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Context of 'February 2002: White House Decides Not to Nominate Doctor as FDA Commissioner Because of Industry Opposition'

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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

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

FDA scientist David Graham has analyzed data on 1.4 million Kaiser Permanente patients who took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. Based on his findings, Graham believes there have been more than 27,000 heart attacks and sudden cardiac deaths in the US that would not have occurred had those patients been prescribed Celebrex instead of Vioxx. [Washington Post, 10/8/2004] When the FDA reviews a summary of his study, which Graham will present in France on August 25 (see August 25, 2004), his conclusion triggers “an explosive response from the Office of New Drugs.” Graham later tells Congress, “I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference. One Drug Safety manager recommended that I should be barred from presenting the poster at the meeting.” [US Congress, 11/18/2004 pdf file] In an August 12 e-mail, John Jenkins, director of the Office of New Drugs, suggests “watering down” the report’s conclusions because the FDA is “not contemplating” a warning against high-doses of Vioxx. In response, Graham says, “I’ve gone about as far as I can without compromising my deeply-held conclusions about this safety question.” In another e-mail, a different top official expresses concern about how the report might impact Merck. The person writes that the company should be warned beforehand “so they can be prepared for [the] extensive media attention that this will likely provoke.” [Wall Street Journal, 10/8/2004; Washington Post, 10/8/2004]

Entity Tags: John Jenkins, David Graham

Timeline Tags: US Health Care

David Graham, associate science director for the FDA’s Office of Drug Safety, presents the findings of a study on Vioxx in a poster exhibit at an international medical conference in Bordeaux, France. According to Graham’s research, thousands of Americans have died from taking the drug. In his study, he analyzed data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. According to Graham’s analysis of the data, the risk of having a heart attack or dying from heart problems is 3.2 times higher for Vioxx patients than people who do not use painkillers, and twice as high for those using Celebrex. Based on these figures, Graham estimates that more than 27,000 Americans have had heart attacks or died from sudden cardiac deaths as a result of taking Vioxx instead of Celebrex. In response to Graham’s study, Merck, the maker of Vioxx, issues a statement insisting that its drug is safe. Alise Reicin, vice president of clinical research at Merck, claims that numerous studies comparing the drug to a dummy pill found “no difference in the risk of having a serious cardiovascular event.” FDA spokeswoman Laura Alvey says the FDA has no plans to ban the drug. “Removing the drug from the market is not on the table,” she says. [Associated Press, 8/26/2004] Prior to the event, FDA officials had pressured him to water down his conclusions (see Mid-August 2004).

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

Timeline Tags: US Health Care

Merck voluntarily withdraws Vioxx from the market after a long term colon-polyp prevention study, called APPROVe, appears to show that the drug doubles the risk of heart attacks or strokes when taken for 18 months or longer. [Merck, 9/30/2004 pdf file] Acting FDA Commissioner Dr. Lester M. Crawford praises Merck for “promptly reporting these finding” to the FDA. [US Food and Drug Administration, 9/30/2004] An estimated 107 million people have used Vioxx since it was approved in 1998. A paper by FDA scientist David Graham, published in the British medical journal Lancet, will later suggest that 88,000-140,000 Americans may have suffered serious coronary heart disease as a result of taking the drug. (see January 25, 2005)

Entity Tags: Lester M. Crawford

Timeline Tags: US Health Care

David Graham, associate science director for the FDA’s Office of Drug Safety, appears before the Senate Committee on Finance to testify on the agency’s ability to protect the American public from harmful drugs. Graham, a twenty-year veteran of the agency, tells the committee that “the FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” Graham was an early critic of Vioxx, a painkiller that was recalled in September (see September 30, 2004) because of its link to heart problems. Graham recounts how in August (see Mid-August 2004), the FDA tried to suppress a study he led which found that “nearly 28,000 excess cases of heart attack or sudden cardiac death were caused by Vioxx.” He says the study’s findings were “extremely conservative” and that “a more realistic and likely… estimate ranges from 88,000 to 139,000 Americans” of which “30-40 percent [or 26,400-55,600] probably died.” He notes that this figure is the “rough equivalent of 500 to 900 aircraft dropping from the sky… [or] 2-4 aircraft every week, week in and week out, for the past 5 years.” [US Congress, 11/18/2004 pdf file] The remainder of Graham’s testimony focuses on problems within the FDA’s Office of Drug Safety (ODS). He makes the following points:
bullet The Office of New Drugs (ONS), which approves all new drugs, is the same division that is responsible for taking regulatory action against those drugs after they have been released on the market. This is an inherent conflict of interest, he notes, because when a problem arises, recognizing it would require the ONS to acknowledge that it had made a mistake. Instead, the office’s “immediate reaction [to a problem] is almost always one of denial, rejection, and heat.” [US Congress, 11/18/2004 pdf file]
bullet The Office of Drug Safety (ODS) is subordinate to the Office of New Drugs, and consequently the management of the former sees its mission as pleasing the latter. [US Congress, 11/18/2004 pdf file]
bullet The culture of the FDA’s Center for Drug Evaluation and Research (CDER) “views the pharmaceutical industry it is supposed to regulate as its client, over-values the benefits of the drugs it approves and seriously under-values, disregards, and disrespects drug safety.” [US Congress, 11/18/2004 pdf file]
bullet The Office of New Drugs refuses to take regulatory action on any drug unless it can be shown with 95 percent or greater certainty that it is unsafe. However “to demonstrate a safety problem with 95 percent certainty, extremely large studies are often needed… [and] those large studies cannot be done.” Graham suggests the 95 percent rule makes as much sense as a person with a 100-chamber pistol loaded with 90 bullets saying that the gun is safe. “Because there is only a 90 percent chance that a bullet will fire when I pull the trigger, CDER would conclude that the gun is not loaded and that the drug is safe.” [US Congress, 11/18/2004 pdf file]

Entity Tags: David Graham

Timeline Tags: US Health Care

The British medical journal Lancet publishes a paper by FDA scientist David Graham suggesting that tens of thousands of Americans probably died from taking Vioxx, a painkiller that was recalled in September (see September 30, 2004). His study looked at data on 1.4 million Kaiser Permanente patients that took Vioxx, Celebrex, or another non-steroidal anti-inflammatory drug (NSDAID) between 1999 and 2003. The data showed that the risk of having a heart attack or dying from heart problems was 1.6 times higher for patients taking standard-dose Vioxx compared with those using Celebrex. The risk was 3.6 times higher for those on high doses. Graham notes that Vioxx’s potential impact on the patient population was likely severe. Using the risk factors from Merck-sponsored randomized clinical trials, and extrapolating these to the estimated 106.7 million Vioxx patients, Graham says that the drug may have caused cardiovascular problems for 88,000-140,000 Americans. It is estimated that 44 percent of acute myocardial infarction’s are fatal. [Graham et al., 2005 pdf file; London Times, 1/25/2005] In November, Graham told Congress that senior managers at the FDA’s Office of Drug Safety had delayed giving Graham permission to publish this study, even after it had been accepted by Lancet. [US Congress, 11/18/2004 pdf file]

Entity Tags: David Graham

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

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