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Unbelievable! FDA Violates Patient Privacy Laws to Bring Down Dr. Burzynski

As we report in our article, “Inside USA Today’s Smear Campaign Against Dr. Burzynski,” USA Today recently published a series of misleading articles, vilifying Dr. Stanislaw Burzynski, a cancer pioneer specializing in hard-to-treat cancers, who has saved many lives. In the course of their otherwise reckless “reporting,” USA Today inadvertently exposed the FDA’s violation of patient privacy laws, destroying the reputation of a natural health practitioner—specifically, the sharing of complete patient records without consent.

In the 1980s—and again in 2012—the Texas Medical Board (TMB) charged this caring and pioneering doctor with breaking a law that didn’t exist, and tried to revoke his medical license. By the USA Today’s own admission, he was cleared each time, and numerous investigations later—including an appearance before the Texas Supreme Court—found there was no violation of any law or standard of care.

“With our treatments, we can save 20,000 American lives annually,” Dr. Burzynski told ANH-USA. “But the FDA is covering this up with insignificant details….The FDA wants to bury this information from the public.” This is evident in the FDA’s recently released warning letter to Dr. Burzynski, and the agency’s apparent cooperation with USA Today.

Part of the FDA’s job is to issue warning letters to drug, food, and dietary supplement manufacturers, as well as drug trial sponsors, in order to notify them of possible FDA violations and encourage voluntary compliance. Warning letters to drug study sponsors, called “483s,” are the most common: they account for about 60% of all warning letters. In 2012, the FDA issued 787 483s.

Although common warning letters aren’t particularly newsworthy, they can be effectively wielded as a political tool: warning letters have been used to censor consumer Internet speech and deny consumer access to at-home DNA testing. But there’s a new, even more alarming trend in warning letters: these interim letters, which have no legal significance, are being cited as evidence by state medical boards of practitioner misconduct.

Essentially, warning letters—which are intended to give practitioners, researchers, and manufacturers a voluntary avenue to address agency concerns without legal repercussions—are being used in a coordinated effort by the FDA and state medical boards to damage the reputations of and pursue legal action against integrative practitioners. We’ve seen this type of FDA/state medical board “cooperation” before—but according to healthcare lawyer Rick Jaffe, a recent 483 sent to Dr. Burzynski and the USA Today’s unusual interest in it, is an update and expansion of this highly questionable tactic.

The USA Today’s article—the third in a series attacking Dr. Burzynski—details the warning letter and the FDA inspection that lead to it, as if such an investigation and letter were novel and unique. In actuality, it’s completely routine; Dr. Burzynski is currently following normal procedure and has recently submitted his response, which among other things details the incorrect statements made in the warning letter.

The article is a win/win/win for the media, the FDA, and the Texas State Medical Board: USA Today gets to tout how it was “right” about Dr. Burzynski (the first paragraph of the story boasts that Dr. Burzynski was “the subject of a USA Today investigation”); the FDA—which has failed to successfully shut down Dr. Burzynski lifesaving clinic—gets to take a pot-shot at Dr. Burzynski outside of the court; and the TMB garners public support for its vendetta against the Burzynski clinic. Who loses? Dr. Burzynski’s patients. Read our article on how several cancer sufferers have been denied his potentially life-saving treatment.

The USA Today article sparked a media firestorm. In the process, however, they inadvertently revealed evidence of FDA misconduct and collusion between the FDA and USA Today:

A high-level Burzynski Clinic staff member told ANH-USA that one concerned patient called the FDA to learn more about Dr. Burzynski’s innovative treatments, and the FDA sent the patient a link to the USA Today article. The FDA violated Burzynski patients’ privacy. “A lot of our patients were obviously very irked about the article, and called the USA Today team,” a Burzynski staff member told us. “The parents of one young patient called a USA Today reporter, who then sent the parents their own child’s confidential medical records—which the reporter had received from the FDA. The family frantically called us [the clinic], ‘I just got an email from USA Today, they sent me our son’s full medical records!’” The reporter had sent not only the son’s medical records, but those of other patients as well.

The FDA is not supposed to release medical records to the public. The agency has always had inappropriate relationships with state medical boards and the media, but now they’ve crossed the line to outright violation of patient rights. ANH-USA is currently assessing the legal ramifications of the FDA’s actions. In the meantime, it’s time to call for a full congressional investigation into the FDA’s actions, including its inappropriate information-sharing with media contacts and state medical boards.