|Selected news articles which highlight important policy issues.||
News: Weekly Archives
News for the week of 02-23-2005
F.D.A. Issues a Guide to Gathering Genetic Data That May Personalize Drug Therapy
The key to developing personalized medicine is expanding our understanding of how the most basic building blocks of life - genes - influence disease and how patients respond to different medical treatments.
The FDA has taken a huge step towards making personalized medicine a reality by issuing new “guidelines for pharmaceutical companies intended to encourage them to gather and submit information about how genetic variations affect the way people respond to their drugs.” In the long run, giving companies incentives and guidelines for submitting better genetic data on their drugs and potential patient groups will not only help make drugs safer and more effective, it will allow doctors to prescribe drugs with confidence that they are really giving the right drug, to the right patient, at the right dose to treat and cure disease.
NIH Clears Most Researchers In Conflict of Interest Probe
It’s nice to know that the principle of collective punishment is alive and well in the federal government.
“Most of the 100 or so National Institute of Health researchers who the agency has said are under investigation for allegedly engaging in secret deals with pharmaceutical companies and biotechnology companies have been cleared by NIH investigators…The unexpected finding that as many as 80 percent of the seeming improprieties were actually the result of errors by government investigators has undermined the rationale behind NIH Director Elias A. Zerhouni’s recent decision to impose severe restrictions on the personal activities and finances of all of the agency’s more than 5,000 employees.” [Ed: emphasis added]
The draconian conflict of interest rules instituted by Director Zerhouni only took effect on February 3 but are already facing withering criticism - criticism sure to increase now that the vast majority of supposed improprieties have been shown to be the result of harmless government errors.
This raises the question of why the rules were put into place even before the NIH had finished its internal investigation. The obvious answer - that the NIH was cowed by Congressional grandstanding - is hardly reassuring for an institution that is supposed to be the nation’s leading repository of scientific research. The rules should be prudently scaled back before the witch hunt for industry collusion spurs a full fledged exodus of the NIH’s best staffers.
Poll: Most Want U.S. Price Limits on Drugs
According to a poll taken by the Kaiser Family Foundation, “78 percent of adults say prescription drugs make a ‘big difference’ in people’s lives, and 91 percent believe drug companies contribute significantly to society by researching and developing new drugs.”
Nonetheless, 70 percent of respondents think drug companies are more concerned with profits than developing new drugs, and 65 percent want price controls or legislation that would allow large scale importation from Canada (73 percent).
How can we reconcile these seemingly contradictory findings?
First we have to remember that, unlike hospital care or visits to doctor’s offices, prescription drug coverage is the single largest out-of-pocket health care cost for most Americans. The relative prices of those other forms of care dwarf that of prescription drugs, but since consumers don’t pay their own hospital bills, they don’t become irritated with hospitals in the abstract.
Second, thanks to our third-party payer system, patients have come to think of health care as a right, something that ought to be free. Most health care costs are hidden from consumers. The pharmaceutical companies may seem unbearably greedy and heartless compared to a family doctor who may have just socked your insurer $500 or more for a 15 minute check up.
Dollar for dollar, pharmaceuticals are among the most cost-effective forms of medical treatment available. Their share of total U.S. health care spending has remained relatively stable (11.8% in 1960; 10.8% in 2000).
As long as there is a gap between how we insure pharmaceuticals vs. other forms of health care, pharmaceutical companies will bear undue stigma, although, in reality, they deserve much more praise than blame.
10 Voters on Panel Backing Pain Pills Had Industry Ties
There are always things about which people are going to disagree - and the right balance between safety and risk at the FDA is one of those things. Impugning the motives, knowledge and professionalism of one half of those people serves no good purpose.
Preventing conflicts of interest is one thing; impugning the integrity of anyone who has ever had a relationship with industry is something else altogether. The Times points out that “ten of the 32 government drug advisors who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs’ makers, according to disclosures in medical journals and other public records.”
The Times goes on to note that “if the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx’s return. The votes of the 10 did not substantially influence the committee’s decision on Celebrex because only one committee member voted that Celebrex should be withdrawn.”
All of the advisors reached by the Times said that their past relationships with drug companies didn’t influence their votes.
Does having a former business relationship impugn the scientific conclusions of the board or the quality of the evidence presented? Isn’t it equally possible that the scientists who had done the most research on these drugs (or the most work on industry projects) might have the best knowledge of their risks and/or benefits? Should we enforce a rule that no one who has worked with industry - or is ever likely to work for industry - should serve an FDA advisory board?
That would preclude either industry or the FDA having access to the best talent available with enormous negative consequences to both groups.
It would also disqualify surgeons from serving on panels investigating the efficacy of surgical procedures, teachers from examining the efficacy of educational programs, and lawyers drawing up ethical standards for lawyers.
One panel member, a neurologist at the University of Pennsylvania, who has “received research support from Pfizer” summed up the point nicely: “I think F.D.A. would have a hard time finding people who are good at what they do who never spoke to a pharmaceutical company.”
This is not to say that conflicts of interest aren’t possible - or that the Times doesn’t have a responsibility to keep the FDA honest. To the contrary. Go find the best scientists who didn’t serve on the panel and ask them to comment on the boards scientific decision. Speak to patients who’ve used the drugs. Review the history of FDA’s rulings on the medicines. All this seems like good reporting, and very much fair game.
But suggesting that the FDA’s advisory system can’t work adequately unless FDA advisors are isolated from industry would bring drug development to a crawl and hurt the very people that everyone is trying to help - the patients.
FDA Drug Approval Times Likely to Grow
“The withdrawal of a multiple sclerosis treatment [Tysabri] is likely to lead to even longer product approval times for pharmaceutical companies as pressure mounts on the Food and Drug Administration to improve drug safety, experts say.”
Said one investment analyst: “I think we are in for a dramatic slowdown in the approval process as the FDA wants to see more extensive trials and data.”
The slowdown won’t come as the result of an official mandate - that would be too obvious. Drug reviewers will just keep pushing for more and more safety data and/or additional clinical trials. “If you are a reviewer on the fence wondering whether you should ask for more data, this environment will push you to ask for that data…I think there will be more risk averse decision making.”
Already, the “average time to win FDA approval for a new drug already has risen to about 17 months from 12.6 months in 1999, according to data from the Pharmaceutical Research and Manufacturers of America.” Will this increase in time lead to an increase in safety for patients?
Reason dictates that at a certain point the FDA reaches the margin of diminishing returns, and that additional research has little, if any, real benefits for safety and ever increasing costs to patients - who wait longer for new treatments.
But an extra five or six months of research has real benefits for bureaucrats who may eventually be called to testify before Congress - and that’s what the FDA is worried about right now.
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