Pharma Fresh Adverse Events

In 1952, penicillin was found to be fully effective against all strains of staphylococcus, such that by the early 1960s, U.S. Surgeon General William Stewart was confident enough to proclaim: "The time has come to close the book on infectious diseases. We have basically wiped out infection in the United States."¹ Or not. Because as he spoke, some 90 percent of these strains were in the process of developing resistance to penicillin.²

In particular, methicillin-resistant S. aureus began to appear in hospitals. Only one antibiotic, vancomycin, remained effective. But in 1997, even that antibiotic was overcome as a hospital in Tokyo reported that a vancomycin-resistant strain had appeared and would spread to six other Japanese hospitals within months.³ Within a decade, the effectiveness of penicillin against hospital-acquired staph infections – to say nothing of Stewart's declaration – was "virtually annulled," according to Alexander Tomasz of the Rockefeller University, due to plasmid epidemics.⁴

Now in U.S. hospitals alone, some 14,000 people die each year from infections picked up there.⁵ And in 2002, the U.S. Centers for Disease and Control estimated that at least 90,000 deaths occur each year which could be attributed to bacterial infections, with more than half caused by bugs resistant to at least one commonly used antibiotic.⁴

What's Wrong With This Picture?

On the one hand, existing antibiotics are used inappropriately to the max, leading to the rampant development of resistance;^4,6 on the other, drug companies appear to have vacated manufacturing new antibiotics – which customarily are taken for a course of two weeks – in favor of peddling antidepressants, which are taken for life and would thus reap substantially greater profits. At least until 2001, pharmaceutical companies were described as not having issued an entirely new antibiotic since the 1970s.¹

Accordingly, in an industry that registers some $593 billion in annual sales for the top 50 companies,⁷ there is – in popular Southern dialect – a lot of 'splainin to do. For here is a situation in which:

• Half of U.S. residents over 65 take three or more medications.⁸
• Adverse drug events caused more than 100,000 hospitals admissions in the U.S. alone.⁹
• As many as 139,000 U.S. residents had heart attacks and strokes as the result of taking rofecoxib.¹⁰
• Some 15,000 U.S. residents die every year from unintentional opioid overdoses,¹¹ with increases in the use of opioids going through the roof.¹²
• And for every death there are 800 drug misusers.¹¹

It gets worse. Much worse. Drugs as the cause of death in 2009 (at least 37,485) exceeded those from motor vehicle accidents. By comparison, deaths from the Vietnam War were 58,148 for the entire 10 years in which U.S. troops were deployed. Between 2000 and 2006:

• Prescription drug fatalities more than doubled among teens and young adults.
• Deaths more than tripled among people ages 50-59.
• Prescription rates for pain meds increased 43 percent, while doses grew by 50 percent.¹³

Side Effects?

Let's look at just one popular new antidepressant: Effexor (venlafaxine), a serotonin-norepinephrine-reuptake inhibitor. Severe side effects include the following: rash, hives, itching; difficulty in breathing; tightness in the chest; swelling of the mouth, face, lips or tongue; bizarre behavior; blood in the stool; chest pain or discomfort; confusion; decreased concentration; decreased coordination; decreased urination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; memory problems; new or worsening aggressiveness; agitation, hostility, impulsiveness; inability to sit still; irritability, panic attacks or restlessness; persistent or severe ringing in the ears; red, swollen, blistered or peeling skin; seizures; severe or persistent anxiety, nervousness, or trouble sleeping; severe or persistent cough; severe or persistent headache; dizziness; stomach pain or weakness; shortness of breath, significant weight loss; suicidal thoughts or attempts; tremor; trouble concentrating; unsteadiness or loss of coordination; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision problems; and worsening of depression.¹⁴

And this from a drug company that was taken to task for inflating the effectiveness of Effexor by 27-28 percent by not publishing negative studies.¹⁵ I'm sorry – they lost me at "hives." As if that weren't bad enough, the effects of stopping Effexor could be even worse, including stomach pains and nausea; memory problems; electrical shocks; head fog; heart issues; and loss of control.¹⁶ Is this some demented scenario forcing people to continue taking this med?

Better Options

Clearly, there must be another route to follow. To discredit alternative methods of intervention in which there is substantial evidence in support of its efficacy is no longer an option. In chiropractic, for instance, the attacks against its presumed dangers ring hollow in light of such data from the RAND Corporation suggesting the rate of vertebrobasilar accidents or other complications (cord compression, fracture or hematoma) stands at 1.46 per million manipulations, with the rates of serious complications and death from cervical spine manipulations estimated to be 0.64 and 0.27 per million manipulations, respectively.¹⁷

While the judicious and well-referenced use of pharmacological interventions for specific conditions should not be so severely questioned in the absence of more conservative treatments found to be effective, there is simply no cause to allow the triple demons of profit motive, huge cost burden, and massive side effects of pharmaceuticals¹⁸ to override both the safety of health care and control of health care costs at both the individual and national levels.

References

1. Surowiecki J. "No Profit, No Cure." New Yorker, Nov. 5, 2001.
2. "Disease Fights Back." Cover story. Economist, May 20, 1995.
3. "Microbe Is Feared to Be Winning Battle Against Antibiotics." Boston Globe, May 30, 1997.
4. Taubes G. "The Bacteria Fights Back." Science, 2008;321:356-361.
5. Bryson B. A Short History of Nearly Everything. New York, NY: Broadway Books:315.
6. "Abuse of Antibiotics." Lead editorial. International Herald Tribune, June 19, 2000.
7. "The 50 Largest Pharmaceutical Companies by Sales." Aug. 14, 2011, reporting 2010 sales.
8. "Almost Half of Americans Use at Least One Prescription Drug, Annual Report on Nation's Health Shows." Centers for Disease Control and Prevention, Dec. 2, 2004.
9. Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. New England Journal of Medicine, 2011;365:2002-2012.
10. Lenzer J. "FDA Is Incapable of Protecting U.S Against Another Vioxx." British Medical Journal, 2004;329:1253.
11. Policy Impact: Prescription Painkiller Overdoses. Centers for Disease Control and Prevention, 2011.
12. Kelly JP, et al., Prevalence and characteristics of opioid use in the U.S. adult population, Pain, 2008.
13. "Drug Deaths Now Outnumber Traffic Fatalities in the U.S. Data Show." Los Angeles Times, Sept. 17, 2001.
14. Effexor side effects. Available online at www.drugs.com/sfx/effexor-side-effects.html.
15. "Stopping Effexor Is a Nightmare." Posted on www.peoplespharmacy.com.
16. "Effexor: The Marketing You Deserve." Posted on www.themarketingyoudeserve.com.
17. Hurwitz EL, Aker PD, Adams AH, Meeker WC, Shekelle PG. Manipulation and mobilization of the cervical spine: a systematic review of the literature. Spine, 1996;21(15):1746-1760.
18. Smith C, Cowan C, Sensenig A, Catlin A. Health spending growth slows in 2003. Health Affairs, 2006;24(1):186-194.