More dangerous "medical" woo...

Metagenics warned again about illegal "medical food" claims. Metagenics, a company that markets dietary supplements mainly through practitioners, has been told by the FDA to stop making illegal claims for products it has been marketing as "medical foods." The warning letter states:

The Orphan Drug Act defines "medical food" as "a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation." The 13 products—UltraClear®, UltraClear® Plus, UltraClear® Plus pH, UltraClear RENEW™, GI Sustain, UltraMeal® Plus, UltraMeal® Plus 360, UltraInflamX®, UltraInflamX® Plus 360, UltraGlycemX®, GlycemX™ 360, Ultracare for Kids®, BariatrX Essentials Bariatric Meal, and ArginCo—fail to fit this definition.
The products are marketed with disease-specific claims that make them classifiable as drugs; and because they are not generally recognized as safe and effective for their intended use they are "unapproved new drugs" that cannot be legally marketed without FDA approval.

The warning letter was issued on the same day that the FDA published a draft industry guidance in the Federal Register, which suggests that the agency may be looking more closely at products marketed as medical foods, but whether there will be actual enforcement remains to be seen. In 2003, the FDA notified Metagenics that four of the above-mentioned products were not medical foods and were being marketed with illegal "new drug" claims. The company reduced the number of disease-related claims for these products but continued to market them as medical foods. Quackwatch has additional information about the company, its associated educational activities, and FTC action against UltraClear.


Two more doctors disciplined for inappropriately diagnosing Lyme disease. Two more doctors have signed consent agreements in which, among other aberrant clinical procedures, they were criticized for diagnosing Lyme disease despite negative laboratory tests and for inappropriately prescribing long courses of antibiotics.

Albert Aniel, M.D., who practices in Rumford, Maine, was criticized for violating the standard of care regarding medical record keeping; diagnosing and treating Lyme disease; and prescribing high dosages of controlled drugs to the patients for the treatment of nonmalignant chronic pain. The agreement requires him to (a) reimburse the board $486.40 for costs, (b) complete an approved course in medical record keeping, (c) not diagnose or treat Lyme disease except with standard modalities that are appropriately recorded in the patient's medical record; and (d) limit his prescription of controlled substances for chronic pain to patients in skilled nursing facilities or long-term-care facilities, in hospice care, or who have metastatic cancer. During the negotiations, Aniel indicated that he plans to stop treating patients at the end of 2013.
Leila Zackrison, M.D., who practices in Fairfax, Virginia, was criticized for inappropriately diagnosing and treating a woman from 2003 through 2007. The Virginia Board of Medicine's order indicates that Zackrison made unsubstantiated diagnoses of arthritis/spondyloarthropathy, pseudogout, salmonella infection, babesiosis, and Lyme disease and inappropriate administered antibiotic therapy during most of this period. In 2005, the Board had similar concerns about her management of three patients but concluded that "while the care . . . rendered to Patients A, B and C was not optimal, a violation of the Board's statutes or regulations was not established by clear and convincing evidence" and the matter was therefore dismissed.


Chelationist caught defrauding insurance companies. A chelation practitioner who defrauded insurance companies but avoided criminal prosecution has been disciplined by three state medical boards. In 2010, the U.S. Government filed a civil complaint charging Parveen Malik, M.D., who practiced in Michigan, with improperly collecting more than $1 million dollars from insurance programs for chelation sessions that were not medically indicated or were billed for treating members of her famuly. The complaint was accompanied by an agreement under which Malik agreed to pay restitution of $889,798.79 to Medicare at a rate of $400 per month and of $174,448.23 to Blue Cross of Michigan at the rate of $100 per month. She was also excluded for 20 years from collecting from any federal agency for medical procedures. In 2011, in response to this proceeding, the Michigan Board of Medicine fined Malik $2,500 and placed her on probation for three years. The board's order noted that from 2001 to 2006, she had improperly billed for chelation therapy using diagnostic codes that applied to other therapies and that she had been responsible for 99% of chelation therapy for Michigan. In 2012, the Iowa Board of Medicine fined Malik $10,000 and placed her license on indefinite suspension and the Florida Medical Board fined her $3,000 and placed her on probation for two years, during which she is not allowed to administer chelation therapy or B12 injections without a medically supported need for these treatments. Dr. Stephen Barrett would like to hear from anyone who has been treated by Dr. Malik or any other doctor who has tried to get an insurance program to pay for inappropriate chelation therapy.