Who says there’s no more creativity in American business?

Alzheimer’s disease is a brain disorder named for German physician Alois Alzheimer, who first described it in 1906. (He forgot about it shortly thereafter.  Kidding!)  Alzheimer’s is a progressive and fatal brain disease. As many as 5.3 million Americans have Alzheimer’s disease. Alzheimer’s destroys brain cells, causing memory [...]]]> Source:  AARP Bulletin, July 2010

Who says there’s no more creativity in American business?

Alzheimer’s disease is a brain disorder named for German physician Alois Alzheimer, who first described it in 1906. (He forgot about it shortly thereafter.  Kidding!)  Alzheimer’s is a progressive and fatal brain disease. As many as 5.3 million Americans have Alzheimer’s disease. Alzheimer’s destroys brain cells, causing memory loss and problems with thinking and behavior severe enough to affect work, lifelong hobbies or social life.  It is the seventh-leading cause of death in the United States.

The most common form of the disease is dementia (general memory loss) which interferes with daily life.  The disease is currently without a cure.

A small company in Philadelphia (of all places), Avid Radiopharmaceuticals, has offered information on a radioactive dye which may be used in connection with currently existing PET scan technology.  The dye “sticks” to the plaques (a protein known as beta-amyloid) on the brain which are associated with Alzheimer’s and appear whiter on the scan.  Reportedly, the dye finds and highlights plaques in 97% of the PET scans.

The test, if approved for marketing by the US Food & Drug Administration, could help diagnose the disease in its early stages to allow for medical intervention.  For those suffering along with a family member who has Alzheimer’s the value of added time can not be denied.

~Posted by D.M. Schwadron, Esquire

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

 The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or [...]]]> FDA NEWS RELEASE

The U.S. Food and Drug Administration today announced approval of the first rapid blood test for antibodies to the hepatitis C virus (HCV) for individuals 15 years and older.

 The OraQuick HCV Rapid Antibody Test is used to test individuals who are at risk for infection with HCV and people with signs or symptoms of hepatitis. HCV is transmitted through exposure to infected blood, which, for example, can occur during intravenous drug use. The virus can also be transferred from an infected mother to her child. Hepatitis C can lead to liver inflammation and dysfunction and, over time, to liver disease and liver cancer.

 OraQuick is a test strip and does not require an instrument for diagnosis. It takes about 20 minutes to obtain results from the test.

 “Approval of OraQuick means that more patients can be notified of their HCV infection faster so that they can consult with their physicians for appropriate health measures,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Getting faster treatment is an important public health step to control this dangerous disease.”

OraQuick is not approved for HCV screening of the general population.

 According to the U.S. Centers for Disease Control and Prevention, there are approximately 3.2 million people in the United States chronically infected with HCV and each year, about 17,000 people are newly infected. Chronic HCV infection is a leading reason for a liver transplants in the United States and HCV is associated with an estimated 12,000 deaths annually. Approximately 75 to 85 percent of people who become infected with the hepatitis C virus develop chronic infection.

 OraQuick is manufactured by Bethlehem, Penn.-based OraSure Technologies Inc.

 Gayle R. Lewis, Esquire

The CDC’s National Healthcare Safety Network (NHSN) (If you think we have too many governmental organizations now, just wait) has compiled its first (Yes, first) State-Specific Summary and Report on Healthcare-Associated Infections.

The results of the NHSN’s 18 page (including references) report are not entirely clear.  However there are [...]]]> Source:  US Centers for Disease Control & Prevention

The CDC’s National Healthcare Safety Network (NHSN) (If you think we have too many governmental organizations now, just wait) has compiled its first (Yes, first) State-Specific Summary and Report on Healthcare-Associated Infections.

The results of the NHSN’s 18 page (including references) report are not entirely clear.  However there are some interesting things which can be discerned from the Government-speak and statistical analysis.  Between January of 2009 and June of 2009 (That’s 6 months)  The State of New Jersey reported 72 central line-associated bloodstream infections from 100 different healthcare facilities in the state. The facilities are not specifically identified in the report.  Neither do we know, for example, if 1 or 2 of those facilities accounted for the majority of the 72 blood stream infections from central-lines.

During the same time frame, the Commonwealth of Pennsylvania reported 204 central line-associated bloodstream infections from 253 different healthcare facilities. You may be wondering how this compares with infections in the State of Rhode Island.  Well Rhode Island reported only 1-4 central line-associated bloodstream infections from 16 healthcare facilities between January 2009 and June 2009.  New York reported 182 central line-associated bloodstream infections from 182 facilities.

Here’s where it gets interesting.  Well to us anyway.  Between January 2009 and June 2009, 818 hospital-associated infections were observed in the Commonwealth of Pennsylvania. Oddly, the NHSN predicted that number would be 1,176.83 which at first glance might suggest that Pennsylvania hospitals are doing something right.  That is until you recognize that there were 818 hospital-associated infections observed and who knows how many others might have been unobserved or unreported as hospital-associated infections.

During the same time frame, the State of New Jersey reported 183 observed hospital-associated infections which was close to the predicted 222.97.

So what does this all mean?  First of all, the report is the result of a limited mandate to report specifically on central line-associated blood stream infections.  Although it is clear from the total number of observed infections in the report that more types of infections were reported.

The back story: From June 2008 to December 2008, Pennsylvania’s own Department of Health reported 13,771 hospital-acquired infections, the most common were Urinary Tract Infections from catheters (UTI’s) (24.83%), surgical site infections (22.23%) and intestinal infections (18.15%).  So why is the CDC concerned only with central line-associated blood stream infections?  Good question.  30% of Pennsylvania hospitals using central lines had more infections than expected as compared with the rest of the US. Therefore Pennsylvania was flagged for reporting.

The State of New Jersey, late to the infection reporting party, only implemented legislation requiring reporting in 2007.  Accordingly, the NJ Department of Health and Senior Services first report on State hospital-associated infections will not be released until the end of 2010.  We await that report.

~Posted by D.M. Schwadron, Esquire

Still think screening for breast cancer doesn’t matter?  In this country there is a lot of debate about that very topic.  Opponents of screening suggest that it results in over-treatment for “lumps” that may be benign cysts or nothing at all.  What is over-treatment?  Sometimes simple referral for ultrasound [...]]]> Source:  BBC Health; Journal of Medical Screening

Still think screening for breast cancer doesn’t matter?  In this country there is a lot of debate about that very topic.  Opponents of screening suggest that it results in over-treatment for “lumps” that may be benign cysts or nothing at all.  What is over-treatment?  Sometimes simple referral for ultrasound or MRI and sometimes referral to a breast surgeon for aspiration (withdrawing cells through a needle), biopsy (cutting out a portion of the lump) or excision (removal of the lump).

Well the latest study, out of England, focused upon 80,000 women aged 50 and over.  (Women in England between 50 and 70 receiving screening every 3 years under the National Health System).  The results?  Over a period of 20 years,  5.7 (yeah, I don’t know what a .7 person is either) breast cancer deaths were prevented for every 1,000 women screened.  2.3 of those 1,000 women were told they had a lump of unclear significance.  Okay, that’s raw numbers, what does it mean?  Well, for every 28 cases diagnosed, 2.5 women had their lives saved and 1 woman was over-diagnosed.

According to the authors of the study, “The benefits in terms of numbers of deaths prevented are around double the harm in terms of over-diagnosis.”  Projecting forward leads them to believe that, “A significant reduction in breast cancer deaths in association with mammographic screening.”

Because of research such as this the NHS plans to extend mammography to women 47 to 73 by 2012.  Meanwhile, here in the United States and with the possible implementation of a National Health Care Service we appear to be going in the opposite direction.  Here we debate the costs of screening women under 50.  Whether or not it’s prudent.  Economically effective.  And whether or not too much screening, rather than resulting in more diagnosis and lives saved, results in over-treatment (read more money).

And back across the pond, a spokesperson for Cancer Research UK, Sara Hiom, was quoted saying, “What we need to remember is that detecting cancers earlier generally means improved survival.  And we know through trials and through research that breast cancer screening can save lives.”

Deputy Directer of the NHS cancer screening programmes (thats Brit for programs) adds, “There is a risk of over-diagnosis and possible subsequent over-treatment associated with any screening programme” and that, “The latest independent study shows that the risk of over-diagnosis is very much lower than some other recent estimates have claimed and that the benefits [of mammography screening] far outweigh the risks.”  Well put.

~Posted by D.M. Schwadron, Esquire

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue [...]]]> Source:  BBC Health News

No, it is not anticipated that home testing for breast cancer, ovarian cancer or prostate  cancer will be available any time in the near future.  However cervical cancer is unique due to it’s associated risk with the human papillomavirus (HPV or genital warts), 13 of it’s 100 variants apparently cause cancer.

The issue is so serious that a vaccine for HPV was introduced in the past few years and made available to school-aged girls.  So then what role does testing play?  First, not all women are receiving vaccinations for HPV.  Second, not all women are undergoing routine screening for HPV at their gynecologist’s or primary care provider’s office.  For these women, the availability of a reliable home test could be an option.

HPV causes cellular damage even after the initial infection clears.  A simple swab may collect damage cells and tell doctors a great deal about a woman’s risk for the development of cervical cancer.  Were it only that all medical solutions were simple solutions.

~Posted by D.M. Schwadron, Esquire

192,000 men are diagnosed with prostate cancer annually.  27,000 cases are terminal.  Currently under investigation is a new chemotherapy drug -Cabazitaxel which is being administered in conjunction with Mitoxantrone (a commonly used drug f0r prostate cancer).   Men receiving this chemo cocktail (no pun intended) had a 30% increase in survival.  [...]]]> Source:  Annual Genitourinary Cancers Symposium; Medline

192,000 men are diagnosed with prostate cancer annually.  27,000 cases are terminal.  Currently under investigation is a new chemotherapy drug -Cabazitaxel which is being administered in conjunction with Mitoxantrone (a commonly used drug f0r prostate cancer).   Men receiving this chemo cocktail (no pun intended) had a 30% increase in survival.  To you or I 15.1 months to live vs. 12.7 may not seem like a lot but if you were dying and those were your options, wouldn’t you want more time?  It is thought that giving the combination of drugs early in the diagnostic stage might translate to even greater survival times.

To that end researchers are developing better diagnostic tools for Prostate Cancer.  Showing promise is the PCA3 urine test.  Apparently overly expressed in men with prostate cancer, gene 3 is a fair predictor for advanced prostate disease.   The current complaints against the standard PSA testing is the high rate of false positives resulting in biposy.

Finally, the tried and true cystoscopy procedure (Yes, the one where they insert a catheter with a small camera into the bladder. Over the river and through the woods…Well not quite.  Cystoscopy has been found to be remarkable cost-effective.  Accordingly, look for it to be featured more in insurance schemes and offered more by urologists.  Cynical? Perhaps.  But you’ll see.

~Posted by D.M. Schwadron, Esquire

Men should discuss the benefits and risks of prostate cancer screening with their doctors, according to revised prostate cancer screening guidelines from the American Cancer Society (ACS).  Yes. That’s what they said.  Not much of a guideline is it?

Okay they say a little more.  But really, only a little.  The American Cancer [...]]]> Source: American Cancer Society

Men should discuss the benefits and risks of prostate cancer screening with their doctors, according to revised prostate cancer screening guidelines from the American Cancer Society (ACS).  Yes. That’s what they said.  Not much of a guideline is it?

Okay they say a little more.  But really, only a little.  The American Cancer Society recommends that doctors more heavily involve patients in the decision of whether to get screened for prostate cancer.

ACS recommends that men with no symptoms of prostate cancer who are in relatively good health and can expect to live at least 10 more years have the opportunity to make an informed decision with their doctor about screening after learning about the uncertainties, risks, and potential benefits associated with prostate cancer screening. These talks should start at age 50. Men with no symptoms who are not expected to live more than 10 years (because of age or poor health) should not be offered prostate cancer screening. For them, the risks likely outweigh the benefits, researchers have concluded.

ACS recommends men at high risk – African-American men and men who have a father, brother, or son diagnosed with prostate cancer before age 65 – begin those conversations earlier, at age 45. Men at higher risk – those with multiple family members affected by the disease before age 65 – should start even earlier, at age 40.

For men who choose to be screened after discussing the pros and cons with their doctor, the new guidelines make the digital rectal exam (DRE) optional and offer the option of extending the time between screening for men with low PSA levels.

There it is. No specific PSA recommendations, or even whether PSA testing should be considered mandatory.  So start “talking to your doctor” about screening.  Does this sound an awful lot like the burden of screening for Prostate Cancer is being placed back upon the patient? Yeah. It sounds that way to me too.

~Posted by D.M. Schwadron, Esquire

Rates of new diagnoses and rates of death from all cancers combined declined significantly in the most recent time period for men and women overall and for most racial and ethnic populations in the United States.

The drops are driven largely by declines in rates of new cases and [...]]]> Source: U.S. Centers for Disease Control & Prevention

Rates of new diagnoses and rates of death from all cancers combined declined significantly in the most recent time period for men and women overall and for most racial and ethnic populations in the United States.

The drops are driven largely by declines in rates of new cases and rates of death for the three most common cancers in men (lung, prostate, and colorectal cancers) and for two of the three leading cancers in women (breast and colorectal cancer). New diagnoses for all types of cancer combined in the United States decreased, on average, almost 1 percent per year from 1999 to 2006. Cancer deaths decreased 1.6 percent per year from 2001 to 2006.

These findings are from a report authored by researchers from the National Cancer Institute (NCI), part of the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), the American Cancer Society (ACS), and the North American Association of Central Cancer Registries (NAACCR). The report was published early online Dec. 7, 2009, in the journal Cancer.

Overall cancer rates continue to be higher for men than for women, but men experienced the greatest declines in incidence (new cases) and mortality (death) rates. For colorectal cancer, the third most frequently diagnosed cancer in both men and women, and the second leading cause of cancer deaths in the United States, overall rates are declining, but increasing incidence in men and women under 50 years of age is of concern.

With accelerated cancer control efforts to get more Americans to adopt more favorable health behaviors (such as quitting smoking) and higher use of screening (colonoscopy), as well as optimal treatment outcomes for colorectal cancer (read more effective chemotherapy), there could be an overall colorectal cancer mortality reduction of 50 percent by 2020.

“The continued decline in overall cancer rates documents the success we have had with our aggressive efforts to reduce risk in large populations, to provide for early detection, and to develop new therapies that have been successfully applied in this past decade,” said NCI Director John E. Niederhuber, M.D. “Yet we cannot be content with this steady reduction in incidence and mortality. We must, in fact, accelerate our efforts to get individualized diagnoses and treatments to all Americans and our belief is that our research efforts and our vision are moving us rapidly in that direction.”

“The continued decline in incidence and death rates for all cancers combined is extremely encouraging, but progress has been more limited for certain types of cancer, including many cancers that are currently less amenable to screening, such as cancer of esophagus, liver and pancreas,” said Betsy Kohler, executive director of NAACCR.

Long-term incidence trends for colorectal cancer have been fairly consistent for men and women, with major declines from 1985 to1995, minor increases from 1995 to1998, and significant declines from 1998 to 2006.

“This report shows that we have begun to make progress reducing colorectal cancer. Yet, colorectal cancer still kills more people than any other cancer except lung cancer,” said CDC Director Thomas Frieden, M.D.

Let’s hope this trend continues downward on incidence and upward on survival.

~Posted by D.M. Schwadron, Esquire

It seems like just last week (okay so it was 3 weeks ago) that I was blogging on the newly announced recommendations relative to mammography.  http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=439

I also suggested that there were larger forces at work behind such things as US Preventative Services Task Force recommendations which surface during governmental [...]]]> Source: Associated Press; The Wall Street Journal

It seems like just last week (okay so it was 3 weeks ago) that I was blogging on the newly announced recommendations relative to mammography.  http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=439

I also suggested that there were larger forces at work behind such things as US Preventative Services Task Force recommendations which surface during governmental debates on health care and which represent a swing in a particular direction.

So you don’t think I’ve put on my tinfoil hat and gone all “Olver Stone” on you, the “Task Force” responsible for the recommendations has now been summoned to testify before the US Congress. Oooh. What did they say? What did they say?

Well, the Task Force acknowledged that ACOG (the American College of Obstetricians & Gynecologists) expressed concern that the panel’s recommendations might be misunderstood by clinicians, patients, policy makers and insurers (funny, no mention of trial lawyers) and said, “Our message was misunderstood.”

So that’s their story. They were “misunderstood.”  They were NOT trying to create some sort of political expediency whereby women under 50 were denied routine mammography as a cost saving measure for the government and for insurers.

Oh and from my prior blog post, the one where I wrote, “That aside, anticipate the pro-mammography lobby to push for a formal adoption/return to the 40 and over recommendation for various reasons both medical and economic.”  Radiologists affiliated with Harvard and UC Irvine have spoken out that adopting the newer guidelines would result in increased deaths and negate the gains made over the past 20 years.

Still think medicine isn’t a business?

~Posted by David Marc Schwadron, Esquire

The US Preventative Services Task Force has released the latest (11/2009) recommendations for Breast Cancer Screening.  Were I a woman or performing breast self-examination (BSE) on, well myself, I’d be confused.

The Task Force has un-recommended (hey if “un-friend” is now a word, this can’t be [...]]]> Source: US Department of Health and Human Services November 2009 Release

The US Preventative Services Task Force has released the latest (11/2009) recommendations for Breast Cancer Screening.  Were I a woman or performing breast self-examination (BSE) on, well myself, I’d be confused.

The Task Force has un-recommended (hey if “un-friend” is now a word, this can’t be far behind) screening mammography for women under 50. In fact, they specifically recommend against routine screening mammography in women ages 40-49.

This represents a return to the previous recommendation for biennial screening mammograms for women ages 50-74.  The Task Force saw no benefit to routine screening for women under 50 or 75 and over.

The Task Force additionally recommends against teaching patients to perform breast self- examination, a position which runs contrary to that taken by this pro BSE blogger. See http://www.medicalmalpracticelawyerblogphiladelphia.com/?p=376 It is the anecdotal and lay experience of the author that many women under age 50 discover masses or lumps on breast self-examination and that this discovery directly leads to their diagnosis.

That aside, anticipate the pro-mammography lobby to push for a formal adoption/return to the 40 and over recommendation for various reasons both medical and economic.

~Posted by David Marc Schwadron, Esquire