Prominent Pain Management Advocate, Forest Tennant, MD, becomes Government Target/Victim

Posted on November 27, 2017 by Pharmaciststeve

www.doctorsofcourage.org/forest-tennant-md-drph/

Prominent Pain Management Advocate, Forest Tennant, MD, becomes Government Target/Victim

On November 16, 2017, the day after he testified in Montana as an expert defense witness for Dr. Chris Christensen, DEA agents raided the offices and home of former West Covina Mayor Forest Tennant, MD in West Covina, CA. The Tennants arrived home that night to find their front door kicked in by DEA investigators.

The warrant (found below) sought to seize financial records, drugs, documents and records related to the distribution of painkillers, written as if the doctor was a Mafioso from Columbia.  The claim to the judge in order to get the warrant made supposition that there would be evidence of crimes including distribution and possession with intent to distribute a controlled substance, health care fraud and money laundering.

Also named in the search warrant was United Pharmacy of Los Angeles and its owner and pharmacist, Farid Pourmorady. Court documents indicate the DEA’s investigation began in 2015 and targets a “drug trafficking organization” (DTO) that includes United and “multiple physicians whose prescriptions are filled at United, focusing in particular on Tennant.”

In the search warrant, (see below), the DEA alleges that Tennant prescribed such high doses of opioid pain medication that his patients must be selling them.  It also alleges that Tennant took financial kickbacks from Insys Therapeutics, a controversial Arizona drug maker that is under federal investigation.

“It’s very lengthy and it goes into things in my past which are totally irrelevant but are obviously designed to smear me and make me look like a bad person. I see what they’re doing,” Tennant told PNN. He believes the raid is part of a broader effort to smear not only his reputation, but to discredit and intimidate other doctors who prescribe opioids to pain patients.

“They’re not just going after me, they’re going after patients,” said Tennant. “I think the country better understand what they’re doing here. They’re saying that regulations don’t count, standards don’t count, and they’ll decide who can get drugs and how much. I’d be worried about every pain patient right now, not just mine.”  In response to the allegations involving Insys Therapeutics, he said “I have no financial relationship with anybody. My clinic is fundamentally almost a charity,” That is collaborated by patients that have written in support of Dr. Tennant in answers to media articles. The main mission, Tennant says, is to study chronic pain and search for alternatives.

“These things [charges] are so far out of line it’s hard to respond almost,” Dr. Tennant said.

Stated in the search warrant: “The crimes perpetrated by the DTO include the sale of powerful prescription narcotics such as oxycodone and fentanyl, along with other dangerous and addictive controlled drugs often sought in combination with narcotics, based on invalid prescriptions issued by practitioners including Tennant,” the documents say. “United has been submitting millions of dollars in fraudulent Medicare prescription drug claims, namely, claims for the cost of filling invalid narcotic prescriptions, including those issued by Tennant.”

“I understand what (DEA is) after. They figure if they go after the big guy, then no one will prescribe,” Tennant told PNN. “If they’re going to hurt me, no doctor is going to be willing to prescribe or do anything. That’s what they’re attempting to do. They’re attempting to neutralize me if they can. And I think there needs to be an outcry.

“The time has come. Is this country going to treat pain patients or not? Are they going to let people die in pain or are they not?” “They’re tragic. People are being harmed mentally emotionally. Families are being destroyed. I’ve never seen anything like it in this country,” Dr. Tennant said. “Are we going to let these people die, miserable, before their time, or provide them some care before they die?”

“People who are not even pain patients are starting to see the gross injustice in all this and the tragedy because, guess what? If they can take this person’s medical treatment away and let them die, is heart failure medicine next? Is insulin next because they don’t like the cost?” Tennant said.

Well, illegal persecution and legal genocide has been going on for 15 years now. Dr. Tennant knows that, but it becomes much more real when it happens to you.

Federal investigators allege that Tennant accepted more than $100,000 in kickback payments from drug manufacturer Insys Therapeutics, which produces a fentanyl-based nasal spray known as Subsys. Several executives of the manufacturer were recently indicted for racketeering. The alleged kickbacks from Insys came in the form of:

  • Consulting fees
  • Gifts
  • Serving as faculty speaker at venue other than continuing education program
  • Education
  • Food/travel reimbursements

During the time the doctors received those benefits, they were prescribing unusually high amounts of the drug, investigators allege, and Dr.Tennant was the top prescriber of Subsys, with 96 claims totaling more than $1.9 million for just five patients between August 2014 and July 2016, according to the affidavit. Two of them resided in California, while three lived in Georgia, Hawaii and Washington.

Dr. Tennant acknowledges getting speaker fees of about $126,000 from Insys Therapeutics. He spoke for Insys about 30 times between 2013 and 2015 across Southern California talking to other doctors in their offices about how to use the drug and also during lunches and seminars. The payments he received covered the cost of travel, lodging and meals. He stopped taking payments in 2015 and was dropped from their speaker’s bureau.

“I’ve spoken for companies since 1973, and now they’re making an issue that the doctor shouldn’t be paid for speaking — that’s what a lot of this is about,” Tennant said, calling the assertion that they were kickbacks “ludicrous.”

For over 50 years, it has been legitimate practice for doctors to speak at events sponsored by drug companies. It is the main way doctors learn about the new products. It is also standard practice for drugs to be used off label. The speaker doesn’t introduce that as recommended, but in the course of the presentation, if questions arise, they can address off-label use. They just identify it as such. How else would Neurontin, approved for treatment of epilepsy, have become a prominent drug for the treatment of pain?

But now the government is again, creating crime where there is no crime, to attack doctors and pharmaceutical companies. Tennant is a revered figure in the pain community because of his willingness to see patients with intractable chronic pain who are unable to find effective treatment elsewhere or have been abandoned by their doctors. At 76, Tennant could have retired years ago, but works one week per month, seeing about 150 patients, many of whom travel from out-of-state and some are in palliative care.

Who Is Dr. Forest Tennant?

Who is Forest Tennant, MD, DrPH? Dr. Tennant’s Current Website is http://foresttennant.com/  On his “About Page”, he unceremoniously describes himself thus:

Forest Tennant, MD, DrPH, is an internist and addictionologist who specializes in the research and treatment of intractable pain at the Veract Intractable Pain Clinics in West Covina, California. Dr. Tennant started his pain clinic in 1975, originally focused on treating the pain of cancer and post-polio disease.

Dr. Tennant is a member of the American Academy of Pain Medicine, the Academy of Integrative Pain Management, the American Pain Society, and the American Society of Addiction Medicine.

Dr. Tennant is Editor-in-Chief of Practical Pain Management journal and a member of the Practical Pain Management Editorial Board.

He has written over 300 medical articles, some of which are listed here: http://foresttennant.com/?page_id=25

A website with more detail is  http://www.countrydocmd.com/DocBio.htm.  Reading through this, I think you will get an idea of the outstanding physician and person Dr. Tennant is.

Personal:

Place of Birth: Dodge City, Kansas
Boy Scouts of America – Eagle Scout
Citizen of the Year – West Covina, CA
Mayor of West Covina, CA
NAACP Service Award

Professional Licenses and Credentials:

Fellow and Diplomate of American Board of Preventive Medicine
California State Medical License
Author of over 300 scientific papers and books

Education:

Hutchinson, Kansas Junior College – Associated Arts (AA)
University of Missouri – Bachelor of Arts (BA)
University of Kansas Medical School – Doctor of Medicine (MD)
University of Louisville, Kentucky – Internship Internal Medicine
University of Texas, Medical Branch – Residency in Internal Medicine
University of California Los Angeles – Masters in Public Health (MPH)
University of California Los Angeles – Residency in Preventive Medicine
University of California Los Angeles – Doctor of Public Health (DrPH)

Former Positions:

Major U.S. Army Medical Corp – Viet Nam
Post-Doctoral Fellowship-U.S. Public Health Service
Advisory Committee-FDA Drug Advisory Committee
Advisory Committee-National Institute on Drug Abuse (NIDA)
Drug Advisor – National Football League, NASCAR, Los Angeles Dodgers
Training Consultant: California Highway Patrol, California Department of Justice
Associate Professor-School of Public Health –UCLA
Founder and Executive Director-Community Health Projects Medical Group
Grantee: National Institute on Drugs

Memberships:

College on Problems of Drug Dependence
American Society of Addiction Medicine
American Society of Bariatric Physicians
American Academy of Pain Medicine
American College of Preventative Medicine
American Academy of Psychiatrist in Addiction
American Medical Association
American Public Health Association 


Areas of Interest:

Current focus on research and education in the field of intractable pain, weight control and substance abuse.
Development of and passage of the Pain Patients Bill of Rights by the California State Assembly and Senate

 

On his home page, he describes:

My Goal and Mission

  1. Identify and treat the underlying causes of severe, chronic intractable pain.
  2. Develop clinical protocols to treat the underlying causes as well as provide symptomatic care that allows the intractable pain patient to function and have a good quality of life.

The Illegal Search Warrant: a Violation of the 4th Amendment

In the section below you will find a revised copy of the Search Warrant presented when the government raided Dr. Tennant’s office.
 

UNITED STATES DISTRICT COURT
for the
Central District of California

In the Matter of the Search of
338 South Glendora Avenue
West Covina, California 91790

APPLICATION FOR A SEARCH WARRANT

I, a federal law enforcement officer or an attorney for the government, request a search warrant and state under penalty of perjury that I have reason to believe that on the following person or property [See Attachment A-3]  located in the Central District of California , there is now concealed [See Attachment B]
The basis for the search under Fed. R. Crim. P. 41(c) is

  • evidence of a crime;
  • contraband, fruits of crime, or other items illegally possessed;
  • property designed for use, intended for use, or used in committing a crime;

The search is related to a violation of:
21 u.s.c. §§ 846,841; 18 u.s.c. §§ 1347, 1349;  18 U.S.C. §§ 1956(a), (h)

The application is based on these facts:
See attached Affidavit

DEA DI Stephanie Kolb
Printed name and title

Sworn to before me and signed in my presence.
Date: 11-13-17
City and state: Los Angeles, California Hon. Alicia G. Rosenberg, U.S. Magistrate Judge

 AUSA: Benjamin R. Barron

ATTACHMENT A – 3

Description of SUBJECT PREMISES-3 to be searched

            SUBJECT PREMISES-3 IS DESCRIBED AS FOLLOWS: 

                      TENNANT’S business located at 338 South Glendora Ave.

ATTACHMENT B

I.     ITEMS TO BE SEIZED

  1. The Items to be seized are evidence contraband, fruits, or instrumentalities of violations of 21 U.S.C. §§ 841 (a) (1) and 846 (distribution and possession with intent to distribute a controlled substance, and related conspiracy), 18 U.S.C. §§ 1347 and 1349 (healthcare fraud and related conspiracy, and 18 U.S.C. § 1956 (money laundering and related conspiracy, for the dates January 1, 2013 and the present, namely:
    1. Controlled substances, including but not limited to Fentanyl, oxycodone, and hydrocodone.
    2. Documents that refer or relate to times when controlled substances were prescribed or dispensed, customer lists, appointment books, pharmacy information, correspondence, notations, logs, receipts, journals, books, and records.
    3. Medical records, patient files, sign-in sheets, charts, billing information, payment records, and identification documents for or that refer to any of the following patients:
      1. Patients who have received any controlled drug from UNITED and/or TENNANT, or
      2. Medicare beneficiaries.
    4. Documents or other materials that refer or relate to the TIRF REMS program or that otherwise address the requirements for safe or appropriate prescribing of TIRF drugs.
    5. Documents that refer or relate to payments to or from INSYS Therapeutics or any agent of INSYS Therapeutics; payments received or paid to attend any event connected to INSYS Therapeutics or the TIRF drug Subsys; or any Medicare or other billing for prescribing or dispensing of a TIRF drug (to include pre-authorization for any such billing),
    6. Documents, including but not limited to emails, check registers, cancelled checks, deposit items, financial instruments, facsimile transmissions, ledgers, or correspondence to/from any insurance provider, that refer or relate to: the prescribing or dispensing of any controlled drug or to any person to whom a controlled substance was prescribed or dispensed.
    7. United States currency, financial instruments and precious metals in an aggregate value exceeding $1,000.
    8. Records, documents, titles, mortgage paperwork, and deeds reflecting the purchase, rental or lease of any real estate and vehicles, such as a car, truck motorcycle, boat, plane, or RV.
    9. Not more than twenty (20) indicia of occupancy, residency, rental, or ownership of each SUBJECT PREMISES, including but not limited to utility bills, telephone bills, loan payment receipts, rent receipts, trust deeds, lease or rental agreements, and escrow documents.
    10. Keys to show ownership of storage facilities, businesses, locked containers, cabinets, safes, conveyances, and/or other residences.
    11. Any digital device used to facilitate the above-listed violations and forensic copies thereof.
  2. With respect to any digital devices used to facilitate the above-listed violations or containing evidence falling within the scope of the foregoing categories of items to be seized:
    1. Evidence of who used, owned, or controlled the device at the time the things described in this warrant were created, edited, or deleted, such as logs, registry entries, configuration files, saved usernames and passwords, documents, browsing history, user profiles, e-mail, e-mail contacts, chat and instant messaging logs, photographs, and correspondence;
    2. Evidence of the presence or absence of software that would allow others to control the device, such as viruses, Trojan horses, and other forms of malicious software, as well as designed to detect malicious software;
    3. Evidence of the attachment of other devices;
    4. Evidence of counter-forensic programs (and associated data) that are designed to eliminate date from the device
    5. Evidence of the times the device was used;
    6. Passwords, encryption keys, and other access devise that may be necessary to access the device;
    7. Applications, utility programs, compilers, interpreters, or other software, as well as documentation and manuals, that may be necessary to access the device or to conduct a forensic examination of it;
    8. Records of or information about Internet Protocol addresses used by the device
    9. Records of or information about the device’s Internet activity, including firewall logs, caches, browser history and cookies, “bookmarked” or “favorite” web pages, search terms that the user entered into any Internet search engine, and records of user-typed web addresses.


II.    SEARCH PROCEDURE FOR DIGITAL DEVICES

5.  In searching digital devices, law enforcement personnel (the “search team”) will employ the following procedure:

  1. Search the digital device (s) on-site or seize and transport the device (s) to an appropriate laboratory. The search should not exceed 120 days without an extension of this warrant.

2-6. Various search procedures

7. The government may retain a digital device itself until further order of the Court or one year after the conclusion of the criminal   investigation, only if the device is determined to be an instrumentality of an offense…
8. After the completion of the search of the digital devices, the government shall no access digital data falling outside the scope of the items to be seized absent further order of the Court.
6.  In order to search for data capable of being read or interpreted by a digital device, law enforcement personnel are authorized to seize the following items:
a. Any digital device capable of being used to commit, further or store evidence of the offense(s) listed above;
b. Any equipment…
c. Any storage device
d. Any applications, programs, …
e. Any physical keys, encryption devices,…
f.  Any passwords,…
7.  During the execution of this search warrant, the law enforcement personnel are authorized to depress the fingerprints and/or thumbprints of any person, who is located at the SUBJECT PREMISES during the execution of the search and who is reasonably believed by law enforcement to be a user of a fingerprint sensor-enabled device that is located at the SUBJECT PREMISES and falls within the scope of the warrant.
8.  The special procedures relating to digital devices found in this warrant govern only the search of digital devices pursuant to the authority conferred by this warrant…

  1. PROCEDURE FOR PATIENT REQUESTS FOR MEDICAL RECORDS
  2. The following procedures will be followed in order to minimize disruption to the legitimate medical needs of patients: A patient whose medical information has been seized pursuant to this search warrant may request that a copy of that seized information be returned to the patient. These requests must be in writing and shall be submitted to Diversion Investigator Stephanie A. Kolb, Drug Enforcement Administration, 1900 East First Street, Santa Ana, California 92701. Requests may also be faxed to (714) 647-4971 or emailed to Stephanie.a.kolb@usdoj.gov. The government must provide to the patient making the request a copy of any medical information it has regarding the patient within 48 hours (excluding weekends and holidays) of receiving the request.

 

AFFIDAVIT

I, Stephanie Kolb, being duly sworn, declare and state as follows:

I  INTRODUCTION

  1. I am presently employed as a Diversion Investigator (“DI”) for the United States Drug Enforcement Administration (“DEA”) and have been so employed since 2012. I am currently assigned to the Los Angeles Field Division, Tactical Diversion Squad (“TDS”), which is tasked solely with the investigation of the illegal trafficking of pharmaceutical controlled substances.
  2. During the course of my employment, I received approximately thirteen weeks of instruction in the investigation of controlled substance registrants (including doctors, physician assistants, and nurse practitioners) and major narcotics traffickers at the DEA Academy in Quantico, Virginia. I received additional training at Quantico in asset forfeiture and money laundering investigations.
  3. I have specialized training and experience in narcotics trafficking conspiracy, and distribution investigations, specifically including pharmaceutical controlled substances investigations. I have participated in all aspects of drug investigations, including the use of confidential sources and undercover officers, electronic surveillance, the execution of search and arrest warrants, investigative interviews, and the analysis of seized record, physical evidence, and taped conversations. Over the course of my employment as a DI, I have been the case agent or lead investigator on several federal investigations that have specifically involved the illegal trafficking of pharmaceutical controlled substances by medical doctors, physician assistants, and nurse practitioners, and I have participated in multiple other investigations that involved the illegal diversion of pharmaceutical controlled substances. I have spoken on numerous occasions with pharmacists, physicians, Dis, Medical Board investigators, patients, and other witnesses having extensive knowledge of pharmaceuticals regarding the methods and practices of individuals trafficking in or diverting pharmaceutical controlled substances.
  4. Through my investigations, my training and experience, and my conversations with other law enforcement personnel, I have become familiar with the tactics and methods used by traffickers to smuggle and safeguard pharmaceutical controlled substances, to distribute and divert pharmaceutical controlled substances, and to collect and launder the proceeds from the sale of controlled substances. Further, I am aware of the tactics and methods employed by pharmaceutical trafficking organizations and individuals to thwart investigation of their illegal activities.
  5. I have participated in the federal prosecution of physicians, physician assistants, and pharmacists. During the course of trial, I have testified both to specific knowledge of the case and my knowledge obtained through training and experience.
  6. The facts set forth in this affidavit are based upon my personal observations, my training and experience, and information obtained from other agents and witnesses. This affidavit is intended to show merely that there is sufficient probable cause for the requested warrant and does not purport to set forth all of my knowledge of or investigation into this matter. Unless specifically indicated otherwise, all conversations and statements described in this affidavit are related in substance ant in part only.

 

II   PURPOSE OF AFFIDAVIT

  1. This affidavit is made in support of an application for search warrants to search the following locations (collectively the “SUBJECT PREMISES”) and to seize evidence, fruits, and instrumentalities of violation of 21 U.S.C. §§ 846,841 (distribution of controlled substances, possession of controlled substances with intent to distribute, and related conspiracy); 18 U.S.C. §§ 1349 (conspiracy to commit health care fraud); and 18 U.S.C. §§ 1956(a), (h) (money laundering and related conspiracy);
    1. SUBJECT PREMISES-1: United Pharmacy Inc., (“UNITED”), located at 1129 South Robertson Boulevard, Los Angeles, California 90035. …
    2. SUBJECT PREMISES-2: a residence located at …, the residence of Farid Pourmorady, Pharmacist and Owner of United.
    3. SUBJECT PREMISES-3: the office location of Dr. Forest Tennant…
    4. SUBJECT PREMISES-4: a second office location of TENNANT.
    5. SUBJECT PREMISES-5: a residence located at … the residence of TENNANT.
  2. The SUBJECT PREMISES are more specifically described … The items to be seized are set forth in Attachment B…
  3. … The instant application for search warrants is specifically requested by Benjamin R. Barron, and Assistant US Attorney for the US Attorney’s Office for the Central District of California…

SUMMARY OF INVESTIGATION

  1. This investigation was initiated in approximately February 2015 and currently targets a drug trafficking organization (“DTO”) involving a pharmacy (UNITED) and multiple physicians whose prescriptions are filled at UNITED, focusing in particular on TENNANT. Specifically, investigators believe that UNITED, TENNANT, and various medical practitioners are profiting from the illicit diversion of controlled substances, including the powerful narcotic fentanyl, which are prescribed and dispensed other than for a legitimate medical purpose. The evidence discussed herein includes analysis of multiple data sets regarding the prescribing, ordering, and billing patterns of UNITED and/or TENNANT; opinions from three separate experts about red flags of diversion and fraud reflected in the data as to both UNITED and TENNANT; witness interviews, surveillances conducted by investigators; summaries of financial records obtained during the investigation; and records of a prior criminal conviction and related medical board adjudication against TENNANT for submitting fraudulent billings to Medi-Cal;

Based on the evidence developed in this investigation, I submit that there is probable cause to believe the following
a.  The crimes perpetrated by the DTO include the sale of powerful prescription narcotics such as oxycodone and fentanyl, along with other dangerous and addictive controlled drugs often sought in combination with narcotics, based on invalid prescriptions issued by practitioners including TENNANT. For example, I submit that expert review of Medicare data along with beneficiary interviews independently demonstrate probable cause that TENNANT prescribed fentanyl drugs to non-cancer patients, even though the drugs prescribed are for use in treatment of breakthrough cancer pain.
b.  UNITED has been submitting millions of dollars in fraudulent Medicare prescription drug claims, namely, claims for the cost of filling invalid narcotic prescriptions, including those issued by TENNANT.
c.  Moreover, both UNITED and TENNANT are implicated in a large-scale federal investigation in the District of Massachusetts, which recently resulted in the issuance of a federal indictment against persons including the executives of a company manufacturing the fentanyl product Subsys. As set forth below, the grand jury’s findings include, among other things, that the defendants would engineer fraudulent insurance claims for Subsys (misleadingly make it appear as though the drugs were prescribed for breakthrough cancer pain), and that they would pay kickbacks to medical practitioners in the guise of purported “speaker fees.” Records obtained by the investigators in that case show that UNITED was among the top purchases of Subsys nationwide, that TENNANT was paid such “speaker fees” for presentations at locations including an expensive steakhouse, and that the owner and pharmacist in charge of UNITED (POURMORADY) attended such purported speaking events.

BACKGROUND REGARDING PROBABLE CAUSE

  1. Based on my training and experience, I know the following about the drugs relevant to the investigation in this case:
    1. Fentanyl is a generic name for a narcotic analgesic classified under federal law as a Schedule II controlled substance, also commonly known by the brand names Astral, Fentora, Actiq, and Subsys. Fentanyl is formulated in several strengths between 200 mcg and 1600 mcg per dosage unit. Fentanyl, when legally prescribed for a legitimate medical purpose, is typically used for breakthrough pain in end stage cancer patients. The Actiq lozenges or “pops” and fentanyl patches are the most sought after on the black market and can go for $100 per patch. A fentanyl prescription is generally issued for a modest number of dosage units to be taken over a short period of time. Fentanyl can be habit-forming and is a commonly abused controlled substance that is often diverted from legitimate medical channels.
    2. Oxycodone (Brand name OxyContin, Percocet, Roxicodone) is a generic name for a narcotic analgesic classified under federal law as a Schedule II narcotic controlled substance. Oxycodone, when legally prescribed for a legitimate medical purpose, is typically used for the relief of moderate to severe pain. Oxycodone is sometimes referred to as “synthetic heroin” or “hillbilly heroin,” and the effects, addiction, and chemical composition of oxycodone are extremely similar to heroin. An oxycodone prescription is generally issued for a modest number of pills to be taken over a short period of time because of the potential for addiction. OxyContin is a time-released formulation available in several strengths between 10mg and 80mg per tablet, designed for absorption into the system over the course of 10 to 12 hours. OxyContin was approved for use in 1996, and by 2001, OxyContin was the largest grossing opiate pain reliever in the United States. In 2010, because of public pressure, the manufacturer reformulated OxyContin to make it more difficult to snort, smoke, or otherwise abuse, and changed the markings on the pill from “OC” to OP” to differentiate the newer tamper-proof version. Roxicodone is an immediate-release formulation available in 5mg, 15mg, and 30mg tablets. Because of the immediate-release component, the potential for overdose and death with Roxicodone is exponentially higher than OxyContin, even though individual tablets generally contain less of the narcotic substance. Oxycodone in either formulation is extremely addictive and is a commonly abused controlled substance that is diverted from legitimate medical channels. Oxycodone typically has a street value of $10 to $15 per 30 mg tablet in the greater Los Angeles area.
    3. Hydrocodone (Vicodin, Norco, and Lortab) is a generic name for a narcotic analgesic classified under federal law as a Schedule II narcotic drug controlled substance; hydrocodone was elevated from a Schedule III to Schedule II drug in October 2014. Hydrocodone, when legally prescribed for a legitimate medical purpose, is typically used for the relief of mild to moderate pain. Accordingly, the prescription is generally for a modest number of pills to be taken over a short period of time. Hydrocodone is formulated in combinations of 5 to 10mg of hydrocodone and 325 to 750mg of acetaminophen. Hydrocodone can be addictive and is a commonly abused controlled substance that is diverted from legitimate medical channels. Hydrocodone typically has a street value of $3 per 10mg tablet in the greater Los Angeles Area.
    4. Individuals on the black market – both drug addicts and drug traffickers – often seek to abuse or sell narcotics such as those listed above in combination with drugs including benzodiazepines and muscle relaxants. Examples of benzodiazepines include alprazolam (brand name Xanax), diazepam (brand name Valium), and clonazepam (brand name Klonopin), each of which are Schedule IV drugs, intended primarily for use in treatment of conditions such as anxiety or insomnia. The primary muscle relaxant sought on the black market is carisoprodol (Soma), also a Schedule IV drug primarily used for treatment of physiological conditions such as muscle spasms. While those drugs are addictive and dangerous even taken alone, the combination of a narcotic with a benzodiazepine and/or a muscle relaxant magnifies the danger of the overall cocktail, and is known among law enforcement to be a major red flag of illicit diversion by medical practitioners such as doctors prescribing and/or pharmacists dispensing such cocktails. A cocktail of all three categories of drugs (a narcotic, benzodiazepine, and muscle relaxant) is commonly referred to on the black market as the “holy trinity” and is among the most sought-after prescription drug cocktails by addicts and dealers.

12.  Based on my training and experience, I know that the distribution of controlled substances must meet certain federal rules and regulations. Specifically, I know the following:

  1. 21 U.S.C. § 812 establishes schedules for controlled substances that present a potential for abuse and the likelihood that abuse of the drug could lead to physical or psychological dependence. Such controlled substances are listed in Schedule I through Schedule V depending on the level of potential for abuse, the current medical use, and the level of possible physical dependence. Controlled substance pharmaceuticals are listed in Schedules II through V because they are drugs for which there is a substantial potential for abuse and addiction. …
  2. Pursuant to 21 U.S.C. § 822, controlled substances may only be prescribed, dispensed, or distributed by persons registered with the Attorney General of the United States to do so. … The Attorney General has delegated to the DEA authority to register such persons.
  3. Under 21 U.S.C. § 823 (f), DEA-registered medical practitioners (including pharmacies, see 21 U.S.C. § 802 (21)) must be specifically authorized to handle controlled substances in any jurisdiction in which they engage in medical practice.
  4. 21 C.F.R. § 1306.04 sets forth the requirements for a valid prescription. It provides that for a “prescription for a controlled substance to be effective (it) must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substance is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.”
  5. 21 C.F.R. § 1306.05 sets forth the manner of issuance of prescriptions. It states that “(a) 11 prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address, and registration number of the practitioner.”
  6. 21 C.F.R. § 1306.12 governs the issuance of multiple prescriptions and states: “An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met:                 i.– v. gives requirements.
  7. California Health and Safety Code § 11172 states: “No person shall antedate or postdate a prescription.”
  8. 21 U.S.C. § 841 (a) (1) makes it an offense for any person to knowingly and intentionally distribute or dispense a controlled substance except as authorized by law. Distribution of a scheduled controlled substance in violation of 21 U.S.C. § 841 (a) (1) (often referred to as “diversion”) by a medical doctor occurs when a medical doctor knowingly and intentionally prescribes a controlled substance, … for a purpose other than a legitimate medical purpose and outside of “the usual course of professional practice.” See United States v. More, 423 U. S. 122, 124 (1975) (“We…hold that registered physicians can be prosecuted under 21 U.S.C. § 841 when their activities fall outside the usual course of professional practice.”), See also United States v. Feingold, 454 F.3d 1001, 1008 (9ty Cir. 2006) (“To convict a practitioner under § 841 (a), the government must prove

(1)   That the practitioner distributed controlled substances,

(2)   That the distribution of those controlled substances was outside the usual course of professional practice and without a legitimate medical purpose, and

(3)   That the practitioner acted with intent to distribute the drugs and with intent to distribute them outside the course of professional practice.”)

  1. The Medical Board of California formally adopted a policy statement entitled “prescribing Controlled Substances for Pain.” The Medical Board’s guidelines for prescribing a controlled substance for pain state that the practitioner must obtain a medical history and conduct a physical examination. Such history and exam include an assessment of the pain and physical and psychological function, substance abuse history, prior pain treatment, assessment of underlying or coexisting diseases and conditions, and documentation of the presence of a recorded indication for the use of a controlled substance.
  2. California Business and Professions Code, Section 2242 (a) states that there must be a logical connection between the medical diagnosis and the controlled substance prescribed. “Prescribing, dispensing, or furnishing dangerous drugs . . . without an appropriate prior examination and a medical indication, constitutes unprofessional conduct.” A practitioner must make “an honest effort to prescribe for a patient’s condition in accordance with the standard of medical practice generally recognized and accepted in the country.” United States v. Hayes 794 F.2d 1348, 1351 (9th Cir. 2006)
  3. As noted above, the drugs implicated in this case include fentanyl, including in particular a form of fentanyl spray marketed under the brand name Subsys. From my training and experience, I know that fentanyl is the most powerful narcotic available on the prescription market, and is approximately 50 times more powerful than heroin. The class of fentanyl particular relevant in this investigation, including Subsys, is commonly referred to as TIRF drugs (transmucosal immediate-release fentanyl). TIRF medicines are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain.
    1. To avoid the risk of misuse, abuse, and addiction associated with TIRF drugs, in December 2011, the United States FDA approved a Risk Evaluation and Mitigation Strategy (“REMS”) for such drugs… REMS requires providers be registered with the program in order to prescribe TIRF medications out-patient. Patients must sign a patient-prescriber agreement form before they can be prescribed any TIRF drugs. REMS requires enrollment of prescribers and pharmacies handling TIRF drugs and mandates specialized training on handling TIRF drugs. …
    2. As discussed below, I submit that the evidence demonstrates probable cause that UNITED and TENNANT were distributing TIRF drugs in violation of the REMS program.

STATEMENT OF PROBABLE CAUSE

A.  Background on Targets of Investigation

  1. UNITED and Pourmorady
    a.  POURMORADY is a licensed pharmacist. UNITED is a licensed retail pharmacy.

. . .

  1. TENNANT
    1. TENNANT is a licensed medical doctor with a specialty in Pain Management and Board Certification in Public Health and General Preventive Medicine.

. . .

  1. TENNANT’s DEA registration is currently listed as “Active Pending,” which means that TENNANT is currently under review/investigation (connected to this investigation)

. . .

  1. Investigators have conducted surveillances at TENNANT’s home and offices. To provide one notable example, on October 30, 2017, DEA SAs witnessed TENNANT leave one office and travel to the other. TENNANT later left that location with patient files in his possession, and he drove to Hamilton Steakhouse in Covina, California. TENNANT sat at a bar at the steakhouse, and agents witnessed TENNANT writing in the patient files while seated at the bar. Later that evening, TENNANT left the steakhouse and was followed to his home.

. . .

  1. My insertion: [MS Kolb drags up past issues:
  2. A decision in 2001 where TENNANT pleas nole contendere or “no contest” to charges of government insurance fraud, which was a misdemeanor and other charges were dismissed. TENNANT agreed to stop submitting billings to the Medi-Cal program, to pay $20,000 in restitution and to submit to a three-year term of formal probation.
  3. Supposed fraudulent Medi-Cal billings while serving as executive director of various methadone clinics, totaling $18.135. ]

Back to the document as written:

From researching TENNANT’s background via the Internet, I [Ms. Kolb] know that: In 1997, the year after OxyContin was introduced to the market (which I know from my training and experience marked the beginning of what eventually became the national opioid epidemic), TENNANT sponsored the “Pain Patient’s Bill of Rights” in the State of California, which called for expanding the use of opiate drugs for medical treatment of pain. Additionally, I know that TENNANT has published on topics including pain medicine and opioids, such as an article in 2009 arguing for using “ultra-high opioid doses” for certain patients with severe chronic pain.

B.  Initiation of Investigation

  1. In February 2015, the DEA initiated the investigation in this case after receiving information from the DEA Fresno Resident Office that Dr. Ernestina Saxton (“SAXTON) was writing large quantities of controlled substance prescriptions to patients in Los Angeles. … the majority of which were controlled substance prescriptions filled at UNITED. . . .

. . . Investigation of UNITED by Dr. Jodi Sullivan. Pharm. D. . . .

g. i. Regarding TENNANT, Dr. Sullivan observed that UNITED submitted 319 prescription drug claims totaling approximately $2,018,652 in payments. Significantly, TENNANT was the top prescriber of Subsys for UNITED. . .. Overall TENNANT prescriptions accounted for 154 claims submitted by UNITED for beneficiaries residing outside of California, all of which were for controlled drugs. Based on these findings, Dr. Sullifan concluded, “the association of Dr. Tennant with United Pharmacy may warrant further investigation.”

F. CURES [California’s Controlled Substance Utilization Review and Evaluation System] Data for Tennant and Related Expert Review

  1. I have reviewed CURES data for drugs prescribed by TENNANT, for the approximate time period of August 2014 to July 2016. My review of the data shows what I recognize to be red flags reflecting the illicit diversion of controlled substances.
    1. For example, of the approximately 597 prescriptions for hydrocodone in tablet form, approximately 85% were for maximum strength 10mg hydrocodone. The remainder was predominately for high potency 7.5mg hydrocodone.
    2. I also observed that TENNANT was prescribing large volumes of benzodiazepines. . . . . Notably nearly half of these prescriptions are for 2mg alprazolam, the maximum strength tablet of the drug available at retail pharmacies, which I know is a drug that even psychiatrists will not ordinarily prescribe for outpatient treatment. Similarly, approximately 72% of the diazepam prescriptions are for maximum strength 10mg. To the best of my knowledge, TENNANT has no advertised specialty in psychiatry; I recognize large volumes of benzodiazepines prescribed by a non-psychiatric specialist, particularly when prescribed in combinations with narcotics, as a major red flag of illicit diversion.
    3. I observed repeated entries throughout the CURES data of patients simultaneously filling TENNANT prescriptions for dangerous combinations, such as combinations of narcotics with benzodiazepines and/or Soma.
  1. [Dr. Tennant’s prescription writing was reviewed by Dr. Timothy Munzing, a family physician who does work for the government. He submitted his report on October 13, 2017]

a.  In conducted his review, Dr. Munzing selected 20 patients for “more detailed” review “based on potential significant areas of concern…” . . .  Dr. Munzing concluded that “all have many extremely concerning findings” reflecting “prescribing patterns [that] are highly suspicious for medication abuse and/or diversion.”
b.  The “non-exhaustive” “areas of concern” cited by Dr. Munzing include the following:
i. TENNANT was writing “extremely high numbers of pills/tablets” at a time. . . . including “multiple opioids/controlled substances concurrently. This increases the risk of overdose and/or death.” Dr. Munzing also observed that “many patients are receiving injectable opioids, hormones, etc.,” which is “highly irregular.”
ii. Dr. Munzing addressed the morphine equivalency dosing. . . . The risk of overdose death increases once a cocktail reaches an MED of 50-100 mg/day. “Many or most patients had levels far over those thresholds.
iii. Many patients are traveling long distances to see Dr. Tennant.

Ultimately, Dr. Munzing stated that “it is not possible to give a final conclusive opinion regarding the legality of the prescriptions in the CURES data, absent review of further evidence.” . . . However, Dr. Munzing concluded “based on the findings, and my extensive experience reviewing such cases, I find to a very high level of certainty that after review of the medical records, that Dr. Tennant failed to meet the requirements in prescribing these dangerous medications. These prescribing patterns are highly suspicious for medication abuse and/or diversion.

G.  Expert Review of Medicare Claims Regarding TENNANT

  1. Dr. Sullivan reviewed Medicare Part D claims for prescriptions issued by TENNANT. . . . From her review, Dr. Sullivan concluded “the overall impression of Dr. Tennant’s prescribing is high opioid analgesic prescribing with questionable practices and combinations that are likely to be harmful to patients.”
  2. Dr. Sullivan’s findings include:
    1. Approximately 44% of all prescription drug claims were for beneficiaries outside California. Dr. Sullivan stated that “a telemedicine registration” may be obtained for prescribers “if they demonstrate a legitimate need for the special registration and are registered in the state in which the patient is located when receiving the telemedicine treatment,” but that “from review of state license sites where Dr. Tennant is associated with beneficiaries, there are no current state licenses for Dr. Tennant outside of California.”
    2. Dr. Sullivan evaluated the prescriptions for TIRF drugs, with higher than recommended doses per day, and at maximum strength. . . .
    3. Dr. Sullivan noted a “trend” in TENNANT’s “prescribing combinations of drugs that are consistent with ‘pill mill’ prescribing practices and are considered high risk prescribing,” such as:
      1. Dr. Sullivan focused in particular on combinations narcotics, benzodiazepines, stimulants, and/or carisoprodol, noting that “patients were commonly given two or three categories of drugs together,” . . .
    4. Dr. Sullivan also noted the large volume of benzodiazepines prescribed by TENNANT, including the observation of a “trend . . . of prescribing for the highest strength of a given benzodiazepine.
  1. Dr. Sullivan reviews the Open payments Database for records of compensation received by TENNANT. . . . [Pertaining to the payments for speaking for Subsys,] “The association of Dr. Tennant with significant prescribing of Subsys, may indicate fraudulent activity specific to this drug in particular.”
    1. Multiple executives of INSYS Therapeutics and other persons are currently under federal indictment in the District of Massachusetts based on a scheme to, among other things, provide kickback payments to doctors in the guise of “speaker fees” promoting Subsys.

. . .

VI.  ADDITIONAL PROBABLE CAUSE FOR ITEMS TO BE SEIZED

  1. Based on my training, education, experience, and discussions with other law enforcement officers, I know the following regarding the common modus operandi of the offenses under investigation in this case, namely controlled drug diversion and health care fraud committed by medical practitioners.
    1. Such practitioners often keep controlled substances and drugs, records of drug transactions, criminal proceeds, ledgers of compromised patients and beneficiaries (i.e., those to whom invalid prescriptions are issued), and other records within their businesses and other secure locations, (i.e., residences, safe deposit boxes, and storage areas), and vehicles, and conceal such items from law enforcement authorities. The drugs/prescriptions may be distributed or sold, but documentary records and ledgers remain. . . .
    2. Such practitioners also often retain personal and business notes, letters, and correspondence relating to their narcotics/prescription orders at their residences, businesses, . . . and electronically via digital devices. . .
    3. Such practitioners often retain telephone and address books and appointment books identifying additional individuals, including patients and patient recruiters, involved in drug diversion or health care fraud.
    4. Such practitioners commonly use personal communication devices and services to coordinate their criminal activities. . . .
    5. Such practitioners often maintain large amounts of United States currency in their residences and businesses, . . . to finance their ongoing illegal activities, and for their personal benefit and expenses.

. . .

VIII. TRAINING AND EXPERIENCE ON DIGITAL DEVICES

  1. Based on my training and experience, I know that doctors routinely store information about patients on computers and other digital devices. . . . Accordingly, I see authority to seize and examine any computers and electronic storage devices found at the SUBJECT PREMISES, pursuant to the protocol set forth in Attachment B.

. . .

VIII. CONCLUSION

  1. Based on the foregoing, I respectfully submit there is probable cause to believe that evidence, fruits, and instrumentalities of violations of 21 U.S.C. §§ 846, 841 (distribution of controlled substances, possession of controlled substance with intent to distribute, and related conspiracy), 18 U.S.C. § 1349 (conspiracy to commit health care fraud); and 18 U.S.C. §§ 1956 (a), (h) (money laundering and related conspiracy) will be located at the SUBJECT PREMISES and request that the Court issue the requested search warrants.

Signed by Stephanie A. Kolb
Diversion Investigator, DEA

 

Presented to the United States Magistrate Judge on November 13, 2017.

Filed under: General Problems | 6 Comments »

In North Dakota, Police Targeting CBD Deferred to DEA ‘Marihuana Extract’ Rule

Posted on November 27, 2017 by Pharmaciststeve

https://www.naturalproductsinsider.com/blogs/insider-law/2017/11/in-north-dakota-police-targeting-cbd-deferred-to.aspx

Editor’s note:This is the fifth in a series of articles examining regulatory hurdles facing cannabidiol (CBD) producers and marketers in the dietary supplement industry, and ongoing efforts to comply with federal regulations. Click the following links for parts 1, 2, 3 and 4 of the series.

 The owner of a health supplements store in the Northern Plains who was threatened with criminal prosecution if she restocks her shelves with cannabidiol (CBD) products said she is not willing to begin reselling the hemp-based substance.

But in interviews with reporters, Lonna Brooks of Terry’s Health Products has been willing to describe an encounter with local law enforcement in Bismarck, North Dakota, highlighting the far-reaching impact of a rule adopted by the Drug Enforcement Administration (DEA).

In May, after a local television station aired a special on the health benefits of CBD, detectives from the Bismarck Police Department purchased CBD products from two retailers, including Terry’s Health Products, to test them at a state crime laboratory. One of Brooks’ products tested positive for CBD, while the other returned a negative result, she said.

Brooks, who has owned the health supplements and specialty food store for five years, was advised CBD was a Schedule I. drug. A detective, Brooks explained, highlighted a “Marihuana Extract” rule in a packet of DEA materials distributed to her.

In a May 12 press release, the Bismarck Police Department said it did not seek charges “against the merchants since it appears that they were unaware that Cannabinol became a Schedule I. controlled substance in December of 2016.” But Brooks said the police made it clear she would face criminal charges if she starting selling CBD again.

“Our police department has been very clear about the fact that if I try putting it back on the shelves, that they will prosecute me for selling a Schedule I. drug,” she said in a phone interview in November.

Impact of ‘Marihuana Extract’ Rule

The police department’s action targeting Brooks’ CBD products highlights the far-reaching impacts of DEA’s marijuana extract rule, which is the subject of litigation in the U.S. Court of Appeals for the Ninth Circuit.

Lawyers with the Hoban Law Group who sued DEA on behalf of the Hemp Industries Association (HIA) and others said the agency overstepped its authority.

“If cannabinoids come from marijuana, they come from flowers of a non-exempt plant, then they’re illegal,” Denver-based attorney Bob Hoban acknowledged in an in-person interview in January 2017 at his law office before he and his colleagues filed the complaint against DEA.

However, Hoban declared if cannabinoids come from other sources, including industrial hemp plants grown in compliance with the 2014 Farm Bill, they are not illegal under the Controlled Substances Act (CSA).

“We don’t think that there shouldn’t be a marijuana extract rule,” Hoban said at the time. “We just think it should track the Controlled Substances Act, which is fundamental in my mind, but apparently not in terms of the process that’s taken place so far.”

Brooks is among several individuals who signed declarations under penalty of perjury in the Ninth Circuit, discussing the adverse impacts of DEA’s rule on the hemp industry.

A panel of appeals court judges could hear oral arguments in HIA’s lawsuit against DEA as early as February 2018. According to the Ninth Circuit, most cases are decided within three months to one year of arguments.

In a declaration filed with the Ninth Circuit, Colleen Keahey, executive director of the HIA, said Customs and Border Patrol has seized hemp product shipments belonging to several of her members since DEA published its final rule.

Based on responses from businesses that responded to a survey, “HIA estimates that the projected 2017 revenues of the survey respondent businesses and the entire U.S. industry would have been tens, if not hundreds, of million dollars higher but for the publication of the final rule,” Keahey wrote in her declaration.

CBD Products Tested

According to Brooks’ July 27, 2017 declaration, Terry’s Health Products sold hemp-derived products for about three years, averaging US$5,000 in monthly sales. But after a local TV station aired a May 2, 2017 feature story on the benefits of CBD oil, sales skyrocketed to $5,000 a week, she declared in the court filing.

The spike in CBD sales was short-lived. On May 11, narcotics investigators visited her store and a food cooperative. The investigators purchased products and had them tested.

During the police department’s confiscation of the hemp-derived products, Brooks said in her declaration, she was provided with documentation, including a copy of the publication of DEA’s marijuana extract rule in the Federal Register and its listing in the code of federal regulations (CFR).

“In fact, one of the … investigators drew an arrow next to the ‘Marihuana Extract’ listing in the CFR,” Brooks declared.

“Terry’s no longer sells hemp-derived products out of fear of further seizure and potential criminal prosecution,” Brooks wrote. She added, “The 100 [percent] loss of these hemp-derived product sales has had a substantial, negative impact on our small local business.”

The Bismarck Police Department referred to cannabinol, a cannabinoid distinguishable from CBD. However, testing results of Brooks’ products by the crime laboratory division of the state Office of the Attorney General identified CBD in one of the bottles. There was “no evidence of controlled substances” in the other bottle tested, according to the results INSIDER obtained from Brooks. (Brooks said third-party documentation actually showed the presence of CBD in the latter product distributed by a North Dakota-based company, Zen Butterfly, contradicting the state lab’s results of a negative finding; Zen Butterfly did not respond to a request for comment).

In the May 12 press release, local police reported one of two items purchased at Terry’s Health Products yielded a positive result for cannabinol, while all three items at the food coop were positive. The stores willingly turned over products for disposal after they were advised of the lab results, the authorities said, describing the merchants as “reputable businesses that had no intention of doing anything illegal.”

Role of State, Federal Authorities Unclear

It’s not clear what prompted detectives to target the products. Brooks said she heard from multiple sources that a tip or direction came from North Dakota Attorney General Wayne Stenehjem based on a citizen complaint. The local newspaper shared a similar account; Sgt. Mike Bolme, a detective with the narcotics unit of the Bismarck Police Department, told the Bismarck Tribune in a May 12 article that its decision came after a tip from the attorney general’s office.

Asked to comment for this article, Sgt. Mark Buschena of the Bismarck Police Department referred questions to Stenehjem’s office whom he said determined CBD is a prohibited substance.

Reached via email, Stenehjem’s office said the issue involves DEA and referred a media inquiry to the U.S. Attorney’s Office. Tanya Abraham, a public information officer with the U.S. Attorney’s Office in Fargo, North Dakota, declined comment.

Patrick Goggin, a senior attorney with the Hoban Law Group, said the case involving Brooks is one in which authorities in North Dakota gave “real deference to the big kahuna agency of the DEA.

“And who knows exactly what communication was made from the DEA to the local and state authorities in North Dakota, but it’s clear that there had to have been some communication to them by the DEA,” the San Francisco-based lawyer said in a brief phone interview. “Or why would they be pursuing and enforcing a rule that by the local law enforcement’s own accounts was low priority, and they didn’t understand it?”

Brooks said information was shared with the local police, explaining the CBD seized was hemp legally sourced from Kentucky.

“It didn’t matter to them,” she said. “They didn’t care. The police department said this is our direction from the attorney general.”

As a wife and mother of a two-year-old, Brooks said she won’t do anything to jeopardize her family—so Bismarck residents aren’t likely to find CBD at her store anytime soon. However, the business owner feels she has an obligation to openly discuss the controversial issue.

“[T]he natural products industry has fought against different FDA and DEA things from the inception, and I kind of feel like it’s my mission,” she said. “I need to be speaking up, or I need to be doing something.”

Filed under: General Problems | 1 Comment »

Human sloths ?

Posted on November 27, 2017 by Pharmaciststeve

https://youtu.be/_j_re2IwSOI

Watch: ‘Drugged-Up’ Cashiers Fall Asleep While Scanning Items

http://popculture.com/2017/11/26/cashiers-fall-asleep-while-scanning-items-opioid-epidemic/

A viral video making the rounds this morning shows two cashiers who viewers assume are on some form of prescription opiates.

The video shows two middle-aged women, who appear to be sleeping, standing up behind the counter at a convenience store. They remain motionless until a customer greets them with a pointed, “Hello?”

 What follows is two arduous minutes ringing up six dollars worth of snacks. The cashiers are both slow and sluggish. Their words are slurred and their eyes are glazed over. The one that’s not ringing up products struggles just to stay awake.

The video is titled, “America’s Opioid Epidemic,” and the caption reads: “Really got to wonder why the powers that be think this type of stuff is okay and marijuana is not…”

 The top comments all share a similar sentiment: “Don’t do drugs, kids,” one user wrote.

The rising trend of opioid abuse in America has been a hot button issue for a while now, as the problem has slowly risen to prominence. Prescription pain killers are being over-prescribed or wrongly prescribed across the country, and the pills are acting as a gateway to heroin addiction.

 The opioid epidemic was one of the key elements to President Donald Trump’s platform, and he’s promised to find a solution while he’s in office. At the end of last month, the president officially declared the situation a public health emergency.

Filed under: General Problems | 4 Comments »

what happens when your doc is controlled by a hospital and is also your insurance company

Posted on November 26, 2017 by Pharmaciststeve

When my phone rings, I don’t always know who is calling… sometimes it someone wanting to sell me an extended warranty on a car that I sold 2.5 yrs ago.. sometimes wants to lower the interest rate on my credit cards… which has no on going balances..

Other times it is from a chronic pain pt “in crisis” from being discharged/abandoned by their long time prescriber, this time it was her oncologist .

Today it was the latter…  a senior female that suffers from a disease that causes nephropathy in her legs.  She has been taking for years about 300mg MME/day and she was presented a prescription for a “10 days supply” and was told that the Hospital that employs this prescriber no longer  wanted their employees to treat chronic pain and that they would give her a referral to a pain specialist.

Often pain specialists are 30-60-90 days out to get an appt and many will not give a new pt any opiates on the first visit.

This pt’s oncologist was just one of several in this “hospital owned cancer clinic” and an estimated 50-75 other pts from this practice were also going to get the same “kicked out the door treatment”.

Apparently this hospital had created a ACO   https://en.wikipedia.org/wiki/Accountable_care_organization  which basically meant that the hospital was the “insurer” and the provider of health care services for this mid-western city/county… and this poor woman’s health insurance was with the same hospital complex that was telling its employed prescribers to stop prescribing opiates for pain.

This pt already is dealing with HYPERTENSION.. one can just imagine when she goes into cold turkey withdrawal within the next two weeks.. what is going to happen to her BLOOD PRESSURE…  since a hypertensive crisis is not untypical with a person being in cold turkey withdrawal and often what follows is a “brain bleed” – stroke and sometimes DEATH.

What is going to be the FINAL TALLY of all the pts of this hospital/insurance system that are going to be thrown into cold turkey withdrawal ? How many are going to suffer a stroke and no longer able to ambulate or even communicate… or worse yet DIE FROM THE STROKE… Or perhaps, those that can’t tolerate their increased pain and take the final action to eliminate their pain FOR GOOD.. and commit SUICIDE ?

Could whatever people within this hospital corporation that were behind this “medical decision” to force their employed prescribers to abruptly discontinue opiate prescribing… be guilty of assisting suicide, involuntary manslaughter, pt/senior abuse, civil rights violations of the Americans with Disability Act and Civil Rights Act.. for starters.

 

 

 

Filed under: General Problems | 1 Comment »

Meet the Doctor Who Refuses to Stop Prescribing Opioids to Pain Patients

Posted on November 24, 2017 by Pharmaciststeve

Filed under: General Problems | Leave a Comment »

How Jeff Sessions Plans to End Medical Marijuana Before the Year Is Over

Posted on November 24, 2017 by Pharmaciststeve

http://www.newsweek.com/will-jeff-sessions-medical-marijuana-718676

VIDEO ON ABOVE LINK

Tears streamed down Claudia Jendron’s face this year as her doctor patted her hand and told her, after eight years of failed pain treatments for her spinal fusion-gone-wrong, “This is going to work, Claudia.” She was talking about medical marijuana.

For “eight years of hell,” Jendron tried opioids, epidural shots and acupuncture in the hopes that she’d be able to sit down or go to her grandchildren’s birthday parties without having to leave and lie down. None of it worked. At one point, she considered checking into an assisted living facility to receive morphine before she tried medical marijuana. 

Then, early this year, the 66-year-old upstate New Yorker got a prescription for medical marijuana to help what she called “excruciating pain.” To Jendron’s surprise, her doctor was right about the weed. Two days after starting a tincture (a liquid cannabis extract dropped under the tongue), her crushing pain subsided to something manageable.

“I can lean over and hug my grandkids without screaming anymore,” she said. “I went to a commitment ceremony in the park the other day, and I lasted all day long without any pain…It’s just, it’s amazing.”

New York is one of 29 states (plus the District of Columbia) that have legalized medical marijuana––a trend that 94 percent of Americans support, according to an August Quinnipiac poll. But on December 8, all of that could begin to change.

Congress has until that day to decide whether to include the Rohrabacher-Farr Act (also known as Rohrabacher-Blumenauer) in a bill that will fund the government through the next fiscal year. Right now, that law, made up of just 85 words, blocks the Department of Justice from using any money to prosecute medical marijuana in states where it’s legal.

11_21_Rohrabacher_Blumenauer_Farr_Act The text of the Rohrabacher-Farr (also known as Rohrabacher-Blumenauer) Act, which blocked the U.S. Department of Justice from spending any money to prosecute medical marijuana in states where it’s legal. H.R. 2029 – Consolidated Appropriations Act, 2016

In May, Attorney General Jeff Sessions pushed back against the bill when he sent a strongly worded letter to Democratic and Republican leaders in Congress, asking them to oppose protections for legal weed and allow him to prosecute medical marijuana. 

“I believe it would be unwise for Congress to restrict the discretion of the Department to fund particular prosecutions, particularly in the midst of an historic drug epidemic and potentially long-term uptick in violent crime,” Sessions wrote in his letter. 

The bill’s 2014 passage, with 170 Democrats and 49 Republicans in favor, was the first time Congress passed legislation that protected medical marijuana users and businesses. It meant that an attorney general could no longer send Drug Enforcement Administration agents (or use other government resources) to bust medical marijuana in states where it was legal. 

It was in line with the Obama administration’s 2013 “Cole Memo,” in which Deputy Attorney General James Cole said the Justice Department would refrain from prosecuting medical marijuana businesses and users in states where it was legal, and that it would prioritize more serious marijuana offenses, like drug cartels and sales to minors. The policy marked a change for the Obama administration, where medical marijuana busts were once rampant.  

With his letter, Sessions pushed Congress to end these protections. In a statement on Friday, Sessions announced that the Justice Department would halt the practice of guidance memos, and review Obama administration guidance memos on legal pot to see if they went too far.

Sessions is known for being one of the nation’s toughest critics of legal pot. He once said the KKK was “OK until I found out they smoked pot.” 

More recently, he said at a speech in March in Richmond, “I am astonished to hear people suggest that we can solve our heroin crisis by legalizing marijuana—so people can trade one life-wrecking dependency for another that’s only slightly less awful.”

In the early decades of his career, denouncing marijuana was an unprovocative viewpoint. In the days of DARE and abstinence-only drug education, marijuana was the bogeyman at the gateway to much more dangerous drugs. But despite new research praising medical pot and the skyrocketing approval ratings for the drug, Sessions has only budged ever so slightly in that view. 

11_21_JeffSessions U.S. Attorney General Jeff Sessions testifies before a House Judiciary Committee hearing on oversight of the Justice Department on Capitol Hill in Washington, U.S., November 14, 2017. REUTERS/Yuri Gripas

He nodded last week and said, “I think that’s correct” when Representative Steve Cohen, a Tennessee Democrat, said cannabis was not as dangerous as heroin. Sessions said he’d consider thorough analyses of medical marijuana, but that he was not optimistic. 

“He’s old fashioned and very conservative,” said Philip Heymann, a Harvard Law School professor and former Justice Department official for the Kennedy, Johnson, Carter and Clinton administrations.. “Literally seven years ago, maybe eight years ago, marijuana was thought to be a very dangerous drug. Why would he focus on this issue? Because he’s seven years out of date.” 

Even the attorney general who set the precedent for federal prosecution of legalized marijuana says Sessions would be remiss to put many resources, amid all of the country’s larger problems, into prosecuting medical marijuana.

“To prosecute an act that is otherwise lawful under state law, one could make the argument [that] as a matter of policy, we’ve got other priorities we ought to be spending our resources on,” Alberto Gonzales, the attorney general for President George W. Bush, told Newsweek. “With respect to everything else going on in the U.S., this is pretty low priority.” 

In theory, without Rohrabacher-Farr in his way, Sessions could send DEA agents into a medical marijuana dispensary or producer in any state to bust it. Experts say, if he did this, he’d likely prosecute a distributor or a producer with other violations, like tax or licensing mistakes, in addition to its violation of the CSA. 

“They can scream all they like that they haven’t violated state laws, but they violated federal law,” said Heymann.

Ilya Shapiro, a constitutional studies fellow at conservative think tank CATO institute and the editor of its Supreme Court Review, said law enforcement would likely first prosecute those in gross violation of federal laws before the average pot smoker––”the same way police go after rapists and murderers before they go after jaywalkers.” 

The Justice Department declined requests for comment on its medical marijuana agenda or on the aftermath of a Rohrabacher-Farr expiration. Representatives Sam Farr (D-Calif.) and Dana Rohrabacher (R-Calif.) introduced and passed the bill in 2014, after years of failed attempts, as part of the Commerce, Justice and Science Appropriations Bill for fiscal year 2015. It has been renewed twice since then, until House Republican leadership blocked a vote on it in September.

Under the bill, none of the funds appropriated by Congress to the D.O.J. can be used “to prevent [states] from implementing their own laws that authorize the use, distribution, possession, or cultivation of medical marijuana.” Congress has to vote on it every year.

Nicholas Vita, the CEO of Columbia Care, a medical marijuana healthcare company with dispensaries across the country, said Sessions “clearly has a bias.” His company owns five dispensaries in New York –– including the one in Rochester, where Jendron gets her weed. But, Vita said, “The toothpaste can’t be put back in the tube.” With such high support across the country, a full reversal seems extremely unlikely. 

11_21_ColumbiaCareDispensary Inside Columbia Care, a medical marijuana dispensary in Manhattan. Newsweek/Melina Delkic

Columbia Care’s Manhattan dispensary looks more like the lobby of a luxury hotel than a place to get weed, but with much more security. Its marijuana is mostly stored in a thick and ominous-looking steel safe, an extra-cautious precaution to make sure the dispensary complies with DEA standards. It comes in three, carefully measured formats –– capsules, a tincture (liquid cannabis extract) that patients take with a dropper, and a vape pen.

 

 

IMG_0765 A pharmacist at the Manhattan branch of Columbia Care, a medical marijuana dispensary chain, holds a vape pen. Newsweek/Melina Delkic

Vita said public perception on dispensaries like Columbia’s has changed rapidly.

“Five years ago, no one even talked to us,” Vita said. “I couldn’t even tell my mom and dad what I do for a living.” Today, he says leading research institutions reach out to him to partner on studies.

Despite the turnaround, strong dissenting voices remain. 

Kevin Sabet, president of the nonprofit Smart Approaches to Marijuana, an anti-marijuana legalization group led by former Representative Patrick Kennedy (D-RI), said legal weed was not as harmless as the recent hype has made it out to be. “A lot of people are being peddled this by an industry that wants to make money, like any other industry,” he said. “I have a really hard time with the very small handful of studies out. They’re just not something that the scientific community agrees upon.”

Studies are indeed limited, because marijuana is a Schedule I drug, making it hard to get DEA funding for that research. A recent study in Colorado found a reversal of opioid deaths following recreational legalization. Two August studies found, however, that evidence of its efficacy in chronic pain or PTSD treatment was lacking. While far from a consensus, its patients seem hopeful. 

For patients like Jendron, the proof is in lived experience. 

Chronic pain “manipulates your life,” she said. “I’m smiling because I don’t hurt anymore.” 

 

Filed under: General Problems | Leave a Comment »

TN veteran sues VA for cutting off pain med prescription

Posted on November 23, 2017 by Pharmaciststeve

TN veteran sues VA for cutting off pain med prescription

http://www.wsmv.com/story/36916192/tn-veteran-sues-va-for-cutting-off-pain-med-prescription

NASHVILLE, TN (WSMV) –

A Veterans Affair initiative to curb addiction by cutting back on opioid prescriptions is backfiring, according to some Tennessee veterans.

East Tennessee Marine veteran Robert Rose Jr. has filed a $350 million lawsuit that names several employees of the Mountain Home Veterans’ Affairs Medical Canter and U.S. Rep. Phil Roe, R-TN.

Rose said he has chronic pain in his back, spine and legs as a result of severe injuries while in the service.

He said he has been tormented since last November, when he was forced off pain medication.

According to the VA, more than 221,000 veterans have been weaned off opioids since fall of 2013.

Rose said the veterans who are not addicted, and have severe pain are being neglected.

“It is a death sentence for people like me who has documented issues from the Marine Corps all the way back to 1985. They just said, no more,” Rose said.

Rose said he isn’t the only one. He said he has spoken with more than 100 other veterans with similar concerns.

A spokesperson with the VA told News 4 this month that when a decision is made to wean a veteran off opioids, every individual situation is taken in to account.

Filed under: General Problems | 1 Comment »

Colorado kratom death: Bereaved woman says government could have saved her brother

Posted on November 23, 2017 by Pharmaciststeve

Colorado kratom death: Bereaved woman says government could have saved her brother

www.denverite.com/colorado-coroner-links-mans-death-controversial-kratom-denver-moves-regulate-45905/

Thirty-six people in the United States have died after using kratom, a largely unregulated drug sold in shops around Denver, according to the federal government. A young man in Boulder may be among them.

Jay Knaus, 25, died in his room this year after ingesting what his sister believes was a typical dose of the substance. The Boulder coroner directly linked his death to kratom’s active component. And his sister wants action.

“How many deaths are there going to be before you do anything about it?” asked Julie Knaus.

The death is one of the reasons that the city of Denver has placed new restrictions on the drug, which also is the subject of a new federal warning.

FOR YOU: You can sell kratom in Denver again

In response, city officials will require labels saying that the product is not for human consumption. They’ll also move to shut down kratom bars that serve the drug on site.

However, the city won’t use its power to ban the sale of the product.

“What we’re seeing is products being sold without any information about dosage. In some cases, very little labeling at all. It really leaves a lot of safety concerns,” said Danica Lee, director of public health inspections for the city.

Jay Knaus was a student at Metro State University.

“Jay was a very healthy, athletic, popular guy. Everyone loved him,” said Julie, his twin sister.

A family member discovered Jay unresponsive in bed at the family home in Longmont this February. They had no idea what was wrong with him, Knaus said, and they wouldn’t have an explanation for six more weeks.

“I was looking in trash cans, all over his room, anything for an answer. We all had no idea how and why,” she said.

When it finally arrived, an autopsy from the Boulder County Coroner’s Office listed the cause of death as accidental “mitragynine intoxication.” Mitragynine is a key active compound in kratom. Knaus’ body contained a “lethal level” of the substance, the autopsy reported.

“It was definitely a product we weren’t even aware he was taking,” Knaus said.

Jay Knaus also was found to have suffered pulmonary edema — fluid in the lungs — and that he had inhaled vomit, all related to mitragynine poisoning, according to the autopsy. The toxicology report found no other substances besides caffeine and drugs that are commonly used in medical treatment and rescue attempts, such as naloxone.

The family had to look at Jay Knaus’ bank statements for hints at what had happened.

“We believe he started the spring of 2016, but then he stopped because he had side effects like itchy skin, hair loss, irritability. We didn’t know this was the product,” said Julie Knaus, who works as a physical therapist aide in California.

While many people use kratom as an alternative to heroin and other opiates, Jay Knaus had no history with those drugs, according to his sister. She believes he was attracted to kratom because he saw it as a health product.

“It was mostly marketed as a health supplement. It’s marketed as a good source of extra energy — helps you focus,” Knaus said.

Kratom is derived from a tropical tree leaf. Its fans liken it to coffee, and it’s informally used to treat chronic pain and to replace other substances, especially opiate painkillers or heroin. A typical cup might cost $1.50 to $3.

Some users say that it saved their lives from hard drugs, and they point to the prevalence of alcohol-related deaths.

Bank records reviewed by the family show that Jay Knaus stopped buying it in the summer of 2016. He apparently started again late in January, making three purchases in the last week of his life. The purchases were of moderate size, his sister said.

His last purchase came from a Denver business, Julie Knaus said, but she declined to name the business.

The death reflects broader concerns.

In a statement issued last week, FDA Commissioner Scott Gottlieb warned that the administration was “aware of reports of 36 deaths associated with the use of kratom-containing products.” It’s unclear whether that figure includes Jay Knaus.

Chris McCurdy, a professor of medicinal chemistry at the University of Florida and leading expert on kratom, told Denverite that it’s “a total ‘buyer beware’ marketplace at this point.”

The drug has been used in Thailand and Malaysia “for centuries with no related deaths” reported, he wrote in an email. “However, in the USA this has obviously been a different story.”

A lack of regulation of dietary supplements is part of the problem, he continued. “This, unfortunately, means that it is impossible to tell what one is purchasing when they believe they are purchasing kratom,” he wrote.

It’s particularly concerning that kratom may be mixed with other substances, McCurdy added. A study found kratom-related deaths tended to involve other drugs too.

The Knaus family has consulted with medical experts who said that the level of mitragynine in Jay’s body was not atypical for kratom use, according to Julie Knaus.

What will Denver do next?

Denver’s new rule will require a label on each kratom package in large font, reading:

“This product is not intended for human consumption. Consuming kratom products may pose a risk, including death, to consumers and has addictive potential. Increased risk of injury or death may be posed by consuming with alcohol and other drugs.”

The city briefly went further than that, issuing a total ban on sales last fall. At the time, Denver was responding to the federal Drug Enforcement Administration, which had proposed a ban and suggested that kratom was an “imminent hazard” to public health.

However, the DEA reversed course. It withdrew its proposal to make the substance illegal and called for more research. One researcher said the change was “shocking.” And Denver followed suit, withdrawing its ban in October 2016.

Julie Knaus says that a different government decision could have saved her brother’s life. “I know if it was scheduled in September 2016 as a drug, he would not have died,” she said. Now, she wants Denver and other governments to go further. Instead of warnings, she wants a ban.

“Putting a label on every single package — I think that’s a step in the right direction,” she said. But she wants it to be restricted as a prescribed medicine, she said.

Lee, the Denver health official, said that instituting a total ban would be a difficult legal move, especially as higher levels of government haven’t banned the sale of the product either.

“At this point in time, we don’t feel it’s appropriate to implement a complete ban, given the fact that there are other uses (of kratom) and the state health department isn’t taking any action,” Lee said.

A local ban “would be using broad authority, and we would definitely have to make sure we’re taking a defensible position. This is what we feel comfortable with at this time.”

There Is No Determined Toxic Level Of Kratom

www.unitedstateskratomunited.wordpress.com/2017/11/12/review-of-ca-deaths-by-amy-hendricks-forensic-pathology-technician-for-ku/

Confirming the subjective nature of that number, in a paper published by Forensic Science International, dated December 2014 and titled “An Accidental Poisoning with Mitragyna” it is stated, “ Toxicity of mitragynine in humans is poorly defined, and no toxic or lethal ranges have been established.  Kronstrand et al. [7] found mitragynine levels in nine cases that varied between 0.02 and 0.18 μg/g. Holler et al.[14] and Neerman et al. [15] found mitragynine concentrations of 0.39 mg/L and 0.60 mg/L in post-mortem blood samples”.

 

Filed under: General Problems | Leave a Comment »

How many pieces are missing from the puzzle ?

Posted on November 23, 2017 by Pharmaciststeve

I have been posting on this blog, now in my SIXTH YEAR…  Hardly a week that doesn’t go by that I get at least one notice that someone has added me to a NEW FACE BOOK PAGE CONCERNING CHRONIC PAIN.

Just how many THOUSAND(s) for Face Book Pages do we need that are focused on those in the chronic pain community and it’s issues ?

Does the old saying “United we stand… divided we fall ” … seem to apply here.

IMO, there is simply a SINGLE ISSUE that effects all of those in the chronic pain community – you are either getting adequate pain management or you are being denied adequate pain management… There are numerous players involved prescribers, pharmacists, insurance companies and various governmental agencies.

There are a number of sub-issues,  but helping getting optimized pain management for all chronic pain pts.. those other issues should go away or become basically non-issues.

It is estimated that there is about 230 million eligible voters and in the typical Presidential election… 106 million will fail to vote and more will fail to vote in “off-year” elections.

Generally speaking, 98% of politicians – especially Congress – will get reelected no matter what they do – or don’t do – when they are in office.

Congress and state legislatures generally function on a seniority basis… those who have been around the longest, get to pretty much control what bills get passed or even what bills even get to be voted on by the entire body.

Everyone should be able to register to vote BY MAIL and vote BY MAIL.. there is no reason for failing to vote… If you don’t know who to vote for… vote for the person challenges the current person holding the office.  Especially those who have been “in power” for decades.

The other issue is that all of these thousands of Face Book Pages either need to consolidate or their members consolidate around a SINGLE FACE BOOK PAGE… so that everyone can get a better picture of what is going on for/against those in the chronic pain community..   A clearer picture – unlike the above puzzle…

You can contact the media and politicians, but the DEA and other agencies have at least a couple of dozen decades lead in putting out anti-opiate propaganda pieces…

Here is a link to all the press releases from the 22 DEA offices across the country back to 2002 https://www.dea.gov/pr/news2006.shtml

We also don’t know how many “behind closed door meetings” that upper level DEA agents have with members of Congress and members of city/county/state of law enforcement that can have “informal -off the record -meetings” with bureaucrats/legislators.

The chronic pain community doesn’t need a SINGLE SPOKESPERSON… but.. they do need a SINGLE MESSAGE… Until that happens, the chronic pain community will look like the above puzzle … no clear picture/message because a lot of pieces are missing.

Filed under: General Problems | 7 Comments »

the DEA can avoid potentially awkward questions about the legality of its evidence

Posted on November 23, 2017 by Pharmaciststeve

DEA Reportedly Hiding NSA Data Used To Prosecute U.S. Citizens

www.theslashgear.com/2017/11/23/dea-reportedly-hiding-nsa-data-used-to-prosecute-u-s-citizens/

The Snowden effect continued to roll today, with fresh revelations detailing how the pervasive surveillance of the National Security Agency (NSA) is in fact linked to domestic criminal prosecution. The idea, and the defense, that NSA activity only impacts non-United States citizens and terrorists, is now utterly specious.

The NSA is one of the member agencies of a DEA unit called the Special Operations Division (SOD). The SOD, according to Reuters who broke the story, is at work “funneling information from intelligence intercepts, wiretaps, informants and a massive database of telephone records to authorities across the nation to help” start, and win criminal investigations of United States citizens.

Therefore, there is a direct connection between the NSA and its surveillance efforts and regular criminal prosecution in the country.

The Washington Post read the Reuters piece as an indication the NSA is leaking phone record information to the DEA, through the SOD, but we’re not convinced that it’s a proper reading of the source. However, the SOD does operate the ‘DICE’ database, which the DEA told Reuters has around 1 billion records, both telephonic and digital. The majority, but not all, are sourced by the DEA itself.

What’s most surprising about today’s revelations is the process by which the DEA covers the tracks of its information. Using “parallel construction,” where information came from is hidden. Reuters tells a story in which a judge was told that a tip kicked off the investigation at hand. However, after pressing, it was admitted that the data had in fact been first captured by the NSA, and distributed by the SOD.

By creating new pasts for received data, the DEA can avoid potentially awkward questions about the legality of its evidence.

And the data that the NSA collects could be very useful to the DEA. The NSA, for example, collects metadata on every phone call placed in the United States. It is not clear what the NSA shares, or how often. However, it’s the fact that NSA data is being handed to the DEA through the secret SOD that is troubling prima facie.

This is not the last time that we will have a conversation similar to this one. According to the New York Times, other agencies inside the Federal government are clamoring for the information that the NSA has collected, and continues to collect.

Oversight?

It has also recently been reported that members of Congress are being denied access to information about the NSA’s activities, both by having requests ignored, or simply denied. Glenn Greenwald has primary source information, letters sent by members of Congress asking for specific information.

Others have reported similar issues in more pedestrian fashion, including Rep. Justin Amash, who tweeted that access to certain information was provided for a mere three hours, and that many Representatives missed the chance, and that those who did see the document in question were not allowed to discuss it with those that did not.

There is work afoot, as you might have expected, to keep information regarding the NSA’s activities out of the public eye. To some extent that is perfectly reasonable, given that such agencies are clandestine by nature. When Congress, tasked with oversight of American intelligence operations, is lied to, denied information, and then provided only select facts for limited periods of time, something is wrong.

And, given that the NSA is slipping the DEA information about domestic phone calls, we’ve never needed more stern hands on the NSA’s wheel.

Filed under: General Problems | 1 Comment »

« Previous Page — Next Page »