Saturday, September 14, 2019

Breakthrough Developments in Drug Regulation

Still More: The state of New York, which is balking at joining the tentative settlement of claims against Perdue Pharma for its role in the opioid epidemic, has traced a billion dollars in wire transfers by the Sackler family including some involving Swiss bank accounts.  Plaintiffs say the transfers indicate attempts to hide their wealth as their company faced a raft of lawsuits. The uncovering of these wire transfers pursuant to subpoenas issued by the NY state's attorney general to 33 financial institutions strengthen New York and Massachusetts refusal to join the settlement agreement. NY Attorney General Letitia James argues that this money should be used to compensate victims of opioid overdose and addiction.  James called the settlement a "lowball", and told media, “Records from one financial institution alone have shown approximately $1 billion in wire transfers between the Sacklers, entities they control, and different financial institutions, including those that have funneled funds into Swiss bank accounts.”  Lawyers for Purdue are seeking to quash subpoenas on the grounds they are, "premature, facially defective, over broad” as well as “harassing, and an improper attempt to avoid the rules and procedures governing party discovery.”

The New York Times reported that court documents filed by James' office focused on one financial institution that responded to subpoena demands for documents: "A series of transfers involving Mortimer D.A. Sackler was highlighted in the filings. In one case, $64 million was transferred in 2009 from a previously unknown trust called Purdue Pharma Trust MDAS, through a Swiss bank account in the Bailiwick of Guernsey, in the Channel Islands, and then to Mr. Sackler". The Island of Guernsey is a notorious tax haven.  State officials argue that such transfers demand more disclosure before a fair settlement can be entered into.  One commentator likened discovering the Sackler family's international financial dealings to an "Easter egg hunt" that could take some time.

More: {11.09.19}The Sacklers have reached a settlement of the opiod epidemic claims against Perdue Pharma, makers of OxyCotin.p; As part of the tentative settlement of most claims, now in excess of 2,300 lawsuits, the company will file for reorganization under Chapter 11 of the bankruptcy code. A new company will take over the assets and all proceeds of the sale of drugs will go to compensate plaintiffs.  The Sacklers will pay $3 billion in cash over seven years without any admission of wrong doing.  Forbes estimates their personal fortune to be about $13 billion. Twenty three states represented by the plaintiffs' negotiating team are said to be in favor of the settlement, but several states have said they will continue to pursue family members individually.  New York's attorney general called the deal, "An insult, plain and simple." From 1999 to 2017 about 218,000 people have died from opiod overdoses.  The economic burden of the epidemic is estimated at $78.5 billion a year by the Center for Disease Control (CDC).

Update: {28.08.19} The ultra-rich Sackler family, who own Perdue Pharma, makers of OxyCotin are reportedly in negotiations to settle all claims against the company for $3 billion of their own money and turning the company into a public trust via bankruptcy that would pay out drug profits to addiction claimants.  The potential deal is worth an estimated $10 to $12 billion.  The company would also provide, without cost, new anti-addiction drugs it is developing.  The opiod epidemic has killed hundreds of thousands of people in the last few decades since OxyCotin was introduced in 1996.  

Two developments have occurred that could be groundbreaking in the regulation of two analgesic drugs.   First is the announcement by the DEA in the Federal Register that it will begin accepting applications for grows of high quality marijuana for medical research.  The announcement comes just before a deadline in a lawsuit by a medical marijuana researcher, Dr. Sue Sisley, against the agency for its refusal to consider such applications.  Up until today, only one marijuana grow for medical and scientific research was allowed.  The marijuana produced by a contractor in Mississippi is not of suitable quality for medical research applications.  Experts think theproposed rule to expand marijuana grows under research permits will result in the eventual reclassification of the plant from Schedule I that includes cocaine and heroin, the most strictly controlled category of narcotics.

DEA has insisted that marijuana, or "marihuana" as the agency revealingly labels it, remain a Schedule I narcotic despite half the states now allow medical or recreational use of the drug. The agency unrealistically claims there is no acceptable medical use for marijuana. If clinicians like Dr. Sisley succeed in identifying specific medical uses of cannabis or its extracts, and the Food and Drug Administration certifies those findings, that would force the DEA to reschedule cannabis nationwide.  Dr. Sisley performs research on medical marijuana applications to treat veterans.  DEA's regulatory announcement is a belated acceptance of reality--huge profits are being made by the marijuana industry in the US.  Ending the Nixon-era "reefer madness" may even eventually empty the nation's jails of its numerous marijuana criminals.

The real drug criminals may be those companies that manufactured and distributed vast amounts of highly addictive opioid drugs causing a nationwide epidemic of abuse.  The first verdict against a manufacturer, Johnson & Johnson, was handed down by a judge in Oklahoma.  Judge Thad Balkman ruled that the company, which supplied sixty percent of the opiod ingredients in pharmaceuticals like oxycotin, pay the state of Oklahoma $572 million in damages.  This is the first ruling against opiod suppliers in over 2,000 lawsuits filed against them.  The state argued that Johnson & Johnson, a family friendly brand familiar to most 'Mericans, aggressively marketed the drug as safe and effective. The verdict proves that J & J profited billions on a drug that is the "root cause of the opiod crisis",  according to a state attorney on the case. Previously Oklahoma settled with two other manufactures, Purdue Pharma and Teva Pharmaceuticals for $270 and $85 million respectively, without an admission of liability.  Company attorneys say they will appeal the verdict.