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Introducing Serenity

Tom Bleakley’s Legal Thriller Focuses on the Pharmaceutical Industry and FDA Approval Process

Lakewood Ranch, Florida, Nov 28, 2012—Trial lawyer and author Tom Bleakley has released a legal thriller, Serenity, his second novel and fourth book. Obtaining FDA approval to market a drug is often knowing the right people and taking good care of them. As deaths have occurred due to a compounding center mishap in Massachusetts, the FDA and pharmaceutical approval process is under scrutiny and new abuses are being reported in that and other situations nearly weekly in every major newspaper in America.

Bleakley’s book is a fictionalized version of a real case. He writes about an unfaithful husband headed toward an unwanted divorce who takes a drug noted for its effects of causing bizarre behavior and winds up killing his wife. The book asks, “Who is to blame?” Is it the killer or the avaricious drug company making huge profits and trying to hide news of the drug’s terrible effects? A jury decides guilt or innocence…or does it?

“The events in the book are similar to experiences I’ve had as a trial lawyer during my nearly forty years of litigating major cases against the pharmaceutical industry,” says Bleakley who has tried cases in 37 states. Bleakley was the first lawyer to try and prevail in the controversial drug DES litigation. He has spent his career trying criminal and civil cases involving complex medical and scientific issues.

Serenity is the story of a drug by that name developed and marketed by the Upright Corporation based in Ann Arbor, Michigan. Before Serenity was approved for marketing by the Food and Drug Administration, animal and human testing indicated the potential for bizarre reactions, including acts of violence while in a state of amnesia. A prisoner given the drug in pre-marketing testing murdered a prison guard and two other prisoners committed suicide while on the drug. The company not only ignored these events, but manipulated the research results to make it appear that the drug was safe. A Detroit attorney, Bob Riley, became involved in both civil and criminal cases arising from the drug. The criminal case involves Jay Slater who kills his wife while taking Serenity. His defense is that the drug caused him to do so. Slater’s trial comes to a unique conclusion and the novel comes to an unexpected ending.

Serenity was published by Pennsylvania publisher Word Association. The book, ISBN 9781595717986, is available for immediate delivery and may be purchased for $16.95 at www.TomBleakleyBooks.com, www.Amazon.com, www.BarnesandNoble.com and www.wordassociation.com or by calling Word Association at 1-800-827-7903.

  All About the Author

Tom Bleakley is a lawyer /novelist with a Ph.D. in psychology who writes about law, medicine and the pharmaceutical industry.


Although he is the co-author of a two volume psychiatric textbook (A Teaching Program in Psychiatry, Vols. I and II, Wayne State University Press), his current work combines legal and medical writing in a thriller genre. Serenity is about a drug intended as a sleep aid which causes some users to enter a state of amnesia during which violent acts are committed.

Bleakley is a graduate of Eastern Michigan University and the Detroit College of Law and attended the University of Michigan Medical School until his Air Force Reserve unit was activated during the Cuban crisis. He divides his time between homes in Michigan and Florida where he lives with his wife Mary Ellen. He has successfully combined legal, pharmacological and medical fact with fantasy to produce books which are both compelling and fascinating. Bleakley’s thrillers are designed, in part, to keep the reader aware of scientific and legal possibilities of ethical problems when drug companies place profits ahead of safe and useful drugs.

Bleakley developed his initial understanding about the pharmaceutical industry by spending eight years as a special representative for one of the largest companies in America after which he became the Director of Substance Services for the Michigan Department of Corrections until he began his practice of law specializing in cases involving prescription drug injuries.

Bleakley’s profession as a lawyer has provided him with the ideas for his novels. His legal work has been at the cutting edge of law and medicine for more than 35 years. He has handled major litigation against the pharmaceutical industry in more than forty states involving such drugs as thalidomide, DES, Cleocin, Bendectin, Dilantin and Oraflex.. In each novel, he strives to write about the issues at the forefront of current legal, pharmaceutical and medical practice. He says, “The main reason I write is to inform the public about the risks of taking prescription drugs. While my work can be described as fiction, I take great care to present a story line which closely adheres to recent and ongoing events occurring with currently marketed drugs.”

Endorsements and Press Placements

Literary Lawyers
Tom Bleakley of Lakewood Ranch released a legal thriller, Serenity, a fictionalized version of a real case. He writes about an unfaithful husband headed toward an unwanted divorce who takes a drug noted for its effects of causing bizarre behavior and winds up killing his wife. The book asks, “Who is to blame?” Is it the killer or the avaricious drug company making huge profits and trying to hide news of the drug’s terrible effects? A jury decides guilt or innocence — or does it? Serenity was published by Pennsylvania publisher Word Association. The book, ISBN 9781595717986, is available for immediate delivery and may be purchased at www.TomBleakleyBooks.com, www.Amazon.com, and www.BarnesandNoble.com.


C. F. (former newspaper journalist); "Serenity . . . should be used as a framework for major changes in our pharmaceutical industry and it's government oversight. I think it should be on every concerned U.S. citizen's Top 10 reading lists in 2013."

B. H.; "I found the book intriguing and I am wondering if you might be available sometime to talk about it and letting me use that time for an interview that I would use in 'From My Divot'?"

L. L.; "Tom, just finished Serenity…. What a great book. Kept me so interested, I wanted to get home right away from golf today to finish the last few chapters. As you have probably witnessed, many in the Pharmaceutical industry have little regard for safety when it comes to the bottom line. Cant wait to read the next book."
    Interviews and
Reviews


A super legal thriller….instantly enthralling.” - Dr. John Telford

“An extraordinary legal thriller.” - Noted author and speaker, Dr. Wayne Dyer

Tom Bleakley is author of the recently released legal thriller, Serenity, his second novel and fourth book. With Serenity, he decided to self-publish again with Word Association. Tom was asked to answer the following questions.
 
1. Where are you from?
I grew up in Detroit, Michigan and now shuttle back and forth between Michigan and Lakewood Ranch, Florida.

 
2. What's the title of your most recent book?
Serenity

 
3. Describe the book.
Serenity is a drug developed and marketed by the Upright Corporation based in Ann Arbor, Michigan. Before the drug was approved for marketing by the Food and Drug Administration, animal and human testing indicated the potential for bizarre reactions in some users, violent acts while in a state of amnesia. A prisoner given the drug in pre-marketing testing murdered a prison guard and two other prisoners commited suicide while on the drug. The company not only ignored these events, but manipulated the research results to make it appear that the drug was safe. A Detroit attorney, Bob Riley, became involved in both civil and criminal cases arising from the drug. The criminal case is about Jay Slater, who kills his wife while taking Serenity and his defense is that the drug caused him to do so. Slater’s trial comes to a unique conclusion and the novel comes to an unexpected ending.

4. Where did you get the idea for the book?
The events in the book are a fictionalized composite of several experiences I’ve had as a trial lawyer during my nearly forty years of litigating major cases against the pharmaceutical industry.

5. Which famous actor or actress would play your main character in a movie?
For the two male leads, I picture Morgan Freeman as Bob Riley and Ben Affleck as Dr. Alex Hartley. As to female lead, Natalie Portman would be perfect as Dr. Jan Emrich. Of course, I would have to interview her first. Anthony Hopkins would be great in the role of Cyrus Messner, the villain who does everything imaginable to get the drug on the market. Penelope Cruz would play a cameo role as Anne Smythe. Obviously, this would be a small budget film. (Laughing).

 
6. How long have you been writing?
Fifty years.

 
7. What inspires you to write?
I've written something nearly every day since my first college course in literature, but the switch from non-fiction and legal briefs occurred gradually. I was unique as a trial lawyer, because I also handled my own appellate work. Writing appellate briefs, more than 75, is a lot different from writing fiction. In shifting to fiction, I did everything I could to learn my craft, including attending writers’ conferences, as well as reading everything in sight. I joined critique groups, too. As a trial lawyer, people used to tell me I was a good storyteller, so in a way, putting stories to paper was a natural sequence of events.

 
8. What is your favorite writing music?
I need quiet when I write, but I occasionally listen to classical music. I am a country music fan, but find that it distracts me when I’m writing.

 
9. Which author(s) do you most admire?
I have always admired Scott Turow. When I read his books, I savor every word. His characters become real to me. Combine that with his obvious grasp of what life as a trial lawyer is really like and I find myself literally reading his books in one continuous setting. John Grisham is a great story teller, but I find that he sometimes takes unrealistic positions regarding the ethics of lawyers. I love the way Elmore Leonard develops his characters. I attended a three hour seminar of his and altered my work habits and approach to writing because of that experience.

10. Who is your biggest fan?
My wife, Mary Ellen. She has been listening to me, reading and editing my stories since the beginning. She is ruthless with her comments and red pen, but also encouraging and supportive. She's an avid reader, too, which is why I believed her when she told me my stories deserved to be published.  


11. What's your favorite book of all time?
Gulliver’s Travels, by Jonathon Swift, because when I read it as a 9th grade student the book changed my life by demonstrating the power of the written word to me for the first time.


12. What are you reading right now?
Jack Higgins The Savage Day, David Baldacci The Innocent and Phillip Margolin, Supreme Justice: A Novel of Suspense. I read a lot of thrillers because that's the genre I write in myself.  


13. What are you writing right now?
I continue to write my blog on a nearly daily basis and I am framing the outline for a non–fiction work on the 7th Amendment. I am also jotting ideas down every day for the sequel to Serenity.

14. What's more important: a book's beginning or ending. The ending. If I don't like the ending of a book, I feel dissatisfied and I won't recommend it because I usually feel as if I wasted my time. Of course, the beginning has to hook the reader or nobody will get to the end in the first place!
 
15. I understand you had writer's block for a while. What did you do to get past that?
In the process of writing Serenity, I blocked for more than three years. I started a blog to maintain my contact with writing words on a daily basis. Looking back, I was two thirds into the writing of Serenity and was frustrated that I couldn’t frame an ending to the story that satisfied me. About a year ago, I woke up early and the ending was in my mind. I jumped out of bed and wrote non-stop for nearly ten hours.

 
16. A book should go through how many rounds of editing before publishing?
As many rounds as the book needs, usually dozens. I then like to enlist readers. I have several friends who read my books. They are big fiction readers and are tough critics. Sometimes a little too tough, but I can trust what they tell me. Every reader brings something different to the table. I also find that I can be my own toughest critic if I leave a piece of writing for a couple of months and then get back to it.

 
17. What is your top marketing tactic?
Saying "yes" to every interview request

 
18. What's the worst piece of advice you've ever received?
One of my readers, said, “Don’t give up your day job.” In a perverse kind of way, this probably was also the best piece of advice I’ve ever received because it irritated me enough to continue writing and work harder to make my writing more readable and enjoyable.

19. What's the most surprising thing you've learned about being an author?
That I enjoy all aspects of social networking, promotion, and marketing.

 
20. If you could pass along one piece of advice to other writers, what would it be?
Write from the heart. Believe in yourself and your books, and you'll go far. And don’t hesitate to re-write until you’re satisfied that you’ve said what you want to say as best you can.

21. What were your goals in writing Serenity?
I read some comments from readers that it is more than just a legal thriller.

22. Did you have a higher purpose than just telling an interesting story?
In the 1990s, our court system took a revolutionary shift away from traditional tort law and made trial judges, most without any scientific training or background, gatekeepers responsible for deciding what kind of scientific evidence and opinions a jury would be permitted to hear. Big business, led by the pharmaceutical and insurance industries, had lobbied and campaigned for years for limitations to be put on the ability of an injured person to obtain redress for injuries caused by products. Scientific evidence was characterized as ‘junk science’ if the opinions being offered in a courtroom by reputable scientists were minority opinions. Most pharmacologists in the country work for the drug industry so it would hardly be surprising that any opinion implicating a drug in causing harm would be in the minority. The events in Serenity occur in this setting where a biased judge, using the prevailing rubric of junk science, tries to control the outcome of a case arising from a man’s killing his wife after taking the drug Serenity.


23. Is junk science the main point of Serenity?
I must apologize because I got sidetracked. No. The main point of Serenity is the demonstration that big drug companies can do what they want to do in developing and marketing their products while the Food and Drug Administration, which is supposed to protect the public, stands idly by. I liken FDA approval of a drug to a teenager getting a license to drive from the state. Neither action is a guarantor of safety.


24. Let’s talk about the FDA. Can you also answer some questions regarding the pitfalls of the FDA approval process, why the process is dangerous, what the public does not know and should know? 
The public does not understand that the FDA does not conduct any testing of its own. It is, more or less, obligated to accept the scientific evidence presented by a manufacturer in evaluating the safety of a drug.
The science that is presented to the FDA for drug approval by a drug company is generally not published and considered a proprietary work product by the company. There is both a moral and legal responsibility on the part of a company to tell the FDA the bad as well as the good about a drug. As a trial lawyer representing thousands of people injured by drugs I have been continuously amazed and disheartened by the flagrant violations of these principles over the years. Why this happens is no mystery because the FDA has many key employees cycling back and forth between the Agency and the drug industry and the profit potential in obtaining FDA approval is so great. The FDA has become, in part, a quasi-political entity acting more like a shill for the drug industry than for the benefit of the public. The recent disclosure that the Agency was surreptitiously monitoring some of its own employees who were engaging in whistleblower-type activities underscores this point.