Tuesday, December 11, 2012

On the Other Hand

Civil discourse is only possible when a variety of positions on a subject are able to be shared without editing.  The following is a rebutal of "The Fog"  It is penned by a person deeply familiar with the FDA and the pharmaceutical industry.  It addresses a number of issues with greater clarity than was originally afforded and presents a clearly different yet not incongruous angle to the issues covered in "The Fog"
It is unfortunate that your rant against the pharmaceutical industry does not pass the “Four-Way Test.”

First, your description of the marketing of thalidomide conflicts with history. “Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States. As many remember, in the early 1960’s, reports were coming in from around the world of countless women who were giving birth to children with extremely deformed limbs and other severe birth defects. They had taken thalidomide. Although it was being used in many countries, Dr. Kelsey discovered that it hadn’t even been tested on pregnant animals.” 1

It was only in 1962 that Congress enacted the Kefauver-Harris amendments to the Federal Food, Drug and Cosmetic Act. Manufacturers had to prove that a drug was not only safe, but also effective. Approvals had to be based on sound science. Companies had to monitor safety reports that emerged postmarket and adhere to good manufacturing practices that would lead to consistently safe products.

Further, in 1998 the FDA approved thalidomide’s use in the treatment of erythema nodosum leprosum, after it was discovered by individual researchers in Brazil and Israel to be effective in the treatment of this complication of leprosy. Because of thalidomide’s potential for causing birth defects, the drug may be distributed only under tightly controlled conditions.

Secondly, “[F]ew health-and-safety statutes enacted during the last three decades have been as heavily criticized as the Food and Drug Act Amendments of 1962. This legislation, a response to public outrage about the distribution of Thalidomide to pregnant women, made it more expensive and time-consuming for new pharmaceutical products to be approved for sale in the United States. Numerous studies have demonstrated that the 1962 statute, far from safeguarding the health of Americans, has actually impaired it by denying them access to drugs available elsewhere. Yet until recently, the amendmentscritics had virtually no political influence. The pharmaceutical industry lobbied for reforming the drug-approval process, but its efforts were thwarted by Ralph Nader’s Public Citizen Health Research Croup and its influential liberal Democratic allies in Congress--all of whom opposed any relaxation of the strict standards for the approval of new drugs. Over the last two years, however, the polities of American drug regulation has been transformed. As a result of the AIDS crisis, for the first time the Food and Drug Administration (FDA) is being challenged politically by a group of articulate and well- organized people who want to facilitate the approval of new drugs. Organizations defending homosexual rights now criticize the FDA on grounds remarkably similar to those of conservatives in the Wall Street Journal and of businessmen in the publications of the Pharmaceutical Manufacturers Association (PMA). Because of the political mobilization of potential consumers of currently unavailable drugs, the advocates of strict drug-approval standards now find themselves on the defensive for the first time in three decades.

In response to pressures from this new constituency, in 1987 the FDA agreed to modify its usual drug-approval procedures in order to make at least one drug available for the treatment of AIDS. Despite evidence that it was highly toxic, AZT was approved for the treatment of AIDS in only eighteen months, faster than any other drug in FDA history. The agency spent $600,000 to speed up the approval process. Yet its action failed to mollify the homosexual community. Larry Kramer, a founder of the Gay Men’s Health Crisis, the largest self-help organization for AIDS patients in the United States, charged that “there is no question on the part of anyone fighting AIDS that the FDA consists of the single most incomprehensible bottleneck in American bureaucratic history--one that is actually prolonging the roll call of death.” Ben Schatz, director of the AIDS Civil Rights Project of the National Gay Rights Advocates (a California public-interest law firm), contended that “the FDA is conducting business as usual when they should be waging war.” 2

Thirdly, the pharmaceutical companies are not alone in being driven by the “profit motive.” While each research-based company would like to have the next “blockbuster” drug, it continues to provide products which improve health and prolong life. As Jon Coleman, Ph.D., points out, “true sustainability involves doing more good, not doing less bad.”

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