Guest Blog: Dr. Jackie Duffin - Big Shortage, Little Action
By Jackie Duffin MD Professor
Hannah Chair of the History of Medicine, Queen's University
The Scope of the Shortage
The generic drug shortage continues, and no one seems to be doing much about it.
The crisis began in 2009. But Canadians became aware in February 2012 when the Sandoz Company in Boucherville closed temporarily. Media interest soon melted away.
But Boucherville was the tip of an iceberg that threatens the entire world. We are now tracking the problem in more than thirty countries. The shortage takes different forms in different places: sterile injectables in the United States, pills for epilepsy, arthritis, and Parkinson's in Canada, tuberculosis in India, malaria in Malawi, thalassemia in Pakistan, etc.
The federal Minister of Health has "announced" its website no fewer than three times over the last 18 months. But it is the same website. Many pharmacists I know do not use it. Scrambling to find replacements, they rely on more accurate information from the private sector, such as Vendredi PM of Sigma Santé. Pharmaceutical companies are "encouraged," but not required to report upcoming shortages, despite a unanimous resolution taken in the House of Commons in March of last year.
Unfortunately, drug shortage is "new normal."
The causes
Causes of the shortage are still unknown. Industry prefers to blame it on scant raw materials and manufacturing slowdowns owing to what it calls inordinate vigilance by the FDA or by Health Canada. Indeed in June 2012 a U.S. congressional committee actually blamed the FDA for the drug shortage.
But we want safe, clean products. Slowdowns for repairs occur when violations are found. FDA's ramped up vigilance followed several, flagrant contaminations. Was plant maintenance neglected in the economic crunch of 2008-9?
Health-care professionals imagine other, equally plausible causes. Are the pharmaceutical companies manipulating the market? If scant raw materials are the cause, why do shortages affect only generics, made from the same raw materials as expensive drugs? Did someone make a business decision to favour more lucrative products? Doctors and pharmacists don't have time to keep searching for alternatives. Eventually, in a self-fulfilling prophecy, they'll stop ordering generics and manufacturers can stop making them, claiming that no one wants them any more.
Extremely low prices for generic drugs are cited as another cause. Profit margins are narrow or non-existent. But recently, Canadians became aware, through the work of UBC's Michael Law, that they pay more for generics than citizens of other nations. To lower costs, provincial health ministers united to bulk by six generics at lower prices, later claiming to have saved millions and proposing to expand their plan. This action may reduce costs, but will it help the drug shortage if one cause is their excessively low price?
Financial analysts cite another cause in the large American group purchasing organizations that grab low cost pharmaceuticals for clients and break anti-trust laws by giving kickbacks to vendors. They drive prices down, while everyone outside the GPO umbrella pays more, or does without. The entire Canadian market is smaller than some GPOs' client base.
Reporters always ask about harm. Sadly, no one is measuring the harm. People die of diseases, not of drug shortages. Death certificates do not allow us to indicate if the illness had been exacerbated by a lack of remedy.
Nevertheless, we know that people with rare diseases have died without medicine, that children with cancer are relapsing more often, and that the spinal meningitis outbreak that killed over 60 people also resulted from the shortage. Many more suffer needlessly.
How could Canada act?
1. By living up to its 2012 resolution for mandatory reporting. In fairness, pharmaceutical firms do not always know of shortages in advance. But timely information would be helpful.
2. By tracking harm.
3. By demonstrating international leadership in working with other countries, perhaps through the OECD or the WHO, to determine the cause and solve it. This effort should involve not only the health ministries, but also Finance and External Affairs.
4. By fostering its own industry. With our intellectual and fiscal capital, why do we not start making these missing remedies ourselves?
Dr. Jacalyn Duffin, is a a professor and the Hannah Chair of the History of Medicine at Queen's University. Her website is canadadrugshortage.com.