NOTE TO READERS: When this project lost substantial funding at the end of 2018, I lost the ability to continue publishing criteria-driven news story reviews and PR news release reviews - once the bread-and-butter of the site going back to 2006. The 3,200 archived reviews, while still educational, are getting old and difficult for me to technically maintain on the back end of the website. So I am announcing that I plan to remove these reviews from the site by April 1, 2021. The blog and the toolkit - two of the most popular features on the site - will remain. If you wish to peruse the reviews before they disappear, please do so by the end of March 2021. After that date you may still be able to access them via the Internet Archive Wayback Machine - https://archive.org/web/.
Read Original Story

Once-a-day AIDS pill may be OK’d soon

Rating

2 Star

Once-a-day AIDS pill may be OK’d soon

Our Review Summary

This article discusses a once-a-day HIV treatment that may be available at some unknown time in the future. The treatment has been submitted to the FDA for approval. While the companies may be genuinely pleased with the studies they have done to demonstrate that the drugs in combination work as well as they do separately, those results still need to be evaluated by the FDA. This is an article on a re-packaging of a combination of medications currently used for the treatment of AIDS. The story fails to discuss issues that such re-formulation may cause that could be of concern to consumers. In several ways the story reads like it came from a drug company news release, although there is no direct evidence of that. The story would have been helped by interviews with independent experts who could address the evidence. There was really no evidence discussed in this story at all.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There was no cost of treatment information; how would this once-a-day pill compare to the two pill once-a-day combination?

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

There was no quantification of benefits of treatment. While it is easy to forget to take medications that are taken several times during the day, it is also easy to forget to take a medication once-a-day. There were no data to indicate how compliance compared.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

No harms of treatment or side effects were mentioned. Does the frequency of side effects differ when medication is taken once or more than once a day?

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

This article does not contain evidence. It appears to have been stimulated by “forward-looking” statements from one of the drug manufacturers involved in this partnership. It contains the view of one patient describing how difficult it is to remember to take daily prescription medications. This is a hurdle faced by many people with a variety of conditions other than HIV. The article did not contain evidence that compliance with taking medication once a day is actually better than dosing strategies that rely on medication taken multiple times a day.

In addition, the article failed to provide information about how effective the once-a-day regiment is as compared to other dosing schemes.

Does the story commit disease-mongering?

Satisfactory

No evidence of disease mongering.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

While there were several people interviewed for the story, an independent source with expertise on the subject should have been asked to comment on the therapeutic claims. One patient provides a single patient perspective; two individuals working for AIDS advocacy groups are also quoted. However no expert was quoted on any clinical evidence demonstrating effectiveness of the proposed treatment.

Does the story compare the new approach with existing alternatives?

Satisfactory

While not mentioning all the approaches to HIV treatment, the article does include mention of a combination of pills that could be taken once a day and gave an example of one patient who had to take only 3 pills twice a day.

Does the story establish the availability of the treatment/test/product/procedure?

Not Satisfactory

The story reports that the FDA is expected to approve the drug this year. But the timing of FDA approval is highly uNPRedictable and in some recent cases the FDA has rejected the advice of expert panels. This medication has only just been submitted for FDA approval.

Does the story establish the true novelty of the approach?

Not Satisfactory

The pill described would represent the first combination therapy for the treatment of HIV that necessitates taking medication only once a day. It is, however, a re-packaging of two existing treatments. So, if the story is going to let someone call this “a breakthrough,” it should at least explore what is novel and what isn’t.

Does the story appear to rely solely or largely on a news release?

Not Applicable

We can’t be sure if the story relied solely or largely on a news release.

Total Score: 2 of 9 Satisfactory

Comments

Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.