Pfizer discontinues drug Conn. teen needs to protect her eyes
“The other medications didn’t seem to be helping her as much. So this was a last resort to help bring down the pressure in her eyes.”
Maria Bravo about her daughter, Faith, who has a congenital eye disease regulated by a Pfizer drug called Phospholine Iodide
For more than two years, Faith Bravo, of Milford, successfully regulated her eye pressure thanks to a single drop of the medication Phospholine Iodide.
Bravo, 16, was born with detached retinas and underwent surgery that involved removing the lenses — part of the eye that focuses light rays as they pass through — in both her eyes. Doctors reattached her retinas, but the procedure left her vulnerable to glaucoma, which can cause high eye pressure, damage the optic nerve and lead to blindness.
Once Bravo was diagnosed with the condition, the challenge of regulating her eye pressure began. For years, she tried different medications until, as a teenager, her doctor suggested Phospholine Iodide. It is an old but effective drug used to treat rare forms of glaucoma, especially the kind resulting from childhood surgery for congenital cataracts in which the ocular lens is removed.
“The other medications didn’t seem to be helping her as much,” her mother, Maria Bravo, said. “So this was a last resort to help bring down the pressure in her eyes.”
It worked — while on Phospholine Iodide, Faith Bravo’s eye pressure was in the low teens (normal eye pressure is between 10 and 21 mm Hg), down from the high 20s.
Though it couldn’t bring back the vision Faith Bravo had lost — the Jonathan Law High School sophomore is legally blind and reads and writes in braille — it gave her a sense of relief knowing the condition was under control.
“We live in a visual world,” Maria Bravo said. “And having a visually impaired child, whatever visions she does have, if we can keep it by keeping the pressure down, that would be great.”
But in the last year, the already hard-to-find drug became increasingly scarce.
By February 2020, Maria Bravo contacted Pfizer, the pharmaceutical giant that distributes the medicine. A representative told her Phospholine Iodide was on back order due to an unexpected manufacturing delay. Before long, the Bravos weren’t able to get the medication at all. In fall 2020, Pfizer announced that it is discontinuing the drug, with supply expected to run out by summer 2021.
The announcement came as a shock to patients, their families and their doctors.
The Bravos decided on a new treatment with her ophthalmologist, Dr. David Walton, a clinical professor of ophthalmology at Harvard Medical School and a surgeon in ophthalmology at the Massachusetts Eye and Ear Infirmary. But without Phopholine Iodide, Faith Bravo’s eye pressure is at risk of rising — and surgery or further loss of vision could follow.
Production issues
In a statement, Pfizer explained that a complex set of circumstances led to its decision.
The New York-based pharmaceutical company does not produce the drug; it relies on a “complex chain of external partners” to manufacture Phospholine Iodide. That supply chain become unstable, the company said, while doctors rarely prescribe the drug. Pfizer estimates that 100 patients in the U.S. are using the eye drop.
“We understand that some patients, caregivers and ophthalmology scientific organizations are disappointed about Pfizer’s decision to discontinue Phospholine Iodide,” the statement said. “We did not come to this decision lightly and made every effort to inform those impacted as soon as the decision was made to allow time to seek the best alternative treatment options.”
But Walton and other doctors, patients and glaucoma advocates question the decision. Walton said he has reached out regularly to Pfizer in recent months about his patients but has received few answers.
He said he is not antiPfizer and said he understands why the company made its decision. But he hoped for more cooperation, given the consequences for certain patients. It’s likely that Pfizer, one of the hundred largest corporations in the U.S. with total revenue of nearly $48 billion at the end of 2020, was losing money on the drug, Walton said.
A Change.org petition, begun by Mabél Balestra, a Greenwich resident and board member of the Children’s Glaucoma Foundation, has collected more than 2,000 signatures and suggests Pfizer eliminated the drug because it was not profitable. The petition calls on Pfizer to continue distributing the drug until an alternative is arranged.
But a solution remains elusive.
Pfizer said it no longer owns the patent for the drug — which was introduced in 1962 — meaning another pharmaceutical company could step in. But that could be a lengthy process, and any prospective drug-maker would likely have the same concerns about the small number of users.
Walton said Pfizer’s estimate that only 100 people in the U.S. use the drug is likely low, though he acknowledges that it is small, in part, because the medicine is so difficult to acquire that most doctors don’t prescribe it. He estimated the number nationally is between 100 and 1,000.
The federal Food and Drug Administration, which regulates pharmaceuticals and the companies that make them, cannot force a firm to continue distributing a drug.
Dr. Steven Kane, associate clinical professor of ophthalmology at Columbia University Medical Center and co-director of the Pediatric Glaucoma Clinic at the Edward S. Harkness Eye Institute, said the situation with Phospholine Iodide is indicative of larger issues with the pharmaceutical industry in America.
Pharmaceutical companies, he said, should not decide which drugs to distribute based on profitability.
“That’s a problem that I have with our pharmaceutical industry, which enjoys enormous benefits in this country,” said Kane, who has dozens of patients who rely on the drug. “I don’t think there’s a pharmaceutical industry anywhere in the world that is as advantaged and as wealthy as ours. They have a moral obligation to take care of us. What that means is to continue making medications, even if they’re old and they’re not profitable anymore.”
No other option?
In its statement, Pfizer listed a series of newer eye drops to treat glaucoma that are more frequently prescribed, including prostaglandins and beta-blockers. But according to Walton and Kane, those alternatives offer little help.
“There’s not been another medication that has been as effective in other medication classes,” Kane said. “And this medication really is in its own class of medicines. It does not have a substitute.”
Kane has encouraged patients to stockpile the small supply left of Phospholine Iodide. Kane and Walton have also begun transitioning patients onto other treatments.
“They’ll be put on alternative medications, but ... they’re not nearly as effective for this subset of glaucoma as this particular drug,” Walton said. “I don’t know how many of the ones whose glaucoma is controlled by this medicine will be controlled by other medicines. But you have a feeling that it’s going to be a significant subset.”
Dropping the drug could force the patients to confront a new reality in which loss of vision, blindness or eye surgeries are increasingly likely.
Linda Laroch’s son, Marco, was diagnosed when he was 10 days old with glaucoma as a result of SturgeWeber syndrome, a rare disorder causing complications with the eyes, skin and brain. Now 16, Marco has had more than 20 ocular surgeries and recently lost his right eye. From 2005 to 2017, he avoided surgery thanks to Phospholine Iodide. Without it, protecting his right eye became more difficult.
Vicki Philhower’s son, Dan, is a 19-year-old college freshman who was born with congenital ectropion uveae, a rare disorder that often leads to glaucoma. He has had five surgeries on his right eye to stabilize the condition and sees Kane every three months to monitor his eye pressure.
According to Philhower, who lives in New Jersey, Kane’s goal for her son’s eye pressure was around 20. On Phospholine Iodide, that was attainable. Off it, the future is uncertain.
“We’re blessed that it’s only one eye, because it effects many people more severely,” Philhower said. “It’s frustrating because I know there’s such a small group of people that this drug works for, but it’s so imperative for those of us who need it.”