MEDDESKTOP

Monday, August 03, 2009

Conn. Sen. Dodd will spend the month of August pushing for health care reform

Sen. Chris Dodd will spend the month of August working for national health care reform. He will also be dealing with his own health care, stemming from detection of cancer. Goog Luck with both, Senetor. We need both.

Malaria, Chimps Gift To Mankind.

UCI’s Francisco Ayala

Deadly parasite jumped to humans from chimpanzees, perhaps through one mosquito

— Irvine, Calif., August 3, 2009 —

Researchers have identified what they believe is the original source of malignant malaria: a parasite found in chimpanzees in equatorial Africa.

UC Irvine biologist Francisco Ayala and colleagues think the deadly parasite was transmitted to humans from chimpanzees perhaps as recently as 5,000 years ago - and possibly through a single mosquito, genetic analyses indicate. Previously, malaria's origin had been unclear.

This discovery could aid the development of a vaccine for malaria, which sickens about 500 million people and kills about 1.5 million each year. It also furthers understanding of how infectious diseases such as HIV, SARS, and avian and swine flu can be transmitted to humans from animals.

"When malaria transferred to humans, it became very severe very quickly," said Ayala, co-author of the study that reports these findings. "The disease in humans has become resistant to many drugs. It's my hope that our discovery will bring us closer to making a vaccine."

The study appears online the week of Aug. 3 in the Proceedings of the National Academy of Sciences.

Human malignant malaria is caused by a parasite called Plasmodium falciparum, which is responsible for 85 percent of all infections and nearly all malaria deaths. Chimpanzees were known to carry a closely related parasite called Plasmodium reichenowi, but most scientists assumed the two had existed separately in humans and chimpanzees for the last 5 million years.

Scientists in the current study examined several new strains of the parasite found in blood taken from wild and wild-born chimpanzees in Cameroon and Ivory Coast sanctuaries during routine health exams.

A gene analysis linked one chimpanzee strain to all worldwide strains of the human malaria parasite. This connection suggests that one mosquito may have transferred malaria to humans. Because there is little genetic variance among strains of the human parasite, scientists believe the transmission occurred in the recent past - maybe 5,000 to 2 million years ago - though an exact time could not be determined.

The results support an earlier hypothesis by Dr. Ajit Varki of UC San Diego and colleagues that genetic mutations made humans first resistant to sickness from the chimpanzee parasite, then extremely susceptible to illness from the human form.

They also corroborate an earlier finding by Ayala and former UCI graduate student Stephen Rich that malignant malaria started spreading throughout the tropics and world about 5,000 years ago, when agriculture began in Africa. Rich, now a professor at the University of Massachusetts Amherst, is the lead author of the current PNAS study.

In addition to Ayala and Rich, Nathan Wolfe of Stanford University worked on the study, along with collaborators from the Robert Koch Institute and the Max Planck Institute for Evolutionary Anthropology in Germany; the Global Viral Forecasting Initiative in San Francisco; the Biotechnology Centre in Cameroon; the U.S. Department of Agriculture; and the Ebola Tai Forest Project in the Ivory Coast.

The study was funded by the National Institutes of Health, with additional support from the Cummings School of Veterinary Medicine at Tufts University and the National Geographic Society Committee for Research & Exploration.

About the University of California, Irvine: Founded in 1965, UCI is a top-ranked university dedicated to research, scholarship and community service. Led by Chancellor Michael Drake since 2005, UCI is among the fastest-growing University of California campuses, with more than 27,000 undergraduate and graduate students, 1,100 faculty and 9,200 staff. The top employer in dynamic Orange County, UCI contributes an annual economic impact of $4.2 billion. For more UCI news, visit http://today.uci.edu/.

Friday, July 31, 2009

FDA Issues Draft Guidelines To Eliminate Microbial Contamination In Tomatoes, Leafy Greens, And Melons.

The U.S. Food and Drug Administration has published three draft guidances designed to help growers and others across the entire supply chain minimize or eliminate microbial contamination in tomatoes, leafy greens, and melons.

The guidances are, in part, based on those originally developed by the produce industry with assistance from FDA. They represent the first step in a fundamental shift in strategy for the agency in the prevention of foodborne hazards associated with fresh fruits and vegetables.

“These guidances embody the Obama Administration’s and FDA’s prevention-oriented food safety strategy,” said FDA Commissioner Margaret A. Hamburg, M.D. “They will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

These commodity-specific guidances were called for by the President’s Food Safety Working Group, which recommends a new, public-health focused approach to food safety. In a report issued earlier this month, the working group made recommendations aimed at creating a stronger food safety system. The recommendations stem from three core food safety principles:

Prevent harm to consumers
Use good data and analysis to ensure effective food safety inspections and enforcement of the law
Identify outbreaks of foodborne illness quickly and stop them

Key elements of the draft guidances related to the working group’s strategies include:

An acceptable baseline standard of industry practices that help both domestic and foreign firms minimize the risk for microbial contamination of their products throughout the entire supply chain
Recommendations regarding growing, harvesting, packing, processing, transportation, and distribution of the product
Recommendations for recordkeeping, including some that will help the FDA determine more quickly the source of outbreaks that do occur.

Comments on FDA’s guidance documents may be submitted at any time. However, to ensure that comments are received in time for consideration in drafting final versions of these guidance documents, written or electronic comments should be submitted within 90 days of publication in the Federal Register. See http://www.regulations.gov for information.

Onglyza (saxagliptin), New Drug To Treat Type 2 Diabetes, Approved By FDA

For Immediate Release: July 31, 2009

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Drug Treatment for Type 2 Diabetes

The U.S. Food and Drug Administration today approved Onglyza (saxagliptin), a once-daily tablet to treat Type 2 diabetes in adults. The medication is intended to be used with diet and exercise to control high blood sugar levels.

The hormone insulin keeps blood sugar (glucose) levels within a narrow range in people who don’t have diabetes. People with Type 2 diabetes are either resistant to insulin or do not produce enough insulin to maintain normal blood sugar levels.

Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which stimulate the pancreas to make more insulin after eating a meal.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with Type 2 diabetes,” said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research. “High blood sugar levels can cause blurry vision and excessive urination and eventually result in such serious conditions as kidney and eye disease.”

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Approval of Onglyza was primarily based on the results of eight clinical trials. The application seeking FDA approval was submitted before December 2008 when the agency recommended that manufacturers of new diabetes drugs carefully design and evaluate their clinical trials for cardiovascular safety. Although Onglyza was not associated with an increased risk for cardiovascular events in patients who were mainly at low risk for these events, the FDA is requiring a postmarket study that will specifically evaluate cardiovascular safety in a higher risk population.

Onglyza is manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., and marketed by Bristol-Myers and AstraZeneca Pharmaceuticals LP, of Wilmington, Del.

Thursday, July 30, 2009

Abbott Vascular Recalls POWERSAIL® Coronary Dilatation Catheters.

Abbott Vascular has recalled three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage.
Recallr: Abbott Recalls POWERSAIL® Coronary Dilatation Catheters
Tags: POWERSAIL® Coronary Dilatation Catheters recall, Abbott Vascular recall, FDA Recall, powersail recall, Coronary Dilatation Catheter recall

Wednesday, July 29, 2009

Guidance for Industry, Drug-Induced Liver Injury

FDA has released a guidance to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug or a product to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).

In particular, the guidance addresses how laboratory measurements that signal the potential for such drug-induced liver injury (DILI) can be obtained and evaluated during drug development.

This evaluation is important because most drugs that cause severe DILI do so infrequently; typical drug development databases with up to a few thousand subjects exposed to a new drug will not show any cases. Databases may, however, show evidence or signals of a drug’s potential for severe DILI if the clinical and laboratory data are properly evaluated for evidence of lesser injury that may not be severe, but may predict the ability to cause more severe injuries. This guidance describes an approach that can be used to distinguish signals of DILI that identify drugs likely to cause severe liver injury from signals that do not suggest such a potential. This guidance does not address issues of preclinical evaluation for signals of DILI, nor the detection and assessment of DILI after drug approval and marketing.
The guidance is available from FDA.
Follow the link below for a PDF file;
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf

New Abd Genetic Drug Approvals By FDA (July 28th 2009)

After being absent for a while, new and generic drug approvals by FDA will be listed again.

Following Drugs were Approved by FDA on July 28, 2009

- Actonel (risedronate sodium) Tablets, P & G Pharmaceuticals, Inc., Efficacy Supp. w/Clinical Data
- Amlodipine Besylate and Benazepril Hydrochloride Capsules, Mylan Pharmaceuticals Inc., Tentative Approval
- Cellcept (mycophenolate mofetil) Tablets, Roche Palo Alto, LLC, Manufacturing Change or Addition
- Lamivudine and Zidovudine Tablets, Aurobindo Pharma Limited, Tentative Approval
- Penicillin G Potassium Injection, G.C. Hanford Manufacturing Company, Approval
- Solodyn (minocycline HCl) Extended Release Tablets, Medicis Pharmaceutical Corporation, Control Supplement
- Zidovudine Tablets, Aurobindo Pharma Limited, Approval