A New Take on the Prescription Drug Flap
Some experts contend generics offer affordable alternatives; others say more must be done
SUNDAY, Aug. 18, 2002 (HealthDayNews) -- Amid the controversy surrounding the high cost of prescription drugs, some health professionals contend there's already a product in place that ensures the fairest prices for consumers.
It's called the generic drug.
"The development of generics has been one of the best success stories in the health-care field in the last 20 years," says Daniel Albrant, president of a Virginia-based health-care consulting company, and a spokesman for the American Pharmaceutical Association.
"And the present medications are probably one of the most cost-effective parts of the health-care system," he adds.
Others disagree, saying access to prescription drugs needs tweaking -- at a minimum -- so it's more palatable to consumers.
"I'm fairly horrified by the cost of drugs -- they should be available at a much lower cost," says Dr. Jean Barbey, interim director of Georgetown University Hospital's division of clinical pharmacology in Washington, D.C.
Generic drugs are copies of brand name drugs whose patents have expired. A drug company that creates a new drug has a 17-year patent on that drug, after which time it loses the exclusive right to manufacture it. Then other companies are free to produce the same drug, Albrant says.
Because those companies don't have to pay for the expensive research and development that goes into the creation of a drug, they can sell it at a much lower cost. The savings to the consumer, or a third-party provider, are considerable -- often half the price of the brand name drug, Albrant says.
Since 1984, when Congress passed a law to streamline the production of safe generic drugs, the Food and Drug Administration has approved the sale of about 250 generic drugs every year. The result has been a huge savings for consumers, either directly or through health-care plans, says Albrant.
"It's difficult for consumers to see, but it's true that all these new drugs have improved people's life spans and the quality of their lives," he says.
But health-care experts like Barbey contend that not enough is being done to keep prescription drugs within the reach of all who need them.
"Money is spent on marketing and direct advertising to potential customers that could constructively be used in other ways," Barbey says. "Right now, no health authority is trying to regulate this free-for-all market, trying to limit it a little bit without stifling research."
Barbey, a Swiss native, says the more socialistic European models are better able to control prices.
In France, for instance, a drug company seeking to develop a drug must consult with the government about its plan. Then the government, weighing the health benefits and cost-effectiveness of the drug, sets the price at which the company can sell it.
In the United States, Barbey says, the free market also allows drug companies to try to extend their patents by manufacturing so-called "new" drugs that are simply variations on the original. This often happens, he says, with drugs that treat common ailments like allergies and depression.
And, Barbey adds, American drug companies seeking to boost profits often manufacture too many of the same kind of drugs, called "me-too" drugs. He points to the approximately one dozen different ACE inhibitor drugs on the market, which are designed to treat high blood pressure.
"This is an excellent class of drugs, and you could argue that you need more than one drug from the class, but do you need 12?" he asks.
But Albrant counters that the very free-market system that Barbey criticizes has actually encouraged the development of more and better drugs. Facing deadlines on their patents, companies are always seeking to develop new products.
"The pharmaceutical industry has become more efficient," he says. "They can't sit back on their laurels. They need to continue to produce more compounds."
This has meant that companies that would have been content to produce drugs for large segments of the population -- such as those with cardiovascular disease or cancer -- have had to target smaller groups of people, developing new drugs for those with conditions like migraines, epilepsy or depression.
Despite their philosophical differences, Albrant and Barbey agree that generic drugs are as effective and as safe as brand name drugs.
"I have no hesitation in prescribing generic drugs," Barbey says.
Adds Albrant: "I recommend them all the time, confident that the products are equivalent in every way to the trade name products, but at a reduced cost."
The testing for generics is quite thorough, Barbey says. In a typical study to compare them to brand name drugs, study participants are divided into two groups. One group takes the brand name drug and the other takes the generic, and both groups have blood samples taken.
Several weeks later, the test is repeated, only this time the participants switch drugs, then give another blood sample.
All the blood samples are then examined to reveal how quickly both drugs were absorbed into the blood, the maximum concentration of the drug in the blood, and how long it stayed in the body.
If the results show that the generic drug comes close to matching the performance of the brand name drug, it is approved as "bio-equivalent" to the original drug.
What To Do
To look up any drug approved by the Food and Drug Administration, check the agency's Orange Book. For more on the difference between generic and brand name drugs, visit this Federal Trade Commission Web site.