Walgreen’s Illegally Distributes Controlled Substances

Is Walgreen,s Pharmacy really “at the Corner of Happy and Healthy”, like their motto claims? Maybe not…

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The Drug Enforcement Agency (DEA) caught Walgreen’s Pharmacy red-handed.  Allegations claim they were knowingly and  illegally distributing controlled substances to known abusers and drug dealers. The DEA found an “unprecedented” number of record-keeping and dispensing violations of the Controlled Substances Act.

Walgreen’s agreed to an $80 million settlement to put the matter to rest.  Part of the deal required Walgreen’s to publicly admit that it had failed to comply with its responsibilities as a DEA registrant. Although they claim they do all they can to stop this activity, there is evidence it is still occurring, even after the large sum of money they were required to pay. According to a recent blog article on bytegeist.com, Walgreen’s is more concerned with making a dollar than the health of its customers.

How Does This Effect Me? 

I have written many times about the problem of prescription drug addiction in America. It is crucial to shut down the supply chains if this problem is ever going to be eliminated. Unlike illicit drugs,  prescription drug dealers aren’t standing on dimly lit street corners in the rough areas of town. To the contrary, much of the supply comes from doctors, pharmacies and clinics who are licensed to distribute  controlled substances. With this license, however, comes the responsibility of complying with the law. Unfortunately, many do not comply, and this effects all of us.

Controlled substances may only be prescribed and dispensed for a legitimate medical purpose. When this fundamental premise isn’t followed, illegal distribution and abuse emerge. Narcotics find their way into the hands of addicts and dealers who sell them illegally on the black market. Sadly, the prescription drug black market makes its way into schools and homes, and destroys lives and families. 

Kudos to the Drug Enforcement Agency for getting the attention of one national pharmaceutical chain. Let’s hope it sends a loud message to the others. We all must do our part, as they are, to stop this epidemic in America.

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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

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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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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.

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FDA Updates Warning for Reclast

The FDA has issued a new safety update for the bisphosphonate Reclast, warning that patients have experienced kidney failure requiring dialysis or resulting in death after having an injection of the drug. Patients should be screened for kidney problems before being given the injection.

(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.

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Google Pays $500 Million in Settlement for Online Pharmaceutical Ads

Google, Inc. has agreed to pay the U.S. government $500 million to settle claims that it improperly profited from selling advertisements to Canadian pharmacies that illegally import drugs into the U.S., potentially harming consumers.

Prescription drug prices in the United States are through the roof.  In 2005, we spent an estimated $251.8 billion on prescription drugs alone.  This year, prescription drug sales are expected to reach $310 billion.

 
If you are lucky enough to have health insurance, then some of your costs associated with filling a prescription are paid.  But if you are one of the more than 50 million people who are uninsured in this country, you are forced to pay for prescriptions at full price.
 
In the last few years, people have turned to Internet pharmacies to get their prescriptions for a reduced price.  But under U.S. law, foreign pharmacies cannot legally ship prescription drugs to consumers in the United States if they are not first approved by the FDA.  The worry is that because these drugs are not approved by the FDA, they are potentially dangerous to consumers.
 
Google, Inc. learned this lesson the hard way when it sold advertisements to Canadian pharmacies that were illegally selling prescription drugs to American consumers.  Rather than face criminal prosecution for allegedly improperly profiting from these advertisements, Google agreed to pay the U.S. government $500 million in a settlement.
 
Sales of online advertisements for health care services and products generate nearly $1.3 billion each year.  Google’s ad sales helped the company generate $39 billion in cash by the end of June 2011.
 
Critics worry that this slap on the wrist for Google will not do much to help consumers who have their health compromised by these illegally imported prescription drugs.  And while U.S. officials continue to track down companies that endanger the health of U.S. citizens, America cannot seem to escape its growing prescription pill problem.
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Darvocet, Darvon and Propoxyphene Products Liability Update

On August 16, 2011, the United States Judicial Panel on Multidistrict Litigation “MDL Panel” created a new multidistrict litigation (“MDL”) for Darvocet, Darvon, and Propoxyphene products liability cases, finding that centralization of these cases is appropriate under 28 U.S.C. § 1407.  The MDL Panel decided to centralize the cases in the Eastern District of Kentucky (Covington Division).  With the consent of that court, the cases will be assigned to Judge Danny C. Reeves.  Accordingly, the MDL Panel ordered transfer of the seventeen actions before it for consideration to the Eastern District of Kentucky (Covington Division).

Defendant drug manufacturers and pharmaceutical companies opposed centralization of the cases.  However, the Panel sided with the plaintiffs, who argued for centralization on the grounds that all of these cases share complex questions of fact concerning the safety of Darvocet, Darvon and Propoxyphene.  According to the Panel, the cases share factual issues as to 1) whether Darvocet, Darvon, and other medications containing Propoxyphene were defectively designed and marketed, 2) which defendants manufactured, licensed, or sold Propoxyphene products during various times, and 3) whether defendants knew or should have known of the increased risk of cardiovascular injuries with these medications and failed to provide adequate warnings of them. 
 
The MDL concerns cardiovascular injuries associated with Darvocet, Darvon and other medications containing Propoxyphene.  However, the MDL Panel left open the question of what particular cardiovascular-related injuries are or are not appropriate for inclusion in this MDL. 
 
Darvocet, Darvon, and Propoxyphene products were removed from the U.S. market in December 2010 because the risk of cardiac complications and deaths related to the drugs outweighed the benefits that the drugs afforded for pain relief.  Since then, about thirty-five cases have been filed against the companies responsible for manufacturing the drugs.  Many more cases are expected to be filed in the future.
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Lipitor More Effective than Zocor

In a recent study, high dose statin drugs were found to increase a person’s risk of getting type-two diabetes. Researchers from that study are now saying Lipitor should be prescribed over Zocor (generic Simvastatin), despite the higher cost of Lipitor.

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In a recent study out of the United Kingdom, researchers from St. George’s University, the University of London, and the University of Glasgow, found that high dose statin drugs increased the risk of patients contracting type-two diabetes.  But when the study compared Lipitor to Zocor and its generics, researchers found that Lipitor was more effective in decreasing the patient’s risk of a heart attack.

 
This finding comes on the heels of the FDA announcement that Zocor’s labeling would be changed to reflect newer restricted prescribing practices of the drug.  Zocor and its generic, Simvastatin, will no longer be prescribed at the 80 mg dosage to patients who are new to the drug.  And patients taking certain other drugs may have to limit their intake of Zocor because of possible adverse drug reactions.
 
Where patients do need a high dose of statins though, doctors may have to chose the pricier Lipitor, which costs $1.20 a day, over generic Simvastatin, which costs a mere $0.04 a day.
 
Over the five-year study, researchers found that more than eight percent of participants developed diabetes, while 20 percent of patients had a major heart problem.  The study did not look at the recent findings by the FDA that 80mg Simvastatin can cause severe muscle damage and deterioration.
 
Professor Kausik Ray of St. George’s University noted that patients already taking high doses of statins should not stop taking these drugs, but should be monitored by their doctors more closely.  But he reiterated that “[t]he net benefit of Simvastatin is clearly very low and patients on Simvastatin 80 mg should be moved to Atorvastatin 80 mg instead.”
 
Unfortunately, for those without health insurance, Lipitor will be more costly than Simvastatin.  “I don’t think we can wait for loss of [Lipitor’s] patent to stop using Simvastatin 80 mg,” Ray said.  
 
Lipitor is scheduled to lose its U.S. patent protection this coming November.
 
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Muscle Damage Risk Higher in Women

Doctors believe that more people may be affected by muscle pain and weakness due to the use of 80mg Simvastatin than the studies show.

With the new warnings released by the Food and Drug Administration (FDA) about Simvastatin, marketed under Zocor and Vytorin, some doctors are questioning the rates of occurrence of muscle damage in patients taking the 80mg dose.

 
Rhabdomyolysis, a condition which breaks down muscle and releases dangerous proteins into the blood stream, affects an estimated five out of every 100,000 people taking an 80mg dose of Zocor for a year.  Based on studies, researchers say that the condition is rare, but that it can lead to kidney failure and even death.
 
Despite the latest statistics, some doctors believe that Simvastatin may cause muscle pain more frequently than what the statistics show.  All statins can cause muscle pain and weakness.  Researchers estimate that five to 10 percent of patients taking 80mg of Simvastatin experience muscle pain and weakness, but they concede that as many as a third of these patients could be suffering with these side effects.
 
Symptoms of rhabdomyolysis include muscle pain, tenderness, weakness, dark or red urine, and unexplained tiredness.  If you are taking Simvastatin and are experiencing or have experienced any of these symptoms, experts say you should contact your healthcare professional immediately.
 
Consumer Reports advises anyone taking cholesterol-lowering drugs to start out at the lowest necessary dose.  If you have high cholesterol, and your doctor recommends you take a statin, you should discuss any side effects of the drug with him.
 
The danger for rhabdomyolysis is greater in older women and in those who are taking Simvastatin with other drugs for blood pressure.  Consumer Reports gives the following advice for people who are taking other prescriptions along with Simvastatin:
 
  • Take no more than 20mg of Simvastatin with amlodipine (market name Norvasc)
  • Take no more than 20mg of Simvastatin with diltazem (market name Cardizem) or verapamil (market name Verelan)
  • Take no more than 20mg of Simvastatin with amiodarone (market name Cordarone)
  • Take no more than 20mg of Simvastatin with ranolazine (market name Ranexa)
  • Never use Simvastatin with cyclosporine, danazol, gemfibrozil, or posaconazole.
 
Of course, you should always consult your doctor before you stop taking any of your medicines.  If you are worried about your medicines interacting, tell your doctor.
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Merck Redesigns Zocor Label after FDA Study

Merck announced it would be redesigning the label for its popular drug Zocor, generic name Simvastatin, after a study conducted by the FDA showed the drug put patients at an increased risk for muscle damage when taking the drug at the 80mg dosage.

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 Merck, the manufacturer of Zocor, drug name Simvastatin, announced it would be redesigning the label of its blockbuster drug.  The redesign comes on the heels of a seven year study that found that patients who took the higher dose of Zocor were at a higher risk of developing rhabdomyolysis, a disease that causes muscle fibers to break down and release myoglobin, a protein that damages the kidneys.

Symptoms of rhabdomyolysis include muscle cramps, muscle tenderness and stiffness, pain, and spasms.  The disease usually occurs in patients over the age of 65 or in those patients who have renal impairment or uncontrolled hypothyroidism.

Sales of the drug have been high in recent years, especially because the generic Simvastatin is available at a relatively low cost compared to some other statins currently on the market.  An estimated 1.2 million Americans are currently taking the 80 milligram dose of Simvastatin, the highest dose sold legally in the United States.

Despite its low cost, researchers urge that patients should talk with their doctors about switching to a newer generation statin, like Crestor, which has had a greater success rate with reducing cholesterol levels, without the harsh side effects.

Before muscle deterioration and damage became a worry to researchers, some worried that statins caused nerve damage.  

In 2002, Dr. David Gaist, MD, a researcher from Denmark, found that patients taking statins were at a nearly 16 times increased risk of developing neuropathy, compared to patients not taking statins.  And those taking statins for two or more years were at a 26 times higher risk for developing neuropathy.  Gaist concluded that the larger the dose given to the patient, the higher the risk that the patient would develop nerve damage.

Although the study conducted by the FDA did not reveal a link between Simvastatin and neuropathy, Dr. Gaist was on the right track with his research and the dangers posed by an increased dosage. Ultimately, Dr. Gaist’s report shows that the concern about the effects of Simvastatin on the human body was well-founded, even before the FDA saw fit to study the drug’s effects.

If you or a loved one has suffered from rhabdomyolysis while taking Simvastatin, call Van Wey Law today.

 

 

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