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LESSONS OF THE PAST
Victoria Lynn Jakubowski
May 2001
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Lessons of the Past
WHY STUDY THE PAST? ........................................................................................................................................3
ANALYSIS...................................................................................................................................................................5
1. FRANKENSTEIN, OR THE MODERN PROMETHEUS ...................................................................................................5
2. THE ISLAND OF DR. MOREAU ................................................................................................................................9
3. THE STRANGE CASE OF DR. JEKYLL AND MR. HYDE ...........................................................................................12
4. THE INVISIBLE MAN ............................................................................................................................................14
5. THE FOOD OF THE GODS ......................................................................................................................................17
CONCLUSION ..........................................................................................................................................................20
BIBLIOGRAPHY......................................................................................................................................................21
ENDNOTES ...............................................................................................................................................................22
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Why study the past?
Most of us are familiar with some variation of the quote "Those who cannot remember the past
are condemned to fulfill it."i
We have much to learn from our past. In the business world we are
encouraged to move forward, plan ahead, and look into the future. Ironically, the past is rarely
examined outside of academic settings. We should explore our past - not just the successes and
failures of the business world but all events which have shaped society. By reviewing the social,
cultural, and corporate issues of the past we can develop into better business leaders now.
Biotechnology is one of the hottest industries today. The field grew out of an early 19th
Century
scientific renaissance, which led to 200 years of rapid medical advances. While these endeavors
were still in their infancy, writers of the genre we now call Science Fiction warned of the
dangerous situations possible with biotech innovations. Science fiction of the 19th
Century is
often now science fact. Mary Shelley, H.G. Wells, and Robert Louis Stevenson wrote fictional
accounts of fringe research and the rogue scientists who dismissed the ethical concerns. Their
stories are even more relevant now. Today we face real-life Frankensteins and Moreaus, albeit it
infrequently. A review of these literary classics can highlight the dangers inherent in the biotech
industry when research is motivated by greed and power.
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What is Corporate Citizenship?
The term corporate citizenship is difficult to define for "there is no single indicator of good
[corporate] citizenship. It must be measured through lenses representing various viewpoints."ii
In
the biotech industry there are definitions (often conflicting) from corporations, academic
researchers, animal right activists, environmentalists, and others. While I cannot claim to have
the answer, I can offer an interpretation for this discourse. The biotech industry - including
medical, biological, and pharmaceutical organizations - faces a unique set of ethical issues.
Every product they bring forth and every piece of data they research will impact this world. As
medical research moves beyond the academic and further into the for-profit business world, good
corporate citizenship must become as important to management as is the bottom line. Here a
good corporate citizen (1) attempts to minimize any negative consequences and (2) takes
responsibility for its actions, including any unforeseen problems.
Bioethics developed in response to the rapid scientific advances of the late 18th
and early 19th
centuries. This new era of biotechnology and medical miracles unfortunately also opened a
Pandora's Box of ethical issues. One of the earliest authors of bioethics is Claude Bernard, a
renowned French physiologist. His 1865 Introduction to the Study of Experimental Medicine is
often quoted as the cornerstone of bioethics. His principle expands on the Hippocratic Oath to
"do no harm,"
It is our duty and right to perform an experiment on man whenever it can save his
life, cure him or gain him some personal benefit. The principle of medical and
surgical morality, therefore, consists in never performing on a man an
experiment, which might be harmful to him in any extent, even though the result
might be highly advantageous to science, that is, to the health of others.iii
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While most mainstream researchers and the biotech industry attempt to observe society's moral
principles, research moves rapidly - often beyond the current scope of rules. When ethical issues
are tackled, it is often as a reaction such as with the Nuremberg Code (in response to Nazi
research atrocities) and the U.S. prohibition on federal funding of cloning research (in response
to Dolly, the cloned sheep). The five science fiction books I examined are extreme situations,
similar to the irregular but dangerous events that have unfortunately occurred in our modern
society. Instead of waiting for Frankenstein to build his monster, the biotech industry should
examine the consequences of medical progress, not just profit potentials but also ethical
considerations.
Analysis
1. Frankenstein, or the Modern Prometheus (Shelley)
2. The Island of Dr. Moreau (Wells)
3. The Strange Case of Dr. Jekyll and Mr. Hyde (Stevenson)
4, The Invisible Man (Wells)
5. Food of the Gods (Wells)
1. Frankenstein, or the Modern Prometheus
Americans are probably more familiar with the Universal movie Frankenstein than with Mary
Shelley's actual gothic tale of an obsessive medical student. The student Victor Frankenstein
fixates on creation - his preoccupation is to create life from death, without thought of
consequence. Ironically Victor is horrified by his creation and abandons it. The subsequent
journey of the creature seeking his creator leaves a path of suffering and death. Finally the two,
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united in fate, are left floating on an iceberg into oblivion.
Shelley's tragic tale of Dr. Frankenstein warns of the dangers of playing God. This problem
expands far beyond a religious discussion; there is a scientific concern of going too far and
exceeding natural limits. Victor is not inspired by some greater good concept, it is his ego which
drives the man, "A new species would bless me as its creator and source; many happy and
excellent natures would owe their being to me."iv
His success at simple tissue animation
convinces him that he can immediately jump into full-scale human reanimation. Victor's
research becomes obsession - obscuring all other interest for nearly two years. Upon completion
he is repelled by his creation, "the beauty of the dream vanished, and breathless horror and
disgust filled my heart."v
It wasn't that he was troubled with the ethical ramifications of his
experiment; rather he was sickened by the final monstrous appearance of the being before him.
Victor continues to struggle with what he has done. He blames the creature solely for the death
and destruction, but Victor feels some guilt, "I had been the author of unalterable evils."vi
Nevertheless, Frankenstein never truly accepts his responsibility for the birth and subsequent
abandonment of his offspring. Ironically, when Victor comes face to face with his monster it is
the child that chastises the father.
Yet you, my creator, detest and spurn me, thy creature,…How dare you sport thus
with life?…Have I not suffered enough that you seek to increase my
misery?…Remember that I am thy creature; I ought to be thy Adam; but I am
rather the fallen angel, whom thou drivest from joy for no misdeed. Everywhere I
see bliss, from which I alone am irrevocably excluded. I was benevolent and
good, misery made me a fiend.vii
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Shelley's parable counsels us to not play God - we must not allow our egos and desire for success
to overshadow our decisions. Biotech corporations must be cautious as they proceed and
consider the consequences of medical advancement. Today researchers and governments debate
on the ethics of cloning and genetic manipulations. In 1996 fiction became fact when the Roslin
Institute in Edinburgh, Scotland presented Dolly - a cloned sheep, and the first cloned mammal.
We now face a reality with gene therapy, cloning (both as therapy and for reproductive purposes),
and the Human Genome Project (the chronicle of human genes). "As we reach these milestones,
the application to business and the human existence is enormous. And the risks are very real."viii
Cloning is a troublesome topic. Even the mainstream scientific community - eager to explore
and discover - prefer to slow down. Dolly was attempt #278, a single success with 277 failures
before it! So even while some fringe groups decide to plow ahead, the scientific world admits it
does not have enough data to successfully (and safely) clone a human. At recent congressional
hearings, the head of the FDA's Center for Biologics and Research Dr. Kathryn C. Zoon
cautioned, "current scientific data doesn't support human cloning because of the extremely high
rate of deaths and defects that have occurred with cloning other animals."ix
Ironically, at these
hearings the only two groups eager to push ahead were reproductive specialists with the bottom
line as their real goal and the company Clonaid who is overseen by a cult called the Raelian
Movement. Fortunately, the mainstream scientific community is not eager to jump feet first; we
are just beginning to comprehend the ethical issues related to cloning. Companies should act
responsibly, considering all consequences before they proceed with cloning.
Slightly less upsetting (yet still challenging) is the gene and cloning therapies currently under
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development. As the Human Genome Project progresses, we understand better how to use
genetics as prevention and treatment for a variety of diseases. As exciting and great as these
developments appear, we must remember that "the ethical and moral pitfalls are equally
monumental."x
We confront two main issues (1) the unintended consequences of these therapies,
and (2) the abuse of the data collected on individuals. Because this area is so new, we do not yet
fully understand the long-term effects of such therapies. Additionally, we do not know how
these therapies could affect the future children of the patient. These, and other important
questions, must be considered before we attempt to cure the world. Conventional scientists are
cautious about the innovations. For example, "James Gusella, the discoverer of the marker for
the dominant Huntington's disease gene, did not make the information available…until four
years after the discovery."xi
A second concern, the abuse of data collected, extends far beyond the privacy debate. As more
tests are developed to detect genetic defects, there is a larger opportunity for abuse of the
information acquired. It is not only the companies who are developing tests and treatments, but
also the employers and insurance companies making health coverage decisions. On one hand,
having all the data available can help providers make better decisions. However, this
information can also be abused - such as denying individuals coverage or employment for no
other reason than a possibility of future problems as detected by a gene map. A case just now
unfolding involves Burlington Northern Railway, who has begun testing workers who complain
of carpal tunnel syndrome to see if they had a genetic disposition. This has expanded the debate:
The real concern involves what might happen to the information such testing
creates. What sorts of decisions will be made based on the information and who
will have access to it? Employers may try to make hiring and firing decisions
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based on the genetic risks of workers. In shades of an Orwellian novel, groups of
potential workers with particular genetic profiles could be excluded from entire
areas of employment and selected for others. In more concrete terms, workers'
benefits could be limited based on a range of genetically pre-existing
conditions.xii
Privacy and civil rights are old debates, but this genetic fortune telling is a new chapter. While
the intent may be to save lives with genetic mapping and treatments, there are unintended
consequences and abuses to examine closely before moving forward.
2. The Island of Dr. Moreau
Like Frankenstein, this H.G. Wells classic demonstrates the dangers of scientific exploration
without a conscience. Dr. Moreau views himself as a creator. Never satisfied with his mutations,
the animal experiments are rejected and tossed out to fend for themselves. We are told the story
of this madman by a shipwrecked Englishman (Edward Prendick) who is rescued and taken to
the island Dr. Moreau calls his laboratory. Moreau is a vivisectionist - a surgeon. He surgically
alters animals, creating a humanoid race of wild beasts. Always dissatisfied with the turnout,
Moreau continues to tamper with the animals' bodies and minds. Ironically, he is eventually
killed by one of his own creations.
The main lesson in this story is that the ends do not justify the means. We cannot allow the act
of research to overshadow the reason for research - which should be medical progress that
benefits society. Edward muses about Dr. Moreau's obsession, "He might perhaps have
purchased his social peace by abandoning his investigations, but he apparently preferred the
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latter, as most men would who have once fallen under the overmastering spell of research."xiii
Further Edward noted that these "triumphs of vivisection"xiv
had no purpose. Moreau's intent
was to experiment for the sake of his own sick curiosity. "It was the wantonness that stirred
me…he was so irresponsible, so utterly careless. His curiosity, his mad, aimless investigations,
drove him on." xv
These animals did not have to be surgically altered - the research had no real
meaning - there was no benefit. Research should have a purpose, and that purpose should be to
benefit society.
Companies want to quickly advance technology, but they should also pause to consider of the
aftermath. The mere fact that it can be done does not it mean that it should be done. Dr. Moreau
ignored the impact of his work, "For my part I'm puzzled why the things I have done here have
not been done before… It all lay in the surface of practical anatomy years ago, but no one had the
temerity to touch it."xvi
He admits he ignores the ethical considerations and feels no
responsibility for his work, "I asked a question, devised some methods of getting an answer, and
got -- a new question…To this day I have never troubled about the ethics of the matter."xvii
To
dismiss and ignore ethical considerations has far reaching consequences. The biotech industry
should realize that the impact of their research and products can extend beyond the original
intent, but not always beneficially.
Nazi Germany is perhaps the most extreme example of modern savagery. The Third Reich,
under administrators such as Dr. Mengella, tortured human beings in the name of research. Few
in the scientific community then or now would embrace the Nazi experiments. It wasn't research
to better the human race, but instead crimes against humanity. In response to the atrocities, the
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Doctors' Trial was held, accusing 23 medical doctors and administrators of
…murder, tortures and other atrocities committed in the name of medical
science…subjecting unwilling victims to medical procedures that were loosely called
'scientific experiments,' thereby having caused their death, disfigurement, or
disability…Never before or since has medicine's major moral mandate, 'do no harm,'
been so flagrantly, unambiguously, and indefensibly violated than by the Nazi crime.xviii
Consequently, the Nuremberg Code (primarily penned by American Dr. Andrew C. Ivy) was
adopted as international law on 19 July 1947. The 10 points of the code include ethical
considerations such as "The voluntary consent of the human subject is absolutely essential.
[…and…] The experiment should be such as to yield fruitful results for the good of society.
[…and…] The experiment should be conducted as to avoid all unnecessary physical and mental
suffering and injury."xix
Ironically, many non-German doctors believed "It was a good code for barbarians but an
unnecessary code for ordinary physicians."xx
No ethical scientist would accept the experiments
as legitimate research: depriving people of oxygen until they died, freezing victims to death,
infecting people with malaria and other diseases then administering experimental treatments
(many died from the infections and many more from the therapies), testing various sterilization
techniques, and poisoning people for observation. However, fringe elements exist, often
clandestine. Fortunately, as research intensified after the war, international and national
organizations were motivated to ensure it did not happen again. The World Medical Association
ratified Principles for Those in Research and Experimentation in 1954. Then in 1964 the
Helsinki Declarations further demonstrated that "research in which the aim is primarily
diagnostic or therapeutic for a particular patient (called clinical research) is distinguished from
research that is purely scientific, without expected benefit for the patient (nonclinical
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research)."xxi
As advancements are made international and national organizations continue to
update bioethics, issuing reports, laws, and moratoriums to keep the risks in check. Altering the
natural order, or playing God, has consequences that must be explored, considered, and dealt
with appropriately.
3. The Strange Case of Dr. Jekyll and Mr. Hyde
Robert Louis Stevenson's story of Jekyll and Hyde is well known by most Americans, having
read the book in high school or seen one of the dozen movie adaptations. Dr. Jekyll is a scientist
determined to separate man into his good and evil sides. "If each, I told myself, could be housed
in separate identities, life would be relieved of all that was unbearable…and no longer exposed to
disgrace and penitence by the hands of this extraneous evil.xxii
Jekyll seems briefly concerned
with the potential negative consequences, but quickly ignores his doubts. The development of
Mr. Hyde allows Dr. Jekyll to toss off the cloak of respectability and live dangerously. Even at
the end Jekyll blames his creation for the depraved activities, ignoring his responsibility for what
he has created. It is only with his own death that his evil is stopped and the truth is released.
Henry Jekyll allows his research to cloud his judgment. "But the temptation of a discovery so
singular and profound at last overcame the suggestions of alarm."xxiii
His preoccupation with
discovery outweighs his concern with the aftermath; he will not stop. "That night I had come to
the fatal cross-roads. Had I approached my discovery in a more noble spirit, had I risked the
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experiment while under the empire of generous or pious aspirations, all might have been
otherwise."xxiv
Upon awakening as Jekyll he would attempt to repair the damage done by Hyde.
Unfortunately, even when Dr. Jekyll realized that negatives of his experiment outweighed the
positives, he would not stop. In today's rapid medical advancements companies must
occasionally pause and consider any negative outcomes before continuing with their research.
Just as Jekyll wanted to spare man of his evil side, we have tried to medicate our troubles away.
Pharmaceutical companies may be crossing ethical lines in their marketing of personality -
changing drugs such as Ritalin and Prozac. There are real disorders that these drugs successfully
treat; they clearly have a societal benefit. Many in the medical population fear are that the
disorders in questions are often overdiagnosed and thus we are over prescribing. "Prescriptions
of the drug Ritalin to control ADHD have increased several-fold over the past decade, leading
many experts to worry that the disorder is being overdiagnosed."xxv
Such a suspicion led
pediatric psychologist Gretchen LeFever to study of 30,000 grade-school students in two school
districts in Virginia. She found the students in these districts were diagnosed 2-3 times the
national average. Dr. Mary Ann Block - author of No More Ritalin - is even more anxious over
current trends, "These drugs are mind-altering drugs. And in the case of Ritalin, it's a drug almost
identical to cocaine -- goes to the same receptor site in the brain, causes the same high when
taken in the same manner."xxvi
We still do not know the long-term effects of Ritalin, which used
to be prescribed for relatively short periods but now kids are on it for years. We do not know
how safe the drug is for younger children, yet we are already giving it to preschoolers.
Additionally, there is concern that these drugs are sometimes used to treat personality and not
illness. It is not ethical to use these drugs in order to change people (even under the guise of
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improvement) when the patient is not ill. The pharmaceutical companies should not market
Ritalin to parents as a "cure" for childhood and the doctors must not be so quick to label and
medicate children. They must demonstrate responsible medicine - using caution when designing
or prescribing pharmaceuticals.
4. The Invisible Man
In this classic mad scientist story by H.G. Wells, Griffin (a well-respected chemistry student)
discovers how light refraction can be manipulated to make things invisible. A recent adaptation
of this story, Hollow Man, aptly depicts the control that experimentation can hold on a scientist.
Griffin is possessed by his ego, "An invisible man is a man of power."xxvii
"To do such a thing
would be to transcend magic…Drawbacks I saw none.xxviii
" He is oblivious to any ramifications,
“I looked about me…and tried to think of all the fantastic advantages and invisible man would
have in the world."xxix
When he runs out of money to fund his research, he turned on everyone -
including his own father. Once again the scientist's research obsession obscures any other
consideration.
His experiments progresses rapidly: a piece of cloth, his landlord's cat, and then himself. "My
head was already teeming with plans of all the wild and wonderful things I had now impunity to
do."xxx
Ironically, he overlooks a weakness - he is walking about town barefoot and naked,
exposed to the elements. "I was half minded to accost some passer-by and throw myself upon his
mercy."xxxi
He is forced to occasionally become visible (through a mummy-like existence).
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Griffin immediately turns to criminal activity in order to finance his new life. Of course he
mistakenly believed his actions as essential not unlawful, “Robbing! Confound it! You'll call me
a thief next."xxxii
The mad scientist believes he is superior to ordinary man and thus his behavior
is always appropriate. Griffin's ultimate insanity - his power makes him a legitimate ruler, a
dictator. "He must take some town…and terrify and dominate it…And all who disobey his
orders he must kill, and kill all who would defend the disobedient."xxxiii
Griffin is undone by his
boasting; eventually beaten to death by the ordinary people he so despised.
We cannot brush aside the concept of a mad scientist as a horror movie cliché. Although
examples are few, some 20th
Century scientists have breached the most basic of medical ethics:
do no harm. The literary scientist Griffin is described as, "He's mad…inhuman. He is pure
selfishness. He thinks nothing but his own advantage."xxxiv
Sadly, these adjectives aptly
describe the scientists who conducted the Tuskegee Syphilis Study in Macon County Georgia,
which began in the 1930 and did not end until discovery in the 1970s. These men simply
watched 400 black males suffer and die from syphilis - without offering any education about the
disease or any treatments. The scientists took this opportunity to observe the natural progress of
the disease. Unfortunately, it was at the expense of the study's unwitting patients. When the
study was exposed, a panel convened to investigate the ethical questions. The panel's 1973
report acknowledged that there was 40 years of hindsight, "nevertheless, one fundamental ethical
rule is that a person should not be subject to avoidable risk of death or physical harm."xxxv
The
scientist behaved unethically. While the world prospers from scientific and medical
advancements, we must proceed with caution. It takes only one renegade researcher to take
science beyond it intended good and turn it into unmitigated horror.
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Griffin was motivated solely by personal gain. His intelligence and passion was wasted on
selfishness. When corporations act selfishly and seek only personal gains, they may
inadvertently harm their community around them. Profit is important for companies to survive,
yet they cannot ignore their obligation to behave ethically and responsibly. We currently face an
international controversy surrounding how companies price the AIDS cocktail, especially in the
developing countries. AIDS treatments are extremely expensive, even by US standards.
Unfortunately, 90% of the people infected with the AIDS virus live in developing countries,
where treatments exceed many times over the annual wages. In a surprise move, several
pharmaceutical companies agreed in April 2001 to lower prices in various countries such as
Brazil and South Africa. Participants in the United Nations discussions included Abbott
Laboratories, Bristol-Myers Squibb Co., Boehringer Ingelheim GmbH, Pfizer Inc., Roche
Holding Ltd. and GlaxoSmithKline. Ironically, by finally agreeing to sell these drugs at a no
profit level, pharmaceuticals companies disclosed a long-kept secret - the true amount of profit
they receive on drug sales. "Several drug makers have revealed that some medicines are priced --
excluding research expenses -- at eight to 10 times their cost of manufacturing and
distribution."xxxvi
Seeking profits does not lead a company to unethical behavior; wanting to
make a profit is not unethical. Nevertheless, if the focus is not on the greater good but confined
to profit margins the biotech industry could face unintended negative consequences.
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5. The Food of the Gods
This H.G. Wells story illustrates how all consequences of scientific endeavors must be
completely considered before proceeding. The scientists in this story are oblivious to any
negative consequences of their growth formula, called the Food. It worked by eliminating the
resting phases between growth spurts found in most organisms. The developers believe that
society would benefit greatly and that they would have amazing monetary rewards, "When he
first thought of the thing he saw, as it were, a vista of enormous possibilities - literally enormous
possibilities."xxxvii
They thought they could end world hunger and food shortages. By feeding
chickens the Food, they could grow larger chickens in shorter times and feed entire towns with
only a few animals.
Unfortunately, the men impatiently jumped right into the trial run with chickens, "Experimental
work is the most tedious thing in the world…and it seemed a long time to Mr. Bensington before
his first dream of enormous possibilities was replaced by a crumb of realization."xxxviii
What
they did not foresee was the negative outcomes. The experimental chickens were bitten by
insects, which then grew. The insects also spread the food to rats. As if fighting giant insects
and rodents was not bad enough, the human experiment was an even bigger disaster. Redwood
had begun feeding the Food to his son even before the chicken experiment. The giant race
created came to see the small humans as inferior beings. The boy and others like him believed
the Food was only good and they plotted to spread it throughout the world. "It is not that we
would oust the little people from the world…in order that we …may hold their world
forever…We fight not for ourselves but for growth, growth that goes on forever." The Food must
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continue.
The pharmaceutical companies seem to be continuously releasing a new miracle drug. Rarely do
these drugs perform miracles, and sometimes with unforeseen (or ignored) consequences. Only a
few decades ago that an amazing new drug Thalidomide was introduced as a sleeping pill.
Believed to also relieve morning sickness, Thalidomide was prescribed to thousands of pregnant
women, resulting in severe birth defects including limb deformity. On 15 July 1962, the
Washington Post broke the story of numerous European children born missing one or more
limbs. At that time Merrell Pharmaceuticals in America was putting intense pressure on the FDA
to approve Thalidomide (brand name Kevedon). Despite its lack of FDA acceptance
Thalidomide was available on the market as an experimental drug. By the time it was stopped,
doctors had given samples of the drug to over 20,000 women in America. In 1960 Dr. Kelsey of
the FDA had noted that "Merrell had compiled an interesting collection of meaningless
pseudoscientific jargon apparently intended to impress chemically unsophisticated readers."xxxix
Later the British Medical Journal cautioned about user side effects, and then possible fetal
effects began to emerge. Merrell finally withdrew its FDA application in March 1962, shortly
before the story broke in the Washington Post. Shortly thereafter the "Kefauver-Harris
amendments [to the Senate's Federal Food, Drug and Cosmetic Act] strengthened the
government's control over the approval of new drugs, demanding 'substantial evidence of
efficacy' and requiring for the first time full and free consent of all subjects of drug trials
conducted within the United States."xl
The tragedy of Thalidomide is "a story of moral
courage…commercial greed and political collusion."xli
Merrell's biggest mistake was putting
profit before benefit.
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Despite these lessons, pharmaceutical companies still bring miracle drugs into the market only to
be recalled after "unforeseen" and tragic events, such as the drug combination known as Fen-
Phen, which was released as a revolution in the realm of weight control. Unfortunately, some of
the drugs - Fenfluramine and Dexfenfluramine - were recalled in 1997. The Mayo Clinic
reported that 24 patients had developed heart valve disease, and then more cases were reported.
Even patients without histories of heart disease developed problems while on the drugs. These
drugs are still off the market. Ironically, around this same time the FDA finally approved
Thalidomide - but only as a treatment for leprosy. The treatment includes extensive warnings for
women. Doctors who prescribe Thalidomide must closely monitor their female patients,
including regular pregnancy tests. Nonetheless, there are still some who complain about the
hurdles in getting drug approval by the FDA. We forget that sometimes getting a drug on the
market is motivated by profit, not the greater good. Drug companies should be inspired more by
patient improvement and less by monetary returns.
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Conclusion
Positive Corporate Citizenship is more vital in the world of biotechnology than in most other
industries, since the actions of this industry will affect millions of people in the most personal
ways. Classical writers of the 19th
Century forewarned us of abuses, now shunned by most
researchers:
• Medical professionals cannot play God - they may not abuse their abilities.
• Companies must consider all consequences to their actions.
• Drugs should be properly tested and marketed appropriately.
• Profits should not be the only motivating factor.
• Research must be conducted in a cautious and ethical manner.
The biotech industry should be aware of the fact that problems can and do arise. However, by
concentrating on the people that they could be helping, and not just on the bottom-line, biotech
companies could address these issues before they develop into problems. A desire for
profitability is to be expected and not dangerous or wrong in itself, but money must not be the
focus in such a sensitive industry. Neither is research for the sake of personal glory noble, for
research can be prone to ego-driven errors. Biotech, medical, and pharmaceutical companies
must never be negligent in their responsibility to be a positive corporate citizen, serving the
needs of its community.
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Dow Jones Newswires
March 27, 2001 Abbott Labs Confirms Cutting AIDS Drugs Prices in Africa
March 28, 2001 Congress, Pres Bush Move Toward Banning Human Cloning
April 4, 2001 South African Pres Advisory Council Releases AIDS Report
April 5, 2001 UN Chief Urges Pharm Co Execs To Cut AIDS-Drug Prices
CNN.com
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http://www.cnn.com/HEALTH/9909/01/adhd.overdiagnosis/index.html
May 2, 2000 Professional group seeks consistency in diagnosing attention deficiency in children
http://www.cnn.com/2000/HEALTH/05/02/adhd.diagnosis/index.html
22
Endnotes
i
George Santayana, Life of Reason, Vol 1, Chapter 12, Flux and Constancy in Human Nature
ii
http://www.business-ethics.com/100best.htm#Cover Story
iii
Jonsen et al, page 5
iv
Shelley, page 47
v
Shelley, page 51
vi
Shelley, page 92
vii
Shelley, Pages 100-101
viii
Baker & deGruyther, page 37
ix
Middleton
x
Brockett and Tankersley, page 1662
xi
Brockett and Tankersley, page 1662
xii
http://www.cnn.com/2001/HEALTH/02/19/ethics.matters/index.html
xiii
Wells, page 88
xiv
Wells, page 113
xv
Wells, page 131
xvi
Wells, page 113
xvii
Wells, page 116
xviii
Jonsen, page 134
xix
Jonsen et al,. page 12
xx
Jonsen, page 137
xxi
Jonsen, page 136
xxii
Stevenson, page 80
xxiii
Stevenson, page 81
xxiv
Stevenson, page 84
xxv
http://www.cnn.com/2000/HEALTH/05/02/adhd.diagnosis/index.html
xxvi
http://www.cnn.com/HEALTH/9909/01/adhd.overdiagnosis/index.html
xxvii
Wells, page 191
xxviii
Wells, page 221
xxix
Wells, page 225
xxx
Wells, page 228
xxxi
Wells, page 232
xxxii
Wells, pages 240-241
xxxiii
Wells, page 244
xxxiv
wells, page 246
xxxv
Jonsen et al, page 78
xxxvi
Harris, page A1
xxxvii
Well, page 534
xxxviii
Wells, page 541
xxxix
Jonsen, page 140
xl
Jonsen, page 141
xli
Jonsen, page 142

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Lessons_of_the_past

  • 1. 1 LESSONS OF THE PAST Victoria Lynn Jakubowski May 2001
  • 2. 2 Lessons of the Past WHY STUDY THE PAST? ........................................................................................................................................3 ANALYSIS...................................................................................................................................................................5 1. FRANKENSTEIN, OR THE MODERN PROMETHEUS ...................................................................................................5 2. THE ISLAND OF DR. MOREAU ................................................................................................................................9 3. THE STRANGE CASE OF DR. JEKYLL AND MR. HYDE ...........................................................................................12 4. THE INVISIBLE MAN ............................................................................................................................................14 5. THE FOOD OF THE GODS ......................................................................................................................................17 CONCLUSION ..........................................................................................................................................................20 BIBLIOGRAPHY......................................................................................................................................................21 ENDNOTES ...............................................................................................................................................................22
  • 3. 3 Why study the past? Most of us are familiar with some variation of the quote "Those who cannot remember the past are condemned to fulfill it."i We have much to learn from our past. In the business world we are encouraged to move forward, plan ahead, and look into the future. Ironically, the past is rarely examined outside of academic settings. We should explore our past - not just the successes and failures of the business world but all events which have shaped society. By reviewing the social, cultural, and corporate issues of the past we can develop into better business leaders now. Biotechnology is one of the hottest industries today. The field grew out of an early 19th Century scientific renaissance, which led to 200 years of rapid medical advances. While these endeavors were still in their infancy, writers of the genre we now call Science Fiction warned of the dangerous situations possible with biotech innovations. Science fiction of the 19th Century is often now science fact. Mary Shelley, H.G. Wells, and Robert Louis Stevenson wrote fictional accounts of fringe research and the rogue scientists who dismissed the ethical concerns. Their stories are even more relevant now. Today we face real-life Frankensteins and Moreaus, albeit it infrequently. A review of these literary classics can highlight the dangers inherent in the biotech industry when research is motivated by greed and power.
  • 4. 4 What is Corporate Citizenship? The term corporate citizenship is difficult to define for "there is no single indicator of good [corporate] citizenship. It must be measured through lenses representing various viewpoints."ii In the biotech industry there are definitions (often conflicting) from corporations, academic researchers, animal right activists, environmentalists, and others. While I cannot claim to have the answer, I can offer an interpretation for this discourse. The biotech industry - including medical, biological, and pharmaceutical organizations - faces a unique set of ethical issues. Every product they bring forth and every piece of data they research will impact this world. As medical research moves beyond the academic and further into the for-profit business world, good corporate citizenship must become as important to management as is the bottom line. Here a good corporate citizen (1) attempts to minimize any negative consequences and (2) takes responsibility for its actions, including any unforeseen problems. Bioethics developed in response to the rapid scientific advances of the late 18th and early 19th centuries. This new era of biotechnology and medical miracles unfortunately also opened a Pandora's Box of ethical issues. One of the earliest authors of bioethics is Claude Bernard, a renowned French physiologist. His 1865 Introduction to the Study of Experimental Medicine is often quoted as the cornerstone of bioethics. His principle expands on the Hippocratic Oath to "do no harm," It is our duty and right to perform an experiment on man whenever it can save his life, cure him or gain him some personal benefit. The principle of medical and surgical morality, therefore, consists in never performing on a man an experiment, which might be harmful to him in any extent, even though the result might be highly advantageous to science, that is, to the health of others.iii
  • 5. 5 While most mainstream researchers and the biotech industry attempt to observe society's moral principles, research moves rapidly - often beyond the current scope of rules. When ethical issues are tackled, it is often as a reaction such as with the Nuremberg Code (in response to Nazi research atrocities) and the U.S. prohibition on federal funding of cloning research (in response to Dolly, the cloned sheep). The five science fiction books I examined are extreme situations, similar to the irregular but dangerous events that have unfortunately occurred in our modern society. Instead of waiting for Frankenstein to build his monster, the biotech industry should examine the consequences of medical progress, not just profit potentials but also ethical considerations. Analysis 1. Frankenstein, or the Modern Prometheus (Shelley) 2. The Island of Dr. Moreau (Wells) 3. The Strange Case of Dr. Jekyll and Mr. Hyde (Stevenson) 4, The Invisible Man (Wells) 5. Food of the Gods (Wells) 1. Frankenstein, or the Modern Prometheus Americans are probably more familiar with the Universal movie Frankenstein than with Mary Shelley's actual gothic tale of an obsessive medical student. The student Victor Frankenstein fixates on creation - his preoccupation is to create life from death, without thought of consequence. Ironically Victor is horrified by his creation and abandons it. The subsequent journey of the creature seeking his creator leaves a path of suffering and death. Finally the two,
  • 6. 6 united in fate, are left floating on an iceberg into oblivion. Shelley's tragic tale of Dr. Frankenstein warns of the dangers of playing God. This problem expands far beyond a religious discussion; there is a scientific concern of going too far and exceeding natural limits. Victor is not inspired by some greater good concept, it is his ego which drives the man, "A new species would bless me as its creator and source; many happy and excellent natures would owe their being to me."iv His success at simple tissue animation convinces him that he can immediately jump into full-scale human reanimation. Victor's research becomes obsession - obscuring all other interest for nearly two years. Upon completion he is repelled by his creation, "the beauty of the dream vanished, and breathless horror and disgust filled my heart."v It wasn't that he was troubled with the ethical ramifications of his experiment; rather he was sickened by the final monstrous appearance of the being before him. Victor continues to struggle with what he has done. He blames the creature solely for the death and destruction, but Victor feels some guilt, "I had been the author of unalterable evils."vi Nevertheless, Frankenstein never truly accepts his responsibility for the birth and subsequent abandonment of his offspring. Ironically, when Victor comes face to face with his monster it is the child that chastises the father. Yet you, my creator, detest and spurn me, thy creature,…How dare you sport thus with life?…Have I not suffered enough that you seek to increase my misery?…Remember that I am thy creature; I ought to be thy Adam; but I am rather the fallen angel, whom thou drivest from joy for no misdeed. Everywhere I see bliss, from which I alone am irrevocably excluded. I was benevolent and good, misery made me a fiend.vii
  • 7. 7 Shelley's parable counsels us to not play God - we must not allow our egos and desire for success to overshadow our decisions. Biotech corporations must be cautious as they proceed and consider the consequences of medical advancement. Today researchers and governments debate on the ethics of cloning and genetic manipulations. In 1996 fiction became fact when the Roslin Institute in Edinburgh, Scotland presented Dolly - a cloned sheep, and the first cloned mammal. We now face a reality with gene therapy, cloning (both as therapy and for reproductive purposes), and the Human Genome Project (the chronicle of human genes). "As we reach these milestones, the application to business and the human existence is enormous. And the risks are very real."viii Cloning is a troublesome topic. Even the mainstream scientific community - eager to explore and discover - prefer to slow down. Dolly was attempt #278, a single success with 277 failures before it! So even while some fringe groups decide to plow ahead, the scientific world admits it does not have enough data to successfully (and safely) clone a human. At recent congressional hearings, the head of the FDA's Center for Biologics and Research Dr. Kathryn C. Zoon cautioned, "current scientific data doesn't support human cloning because of the extremely high rate of deaths and defects that have occurred with cloning other animals."ix Ironically, at these hearings the only two groups eager to push ahead were reproductive specialists with the bottom line as their real goal and the company Clonaid who is overseen by a cult called the Raelian Movement. Fortunately, the mainstream scientific community is not eager to jump feet first; we are just beginning to comprehend the ethical issues related to cloning. Companies should act responsibly, considering all consequences before they proceed with cloning. Slightly less upsetting (yet still challenging) is the gene and cloning therapies currently under
  • 8. 8 development. As the Human Genome Project progresses, we understand better how to use genetics as prevention and treatment for a variety of diseases. As exciting and great as these developments appear, we must remember that "the ethical and moral pitfalls are equally monumental."x We confront two main issues (1) the unintended consequences of these therapies, and (2) the abuse of the data collected on individuals. Because this area is so new, we do not yet fully understand the long-term effects of such therapies. Additionally, we do not know how these therapies could affect the future children of the patient. These, and other important questions, must be considered before we attempt to cure the world. Conventional scientists are cautious about the innovations. For example, "James Gusella, the discoverer of the marker for the dominant Huntington's disease gene, did not make the information available…until four years after the discovery."xi A second concern, the abuse of data collected, extends far beyond the privacy debate. As more tests are developed to detect genetic defects, there is a larger opportunity for abuse of the information acquired. It is not only the companies who are developing tests and treatments, but also the employers and insurance companies making health coverage decisions. On one hand, having all the data available can help providers make better decisions. However, this information can also be abused - such as denying individuals coverage or employment for no other reason than a possibility of future problems as detected by a gene map. A case just now unfolding involves Burlington Northern Railway, who has begun testing workers who complain of carpal tunnel syndrome to see if they had a genetic disposition. This has expanded the debate: The real concern involves what might happen to the information such testing creates. What sorts of decisions will be made based on the information and who will have access to it? Employers may try to make hiring and firing decisions
  • 9. 9 based on the genetic risks of workers. In shades of an Orwellian novel, groups of potential workers with particular genetic profiles could be excluded from entire areas of employment and selected for others. In more concrete terms, workers' benefits could be limited based on a range of genetically pre-existing conditions.xii Privacy and civil rights are old debates, but this genetic fortune telling is a new chapter. While the intent may be to save lives with genetic mapping and treatments, there are unintended consequences and abuses to examine closely before moving forward. 2. The Island of Dr. Moreau Like Frankenstein, this H.G. Wells classic demonstrates the dangers of scientific exploration without a conscience. Dr. Moreau views himself as a creator. Never satisfied with his mutations, the animal experiments are rejected and tossed out to fend for themselves. We are told the story of this madman by a shipwrecked Englishman (Edward Prendick) who is rescued and taken to the island Dr. Moreau calls his laboratory. Moreau is a vivisectionist - a surgeon. He surgically alters animals, creating a humanoid race of wild beasts. Always dissatisfied with the turnout, Moreau continues to tamper with the animals' bodies and minds. Ironically, he is eventually killed by one of his own creations. The main lesson in this story is that the ends do not justify the means. We cannot allow the act of research to overshadow the reason for research - which should be medical progress that benefits society. Edward muses about Dr. Moreau's obsession, "He might perhaps have purchased his social peace by abandoning his investigations, but he apparently preferred the
  • 10. 10 latter, as most men would who have once fallen under the overmastering spell of research."xiii Further Edward noted that these "triumphs of vivisection"xiv had no purpose. Moreau's intent was to experiment for the sake of his own sick curiosity. "It was the wantonness that stirred me…he was so irresponsible, so utterly careless. His curiosity, his mad, aimless investigations, drove him on." xv These animals did not have to be surgically altered - the research had no real meaning - there was no benefit. Research should have a purpose, and that purpose should be to benefit society. Companies want to quickly advance technology, but they should also pause to consider of the aftermath. The mere fact that it can be done does not it mean that it should be done. Dr. Moreau ignored the impact of his work, "For my part I'm puzzled why the things I have done here have not been done before… It all lay in the surface of practical anatomy years ago, but no one had the temerity to touch it."xvi He admits he ignores the ethical considerations and feels no responsibility for his work, "I asked a question, devised some methods of getting an answer, and got -- a new question…To this day I have never troubled about the ethics of the matter."xvii To dismiss and ignore ethical considerations has far reaching consequences. The biotech industry should realize that the impact of their research and products can extend beyond the original intent, but not always beneficially. Nazi Germany is perhaps the most extreme example of modern savagery. The Third Reich, under administrators such as Dr. Mengella, tortured human beings in the name of research. Few in the scientific community then or now would embrace the Nazi experiments. It wasn't research to better the human race, but instead crimes against humanity. In response to the atrocities, the
  • 11. 11 Doctors' Trial was held, accusing 23 medical doctors and administrators of …murder, tortures and other atrocities committed in the name of medical science…subjecting unwilling victims to medical procedures that were loosely called 'scientific experiments,' thereby having caused their death, disfigurement, or disability…Never before or since has medicine's major moral mandate, 'do no harm,' been so flagrantly, unambiguously, and indefensibly violated than by the Nazi crime.xviii Consequently, the Nuremberg Code (primarily penned by American Dr. Andrew C. Ivy) was adopted as international law on 19 July 1947. The 10 points of the code include ethical considerations such as "The voluntary consent of the human subject is absolutely essential. […and…] The experiment should be such as to yield fruitful results for the good of society. […and…] The experiment should be conducted as to avoid all unnecessary physical and mental suffering and injury."xix Ironically, many non-German doctors believed "It was a good code for barbarians but an unnecessary code for ordinary physicians."xx No ethical scientist would accept the experiments as legitimate research: depriving people of oxygen until they died, freezing victims to death, infecting people with malaria and other diseases then administering experimental treatments (many died from the infections and many more from the therapies), testing various sterilization techniques, and poisoning people for observation. However, fringe elements exist, often clandestine. Fortunately, as research intensified after the war, international and national organizations were motivated to ensure it did not happen again. The World Medical Association ratified Principles for Those in Research and Experimentation in 1954. Then in 1964 the Helsinki Declarations further demonstrated that "research in which the aim is primarily diagnostic or therapeutic for a particular patient (called clinical research) is distinguished from research that is purely scientific, without expected benefit for the patient (nonclinical
  • 12. 12 research)."xxi As advancements are made international and national organizations continue to update bioethics, issuing reports, laws, and moratoriums to keep the risks in check. Altering the natural order, or playing God, has consequences that must be explored, considered, and dealt with appropriately. 3. The Strange Case of Dr. Jekyll and Mr. Hyde Robert Louis Stevenson's story of Jekyll and Hyde is well known by most Americans, having read the book in high school or seen one of the dozen movie adaptations. Dr. Jekyll is a scientist determined to separate man into his good and evil sides. "If each, I told myself, could be housed in separate identities, life would be relieved of all that was unbearable…and no longer exposed to disgrace and penitence by the hands of this extraneous evil.xxii Jekyll seems briefly concerned with the potential negative consequences, but quickly ignores his doubts. The development of Mr. Hyde allows Dr. Jekyll to toss off the cloak of respectability and live dangerously. Even at the end Jekyll blames his creation for the depraved activities, ignoring his responsibility for what he has created. It is only with his own death that his evil is stopped and the truth is released. Henry Jekyll allows his research to cloud his judgment. "But the temptation of a discovery so singular and profound at last overcame the suggestions of alarm."xxiii His preoccupation with discovery outweighs his concern with the aftermath; he will not stop. "That night I had come to the fatal cross-roads. Had I approached my discovery in a more noble spirit, had I risked the
  • 13. 13 experiment while under the empire of generous or pious aspirations, all might have been otherwise."xxiv Upon awakening as Jekyll he would attempt to repair the damage done by Hyde. Unfortunately, even when Dr. Jekyll realized that negatives of his experiment outweighed the positives, he would not stop. In today's rapid medical advancements companies must occasionally pause and consider any negative outcomes before continuing with their research. Just as Jekyll wanted to spare man of his evil side, we have tried to medicate our troubles away. Pharmaceutical companies may be crossing ethical lines in their marketing of personality - changing drugs such as Ritalin and Prozac. There are real disorders that these drugs successfully treat; they clearly have a societal benefit. Many in the medical population fear are that the disorders in questions are often overdiagnosed and thus we are over prescribing. "Prescriptions of the drug Ritalin to control ADHD have increased several-fold over the past decade, leading many experts to worry that the disorder is being overdiagnosed."xxv Such a suspicion led pediatric psychologist Gretchen LeFever to study of 30,000 grade-school students in two school districts in Virginia. She found the students in these districts were diagnosed 2-3 times the national average. Dr. Mary Ann Block - author of No More Ritalin - is even more anxious over current trends, "These drugs are mind-altering drugs. And in the case of Ritalin, it's a drug almost identical to cocaine -- goes to the same receptor site in the brain, causes the same high when taken in the same manner."xxvi We still do not know the long-term effects of Ritalin, which used to be prescribed for relatively short periods but now kids are on it for years. We do not know how safe the drug is for younger children, yet we are already giving it to preschoolers. Additionally, there is concern that these drugs are sometimes used to treat personality and not illness. It is not ethical to use these drugs in order to change people (even under the guise of
  • 14. 14 improvement) when the patient is not ill. The pharmaceutical companies should not market Ritalin to parents as a "cure" for childhood and the doctors must not be so quick to label and medicate children. They must demonstrate responsible medicine - using caution when designing or prescribing pharmaceuticals. 4. The Invisible Man In this classic mad scientist story by H.G. Wells, Griffin (a well-respected chemistry student) discovers how light refraction can be manipulated to make things invisible. A recent adaptation of this story, Hollow Man, aptly depicts the control that experimentation can hold on a scientist. Griffin is possessed by his ego, "An invisible man is a man of power."xxvii "To do such a thing would be to transcend magic…Drawbacks I saw none.xxviii " He is oblivious to any ramifications, “I looked about me…and tried to think of all the fantastic advantages and invisible man would have in the world."xxix When he runs out of money to fund his research, he turned on everyone - including his own father. Once again the scientist's research obsession obscures any other consideration. His experiments progresses rapidly: a piece of cloth, his landlord's cat, and then himself. "My head was already teeming with plans of all the wild and wonderful things I had now impunity to do."xxx Ironically, he overlooks a weakness - he is walking about town barefoot and naked, exposed to the elements. "I was half minded to accost some passer-by and throw myself upon his mercy."xxxi He is forced to occasionally become visible (through a mummy-like existence).
  • 15. 15 Griffin immediately turns to criminal activity in order to finance his new life. Of course he mistakenly believed his actions as essential not unlawful, “Robbing! Confound it! You'll call me a thief next."xxxii The mad scientist believes he is superior to ordinary man and thus his behavior is always appropriate. Griffin's ultimate insanity - his power makes him a legitimate ruler, a dictator. "He must take some town…and terrify and dominate it…And all who disobey his orders he must kill, and kill all who would defend the disobedient."xxxiii Griffin is undone by his boasting; eventually beaten to death by the ordinary people he so despised. We cannot brush aside the concept of a mad scientist as a horror movie cliché. Although examples are few, some 20th Century scientists have breached the most basic of medical ethics: do no harm. The literary scientist Griffin is described as, "He's mad…inhuman. He is pure selfishness. He thinks nothing but his own advantage."xxxiv Sadly, these adjectives aptly describe the scientists who conducted the Tuskegee Syphilis Study in Macon County Georgia, which began in the 1930 and did not end until discovery in the 1970s. These men simply watched 400 black males suffer and die from syphilis - without offering any education about the disease or any treatments. The scientists took this opportunity to observe the natural progress of the disease. Unfortunately, it was at the expense of the study's unwitting patients. When the study was exposed, a panel convened to investigate the ethical questions. The panel's 1973 report acknowledged that there was 40 years of hindsight, "nevertheless, one fundamental ethical rule is that a person should not be subject to avoidable risk of death or physical harm."xxxv The scientist behaved unethically. While the world prospers from scientific and medical advancements, we must proceed with caution. It takes only one renegade researcher to take science beyond it intended good and turn it into unmitigated horror.
  • 16. 16 Griffin was motivated solely by personal gain. His intelligence and passion was wasted on selfishness. When corporations act selfishly and seek only personal gains, they may inadvertently harm their community around them. Profit is important for companies to survive, yet they cannot ignore their obligation to behave ethically and responsibly. We currently face an international controversy surrounding how companies price the AIDS cocktail, especially in the developing countries. AIDS treatments are extremely expensive, even by US standards. Unfortunately, 90% of the people infected with the AIDS virus live in developing countries, where treatments exceed many times over the annual wages. In a surprise move, several pharmaceutical companies agreed in April 2001 to lower prices in various countries such as Brazil and South Africa. Participants in the United Nations discussions included Abbott Laboratories, Bristol-Myers Squibb Co., Boehringer Ingelheim GmbH, Pfizer Inc., Roche Holding Ltd. and GlaxoSmithKline. Ironically, by finally agreeing to sell these drugs at a no profit level, pharmaceuticals companies disclosed a long-kept secret - the true amount of profit they receive on drug sales. "Several drug makers have revealed that some medicines are priced -- excluding research expenses -- at eight to 10 times their cost of manufacturing and distribution."xxxvi Seeking profits does not lead a company to unethical behavior; wanting to make a profit is not unethical. Nevertheless, if the focus is not on the greater good but confined to profit margins the biotech industry could face unintended negative consequences.
  • 17. 17 5. The Food of the Gods This H.G. Wells story illustrates how all consequences of scientific endeavors must be completely considered before proceeding. The scientists in this story are oblivious to any negative consequences of their growth formula, called the Food. It worked by eliminating the resting phases between growth spurts found in most organisms. The developers believe that society would benefit greatly and that they would have amazing monetary rewards, "When he first thought of the thing he saw, as it were, a vista of enormous possibilities - literally enormous possibilities."xxxvii They thought they could end world hunger and food shortages. By feeding chickens the Food, they could grow larger chickens in shorter times and feed entire towns with only a few animals. Unfortunately, the men impatiently jumped right into the trial run with chickens, "Experimental work is the most tedious thing in the world…and it seemed a long time to Mr. Bensington before his first dream of enormous possibilities was replaced by a crumb of realization."xxxviii What they did not foresee was the negative outcomes. The experimental chickens were bitten by insects, which then grew. The insects also spread the food to rats. As if fighting giant insects and rodents was not bad enough, the human experiment was an even bigger disaster. Redwood had begun feeding the Food to his son even before the chicken experiment. The giant race created came to see the small humans as inferior beings. The boy and others like him believed the Food was only good and they plotted to spread it throughout the world. "It is not that we would oust the little people from the world…in order that we …may hold their world forever…We fight not for ourselves but for growth, growth that goes on forever." The Food must
  • 18. 18 continue. The pharmaceutical companies seem to be continuously releasing a new miracle drug. Rarely do these drugs perform miracles, and sometimes with unforeseen (or ignored) consequences. Only a few decades ago that an amazing new drug Thalidomide was introduced as a sleeping pill. Believed to also relieve morning sickness, Thalidomide was prescribed to thousands of pregnant women, resulting in severe birth defects including limb deformity. On 15 July 1962, the Washington Post broke the story of numerous European children born missing one or more limbs. At that time Merrell Pharmaceuticals in America was putting intense pressure on the FDA to approve Thalidomide (brand name Kevedon). Despite its lack of FDA acceptance Thalidomide was available on the market as an experimental drug. By the time it was stopped, doctors had given samples of the drug to over 20,000 women in America. In 1960 Dr. Kelsey of the FDA had noted that "Merrell had compiled an interesting collection of meaningless pseudoscientific jargon apparently intended to impress chemically unsophisticated readers."xxxix Later the British Medical Journal cautioned about user side effects, and then possible fetal effects began to emerge. Merrell finally withdrew its FDA application in March 1962, shortly before the story broke in the Washington Post. Shortly thereafter the "Kefauver-Harris amendments [to the Senate's Federal Food, Drug and Cosmetic Act] strengthened the government's control over the approval of new drugs, demanding 'substantial evidence of efficacy' and requiring for the first time full and free consent of all subjects of drug trials conducted within the United States."xl The tragedy of Thalidomide is "a story of moral courage…commercial greed and political collusion."xli Merrell's biggest mistake was putting profit before benefit.
  • 19. 19 Despite these lessons, pharmaceutical companies still bring miracle drugs into the market only to be recalled after "unforeseen" and tragic events, such as the drug combination known as Fen- Phen, which was released as a revolution in the realm of weight control. Unfortunately, some of the drugs - Fenfluramine and Dexfenfluramine - were recalled in 1997. The Mayo Clinic reported that 24 patients had developed heart valve disease, and then more cases were reported. Even patients without histories of heart disease developed problems while on the drugs. These drugs are still off the market. Ironically, around this same time the FDA finally approved Thalidomide - but only as a treatment for leprosy. The treatment includes extensive warnings for women. Doctors who prescribe Thalidomide must closely monitor their female patients, including regular pregnancy tests. Nonetheless, there are still some who complain about the hurdles in getting drug approval by the FDA. We forget that sometimes getting a drug on the market is motivated by profit, not the greater good. Drug companies should be inspired more by patient improvement and less by monetary returns.
  • 20. 20 Conclusion Positive Corporate Citizenship is more vital in the world of biotechnology than in most other industries, since the actions of this industry will affect millions of people in the most personal ways. Classical writers of the 19th Century forewarned us of abuses, now shunned by most researchers: • Medical professionals cannot play God - they may not abuse their abilities. • Companies must consider all consequences to their actions. • Drugs should be properly tested and marketed appropriately. • Profits should not be the only motivating factor. • Research must be conducted in a cautious and ethical manner. The biotech industry should be aware of the fact that problems can and do arise. However, by concentrating on the people that they could be helping, and not just on the bottom-line, biotech companies could address these issues before they develop into problems. A desire for profitability is to be expected and not dangerous or wrong in itself, but money must not be the focus in such a sensitive industry. Neither is research for the sake of personal glory noble, for research can be prone to ego-driven errors. Biotech, medical, and pharmaceutical companies must never be negligent in their responsibility to be a positive corporate citizen, serving the needs of its community.
  • 21. 21 Bibliography Baker, Mark W. And Degruyther, Nigel: October 2000, "Protecting Ideas", Risk Management Magazine, pages 35-43. Blank, Robert H. and Bonnicksen, Andrea L. [editors]: 1992, Emerging Issues in Biomedical Policy, (Columbia University Press, New York). Brocket, Patrick L. and Takersleym E. Susan: November 1997, "The Genetics revolution, Economics, Ethics, and Insurance", Journal of Business Ethics, pages 1661-1676. Harris, Gardiner (April 23, 2001): "AIDS Gaffes in Africa Come Back To Haunt Drug Industry in the U.S.", the Wall Street Journal. Jonsen, Albert R.: 1998, the Birth of Bioethics, (Oxford University Press, New York). Jonsen, Albert R. et al [editors]: 1998, Source Book in Bioethics, (Georgetown University Press, Washington D.C.). Levine, Carol [editor]: 1999, Taking Side - Clashing Views on Controversial Bioethical Issues 8th Edition, (Duskin/McGraw-Hill, Connecticut). Middleton, Otesa (March 28, 2001): "FDA Official Says Cloning Too Unsafe To Approve", The Wall Street Journal. Newton, Lisa H. and Ford, Maureen M. [editors]: 1998, Taking Side - Clashing Views on Controversial Business Ethics and Society 5th Edition, (Duskin/McGraw-Hill, Connecticut). Shelley, Mary: 1818 [1973 reprint), Frankenstein or the Modern Prometheus, (Dutton, New York). Stevenson, Robert Louis: 1886 [1981 reprint], Dr. Jekyll and Mr. Hyde, (Bantam Books, New York) Wells, Herbert George: 1978 edition, The Complete Science Fiction Treasury of H. G. Wells, (Avenel Books, New York). The Invisible Man The Island of Dr. Moreau The Food of the Goods Wilmont, Stephen: 2001, Corporate Moral Responsibility: "What Can We infer from Our Understanding of Organizations", Journal of Business Ethics, Volume 30, pages 161-169. Dow Jones Newswires March 27, 2001 Abbott Labs Confirms Cutting AIDS Drugs Prices in Africa March 28, 2001 Congress, Pres Bush Move Toward Banning Human Cloning April 4, 2001 South African Pres Advisory Council Releases AIDS Report April 5, 2001 UN Chief Urges Pharm Co Execs To Cut AIDS-Drug Prices CNN.com September 1, 1999 ADHD may be overdiagnosed, study says http://www.cnn.com/HEALTH/9909/01/adhd.overdiagnosis/index.html May 2, 2000 Professional group seeks consistency in diagnosing attention deficiency in children http://www.cnn.com/2000/HEALTH/05/02/adhd.diagnosis/index.html
  • 22. 22 Endnotes i George Santayana, Life of Reason, Vol 1, Chapter 12, Flux and Constancy in Human Nature ii http://www.business-ethics.com/100best.htm#Cover Story iii Jonsen et al, page 5 iv Shelley, page 47 v Shelley, page 51 vi Shelley, page 92 vii Shelley, Pages 100-101 viii Baker & deGruyther, page 37 ix Middleton x Brockett and Tankersley, page 1662 xi Brockett and Tankersley, page 1662 xii http://www.cnn.com/2001/HEALTH/02/19/ethics.matters/index.html xiii Wells, page 88 xiv Wells, page 113 xv Wells, page 131 xvi Wells, page 113 xvii Wells, page 116 xviii Jonsen, page 134 xix Jonsen et al,. page 12 xx Jonsen, page 137 xxi Jonsen, page 136 xxii Stevenson, page 80 xxiii Stevenson, page 81 xxiv Stevenson, page 84 xxv http://www.cnn.com/2000/HEALTH/05/02/adhd.diagnosis/index.html xxvi http://www.cnn.com/HEALTH/9909/01/adhd.overdiagnosis/index.html xxvii Wells, page 191 xxviii Wells, page 221 xxix Wells, page 225 xxx Wells, page 228 xxxi Wells, page 232 xxxii Wells, pages 240-241 xxxiii Wells, page 244 xxxiv wells, page 246 xxxv Jonsen et al, page 78 xxxvi Harris, page A1 xxxvii Well, page 534 xxxviii Wells, page 541 xxxix Jonsen, page 140 xl Jonsen, page 141 xli Jonsen, page 142