FDA Sharing Patients’ Private Medical Records in Order to Harass Integrative DoctorsSeptember 3, 2013
ANH-USA has learned that the FDA is working with state medical boards behind the scenes—sometimes in violation of the law.
According to our sources, professional medical boards are launching investigative actions against integrative physicians not because of patient complaints, but because of materials forwarded to them by the FDA before they are made public. These boards are treating the FDA documents as if they were formal complaints.
In other words, the US Food and Drug Administration, which is barred from interfering with the practice of medicine, is in fact deliberately but secretly ignoring the rules—something practitioners and consumers alike need to be warned about.
We suspect, but cannot yet prove, that this is widespread and is being orchestrated by a shadowy private group called the Association of State Medical Boards.
Today we will offer just a few examples:
One doctor in Louisiana was accused by the FDA of not following his IND (investigational new drug study) protocol involving stem cells. The state’s medical board—prompted by the FDA—then went after his license. In the end, the doctor kept his license by signing a consent agreement. Demanding the signing of an onerous consent decree is a favored government tactic. Because the government has unlimited legal funds, it can threaten to bankrupt the doctor if the decree is not signed, and then include provisions in the decree that are not only humiliating but difficult to follow, so that further charges can be threatened or filed.
The system sometimes works in reverse as well. The California medical board notified the FDA about a possible contamination problem with intravenous garlic that a doctor was using to treat Lyme disease. The FDA started its own investigation and obtained the patients’ private medical records. When the agency closed its investigation, it then handed the patient records over to the medical board, exposing the patients’ private information. This is illegal in California, but sadly, not in most other states, where a state board may obtain patients’ medical records without their consent.
In response, a case was filed in Sacramento on behalf of the patients whose medical records were improperly given to the board by the FDA. For strategic reasons, it was a narrow action: the suit went after the medical board and its agents, not the FDA. California’s constitution includes the right to privacy, which the courts have interpreted to mean that absent explicit consent from the patient, the medical board has to prove good cause for a request for private records.
There are other areas in which the FDA is aggressively interfering in the practice of medicine. As we reported last year, the agency asserts that one’s own stem cells, when used in a medical procedure, are drugs—and therefore to be regulated as drugs. For example, a Colorado company offered a treatment in which stem cells were isolated from the patients’ bone marrow, processed, and the resulting cells injected back into the same patient to treat joint pain. The FDA said the company was “manufacturing, holding for sale, and distribution of [sic] an unapproved biological drug product,” and issued an injunction to stop the treatment. The company sued, but the court sided with the FDA, stating that the biological characteristics of stem cells are changed enough in the procedure that they warrant regulation by the FDA. The company plans to appeal the ruling.
In another attempt to regulate the human body, FDA tried to claim human excrement as a drug. No, we’re not kidding. There’s a medical procedure to treat gut infections by implanting the intestine with healthy bacteria from healthy family member-donors’ fecal matter. FDA said the stools were unregulated drugs, and would require investigational new drug applications and would have to be taken through the extraordinarily expensive approval process before doctors could continue to perform the procedure. In June, as a direct result of embarrassing publicity, the FDA said they won’t enforce the new requirement after all.