Eli Lilly and Co. is gearing up to fight legislation that would allow Americans to import lower-priced prescription drugs from other countries, saying it would put consumers at huge risk of dangerous counterfeit medicines, which it says is growing to epidemic proportions. About counterfeit medicines
• Sales: Estimates range from around 1 percent of overall prescription drug sales in developed countries to more than 10 percent of sales in developing countries.
• Types of drugs: Law enforcement agents have seized nearly every kind of drug in counterfeit raids, from cough syrups and inexpensive generic versions of simple pain killers to anti-cancer and anti-psychotic drugs.
• Threat to patients: Many of the drugs have too little of the needed active ingredient or the wrong active ingredient. Others have toxic fillers. Source: World Health Organization
The Indianapolis company and other U.S. drug makers won a similar battle last year when the Senate killed a drive that would have allowed consumers, pharmacists, drug wholesalers and distributors to import drugs from Canada, Japan, Australia and many European countries.
But what the drug industry sees as a threat to patient safety and its intellectual property, some consumer groups say is a needed way to provide lower-cost drugs to Americans, who pay the highest prices in the world for prescription medicines. Supporters say the bill adequately protects the public against counterfeit drugs.
The bill has yet to be set for a vote, and both sides say it could come up with little notice.
As the cost of prescription drugs rise and health-care costs loom as a top issue in this year's presidential election, the issue of affordability and accessibility are sure to resonate in Washington and around the country.
The stakes are high for drug makers. Many other countries keep drug prices low through government controls. But Americans wind up paying the higher market price for drugs, meaning they often pay two-thirds more than Canadians, 80 percent more than Germans and 100 percent more than French residents pay for identical prescription drugs.
"The issue of importation is a big fear for the entire pharmaceutical industry," said Robert Hazlett, a drug analyst for BMO Capital Markets in New York. "It's tough to put a dollar figure on what it could cost drug companies if importation legislation passed."
Lilly, for its part, say price controls stifle innovation and reduce competition. Along with other drug makers, Lilly counts on higher prices paid by Americans to fund expensive research for new drugs.
The real issue, Lilly said, is the sharply rising epidemic of counterfeit drugs -- fake, unregulated, illegal drugs made in Third World countries. Since January 2006, customs officials around the world have seized more than 3 million counterfeit or suspected counterfeit tablets, in more than 1,000 separate actions, the company said.
Lilly said counterfeit versions of six of its branded drugs have been seized around the world, including antipsychotic Zyprexa, erectile-dysfunction drug Cialis and antidepressant Cymbalta.
Wide span of fakes
According to the World Health Organization, just about every type of drug has been counterfeited, from antihistamines and erectile dysfunction drugs to medicines designed to treat serious diseases, such as cancer, malaria and AIDS.
The organization calls counterfeiting "an enormous public health challenge." A woman in Argentina who had mild anemia died of liver failure in 2004 after taking a highly toxic counterfeit. A woman from Canada was fatally poisoned by fake drugs she received over the Internet laced with deadly metals.
Many of the drugs, the industry says, are made by organized criminals in unsanitary conditions that would never pass FDA approval. They can make huge profits without overhead costs, quality control or regulatory enforcement.
"They might run a batch of Viagra, then a batch of Cialis, then a batch of Lipitor, and then they might do some narcotics," Michael J. Muller, director of Lilly's global anti-counterfeiting operations. "These guys are after money, a quick buck."
Lilly says the volume of global counterfeiting comes to about $30 billion, which would represent about 5 percent of global sales. The company expects the figure to double by 2010.
Only a tiny fraction of counterfeit drugs enter the U.S. market. But Lilly and other drug makers say they could widen to dangerous levels if Congress relaxes the federal ban on imported drugs.
High costs
Last year, Lilly sold its case by taking out newspaper advertisements, enlisting help from the powerful industry trade groups, and telling its story to more than 100 congressional staffers.
In the meantime, the company said it spends more than $1 million a day to fight drug counterfeiting around the world, beefing up its security, legal, anti-counterfeiting, quality control and other functions.
But advocates of drug importation say keeping the ban in place is more of a protection for the industry than a safety measure for consumers. They say U.S. regulators can protect consumer safety.
"The counterfeit argument is absolutely a red herring," said Barry Piatt, press secretary to U.S. Sen. Byron L. Dorgan, D-N.D., who was the chief sponsor of last year's measure. "What the drug companies don't tell you is they themselves import medicines into this country from their plants overseas."
Dorgan's bill, he said, includes provisions that would allow the Food and Drug Administration to inspect warehouses of foreign exporters and domestic importers.
Consumer support
Many consumer groups support a bill to allow imports. Union Senior Action, an Indianapolis advocacy group that represents about 13,000 senior Hoosiers, said it has helped dozens of people travel to Windsor, Canada, to buy drugs.
"When you're taking several medications a day, the savings can be substantial," said Paul Severance, the group's founder and retired executive director.
The AARP, the nation's largest advocacy group for seniors, has steadily supported relaxing the ban on drug imports. The group points out that drug prices are rising at nearly twice the annual rate of inflation, taking a toll on consumers, private sector health insurance and state budgets.
"If Eli Lilly can have manufacturing facilities all over the world, and bring their product into the U.S. safely to sell here, why is it that similar safety provisions can't be put in place to allow individuals to purchase drugs from abroad," said Anna Howard, a senior legislative representative with the AARP.
But the Bush administration has said the worldwide drug market is so vast, it can't guarantee the safety of imported medicines.
Lilly said that it offers several programs for needy consumers, including uninsured Americans, to obtain drugs. Medicare Part D, a federal program that subsidizes the cost of prescription drugs, has helped millions of seniors obtain cheaper drugs, the company said.
Apparently the global economy we hear so much about has gotten to Big Pharm's pocketbook. Oops. Time to ramp up the War on (Certain) Drugs... perhaps this will lead us to an unlikely ally in the aging population in need of cheap meds. Though probably not.
22-01-2008, 14:33
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