Senator Warns FDA about New, Stronger Painkillers

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

A Tribute to Ken & Esther Scarborough

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.

FDA Updates Warning for Reclast

(Image: m_bartosch / FreeDigitalPhotos.net)

The Food and Drug Administration (FDA) has issued an update to the drug label for Reclast, an injection used to prevent or treat osteoporosis.  The new warning is in regards to the risk of renal failure.

Reclast, generic name zoledronic acid, is a bisphosphonate that is used to treat or prevent osteoporosis in women who are in menopause and to increase bone mass in men with osteoporosis.  The injection is given in a single dose every one to two years.

The FDA has recently received reports of patients experiencing kidney failure while taking Reclast.  These patients reporting kidney failure either required dialysis or died from the complication.

While kidney failure is a rare condition in patients using Reclast, it is more likely to occur in those patients who have a history of or risk factors for kidney problems.  Risk factors include an underlying moderate to severe renal impairment, use of kidney-damaging or diuretic medicines, and severe dehydration before or after receiving Reclast.

The risk of developing renal failure increases with age.  Your doctor should screen you for any kidney problems prior to giving you Reclast.  You should tell your doctor about any medications you are taking so that he or she can better identify whether these medications will adversely react with Reclast.

Earlier this year, Reclast was identified as a drug that is likely to cause a femur fracture in patients.  The FDA has sent out a safety announcement warning patients about the risks bisphosphonates pose and is continuing to review data regarding the risk of femur fractures in patients.

Tylenol Lowers Daily Recommended Dose

Tylenol! Pictures, Images and Photos

Do you take over-the-counter (OTC) pain medications daily at the maximum recommended dosage?  If so, you may be over-medicating yourself.  

Johnson & Johnson, the manufacturer of the popular OTC pain pill Tylenol recently announced that it would be reducing the recommended dose of its Extra Strength Tylenol from 4,000 mg or eight pills a day to 3,000 mg or six pills a day.  Tylenol contains acetaminophen, which is found in more than 600 medicines, including Alka-Seltzer, Nyquil, and Sudafed.   People mixing these medicines often unknowingly overdose on acetaminophen.
 
So why is Johnson & Johnson changing its dosing instructions now?  More than 56,000 Americans are hospitalized each year after overdosing on acetaminophen, which can cause liver failure.  In fact, acetaminophen overdoses are the leading cause of liver failure in the United States and lead to nearly 458 deaths each year.
 
Because acetaminophen is found in so many other OTC products, Johnson & Johnson thought it would be best for consumers if the company lowered the daily recommended dose.  New labels on Extra Strength Tylenol with the reduced dosage will start rolling out this fall.  Next year, Johnson & Johnson will also change the dosing instructions on its regular Tylenol.
 
While health experts are praising Johnson & Johnson for voluntarily changing the labels to reflect the lower recommended dosage, they are also worried that companies that produce similar OTC products are not informing consumers sufficiently about these medicines and how they may interact with other medicines.
 
Beginning as early as 2009, some medical experts called on Johnson & Johnson and the Food & Drug Administration (FDA) to lower the recommended dose to as little as 2,600 mg per day.  They also urged the major pharmaceutical company to require a prescription be written for Extra Strength Tylenol 500 mg.  Neither of these changes were made at the time, and Extra Strength Tylenol is still available as an OTC medication.
 
In recent years, Johnson & Johnson has suffered major setbacks in manufacturing several of its popular OTC drugs.  Just this year, the company recalled 43 million packages of Tylenol, Benadryl, Sudafed, and Sinutab products because the equipment used to produce the drugs was not sufficiently cleaned.
 
Even with “safe” OTC drugs on the market, pharmaceutical companies need to help consumers understand what ingredients are in the medicines they are taking, how those interact together, and the maximum dosage of each drug they should be taking per day.
 

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.