health

Category Tags: Fraud, Marketing, Defense of corporate interests

Concerned about Democratic plans (see After November 7, 2006) to push for lower drug prices and tighter regulation of the pharmaceutical industry, drug companies begin communicating with Democrats and recruiting lobbyists with Democratic connections. [New York Times, 11/24/2006]
bullet Billy Tauzin, president of the drug lobbying organization Pharmaceutical Research and Manufacturers of America (PRMA), meets with Senator Byron L. Dorgan, a North Dakota Democrat who has spent six years pushing for legislation that would allow drug imports from Canada. [New York Times, 11/24/2006]
bullet Amgen, a biotechnology firm, retains George C. Crawford, a former chief of staff for Representative Nancy Pelosi (D-Ca), as a lobbyist. [New York Times, 11/24/2006]
bullet Merck hires Peter Rubin, a former aide to Representative Jim McDermott of Washington. [New York Times, 11/24/2006]
bullet Cephalon contracts Kim Zimmerman, a health policy aide to Senator Ben Nelson (D-Ne). [New York Times, 11/24/2006]
bullet The Biotechnology Industry Organization retains Paul T. Kim, a former aide to Senator Edward M. Kennedy (D-Ma) and Representative Henry A. Waxman (D-Ca). [New York Times, 11/24/2006]
bullet One unnamed medicare expert who works for House Democrats tells the New York Times in late November that he received three separate job offers in one day from the drug industry. [New York Times, 11/24/2006]

Entity Tags: Kim Zimmerman, Paul T. Kim, W.J. (“Billy”) Tauzin, Peter Rubin, Merck, Biotechnology Industry Organization, Amgen, Byron L. Dorgan, George C. Crawford, Cephalon

Category Tags: Intellectual property, Medicare

Oxfam publishes a report concluding that poor people in developing nations are dying needlessly because drug companies and the governments of certain wealthy nations are putting a higher priority on defending intellectual property rights than protecting human life. According to the report, the United States has used free-trade agreements and threats of sanctions to prevent countries from producing and distributing low-cost generic drugs in order to preserve the monopolies of large drug companies. Likewise, the drugs makers themselves are pushing countries to prevent the sale of cheaper drugs. “Pfizer is challenging the Philippines government in a bid to extend its monopoly on Norvasc, a [blood] pressure drug. Novartis is engaged in litigation in India to enforce a patent for Glivec, a cancer drug, which could save many lives if it were available at generic prices,” the Guardian reports. The Oxfam report says that efforts to block the poor’s access to affordable medicine undermines the five-year old Doha declaration, which sought to improve poor countries’ access to cheap drugs. “[R]ich countries have failed to honor their promises. Their record ranges from apathy and inaction to dogged determination to undermine the declaration’s spirit and intent. The US, at the behest of the pharmaceutical industry, is uniquely guilty of seeking ever higher levels of intellectual property protection in developing countries,” the report says. [Guardian, 11/14/2006; Oxfam, 11/14/2006 pdf file]

Entity Tags: United States, Oxfam

Category Tags: Intellectual property

At a Pharmaceutical Research and Manufacturers of America (PRMA) board meeting, top executives from two dozen drug companies meet to work on a strategy to prevent the incoming Democratically-controlled Congress from passing legislation that would lower drug prices and tighten regulation of the industry (see After November 7, 2006). Their top concern is a bill they expect Democrats to push that would allow the government to negotiate lower drug prices for millions of older Americans on Medicare. Lobbyists for the industry concede that it is probable that such legislation will be passed by the House. But they say they are determined to have it killed in the Senate. If their efforts fail, and the Senate does pass such a bill, the drug industry believes that President Bush would veto it and that the veto would be upheld by the remaining Republicans in the Senate. Among those attending the meeting are Kevin Sharer, chairman of Amgen; Jeffrey B. Kindler, chief executive of Pfizer; Sidney Taurel, chairman of Eli Lilly; and Richard T. Clark, chief executive of Merck. [New York Times, 11/24/2006]

Entity Tags: Eli Lilly, Pfizer, Pharmaceutical Research and Manufacturers of America, Amgen, Sidney Taurel, W.J. (“Billy”) Tauzin, Jeffrey B. Kindler, Kevin Sharer, Richard T. Clark, Merck

Category Tags: Intellectual property, Medicare

Dr. Pearson “Trey” Sunderland.Dr. Pearson “Trey” Sunderland. [Source: CreativityFound (.org)]Dr. Pearson “Trey” Sunderland III, a National Institute of Health (NIH) senior researcher on Alzheimer’s disease, pleads guilty to a federal charge that he committed a criminal conflict of interest. The charges stem from Sunderland’s contract with the pharmaceutical firm Pfizer as a paid consultant for work that overlapped his duties as a public servant. Sunderland is the first official in 14 years to be prosecuted for conflict of interest at NIH, an agency rocked in recent years by revelations of widespread financial ties to the drug industry. According to the original court filing, in early 1998, “Sunderland initiated negotiations with Pfizer, the pharmaceutical giant, to be paid as a consultant for his work on the same project” that he headed for NIH, a research project into Alzheimer’s disease. In June 2006, Sunderland was revealed to have engaged in a secret contract with Pfizer to supply thousands of samples of spinal fluid collected from Alzheimer’s patients at taxpayer expense and slated to be used in NIH research. Sunderland turned those samples over to Pfizer, which in turn used them to refine and market its drug Aricept, a leading prescription drug for treating the disease (see June 14, 2006). According to the original charging document filed with the court, in 1998 Sunderland approached Pfizer with a proposal that he be paid $25,000 a year for “consulting” with the firm, plus $2,500 every time he attended a one-day meeting with company representatives. Pfizer agreed. Later that same year, Sunderland set up another deal with Pfizer to be paid another $25,000 a year, according to prosecutors. The House Energy and Commerce Committee received little cooperation from NIH—Sunderland himself invoked his Fifth Amendment right against self-incrimination when called to testify before the committee in June 2006—but subpoeaned 21 drug manufacturers known to have paid NIH researchers. Sunderland’s history of payments from Pfizer, which he did not reveal to the NIH as required by law, were some of those discovered. After that information was revealed in 2004, NIH director Elias Zerhouni requested that the inspector general of the Department of Health and Human Services investigate the matter. Government researchers found that 44 researchers, including Sunderland, had off-the-books relationships with drug and biotech companies; many of those researchers were reprimanded and/or took early retirement. At the time of Sunderland’s contracts with Pfizer, NIH restrictions against public-private collaborations were far more lax than they are today. [Associated Press, 12/4/2006; Associated Press, 12/5/2006; Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006]
'Public Trust Has Been Violated' - Congressman John Dingell (D-MI) asks, “Will a criminal conviction for conflict of interest be enough to get someone fired from NIH?” Bart Stupak (D-MI) adds, “If the National Institutes of Health and Commissioned Corps fail to discipline Dr. Sunderland, even after criminal charges have been brought, we can only conclude that no one is being held accountable, the system is broken, and the public trust has been violated.” [Associated Press, 12/5/2006; Los Angeles Times, 12/5/2006] Committee member Tammy Baldwin (D-WI) says: “I found this story incredibly distressing because it is so important that people have confidence in the NIH. It is a pretty big move for people to donate human tissue to further scientific discovery. People have to have confidence that that decision… is treated with the utmost respect.” [Washington Post, 12/5/2006]
Guilty Plea Avoids Jail Time - Sunderland pleads guilty to the charge under a plea agreement in which he admits to taking some $285,000 in “unauthorized” consulting fees from Pfizer as well as $15,000 in travel expense payments between 1998 and 2003. During the same period, he provided Pfizer with spinal-tap samples collected from hundreds of patients as part of a research collaboration approved by the NIH. He agrees to pay the government $300,000, perform 400 hours of community service, and serve two years’ probation. Sunderland faced up to a year in prison and a $100,000 fine, but avoided those penalties through his plea agreement. After the hearing, US Attorney Rod Rosenstein tells reporters that Sunderland’s actions constitute a breach of the public trust. [Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006] According to NIH spokesman Don Ralbovsky, Sunderland remains an employee, working as a “special assistant and senior adviser” in a division that gives out grants; Rabolvsky refuses to comment on whether Sunderland faces termination procedures. The branch of NIH that Sunderland once headed, the Geriatric Psychiatry Branch, no longer exists, according to Ralbovsky. [Washington Post, 12/5/2006] One media report says Sunderland is planning to retire. [Associated Press, 12/4/2006] Sunderland will later become a doctor and director of the Alzheimer Research Center at the Albert Einstein College of Medicine in New York. [Lundbeck Institute, 12/11/2008]
Pfizer Denies Wrongdoing - For its part, Pfizer maintains that it broke no laws and breached no ethics, saying in a statement: “We believe our actions complied with applicable laws and ethical standards. We are not aware of any allegation that we violated any law or regulation.” [Los Angeles Times, 12/5/2006; Washington Post, 12/5/2006; Los Angeles Times, 12/11/2006]

Entity Tags: Pfizer, Pearson (“Trey”) Sunderland III, Rod Rosenstein, John Dingell, Bart Stupak, Don Ralbovsky, Elias Zerhouni, United States National Institutes of Health, Tammy Baldwin

Category Tags: Fraud, Marketing, Defense of corporate interests

Betsy McCaughey (R-NY), the former lieutenant governor of New York and a fellow at the conservative Hudson Institute, writes that health care provisions in the Obama administration’s economic stimulus plan will affect “every individual in the United States.” McCaughey writes: “Your medical treatments will be tracked electronically by a federal system. Having electronic medical records at your fingertips, easily transferred to a hospital, is beneficial. It will help avoid duplicate tests and errors. But the bill goes further. One new bureaucracy, the National Coordinator of Health Information Technology, will monitor treatments to make sure your doctor is doing what the federal government deems appropriate and cost effective. The goal is to reduce costs and ‘guide’ your doctor’s decisions.” McCaughey says the provisions are similar to suggestions in the book Critical: What We Can Do About the Health Care Crisis, by former Senate Majority Leader Tom Daschle (D-SD), until recently Obama’s pick to head the Department of Health and Human Services. McCaughey writes that hospitals and doctors who do not use the system will be punished, by a federal oversight board to be called the Federal Coordinating Council for Comparative Effectiveness Research. Perhaps most worrisome is McCaughey’s claim that elderly Americans will be given reduced health care based on their age and expected productivity. “Medicare now pays for treatments deemed safe and effective. The stimulus bill would change that and apply a cost-effectiveness standard set by the Federal Council,” she writes. “The Federal Council is modeled after a UK board discussed in Daschle’s book. This board approves or rejects treatments using a formula that divides the cost of the treatment by the number of years the patient is likely to benefit. Treatments for younger patients are more often approved than treatments for diseases that affect the elderly, such as osteoporosis. In 2006, a UK health board decreed that elderly patients with macular degeneration had to wait until they went blind in one eye before they could get a costly new drug to save the other eye. It took almost three years of public protests before the board reversed its decision.… If the Obama administration’s economic stimulus bill passes the Senate in its current form, seniors in the US will face similar rationing. Defenders of the system say that individuals benefit in younger years and sacrifice later. The stimulus bill will affect every part of health care, from medical and nursing education, to how patients are treated and how much hospitals get paid. The bill allocates more funding for this bureaucracy than for the Army, Navy, Marines, and Air Force combined.” [Bloomberg News, 2/9/2009] McCaughey’s claims are very similar to the ones she made against the Clinton administration’s attempt to reform health care in 1994 (see Mid-January - February 4, 1994). They will be proven false (see July 23, 2009).

Entity Tags: Hudson Institute, Elizabeth (“Betsy”) McCaughey, US Department of Health and Human Services, Tom Daschle, Obama administration

Timeline Tags: Domestic Propaganda, 2010 Elections

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

The Department of Health and Human Services rescinds the controversial “conscience rule” that allows health care workers to refuse to provide abortion counseling or other family-planning services if doing so would violate their moral or religious beliefs. The rule was announced on December 19, 2008 as one of the Bush administration’s final policy initiatives. Seven states have already challenged the rule in court, arguing that it sacrifices the health of patients to religious beliefs of medical providers. The American College of Obstetrics and Gynecology has reported numerous cases regarding the rule, including a Virginia mother of two who became pregnant after being denied emergency contraception, and a rape victim whose prescription for emergency contraception was rejected by a pharmacist. Obama officials say the administration will consider drafting a new rule to clarify what health care workers can reasonably refuse for patients. The public has 30 days to respond to the move before it becomes viable. Sister Carol Keehan, president of the Catholic Health Association, said in December that her organization supported the rule because in recent years “we have seen a variety of efforts to force Catholic and other health care providers to perform or refer for abortions and sterilizations.” However, opponents of the rule, including the American Medical Association, the National Association of Chain Drug Stores, and Planned Parenthood, said it could have voided state laws requiring insurance plans to cover contraceptives and requiring hospitals to offer emergency contraception to rape victims. It could also allow drugstore employees to refuse to fill prescriptions for contraceptives. And the Civil Rights Act of 1964 already offers broad protection against discrimination based on religion, mandating that an employer must make reasonable accommodations for an employee’s practices and beliefs. Cecile Richards of Planned Parenthood says, “Today’s action by the Obama administration demonstrates that this president is not going to stand by and let women’s health be placed in jeopardy.” [Chicago Tribune, 2/27/2009; New York Times, 2/27/2009]

Entity Tags: Catholic Health Association, American Medical Association, American College of Obstetrics and Gynecology, Carol Keehan, US Department of Health and Human Services, National Association of Chain Drug Stores, Obama administration, Cecile Richards, Civil Rights Act of 1964, Bush administration (43), Planned Parenthood

Category Tags: Disregard for Public Safety

The Pharmaceutical Research and Manufacturers of America (PhRMA) acknowledges it has funded a series of television advertisements in support of legislation primarily written by Max Baucus (D-MT), chairman of the Senate Finance Committee, to reform US health care. The television ads are part of an agreement between the Obama administration, Baucus, and PhRMA in June, where the organization agreed to various givebacks and discounts designed to reduce America’s pharmaceutical spending by $80 billion over 10 years. PhRMA then set aside $150 million for advertising to support health care legislation. More progressive House Democrats such as Henry Waxman (D-CA) are pushing for stiffer drug industry givebacks than covered in the deal. PhRMA is led by Billy Tauzin, a former Republican congressman. Until recently, the organization spent some $12 million on ads by an offshoot coalition called Americans for Stable Quality Care, and aired television ads such as “Eight Ways Reform Matters to You.” PhRMA’s new ads will specifically support the Baucus bill. Many are critical of the deal, with James Love of the progressive research group Knowledge Ecology charging, “Essentially what the US got was not $80 billion, but $150 million in Obama campaign contributions.” [New York Times, 9/12/2009] Investigative reporter Matt Taibbi agrees with Love, accusing the White House of colluding with Baucus and Tauzin’s PhRMA to orchestrate a “big bribe” in exchange for the Democrats’ dropping of drug-pricing reform in the Baucus bill. Taibbi writes that in June, White House chief of staff Rahm Emanuel met with representatives from PhRMA and drug companies such as Abbott Laboratories, Merck, and Pfizer to cut their deal. Tauzer later told reporters that the White House had “blessed” a plan involving the $150 million in return for the White House’s agreement to no longer back government negotiations for bulk-rate pharmaceuticals for Medicare, and to no longer support the importation of inexpensive drugs from Canada. Taibbi writes that the White House worked with Baucus and PhRMA to undercut Waxman’s attempts to give the government the ability to negotiate lower rates for Medicare drugs. PhRMA’s ads are being aired primarily in the districts of freshmen Democrats who are expected to face tough re-election campaigns, and in the districts of conservative “Blue Dog” Democrats, who have sided with Baucus, Obama, and PhRMA to oppose the Waxman provision in favor of PhRMA’s own provision, which would ban the government from negotiating lower rates for Medicare recipients. [True/Slant, 9/14/2009]

Entity Tags: James Love, Henry A. Waxman, Americans for Stable Quality Care, Abbott Laboratories, Rahm Emanuel, Pharmaceutical Research and Manufacturers of America, Senate Finance Committee, Obama administration, Medicare, Max Baucus, Matt Taibbi, Pfizer, Merck, W.J. (“Billy”) Tauzin

Category Tags: Marketing, Defense of corporate interests, US Health Insurers, Obama Health Care Reform, Medicare

The Public Campaign Action Fund (PCAF), a campaign finance watchdog organization, finds that insurance and health management organizations (HMOs) have spent over $700,000 a day during the first half of 2009 to defeat health care reform. It also notes that health care and insurance interests, which include organizations outside of the HMOs and insurance companies, have spent roughly $1.4 million a day during the first quarter of 2009 to defeat reform efforts. During the first six months of 2009, the companies spent $126,430,438, mostly on hired lobbyists, to oppose the health care reform legislation working its way through Congress. Since 2007, the companies have spent around $585 million to defeat health care reform. “The insurance and HMO interests are fighting health care reform with hundreds of millions of dollars,” says PCAF’s David Donnelly. “Why are so many in Congress willing to listen to an industry that is spending tens of millions every month on politics rather than on lowering their premiums or helping to address the costs of health care? They need the cash to pay for their campaigns.” The HMO and insurance companies have 1,795 lobbyists registered in Washington to represent their concerns to Congress and members of the Obama administration; the same firms hired almost 2,000 lobbyists in 2008. PCAF says it compiled its data from information provided by the Center for Responsive Politics and the Senate lobbying disclosure Web sites. [Public Campaign Action Fund, 9/15/2009]

Entity Tags: Center for Responsive Politics, Public Campaign Action Fund, David Donnelly

Category Tags: Marketing, Defense of corporate interests, Obama Health Care Reform

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