How can you help?   

I've tried to make it easy for you to make your(our) voice heard by doing the following

I've included my comments, below and in a text document. These were entered in the USPSTF website on Monday morning. Dave Stevens has worked mightily and will overnight a letter to the USPTF leader on Monday overnight.  Edits to the letter may occur during the day tomorrow but the current version will be kept on the ProtonPals website.   

In order to make comments on the Recommendation Statement you'll have to navigate over to the site and enter your comments in each of 6 text entry panels on the form. Your comments are confidential and will serve to overturn or significantly change the classification of the draft.  

Make Your Comments at this location  

Text Entry Area 1:
How could the USPSTF make this draft Recommendation Statement clearer?  

I believe the Recommendations Statement is premature and inaccurate because of the reasons stated in the letter and we strongly urge that it be withdrawn.

"November 7, 2011 letter by David O. Stevens on behalf of ProtonPals to Dr. Cosby, USPSTF"  The letter in PDF. 

Noting the Clarifications that You Need to Make:

The Recommendation Statement plus your communication with the media and in conference calls you gave us the impression that:

PSA test is not effective in reducing cancer deaths. There are recent randomized trials which confirmed that the PSA screening test reduces deaths from prostate cancer, by as much as 44%,

Prostate cancer is a slow growing indolent form of cancer common in old men and only a small percentage of cancers which are diagnosed will cause problems. What's needed is an emphasis on saving lives with a clarification stating that prostate cancer is a killer and the most common non skin cancer in men in the United States, and the second leading cause of cancer death in men. Over 30,000 men will die from the disease in 2011. (American Cancer Society and American Urological Association. http://www.auanet.org/content/media/psa1.pdf 

We're led to believe that treatment at any stage is equally successful based on how the analysis was done. It should be emphasized that if caught early PCa is easier to treat and the cure rates are higher; but diagnosis at a late stage does not automatically lead to the same degree of cure rate.

In crafting the study and the report prostate cancer specific death was the only metric of interest in the analysis. It should be made clear that delays in receiving a diagnosis may lead to more advanced disease with men presenting at a later stage, and that means more toxic treatment.

The test is harmful. Clarification should be made that the PSA test is only a simple blood test very much like a venipuncture to run a lipid or liver function panels. In addition the test is not the diagnostic and is the first in the diagnostic tree. The second step when the DRE is considered.

Text Entry Area 2:

What information, if any, did you expect to find in this draft Recommendation Statement that was not included?

 

We expected to see acknowledgement that there are some facts which are irrefutable as reported by eminent experts in the field of urology. They are:

• The mortality from prostate cancer has decreased coincident with the use of PSA screening over the last 25 years.
• Over that same period there has been a stage migration in diagnosis, meaning it is much less common to see patients presenting with metastatic or even extensive local disease
• It is illogical that late, advanced disease is as easily cured or successfully managed as early stage disease detected with PSA screening.
• The PSA test is just the start of a diagnostic tree and the best practices used by centers of excellence to diagnose and track the severity of original diagnosis is considerably more complex. They do not rely on the PSA test alone to determine if a cancer is aggressive and should be treated.  

Ref: "November 7, 2011 letter by David O. Stevens on behalf of ProtonPals to Dr. Cosby, USPSTF"

Text Entry Area 3:

Based on the evidence presented in this draft Recommendation Statement, do you believe that the USPSTF came to the right conclusions? Please provide additional evidence or viewpoints that you think should have been considered?  

The conclusions reached by USPSTF are premature and inaccurate. Regrettably the recommendations are so specific and have had such wide publicity the we believe much harm has been done. 

Reasons:

All data published was not reviewed and the interpretation of the data has been called into question by many experts.

Best practices of specialists/physicians who have prostate cancer patients in their care was not studied, or if studied their approach to stratifying risk, i.e determining which cancers are aggressive, was not used in crafting the draft of the Statement.  

Results of recent studies show that overtreatment is exaggerated in the literature and popular media.

Presenting very specific recommendations that would pull the PSA test without an alternative stratified approach to screening is harmful.

Given the draft Recommendation Statement private insurance companies and Medicare have started their studies to discontinue reimbursement.

Text Entry Area 4:

What resources or tools could the USPSTF provide that would make this Recommendation Statement more useful to you in its final form?

The Recommendation Statement is focused on the slow growing form of cancer and makes the argument that doctors who have prostate cancer patients under their care cannot tell the indolent cancer from the aggressive cancer. That is completely wrong and as an example the AUA has done a superb job of setting up guidelines and of assessing relative risk. Studying how urologists, genitourinary oncologists track their patients would have made all the difference in the focus of the Recommendation Statement. Use of ERSPC risk stratification process would have been far more beneficial to the population than coding the PSA test as Class D.   
Ref: "November 7, 2011 letter by David O. Stevens on behalf of ProtonPals to Dr. Cosby, USPSTF"

Text Entry Area 5:   

The USPSTF is committed to understanding the needs and perspectives of the public it serves.  Please share any experiences that you think could further inform USPSTF on this draft Recommendation Statement.

My study in this area started 5 years ago when I was diagnosed with prostate cancer after a specific PSA velocity change. I am a 76 year old patient survivor was was diagnosed with T1C, Gleason 6 with a PSA of 4.2.  While I was being treated we started a survivors group that eventually grew to become a non-profit with an all volunteer support team and a contact list of over 900.  In my group's volunteer work with a 22 prostate patient contact list, we take calls and notes from a national population and come in contact with exceptions to almost all the recommendations made in the Recommendation Statement. These exceptions are supportive of early detection as any age not only to continue with a quality of life but prolong life.
What would you say to our oldest member, the sharp, active 90 year old research scientist from the famous nuclear physics lab with no comorbidity? 

• Men who are active in their 80s and 90s with no comorbidity and many years of life expectancy after treatment with low or no side effects.
• Physicians who did not get screened annually because of guidelines like this one that said only 2% of men under 50 are expected to have prostate cancer;  but they presented as a patient with late stage metastatic prostate cancer with PSA of 20.  
• Men who did not have complete physical work ups prior to being diagnosed, like a 15 second DRE.  PSA was 2.2 with no velocity low but on a digital exam presented palpable nodules.
• Men who were diagnosed with a recurrence after surgery, only much later than then optimal because did they not get a physical DRE. 
• Men who believed in the stratification but went on an active surveillance program and learned of having a late stage disease.

Do you have other comments on this draft Recommendation Statement?

Rather than highlighting the risk of side effects, as a scare tactic (as some renown experts have labeled the headlines from the committee), along with the Task Force giving the impression of a low threat disease, you should have headlined and reported the reality -  that prostate cancer being one of the top ten causes of death (32,000 men dying of metastatic cancer in 2011) should be stated. (American Cancer Society).

Public media statements by the Chair disparaging the use of PSA screening should be retracted and stated in context of "do no harm." Several studies not cited in the Recommendation Statement show irrefutable data that support 1) PSA screening saves lives. 2) Use of PSA screening has led to stage migration of 40% over 25 years.