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Journalist Max Nisen concludes the article by saying that the failure of Incyte to demonstrate the synergistic effect of combining the drugs Epacadostat and Keytruda is a good example of time and money wasted on combination drugs made from PD-1/L1 inhibitors. He does not believe that investors should keep pouring money into researching these combination products. However, Nisen is pretty confident that this incident will not stop drug developers from reattempting to make similar medications because of their overwhelming desire to profit. Nisen states that it will probably require a few more setbacks in the future to discourage the drug developers from making more of these products. According to Nisen, Merck and several other drug companies have put a large amount of their funds into research and development. Currently, there are 30 active trials involving Epacadostat in different cancers. There are also additional tests that are using other medicines in the same drug class. Earlier last year, analysts projected that Epacadostat would generate $3 billion in revenue in 2022. Now the revised figure has decreased to $600 million.
Student’s Conclusion (Keeon Zimmerman):
The article that I found was published on a site by Bloomberg by a columnist named Max Nisen. In the article, Nisen discusses the failure of drug developer, Incyte, to successfully demonstrate the synergistic effect of combining Epacadostat and Keytruda. Nisen believes that these combination drugs are a bad idea and that companies should stop investing so much money into the development of these drugs. Throughout the article, he states that combination drugs involving PD-1/L1 inhibitors such as Keytruda are a waste of time. In my opinion, the article was not credible because it did not list any concrete findings from the primary research done involving other drug combinations with PD-1/L1 inhibitors. There were no statistical findings such as p-values or confidence intervals. Also, Nisen does not have a medical background. For such a huge generalization to be made in regards to a certain class of drugs, without any concrete proof, by a media/PR officer is absurd.
Journal club: “Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomized, double-blind, parallel-group, phase III trial.”
Evaluator Name: Katelyn Griffith
Hampton University School of Pharmacy
Doctor of Pharmacy Candidate 2018
Article Title: “Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomized, double-blind, parallel-group, phase III trial.”
Citation: Burmester, G.R., Lin, Y., Patel, R., et al. (2017). Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomized, double-blind, parallel-group phase III trial. Annals of the Rheumatic Diseases, 76(5), 840-847. Retrieved from http://ard.bmj.com/content/annrheumdis/early/2016/11/16/annrheumdis-2016-210310.full.pdf
Journal: Annals of the Rheumatic Diseases (Volume 76, Issue 5) (more…)
“IbTX significantly reduces disease severity in two rat models of RA. Unlike paxilline, IbTX does not induce tremors or incontinence in rats. Overall, IbTX inhibits KCa1.1 channels on FLS and treats rat models of RA without inducing side effects associated with non-specific KCa1.1 blockade and could become the basis for the development of a new treatment for RA.”
The article I found was on a website called Medical News Today and talks about how poison from scorpions may be used to treat pain in certain parts of the body. The article says that the scorpion poison does not cause shaking or urination on accident. It also says that the scorpion poison helped make pain feel better in the rats. The problem is that only a few rats were used, and a lot of results are missing. The scorpion poison has not been tested in humans yet. More studies are needed before the scorpion poison can be used in humans. Based on the research I’ve done for this article, I would not recommend this article for anyone to read or review.
The author of the article concluded that “For now, the researchers state that the findings of the current study do not support the use of oral insulin as a preventative measure in type 1 diabetes.” Throughout the article, the author stated the results of the research and the inclusion criteria for participants. The author goes on to state that based on the lack of statistically significant results, “The researchers are planning another trial to see if a greater dose of oral insulin would improve the results.”
Student’s Conclusion (Nyesha Fulton):
The article that I found was published on a website called Diabetes News by an author named Benedict Jephcote. The article briefly describes the study design and results related to the clinical trial that studied the use of insulin in participants that had a family history of type 1 diabetes but have not yet been diagnosed. The trial included 560 patients that were at high risk for developing type 1 diabetes. The inclusion criteria, according to the article, stated that each subject must have a relative with at least 2 autoantibodies. The article goes on to say that subjects were randomly split into 2 groups, control vs experimental, were observed for approximately 2.7 years and were tested for the development of type 1 diabetes every 6 months. Although the group that was administered oral insulin had a lower number (28%) of children to develop diabetes, compared to the control group (33%), the results were not proven to be statistically significant. The article clearly states the disappointing results of the clinical trial, and even goes on to provide the definition of “statistically significant”, and why the results from the trial are not considered as such. Although the article is very blunt about the lack of statically significant results, it fails to provide any numbers from the trial that would support that claim. All in all, I would recommend this article to someone that is looking for a quick answer to their question, but I would not recommend it to someone that is looking for more background information.
Bad Science: “Diabetes Therapy Byetta Improves Parkinson’s Patients’ Movement, Clinical Trial Shows”
The author of the article didn’t state a conclusion but instead sited quotes from the researchers that conducted the study. The author wrote,
The study did not shed light on why Byetta benefits Parkinson’s patients, researchers said. “Whether exenatide affects the underlying disease pathophysiology or simply induces long-lasting symptomatic effects is uncertain,” they wrote.
The results spotlighted Byetta’s potential as a Parkinson’s therapy, however. That potential needs to be investigated in longer-term trials, the team said.
“This is the strongest evidence we have so far that a drug could do more than provide symptom relief for Parkinson’s disease,” Foltynie said.
“Using approved therapies for one condition to treat another, or drug repurposing, offers new avenues to speed Parkinson’s therapeutic development,” said Dr. Brian Fiske, the Fox foundation’s senior vice president of research programs. “The results from the exenatide studies justify continued testing, but clinicians and patients are urged not to add exenatide to their regimens until more is known about their safety and impact on Parkinson’s,” he added.
In the actual journal article, the researchers concluded that although exenatide had positive effects on defined motor scores in Parkinson’s disease, it’s use needs to be investigated further to ensure the effects are long-lasting.
Student’s Conclusion (Nyesha Fulton)
The article “Diabetes Therapy Byetta Improves Parkinson’s Patients’ Movement, Clinical Trial Shows” written by Patricia Inacio, Ph.D., and was published on the Parkinsons News Today website. The article summarizes the findings from the clinical trial that was conducted but didn’t include any statistics. The trial included 60 participants with moderate Parkinson’s disease. The subjects were randomly assigned to 2 different groups, a placebo, and an exenatide group. The subjects took the medicine, along with their other Parkinson’s medication for 48 weeks. The subjects were examined the 48 and 60 weeks mark. At the 60 weeks mark, it states that participants in the Byetta group were able to “move better” after injecting themselves with the drug every week for a year. While the placebo group, on the other hand, remained on a steady decline. The article also goes on to warn the results may not be trustworthy yet. The article went on to quote the researchers, “The results spotlighted Byetta’s potential as a Parkinson’s therapy, however. That potential needs to be investigated in longer-term trials… This is the strongest evidence we have so far that a drug could do more than provide symptom relief for Parkinson’s disease.” As previously stated the article didn’t state statistics but the linked journal article did. In the journal article, the statistics revealed the data was not statistically significant.
At 60 weeks, off-medication scores on part 3 of the MDS-UPDRS had improved by 1•0 points (95% CI −2•6 to 0•7) in the exenatide group and worsened by 2•1 points (−0•6 to 4•8) in the placebo group, an adjusted mean difference of −3•5 points (−6•7 to −0•3; p=0•0318)
From the article and the clinical trial, I concluded that based on the data exenatide isn’t effective as add-on therapy for Parkinson’s treatment. There were not enough subjects, the trial wasn’t conducted long enough and the subjects should have been monitored longer than 12 weeks post-treatment to determine if the effects were long-lasting.
The author of this article was not listed but the article concluded that “the results from the integrated analysis showed canagliflozin significantly reduced the combined risk of CV death, myocardial infarction (MI), and nonfatal stroke versus placebo in patients with T2DM at risk for, or with a history of, CV disease. Additional analysis revealed canagliflozin treatment was associated with a reduced risk of hospitalization for heart failure and demonstrated potential renal protective effects. Canagliflozin demonstrated consistent improvement of renal outcomes across multiple composite endpoints that were independently confirmed by an Endpoints Adjudication Committee.”
Student’s Conclusion (Nyesha Fulton)
The article that I found was published on a site called Managed Care by an unknown author. This article mainly discusses the use of the oral diabetic medication, Canagliflozin, to treat diabetes type 2 and its potential renal protective benefits by reducing the risk of kidney disease progression, reducing urinary albumin excretion and stabilizing estimated glomerular filtration rate. The article concluded that Canagliflozin reduced the rates of renal endpoints (end-stage kidney disease, renal death, etc.) by 47% (95% confidence interval [CI], 33%–84%). The article also goes on to state urinary albumin excretion was 18% lower in all participants treated with Canagliflozin compared with placebo (95% CI, 16%–20%). Overall the article suggested that the study demonstrated consistent improvement of renal outcomes across multiple composite endpoints. The article doesn’t seem to be a reliable source. The article didn’t have an author listed nor a direct link to the primary literature, but instead to another article where they plagiarized half of that article. Also, the results from the article and the results from the primary literature didn’t quite match up exactly, which made the results questionable. Therefore, based on these findings, or lack thereof, I wouldn’t recommend this article.
The initial author of the article did not have a conclusion. He ended his article with some quotes from an author of article that he referenced.
The conclusion from the article:
“The FDA safety investigation was associated with large reductions in codeine prescribing to children after tonsillectomy and/or adenoidectomy. However, ∼1 in 20 children were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues. Future quality-improvement efforts should focus on eliminating this residual inappropriate codeine prescribing and on encouraging the use of effective non-opioid medications such as ibuprofen.”
Student’s Conclusion (Rachel Allman)
The article I found was published on Forbes.com and used many quotes from one of the authors of the study, Dr. Chua. The article has a link that takes the reader to the “Official Journal of the American Academy of Pediatrics” table of contents but Dr. Glatter, the author, didn’t reference the study or mention the title in the article. I believe I found the article that was written by Dr. Chua that was titled, “Effect of FDA Investigation on Opioid Prescribing to Children After Tonsillectomy/Adenoidectomy” by searching the whole site.
The study was put together using insurance claims made for tonsillectomy and adenoidectomy along with MarketScan for prescription drug files. With this information, the researchers were able to put together enough data to claim that prescribing habits haven’t changed much since the FDA added the black box warning to acetaminophen with codeine. Obstructive sleep apnea data was also captured to see if the prescribing rates changed for children with obstructive sleep apnea. According to the results from 2010 up until 2015, there was a 13.3% drop in codeine prescriptions to children who had tonsillectomy/adenoidectomy. They saw that 5.1% of all children and 3.0% of children with OSA were still prescribed codeine in December 2015, the last month of their data review.
They gathered data for 72 months starting January 2010 until December 2015 with the main focus on months 32-38 (Aug 2012 –Feb 2013). This 6-month focus was when the FDA announced the safety investigation on codeine until the FDA put a black box warning on codeine for children. The graph below shows an impressive decline in prescribing and what looks like an equal rise in hydrocodone prescriptions. I was impressed by the results, I didn’t think the prescribing habits would change much but visually they look like they did considerably.
In conclusion, the website article had a nice summary of the main study. The study needed more numbers to back up their claims. The article was mainly to inform the reader that prescribers are making adjustments to their prescribing habits. The original article was easy to read and understand and the author’s main point did get across to the reader.
Tags (key terms to improve searching the website for this post; examples below)
Tonsillectomy, Adenoidectomy, FDA, codeine, opioid, black box warning, children