How Neglecting Industry Regulations led to a Prison Sentence for Pharmacy Executive
Yesterday morning NPR reported on a case that made me want to know much, much more. Barry Cadden, the part owner of a Massachusetts Compound Pharmacy, was sentenced to nine (9) years in prison for racketeering and mail fraud.
In March, Cadden was found not guilty of second-degree murder. That’s right, murder charges were filed at one point. There will, of course, be appeals. Nothing herein should be taken in any way to limit Mr. Cadden’s right to a fair trial and to whatever appeals to which he is entitled.
He was convicted of conspiracy and fraud charges and WBUR in Boston has been following his case:
Prosecutors say Cadden, 50, ran the center in a dangerous way by skirting industry regulations on sterility in an effort to push production and make more money. Assistant U.S. Attorney Amanda Strachan said the center was “a massive reckless and fraudulent organization.”
The outbreak of fungal meningitis and other infections in 20 states was traced by the Centers for Disease Control and Prevention to contaminated injections of medical steroids, given mostly to people with back pain.
http://www.wbur.org/news/2017/06/26/barry-cadden-sentenced-to-nine-years-in-prison-for-role-in-deadly-meningitis-outbreak
…
That is twenty states. WBUR correctly points out that Compound Pharmacies are not subject to the same restrictions as ordinary drugstores and can mix to create their own custom medications. Compound pharmacies exist as part of the old idea that a pharmacist should be free to make up a special medication for a patient.
In practice in the marketplace, they are not so simple or small, they produce medications in large quantities. The FDA may be under attack from industry as being too stringent on the producers of medical devices and drugs, but this case provides some background as to what can go wrong when we do not pay attention to the business of medicine.
In Cadden’s case according to the jury, there was fraud, and fraud with about as serious consequences as is possible to imagine for those that trusted the medication.
The government long ago seized $18 million of the company’s assets, which indicates that the company had apparently been successful in business for quite a while before anyone caught up to it.
https://www.justice.gov/usao-ma/pr/18-million-seized-owners-new-england-compounding-center
While Cadden was acquitted of the murder charges, and the government certainly seems to have done its part to crackdown on this pharmacy and its owners, I really want people to consider what this matter means. Should it have to get to the point of murder charges for people to understand that we need to ensure drugs are produced safely?
Should it take a meningitis outbreak? Well, of course, it should not, but in this case, there really was a meningitis outbreak.
That is why when whistleblowers come forward and report cases of health care providers and drug companies putting business ahead of public safety we should all be concerned. Medical judgment can be affected by money. Our safety is only a little bit removed from such judgment.
A meningitis outbreak will not occur in every case when the health care providers commit fraud. This case, though, shows that those of us who want to make sure medical judgment is not overruled by business considerations are not just crying wolf. People can get hurt badly.
