Life Extension Magazine

Life Extension Magazine March 2012

As We See It

Crooked Practices That Are Destroying Our Health Care System

By William Faloon

FDA's Response to Pfizer's Misdeed

The FDA’s response to this latest scandal was to force Pfizer to resubmit all reports of adverse reactions through the “proper channel” that would enable the agency to identify serious problems such as suicide, depression, and other psychiatric disorders induced by Chantix®.

FDA officials said these new reports did not change the agency’s position on the risks and benefit of the controversial drug, which received a black box warning that included suicide—the strongest caution possible—in 2009. In other words, other than warning of the lethal side effects a user of Chantix® faces, the FDA has no plans to withdraw it from the market.

FDA officials did say they are considering changing regulations to allow expedited reports of suicides and other serious problems. This change was first proposed by the FDA in 2003, but is still pending. This is just another example of the glacial pace at which the FDA moves even as body counts pile up from side effects inflicted by prescription drugs the agency erroneously approves and then allows to remain on the market far too long.

A one-month supply of Chantix® costs about $179, which is typical of what patented drugs now sell for.

Suicide Risk of Chantix® Higher than Expected
FDA Black Box Warning

As we were finishing this article, a new study found that Chantix® was 8 times more likely to result in reports of suicidal behavior or depression compared to nicotine-replacement products.48

The findings contradict those of the FDA that found Chantix® did not increase the risk of being hospitalized for psychiatric problems such as depression.

The authors of this new study stated that the FDA hospitalization studies were flawed because they could not capture most of the serious psychiatric side effects, including suicide, depression, aggression, and assaults.

Another reason FDA failed to ascertain the magnitude of the problem with Chantix® is they omitted suicidal and depression events that did not lead to hospitalization. These can be catastrophic events but do not normally result in hospitalization.49

Pfizer Seeks to Delay Sales of Generic Lipitor®

According to the New York Times, the largest introduction of a generic drug in history is being impeded in another devious scheme perpetrated by Big Pharma.

Lipitor® is the best-selling drug of all time, generating sales of $106 billion over the last decade. Pfizer has told financial analysts it is preparing for the loss of Lipitor®’s patent with a variety of business moves to preserve market share.

In a letter to pharmacists, Pfizer is asking many drugstores to block prescriptions for a generic version of Lipitor®. This cholesterol-lowering drug lost patent protection on November 30, 2011.50

One of the nation’s largest pharmacy benefit managers issued instructions seeking to have pharmacists keep filling prescriptions with the more expensive Lipitor® for six months. Pfizer will provide large discounts to benefit managers that block the use of generic versions of Lipitor®.

This tactic will benefit Pfizer and benefit managers at the expense of employers and taxpayers, who are on the hook for paying more than they should for an off-patent drug.

Pharmacy benefit managers function as middlemen between drug companies and insurers and employers that sponsor health insurance plans. In too many cases, these “pharmacy benefit managers” function as shills for pharmaceutical companies to cause more expensive name-brand drugs to be used in place of low-cost generics.

How Generic Price Gouging Impacts Members

Through the International Strategic Cancer Alliance that was founded five years ago, we at Life Extension are constantly interacting with patients who utilize off-label drugs to better control their disease. Since insurance does not fully cover these medications, patients are finding it difficult to afford the cost of their medications. Here is an email excerpt from a prostate cancer patient regarding a generic medication he is using:

Cabergoline is very costly, around $600 for 60 days’ supply. This has eaten up my insurance allowance for drugs. Your latest email indicates necessity, but is it possible to lessen amounts taken without hindrance to outcomes?

Cabergoline is a generic drug that suppresses prolactin release from the pituitary gland. Life Extension has long recommended this drug to certain cancer patients, though it is not recognized by the FDA for this purpose.55 Prolactin makes prostate cells more sensitive to the growth-promoting effects of testosterone. By reducing prolactin levels, cabergoline has a potential role in prostate cancer treatment. In addition, lowering prolactin results in a reflex increase in dopamine, which has the beneficial effect of inhibiting angiogenesis—the formation of new blood vessels that facilitate the growth and spread of most cancers. Furthermore, increased dopamine enhances neurotransmission which improves clarity of thinking or cognition. Therefore, cabergoline is a true multi-tasking pharmaceutical agent that increases the therapeutic index or ratio.

The patient who sent us this email concerned about the high cost of cabergoline may risk his life by taking a lower-than-recommended dose because he can no longer afford it. Yet this is an off-patent generic drug that should cost only a fraction of what is being charged. Generic drug prices change daily, so by the time this article is published, generic cabergoline might once again be affordable, or it could cost even more.

A physician on the Life Extension’s Scientific Advisory Board wrote us about eye drops he needs for glaucoma that will cost $99.20 a month for the rest of his life, despite having Medicare and AARP. That’s $1,200 a year just for eye drops. This physician wonders how our health care system can tolerate such blatant price gouging. A calculation of the price for the generic version of this eye drug is $2.50 per drop, which prompted the dispensing pharmacist to say to the doctor, “This is a license to steal.”

Life Extension® has published over the past four decades about how generic drug prices are artificially inflated because of FDA over-regulation and pharmaceutical industry corruption.

Johnson and Johnson Settles Bribery Complaint for $70 Million
Johnson and Johnson Settles Bribery Complaint for $70 Million

As was reported in the New York Times last year, pharmaceutical behemoth Johnson & Johnson admitted to bribing European doctors and agreed to pay $70 million in civil and criminal penalties.51

The bribes were so egregious that one copy of an internal company email stated that providing “cash incentives to surgeons is common knowledge in Greece, and that once a company stops paying bribes, “We’d lose 95% of our business by the end of the year.”50

The Securities and Exchange Commission director stated that Johnson & Johnson tried to hide its activities by “using sham contracts, offshore companies and slush funds.”50

In the United States, these same kinds of activities have been uncovered whereby doctors have been paid cash kickbacks to prescribe prescription drugs against the interest of the patient.52-54

What We Are Doing to Fight Back

The October 2011 edition of Life Extension Magazine launched a new book titled Pharmocracy. This book exposes how pharmaceutical companies collude with their allies in the FDA and Congress to cause inflated drug prices.

Copies of Pharmocracy have been sent to the president, all presidential candidates, and every member of Congress. The purpose is to enlighten political leaders about free-market approaches that can resolve today’s health care cost crisis that will otherwise put Medicare, Medicaid, and the private sector on the chopping block of bankruptcy.

We initiated a massive promotion to get this book into the hands of policy-making think tanks and to the public. We need to alert them to the harsh reality that it is mathematically impossible to resolve the health care cost crisis by increasing taxes, slashing payments to doctors, or asking Medicare recipients to pay more toward their own medical expenses.

The only solution to overpriced medicine is to abolish all restrictive bureaucratic regulations and let the free market do for medical practice what it did for computers and cell phones, i.e. enable scientific breakthroughs of unparalleled magnitude to occur at rapid speed while slashing consumer costs to comparatively nothing.

Dangerous Anti-Psychotic Drugs Dumped into Demented Patients
Dangerous Anti-Psychotic Drugs Dumped into Demented Patients

An audit by the Department of Health and Human Services found that powerful drugs with horrific side effects were inappropriately prescribed to nursing home patients with dementia.56

More than half of these anti-psychotic drugs (such as Zyprexa®, Risperdal®, and Seroquel®) were paid for with Medicare dollars, costing the program $116 million over just a six-month period. These drugs are not approved for use in demented individuals because the FDA says they increase the risk of death!57

In announcing the audit results, the inspector general of the Department of Health and Human Services stated, “Government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions.”57

A pharmacy chain for nursing homes called Omnicare Inc. paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.57

In 2008, Eli Lilly, maker of Zyprexa®, settled a lawsuit with the state of Alaska for $15 million based on claims that this drug caused patients to develop diabetes.58 Despite this serious side effect, Zyprexa® was nonetheless among the drugs dumped into the bodies of elderly demented patients—often at Medicare’s expense.

The real shocker is why these anti-psychotic drugs were ever prescribed in the first place. It turns out that these drugs are used to sedate demented patients into a drugged state where they can easily be “watched.” In other words, instead of meeting the needs of the patient, they are instead drugged into a state where there is less need for one-on-one nursing care.

The care of these demented patients was thus facilitated by prescribing drugs that cause them to die sooner. In case you are wondering about the cost per patient, 30 tablets of Zyprexa® (10 mg/pill) cost over $440, and Medicare and other insurance are paying most of this!

Zyprexa® has a half-life of 21-54 hours that is 1.5 times greater in those over age 65. This means that many demented patient prescribed Zyprexa® were kept in a chronically drugged state for the duration of their lives, while pharmaceutical giant Eli Lilly took in around $14 per pill! This is just one of many reasons why Medicare is descending into insolvency.

I want to thank Life Extension members who purchased four copies of Pharmocracy (at only $8 each) to personally send one each to their two senators and representative.

For those who have not done this yet, please do not let apathy stop you from letting your voice be heard in Congress. In Syria, protestors are being murdered in the streets and dragged from their homes, yet they still defy government edicts knowing that snipers are waiting to kill them. For just $32, you can obtain four copies of Pharmocracy and send them to those in our government who have the power to change the corrupt health care system that is bankrupting this country.

While it may seem impossible to dislodge the stranglehold that pharmaceutical interests hold over the federal government, I am convinced that unrelenting exposition of the truth will tear down corrupt barriers that cause consumers to be serfs of the pharmaceutical industry.

For longer life,

For Longer Life

William Faloon

References

1. Available at: http://myhealthcafe.com/generic-drug-news-roche-files-lawsuit-to-block-low-cost-version-of-anti-nausea-drug-aloxi. Accessed November 1, 2011.Generic Drug News: Roche Files Lawsuit To Block Low-Cost Version of Anti-Nausea Drug Aloxi. July 13, 2011.

2. Available at: http://www.gnaipr.com/Articles/Astrazeneca%20files%20patent%20lawsuit%20against%20Torrent%20for%20blockbuster%20drug,%20Crestor.pdf. Accessed November 1, 2011.

3. Available at: http://www.firstwordplus.com/Fws.do?articleid=2B6F0583E27545E2BAA966606DC76FDF. Accessed November 1, 2011.

4. Available at: http://finance.yahoo.com/news/Momenta-sues-3-drugmakers-apf-3561338019.html. Accessed November 1, 2011.

5. Available at: http://www.astellas.com/en/corporate/news/pdf/080722_eg.pdf. Accessed November 1, 2011.

6. Available at: http://www.wellbutrin-lawsuit.net/blog/2010/wellbutrin-lawsuit/wellbutrin-class-action-lawsuit-against-makers-of-generic-wellbutrin-xl/. Accessed November 1, 2011.

7. Available at: http://depatentlaw.morrisjames.com/uploads/file/11%20107%20676.pdf. Accessed November 1, 2011.

8. Available at: http://www.bizjournals.com/philadelphia/stories/2010/08/16/daily28.html. Accessed November 2, 2011.

9. Available at: http://www.atg.wa.gov/pressrelease.aspx?id=19358. Accessed November 2, 2011.

10. Available at: http://www.shire.com/shireplc/en/investors/.../irshirenews?id=467. Accessed November 2, 2011.

11. Available at: http://www.biosciencetechnology.com/News/FeedsAP/2011/05/j-j-files-new-concerta-lawsuit-against-impax-labs/. Accessed November 2, 2011.

12. Available at: http://www.ssab.gov/documents/Prepub_TheUnsustainableCostofHealthCare.pdf. Accessed November 2011.

13. Available at: http://findarticles.com/p/articles/mi_m0FSW/is_5_22/ai_n17207635/. Accessed November 2, 2011.

14. Faloon W. Would you tolerate this abuse? Life Extension Magazine®. 2008 Sep; 14(9):7-12.

15. Faloon W. How much more FDA abuse can Americans tolerate? Life Extension Magazine®. 2010 Mar;16(3):12-3.

16. Faloon W. Ending the atrocities. Life Extension Magazine®. 2009 Mar; 15(3):7-12.

17. Greenwell I. Integrative approaches to cancer, cardiovascular disease and diabetes treatment. ACAM Conference, Nashville 2001. Life Extension Magazine®. 2002 Feb;8(2).

18. Cosgrove RH, Zacharski LR, Racine E, et al. Improved cancer mortality with low-molecular-weight heparin treatment: a review of the evidence. Semin Thromb Hemost. 2002 Feb;28(1):79-87.

19. Available at: http://online.wsj.com/article/SB10001424052748703632304575452450498653036.html. Accessed November 3, 2011.

20. Available at: http://www.hpm.com/pdf/LOVENOX%20-%20Sanofi%20MSJ.pdf. Accessed November 3, 2011.

21. Available at: http://finance.senate.gov/library/prints/?maxrows=25. Accessed November 3, 2011.

22. Available at: http://cardiobrief.org/2011/05/25/senate-report-uncovers-sanofi-attempts-to-stifle-generic-lovenox/. Accessed November 3, 2011.

23. Available at: http://online.wsj.com/article/SB10001424052702303654804576343753512740330.html. Accessed November 3, 2011.

24. Available at: http://www.pharmalot.com/2011/05/sanofi-enlisted-third-parties-to-influence-the-fda/. Accessed November 21, 2011.

25. Available at: http://pharmacyblogbuy.com/duke-investigates-professor-over-sanofi-contoversy/. Accessed November 3, 2011.

26. Available at: http://finance.senate.gov/newsroom/chairman/release/?id= 53bf8124-5319-4d2c-8c66-f01274a271c7. Accessed November 3, 2011.

27. Faloon W. Drug company pleads guilty to health fraud. Life Extension Magazine®. 2010 Mar;16(3):7-10.

28. Faloon W. The FDA’s most heinous drug approval. Life Extension Magazine®. 2011 Jun;17(6):7-12.

29. Faloon W. Death by regulation. Life Extension Magazine®. 2005 Mar;11(3):7-13. Death by Regulation.

30. Faloon W. Inside the Vioxx® debacle. Life Extension Magazine®. 2005 Apr; 11(4):22-8.

31. Available at: http://www.cdc.gov/injury/wisqars/pdf/Death_by_Age_2007_BW-a.pdf. Accessed November 4, 2011.

32. Brambilla P, Cipriani A, Hotopf M, Barbui C. Side-effect profile of fluoxetine in comparison with other SSRIs, tricyclic and newer antidepressants: a meta-analysis of clinical trial data. Pharmacopsychiatry. 2005 Mar;38(2):69-77.

33. Preda A, MacLean RW, Mazure CM, Bowers MB Jr. Antidepressant-associated mania and psychosis resulting in psychiatric admissions. J Clin Psychiatry. 2001 Jan;62(1):30-3.

34. Gerber PE, Lynd LD. Selective serotonin-reuptake inhibitor-induced movement disorders. Ann Pharmacother. 1998 Jun;32(6):692-8.

35. Available at: http://www.nytimes.com/2004/09/14/health/14depress.html. Accessed November 4, 2011.

36. Healy D, Aldred G. Antidepressant drug use & the risk of suicide. Int Rev Psychiatry. 2005 Jun;17(3):163-72.

37. Lovrin M. Treatment of major depression in adolescents: weighing the evidence of risk and benefit in light of black box warnings. J Child Adolesc Psychiatr Nurs. 2009 May;22(2):63-8.

38. Available at: http://psychcentral.com/blog/archives/2008/06/16/cover-up-paxil-and-suicide-risk/. Accessed November 7, 2011.

39. Available at: http://news.bbc.co.uk/2/hi/health/6308871.stm. Accessed November 7, 2011.

40. Available at: http://www.reuters.com/article/2011/11/02/us-smoking-drug-idUSTRE7A181220111102. Accessed November 7, 2011.

41. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm124818.htm. Accessed November 7, 2011.

42. Available at: http://www.ismp.org/docs/vareniclineStudy.asp. Accessed November 7, 2011.

43. Moore TJ, Glenmullen J, Furberg CD: Prescription drugs associated with reports of violence towards others. PLoS One. 2010 5:e15337.

44. Available at: http://www.fairwarning.org/2011/05/watchdog-group-says-pfizer-played-down-suicides-tied-to-chantix/. Accessed November 7, 2011.

45. Available at: http://www.msnbc.msn.com/id/43187290/ns/health-health_care/t/smoking-pill-suicides-overlooked-missing-reports/. Accessed November 7, 2011.

46. Available at: http://healthfreedoms.org/2011/06/01/high-suicide-violence-rates-from-chantix-left-out-of-safety-reviews/. Accessed November 7, 2011.

47. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm255918.htm. Accessed November 7, 2011.

48. Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S. Suicidal behavior and depression in smoking cessation treatments. PLoS One. 2011 6(11):e27016.

49. Available at: http://www.sciencedaily.com/releases/2011/11/111102190026.htm. Accessed November 19, 2011

50. Available at: http://www.nytimes.com/2011/11/12/health/plan-would-delay-sales-of-generic-for-lipitor.html?ref=business. Accessed November 13, 2011.

51. Available at: http://www.nytimes.com/2011/04/09/business/09drug.html?_r=1. Accessed November 7, 2011.

52. Available at: http://www.thehealthyhomeeconomist.com/2011/06/is-your-doctor-getting-drug-kickbacks/. Accessed Nov. 7, 2011.

53. Available at: http://www.naturalnews.com/001298.html. Accessed November 2011.

54. Available at: http://www.naturalnews.com/026963_Pfizer_Bextra.html. Accessed November 7, 2011.

55. Strum SB. Unfounded fears could limit prostate cancer treatment options. Life Extension Magazine®. 2007 Jul;13(7):12.

56. Available at: http://oig.hhs.gov/newsroom/testimony-and-speeches/levinson_051011.asp. Accessed November 7, 2011.

57. Available at: http://www.nytimes.com/2011/05/10/health/policy/10drug.html. Accessed November 7, 2011.

58. Available at: http://www.nytimes.com/2008/03/26/business/26cnd-zyprexa.html?adxnnl=1&adxnnlx=1311116701-eqFL+QZ6tJ8n5Eoh2mnTRw. Accessed November 7, 2011.