New Drug Approved to Treat Severe Frostbite in Adults, but Experts Question Its Effectiveness and Need for It

Whitehorse, Yukon territory Canada
Frostbite is a serious condition that can occur when skin and underlying tissue are exposed to freezing temperatures, causing blood vessels to narrow and limiting blood flow. This slowed circulation and reduced heat cause ice crystals to grow inside the tissue.
Iloprost is given intravenously for several hours a day over a little more than week and works by opening blood vessels to improve circulation, limiting inflammation and stopping the formation of platelet clumps that can stop circulation and kill tissue. Most at risk are a person's toes, fingers, ears, cheeks and nose.
The approval of this drug is as much scientific novelty as it is pharmaceutical industry moneymaking bonanza.
New Drug Approved to Treat Severe Frostbite in Adults, but Experts Question Its Effectiveness and Need for It

Frostbite is a serious condition that can occur when skin and underlying tissue are exposed to freezing temperatures, causing blood vessels to narrow and limiting blood flow. This slowed circulation and reduced heat cause ice crystals to grow inside the tissue. Frostbite usually affects the extremities, such as fingers and toes, but it can also occur on other parts of the body. People with health issues such as vascular disease and diabetes are at particular risk for frostbite. Those without housing or adequate clothing or people who work outdoors for prolonged periods during winter are also at risk.

The Food and Drug Administration (FDA) recently approved a new drug, iloprost, to treat severe frostbite in adults. Iloprost is given intravenously for several hours a day over a little more than week and works by opening blood vessels to improve circulation, limiting inflammation and stopping the formation of platelet clumps that can stop circulation and kill tissue. Most at risk are a person's toes, fingers, ears, cheeks and nose.

The approval of this drug is as much scientific novelty as it is pharmaceutical industry moneymaking bonanza. Experts say there is not good data on how many people suffer severe enough frostbite to receive this therapy. But the cases could be as few as several dozens of people a year in the United States, according to Dr. Norman Stockbridge, head of the FDA's division of cardiology and nephrology in the agency's center for drug evaluation and research.

The most severe cases of frostbite require amputation of affected limbs or digits. A 2021 study found that at least 20 percent of frostbite-injured patients become disabled from amputations and that such injuries disproportionately affect the homeless population.

In a randomized clinical trial, none of the 16 patients who received only iloprost had to have amputations compared with three patients who received other medications along with iloprost. The drug will become available this spring.



Confidence

80%

Doubts
  • The approval of this drug is as much scientific novelty as it is pharmaceutical industry moneymaking bonanza.
  • There isn't good data on how many people suffer severe enough frostbite to receive this therapy.

Sources

72%

  • Unique Points
    • The F.D.A recently approved the first therapy for patients in danger of losing their toes, fingers and other exposed parts of the body due to severe frostbite.
    • `Iloprost`, a drug given intravenously for several hours a day over a little more than week, has been approved by the F.D.A. to treat severe frostbite.
    • Frostbite usually affects the extremities, such as fingers and toes,
  • Accuracy
    • Frostbite usually affects the extremities, such as fingers and toes, but it can also occur on other parts of the body.
  • Deception (50%)
    The article is deceptive in several ways. Firstly, the title of the article suggests that it will provide information on a new treatment for frostbite that can prevent amputation. However, this is not entirely accurate as the drug iloprost only helps to treat severe cases of frostbite and does not guarantee prevention of amputation. Secondly, Dr. Hackett's experience with treating cold-weather injuries is presented in a way that suggests he has had success in preventing amputations through his treatment methods when there is no evidence to support this claim.
    • Dr. Hackett's experience with treating cold-weather injuries is presented in a way that suggests he has had success in preventing amputations through his treatment methods when there is no evidence to support this claim.
    • The title of the article implies that it will provide information on a new treatment for frostbite that can prevent amputation. However, this is not entirely accurate as the drug iloprost only helps to treat severe cases of frostbite and does not guarantee prevention of amputation.
  • Fallacies (70%)
    The article contains several examples of informal fallacies. The author uses anecdotes to illustrate the severity of frostbite and its potential consequences, but these anecdotes are not representative of the general population. Additionally, the author quotes experts who use inflammatory language when discussing the drug's approval process.
    • The first time Dr. Peter Hackett saw a patient with frostbite, the man died from his wounds.
  • Bias (85%)
    The article contains a statement that implies the author has personal experience with treating frostbite. The sentence 'Dr. Hackett later worked at Mount Everest Basecamp, on Denali, Alaska and now in Colorado' suggests he may have treated patients there for frostbite. This is an example of religious bias as it assumes that Dr. Hackett has a personal connection to the topic due to his work experience.
    • Dr. Hackett later worked at Mount Everest Basecamp, on Denali, Alaska and now in Colorado
      • The approval of the treatment is as much scientific novelty as it is pharmaceutical industry moneymaking bonanza.
      • Site Conflicts Of Interest (100%)
        None Found At Time Of Publication
      • Author Conflicts Of Interest (50%)
        The author Matt Richtel has a conflict of interest on the topic of frostbite and therapy as he is reporting on Dr. Peter Hackett's treatment at the University of Colorado's Anschutz Medical Campus.

        68%

        • Unique Points
          • . The Food and Drug Administration this month approved the first-ever medication to treat severe frostbite in adults.
          • . Severe frostbite occurs when skin and underlying tissue are exposed to freezing temperatures, causing blood vessels to narrow and limiting blood flow. Eventually, the slowed circulation and reduced heat cause ice crystals to grow inside the tissue.
          • . Frostbite usually affects the extremities, such as fingers and toes, but it can also occur on other parts of the body.
          • . People with health issues such as vascular disease and diabetes are at particular risk for frostbite. Those without housing or adequate clothing or people who work outdoors for prolonged periods during winter are also at risk.
        • Accuracy
          No Contradictions at Time Of Publication
        • Deception (30%)
          The article is deceptive in several ways. Firstly, the author claims that severe frostbite occurs when skin and underlying tissue are exposed to freezing temperatures. However, this statement is not entirely accurate as it does not take into account other factors such as genetics or pre-existing conditions that can increase a person's risk of developing frostbite. Secondly, the article states that severe frostbite usually affects the extremities but fails to mention that it can also occur on other parts of the body such as the nose and ears. Lastly, while Aurlumyn is marketed as a treatment for severe frostbite in adults, there is no evidence to suggest that it has been tested or approved specifically for this purpose.
          • The article states that severe frostbite usually affects the extremities but fails to mention that it can also occur on other parts of the body such as the nose and ears.
          • The article claims that severe frostbite occurs when skin and underlying tissue are exposed to freezing temperatures. However, this statement is not entirely accurate as it does not take into account other factors such as genetics or pre-existing conditions that can increase a person's risk of developing frostbite.
        • Fallacies (70%)
          The article contains an appeal to authority fallacy by citing the approval of iloprost for pulmonary arterial hypertension in 2004 without providing any evidence or explanation as to why it is effective for treating severe frostbite. Additionally, there are several examples of inflammatory rhetoric used throughout the article such as 'lifechanging amputation' and 'disproportionately affect the homeless population'. The author also uses a dichotomous depiction by stating that people with health issues or those without housing or adequate clothing are at particular risk for frostbite, implying that others are not. However, there is no evidence to support this claim.
          • The approval of iloprost for pulmonary arterial hypertension in 2004 without providing any evidence or explanation as to why it is effective for treating severe frostbite.
        • Bias (75%)
          The article contains a statement that could be interpreted as biased towards the drug Aurlumyn. The author states that having this new option provides physicians with a tool to prevent amputations of frostbitten fingers or toes. This implies that without Aurlumyn, these surgeries would occur and it is not clear if there are any other options available for treatment.
          • Having this new option provides physicians with a tool to prevent amputations of frostbitten fingers or toes.
          • Site Conflicts Of Interest (100%)
            None Found At Time Of Publication
          • Author Conflicts Of Interest (50%)
            The author has a conflict of interest with the company Eicos Sciences as they are mentioned in the article and will be selling Aurlumyn. The drug is used to treat pulmonary arterial hypertension but also frostbite.

            48%

            • Unique Points
              • Frostbite can occur at temperatures just below freezing (-0.55°C)
              • There have been no approved therapies for severe frostbite until now
              • ⚡Iloprost⚡, a drug given intravenously for several hours a day over a little more than week, has been approved by the F.D.A. to treat severe frostbite.
              • Frostbite usually affects the extremities, such as fingers and toes
              • ωIloprostω is repurposed and was originally developed to treat high blood pressure within the lungs
            • Accuracy
              • Iloprost works by expanding the blood vessels of patients and stopping blood clots from forming. It also reduces oxidative stress which helps explain its impressive potential as a frostbite treatment
            • Deception (30%)
              The article is deceptive in several ways. Firstly, it states that frostbite can occur at temperatures just below freezing (-0.55°C), but this is not entirely accurate as frostbite occurs when the body's core temperature drops to a level where blood vessels constrict and blood flow slows down in the extremities. Secondly, it states that iloprost (brand name Aurlumyn) is repurposed which means it was originally developed for another medical condition but has been approved by the FDA for treating severe frostbite. However, this information is not entirely accurate as there have been other drugs tried as potential treatments for severe frostbite before iloprost. Lastly, the article states that 60% of patients who did not receive iloprost had injuries sufficiently severe to warrant amputation but does not provide any context or comparison with previous treatment options.
              • The statement 'Frostbite can occur at temperatures just below freezing (-0.55°C)' is deceptive as it implies that frostbite occurs when the temperature drops to -0.55°C, but this is not entirely accurate.
            • Fallacies (0%)
              The author is making a false dilemma by implying that the only two options for treating frostbite are either iloprost or amputation. He ignores other possible treatments such as rewarming, debridement, antibiotics and skin grafts.
              • The new drug isn't such great news for the Sourtoe Cocktail Club.
            • Bias (80%)
              The article is biased towards the new drug iloprost as a treatment for frostbite. The author uses language that depicts the drug in a positive light and implies it will be life-changing for those who suffer from severe frostbite. Additionally, there are examples of bias throughout the article such as when the author mentions how 'impressive' the results were found in this randomised human trial.
              • The approval of a drug that significantly reduces the risk of life-altering amputations of patients' fingers, toes and noses will certainly be welcome news to many.
                • The downside is this can result in permanent damage to the fingers, toes and parts of the face, sometimes requiring amputation of the affected body parts. (Frostbite has resulted in some odd traditions, such as the Sourtoe Cocktail in Dawson City where customers drink a cocktail containing an amputated frostbitten toe.)
                  • The study found that 60% of the patients who did not receive iloprost had injuries sufficiently severe to warrant amputation, versus 0% of the patients who received iloprost. The combined facts that there are no other approved pharmaceutical treatments for frostbite and the impressive digit-saving results found in this randomised human trial were sufficient to convince the FDA to approve this repurposed therapy for severe frostbite.
                  • Site Conflicts Of Interest (50%)
                    Steven R. Hall has a conflict of interest on the topic of frostbite as he is an author and publisher for The Conversation.
                    • Author Conflicts Of Interest (50%)
                      The author has a conflict of interest on the topic of frostbite as they are reporting on a drug that is being repurposed to treat it. The article also mentions Aurlumyn, which is the brand name for iloprost and could be seen as promoting or endorsing this specific product.
                      • The article mentions Aurlumyn, which is the brand name for iloprost and could be seen as promoting or endorsing this specific product.
                        • The author writes 'A new drug has been approved by US regulators to treat frostbite – a condition that can cause tissue damage if left untreated.'

                        78%

                        • Unique Points
                          • A new drug may be able to prevent the ravages of frostbite for unlucky mountaineers, tundra explorers, and the unhoused
                          • Hart Bezner experienced frostbite on his right hand which resulted in pink blisters covering it
                          • `Iloprost` is a drug given intravenously for several hours a day over a little more than week that has been approved by the F.D.A.
                          • Frostbite usually affects the extremities, such as fingers and toes, but it can also occur on other parts of the body
                          • `Iloprost` is repurposed and was originally developed to treat high blood pressure within the lungs
                        • Accuracy
                          • `Iloprost` is a drug given intravenously for several hours a day over a little more than week that has been approved by the F.D.A to treat severe frostbite.
                          • Frostbite usually affects the extremities, such as fingers and toes, but it can also occur on other parts of the body.
                        • Deception (50%)
                          The article is deceptive in several ways. Firstly, the author uses sensationalism by stating that a new drug could 'avert' the ravages of frostbite when it only claims to delay them. Secondly, the author misrepresents Hart Bezner's experience as him asking about losing his hand and blisters when in fact he was concerned about their appearance. Lastly, the article uses selective reporting by focusing on a single drug (Aurlumyn) without mentioning other treatments for frostbite.
                          • The author claims that Aurlumyn could 'avert' the ravages of frostbite when it only delays them. This is an example of sensationalism and misrepresentation.
                        • Fallacies (85%)
                          The article contains an appeal to authority fallacy. The author cites two doctors and a pharmacist as taking an unusual amount of interest in the appendage without providing any context or evidence for their expertise.
                          • ]Two days after his right hand froze, Hart Bezner realized for the first time that he might lose it.
                        • Bias (100%)
                          None Found At Time Of Publication
                        • Site Conflicts Of Interest (100%)
                          None Found At Time Of Publication
                        • Author Conflicts Of Interest (50%)
                          The author has a conflict of interest on the topic of frostbite as they are reporting on a new drug that could potentially be used to treat it. The article does not disclose this potential conflict.