Sunday, June 28, 2020

Interview with a Drug Company Whistleblower Turned Author


 Pharma Whistleblower Exposes Illegal Off-Label Drug Marketing Practices That Contributed to Opioid Epidemic
In Explosive New Book


 



Bruce Boise, having worked as a top pharmaceuticals sales manager for 24 years, did not intend to become a whistleblower nor did he fully understand what he was getting himself into when he encouraged his company to stop illegally marketing off-label use of prescription drugs. He ended up losing his job, getting black-balled by the industry, becoming homeless after going through a million dollars in assets and savings, and fearing all of his sacrifices and efforts would lead to nothing being done to the company that contributed to our nation’s deadly opioid overdose epidemic.

He tells his story in an explosive new book, Cold Comfort: One Man's Struggle to Stop the Illegal Marketing of Powerful Opioid Drugs and Save Lives (June 15, 2020), serving as inspiration to all future whistleblowers while warning the nation of the dangerous practices of the pharmaceutical and medical  industries and the shortcomings of the FDA to adequately protect the American public.

“Big Pharma all too willingly accepts fines, even ones in the hundreds of millions of dollars, as merely the price of doing business when it knows it can make tens of billions from illegally marketing its products,” asserts Boise. “This has to stop now – before others die.”

For more information, please consult www.bruceboise.com. He lived in Melbourne and Key West, Florida for a decade but the Ohio native has lived most his life in Columbus, Ohio.

Boise, who is a client of the PR firm that I work for, was interviewed below:

1. What inspired you to pen your new book? I wanted to stop illegal marketing of potentially dangerous pharmaceutical drugs and protect the American people. I think it is important to expose just how prevalent and life-threatening off-label marketing is and that this marked the beginning of the opioid crisis. I hope the book also empowers consumers to ask more questions and stand up against fraud of any kind. 

2. What was the drug company that you worked for, Cephalon, doing that was so wrong? Cephalon was marketing their products off-label, which is illegal. Doctors can prescribe a medication for an off-label indication, but pharma companies cannot promote a drug for off-label indications. In the package insert the drug has indications that the drug has been tested with controlled studies. Its approval by FDA is based on these extensive studies. Drug A is approved for epilepsy, but not approved for a  mood disorder. Drug B is approved for “breakthrough” cancer pain, but not approved for migraines. It’s very dangerous to promote a drug for a medical condition when patients could overdose. 

3. And this led to an explosive crisis with opioid addiction in the United States? In the early 2000s, three companies were selling their products off-label that were controlled drugs, (schedule 2). Purdue-Oxycontin/ J&J- Duragesic/ Cephalon-Actiq. Overdoses jumped in America because these drugs were being prescribed to high-risk patient populations or “drug naive patients.” (e.g. migraine patients.) 

Opioid-involved overdose deaths rose from 21,088 in 2010 to 47,600 in 2017 and remained steady in 2018 with 46,802 deaths.” (NIH)

4. Your book takes a look at America’s War Against Drugs and shows who you believe is really culpable: government (legislators, judicial, FDA), big pharma, physicians, and pharmacists. What is the solution to this deadly problem? We need a multi-organizational approach to the opioid crisis (drug addiction). We need more rehab organizations for the mental and physical addiction. We need more family organizations and social services for the family members and their collateral damages.

These key groups play a critical role to fight the drug pandemic:

Government – We need to have laws that force government departments to be more immediately responsive to fraud, not 10 years later. We must limit the big pharma lobbyist and money going to Congress.        

Judicial - Limit the judges that are appointed to the bench that have had experience in leading big pharma’s legal teams. Conflict of interest is rampant.

FDA – Appointments to the FDA must stop being influenced by Big Pharma. We need to draw from the science side or research side of the medical community.

Physicians/Pharmacists - Just make it uncomfortable professionally for them to practice on the wrong side of fraud-like activities.

5. Do they each have blood on their hands? Yes, in some measure they all do, and each of them will have to answer for their own misdeeds. There are many physicians/pharmacists that are doing the right thing and have objected to this fraudulent activity, but there has to be more than objection. People need to go to jail for this. Paying large fines to the government is not enough and is often just a cost of doing business. 

6. So what did you do about this problem?  I wanted to fix it, stop the illegal marketing so patients wouldn’t be harmed (or overdose), and save my job, which I loved. I went to my boss and boss’s boss to report the fraud. Once I realized that the company was okay with this fraud I had to decide to go outside the company. At first I did not know how or whom to contact about fraud in my company. It was a phone call from a nurse that had a contact in the FBI that got everything started. That's how I finally wore a wire.

7. Were you afraid to wear a wire and testify in court? Did you fear for your life? Yes to all of those. I was told if I do a really good job with helping the government, I may not have to testify in court. My biggest fear was losing everything that I had worked for me. I knew I was going to take a big hit and had written about it in my journals, but I did not realize how bad it really was going to be for me and my family. My losses were horrendous…I also worried if physical harm would come to me for what I did, or worse to my family. Even when the settlement came, I then worried about someone retaliating against me or my family for what I did.  

8. Did you really know what you were getting yourself into? Wouldn’t it be easier to just look away, or more lucrative to join in? Not really what I set out to do. It's not like you think it through, “Oh I am going to be a whistleblower.” At the time I got the call from the nurse friend that had the FBI contact, I was just going to dust off my resume and go find another job after helping them with their case. I reported it because it was just the right thing to do. Patients were being put at risk for bigger profits. 

9. Your book also reveals what actually happens to someone who becomes a whistleblower and the toll it takes on them and their family life. What happened to you once you stepped forward to cooperate with the federal government? Once I agreed to wear a wire my life changed. Little do you know that you are going to lose your job and career. You will be black-balled from the industry you loved for decades. You are going to lose everything and never work in the industry that you have trained and developed in. It is going to hurt you emotionally (being out of society, not a functioning part) and financially (I was worth over a million before wearing the wire and lost everything to the point that I had no assets, and was flipping burgers for $10 an hour at a carnival). I was out of society with little chance of a future. The toll on my kids was just as devastating. I worked with the FDA/DOJ for too long in some ways, that I didn’t even know I needed to find legal representation in the case (I was third to file though I built the case).


13. Your story is also about the pharmaceutical industry’s illegal and unethical practices, not just the grossly negligent behavior of one company. Why are these drug companies allowed to keep operating this way? The current laws aren’t sending people to jail for this white collar crime. The rewards of selling off-label are far greater than the fines. For example, Cephalon was fined $425 M for off-label fraud but the company generated $30B in sales from the practice. Also, the industry utilizes Pharmaceutical Manufacturer Association (PMA) lobbyists who protect Big Pharma’s interests in Washington, which in turn, prevents stronger laws from being legislated to stop this kind of fraud. Many times what occurs in a False Claims Act case, companies are able to separate the civil (brought by whistleblower) from the criminal (brought by DOJ) investigations and in doing so delay or eliminate the criminal charges. And in doing so, the civil charges also become minimal. It equates to a slap on the wrist really. Or, just a part of doing business.  

14. How was the writing of Cold Comfort a cathartic process?  It finally puts this part of my life to rest. I can let it go now in some ways. It does help to think that this book could be a roadmap for other whistleblowers and encourage them to be courageous and report wrongdoing. Before these cases, I was defined by Corporate America with a great salary and bonus, and after I went against the grain, I was defined by issues that were bigger than that. In essence I became a better citizen, more conscientious, and a real advocate for patients and those at risk, the ones without a voice.  


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Brian Feinblum’s insightful views, provocative opinions, and interesting ideas expressed in this terrific blog are his alone and not that of his employer or anyone else. You can – and should -- follow him on Twitter @theprexpert and email him at brianfeinblum@gmail.com. He feels much more important when discussed in the third-person. This is copyrighted by BookMarketingBuzzBlog ©2020. Born and raised in Brooklyn, he now resides in Westchester. His writings are often featured in The Writer and IBPA’s Independent.  This was named one of the best book marketing blogs by Book Baby http://blog.bookbaby.com/2013/09/the-best-book-marketing-blogs and recognized by Feedspot in 2018 as one of the top book marketing blogs. Also named by WinningWriters.com as a "best resource.” He recently hosted a panel on book publicity for Book Expo 

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