New drugs, big dollars

New drugs, big dollars
To secure the approval of the Food and Drug Administration for a new drug, its manufacturer need prove only that it works better than a sugar pill, not that it's better than other remedies. So most of the "new" drugs that the FDA approves--75 percent in 2005--are me-too versions of existing remedies rather than genuine breakthroughs. Drugmakers must convince consumers and physicians that their new pink pill is better than the older green one.

For example, clinical studies conclude that an older type 2 diabetes drug, metformin (Glucophage, generic), controls blood sugar just as well as the latest brand-name drugs, rosiglitizone (Avandia) and pioglitizone (Actos), which cost about four times as much per month. But by promoting Actos and Avandia to doctors and consumers, their manufacturers have succeeded in capturing 21 percent of the market and, because the two drugs are so costly, 82 percent of revenues, according to data from Wolters Kluwer Health, Pharmaceutical Audit Suite, a medical information company.

Results like that explain why the pharmaceutical industry finds it cost-effective to spend an estimated $29.9 billion a year promoting its latest brand-name prescription drugs, according to 2005 figures published in the Aug. 16, 2007, issue of the New England Journal of Medicine.

More familiar to laypeople are the direct-to-consumer ads they see in magazines and on TV. We have tracked alleged violations of ad standards by analyzing letters of complaint to drugmakers that the FDA posted on its Web site from January 1997 through July 2007. (None involved the Requip ad we dissect below.) Among the common problems: minimizing drug risks and side effects, omitting critical safety information, exaggerating the drug's effectiveness, and falsely implying that the drug is superior to a competitor's brand.

But drugmakers lavish most of their marketing efforts on prescription-pad-wielding doctors. They start by handing out free samples, with a retail value of $18.4 billion in 2005, to help get patients on the brand-name drug, when generic equivalents might be available.

Giving patients a few days of free medicine might seem like a benefit, but in the long run it might cost them more, as illustrated in a study reported in the September-October 2006 issue of the Journal of the American Board of Family Medicine. The study compared prescription costs of three medical clinics belonging to the same health-care system. Two had a policy of never giving away free samples, while the third did so. Doctors at the clinic that gave away free samples prescribed significantly fewer drugs from the system's preferred list of medications, and the average monthly cost of a prescription at that clinic was $48, compared with $40 and $41 at the other two clinics.

Drugmakers also shower physicians and their office staffs with money, gifts, meals, and junkets. Vermont and Minnesota collect information about this largesse from drug companies and make it publicly available. In the small state of Vermont alone, those payments totaled $2.2 million in 2006.

One practice the public might not notice is the subtle promotion of expensive drugs for "off-label" uses. The FDAapproves drugs for specific diseases, but once a drug is approved, doctors can legally prescribe it for any purpose they see fit. It's in drugmakers' interest to encourage off-label prescribing because it can add millions to sales without requiring the costly clinical trials needed to secure FDA approval for a new use. The FDA doesn't allow direct promotion of off-label uses.

A Medicaid fraud lawsuit, filed by Pennsylvania regulators last February, accused AstraZeneca, Eli Lilly, and Janssen Pharmaceutica of engaging in a concerted campaign to persuade doctors to prescribe the antipsychotic drugs Seroquel, Zyprexa, and Risperdal for off-label uses by children and elderly patients. According to the lawsuit, the drugmakers paid doctors to promote the drugs and paid other doctors to attend the programs and lend their names to company-ghostwritten journal articles, paid researchers to create misleading medical literature, and knowingly concealed or misled physicians about the risk of side effects.

This campaign helped boost off-label uses of the three drugs to more than 50 percent of worldwide sales in 2005, alleges the suit, which is ongoing. Asked for comment, Eli Lilly said it plans to vigorously defend itself, AstraZeneca said the claims are without merit, and Janssen Pharmaceutica said it is committed to the highest ethical standards.

What you can do. Consumers are already voting with their dollars for generics, which now make up more than 60 percent of U.S. prescriptions dispensed. Half the doctors we surveyed said their patients frequently ask for them. But research suggests that the U.S. could save more than $8 billion with increased use of generics. If you're offered a newer drug, ask whether it has been proven better or safer than its predecessors. Twenty-five percent of doctors in our survey said they frequently observed adverse effects from newer drugs.

A free Consumers Union Web site, Best Buy Drugs, at www.BestBuyDrugs.org, has comparative treatment and cost information on most major categories of drugs, based on careful analysis of published studies of the drugs' effectiveness and safety.

To secure the approval of the Food and Drug Administration for a new drug, its manufacturer need prove only that it works better than a sugar pill, not that it's better than other remedies. So most of the "new" drugs that the FDA approves--75 percent in 2005--are me-too versions of existing remedies rather than genuine breakthroughs. Drugmakers must convince consumers and physicians that their new pink pill is better than the older green one.To secure the approval of the Food and Drug Administration for a new drug, its manufacturer need prove only that it works better than a sugar pill, not that it's better than other remedies. So most of the "new" drugs that the FDA approves--75 percent in 2005--are me-too versions of existing remedies rather than genuine breakthroughs. Drugmakers must convince consumers and physicians that their new pink pill is better than the older green one.

Labels: big dollars, New drugs

posted by Robert Heard at 2:42 PM