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TGen uses slippery language to get around fact that “breakthrough” drug for brain tumors never tested in humans

TGen identifies drug that could limit the spread of deadly brain tumors

Our Review Summary

Brain tumorThis news release describes the discovery of propentofylline, a drug that researchers claim could help patients with brain tumors. But there’s no justification for calling this test of a drug on brain tumor cells in a lab dish “a significant breakthrough.” Because of the murky wording of the release, and the many mentions of potential benefits to patients, as well as references to clinical trials (without being clear that those trials involved patients with Alzheimer’s and other diseases, not brain tumors), readers may not realize that the number of patients in this trial was exactly zero. The release also miscasts the threat posed by glioblastoma multiforme. It calls the disease the most common primary tumor of the brain and central nervous system and warns that “it affects people of all ages,” without noting that the disease is diagnosed in only about 2 or 3 people per 100,000 population each year, or only about 1 percent of all cancer cases.

 

Why This Matters

Glioblastoma multiforme is a devastating disease with little in the way of effective treatments. It is for this very reason that reports of potential new approaches should be measured and free of hyperbole and false hope. Most people are unaware just how few experimental drugs that show encouraging results in laboratory tests eventually show they can help real patients. While the results of this cell culture test may be worth investigating further, it is far too early to crow about potential benefits to patients.

Criteria

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

Not Satisfactory

Even though propentofylline, the drug being studied, is not FDA approved for use in people, the release could have easily included some basic price information since the drug is currently sold for use in elderly dogs in many countries. One online pharmacy quotes a price of $67 for sixty 100 mg tablets tablets. Of course, the price would likely be higher for a drug that meets FDA standards for human use.

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

Not Satisfactory

The release is riddled with suggestions — but no specifics — of potential benefits. Some examples:

  • “In a significant breakthrough…,”
  • “… PPF works to limit the spread of glioblastoma multiforme, or GBM,”
  • “…PPF increases the effectiveness of a standard-of-care chemotherapy drug called temozolomide (TMZ), and radiation, to treat glioblastoma…”
  • “Our data suggests that PPF, working in combination with TMZ and radiation, could limit glioblastoma invasion and improve the clinical outcome for brain tumor patients” 

The release is explicitly silent on the fact that the research was confined to the laboratory and did not involve patients.

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

Not Satisfactory

Not only does the release fail to mention any potential harms, it dismisses such concerns with a quote about “minimal side effects.”

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

Not Satisfactory

Readers would be forgiven for not realizing this study was done only on cells in a lab, not real patients, since that fundamental fact is glossed over in the release.

Does the news release commit disease-mongering?

Not Satisfactory

The release calls glioblastoma multiforme “the most common primary tumor of the brain and central nervous system,” without noting how rare brain tumors are. The release should have noted that glioblastoma multiforme is diagnosed in about 22,000 people in the United States each year, accounting for barely more than 1 percent of all cancer cases. Glioblastoma multiforme kills about 15,000 people in the U.S. annually, representing about 2-1/2% percent of the total deaths attributed to cancers of all types.

This type of tumor is indeed usually life threatening, but this news release misleads readers when it uses the term “common” without providing the full picture.

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

Satisfactory

The release notes that the research was funded by the Ben & Catherine IVY Foundation and NIH grants.

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

Not Satisfactory

While there are no truly effective treatments for glioblastoma multiforme, in this case it would have been helpful to compare this experimental approach to others being studied. In particular, the release could have noted that gene therapy, therapeutic vaccines, radio-labeled drugs and antibodies are also being tested, including tests in patients, an important contrast to this study, which was just a cell culture test.

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

Not Satisfactory

Although the release is clear that this approach is experimental, by failing to clearly point out the fact that the drug has yet to be tested in a single glioblastoma multiforme patient, it obscures just how preliminary and tentative these results are.The release gives the reader the false impression that PPF has already been approved for this purpose with this statement:

“An advantage of small-molecule PPF — which has been previously used in clinical trials in an attempt to treat Alzheimer’s disease and dementia — is that it can penetrate the blood-brain barrier and reach the tumor. And, the FDA has already approved it.”

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

Not Satisfactory

The release fails to note that other researchers have previously released similar findings based on tests on propentofylline in rats and cell culture.

Propentofylline decreases tumor growth in a rodent model of glioblastoma multiforme by a direct mechanism on microglia.

Propentofylline Targets TROY, a Novel Microglial Signaling Pathway

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

Not Satisfactory

Calling this lab test “a significant breakthrough” misleads readers. Quotes and text throughout the release refer to potential benefits to patients even though this test was done in cell cultures. The actual effects in patients with glioblastoma multiforme are unknown.

Total Score: 1 of 10 Satisfactory

Comments (1)

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Vickie Smith

January 8, 2016 at 4:40 pm

I emailed Galen Perry, Vice President of Marketing and Communications at TGen to ask about the FDA approval issue. He emailed me with the following response within a couple of hours. I appreciated his timely response but the news was very disappointing. It’s hard to believe professionals could accidentally overlook inaccurate details in a scientific health related report.

His email follows:
Dear Ms. Smith,
Thank you for reaching out for clarification on PPF. First know, however, I am so sorry to learn of your loved one’s diagnosis of brain tumor.

I have spoken with one of the co-authors on the study regarding the repurposing of the drug, propentofylline, to arrest the invasive process of glioblastoma. While they are very encouraged by what they have discovered so far, the work is still very early. And while they believed the drug had received FDA Approval, it has in fact, not. That said, I am sorry for any confusion this has caused.

In the U.S., propentofylline is not available for use in humans (although it has been safely used in human clinical studies for over a decade), suggesting it may be a safe compound, but further work is obviously needed.

We will be revising our release shortly to correct his error.

Regards,
Galen Perry

Reply