Heartburn Drug Ban Is Crisis for Some Patients

Unable to speak, Rob O’Neill moans in pain as his stomach and intestines struggle to digest food. It’s a sound the parents of this disabled man have heard since July, when the only therapy that helps--the heartburn drug Propulsid--was pulled from pharmacy shelves.

Propulsid’s maker promised a special program to keep shipping the pill to certain people with no other hope, but doctors say many patients like the 22-year-old O’Neill of Lexington, Ky.--who cannot process food because of severe cerebral palsy--are still waiting.

His struggle illustrates a story usually untold: What happens to seriously ill people when the only drug that has ever helped them is banned?

“We’re living with a person who’s been suffering every single day since July,” said O’Neill’s mother, Jenny. “I just want them to have a face on it that’s human. This isn’t academic to us.”

Propulsid, once a best-selling heartburn remedy, was banned from general use in July after the Food and Drug Administration linked it to dangerous irregular heartbeats in 340 people, including 80 who died.

For some patients with more serious disorders than simple heartburn, Propulsid was the only treatment that pushed food through their partly paralyzed digestive tracts.

So the FDA and Propulsid maker Janssen Pharmaceutica created a unique “compassionate-use” program: Certain very ill patients could keep taking Propulsid in special scientific studies that carefully monitor their hearts. Doctors and patients must meet strict criteria to participate.

Janssen says it has shipped medication for 144 patients since registration began in May and is evaluating whether to accept an additional 90 participants who doctors say are eligible.

Some doctors say hundreds more people--particularly diabetics whose digestive tract progressively degrades--may need Propulsid but, like O’Neill, have not made it onto the list.

“We haven’t found them [Janssen] unhelpful, but I think they are being inundated with requests,” said O’Neill’s doctor, University of Kentucky gastroenterologist Willem de Villiers. “It’s really very difficult. You have to jump through a lot of hoops.”

To ease such frustration, the FDA just approved some steps to help more ill patients get Propulsid faster--including letting doctors seek a 60-day emergency supply of pills before a patient is formally accepted into the program.

“It’s a stopgap measure to make sure appropriate patients don’t run out of the drug,” Janssen spokesman Greg Panico said. He acknowledges some doctors find enrollment difficult but says it has to be strict: “The whole purpose of the program is to make sure the drug is used safely.”

Why all the clamor for a drug deemed so dangerous it could not be sold to most Americans?

Propulsid helps activate electrical rhythms in the stomach to push food through the digestive tract. For average heartburn, most doctors agree that it is not needed. But for some severe disorders, such as the partial digestive tract paralysis that plagues O’Neill and many diabetics, specialists say it is a treatment mainstay.

The question is whether Janssen’s special program can let these people safely use Propulsid. Hence the restrictions: Doctors must qualify and get permission to participate from hospital panels that review scientific studies. Then they choose patients who qualify for studies of a few specific diseases, have failed other treatments, have no heart risks and pass an EKG. The company double-checks that patients are appropriate.

“I’m glad if it was giving people heart arrhythmias that they’re protecting people from that,” Jenny O’Neill said.

But she has watched her son suffer for four months without Propulsid, and although her doctor believes Rob O’Neill will be accepted into Janssen’s program within another month, she questions the holdup. “This is the only thing that helped him. What about those people?”

Janssen says the new emergency steps should help--the 60-day stopgap supply and letting doctors specially enroll a few people who do not qualify for the bigger studies by proving “a compelling medical reason.”

For information, doctors can call (877) 795-4247.

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Janssen Pharmaceutica information on Propulsid program: https://us.janssen.com/products/pi_files/propuls_lim_acc_prod.html

Food and Drug Administration on Propulsid: https://www.fda.gov/bbs/topics/ANSWERS/ANS01007.html