Prostate Cancer and PSA Screening - BIG Business!

DID YOU KNOW??!!

Prostate cancer kills almost 30,000 American men every year.  But worldwide almost all men will die 'with' prostate cancer but not 'of' it.  About half of men over 60 have prostate cancer, and most men will develop it if they live long enough.  After age 70, 80% of men have it, but most of those men will die of other causes. (http://www.jwatch.org/na31811/2013/08/08/prevalence-occult-prostate-cancer-autopsy-high). 

Dr. Albin, who first discovered PSA in the 1970's, was appalled to find out that two decades later, the FDA approved the use of PSA not only to test for recurrence of cancer, but also as a possible predictor of cancer.  Since then, Dr. Ablin maintains, "the United States spends billions each year administering a preventive prostate cancer screening test to men, using PSA, that produces false positives in the majority of cases."  http://www.medscape.com/viewarticle/828854

PSA test readings can differ depending on manufacturer and the way the kit is calibrated which differs from lab to lab.  Human error is also a factor.  Essentially, this results in diagnosing an unstable marker with an unreliable test.  In response to mammography, in the 1980’s, men wanted their own detection tool.  Fear of prostate cancer drove it and they formed their own advocacy groups.  Biotech and urology industries noticed there were 30 million age-appropriate American men who were candidates for screening and wanted it.  Next thing you know, a campaign was rolled out by major cancer organizations and the government.  The Post Office issued stamps advocating PSA tests in 1999.  PSA test has been misused for 30 years.

 “When powerful people repeat an idea often enough – even when it is false – a mind-blunting form of authority is established, and getting there can be an alarmingly swift process.”

The powerful Roswell Park was designated as the first National Cancer Institute Comprehensive Cancer Center

  • 1979 – researchers at Roswell Park Cancer Center purified and characterized PSA and developed a PSA test.
  • 1984 – Roswell Park received a patent for an immunoassay blood test in prostate cancer.
  • Roswell Park suggested that PSA could be a marker for cancer in spite of the fact that Dr. Ablin insisted since the beginning that this was not the case.
  • Technology handed it off to the biomedical industry and mistakenly promoted it as a cancer screening tool, “mass marketed to eager but uninformed doctors and their patients.”

THE PATH TO DECEPTION

Hybritech formed in 1978. The “most seductive product” in biotech business is a blockbuster cancer drug.  Hybritech needed a new revenue-generating product so they decided to develop a diagnostic test to generate revenue while developing therapeutic drugs...it's so much easier to get approval from the FDA for tests.  Hybritech’s scientists read about PSA and research at Roswell Park, and proposed making an antibody for prostate cancer.  

Scientists had to know that PSA was not cancer specific and could not be a marker for cancer.  According to Dr. Ablin they were motivated by money.  Hybritech licensed PSA antigen from Roswell Park, and developed Hybritech Tandem-R PSA assay.  Then Hybritech was purchased by Eli Lilly in 1985.  

December 9, 1985 - 14 men participated in an FDA advisory committee meeting - Immunology Devices Panel...4 voting members, 5 consultants, 3 FDA reps, and 2 presenters for Hybritech.  The FDA executive secretary stated the purpose of the meeting was to “discuss a tumor marker kit used as an aid in the management of patients with prostate cancer”.  Well, there's not much money to be made in monitoring men who already have prostate cancer.  The money is in testing all men who are over 50; 30-40 million tests per year!!

Hybritech had no data to support an early detection test; only a monitoring test. Sleight of hand used to justify it --> PSA was presented as a better marker than PAP (prostatic acid phosphatase), also produced in the prostate gland (already determined PAP was useless, so info presented compared PSA test against another useless test).  The presentation was made by Paul Lange, M.D., urologist and Chair of Urology Department at University of Washington Medical School.  Lange’s assertions were challenged numerous times during the hearing.  He was asked if factors other than cancer caused an increase in PSA, he acknowledged that this was so (massaging prostate increases PSA).  He could not defend the accuracy of the test.  He acknowledged that the choice of 4.0 ng/mL as threshold was arbitrary: “We could have changed the data, made it 6.0, 8.0, made it 10, anything we want.  Okay?"  Lange acknowledged that they had followed NO PATIENTS after PSA testing to determine if 5-year survival was improved...all of the data were retrospective - much more prone to error.

CONCLUSION OF PANEL -  The panel chairman said that the data were incomplete; prospective studies should have been done. BUT the 4 voting members approved the test subject to very strict limitations - to be used for monitoring men who had been treated for prostate cancer.  The FDA approved the PSA test for managing men who had already been diagnosed with prostate cancer. Any other use would be off-label. 

Now...the FDA is supposed to monitor and make sure drugs and devices are used for approved application (which the agency rarely does).  Even when caught, companies just pay fines, which to them is just the cost of doing business and then they continue on.  Marketing of PSA testing for screening general population represented flagrant violation of the terms of approval!  Since the FDA took no action against the off label use, other companies started making PSA tests too, including Abbott.

1997 - Abbott formed partnership with TAP which makes Lupron - suppresses testosterone & used to treat prostate cancer.  Doctors started prescribing Lupron for men with high PSA's who had not been diagnosed with cancer!  TAP was charged with bribing urologists, illegally inflating prices, and Medicare fraud; they paid a fine of $875 million!  

William Catalona, M.D. had performed over 6,000 radical prostatectomies using PSA to “recruit” his patients.  Many were celebrities who he used to convince others.  In 1995, he led a study...322 men with PSA levels between 2.6 and 4 were biopsied and 22% had “cancer”.  He led the charge to biopsy men with a PSA of 2.5 or higher.  When pressed, he admitted that the PSA test was not cancer specific and the cutoff of 4.0 was arbitrary.  Studies tend to look only at benefit and not at harm.  Catalona formed a relationship with Beckman Coulter/Hybritech. The company pays for his “research”, consulting fees, speaking fees; in exchange he promotes their PSA test.

In a FDA Hearing on June 29, 1993, using Catalona’s data, Steven H. Woolf (USPSTF) reported that the positive predictive value of PSA testing was 1.9%.  At least 50 men with elevated PSA's run the risk of becoming impotent and wearing diapers to potentially save one man.  There is no evidence that early detection of prostate cancer saves lives, not even one man benefits based on this metric.  He stated that “evidence” was from studies with serious design flaws and concluded that PSA testing costs billions and harms many.  It should be of no surprise that the AUA supports PSA testing, it’s how their members make money!

Peter Maxim, from NCI: “there is currently no data showing that early detection of prostate cancer by PSA reduces mortality or morbidity from this disease.”

FDA scientific advisor, Raynor Appell, PhD, reported that PSA was widely used and had become a standard of care in monitoring prostate cancer patients.  He skirted the early detection issue. He also reported that 3 different Hybritach tests showed 3 different results and acknowledged that the tests were unpredictable.  No one even questioned the variability in test results!

Jules Harris M.D., voting member of the panel:  “What I want to avoid is this panel giving out the impression to the American public that this is a test which should now be used in all 30 million to 40 million men in the United States who are 50 years and older and on an annual basis…it will overwhelm us in terms of cost.”

In 1989 Schering Plough paid $1.2 million to an advertising firm to promote Prostate Cancer Awareness Week. It became the nation’s largest screening program in history - the number of screening centers grew from 100 to 1,800 in 3 years!!!  Problem:  it’s illegal to promote off-label uses for products, and promotion started 5 years before the PSA test was approved for population screening! The FDA did not charge or discipline Schering-Plough!  90% of PSA tests were used off-label!

1995 - FDA’s Center for Devices and Radiologic Health sent warning letters to labs: stated that some labs were using PSA tests approved for monitoring patients with prostate cancer to screen the general population; stated that safety and efficacy for this purpose was never established; noted that different PSA tests produced different results and acknowledged that accuracy was arbitrary.

There are more than 1 million needle biopsies performed on American men every year after prostate screening.  An increasing number of men are becoming critically ill from antibiotic-resistant bacteria contracted during biopsy.  The biopsy needle drags bacteria from the bowel into the prostate and back out again, which can contaminate the bloodstream.  The FDA adverse report website lists hundreds of cases!

RADIATION

In terms of radiation, promoters of proton therapy state protons can be controlled and targeted directly to the tumor, allowing more radiation with less damage to surrounding tissue.  They state proton therapy is safer and causes less side effects (incontinence and impotence) than regular radiation treatment.  This is simply not true.  Currently, there are 11 proton centers in the US; 12 in development. They cost $200 million each. There is no evidence that proton therapy is better except for a very small percentage of patients, brain and spinal cord cancers.  Centers must generate business elsewhere, prostate cancer is an easy target - 250,000 new diagnoses each year.

According to Ezekiel Emanuel, M.D., advisor to the Obama administration:  “There is no convincing evidence that proton beam therapy is as good, much less better than, cheaper types of radiation therapy.  ”Medicare pays $32,000 per prostate cancer patient for proton therapy; standard therapy is only $18,000.  Analysis of Medicare patients showed that there is no evidence that proton therapy is better, or that side effects are less than traditional radiation; it does not extend lifespan.  SO...why is this reimbursable??  Once the FDA approves a drug, test, or procedure, insurance companies and government are obligated to pay for it even if it is useless. According to Zeitman, it's impossible for proton centers to make money without prostate cancer business.  

PSA IS BIG BUSINESS

PSA testing fuels business...not just tests and procedures - penile implants, erectile dysfunction drugs, urinary cuffs, artificial sphincters, catheters, diapers, etc.  All have a ready-made market - there are tens of millions of baby boomers who will inevitably be diagnosed with prostate cancer by virtue of their age - and will be herded into a system that leaves them incontinent and impotent.  65% of men aged 60-69 will be diagnosed with prostate cancer simply because of their age.

  • The incontinence business - $1.32 billion per year in the U.S.
  • The impotence business -  $1 billion per year (for just Viagra)  
  • The implants business - $500 million in penile implants every year in U.S. - $1.7 billion worldwide; surgery an additional $20,000 per man

Bottom line, men should be aware of all these factors so they can make well informed decisions as to whether or not to have a PSA screening.  The false positive rate for PSA testing is as high as 80%.  The Gleason score means nothing.  Biopsies are risky. Prostatectomy leads to incontinence and impotence, and does not extend life, even for men with prostate cancer.