Wednesday, March 23, 2011

Hepatitis News;101 Patients Told To Get Tested-Reuse of needle guides during biopsies

Mar 23
LAS VEGAS (AP) -- Southern Nevada health officials are notifying 101 patients of a Las Vegas urologist they may be at risk of blood-borne disease because of the reuse of medical implements during office biopsy procedures.

The Las Vegas Review-Journal reported Tuesday that letters from the Southern Nevada Health District advise patients of Dr. Michael Kaplan to get tested for HIV and hepatitis B and C.
The Nevada Board of Medical Examiners last week suspended Kaplan's medical license, citing "imminent risk of harm."

Kaplan is accused of reusing single-use endocavity needle guides for prostate biopsies. The fear is that reuse could spread blood and bodily fluids from one patient to the next.
Health district chief Dr. Lawrence Sands says in the letter that investigators haven't identified any cases of disease related to the procedures.


Are lawsuits on the way now that more than 100 patients of Doctor Michael Kaplan are getting letters saying they should be tested for hepatitis or HIV?
The letters went out after Kaplan's license was suspended for allegedly re-using single-use only endocavity needle guides. But this type of letter to patents is not new to the valley.
The same kind of panic and worry that felt by the thousands of endoscopy patients is the exact feeling some of Kaplan's patients are now feeling. They are worried about what to do next and where to turn for help.

"There's a whole bunch of stuff going through your head because you don't know what to think. You don't know if you can really trust your own doctor now," said patient Martin Bellot.
Bellot recently had a procedure done by Dr. Kaplan. He found out about his possible exposure to HIV and hepatitis Monday.

Now there are questions about lawsuits. Attorney Ed Bernstein's office has received dozens of calls from concerned patients asking what to do.
"Under basic common law, you have a right to sue for medical negligence. If Dr. Kaplan fell below the standard of care, which in this case it appears since he was reusing single-use plastic biopsy guides, that he may have fallen below that standard," he said.

Even though you can sue if you are found to have not contracted any diseases, finding an attorney to represent you will be hard. Several attorneys say they will not take on clients who don't test positive because it is too expensive for a small case.

The best thing to do right now is to get tested for your own safety.
The other thing to remember is that HIV and hepatitis have an incubation period of six months. Those patients who are at risk fall between December of 2010 and March of 2011, so experts recommend you get tested now and again six months from your last procedure.
New On The Blog;
Last week we had a sneak peek at a small study being presented at this months EASL.According to the recent media frenzy Pharmassets two oral drugs in development "PSI-938 and PSI-7977" showed in early-stage data that 15 out of 16 patients had an antiviral response after 14 days on treatment.The HCV community, although excited about a regimen of "interferon free" therapy, keep it all in perspective and wait until Pharmasset conducts their phase II study of " interferon-free combinations" with an SVR endpoint, expected in mid-2011.
For this community the bottom line is SVR......continue reading...

.SUMMARY: Women who enter menopause early have worse liver disease but are less likely to achieve sustained response to interferon-based therapy for chronic hepatitis C.

SUMMARY: New HCV antiviral drugs can interact with some antiretroviral drugs for HIV, but others are not affected and HIV/HCV coinfected patients can be treated successfully with minimal dose adjustments.

NasVax Announces The Success Of A Phase 2a Clinical Trial Of A New Oral Immunotherapy For Fatty Liver Disease
23 March 2011

NasVax (TASE: NSVX) ("Company") announces the success of a Phase 2a clinical trial of a new oral immunotherapy for non-alcoholic steatohepatitis (NASH), an inflammatory disease associated with fatty liver disease and the metabolic syndrome...[read article]
Ismail MH; American Journal of the Medical Sciences (Mar 2011)
Nonalcoholic fatty liver disease (NAFLD) is an increasingly recognized cause of liver disease worldwide. With obesity being a universally important risk factor, NAFLD is now receiving greater attention as a public health issue, and the burden of NAFLD is expected to increase in years to come. The prevalence of NAFLD among subjects with diabetes and with severe obesity is on the rise around the world, including in Saudi Arabia. Efforts in developing new strategies for its prevention, diagnosis and management are needed to alter the course of this disease. The purpose of this review is to enhance awareness about the close interrelationship between NAFLD and type 2 diabetes mellitus and recent diagnostic and treatment advances in the field.

Blood Supply Safety And Screening To Be Highlighted At Pathogens In The Blood Supply Symposium
23 March 2011

Some 14 million units of blood are transfused in the US every year. Routine blood screening protocols test for several common pathogens, including Hepatitis B and C, HIV types 1 and 2, and syphilis, but not others such as...[read article]


Liver Cancer

Nordion announced approval to conduct Phase III trial for TheraSpere in colorectal cancer patients whose disease has metastasized to the liver

OTTAWA, March 23 -- /PRNewswire/ - Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services to the global health science market, today announced that it has received U.S. Food and Drug Administration (FDA) approval to conduct a Phase III clinical trial for TheraSphere® under an Investigational Device Exemption (IDE) to evaluate the safety and effectiveness of TheraSphere treatment in colorectal cancer patients whose disease has metastasized to the liver.

This randomized Phase III clinical trial, known as the EPOCH study, will take place at up to 30 sites worldwide, with a target enrolment of approximately 350 patients. The Principal Investigator is Dr. Mary Mulcahy of Northwestern University in Chicago, IL.
The trial will examine a number of safety and efficacy endpoints in patients who have developed liver tumours from colorectal cancer and who have failed first-line chemotherapy. Participants in the treatment group will receive both TheraSphere and second-line chemotherapy, while patients in the control group will only receive the chemotherapy regimen. The Company intends to design the trial to comply with all FDA and institutional review board requirements in the U.S. and to meet all relevant regulatory requirements for the study of an investigational device in other countries.

"The goal is to investigate whether TheraSphere used in combination with chemotherapy can offer patient outcome advantages that are superior to those of chemotherapy alone," explained Dr. Mulcahy.

According to the U.S. National Cancer Institute, colorectal cancer (CRC) is the third most common cancer in both men and women. An estimated 60 percent of CRC patients will eventually develop liver tumours. Most deaths associated with CRC are due to inoperable liver tumours.
"The EPOCH trial will help determine TheraSphere's clinical utility in combination with chemotherapy, and further advance our knowledge about TheraSphere's potential benefit to patients with liver metastases from colorectal cancer," said Dr. Peter Covitz, Nordion's Senior Vice-President of Innovation.

Discovery In Liver Cancer Cells Provides New Target For Drugs
23 March 2011

Researchers at Virginia Commonwealth University Massey Cancer Center and VCU Institute of Molecular Medicine (VIMM) have discovered a novel mechanism in gene regulation that contributes to the development of a form of liver...[read article] .


Healthy You

Journal of Clinical Endocrinology and Metabolism

Exposure to chemicals in environment associated with onset of early menopause

A recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism found that higher levels of perfluorocarbons (PFCs) in the body are associated with increased odds of having experienced menopause in women between 42 and 64 years old. Women in this age group with high levels of PFCs also had significantly lower concentrations of estrogen when compared to women who had low levels of PFCs.

Norovirus Outbreak Suggests Change Needed

Norovirus infection on a cruise ship resulted in a 15% attack rate despite early detection and aggressive measures to contain illness, CDC investigators reported, suggesting a change is needed in parameters defining an outbreak.

A Guide to Smarter, Safer Antibiotic Use
In a world beset with an unprecedented wave of infections, it is important that antibiotics work well when people need them.

Riddled With Metal by Mistake in a Study
A device meant to shield healthy tissue from radiation during surgery for breast cancer left hundreds of tiny particles of the heavy metal tungsten inside dozens of patients.


The Claim: Eating Flaxseed Can Help Relieve Hot Flashes
Alternative remedies for hot flashes have become increasingly popular, but there’s little research to support many of them.


From; Celebrity Diagnosis

By: Michele R. Berman, MD March 15, 2011
Golfer Phil Mickelson has had a rough year and a half. First, his wife and mother are diagnosed with breast cancer, and then he has a health scare of his own. Last year, after the U.S. Open, Mickelson began to experience some troublesome symptoms. In an interview with Extra's A.J. Calloway on Friday, Mickelson opened up about what was going on:
"After the U.S. Open last year, I wasn't able to move. I couldn't get out of bed. I had swelling, stiffness in my joints and couldn't move, just excruciating pain. I couldn't swing a golf club, and I was a little worried."............continue reading......

Around The World

Medical Journal Australia

Who owns our blood?

The absence of specific laws which define the ownership, storage and use of blood drops taken from every Australian baby since 1971 could threaten public trust in newborn screening (NBS) programs in Australia, a University of Melbourne academic has warned.

Bangladesh Bans Sale of Palm Sap After an Unusually Lethal Oubreak
Large fruit bats lap up the running sap, sometimes fouling pots with their saliva, urine or feces; the recent outbreak has killed 35 of the 40 people known to have been infected.

.One child dies every minute in Pakistan
Updated at 1810 PST Wednesday, March 23, 2011


KARACHI: In Pakistan the situation of child health is pathetic and serious efforts are needed by the government and civil society to save lives of hundreds of thousands of kids, who die every year from preventable diseases.The grim picture of child health situation could be seen in the annual health report of Pakistan Medical Association (PMA) for the year 2011, which says one child died every minute from EPI (expanded program on immunization diseases), diarrhea and acute respiratory infection (ARI). The report also reveals that every year about 400000 infants die in the first year of their life.Child health in Pakistan is among the most important national issues that need a proper and serious attention.

The child mortality in Pakistan is a major cause of concern, with every 1 among 10 children dying before reaching the age of five and 1 among 30, just after they are born. Pakistan is among the developing nations of the world that has yet to do much for the welfare of the general public.Pneumonia and air pollution seem to be the factors affecting the health of the children in Pakistan. The air pollution is mostly caused by harmful emissions of biogas, which is used in most houses of Pakistan.The main reason behind growing child mortality in Pakistan is lack of child healthcare facilities in rural areas, where majority of population lives.

Low state spending on healthcare, abject poverty, low literacy, lack of skilled birth attendants, widespread communicable diseases, insufficient emergency child health services in government run district and rural hospitals are amongst other major reasons behind growing diseases in children. Maternal, newborn and child health care statistics in Pakistan are some of the poorest in South Asia. A holistic approach is needed to improve maternal and newborn health, mainly by improving and upgrading facilities at the district hospitals.
Most common and lethal diseases in Pakistan include (ARI) acute respiratory, infection, viral hepatitis, malaria, diarrhea, dysentery, scabies, goiter, hepatitis and tuberculosis.Among the victims of Acute respiratory infection (ARI) most vulnerable are children whose immune systems have been weakened by malnutrition. Majority of children visiting hospitals and dispensaries suffer from the respiratory ailments and serious attention is needed to provide better medical treatment to children living in rural areas. Viral hepatitis, particularly that caused by types B and C are major epidemics in Pakistan with nearly 12 million individuals infected with either of the virus.

The main cause remains massive overuse of therapeutic injections and reuse of syringes during these injections in the private sector healthcare. Children are also amongst the hepatitis patients and their number is growing sharply. Malaria is a problem faced by the lower class people in Pakistan. The unsanitary conditions and stagnant water bodies in the rural areas and city slums provide excellent breeding grounds for mosquitoes. Like adults children also suffer from malarial diseases, which needs serious attention of healthcare policymakers. Diarrhea is rampant in the country due to use of contaminated water. It is estimated that about 20percent of diarrhea patients are children. Similarity, diseases like dysentery, scabies, dengue, goiter are also on the rise.Expanded Programme on Immunization (EPI) Pakistan provides vaccination against childhood tuberculosis, poliomyelitis, diphtheria, pertussis, tetanus, hepatitis B, haemophilus influenza type b and measles, besides protecting pregnant ladies with tetanus toxoid and their neonates against neo-natal tetanus. However, there is no success even to control polio.

Most births which take place at home under untrained supervision, which are responsible for alarming mortality of mothers and newborns. Children under the age of five face multiple obstacles, including birth injuries and infectious diseases. Millions of children suffer from short- and long-term adverse consequences of illnesses, malnutrition and injuries that impact their well-being and options in life, including fewer educational opportunities and diminished future economic prospects.

Child health is closely related to maternal health, as nutrition during pregnancy, birth conditions, birth spacing, and health status of the mother impact the health of the child prior to, during and after birth. Largely because of these factors, 3 million infants are stillborn each year.Recent devastation floods in Pakistan have further increased the disease burden. United Nations Children's Fund (UNICEF) says as many as three and a half million children in flood-ravaged Pakistan may be at risk of contracting deadly diseases carried through contaminated water and insects.UNICEF says the greatest threats to public health in Pakistan at the current time are certainly from waterborne diseases, which can intensify in precarious hygiene conditions, and when people have limited or poor access to safe water and sanitation services.

Diseases like cholera or acute watery diarrhoea, dysentery or bloody diarrhoea, typhoid fever and hepatitis, can all cause excess mortality and morbidity amongst the susceptible populations in the flood-hit areas. There is also an increased risk of malaria and dengue fever, since the stagnant water may provide an ideal breeding ground for mosquitoes - the vector that is responsible for transmission.To cope with the situation, the government must open more children hospitals in the country. In Sindh province, there is just one big children hospital, National Institute of Child Health (NICH), running in Karachi by the federal government.

There is dire need to open more children hospitals in the province and improve children departments in the hospitals of government-run teaching colleges in Karachi, Hyderabad, Jamshoro, Nawabshah, Sukkur and Larkana. In order to save lives of children, pediatric wards should be opened in all district headquarter hospitals, where emergency services along with trained child disease experts should be made available.Children are precious asset of the country and the government at federal, provincial and local government level should take serious efforts to improve healthcare facilities for them.


Low radioactivity seen heading towards N.America -

Thu Mar 17, 2011 10:35am EDT

* Particles not normal, but not dangerous-Swedish official

* U.S. nuclear body sees no "levels of harmful radiation"

* U.N. weather agency predicts northwesterly winter monsoon

By Fredrik Dahl VIENNA, March 17 (Reuters) -

Low concentrations of radioactive particles from Japan's disaster-hit nuclear power plant have been heading eastwards and are expected to reach North America in days, a Swedish official said on Thursday. In Washington, the U.S. Nuclear Regulatory Commission (NRC) said radioactivity would disperse over the long distance and it did not expect any harmful amounts to reach the country. "We expect the United States to avoid any levels of harmful radiation," NRC spokesman Joey Ledford told Reuters. "We do not anticipate any threat to American interests."

The Swedish official, research director Lars-Erik De Geer of the Swedish Defence Research Institute, was citing data from a network of international monitoring stations set up to detect signs of any nuclear weapons tests. Also stressing the levels were not dangerous for people, he predicted particles would eventually also continue across the Atlantic and reach Europe. "It is not something you see normally," he said by phone from Stockholm, adding the results he now had were based on observations from earlier in the week. But, "it is not high from any danger point of view." De Geer said he was convinced they would eventually be detected over the whole northern hemisphere. "It is only a question of very, very low activities so it is nothing for people to worry about," De Geer said. "In the past when they had nuclear weapons tests in China ... then there were similar clouds all the time without anybody caring about it at all," he said.


De Geer said the main air movement in the northern half of the globe normally went from west to east, but suggested the direction occasionally changed and at times turned. In Geneva, the U.N.'s World Meteorological Organisation (WMO) said on Thursday that a "northwesterly winter monsoon flow prevails over the eastern and northern part of Japan" and that this was expected to remain the case until around midnight GMT. The New York Times earlier said a forecast of the possible movement of the radioactive plume showed it churning across the Pacific, and touching the Aleutian Islands on Thursday before hitting southern California late on Friday. It said the projection was made by the Comprehensive Test Ban Treaty Organisation (CTBTO), a Vienna-based independent body for monitoring possible breaches of the test ban.

The CTBTO has more than 60 stations around the world which can pick up very low levels of radioactive particles such as caesium and iodine isotopes. It continuously provides data to its member states, including Sweden, but does not make the details public. De Geer said he believed the radioactive particles would "eventually also come here".

The New York Times said health and nuclear experts emphasized radiation would be diluted as it travelled and at worst would have extremely minor health consequences in the United States. In a similar way, radiation from the Chernobyl disaster in 1986 spread around the globe and reached the west coast of the United States in 10 days, its levels measurable but minuscule.

(Additional reporting by David Morgan in Washington; editing by Diana Abdallah)

US West Coast radiation risk low but fears persist

By Mary Milliken and Allan Dowd LOS ANGELES/VANCOUVER

Fri Mar 18, 2011 6:26am EDT LOS ANGELES/VANCOUVER (Reuters) - North America is at little risk of receiving harmful levels of radiation from Japan's nuclear crisis, officials said on Thursday, but that has not stopped a scramble on the West Coast for items like potassium iodide and Geiger counters. Low concentrations of radioactive particles from Japan's stricken nuclear plants are expected to drift over the Pacific Ocean but nothing has been detected as of late Thursday by U.S. or Canadian monitoring stations, officials said. Health and safety authorities sought to reassure nervous residents that any radioactive particles would disperse as they cross the Pacific from Japan and not pose a public risk when they arrive.

Even President Barack Obama weighed in. "We do not expect harmful levels of radiation to reach the United States, whether it is the West Coast, Hawaii, Alaska or U.S. territories in the Pacific," Obama said in a televised statement. "That is the judgment of our Nuclear Regulatory Commission and many other experts." Officials have said it would take five or six days for any particles to cross the ocean. Vancouver is more than 4,700 miles (7,500 km) from Tokyo, while Los Angeles is more than 5,400 miles (8,800 km) away. Public fear about the situation in Japan can be seen in prices being charged for online purchases of the potassium iodide antidote and Geiger counters that measure radiation.

At least five merchants on were selling packages of potassium iodide tablets for between $300 and $400, far above the usual list price of $10. Two big online sellers said on their websites they were sold out. A website for a company offering Geiger counters also announced it was no longer accepting new orders because demand had out-stripped supply.


Potassium iodide tablets can saturate the thyroid gland and prevent the absorption of radioactive iodine. When given before or shortly after exposure, that can reduce the risk of cancer in the long term. Health officials warn potassium iodide can pose its own risks if misused. "People should not take it anywhere in North America for the things that are happening in Japan," Donn Moyer of Washington state's Department of Health told Reuters.

Authorities also discouraged people from shopping online for home remedies to fight radiation, and British Columbia health officials warned not to confuse iodide with iodine solution - which can hurt them if ingested. The run on items is a common reaction in America's consumer-based culture, when media reports of possible disaster cause people to buy things they think will become scarce, said marketing expert Pamela Kennett-Hansel of the University of New Orleans. "Under these conditions, people are not going through the rational consumer process they usually go through," said Kennett-Hansel, who studied patterns after Hurricane Katrina hit New Orleans in 2005.

British Columbia's chief medical officer, Perry Kendall, said most people will heed warnings not to overreact but acknowledged his office has received calls alleging the government is engaging in a cover-up. (Additional reporting by Ross Kerber in Boston, Laura Zuckerman in Salmon, Idaho; Editing by Bill Trott)


FDA to Block Some Japanese Food Imports

The FDA has announced that it will detain all dairy products, fruits, and vegetables originating in the vicinity of Japan's damaged atomic energy complex that was heavily damaged in the March 11 earthquake and tsunami.

FDA Perspective on Developing Novel Combination Therapies
by Anna Azvolinsky March 23, 2011

As we learn more about the network of cellular pathways that function in the proliferation of cancer cells, it is becoming abundantly clear that there is no “magic bullet” cancer treatment. The latest oncology treatments being developed are often targeted drugs that block the activity of a specific molecule that contributes to tumor growth. However, as we have learned over the last 10 years, targeted treatments can often lead to resistance as redundant or alternative pathways are activated due to selective pressure from targeted agent exposure. It is becoming more and more apparent that combination therapies for cancer will be more efficacious in destabilizing tumor growth.

In the March edition of the New England Journal of Medicine (NEJM), Janet Woodcock, M.D. and director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), has written a perspective on this topic, highlighting the goals and current developments at the FDA to progress the combination clinical trial process (DOI:10.1056/NEJMp1101548).

The perspective is In response to concerns that the policies of the FDA are too rigid to facilitate efficient and effective combination clinical trials, especially because the established policies are focused on combined treatments within the same tablet (fixed-dose combinations) of drugs that are already on the market. Currently, the FDA is in the process of revamping its regulations for drug development. The focus is specifically the co-development of two or more distinct investigational drugs intended to be used in combination, but not in fixed dose combinations.
Going Beyond Single Agent DevelopmentEven for diseases for which combination therapies are necessary, new drug development has historically been pursued linearly, one agent at a time. Add-on clinical trials have been used to test the efficacy of combination treatments in which a standard regimen plus a new drug is compared to the standard regimen alone. As the head of the CDER states in her perspective, “Successful development of future targeted therapies will require modernizing this paradigm to provide the flexibility needed to rapidly evaluate combination regimens involving new targeted agents in a single development program."

FDA Takes Necessary Steps to Aid the Process of Combination Therapy Drug Development“Innovative drug development requires science and regulation to advance in concert,” writes Janet Woodcock, M.D.

The first step was the June 2010 Federal Register request for public comments on the co-development of investigational drugs. The FDA specifically requested comments on both the methodology and regulatory issues that arise when developing investigational drugs in combination, particulary for oncology and other therapeutic areas in which co-development is more likely to occur.

Arthur D. Levinson, Chairman of Genentech, had stated that this is “an important step in the development of guidance” and stressed the importance of “decreasing both real and/or perceived barriers to bringing novel combination therapies to patients with serious and unmet medical conditions.”

The next step was the release of the “Guidance for Industry Co-development of Two or More Unmarketed Investigational Drugs for Use in Combination” in December 2010. The guidance is intended to ensure that regulatory expectations are transparent and provides recommendations on preclinical testing, safety, pharmacology studies, and phase 1 through 3 efficacy studies for co-development. Importantly, the guide carves out the type and amount of data that the FDA requires to demonstrate the contribution of each drug to the overall efficacy of the combination. The result is a road map for co-development for appropriate therapeutic categories.
Uncertainties in Co-Development ProcessThe head of the CDER points out that co-development will not make it possible to fully characterize the effects of a single drug component, resulting in less information about both safety and effectiveness. Dr. Woodcock stresses that co-development should be used only for treatment of life-threatening disease for which there is no satisfactory standard of care. Additionally, there should be “compelling biologic rationale for use of the combination” writes the author.

Janet Woodcock points out that co-development will likely mean increased collaboration, and increased private-private and private-public partnerships. Importantly, the perspective emphasizes the FDA’s commitment to the therapeutic potential of innovative combination therapies and their development as well as mitigating the risks associated with such development programs.


Off The Cuff

How Independent Are Our Peer-Reviewed Scientific Journals?

By: Dr. Wes March 17, 2011
On September 27, 2010, the peer-reviewed scientific journal Europace published online-before-print a case report entitled "Spontaneous explosion of implantable cardioverter-defibrillator" by Martin Hudec and Gabriela Kaliska. In the pdf of that case report, a figure containing a color photo of the affected patient's chest, chest xray, and two pictures of the extracted device (one seen here) were included. The pictures and case presentation were dramatic. The case very rare. Both were perfect reasons to report such an important case to the medical literature.And so these doctors sent the case to Europace on 29 June 2010 and the article was accepted after revision on 16 Aug 2010 with the article appearing online 27 September 2010......

J&J Faces $360M Penalty Over Risperdal Marketing

A South Carolina state court jury decided late yesterday that a Johnson & Johnson unit violated consumer protection laws by sending doctors a misleading letter in 2003 about the safety and effectiveness of the Risperdal antipsychotic. The jurors also found warning label info was deceptive. And so a judge will now decide whether $360 million in penalties will be paid, Bloomberg News writes.


1 comment:

  1. Thanks for this wonderful article. I'm a health conscious guy and this post will be my new resource from now on.