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Context of 'July 27, 2000: FDA Endorses Anthrax Antibiotic Cipro, Despite Conflict of Interest and Health Concerns'

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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

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

May 20, 1999: Vioxx Approved by FDA

The Food and Drug Administration approves Vioxx as a treatment for acute pain, dysmenorrhea, and osteoarthritis in adults, making the drug the second Cox-2 inhibitor available by prescription in the United States. [US Food and Drug Administration, 2005]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

The Sunday Times reports that an inquiry has been launched into the behavior of Bayer, after revelations in a British trial regarding the anthrax antibiotic drug Cipro. The drug has been tested on hundreds despite the company having conducted studies which showed it reacted badly with other drugs, seriously impairing its ability to kill bacteria. These results are kept secret. Nearly half of those on whom the drug was tested at one test center develop a variety of potentially life-threatening infections, while data at other test centers is unknown. [Sunday Times (London), 5/14/2000]

Entity Tags: Bayer

Timeline Tags: 2001 Anthrax Attacks

The FDA endorses the use of Bayer’s Cipro drug to prevent inhalation anthrax. [Reuters, 7/28/2000] An official recommendation like this is highly unusual for the FDA. A 1997 Pentagon study of anthrax in rhesus monkeys showed that several other drugs were as effective as Cipro. The reason given for only recommending Cipro is the government wants a weapon against anthrax should it come up against a strain resistant to drugs in the penicillin and tetracycline families of antibiotics. [New York Times, 10/21/2001] The pharmaceutical industry spent $177 million on lobbying in 1999 and 2000—more money than any other industry. The FDA has been accused of conflicts of interest with companies including Bayer. [New York Times, 11/4/2001]

Entity Tags: US Food and Drug Administration, Bayer

Timeline Tags: 2001 Anthrax Attacks

The Canadian government overrides Bayer’s patent for the anthrax antibiotic Cipro and orders a million tablets of a generic version from another company. The US government says it is not considering a similar move. Patent lawyers and politicians state that adjusting Bayer’s patent to allow other companies to produce Cipro is perfectly legal and necessary. [New York Times, 10/19/2001] The New York Times notes that the White House seems “so avidly to be siding with the rights of drug companies to make profits rather than with consumers worried about their access to the antibiotic Cipro,” and points out huge recent contributions by Bayer to Republicans. [New York Times, 10/21/2001]

Entity Tags: Bush administration (43), White House, Bayer

Timeline Tags: 2001 Anthrax Attacks

The Bayer Corporation, holders of the US patent on the anthrax antibiotic Cipro, agrees with the US to reduce the price of Cipro in the US from $1.83 to 95 cents. Analysts say the price reduction will reduce Bayer’s profit margin from 95% to 65%. This reduction applies only to sales to the US government, not sales to the public. [New York Times, 11/4/2001] Bayer has allowed no other companies to produce or import Cipro into the US. Other countries with less stringent patent laws sell Cipro for 1/30th the US price, and have offered to import large quantities into the US. [New York Times, 10/21/2001] Nevertheless, a class action suit by over one million Americans has been filed against Bayer and two other companies, alleging that Bayer has paid $200 million to two competitors to not make generic versions of Cipro. [Lieff Cabraser Heimann & Bernstein, 10/25/2001] The profits from Cipro are considered a “lifesaver” for Bayer, which had been considering pulling out of pharmaceuticals altogether. [Guardian, 10/31/2001]

Entity Tags: Bayer

Timeline Tags: 2001 Anthrax Attacks

The New York Times reports that health officials and experts believe numerous other drugs are as effective as the antibiotic Cipro in combating anthrax. “Several generic antibiotics, including doxycycline, a kind of tetracycline, and various penicillins, are also effective against the disease,” and they all are in plentiful supply. [New York Times, 10/23/2001] A 1997 Pentagon study of anthrax in rhesus monkeys showed the other drugs to be equally effective. But Cipro remains the only drug officially recommended by the FDA (see July 27, 2000). [New York Times, 10/21/2001]

Entity Tags: US Food and Drug Administration

Timeline Tags: 2001 Anthrax Attacks

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

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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