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 an animal to a human, they will assert the validity of using them in place of humans for their drugs, held up like religion, 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 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 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.
Thos
e 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 re present 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.
[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. http://www.nti.org/d_newswire/issues/2002/6/4/9s.html
[5] United States Department of Labor, Bureau of Labor Statistics: “Pharmaceutical and Medicine Manufacturing” http://www.bls.gov/oco/cg/CGS009.htm
[6] FDA, “Adverse Event Reporting System (AERS)” 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
Here are some 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/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/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.
http://www..fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm054709.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/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/PublicHealthAdvisories/ucm051284.html
“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/PublicHealthAdvisories/ucm051285.html
“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/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
Stacey Rakic is a Featured Writer for the Negotiation Is Over Blog Network. Stacey is an uncompromising animal liberationist and committed activist. She shares NIO’s vision and, while we are above-ground activists, we value and defend the real freedom fighters — our underground militant direct actors. This project unites animal liberationists with a specific agenda: TO KEEP THE PRO-VIVISECTION MOVEMENT UNDER A MICROSCOPE.
I invite you to join the NIO blog network and take a stand for those imprisoned in labs. Remember, if they could fight back, their tormentors would have expired long ago. We have an obligation to expose the abusers. It is the LEAST we can do! I welcome your emails & look forward to adding your name to our team.
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I guess its truth time. And this needs to be said.
I suffer terribly from Fibromyalgia. I was bedridden for almost three years on heavy pain meds just to get me through the days so I wouldn’t blow my brains out. All the the nerves in my back are shot, my nerves in my back are all over active, it crippling. It all started about 15 years ago and then finally put me in bed.They had me on some really heavy drugs including Halcion, what a trip…I’ll make a long story short, then my doctor called me 5 years ago and said there is a new drug out just for Fibro, do you want to be part of this, I said, oh yes..They put me on a drug called, Lyrica, I’m sure you’ve seen it on the tube. I’m 5′2″ and have always weighed between 110 and 115 pounds at the most. I’m not a big eater, my favorites being salads and my husbands vegan pasta and pumpkin raviolis. This is so fucking hard for me..My weight is now almost 40 pounds more, the drugs took at least 75% of my pain away but they didn’t test the humans like they said they did. My diet never changed, its still the same. Nothing helps, I was able to get in touch with many people that started this drug and its the same damn story. We started calling the drug company and they told us nobody had complained about this and they knew nothing about it. BULLSHIT!!! Hundreds of us have called, maybe in the 1000’s…They also told us this drug was not addicting, jesus christ, it takes so much to addict me and when I tried to go off, my body ended up in shock and I was rushed to the hospital. They said, never try this alone. I was weaned off and ended up back in bed with pain I just couldn’t live with. It was either take my life or go back on Lyrica, I chose the drug, they have me hooked and 40 pounds over weight, I hardly ever leave our home. I’ve put all of my clothes away and now wear sweatshirts, I really like them but I’m wearing them for the wrong reason. If my husband of 40 years was not so patient and loving, he would have been gone long ago. I could go on forever but I’m tired. For the last 15 years, drugs have ruled my life. Don’t judge me until you’ve lived my life……
i am thankful to stacey rakic for article of Dec.1
I am trustee at rajkot cancer hospital a charitable hospital similar to 501(c) 3 organisation in USA enjoying tax exemption. last year poniard of california had a clinical trial of their drug picoplatin at our hospital and signing contract with our radiotherapist dr gupta as prinicpal investigator without taking any permission from trusteeboard. We have doubt about the working of ethic committe and we have been requesting poniard to get their trial audited by independent firm for clincial trails.
We are not getting any respond to our e mails.
I can send you copy of my letters sent.
Due to this commercial practice our institute has lost tax exemption.
Are there any restriction in USA for 501(C)3 trust on commercial income.
Where can i complaint in usa for this unfair practice at our hospital.
Are there any internationall human right group with connections in India who may visit our institute and verify all is well with poor patients.
Kishore Ghiya mob.+919825217857 e mail pcbak@sify.com
To, stacey,
Pl find my e mail on poniard
From Kishore P. Ghiya
M .K.Ghiya Bldg, Diwanpara, Rajkot India. Dt 19.8.09 Mob. 09825217857
To, Anna Lewak Wight,
Vice President legal
Poniard, USA
Dear Mem,
I am referring to your letter dt. May 7th addressed to our chairman Dr. Pravin Doshi,the copy of which is sent to all the members of governing council who are meeting today on 19.8.2009.Received the copy only two days back and since you had mentioned my name ,I am addressing this letter.
It would have been very much appreciated if the same letter’s copy was sent to me so that I could have discussed the matter with other donors and trustees of this not for profit(charitable) hospital. Which is solely dependent upon public donor’s contributions for carrying out the noble work of treating cancer patients.
We are governed by an original mandate of October 1969 which is recorded with the office of charity commissioner’s office. If you wish you can get copy from your PI dr. gupta with whom you have signed an agreement,it is a public document, it prohibits this institute to carry any commercial activity and for this sacrifice government gives income tax exemption to the trust and also donors get concessional treatment on their tax payments.
Our Income tax exemption under 80(g) and Under 135 2(c) is no more valid after 1.4.2009. We are now without any tax benefits and our donors have abandoned us.. This has happened solely because your man Partha Chaterjee signed contract directly with dr. Gupta without even taking donor’s or trustees in confidence.
The issue now is a moral and ethical one, would Poniard done such thing in USA, where people believe in democracy and right to information?. I wish you can at least reply me whether I have any right to write this letter. Your Mr. Ajit Nair in India does not believe and in spite of several requests to visit and meet all the members of governing council and trustees to learn the issue, he has not even cared to initiate the dialogue.
A kind response from your side will soothe the feelings of my family members and friends who have donated their hard earned wealth to the cause of treatment of poor cancer patients in this area. Cancer Patients are without any insurance companies help and govt. is overburdened and private donations are the only source of help..
By separate mail I have sent an article called BODIES FOR HIRE for your information.
Yours sincerely,
Kishore Ghiya Donor, trustee, Founder Member and Member of governing council.
Rajkot Cancer Society, a public trust no. F 111.
I agree with everything that Ms. Stacy Rakic wrote in this informative and real article.
I know what I am about to say will be shocking and appalling to some. We have so many humans on this planet that should not be able to waste the air we breathe. I believe in “human testing”. It is logical and is the only way to move forward in developing real medical breakthroughs, safely and in a timely fashion. To this day, I cannot figure out what makes us humans so self righteous and narcissistic to believe we are the higher being on this planet. Believing that we have rights to do what we want to anything…other than to our own species. We have more faults than any other living creature. Along with the power of having a brain that works in a way that we can build bombs, drive cars, etc., comes a brain is also riddled with faults and sin. Such as rape, murder, lying, cheating, stealing, etc. Now why would our brain be considered higher than and more prized than that of an animal? In believe, we are the “dumb” creatures existing on this planet. Just in the past two weeks, I would be able to hand pick countless qualified humans I think should be put into a human testing program. What right does a human have when they have raped or killed another? What value do they have? Some might say, what value does a rat have”. I say, when man commits a horrible act, their rights to exist should be denied or they relinquish the common human rights to whatever us ethical humans see fit, such as human testing. I for one, do not wish to pay for these monsters food, special snacks in commissary, health care, recreation, special programs, college or GED programs, water, electricity, television, cable, phone service, laundry detergent, internet court appeals, lawyers, paper work, clothes, art supplies, etc. Some criminals are in jail for 50 years, costing us, the hard working, taxpaying, law abiding, ethical, American citizens millions. Some living better than people on the outside. These humans to me are perfect candidates to help mankind and pay back what is due to society. People believe that my thinking will be suggesting that atrocities such as the holocaust were okay. That is not true and cannot be compared to justified human testing. If we need to play PSA’s twenty-four hours a day (stating what should already be common sense), “if you commit a crime, you will be appropriately punished.” “If you have willing committed a horrific crime you will become a human lab rat.” That way every human cannot claim they didn’t know the consequences of being a worthless human in society. No surprises and no whining and crying about it. Everyone would be informed of the obvious. It is a sad truth that people get all up in arms when they or their loved one gets locked up for life with the three strikes you’re out law or the receives the death penalty. All of the sudden the laws are unjust and you hear, “my baby is a good person”. There are no victim’s rights, just as animals do not have any rights. Even though animals, think, feel and want what we want…to live and be happy and healthy. Shame on humans for thinking we are so wonderful, all knowing and the highest creatures. Those descriptions are that of only one… God. I am sure God doesn’t ever look down and bow his head with sadness, about anything an animal has ever done, but I believe he does when he looks at the train wreck of what humans have done and become. I would rather be judged by my maker for testing on humans that are monsters, than mostly worthless testing on another living creature that has never even had a bad thought. We can improve the health and future of deserving humans, by eliminating the faulted, evil humans and utilizing the one thing they can offer back to society, their bodies for testing.
Greg, you’ve said it all…..