The pharmaceutical industry is spending more money than ever on research, but most of it is going to 'me too' drugs, variations of what are currently available, rather than to new approaches to treating diseases.
The General Accountability Office ( GAO ) reached that conclusion in a report, New Drug Development. It analyzed data from all 1,264 new drug applications filed with the Food and Drug Administration ( FDA ) from 1993 through 2004. And it spoke with numerous experts in the field. The report was released on Dec. 19.
It found that industry increased spending on research by 147 percent, to nearly $40 billion a year, but the number of new molecular entities increased by only 7 percent. Those are the new categories of drugs that often represent the greatest advance in treatment.
This was particularly troubling because it came during a period when completion of the human genome; advances in imaging technology; and the ability to synthesize and screen thousands of compounds for activity 'created expectations that the pharmaceutical industry would soon be producing an increasing number of new and innovative drugs to more effectively treat disease,' the report stated.
Interestingly, the one field that showed major advances was the treatment of HIV. During that period the protease inhibitor class of drugs, as well as the fusion inhibitor Fuzeon were introduced. CCR5 inhibitor and integrase inhibitor classes of drugs are in advanced development. ( CCR5 plays a role in inflammatory responses to infection. )
The FDA approved roughly 80 percent of the drugs submitted to it. The average time to review a standard application declined from 669 days ( 1993 ) to 442 days ( 2002 ) , while drugs for which there is an urgent need were submitted under accelerated approval and were reviewed within six months.
Among the reasons why it is taking longer and costing more money to develop innovative new drugs are that there already are good therapies for many of the infectious diseases of the industrialized world, and that pharmaceutical companies have turned to chronic diseases. These diseases often are more complex, less understood and more time-consuming to evaluate what, if any, impact a drug may have on them.
The report also cited business policies such as the aversion to risk and the quest for blockbuster drugs that have the potential for sales of at least $1 billion a year as helping to drive decisions on drug development.
'This new GAO study refutes many of the pharmaceutical industry's myths about the drug development process,' said Rep. Henry Waxman, D-Calif. 'Most prominently, it indicates that the link between high research expenditures—which the industry claims must be driven by high prices—and new drug development is unclear at best.'
Sen. Ted Kennedy, D-Mass., said, 'The report shows that much drug industry research doesn't translate into real breakthroughs for patients.' The two congressmen asked the GAO to conduct the study.
Waxman said that many aspects of the drug development process need to be examined 'to determine how to encourage research that focuses on breakthrough treatments rather than drug industry profits.'
Reauthorization of the FDA is scheduled for consideration in 2007. Senator Kennedy already has introduced his version of such a bill and both houses of Congress will play important roles in that process.