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

Researchers at the Cleveland Clinic’s Lerner Research Institute (for those not “in the know”, the Cleveland Clinic is  a highly regarded institution)  are now conducting human trials of a breast cancer vaccine.  The vaccine specifically targets a protein common to breast cancer tumors (a-lactalbumin).

Studies upon mice (Sorry PETA, that’s what [...]]]> Source:  BBC Health; Journal Nature Medicine.

Researchers at the Cleveland Clinic’s Lerner Research Institute (for those not “in the know”, the Cleveland Clinic is  a highly regarded institution)  are now conducting human trials of a breast cancer vaccine.  The vaccine specifically targets a protein common to breast cancer tumors (a-lactalbumin).

Studies upon mice (Sorry PETA, that’s what they’re really good for) have demonstrated reason to be hopeful.  There are currently two cancer vaccines approved for use in the US, however neither of these actually prevent cancer.  One (Gardasil) prevents HPV while the other prevents Hepatitis B, both precursors to cancers.  If the breast cancer vaccine is effective in human trials it would be the first vaccine against cancer tumors.

Some background is in order.  Cancer actually describes a process of rapid and unrestrained cell growth.  The inability of the human body to switch off the growth of cells results in formation of clusters of cells forming tumors or spreading (metastasizing) throughout the body.  Where viruses are foreign to the immune system and defended against, cancerous cells are not.

The vaccine would target the proteins at the cellular level so that they can not continue to form tumors.  Unlike traditional chemotherapy (chemical agents) or radiation, which destroys not only cancer tissue but a good deal of healthy tissue and organs with it, a targeted vaccine would actually prevent one from ever developing breast cancer (in theory) in much the same way that the polio vaccine prevented generations of children from contracting polio.

Definitely one to watch.

~Posted by D.M. Schwadron, Esquire

I know what you’re thinking.  Yes, HPV (human papillomavirus or genital warts) is a sexually transmitted disease which has been related with a specific cancer.  Evidence appears to be mounting (sorry, I had to) that the incidence of oral HPV cancer has increased since the 70′s.  According to statistics in the International [...]]]> Source: Medscape Medical News

I know what you’re thinking.  Yes, HPV (human papillomavirus or genital warts) is a sexually transmitted disease which has been related with a specific cancer.  Evidence appears to be mounting (sorry, I had to) that the incidence of oral HPV cancer has increased since the 70′s.  According to statistics in the International Journal of Cancer (2009: 125:362-366) rates of HPV related oropharyngeal (mouth and throat) cancer were 23.3% in the 1970′s, 57% in the 199o’s and up to 93% in 2006-20007.

Why the increase in oral cancer?  According to researchers it’s due to an increase in oral in general.  Yes, some things do write themselves.  Apparently it can take from 15 to 30 years for HPV to develop into cancer.  While there is some concession that much of this is speculation as people are not necessarily candid in providing such information to researchers, the implications for treatment could be significant.

It is medically accepted that HPV causes cancer.  In fact, the molecular mechanisms are well known enough for the development of the available HPV vaccine.  Currently, the HPV vaccine is targeted to young women for the prevention of cervical cancer, which can originate from HPV.  The vaccine was also recently approved for use with young men to prevent genital wart infection.

But could the same vaccine eventually be used to prevent against HPV-related oral cancer?  Well, one would expect that it might, however, genital surfaces and fluids do differ from oral surfaces and fluids so no one is actually certain.  The efficacy of the currently available HPV vaccine appears clear.  But is it cost effective?  That is, will big pharma seek to develop a vaccine for something potentially ineffective and potentially socially problematic.

Not as unusual as it might seem given our Puritanical heritage.  Remember, if the studies correlating sexual behavior with increased incidence of oral HPV are correct this would seem to limit the transmission of this type of cancer to an act still defined as sodomy in many states in the United States and criminalized in some.

Perhaps the only other social-medical parallel would be with the medical marijuana debates going on in most states.  Where medicine and societal “norms” or “values” intersect is where we start getting into problem territory.  The manufacturers and marketers of the HPV vaccine took a lot of criticism for essentially targeting school-aged girls.  When one finally “gets over” the fact that school-aged girls are sexually active the criticism seems nonsensical.  A vaccine which could potentially prevent women from dying in their middle age from cancer inherently seems like a worthy investment.  We will follow the emerging debate on this one.

~Posted by D.M. Schwadron, Esquire

Dutasteride (Avodart according to GalxoSmithKline) is used to treat an enlarged prostate. It works by blocking the production of a natural substance that enlarges the prostate. This shrinks the prostate, relieves symptoms of BPH (benign prostatic hypertrophy), such as frequent and difficult urination, and decreases [...]]]> Source: New England Journal of Medicine; BBC Health

Dutasteride (Avodart according to GalxoSmithKline) is used to treat an enlarged prostate. It works by blocking the production of a natural substance that enlarges the prostate. This shrinks the prostate, relieves symptoms of BPH (benign prostatic hypertrophy), such as frequent and difficult urination, and decreases the chance that surgery will be needed to treat this condition.

Why am I telling you this? Have I suddenly started working for GlaxoSmithKline and wish to pitch their on-patent medications to stave off the competition from the generics?  No.  Not at all.  I’m telling you because the results of a 4 year study of some 6,500 men taking dutasteride showed a 23% lower risk of prostate cancer compared with those taking a placebo (a fake pill, typically made of sugar).

This isn’t the first study to initially show promise. In 2003, a study of men taking finasteride, a BPH drug now marketed as Propecia by Merk.  (Yes for hair loss), was said to also lower the risk of prostate cancer.  However, there were issues with the aggressive nature of the tumors found in that group.  Oh and both medications can cause sexual dysfunction and frequent and painful urination.

The Glaxo funded study (you had to know that) looked at men aged 50 to 75 years in the “high risk” for prostate cancer category given elevated PSA scores but without demonstrable cancer.  Among those with a family history of prostate cancer, those also taking dutasteride are reported to have cur their risk of developing cancer by 31.4%.  Why the disparate numbers?  It’s not clear.  And what about the tumors that did develop?  The researchers felt that those found during the trial were likely present to begin with but too small to be detectable.  According to them, this suggest that the drug shrinks early prostate tumours or keeps their growth at sub-detectable levels.  (The later of which doesn’t appear to be all that helpful).

The proponents of the study believe that the drug might offer thousands of men a simple way to reduce their risk of disease.  This would mean that more men with a high PSA could potentially avoid unnecessary or more involved treatment including surgery on the prostate, chemotherapy and radiation and all of the attendant side effects and symptoms which follow.

Others, like Dr. Helen Rippon of the Prostate Cancer Charity, aren’t so charitable.  (See what I did there?)  According to Dr. Rippon, “[W]e don’t yet know what will happen to these men in the coming years and whether they will still go on to develop the disease [Prostate Cancer] and it will be many years before we know if the drug [dutasteride] can provide any long-term benefit to men.”

~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

As it sometimes happens in medicine, a drug that has been proven to work in less than stellar ways for a given condition may have a completely unintended but surprisingly beneficial medical outcome.  What the heck am I talking about?  Some examples may be in order here.  You [...]]]> Source:  BBC Health; European Breast Cancer Conference, Barcelona

As it sometimes happens in medicine, a drug that has been proven to work in less than stellar ways for a given condition may have a completely unintended but surprisingly beneficial medical outcome.  What the heck am I talking about?  Some examples may be in order here.  You may have heard of a drug called Imitrex, used for the treatment of migraines.  Well it was originally formulated as an anti-seizure drug with mixed results.  A few accidental results and a new generation of migraine treatments was born.

Not familiar with that one?  Okay, you may have heard of a drug called Viagra which is fairly well-knonw (to the internet spam community in particular).  Well, Viagra, was an anti-hypertensive drug which despite years of development and testing did less for hypertension than it did for…well, you get the idea.

Enter beta blockers, a classification of blood pressure medications estimated to be currently prescribed to over two million people in the UK alone.  A team of UK and German researchers has found that in a study of women with breast cancer tumors, those taking beta blockers had a 71% lower chance of dying from metastatic (spreading) disease.

Granted the study was small, focusing upon some 466 European women with breast cancer.  However, the results could be significant.  Breast cancer remains the single largest killer of women, with some 30,000 diagnosed in the UK each year.  It is thought that beta blockers may also block hormones which trigger the spread of cancer cells beyond the breast.  The chances of curing breast cancer differ remarkably where cancer can be confined to the breast or to a small area of the breast.  Once cancer metastasizes (spreads) throughout the body, chances of a cure diminish.

Beta blockers attach to the same cancer cell receptors as metastatic associated hormones, thereby reducing the ability of the cancer cells to spread beyond the confines of a tumor.  So it may just be that the hope for a “new” drug to treat breast cancer exists in an old drug, beta blockers, which have been used for years now with relative safety.  It is hoped that a combination of existing chemotherapy drugs and beta blockers may offer breast cancer patients greater chance of cure and certainly greater chance of confining, and thereby surviving, breast cancer.

The even better news?  Unlike the introduction of a completely new drug, the re-purposing (If I may) of a drug isn’t as rigorous a process and it appears that the studies are well into the clinical trial stages.  Granted this is taking place in Europe and our FDA may not be as enlightened.  However, this also means that it might not take another 7 years for beta blockers to emerge as accepted treatment for breast cancer.

~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

It may be still in the early lab stages -how early? Well they are still testing the technique upon mice with tumors, however, researchers have found that freezing breast cancer tumors (cryoablation) helps to stop the spread of breast cancer.

Not only did the rapid freezing, through application of a cold [...]]]> Source: Annals of Surgical Oncology; Medline

It may be still in the early lab stages -how early? Well they are still testing the technique upon mice with tumors, however, researchers have found that freezing breast cancer tumors (cryoablation) helps to stop the spread of breast cancer.

Not only did the rapid freezing, through application of a cold probe to the tumor site, kill breast cancer tumors, there was a better outcome in terms of tumor spread (metastasis) to the lungs.

All is not lab mice though.  Cryoablation is being actively used to treat actual human patients with prostate cancer, kidney cancers and cancers that have spread to the bone marrow with encouraging results.  Hopefully this will be another tool to fight breast cancer in the near future.

~Posted by D.M. Schwadron, Esquire.