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Context of 'January 27, 2003: FDA Does Not Approve Drug Ketek, Requests Additional Information'

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Vice President Dan Quayle, chairman of the President’s Council on Competitiveness, and Louis Sullivan, secretary of health and human services, announce the FDA’s new policy on the regulation of genetically engineered foods. In the policy statement that is published three days later, the FDA will say it has determined that genetically modified (GM) foods are “substantially equivalent” to conventionally grown foods and therefore will not be subject to any special regulations. The agency justifies its position saying that assessments concerning the safety of food products should be based on the characteristics of the food product and not on the methods used to develop that product. [US Food and Drug Administration, 5/29/1992 pdf file] Specifically addressing the issue of labeling for GM foods, the May 29 statement will read: “The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding. For this reason, the agency does not believe that the method of development of a new plant variety… would… usually be required to be disclosed in labeling for the food.” Labeling would only be required in special cases, the FDA says. For example, if a genetically engineered tomato contains a peanut protein that is a proven allergen, a label will be needed. [US Food and Drug Administration, 5/29/1992, pp. 22991 pdf file] In their statement to the press, Sullivan says that biotechnology promises to develop new food products “that are tastier, more varied, more wholesome, and that can be produced more efficiently.” Quayle’s council played a key role in expediting the development of the policy. [Food and Drug Administration, 5/26/1992] Quayle explains that the policy will ensure the competitiveness of US firms. “The reforms we announce today will speed up and simplify the process of bringing better agricultural products, developed through biotech, to consumers, food processors, and farmers,” he says. “We will ensure that biotech products will receive the same oversight as other products, instead of being hampered by unnecessary regulation.” [New York Times, 1/25/2001]

Entity Tags: Dan Quayle, Louis Sullivan, US Food and Drug Administration

Timeline Tags: Seeds

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

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

The Food and Drug Administration holds an advisory meeting on the VIGOR study, a clinical trial for the drug Vioxx, to assess whether there is a connection between the drug and heart problems. Unlike the VIGOR study published in the New England Journal of Medicine (see November 23, 2000), this group includes heart attacks 18, 19, and 20 (see March 2000) in their analysis. The meeting’s members conclude that there is not enough data to draw a solid conclusion. [US Food and Drug Administration, 3/8/2001; National Public Radio, 6/8/2006] Notwithstanding, they do recommend that physicians be informed that the VIGOR study showed “an excess of cardiovascular events in comparison to naproxen.” [Office of Representative Henry A. Waxman, 5/5/2005, pp. 21 pdf file] On March 7, the agency publishes all of the VIGOR data on its website, as well as its analysis. [US Food and Drug Administration, 3/8/2001]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

In a 7 to 3 vote, an FDA advisory panel recommends approving the antibiotic Ketek, also known as telithromycin, for use in treating streptococcus pneumonia. But the panel does not recommend approving it for use against acute chronic bronchitis, sinusitis, or penicillin-resistant or erythromycin-resistant strep. The panel also recommends conducting additional clinical trials to “see if hints of concern… are real or not” about the drug’s potential side affects on the heart and liver. [Associated Press, 4/26/2001]

Timeline Tags: US Health Care

The FDA informs Aventis that it will not approve the drug Ketek until the company has provided enough information to determine the drug’s safety profile. [Aventis, 6/4/2001] In April, an FDA advisory board recommended additional clinical studies for the drug because of concerns about potential side effects on the heart and liver (see April 26, 2001).

Entity Tags: Aventis, US Food and Drug Administration

Timeline Tags: US Health Care

Aventis contracts Pharmaceutical Product Development, Inc. to do a clinical trial for Ketek, an antibiotic designed to treat respiratory infections. The trial, named “Study 3014,” is being done because of FDA concerns (see Early June 2001) about possible links to heart and liver problems. The company pays doctors $400 for each patient they enroll in the study. Some of the doctors—a bit overzealous in recruiting patients—forge signatures, sign up family members, and invite patients into the study who do not have infections. There are also problems with the way some of the doctors collect and record their data. One doctor, who enrolls 251 patients, does not follow the study’s instructions and fails to report adverse drug reactions. Another physician, Dr. Maria Anne Kirkman-Campbell, who runs a weight-loss clinic, signs up 407 patients—but only 10 percent of them actually take the drug. These problems are discovered by FDA inspectors in fall 2002. [ABC, 1/14/2006; Wall Street Journal, 5/1/2006 pdf file]

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

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

Aventis announces that the FDA has again declined to approve the company’s antibiotic drug Ketek, citing the need for additional analyses and information pertaining to Study 3014 (see October 2001-Fall 2002). [Aventis, 1/27/2003]

Entity Tags: Aventis, US Food and Drug Administration

Timeline Tags: US Health Care

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

Timeline Tags: US Health Care

April 1, 2004: FDA Approves Ketek

The FDA approves the drug Ketek for treatment of chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia in patients age 18 and older. [Aventis, 4/1/2004] The approval decision is made despite evidence that a 2001-2002 clinical trial for the drug, study 3014, was replete with fraudulent data (see October 2001-Fall 2002). The FDA says the approval is based on data submitted in 2000, other studies, and the drug’s safety record overseas where the drug has been in use for several years. [Wall Street Journal, 5/1/2006 pdf file]

Entity Tags: Aventis, US Food and Drug Administration

Timeline Tags: US Health Care

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

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

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 Annals of Internal Medicine posts an “early release” version of an article reporting three cases of acute liver failure in previously healthy patients who had taken Ketek. [Los Angeles Times, 6/17/2006] The final version of the article will be published in late March. [Clay et al., 3/21/2006] The FDA, responding to the new data, insists the drug presents no more danger to the liver than other antibiotics. The agency even cites the results of Study 3013, which FDA investigators previously determined relied upon fraudulent data (see October 2001-Fall 2002 and March 25, 2004). [Wall Street Journal, 5/1/2006 pdf file]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

In a memo, FDA safety investigators warn that the link between Ketek and liver damage could be more serious than a recent study published in the Annal of Internal Medicine suggested (see January 2006). The memo says there have been 12 cases of liver failure among Ketek patients, including one patient who took only one dose of the medication. Four patients are known to have died, and one had to undergo a liver transplant. They suffered a “profound degree” of liver damage, the memo says. “The rapid tempo and severity of injuries… suggest an acute hypersensitivity-like process.” A review of data on three similar drugs showed far fewer incidents of liver failure, according to the memo. [Los Angeles Times, 6/17/2006]

Entity Tags: 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

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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