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 Release

Even when a release is touting a new dosing formula of an old drug, readers still need evidence

KVK Tech Announces FDA-Approval of Lomaira™ (phentermine hydrochloride USP) 8 mg tablets, CIV, A Low-Cost, Low-Dose Phentermine That Can Be Used Up To Three Times Daily for Weight Reduction

Our Review Summary

Diet PillsThis release describes a new low-dose, low-cost form of the drug Lomaira (phentermine hydrochloride USP) for use in weight control along with exercise and a controlled diet. While it gets points for addressing the issue of costs and it is exuberant in its information on possible side effects and other medical concerns, the release doesn’t offer any quantification of benefits or evidence needed to assess the usefulness of the drug compared with other weight-control measures.

As a generic version of an already approved drug, the manufacturer of Lomaira needed to demonstrate therapeutic equivalence with phentermine, meaning it needs to contain the same active ingredient and be just as safe as the originator drug. A discussion of the quantified benefits of other formulations of phentermine and a comparison with other methods of weight loss would have been helpful to readers.

 

Why This Matters

According to the National Institutes of Health, in America, “more than two-thirds (68.8 percent) of adults are considered to be overweight or obese. More than one-third (35.7 percent) of adults are considered to be obese. More than 1 in 20 (6.3 percent) have extreme obesity. Almost 3 in 4 men (74 percent) are considered to be overweight or obese.” So drugs that play a safe, effective role in reducing a person’s weight are an important public health aid. But the issue of weight control is also inundated with fad diets, questionable supplements and potentially risky alternatives, so strong, informative, data-rich information about research into weight control approaches is extremely important and necessary for consumers to make good decisions.

Criteria

Does the news release adequately discuss the costs of the intervention?

Satisfactory

This release makes the specific point that this newly approved dosage of the drug Lomaira (phentermine hydrochloride USP) will cost eligible patients “no more than 50¢ per tablet for the duration of treatment” if they qualify for the manufacturer’s assistance program. It makes the point that many insurance plans will not cover the cost of weight management drugs and that the low cost of this formulation should aid those who are prescribed it. The low-cost aspect of the drug is mentioned in both the headline and in the first paragraph of the release. The release would have been stronger had it mentioned the basic cost of the drug, regardless of any manufacturer’s qualifying discount.

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

Not Satisfactory

The release basically offers no information that quantifies any benefits from taking this drug. Because the originally approved drug has been used for many years for weight reduction the release implies that this drug works as advertised. But no data at all is offered about the degree of weight reduction that can be achieved from the drug. It does mention that patients reducing their weight by 5 to 10 percent enjoy a reduction in cardiovascular risk but no study evidence is offered.

Also important is that although the release correctly identifies obesity as a chronic condition, here we’re talking about a medication that is approved for “a few weeks.” If treatment for a chronic condition has a benefit, and then treatment is stopped, the benefit consequent to that treatment tends to disappear. Many physicians in weight management have been using phentermine in an off-label manner (either for longer periods of time than “a few weeks,” or with a cyclical prescription pattern). This would have been worth exploring in the release.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

This release lists nine separate possible side effects of the use of the drug in question and then adds to that the statement that, “These are not all of the potential side effects of phentermine.”  It then offers seven additional paragraphs with cautions, contraindications and warnings pertaining to taking the drug, all under the heading of “Important Safety Information.”  Readers will at least be informed, if not alarmed, after reading.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

This release is basically announcing a new dosage of an existing drug, rather than the results of any studies. It does state that, “In relatively short-term clinical trials, adults with obesity who were instructed in dietary management and treated with ‘anorectic’ drugs (appetite suppressants) lost more weight on the average than those treated with placebo and diet.”  But no information is offered about those trials, nor is it made specifically clear that the trials focused on the use of the drug Lomaira. Readers are offered really no evidence, much less information that could be useful in evaluating the quality of it.

Does the news release commit disease-mongering?

Satisfactory

The drug Lomaira is designed to treat persons who are obese or overweight and therefore plays on the interests of a large portion of the population who are concerned about their weight. While it does not seem to cross the line into the realm of disease-mongering, it does get about as close as possible without stepping over.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

There is no mention of who funded the studies that the FDA would have required for them to approve this use of the drug, nor is there any mention of potential conflicts of interest on the part of any investigators. The study referenced at the end of the release, however, did identify funders and addressed potential conflicts.

Does the news release compare the new approach with existing alternatives?

Not Satisfactory

The release makes no mention of other drugs or methods of weight control. Nor does it compare its efficacy with the multitude of dietary approaches available today. It does say that Lomaira “should be used together with regular exercise and a reduced-calorie diet.”

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release states that, “Lomaira is anticipated to be available by the end of September 2016.”

Does the news release establish the true novelty of the approach?

Satisfactory

We’ll give this release the benefit of the doubt for this category. Lomaira isn’t a new drug, this is only a new dosage that may be more effective for some patients and their prescribing physicians.  As such, the novelty of this release is minimal at best.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

We see no unjustifiable language being used in this release.

Total Score: 6 of 10 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.