This news release offers uniformly positive assessments about a trial of a drug that, theoretically, might help save thousands of lives. It is an important topic, but the release gave little in the way of meaningful data to support the assertions.
It contains all the ingredients of what could be a useful news release — discussion of the study, its design, its findings, comments from company officials and two academics. But, absent meaningful numbers and context, those elements are not enough to help the reader decide how much importance to attribute to the news release’s claims.
According to the World Health Organization (WHO), about 69,000 people die each year from opioid overdose. In addition, some 15 million people are addicted to opioids — most of them to heroin.
Though treatments exist, only 10% of those who need them get them, the organization says. Those treatments include “psychosocial support, opioid maintenance treatments such as methadone and buprenorphine, supported detoxification and treatment with opioid antagonists such a naltrexone,” according to WHO.
Treatment with buprenorphine (marketed as Subutex and Suboxone), which can be given in a variety of formulations, typically requires daily doses. If a once-a-week or once-a-month version of the drug were available, patients might be more likely to stick to their treatment plan and, as a result, be more likely to overcome their dependence on opioids.
The drug cited in the news release, CAM2038, is a long-acting form of buprenorphine, which is used to treat pain as well as to treat opioid addiction.
No mention is made of the projected cost of the treatment and it is likely to be significant. In addition to the cost of the medication, if it requires a health care professional to administer it — that will add to the cost. It is also not clear how long the treatment might last. If the treatment is successful, the cost/benefit may be fine, but who pays for the treatment will be an issue.
The claimed benefits are cited in only the broadest of terms.
“The primary endpoint was met for both CAM2038 doses, demonstrating blockade of the subjective effects of hydromorphone as measured by the Drug Liking Visual Analog Scale,” the news release says.
Camurus’ president tells us that the study showed that the drug “provides rapid and extended blockade of opioid effects,” but he does not say how rapid or how extended.
A professor at the University of Kentucky is quoted as saying that the study “demonstrated that weekly injections of CAM2038 produced significant and robust opioid blockade” and that the drug “has the potential to alter the current treatment paradigm for opioid dependence.” But we are not given the data on which she bases that view, nor are we told whether she was involved in the study, nor are we told what the current treatment paradigm is.
Similar questions apply to the comments from a neurobiologist at Columbia University.
“We feel that this medication, with its ease of administration and flexible dosing capabilities, could significantly improve management of patients,” Prof. Sharon Walsh says. It is not clear who “we” is — the neurobiology department at Columbia? The company?
“We were pleased to be involved in the development” of the drug, she adds. Does that mean she was part of the study? Does she have a financial stake in the drug? Such information might help a reader decide how to evaluate her statements.
Finally, it appears the treatment regimen has hot been tested for the most important outcomes: continued opiate use and reduced opiate overdose deaths.
No mention of potential harms was offered beyond saying the drug was “well tolerated across the course of treatment.” What does that mean? We do not know.
We do know that the drug is not wholly benign. Here are some side effects listed by the U.S. government’s Substance Abuse and Mental Health Services Administration: nausea, vomiting, constipation, muscle aches and cramps, cravings, inability to sleep, distress and irritability and fever.
Until this is tested in a larger cohort, we do not know the potential array of side effects.
We get this about the study design — “three-center, randomized, double-blind, inpatient study to evaluate the degree of subjective opioid blocking efficacy of CAM2038 q1w in non-treatment-seeking participants with moderate-to-severe opioid use disorder.”
We are told that “The primary endpoint was met for both CAM2038 doses, demonstrating blockade of the subjective effects of hydromorphone as measured by the Drug Liking Visual Analog Scale.”
But without more detail, it is impossible to draw conclusions about the findings. How many people entered the trial? How many dropped out? How many stayed off opioids? How was compliance assessed? How significant were the findings? Why was there no comparison arm of the study?
The testimonial from one professor also fell short. “The current study demonstrated that weekly injections of CAM2038 produced significant and robust opioid blockade, a critical mechanism of efficacy for medications treating opioid dependence,” said Sharon Walsh, Ph.D, Professor of Behavioral Science and Director of the Center on Drug and Alcohol Research, University of Kentucky.
How significant? How robust? How do they compare with the significance and robustness of current treatments?
The news release says that more information about the trial design is available on www.clinicaltrials.gov. But, without a link, it was not clear which of several CAM2038 studies listed there was being cited.
The release doesn’t overstate the impact of opioid overdose. On the other hand, it would have been nice to include some context on the incidence of opioid addiction which this drug is designed to treat.
No mention is made of funding, and the roles of the two academics quoted are never made clear. We are not told whether they helped carry out the study itself, whether they have a financial interest in the product, or whether they are speaking as disinterested expert observers.
According to a speakers bio for a conference on treating opioid addiction, one of the experts quoted has financial ties to the sponsors of the drug tested. This conflict of interest should have been mentioned in the release.
The FDA approved buprenorphine in 2002. According to SAMHSA, medication-assisted treatments like buprenorphine should be given in combination with counseling and behavioral therapies. No mention is made of whether the subjects in the experiment were given those supplementary therapies. Nor was any mention made of alternative drug treatments to buprenorphine. One of the most common ones is methadone.
The news release doesn’t provide a time frame for when the drug, which is still under development, will be available but suggests it will be “a future treatment alternative.” We don’t fault them for not providing a date following a phase 2 trial. There are many steps to be completed before or if it is approved and marketed.
The news release suggests the product under development is “novel” and that it “has the potential to alter the current treatment paradigm for opioid dependence.” We aren’t really told what is novel about the formula, though. A weekly or monthly administered opiate antagonist would be a new addition to the treatment options but it is not really novel.
The news release doesn’t use overly promotional or inexact language.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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