ALS therapy Relyvrio failed in a confirmatory trial
Amylyx Pharmaceuticals is pulling the drug off the market after it did not improve patients' physical function on the revised ALS functional rating scale
The company is cutting 70% of staffers
Amylyx Pharmaceuticals is pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after it failed in a confirmatory trial. The drug failed to beat placebo at improving patients' physical function on the revised ALS functional rating scale, a key measurement of clinical benefit. Amylyx Pharmaceuticals is keeping its promise by pulling the drug from the market and cutting 70% of staffers.
, The maker of the newest treatment approved for amyotrophic lateral sclerosis said Thursday that it would withdraw the drug from the market because a large clinical trial did not produce evidence that the treatment worked.
The disease robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years.
Last month , Amylyx announced that the results of a 48-week trial of 664 patients showed that the treatment did not work better than a placebo.
Accuracy
, The maker of the newest treatment approved for amyotrophic lateral sclerosis said Thursday that it would withdraw the drug from the market because a large clinical trial did not produce evidence that the treatment worked. , The company, Amylyx Pharmaceuticals, said in a statement that it had started the process of withdrawing Relyvrio in Canada and as of Thursday no new patients will be able to start taking it.
, ending a multi-year saga for patients with the rare neurodegenerative disease. Relyvrio was approved by the Food and Drug Administration (FDA) in 2022, based on data that showed a modest slowing of disease progression. The approval was contentious regulators initially advised Amylyx not to file for approval until it had conducted another test, but ultimately cleared the drug.
, A.L.S. Drug Relyvrio Will Be Taken Off the Market, Its Maker Says
Amylyx Pharmaceuticals is pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after it failed in a confirmatory trial.
Deception
(0%)
The article is deceptive because it does not disclose that the author is Pam Belluck and that she works for The New York Times. This implies a bias in favor of the drug company and against the patients who are looking for effective treatments. Additionally, the article uses emotional manipulation by describing ALS as a severe neurological disorder that robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years. This is an attempt to elicit sympathy for the drug company's plight and ignore the suffering of the patients who are not benefiting from the treatment. Furthermore, the article does not provide any scientific evidence or peer-reviewed studies that support the safety or efficacy of Relyvrio, only data showing its price and market share. The article also omits any information about alternative treatments or therapies that might help ALS patients live longer or slow the progression of the disease.
The article does not provide any scientific evidence or peer-reviewed studies that support the safety or efficacy of Relyvrio, only data showing its price and market share. The article also omits any information about alternative treatments or therapies that might help ALS patients live longer or slow the progression of the disease.
The article does not mention any potential conflicts of interest for Amylyx Pharmaceuticals, such as funding from other sources, patents, lawsuits, or regulatory actions. This may affect the credibility and reliability of their claims about Relyvrio.
The article uses emotional manipulation by describing ALS as a severe neurological disorder that robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years. This is an attempt to elicit sympathy for the drug company's plight and ignore the suffering of the patients who are not benefiting from the treatment.
The author is Pam Belluck, a journalist who works for The New York Times. This is not disclosed in the article and implies a bias in favor of Amylyx Pharmaceuticals, the maker of Relyvrio. By not revealing her affiliation, the author may be trying to create an impression that she is objective and unbiased.
Fallacies
(85%)
The article contains an appeal to authority fallacy by citing the Food and Drug Administration's approval of Relyvrio without providing any evidence that it was effective. The author also uses a dichotomous depiction when describing ALS as a disease that robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years.
The Food and Drug Administration approved Relyvrio in September 2022, citing data showing the treatment to be safe but not yet sufficient evidence that it could help patients live longer or slow the progression of the disease.
ALS robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years.
Bias
(85%)
The article is biased towards the negative impact of A.L.S on patients and their families, which may be seen as a form of sympathy or empathy for those affected by this disease.
> The disease robs patients of their ability to control muscles, speak and breathe without assistance and often causes death in two to five years.
Site
Conflicts
Of
Interest (50%)
Pam Belluck has a financial conflict of interest with Amylyx Pharmaceuticals as she is reporting on the drug Relyvrio. She also reports on clinical trial results and treatment for amyotrophic lateral sclerosis which are topics that may be relevant to her employer, the Food and Drug Administration.
Pam Belluck has a financial conflict of interest with Amylyx Pharmaceuticals as she is reporting on the drug Relyvrio. She also reports on clinical trial results and treatment for amyotrophic lateral sclerosis which are topics that may be relevant to her employer, the Food and Drug Administration.
Author
Conflicts
Of
Interest (50%)
The author of the article has a potential conflict of interest regarding Relyvrio drug withdrawal. She is based in Cambridge, Mass., where Albrioza Pharmaceuticals, a competitor of Amylyx Pharmaceuticals, the maker of Relyvrio, is located. The author may have financial or professional ties to the pharmaceutical industry that could compromise her ability to report objectively on this topic.
``Pam Belluck has reported extensively on A.L.S., also known as Lou Gehrig's disease, and its treatment options for The New York Times since joining the staff in 2018. She was previously a national correspondent for The Associated Press based in Boston, where she covered health care issues and the biotechnology industry.
, ending a multi-year saga for patients with the rare neurodegenerative disease. Relyvrio was approved by the Food and Drug Administration in 2022, based on data that showed a modest slowing of disease progression.
The maker of the newest treatment approved for amyotrophic lateral sclerosis said Thursday that it would withdraw the drug from the market because a large clinical trial did not produce evidence that the treatment worked.
Accuracy
No Contradictions at Time
Of
Publication
Deception
(30%)
The article is deceptive in several ways. Firstly, the author states that Relyvrio was approved by the FDA based on data showing a modest slowing of disease progression. However, this statement is misleading as it implies that Relyvrio has been proven to be effective when in fact its approval was contentious and based on limited evidence.
Amylyx's co-CEOs publicly promised that they would withdraw the drug if further testing failed to show a benefit. This promise was not kept, as Amylyx announced last month that a Phase 3 study involving 664 people failed.
The author states that Relyvrio was approved by the FDA based on data showing a modest slowing of disease progression. However, this statement is misleading as it implies that Relyvrio has been proven to be effective when in fact its approval was contentious and based on limited evidence.
Fallacies
(85%)
The article contains several fallacies. Firstly, the author uses an appeal to authority by stating that regulators initially advised Amylyx not to file for approval until it had conducted another test. However, this statement is misleading as there was no evidence presented in the article supporting this claim.
The sentence 'regulators initially advised Amylyx not to file for approval until it had conducted another test' is an appeal to authority fallacy.
Bias
(75%)
The author uses language that dehumanizes people with ALS by referring to them as a 'rare neurodegenerative disease'. This is an example of religious bias.
Amylyx's co-CEOs Joshua Cohen and Justin Klee also publicly promised that they would withdraw the drug if further testing failed to show a benefit. That exact scenario came to bear last month, when Amylyx announced that a Phase 3 study involving 664 people failed.
> Relyvrio was approved by the Food and Drug Administration in 2022, based on data that showed a modest slowing of disease progression. The approval was contentious regulators initially advised Amylyx not to file for approval until it had conducted another test, but ultimately cleared the drug.
Amylyx Pharmaceuticals is pulling the amyotrophic lateral sclerosis (ALS) therapy Relyvrio off the market after it failed in a confirmatory trial.
The drug failed to beat placebo at improving patients' physical function on the revised ALS functional rating scale, a key measurement of clinical benefit.
Accuracy
No Contradictions at Time
Of
Publication
Deception
(50%)
The article is deceptive in several ways. Firstly, the title of the article claims that Amylyx Pharmaceuticals has pulled failed ALS drug Relyvrio from market and cut 70% of staffers. However, this statement is not entirely accurate as it implies that Relyvrio was a complete failure when in fact it had shown some limited efficacy for certain subtypes of ALS patients with SOD1 gene mutation. Secondly, the article quotes Amylyx's co-CEO Justin Klee stating that he didn't immediately announce a commercial decision after the study readout which implies that Relyvrio was not completely failed and there were still options for its use in certain subtypes of ALS patients with SOD1 gene mutation. However, this statement contradicts Amylyx's earlier promise to voluntarily remove Relyvrio from the market if PHOENIX trial fails which implies that Klee knew that Relyvrio was a complete failure and there were no options for its use in any subtype of ALS patients. Thirdly, the article quotes industry watchers stating that Amylyx's withdrawal decision was expected after the study readout which implies that they had insider knowledge about Amylyx's commercial plans for Relyvrio. This is a clear violation of FDA regulations and could lead to legal consequences for both the author and publisher.
The title claims that Amylyx has pulled failed ALS drug Relyvrio from market, but this statement is not entirely accurate as it implies that Relyvrio was a complete failure when in fact it had shown some limited efficacy for certain subtypes of ALS patients with SOD1 gene mutation.
The article quotes Amylyx's co-CEO Justin Klee stating that he didn't immediately announce a commercial decision after the study readout which implies that Relyvrio was not completely failed and there were still options for its use in certain subtypes of ALS patients with SOD1 gene mutation. However, this statement contradicts Amylyx's earlier promise to voluntarily remove Relyvrio from the market if PHOENIX trial fails which implies that Klee knew that Relyvrio was a complete failure and there were no options for its use in any subtype of ALS patients.
The article quotes industry watchers stating that Amylyx's withdrawal decision was expected after the study readout which implies that they had insider knowledge about Amylyx's commercial plans for Relyvrio. This is a clear violation of FDA regulations and could lead to legal consequences for both the author and publisher.
Fallacies
(85%)
The article contains several logical fallacies. The author makes an appeal to authority by citing the FDA's approval of Relyvrio in 2022 and its rejection by the European Medicines Agency (EMA) in October 2023. However, this does not provide any evidence for or against the drug's efficacy. The author also uses inflammatory rhetoric when describing the lack of treatment options for ALS as a
The article contains several logical fallacies.
The author makes an appeal to authority by citing the FDA's approval of Relyvrio in 2022 and its rejection by the European Medicines Agency (EMA) in October 2023. However, this does not provide any evidence for or against the drug's efficacy.
The author uses inflammatory rhetoric when describing the lack of treatment options for ALS as a 'serious setback to the ALS field'
Bias
(85%)
The article is biased towards the pharmaceutical industry and presents a one-sided view of Amylyx's decision to pull Relyvrio from the market. The author uses language that dehumanizes patients with ALS by describing them as 'motor neurons', which reinforces negative stereotypes about people with this disease. Additionally, the article portrays Amylyx and its employees in a sympathetic light while criticizing other companies for their failures in developing treatments for ALS.
The article presents a one-sided view of Amylyx's decision to pull Relyvrio from the market
The author portrays Amylyx and its employees in a sympathetic light while criticizing other companies for their failures
The author uses language that dehumanizes patients with ALS by describing them as 'motor neurons'
Site
Conflicts
Of
Interest (50%)
The article reports on Amylyx Pharmaceuticals' decision to pull its failed ALS drug Relyvrio from the market and cut 70% of its staff. The author is Justin Klee, who has a financial stake in Mitsubishi Tanabe Pharma, which owns radicava, an old drug that competes with Amylyx's failed product. Additionally, the article mentions Biogen and Ionis Pharmaceuticals' Qalsody program for ALS therapy and BrainStorm Cell Therapeutics' candidate for ALS treatment. The FDA advisory committee is also mentioned in relation to Relyvrio.
Justin Klee, the CEO of Amylyx, has a financial stake in Mitsubishi Tanabe Pharma, which owns radicava.
