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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Big Pharma’s Marketing of Painkillers Launches Senate Probe

Accidental overdosing on prescription drugs now kills more people in some states than car accidents.  Now, the U.S. Senate Finance Committee is investigating the marketing practices of pharmaceutical companies that make highly addictive narcotic painkillers.

The Senate Finance Committee launched the investigation to help ensure consumers are not being misled into thinking that these opioid painkillers are completely safe. 

“Overdoses on narcotic painkillers have become epidemic, and it’s becoming clear that patients aren’t getting a full and clear picture of the risks posed by their medications,” said Senator Max Baucus, who along with Senator Charles E. Grassley has launched the investigation.

Non-Profits Promote Pain Drugs

Pain advocacy organizations have popped up in the past decade, including groups like the American Pain Foundation, which received nearly 90 percent of its funding in 2010 from the pharmaceutical and medical device industries.  These groups highlight the benefits of opioid painkillers and downplay the risks, which include addiction.

The American Pain Foundation has decided to dissolve amid the allegations that it has illegally marketed painkillers. However, the group has cited the decision to dissolve based on operational and financial problems.

The Senate investigation comes just months after Purdue Pharma (maker of the highly addictive Oxycontin) announced plans to release a painkiller 10 times stronger than Vicodin.  The painkiller contains pure hydrocodone, which doctors believe will lead to more accidental overdoses.

Three pharmaceutical companies are being investigated in the Senate probe, including Purdue Pharma, Endo Pharmaceuticals, and Johnson & Johnson.  Five different pain support groups are also being investigated, including the American Pain Foundation, the American Academy of Pain Medicine, the American Pain Society, the Wisconsin Pain & Policy Studies Group, and the Center for Practical Bioethics.

Even the Joint Commission, a nonprofit hospital accreditation group, is being investigated for its partnership with Purdue Pharma.  The group not only brought pain management to hospitals’ attention as a national priority in 2001, but also distributed to those hospitals pain education materials promoting Oxycontin.  The group already pled guilty in 2007 to criminal charges that it understated the risk of addiction with Oxycontin.

Experts Voice Concern about Painkiller Addiction

Narcotic painkillers are currently the most widely prescribed drugs in the United States, despite their classification as highly addictive substances akin to illegal drugs.

Sales of painkillers have risen nearly 300 percent since 1999, and in proportion, the number of deaths due to painkiller overdoses has also risen.  Prescription painkillers are now available even to high school students who have held “pill parties” in which they bring different medications they find around their homes, including painkillers, and take pills without knowing what those pills are.

Even newborns are being born addicted to painkillers.  The Journal of the American Medical Association recently released a report finding that newborns are being born with drug withdrawal at a rate five times that of levels in 2000.

Pain awareness groups have “helped usher in an epidemic that’s killed 100,000 people by promoting aggressive use of opioids.  What makes this especially disturbing is that despite overwhelming evidence that their effort created a public health crisis, they’re continuing to minimize the risk of addiction,” said Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in New York.

Since the 1990s, big pharma has marketed these painkillers to more groups of people.  Before, the pills were largely used to help cancer patients, but companies like Purdue Pharma have sold doctors and consumers on broader uses for the pills, including arthritis and back pain.  Senators Baucus and Grassley noted “There is growing evidence pharmaceutical companies that manufacture and market opioids may be responsible, at least in part, for this evidence by promoting misleading information.”

While these painkillers do have their uses in some patients, the overprescribing of these pills is clearly out of control.  Oftentimes, doctors prescribe the pills without fully explaining to the patient the risk of addiction and overdose.  Critics have said that many doctors need to be retrained on when it’s appropriate to prescribe narcotic painkillers.

I will continue to post updates about this and other pill mill news.  For the latest information on prescription painkillers and pill mills, subscribe to my blog.

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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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Prescription Drug Abuse Costs Medicare $148 Million

A recent government report shows that prescription drug abuse by elderly and disabled Medicare beneficiaries cost the U.S. government approximately $148 million in 2008, leading some to call for tighter controls on the program.

(Image: markuso / FreeDigitalPhotos.net)

Prescription drug abuse is on the rise in seniors and the disabled who rely on Medicare Part D to get their prescriptions. A report issued by Senate Homeland Security and Governmental Affairs Committee Chairman Tom Carpenter, along with senior Republican Scott Brown, found that nearly 170,000 people enrolled in the program went “doctor shopping” for powerful pain killers like oxycodone and hydrocodone.

In terms of prescription drug abuse, “doctor shopping” is where patients go to different doctors to get multiple prescriptions. The report found that some patients had gone to at least five doctors for prescriptions of drugs that are often abused. In all, these patients accounted for 1.8 percent of the total number of patients enrolled in the program.

Senator Scott Brown called the program “taxpayer-funded drug dealing,” and the Government Accountability Office (GAO) called for more strict control of the program to prevent Medicare fraud.

Why Older Patients are more at Risk

Today, older patients are being prescribed more long-term prescriptions and as many as 30 pills a day, which can lead to unintentional misuse of prescription drugs. For many seniors, the difficulty lies in simply being able to keep track of the pills and dosages they are taking.

According to the National Institute on Drug Abuse (NIDA), Americans ages 65 and older account for 13 percent of the population, but are prescribed one-third of all medicines prescribed in the United States. Combine their multiple prescriptions with over-the-counter medicines and dietary supplements, and the risk that they will have negative drug interactions soars.

Additionally, some seniors take medications that are not medically necessary or use medications for conditions that the medications were not originally prescribed. Seniors also tend to self-medicate for depression.

Benzodiazepines like Valium and Xanax are especially dangerous for seniors because they are more likely to feel stronger effects from the drugs than are younger people. These drugs can lead to falls and motor vehicle accidents for seniors, which can cause dangerous hip and thigh fractures.

Despite the risks these medicines pose, the government is expected to expand Medicare’s $62 billion drug program to cover benzodiazepines and other sedatives, both of which are commonly abused drugs.

To learn more about prescription drug abuse in the United States, read my article entitled “America’s Growing Addiction,” available at www.vanweylaw.com.

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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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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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Online Pharmacies Put Consumers at Risk

Prescription drug addiction is on the rise, especially among teens. The Department of Justice is now investigating online pharmacies for providing highly addictive and dangerous prescription drugs to people without legitimate prescriptions. Also being investigated is Google for selling advertisements to these online pharmacies, knowing that they did not follow proper procedures.

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Last year, Americans spent $307.4 billion on prescription drugs (IMS Institute), the most of any other country.  And with the price of many prescription drugs so high, 36 million people have turned to online pharmacies to purchase their prescriptions.  But these online pharmacies aren’t as trustworthy as they may seem.

Desperate to cut off the supply of potentially dangerous and highly addictive prescription drugs to America’s youth, the U.S. Department of Justice has now opened a criminal investigation into Google for profiting from advertisements on its site, sold to these online pharmacies.  Google has reportedly set aside $500 million to pay fines for facilitating online pharmaceutical advertisements.  Experts are expecting this will be the biggest fine charged in U.S. history.
 
To consumers in need of medications, online pharmacies seem like a good idea because their prices are much lower than their retail counterparts.  But these companies also make it easy for consumers to order dangerous drugs over the Internet without a prescription.  Some consumers have even reported receiving prescriptions they ordered that were signed by doctors they had never met.  If you google “online prescriptions,” you will find that the first website that pops up claims that no prescription is needed for consumers to get any drugs they want.
 
Google has filed lawsuits against many of the online pharmacies that bought advertisements on Google.  Joseph Califano, president of Columbia University’s National Center on Addiction and Substance Abuse, warned Google in 2008 that the advertisements they were selling were being bought by these online pharmacies, which were being operated without the proper supervision.  He says he also warned Google that these online pharmacies were being used by youth to obtain highly addictive prescription drugs.
 
Google didn’t do anything about the problem then, but has since said that they stopped selling advertisements to these online pharmacies over a year ago.
 
In the past decade, online pharmacies have fed the United States’ addiction to prescription drugs.  A recent study out of the University of Southern California has found that states that had the fastest expansion of high-speed internet in the early 2000s also had the highest number of hospital admissions for drug overdoses.
 
Today, an estimated seven million people use prescription drugs illegally, according to the National Institute of Drug Abuse (NIDA).  And prescription drug abuse is growing among teenagers, 59 percent of whom say they were given the drugs from family and friends.  NIDA reports that one out of every 12 high school seniors uses vicodin, and one out of every 20 high school seniors uses oxycontin.
 
Law enforcement authorities say they have no doubts that online pharmacies have led to higher addiction rates in the United States.  But law enforcement alone cannot stop these rouge pharmacies from dispensing dangerous drugs without prescriptions.  They need the help of Internet companies like Google to shut down these pharmacies.
 
Another issue with online pharmacies is that they dispense counterfeit drugs, which can be very dangerous.  Even people buying prescriptions online for legitimate reasons may be cheated by these online companies.
 
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American appetite for prescription drugs soars

America leads the world in its consumption of prescription drugs.

Money and Medicine

 We have become a pill popping nation.  Billions of dollars are spent by Big Pharma every year  in  Direct to Consumer advertising (DTC) and even more is spent  wooing doctors to prescribe more and more pharmaceutical products. So, it comes as no surprise that the U.S.A. leads the world in its’ consumption of prescription drugs.

A recent press release issued  by IMS Health (a pharmaceutical industry consulting organization), revealed that in 2011 it expects Americans to spend between $320-330 billion (YES that is a B not an M) on prescription drugs. 

Why do Americans spend more on prescription drugs than the citizens of other countries? In my personal opinion, it is because the slick marketing machines of Big Pharma have convinced us that we NEED drugs to improve our health and our quality of life. DTC marketing has led some patients to self-diagnose and actually request prescriptions by name brand from their physicians.

Of course, I concede that there are many good drugs on the market that are medically necessary and that actually do cure illnesses, or at least improve the quality of life for some patients. However, our nation’s addiction to prescription drugs is out of control.

Part of the problem rests with doctors who are under more and more pressure to prescribe drugs.  It has been estimated that there is one drug salesperson for every six doctors in America, and each of them are armed with cash, gifts, and perks. 

The time has come for consumers to take the reins and educate themselves about the drugs they are being prescribed.  I will be writing more about particular drugs that are of current concern and I will also be providing resources to consumer advocacy groups and watchdog organizations that track prescription drugs.

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