Pharmaceutical Roulette

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By Stacey Larson

We are physiologically complex beings, a mystery in so many ways. But when we fall ill, we applaud the availability and ease of drugs and rarely study the warnings and potential interactions. Indeed, even with ineffective experiences or negative reactions, we drop dollar after dollar satisfying our seemingly-insatiable appetite for drugs, spending billions of dollars per year supporting our medical addiction. Our culture celebrates drugs; we see glossy advertisements promising the prevention of cancer and diseases and flirty commercials offering sexual youth and practically run to our doctors faster than they can enable our addiction with promises scribbled on pads. We take these drugs in faith, awaiting results that provide physical well-being. Some are grateful: the antibiotic medically necessary to cure potentially-lethal infections will have few critics. Some are satisfied: the drugs meant to create lala interludes may produce happy customers. And then there are those who are unsatisfied: the medications meant to help or heal will result in disastrous and even fatal effects, their victims succumbing to detrimental conditions, paying with their well-being, longevity, or life.

In what can almost be considered an indifferent attitude towards these harmful and lethal effects, we ignore these stories, our momentary shock quickly evolving to moderate disinterest, not concerned with the messy details of medical errors and drug reactions. The story of the child dying unexpectedly from a drug reaction is met with horror and then quickly dissolves into relief over the well-being of our own children, with the mental note to never accept the bad drug. The story of the teenager who committed suicide after being prescribed a medication to prevent such is met with questions, some doubt, and little interest: maybe he didn’t take it or maybe she was too mentally ill. But whatever the news, whatever the article, whatever the gossip, we embrace our drugs with zeal and anticipation, the negative stories little more than casual talk with neighbors or the topic of special-interest groups we largely ignore.

Except this is not a minor problem or an isolated incident to be met with temporary feigned interest or apathetic attention. Pharmaceuticals breed adverse drug reactions (ADR) in the amount of two million “serious” separate occurrences per year, causing necessary hospital admissions as the result of potentially-fatal and even lethal effects, and, according to the FDA, making ADRs the “4th leading cause of death—ahead of pulmonary disease, diabetes, AIDS, pneumonia, accidents, and automobile deaths.” [1] We cannot pride ourselves on our attention to safety or pseudo compassionate approaches to healthcare with these statistics shadowing the pharmaceutical industry like ominous dark clouds.

Sadly, in yet another tale of greed, the pharmaceutical industry, worth tens of billions of dollars [2], is based largely on what I would consider guesswork, sloppy attention, and fraudulent data derived from testing on non-human species for the primary development of human species-based drugs. The premise itself is laughable in any other context: talk about a mouse being used as a human replacement and you are met with the shocked and indignant reactions of speciest banalities: you absolutely, positively, unequivocally cannot compare a mouse to a human! a mouse is not a person! my child is more important than a mouse! We’ve heard it, over and over, but as much as the majority collective whines about the indecency of comparing a non-human animal to a human animal, they will assert the validity of using them in place of humans for their drugs, held up like religion and worshiped like an idol. Indeed, we are witness to an epic contradiction, but we’ve discussed that…

The FDA, which regulates drugs, has established protocols regarding the testing, approval, and administration of new medications. This is a rather rigorous process taking years and consisting of preclinical trials, in which non-human animals are used as testing subjects, and clinical trials, of which are four human-testing phases [3]. In what is indicatively a game of trial and mostly error, according to Imre Szebik of the Biomedical Ethics Unit of McGill University, “less than 25 percent of those drugs that have been shown effective on animals gets approval from authorities,” [4] or to present it in total numbers, according to the FDA, “drug screening is an incredibly risky, laborious, and costly process—only 1 in every 5,000 to 10,000 compounds screened eventually becomes an approved drug.” [5] which leads me to the obvious question: what happened to the other 75%, and why don’t those figures coincide mathematically?

Indeed, if less than 25% of all drugs that even advance to the human phase testing level are considered “successful” following the human trials, why do you suppose the other 75% is considered unsuccessful? Because they proved harmful, ineffective, or inadequate when used in humans? Yes. This establishes the fact that animals are not accurate predictors of human drug effects and therefore, if you cannot adequately predict safety or efficacy issues, then using animals is ineffective in general. Indeed, if we could adequately determine the effects of drugs using animals, then human trials would be completely unnecessary. As such, if we acknowledge that data from animal testing cannot be extrapolated to humans, as demonstrated by the need for human testing trials prior to a general administration of drugs, then why are animals used at all? To determine a “general” idea relative to safety of them? If they cannot be used to predict a human outcome in general, then how can they be used to predict safety? They cannot, but like every other punned cash cow, the profiteers of such will shield their illogical and unethical practices under the auspices of moral pursuit, concealed within a euphemistic cloak of human solicitude. And it’s rarely questioned.

If it seems convoluted, it’s because it is convoluted, the details of fussy spreadsheets and tedious studies. A brief examination will reveal the chaotic nature of non-human animal testing, the results redundant and inconsistent, the effects hidden in obscure references and manuals. But, the essence of my mathematical challenge is the fact that only a fraction of drugs initially tested on animals actually receive subsequent FDA approval. Additionally, any confidence in animal testing providing legitimate results fails to acknowledge that, if credible, human testing would be inessential. Animal testing is therefore fundamentally erroneous, a landscape of quicksand upon which the foundation of your health is precariously posed, the potentiality of disaster always looming. Indeed, when a chunk of the population is consistently victimized by drugs deemed safe and effective as the result of animal testing, we as a population need to demand efficacy in the process, eliminating that which has proven not only false, but also debilitating and fatal: the reliance on the antiquated process of animal testing.

Animals are not the benefactors of human moral conscience or logic. They are also not valid testing subjects; indeed, as established, the actual test subjects are humans: your family, your friends, your neighbors, children, the elderly, society. In fact, the FDA maintains an electronic clearinghouse used to gather and disseminate information relative to negative drug reactions and interactions; this reference is referred to as the Adverse Event Reporting System (AERS) as part of the FDA’s MedWatch program. [6] Although unarguably an important resource, serving to assemble and distribute vital and even life-saving information, the necessity of its existence is disturbing. Browse through the site and you’ll be confronted with thousands of cases, the results of drugs and their subsequent negative impacts, not determined previously via animal testing. Because the scope of such is so irrefutably large, it should cause a protestation of substantial proportions including those outside the AR community, but while there are interested groups, a larger outcry is necessary but disturbingly silent.

In yet another example, a common administration of drugs, called off-label use, is nothing short of hazardous speculation using humans as unapproved testing subjects: not endorsed by the FDA, off-label drug use is a physician’s legal practice of prescribing a medication for an unintended use. [7] Indeed, the commonality of the practice is disturbing in both its ease and acceptance, especially considering that, in one medical specialty, pediatrics, according to Dr. Sydney Spiesel, Yale Medical School of Pediatrics, “somewhere between 50 percent and 75 percent of all medications used by pediatricians are, in fact, used off-label..” [8] Parents, your children are the testing subjects, prescribed alarmingly strong and potentially dangerous medications in the absence of known effects. If you embrace animal testing as a means to avoid any unanticipated and hazardous results, especially in children, your loyalty is misplaced. One not only has to object to animal testing in general, but also when drugs are used in manners outside their FDA-approved applications, rendering animal testing even more pointless.

Those who relentlessly, ignorantly, and selfishly uphold animal testing as legitimate will join the idiot parade of the greedy leading the blind. But, when something is broken, you fix it. This is not an arguable premise. When drugs prove harmful to such a large segment of people there is something fundamentally wrong with the testing process; we are not dogs or rats or sheep and it is therefore an accurate conclusion that animal testing is the element that needs improvement by abolition and replacement. I accept that doctors and scientists with long names and bookish resumes would scoff at my pretentiousness and arrogance, the little gal with no initials or scientific accolades. But I represent each one of those two million people who are also absent the scientific requisites and ivory tower admittance: we are all patients and potential patients who rely on drugs to improve our health or heal us, not make us ill or kill us, and these victims should be more than mere statistics, ignored after the nightly news and forgotten after the morning. Yes, we are complex beings, but that complexity should also pave our roads with intellectual contributions and reliable testing protocols, driving us to the 21st century where, in person we are, but in thought we are not.

Animal testing is fundamentally sadistic and cruel. But to those who regard specieism with selfish and arrogant attitude, you must – must – accept the inherent barbarity of using humans as testing subjects. It is with complacency that you fail to make this injurious and essentially inhumane connection, and when we fail to demand change, we are absolutely supporting the status quo of non-change. Why are there not more people demanding a movement so loud and brazen as to effect this ethical change? Where are you all? Yes, I am an animal rights activist, and yes, I may embrace bias as do all, but there is a lack of human concern that is infecting everyone, limiting our potential, masking our selfishness with financial and self success and camouflaging our apathy with personal concern; we have an opportunity to produce moral results, shaming our animal testing into history and disavowing our self-serving promotions. While mine is ethical endeavor, yours may be more practical, but with commitment comes comradeship. It is time to excuse marginal attempts and embrace reality: the need to change begins with you.

SRL


[1] “FDA, Preventable Adverse Drug Reactions: A Focus on Drug Interactions” http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm110632.htm

[2] Annual Reports: Industry, Major Drug Manufacturers. http://www.annualreports.com/

[3] “The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective” http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm

[4] “U.S. Response: Some Experts Express Caution on New FDA Measures”, June 4, 2002. David Ruppe, U.S. Response; Some Experts Express Caution on New FDA Measures, Harvard

[5] United States Department of Labor, Bureau of Labor Statistics: “Pharmaceutical and Medicine Manufacturing” http://www.bls.gov/oes/2011/may/naics4_325400.htm

[6] FDA, “Adverse Event Reporting System (FAERS)” http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm

[7] US Department of Health and Human Services, “Off-Label Drugs: What You Need to Know”, Carolyn M. Clancy, M.D. http://www.ahrq.gov/consumer/cc/cc042109.htm

[8] NPR podcast transcript, “Prozac Isn’t The Same In A Kid’s Body” http://www.npr.org/templates/transcript/transcript.php?storyId=95985619


Adverse event examples:

“7/1/2009 The FDA is notifying the public that the use of Chantix (varenicline) or Zyban (bupropion hydrochloride), two prescription medicines that are used as part of smoking cessation programs, has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions. The FDA is requiring the manufacturers of these products, including generic versions of Zyban (bupropion), to add a new Boxed Warning to the product labeling to alert healthcare professionals to this important new safety information.”
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm169988.htm

“Public Health Advisory: Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings
The FDA has been made aware of information about certain transdermal patches (medicated patches applied to the skin) that contain aluminum or other metals in the backing of the patches. Patches that contain metal can overheat during an MRI scan and cause skin burns in the immediate area of the patch.”
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm111313.htm

“Suicidal Thoughts and Behavior Antiepileptic Drugs
FDA is issuing this advisory to inform you of the results of our completed review of clinical trials to see if patients who took antiepileptic drugs had more episodes of suicidal thoughts or behaviors than those who did not take one of these drugs.
<span style=”text-decoration:underline;  http://www.fda.gov/Drugs/DrugSafety/DrugSafetyPodcasts/ucm077078.htm

“Use of Codeine By Some Breastfeeding Mothers May Lead To Life-Threatening Side Effects In Nursing Babies
FDA has important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine. Differences in drug metabolism among mothers taking codeine may contribute to side effects in nursing infants.”
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm054717.htm

“Tegaserod maleate (marketed as Zelnorm)
FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm. Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.”
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051284.htm

“The FDA is notifying you that the companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage. Two new studies showed that patients with Parkinson’s disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug.”
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051285.htm

“Life-threatening Brain Infection in Patients with Systemic Lupus Erythematosus After Rituxan (Rituximab) Treatment
FDA has received reports of the death of two patients who were treated with Rituxan for systemic lupus erythematosus (SLE). Both patients developed a life-threatening viral infection of the brain. This infection is called progressive multifocal leukoencephalopathy (PML). PML is caused by the JC virus and is usually fatal. There are no known effective treatments for PML.”
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm124345.htm

“Six men remain in intensive care after being taken ill during a clinical drugs trial in north-west London. The healthy volunteers were testing an anti-inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction. Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill.”
http://news.bbc.co.uk/2/hi/uk_news/england/london/4807042.stm




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fix one thing,
by breaking
another.
big pharm
gets its way.
we pay the
price,
not very nice…
but for big pharm
profits(like crime)
pays..

grrrrrrrrrrrrrrrrrrrrrr

Karen Lyons Kalmenson