Severe frostbite receives treatment that can prevent amputation

Severe frostbite receives treatment that can prevent amputation

The first time Dr. Peter Hackett saw a patient suffering from frostbite, the man died from his injuries. It was Chicago in 1971, and the man had gotten drunk and passed out in the snow, his fingers so frozen that gangrene had finally set in.

Dr. Hackett went on to work at Mount Everest Base Camp, Denali, Alaska, and now Colorado, becoming an expert in treating cold injuries. The experience was often the same: there was little you could do about frostbite other than rewarm the patient, give them aspirin, amputate in severe cases, and, more often than not, wait. and accept that six months later, the patient’s body may “self-amputate” by naturally losing a dead finger or toe.

His mentor in Anchorage used to say, “Frostbite in January, amputation in July,” recalls Dr. Hackett, a clinical professor at the Altitude Research Center at the University of Colorado Anschutz Medical Campus. “For centuries there was nothing else to do.”

This month, the Food and Drug Administration has approved the first therapy for the treatment of severe frostbite in the country. The drug, iloprost, is administered intravenously several hours a day for a little over a week. It works by opening blood vessels to improve circulation, limit inflammation, and stop the formation of platelet clumps that can stop circulation and kill tissue. Toes, fingers, ears, cheeks and nose are most exposed.

The treatment’s approval is as much a scientific novelty as it is a lucrative boon for the pharmaceutical industry. Experts say there is no reliable data on how many people have frostbite severe enough to receive this treatment. But the cases may only affect several dozen people per year in the United States, according to Dr. Norman Stockbridge, chief of the FDA’s division of cardiology and nephrology in the Center for Drug Evaluation and Research. the agency, which approved the drug.

“When it comes to people who are really frozen and really at risk of losing numbers, it’s pretty rare,” Dr. Stockbridge said. However, “it is better to have medicine than nothing”.

In fact, the frostbite drug’s approval highlights an unspoken reality of the severe form of the injury: It’s rare.

Most at risk are high-altitude mountain climbers, people who work outdoors without proper equipment, and homeless people, especially those with poor circulation. Frostbite occurs in ‘extremely cold temperatures’ according to the Centers for Disease Control and Prevention, Injuries often occur during the thawing process as vessels become damaged by clots and inflammation, strangling blood flow.

According to Allison Widlitz, vice president of medical affairs at Eicos Sciences, a startup in San Mateo, Calif., about two-thirds of cases of frostbite are milder, sometimes called frostbite, and are probably not candidates for frostbite. use of this medicine. which received FDA approval to sell the drug. She estimated that the U.S. market for iloprost would represent fewer than 1,000 people per year.

“Even though it’s a small market, it’s an important new option,” she said. Eicos, which has seven employees, has not yet set a price for the drug, Ms. Widlitz said.

Many infusion therapies for such rare conditions are very expensive. Treatment with iloprost would involve intravenous infusions for six hours a day for up to eight days.

Ms. Widlitz added that the company was created to explore iloprost and drugs for other unmet medical needs.

This is not the first use of the drug. An inhaled version of iloprost was first approved in 2004 by the FDA to treat pulmonary hypertension. Over the past decade, the IV version has been approved for severe frostbite in many European countries after a French doctor, Dr. Emmanuel Cauchy, demonstrated its effectiveness in treating frostbitten climbers.

Last year, a article in The International Journal of Circumpolar Health, a publication devoted to health issues affecting people living in the Arctic Circle, found similar results in subsequent research. He noted that the use of iloprost “has demonstrated decreased amputation rates compared to untreated patients.”

As an example, a 2018 article, published in Wildlife and environmental medicine, examined iloprost treatment in five Himalayan climbers and found that the drug prevented tissue loss in two of them and limited tissue loss in two others. These case studies showed that the drug was effective when administered 48 to 72 hours after the onset of the injury, an important issue because climbers are often not able to receive immediate treatment.

In cases where frostbite is detected more immediately, a stroke medication called tissue plasminogen activator, or tPA, may be used to limit clot formation and reduce the risk of amputation. However, this medication, if not administered within a few hours, can cause serious complications or even death. Unlike iloprost, tPA is not approved by the FDA for severe frostbite, but doctors have used it off-label.

Dr. Hackett said the universe of people suffering from severe frostbite includes “mountaineers, stranded snowmobilers, mushers, military personnel” and others working in freezing conditions, as well as the homeless and ” people with drug and alcohol problems who are exposed to cold for long periods of time.

That’s how Jennifer Livovich, a resident of Boulder, Colorado, who was homeless, contracted severe frostbite on an extremely cold night in December 2016.

She remembered that she had drunk a lot and that the weather the day before was good: “Then I woke up the next day, covered in snow, and my shoe had come off while I was sleeping – maybe I I had taken off – and my left foot was stuck to the ground.

“I kept walking and I could tell my foot felt different, but I just thought I was cold,” she said. Five days later, she found herself in a rehab unit where, as she warmed up and her foot thawed, “I felt excruciating pain.”

The thawing stage is where damage begins to set in and capillaries deteriorate, sometimes irreparably. “Different parts of my foot turned from black to light blue,” she said.

Under the supervision of a doctor, she tried warm water baths and elevated her foot, putting gauze between her toes so that the rejuvenating skin cells would not fuse together. Pieces of skin fell off and she lost all her nails. When doctors were finally satisfied that the foot had healed as much as it could, “they shaved off – that’s what they call it, ‘shaved’ – a quarter of an inch off my big toe,” she declared.

The shaving took place in the summer, which is roughly the six-month time frame according to Dr. Hackett’s mentor’s adage: injury in early winter and amputation in summer.

As small as the market for the new drug may be, Dr. Hackett hopes it will save some numbers.

“It’s fabulous,” he said. “This might change the old adage.”

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Eric D. Eilerman

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