Tuesday, October 19, 2021

Weighed down by lawsuits, don’t try Lyrica anymore for pain, FDA warns

By Patrick Downes, for CNN • Updated 5th October 2020

After months of strained negotiations between patients and drugmakers, a federal advisory panel has told Pfizer to withdraw its pain medication Lyrica from hospitals and senior centers.

Lyrica was the subject of two highly-publicized congressional hearings this year amid accusations that insurers were steering doctors to get non-pharmacy salespeople to push the drug, which they were not legally allowed to do.

At the same time, lawmakers were outraged by reports of hospital lawsuits, saying that physicians had sought to prescribe the drug to patients who could not benefit from it.

During a two-hour meeting Wednesday morning, the panel unanimously said a trial to help determine just how dangerous Lyrica was for elderly people in high-risk situations should proceed.

In June, a federal judge ordered Pfizer to pay $3 million to a patient suffering from kidney failure and related infections associated with the medication.

The medication was also pulled from Medicare earlier this year.

And like almost all other drugs, doctors are still able to prescribe it to patients without insurance, though it could stop doing so if the company appeals.

“I just don’t believe you have enough evidence to move on from seniors,” said Dr. Philip Bushey, who chairs the advisory panel on Renal Drugs. “They got to something that was risky, and you can’t undo that, we just can’t.”

Dr. Paul Adams, an Endocrinologist at Georgetown University School of Medicine, disagreed.

“Personally, I think this group of patients has good reasons to have stayed on Lyrica for as long as they did,” Adams said. “You don’t have to hold your breath for a long time, 10 years, 15 years for people to respond well to drugs like this. There just aren’t that many people.”

Dr. William Vickery, the FDA’s acting deputy director for Center for Drug Evaluation and Research, said an appeal will likely be filed in the next two to three weeks, and the ruling could be appealed by Pfizer itself or as well as in federal court, so it’s still unclear what will happen to the drug.

But if the FDA does not issue an approval, it would be in its best interest to pull it off the market entirely.

“The most responsible thing for Pfizer to do is if they feel that the product will be safe in those areas where we don’t have a lot of patients, they should voluntarily withdraw it,” he said.

Pfizer defended its practice of doing non-pharmacy drug sales, saying that only 10% of patients — and about 1% of doctors — have brought it up during the development process. Those doctors, though, are unlikely to inject any of the patients they have been prescribing to into the overall Lyrica program, so they could serve as the basis for testing.

In a statement, the company said, “In addition to the circumstances raised during today’s meeting, Lyrica is approved to treat patients of all ages, and we will continue to work with CMS and other regulators to make sure patients have access to this important treatment.”

The earlier, earlier

The hearing was among the most contentious to ever come before the advisory panel.

Pfizer reached a new agreement with the head of the Medicare program that would allow doctors who refused to prescribe the drug to take part in the trial to determine the drug’s risk to Medicare beneficiaries and to reimburse them for it.

After President Donald Trump criticized the insurance program for funneling money to drug companies, former House Speaker John Boehner ordered the CMS director to testify before Congress about Lyrica. He blamed drugmakers for helping push up Medicare expenses.

Other allegations

What’s known about Lyrica in 2018 does not support the claims that the drug was being resold illegally.

The most recent FDA warning notice and another postmark 2011 warning sent to the U.S. Centers for Disease Control and Prevention outline warnings about Lyrica causing nausea, drowsiness and slow mental performance. The agency had no formal investigation involving the drug.

The executive director of a consumer advocacy group that provided a list of 3,000 hospitals that doctors could use to fill Lyrica prescriptions, told CNN that, in all, the group had received 130 reports of doctors inappropriately prescribing it to patients, including many instances where patients suffered from kidney failure. CNN could not independently verify that claim.

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