FDA Approved Treatment for Postmenopausal Osteoporosis Get important product information on another FDA approved postmenopausal osteoporosis medication. 

June 29, 2010 — A new Endocrine Society scientific statement published in the July 2010 issue of the Journal of Clinical Endocrinology & Metabolism evaluates benefits and risks for postmenopausal hormone replacement therapy (HRT), now [...]]]> Laurie Barclay, M.D. – Medscape, LLC

 FDA Approved Treatment for Postmenopausal Osteoporosis
Get important product information on another FDA approved postmenopausal osteoporosis medication. 

June 29, 2010 — A new Endocrine Society scientific statement published in the July 2010 issue of the Journal of Clinical Endocrinology & Metabolism evaluates benefits and risks for postmenopausal hormone replacement therapy (HRT), now known as menopausal hormone therapy (MHT). The statement, entitled “Postmenopausal Hormone Therapy: An Endocrine Society Scientific Statement,” was also posted online ahead of print on June 21 and presented in San Diego, California, at ENDO 2010: The 92nd Annual Meeting & Expo.

Although MHT was in widespread use in the 1990s in hopes of lowering cardiovascular disease risk as well as to treat menopausal symptoms, the Women’s Health Initiative (WHI) Study showed that MHT was actually associated with an increased risk for heart disease, stroke, and breast cancer. However, recent evidence suggests that these risks may be affected by time after onset of menopause when MHT was started, a factor not considered in the WHI assessment of MHT safety and efficacy.

“Before the WHI, MHT was believed to prevent heart disease, fractures, memory loss and dementia in addition to relieving uncomfortable menopausal symptoms,” said task force chair Richard J. Santen, MD, professor of medicine at the University of Virginia in Charlottesville, in a news release. “Following the WHI reports of increased health risks associated with MHT, MHT use declined by 80%. New data however [show] that these health risks may not apply to all women using MHT, and that MHT may in fact be very beneficial to some women.”

Controversy regarding WHI’s applicability to women just entering menopause stems from the fact that the average age of participants was 63 years, and only 3.5% of the women were aged 50 to 54 years, which is the age range when women typically decide whether to start MHT. Furthermore, the WHI did not address menopausal symptom relief. Therefore, this scientific statement considered new data from later studies evaluating the effects of MHT in women aged 50 to 55 years.

Compared with women who begin MHT after age 60 years, those who begin MHT a short time after onset of menopause at ages 50 to 59 years appear to benefit. According to recent evidence, women in the short-time group using MHT for 5 years had a 30% to 40% reduction in mortality risk and no increased cardiovascular disease risk. In addition, they had a 90% decrease in hot flashes, overactive bladder, or other menopausal symptoms.

“Some women in the short-time group still developed breast cancer but only with the combination of estrogen plus a progestogen, not with estrogen alone,” Dr. Santen said. “This may be due to the stimulation and uncovering of very small, undiagnosed breast cancers, rather than causing these cancers de novo.”

Conclusions Reached

Evaluation of the new data along with WHI evidence led the task force to reach the following conclusions, with level of evidence A:

• “Standard-dose” estrogen used with or without a progestogen is associated with marked reduction in frequency and severity of hot flashes. For many women, lower doses of estrogen are also effective.
• An alternative hormonal therapy for postmenopausal vasomotor symptoms is tibolone, which is widely available worldwide, but not in the United States.
• For symptoms of vaginal atrophy, very low doses of vaginal estradiol are effective.
• Symptoms of overactive bladder may be reduced by estrogen given vaginally or systemically.
• Vaginal estrogen is associated with lower rates of recurrent urinary tract infections.
• Tibolone improves urogenital atrophy.
• For women in late postmenopause, estrogen given with or without a progestogen is as effective as bisphosphonate therapy for preventing early postmenopausal bone loss and increasing bone mass.
• Use of estrogen alone and estrogen plus a progestogen is associated with a lower incidence of hip and vertebral fractures.
• For osteoporotic women older than 60 years, tibolone is associated with significantly lower rates of vertebral and nonvertebral fractures.
• Treatment with the selective estrogen receptor modulator raloxifene is associated with increased bone mineral density and lower rates of vertebral, but not hip, fractures.
• Use of MHT containing estrogen plus a progestogen is linked to a lower risk for colon cancer.
• Raloxifene is associated with a lower risk for breast cancer.
• Mammographic density is increased in women taking estrogen alone or with a progestogen.
• Use of tibolone is associated with a greater risk for breast cancer recurrence.
• Sexual function is improved by physiologic amounts of transdermal testosterone, but not by dehydroepiandrosterone.
• Risk for venothrombotic episodes is approximately doubled in women using MHT, and this risk is multiplicative with baseline risk factors such as age, increased body mass index, thrombophilias, surgery, and immobilization.
• Use of raloxifene is associated with an increased incidence of venothrombotic episodes.
• In older, but not younger, women, tibolone is associated with an increased risk for stroke.
• Raloxifene is not associated with any increase in stroke risk.
• In older women with preexisting vascular disease, hormone use does not reduce stroke incidence.
• Although continuous estrogen plus a progestogen does not cause endometrial cancer, estrogen alone without a progestogen is associated with an increased incidence in endometrial cancer.
• Tibolone is not associated with an increased incidence of endometrial hyperplasia or carcinoma.
• Risk for gallbladder disease is increased in women using estrogen alone or with a progestogen.
• MHT started after age 60 years does not improve memory.

“It is important to remember that most women considering MHT are between the ages of 50 and 55 and in this group MHT may have many benefits,” Dr. Santen concluded. “Physicians and their patients need to re-think the use of [MHT] based on data pertinent to the 50-55 year old and therapy should be individualized based on symptoms and underlying risks of breast cancer and heart disease.”

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

Drug maker GlaxoSmith Kline has agreed to begin settling cases where plaintiffs allege the use of antidepressant Paxil caused birth defects.

 Only one case in Philadelphia’s mass tort Paxil program has gone to trial. Children born with birth defects where a mother is taking the Paxil drug during pregnancy is such [...]]]> Source: The Legal Intelligencer, June 2010

Drug maker GlaxoSmith Kline has agreed to begin settling cases where plaintiffs allege the use of antidepressant Paxil caused birth defects.

 Only one case in Philadelphia’s mass tort Paxil program has gone to trial. Children born with birth defects where a mother is taking the Paxil drug during pregnancy is such a devastating circumstance. We at the Lewis Law Firm want to hear from any family who has not yet exercised their rights to seek compensation. Contact us.

 Posted: Gayle Lewis, Esquire

The US Department of Health and Human Services is a broad agency.  One of it’s charges is the administration of Medicare and Medicaid.  In this time of financial unrest, one of the measures taken by the Department is to reduce the amount of reimbursement to [...]]]> Source:  The US Centers for Medicare & Medicaid Services (CMS)

The US Department of Health and Human Services is a broad agency.  One of it’s charges is the administration of Medicare and Medicaid.  In this time of financial unrest, one of the measures taken by the Department is to reduce the amount of reimbursement to hospitals.  How does one do that?  by identifying things which occur in hospitals that are “reasonably preventable” of course.  Let’s review the Government’s own top 10 list of HAC’s or Hospital Acquired Conditions.

Section 5001(c) of Deficit Reduction Act of 2005 requires the Secretary to identify conditions that are:  (a) high cost or high volume or both, (b) result in the assignment of a case to a DRG that has a higher payment when present as a secondary diagnosis, and (c) could reasonably have been prevented through the application of evidence‑based guidelines.

The Inpatient Prospective Payment System (IPPS) Fiscal Year (FY) 2009 Final Rule, CMS included 10 categories of conditions that were selected for the HAC payment provision.  The IPPS FY 2009 Final Rule is available in the Statute/Regulations/Program Instructions section, accessible through the navigation menu at left.

The 10 categories of HACs include:

1. Foreign Object Retained After Surgery (Seriously? Still number 1 after all these years?)
2. Air Embolism
3. Blood Incompatibility
4. Stage III and IV Pressure Ulcers (Also a big Nursing Home Issue)
5. Falls and Trauma
   • Fractures
   • Dislocations
   • Intracranial Injuries
   • Crushing Injuries
   • Burns
   • Electric Shock
6. Manifestations of Poor Glycemic Control  (If you’re in the hospital they should be controlling this)
   • Diabetic Ketoacidosis
   • Nonketotic Hyperosmolar Coma
   • Hypoglycemic Coma
   • Secondary Diabetes with Ketoacidosis
   • Secondary Diabetes with Hyperosmolarity
7. Catheter-Associated Urinary Tract Infection (Common and preventable)
8. Vascular Catheter-Associated Infection
9. Surgical Site Infection Following:
   • Coronary Artery Bypass Graft (CABG) – Mediastinitis
   • Bariatric Surgery
     • Laparoscopic Gastric Bypass
     • Gastroenterostomy
     • Laparoscopic Gastric Restrictive Surgery
   • Orthopedic Procedures
     • Spine
     • Neck
     • Shoulder
     • Elbow
10. Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)

We aren’t suggesting that everything hospitals do is incorrect.  However, if the US Government is limiting reimbursement or withholding reimbursement to hospitals when these incidents occur then it may be a good indicator that a hospital has committed an act of malpractice.

~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

Okay, I still don’t understand the pepper connection.  (Even the FDA’s own reports say that it was “unusual”).

Spice Barn is recalling two lots of Black Pepper due to the possibility of contamination with Salmonella. Salmonella is a common food [...]]]> Source:  U.S. Food & Drug Administration

Spice Barn, Inc. Voluntarily Recalls Two Lots of Black Pepper

Okay, I still don’t understand the pepper connection.  (Even the FDA’s own reports say that it was “unusual”).

Spice Barn is recalling two lots of Black Pepper due to the possibility of contamination with Salmonella. Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea. (You really should know this by now). While most individuals recover without medical intervention, the infection can be life-threatening in some cases such as young children, the elderly and those with compromised immune systems. There have been no reports of Salmonella-related illness to date in relation to these products.  (Right, we just recall things because it’s fun).

The Products are:  Malabar Peppercorns Lot MTC-3258 in 1 and 5 Pound Bags Distributed between: 1/26/10 to 2/8/10; Ground Black Pepper Lot MO-3258T in 1 and 5 Pound Bags Distributed between:12/08/09 to 2/8/10.

All items packaged with this lot number are subject to this recall. The items were distributed to a small number of customers in the following states VT, NY, PA, MA, GA, VA, CA, TX, CO, MO, WA, FL, AL, MI, AZ, AR, WA. Spice Barn is contacting each customer directly and offering a replacement or refund. Consumers who have purchased these products are asked not to us them and to destroy the product. Consumers with questions regarding the products listed may call Spice Barn at 1-866-670-9040 8:30AM-2:30PM M-F(EST) and speak with customer service.

AND JUST IN CASE YOU THINK YOU ARE BEING ALL SAFE AND HEALTHY AND ALLERGEN FREE WITH YOUR GLUTEN FREE SELF…

GFN Foods, LLC of Cranford, NJ (Hi Cranford!) is voluntarily recalling:

Gluten-Free Naturals Pancake Mix – UPC 187058 000043
Lots   09159 (exp 12/8/2010), 09320 (exp 5/16/12) 09322 (exp 5/18/12)
Gluten-Free Naturals Light & Moist Yellow Cake Mix – UPC 187058 000067
Lots   09083 (exp 9/24/10) and 09322 (exp 5/18/12)
Gluten-Free Naturals Cookie Blend Flour – UPC 187058 000029
Lots   09086 (exp 6/24/10), 09219 (exp 11/7/10) and 10035 (exp 5/4/11)

These products, manufactured by GFN Foods, are being recalled because they have the potential to be contaminated with…You got it! Salmonella. The FDA and Thumb Oilseed Producers Cooperative of Ubly, MI found traces of salmonella in Thumb Oilseed’s facility. GFN Foods, LLC is voluntarily recalling the products that contain the ingredient supplied by Thumb Oilseed.

Salmonella is an organism…blah…blah…blah…say it with me…which can cause serious and in some cases fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with salmonella often experience fever, diarrhea (which can be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with salmonella can result into getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis and arthritis.

The safety of our products is of paramount importance to GFN Foods. Customers that have purchased the above products should contact GFN Foods at 866-761-6147 for a refund or to arrange for replacement product. You can also email sales@gfnfoods.com or call with any questions.

Okay! It’s Friday. Weekend coming up.  Safe eating.

~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

We elaborated on just one of these but apparently March is National Salmonella month here in the U.S.  Among the products affected are dips, chips (a double whammy), spices and soup.

Just why are there so many products affected with Salmonella?  Maybe it’s time we stopped mass producing food in factories [...]]]> Source:  U.S. Food & Drug Administration

We elaborated on just one of these but apparently March is National Salmonella month here in the U.S.  Among the products affected are dips, chips (a double whammy), spices and soup.

Just why are there so many products affected with Salmonella?  Maybe it’s time we stopped mass producing food in factories and “engineering” foods genetically.  Radical concepts, I’m aware but still, click through the evidence.  The system is broken and needs some fixes.

March 2010

• March 03, 2010 – Earth Island Announces Voluntary Recall On Select Follow Your Heart Products That Contain Natural Flavor Because Of Possible Health Risk³
• March 03, 2010 – Homemade Gourmet Voluntarily Recalls “Tortilla Soup Mix” Because of Possible Health Risk⁴
• March 03, 2010 – Reser’s Fine Foods Inc Press Release⁵
• March 02, 2010 – Tim’s Cascade Snacks Recalls ‘Hawaiian^® Kettle Style Potato Chips – Sweet Maui Onion’ and ‘Hawaiian- Sweet Maui Onion Rings’ Because of Possible Health Risk⁶
• March 02, 2010 – Castella Imports, Inc. Conducts Nationwide Recall of Castella Chicken Soup Base Because of Possible Health Risk⁷
• March 01, 2010 – Heartland Foods, Inc. voluntarily recalls Coarse Ground Black Pepper because of possible Salmonella Contamination⁸
• March 01, 2010 – T. Marzetti Company Announces a Voluntary Recall of Dips Due to Possible Health Risk

~Posted by D.M. Schwadron, Esquire