Serious Bleeding Events Reported in Patients Taking Pradaxa

Since November 2011, at least 260 deaths worldwide have been linked to new blood thinner Pradaxa.  An estimated 1.1 million prescriptions have already been written for Pradaxa, and 371,000 patients are currently taking the drug.

Serious Bleeding Events

Pradaxa was approved by the Food & Drug Administration (FDA) in October 2010 to reduce the risk of blood clots and strokes in patients with non-valvular atrial fibrillation.  Just over a year after being approved, the FDA issued a safety communication for Pradaxa, warning consumers that patients taking the drug have reported experiencing serious bleeding events.

Symptoms of these adverse events include the following:

  • Persistent nose bleeding
  • Unusual gum bleeding
  • Vomiting or coughing up blood
  • Bruising
  • Heavier than normal menstrual bleeding
  • Red or black stool
  • Pink or brown urine
  • Severe or uncontrollable bleeding

The FDA recommends that if you or a loved one experiences any of these symptoms, you seek the help of a health care provider immediately.

Can We Trust the FDA?

Although the FDA is currently investigating claims that Pradaxa has caused serious bleeding, the agency maintains that "[a]t this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label.”

The FDA has made statements like this before for drugs that were later proven to indeed be very dangerous.  Patients taking Avandia, for example, reported adverse events like heart attacks.  The FDA had approved Avandia in 1999 simply because it helped diabetics to control blood sugar levels.  But after nearly 47,000 people taking Avandia suffered a heart attack, stroke, or even death, the FDA finally restricted the use of the drug in 2010.

More recently, the FDA has received criticism for allowing experts with conflicts of interest to sit on a panel to determine whether the popular birth control pills Yaz and Yasmin should be taken off the market.  At least four of the experts on the panel had received compensation from Yaz and Yasmin’s manufacturer Bayer.  All of them voted in favor of keeping the pills on the market.

And it seems as though the FDA may be behind the curve on Pradaxa. Both Japan and Australia have issued safety warnings, linking Pradaxa to serous bleeding events.

To learn more about the pharmaceutical industry and why the FDA approves these dangerous drugs, download my FREE e-book Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know at www.vanweylaw.com today.

Pastry Chef Reverses Type-2 Diabetes Diagnosis without Drugs

Southern chef Paula Deen recently announced that she has type-2 diabetes, which did not surprise many Americans, who for years have watched the chef make dishes loaded with calories, fat, and sugar.  With her health announcement, Deen also announced that she was endorsing diabetes drug Victoza, made by drug company Novo Nordisk.

Big Pharma Influences How People View Diabetes

Deen’s partnership with big pharma drew criticism not only from her critics, but also from her fans.  Chef Anthony Bourdain has criticized Deen’s cooking for years, and upon learning of her announcement, took to Twitter writing “Thinking of getting into the leg-breaking business, so I can profitably sell crutches later.”

While Deen has said she has changed her eating habits and has cut out the sweet tea, many question whether she really has changed the way she eats or whether she’s simply using Victoza to counteract eating poorly.  Either way, her recent partnership sends the message that people can eat what they want, and if they happen to develop diabetes, there’s a drug for that.

Diet & Exercise May Reverse Type-2 Diabetes

Health experts say people with type-2 diabetes don’t necessarily need to take diabetes drugs, many of which have been found to cause bladder cancer, thyroid cancer, and pancreatitis.  For many patients, eating better and exercising can reverse a type-2 diabetes diagnosis. Pastry chef Michael Mignano is proof of this.

Mignano spent years sampling his own sugar-filled creations and picking up fast food after a long day at work.  By the time he turned 36 years-old, he weighed 500 pounds and had been diagnosed with type-2 diabetes.  Realizing the risks he was taking by eating unhealthy, Mignano agreed to go on “Fat Chef,” a new show on Food Network in which chefs like Mignano learn how to eat healthy and exercise.

Since filming, Mignano has lost over 100 pounds and has reversed his type-2 diabetes diagnosis, all without taking pills.  “Medicine is great, but it gives you this false sense of healing, but it’s not really doing what it’s supposed to do,” he said in a recent interview with ABC News.

Mignano is the first to admit that working with the food that contributed to his obesity is not easy, and neither is getting into a regular exercise routine.  But he says “It just makes me a happier chef, a happier person, which the result, you have happier food.”

Although “Fat Chef” is done filming, Mignano says he plans to stick with his diet and exercise regimen.  He hopes to drop his weight down to 250 and stay diabetes free.

Big Pharma’s Influence

For years, major pharmaceutical companies have pushed diabetes drugs on Americans with ever-growing waistlines, sending the message that you can eat whatever bad food you want because a pill will nullify the food’s bad effects.  But drugs like Avandia, Actos, and even Paula Deen’s Victoza may be more dangerous than helpful.  Avandia was pulled from the U.S. market completely after studies showed it caused heart attacks and death.  Actos is still on the market, but has been shown to cause bladder cancer.  And Victoza may cause thyroid cancer and acute pancreatitis.

To learn more about how big pharma influences consumers and their doctors, download my free e-book Prescription Drug Safety today at www.vanweylaw.com.

FDA's Yaz Panel Influenced by Big Pharma

Looks like the Food & Drug Administration (FDA) will face pressure to take another vote on the popular birth control pills Yaz and Yasmin as reports surface that at least four of the experts had ties with manufacturer Bayer.

FDA experts met on December 8, 2011, to determine whether Yaz and Yasmin are safe for women to take.  The panel voted 15 to 11 to keep the pills on the market, citing that the benefits of the pills outweighed the risk of blood clots. 

Experts Received Money from Bayer

Dr. Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, was one of the experts who served on the Yaz panel and had ties with Bayer.  Before 2009, Dr. Johnson was paid by Bayer for work she did for the company. 

Additionally, she conducted clinical trials for Berlex, a pharmaceutical company acquired by Bayer, studying the effects of Drospirenone.  Drospirenone is the synthetic hormone found in Yaz and Yasmin that health experts believe may be contributing to the increased risk of blood clots in women taking the drugs.  That clinical trial involved a hormone replacement therapy, not birth control, and Dr. Johnson has denied any bias for Bayer or its products.

Another expert on the panel who received funding from Bayer was Dr. Anne Burke.  On a Bayer internal document, Dr. Burke is listed as a Bayer contraception expert.  She received research funding from Bayer, but stated that this occurred several years ago.

Two other experts admitted to having either past financial ties or research ties with Bayer.

All four of the experts voted in favor of Yaz and Yasmin, noting that they believe the risk of blood clots associated with the birth control pills is outweighed by the benefits of the drugs.

One expert who was not allowed on the panel because of an “intellectual conflict of interest” was Dr. Sidney Wolfe of consumer advocacy group Public Citizen.  Because he has criticized Yaz as being an unsafe drug in the past, the FDA determined that Dr. Wolfe was too biased to serve on the panel.

This recent development raises the question: To whom is the FDA really catering--consumers or big pharmaceutical companies?  Based on the background of the Yaz  panel, it would seem that consumers are taking a backseat to pharmaceutical companies with money to hand out.

To learn more about how big pharma influences the FDA, download my free e-book Prescription Drug Safety at www.vanweylaw.com.

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.

New Pain Pill to be Stronger than Vicodin

Pharmaceutical company Purdue Pharma and three other companies have announced a new prescription drug that will contain pure hydrocodone, a highly addictive narcotic painkiller.  The pill is expected to be 10 times stronger than Vicodin, one of the strongest painkillers available on the market.

Hydrocodone is an opiate much like heroin, oxycodone, codeine, and morphine.  The United States is the largest consumer of hydrocodone prescription pills, using 99 percent of what is on the world market.  Much of the hydrocodone available today is combined with other painkillers like acetaminophen.

Over the years, these pain pills have been criticized for being too addictive.  For example, OxyContin, produced by Purdue Pharma, is the most abused pain pill in the United States. When OxyContin was first introduced onto the market in 1995, abusers quickly learned that they could get a stronger high from the time-release caplets by crushing them.

Today, prescriptions that contain hydrocodone are a quick second to oxycodone in terms of abuse.  A stronger painkiller that contains pure hydrocodone could be disastrous for a nation already suffering with substance abuse and addiction.

The market for pain pills is $10 billion, and pharmaceutical companies are coming up with new drugs to get into the lucrative market. But big pharmaceutical companies are marketing the new drugs as safer, arguing that fewer patients will experience liver problems like they do with drugs that contain acetaminophen.

A form of pure hydrocodone could be on the market as early as 2013, but with an even more addictive prescription on the market, more patients may become addicted to the drugs, leading to numerous overdoses that will strain hospitals resources.  Abuse of hydrocodone alone has led to an uptick in the number of emergency room visits related to hydrocodone abuse.  In 2000, more than 19,000 visits to the emergency room were related to hydrocodone abuse, but in 2008 that number grew more than four times to more than 86,000 visits.

Prescription drug addiction is a brain disease that can be fatal if undetected or untreated. To learn more about America’s prescription drug addiction epidemic, visit www.vanweylaw.com.

Prescription Drug Overdose Deaths on the Rise

(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.

FDA Downplays Chantix Risks, New Study Finds Chantix is Dangerous

Chantix shown to have dangerous side effects

(Image: dan / FreeDigitalPhotos.net)

Last week, the Food & Drug Administration (FDA) released the findings of two federally-funded studies and found that anti-smoking drug Chantix did not increase psychiatric problems in patients taking the drug.

The studies relied upon by the FDA followed more than 26,000 patients taking Chantix.

Volatile History

Chantix, which is manufactured by major pharmaceutical company Pfizer, was first approved for use in 2006. Beginning in 2007, experts began raising safety concerns about Chantix, citing cases of cardiovascular problems and changes in vision.

As more people began to take Chantix, more reports of depression and suicidal thoughts were reported by patients taking the drug.  This prompted the FDA to place a black box warning label on Chantix in 2009 to caution doctors and patients about the drug’s risk of causing depression, suicidal thoughts, and hostility.

FDA’s Studies Miss the Mark

The two studies cited by the FDA did not produce definitive findings.  The studies, conducted by the Department of Veterans Affairs and the Department of Defense, were not large enough to determine rare side effects.  Additionally, the studies reported psychiatric problems that led to hospitalizations only, which completely disregarded any unreported issues.

New Study Urges FDA to Update Chantix Warning Label

A study published in PLoS One Journal found that Chantix makes psychological symptoms far worse than any other nicotine replacement drug.  Although this study was much smaller than the federally-funded studies, it focused specifically on adverse event reports of depression and suicidal behaviors in people taking Chantix, its competitor Zyban, or other nicotine replacement drugs.  The adverse events were reported through the FDA’s Adverse Event Reporting System (AERS).

The findings of the study are alarming. A staggering 90 percent of the 3,000 reports of suicidal thoughts and depression were linked back to Chantix.  Of those completed suicides, 92 percent were linked to Chantix.

Despite these findings, the FDA continues to report that Chantix is a safe and effective way for smokers to kick the habit.  Pfizer released a statement regarding this most recent study, saying “often these reports lack sufficient medical information to enable meaningful assessment.”

Know Your Risk

Nearly 22 million prescriptions have been written for Chantix since it was first approved in 2006. Since then, commercial pilots have been banned and truck drivers have been restricted from taking the drug, due to black-outs and vision problems.

The Veterans Administration recommends its patients undergo a mental health evaluation before being prescribed Chantix.  Experts behind the most recent study agree, saying that the risks associated with Chantix outweigh the benefits.

Prescription Drug Abuse Costs Medicare $148 Million

(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.

Google Pays $500 Million in Settlement for Online Pharmaceutical Ads

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.

What You Should Know about Prescription Drug Addiction

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Each year, millions of Americans turn to prescription painkillers to help ease their pain.  But these painkillers may be doing some patients more harm than good.

Emergency rooms across the United States are seeing an increase in the number of prescription drug overdoses.  In fact, emergency room visits due to overdoses have alarmingly doubled over a five year period to 1.2 million.
 
Part of the problem is that doctors are not properly trained on how to manage pain and are often pressured by major pharmaceutical companies to give patients unnecessary drugs.  Last year, physicians wrote more than 200 million prescriptions for highly addictive pain medications.  Yet, some question the effectiveness of these painkillers, especially for patients suffering with chronic pain. 
 
As Dr. Nora Volkow, head of the National Institute on Drug Abuse (NIDA), puts it, “physicians are the nation’s pushers.”  And patients trust that the drugs their doctors are prescribing them are safe, without ever giving much thought as to whether they may become addicted to the drugs.
 
Often, people who become addicted to prescription painkillers are labeled morally weak and are considered menaces to society.  These stereotypes are simply not true.
 
Addiction is a brain disease that can be treated.  In some people, prescription drugs can have such a profound effect that they change the way in which the brain processes judgment, decision making, memory, learning, and control.  These drugs activate dopamine, a chemical that regulates the reward system in our brains, motivating future behavior.
 
While scientists have not yet been able to determine who will become addicted to a certain prescription, they have been able to lessen the addictive properties of certain pain relievers.
 
To learn more about addiction and the addition epidemic in the United States, read my article entitled “America’s Growing Addiction.”

Florida Attempts to Crack Down on Pill Mills

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.

U.S. Supreme Court Deals a Low Blow to Consumers

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It is no secret that the highest court in our country, the United States Supreme Court, is sharply divided along political lines. Currently, the Court is comprised of two Reagan appointees, one George H.W. Bush appointee, two George W. Bush appointees, two Clinton appointees, and two Obama appointees. Sadly, the decisions of the Court often come down to legal interpretations, which are heavily influenced by political ideology.

On June 23, 2011, the U.S. Supreme Court handed down an opinion in Pliva, Inc. v. Mensing, which arguably has far reaching consequences for drug safety.  In that case, the Court considered the issue of “whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state law claims.”  Justice Clarence Thomas for the plurality wrote an opinion holding that the state law claims are pre-empted by federal drug regulations.

The holding of the case came as a surprise to many who thought that the Supreme Court would uphold the rulings of the 5th and 8th Circuit Courts.  Both of those courts rejected the manufacturers’ argument that federal law pre-empted any state tort claims and held that the plaintiffs’ claims were not pre-empted.

Justice Sonya Sotomayor wrote a dissenting opinion in which Justices Ginsburg, Breyer, and Kagan also took part.  In her opinion, she noted that "...the majority's pre-emption analysis strips generic-drug consumers of compensation when they are injured by inadequate warnings."  She also sharply criticized the plurality opinion for its contorted reading of pre-emption, arguing that Pliva “effectively rewrites our decision in Wyeth v. Levine.”

Because Justice Thomas’ decision was a plurality opinion, there was no clear majority of the Court that adopted Justice Thomas' reasoning.  Anyone who is interested in consumer issues, drug safety issues, or in how the Court works should read Justice Sotomayor’s blistering dissenting opinion.  As they say, “you don't really want to see how the sausage is made.”

So what does all of this legalese mean for consumers?  The gist of the Court's opinion is this: if a consumer is injured by a drug’s inadequate safety warnings, his/her right to sue now depends on whether the pharmacist fills the prescription with a name brand drug or a generic drug.  Under the plurality’s holding, the consumer injured by a name brand drug will be able to bring suit, but the consumer injured by a generic equivalent of a brand name drug will be left with no remedy for his injuries.

Unfortunately for consumers, generic drugs now comprise 75 percent of all prescription drugs dispensed in this country. The consumer usually has little control over whether the name brand or generic is provided.  Oftentimes, large insurance companies control the decision about which drug a consumer receives.  This decision is made in the board rooms of large insurance companies who negotiate with drug manufacturers for the cheapest prices.

According to Justice Sotomayor, "Today's decision eliminates the traditional state-law incentives for generic manufacturers to monitor and disclose safety risks.  When a generic drug has a brand-name equivalent on the market, the brand-name manufacturer will remain incentivized to uncover safety risks.  But brand-name manufacturers often leave the market once generic versions are available, meaning that there will be no manufacturer subject to failure-to-warn liability.  As to those generic drugs, there will be no additional layer of consumer protection."

Look for more about this landmark case and how it affects consumers on www.vanweylaw.com.

 

Online Pharmacies Put Consumers at Risk

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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.
 

U.S. Soldiers Suffering at Hands of Lawmakers, Big Pharma

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We hear the reports on the news all the time about military service personnel who have survived bombings in Iraq and Afghanistan, but who have also lost limbs or have been seriously injured. They remind us of the great sacrifice they are making to protect our freedom. But the news media do not tell us about the stories of service personnel who were injured and have subsequently become addicted to prescription pain killers.

The wars of today are different than those fought previously.  In both World Wars I and II, thousands of U.S. soldiers died on foreign soil fighting for the freedom that we hold so dearly.  Today, soldiers are still dying, but due to advancements in medical technology, many are also surviving.  Unfortunately for those survivors, many live in fear and pain even after returning home.
 
Thanks to lobbying efforts by the pharmaceutical industry and its various pain management groups, lawmakers were convinced that prescription drugs would cure these ailing soldiers.  In 2008, two bills were passed that provided greater access to prescription pain killers and other drugs for active-duty soldiers and veterans.  One of the bills was the Veterans Pain Care Policy Act, and the other was the Military Pain Care Policy Act of 2008, which required the Department of Defense to implement a program where comprehensive pain care would be provided for active and retired military service men and women.  
 
In 2010, the U.S. Army Surgeon General expressed concern that soldiers were being overmedicated.  This came just two years after the passage of the Military Pain Care Policy Act of 2008, in which a study revealed that the comprehensive pain care provided was in the form of highly addictive prescription pain killers.
 
A study conducted by the U.S. Army found that 14 percent of soldiers had been prescribed an opiate prescription drug to treat their pain, and 95 percent of those prescriptions were for OxyContin or its generic, Oxycodone.  Other commonly prescribed drugs for soldiers include Seroquel, an antipsychotic drug, and Valium, an anti-anxiety drug.  All of the aforementioned drugs are highly addictive and have disastrous side effects, including irritability, suicide, and reduced reaction times.
 
After the results of the study came out, Lieutenant General Eric Schoomaker remarked, “we’re very concerned about the panoply of drugs that are being used and the number of drugs that are being used.”  A Military Times report found that one out of every six service members is on some type of psychiatric drug.  In a 2008 survey conducted by the Pentagon, 15 percent of soldiers said they had abused prescription drugs within the past month.
 
Lawmakers are now calling on the military to closely monitor the prescriptions that are given to soldiers, while others in the military want the focus to shift to alternative pain management practices like yoga, meditation, acupuncture, and movement therapy. Currently, the Department of Defense does not keep track of prescriptions given to service members.
 
Whatever the military and lawmakers decide, they must not let the pharmaceutical industry bully them into giving our already injured soldiers highly addictive and dangerous pain pills.
 
I would like to thank Marianne Skolek, a staff writer at Salem-News.com and an activist for victims of OxyContin and Purdue Pharma. She first wrote about the devastating effects these highly addictive painkillers are having on our troops and brought it to my attention. You can read her full article at http://www.salem-news.com/articles/june232011/drugged-soldiers-ms.php.

Lipitor More Effective than Zocor

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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.
 

Nonmedical Prescription Drug Use Among Adolescents

Rural adolescents are 26% more likely than urban adolescents to have used prescription drugs nonmedically, concludes a groundbreaking study that Archives of Pediatrics & Adolescent Medicine published online this month. The article, Nonmedical Prescription Drug Use in a Nationally Representative Sample of Adolescents, highlights factors thought to influence nonmedical prescription drug use ("NMPDU") and related intervention points:

  • School enrollment correlates with lower likelihood of NMPDU. Increase school retention and prevent initiation of NMPDU.

  • Residing in a two-parent household correlates with lower likelihood of NMPDU. Develop interventions aimed at family involvement.

  • A history of at least one major depressive episode and lower health status correlates with a higher likelihood of NMPDU. Increase access to health care among rural adolescents.

  • Use of other illicit drugs and alcohol strongly correlates with higher likelihood of NMPDU. Aim interventions at adolescents who have already initiated substance use.

At a time when teens are abusing prescription drugs at rates higher than any other drugs except marijuana, with NMPDU increasing 212% from 1992 to 2003 alone, this study prods us as a society to wake up, to take notice, and to intervene to curb the problem. If we do not, today’s teenagers who abuse prescription drugs in lieu of less accessible, more stigmatized street drugs become tomorrow’s prescription drug addict who leave broken lives, broken families, and broken communities in their wake.

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.