FDA Censorship: Freedom on Trial

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FDA; it may come as a surprise to you, but the federal Food and Drug Administration prohibits makers of foods and dietary ingredients from informing you of the effects those substances have on disease. Most of us know that water treats dehydration and that prune juice treats chronic constipation, but if bottled water or prune juice sellers were to tell you that, they would be violating federal law and could go to jail. If those companies were to send you scientific articles on water curing dehydration or prune juice relieving chronic constipation, that too would violate federal law.

Telling you that saw palmetto extract may reduce symptoms of mild benign prostatic hyperplasia (an enlarged prostate) or that glucosamine and chondroitin sulfate may reduce cartilage deterioration and thereby lessen the risk of osteoarthritis or that calcium may reduce the risk of colon cancer can land the makers of those dietary ingredients in jail. Although those statements are backed by credible scientific evidence and could relieve the pain and suffering of millions, telling you that truth on the label of, or in advertising for, a dietary supplement or food product violates federal law.

You may be aware that folic acid reduces neural tube defect births (e.g., spina bifida). In September of 1992 the Public Health Service recommended that all women of child-bearing age (before pregnancy) consume 0.4 mg of folic acid daily to reduce their risk of neural tube defect births. The risk reduction can be as great as 40% to 80%.

Despite the PHS recommendation, FDA banned the claim for years, even refusing to comply with a court order compelling the agency to allow a claim that 0.8 mg of folic acid in a dietary supplement was superior in its effectiveness to a lesser amount in foods. Congress found FDA's suppression of the folic acid/neural tube defect claim indefensible, explaining that it contributed to preventable neural tube defect births each year the ban remained in place.

You may wonder if our First Amendment still means what it says. The First Amendment to our Constitution protects Americans' rights to tell the truth and to receive truthful information. Like a throwback to the Fifteenth Century Courts of Star Chamber, the FDA blocks access to the truth. It censors health information every day and by doing so it not only violates all of our rights, it also sacrifices the lives and health of those who, if fully informed, could avoid certain catastrophic diseases or could lessen the severity of them.

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New Drugs Hit the Market, but Promised Trials Go Undone

Published: March 4, 2006

WASHINGTON, March 3 ~ When it approves new drugs for sale, the Food and Drug Administration often requires their manufacturers to study whether they are working as intended and whether they have unwanted side effects. But the agency reported Friday that two-thirds of the studies had not even been started.

Hundreds of studies have been pending for years, the F.D.A. said, with one dating to 1955. In many cases, pharmaceutical makers promised to undertake the studies as a way to speed their drugs' approval.

Critics of the industry promptly seized on the new numbers, saying they demonstrated that the drug agency needed more power to compel drug makers to complete needed studies.

Representative Maurice D. Hinchey, Democrat of New York, said that while the agency insisted that it demanded that drug makers prove their medicines safe, those demands "continue to be blatantly ignored by the pharmaceutical industry."

Mr. Hinchey has introduced legislation that would authorize the agency to require drug makers to follow through on their promised commitments.

But Dr. John Jenkins, director of the Office of New Drugs at the agency, said that many drug companies who promised to undertake trials "are taking that commitment very seriously."

Dr. Jenkins emphasized that only 5 percent of the promised drug trials were officially considered "delayed." In many cases, trials have been pending for more than a decade but are not considered delayed because the agency never insisted on a specific timeline for the tests.

As with many debates regarding the F.D.A., the controversy over promised but uncompleted trials revolves around what level of certainty drug reviewers should insist upon before approving medicines.

Conservatives and some patient-advocacy groups have long argued that the F.D.A. should approve medicines as rapidly as possible even when there are significant doubts about whether they work or are safe. Drug-safety advocates have argued that the agency needs to slow its approval process by demanding more thorough drug testing.

The agency often compromises by approving a drug quickly and then insisting that its maker prove after approval that the drug actually works. This strategy, as the numbers released Friday show, has been only marginally successful.

As of Sept. 30, of the 1,231 promised drug trials, 797, or 65 percent, had not begun or were "pending," according to the F.D.A. Another 231 were considered "ongoing" and 28 were "delayed." In the 2005 fiscal year, drug makers completed and submitted the results of 172 trials, the agency reported.

Dr. Scott Gottlieb, the deputy F.D.A. commissioner for medical and scientific affairs, said last month that the agency would ask an outside group to evaluate the problem, a process that could take a year.

Dr. Steven E. Nissen, chairman of the cardiology department at the Cleveland Clinic Foundation, said, "I think it's very disappointing that we're not seeing the studies that are promised being done."

Companies complete trials rapidly when the F.D.A. demands the results as a condition for approval, Dr. Nissen said.

Alan Goldhammer, an associate vice president of the Pharmaceutical Research and Manufacturers of America, a trade group, said that "approving medicines for public use is a lengthy and difficult process."

Although the controversy about these numbers has raged for years, the ratio of uncompleted trials has remained largely unchanged. In 2002, the first year that the F.D.A. began closely monitoring the issue, 820 of 1,339 promised trials, or 61 percent, were "pending."

One problem is that the promised studies are often difficult to complete. For instance, few cancer patients would willingly risk enrolling in a study that might result in their receiving a placebo when the active drug was easily available at any oncologist's office.

As a result, just one cancer medicine in five has ever proved that it extends patients' lives ~ the usual endpoint demanded of postapproval cancer trials.

The trials are also expensive, and drug makers sometimes have few incentives to complete them. The F.D.A.'s only recourse is to withdraw the drug, but because such a step might hurt patients it is considered so draconian that regulators have never taken it over a failure to complete a study.

Dr. Alastair Wood, associate dean of Vanderbilt medical school, said the F.D.A. needed to get tougher on drug makers. "Who would turn in their homework if they didn't have to?" Dr. Wood asked.


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