Posted by: Audrey Erbes | August 27, 2011

Vital Medicine Shortage Blamed on Profit Motive and Manufacturing Problems Plus Events

Shortages of vital medicines is becoming quite severe, especially, in the treatment of cancer. An NCI bulletin reports “There is an increasing shortage of old chemotherapy drugs, many of which form the backbone of standard of care treatment regimens, resulting in rationing and substitutions of other drugs.” They note that some shortages are a result of manufacturing problems, but now more frequently manufacturers have stopped producing these low-profit drugs in favor of newer more profitable drugs.

In recent a NY Times article it’s reported that at least 180 drugs that are crucial for treating childhood leukemia, breast and colon cancer, infections and other diseases are in short supply. This is a record number.

Prices for some of these earlier branded drugs have risen as much as twentyfold, and clinical trials for some experimental cures have been delayed because there isn’t sufficient supply of these older, genericized drugs that are needed to offer patients in the study.

The New York Times article agreed with the NCI bulletin in blaming the loss of profit for producing these older drugs in the U.S. and the manufacturing problems of supplies from outside the U.S. as well as inside as the source of the problem. Who would have predicted that the rapid uptake of generics would mean the elimination of certain essential drugs from our medicine arsenal as companies stopped producing the lower price margin products.  With the dramatic increases in the price of branded oncology therapies and other branded drugs, companies have eliminated the older drugs from their production lines.

The closing of U.S. plants by international pharmaceutical companies in favor of building new facilities in China and India have also surely hurt the production capacity in the U.S. We witnessed supply problems in years past when the low margins turned away companies from producing needed vaccines in country and overseas plants had contamination problems. The FDA’s mandate to protect our citizens from harmful drugs as well as food from overseas manufacturers for whom they lack manpower and resources to inspect has led to additional responsibilities on the agency while they are being asked to cut back expenditures by 5% in 2012 and 10% in 2013.

Lawmakers are concerned about this problem and one suggestion is that the Centers for Disease Control and Prevention build up stockpiles of these needed drugs similar to the way they already stockpile antibiotics, antidotes and other drugs needed in the event of a terrorist attack or earthquake. Another possible approach is storage of the dry ingredients for cancer drugs and, in the face of a shortage, distribution of them to hospitals, where pharmacists could mix them into injectable compounds. But this wouldn’t solve the problem of shortages at experimental clinical trial sites that don’t have staff to make this conversion. This will be an interesting new issue that may involve government intervention to solve.

Meeting highlights for this coming week include:

  • BioCentury TV Today, Viewable after Sunday Morning, August 28, 2011; Topic: “Medicare Drugs: CMS and Harvard Assess the Picture;” Speakers: Dr. J. Michael McWilliams, lead author of the Harvard study and Professor of Health Care Policy at Harvard Medical School; Sean Keehan, Senior Economist at the CMS Office of the Actuary; Dr. Tanisha Carino, SVP and head of the Center on Evidence-Based Medicine and Health Information Technology at Avalere Health LLC
  • CACO Workshop, Monday, Aug. 29, 2011; Workshop Title: “Preclinical Development and IND Filing;” Speakers: Cuiping “Tracy” Chen (Depomed), Bert Ho (ChemoCentryx), Linval Depass (Durect), Jim Wei (Medpace)
  • Bio2Device Group, No Meeting on Aug. 30, 2011
  • Stanford AIMS Postdoc Link to Entrepreneurship and Industry, Wednesday Evening, Aug. 31, 2011; Topic: “Bridging Science and Business;” Speaker: With Peter Reiss, PhD, Director of the Summer Institute for Entrepreneurship (SIE) and the Program in Innovation and Entrepreneurship (PRIE) at the Stanford Graduate School of Business
  • Medtech Frontiers, Thursday Evening, Sept. 1, 2011; Topic: “Open Medicine: Rethinking the Translational Research for the -omic Era;” Speaker: Dr. Andreas M. Kogelnik, founding Director of the Open Medicine Institute
  • BOLD Workshop, Thursday Morning, Sept. 1, 2011; Event: BOLD Workshop: Mentoring: Gold Mine or Minefield?

You can access the full list that includes details for this coming week’s events as well as those through October by right clicking on the highlighted Audrey’s Picks of the Week.

Have a great week!

Audrey

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