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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