Shortages of many prescription drugs have become a major problem for patients, physicians and pharmacists over the past two years. Now, a growing number of medical experts are raising questions about whether the shortages are a result of the drug industry's desire to phase out older drugs in favour of newer, more expensive ones.
The problem of drug shortages is so serious that last week, U.S. President Barack Obama addressed the problem himself, urging that country's Food and Drug Administration to get information about shortages to the public sooner and speed reviews of applications from manufacturers that want to make production changes to deal with shortages. He also wants FDA officials to tell the U.S. Justice Department about potential instances of collusion and price gouging.
In August, Canadian Health Minister Leona Aglukkaq asked a working group of industry members and medical organizations what they were planning to do to address the shortage issue. They responded in September with a pledge to post information about drug shortages online and establish a national monitoring system accessible to Canadians.
Medications in short supply in recent months include antibiotics, heart drugs, antidepressants and others. But there have also been emerging shortages of chemotherapy drugs and medications used to anesthetize patients, which has been a source of major concern in the health community.
The pharmaceutical industry says that reasons for the shortages have nothing to do with market manipulation, but that they are complex and varied, such as contamination or unavailability of important raw ingredients, regulatory problems, safety issues with manufacturing plants, or a sudden and unexpected increase in demand for a particular drug.
Some experts, however, suspect the problem is actually much simpler and may hinge on whether the drugs in question can generate enough sales to make them viable to the company selling them.
The vast majority of drugs that have been in shortage are older generic drugs, which are much cheaper and often in less demand than newer drugs. In some instances, alternatives to these unavailable drugs are more expensive brand-name medications.
A analysis published last week in the New England Journal of Medicine raised serious questions about the fact that most supply problems seem to revolve around inexpensive older drugs that likely don't generate significant revenue.
"The main cause of the drug shortage is economic," wrote authors Mandy Gatesman of the Virginia Commonwealth University Health System and Thomas Smith of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine. "If manufacturers don't make enough profit, they won't make generic drugs."
The analysis cites the example of paclitaxel, an important chemotherapy drug that has been in shortage in the U.S. The alternative, Abraxane, costs 19 times the price of the generic paclitaxel, the authors found.
In an interview, Prof. Gatesman, a clinical pharmacy specialist, said it's difficult to find another explanation for the fact that shortages are disproportionately affecting generic brands.
"Even though no generic company, as far as I'm aware, has come out and said economics was the reason for shutting anything down, it's really hard to think that that's not true," she said.
It's a position shared by Jacalyn Duffin, a hematologist and medical historian at Queen's University in Kingston, Ont. Dr. Duffin launched a website last year to raise awareness of drug shortage problems after one of her cancer patients was unable to get a prescription for an anti-nausea drug filled. She fears that drug manufacturers may simply be phasing out older, less expensive drugs, which would force patients and the health-care system to pay more for newer drugs, she said.
"They're just letting those drugs go away," Dr. Duffin said. "The bottom line for patients is to expect more shortages and it could be shortages of really significant drugs like chemotherapy drugs."
The president of the largest Canadian-owned pharmaceutical company, Apotex, which produces generics, said there is no truth to any claims about shortages being the result of economics. Jack Kay said a major problem is the difficulty in sourcing good active ingredients that meet Canadian standards. Generic companies rely on third parties for active ingredients, which means they are at the mercy of supply-chain glitches, contamination issues and other problems that can result in lengthy drug shortages.
This can be a particular problem for older drugs because the active ingredient may only be produced by a few third parties, Mr. Kay said.
"I think it's important for Canadians to know there is no manipulation going on here," he said.
Jeff Connell, vice-president of corporate affairs for the Canadian Generic Pharmaceutical Association, which represents makers of generic drugs, said in an e-mail he knows of "no instance in the Canadian market of a shortage due to the withdrawal of a drug product based on it being unprofitable."
A statement on the organization's website says it is working with various partners to find ways to mitigate the impact of shortages on patients. The association also says generic companies in Canada are enacting a host of measures, including investing nearly $100-million over the next three years in new facilities, equipment, systems and staff and allocating more resources to quality control and assurance operations in order to comply with the standards of Health Canada and other regulatory agencies.
Russell Williams, president of Canada's Research-Based Pharmaceutical Companies, which represents companies selling brand-name drugs, said the industry is dedicated to addressing shortages and working to set up the national monitoring database.