June 20, 2013 ~Mark K. is a laboratory technician whose job it is to read PAP smears, the annual test recommended to screen for cervical cancer for most women. In a rare insider opinion, he shares with readers of MDND what he feels is not working.
It is a rare look at what many rank and file technicians are afraid to say about this commonly used medical device. Thank you Mark for speaking up!
I am a laboratory technician who screens pap smears, a cytotechnologist, cytotech for short, and I believe that fraud is taking place in this field as a result of falsely advertised and/or dysfunctional products approved by a scandal-ridden Food and Drug Administration.
Currently most pap smears are no longer smears, they are monolayered preparation. The cellular material is dropped into a vial containing an alcohol solution. Some mucous and blood are dissolved and debris is removed. The sample is deposited on a slide in a single cellular monolayer. The great majority of cytotechs like it, including myself, as it is easier to read. Apparently the major reason it is in place is because of higher profitability.
The monolayer pap has an apparent dark side. It is advertised as being extraordinarily more accurate than a conventional pap smear. One corporation cites studies claiming accuracy increases of over 100-230 %. A Dutch-Belgian study, published in 2009 in the Journal of the American Medical Association, found no increases. The U.S. Preventive Services Task Force concluded the same. An Australian study found an increase of 12 %. I think we may have seen an accuracy increase of 5-10 % at my laboratory. It appears that the manufacturer has major credibility issues with honesty in advertising.
Mark K. FB page on FDA
The apparent deceptive advertising may be deliberate for the monolayer pap may have really been designed for an FDA approved, computerized microscope. One is advertised as being approximately 20-45 % more accurate than a cytotech alone. Our lab did not see any accuracy increases. Studies in Australia, Ireland and USA concluded the same. More dishonest advertising? Apparently the device is highly profitable. It significantly increases the cost of the pap test.
After our lab procured the computerized microscope , we were alarmed by the tendency of the device to miss abnormal cellularity if present in large clusters. We also noticed that the device tended to zero in on air bubbles, chips in the glass, dirt, dark colored benign cells or just blank space. In many cases, abnormal cellularity seemed to be found by accident. The artificial intelligence of the device appears slipshod. Sometimes the device finds abnormal cells quite well, but this is an exception, in my experience. In my opinion, the device is not worth the money spent on it.
Then we wondered: How could this device have gotten past the scrutiny of the FDA? Ideas surfaced. In April 2008, a Readers Digest article, Can We Trust The FDA? , the author claims the FDA is the best agency the pharmaceutical industry can buy and said the agency is lurching from one disaster to the next , one shocking lapse after another. A CBS author wrote in Money Watch, March 10, 2010, that the FDA is riddled with politics, conflicts of interest and outright corruption. Later citing issues of data manipulation and harassment of whistle blowers. The New York Times, on July 15 , 2012, exposed a massive FDA spying debacle of some 80,000 pages involving the unit that investigates medical devices.
Alleged FDA impropriety and incompetence may have allowed harmful medical devices to be marketed. A whistleblower lawsuit claims FDA scientists warned that the agency approved colonoscopy and mammography instrumentation that delivered dangerous radiation doses . Those scientists were spied upon and fired. In their book, The Battle Over Health Care, authors Gibson and Singh point out that of the high-risk medical devices recalled by the FDA, 75 % were never evaluated. Some 20 % of cardiac defibrillators were recalled and hundreds died due to malfunctions. Many cytotechs suspect that the computerized microscope was rubber stamp approved because of some combination of corporate financial hooliganism and FDA absentmindedness.
Some cytotechs have complained to the FDA to little avail. One reason is that corporate representatives and laboratory managers seem to have a well crafted stratagem of obfuscation tactics to deflect criticism and outmaneuver Federal regulators. An author for TIME Magazine wrote that such tactics are “disturbingly common,” in an August 23, 2010 article: Is the FDA on Drugs?
Cytotechs complaining to supervision about the computerized microscope is often analogous to telling The Flat Earth Society that the Earth is spheroid. Data , studies , FDA slovenliness , errors or haphazard handling of cancer cases mean nothing . They sit with a blank faced insouciance. I presume their only concern is the profitability of the device. Cytotechs can face scathing vitriol for protesting and many are afraid to speak up.
While outright misses by the device seem more frequent than by a cytotech, they are not high in number. When they do occur, the missed cellularity is often clearly visible; near misses are common. This should make lab supervision nervous, most seem unconcerned. Often, misses are never discovered.
I asked my senior lab manager: How would you justify to the women in our community that this device is beneficial and worth the extra money charged? She looked stunned, totally silent, no response.
The computerized microscope appears to be a typical case of a substandard, fraudulent medical product getting past a sleeping and/or corrupt governmental watchdog. Its use constitutes a cavalier disregard for basic bio-medical ethical standards that is totally cynical and leaves much to be said for the quality of the character of involved corporate elites, their sales representatives and laboratory managers alike.
Thank you very much for your consideration,
Mark J Krause
22 May 2013