With gabapentin risks back in the news and Trump’s friendship with Pfizer CEO Albert Bourla reportedly behind new drug pricing agreements, it’s time to revisit questions about the drug, the company and its misleading marketing.

Two Neurontin Widows

After years of silence, two women who say their doctor husbands died from taking Neurontin (gabapentin) spoke out.

What began as something personal and private in their lives became a call for social justice, awareness and protecting the health and safety of others both women, Debbie Alsberge and Robin Briggs, told a reporter.

Adverse reactions to Neurontin have been greatly underestimated and unreported, Debbie Alsberge said, harming unsuspecting families and their physicians. “We must have the full and accurate facts about a drug’s risks to make good decisions when family members consider treatment, especially with psychoactive drugs. We cannot do that if pharmaceutical companies are allowed to taint the outcome of clinical trials and bury the harmful evidence.”

Growing up in northern California, the son of a surgeon, husband Dr. Doug Alsberge practiced occupational medicine near Seattle. A father of two sons, he enjoyed hiking, sailing, swimming and golfing and liked to write and play his acoustic guitar.

But when back pain from a pre-existing condition surfaced, Doug sought treatment from a pain specialist. The doctor gave him a narcotic analgesic and the recently approved Neurontin, heavily marketed for pain, though only FDA approved for epilepsy. “There was nothing in the medical literature to alert his physicians that it might not be effective, or worse, cause further harm,” said Debbie.

Though off the narcotics, Doug’s demeanor change on Neurontin; he was agitated, couldn’t concentrate, couldn’t sleep and had tremors. The Alsberges attributed the symptoms to Doug’s bipolar disorder, diagnosed in the 1990s. But whereas the condition had stabilized with treatment before, this time, Doug went into a psychological “free-fall” that began to affect his ability to work. His appearance degenerated, he stopped eating normally and police had to be called to the house for his emotional volatility.

“We didn’t know his extreme internal restlessness was akathesia, which is linked to suicide in medical journals, or that it was from Neurontin,” says Debbie. In his last, dark days, Doug drove for miles “searching for a knife to end his life,” buying one at a nearby hardware store and another at a culinary store hours away. On Palm Sunday, April 13, 2003, in an apartment he had rented away from his family, Doug died of multiple, self-inflicted stab wounds to the chest. He was 52.

Only when Debbie saw an article about Neurontin suicide links did she realize the increases in drug dosages correlated with his symptoms and personality change. “I just stood there in the parking lot outside of the pharmacy holding the documents in stunned disbelief,” she remembers.

Another Casualty

Dr. Douglas Briggs was a Princeton graduate who practiced family medicine near Charlotte, N.C. He also coached soccer, headed the PTA and played tennis.

But after back surgery, Briggs was also put on Neurontin for the pain it was widely marketed to treat. “Medicine had been Doug’s passion and his whole life” said his wife, Robin, a former nurse. “But after a few months on Neurontin, his bedside manner became curt. He stopped reading his journals and just lay on the couch. He had always been a stoic and he became whiny about his back ache. We had never fought and we began fighting. He became a different person.”

Doug was a conservative prescriber and grilled his Pfizer rep about Neurontin’s safety more than once, says Robin. Still, “He did not know his suicidal thoughts were drug-induced and not his own.”

On Christmas day, 2004, after opening presents, Doug urged Robin and the boys to go to a movie. Hesitant to separate on a holiday at first, Robin says she remembered an “Oprah” show about how men should get the chance to be alone in the house, to unwind, like women have, so the three went to the movies. When they returned, they found Doug had hung himself in the foyer. He had been on Neurontin for 10 months. He was 54.

Like Debbie Alsberge, Robin Briggs’s “aha” moment came later. Two weeks after Doug’s funeral, a distraught patient literally drove up on the Briggs’ lawn and demanded to know what antidepressant Dr. Briggs was on, recounted Robin. She ran upstairs to the medicine cabinet to read the Neurontin patient information for the first time

A Risky Drug Delivered Profits

Even though Pfizer pled guilty to criminal marketing of Neurontin in 2004 and was found guilty again in 2010, it earned $387 million from the drug in 2008. Who says crime doesn’t pay?

In just three years, Parke-Davis which became a subsidiary of Pfizer planted 13 ghostwritten articles in medical journals promoting off-label uses for Neurontin including a supplement to the prestigious Cleveland Clinic Journal of Medicine that Parke-Davis made into 43,000 reprints to mail to the journal’s “psychiatry audience” and to hand out by door-to-door sales reps. (”See, Doc -- it says right here ...”)

Even Scott Reuben, MD of Baystate Medical Center -- termed the Bernie Madoff of medicine because he never conducted any of the clinical trials on which his conclusions were based -- stumped for Neurontin. “Gabapentin would seem to be the ideal analgesic for managing acute and chronic pain following breast cancer surgery,” effused the researcher who was a paid member of Pfizer’s speakers bureau and recipient of five Pfizer grants in five years. In 2010, Reuben was sentenced in federal court to six months imprisonment.

In fact, the US Cochrane Group, which reviews healthcare interventions, was likely the only organization to retract phony Neurontin studies.

After being presented with evidence of hundreds of Neurontin-linked suicides in 2005, the FDA added warnings to all epilepsy drugs in 2008. But not before Dr. Robert Temple, FDA’s associate director for medical policy for the Center for Drug Evaluation and Research at the time, both legitimized Neurontin’s off-label uses and blamed patients, not the drug, for suicides.

Referring to Neurontin’s popular pain, migraine, insomnia and bipolar uses without mentioning their lack of FDA approval, he told the Boston Globe, “These are the sorts of people who are complicated to think about because they tend to be at risk already.” Adverse event reports “can’t really tell you whether the suicidal event is because of the drug or despite the drug,” he added. END Thanks For Reading here is more

Post Covid Analysis: Pfizer is not Our Pfriend

may be republished for author credit

Covid created a huge image windfall for Pharma among the pubic –– including, among anti-corporatist progressives. Suddenly, Pharma was no longer the industry responsible for 100,000 US opioid overdose deaths or a growing number of talcum powder-related ovarian cancers and 38,000 deaths (and 88,000 heart attacks) from Vioxx.

Suddenly, Pharma was no longer the industry that launched and profited from withdrawn drugs like Ranitidine, Baycol, Trovan, Seldane, Hismanal, Darvon, Vioxx, Bextra, Mylotarg, Lotronex, Propulsid, Raxar, phenylpropanolamine (PPA), Manoplax, fenfluramine, DMAA, Rezulin, temafloxacin and phenacetin; no longer the industry that boasts three lobbyists for every member of Congress –– but the business sector that saved lives

A quick look at Pfizer’s past should send chills down the back of anyone who cares about drug safety. In one week in 2010 Pfizer:

Suspended pediatric trials of Geodon two months after the FDA said children were being overdosed in the trials

Was investigated by the US House of representatives for off-label marketing (promoting uses not approved by the FDA) of the kidney transplant drug Rapamune, specifically targeting African-Americans

Agreed to pull its 10-year-old leukemia drug Mylotarg from the market because it caused more not less patient deaths

Received a letter from Sen. Charles Grassley (R-Iowa) requesting its whistleblower policy

Saw the researcher who put Bextra, Celebrex and Lyrica on the map, Scott S. Reuben, MD, trotted off to prison for research fraud

Suspended trials of tanezumab, an osteoarthritis pain drug, because patients got worse not better, some needing joint replacements

Was sued by Blue Cross Blue Shield to recoup money it overpaid for Bextra and other drugs

Saw its appeal to end lawsuits by Nigerian families who accused it of illegal trials of the antibiotic Trovan in which 11 children died rejected by the Supreme Court

While Pfizer was under a 5-year Corporate Integrity Agreement (CIA)* with the US Health and Human Services for withholding $20 million in Lipitor rebates owed to Medicaid in 2002,( *essentially a promise to “sin no more” ) it was already marketing Neurontin for off-label indications which earned it a second CIA in 2004. Undaunted, Pfizer proceeded to market Lyrica, a drug similar to Neurontin, off-label while under its second CIA, earning it a third. (Does anyone think CIAs are a deterrent?)

Before its COVID-19 “good guy” makeover, Pfizer was linked to some of the most notoriously unsafe drugs that have come down the pipeline. It bought Warner-Lambert in 2000 knowing the company’s marketing practices were under criminal investigation and its Rezulin (mentioned above) had been withdrawn. Then Pfizer bought the hormone maker Wyeth knowing it carried the baggage of Fen-Phen heart valve suits and cancer lawsuits related to Prempro, a hormone replacement drug.

Pfizer’s CEO may be a pfriend at Mar-a-Lago but the company is not a pfriend to the public.

END Thanks for reading

For more information about Pfizer’s dark history please read

Son of Neurontin Meets the Fibromyalgia Epidemic

https://www.counterpunch.org/2009/01/27/son-of-neurontin-meets-the-fibro...