by Kenneth Woliner, MD www.holisticfamilymed.com
On Tuesday, February 5, 2013, ApothéCure Inc, a compounding pharmacy based in Dallas, Texas, voluntarily relinquished its Florida pharmacy license and ability to mail prescription medications into the State of Florida. http://ww2.doh.state.
ApothéCure (and its pharmacist owner, Gary Osborn) can't blame the fallout from the NECC-fungal meningitis outbreak or anyone else for its fate. ApothéCure's wounds were all self-inflicted. It was a combination of bad pharmacy practices, a history of having introduced adulterated drugs in the past, and most of all, arrogance, that it could do whatever it wanted, including operating as a manufacturer and wholesale distributor without having licenses to do so, violating the Federal Trade Commission and Federal Food, Drug, and Cosmetic Acts by advertising drugs for purposes not approved by the FDA, and for aiding and abetting the unlicensed practice of medicine. When the pharmacy was told what it was doing was not just dangerous, but also illegal, it ignored those warnings, and continued to operate business as usual. At least until now.
INTRAVENOUS COLCHICINE
ApothéCure is a compounding pharmacy. As a pharmacy it is allowed to fill prescriptions for specific patients based upon individual prescriptions which are based upon a valid doctor-patient relationship. As a compounding pharmacy, it often reformulated certain medications into other dosage forms. There is a protocol using intravenous colchicine to treat low back pain and herniated discs created by Michael R. Rask, M.D. (1930-1994), a Las Vegas Orthopedic Surgeon who specialized in neurological orthopedic surgery. http://www.ncbi.nlm.nih.gov/
Colchicine can be very toxic when given in high doses, with deaths being reported with cumulative doses as low as 5.5 mg. The colchicine produced by ApothéCure was labeled as 0.5 mg/mL, but instead, each vial contained 4 mg/mL. When an intended dose of 2 mg was administered, the patient actually received 16 mg! That compounding error (making the drugs mislabeled and adulterated) lead to three deaths of patients who were treated at a Portland naturopathy clinic (Oregon allows naturopaths to prescribe and inject prescription drugs). What was more galling, however, was that ApothéCure did not even have a license to operate in Oregon, even though it sent 43 batches of colchicine to Oregon clinicians over a one and a half year period. Over 3,500 vials of the drug, distributed nationwide, were recalled. http://www.cdc.gov/mmwr/
The Oregon attorney general sued ApothéCure, alleging, among other things, that ApothéCure used low-quality water for its products, which could increase the possibility of contamination, and did not properly test its products for contamination or potency. ApothéCure and the state of Oregon reached a settlement agreement in which ApothéCure agreed to pay a $100,000 fine and to pay a $500,000 civil penalty if it ever wanted to do business in Oregon again. http://portlandtribune.com/
CRIMINAL CONVICTION
On February 10, 2012, the United States Department of Justice charged ApothéCure Inc., and its owner, Gary Osborn, with two misdemeanor criminal violations of the Federal Food, Drug and Cosmetic Act in relation to the misbranded injectable colchicine. Apothecure pleaded guilty to those charges on April 24, 2012. On May 15, 2012, in the United States District Court for the Northern District of Texas, Dallas Division, in case number 3:13-CR-047M(01), Osborn entered a plea of guilty to two (2) counts of introducing or causing the introduction or delivery for introduction into interstate commerce of ay food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, a misdemeanor in violation of 21 United States Code 331(a). Osborn was placed under house arrest (home detention) and probation for one year, while ApothéCure was placed on probation for five years. Both were ordered to pay a $100,000 fine.
Violating the FFDCA by adulterating and misbranding drugs is a crime related to the practice of pharmacy, and, Section 465.023(1)(f), Florida Statutes, provides that the Board of Pharmacy may revoke or suspend the permit of any pharmacy permittee, ad may fine, place on probation, or otherwise discipline the pharmacy permittee if the permittee, or any affiliated person, partner, officer, director, or agent of the permittee, including a person fingerprinted under s. 465.022(3), has been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a crime in any jurisdiction which relates to the practice of, or the ability to practice, the profession of pharmacy. http://ww2.doh.state.fl.us/
DRUG FIRM HAS HISTORY
This was not the first time Apothecure has been cited for violations. http://portlandtribune.com/
In response to the Pennsylvania alert, FDA officials and investigators from the Texas pharmacy board undertook an inspection of ApothéCure's facility in Dallas. The inspection revealed a number of deficiencies in the company's operation, according to inspection reports. And at least one of those deficiencies might have a connection to the Portland and Washington deaths. The August 2004 inspection cited the company for six violations ranging from refrigerators lacking adequate thermometers and temperature logs, to a lack of documentation of training for pharmacy personnel. But the potentially most significant citation, in the context of the Oregon deaths, was for the pharmacy not having properly registered the balance scales used to weigh substances. An ApothéCure spokesman told The Associated Press that the batch of colchicine responsible for the Oregon and Washington deaths was the result of a weighing error. 'This is significant,' Sasich of Public Citizen said. 'What it means is that there is no quality control within this organization.'
In 2007, the FDA seized 17 vials of injectable DMPS that ApothéCure was illegally compounding. http://www.casewatch.org/fda/
COMPOUNDING PHARMACY OR DRUG MANUFACTURER?
At the heart of the latest investigation into ApothéCure is the company's status as a compounding pharmacy. That status means that, unlike a drug manufacturer, it does not have to submit its products for sample tests to any government agency. In addition, federal law prohibits compounders from selling drugs that are available in the same form and dosage from manufacturers. Injectable colchicine was available from manufacturers.
State boards of pharmacy, which oversee compounding pharmacies, do not routinely test products.
Authorities have suggested that, in supplying a large batch of colchicine (without patient-specific prescriptions) to the Portland Center for Integrative Medicine, ApothéCure may have broken a number of laws, and may have been acting more as a manufacturer than as a compounding pharmacy.
In addition to the rules that ApothéCure may have broken in its distribution of colchicine, medical practitioners at the Center for Integrated Medicine also may have acted improperly by purchasing colchicine from a compounding pharmacy rather than a manufacturer. Another possible violation may have occurred with colchicine that the center supplied to another medical practitioner. The two Portland deaths attributed to the bad batch came after the patients were injected at the center, according to a physician there. But the Yakima, Washington death, according to the same physician, occurred with colchicine supplied by the center. This amounts to re-dispensing, which is not allowed.
ApothéCure is among the largest compounding pharmacies in the country, and sells its products in virtually every state. It also has been a leader among compounding pharmacies that have battled the FDA in court to fend off federal regulation as manufacturers.
ADVERTISING HCG DIET TREATMENTS - A BIG NO-NO
ApothéCure, through its website, as well as through its sister company, the Texas Institute of Functional Medicine, advertises drugs for purposes not approved by the U.S. Food and Drug Administration. One of the most glaring examples is its blatant advertising of diet treatments utilizing Human Chorionic Gonadotropin (hCG). http://www.tifm.com/?id=10066 Not only has HCG been disproven as having any role in weight loss, the FDA requires each bottle of HCG to include in its labeling the following disclaimer, in all-caps, "
HCG HAS NO KNOWN EFFECT ON FAT MOBILIZATION, APPETITE OR SENSE OF HUNGER, OR BODY FAT DISTRIBUTION.HCG HAS NOT BEEN DEMONSTRATED TO BE EFFECTIVE ADJUNCTIVE THERAPY IN THE TREATMENT OF OBESITY. THERE IS NO SUBSTANTIAL EVIDENCE THAT IT INCREASES WEIGHT LOSS BEYOND THAT RESULTING FROM CALORIC RESTRICTION, THAT IT CAUSES A MORE ATTRACTIVE OR "NORMAL" DISTRIBUTION OF FAT, OR THAT IT DECREASES THE HUNGER AND DISCOMFORT ASSOCIATED WITH CALORIE RESTRICTED DIETS.
In addition, in the 1970's the U.S. Federal Trade Commission sued various diet clinics, winning a verdict (affirmed on two appeals) that it was false, misleading, and deceptive to advertise HCG diet treatments without a similar disclaimer.
It gets worse. HCG is a big molecule, weighing approximately 30,000 daltons, about 6x bigger than insulin. ApothéCure advertised that it could compound HCG into topical creams, sublingual drops, and slow-dissolving tablets, that could be absorbed through the skin, under the tongue, or even orally. Really? If ApothéCure has the technology to absorb big peptide hormones sublingually, then there are 20 million insulin-dependent diabetic patients that want to know about it.
AIDING THE UNLICENSED PRACTICE OF MEDICINE
In 2011, I alerted Jarvis Savage of ApothéCure that they were aiding the unlicensed practice of medicine, by taking prescription orders from Wendy Lazar, a massage therapist (who calls herself a naturopath), sending those compounded medications to her office, and allowing her to dispense these compounded medications to patients. The response from ApothéCure was that, even though it was obvious that Ms. Lazar was just "renting the license" of other physicians (and not based upon a valid doctor-patient relationship), they felt their hands were clean, and they would continue to dispense compounded drugs to her.
FLORIDA BOARD OF PHARMACY TAKES ACTION
ApothéCure's blatant disregard for the safety of its patients, or for the rules of the State of Florida or that of the Federal Government, lead to its license being voluntarily relinquished (revoked). Pleading guilty to a misdemeanor might just put the pharmacy on probation (as the Texas Board of Pharmacy did). Having a track record of engaging in manufacturing and wholesale distribution of drugs without a license to do so, of adulterating and misbranding drugs causing three (3) deaths, and multiple pieces of evidence of lack of ethical behavior (scamming patients with HCG Diet treatments; aiding the unlicensed practice of medicine), sealed its fate. When this action gets reported to the National Practitioner Data Bank, it is very likely other states will follow suit.
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