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:

Senator Warns FDA about New, Stronger Painkillers

New York Senator Charles Schumer is warning the FDA that approving a new painkiller containing pure hydrocodone could have disastrous consequences across the nation. Painkillers that contain hydrocodone currently on the market are known to be highly addictive and have caused fatal overdoses.

New York Senator Charles Schumer has seen the effects of prescription drug addiction in his state and has vowed to fight it.  He warns that a new painkiller promising to be 10 times stronger than Vicodin could lead to more violent and deadly drug store robberies.

In June 2011, New York resident David Laffer was charged with robbing a Long Island drug store of more than 10,000 highly addictive prescription painkillers and killing four people in the pharmacy.  He and his wife had been doctor shopping before the robbery in an effort to get prescription pain pills like hydrocodone, which is highly addictive.

Nationwide, more than 1,800 pharmacies have been robbed in the past three years alone.  Long Island alone has experienced a 125 percent increase drug store robberies.

“It’s tremendously concerning that at the same time policymakers and law enforcement professionals are waging a war on the growing prescription drug crisis, new super-drugs could well be on their way, flooding the market.  The FDA needs to grab the reins and slow down the stampede to introduce these powerful narcotics” Senator Schumer said.

The new painkillers, which contain pure hydrocodone, could come onto the market as early as 2013, with big pharmaceutical companies looking to cash in on the $10 billion prescription painkiller market.  At present, hydrocodone is classified as a strictly controlled Schedule II drug under the 1970 Controlled Substances Act. 

Products that contain hydrocodone and another painkiller like acetaminophen fall into Schedule III, which is less strictly controlled.  Some experts argue that because of this, highly addictive hydrocodone has been given to more patients, which has increased abuse of the drug and overdose rates in the United States.

A prescription painkiller that contains pure hydrocodone could lead to more accidental overdoses, leading to more emergency room visits.  Experts say that already thin hospital emergency room resources could become even more strained if this new drug is allowed on the market.  In 2008 alone, emergency room visits related to hydrocodone abuse totaled more than 86,000, up more than 400 percent from 2000 when an estimated 19,000 visits were recorded.

To learn more about prescription drug addiction, read my article “America’s Growing Addiction” at www.vanweylaw.com


Prescription Drug Overdose Deaths on the Rise

Deaths due to prescription drug overdose have nearly tripled within the past 10 years. Experts say that irresponsible doctors are to blame for the abuse of highly addictive prescription painkillers.

(Image: Michelle Meiklejohn / FreeDigitalPhotos.net)

The Centers for Disease Control and Prevention (CDC) has issued a new report detailing that as many as 40 Americans die each day from overdosing on prescription painkillers.  That amounts to nearly 15,000 deaths each year.

Deaths due to prescription overdose are now more common than deaths caused by heroin and cocaine combined.  And the problem does not look like it will be ending anytime soon.  Prescription painkiller overdose deaths have increased three times over within the past decade.

80% of the World’s Painkillers are Taken in the U.S.

Director of the CDC, Dr. Thomas Frieden, blames irresponsible doctors for the uptick in prescription painkiller abuse.  He and other CDC experts have estimated that in 2010 enough painkillers were prescribed to supply every American adult with a one-month supply.

More than 600,000 doctors are licensed to prescribe opiate-based painkillers.  Vicodin is one of the most popular prescription painkillers, because it is not as strictly regulated as its counterparts, making it easier for doctors to prescribe.  In fact, 99 percent of the entire world’s supply of Vicodin is used by patients in the United States.

Accidental Overdoses from Prescription Painkillers Now Kill More People than Car Accidents in 17 States

The overprescribing of prescription painkillers is not only causing death, it is also costing an estimated $72.5 billion.  And, three of the hardest hit states are Oklahoma, New Mexico, and Florida.

The federal government has proposed expanding statewide prescription drug monitoring programs to monitor electronically the number of painkillers prescribed in each state.  But critics say these programs will not work alone.  Patients need to be educated about the dangers of abusing and overdosing on prescription painkillers.

National Drug Czar Gil Kerlikowske says doctors need to be retrained on writing prescriptions for narcotic pain relievers.  He adds that people with moderate pain, such as back pain, should not be prescribed these highly addictive painkillers.

To learn more about America’s epidemic of prescription drug addiction, read my article “America’s Growing Addiction” at www.vanweylaw.com.


Houston Pill Mills targeted

Houston doctors and pill mill operators arrested.

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.