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The FDA's Most Heinous Drug Approval
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   2002
The FDA Versus the American Consumer
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Dying From Deficiency
Are Offshore Drugs Dangerous?
Drugs the FDA Says You Can't Have
Does Cholesterol Cause Artery Disease?
What's Wrong with the FDA
FDA Suffers Second Massive Legal Defeat in Pearson v. Shalala
FDA Loses Case Against Compounding Pharmacies on First Amendment Grounds
Ending The Cancer Bureaucracy
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Life Extension Wins in the House and Senate
Congress Recognizes The Prescription Drug Problem
Americans are getting Healthier... But the FDA Remains a Major Impediment
Are We to Become Serfs of the Drug Monopoly?
   1999
A Glorious Victory Over FDA Tyranny
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The Plague Of FDA Regulation
Health Costs to Double Is there a free-market solution?
The FDA versus Folic Acid
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They Want You Brain Dead
Life Extension vs. the FDA a Hollow Victory: Why the Agency's Approval of Ribavirin is Inadequate
 
http://www.fdareview.org/

The FDA's Most Heinous Drug Approval

By William Faloon
One Thousand Lives Lost Each Month Because of the FDA’s Delay in Removing Trasylol

Why Health Care Costs So Much

The side effects attributed to Trasylol include heart attack, stroke, kidney failure, and excruciating slow deaths.25

The medical costs of caring for patients injured by Trasylol are incomprehensible. In some cases, relatively healthy people suffered so much tissue damage that they were hospitalized in ICU units for months before they died. Other victims require thrice weekly kidney dialysis, kidney transplants, lifetime nursing home care, and numerous other medical costs, not to mention lost productivity.26,27

If you ever wonder why medical costs are bankrupting the United States, look no further than the fraudulently approved drugs that permeate the marketplace. When government-approved medicines inflict this kind of carnage, the inevitable result is an explosive growth in the numbers of Americans requiring expensive chronic healthcare.

Federal Government Does Not Protect Us

In this issue of Life Extension Magazine, we reprint an article published by CNN titled "Feds Found Pfizer Too Big to Nail." It describes in detail the criminal activities Pfizer perpetrated to illegally market the drug Bextra to treat surgical pain.

Like other drugs in the COX-2 inhibitor class, Bextra was shown to increase heart attack risk and was withdrawn from the market.28 The unfortunate consequence for many surgical patients, however, is that they were exposed to two lethal drugs (Trasylol and Bextra) at a time when these patients were particularly vulnerable to pathological clotting inside blood vessels (thrombosis).

Now That Trasylol Is Gone Alternative Drug Prices Skyrocket
Now That Trasylol Is Gone…Alternative Drug Prices Skyrocket

When CBS News first broke this story, they stated that safer drugs that effectively reduced bleeding complications cost only around $50.00 (compared to around $1,000 for Trasylol).10

Now that Trasylol has been removed from the market, alternative drugs (such as aminocaproic acid) cost around $750 per surgical procedure based on information that took us months to extract from hospitals. No hospital wanted to volunteer what they charge for aminocaproic acid. This may be because of the absurd price gouging that routinely occurs at hospital pharmacies, such as charging $10 for an aspirin tablet.

This kind of unconscionable overcharging is just one of many reasons why our sick-care system is collapsing into a financial abyss.

Trasylol was first administered intravenously to prevent excess bleeding, but in reality it caused excess blood clotting inside the arteries of many of its victims.29 In the post-surgical setting, patients were sometimes prescribed a double dose of Bextra to alleviate surgical pain. One pathological effect of Bextra is to increase a fatty acid metabolite called thromboxane A2, which further increases thrombotic risk.4,5 If you wonder why so many hospital patients die from "surgical complications," look no further than FDA-approved drugs they were given.

Trasylol was allowed to remain on the market for 14 years, whereas Bextra was illegally touted for less than 5 years before being withdrawn.30 Life Extension warned about the dangers of drugs like Bextra and Vioxx within a year of the FDA approving them.31 We were in the dark about Trasylol, however, since this was a drug that surgeons made a decision on using.

The bottom line is that prescription drug costs are contributing to the bankruptcy of this nation's healthcare system. Yet the federal government continues to deceive consumers into believing that they must pay inflated costs in order to be assured of safety and efficacy.

The reality is that high costs give pharmaceutical companies enormous profits that they use to fraudulently promote their drugs, pay off doctors, and lobby the FDA/Congress to protect their stranglehold over what drugs consumers have access to.32-34

Life Extension remains committed to protecting its members against the blatant corruption that exists today between pharmaceutical companies that engage in fraud to promote dangerous drugs and the politicians and bureaucrats who allow this murderous conspiracy to perpetuate.

Blood Tests Can Detect Drug Toxicities in Time to Reverse Damage

Blood tests that evaluate liver, kidney, muscle, and bone marrow function can detect a wide range of drug toxicities long before permanent damage occurs.

For instance, if a blood test finding uncovers specific tissue damage, a careful evaluation of the drugs you are taking can pinpoint the one causing the problem so you can discontinue it. This usually reverses the damage. Failure to catch a drug-induced pathology in time can result in irreversible system failure.

Regular blood testing can also enable your doctor to adjust the dose of drugs you are taking, and enable you to change your nutrient dose in order to obtain better and safer results.

For example, doctors often prescribe the same dose of a statin drug to every patient. The problem is that the dose of statin drugs required varies considerably between patients. Some can take a small dose (10 mg/day) of a drug like simvastatin and achieve LDL levels below 80 mg/dL, whereas others require higher doses (in addition to nutritional interventions).

Comprehensive blood tests function as a "report card" to verify that medications, hormones, and supplements you take each day are providing the desired benefits and not inflicting side effects.

Low-Cost, Convenient Blood Testing

When it comes to over-the-counter (OTC) drug toxicity, we at Life Extension have uncovered it in people as young as 21 years old and reversed it by getting them off high-dose analgesics like ibuprofen.

Annual blood testing saves lives not only by detecting drug toxicities, but also revealing vascular risk factors such as elevated triglycerides, glucose, C-reactive protein, and LDL in time to take corrective actions. Hormone imbalances can also be uncovered by proper blood testing. Results from these tests provide a roadmap to enable hormones to be safely restored to youthful ranges.

Low-Cost, Convenient Blood Testing

The high prices charged by commercial labs deny most people access to comprehensive blood tests. This is a tragedy as proper blood testing can identify reversible factors before stroke, cancer, kidney failure, diabetes, or coronary artery blockage is diagnosed.

Life Extension has torn down these high-cost barriers by offering comprehensive Male and Female Blood Test Panels. Once a year, we discount these popular panels down to only $199 which is about 80% less than what commercial labs charge.

When you place your order, we send you a pre-filled-in requisition form and list of drawing stations in your area where you can go at your convenience.

The Blood Test Super Sale this year expires on June 6, 2011. You should not delay in placing your order to take advantage of these extra-discounted prices.

Once you have your requisition form, you can have your blood drawn anytime thereafter. The results are mailed directly to you. If you have any questions when your results come back, you are welcome to call our health advisor helpline.

The chart below describes the many tests included in the comprehensive Male and Female Blood Test Panels and the ease with which you can order them today.

For longer life,

For Longer Life 

William Faloon

P.S. If you want to view the televised report that CBS News did on the Trasylol travesty, just go to Google and type in: "Trasylol and 60 Minutes.

References

1. Available at: http://www.mefmaction.net/MECFSFM/Articles/Treatment/GlutathioneDeficiency/tabid/236/Default.aspx. Accessed November 25, 2010

2. Available at: http://www.chiro.org/nutrition/FULL/Recognizing_Drug_Induced_Nutrient_Depletion.shtml. Accessed November 25, 2010.

3. Jaeschke H, Bajt ML. Intracellular signaling mechanisms of acetaminophen-induced liver cell death. Toxicol Sci. 2006 Jan;89(1):31-41.

4. Fitzgerald GA. Coxibs and cardiovascular disease. N Engl J Med. 2004 Oct 21;351(17):1709-11.

5. Oates JA, FitzGerald GA, Branch RA, Jackson EK, Knapp HR, Roberts LJ 2nd. Clinical implications of prostaglandin and thromboxane A2 formation (1). N Engl J Med. 1988 Sep 15;319(11):689-98.

6. Fischer JH, Knupfer P. High-dosage aprotinin (Trasylol) therapy--is it safe for the kidney? Langenbecks Arch Chir. 1983;360(4):241-9.

7. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142740.htm. Accessed March 15, 2011.

8. Sundt TM 3rd, Kouchoukos NT, Saffitz JE, Murphy SF, Wareing TH, Stahl DJ. Renal dysfunction and intravascular coagulation with aprotinin and hypothermic circulatory arrest. Ann Thorac Surg. 1993 Jun;55(6):1418-24.

9. Mangano DT, Miao Y, Vuylsteke A, et al. Mortality associated with aprotinin during 5 years following coronary artery bypass graft surgery. JAMA. 2007 Feb 7;297(5):471-9.

10. Available at: http://www.cbsnews.com/stories/2008/02/14/60minutes/main3831900.shtml. Accessed December 6, 2010.

11. Mangano DT, Tudor IC, Dietzel C; Multicenter Study of Perioperative Ischemia Research Group; Ischemia Research and Education Foundation. The risk associated with aprotinin in cardiac surgery. N Engl J Med. 2006 Jan 26;354(4):353-65.

12. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108592.htm. Accessed November 30, 2010.

13. Available at: http://www.investor.bayer.de/en/news/archive/investor-news-2006/investor news/showNewsItem/669/1170082441/9c4ca18b75/. Accessed November 30, 2010.

14. Available at: http://www.investor.bayer.de/en/news/archive/investor-news-2006/investor-news/showNewsItem/673/1168957317/5620356922/. Accessed November 30, 2010.

15. Available at: http://www.corpwatch.org/article.php?id=14185. Accessed December 2, 2010.

16. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142736.htm. Accessed December 2, 2010.

17. Available at: http://www.washingtonpost.com/wp-dyn/content/article/2008/05/14/AR2008051401658.html. Accessed December 2, 2010.

18. Available at: http://www.bayer.ca/files/Trasylol,%20BART,%20November%205,%20FINAL,%20Release.pdf. Accessed December 2, 2010.

19. Available at: http://www.investor.bayer.de/en/news/archive/investor-news-2007/investor-news/showNewsItem/868/1201512120/450afb010b. Accessed December 2, 2010.

20. Available at: http://www.fda.gov/downloads/NewsEvents/Newsroom/MediaTranscripts/UCM122284.pdf. Accessed December 2, 2010.

21. Available at: http://www.consumeraffairs.com/news04/2008/05/fda_trayslol.html. Accessed December 6, 2010.

22. Available at: http://articles.latimes.com/2006/oct/14/business/fi-bayer14. Accessed March 15, 2011.

23. Faloon W. FDA threatens to raid cherry orchards. Life Extension Magazine. 2006 Mar;12(3): 7-11.

24. Faloon W. FDA says walnuts are illegal drugs. Life Extension Magazine. Publication pending.

25. Available at: http://www.drugwatch.com/trasylol/side-effects.php. Accessed December 6, 2010.

26. Available at: http://www.fda-reports.com/Trasylol.html. Accessed December 9, 2010.

27. Available at: http://www.adrugrecall.com/trasylol/kidney-failure.html. Accessed December 10, 2010.

28. Available at: http://doublecheckmd.com/EffectsDetail.do?dname=Trasylol&sid=1439&eid=3076. Accessed December 10, 2010.

29. Available at: http://www.kcrlegal.com/trasylol.aspx. Accessed December 13, 2010.

30. Available at: http://arthritis.webmd.com/news/20050407/bextra-taken-off-market-celebrex-gets-warning. Accessed December 15, 2010.

31. Medications side effects. Life Extension Magazine. 2003 Mar.

32. Available at: http://www.naturalnews.com/030111_drug_companies_illegal.html. Accessed December 17, 2010

33. Loewenberg S. US FDA feels the heat from Congressional hearings. Lancet. 2008 May 10;371(9624):1565-6.

34. Available at: http://projects.publicintegrity.org/rx/report.aspx?aid=723. Accessed December 17, 2010.

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