The story reports on lapatinib (trade name Tykerb) – a tailored treatment for advanced Her-2/neu breast cancer. Several times in this piece this recently approved drug is called a "breakthrough". This is hyperbole and premature as this drug has not been studied in large numbers of women outside of clinical trials. The trial described in this story was stopped early due to the positive effect of the drug, so there is not yet long-term data to declare this drug a "breakthrough", especially as we do not have evidence this drug helps women with metastatic breast cancer live longer than with other therapies.
It is noteworthy that the patient profiled in this story was also used for a similar ABC News story on the approval of lapatinib. Coincidence? Or did drug company PR people and/or hospital PR people offer journalists the same woman because of her overwhelmingly positive experience with the drug?
The story also quotes the woman's doctor who was involved in the lapatinib study and has an interest in the positive outcome of the study. Other medical opinions are needed for this piece to provide balance, as we are only given the pros or taking this new drug which is again touted by this doctor as a "major medical breakthrough".
The story does not mention the potential harms of this newer treatment, but relies on one patient's testimony that she has "experienced no side effects". In clinical trials of lapatinib, side effects reported included: gastrointestinal problems, and hand-foot syndrome which may include numbness, tingling, redness, swelling and shortness of breath. More serious, but rare reports of heart failure (in most cases reversible) were also reported in clinical trials. The story also does not list the incidence of side effects common among women who took lapatinib with capectabine (Xeloda) – another cancer drug. The failure to include comments about the side effect profile of Xeloda is significant.
The story says that the woman profiled "had no other options" but to take the drug. This woman did have the option to forego further treatment for her metastatic cancer. The side bar describing different pharmaceutical therapies used in breast cancer treatment is a good addition to this story.
Lastly, The story should have included the cost of this new drug, which is $2,900/month and the fact that it is approved for use with another drug – capecitabine (Xeloda). Xeloda costs about $1,500/month. The story does not mention if the new drug is covered by Medicare or private health insurance.
The story should have included the cost of this new drug, which is $2,900/month and the fact that it is approved for use with another drug – capecitabine (Xeloda) – which costs about $1,500/month. The failure to include comments about the side effect profile of Xeloda is significant. The story does not mention if the new drug is covered by Medicare or private health insurance.
The story provides no quantitative evidence on the benefits of lapatinib over other targeted therapies for aggressive breast cancer.
The story does not mention the potential harms of this newer treatment, but relies on one patient's testimony that she has "experienced no side effects". In clinical trials of lapatinib, reported side effects included: gastrointestinal problems, and hand-foot syndrome which may include numbness, tingling, redness, swelling and shortness of breath. More serious, but rare reports of heart failure (in most cases reversible) were also reported in clinical trials. We are not told just how long a woman needs to take lapatinib.
There is some quantitative evidence from one clinical trial presented in this story, but it is incomplete. We are told that of 160 women, those who took lapatinib with a chemotherapy drug had double the time to recurrence (8.5 vs. 4.5 months with chemotherapy alone); however, we are not told of the trial design, how many women took lapatinib or their relative and absolute reduction in the risk of recurrence. We are told that there is no proven survival benefit from the drug, but the story relies heavily on one woman's testimony as well as that of her personal physican who also was also involved in the lapatinib study. Both are far from un-biased sources on this new treatment. Additionally, lapatinib is a new drug. The trial desribed was stopped early due to the positive effect of the drug, so there is not yet long-term data to declare this drug a "breakthrough", especially as we do not have evidence this drug helps women with metastatic breast cancer live longer than with other therapies.
The story does not engage in disease mongering as this drug is only for women with the HER2/neu gene, which means they have a more aggressive form of breast cancer in which cancer cells make too much of a certain protein.
The story quotes a physician who was involved in the lapatinib study and has an interest in a positive outcome. Other medical opinions are needed for this piece to provide balance, as we are only given the pros of taking this new drug touted by one of the researchers involved in the trial, who called it a "major medical breakthrough".
The story does mention Herceptin, chemotherapy and other drugs as treatments typically used prior to lapatinib in women with metastatic cancer. The story also mentions that lapatinib is given in combination with a chemotherapy drug. The story does say that the woman profiled "had no other options" but to take the drug. This woman did have have the option to forgo further treatment for her metastatic cancer. The side bar describing different pharmaceutical therapies for breast cancer is a good addition to this story.
The story mentions recent FDA approval of lapatinib and that it is expected to be on the market this year.
The story mentions that lapatinib (Trade name Tykerb) in various combinations – with and without Herceptin – is a tailored treatment for advanced Her-2/neu breast cancer. The story references the drug as a "breakthrough" several times. This term may be premature and hyperbole as this is a very new drug and has not been studied in large numbers of women outside of clinical trials.
We can't be sure if the story relied solely or largely on a news release. We do know it was based on the story of one woman and her doctor, who was involved in the trial. It is noteworthy that the patient profiled in this story was also used for a similar ABC News story on the approval of lapatinib. Coincidence? Or did drug company PR people and/or hospital PR people offer journalists the same woman because of her overwhelmingly positive experience with the drug?
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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