CAMLAW: Complementary and Alternative Medicine Law Blog

Deaths allegedly attributable to bad batch of IV colchicine

Two patient deaths are reportedly attributable to an improper mixture of colchicine which was administered intravenously.

Administration of IV colchicine is known as complementary therapy in some quarters and as an innovative or emerging therapy in others. The therapy was used in an integrative medicine clinic and the deaths are being blamed on the supplier:

ApothéCure is under investigation by Oregon, Texas and federal authorities following the discovery last week that a batch of a drug called colchicine supplied to the Portland Center for Integrative Medicine was 10 times the potency stated on the label.

The center, in Southwest Portland, supplied the colchicine to two Portland patients and a third person in Yakima, Wash., all of whom subsequently died - in late March and early April.

All three patients received intravenous colchicine as treatment for chronic back and neck pain. The improperly mixed medicine was so potent that one injection was enough to kill each patient, according to state medical authorities.

Some medical literature apparently gives positive reports about the therapy, but the problem here is said to lie with the manufacturer. There is also concern that regulating the product through regulation of compounding pharmacies, instead of drug regulation, is part of the problem:

ApothéCure is not considered a drug manufacturer but a compounding pharmacy, a designation traditionally reserved for small pharmacies that mix medications not available from manufacturers.

Compounding pharmacies and the drugs they produce are not regulated by the federal Food and Drug Administration, but are overseen by state boards of pharmacy...

ApothéCure is not licensed to sell drugs in Oregon.

In addition, Schnabel said, federal law prohibits compounders from selling drugs that are available in the same form and dosage from manufacturers. Injectable colchicine is available from manufacturers.

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.

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.

No doubt private malpractice and products liability litigation, FDA inquiry, state enforcement action, and other mechanisms will begin to unravel the story and tighten regulatory controls.

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Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law with a unique focus on alternative, complementary, and integrative medical therapies. The firm represents medical doctors, allied health professionals (from psychologists to nurses and dentists) and other clinicians (from chiropractors to acupuncturists), solo entrepreneurs, hospitals, and educational and health care institutions.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of the Institute for Integrative and Energy Medicine (also known as the Institute for Health, Ethics, Law, Policy & Society), a forum for exploring legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, and herbal medicine) and conventional clinical care. The most recent published book by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary, alternative and integrative medicine and related fields is Healing at the Borderland of Medicine and Religion, which follows Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Health care and corporate lawyer Michael H. Cohen is licensed has been admitted to the Bar of California, Massachusetts, New York, and Washington D.C., and to the Bar of England and Wales as a Solicitor (non-practicing).
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Law Offices of Michael H. Cohen offers general corporate legal services, litigation consultation, and expertise in health law with a unique focus on alternative, complementary, and integrative medical therapies. The firm represents medical doctors, allied health professionals (from psychologists to nurses and dentists) and other clinicians (from chiropractors to acupuncturists), solo entrepreneurs, hospitals, and educational and health care institutions.

Michael H. Cohen is Principal in Law Offices of Michael H. Cohen and also President of the Institute for Integrative and Energy Medicine (also known as the Institute for Health, Ethics, Law, Policy & Society), a forum for exploring legal, regulatory, ethical, and health policy issues involved in the judicious integration of complementary and alternative medical therapies (such as acupuncture and traditional oriental medicine, chiropractic, massage therapy, and herbal medicine) and conventional clinical care. The most recent published book by Michael H. Cohen on health care law, regulation, ethics and policy pertaining to complementary, alternative and integrative medicine and related fields is Healing at the Borderland of Medicine and Religion, which follows Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives (1998), Beyond Complementary Medicine: Legal and Ethical Perspectives on Health Care and Human Evolution (2000), and Future Medicine: Ethical Dilemmas, Regulatory Challenges, and Therapeutic Pathways to Health Care and Healing in Human Transformation (2003).

Health care and corporate lawyer Michael H. Cohen is licensed has been admitted to the Bar of California, Massachusetts, New York, and Washington D.C., and to the Bar of England and Wales as a Solicitor (non-practicing).
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