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Sunday, December 30, 2012
A wish for relief, a tainted drug, a tragic outcome Meningitis caused by a Framingham pharmacy’s steroids cut short 39 lives, leaving behind a web of anguish
Kenneth Denesha had just finished mowing the lawn outside his Florida home one day last summer when he sensed something wasn’t quite right. It wasn’t his perennially painful shoulders. The 70-year-old retired laborer had been getting headaches, and now his vision was blurry and his speech slurred.
His wife took him to a hospital; within two days, he was dead.
Nobody in the family thought to question the doctor’s conclusion that a massive stroke killed him on July 15. They figured that, for men of acertain age, death can come seemingly out ofnowhere, and at almost any time.
Three months later, health officials told the family that something else was likely behind Denesha’s death — they believed that the stroke was brought on by a case of fungal meningitis caused by a contaminated steroid injection. He had received the drug, made by a Massachusetts compounding pharmacy, to ease the ache in his shoulders.
“We’re very bitter and emotional,” said Kay McIntosh, Denesha’s sister. “He was always the backbone of the family.”
His death appears to have been the first of at least 39 linked to the pharmacy’s steroids, and it launched one of the nation’s worst public health disasters involving medications. The Boston Globe has examined who died, why some lived while others perished, and the anguish felt by the victims’ families and the doctors who unwittingly gave them drugs that harbored a lethal black mold.
The outbreak disproportionately killed older Americans, and more women than men. The majority of the deceased were from Tennessee and Michigan, perhaps because doctors in those states received many vials from the most-corrupted lot produced by the pharmacy. Among the dead, who came from eight states, were great-grandparents and parents of children still in school, as well as a librarian, a teacher, a judge, and an auto worker. They had diverse hobbies, from driving race cars to studying genealogy. Some prayed in churches, others focused on the divinity of nature.
“She gave the best hugs, and was an exceptional cook, gardener, knitter, and had a way of making people feel accepted and understood,” a friend of Karina Baxter posted on an obituary website. The 56-year-old retired math teacher from Burton, Mich., died in late September.
“Sharon, we can’t say how much we are hurting for you and the kids,” said another message, aimed at comforting the wife and two children of Douglas Wingate, 47, a PepsiCo Inc. account manager from Salem, Va. He died Sept. 18, soon after receiving a tainted steroid shot. “He was such a great man, and had so much love for all 3 of you. He was so proud of the kids, and of you.”
In the annals of deaths caused by improperly made drugs, this case may be second only to a 1937 crisis when more than 100 people, mostly children, were killed after taking an untested drug mixture intended to treat streptococcal infections. The outrage over that incident led Congress, a year later, to grant the US Food and Drug Administration far broader authority to regulate medications.
The latest tragedy has similarly triggered urgent calls for more federal oversight of operations like the New England Compounding Center, a Framingham-based company that acted more like a manufacturer, in violation of state regulations, than a traditional compounder that creates custom-made drugs for individual patients.
The outbreak appears to have started slowly. Based on cases confirmed by US health officials, Denesha’s death in Florida was not followed by another one until eight weeks later.
But then in September, five people from five states — Kentucky, Maryland, Tennessee, Michigan, and Virginia — died within about a week. All had struggled against a fast-proliferating fungus, which health officials later determined was introduced by pain-relieving steroid injections near their spines.
The autumn months brought bleak reminders almost daily that people were dying, even though the corrupted vials of drugs had been identified and removed from the shelves of hospitals and clinics after being recalled Sept. 26. Days later, federal officials asked New England Compounding, which had a record of sanitation and drug-preparation problems, to recall everything it had ever sent out, and the company soon shut down altogether.
Doctors scrambled to locate patients who might have received a shot and warn them to watch out for meningitis symptoms, which include headaches, numbness, sensitivity to light, slurred speech, and fever. Many physicians who had delivered the fateful steroid injections were in anguish.
One of them appeared at the bedside of 77-year-old Elwina Shaw after she was hospitalized in North Carolina for a fungal infection that was spiraling out of control, said Shaw’s daughter, Anna Allred.
She said the doctor begged her mother for forgiveness.
Shaw, gravely weakened, replied: “You didn’t know.” She would die soon after, on Oct. 19.
By then, hundreds of people were falling sick after receiving at least one of the estimated 17,000 vials of fungus-contaminated steroids that had been shipped by New England Compounding during the spring and summer.
Doctors and nurses administered aggressive antifungal medicines to try to keep the sick alive, yet it was often too late.
By the time clinicians notified J.W. Ragland, a 71-year-old retired foreman and Air Force veteran from Adolphus, Ky., that he might have received tainted steroid shots, he was already severely sick. His wife, Becky, said doctors repeatedly gave him antifungal medicines and other powerful drugs, but they could not reverse the damage already done by the injections he received from a Tennessee clinic in August.
“He was so swollen, it was pitiful,” his wife said.
In Ragland’s final days, he began hallucinating, his wife said, though he had the dim, horrific awareness that injections he voluntarily accepted to help soothe the arthritis pain in his back had caused this disastrous turn of events. He had recently become a grandfather, and he loved nothing more than this new role in his life.
Ragland died on Oct. 16, during a brutal two-week stretch in which 10 deaths in six states were linked to the injections.
By late fall, more than 600 people had turned up sick with fungal infections, though some patients who had received the tainted drugs were spared symptoms. Still, doctors urged them to stay vigilant for at least several months.
Few new deaths have been reported since Thanksgiving. That the crisis appears to have ebbed has been little comfort to family and friends left behind, their memories of funerals still fresh. Loved ones directed anger against New England Compounding and, in some cases, the clinicians who chose to use the company’s steroids.
Amid the anguish, many relatives have visited lawyers and prepared wrongful-death lawsuits — though there is widespread concern that the company, which filed for bankruptcy this month, will ultimately have little left to offer the families. The company is also the focus of investigations by federal prosecutors, as well as federal and state health agencies.
Public health officials say there is little surprise that older patients and women were hardest hit by the outbreak. Age diminishes a patient’s ability to fight infections, and women tend to outlive men and often suffer from the kind of chronic back pain that invites the use of steroid injections.
The death toll could still rise. Some of the sick may take a turn for the worse in the weeks ahead, and earlier deaths among people who might have been treated with the contaminated steroids — including ones from July and August — are being reevaluated for a possible link to the outbreak.
“We wouldn’t be surprised if more earlier cases come to light,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center, where some of the earliest fungal meningitis cases were identified.
Attributing earlier deaths conclusively to the tainted steroids is not easy. Dr. Stephen Pyles, who gave the injection to Denesha, said he has yet to be convinced that his 70-year-old patient, who had a range of other health problems, died primarily from the steroid shot, though he expressed heartbreak at the suffering experienced by so many families. An autopsy might have yielded more information, but Denesha’s sister said his body was cremated long before the crisis surfaced.
Public health officials say they confirm a death as being related to the steroid shots only after detailed reviews of medical records, as well as accounts from doctors and family members. In Denesha’s case, Florida health officials said he showed signs of a particular type of stroke that is more common in meningitis victims.
As anguishing as the decision was, Joyce Lovelace had her husband’s body exhumed to determine whether he had died of fungal meningitis.
When 78-year-old Eddie Lovelace, a busy circuit court judge from Albany, Ky., died on Sept. 17, doctors blamed a stroke. Then when news reports several weeks later announced the recall of tainted steroids, the family put two and two together. Lovelace had received steroids at a Tennessee clinic as a treatment for back pain from an auto accident.
The judge had been buried for about a month when his wife chose to have the casket pulled out of the ground. She said a consulting pathologist’s report was conclusive: It found that the fungus from the steroid shot caused a blood vessel infection, which led to a blockage of blood flow at the base of his skull, leading to the fatal stroke.
Joyce Lovelace said her husband, if alive today, would want nothing more than to don his judicial robe and return to his place on the bench. And there, he would resume mentoring his new law clerk: a granddaughter who had recently finished law school.