PUBLIC CITIZEN SEEKS PROLIA BLACK BOX WARNINGS

Public Citizen, the consumer watchdog organization founded over 50 years ago by Ralph Nader, has petitioned the Food and Drug Administrations for Black Box Warnings on Prolia.

April 16, 2019

Link to the Petition and Related Documents:  https://www.citizen.org/article/petition-to-the-fda-to-require-a-black-box-warning-for-the-osteoporosis-drug-prolia/

Link to the Press Release: https://www.citizen.org/news/patients-doctors-must-be-warned-about-risk-of-spinal-fractures-soon-after-stopping-osteoporosis-medication/

See text of Press Release April 16, 2019 below:

April 16, 2019  

Patients, Doctors Must be Warned About Risk of Spinal Fractures Soon After Stoping Osteoporosis Medication.

Prolia’s Effects Are Short-Lived; Fractures Can Occur as Soon as a Month After Drug Wears Off

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must immediately require that stronger warnings be provided to doctors and patients about the increased risk of spinal fractures when patients stop taking the commonly used osteoporosis drug Prolia, Public Citizen said today in a petition to the agency.

Prolia, which is administered by injection every six months, was first approved by the FDA in 2010 to treat postmenopausal women with osteoporosis at high risk for fracture, but its use has since been expanded to include men. Its effects last six months. Public Citizen’s petition highlights a growing body of evidence showing that patients who stop using the drug have an increased risk of multiple vertebral fractures in the spine as soon as seven months after their last dose. Such fractures can cause severe, disabling pain.

Unlike other osteoporosis treatments, Prolia’s positive effects on bone are short-lived and readily reversible if the drug is discontinued. One study cited in the petition described 24 patients who collectively had experienced 112 new spinal fractures, which represents an average of nearly five fractures per patient.

The petition asks the FDA to upgrade the warning about this risk, which is buried deep in the label, by replacing it with a more prominent black box warning at the top of the product labeling, the strongest warning that the agency can require. The petition also asks the FDA to require Amgen, the maker of Prolia, to send letters to doctors and develop updated patient brochures that warn about the increased risk of spinal fractures if the medication is stopped or a scheduled dose is missed. 

“It is critical that the FDA require a black box warning to ensure that doctors are fully aware of the risks involved with stopping Prolia,” said Meena Aladdin, health researcher at Public Citizen’s Health Research Group. “Patients should be given a patient brochure every time they receive a dose of Prolia that explicitly warns them about the risk of spinal fractures if they stop taking the medication and don’t receive alternative osteoporosis therapy to mitigate this risk.”

Read the petition.

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EDITORIAL: WHERE IS THE RESTORATIVE JUSTICE HERE?

I recently watched a program about Restorative Justice on 60 Minutes about how crime victims of have met with the perpetrators of these crimes, and in so doing so, and having accepted sincere apologies, have helped their own recovery.

Much of this blog has discussed how I have been injured by Amgen's failure to give adequate warnings to patients, and doctors as well, about its osteoporosis drug Prolia (denosumab).

Like any private corporation, Amgen seeks to make a profit for itself and its stockholder.  And as a capitalist enterprise, it relies upon a relationship between a willing seller and a willing buyer.

But the drug industry is set apart from many other consumer industries in the following manner:

1. It deals with the most personal issues in the consumer's life: life and death, health and illness, injury and recovery.

2. Choices about goods sold and their use are typically not made by the consumer.  They are made by licensed professionals, generally physicians, who are presumed to understand the effects (whether therapeutic or adverse) of the drugs they prescribe for a particular patient.

3. Prescription drugs in the U.S. must be approved by the Food and Drug Administration.  Once such approval is established, drugs may be freely prescribed by any duly licensed medical practitioner.

4.  While consumers may not be able to self-prescribe, since 1978 drug companies have been allowed to advertise their wares directly to consumers via TV and other media, creating demand upon physicians who may themselves be in a competitive situation with other health care prescribers and therefore consciously or unconsciously be anxious to please their patient-consumers.

5. Pharmaceuticals are one of the most profitable sectors in the U.S.. economy, and, individually and through associations, has demonstrated its ability to offer strong support to candidates for public office.  This in turn has created a climate in which industry profit may take first place ahead of product safety and efficacy, and may even affect the information value of product information available for doctors and patients.

So how do I, a consumer, living with pain and disability resulting from several issues in connection with a drug, go on to make my peace with what may be a permanent condition affecting every aspect of what is left of my life?

It would be remarkable to have a sit down with Mr. Robert Bradway, Chief Executive Officer of Amgen, the manufacturer of Prolia. 

It would be remarkable if Mr. Bradway would actually review the sales figures for this drug and also the figures for reported adverse drug reactions, bearing in mind the likelihood that only a small fraction of adverse drug reactions ever get reported.  

It would be remarkable if Mr. Bradway would reach out to people on medical social media whose lives have allegedly been ruined by Prolia and ask how Amgen could make this up to them, even by supporting the extra help and therapy they might need now.

It would be remarkable if, having heard these stories of lives ruined, Mr. Bradway would implement a stop on direct to consumer advertising for Prolia (as well as any direct to consumer advertising planned for their new monoclonal antibody Evenity (romosozumab-aqqg)

What is the likelihood of any his happening?