Guest guest Posted February 5, 2009 Report Share Posted February 5, 2009 ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountabilityhttp://www.ahrp.org and http://ahrp.blogspot.com FYIIn an interview on NBC Today show, Feb 2, 2009, President Obama indicatedthat he is ordering a "complete review" of the Food and Drug Administrationafter it failed to detect shipments of salmonella-contaminated peanutproducts that have sickened more than 500 people and may be linked to asmany as eight deaths."At a bare minimum, we should be able to count on our government keeping ourkids safe when they eat peanut butter," the president said."That's what Sasha eats for lunch," President Obama said, referring to his7-year-old daughter. "Probably three times a week. I don't want to worryabout whether she's going to get sick as a consequence of eating her lunch."Beyond food processing--which is of vital importance--the following FDApolicies and processes need an independent thorough assessment, followed bythe appointment of a new leadership to implement much needed reforms:1. FDA's hasty reversal of a regulatory prohibition against off-labelpromotion of prescription drugs. This change, widely seen as a gift to the pharmaceutical industry, wasauthorized during the last days of the Bush Administration. To appreciate the $$ value of FDA's "gift" to industry one need only look atthe costs companies absorb in legal fees, civil liability, coupled withcriminal suits by the Department of Justice--for off-label promotion. Just this month, Eli Lilly pled guilty to criminal marketing of Zyprexa foroff-label uses, settling for $1.4 billion. The FDA stood idly by as Lillyembarked on a Zyprexa marketing blitz --"Viva Zyprexa"-- misleadingphysicians and the public with false claims about its efficacy and safety.http://blogs.wsj.com/health/2009/01/15/justice-department-beats-chest-over-zyprexa-settlement/ Similar suits against Pfizer for off-label marketing of Bextra and Celebrexwill cost the company $2.3 billion.http://blogs.wsj.com/health/2009/01/26/pfizer-takes-23-billion-charge-linked-to-bextra-probe/ 2. The FDA has failed to carry out due diligence--as mandated by law--toprotect the public from unsafe drugs and medical devices. Federal lawrequires manufacturers to prove safety and effectiveness "with substantialevidence through the conduct of well controlled trials" before marketinglicensure is granted. Furthermore, FDA's mission requires the agency to help"the public get the accurate, science-based information they need to usemedicines and foods to improve their health."FDA officials fail to implement federal law. FDA has been severely criticized for its minimal post-marketing drug safetyassessment coupled with minimal inspections of manufacturing plants. FDA'sfailures are measurable in the number of patients being harmed by defectiveor inadequately tested drugs and devices. Most are approved without labelwarnings. Below, three current case examples encapsulate a failed regulatoryenvironment under the current FDA administration that has led to theperversion of "evidence-based medicine." They provide but a glimpse into thetip of a hidden iceberg. The truth is, Americans can no longer rely on thesafety of drugs their doctor prescribes because the FDA has given marketingapproval to both patented and generic prescription drugs that are shown toincrease the risk of death. 3. FDA's hands-off policy--its failure to intervene when companies makefalse claims about a drug's safety and efficacy-- allows medical practice tobe dictated by manufacturers' business interests-even if they underminepublic health. That hands-off policy costs the American taxpayer billionsof dollars not only for ineffective drugs, but the high cost of treatmentsto counteract drug-induced chronic diseases. In part, FDA's failure to monitor serious adverse drug event reports stemsfrom an inherent conflict of interest within the agency. Officials of the Center for Drug Evaluation and Research (CDER) whorecommended a drug's approval for marketing are invested in NOTacknowledging they erred, even when the drug-related injuries and deathsmount. CDER officials wear both hats while the drug safety officers arerelegated to the sidelines.4. Conflicts of interest introduce biased safety / efficacy analyses andbiased claimed findings.FDA's drug evaluation process has led to the approval of unsafe, ineffectivedrugs on the basis of scientifically flawed trials. The latest is a report by The Office of Inspector General (Jan. 2009) whichfound: "the Food and Drug Administration does almost nothing to police thefinancial conflicts of doctors who conduct clinical trials of drugs andmedical devices in human subjects." Furthermore, the investigators say,"agency officials told them that trying to protect patients from suchconflicts was not worth the effort."http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf In January 2009, The New York Times reported that internal documents confirmthat FDA's approval process has been corrupted by political influencepeddling. http://www.nytimes.com/2009/01/13/health/policy/13fda.html5. FDA's preemption position, adopted during the Bush Administration, is aradical departure from FDA's longstanding policy--and should be rejected.By invoking the argument of preemption, manufacturers are shielded fromproduct liability suits--no matter what the defect. That policy not onlyprevents citizens from seeking just compensation for harm caused bydefective drugs and devices, but the policy encourages manufacturers to cutcorners, sacrificing safety for increased profits.Fairness and justice aside, the body of evidence documenting FDA'sdemonstrable incapacity to protect the public from unsafe drugs and devicesspeaks for itself. No reasonable argument can be made to claim that FDAapproval is sufficient to warrant preemption of all state product safetylaws.THREE CURRENT EXAMPLES encapsulate a failed regulatory environment. FDAofficials do little to ensure drug safety by failing to implement federallaw requiring manufacturers to prove safety and effectiveness "withsubstantial evidence through the conduct of well controlled trials" beforemarketing licensure is granted. Instead, FDA officials rationalize and bends over backwards to approve drugswhose manufacturers have not proven safety and effectiveness. 1. After years of controversy, the FDA has finally called upon Eli Lilly toconduct safety trials for its controversial drug, Xigris, for the treatmentof sepsis. http://www.fda.gov/medwatch/safety/2009/safety09.htm#Xigris FDA approved the drug despite a split vote (10 to 10) of the advisorycommittee, due to concerns about the validity of the claimed efficacy andsafety findings. http://www.fda.gov/ohrms/dockets/ac/01/minutes/3797m1.pdfFDA's current hands-off policy has led companies to disseminate dubiousmarketing claims under the mantle of "science-based" authority in practiceguidelines: Indeed, clinical guidelines for the treatment of sepsis were orchestrated asan extension of Eli Lilly's "Surviving Sepsis" marketing campaign. WhereasLilly proclaimed: "Xigris offers safe and effective treatment so moresurvive." FDA officials knew that the scientific evidence shows the oppositeto be true.See: Vioxx Redux - FDA on Sidelines as Marketing Subsumes Evidence:Surviving Sepsis (NEJM)http://ahrp.blogspot.com/2006/10/vioxx-redux-fda-on-sidelines-as.htmlThe latest study, published in the current issue of Critical Care Medicine,confirmed that patients prescribed Xigris have an increased risk of death.[1] 2. The FDA has been negligent when it failed to inform physicians and thepublic--in some cases for decades--about the suicide risk linked to numerousprescribed drugs--including drugs prescribed for non-psychiatric conditions.These include: - Singulair (prescribed for asthma) - SSRI antidepressants(including Paxil, Prozac, Zoloft, Effexor, Cymbalta) - Chantix (prescribedfor smoking cessation) - Tamiflu (anti-flu) - Accutane (prescribed for acne)- Epilepsy drugs (including carbamazepine, gabapentin, felbamate,lamotrigine, levetiracetam, oxcarbazepine, pregabalin and valproate) FDA officials have consistently downplayed the risks when independentanalysts who examined FDA's MedWatch database, reported a significantsuicide risk. For example, FDA's latest Drug Safety Newsletter comparesreports of suicidality for Chantix and Zyban / Wellbutrin prescribed againstsmoking.http://www.fda.gov/cder/dsn/2009_v2_no1/DSN_Vol2Num1.pdfFDA's presentation of the data would suggest the risk for Chantix is roughlydouble the risk for Zyban:--153 reported cases of suicidality for Chantix, of which 37 were suicidescompared to -75 reported cases of suicidality for Zyban, of which 29 werecompleted suicidesHowever, that is a distortion: The FDA compared suicide reports for bothdrugs since FDA approval for smoking cessation.Zyban was approved in May 1997--it's been on the market for 120 months (10years).Chantix was approved in May 2006--it's been on the market for just 17months. A fair comparison would be to compare the first 17 months of Zyban with thefirst 17 months for Chantix.The data shows that Chantix, with 37 reported SUICIDES in just 17 monthsposes a risk, perhaps 14 times greater than Zyban with 29 SUICIDES in 10yearsFurthermore, Chantix could be even worse. Zyban / Wellbutrin carries a black box warning about suicidalbehavior--Chantix does not. Zyban is mostly used to treat depression, only afraction of its use is as an aid to smoking cessation. The FDA didn't saywhether it excluded suicidality reports where the drug was indicated fordepression.3. The number of defective generic drugs has reached critical proportions:In Sept. 2008, the FDA sent a warning letter to the Indian generic druggiant Ranbaxy about its shoddy production of some 26 widely used drugs inAmerica. The list of drugs produced at two Ranbaxy plants and subject to FDA'swarning contains 26 drugs, including low-cost versions of such mainstays aspravastatin and simvastatin (commercially known as Pravachol and Zocor, usedto lower cholesterol), metformin and glimeperide (for diabetes), acyclovirand ciprofloxacin (an antiviral and antibiotic medication) and gabapentin(known as Neurontin and used for epilepsy and some psychiatric conditions).However, "the FDA says it has found no evidence that consumers have beenharmed by shoddy production standards that were observed in manufacturingthese generics at two plants in India. It's not issuing a recall, and urgespatients who take these medications to continue to take them rather thanstop without a doctor's recommendation, which could be dangerous."http://latimesblogs.latimes.com/booster_shots/2008/09/fda-issues-warn.htmlToday, a massive recall by generic manufacturer, Ethex, was issued for over60 generic drug products at the wholesale level: http://www.ethex.com/news/pdf/recall_020309.pdfhttp://www.ethex.com/news/pdf/recall_wholesale.pdfThe FDA advisory recommended "Patients who may have these medicines in theirpossession should continue to take them in accordance with theirprescriptions, as the risk of suddenly stopping needed medication may placepatients at risk. Patients should contact their physician or healthcareprovider if they have experienced any problems that may be related to takingor using these products..." If the drugs a defective what is the rationalefor recommending continued use? Wouldn't patients be better served by adviceto see their doctor at once?An exasperated physician emailed us this morning: "Our hospital has loads oftheir drugs on the shelves....When will the government say enough is enoughand really monitor this stuff and deal with things like this at an earlierstage?"Reference:Chris A. Gentry, PharmD; Kristin Busse Gross, PharmD; Bhanu Sud, MD; DouglasA. Drevets, MD Adverse outcomes associated with the use of drotrecogin alfa(activated) in patients with severe sepsis and baseline bleedingprecautions, Critical Care Medicine. 37(1):327-329, January 2009.Contact: Vera Hassner Sharavveracare212-595-8974http://pharmalittle.blogspot.com/2009/02/obama-congress-may-reverse-liberalized.html Sunday, February 1, 2009OBAMA, CONGRESS MAY REVERSE "LIBERALIZED" OFF-LABEL GUIDELINES Good-bye to the Good-bye PresentsAs most here will know, as part of their final act, the political appointeesand (most likely) some of the FDA career staff declared a change inguidelines for off-label promotion of drugs. The core of the new guidelinesis that FDA would not require prior review of the off-label promotionalmaterials when they were used for marketing to docs. The text about"peer-reviewed journals" remained.As is conventional, those proffering the guidelines said that this was onlyformalizing what was already policy. Those not inclined to agree describedthe change as one more last-ditch attempt to save the world for off-labelpromotion. Given that the past few weeks have seen the largest busts foroff-label promotion in history - both Lilly/Zyprexa and Pfizer/Bextra - addsa little irony to the development.The Fort Worth Star Telegram reports that both the administration and keymembers of Congress - particular Senator Grassley and Representative Waxman- will act to reverse the guidelines.Dare I ask: Opinions out there? http://www.star-telegram.com/health/story/1177352.htmlTuesday, Feb 3, 2009 Obama may look at FDA's new guidelines on off-label drug marketing By CHRIS ADAMS McClatchy Newspapers CORNELIUS, N.C. - In the waning days of the Bush administration, theFood and Drug Administration finalized new guidelines to make it easier fordrug manufacturers to promote "off-label" prescription drug uses, which canbe deadly. The move came despite criticism from then-President George W. Bush'sDepartment of Veterans Affairs, which said the change "favors businessinterests over public safety" and could lead to a "decline in drug safety."It was also crafted despite efforts by state and federal law enforcementexperts to clamp down on off-label drug marketing. The new guidelines were issued four years after Robin Briggs ofCornelius, N.C., buried her husband, Doug, who committed suicide on a chillyChristmas Day after taking a drug off-label. Doug Briggs, a physician, took the epilepsy drug Neurontin for hispersistent back pain. It didn't do much for his back, but Robin Briggs saidthe drug changed his demeanor and led to his death. Federal officials have since told Pfizer and other makers ofanti-epilepsy drugs to add suicide-risk warnings to their drugs' packaginglabels. Robin Briggs sued Pfizer and the maker of a generic version of thedrug. The case is pending. As the Obama administration reviews all the rules that the departingBush administration issued, it will have to decide whether to try to modifyor reverse this last-minute change in the FDA's oversight of off-label drugmarketing. Congressional leaders from both parties criticized the guidelinewhen it was proposed last year. Sen. Charles Grassley, an Iowa Republicanwho has repeatedly investigated the FDA, said he had serious concerns aboutthe proposal, which he said would deem appropriate something that "the FDAonce considered evidence of unlawful marketing." "A legislative fix may be in order," Grassley said Thursday. In the House of Representatives, Rep. Henry Waxman, D-Calif., calledthe guideline a "long-coveted parting gift" for the pharmaceutical industrythat "fundamentally undermines" the FDA's authority. The use of drugs "off-label" - for reasons the FDA hasn't approved -has long been tolerated and sometimes encouraged. It can be helpful forcertain ailments. But the practice can also be dangerous. Nearly every drug has sideeffects, some of them serious. Those risks can be worth the potentialbenefit that comes with an FDA-approved, on-label use. With an off-labeluse, however, the risks remain but the benefits are far less certain. While it's legal for physicians to prescribe drugs off-label - oftenbased on their reading of the latest medical research - it's illegal fordrugmakers to push such uses. Over the past five years, federal prosecutors and state attorneysgeneral have brought more than a dozen cases against drugmakers foroff-label marketing and won more than $6 billion in criminal and civilsettlements, according to the Government Accountability Office and theDepartment of Justice. In January, two of the nation's largest drugmakers, Pfizer and EliLilly and Co., said they'd agreed to two of the biggest off-labelsettlements ever. "The FDA has been abysmal policing this area," said ConnecticutAttorney General Richard Blumenthal, who helped engineer a major off-labelcase against drugmaker Cephalon. "One reason the states have been more andmore active is that the federal government has been asleep at the switch." In its final week, the Bush administration opened the door to someoff-label marketing. In what's called a "guidance" document, the FDAspecified how drug companies could hand out medical journal articles thathighlight potential off-label drug uses. The guidance was complicated, and the main players in the issuestill disagree about what it means for FDA oversight of off-label marketing.FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 5, 2009 Report Share Posted February 5, 2009 If Obama can dismantle the FDA I will personally declare him the most courageous pres of my long lifetime. His presidency will be declared a success no matter how many errors in judgement he makes on other subjects.--- On Wed, 2/4/09, Viviane Lerner <vivlerner wrote: Viviane Lerner <vivlerner Fwd: Obama Calls for FDA Review: Issues That He Should Consider Examining"HEALTH & HEALING" Cc: "ALTERNET" <joshua.holland, "PROGRESSIVE REVIEW" <newsWednesday, February 4, 2009, 7:05 PM ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp. org and http://ahrp. blogspot. com FYI In an interview on NBC Today show, Feb 2, 2009, President Obama indicated that he is ordering a "complete review" of the Food and Drug Administration after it failed to detect shipments of salmonella-contamin ated peanut products that have sickened more than 500 people and may be linked to as many as eight deaths. "At a bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter," the president said. "That's what Sasha eats for lunch," President Obama said, referring to his 7-year-old daughter. "Probably three times a week. I don't want to worry about whether she's going to get sick as a consequence of eating her lunch." Beyond food processing-- which is of vital importance-- the following FDA policies and processes need an independent thorough assessment, followed by the appointment of a new leadership to implement much needed reforms: 1. FDA's hasty reversal of a regulatory prohibition against off-label promotion of prescription drugs. This change, widely seen as a gift to the pharmaceutical industry, was authorized during the last days of the Bush Administration. To appreciate the $$ value of FDA's "gift" to industry one need only look at the costs companies absorb in legal fees, civil liability, coupled with criminal suits by the Department of Justice--for off-label promotion. Just this month, Eli Lilly pled guilty to criminal marketing of Zyprexa for off-label uses, settling for $1.4 billion. The FDA stood idly by as Lilly embarked on a Zyprexa marketing blitz --"Viva Zyprexa"-- misleading physicians and the public with false claims about its efficacy and safety. http://blogs. wsj.com/health/ 2009/01/15/ justice-departme nt-beats- chest-over- z yprexa-settlement/ Similar suits against Pfizer for off-label marketing of Bextra and Celebrex will cost the company $2.3 billion. http://blogs. wsj.com/health/ 2009/01/26/ pfizer-takes- 23-billion- charge-linked -to-bextra-probe/ 2. The FDA has failed to carry out due diligence--as mandated by law--to protect the public from unsafe drugs and medical devices. Federal law requires manufacturers to prove safety and effectiveness "with substantial evidence through the conduct of well controlled trials" before marketing licensure is granted. Furthermore, FDA's mission requires the agency to help "the public get the accurate, science-based information they need to use medicines and foods to improve their health." FDA officials fail to implement federal law. FDA has been severely criticized for its minimal post-marketing drug safety assessment coupled with minimal inspections of manufacturing plants. FDA's failures are measurable in the number of patients being harmed by defective or inadequately tested drugs and devices. Most are approved without label warnings. Below, three current case examples encapsulate a failed regulatory environment under the current FDA administration that has led to the perversion of "evidence-based medicine." They provide but a glimpse into the tip of a hidden iceberg. The truth is, Americans can no longer rely on the safety of drugs their doctor prescribes because the FDA has given marketing approval to both patented and generic prescription drugs that are shown to increase the risk of death. 3. FDA's hands-off policy--its failure to intervene when companies make false claims about a drug's safety and efficacy-- allows medical practice to be dictated by manufacturers' business interests-even if they undermine public health. That hands-off policy costs the American taxpayer billions of dollars not only for ineffective drugs, but the high cost of treatments to counteract drug-induced chronic diseases. In part, FDA's failure to monitor serious adverse drug event reports stems from an inherent conflict of interest within the agency. Officials of the Center for Drug Evaluation and Research (CDER) who recommended a drug's approval for marketing are invested in NOT acknowledging they erred, even when the drug-related injuries and deaths mount. CDER officials wear both hats while the drug safety officers are relegated to the sidelines. 4. Conflicts of interest introduce biased safety / efficacy analyses and biased claimed findings. FDA's drug evaluation process has led to the approval of unsafe, ineffective drugs on the basis of scientifically flawed trials. The latest is a report by The Office of Inspector General (Jan. 2009) which found: "the Food and Drug Administration does almost nothing to police the financial conflicts of doctors who conduct clinical trials of drugs and medical devices in human subjects." Furthermore, the investigators say, "agency officials told them that trying to protect patients from such conflicts was not worth the effort." http://www.oig. hhs.gov/oei/ reports/oei- 05-07-00730. pdf In January 2009, The New York Times reported that internal documents confirm that FDA's approval process has been corrupted by political influence peddling. http://www.nytimes. com/2009/ 01/13/health/ policy/13fda. html 5. FDA's preemption position, adopted during the Bush Administration, is a radical departure from FDA's longstanding policy--and should be rejected. By invoking the argument of preemption, manufacturers are shielded from product liability suits--no matter what the defect. That policy not only prevents citizens from seeking just compensation for harm caused by defective drugs and devices, but the policy encourages manufacturers to cut corners, sacrificing safety for increased profits. Fairness and justice aside, the body of evidence documenting FDA's demonstrable incapacity to protect the public from unsafe drugs and devices speaks for itself. No reasonable argument can be made to claim that FDA approval is sufficient to warrant preemption of all state product safety laws. THREE CURRENT EXAMPLES encapsulate a failed regulatory environment. FDA officials do little to ensure drug safety by failing to implement federal law requiring manufacturers to prove safety and effectiveness "with substantial evidence through the conduct of well controlled trials" before marketing licensure is granted. Instead, FDA officials rationalize and bends over backwards to approve drugs whose manufacturers have not proven safety and effectiveness. 1. After years of controversy, the FDA has finally called upon Eli Lilly to conduct safety trials for its controversial drug, Xigris, for the treatment of sepsis. http://www.fda. gov/medwatch/ safety/2009/ safety09. htm#Xigris FDA approved the drug despite a split vote (10 to 10) of the advisory committee, due to concerns about the validity of the claimed efficacy and safety findings. http://www.fda. gov/ohrms/ dockets/ac/ 01/minutes/ 3797m1.pdf FDA's current hands-off policy has led companies to disseminate dubious marketing claims under the mantle of "science-based" authority in practice guidelines: Indeed, clinical guidelines for the treatment of sepsis were orchestrated as an extension of Eli Lilly's "Surviving Sepsis" marketing campaign. Whereas Lilly proclaimed: "Xigris offers safe and effective treatment so more survive." FDA officials knew that the scientific evidence shows the opposite to be true. See: Vioxx Redux - FDA on Sidelines as Marketing Subsumes Evidence: Surviving Sepsis (NEJM) http://ahrp. blogspot. com/2006/ 10/vioxx- redux-fda- on-sidelines- as.html The latest study, published in the current issue of Critical Care Medicine, confirmed that patients prescribed Xigris have an increased risk of death. [1] 2. The FDA has been negligent when it failed to inform physicians and the public--in some cases for decades--about the suicide risk linked to numerous prescribed drugs--including drugs prescribed for non-psychiatric conditions. These include: - Singulair (prescribed for asthma) - SSRI antidepressants (including Paxil, Prozac, Zoloft, Effexor, Cymbalta) - Chantix (prescribed for smoking cessation) - Tamiflu (anti-flu) - Accutane (prescribed for acne) - Epilepsy drugs (including carbamazepine, gabapentin, felbamate, lamotrigine, levetiracetam, oxcarbazepine, pregabalin and valproate) FDA officials have consistently downplayed the risks when independent analysts who examined FDA's MedWatch database, reported a significant suicide risk. For example, FDA's latest Drug Safety Newsletter compares reports of suicidality for Chantix and Zyban / Wellbutrin prescribed against smoking. http://www.fda. gov/cder/ dsn/2009_ v2_no1/DSN_ Vol2Num1. pdf FDA's presentation of the data would suggest the risk for Chantix is roughly double the risk for Zyban: --153 reported cases of suicidality for Chantix, of which 37 were suicides compared to -75 reported cases of suicidality for Zyban, of which 29 were completed suicides However, that is a distortion: The FDA compared suicide reports for both drugs since FDA approval for smoking cessation. Zyban was approved in May 1997--it's been on the market for 120 months (10 years). Chantix was approved in May 2006--it's been on the market for just 17 months. A fair comparison would be to compare the first 17 months of Zyban with the first 17 months for Chantix. The data shows that Chantix, with 37 reported SUICIDES in just 17 months poses a risk, perhaps 14 times greater than Zyban with 29 SUICIDES in 10 years Furthermore, Chantix could be even worse. Zyban / Wellbutrin carries a black box warning about suicidal behavior--Chantix does not. Zyban is mostly used to treat depression, only a fraction of its use is as an aid to smoking cessation. The FDA didn't say whether it excluded suicidality reports where the drug was indicated for depression. 3. The number of defective generic drugs has reached critical proportions: In Sept. 2008, the FDA sent a warning letter to the Indian generic drug giant Ranbaxy about its shoddy production of some 26 widely used drugs in America. The list of drugs produced at two Ranbaxy plants and subject to FDA's warning contains 26 drugs, including low-cost versions of such mainstays as pravastatin and simvastatin (commercially known as Pravachol and Zocor, used to lower cholesterol) , metformin and glimeperide (for diabetes), acyclovir and ciprofloxacin (an antiviral and antibiotic medication) and gabapentin (known as Neurontin and used for epilepsy and some psychiatric conditions). However, "the FDA says it has found no evidence that consumers have been harmed by shoddy production standards that were observed in manufacturing these generics at two plants in India. It's not issuing a recall, and urges patients who take these medications to continue to take them rather than stop without a doctor's recommendation, which could be dangerous." http://latimesblogs .latimes. com/booster_ shots/2008/ 09/fda-issues- warn.html Today, a massive recall by generic manufacturer, Ethex, was issued for over 60 generic drug products at the wholesale level: http://www.ethex. com/news/ pdf/recall_ 020309.pdf http://www.ethex. com/news/ pdf/recall_ wholesale. pdf The FDA advisory recommended "Patients who may have these medicines in their possession should continue to take them in accordance with their prescriptions, as the risk of suddenly stopping needed medication may place patients at risk. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these products..." If the drugs a defective what is the rationale for recommending continued use? Wouldn't patients be better served by advice to see their doctor at once? An exasperated physician emailed us this morning: "Our hospital has loads of their drugs on the shelves....When will the government say enough is enough and really monitor this stuff and deal with things like this at an earlier stage?" Reference: Chris A. Gentry, PharmD; Kristin Busse Gross, PharmD; Bhanu Sud, MD; Douglas A. Drevets, MD Adverse outcomes associated with the use of drotrecogin alfa (activated) in patients with severe sepsis and baseline bleeding precautions, Critical Care Medicine. 37(1):327-329, January 2009. Contact: Vera Hassner Sharav veracare (AT) ahrp (DOT) org 212-595-8974 http://pharmalittle .blogspot. com/2009/ 02/obama- congress- may-reverse- liberali zed.html Sunday, February 1, 2009 OBAMA, CONGRESS MAY REVERSE "LIBERALIZED" OFF-LABEL GUIDELINES Good-bye to the Good-bye Presents As most here will know, as part of their final act, the political appointees and (most likely) some of the FDA career staff declared a change in guidelines for off-label promotion of drugs. The core of the new guidelines is that FDA would not require prior review of the off-label promotional materials when they were used for marketing to docs. The text about "peer-reviewed journals" remained. As is conventional, those proffering the guidelines said that this was only formalizing what was already policy. Those not inclined to agree described the change as one more last-ditch attempt to save the world for off-label promotion. Given that the past few weeks have seen the largest busts for off-label promotion in history - both Lilly/Zyprexa and Pfizer/Bextra - adds a little irony to the development. The Fort Worth Star Telegram reports that both the administration and key members of Congress - particular Senator Grassley and Representative Waxman - will act to reverse the guidelines. Dare I ask: Opinions out there? http://www.star- telegram. com/health/ story/1177352. html Tuesday, Feb 3, 2009 Obama may look at FDA's new guidelines on off-label drug marketing By CHRIS ADAMS McClatchy Newspapers CORNELIUS, N.C. - In the waning days of the Bush administration, the Food and Drug Administration finalized new guidelines to make it easier for drug manufacturers to promote "off-label" prescription drug uses, which can be deadly. The move came despite criticism from then-President George W. Bush's Department of Veterans Affairs, which said the change "favors business interests over public safety" and could lead to a "decline in drug safety." It was also crafted despite efforts by state and federal law enforcement experts to clamp down on off-label drug marketing. The new guidelines were issued four years after Robin Briggs of Cornelius, N.C., buried her husband, Doug, who committed suicide on a chilly Christmas Day after taking a drug off-label. Doug Briggs, a physician, took the epilepsy drug Neurontin for his persistent back pain. It didn't do much for his back, but Robin Briggs said the drug changed his demeanor and led to his death. Federal officials have since told Pfizer and other makers of anti-epilepsy drugs to add suicide-risk warnings to their drugs' packaging labels. Robin Briggs sued Pfizer and the maker of a generic version of the drug. The case is pending. As the Obama administration reviews all the rules that the departing Bush administration issued, it will have to decide whether to try to modify or reverse this last-minute change in the FDA's oversight of off-label drug marketing. Congressional leaders from both parties criticized the guideline when it was proposed last year. Sen. Charles Grassley, an Iowa Republican who has repeatedly investigated the FDA, said he had serious concerns about the proposal, which he said would deem appropriate something that "the FDA once considered evidence of unlawful marketing." "A legislative fix may be in order," Grassley said Thursday. In the House of Representatives, Rep. Henry Waxman, D-Calif., called the guideline a "long-coveted parting gift" for the pharmaceutical industry that "fundamentally undermines" the FDA's authority. The use of drugs "off-label" - for reasons the FDA hasn't approved - has long been tolerated and sometimes encouraged. It can be helpful for certain ailments. But the practice can also be dangerous. Nearly every drug has side effects, some of them serious. Those risks can be worth the potential benefit that comes with an FDA-approved, on-label use. With an off-label use, however, the risks remain but the benefits are far less certain. While it's legal for physicians to prescribe drugs off-label - often based on their reading of the latest medical research - it's illegal for drugmakers to push such uses. Over the past five years, federal prosecutors and state attorneys general have brought more than a dozen cases against drugmakers for off-label marketing and won more than $6 billion in criminal and civil settlements, according to the Government Accountability Office and the Department of Justice. In January, two of the nation's largest drugmakers, Pfizer and Eli Lilly and Co., said they'd agreed to two of the biggest off-label settlements ever. "The FDA has been abysmal policing this area," said Connecticut Attorney General Richard Blumenthal, who helped engineer a major off-label case against drugmaker Cephalon. "One reason the states have been more and more active is that the federal government has been asleep at the switch." In its final week, the Bush administration opened the door to some off-label marketing. In what's called a "guidance" document, the FDA specified how drug companies could hand out medical journal articles that highlight potential off-label drug uses. The guidance was complicated, and the main players in the issue still disagree about what it means for FDA oversight of off-label marketing. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a 'fair use' of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit. ===== In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. Quote Link to comment Share on other sites More sharing options...
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