This mouse might have reason to be enthusiastic about positive results from preliminary research in mice, but humans don’t.

Some men suffer from premature ejaculation. Press releases and media reports of scientific studies often suffer from premature enthusiasm. Here are some examples:

An immune-like function of epithelial cells explained

This study reportedly “advances us closer to more effective cancer treatments in the future”. Cell competition by epithelial cells can eliminate precancerous cells, but it’s not known how they identify the abnormal cells. Researchers at Waseda University in Japan identified a plasma membrane protein in dog epithelial cells that was a recognizing protein for cell competition. They speculated that the protein in humans that is most similar to the dog protein might be able to recognize precancerous epithelial cells and generate a mechanical force to push the precancerous cells out and eliminate them from the body. Maybe, but that’s only a far-fetched speculation at this point. The researchers themselves were less optimistic. They only said they hope that their findings may someday be useful for developing a therapeutic candidate for human cancer.

It’s a bit of a stretch to predict that their findings will advance us closer to more effective cancer treatments in the future. First, the discovery would have to stand up to further study. It might be corroborated, or it might not pan out. If confirmed, there are still many questions that would have to be answered before a treatment could be considered for humans. How would the protein reach the site of action, by pill or by injection? How is it metabolized? Is it safe? What side effects might emerge? How effective would it be? Before a new treatment is approved for marketing, it must be proven safe and effective in a series of human studies. If it passes Phase I and II studies, the series typically culminates in a large double-blinded Phase III randomized placebo-controlled clinical trial. Of all the promising candidates, few pass the tests and are approved for marketing.

Cell competition is an immune-like function of cells not generally considered to be part of the immune system. If anything, it underlines the complexity of the immune system. “Boosting the immune system” might be a bad idea. Autoimmune diseases might get worse. On the other hand, immunosuppression might not be a good idea either: it might increase susceptibility to infections and cancer. It is risky to try to intervene in a complex web that we don’t fully understand. Interfering with one part of a complex system of interacting effects might have unexpected effects on other parts of the system.

New compound “potentially” safer than current drugs

A press release said “Killing Pain Without Hurting the Body: Novel Compound that Is Potentially Safer than Current Drugs”.

Researchers in Japan studied the novel pyrazole derivative AD732 in rat models of paw edema and in hot plate pain tests and compared it to the non-steroidal drugs (NSAIDs) indomethacin and celecoxib. Why choose those two drugs? Indomethacin is not a first choice NSAID, and celecoxib was briefly withdrawn from the market after it was found to increase the risk of heart attacks. In a following in vitro investigation the researchers found that AD732 was a less potent inhibitor of COX-2 than celecoxib. This led them to speculate that the new compound might be less likely to cause heart attacks and other side effects. They inferred that it appeared to be a safer and more effective molecule with promising potential for the management of pain and inflammation even in difficult diseases such as ulcerative colitis and Crohn’s disease. Come on, folks! This was a preliminary study in a rat model and the speculations went far beyond the data.

An elevated heart rate is associated with dementia?

The Washington Post reported that this study showed a correlation between elevated heart rate and dementia. They failed to mention that correlation is not causation. They went on to advise readers to check their resting heart rate and (if it is too high) take measures to lower it. That advice is not warranted from the data.

A nasal vaccine for Alzheimer’s?

MedicalNewsToday reported research on a nasal vaccine for Alzheimer’s. It was found effective in mice. If you know any mice with dementia, you might want to share this news with them, but it’s way too early for humans to start celebrating. This is preliminary research. The vaccine has only been studied in animals so far; a small (16 subjects) preclinical human phase I trial is just now beginning. The vaccine targets amyloid and we still haven’t determined whether amyloid is a cause or a consequence of Alzheimer’s. A vaccine would be great, but I’m not optimistic.

Novel vaccine may yield affordable solution to lipid disorders?

Researchers at Kumamoto University in Japan have developed a peptide vaccine to treat dyslipidemia and say they have proven its efficacy. They confidently surmised that it “could become one of the most cost-effective treatments for obesity/cholesterol-related disorders like atherosclerosis and fatty liver disease”. Really? They injected an experimental vaccine into a mouse model of obesity-induced dyslipidemia. They showed that it was effective – in mice! – and one of the researchers was quoted as saying “The vaccine is projected to become one of the new economical therapy choices for dyslipidemia and dyslipidemia-related disorders”.

The press release says the authors plan to conduct preclinical research to test the vaccine’s efficacy and safety, as well as make improvements to prolong its effectiveness. Prof. Oike said “We will modify the vaccine formulation and optimize the dosage and administration for clinical trials. Re-immunization every 5 or 6 months could maintain the therapeutic efficacy of the E3 vaccine therapy, and more investigation is necessary to see if a vaccination booster would extend its durability”.

Wait a gol-durned minute! It has only been tested in mice, they are planning to conduct preclinical research but haven’t actually started yet, they are going to change the vaccine formula, and they think booster shots may be required as often as 5 months. They have no idea what a human vaccine would cost, but they are guessing it might be more economical for worldwide use. Talk about premature enthusiasm and going beyond the data!

Conclusion: Those who report scientific studies need to get a grip on reality

Press releases may be very unreliable sources of information. They are not likely to announce negative results and when they announce positive results, one of their goals is to favorably impress their financial sources so funding will continue. They may omit crucial information. Wouldn’t it be wiser to make an announcement after the study is published and peer-reviewed? When science journalists simply regurgitate a press release, they are doing their readers a dis-service.

Science journalists need to get a grip on reality. They need to develop a better appreciation of how science works. All too often they are content to just copy from a press release without any critical analysis. They commonly confuse correlation with causation and make recommendations not justified by the data. They may report preliminary studies as if they were proven facts. Enthusiastic predictions based on preliminary research may raise hopes for new treatments, but all too often those hopes turn out to be false. Not exactly “fake news” but surely misleading. It’s fun to speculate, but it’s not reasonable to ask people to take medicines or change their diet or lifestyle based on untested speculations.

Author

  • Harriet Hall, MD also known as The SkepDoc, is a retired family physician who writes about pseudoscience and questionable medical practices. She received her BA and MD from the University of Washington, did her internship in the Air Force (the second female ever to do so),  and was the first female graduate of the Air Force family practice residency at Eglin Air Force Base. During a long career as an Air Force physician, she held various positions from flight surgeon to DBMS (Director of Base Medical Services) and did everything from delivering babies to taking the controls of a B-52. She retired with the rank of Colonel.  In 2008 she published her memoirs, Women Aren't Supposed to Fly.

Posted by Harriet Hall

Harriet Hall, MD also known as The SkepDoc, is a retired family physician who writes about pseudoscience and questionable medical practices. She received her BA and MD from the University of Washington, did her internship in the Air Force (the second female ever to do so),  and was the first female graduate of the Air Force family practice residency at Eglin Air Force Base. During a long career as an Air Force physician, she held various positions from flight surgeon to DBMS (Director of Base Medical Services) and did everything from delivering babies to taking the controls of a B-52. She retired with the rank of Colonel.  In 2008 she published her memoirs, Women Aren't Supposed to Fly.