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Lowering the High Cost of Cancer Drugs—III

      To the Editor:
      In their commentary published in the August 2015 issue of Mayo Clinic Proceedings, Tefferi et al
      • Tefferi A.
      • Kantarjian H.
      • Rajkumar S.V.
      • et al.
      In support of a patient-driven initiative and petition to lower the high price of cancer drugs.
      correctly argue that new cancer medicines in the United States are priced above international norms, at times prohibitively so. However, their recommendation that patients import cancer medicines for “personal use,” while pointing out that “prices in Canada are about half of prices in the United States,” is so fraught with danger as to be foolish.
      Canada has cheaper new cancer medicines because federal law regulates the prices of patented drugs (although generic drugs are often more expensive).
      • Menon D.
      Pharmaceutical cost control in Canada: does it work?.
      • Beall R.F.
      • Nickerson J.W.
      • Attaran A.
      Pan-Canadian overpricing of medicines: a 6-country study of cost control for generic medicines.
      American patients can buy drugs at lower Canadian prices by crossing the border, but it is usually easier to order from Canadian Internet pharmacies.
      The trouble is, most “Canadian” Internet pharmacies are anything but. The US Food and Drug Administration (FDA) reports that 85% of medicines purchased from “Canadian” Internet pharmacies are actually foreign frauds, “falsely promoted as being of Canadian origin”.

      US Food and Drug Administration. FDA operation reveals many drugs promoted as “Canadian” products really originate from other countries [press release]. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108534.htm. Published December 16, 2005. Updated November 14, 2013. Accessed January 25, 2016.

      Investigations by an Internet security company found foreign organized criminals masquerading as Canadian pharmacists and using fake pharmacy licenses.

      Rogues and registrars: are some domain name registrars safe havens for Internet drug rings? LegitScript website. http://www.legitscript.com/download/Rogues-and-Registrars-Report.pdf. Accessed January 25, 2016.

      Further, even Internet pharmacies on Canadian soil that advertise medicines to Americans do so illegally. The worst are not licensed pharmacies at all but just call centers, while others are licensed pharmacies that advertise medicines from countries such as India or Turkey whose safety has never been scrutinized or approved by either Health Canada or the FDA.
      • Attaran A.
      • Beall R.F.
      Internet pharmacies: Canada's transnational organized crime.
      Touting these unapproved medicines, Health Canada writes, “is a violation of the Food and Drugs Act and Food and Drug Regulations.”

      Reminder of obligations with respect to the advertising and sale of drugs. Health Canada website. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/reminder-rappel_adver-pub_tc-tm-eng.php. Published October 6, 2006. Accessed September 9, 2015.

      As the commissioner of the FDA has warned, when the unapproved medicines arrive in the United States, that violates American law as well.
      • Henney J.E.
      Cyberpharmacies and the role of the US Food and Drug Administration.
      The danger of unapproved medicines is obvious. A prominent licensed Canadian Internet pharmacy, CanadaDrugs.com, and its associates advertised and sold discounted versions of the expensive anticancer medication bevacizumab (Avastin) directly to American physicians. The product that arrived came from Turkey and was fake: it contained no active ingredient.

      United States of America v Canadadrugs.com Ltd, United States District Court for the District of Montana (CR 14-27-BU-DLC).

      US. Food and Drug Administration. April 24, 2013: Paul Daniel Bottomley pleads guilty in U. S. federal court [press release]. US Food and Drug Administration website. http://www.fda.gov/ICECI/CriminalInvestigations/ucm349880.htm. Published April 24, 2013. Updated January 28, 2015. Accessed January 25, 2016.

      Weaver C, Whalen J. How fake cancer drugs entered U.S. Wall Street Journal website. http://www.wsj.com/articles/SB10001424052702303879604577410430607090226. Updated July 20, 2012. Accessed January 25, 2016.

      CanadaDrugs.com and its associates have now been indicted by the US Department of Justice for criminal activities including conspiracy to smuggle and money laundering.
      • Mackey T.K.
      • Cuomo R.
      • Guerra C.
      • Liang B.A.
      After counterfeit Avastin®—what have we learned and what can be done?.
      In addition to Canadadrugs.com, several people, including physicians, have been and still are being prosecuted for the importation and sale of counterfeit Avastin in the United States, and some have gone to prison.
      • Mackey T.K.
      • Cuomo R.
      • Guerra C.
      • Liang B.A.
      After counterfeit Avastin®—what have we learned and what can be done?.
      Shamefully, Canada's government encourages this sort of organized crime: Parliament even voted to not enforce the law against Internet pharmacies.
      • Attaran A.
      • Beall R.F.
      Internet pharmacies: Canada's transnational organized crime.
      Accordingly, in subsequent criminal investigations by the Royal Canadian Mounted Police, no one was prosecuted.
      • Attaran A.
      • Beall R.F.
      Internet pharmacies: Canada's transnational organized crime.
      However, the biggest problem of recommending that American cancer patients obtain medicine from Canada—a country having about one-tenth the population of the United States—is that it would drain Canada's much smaller supply of drugs and assuredly cause drug shortages for Canadian cancer patients. Oncology practice suffers from drug shortages already.
      • Kehl K.L.
      • Gray S.W.
      • Kim B.
      • et al.
      Oncologists' experiences with drug shortages.
      For Tefferi et al
      • Tefferi A.
      • Kantarjian H.
      • Rajkumar S.V.
      • et al.
      In support of a patient-driven initiative and petition to lower the high price of cancer drugs.
      and others to advocate that their American patients parasitize Canada's limited drug supply not only threatens to make that worse but is also appallingly unethical because it amounts to redistributing scarce, lifesaving resources to Americans at the expense of Canadian cancer patients' lives—in violation of the rule of distributive justice in medical ethics.
      • Gillon R.
      Medical ethics: four principles plus attention to scope.
      Simply put, good neighbors do not raid one another's medicine chest. That is not only unethical advice but could also land American doctors in prison if they play a part in importing medicines illegally.
      Obviously, America needs homegrown solutions to its drug access challenges. Regardless of the form that takes, advocates must remember that it is the responsibility of elected representatives in Washington, and not foreigners in Ottawa, to provide what Americans need.

      References

        • Tefferi A.
        • Kantarjian H.
        • Rajkumar S.V.
        • et al.
        In support of a patient-driven initiative and petition to lower the high price of cancer drugs.
        Mayo Clin Proc. 2015; 90: 996-1000
        • Menon D.
        Pharmaceutical cost control in Canada: does it work?.
        Health Aff (Millwood). 2001; 20: 92-103
        • Beall R.F.
        • Nickerson J.W.
        • Attaran A.
        Pan-Canadian overpricing of medicines: a 6-country study of cost control for generic medicines.
        Open Med. 2014; 8 (Published October 2014. Accessed January 25, 2016)
      1. US Food and Drug Administration. FDA operation reveals many drugs promoted as “Canadian” products really originate from other countries [press release]. US Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108534.htm. Published December 16, 2005. Updated November 14, 2013. Accessed January 25, 2016.

      2. Rogues and registrars: are some domain name registrars safe havens for Internet drug rings? LegitScript website. http://www.legitscript.com/download/Rogues-and-Registrars-Report.pdf. Accessed January 25, 2016.

        • Attaran A.
        • Beall R.F.
        Internet pharmacies: Canada's transnational organized crime.
        Health Law Canada. 2014; 34: 93-120
      3. Reminder of obligations with respect to the advertising and sale of drugs. Health Canada website. http://www.hc-sc.gc.ca/dhp-mps/compli-conform/info-prod/drugs-drogues/reminder-rappel_adver-pub_tc-tm-eng.php. Published October 6, 2006. Accessed September 9, 2015.

        • Henney J.E.
        Cyberpharmacies and the role of the US Food and Drug Administration.
        J Med Internet Res. 2001; 3: E3
      4. United States of America v Canadadrugs.com Ltd, United States District Court for the District of Montana (CR 14-27-BU-DLC).

      5. US. Food and Drug Administration. April 24, 2013: Paul Daniel Bottomley pleads guilty in U. S. federal court [press release]. US Food and Drug Administration website. http://www.fda.gov/ICECI/CriminalInvestigations/ucm349880.htm. Published April 24, 2013. Updated January 28, 2015. Accessed January 25, 2016.

      6. Weaver C, Whalen J. How fake cancer drugs entered U.S. Wall Street Journal website. http://www.wsj.com/articles/SB10001424052702303879604577410430607090226. Updated July 20, 2012. Accessed January 25, 2016.

        • Mackey T.K.
        • Cuomo R.
        • Guerra C.
        • Liang B.A.
        After counterfeit Avastin®—what have we learned and what can be done?.
        Nat Rev Clin Oncol. 2015; 12: 302-308
        • Kehl K.L.
        • Gray S.W.
        • Kim B.
        • et al.
        Oncologists' experiences with drug shortages.
        J Onc Pract. 2015; 11: e154-e162
        • Gillon R.
        Medical ethics: four principles plus attention to scope.
        BMJ. 1994; 309: 184-188

      Linked Article

      • In Support of a Patient-Driven Initiative and Petition to Lower the High Price of Cancer Drugs
        Mayo Clinic ProceedingsVol. 90Issue 8
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          The high prices of cancer drugs are affecting the care of patients with cancer and our health care system.1 In the United States, the average price of new cancer drugs increased 5- to 10-fold over 15 years, to more than $100,000 per year in 2012. A study by Howard et al2 documented the escalation in cancer drug prices by an average of $8500 a year over the past 15 years. The cost of drugs for each additional year lived (after adjusting for inflation) has increased from $54,000 in 1995 to $207,000 in 2013.
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      • In Reply—Lowering the High Cost of Cancer Drugs
        Mayo Clinic ProceedingsVol. 91Issue 3
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          We thank our colleagues for their perspectives on our commentary.1 We agree with the comments of Drs Braillon and Martenson, and we thank Dr Messori and coauthors for their thoughtful analysis.
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