Instant Recall
gottlieb, scoff
"INSTANT RECALL" BY SCOTT GOTTLIEB, M.D. nervous patients called their doctors after recently hearing news that Baycol, a cholesterol-lowering drug used by 700,000 Americans, was being pulled off the...
...An increasing number of recalls is sta:istically inevitable...
...And even if a drug company could afford trials large enough to uncover risks so statistically remote, it would not be practical to recruit enough eligible patients...
...Pharmacogenomics, as this wonderful new science is called, can be used today to bolster postmarketing surveil lance...
...A better approach is to place limits on what government does with the information it collects...
...These snips contain the genetic variations that determine everything from the color of one's hair to whether a drug will trigger horrendous side effects.They provide doctors with a quick and accurate way to scan your genes for crucial differences...
...In 2001, new molecular entitiesNMEs, drugs with ingredients never before marketed in the U.S.-spent an average of 18.5 months being reviewed by regulators before approval.That compares with an average of 11.6 months in 1999...
...So what can the FDA do, if even the best doctors and exhaustive clinical trials can't be relied upon to uncover rare but recall-prompting side effects...
...Drugs have obviated the need for costly surgeries, given us hair back, made our allergies go away and our sex lives return...
...Tampa police have acknowledged that their much ballyhooed facial recognition system, made by Visionics and launched in June, has failed to identify a single suspect and was taken o f active use in August...
...So the FDA regulators believe they themselves must become more vigilant...
...This has combined with the advent of better drug discovery technology and powerful new computational tools on the desktop...
...In fact, the bark of today's surveillance technologies may be worse than its bite...
...Scientists are learning how to read your genes to tell if you'll suffer a bad reaction before you pop a pill...
...The analgesic bromfenac resulted in four r QS VORDS Q(AD;MY Purposed to develop and strengthen young \ men morally, physically, and intellectually...
...Biotechnology firms, more so than pharmaceutical giants, are especially vulnerable to delays...
...The FDA's critics cite these recalls as evidence that pressure from the pharmaceutical industry has accelerated the drug review process to the point of endangering public health...
...drug regulators have responded by hitting the brakes, taking longer to approve new drugs, and forcing drug makers to reset Wall Street's earnings expectations...
...Happily, a new technology can mitigate their effects-pharmacogenomics...
...Interested parties contact Light of Day Films, LLC 1718) 422-0347 0 0 0 O JANUARY/FEBRUARY 2002 • THE AMERICAN SPECTATOR 25 ~'AI IjERS (ANGER- TONJ1 ;-, THEGREAT H£ALTH,eSTRfNlT'H 4 6P'r ,r: deaths and eight liver transplants among 2.5 million treated patients...
...In effect, genetic information can be transduced into bits and bytes and follow you around like a personal bar code, ready to be scanned each time you're offered a new drug or battery of medical treatments...
...At particular issue is post-marketing surveillance, the so-called Phase 4 of clinical trials.This is where FDA regulators rely on doctors to spot and report rare but serious side effects caused by newly approved drugs.The problem: FDA officials charge doctors have done a miserable job, and can no longer be relied upon...
...The number of new compounds approved annually more than doubled during the l 990s, from an average of 20 prod Dr Scott Gottlieh is a physician at ~11oirnt Siuai Hospital in Nenehiirk anti editor of the Gilder Biotech Report...
...The old assumption of 12 months to 15 months for approval is being stretched out to as long as a year and a half...
...But more people taking more new pills also results in more adverse reactions, a statistical inevitability and one more bittersweet fact of medical progress...
...ervous patients called their doctors after recently hearing news that Baycol, a cholesterol-lowering drug used by 700,000 Americans, was being pulled off the market because of questions about its safety...
...Part of the answer lies in how we deal with issues raised by increased use of new digital surveillance technologies...
...More money plus better science equals more new drugs...
...The big drug companies have been flush with cash for research and development since the launch of several highly profitable drug classes starting in the slid-1980s...
...Rare but recall-prompting side effects are the inevitable result of market progress, making the drug manufacturers ironic victims of their own success...
...The biotechnology industry is already developing the infrastructure to do this, even as the FDA stands on the sidelines, failing to even issue guidelines outlining how a company might receive an approval based on pharmacogenomics...
...Most drugs work by interacting with proteins-receptors, enzymes and cell-signaling mechanisms...
...Some oppose any increased deployment...
...But powered by Moore's lawthe relentless march of computer processing power-and by everspreading high-speed data net 26 THE AMERICAN SPECTATOR • JANUARY/FEBRUARY 2002...
...All the thousands of patients prescribed a new medication could have blood spots taken and stored in an approved location...
...Several airports, including Boston, Fresno and Palm Beach, are deploying similar systems, and it is widely expected their use will spread further...
...The stock prices of companies that make such systems-Viisage andVisionics are the industry leaders-have more tripled since September 11...
...These variations can be read right from your DNA...
...Healthcare economists cite many reasons for the outpouring...
...Over the years, it's been shown that these proteins in individual patients contain genetic variations that can affect response to drugs...
...Drugs on a special "sit-month" fast-track for critical new medicines now take 9 months or more to be approved...
...Will the republic survive having its big picture views coming out of this small screen...
...acts at the beginning of the decade to 40 in 2000...
...Like computer code, it takes thousands, even millions of different chemical signals-so-called base pairs-to make up each of the 40,000 genes distributed among the chromosomes...
...When one of these signals is out of sequence, it is called a single nucleotide polymorphism or "snip...
...It's the most recent in a series of embarrassing drug withdrawals, 14 in all since 1997, each the result of safety concerns that cropped up after the drugs were approved by the FDA...
...COLLEGE LEVEL SUMMER ACADEMY Shawnee, Oklahoma June 16 - July 27, 2002 Apply to CrossRoads Academy on the world wide web at www.crossroadsacademics.org I veritas victus vocare vigere victor or telephone 785.827.5489 I FEATURE FILM Back Indiana Jones' fight against media bias...
...PAR KERS GINGER TON ICc n Pd L *R DETECTIVES BY JEFFREY A. EISENACH Will American civil liberties be a victim of the war on terrorism...
...It is linked to 31 deaths in the US and at least nine abroad...
...We never lose our sense of humor, but we're talking serious business here...
...More and better drugs, in wider use, are propelling pharmaceutical companies to record profits, but also exposing them to risks that jeopardize their business...
...INSTANT RECALL NBY SCOTT GOTTLIEB, M.D...
...Such an incidence could not have been detected in the product's standard clinical trial of 2,500 patients...
...A rising number of rare side effects are indeed inevitable, as more new drugs with narrow indications are administered to heterogeneous populations far larger and sicker than any reasonable clinical trial can replicate...
...The Virginia Beach City Council's vote in November to approve the use of facial-recognition technology in high-crime areas is only one example of the post-9/11 expansion of high-tech surveillance...
...Whenever serious adverse events are documented and characterized, DNA from patients who experienced the problem could be extracted and compared with DNA from control patients who received the drug and did just fine...
...But recalls occur in direct proportion to the number of new drugs approved and launched...
...This would enable the creation of "snip" profiles that could then be used to screen those most at risk from being prescribed the new medication...
...For all the actuarial certainty of more recalls, this classic expression of the law of averages provides little comfort to FDA critics, who dwell on the (undoubted) human suffering associated with every recall...
...This time around, Baycol was believed to cause a rare side effect resulting in destruction of muscle...
...Companies such as Ardais, Genomics Collaborative (GCI), IMPATH, and LifeSpan Biosciences have sprung up for the sole purpose of banking tissue samples and correlating them with information about the patients they come from...
...Jeffrey A. Eisenacli is president of the Progress & Freedom Foutindation, a tednwlogy focused think tank iii Waslhington, D. C. WATCHING THE lYorde ~fu~ cu res , F R~eamai ~smKerrusnrss MD KioPcr COMPL wr KWEnAOE...
Vol. 35 • January 2002 • No. 1
