NEURONTIN STORY
 Many of you are taking Neurontin, made by Pfizer, or its generic Gabapentin, for all kinds of pain relief, including diabetic neuropathy, postoperative pain, and chronic pain.
Neurontin off label use fails the test.

A lawsuit filled in Boston, accusing Pfizer failed to release and altered conclusions on the use of this drug. Health insurers and patients want their money back for being used as human experimental subjects.

HISTORY

The drug, made by Warner Lambert, later acquired by Pfizer, was FDA approved around 1998 as a treatment for epilepsy. Pfizer bought Warner Lambert in 2000. In 2002 the FDA approved the drug for shingles.

Two years later, Pfizer pleaded guilty for promoting the drug for all chronic pain and bipolar disorders. Pfizer paid back to Medicaid $430 million to settle the case.

You would think that would end it. But Pfizer made over $12 Billion on the sales of the drug after this settlement. The patent expired in 2004 but doctors are still hotly prescribing this drug for off label use, chronic pain and bipolar problems.

COVERUP OF STUDIES
EUROPEAN STUDY ON DIABETIC PAIN

1998 European study failed to find a significant effect on diabetic pain. Warner Lambert team leader Rowborthan wrote an email in 2000 saying, “It will be more important how WE write up the study”.

Scientific manager Roder wrote, “We should take care not to publish anything that damages Neurontin’s marketing success.” Senior marketing manager Crespo wrote an email in 2002 about the studies results: “We are not interested at all in having this paper published because it is negative.”

Two medical journals rejected to publish the studies, because the company was putting too rosy a spin on the results.

SCANDINAVIA STUDY ON POSTOP NERVE PAIN

The study on postoperative nerve pain found that Neurontin didn’t work measurably better than a sugar pill. It never got published.

SPAIN STUDY ON BIPOLAR DISORDERS

The findings of this summary “did not show statistically any differences between Gabapentin (the generic Neurontin) and Placebo. This five-year study also never hit the medical journals.

A Spanish psychiatrist Dr. Vieta, a paid consultant to Pfizer, came to Pfizer's rescue. He published a report on the study claiming a statistically significant benefit. He modified the scale to assess the symptoms of bipolar disorders. This increased the score for Neurotin in the study.

The change he made in the assessment never was mentioned. He also included results on patients the doctors intended to treat, and excluded 16 patients from the study review because they did not take the entire pill given them.

These two changes in the report turned a negative study into a success story. Vieta defended himself by saying he “ took a broader interpretation of the intention to treat concept."

OFF LABER DRUGS

If you are given a drug for a problem you have and it is listed as a drug for other illnesses other than your problem, it is called off label use.

Off label uses for drugs are not supported by good evidence. They account for 21 percent of all prescriptions written. 73% percent of them showed to have no scientific support.

ON THE PLUS SIDE, your doctor is free to prescribe drugs for any illnesses, it provides him important advantages. Your doctor can be different and innovative especially when routine treatments do not work for you.

You are provided early access to drugs that might be valuable. It also allows your doctor to apply new ideas on emerging evidence, and it may be the only treatment possible for unusual conditions.

But here are also negative consequences to off label drug use. Newer drugs used for off label illnesses certainly increase health costs. It also downgrades your expectations of safety and effectiveness of the drug. In Neurontin’s case, doctors are encouraged to use the drug even where it does not work.

Insurance is paying for products that are not proven. Doctors want the freedom to try drugs on patients that were not made for their illness.

It is hard enough to stay on top of rapidly evolving evidence. You, the public wants safe and proven drugs that are also affordable. Yet you also want the newest therapies as long as supporting evidence is disclosed.

NEURONTIN SIDE EFFECTS

Many patients exhibit side effects that they feel are due to their illness. They range from brain symptoms of dizziness, wobbliness and in coordination, amnesia, hostility, and thought disorders including hallucination.

Other symptoms are back pain, dry mouth, and itching and stomach pains. The drug should not be taken if patient is taking alcohol or is on antidepressants. I find many of my patients have several of these side effects while on the medication. Is this enough to make you wonder and become cautious?

But withholding negative medical information from you and your doctors breaks this ethical obligation. You were not taking Neurontin to be experimented on.



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