ࡱ> FHCDE[ Kdbjbj .ΐΐK\4%|||$$$$$$$&(D$||$$"""v$"$"""0e= >"$$0%"(X"X(""($ ||"|||||$$" |||%|(||||||||| : Legal Murder by William Faloon  INCLUDEPICTURE "http://www.lef.org/magazine/mag2012/images/aug2012_William-Faloon.jpg" \* MERGEFORMATINET  William Faloon No one knows exactly how many Americans were killed byVioxx. According toDr. David Graham, the hero who defied his corruptFDAsuperiors, Vioxxcaused88,000to139,000excess cases ofheart attackandstroke.1,2 This carnage occurred asMerck(the maker of Vioxx) worked closely with high-levelFDAofficials tosuppressdata showing the lethal dangers of this once-popular arthritis drug.3,4 According to a review published in theArchives of Internal Medicine, Merck held back initial data showingVioxxcaused an increase in heart attack and stroke risk.5It tookthree more yearsof patients needlessly dying before Vioxxwas pulled off the market. TheFDAnever mandated Vioxxbe banned. As lawsuits started piling up,Merckmade a business decision to withdrawVioxxworldwide, while denying there was a safety issue.6 Merck Pleads Guilty To Criminal Charges After a seven-yearJustice Departmentinvestigation,Merckpled guilty to acriminal misdemeanorthat it illegally promotedVioxxand deceived the government about the drug'ssafety.7 Merck paid the federal government a$950 millionfine. It has also paid over$4 billionin compensation to victims (or their family members) for the side effects Vioxxcaused, along with punitive damages for covering up the lethal dangers.7 Before it was withdrawn, Merck racked up$11 billionin Vioxxsales.8So with the criminal fine paid to the government and the money paid out so far to victims, Merck appears to bebillions of dollarsahead financially by knowingly selling a drug that killed tens of thousands of human beings! Egregious Cover Up  INCLUDEPICTURE "http://www.lef.org/magazine/mag2012/images/oct2012_Legal-Murder_01.jpg" \* MERGEFORMATINET  Four years before Vioxxwas withdrawn, the results from a large clinical trial were published comparing patients usingnaproxenorVioxx. The findings showed a500% increased riskof heart attack inVioxxusers compared to those takingnaproxen.9 This trial was designed, performed and paid for by the drug industry. The findings from this trial should have resulted in theFDAwithdrawing approval ofVioxx. Instead, the drug industry (working in cahoots with FDA) came up with a ridiculous upside-down analysis of the data. They concluded thatVioxxdid not cause a500% increasein heart attacks, but instead thatnaproxenresulted in a500% decreasein heart attack incidence.10 Dr. David Grahamis the senior epidemiologist in the FDA'sOffice of Drug Safety. Dr. Graham knew thatnaproxendid not reduceheart attack riskby500%. When Dr. Graham saw how data from this study was being manipulated to cover up Vioxx's lethal dangers, he broke rank with corrupt FDA officials. As you'll read in an eye-opening interview in this month's issue, Dr. Graham's battle to expose the lethal dangers of Vioxxalmost got himfiredfrom theFDA. Government Doesn't Care About Victims  INCLUDEPICTURE "http://www.lef.org/magazine/mag2012/images/oct2012_Legal-Murder_02.jpg" \* MERGEFORMATINET  As most of you know, the intentional killing of a human is a felony, often punishable by life in prison (or worse). In theJustice Department'ssettlement withMerck, there is no discussion of murder. Instead, Merck agreed to plead guilty to FDA "regulatory" violations involving its promotion of Vioxxtorheumatoid arthritispatients when it was approved only to treatosteoarthritis.Merck also pled guilty to misleadingMedicaidofficials about thesafetyof Vioxx.11 Dr. David Graham estimates that Vioxxdirectly killed more Americans than died during the entireVietnam War.9 Yet no where in the criminal settlement agreement does Merck have to admit to "intentionally killing people." It appears that theJustice Departmentis not concerned by the human body count. The settlement only requires thatMerckadmitthey failed to comply with FDA and Medicaidregulations.12 Interestingly, there are published studies showing that Vioxxwas effective againstrheumatoid arthritis, but such data is irrelevant since the FDA had not "approved" Vioxxfor this indication.11Our government was more concerned about "regulatory violations" than accurately assessing scientific facts about Vioxxin the treatment of rheumatoid arthritis. The rationale you'll read next for Merck not being charged withfelony murderdemonstrates the insidiousinfluencepharmaceutical behemoths exert over the federal government.13 Why Pharmaceutical Companies Aren't Criminally Prosecuted MedicareandMedicaidpay out such a large portion of this nation's healthcare costs that pharmaceutical companies must maintain access to these government spigots to remain in business. If a drug company is convicted of "serious healthcare fraud," they are automatically excluded from receiving federal payouts.  INCLUDEPICTURE "http://www.lef.org/magazine/mag2012/images/oct2012_Legal-Murder_03.jpg" \* MERGEFORMATINET  To protect the financial interests of large pharmaceutical companies, the federal government works out specials deals that enables them to avoid accountability for their illicit actions. In recent years, our government has allowed pharmaceutical companies to escape felony fraud charges, or allows a shell company-subsidiary to take the blame for the parent company's misdeeds. This is analogous to you committing a murder, but persuading a terminal cancer patient to take the blame for it, and prosecutors then letting you off the hook. Vioxxis in a class of drugs known asCOX-II inhibitors. Another drug in this class approved by the FDA wasBextramade by pharmaceutical behemothPfizer.Bextrawas also withdrawn because of increased risks of heart attacks, strokes, anddeathsin patients prescribed it.14-16 As we reported in 2010, Pfizer was allowed to use a subsidiary shell company to plead guilty to a criminal charge that it fraudulently sold Bextra.17The fraud was based on Pfizer promoting Bextra's use inhigher dosesto relieveacute surgical pain, something the drug was never approved for.18Using a subsidiary to plead guilty to theBextrachargesenabledPfizerto continue receiving lucrativeMedicare/Medicaidreimbursement on its other drugs. By allowing theVioxxatrocities to be settled onmisdemeanorcharges instead offelonycounts,Merckwill continue receivingbillions of dollarsof annual payments fromMedicare/Medicaid. Bextra's Fatal Side Effects Overlooked by FDA In an analysis presented at theAmerican Heart Association,Bextrawas shown to more than double the risk of heart attack or stroke. The lead author of this study commented that,"This is a time bomb waiting to go off."19 Pfizerpaid a settlement to the federal government of$1.195 billionfor the fraudulent marketing of Bextra.20The record financial payout was not because Bextrainjured and killedarthritis patients. The fine was to settle government claims that Pfizer illegally promoted the sale of Bextrafor uses and dosages that the FDA specifically declined to approve. Just as withVioxx, the government bases itsBextrafine onregulatoryviolations instead of the fact thathuman beings were killed! No Equal Justice  INCLUDEPICTURE "http://www.lef.org/magazine/mag2012/images/oct2012_Legal-Murder_04.jpg" \* MERGEFORMATINET  The slap-on the wrist settlements of the Vioxxand Bextracharges represents an egregiousevasionof laws that are supposed to prohibit companies engaged in "serious healthcare fraud" from receiving tax dollars. Of course none of the individual perpetrators at drug companies that caused these horrific numbers ofdeathsever have to worry aboutjail time. If asupplement companyowner knowingly sold a product that caused even one death, he would likely face decades in prison. As you'll read in the first article in this month's issue, a man namedJay Kimballsold a drug (liquid deprenyl) that harmed no one, but he is still serving out a13-yearprison sentence. Thewrongful prosecutionof Jay Kimball, represents one of the worst miscarriages of justice in the history of the American jurisprudence. In comparingJay Kimball'scase to the real crimes ofMerckandPfizer, theFDAdid not even attempt to show that Jay'sliquid deprenylharmed anyone. The FDA merely cited "regulatory violations" involving his improper export of his liquid deprenyl to other countries. The result is13-years in jailforJay Kimballandfinancial ruinationfor his family.21 MerckandPfizerknowingly sold drugs (Vioxxand Bextra) that killedtens of thousandsof Americans, yet they continue receivingbillions of Medicare/Medicaid dollarseach year, with no one facing jail time, while their executives lead lavish lifestyles. COVERING UP OF VIOXX'S LETHAL DANGERS By April 2001,Merckhad compiled internal data from two large human trials showing a staggeringthree-fold increaseintotal mortality(deaths) in patients usingVioxx.22 In articles that reported the results of these trials, analyses and statistical tests of the mortality data were obscured. Even the study author's conclusion regardingsafetyofVioxxwas absurdly stated as the drug being "well tolerated."23 Data submitted to theFDAwas manipulated to understate the higher numbers of deaths in Vioxxusers. For example, if heart attack or stroke deaths occurred more than 14 days after Vioxxwas discontinued, it was often omitted. Just imagine how many heart attack and stroke victims stopped taking Vioxxbecause arthritis was no longer their major medical concern. Paralyzed stroke patients, for instance, have little need for Vioxx, yet many of these stroke victims die more than 14 days after discontinuing Vioxx. After the VIGOR study was published showing a500% increasein myocardial infarction (heart attack) inVioxxusers,24Merckdirected its sales force to provide physicians with a distorted picture of the relevant scientific evidence. For instance, Merck sent a bulletin to its Vioxxsales force of more than 3,000 representatives that ordered: "DO NOT INITIATE DISCUSSIONS ON THE FDA ARTHRITIS ADVISORY COMMITTEE OR THE RESULTS OF THE VIGOR STUDY."25 The Merck bulletin further advised that if a physician inquired about the VIGOR study, the sales representative should indicate that the study showed a gastrointestinal benefit and then say, "I cannot discuss the study with you."25 Merck further instructed its sales reps to show those doctors who asked whether Vioxxcaused myocardial infarction a pamphlet called "The Cardiovascular Card." This pamphlet, prepared by Merck's marketing department, indicated that Vioxxwas associated with 1/8 the mortality from cardiovascular causes of that found with other anti-inflammatory drugs. The Cardiovascular Card, however, provided a misleading picture of the evidence on Vioxx. The card did not include any data from the VIGOR study that showed a500% increasein heart attack risk. Instead, it presented a pooled analysis of preapproval studies, in most of which low doses of Vioxxwere used for a short time. None of these studies were designed to assess cardiovascular safety, and none included a proper determination of cardiovascular events. In fact, FDA experts had publicly expressed "serious concerns" to the FDA's advisory committee about using the preapproval studies as evidence of Vioxx's cardiovascular safety.24 The cover up of the lethal dangers of Vioxxspanned a period of years, all the while tens of thousands of innocent victims worldwide perished needlessly. Merckcontinues to deny there is any safety problem withVioxx. Merck Controls Timing of Announcement of Guilty Plea  INCLUDEPICTURE "http://www.lef.org/magazine/mag2012/images/oct2012_Legal-Murder_05.jpg" \* MERGEFORMATINET  Even for a company as huge asMerck, pleading guilty to criminal misdemeanors is embarrassing. While the credibility of pharmaceutical companies has sunk to an all-time low, they still pretend to care about the public's health. Merck's guilty plea was an-nounced the daybefore Thanks-giving(2011), which is one of the busiest travel days of the year and a time when the fewest people are paying attention to the news. Talk about absolute power, Merck avoids felony charges, jail time for executives, and embarrassing publicity, all while keeping billions of surplus dollars on Vioxxsales. Jay Kimball, on the other hand, remains incarcerated and his family left indigent. We Warned Members About Dangers of COX-2 Inhibiting Drugs WhileMerckwas bombarding the public with television commercials claiming that one little pill a day ofVioxxtook away arthritis pain,Life Extensionwarned its members about the lethal dangers of Vioxxand other drugs that inhibitonlythe COX-2 enzyme. We knew that Vioxx's mechanism of action would result in sharply higher rates of coronary artery blockage and ischemic stroke. So did scientists who evaluated Vioxxbefore the FDA approved it. Despite the criminal guilty plea, the$950 million settlement, and its withdrawal of Vioxxworldwide, Merck still denies any wrongdoing on the part of its higher level executives or the company itself. In this issue, we re-print a fascinating interview withDr. David Graham, the head of the FDA'sOffice of Drug Safety. Dr. Graham provides meticulous details about what really goes on inside the FDA as it relates to approving dangerous drugs, with many specifics about the Vioxxmassacre that should have never happened. Most important is an article on page 24 of this issue aboutJay Kimball, who remains imprisoned for selling a drug that harmed no one. Life Extension and its volunteer members have finally completed a petition to commute the sentence of Jay Kimball to the outlandish time he has already served. I ask all members to log on to our convenient website HYPERLINK "http://www.lef.org/lac" www.lef.org/lacto easily affix your name to petitions urging President Obama to immediately grant Jay Kimball a commutation of sentence. For longer life,  INCLUDEPICTURE "http://www.lef.org/magazine/mag2006/images/signature_faloon.jpg" \* MERGEFORMATINET  William Faloon MORE GUILTY PLEAS BY BIG PHARMA  INCLUDEPICTURE "http://www.lef.org/magazine/mag2012/images/oct2012_Legal-Murder_06.jpg" \* MERGEFORMATINET  As we were finalizing this article,GlaxoSmithKlinehad reached the largest illegal drug settlement to date, agreeing to pay$3 billionand plead guilty to criminal charges that included the drugsAvandiaandPaxil.26 Avandiais a drug used to treattype II diabetes. Vascular disease is the leading cause of mortality in diabetic patients.27,28In a study of 227,571 patients, those receivingAvandiawere27%more likely to sufferstrokes,25%more likely to developheart failureand14%more likely todiecompared to those taking another anti-diabetic drug called Actos.29,30Avandiaincreased the very diseases that diabetic patients are most vulnerable toand GLAXOcovered upthese deadly side effects!31 Paxilis a drug prescribed to treat depression. After years of cover up, Glaxo sent a letter to physicians admitting that the risk of suicidal behavior was6.7 times higherin study subjects taking Paxilcompared to placebo.32Suicide risk is high in depressed individuals, yet Glaxo covered up suicidal risks as it promoted the so-called "benefits" of Paxilin treating depression.32 GLAXO's guilty plea to criminal charges was announced two days beforeJuly 4, 2012, another busy travel time when few Americans are reading the news. Two weeks after Glaxo's record settlement,Johnson and Johnsonagreed to pay$2.2 billionfor its illegal marketing of the drugRisperdalto demented elderly patients.33Risperdalis approved mainly to treat schizophrenia, but is associated with a number of deadly side effects including high blood sugar, irregular pulse, and blood pressure irregularities.34The most troubling side effect of Risperdalis impairment of judgment and thinking, which is the last thing a demented patient needs.34 In each of these cases, pharmaceutical companies were promoting drugs that worsened the diseases they were intending to treat. We don't yet know how theirguilty pleaswill be manipulated so they don't lose out on lucrativeMedicare/Medicaidreimbursement. References 1. Available at: HYPERLINK "http://www.consumersunion.org/pub/core_health_care/001651.html" http://www.consumersunion.org/pub/core_health_care/001651.html. Accessed April 12, 2012. 2. Available at: HYPERLINK "http://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf" http://www.finance.senate.gov/imo/media/doc/111804dgtest.pdf. Accessed April 12, 2012. 3. Available at: HYPERLINK "http://www.marshall-attorneys.com/Press/2004_11_01_WSJ.htm" http://www.marshall-attorneys.com/Press/2004_11_01_WSJ.htm. Accessed April 12, 2012. 4. Horton R. Vioxx, the implosion of Merck, and aftershocks at the FDA.Lancet.2004 Dec 4-10;364(9450):1995-6. 5. Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance.Arch Intern Med. 2009 Nov 23;169(21):1976-85. 6. Available at: HYPERLINK "http://hcrenewal.blogspot.com/2011/12/merck-admits-little-while-settling.html" http://hcrenewal.blogspot.com/2011/12/merck-admits-little-while-settling.html. Accessed January 18, 2012. 7. Available at: HYPERLINK "http://wprsam.com/news/articles/2011/nov/22/merck-to-pay-nearly-1-billion-to-settle-us-charges/" http://wprsam.com/news/articles/2011/nov/22/merck-to-pay-nearly-1-billion-to-settle-us-charges/. Accessed April 12, 2012. 8. Available at: HYPERLINK "http://www.examiner.com/health-in-los-angeles/vioxx-settlement-hits-merck-for-950-million" http://www.examiner.com/health-in-los-angeles/vioxx-settlement-hits-merck-for-950-million. Accessed January 20, 2012. 9. Available at: HYPERLINK "http://www.naturalnews.com/011401.html" http://www.naturalnews.com/011401.html. Accessed January 25, 2012. 10. Available at: HYPERLINK "http://fl1.findlaw.com/news.findlaw.com/hdocs/docs/vioxx/111804singh.pdf" http://fl1.findlaw.com/news.findlaw.com/hdocs/docs/vioxx/111804singh.pdf. Accessed February 25, 2012. 11. Available at: HYPERLINK "http://www.businessweek.com/news/2011-12-05/merck-to-plead-guilty-pay-950-million-in-u-s-vioxx-probe.html" http://www.businessweek.com/news/2011-12-05/merck-to-plead-guilty-pay-950-million-in-u-s-vioxx-probe.html. Accessed January 27, 2012. 12. Available at: HYPERLINK "http://www.bloomberg.com/news/2011-11-22/merck-agrees-to-pay-950-million-to-settle-u-s-government-s-vioxx-probe.html" http://www.bloomberg.com/news/2011-11-22/merck-agrees-to-pay-950-million-to-settle-u-s-government-s-vioxx-probe.html. Accessed February 8, 2012. 13. Available at: HYPERLINK "http://www.medscape.com/viewarticle/538025" http://www.medscape.com/viewarticle/538025. Accessed February 15, 2012. 14. Available at: HYPERLINK "http://www.medicinenet.com/script/main/art.asp?articlekey=46601" http://www.medicinenet.com/script/main/art.asp?articlekey=46601. Accessed February 15, 2012. 15. Roumie CL, Mitchel EF Jr, Kaltenbach L, Arbogast PG, Gideon P, Griffin MR. Nonaspirin NSAIDs, cyclooxygenase 2 inhibitors, and the risk for stroke.Stroke. 2008 Jul;39(7):2037-45. 16. Roumie CL, Choma NN, Kaltenbach L, Mitchel EF Jr, Arbogast PG, Griffin MR. Non-aspirin NSAIDs, cyclooxygenase-2 inhibitors and risk for cardiovascular events-stroke, acute myocardial infarction, and death from coronary heart disease.Pharmacoepidemiol Drug Saf. 2009 Nov;18(11):1053-63. 17. Available at HYPERLINK "http://www.lef.org/magazine/mag2011/jun2011_Obscene-Profits-Over-Human-Life_01.htm" http://www.lef.org/magazine/mag2011/jun2011_Obscene-Profits-Over-Human-Life_01.htm. Accessed March 8, 2012. 18. Available at: HYPERLINK "http://www.doj.state.wi.us/absolutenm/templates/template_share.aspx?articleid=837&zoneid=4" http://www.doj.state.wi.us/absolutenm/templates/template_share.aspx?articleid=837&zoneid=4. Accessed April 12, 2012. 19. Available at: HYPERLINK "http://www.medscape.com/viewarticle/538008" http://www.medscape.com/viewarticle/538008. Accessed February 22, 2012. 20. Available at: HYPERLINK "http://www.hhs.gov/news/press/2009pres/09/20090902a.html" http://www.hhs.gov/news/press/2009pres/09/20090902a.html. Accessed February 22, 2012. 21. Available at: HYPERLINK "http://www.proliberty.com/observer/20001201.htm" http://www.proliberty.com/observer/20001201.htm. Accessed April 12, 2012. 22. Available at: HYPERLINK "http://www.cbsnews.com/stories/2008/04/15/health/webmd/main4018030.shtml" http://www.cbsnews.com/stories/2008/04/15/health/webmd/main4018030.shtml. Accessed February 23, 2012. 23. Available at: HYPERLINK "http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a5z.VogSbbXo&refer=home" http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a5z.VogSbbXo&refer=home. Accessed February 24, 2012. 24. Bombardier C, Laine L, Reicin A, et al. VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group.N Engl J Med. 2000 Nov 23;343(21):1520-8, 2 p following 1528. 25. Available at: HYPERLINK "http://www.nejm.org/doi/full/10.1056/NEJMp058136" http://www.nejm.org/doi/full/10.1056/NEJMp058136. Accessed February 24, 2012. 26. Available at: HYPERLINK "http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?_r=1&pagewanted=all" http://www.nytimes.com/2012/07/03/business/glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.html?_r=1&pagewanted=all. Accessed July 25, 2012. 27. Available at: HYPERLINK "http://www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/" http://www.world-heart-federation.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/. Accessed July 25, 2012. 28. Haffner SM, Lehto S, Rnnemaa T, Pyrl K, Laakso M. Mortality from coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects with and without prior myocardial infarction.N Engl J Med. 1998 Jul 23;339(4):229-34. 29. Available at: HYPERLINK "http://www.cbsnews.com/2100-204_162-6627074.html" http://www.cbsnews.com/2100-204_162-6627074.html. Accessed July 25, 2012. 30. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone.JAMA. 2010 Jul 28;304(4):411-8. 31. Available at: HYPERLINK "http://www.drugwatch.com/2012/07/03/glaxosmithkline-pays-3-billion-for-illegal-drug-marketing/" http://www.drugwatch.com/2012/07/03/glaxosmithkline-pays-3-billion-for-illegal-drug-marketing/. Accessed July 25, 2012. 32. Available at: HYPERLINK "http://us.gsk.com/docs-pdf/media-news/Paxil-CR-and-Paxil-Adult-Suicide.pdf" http://us.gsk.com/docs-pdf/media-news/Paxil-CR-and-Paxil-Adult-Suicide.pdf. Accessed July 25, 2012. 33. Available at: HYPERLINK "http://abcnews.go.com/Business/wireStory/report-jj-pay-22b-risperdal-settlement-16815635" http://abcnews.go.com/Business/wireStory/report-jj-pay-22b-risperdal-settlement-16815635. Accessed July 25, 2012. 34. Available at: HYPERLINK "http://www.pdrhealth.com/drugs/risperdal" http://www.pdrhealth.com/drugs/risperdal. Accessed July 25, 2012.      / 0 1 7 8 > ? 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