No News Is Bad News
Gottlieb, Scott
"No News Is Bad News" Dr. Scott Gottlieb is a physician at Mount Sinai Hospital in New York and editor of the Gilder Biotech Report. that conducted the trials to nasty criticism....
...2 MAY/JUNE 2002 • THE AMERICAN SPECTATOR 25...
...Be heartened by their concern...
...But there's another reason you shouldn't hold your breath waiting for Big Pharma to approve the rapid release of any of this information...
...Of course, the drug industry is reflexively against releasing more information, especially given the FDA's poor track record of knowing what to redact to protect truly proprietary information...
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...The FDA responded to the outcry by offering to allow public disclosure of all the product and patient safety data from new drug applications, plus all the updates companies are required to submit to the FDA during ongoing clinical trials-but only for gene therapy...
...J n 1999, doctors at the University of Pennsylvania injected 18year-old Jesse Gelsinger with an experimental gene therapy as part of an FDA-approved clinical trial...
...Reporters found some fine print in one of the filing documents that wasn't included in the informed-consent agreements patients signed...
...Every day, information is routinely withheld from thousands of patients participating in clinical trials...
...But companies can and should bring their own lawyers to the task, steering the FDA to which sections should be redacted...
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...Clearly, the intellectual property contained in these filings deserves strong protections, and the FDA could black out methodologies and trade secrets while releasing pertinent bottom-line results...
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...Minimalist disclosure also invites the media to demonize medical centers and researchers with "gotcha" stories that sensationalize every bad outcome...
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...Information is the currency of sound medical care and efficient capital markets...
...Doctors and patients, especially, should not have to rely on documents leaked to the financial press, as they routinely are...
...Information drives investment and medical decision-making alike...
...The experimental gene therapy that killed him was aimed at correcting the rare disorder disabling his liver...
...The answer is no...
...BODY, AND ALL...
...No matter how long the informed consent forms that patients sign before they enter a clinical trial (they're now routinely 100 pages), reporters can always dig something up that companies didn't disclose in advance...
...In the case of ImClone, a competitor such as OSI Pharmaceuticals-which is developing Tarceva, an experimental drug similar to ImClone's Erbitux-might have been able to re-target their drug toward colon cancer, the same use ImClone was after...
...The last thing we want are millions of people just like yourselves wandering around, bewildered by knowledge...
...why it takes the FDA 18 months to come to the same conclusions they made the day the documents were first submitted...
...Gene treatments, the FDA insisted, posed unique public health risks...
...On its face, the ImClone debacle may be a case of defrauding Wall Street, but it also points to an antiquated honor system protected by a paternalistic federal agency out of step with the realities of the new medical information age.The FDA's presumption that the average patient is incapable of interpreting clinical trial data ignores a decadelong groundswell of data-driven patient advocacy and the growing popularity of information sources long thought to be intelligible only by doctors...
...Patients suffer because, as it stands now, none of these drugs are likely to be approved for colon cancer anytime soon...
...There is no Sort ft will Not Seal, No Peie it will not Subdue...
...In cases where it has released filing documents, the agency has often goofed and released trade secrets...
...Transparency would also pressure the FDA into speedier reviews...
...Venturesome doctors routinely prescribe drugs for nonapproved, "off label" indications, based on conclusions teased from data sets just like these...
...The current regulatory obfuscation benefits them at the expense of smaller biotech companies, because the information barrier and the ensuing uncertainty keep smaller companies from taking risks in potential markets already "taken...
...Were they told all the FDA knew about the risks and benefits of the treatment...
...But reform was limited to gene therapy trialsthat's where the political heat was...
...Enron insiders were able to conceal their magical transactions behind the guise of an annual accounting audit...
...Clearly, greater transparency is in order-in ImClone, in Enron and in every case where consumers and investors are deceived by rules that allow companies to hide pertinent information in perpetuity...
...S NO NEWS IS BAD NEWS IT'S TIME TO OPEN UP THE FDA BY SCOTT GOTTLIEB, M.D...
...Hurd's books and subscriptions to The Living Resources Nelswtleller are available at www.DrHurd.com Grow Up America...
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...Jesse Gelsinger's death prompted minimal reform...
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...This includes particularly the mainstream medical journals, which now have substantial readerships among a motivated lay public-their fastestgrowing circulation segment...
...Call 800-358-35117 ext...
...The refrain from the industry, echoed by the FDA, is that more information turns out to be less information because it only confuses ordinary people...
...On the strength of promising early reports, ImClone's market capitalization rose to $5.5 billion, and drug giant Bristol Myers paid $2 billion for a stake...
...In the case of ImClone, troubles disappeared behind bizarre FDA rules that allow companies to bury most of their raw results...
...It's not at all clear that the information would have helped Jesse Gelsinger make a different decision...
...And in the end, even this modest proposal was struck down...
...The FDA had hinted all along to ImClone that it might reject the application, but the documents were sealed from view...
...The compound is first tested in healthy volunteers to prove it is safe, then in sick patients to prove it works...
...Better yet, the FDA could release the progress reports that companies conducting FDA-sanctioned clinical trials must file annually...
...Four days later, he died...
...Had doctors, patients and investors been privy to cantankerous communications between ImClone and the FDA, they wouldn't have been surprised when the bottom fell out of ImClone's trials...
...a voice the world needs to hear...
...Doctors, patients and markets could then judge for themselves, without waiting the average 18.5 months it now takes for the FDA to reach its conclusions...
...Read The Daily Dose o f Reason by psychologist and author Michael J. Hurd free--every day-at DrHurd.com Not online...
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...Instead, companies typically take the easy way out, arguing that such information is just too confusing for lay patients or investors-a sure guarantee you ought to know it...
...Finally, companies send the FDA a New Drug Application or Biological License Application (depending on the type of drug), containing everything the company has learned from the trials and asking for permission to go on the market...
...If patients and investors had access to the complete application, with all its facts showing how well a new drug works, they would start wondering PRICE 5.00...
...And it's not only patients and their families who are kept in the darkinvestors are burned as well...
...But one of the few enduring lessons is the role of FDA information-hoardingnot only on patients, but on the financial markets essential to capitalizing live-saving research...
...But the trial promised nothing in the way of a cure for Jesse Gelsinger-its goal was to test the safety of the treatment for use in infants...
...The medical data are sealed up at the Food and Drug Administration, in the voluminous applications that researchers must file before gaining approval to conduct clinical trials like these or to market new drugs...
...Most investors never saw it coming...
...Look no further than the celebrated case of the Fred Hutchinson Cancer Institute, the subject of a stinging series of articles published in the Seattle Timnes after a Nobel Prize winner was accused of not adequately informing patients about the risks in a clinical trial...
...Patient advocacy groups protested...
...In the recent case of ImClone, the markets were stunned when the FDA refused even to consider an application by that company to market its new drug Erbitux, one of a new class of highly anticipated anti-cancer treatments called epidermal growth factor inhibitors...
...Right now, after a new compound has been identified in the laboratory, drug companies file what's called an investigational new drug application, asking the FDA for permission to begin clinical trials...
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...Government rules should enforce greater transparency, not enable information bottlenecks...
...Had Gelsinger or his family been given informed consent to what turned out to be a deadly human experiment...
...Transparency stops bad stories before they startand the law suits from patients every time a clinical trial doesn't work...
...If there were more transparency in each phase of the clinical trials process, smaller companies with similar drugs would be able to adjust their own trials to take advantage of what they could glean from the strengths and weaknesses of competing compounds...
...Here's a modest proposal: The FDA should release information at each stage in the approval process, from initial filing through the safety and efficacy phases of actual clinical trials...
...But it certainly opened the center 24 THE AMERICAN SPECTATOR • MAY/JUNE 2002 HAIff LAW'S WIZARD OIL TEE GREAT XEDICAL WONDER...
...There are many interpretations of what went wrong with ImClone...
...And shockingly, there is nothing unusual about that...
Vol. 35 • May 2002 • No. 3
