Dutasteride Black Box Warning Label is Inappropriate.

[janebob99]

This plot that I made goes back to the original paper by Thompson et al. (2003), that was the basis for slapping the Black Box Warning Label on Dutasteride prescriptions.

pubmed.ncbi.nlm.nih.gov/128...

There are some important points that should be considered:

(1) Thompson only studied Finesteride, not Dutasteride;

(2) The absolute difference in % of men who have high-grade prostate cancer (GS = 8, 9, 10) is very small (only 1%), as shown in the plot: 6% for men on Finesteride and 5% for Placebo. That's within the noise and is not statistically significant.

(3) Thompson et al. speculated in their paper that the large shrinkage of the prostate (~25%) when on Finesteride may cause an error (a "bias") that "affects the evidence".

It is true that the probability of a random biopsy needle hitting a tumor increases as the prostate volume decreases, (assuming that the number of tumors remains the same before and after Finesteride). That factor is called a "detection bias".

pubmed.ncbi.nlm.nih.gov/17848668/

After Thompson et al. was published, doctors and researchers have written papers/comments that the black box warning label on Finesteride and Dutasteride should be removed.

I agree!!

Bob Watson

[Justfor_]

No catastrophising on the other side of the pond.

[janebob99 in reply to Justfor_]

What do you mean?

[Justfor_ in reply to janebob99]

No silly warnings on the Avodart box, apart from: "To be used by men only".

[janebob99 in reply to Justfor_]

Gosh, maybe they removed the label! I will investigate. Thanks!

[janebob99 in reply to janebob99]

I checked ChatGPT, and you are correct. There is no warning in the UK for high-grade PCa. Only in the USA. Good catch !

[lancer82801]

To me this is a problem that should at least be discussed prior to treatment

Video for your information

[j-o-h-n]

Blimey, It may be on the left side........... Yanks on the right side.........

Good Luck, Good Health and Good Humor.

j-o-h-n

[RodriguezJ]

Hi Bob Watson! Thanks for the insightful analysis. Let's break it down further.

First, it’s crucial to note that the study by Thompson et al. (2003) focused specifically on Finasteride, not Dutasteride. While these drugs are similar in their action, they inhibit different types of 5-alpha-reductase, which might affect their safety and efficacy profiles differently.

Second, the absolute difference in the percentage of men with high-grade prostate cancer (Gleason Score 8, 9, 10) is indeed very small—only 1%. As you correctly pointed out, this is within the margin of statistical noise and is not statistically significant.

Third, the issue of prostate volume reduction with Finasteride is also important. A significant reduction in prostate size (~25%) could indeed introduce a detection bias, as the probability of a biopsy needle hitting a tumor increases when the prostate volume decreases, assuming the number of tumors remains constant. This factor could potentially skew the results, which the original authors acknowledged.

After the publication of Thompson et al., many doctors and researchers have written papers and comments suggesting that the black box warning on Finasteride and Dutasteride should be reconsidered.

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I agree with you!! Thank you for your contribution to this discussion!

[janebob99 in reply to RodriguezJ]

Thank you for the positive feedback! I appreciate it. I agree with everything you have said.