Neurontin for Everything?

Neurontin for Everything?

How does a drug company take an unproven, worthless, and potentially dangerous drug like Neurontin, and turn it into a billion dollar blockbuster?  Through deceit, lies, and bribery, reports New York Times health writer and author Melody Peterson.

Peterson, in her book "Our Daily Meds," reveals the chicanery, pseudoscience, and greed behind the marketing of many of today's well-known drugs.

The history of one drug in particular, Neurontin, shows just how deceitful, ruthless, and cold-hearted some drug executives can be.

The original clinical studies evaluating the efficacy of Neurontin for treating epilepsy were less than impressive.

The studies not only showed that the drug was ineffective, and potentially dangerous, but that in 5-10% of patients it actually increased the frequency and severity of the epileptic seizures.

The FDA found the drug be worthless and had grave concerns over its potential dangers. But, eventually they gave in to pressure and allowed Neurontin to be marketed as a second line drug. This meant that it was to be used only after other epilepsy drugs had first been tried and failed.

No problem - drug executives were determined to make Neurontin into a million dollar blockbusting drug and a little thing like science wasn't going to stop them.

It didn't matter that legitimate research had proven that Neurontin was ineffective in the 10 conditions it was being promoted for, including attention deficit disorder, fibromyalgia, chronic pain, diabetic neuropathy, fibromyalgia, mood disorders, migraines, and bi-polar disorder.

Worried the scientific truth may interfere with their plans for establishing Neurontin as a block buster, Pfizer sought to cover-up these studies including the one showing Neurontin was no better than a placebo in reducing diabetic nerve pain- "I think we can limit the potential down sides of the study by delaying the publication for as long a possible...it will be more important to how we write up the study."

Realizing that new studies would be expensive and most likely negative, they aggressively hatched a plan to ignore science, clinic trials, and morals, and began to market Neurontin for an assortment of chronic illnesses.

John Ford, a senior marketing executive had this to say at one sales meeting, "Neurontin for pain, Neurontin for monotherapy, Neurontin for bi-polar, Neurontin for everything."

Not to be out done Phil Magistro a senior level sales executive left a voice message for his sales force stating, " When we get out there, we want to kick some ass. We want to sell Neurontin for pain. All right? And monotherapy and everything we can talk about. That's what we want to do."

And that's exactly what the sales reps did; they drank the "purple Kool-Aid" and hyped the snake oil for every illness they could think of. And it worked; eventually 90% of the 2.7 billion dollars in Neurontin sales came from off-label use - 90% of the prescriptions were for unproven uses.

So how does a drug company take an unproven, potentially dangerous drug and successfully market it to doctors?

Easy, deceive then bribe them. The company paid marketing copywriters to write pseudoscientific, and of course, incredibly favorable articles on the wonders of Neurontin.

Medical Education Services, a ghost writing marketing firm was paid $60,000 to create dozens of fabricated studies on Neurontin. Doctors were then paid $1,000 each to "sign-off" on the article.

One in-house memo from this group is revealing - "Draft completed. We just need an author." This particular piece was targeted at children with attention deficit disorder.  Consider the side effects of Neurontin which include:

  Muscle pain

  Skin rash and itching

  Swollen glands

  Sore throat and fever

  Aggressiveness

  Difficulty in concentration

  Mental depression

  Nightmares

  Chills

  Increased chance of certain types of seizures

  Mood or mental changes

  Nosebleeds or other unusual bleeding or bruising

  Shortness of breath

  Sores, ulcers, or white spots on lips or in mouth

  Unusual tiredness or weakness

  Wheezing, tightness in chest, or troubled breathing

Sales reps were paying doctors to recommend this drug to 10 year olds. Scary huh?

Sales reps found doctors were enthusiastic to attend- "meet, greet, and treat dinners." Doctors were paid to up to $300 to hear sales pitches for Neurontin while dining at 4 star restaurants. The doctors giving these dinner talks were paid up to $100,000 a year.

And Neurontin sales executives were also happy to pay doctors $750 each to attend all expense paid vacations including one at the posh Château Élan located just outside Atlanta. Doctors received continuing education hours while being brainwashed on the wonders of Neurontin in the morning, leaving their afternoons free to lounge by the pool, get their daily spa-treatment, play golf, dine on gourmet meals, and enjoy the nightly entertainment, including free tickets to the 1996 Summer Olympic Games.

Not satisfied with their growing largesse, marketing executives decided to simply pay doctors $350 for every patient they placed on Neurontin.

In 2004, the lies and deceit campaign came to end. Pfizer pleaded guilty to criminal fraud in the promotion of Neurontin, and agreed to pay $430 million.

In October 2008 a new lawsuit, brought by the same attorney, alleges that the company's misdeeds went much further than originally charged.

According to newly unsealed court documents, not only did the company and its subsidiaries push Neurontin for unapproved uses--the practice at the center of the first suit, which Pfizer admitted to as part of its settlement--they did so knowing that the drug was ineffective for several of those conditions.

Pfizer, according to the documents, engaged in "outright deception of the biomedical community, and suppression of scientific truth"--stalling or stopping the publication of negative study results; manipulating both trial designs and data to make the drug look more effective than it was; and using questionable tactics to enhance the drug's image and increase its sales.

The question is how many other drugs are being marketed with little to no scientific studies to prove them effective? Could Pfizer's Lyrica, the spitting image of Neurontin (same drug, different packaging) be the snake oil? Perhaps, so since the studies for it and fibromyalgia are less than stellar- in spite of the real likelihood that the study was manipulated to yield positive results.

Melody Peterson's book "Our Daily Meds" is a must read for anyone who wants to make informed decisions about their most important asset, their health.

Traditional Medicine Offers Little Hope For Fibromyalgia Sufferers

Excerpt from Dr. Rodger Murphree’s “Treating and Beating Fibromyalgia and Chronic Fatigue Syndrome.”

With so many different symptoms, it’s no surprise that fibromyalgia and CFS patients are typically taking 6–12 different prescription drugs. Lyrica, Elavil, Klonopin, Paxil, Effexor, Xanax, Trazadone, Neurontin, Zanaflex, Ambien, Lunesta, Cymbalta,  and Provigil have all been heralded as “the drug” for fibromyalgia. Some of these are helpful, some worthless, and some really dangerous.

Drug management alone typically fails to yield lasting relief from the most common fibromyalgia and CFS symptoms, and patients’ and doctors’ optimism over a new drug treatment eventually gives way to this sad reality. Oh well, a new drug with an even larger marketing budget is on the horizon. (Forgive my cynicism. I’ve just seen this situation so many times!)

Many of the most commonly prescribed drugs for fibromyalgia have side effects that are similar or identical to the symptoms of FMS and CFS. These similarities can cause a lot of confusion when doctors are trying to determine the effectiveness of treatment. Ambien, for instance, can cause flu-like symptoms, achy muscle pain, sore throat, and fatigue. Sounds like CFS, doesn’t it?

Tranquilizers are often prescribed for restless leg syndrome; achy, tight muscles; and sleep problems. But these drugs deplete the sleep hormone melatonin, which then leads to a disruption of a person’s circadian rhythm (sleep-wake cycle). Instead of promoting deep restorative sleep, these drugs prevent it!

It’s important to realize that your drug or drugs may be causing or contributing to some or all of your symptoms. I spend a great deal of time with my new patients reviewing and discussing their current drugs—how they interact with each other, and the potential side effects.

I often find that by asking the right question, I can help the patient realize that her symptoms began or worsened soon after the drug treatment began.

Sometimes, though, I do find drug-induced symptoms that began months after the start of the drug treatment. Drugs deplete essential nutrients that the body needs to properly function, but it can take weeks, months, or even years for the drug to fully deplete the nutrient and for you to see the side effects surface.

Still, not everyone can be drug free, and most of my patients are on at least one prescription medication. But the least offensive drug should be used—sparingly—and only to manage symptoms unresponsive to more natural therapies.

A study conducted by the Mayo Foundation for Medical Education and Research demonstrates the need for FMS and CFS treatment beyond drug therapy.

Thirty-nine patients with FMS were interviewed about their symptoms. Twenty-nine were interviewed again 10 years later. Of these 29 (mean age 55 at second interview), all had persistence of the same FMS symptoms. Moderate to severe pain or stiffness was reported in 55% of patients, moderate to a great deal of sleep difficulty was noted in 48%, and moderate to extreme fatigue was noted in 59%. These symptoms showed little change from earlier surveys. The surprising finding was that 79% of the patients were still taking medications to control symptoms. We can conclude that the medications weren’t making a significant impact.

Conventional medical treatments for FMS and CFS is a controversial topic, and I certainly have no desire to offend the many brilliant medical doctors out there. Still, in my experience, most traditional doctors continue to rely on prescription medications to treat fibromyalgia, even though their own studies show them to be ineffective and potentially dangerous.

They still just don’t get it. Those with fibromyalgia and CFS are sick and they want to feel well, not drugged.

Just try to find a doctor who really knows anything about these illnesses. Most don’t. It’s even harder to find one who is having any lasting success treating these illnesses. How many folks with fibromyalgia get well under the care of a traditional rheumatologist?

I speak to fibromyalgia support groups across North America, and I can tell you what the answer is: very few. The three-month wait for a new patient appointment typically ends in a two-hour interview and exam followed by a 10-minute visit to discuss test results, and then several prescription drugs and a follow-up appointment every 3–6 months.

And let’s face it, those with fibromyalgia are medical misfits, they don’t usually respond to medications like other folks. The ACR has, like many physicians, thrown up their hands and admitted they have little if anything to offer for those suffering from fibromyalgia. They focus more on helping their patients “cope.” At least they’re honest about their limitations.

Traditional Doctors Are Often Opposed To Natural Medicine

I find that people in general are usually down on what their not  up on.

Many conventional doctors are quick to ridicule nutritional
therapies, even though these therapies have consistently shown themselves effective in treating fibromyalgia. This prejudice just doesn’t make sense.

The usual accusation is that “there are no controlled studies.…”

But actually, there are numerous studies that validate the use of nutritional supplements to manage and often correct the symptoms of poor health. There are over 1,000 studies demonstrating the positive effects of various supplements and foods in the treatment of hypertension alone. And hundreds of studies demonstrate magnesium’s benefits in treating high blood pressure, angina, heart arrhythmias, chronic pain, muscle spasms, anxiety, mitral valve prolapse, and fatigue.

Dr. Janet Travell, White House physician for Presidents John F. Kennedy and Lyndon B. Johnson, and Professor Emeritus of Internal Medicine at George Washington University, co-wrote Myofascial Pain and Dysfunction: The Trigger Point Manual, which is acknowledged as the authoritative work on muscle pain. In one chapter alone, Dr. Travell references 317 studies showing that problems such as hormonal, vitamin, and mineral deficiencies can contribute to muscle pain and soreness.

And modern medicine itself, despite the millions of dollars spent to promote it’s superiority over other forms of health care, is largely an art—with a lot of unproven science. The Office of Technology Assessment, under the authority of the Library of Congress, published a year-long study entitled “Assessing the Efficacy and Safety of Medical Technology.”

The study showed that only 10–20 percent of all present-day medical practice have been shown to be beneficial by scientific controlled clinical trials. The study concluded that the vast majority of medical procedures now being utilized routinely by physicians are “unproven.”

Or how about, “Nutritional supplements aren’t regulated and therefore are dangerous.” Too much might make you queasy, but no one dies from taking vitamins, minerals, and other essential nutrients! The same can’t be said about drug therapy.

The great physician Oliver Wendell Holmes once said, “A medicine…is always directly hurtful; it may sometimes be indirectly beneficial. I firmly believe that if most of the pharmacopoeia [prescription drugs] were sunk to the bottom of the sea, it would be all the better for Mankind and all the worse for the fishes.”

Prescription drug therapy attempts, for the most part, to cover-up symptoms. This approach does little to correct the underlying problem(s).

After seventeen years of specializing in treating and beating fibromyalgia I’ve learned that traditional medicine alone yields little if any long-term results.

The best hope for those with fibromyalgia is to find and work with a doctor who practices integrative medicine-combining judicious use of prescription drugs (short-term if possible) and natural therapies (vitamins, minerals, and other nutrients).

Combining prescription drugs (when needed) with natural supplements allows the symptoms associated with fibromyalgia to be corrected, not just covered-up.

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