WASHINGTON – Retired Scripps Howard News Service reporter Lance Gay noticed something strange about his prescription asthma medication two years ago.
The drug,called Advair,came in the familiar purple package,but the label looked as if it had been made with an office printer. And instead of alleviating his symptoms,the drug made them worse.
Gay alerted the pharmaceutical company GlaxoSmithKline,which produces Advair,that something was amiss.
“I called them up and said,‘I think I have one of these counterfeit drugs I've been reading about,” Gay said.
Defined by the World Health Organization as “medicine which is deliberately and fraudulently mislabeled with respect to identity and/or source,” counterfeit drugs are estimated to make up about 10 percent of drugs sold globally,earning $32 billion per year in sales.
The American Enterprise Institute held a conference Tuesday,”The Global Impact of Fake Medicine,” to discuss the counterfeit drug problem. Eight panelists representing drug companies,health-related nonprofits and foreign and United States government agencies spoke about the extent of the counterfeit drug penetration into the global market and possible solutions.
Roger Bate,an AEI fellow who moderated the discussion,said that counterfeit drugs have no curative effect at best and at worst can contain harmful ingredients that sicken or kill those who take them. He showed pictures of raids on counterfeit drug-production sites where active ingredients were stored in mold-ridden rooms or mixed in industrial cement mixers.
Besides causing direct harm to patients,counterfeit drugs can also lead to resistance,or the reduction of a medicine's effectiveness,if the drugs contain inadequate doses of an active ingredient,Bate said.
“The wider impacts for infectious diseases with too low active ingredient,but that contain active ingredient in them,is that resistance can be built up at the population level,making entire classes of drugs useless or at least damaged in some way,” Bate said.
Panelists highlighted several reasons for the global prevalence of the counterfeit drug problem,including the rise of Internet drug sales,the great moneymaking potential and the number of foreign pharmacies in the U.S. market.
Bate said counterfeit drugs in the United States represented less than 1 percent of the market. However,Ilisa Bernstein,director of pharmacy affairs for the Food and Drug Administration,said such estimates reveal relatively little about how widespread counterfeits really are.
“With almost 4 billion prescriptions written last year in the United States – if you just think about 1 percent as 40 million – I highly,highly,highly doubt that 40 million prescriptions were filled in the United States with counterfeits,” Bernstein said.
She did report that the number of court cases on counterfeit drugs has risen,from 31 in 2007 to 56 in 2008.
Patrick Ford,senior director of global security for Pfizer,said that more than 2 million counterfeit tablets,capsules or vials of Pfizer drugs were seized in the Americas in 2008,particularly Viagra,a treatment for erectile dysfunction,and Lipitor,a treatment for high cholesterol.
Scott LaGanga,executive director of the Partnership for Safe Medicines,said that at least 651 branded generic and over-the-counter medications were counterfeited in 2008.
Panelists mentioned several possible solutions to counterfeiting,including stricter regulations,greater enforcement of current anti-counterfeiting laws and the creation of international coalitions to prevent phony drugs from traveling across borders.
Paul Orhii,director general of Nigeria's National Agency for Food and Drug Administration and Control,said counterfeit drugs represented 60 percent of the Nigerian market.
“You see children hawking medicine under the sun,” Orhii said.
He described several stumbling blocks to cracking down on the problem,including his agency's lack of resources,Nigeria's porous borders and the mixture of good drugs with the counterfeits.
Panelists encouraged the adoption of a universal definition of counterfeit drugs,the absence of which makes it difficult to standardize anti-counterfeiting laws internationally. Bernstein said the lack of comprehensive numbers about the extent of the problem makes it difficult to take action .
“Sometimes it does take major incidents to strengthen authority on these issues,” she said in an interview. “People always ask,‘Where are the injuries? Where are the bodies?'”
Even when an injury does occur,action does not necessarily follow.
When Gay called GlaxoSmithKline about his faulty Advair,he sent in a sample of the drug at the company's request. In the two years since,he has never heard back.
“If they're not going to tell me about it,why should I bother reporting it?” Gay said.
A GlaxoSmithKline spokeswoman said she would try to confirm whether there had been breach of the Advair supply chain two years ago or the procedure for following up with patients but did not do so by the time she had specified.
Despite his frustration with the company's lack of follow-up,Gay said he hopes the information he provided gave GlaxoSmithKline the chance to solve the problem.
“I was more interested in reporting it – having them look into the drug supplier,get them out of the system,go down and take a look at the warehouse,” Gay said. “I was more interested in making sure that the rest of the drugs they were giving out were OK.”