The Case of Pfizer

"Pfizer" is sometimes a bad word in the medical industry. I've even heard some people at work say that when they interact with anything Pfizer, they immediately run. However, this is an interesting dichotomy we are dealing with, because while many distrust this huge pharmaceutical company (pharma), it is simultaneously the world's largest pharma company. I decided this week to look at a recent and ongoing case involving Pfizer, and analyze it from a bioethicist's point of view.

Pfizer is currently involved in a multimillion dollar lawsuit involving "off-label" claims they had trained their sales staff to make about their product Rapamune. Once again, we have another case of a pharma company unable to find a balance between being ethical and selling their product in any way that they can. In this particular case, Pfizer is being accused of targeting patients who need a heart, lung, liver, or pancreas transplant and trying to get doctors to prescribe Rapamune. Rapamune is a drug that reduces immune response in patients so that they don't reject a new transplant. However, the only FDA-approved transplants that this drug has been approved for on-label is kidney transplants. Many sources in this case claim Pfizer reps approached them encouraging the use of their drug in off-label cases such as heart, lung, and liver transplants. These uses have no data to support their efficacy, so should not be encouraged in the least. This is just one of many cases of pharma companies (or medical device companies) stretching the limits of what claims they can make just for a pretty penny.

This should really be alarming to most people. It begs the question, what is most important to these companies? Communicating the safe and correct use of a drug or device, or making a large profit off of the sickness and health problems of others? Having worked in the industry, I'd like to think that generally, most professionals and businesses want to be honest and ethical. They're not out there trying to harm people. However, the greed of big business and promotion may motivate some to participate in minor ethical hiccups.

Because of these occasional hiccups in moral and ethical decision-making, it is ever-important to maintain regulatory bodies and bioethical communities to serve as watchdogs of what is going on. Their role is not to surpress innovation, but to enhance a companies ability to design and innovate safe and effective drugs or devices. Once again, more time and money needs to be invested in this up-and-coming industry of bioethics.

http://www.huffingtonpost.com/2010/05/25/pfizer-rapamune-lawsuit-p_n_589251.html

Communications Ethics in the Medical Industry

Mackintosh, Alasdair (2004). "Marketing Strategy, Innovation in the pharmaceutical marketing strategy: How to overcome the 30-second detailing dilemma". International Journal of Medical Marketing 4 (1): 15–17.

Another key area that bioethicists look at in the medical arena is communications marketing strategies. After studying the article above, the difficulties of marrying business with science become even more apparent. This is a battle and struggle faced every day in the medical device or pharmaceutical industries. A company is designing, manufacturing, and distributing a product just like any other company would, but how do you find the ethical balance of claiming what your product will do with the evidence that science has given? And how do you do all of this in the 30 seconds a tv commercial or doctor will allow? It's a very difficult question that many companies are still trying to figure out.

We've seen the results of what happens when a company disregards science and starts making claims that aren't supported or proven. The likes of Pfizer and AstraZeneca have faced multimillion dollar lawsuits because of their unsupported claims the FDA became aware of. This is why regulatory scientists are so important (or bioethicists for that matter), because they play policeman for the company and the marketing teams, keeping them out of trouble. The article above spoke of three ways the medical industry can help fix this ethical dillemma.

First, companies can participate in segmentation. Segmenting means only marketing to doctors and hospitals that have similar attitudes towards treatments and health economics. Instead of sending out a message or a sales force as one giant catch-all, tailor the message to match the receiver. This can create a better dialogue and a greater understanding of what your product is really claiming to do. Sales forces won't feel so pressured into stretching their claims into something the FDA has not approved their product to be or do.

Second, personalization can be used by building up three dimensional profiles of the doctors and hospitals that will be marketed to. If a company is segmenting properly, that will better allow them to analyze who these people and hospitals really are, what they care about, and how your product can benefit their goals most. A more personable feeling while communicating product value will lead to greater trust in the product and its legal claims.

Third, training of the sales force to be scientists instead of businessmen will go a long way to smoothing over relationships with the FDA and with hospitals and doctors. This must involve weeks of intense training on the product in question--helping the sales force to understand the science behind the device so they can relay that message to doctors. Marketing and sales in the medical device and pharma world are very different from other marketing and sales tactics. They are embedded deep in a scientific, legal, and ethical world that must be understood before a sale will ever be made.

I interact with the marketing team constantly at work, reviewing their sales brochures and marketing pitches. All messages and communications must be analyzed and processed by the regulatory team to make sure claims are FDA approved and on label. It's a very delicate process, but one that is extremely important in maintaining the health and safety of the public as well as the business. It was interesting to further understand how my study plan really does involve the area of media effects in the medical industry.

Advancing Regulatory Science for Public Health

Having read through a lot of articles and researched other topics related to Bioethics in the Medical Industry, I find myself returning to the same question over and over again: am I more a proponent of the advances in the medical field, or am I helping to enhance the dialogue of bioethics and thus hindering the advances of medical technology? What role do I play as a regulatory scientist at work? To answer these questions and adequately reflect on what role I play in this world of bioethics and medical advancements, I turned to an article written by the chief scientists at the FDA called "Advancing Regulatory Science for Public Health." This article can be found at http://www.fda.gov/ScienceResearch/SpecialTopics/RegulatoryScience/ucm228131.htm. This article discusses the role of the FDA and regulatory bodies in the advancement of medical technologies and public health, but does so in the framework of a regulatory body that limits what companies and scientists can do to promote medical advancement. I struggle with the apparent contradiction that regulatory work furthers the field of medical technology by limiting what it can do. Ultimately I discovered that for advancement to take place, there must be barriers, limitations, and discussions set forth to correctly advance medical technology.

The field of regulatory science is essentially a body of people devoted to evaluating the bioethics of medical technologies. I would have never thought before I started this project that I myself was in the field of bioethics, contributing to the body of work that strives to control, regulate, and caution the advancement of certain medical technologies and practices. At one point in the article I read, the following definition of regulatory science was given: "regulatory science: the science of developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products." Nowhere in the article did it discuss regulatory science as a body who's main goal is to prevent the advancement of medical science. Yes, regulatory scientists question the value of products and practices; yes they question the efficacy of products and practices; yes they question the safety of products and practices, but they do so with the hope that medical advancements can be made in a quick, efficient, and correct matter. This new angle on bioethics helped me to understand what the field is all about. I had been thinking this whole time that bioethicists were all about preventing medical advancements out of some moral reasoning, but now I see that there can be two kinds of bioethicists. One kind tries to prevent advancement out of some moral obligation, and the other kind (the kind I like to think I'm a part of) facilitates medical advancements through tested standards of safety and efficacy. I still don't want certain medical technologies to be created because of health reasons, but overall my position is that of medical advancement in the correct way.

Now the next time a coworker at work is teasing us regulatory people for preventing them from designing and implementing the next big thing, I can argue that our goal is not to prevent, but make sure the design and implementation of the new device is done correctly and as efficiently as possible. People should be thanking us for the work we do, not grumbling about how difficult we make the process. After all, we're keeping them out of prison or from filing for bankruptcy!

To engineer, or not to engineer? That is the question.

Many bioethicists in the field are concerned with this question of modern science. Should we further our research into genetic engineering or not? Is it too expensive? Is it too dangerous to humans to provide any real benefit? Does this dehumanize us, turning us into mere machines? Is this just our chance to play God? So many other questions and concerns have been raised about the ethics of genetic engineering and gene therapy. If I had to take a stance, I would argue that gene therapy has some benefits, but the cost to human lives is too great to outweigh the benefits.

My first concern with gene therapy comes from what I read in the article I cited previously. Most, if not all testing has to be done on human beings in a clinical trial, because testing different "vectors" as they are called in animals has different effects than it would on humans. Viruses react differently in humans than any other animal, therefore tests can only be done on humans to ensure safety and success. The times tests have been done on animals and then transfered over to humans has proved fatal or debilitating. This raises an ethical question in my mind of who, then, we choose to be patients in a clinical test? Do we choose the terminally ill, that we already know are going to die? Or do we choose younger, healthier patients that then risk developing a toxic reaction to the therapy? This is a very difficult question, one that logically leads me to conclude that if gene therapy is so dangerous, (which it has been proven to be), then we should avoid playing God and not mess with our genetic code at all.

However, those who are less inclined to believe there is a God would argue that there is so much potential benefit in genetic engineering, that those who are willing to sacrifice their health for the development of research should be applauded and allowed to do what they want. While I agree with this--that people should be allowed to do what they want to do--there is something deeper within in me that says we shouldn't alter our genetic code, or manufacture babies. My feelings are a product of my upbringing and faith in God, which I acknowledge make me very biased and subjective. However, this is what the field of bioethics is all about. Dr. John Polkinghouse--who I spoke of in a previous post--is also a reverend in his community. As I discussed earlier, most of the leading researchers in the field of bioethics are from a variety of different backgrounds and faiths, creating a community of scholars that are unapologetic about their opinion and viewpoint. This community of sharing personal concerns and opinions about the ethics of medical advancement is essentially what bioethics is all about. With many opinions and sentiments being expressed, the nation and world as a whole can come to a more well-informed consensus as to what should occur in the case of genetic engineering.

My last concern that I would like to express about gene therapy is an argument that Neil Postman would most likely agree with. With increased technological development, my fear is that we would become too dependent on the technology, and let it shape our world. True humanity may cease to exist if all we have to do is order this set of genes here, and that set of genes there to create the perfect child or perfect human. The pains and struggles and trials of life that help us to grow and understand the contrary, joy, would also cease to exist. I think it would be a lost and numb world if our humanity, or realness were stripped from us. Possibly an extreme example, but good one nonetheless, comes from the movie Surrogates. In this movie, the real humans live in a completely manufactured world where they never leave their house, but instead tap into the mind of a robot surrogate to live their life. While the real human wastes away at home, forgetting what reality is like, the surrogate goes on living and experiencing everything for them. This extreme example might help to illustrate what would happen if genetic therapy could solve all of our health problems and physical imperfections. We would become numb to reality and not remember how to experience true joy or pain.

What the future of genetic engineering and therapy is, I can't rightly guess. But I do know that with the voices and opinions of many bioethicists, a well-rounded view of the pros and cons can be presented and the right decisions made.

Case Study---Gene Therapy/Engineering

Recent Developments In Gene Transfer: Risk And Ethics

Jonathan Kimmelman

BMJ: British Medical Journal

Vol. 330, No. 7482 (Jan. 8, 2005), pp. 79-82

Published by: BMJ Publishing Group

In the world of bioethics, gene therapy/engineering is a hot topic. Now that we've taken a look at what bioethics is, the above case study gives me the opportunity to become the bioethicist. After reading and analyzing the above journal article, many questions and considerations should be given to gene therapy. Before I offer my own analysis, let me explain the five conceptual characteristics of gene therapy as laid out by the author of the above article.

1) Gene therapy uses active agents rather than chemicals to transfer genetic material. This can be problematic, because viruses have greater volatility than chemicals, and could therefore spread in an uncontrollable way.

2) Gene therapy functions on our genetic information. With viruses having the ability to alter our DNA, gene therapy could negatively impact our genetic code.

3) During gene therapy, many different agents and processes are acting simultaneously. This heightens the confusion and loss of control that could occur within our cells.

4) Gene therapies can require long latencies. The longer someone is exposed to gene therapy, the more time the vectors have to become toxic to the body.

5) Finally, toxicity is mediated through the immune system. If the procedures require long latencies, the immune system may overreact, leading to death.

These five conceptual characteristics of gene therapy lay the foundation for any discussion of ethics in gene therapy.

Exploring Bioethics

http://www.5min.com/Video/Exploring-Bioethics-Part-15-315104177

(Video 1)

http://www.5min.com/Video/Exploring-Bioethics-Part-25-315104214

(Video 2)

http://www.5min.com/Video/Exploring-Bioethics-Part-35-315104235

(Video 3)

http://www.5min.com/Video/Exploring-Bioethics-Part-45-315104252

(Video 4)

http://www.5min.com/Video/Exploring-Bioethics-Part-55-315104279

(Video 5)

The links above show a series of short videos that comprise an episode of Matter and Beyond called "Exploring Bioethics." Matter and Beyond is a local webcast/cable tv show in New Jersey. This episode when taken as a whole explains the main concerns and research that is emerging in the fairly new field of bioethics. I invite you to watch the videos for the best understanding of what it's all about.

Let me expand on what the field of bioethics is according to the initial research I've done through these videos. If a kindergarten explanation needs to be given, bioethics can be summed up in the idea of an open discussion among many different kinds of people about what's right and what's wrong in biomedical exploration. With the advent of genetic testing, cloning research, genetic engineering, and other lifesaving medical technologies becoming more ubiquitous, the questions of what's right and what's wrong seem to be on the minds of many. I often find myself asking this question at work (I work for a medical device company) as I learn of new and advanced medical products that I am helping to research and develop.

Taking a deeper look into the field of bioethics reveals even more questions that need to be answered. Many of the top researchers in this blossoming field were interviewed in the above videos. Rev. Dr. John Polkinghouse adds to the above definition of bioethics by saying that the research and discussion of bioethicists is helping to prevent the instrumentalizing of human beings. As was discussed in our study of Postman's book, Technopoly, the more sophisticated our medical devices and the more dependent we become on them, the less we look at patients as humans, and more as instruments to be experimented on. This is a great concern of Polkinghouse. I hope to review some of his own articles on bioethics.

Mark P. Aulisio was also interviewed in these videos. His main emphasis was the fact that bioethics need to guide our medical advances. We should not be asking what can we do, but rather what should we do when it comes to medical advances. Imagine advancing medicine without care or caution given to the human life and human nature. We need to set limits based on natural human processes, and not attempt to play God.

Jessica Wilen Berg offers a legal perspective to this question of bioethics. Bioethics has not fully been embraced by the law books, but she guesses that it will only be a matter of time before the law adopts some of its tenets, because these are things that are being discussed and dealt with day in and day out. As more and more lawsuits are filed against medical doctors and medical device companies, the law with have to consider and legislate ethics. Boundaries will eventually be written into law, and the battle of ethics and legality will begin all over again. This discussion is already brewing. It really is the heart of bioethics. What's legal or illegal? What's ethical and what's not?

Stuart J. Youngner describes the kind of people that are getting involved in these bioethical discussions. They come from all walks of life, every field of study one can imagine. The discussions are driven by medical technology. How long should we keep someone alive with machines? How hard should we try to alter natural life processes? How much money should we spend on medical technologies? These types of questions lend themselves to a variety of different people from different backgrounds answering the questions.

The concepts and questions introduced in the video only crack the surface of my study that will take place throughout the remainder of this semester. I will continue to study the words of the researchers above, and give many examples of real life dilemmas we are currently facing in the field of bioethics.