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The reality behind fake and counterfeit medicines

Are falsified and substandard medicines causing damage and death around the world?

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By Narda Robinson, DO, DVM

The matter of “fake” medicines has been gaining much media attention of late.1

This publicity followed the release of a special issue of the American Journal of Tropical Medicine and Hygiene dated April 20, 2015. The supplement, titled “The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives,” included 17 articles describing the damage that falsified and substandard medicines are doing around the world.2 The majority of reports focused on the risks that counterfeit compounds pose for people with malaria, including the anticipated demise of more than 100,000 children in sub-Saharan African countries as a result of their receiving falsified anti-malarial agents.

Those who make fake, counterfeit and substandard medications deliberately create them to resemble brand name drugs.3 These products either contain less or no active ingredients, contrary to what is listed on the label, or they may have undisclosed substances that could harm health. According to the CDC, “Counterfeiters tend to focus on the more expensive brands. Substandard drugs are found even among cheaper products, because some manufacturers try to avoid costly quality control and good manufacturing practices.”4 The majority of these imitations come from China and seven of its southeast Asian neighbors.5

Rather amazingly, America has its own history of producing medicines with tiny amounts of active ingredients. The practice of homeopathy, which many critical thinkers liken to “fake” medicine, has its own history of treating (actually not treating) malaria, in keeping with the fake medicines described above. Its founder, Samuel Hahnemann (1755-1843), a German physician, coined the term “homeopathy” by referring to a “law of similars” utilized previously by many cultures and resting on the premise that “like cures like.” That is, this approach involves the administration of substances in small, even undetectable amounts, that when provided in larger amounts would lead to similar symptom patterns. This “like cures like” idea suggests that, for example, administering a very tiny dose of coffee might alleviate anxiety symptoms that one might experience after a large cup of dark coffee.

Through a series of self-experimentations, Hahnemann claimed that ingesting repeated doses of quinine caused in him symptoms similar to malaria. He reasoned quinine’s effectiveness against malaria must relate to the “like cures like principle” because both quinine and malaria can cause fever, chills, headache, abdominal pain, nausea and fatigue. (Hahnemann later proposed the “law of infinitesimals,” which states that more diluted doses of medicines have greater effects on the body, especially after each dilution undergoes vigorously shaking to liberate vibrations from the original material into the diluent.)

Alas, homeopathy has never been proven to be a successful treatment for malaria, nor has it repeatedly shown effectiveness against any other disease or disorder when studied in a rigorous scientific manner. Nonetheless, despite evidence of effectiveness for standard malarial drugs, some are drawn to claims made by homeopathic proponents that certain diluted remedies can both prevent and treat malaria.6,7

The CDC website tells the tale of a seasoned medical missionary who traveled the globe for 25 years, succumbing to the promises and glowing testimonials that a homeopathic preparation could essentially replace mefloquine at half the cost. After returning from Nigeria, he began to feel flu-like symptoms. He upped his dose of homeopathy according to the manufacturer’s instructions, but he continued to worsen steadily. The fever, nausea and rash escalated in intensity; the doctors diagnosed malaraia after finding Plasmodium falciparum on a blood smear. Soon, he found himself on a ventilator in the intensive care unit with renal insufficiency, anemia, disseminated intravascular coagulation and encephalopathy. Fortunately, after multiple transfusions and dialysis, the patient survived and left the hospital with a bill of $35,000. This story about homeopathy failing to treat malaria links to a story about counterfeit and substandard antimalarial drugs.8 Fake is fake. An author of a letter to the editor of the British Medical Journal asked the question, “Is homeopathy a fake from the beginning?”9 Apparently, the 18th century founder of homeopathy, Samuel Hahnemann, prescribed placebos to his patients in the form of milk sugar. Still today, homeopathic remedies use lactose pellets as the vehicle.

This curious convergence of homeopathy and fake medicines compels us to consider why those who can afford scientifically based, effective medications would opt for substances that most well-done studies cannot distinguish clinically from placebo.

At around the same time as the NIH fake drug report in the spring of 2015, the FDA announced a review of the safety and effectiveness of homeopathic drugs — substances also considered “fake” medicine by some. After decades of relative inaction, the FDA appears poised to take a more hands-on approach to regulating homeopathic remedies. The FDA does not review the safety or effectiveness of homeopathic remedies prior to sale, which is similar to dietary supplements. While many assume that due to their dilutions homeopathy must be safe, this is not always the case and requires more study. According to a CNN report, one homeopathic cold remedy, for example, “if taken according to the recommendations on the label, would be 10 times the recommended dietary allowance (RDA) of zinc for adult females and eight times the recommendation for males.”10 Excess zinc can produce toxic effects, such as loss of olfaction. Indeed, over 130 people using a zinc-containing homeopathic product reported to the FDA their lost sense of smell. The CNN report continues, “There is a misconception that all homeopathic products are ‘natural’ according to the FDA ‘and therefore safe. Unfortunately, FDA has become aware of significant safety issues associated with homeopathic products in recent years,’ according to an email from the agency.”11

This is a matter that the AVMA House of Delegates sidestepped in 2013 when they refused to support a resolution that would have declared homeopathy ineffective, despite the findings of their own Council on Research.12,13

At a time when public health workers around the world are sounding the alarm about a global pandemic of falsified medicines leading to death and injury, one might ask which of the following scenarios is worse — a practitioner recommending medications shown to work if made correctly but turn up fake because of unscrupulous manufacturers or a homeopath knowingly prescribing remedies indistinguishable from placebo in terms of effectiveness and unknown safety?

References

  1. Sohn E. “Fake medicines do real damage: thousands die, superbugs get stronger.” NPR. April 24, 2015.
  2. American Society of Tropical Medicine and Hygiene website. “AJTMH Special Supplement Tackles Global Drug Quality Issues.” Accessed at http://astmh.org/Content/NavigationMenu/Publications/ASTMHNews/AJTMHFakeDrugsSupplement/default.htm on 04-27-15.
  3. World Health Organization. “General information on counterfeit medicines.” Accessed at http://www.who.int/medicines/services/counterfeit/overview/en/ on 04-27-15.
  4. CDC. “Counterfeit and substandard antimalarial drugs: information for travelers.” Centers for Disease Control and Prevention. Accessed at http://www.cdc.gov/malaria/travelers/counterfeit_drugs.html on 04-27-15.
  5. World Health Organization. “Growing threat from counterfeit medicines.” Bulletin of the World Health Organization. 2010;88(4):241-320. Accessed at http://www.who.int/bulletin/volumes/88/4/10-020410/en/ on 04-27-15.
  6. Coffman B. “A cautionary tale: the risks of unproven antimalarials.” Centers for Disease Control and Prevention. Accessed at http://www.cdc.gov/malaria/stories/homeopathic_drugs.html on 04-27-15.
  7. Ullman R and Reichenberg-Ullman J. “The homeopathic treatment of malaria.” Healthy Homeopathy. Accessed at http://healthyhomeopathy.com/articles/the-homeopathic-treatment-of-malaria/ on 04-27-15.
  8. CDC. “Counterfeit and substandard antimalarial drugs: information for travelers.” Centers for Disease Control and Prevention. Accessed at http://www.cdc.gov/malaria/travelers/counterfeit_drugs.html on 04-27-15.
  9. Chirumbolo S. “Is homeopathy a fake from the beginning?” The BMJ. August 21, 2014. Accessed at http://www.bmj.com/content/348/bmj.g2417/rr/763086 on 04-26-15.
  10. Christensen J. “Homeopathic medicine under FDA scrutiny.” CNN. April 21, 2015. Accessed at http://www.cnn.com/2015/04/20/health/homeopathic-medicine-fda/ on 04-27-15.
  11. Christensen J. “Homeopathic medicine under FDA scrutiny.” CNN. April 21, 2015. Accessed at http://www.cnn.com/2015/04/20/health/homeopathic-medicine-fda/ on 04-27-15.
  12. JAVMA News.   “A debate on homeopathy.”   March 1, 2013.   Accessed at https://www.avma.org/News/JAVMANews/Pages/130301c.aspx on 04-27-15.
  13. JAVMA News.  “House of Delegates to deliberate again on homeopathy, acupuncturists.”  December 18, 2013.   Accessed at https://www.avma.org/News/JAVMANews/Pages/140101b.aspx?PF=1 on 04-27-15.

Originally published in the June 2015 issue of Veterinary Practice News. Like this article? Then subscribe today

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