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A federal medical advisory panel recommended last month that the diabetes drug, Avandia, should either be withdrawn from the market or have sales severely restricted because it increases the risk of heart attacks. The panel listened to two days of intensive scientific discussion before it members took a vote. GlaxoSmithKline, which makes Avandia, claims that the drug is a safe and a needed option in treating diabetes. But there have been serious safety concerns by a tremendous number of medical professionals.
Panel members voiced great skepticism about the company’s trustworthiness after questions were raised about its clinical trials. Internal company documents reveal that GlaxoSmithKline kept crucial safety information about Avandia from the public for years. On the critical vote, which was on what the FDA should do, then members voted that the drugs’ sales should be restricted and the earnings on its label enhanced. Twelve voted that Avandia should be withdrawn, but seven voted only to support enhanced warnings the drug’s label.
Approved in 1999, Avandia helps control blood sugar levels in diabetics by making patients more sensitive to their own insulin. It is one of a class of three drugs, the first of which, Rezulin, was withdrawn because it caused liver damage. The other drug in the class, Actos, made by Takeda, has appeared relatively safe. The sales of Avandia, which was once the biggest-selling diabetes medicine in the worked, abruptly declined in 2007. That came after a study by Dr. Steven Nisssen, a noted Cleveland Clinic cardiologist, found that Avandia increased the risk of heart attacks. An advisory committee in 2007 decided that Avandia did increase heart risks but voted to keep it on the market.
Many of the same experts who decided to deep the drug on the market in 2007 voted that it should be withdrawn or restricted. Those restrictions cold mean that patients would have to apply for special permission to use the drug. Reactions to the panel’s vote have been as mixed as the vote itself. The FDA generally undertakes programs to restrict a drug’s sales only when a drug offers a unique benefit, something not one study has shown about Avandia. A majority of the committee found that Avandia increased the risk of heart attacks, but a majority also said that studies had failed to prove it increased the risk of death.
A majority decided that if Avandia where to continue to be sold, the company should complete a clinical trial to prove it was safe. But several members said that the vote probably made a trial impossible because patients would not want to risk taking Avandia. You might now wonder how in the word the committee, which should put a drug’s safety at the top of its priority list, could have come up with so many different conclusions. If so, I share your concern.
It’s quite obvious that the manufacturer of Avandia has not been honest with the FDA. Marketing seems to have been the driving force when critical decisions were made by the company. It was said during the panel’s hearings that studies were not completed because the company feared that the results might hurt sales. This information came from internal company documentation
Sources: New York Times and USA Today
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Sources: Web MD; Julia Body, PhD, The Silent Spring Institute; Zota, A., Environmental Health, July 20, 2010; Michael Thun, MD, VP emeritus of epidemiology, American Cancer Society; Susan Brown, Dir. Health Education, Susan G. Komen for the Cure
A recent study published in the Journal Environmental Health has, not surprisingly, been criticized strongly by Industry and their medical experts alike. A link has been suggested between the frequent use of household cleaners and increased risk for breast cancer. In particular, air fresheners and mold and mildew cleaners are most strongly linked.
None of this should be particularly surprising. From 1999 to 2004, sales of air fresheners rose nearly 30% in current dollars. The advent of air freshener candles and widespread acceptance of plug-in air fresheners has been primarily responsible.There are numerous volatile organic compounds and manufactured compounds in household cleaners. A simple whiff of them while cleaning the shower confirms this. What is surprising is that this is the first published study to make the link between these cleaning products and the increased risk of breast cancer.
But how reliable is this information? That answer is mixed. The methodology was simple. It was what is known as a “retrospective” study. Researchers asked 787 women who were diagnosed with breast cancer about their historical use of household cleaning products. 721 additional women without a breast cancer diagnosis were asked the same questions. Critics say this is not reliable and that it accentuates a concern with exposure slanting the responses. The best methodology is a prospective (forward looking) study which tracks women and their exposure to a diagnosis of breast cancer.
The researchers found a greater link between household cleaners and breast cancer than with domestic pesticide use. One reason might be that exposure indoors in a confined space is greater than applying chemicals outdoors.
Solid air fresheners, common to many homes, generated a significant amount of response. Although difficult to quantify, it appears that those who used them 7 or more times in a year had 2x the risk of breast cancer than those who never used them in their homes.
While the debate is just getting started it is a welcome one. There are a number of non-toxic organic household cleaners and companies committed to their manufacture. If you have significant concerns that the risk has not been sufficiently quantified or qualified then perhaps you should consider switching your products.
~Posted by D.M. Schwadron, Esquire
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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
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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.”
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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
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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
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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
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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
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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:
- Foreign Object Retained After Surgery (Seriously? Still number 1 after all these years?)
- Air Embolism
- Blood Incompatibility
- Stage III and IV Pressure Ulcers (Also a big Nursing Home Issue)
- Falls and Trauma
- Fractures
- Dislocations
- Intracranial Injuries
- Crushing Injuries
- Burns
- Electric Shock
- 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
- Catheter-Associated Urinary Tract Infection (Common and preventable)
- Vascular Catheter-Associated Infection
- 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
- 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
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Gardasil, Merck Sharp & Dohme’s cervical cancer vaccine caused an uproar in 2006 when it was marketed to girls and women aged 9 to 26. It is estimated that over 25 million young women in the US have received the vaccine which was designed to prevent 4 types of HPV (Human papillomavirus types 6, 11, 16 and 18) which are associated with the risk of genital warts and cause about 70 percent of all cervical cancers.
The vaccine manufacturer’s recommendations have also been extended to boys. But one may (or may not if you read this blog) be surprised to know that there are questions being raised about the safety of Gardasil. A constellation of auto-immune disease symptoms (over 16,000 reports) including: Rheumetoid arthritis and lupus have been reported in otherwise healthy girls and there have been 50 deaths. Well 16,000 adverse events out of approximately 25 million isn’t a lot at all so we’ll just give Merck a pass on that one, shall we? Unless of course your daughter or loved one is one of the 16,000.
Questions have been raised as to whether Gardasil was tested adequately for safety in girls under age 15. Shocking, we’re aware. Not that it matters but…the first quart profits for Gardasil were $390 million. Gardasil is predicted to jump to $3 billion in profits by 2012.
~D.M. Schwadron, Esquire
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