Money Before Medicine


On its seventh day of deliberations, a federal jury on Thursday, June 24 found Kansas  doctor Stephen Schneider and his nurse wife Linda Schneider guilty of conspiring to profit from illegally prescribing painkillers to patients, many of whom later died. The jury also found the Schneiders guilty on five counts of unlawfully writing prescriptions and on 11 health care fraud counts. The jury found Linda Schneider guilty of 15 money laundering charges.


Assistant U.S. Attorney Tanya Treadway prosecuted the case, which consumed eight weeks of trial. In a 34-count indictment, the Schneiders were charged with conspiring to illegally distribute prescription drugs that contributed to 21 deaths, fraud, and money laundering. The prosecution put on evidence of 176 overdoses and 68 deaths related to the pill mill.


This was a case of “money before medicine,” Tanya Treadway said. According to the prosecution, about half of the 10,000 patients treated at the Schneider Medical Clinic received pain medication. The clinic was open 11 hours a day every day, had 14 exam rooms and  scheduled patients 10 minutes apart.  Prosecutors allege the clinic made $7 million in a little over four years through health care fraud. The Schneiders pocketed about $1.5 million. The prosecution put on evidence of 176 overdoses and 68 deaths related to the pill mill.


Dr. Schneider’s attorney, reportedly supported by the advocacy group Pain Relief Network that advocates for the right to pain treatment, argued that Dr. Schneider acted “with a pure heart.” He said that “what [Dr. Schneider] did with his patients, he did so innocently, he did so honestly, and he did so courageously.”

 

Curiously, Dr. Schneider chose to drive a bright yellow hummer emblazoned with skull and crossbones to and from the pill mill on a daily basis. I wonder what kind of message he was trying to send? Was he  in a state of deep denial or did he have  so little fear of ever being prosecuted for his pill peddling that he felt bulletproof? We will probably never know, but I am sure the vehicle represents to the victims everything that was wrong with the Schneiders and their so called medical practice.


Sentencing has not yet been set. The Schneiders could face up to a life sentence.  The Schneiders also will stand trial in several civil wrongful death lawsuits which have been filed against them.
 

 We applaud the courage of Tanya Treadway in stepping up to the plate to prosecute this case.  It takes hard work and effort to bring persons such as these to justice.  Prosecutions such as these must continue to happen. Pill mill operators need to go to jail  just like persons who peddle street drugs go to jail. Pill mill operators must also be held liable for monetary damages for the devastation that they are causing while lining their pockets with blood money.Hopefully, the combination of vigorous criminal and civil prosecution will stem the tide of prescription drug overdose deaths.
 

Houston Pill Mills targeted

The Houston Chronicle recently reported a story of  alleged pill mills (S&G Medical Clinic, Texas Medicine Direct, and Uptown Medical Clinic) which stand accused of distributing large quantities of Vicodin, Xanax and Soma without a valid medical purpose.

Dr. Nancy Sellars of Houston has been charged with engaging in organized crime and practicing medicine without a license at S&G Medical Clinic at 9110 Jones Road.  See a copy of the Complaints [PDF]. Non-licensed personnel were allegedly filling out pre-signeded medical prescriptions for a variety of medicines, the majority of which were the commonly abused "cocktail" of Vicodin, Soma and Xanax.  Dr. Sellars was disciplined by the Texas Medical Board in 2001 after pleading guildy to fraudulenty prescribing controlled substances.  See a copy of the Agreed Order [PDF]. 

A non-physician , Barry Ransom, 51, the owner of Texas Medicine Direct on Interstate 10, has been charged with engaging in organized crime through knowingly delivering a prescription for other than a valid medical purpose in the course of professional practice.  See a copy of the Complaint [PDF].  According to public records, Ransom has numerous prior convictions, including a conviction for possession of a weapon (1981), controlled substance felony convictions (1983, 1986), a conviction for possession of marijuana (2007), and a charge for driving while intoxicated, dismissed because Ransom was convicted on another count (1981).  In April, he was charged with yet another drug offense.

 According to the complaint against Dr. Sellars,

  • The "cocktail" Vicodin, Soma and Xanax are the most commonly abused narcotics in the houston area.

  • Vicodin abuse has surpassed the illcit use of marijuana in the Greater houston area.

  • The Harris County Medical Examiner's Office has directly attributed 111 deaths from June 2009 to December 2009 as related to the overdose of the narcotics included in the "cocktail."

  • At least two of the deaths have been directly linked to prescription sissued by Dr. Christina Clardy (Medical Director of S&G Clinic and Uptown Medical Clinic).

     

Dr. Clardy, 61, who lives in West University, was charged in March with engaging in organized crime at S&G Clinic and the Uptown Medical Clinic.  See a copy of the Complaint [PDF].

According to the Complaint against Dr. Christina Clarda,

  • Christina Clardy admitted that she knew that the prescription forms that she signed for uptown Medical Clinic were not used for medical purposes

  • During the 11 days the Uptown Medical Clinic was open, they had seen 171 patients

  • The patients came from all over the country, including New York, Arkansas, Louisiana, Wisconsin and Texas

  • Over 95% of the patient's diagnosis was "lumbar"

  • There were no refills cirlced on the prescriptions which creates a monthly client for the clinic, which is not typical for a therapeutic medical purpose

  • The clinic did not accept medical insurance, Medicare or Medicaid and only accepted cash as a form of payment, which is a common scheme for a clinic operating for purposes of illicit distribution of prescription drugs to stay off the radar and prevent being shut down by the Dexas Department of Public Safety who regulates such businesses

According to authorities, the clinics were responsible for illegally distributing more than 3 million tablets of Vicodin, Xanax and Soma in 2009, and before they recently shut down, they were on pace to distribute 5 million this year.  The two operations grossed over $1.4 million last year alone, according to Deutsch.

We are relieved to see that law enforcement is addressing the rampant pill mill problem which exists in Houston and throughout Southeast Texas. 

Sanchez v. Wal-Mart Update

 On December 25, 2010, the Nevada Supreme Court issued its opinion in Sanchez v. Wal-Mart et al. Disappointingly, the Court held that under the circumstances of this case, pharmacies do not owe a duty of care to unidentified third parties like those injured by the impaired driver, Patricia Copening, in this case. The Court further held that Nevada’s pharmacy statutes and regulations, including NRS 453.1545, are not intended to protect the general public from the type of injury sustained in this case and do not express standards of care that extend to unidentified third parties like the appellants in this case. 

The good news is that the Nevada Supreme Court left open important questions that deserve answers different from the conclusions arrived at in this case. Significantly, the Court limited its holding to unidentifiable third parties affected by pharmaceutical practices before 2006 because the events in this case took place before 2006. The Court related that under 2006 amendments to its regulations, reflected in NAC 639.753, the Board of Pharmacy may have imposed a duty on pharmacies or created a special relationship that could justify imposing a duty in favor of third parties. The Court expressly did NOT determine whether that regulation does impose such a duty or create such a relationship.

Further, the Court did not discuss whether pharmacies owe a duty of care to customers or to identifiable third parties, such as relatives of customers. The Court’s holdings applied only to unidentifiable third parties.

 

Although I had hoped that the majority would reach different conclusions, I do applaud Justice Cherry and Justice Saitta for their well-reasoned dissent in this case. They argued that in the same way that the courts recognize that a special relationship exists between an innkeeper and guest, a teacher and student, and an employer and employee, a special relationship also exists between a pharmacist and a pharmacy customer. Therefore, pharmacies have a duty to take measures to protect foreseeable victims, like the third parties injured in this case, from foreseeable harm. The pharmacies should have foreseen the possibility that Patricia Copening would harm the victims in this case because of the actual notice that the pharmacies received from the Task Force, warning them that Copening had bought $4,500 hydrocodone pills within a 12-month period by having numerous prescriptions filled at 13 different pharmacies. After receiving this notice, the pharmacies should have recognized that Copening may be misusing the prescription drugs and that continuing to fill Copening’s prescriptions for hydrocodone or SOMA could result in harm to Copening or to others. They had a duty to review her records and to consider the Task Force letter before filling additional prescriptions.

 

The dissent also argued that the legislature designed various Nevada statutes to protect others against the type of injury that the appellants suffered in this case. According to the language of NRS 639.213 and 639.0070(1)(a), pharmacology affects the public safety and welfare, and the Board must adopt regulations pertaining to pharmacy practice in order to protect the public. Those provisions, coupled with other statutes that require pharmacists to ensure that substances are being dispensed only for medically necessary purposes, make it apparent that the legislature “intended to prevent pharmacy shopping and the overfilling of certain controlled substances, and ultimately to protect the general public from prescription-drug abuse and its effects.” Based on those statutes, the appellants in this case should be able to file a lawsuit against the pharmacies for negligence per se.

 

The law provides standards for pharmacists confronted with suspect prescriptions.  The Controlled Substances Act (Title 21 CFR 1306.04) recognized a pharmacist's independent duty to determine whether a prescription has been issued for a "legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice" before dispensing the controlled substance to the customer.  The DEA's Pharmacist's Manual emphasizes this responsibility in its chapter "Prescription Requirements," section "Purpose of Issue," and again in its  chapter "Dispensing Requirements," sections "Internet Pharmacy" and "Central Fill Pharmacy." 

 

It is important to remember that sometimes pharmacies are the last line of defense and that a prescription is only worth the paper it is written on until it is filled.  Pharmacies and pharmacists cannot morally or legally turn a blind eye to suspect prescriptions and expect to suffer no consequences.

War Wounds: Prescription drug abuse in US Military Skyrockets

 A recent Pentagon study revealed alarming rates of prescription drug abuse among active duty soldiers. The study revealed that an alarming 1 in 4 soldiers admitted to abusing prescription drugs, most commonly pain killers.  A spokesman for the military stated that the prescription pain killers were being used for pain and also for "behavioral health issues".

 

Without question, the wounds of war include those that are physically painful. The horrors of war  also create an environment ripe for self-medicating psychological wounds. 

 

There is no doubt that most, if not all, of the men and women reportedly abusing prescription drugs present with some sort of physical pain or psychological injury. However, there are many alternative  ways to treat pain other than dolling out powerful addictive narcotics. Narcotic pain killers are not and never have been an acceptable treatment for psychological conditions. Moreover, prescribing powerfully addictive narcotics to persons who have co-existing mental health issues calls for greater vigilance on the part of the prescribing physician. 

 

 

USA TODAY reported last year that narcotic pain-relief prescriptions for injured or wounded U.S. troops jumped from 30,000 a month to 50,000 since the Iraq war began.This suggests that military doctors may be throwing prescription pain killers at  problems which require a more thoughtful and deliberate approach.

 

Lt. Gen. Eric Schoomaker, the Army surgeon general, created a task force to review the service's pain management practices. Creating a task force is a great start, but so much more is needed, such as education of the physicians who are prescribing these drugs.

The Army says it is expanding programs to treat and educate soldiers about drug abuse. But according to  Gen. Peter Chiarelli, Army vice chief of staff, the service struggles to provide enough drug counselors and needs to hire 270 to 300.

The problem is that a) we the taxpayers are paying for all of these prescriptions; and b) these fine young men and women who have served our country will now be returned to  society with not only physical and psychological wounds , but also a drug addiction that may have been created and/or enabled by the military itself.

 

 

Nevada Supreme Court weighs pharmacists' liability for narcotics distribution

In the legal profession, we have an expression: "an oral contract is worth the paper it's written on." I think of this when considering the distribution of controlled substances. My rendition is : "a prescription is worth the paper it's written on until it is filled".

Pharmacists have the legal responsibility to ensure that a prescription is written for a valid medical purpose prior to filling it. However, a case that is currently pending in the Nevada Supreme Court may help to better define the duty of pharmacists in preventing prescription drug diversion.

The case, Sanchez vs. Wal-Mart et al, asks whether drugstores must use information at their disposal to protect the public from potentially dangerous customers.

As Amy Merrick reported in her article on SanchezCase Spurs Pharmacies' Fears of Lawsuits Over Drug Abuse, Patricia Copening bought nearly 4,500 doses of prescription painkillers in one year.  In June 2003, the Nevada Prescription Controlled Substance Abuse Prevention Task Force, which administers a computerized program mandated by Nevada Revised Statutes 453.1545 to track prescriptions for controlled substances, sent letters to 14 pharmacies in the Las Vegas area “warning them that Ms. Copening had purchased during the prior year 60 prescriptions, or nearly 4,500 doses, of controlled substances.” There is no record of any pharmacist so much as noting the task-force letter in Ms. Copening’s records.  Instead, the pharmacies continued to allow Ms. Copening to buy large quantities of hydrocodone and Soma, a cocktail “said to produce a euphoria similar to that induced by heroin.” 

On June 4, 2004, a year after the warning letters were sent to the pharmacies, Ms. Copening, under the influence of hydrocodone, ran her car into a 21-year-old delivery van driver, killing him at the scene, and hit a 33-year-old man, causing a head injury, broken right leg, and other wounds.  Ms. Copening faced charges of reckless driving, driving while intoxicated, and being involved in a fatal accident.  The injured and his family and the family of the deceased filed suit against Ms. Copening, the doctors responsible for most of the prescriptions, and multiple pharmacy-chain owners, including Wal-Mart, Walgreen, CVS Pharmacy and Rite-Aid.  Now the Nevada Supreme Court is left to define the responsibility that the pharmacies should have taken to protect the public from the effects of prescription drug abuse. 

In my opinion, this should serve as a wake-up call to pharmacies and large drugstore chains. They have the tools at their disposal to fight prescription drug diversion. If they can develop sophisticated systems to track the productivity of the pharmacists and to track inventory losses, they can also do a better job of slowing the flow of controlled substances for illicit purposes. Tracking productivity and inventory losses is good for drug stores because it helps make them more profitable. Saying no, on the other hand, costs money. Warranted refusals to fill prescriptions means "no sale." Make no mistake that these drugstores are about making money. This is one reason why holding pharmacies responsible for monetary damages is important. It is only when they think that they could be hit in the pocketbook for their negligence that they might take heed.

We at the Pill Mill Monitor will be watching this interesting case and will keep you posted.

Of Money and Mummies

I recently visited the Metropolitan Museum of Art in New York City. There, you will find the Sackler Wing which contains treasures from the age of the Egyptian pharaohs. You will also find Arthur M. Sackler galleries at the Smithsonian Institute ,Harvard and Beijing University. Many people do not know the Sackler name apart from their association with these lofty cultural institutions.

Arthur M. Sackler has been referred to as a marketing genius and the godfather of the modern-day drug advertising industry.  He developed  drug marketing techniques such as: direct to consumer advertising , sponsoring luxurious all expense paid medical education courses for doctors, glamorizing drugs as a quick fixes, and  paying for "scientific" studies backing the need for and/or efficacy of the particular drug being studied.

Arthur Sackler, who was already rich, made a fortune marketing and selling Librium and Valium. Later, younger brothers Mortimer and Raymond  joined Arthur in acquiring a little known drug company called the Purdue Frederick Company. Arthur died in 1987 at the age of 73.  In 1996 the family owned company, now known as Purdue Pharma introduced it's new blockbuster drug, Oxycontin.

Oxycontin is a very powerful, long acting narcotic which is should only be prescribed for  serious pain. Purdue Pharma  recognized even before the drug was marketed that they would face stiff resistance from doctors who were concerned about the potential for  OxyContin to be abused by patients or cause addiction.

Taking a chapter from brother Arthur's drug marketing playbook, Mortimer and Raymond embarked on the most aggressive marketing campaign ever undertaken by a pharmaceutical company for a narcotic painkiller. Purdue Pharma marketed  OxyContin to doctors like general practitioners, who often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients. One of their techniques was to fly physicians in to conferences about the "inadequate treatment of pain" and the need for doctors to aggressively prescribe narcotics like Oxycontin to their patients.

Just a few years after the drug’s introduction in 1996, annual sales reached $1 billion.

 In reality, Oxycontin proved to be a powerfully addictive drug. Some users  including teenagers, soon discovered that chewing an OxyContin pill or crushing one and then snorting the powder or injecting it with a needle produced a high as powerful as heroin. By 2000, parts of the United States, particularly rural areas, began to see skyrocketing rates of addiction and crime related to use of the drug. The drug came to be known among certain circles as "hillbilly heroin"

 A  comprehensive review of the problem appeared in the journal Pain Physician http://www.painphysicianjournal.com/2006/october/2006;9;287-321.pdf

CDC and DEA data included in the review suggested that from 1997-2004 there was a:

> 556% increase in the sales of oxycodone;

> 500% increase in therapeutic grams of oxycodone used,

> 568% increase in the non-medical use of OxyContin (especially among young people)

 > 129% increase in opioid-related deaths [without heroin or cocaine]:

Using this data, the author extrapolated that the number of deaths from Oxycontin could surpass the deaths from 911 and the Iraq war combined!

 By 2007 the government caught up with Purdue which resulted in  three current and former executives pleaded guilty  to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused. Purdue paid over $600 million in criminal and civil penalties.

Photographs by Don Petersen for The New York Times

From left, Howard R. Udell, the top lawyer for Purdue Pharma; Dr. Paul D. Goldenheim, the company’s former medical director; and Michael Friedman, Purdue’s president.

The last chapter of the Oxycontin saga has not been written. Despite their assertions to the contrary, Purdue Pharma has not cleaned up their act. Read between the lines on Partners Against Pain and you'll see some of Arthur's old tricks still being used.

There is much more to be written about Purdue Pharma and their dirty and deadly deeds. However, I was just so struck by seeing the Sackler name associated with such a venerable institution as the Metropolitan Museum of Art that I thought you should know what this family did to deserve having a wing of a famous art museum named after them.

Drugged Driving in America

The data relating to drivers under the influence of drugs is very worrisome. A 2007 Survey by the National Highway Traffic Safety Administration (NHTSA) found that 16.3% of all nighttime weekend drivers were drug positive.

According to Gil Kerlikowske, Director of the Office of National Drug Control Policy:

"This troubling data shows us for the first  time, the scope of drugged driving in America, and reinforces the need to reduce drug abuse. Drugged driving, like drunk driving is a matter of public safety and health. It puts us all at risk and must be prevented."

Interestingly, a new NHTSA survey found that drunk drivers are on the decline. In 1973, 7.5% of drivers surveyed had a blood alcohol level of 0.8% or higher. In the latest survey, that figure had fallen to 2.2%.

In my opinion, one of the reasons for the decline in drunk driving is the public awareness campaigns by organizations such as MADD. Another reason is strict enforcement of DUI laws.

The data suggests that drugged driving may prove to be even a bigger threat to public safety than drunk driving. Fortunately, organizations like Parents Against Prescription Drug Abuse (PAPDA)  and Stop Drugged Driving are stepping up to the plate to raise awareness of our nation's prescription drug epidemic.

We must call upon law enforcement to increase screening of drivers who are suspected of being under the influence of drugs and for strict prosecution of those who are found to be driving while drugged.

Is Big Pharma's next blockbuster Viagra for the brain?

I was recently walking through La Guardia airport in a typical traveler's daze when a prominently displayed magazine cover jumped out at me.The title was "Pills to make you smarter".

I was hooked. I had to read more. Make no mistake. I wasn't in the market for a magazine in the first place. I was already heavily laden with the six issues of my local bar publication that I had been intending to read. And frankly, if I was going to buy a magazine it was pretty tempting to succumb to the urge to find out what exactly is going on with Lindsey Lohan. But the magazine marketing geniuses made a first time purchaser of Scientific American out of me.

The article, "Turbocharging the brain", queries: "Will a pill at breakfast improve concentration and memory-and will it do so without long term detriment to your health"? The article chronicles the fascinating scientific developments in cognitive enhancement drugs to treat Alzheimers and other dementias. But, it also raises a very disturbing question. Will these drugs ultimately be marketed and sold to healthy people as "lifestyle enhancement" drugs?

Currently, neuroethicists are debating this issue in the neuroscientific community. I certainly am not qualified to enter that debate. However, this is what I do know. With the advent of direct to consumer marketing, the big pharmaceutical companies have spoon fed us a steady diet of propoganda that there is a pill for everything that ails us. We are the "super size me" generation who believes that more is better. Multi-billion dollar industries have profited from our desire to eat more, be stronger, look better, and perform better in the bedroom.

The temptation to "super size" our brains could create an enormous demand for these "smart drugs", or as some have referred to them "viagra for the brain". As one neuro ethicist put it "Within the pharmaceutical field, people recognize that a successful cognitive enhancer could be the best selling pharmaceutical of all time".  We needn't say more at this point. With the potential for hundreds of billions of dollars to be made, the pharmaceutical industry will find a way to use their slick marketing machines to convince us that we "need" these drugs. They will pay scientists and physicians to write articles in esteemed medical journals advocating their use and minimizing any potential side effects. Mark my words. It may not be in my lifetime, but this will come to fruition.

So, at the end of the day, the pharmaceutical industry will continue to wield enormous power over us. Some futurists have concocted the symbol "H1" to denote an enhanced version of humanity. Think of all the "lifestyle enhancement " drugs that can be peddled to the super-sized human.  The question is what does this make us as human beings, what would a society of super-sized humans look like and would you want to live in it?

Appearance on Dan Rather Reports Tonight, October 27th!

Please tune in for a special Dan Rather Reports episode tonight , Tuesday October 27th at 8:00 PM EST on HDNet . The episode will feature the growing national pill mill problem by profiling Ken and Esther Scarborough of Beaumont, Texas, whose 25-year-old son, Christopher, died an accidental death caused from combined drug toxicity on September 23, 2007.  

I represent the Scarborough family and will also appear on the episode to discuss prescription drug diversion throughout the U.S.

VIEWING DETAILS:

  • Where: HDNet Dan Rather Reports
  • Live:  Viewing details at HDnet
  • Recording: download the episode on iTunes

 

What is a pill mill?

A pill mill is a doctor's office or medical clinic whose purpose is not to treat sick or injured patients, but instead to reap enormous profits through the illegal diversion of prescription drugs. Law enforcement estimates that there may be tens of thousands of these pill mills currently operating in the United States.

While not all pill mills look alike, they can often times be spotted by the crowds of people gathering in their parking lots or the makeshift banner advertising "pain management" or "pain clinic". Pill mill doctors rarely have any pain management credentials, usually do not have hospital privileges, see 80-100 patients per day and typically only accept cash.

Pill mills work in conjunction with shady pharmacies and unethical pharmacists who are willing to turn a blind eye to apparent non-therapeutic prescribing practices.  Remember, the prescriptions are only worth the paper they are written on until a willing pharmacist agrees to dispense the drugs.

Some pill mills may have the appearance of a legitimate medical practice. However, the encounter will typically be very brief. Oftentimes, there will be very little medical history, little or no physical examination, no laboratory or diagnostic studies performed.  Some pill mills routinely write prescriptions for a drug cocktail, which is a combination of Lorcet or Vicodin, Soma and Xanax. This combination of drugs is commonly referred to as a "party pack", "Holy Trinity" or in some parts of the country a "Las Vegas Cocktail".

A legitimate pain management practice may also dispense narcotic pain medications, but only after a thorough physical examination, detailed understanding of the patient's medical history, and diagnostic tests. Typically, medical treatment such as physical therapy, injections, surgical procedures and psychotherapy are provided in conjunction with the prescription. 

Some pill mill operators have become smarter about flying under the radar screen and have adopted ways of looking more like legitimate medical practices.

Partially gathered by the CBS Evening news and myself, here are some tell tale signs of a typical pill mill:

  • It accepts cash only
  • You may or may not be seen by a physician
  • No physical exam required or performed
  • No medical records or X-rays are needed
  • Prior medical records not required
  • You ask for the medications rather than the doctor deciding what you need
  • The same drugs and combinations of drugs are prescribed over and over to most patients
  • There is scant medical documentation
  • You’re directed to "their” pharmacy
  • They treat pain with pills only
  • They give you a set number of pills and tell you specific date to come back for more
  • Huge quantities of drugs are prescribed at one time
  • They may have security guards
  • They may have a line of people outside or in the waiting room
  • They may accept out of town or out of state patients
  • Patients may arrive in carloads

Again, pill mills come in all shapes and sizes and some are better at hiding their true colors. However, there are a staggering number of pill mills that are operating right under the noses of law enforcement, medical licensing boards and other government regulatory agencies. Law enforcement is well aware of these types of clinics, but little has been done to eradicate them.  Meanwhile, enormous fortunes are being made and people continue to die from prescription drug addiction.