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US Health Care System

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Project: US Health Care System
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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 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

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

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

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

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

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, Medicare, Medicaid

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 pdf file; 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

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 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:
bullet 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.
bullet 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.
bullet The FDA should be given new powers to impose fines, injunctions, and withdrawals when drug companies fail to complete the required safety studies.
bullet The agency should be given the authority to impose a wider range of restrictions on drugs it considers potentially unsafe.
bullet 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.
bullet 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

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

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

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 pdf file] 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

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, Medicare

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, Medicare, Medicaid

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 pdf file]

Entity Tags: Aventis, US Food and Drug Administration

Category Tags: Clinical drug studies

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 (43), James Trussell, John Kerry, Food and Drug Administration

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

The Center for Reproductive Rights (CRR) files a lawsuit against the Food and Drug Administration (FDA) asking that the courts reverse a recent FDA decision not to allow the so-called “morning-after” birth-control drug “Plan B” to be sold without a prescription (see May 6, 2004 and After). The CRR says the FDA’s decision was made based on politics and not science. CCR president Nancy Northrup will say that the FDA’s decision “broke its own rules, held Plan B to a higher standard than other over-the-counter drugs, and [as a result,] women have suffered the consequences.” Testimony and depositions gathered indicate that the FDA indeed placed politics over science in its decision. One scientist says that a deputy FDA commissioner told her that the over-the-counter (OTC) application for Plan B had to be rejected “to appease the administration’s constituents,” and that it could later be quietly approved for adults only (see March 4, 2008). Another scientist testifies that he learned before the 2004 decision was issued that then-FDA commissioner Mark McClellan—the brother of White House press secretary Scott McClellan—had already decided to disapprove the drug even before the FDA’s advisory panel had completed its analysis. However, McClellan will deny the accusation. [Center for Reproductive Rights, 11/14/2005; Savage, 2007, pp. 301-302]

Entity Tags: Mark McClellan, Center for Reproductive Rights, Nancy Northrup, Food and Drug Administration, Scott McClellan

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

An expert panel convened by the US Food and Drug Administration unanimously agrees that Celebrex, Bextra, and Vioxx “significantly increase the risk of cardiovascular events” such as heart attacks. However the panel does not believe that the risk is so great that these drugs should be banned from the market. (Vioxx was withdrawn from the market voluntarily by its manufacturer in September (see September 30, 2004).) The sales of these drugs should be permitted to continue, but only under strict conditions, the panel says. It also recommends a prohibition on direct marketing to consumers, a patient’s guide for the drug, and a black box warning—the most severe possible—detailing the drug’s cardiovascular side effects. [CNN, 2/18/2005; Washington Times, 2/19/2005] After the vote, the New York Times reveals that 10 of the panel’s 32 members had at one time been paid-consultants to the makers of the drugs in question. In analyzing the votes, the Times discovers that neither Bextra nor Vioxx would have survived the vote if the scientists with connections to the company had not voted. For both Bextra and Vioxx, the industry-connected panelists voted 9 to 1 in favor, while the experts with no ties voted 14 to 8 and 17 to 15 to ban Bextra and Vioxx, respectively. The Times notes in its article that “these votes were deeply important” for the makers of those drugs. After the votes, the shares of Merck and Pfizer increase substantially. In e-mails to the Times, eight of the panelists, responding to questions from the newspaper, say their votes were not influenced by their ties to the companies. Two of the panelists do not respond. One of the panel members, Dr. John Farrar, who has received research support from Pfizer, says, “I think FDA would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company.” But another panel member, Dr. Curt Furberg, who has no ties, says he was “uncomfortable with the Pfizer-friendly undertone” at the meeting and he felt the industry ties might have contributed to that tone. Furberg adds that it has never been proven that Celebrex, Bextra, or Vioxx offer better pain relief than ibuprofen or more than a dozen other over-the-counter drugs. Daniel E. Troy, the FDA’s former chief counsel and a longtime advocate of drug-maker interests, plays down the importance of the ties, saying that any suggestion that experts’ votes were influenced by industry connections “buys into an overly conspiratorial view of the world.” [New York Times, 2/25/2005]

Entity Tags: Daniel E. Troy, John Farrar, Curt Furberg, US Food and Drug Administration

Category Tags: FDA advisory panels, Vioxx

Dr. Maria Rosa Costanzo presents the findings of a study on the effectiveness of a $14,000 blood filtering device manufactured by Minnesota-based CHF Solutions. The study—performed by Midwest Heart Foundation, but designed with the help of CHF Solutions—concluded that the device does a better job of removing excess fluid from patients with heart failure than intravenous diuretic drugs. Costanzo does not disclose to her audience that CHF Solutions is one of Midwest Heart Foundation’s largest donors—contributing about $180,000 in 2004. She does say that she is a paid consultant of the company and a stockholder. Some doctors criticize the study, noting that subjects of the study may not have taken enough medicine to provide meaningful comparisons. [New York Times, 6/28/2006] Cardiologist Dr. JoAnn Lindenfeld, for example, tells Heartwire, “I wouldn’t view these data as persuasive enough to use it full-scale in a million patients a year with acute decompensated heart failure.” [HeartWire, 3/15/2006]

Entity Tags: CHF Solutions, Midwest Heart Foundation, JoAnn Lindenfeld, Maria Rosa Costanzo

Category Tags: Published studies

In a 93-1 vote, the US Senate passes the Food and Drug Administration Improvement Act of 2007 (H.R.2273), which grants the FDA broad new authority to monitor the safety of drugs after they are approved. It was based in part on the recommendations of a 2001 report by the Institute of Medicine (see September 22, 2001). The institute had been asked by the FDA to examine drug safety after it was revealed that the FDA and drugmaker Merck had permitted the drug Vioxx to stay on the market despite numerous indications that it increased patients’ risk of a heart attack. But the bill that is passed is much weaker than the original version, and ignores some of the institute’s most critical recommendations. A USA Today investigation will find that industry-friendly changes made to the bill were instigated by senators “who raised millions of dollars in campaign donations from pharmaceutical interests.” For example, 49 senators successfully defeated an effort that would have allowed US consumers to import lower-cost drugs from Canada and other industrialized countries. The senators who opposed the provision “received about $5 million from industry executives and political action committees since 2001—nearly three quarters of the industry donations to current members of the Senate,” USA Today found. Another factor contributing to the amendment’s failure was that President Bush said he would veto the bill if it permitted the imports. Also excised from the bill was language that would have give the FDA the authority to ban advertising of high-risk drugs for two years. This was one of the Institute of Medicine’s key recommendations. Senator Pat Roberts (R-Kan) argued that the change would restrict free speech. Drug interests have given Roberts $18,000 so far this year, and $66,000 since 2001. Sen. Judd Gregg (R-NH) was responsible for a change that reduced the agency’s power to require post-market safety studies. He insisted on limiting this authority so that the FDA could only target drugs when there’s evidence of harm. Gregg has received $168,500 from drug industry interests since 2001. The bill’s main sponsors—senators Edward Kennedy, (D-Mass) and Mike Enzi (R-Wyo)—agreed to water down a proposal that would have required all clinical drug studies be made public after meeting with industry officials. The senators agreed to change the language so that only studies submitted to the FDA would be available. Enzi and Kennedy have received $174,000 and $78,000, respectively, from drug interests since 2001. Amendments aimed at reducing industry conflicts of interest on FDA expert advisory panels were also stripped from the bill. One of those amendments would have made it more difficult for scientists to advise the FDA on drug approval applications from a company the scientist had received money from. Another would have required that FDA panels consist of no more than one member with financial ties to the drug industry. The Senate also rejected an amendment to establish an independent FDA office to monitor the safety of drugs after they are released on the market. The office that currently has this authority is the same one that approves new drugs, an arrangement that lawmakers and at least one FDA scientist (see November 18, 2004) believe is a conflict of interest. [WebMD Medical News, 5/9/2007; US Congress, 5/10/2007; USA Today, 5/14/2007]

Entity Tags: George W. Bush, Edward M. (“Ted”) Kennedy, Judd Gregg, Mike Enzi, US Food and Drug Administration, Pat Roberts

Category Tags: Clinical drug studies, FDA advisory panels, Defense of corporate interests, Vioxx

A federal judge dismisses a lawsuit seeking to halt sales of the so-called “morning-after” birth control pill, the only such drug available in the US without a prescription. In 2006, the FDA reversed its 2004 decision not to allow the drug to be sold over the counter (see May 6, 2004 and After) to anyone 18 years of age or older. The suit was brought by the Association of American Physicians and Surgeons and a number of anti-abortion and social conservative groups. The US District Court in the District of Columbia finds that the plaintiffs failed “to identify a single individual who has been harmed by Plan B’s OTC [over-the-counter] availability.” The ruling is widely considered to be a victory for advocates of reproductive rights. “They still don’t have any evidence in terms of why they think it is harmful,” says Janet Crepps of the Center for Reproductive Rights (CRR). “This is the right decision for women.” A lawsuit filed by the CRR to force OTC sales of the drug to girls under 18 is still pending (see April 22, 2009). [Reuters, 3/4/2008]

Entity Tags: Association of American Physicians and Surgeons, Food and Drug Administration, Janet Crepps, Center for Reproductive Rights

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

The Food and Drug Administration (FDA) announces that, in line with a judge’s recent ruling, it will approve the sale of the so-called “morning-after” emergency contraception pill to 17-year olds without a doctor’s prescription. A judge recently ruled in favor of the Center for Reproductive Rights (CRR) in a lawsuit against the FDA (see January 21, 2005 and After). Under the Bush administration, the FDA ruled that the pill, called “Plan B,” could not be sold without a prescription (see May 6, 2004 and After), a decision partially reversed in 2006. Conservative groups say the decision will make it more difficult for parents to supervise their teens; women’s rights groups say the decision strengthens the rights of women. District Judge Edward Korman ruled that the FDA’s political appointees placed politics over science in its decision to restrict over-the-counter (OTC) sales of the drug; he wrote that evidence showed White House officials pressured the FDA to reject the drug’s OTC sales. His ruling orders the FDA to allow OTC sales to 17-year olds, and to evaluate whether all age restrictions should be lifted. CRR’s Nancy Northrup says, “It’s a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science.” Wendy Wright of the conservative action group Concerned Women for America says, “Parents should be furious at the FDA’s complete disregard of parental rights and the safety of minors.” In 2008, a judge ruled that conservative groups had failed to prove that the drug posed a risk to anyone (see March 4, 2008). Former FDA official Susan Wood, who resigned in 2005 over the issue, says the battle over Plan B came to symbolize just how politicized the agency became under President Bush. “The FDA got caught up in a saga, it got caught up in a drama,” she says. “This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas.” [Associated Press, 4/22/2009; Washington Post, 4/23/2009] “We need to have a very strong and science-based agency, and this is one of those steps that will help strengthen it,” Wood says. [USA Today, 3/23/2009]

Entity Tags: George W. Bush, Bush administration (43), Center for Reproductive Rights, Food and Drug Administration, Susan Wood, Wendy Wright, Nancy Northrup, Edward Korman

Timeline Tags: Civil Liberties

Category Tags: FDA advisory panels

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