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The PSA Fiasco

Posted Jun 20 2012 12:24pm

Stanley Feld MD.FACP,MACE

It is common knowledge that prostate cancer is a slow growing cancer. It is also believed that something happens and suddenly this slow growing cancer becomes aggressive and then metastatic.  

As the cancer increases in size, the Prostatic Specific Antigen (PSA) value increases. It is obvious that a baseline PSA should be obtained. The PSA’s value should be followed yearly to see if it is increases over time. 

The United State Preventative Task Force’s (USPTF’s) conclusions are incorrect. There are problems with the studies reviewed leading to its conclusions.

The media sensationalism of the USPTF’s conclusions was an indictment of PSA testing and urologists’ judgment.

"The USPSTF concludes that there is moderate certainty that the benefits of PSA-based screening for prostate cancer do not outweigh the harm," the report stated.

“The U.S. Preventive Services Task Force said in a report that the  PSA test is too inaccurate , creates needless anxiety for patients, and can lead to costly and potentially harmful follow-up procedures”.

Clinical judgment by physicians is ignored by the USPTF. The PSA increases as prostate cancer progresses. How are you going to know if the PSA is increasing, if you do not have a baseline PSA?

The nation's leading urology associations are fuming over a USPTF report  that discredits the widely used prostate-specific antigen-screening test for prostate cancer.

 "It's an absurd recommendation. It is ill-researched and ill-conceived," Sanford J. Siegel, MD, a board member with the Large Urology Group Practice Association, told HealthLeaders Media. "This will only do damage to all the great work that has been done for prostate cancer awareness and to control the deaths from prostate cancer."

The USPTF should have at least had an urologist on its task force to evaluate the literature of PSA testing.

The USPTF is a “non-government agency” that will be used by the administration to ration medical care.

How can the government say it advocates preventing cancer when it’s setting us up to restrict access to care (prevention)?

American Urological Association President Sushil S. Lacy, MD, said in prepared remarks that he was  "outraged" by the report . "It is inappropriate and irresponsible to issue a blanket statement against PSA testing, particularly for at-risk populations such as African-American men," Lacy said. "Men who are in good health and have more than 10-15 years life expectancy should have the choice to be tested and not discouraged from doing so."

 The American Association of Clinical Urologists issued a similar  statement   week,

The AACU called the USPSTF recommendations "misleading and harmful."

The major urological associations say the USPSTF ignored new studies supporting the value of PSA tests, and that the panel refused to address concerns they raised about the conclusions during the comment period. In addition, the urologists complain that there were no urologists or oncologists on the panel.  

The major urological groups said,

 "It is just a screening test, one of several things we look at when we decide whether a man needs a biopsy or not," he says.

"Yes, it is true that many men can live with this disease their whole life. That is why active surveillance has become a treatment option," he says. "If we knew in advance who would and who wouldn't advance in the cancer, that'd be great!"

"There is no question that men get prostate biopsies that obviously in hindsight shouldn't happen.  But we are looking at improving PSA testing and other testing to help us find out which men will progress with more advanced prostate cancer."

The problem is that no one has yet come up with an alternative to determine which patients will develop advanced prostate cancer

There is case of a famous Texan who yearly had normal PSAs. His physicians told him it was not necessary to get further PSA test since he had been normal all these years. He was now past 80.   

At 86 he presented with severe bone pain.  Laboratory studies and a bone scans revealed a sky-high PSA (over 100) and widely metastatic prostate cancer.

If his PSAs were monitored the rising PSA would have been detected perhaps early enough to cure him. Prior to the bone pain this man felt perfectly well.

Urologists have many of these same stories.

The USPTF conclusion might aid clinical judgment. However, it should not trump clinical judgment.

Obamacare is getting set to make committee judgments about healthcare policy and clinical care while ignoring physicians’ clinical judgment.

 About 250,000 men are diagnosed with prostate cancer each year. The diagnosis is made by physical examination and PSA measurement. The final diagnosis and decision for surgery or radiation is made after a fine needle biopsy of the lesion.

A prospective double blind study does not exist to predict the grade of cancer that will be cured by surgery, radiation or no treatment.

Nor is there a study for the USPTF to grade about quality of life post op compared to the quality of life during progression of disease. Until then the USPTF conclusions on the basis of the studies they did review are relatively meaningless.

The incidence of 250,000 new cases of prostate cancer a year has been stabile over the last 30 years. 

With early detection the number of males dying per year from metastatic prostate cancer has dramatically fallen from 48,000 per year to 28,000.

 The USPTF statement does not seem correct,

“It could find no evidence to support claims that PSA tests are responsible for "reduction in all-cause mortality."

"Many more men in a screened population will experience the harms of screening and treatment of screen-detected disease than will experience the benefit."

The USPTF report ignores the dramatic decrease in deaths from prostate cancer over the last several decades.

Dr. Marc Siegel, a practicing urologist for 30 years, said,

 When I started training, 40% of African-American men at that time presented with metastatic disease. Now that number is miniscule," Siegel says. "Tell me how that happens without early screening? How do death rates go down from 48,000 when I trained to 28,000 now? How do you explain that without screening? You can't! It's impossible!"

I believe the defect in the USPTF conclusions have to do with the specificity of the PSA and not its clinical value. A more accurate PSA test needs to be developed.

The USPTF’s conclusions will save President Obama a little money in the short run.

However, the cost of care for prostate cancer along with the morbidity and mortality will cost Americans greatly in the long term. 

  The USPTF has to re-examine its premises and methodology.

 

The opinions expressed in the blog “Repairing The Healthcare System” are, mine and mine alone

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