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GlaxoSmithKline seeks new approval for breast drug
April 01, 2009
Reads like a drug co. news release. Costs (several thousand a month) not mentioned. Woefully incomplete tally of benefits and harms. Women with advanced breast cancer deserve better information.
Our Review Summary
A drug company applies to expand its approval for a drug (Tykerb) for advanced breast cancer in the US and Europe.
And the only source quoted in the story is an employee of the drugmaker. That is not sound journalism.
The story failed to:
- discuss costs, which are considerable with this drug;
- give a complete description of common side effects and rare but serious problems that can occur;
- quantify the benefits that the drug company put in its application for expanded approval.
Instead, the story read like a drug company news release. Women with advanced breast cancer deserve better information than this.
Finally, the story failed to give the highly significant context that just last month the UK's National Institute for Health and Clinical Excellence (NICE) recommended that the drug "should not be used, except in the context of clinical trials, as it is not a cost effective use of resources."
Click on Criteria for definitions.
The angle of the story is the drug company applying for approval in the US and Europe for its drug Tykerb as a first-line treatment for advanced breast cancer that is hormone sensitive..
There was no mention of cost - and Tykerb is a VERY expensive drug - thousands of dollars each month.
The study didn't exaggerate the condition of advanced breast cancer.
The story cites one GlaxoSmithKline study presented last December. But is that the entire body of evidence upon which the new approval application is based? Because it's the only evidence cited in the story.
The story says that Tykerb can damage the liver and harm a fetus. But that's an incomplete listing. Tykerb can cause rare but very serious problems with heart failure and pulmonary toxicity. The drug can also cause diarrhea, skin rash, swelling, redness, pain and or peeling of the skin on the hands and feet, anemia, nausea and vomiting - along with a host of less common side effects. The story was way off in this regard.
The past use of Tykerb was clearly explained in the story.
There was no quantification of benefit in the story - strange when the entire story is about the drugmaker seeking new approval for the drug. Upon what evidence is that request based?
We can't be sure the extent to which the story may have relied on a news release. We do know that the only source quoted in the story was from the drugmaker.
The only source interviewed in the story is an employee of the drugmaker. Where was any perspective from an independent clinician?
While the story gave a brief description of hormone therapy combined with chemotherapy, it wrote these off as causing "nasty side effects" without giving any substantive data-driven comparison of this approach vs. Tykerb, whose side effects can be pretty "nasty" as well.
Total Score: 3 of 9 Satisfactory
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