This story about a drug company’s announcement of positive study results fails readers in every important way.
It portrays a "decisive" clinicial trial that shows a first-of-its-kind prostate cancer drug "prolonged the lives of men." It spins the tale of a determined company rewarded for its persistence against a slow-witted bureaucracy, whose earlier inaction led to the loss of "a lot of good men." It presents testimony of a cancer-stricken patient "looking into the abyss," seeking only "a chance." It anticipates the drug’s approval, and documents Wall Street’s instant validation of the study findings.
Not until paragraph eight does the story state that the company has not released the results, that the findings will not be discussed in public for two weeks, and that even then they will not have been peer-reviewed or published. It does not say that the results of this medical study were announced in a conference call to investors.
It recklessly, even perversely, suggests that the FDA’s earlier inaction, combined with patient protests and what are now claimed to be positive results, constitute proof of efficacy.
It’s hard to imagine why a story would delay and omit key information, imply efficacy had been demonstrated in the absense of evidence, or fail to balance all the positive views with those of a skeptic, or at least someone who urges prudence until the data are made public.
It is true that this story was originally published in the paper’s business section. But all journalists share a common responsibility to the public when writing stories about diseases and treatments. In today’s media environment, where a story’s readers usually encounter it out of context of a "section," few readers will be "savvy" enough, if that is the word, to bring lower expectations of accuracy, balance and fairness to a story about what a drug can do for a deadly disease merely because it was originally written for the "business" section.
It’s painful to imagine how families affected by advanced prostate cancer may respond to this article, and then to what they will subsequently learn. Even investors are badly served by such an unbalanced, incomplete story.
In any case, it is distressing to see such credulous, feeble, negligent journalism published anywhere in the New York Times.
While the story anticipates approval and comments on the drug maker’s stock price, it fails to anticipate the drug’s cost or comment on the expense required to extend life by several months.
The drug maker’s chief executive is quoted saying the results were "an unambiguous hit on the primary endpoint of overall survival." It paraphrases his saying the outcome met the goals the FDA had previously set for the drug.
The story additionally paraphrases the chief executive verifying that the drug "would have had to reduce the risk of death by 22 percent compared to a placebo" to meet FDA requirements.
The chief executive is parsing his language very carefully, skillfully avoiding making an explicit claim about the drug’s proven benefits.
Rather than stating that the chief executive would not plainly describe the results, the reporter enables his evasion by connecting the dots between what the FDA said must be shown with the chief executive’s assurances that it had been.
For context, see "Relies on Press Release," below.
The story suggests the drug’s side effects are milder than those of standard chemotherapy. But the source of this assessment is a member of the study team who is a consultant to the drug maker.
There is no description from an independent source of the drug’s safety profile.
The story does not report until paragraph eight that the "decisive" study results have not been released by the company and will not be presented at a medical meeting for about two weeks.
The story does not indicate that even then, the results will not have been peer-reviewed or published.
The story quotes the drug maker’s chief executive estimating that 100,000 American men per year are diagnosed with cancer that has spread beyond the prostate gland and is not benefitting from other therapies.
The reporter should not have depended on this self-interested source.
Other news stories, quoting a variety of independent sources, estimated the number of affected men at 40,000 to 60,000 per year.
In addition, the reporter allows a source with dual conflicts of interest–he is a patient who could benefit from the treatment and a stockholder in the company that makes the drug–to make emotional appeals for approval.
He says many men have been "lost" since the FDA’s failure to approve the drug, and that he and other patients are "looking into the abyss" and just "want a chance" to live.
The story quotes six sources:
Too many sources are biased in favor of the company and its product, and they are given signficantly more space in the story than independent voices.
There is no source who is openly skeptical or even ambivalent about the findings. There is no one who suggests that conclusions made before findings are published may be premature.
The story says the only approved treatment for the cancers Provenge treats is Taxotere, which has been shown to extend life by three months.
This may be technically accurate as stated. But the American Cancer Society lists at least eight other chemotherapy agents used to treat advanced prostate cancer.
The story describes the findings of the clinical trial as "decisive," and speculates the "widely anticipated results could pave the way" for the drug’s approval.
The result is to imply imminent availability, an outcome that is by no means certain.
The story accurately describes Provenge as a novel type of cancer vaccine therapy. It describes the history of similar drugs, none of which has been approved.
The story’s tortured formulation suggesting that the goals the FDA had set for the drug had been met–while avoiding plainly stating what the FDA had required and what the results showed–first appears in the company’s press release.
Dendreon Corporation (Nasdaq: DNDN) announced today that the pivotal Phase 3 IMPACT study of PROVENGE® (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study’s design.