Health News Review

This story does some things quite well, but still gets unsatisfactory scores on some of what we consider to be key criteria.

Our Review Summary

The story does a great job in highlighting a potential conflict of interest and also in cautioning that data presented at scientific meetings are typically considered preliminary until published in a peer-reviewed journal. However, the article should have provided more in-depth reporting on the limitations of the study.

Reporting on papers presented at scientific meetings is difficult, since results are preliminary and perhaps not all explicitly stated as in a peer-reviewed journal. That is why it is even more important that the story is accurate and clear, so that readers do not walk away with any false impressions or hopes regarding a new approach.


Why This Matters

This is important work because better treatments for depression are needed.  This trial appears to support the possibility that the compound in question may be useful.  But reporting preliminary findings is difficult.   Getting additional outside expert opinions could have been helpful.  Giving the reader information on how often promising drugs make it to the market, the next steps in evaluation, etc., could provide important context


Criteria

Not Satisfactory

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

There is no discussion of costs in this story, either for the new drug GLYX-13 or for existing drugs, such as Prozac, Paxil, Zoloft and Lexapro.

Not Satisfactory

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

Not Satisfactory

The story talks about how antidepressant effects of the drug were seen within 24 hours, but it fails to quantify how many patients out of the 120 saw such effects. And how were the effects measured in these patients? The article also notes, “The effect of the drug was substantially better than seen with other antidepressants,” but what exactly was better? How much were depressive symptoms reduced?  What proportion of study participants benefited?

Not Satisfactory

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

Not Satisfactory

The lead researcher is quoted as saying, “In addition, we have shown little or no side effects with our compound.” And the story does caution that many unknowns remain about GLYX-13, including its long-term effects and the effects of stopping its use. The story also adds that the drug does not display side effects of hallucinations and schizophrenia-like symptoms.

However, here’s why we rule this one unsatisfactory on the harms criterion:  A single dose of a medication (which appears to be the design here) can’t establish harms.  The story should have been less accepting of the statement that there were no side effects.  The compare-and-contrast to other drugs targeting the same receptors and the apparent lack of short-term and severe side effects (e.g., hallucinations) was useful but not close to the whole story.

Not Satisfactory

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

Not Satisfactory

This was a mixed bag. The story does mention that long terms effects of the drug need to be studied and that findings are preliminary, since the findings were presented at a medical meeting. However, it does not explicitly state that this was a small phase II trial, in which researchers are only beginning to assess the drug’s effectiveness. The only published research cited in this story was the team’s animal research that led to this new method, and no caveats on the limitations of animal research are mentioned.

Overall, the information given is grossly inadequate.  All we know is that it is a short-term trial in about 120 humans.  We don’t know:  if it was randomized; how outcomes were measured, completeness of followup, blinding of subjects and outcome assessment, whether intervention and control groups were balanced at baseline in terms of important prognostic factors. We do know that there are important conflicts of interest.  We don’t know if there have been other studies that have failed to show an effect.

We’re not looking for a news story that reads like a journal article.  But if you’re going to report on research, we think that there are some basic fundamentals that we think need to be covered.

Satisfactory

Does the story commit disease-mongering?

Satisfactory

The story does not commit disease mongering.

Satisfactory

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

Satisfactory

Dr. Bryan Bruno is the independent expert in this story. It would have been helpful if he could have talked more about the study’s limitations, but he does mention that long-term effects of the drug need to be studied before it can be used regularly in clinical practice. The article does an excellent job in bringing up a potential conflict of interest. The study’s lead researcher is the founder and chief scientific officer of the biotechnology firm Naurex Inc., which “discover and develop compounds that modulate the NMDA receptor in a new way,” according to the firm’s website. Naurex conducted the clinical study.

Satisfactory

Does the story compare the new approach with existing alternatives?

Satisfactory

The story mentions the most popular drugs on the market, which include Prozac, Paxil, Zoloft and Lexapro. The lead researcher is also quoted in saying that all current medications take longer to start working and to take full effect for most people.  Satisfactory – but just barely – since it didn’t mention other major treatment options (therapy, exercise, self-help).

Satisfactory

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

Satisfactory

The article states that the study is in phase II clinical trials and that results are considered preliminary. The lead researcher says that the new drug is not projected to be available before 2016. The independent expert also cautions that the long-term effects of the drug need to be studied before it can be used regularly in clinical practice.

Satisfactory

Does the story establish the true novelty of the approach?

Satisfactory

This is also a mixed bag. The story got rid of some of the more scientific jargon that was included in the press release, but in the process, some bits became ambiguous. Establishing novelty is one example. This is a novel approach; no drugs on the market have the same mechanism.  There is intense interest in this field by the National Institutes of Health. The story states, “Moskal’s team developed a new way to target the brain’s NMDA (N-methyl-D-aspartate) receptor…” but in fact, other antagonists, such as the anesthetic ketamine, work in a somewhat similar fashion.  GLYX-13 targets brain receptors responsible for learning and memory, which is a different approach from most popular antidepressants that work by improving levels of the hormone serotonin. Although pieces of this information are stated in the article, this does not clearly come across to the reader. Nonetheless, we’ll give the story the benefit of the doubt on this criterion.

Satisfactory

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

Satisfactory

Although the story uses similar wording and information from the Northwestern press release, there is evidence of original reporting, shown by the independent comment by Dr. Bryan Bruno.

Total Score: 6 of 10 Satisfactory


Comments

Paul Scott posted on December 28, 2012 at 12:56 pm

There’s actually quite a bit more about this story that is deeply troubling — in fact, unless I am missing something it is a good example of the tacit complicity of health journalists in the marketing of new drugs with little benefit, and of studies which seem designed primarily as a vehicle to raise venture capital. The drug is apparently a “clean” version of ketamine, which is a veternary tranquilizer and rave drug. It affects the same receptors without getting you into the land of sugar plumb fairies. That right there should tell us something about how far the research has strayed from the notion of treating disease and instead tinkering with altered states of consciousness. Nonetheless, if the reporter had looked more deeply into its background, it is being touted as the next everything drug — “our goal is to eventually sell the drug and possibly the company to a big Pharma company,” says Naurex CSO Joe Moskal on a Northwestern newsletter available online. “There is a lot to be said for holding on to the company and nurturing our next generation programs while extracting value GLYX-13, but it will cost a lot of money to do that.” So much for basic science, disease and discovery– this is about product development. Moskal says the drug is hoped to also one day be taken for alzheimer’s, neurodegeneration due to stroke, schizophrenia, autism and depression. And after this study and the stories like this came out, Naurex announced another round of VC and PE financing to the tune of $38 m. So the study moved the drug along towards market — but what did it really find? What’s troubling is that while it is touted as effective for treatment resistant depression, if you look at the movement in the depression scores –4-5 units on HAMD — that is seemingly no greater than the amount of movement (less than 25% for a minimum score of 21) on the depression rating scores that got the people labeled treatment resistant in the first place. (For comparison, Irving Kirsch has called 2 points on the HAMD the amount of benefit you get from a good night’s sleep.) In other words, it satisfies the purpose of depression ratings scales, as David Healy has argued, which is to justify the sale of drugs, as opposed to curing illness. Source-wise, the second authority quoted in this piece, while a psychiatry head at a large hospital, seems to be an authority only insomuch as he is the guy this particular publication calls for comment on psychiatry related stories. He doesn’t appear to have any research expertise in this area.

The backstory to drug development is so critical, and I didn’t see it here. This seemed like health churnalism — an incident in which a reporter got their hands on a press release, found the study, rewrote the findings and called up an all-purpose commenter for “balance.”

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