FDA Panel Considers Tightening Rules on Hydrocodone Prescriptions

 According to recent statistics, the United States consumes 99 percent of all Hydrocodone in the world, yet the United States is merely 4.5 percent of the world’s population.  In 2010, an estimated 131.2 million prescriptions were written for Hydrocodone, making it the most prescribed drug in the United States.  Hydrocodone is a highly addictive painkiller and has been blamed on overdoses and deaths.

Prescription Painkiller Addiction is an Epidemic in the United States
Abuse of prescription painkillers in the United States is an epidemic.  Reports of pharmacies being robbed for Hydrocodone and other strong narcotic painkillers are all too commonplace.  Now the Drug Enforcement Administration (DEA) is asking for help from the Food & Drug Administration (FDA) to tighten regulations and make it more difficult to get prescription drugs containing Hydrocodone.  
 
“If Hydrocodone has more restrictive manners tied to it, it could help reduce the abuse potential,” says Special Agent Robert Hill of the DEA Pharmaceutical Investigations Section.
 
FDA Advisory Panel Could Mandate Tighter Restrictions on Hydrocodone
In response, the FDA convened an advisory panel for a two-day meeting on Thursday, January 24, 2013.  The panel is to consider tighter regulations for the prescribing of drugs and other products that contain Hydrocodone.  One of the proposed regulations would limit prescriptions of pills and cough syrups containing Hydrocodone to a 90-day supply.  Currently, these products are available to be filled with five refills within six months.  The advisory panel will also consider moving Hydrocodone-combination products like Vicodin up from a Schedule III to a Schedule II drug, which is more highly regulated.  Drugs currently in Schedule II include OxyContin and pure Hydrocodone.
 
Advocates of tighter restrictions on Hydrocodone believe that moving Hydrocodone-combination drugs to a Schedule II classification will make the drugs less available.  A similar measure was attempted in 2012 with a proposed amendment to the Prescription Drug User Fee Act (PDUFA), but lobbyists for pharmaceutical companies fought against the amendment, and ultimately it was defeated.
 
Big Pharma Looks to Cash-in on Hydrocodone with New Drugs
Another FDA panel recently voted against approving Zohydro, an extended-release drug that contains pure Hydrocodone.  Manufactured by Zogenix Inc., the new painkiller is ten times more powerful than Vicodin and highly addictive.  Although the FDA panel found that the new drug met FDA standards for safety and efficacy, it voted against approval of the drug based on its high potential for addiction.  The FDA will consider the panel’s findings, but may still approve Zohydro in March when it comes up for consideration.
 
For more information about Hydrocodone and prescription drug addiction, read:
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Raid on Dallas Pill Mill yields more details

May 2012 raid on Dallas Pill Mill yields more details, including the name of the doctor who allegedly owned and operated the lucrative criminal enterprise.

Dr. Lee Roy McCurley

 

The name of the physician who allegedly owned and operated the South Dallas Pill Mill has been released. According to the Texas Medical Board,  Leeroy McCurley, M.D. is a family practice physician. Dr. McCurley appears to have no specialty training whatsoever in pain management. Dr. McCurley is not board certified in family practice or any other medical specialty, which according to many doctors is the "gold standard" for physician competence. 

In my experience, it is not uncommon to see family practice doctors self-declare themselves as pain management specialists. And, to my knowledge, there is no requirement that a doctor receive any type of special training in pain management in order to prescribe any quantity or combination of potentially lethal narcotics.

However, let’s be mindful of the fact that based upon what we know thus far, it wouldn’t appear that there was any medicine being practiced at this clinic. By all accounts it appears to be a storefront drug dealing operation, which operated for well over a year in plain sight.

I have often questioned the motives of physicians who like Dr. McCurley become involved in a criminal operation like what has been alleged in this case. We really don’t have to look much further than what was reported in the newspaper as $2 million dollars per year in cash.

Even though we do see the occasional raid like this one, there still remains the potential for enormous cash profits with very low probability of arrest and prosecution. Therefore, as long as white coat drug dealing is profitable the pill mills will flourish.. People will continue to die and the prescription drug epidemic we have in this country will continue to claim lives.

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Dallas Pill Mill Raided

On May 1 ,2012 a Dallas medical clinic was raided by local and state authorities. The allegations stem around the accusation that the doctor who owned the clinic was operating a pill mill.

 

On May 1, 2012,  local and federal officials descended upon a Dallas medical clinic suspected of operating as a pill mill.

Details are lacking at this time about the identity of the doctor accused of operating a Dallas Pill Mill. However, it has been reported that this doctor has previously been sued and may have also operated a similar practice in Grand Prairie, Texas.

I am anxiously awaiting the news of this clinic and doctor and will hopefully have more to report soon. It is good to see Law enforcement acting on clinics like these that seem to operate their questionable practices in broad daylight. 

To read more about how to spot a pill mill, click here to read an article I previously wrote on the subject.

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A Tribute to Ken & Esther Scarborough

The Scarborough family of Kountze, Texas, has been instrumental in the fight against prescription drug addiction. After their son died from a prescription drug overdose, the Scarboroughs realized the need to help other families who had lost a loved one.

Far too many families have been devastated by a loved one’s addiction to prescription drugs. Unlike the images we conjure up when we think of a typical drug addict, the faces of prescription drug addiction are the faces of ordinary Americans. One of the casualties of prescription drug addiction was Christopher Scarborough, the 25 year-old son of Ken and Esther Scarborough of Kountze, Texas.

I came to know the Scarboroughs when I represented them in a legal case, which sought to hold the negligent parties accountable for Christopher’s death and to raise awareness about these pill mills, which often masquerade as pain management clinics. In the lawsuit, we alleged that the healthcare providers and clinic owners were nothing more than “drug dealers” who were trying to pass off their “pill mill” as a legitimate pain management clinic.

When Christopher went to this walk-in “pain management clinic,” he was prescribed a cocktail of more than 300 highly addictive narcotic pills, without even receiving an exam or seeing a doctor. Shortly thereafter, Christopher tragically died of an accidental overdose.

Rather than dwell on their son’s heartbreaking death, the Scarboroughs have chosen to help other families who have lost loved ones to prescription drug addiction and accidental overdose.

Since their son’s death, the Scarboroughs have worked every day to fight against the prescription drug epidemic in their son’s name. In 2009, they founded Parents Against Prescription Drug Abuse (PAPDA), a 501(c)(3) nonprofit corporation. They have also testified before the Texas Senate, worked to pass legislation to regulate the so-called pain clinics, given countless talks, and comforted other parents who have also lost their children to prescription drug overdoses.

The Scarboroughs need your help to continue their fight. You can help by making a tax deductible contribution to PAPDA at www.papda.net. Your contribution, no matter how slight, will help Ken and Esther keep fighting every day to prevent the reckless prescribing of narcotics from claiming another innocent life.

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Florida Attempts to Crack Down on Pill Mills

Florida has been criticized as being the “Pill Mill Capital of the U.S.” But a new database to track the prescribing and filling of prescription drugs is a needed addition that could help stop the state’s prescription drug epidemic.

Dallas dangerous drug attorney Kay Van Wey talks about pill mills

Known as the “Pill Mill Capital of the United States,” Florida has seen its fair share of problems associated with prescription drug abuse.  

But legislators are hoping to change the state’s bad reputation by implementing the Prescription Drug Monitoring Program, which keeps track of when, where, to whom, and by whom a prescription containing a controlled substance is prescribed.

Florida is not the first state to implement a prescription drug database.  More than 30 states currently have these databases in place.
 
Under Florida’s database, doctors and pharmacists must register beginning October 1st and will have seven days to file information regarding prescriptions for certain drugs that contain controlled substances.  Doctors and pharmacists will be able to check a patient’s prescription history before writing or filling any prescriptions.  Lawmakers hope that this will prevent pharmacy-hopping and give doctors an outlet in which suspicious activity can be reported.
 
Currently, nearly seven Floridians a day overdose on prescription drugs.  And according to Florida’s Attorney General Pam Bondi, more people are dying from overdosing on prescription drugs than they are from overdosing on illegal drugs.  
 
In 2010, doctors in Florida bought 89 percent of all Oxycodone sold in the United States.  That same year, the state had 1000 pain clinics up and running, but tougher laws have shut down 400 of them within the past year. And so far, 80 doctors have had their licenses suspended for prescribing large numbers of pills to patients without clear medical needs.  A doctor in Palm Beach County has even been charged with murder for prescribing a patient drugs on which he later overdosed and died.
 
As of now, the program must rely on private contributions and federal grants to continue running through June 30, 2012. The legislature is not allowing the program to accept donations from pharmaceutical companies in general, and particularly Purdue Pharma, the maker of the most widely abused prescription painkiller, OxyContin, which offered the program a donation of $1 million.
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Texas’ Top Prescriber of Hydrocodone Busted in Raid

Texas’ top prescriber of hydrocodone nabbed in raid.

The Texas Medical Board announced that it had nabbed the state’s biggest prescriber of Hydrocodone. Dr. Gerald Ratinov was acting as medical director for several Houston area "pain clinics." Several pharmacies were also targeted in the raid. Dr. Gerald Ratinov, an elderly neurologist, claimed to have been dupped by unscrupulous pill mill clinic operators. 

I applaud the efforts of all involved in their efforts to shut down sources of prescription drug diversion. It is also refreshing to see law enforcement enforcing recent legislation which was enacted to shut down pill mills. 

 

 

 

 

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“Schneider the Writer” sentenced to 30 years

Kansas doctor and his wife sentenced to 66 years for operating a pill mill.

Yesterday U.S. District Court Judge Monti Belot sentenced Dr. Stephen Schneider to 30 years in prison and his wife Linda Schneider to 33 years in prison, in what Judge Belot called an “unavoidable tragedy motivated by greed.” Judge Belot told Dr. Schneider that the evidence showed that he had earned the nickname “Schneider the Writer” because often his only form of medical care consisted of writing prescriptions.

 

 

 

Judge Belot also criticized Mrs. Schneider, who served as office manager for the pill mill, emphasizing her culpability for creating and perpetuating the clinic as a generator of income, not as a place for competent medical care. The judge’s apparent view of Mrs. Schneider as the mastermind of the clinic, coupled with her additional convictions of money laundering (15 over Stephen Schneider’s two), may have led to her harsher sentence.

Given the number of deaths linked to this case, the government asked for a life sentence. The defense asked for the minimum mandatory 20 years in prison.

A jury found the Schneiders guilty on five counts of unlawfully writing prescriptions and 11 health care fraud counts; Linda Schneider guilty of 15 money laundering charges, and Stephen Schneider guilty of two. The jury found that the Schneiders’ conduct resulted in serious bodily injury to 14 people, and the deaths of 10 patients.

Assistant U.S. Attorney Tanya Treadway has demonstrated that through tenacity, hard work, and courage, it is possible to bring pill pushers to justice, even if the pill pusher happens to have an "M.D." behind their name. I hope that more prosecutors will follow her example. With more prosecutions like this one, we can take a step closer to deterring doctors and those who conspire with them from writing prescriptions solely for their own personal financial gain.

 

 

 

 

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