Pill Mill Monitor : Personal Injury Lawyer & Attorney : Kay Van Wey Law Firm : Prescription Drug Overdoses & Pharmaceutical Abuse

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.

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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.

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 “...when ya’all sit down to a simple plate of crisp fried chicken; a fluffy, warm, just-buttered biscuit; a mess of greens cooked down with a bit of ham; and a tall, handsome banana cream pie topped with ice-cold whipped cream afterward, well, you’ll have to agree; there is just nothing better.” Paula Deen, Southern Cooking Bible

Don’t get me wrong, I like Paula Deen. Her down home genuineness is familiar to me, although, I have wondered on occasion if that southern drawl is drawn out just a little more for the cameras.

At my roots, I am a southern lady. I am a baby boomer who grew up in a small town in southwestern Oklahoma.  I am a foodie, and I hail from a family that loves to eat.  Even before Paula Deen became a household name, my mother used to say that she’d slip in an extra stick of butter into her cheese grits recipe when Dad wasn’t looking.  Of course, back then we didn’t really completely understand the health dangers of some of the foods we were eating.

Just a few weeks ago, we enjoyed the holidays with some of Paula’s best recipes, including gooey pumpkin bars for Thanksgiving, chocolate pecan pie for Christmas, and brisket and cheese grits for New Year’s Day.

But the recipes that live on in our family traditions precede the advent of direct-to-consumer advertising by pharmaceutical companies.  The Gen X and Gen Y kids have grown up being fed a steady diet of pharmaceutical company ads, sending the message that drugs are good and that a little pill will cure us of our ailments.  We are being trained by these pharmaceutical companies and their Madison Avenue advertising agencies to eat whatever we want, including that high fat cheeseburger; after all, we have a pill to lower high cholesterol.  And if you develop diabetes, it isn’t a death sentence. We have pills for that. Want to perform better in bed? We have pills for that. Want longer eyelashes? You guessed it…we’ve got a pharmaceutical solution.

Now, as I have said before, there are many good drugs on the market that actually cure disease. There are many drugs on the market that some people can’t live without.  But, major pharmaceutical companies are also coming up with a whole new generation of drugs that are more like lifestyle drugs. They don’t cure anything, and they allow people to make really poor choices, thinking that a pill will make up for their bad decisions.

I wish a fraction of the money that was spent peddling drugs for chronic illnesses such as diabetes, high blood pressure, high cholesterol, and the like was spent on educating people about how to prevent themselves from getting these conditions in the first place.

What many people don’t know is the high risk and sometimes deadly toll some of these drugs can have on people. For example, the diabetes drug Avandia caused an estimated 83,000 heart attacks between 1999 and 2007, some of which resulted in death. The FDA finally pulled the drug from the market after trial lawyers had filed thousands of lawsuits against Avandia’s maker.

Another popular diabetes drug, Actos, has been pulled from the market in France and Germany after studies show it dramatically increases the risk of bladder cancer.  But Actos remains on the market in the United States, putting patients in danger of developing the disease.

I won’t stop buying Paula Deen cookbooks, and I will still make some of her recipes on special occasions. But listen up y’all, I can’t help but wonder why she waited three years to make the announcement that she has type-2 diabetes. Three years Paula? Come on now. Did it take your lawyers and agents that long to strike a 7 figure deal with a pharmaceutical company to endorse its diabetes drug? Was the timing of your announcement pure coincidence when it coincided with the announcement of your endorsement deal with Novo Nordisk?

While I am truly sorry to hear about Paula’s diagnosis, I can’t help but be disappointed in the fact that she has teamed up with a pharmaceutical company to market drugs for people to rely upon, instead of focusing on helping people lead healthier lives.  To learn more about how pharmaceutical companies get you to buy their drugs, download my free e-book Prescription Drug Safety: 7 Secrets the Pharmaceutical Industry Does NOT Want You to Know today at www.vanweylaw.com.

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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.

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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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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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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.

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Recent studies have shown that women using Yaz and Yasmin birth control pills have a higher risk of experiencing a blood clot while on the pills, but new findings show Bayer knew about the risk as early as 2004.

Former FDA commissioner David Kessler testified in an Illinois federal court that Bayer omitted from its safety analysis of Yaz/Yasmin reports of an increased risk of venous thromboembolism, which can lead to a potentially deadly pulmonary embolism.

By omitting this data, Kessler testified that “Bayer presented a selective view of the data, and that the presentation obscured the potential risks associated with Yasmin.”

Venous Thromboembolisms

One of the most significant risks associated with Yaz/Yasmin is that of a venous thromboembolism, or a blood clot.  Blood clots can be deadly if they lead to deep venous thrombosis (DVT) or a pulmonary embolism.

DVT mainly occurs in the lower extremities, but can occur in the upper extremities as well. Symptoms of DVT include swelling, pain, tenderness, and skin that is warm to the touch.

Pulmonary embolisms occur after a blood clot has been released into the bloodstream.  If the blot gets stuck in the heart, brain, or other major organs, severe damage or even death may occur.

Yaz & Yasmin Lawsuits

More than 10,000 lawsuits have been filed against Bayer, alleging women taking the pills suffered injuries.  At least 50 women died from taking Yaz and Yasmin between 2004 and 2008.

Yaz and Yasmin are two of the top oral contraceptives on the U.S. market, generating $1.58 billion in sales last year alone.

If you or a loved one has experienced a blood clot, DVT, or pulmonary embolism while taking Yaz, Yasmin, or another birth control containing the synthetic hormone Drospirenone, experienced dangerous drug attorney Kay Van Wey may be able to help you. Call Van Wey Law today at (800) 498-5082 for more information.

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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).

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Zocor (generic Simvastatin) is a drug prescribed to lower cholesterol in patients with high cholesterol.  The drug was first introduced on the market in 1991 by major pharmaceutical company Merck.  But nearly 10 years later, after studies showed a risk of patients developing severe muscle damage, or rhabdomyolysis, the FDA required Merck to put a warning on Zocor’s label explaining the risk for muscle injury in patients taking 80mg, the highest dosage of the drug.

Further studies since then have shown that the higher the dosage of Zocor a patient takes, the more likely he or she is to develop some form of muscle damage.  Patients who develop rhabdomyolysis, the most severe form of muscle damage, are at risk for kidney failure and even death.

If you are currently taking Zocor, Vytorin, or one of Zocor’s generic equivalents, and you develop sudden unexplained muscle pain, you should contact your healthcare professional immediately. 

Other signs of rhabdomyolysis include dark or red urine, weakness, muscle stiffness or aching, and muscle tenderness.  Additionally, patients with the condition may experience fatigue, weight gain, seizures, and joint pain.

If you or a loved one took or are taking Zocor, Vytorin, or any generic equivalent of Simvastatin and have experienced severe muscle pain or have been diagnosed with rhabdomyolysis, contact Van Wey Law today.
 

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Since the Food and Drug Administration (FDA) announced restrictions on prescribing 80mg doses of Zocor (generic name Simvastatin), many have questioned whether Merck, the maker of Zocor, knew about the drug’s potential to cause severe muscle damage without providing more warning to patients.

This is not the first time Merck has been accused of withholding information about negative results of its drugs in medical studies.  In 2004, after heavily promoting its blockbuster drug Vioxx, Merck voluntarily pulled Vioxx off the market, because studies revealed the drug increased the risk of heart attacks, blood clots, and strokes in patients.  

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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.

• 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.

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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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 The FDA recently announced that it will require the makers of Simvastatin (generic) and Zocor to strengthen their warnings. It seems that the FDA has been studying the effects of this drug for 7 years.  The FDA study revealed that some of the patients in the study taking the highest dosage (80 mgs) of Simvasatin or Zocor  sustained muscle damage. 

Critics question why the FDA waited so long to issue the warning about the increased risk of muscle damage associated with Zocor and it's generic equivalent, Simvastatin.

The kind of muscle damage associated with Simvastatin and Zocor can lead to a condition known as rhabdomyalisis which can shut down the kidneys and result in death.

It is estimated that 2.1 million Americans are taking the 80mg dose of Simvastatin or Zocor. If you or a loved one are taking either of these drugs, particularly at higher doses, you would be well advised to call your doctor as soon as possible and discuss your options.

To learn more about Zocor lawsuit, visit vanweylaw.com. If you are interested in learning more about how dangerous drugs like Zocor stay on the  market, download your free copy of attorney Kay L. Van Wey's recent book on the subject, "Prescription Drug Safety. Seven Secrets the Pharmaceutical Industry Does Not Want You To Know".

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Darvon, Darvocet and the generic Propoxyphene are bad drugs that should have been taken off the market a long time ago. Efforts to ban the drug began more than thirty (30) years ago. Yes, I said 30. The truth is they never were very good drugs to begin with. There were animal studies that signalled heart problems even before the drug was first approved. The fact that they were allowed to remain on the market for so many years is a case study in the unbridled power and influence of Big Pharma over Congress and the FDA. For an excellent chronology of the efforts to get propoxyphene (Darvon and Darvocet) removed from the market, see Public Citizen's Report.

Sidney M. Wolfe, M.D., Director of the Health Research Group at Public Citizen testified at the 2009 FDA hearings on Propoxyphene. This is what he said:

There is little doubt that were propoxyphene and propoxyphene-containing products to come before these committees today for approval, based on what is now known, they would be rejected because of one of the most unfavorable benefit-to-risk ratios ever seen for a drug. This is not to say that there was insufficient evidence for a ban 30 years ago when we first petitioned the Food and Drug Administration (FDA) to withdraw the approval. But the forceful and successful war then waged by Lilly in opposition to such a ban tended to drown out evidence of minimal benefit and rapidly growing evidence of life-threatening, often lethal harm.

The entirety of his testimony lays out a grim scenario of deaths directly related to the use of propoxyphene.

Another notable expert, Dr. Steven B. Karch also testified before the FDA panel. Dr. Karch is a former medical examiner in San Francisco where he investigated deaths related to drug toxicity. He also wrote a textbook, Karch's Pathology of Drug Abuse  in which a section is specificallly devoted to propoxyphene-related deaths.

Dr. Karch laid out the case for banning the drug, in saying:

(1) It is a dangerous drug: Large amounts are rapidly absorbed from the GI tract very quickly, making attempted suicide difficult to treat.

(2) Even modest amounts of this drug can cause lethal cardiac arrhythmias in any individual with an undiagnosed hERG genetic polymorphism.

(3) Use of propoxyphene  can lead to toxic levels of antibiotics and anticonvulsants

(4) The drug is not particularly effective. For far less money, patients would get more pain relief if they took aspirin or acetaminophen.

Yet, rather than immediately recalling the drug from the market and thereby preventing more needless deaths, the FDA inexplicably called for stricter warnings. When, In November 2010 the FDA finally pulled Darvon off the market, Dr. Sidney Wolfe issued a statement calling for a Congressional Investigation of the FDA and estimating that the FDA's delay cost 1000-2000 lives.

According to Dr. Wolfe, 

The FDA's pitiful excuse that it needed to order a human study to find that "the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities" before deciding whether to ban propoxyphene only emphasizes how out-of-step the agency is with the rest of the world - which already had enough human evidence of death and near-death in tens of thousands of people to act accordingly.

In a study on dogs published 31 years ago, researchers at Lilly, the discoverer of propoxyphene, stated that "cardiac conduction depression may be a factor in some of the [human] cardiac toxicities associated with propoxyphene overdose." This study examined the same kind of function measured in the human study now being put forth by the FDA as a justification for belatedly banning propoxyphene.

We will ask for and support a congressional investigation into whom in the FDA, specifically in the Center for Drug Evaluation and Research, was responsible for the loss of so many lives in this country. It is clear that long before today, many drug safety experts in the Office of Surveillance and Epidemiology had decided the drug should be removed from the market.

Dr. Wolfe was a severe critic of the FDA under the Bush Administration, decrying in 2006 that the FDA had embarked upon an  "unprecedented assault on the American public.

Only time will tell whether any such Congressional investigation will ever  take place. I have my doubts given the current state of political affairs in this country. I would love to be proven wrong.

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 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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The FDA announced that it is banning the sale of Darvon and Darvocet in the United States. According to a FDA spokesperson, 

"We concluded that the pain relief benefit no longer outweighed the health risks."  

The FDA based it's decision on animal studies that have been available for 30 years. In 2005 Britain banned the drugs. At least 1,000 people have died in the United States from using the ingredient in Darvon and Darvocet, propoxyphene since the 2005 ban in Britain.

Darvon and Darvocet are made by Xanodyne Pharmaceuticals Inc., of Newport, Kentucky, which said it would comply with the FDA's request to withdraw the drug. Generic makers of propoxyphene are expected to follow suit.

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I recently visited the Metropolitan Museum of Art in New York City. There, you will find the Sackler Wing which contains treasures from the age of the Egyptian pharaohs. You will also find Arthur M. Sackler galleries at the Smithsonian Institute ,Harvard and Beijing University. Many people do not know the Sackler name apart from their association with these lofty cultural institutions.

Arthur M. Sackler has been referred to as a marketing genius and the godfather of the modern-day drug advertising industry.  He developed  drug marketing techniques such as: direct to consumer advertising , sponsoring luxurious all expense paid medical education courses for doctors, glamorizing drugs as a quick fixes, and  paying for "scientific" studies backing the need for and/or efficacy of the particular drug being studied.

Arthur Sackler, who was already rich, made a fortune marketing and selling Librium and Valium. Later, younger brothers Mortimer and Raymond  joined Arthur in acquiring a little known drug company called the Purdue Frederick Company. Arthur died in 1987 at the age of 73.  In 1996 the family owned company, now known as Purdue Pharma introduced it's new blockbuster drug, Oxycontin.

Oxycontin is a very powerful, long acting narcotic which is should only be prescribed for  serious pain. Purdue Pharma  recognized even before the drug was marketed that they would face stiff resistance from doctors who were concerned about the potential for  OxyContin to be abused by patients or cause addiction.

Taking a chapter from brother Arthur's drug marketing playbook, Mortimer and Raymond embarked on the most aggressive marketing campaign ever undertaken by a pharmaceutical company for a narcotic painkiller. Purdue Pharma marketed  OxyContin to doctors like general practitioners, who often had little training in the treatment of serious pain or in recognizing signs of drug abuse in patients. One of their techniques was to fly physicians in to conferences about the "inadequate treatment of pain" and the need for doctors to aggressively prescribe narcotics like Oxycontin to their patients.

Just a few years after the drug’s introduction in 1996, annual sales reached $1 billion.

 In reality, Oxycontin proved to be a powerfully addictive drug. Some users  including teenagers, soon discovered that chewing an OxyContin pill or crushing one and then snorting the powder or injecting it with a needle produced a high as powerful as heroin. By 2000, parts of the United States, particularly rural areas, began to see skyrocketing rates of addiction and crime related to use of the drug. The drug came to be known among certain circles as "hillbilly heroin"

 A  comprehensive review of the problem appeared in the journal Pain Physician http://www.painphysicianjournal.com/2006/october/2006;9;287-321.pdf

CDC and DEA data included in the review suggested that from 1997-2004 there was a:

> 556% increase in the sales of oxycodone;

> 500% increase in therapeutic grams of oxycodone used,

> 568% increase in the non-medical use of OxyContin (especially among young people)

 > 129% increase in opioid-related deaths [without heroin or cocaine]:

Using this data, the author extrapolated that the number of deaths from Oxycontin could surpass the deaths from 911 and the Iraq war combined!

 By 2007 the government caught up with Purdue which resulted in  three current and former executives pleaded guilty  to criminal charges that they misled regulators, doctors and patients about the drug’s risk of addiction and its potential to be abused. Purdue paid over $600 million in criminal and civil penalties.

From left, Howard R. Udell, the top lawyer for Purdue Pharma; Dr. Paul D. Goldenheim, the company’s former medical director; and Michael Friedman, Purdue’s president.

The last chapter of the Oxycontin saga has not been written. Despite their assertions to the contrary, Purdue Pharma has not cleaned up their act. Read between the lines on Partners Against Pain and you'll see some of Arthur's old tricks still being used.

There is much more to be written about Purdue Pharma and their dirty and deadly deeds. However, I was just so struck by seeing the Sackler name associated with such a venerable institution as the Metropolitan Museum of Art that I thought you should know what this family did to deserve having a wing of a famous art museum named after them.

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I was recently walking through La Guardia airport in a typical traveler's daze when a prominently displayed magazine cover jumped out at me.The title was "Pills to make you smarter".

I was hooked. I had to read more. Make no mistake. I wasn't in the market for a magazine in the first place. I was already heavily laden with the six issues of my local bar publication that I had been intending to read. And frankly, if I was going to buy a magazine it was pretty tempting to succumb to the urge to find out what exactly is going on with Lindsey Lohan. But the magazine marketing geniuses made a first time purchaser of Scientific American out of me.

The article, "Turbocharging the brain", queries: "Will a pill at breakfast improve concentration and memory-and will it do so without long term detriment to your health"? The article chronicles the fascinating scientific developments in cognitive enhancement drugs to treat Alzheimers and other dementias. But, it also raises a very disturbing question. Will these drugs ultimately be marketed and sold to healthy people as "lifestyle enhancement" drugs?

Currently, neuroethicists are debating this issue in the neuroscientific community. I certainly am not qualified to enter that debate. However, this is what I do know. With the advent of direct to consumer marketing, the big pharmaceutical companies have spoon fed us a steady diet of propoganda that there is a pill for everything that ails us. We are the "super size me" generation who believes that more is better. Multi-billion dollar industries have profited from our desire to eat more, be stronger, look better, and perform better in the bedroom.

The temptation to "super size" our brains could create an enormous demand for these "smart drugs", or as some have referred to them "viagra for the brain". As one neuro ethicist put it "Within the pharmaceutical field, people recognize that a successful cognitive enhancer could be the best selling pharmaceutical of all time".  We needn't say more at this point. With the potential for hundreds of billions of dollars to be made, the pharmaceutical industry will find a way to use their slick marketing machines to convince us that we "need" these drugs. They will pay scientists and physicians to write articles in esteemed medical journals advocating their use and minimizing any potential side effects. Mark my words. It may not be in my lifetime, but this will come to fruition.

So, at the end of the day, the pharmaceutical industry will continue to wield enormous power over us. Some futurists have concocted the symbol "H1" to denote an enhanced version of humanity. Think of all the "lifestyle enhancement " drugs that can be peddled to the super-sized human.  The question is what does this make us as human beings, what would a society of super-sized humans look like and would you want to live in it?

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