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Context of 'September 22, 2001: Expert Panel Recommends Changes to FDA'

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1960: US Introduces Trade Embargo against Cuba

The US begins a 40-year plus trade embargo on Cuba. [Perez, 1995; Guardian, 11/28/2001] The embargo applies to a wide range of goods including both food and medicine. [Perez, 1995; Guardian, 11/28/2001] Beginning in 1992, the UN General Assembly will annually condemn these sanctions against Cuba. [Guardian, 11/28/2001]

Timeline Tags: US-Cuba (1959-2005)

Upon learning that the Food and Drug Administration (FDA) has decided not to require special regulation for genetically engineered foods (see May 26, 1992), FDA scientist Dr. Louis J. Pribyl blasts the decision in a memo to his colleagues. “This is the industry’s pet idea, namely that there are no unintended effects that will raise the FDA’s level of concern,” he writes. “But time and time again, there is no data to back up their contention.” Pribyl, one of 17 government scientists who have been working on a policy for genetically engineered food, knows from his own research and studies that the introduction of new genes into a plant’s cell can produce toxins. [New York Times, 1/25/2001]

Entity Tags: Louis J. Pribyl, Food and Drug Administration

Timeline Tags: Seeds

The UN Security Council votes to impose tough sanctions on Yugoslavia, which effectively refers to Serbia since most other Yugoslav republics have declared independence. The embargo requires all the countries of the world to cease trading in any commodity, including oil, and to freeze all of Serbia’s foreign assets. All air traffic links are suspended as well. Sales of medicine and food are exempted. The sanctions are meant to pressure Serbia to agree to a cease fire in the war in Bosnia. [New York Times, 5/31/1992]

Entity Tags: United Nations

Timeline Tags: Complete 911 Timeline

Frederick Seitz, a former tobacco company scientist and former National Academy of Sciences president, writes and circulates a letter asking scientists to sign a petition calling upon the US government to reject the Kyoto Protocol. The petition was authored by an obscure group by the name of “Oregon Institute of Science and Medicine.” [Seitz, 1998] Seitz includes in his letter a report arguing that carbon dioxide emissions do not pose a threat to the global climate. The report—which is not peer reviewed—is formatted to look like an article from the esteemed Proceedings of the National Academy of Sciences (PNAS). The organizers of the petition will claim that some 17,000 scientists signed the petition. But it is subsequently discovered that few credentialed climate scientists added their signature to the list. Moreover, the petition contains the names of several fictional characters. The magazine Scientific American analyzes a random sampling of the signers and concludes that only about one percent of the petition signatories claiming to have a Ph.D. in a climate-related field actually do. And in a highly unusual move, the National Academy of Sciences issues a statement disavowing Seitz’s petition and disassociating the academy from the PNAS-formatted paper. [Union of Concerned Scientists, 2007, pp. 16 pdf file]

Entity Tags: Frederick Seitz, Oregon Institute of Science and Medicine

Timeline Tags: Global Warming

In Geneva, at the 1998 World Health Assembly, delegates from the US State Department and the Food and Drug Administration (FDA ) threaten to withdraw funding for the World Health Organization (WHO) when members propose including a provision in its resolution on the Revised Drug Strategy that would urge countries “to ensure that public-health interests rather than commercial interests have ‘primacy’ in pharmaceutical and health policies.” As a result of the United States’ opposition, the statement is not adopted. The US also opposes a proposal to give the WHO a role in monitoring international trade agreements. [Consumer Project on Technology, 5/13/1998; Consumer Project on Technology, 10/16/1998; Wilson et al., 11/27/1999]

Entity Tags: World Health Organization, Clinton administration

Timeline Tags: Neoliberalism and Globalization

Merck submits its New Drug Application (NDA 21-042) to the Food and Drug Administration (FDA) for Vioxx, which is intended to treat acute pain in adults, dysmenorrhea and osteoarthritis. The drug is supposed to cause fewer gastrointestinal problems than painkillers currently on the market. The NDA includes results from clinical studies that involved 5,400 subjects. [US Food and Drug Administration, 2005]

Entity Tags: US Food and Drug Administration, Merck

Timeline Tags: US Health Care

Merck submits the results of the VIGOR clinical trial for its drug Vioxx to the New England Journal of Medicine (NEJM) for publication. The data include only 17 of the 20 deaths that occurred among patients taking Vioxx (see March 2000). [National Public Radio, 6/8/2006] Data concerning the last three deaths were deleted two days before, according to Dr. Gregory Curfman, executive editor of the journal, who does not discover the missing data until December 2004. “When you hover the cursor over the editing changes, the identity of the editor pops up, and it just says ‘Merck,’” Curfman later tells Forbes magazine. [Forbes, 12/8/2005]

Entity Tags: Merck

Timeline Tags: US Health Care

The New England Journal of Medicine publishes the VIGOR paper (see May 18, 2000) summarizing the results of a clinical trial for the drug Vioxx. The paper’s main conclusion is that patients taking the drug experienced fewer gastrointestinal complications than patients taking naproxen, another painkiller. This conclusion is important to Merck, the maker of the drug, because this is Vioxx’s only selling point. There is no evidence that Vioxx is a more effective painkiller than any other drug available on the market. But the paper’s section on “General Safety” is misleading because the authors leave out the deaths of three Vioxx patients (see March 2000). The authors were aware of the fatal heart attacks and had at least two opportunities to correct these omissions (see July 2000-November 2000). Notwithstanding their knowledge of these deaths, the authors say there is no causal relationship between Vioxx and heart problems. [Bombardier et al., 2000; National Public Radio, 6/8/2006] When the Journal learns about the missing deaths, executive editor Dr. Gregory Curfman, demands a correction. He tells Forbes magazine, “I was somewhere between surprised and stunned. They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health.” [Forbes, 12/8/2005]

Timeline Tags: US Health Care

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

Scientists with the Armed Forces Institute of Pathology and a microbiologist from the Mount Sinai School of Medicine in New York genetically reconstruct the “Spanish Flu” influenza virus that killed 20-40 million people in 1918. [Sunshine Project, 10/9/2003; Sunshine Project, 10/9/2003]

Entity Tags: Sunshine Project

Timeline Tags: US Military

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: US Health Care, Civil Liberties

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

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

Entity Tags: US Food and Drug Administration

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

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

Timeline Tags: US Health Care

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: US Health Care, Civil Liberties

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

For the fourteenth consecutive year, the UN General Assembly, in a record 182 to 4 vote, calls on the US to end its four-decade-old embargo against Cuba (see 1960). Voting against the measure are the US, Israel, Palau, and the Marshall Islands. Micronesia abstains, while El Salvador, Iraq, Morocco, and Nicaragua do not vote. [Associated Press, 11/8/2005; CBC News, 11/8/2005; EuroNews, 11/9/2005] (The Palau Archipelago was administered by the United States as the last UN trust territory until 1994. The Marshall Islands, taken by the US during World War II, became self-governing under US military protection in 1976, achieving free-association status in 1986. The combined population of Palau and the Marshall Islands is less than 80,000.) [Columbia Encyclopedia, 6th ed., 2005; Columbia Encyclopedia. Sixth edition, 2005] Before the vote, speaker after speaker in the General Assembly debate speaks out against the US sanctions [Associated Press, 11/8/2005] , while Ronald Godard, a deputy United States ambassador, asserts that “if the people of Cuba are jobless, hungry, or lack medical care, as Castro admits, it’s because of his economic mismanagement.” [New York Times, 11/9/2005] After the votes are tallied up, many delegates in the General Assembly hall reportedly burst into applause. [Associated Press, 11/8/2005] US Ambassador to the UN John Bolton, calls the vote “a complete exercise in irrelevancy.” [Associated Press, 11/8/2005]

Entity Tags: John R. Bolton, Israel, UN General Assembly, Ronald Godard, United States

Timeline Tags: US-Cuba (1959-2005)

The Congressional Committee on Government Reform ends a 15-month investigation aimed at assessing how the FDA is fulfilling its regulatory responsibilities. The committee’s report, based on thousands of pages of internal agency enforcement records, concludes that enforcement activity has dropped dramatically under the Bush administration. According to the review, the annual number of FDA warning letters fell 54 percent between 2000 and 2005, from 1,154 to 535, a 15-year low. Additionally, the number of seizures of mislabeled, defective, and dangerous products dropped by 44 percent. According to the investigation, there were at least 138 cases where the FDA ignored recommendations from agency field inspectors to take enforcement actions. [US Congress, 6/26/2006 pdf file; New York Times, 6/27/2006] In letters written to the committee, experts voiced concern that the FDA is becoming less vigilant in its oversight duties. Dr. Jerry Avorn of the Harvard Medical School, wrote that there is “a growing laxity in FDA’s surveillance and enforcement procedures,” a “dangerous decline in regulatory vigilance,” and an “obvious unwillingness to move forward even on claims from its own field offices.” Avorn describes the FDA as “an agency unwilling to exert its regulatory authority in defense of the public’s health.” [Avorn, 6/26/2006 pdf file] Dr. Michael Wilkes of the University of California, Davis, School of Medicine, says the FDA has “systematically ignored District Field Officers and regularly overridden their explicit and well documented concerns about drug safety and public health.” It “seems unable and unwilling to step in to protect the American public,” he adds. [Wilkes, 6/10/2006 pdf file] Another problem identified during the committee’s review of the documents concerns the agency’s record keeping. In response to questions from the committee, officials said the FDA lacks a centralized case tracking system and does not maintain a record of the enforcement recommendations made by its district offices. As a result, the investigation had to rely on the personal recollection of field office employees. [US Congress, 6/26/2006 pdf file]

Entity Tags: Michael Wilkes, Jerry Avorn, House Committee on Government Reform, US Food and Drug Administration

Timeline Tags: US Health Care

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

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

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: US Health Care, Civil Liberties

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: US Health Care, Civil Liberties

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