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Cancer drug dramatically shrinks prostate tumors, study finds

July 22, 2008

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RATING:

This story reports on studies of a drug for aggressive prostate cancer. It overstates the importance of early research, garbles the findings, and exaggerates the benefits.

Our Review Summary

This Los Angeles Times story reports on research into abiraterone, a new drug being studied to treat aggressive prostate cancer.

The report overstates the importance of early research and improperly anticipates the findings of studies not yet completed. It predicts approval and arrival on the market the same year as the lead investigator, whose work is funded by the drug's patent holder. It garbles the findings in a way that exaggerates the benefits shown.

These significant shortcomings are unfortunate. The story itself, unlike many that involve early stage trials, is probably worth reporting. The drug operates by a novel mechanism and appears to be very effective against a fatal form of cancer that resists most treatments. A number of other studies are underway and experts in the field are genuinely hopeful this drug will provide an effective treatment for aggressive cancer.

With a few key additions, the story could have been more responsible.

  • The report should have said the results are from a Phase I trial and that efficacy and safety have not been proven. In order to justify its enthusiasm, the story should have provided some detail about what similar published studies have found. 
  • The reporter should have described the benefits shown in the research more accurately. 
  • The story should have said the drug may not be approved; it should not have predicted a date for an event that is not certain to happen.
  • It should not have speculated that the drug "could find use among most" of the 28,000 U.S. men diagnosed with aggressive prostate cancer each year. 
  • And it most certainly should not have taken quotes from a patient directly from a press release. That is inexcusable. 


 

Click on Criteria for definitions.

The story makes clear that the drug abiraterone is experimental and is not yet available.

The report says experts predict the drug will be "widely available" by 2011. This statement comes directly from the lead researcher, whose work is supported by the drug's maker. He makes the statement in the press release

This prediction should not have been published, or it should have been attributed to the self-interested researcher.

It should certainly not have been attributed to "experts," unless someone other than the lead investigator made this precise prediction independently. 

Not applicable
Discuss costs? - NOT APPLICABLE

The drug is not commercially available.

And since it is being tested to treat only a very aggressive, usually fatal form of cancer and not a chronic condition, we can accept the fact that cost wasn't mentioned at  this point.

The story does nothing to exaggerate the frequency or danger of aggressive prostate cancer.

The story is based on the findings of a very small Phase I study of only 21 men. The study was published in a major journal. A following study of 250 men continues and is reported to show "similar results."

The latter is risky speculation that at least should have been hedged with a reminder that it's too early to conclude the drug is safe and effective. 

The story properly discloses the drugmaker's interest in the study. 

 

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The story mentions that "Side effects were minimal." The study itself suggests that there were complications, particularly involving hypertension and adema, but they were easily managed.

The way the story ends--with the thought that the drug could have applications to those with less aggressive or deadly cancers--raises questions about the side effects. Those whose cancers are less serious would need to take into account the balance of benefits and harms.

The drug appears to remove all testosterone and also blocks estrogen. The reporter should not accept the assertion that side effects of this are "minimal."      

The story does an extraordinary job of explaining the novel mechanism by which the drug works, and how it is different from other "chemical castration" treatments.

The story does not appear to describe the findings accurately. The lede of the story says: "the drug shrank prostate tumors dramatically and more than doubled survival in 70% to 80% of patients with aggressive cancers."

According to the press release: "Clinical benefits included evidence of PSA falls and tumour shrinkage which was observed in 70-80 per cent of patients."

According to the study abstract: "Declines in prostate-specific antigen (PSA) ≥ 30%, 50%, and 90% were observed in 14 (66%), 12 (57%), and 6 (29%) patients, respectively..."

The man featured in the anecdote at the end of the story also appears in the press release. Two of the quotes are identical. [Emphasis added below.]

 The press release:

Simon Bush, 50, from London, was involved in the abiraterone clinical trial. He said: "Last year I was in severe pain because of my prostate cancer, which had worsened and spread to my bones. Chemotherapy and other treatments had failed and news that I had very few treatment options available to me was devastating for my family. Fitness and travelling were always my main interests and abiraterone has allowed me to have a year so far of near normality. The changes in my life have been dramatic, from managing thousands of people in a major bank, to facing a very uncertain future, then to renewed hope thanks to this drug trial."

The L.A. Times story:

Simon Bush, a 50-year-old retired banker in London, was one of the patients in the trial. First diagnosed with prostate cancer three years ago, he tried all other forms of therapy without success.


"Last year, I was in severe pain because of my prostate cancer, which had worsened and spread to my bones," he said.

He began taking abiraterone in May 2007, and the improvement began within a week. Within two months, he said, his PSA level -- a marker of tumor growth -- had dropped by 95%.

Within three months, he had stopped taking painkillers entirely and was able to resume a normal life.

"The changes in my life have been dramatic, from managing thousands of people in a major bank, to facing a very uncertain future, then to renewed hope thanks to this drug trial," Bush said.

The story quotes the lead investigator, whose work is funded by the drug's owner. The story reports this relationship. 

It also quotes three independent experts, two of them local in the Los Angeles market.

This sourcing is sufficient to meet the minimum criteria here. 

The story satisfactorily describes the current drugs used to treat advanced aggressive prostate cancer and indicates that they are generally ineffective.

Total Score: 4 of 9 Satisfactory

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