Thursday, April 6, 2017

Scott Gottlieb, the Food and Drug Administration and the Opioid Crisis

The Food and Drug Administration is one of those government appendages that we rarely think about, largely because it doesn't get the kind of exposure that other departments like Defense and State get in the mainstream media, at least until there is some major problem with a failed drug.  As you will see in this posting, Donald Trump's pick for head of the FDA, Dr. Scott Gottlieb, has an interesting link to the business that he will be responsible for heading.

Let's look at a bit of background first.  As many of you are aware, the United States is suffering through an opioid crisis with one of the best known opioids being oxycodone, a semisynthetic opiate used for treatment of pain.  According to the U.S. Department of Health and Human Services, drug overdose deaths are the leading cause of injury death in the United States.  Here is a map showing the drug overdose death rates for the United States in 2014:

In 2014, there were 47,055 deaths from drug overdoses in the United States, up 6.5 percent from 2013.  More than 60 percent of those deaths involved an opioid.  Here is a map showing the rate of past-year opioid abuse or dependence:

Here are some sobering statistics.  On an average day in the United States:

1.) more than 650,000 opioid prescriptions are dispensed

2.) 3900 people initiate non-medical use of prescription opioids

3.) 580 people initiate heroin use

4.) 91 people die from an opioid-related overdose including both prescription and illegal opioids

In 2014, more than 240 million prescriptions were written for prescription opioids.  In 2014, there were 47,055 deaths from drug overdoses  Here is a graphic from the Centers for Disease Control showing the rapid increase in drug overdose deaths involving opioids since the turn of the millennium:

Lastly, here is a graphic showing the drug overdose deaths by type of opioid:

Now, let's go back to Dr. Scott Gottlieb.  Dr. Gottlieb graduated from Mount Sinai School of Medicine of New York University in 2002.  He is currently a resident fellow at the American Enterprise Institute, a conservative think tank, and an internist at Tisch Hospital.  Thanks to "The Intercept", we now have access to Dr. Gottlieb's financial disclosure documents which give us insight into his income stream and his leanings. 

Here is the first page, introducing the potential Commissioner of the FDA:

Here are the three pages which show his speaking honorariums (which, incidentally, pale in comparison to the Clinton family!):

There are a couple of things to note:

1.) the speech in London, U.K. on November 11, 2016 for Mallinckrodt Pharmaceuticals for which he was paid $22,500.

2.) the speech to the Healthcare Distribution Management Association (aka Healthcare Distribution Alliance) on September 27, 2016 for which he was paid $11,250.

3.) the speech to Johnson & Johnson on January 17, 2017 for which he was paid $11250. 

While you likely have not heard of some of these companies, here is some background information.  Mallinckrodt Pharmaceuticals is one of America's largest manufacturers of oxycodone (an opioid as I noted above), selling 500 million of its pills in the state of Florida between 2008 and 2012, a whopping 66 percent of all oxycodone sold in the state.  Mallinckrodt has very recently agreed to pay $35 million to resolve United States probe into its monitoring and reporting of suspicious orders of opioids.   

Healthcare Distribution Alliance has an interesting connection to the opioid business.  Its Chairman, Jon Giacomin, is the Chief Executive Officer, Pharmaceutical Segment at Cardinal Health Inc.  In late 2016 and early 2017, Cardinal Health, a drug distributor/wholesaler, paid a total of $64 million for violations related to suspicious orders of controlled substances.  Of the total, $44 million was paid to the United States government for violating the Controlled Substances Act as shown here:

...and $20 million was paid to the Sate of West Virginia for its role in distributing controlled substances in West Virginia, particularly pain control medications as shown here:

These fines were the last aspect of a 2012 settlement with the Drug Enforcement Agency which saw the DEA suspend Cardinal's ability to sell controlled substances from its Lakeland, Florida facility for two years.  In just three years, Cardinal Health's Lakeland centre had supplied more than 12 million doses of oxycodone to four area pharmacies.

Finally, Johnson & Johnson's subsidiary, Janssen Pharmaceuticals, announced in early 2015, that it had signed an agreement with Depomed Inc. to sell its U.S. license rights to the opioid painkiller, Nucynta, for $1.05 billion.  That said, Johnson & Johnson has the right to market Nucynta in a total of 80 nations around the world. 

In case you are interestedhere is a link to Dr. Gottlieb's entire financial disclosure document.

While Dr. Gottlieb's links to the manufacturers of opioids do not make him guilty of anything, the association does bring into question his ability to be completely unbiased when making decisions about the opioid business in his role as Commissioner of the Food and Drug Administration.  Given the severity of the opioid crisis in the United States, this will prove to be one of the critical issues facing the federal agency that is ultimately responsible for controlling and supervising prescription drugs. 

No comments:

Post a Comment