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5110 Kali Era, Sarvadhari
Vikramarka Era, Sarvadhari
Chronic Diseases in America
For the first time, it appears that more than half of all insured Americans
are taking prescription medicines regularly for chronic health problems, a
study shows. The most widely used drugs are those to lower high blood
pressure and cholesterol -- problems often linked to heart disease, obesity
and diabetes. The numbers were gathered last year by Medco Health Solutions
Inc., which manages prescription benefits for about one in five Americans.
Experts say the data reflect not just worsening public health but better medicines
for chronic conditions and more aggressive treatment by doctors. For example,
more people are now taking blood pressure and cholesterol-lowering medicines
because they need them. In addition, there is the pharmaceutical industry's
Companies Don’t Face These Problems
Hundreds of patients taking Pfizer Inc's anti-smoking drug Chantix have
reported serious accidents, vision problems and heart trouble, researchers
said, sending shares of the world's largest drugmaker to their lowest level
since 1997. U.S. aviation regulators responded quickly to the research,
saying they would prohibit use of the drug by private and commercial pilots.
Chantix, also known as varenicline, has already been linked to depression
and suicide, among other problems. Researchers at the nonprofit Institute
for Safe Medication Practices, and Wake Forest University, said they found
hundreds of reported problems since the drug's 2006 approval that included
blurred vision, dizziness, confusion and loss of consciousness, which were
already mentioned on the drug's label.
In a letter to the chief executives of Merck & Co Inc, Pfizer Inc, Johnson
& Johnson and Schering-Plough Corp, Reps. John Dingell and Bart Stupak
asked the companies to refrain from marketing products to consumers until
certain studies are completed. The Democratic lawmakers also called
on several drug companies to voluntarily curb advertisements targeting consumers,
including withholding any ads for new products for two years.
The Michigan Democrats are investigating whether companies are misleading
potential patients through television commercials and other direct-to-consumer
advertisements. The letters come less than two weeks after the committee's
health panel questioned lower executives from the drugmakers about aggressive
marketing tactics for two cholesterol drugs -- Pfizer's Lipitor and Merck
and Schering-Plough's Vytorin joint venture. The committee also probed
ads for Johnson & Johnson's anemia drug Procrit.
Google Inc unveiled Google Health, U.S. health information service that
combines the leading Web company's classic search services with a user's
personal health records online. The password-protected service, which can
be found at www.google.com/health/, stores a user's basic medical history
and gathers relevant information connected to their health conditions. The
service includes links to major U.S. pharmacies, doctors' groups and medical
testing labs. Partners include Walgreen Co, Longs Drugs Stores Corp, CVS
Caremark Group, AllScripts, Quest Diagnostics and the Cleveland Clinic. The
company had previously said it was working with health insurers such as Aetna
Inc and Wal-Mart Stores Inc pharmacies.
RNA Interference (RNAi)
RNAi (RNA interference) is a revolution in biology, representing a breakthrough
in understanding how genes are turned on and off in cells, and a completely
new approach to drug discovery and development. Its discovery has been heralded
as “a major scientific breakthrough that happens once every decade or so,”
and represents one of the most promising and rapidly advancing frontiers in
biology and drug discovery today which was awarded the 2006 Nobel Prize for
Physiology or Medicine. RNAi is a natural process of gene silencing that occurs
in organisms ranging from plants to mammals. By harnessing the natural biological
process of RNAi occurring in our cells, the creation of a major new class
of medicines, known as RNAi therapeutics, is on the horizon. RNAi therapeutics
target the cause of diseases by potently silencing specific messenger RNAs
(mRNAs), thereby preventing disease-causing proteins from being made. RNAi
therapeutics have the potential to treat disease and help patients in a fundamentally
SE Vascular Closure System
Abbott announced the launch of the StarClose® SE Vascular Closure System,
a next-generation vessel closure device engineered to enable fast, safe and
secure closure of the femoral artery access site following a catheterization
procedure. StarClose SE is available in the United States and Europe.
StarClose SE, which stands for "Safe and Extravascular," builds upon the
premium design of its predecessor, StarClose, with more ergonomically-friendly
design features. StarClose SE advancements include:
Improved ease of use, with an intuitive, numbered system,
providing visual guidance and audible "clicks" for each step leading to clip
Immediate vessel closure with deployment of a shape-memory
clip onto the surface of an artery, allowing patients to recover and be discharged
sooner than with manual compression
Added device stability for the operator during clip deployment.
StarClose SE utilizes the same nitinol (nickel and titanium) clip technology
as StarClose to close the femoral artery access site after a catheterization
procedure. When deployed, the small nitinol clip grasps the tissue on top
of the artery around the access site in a purse-string fashion and closes
the opening in the femoral artery rapidly and securely with minimal affect
to the lumen diameter or the blood flow inside the vessel.
Catheterization is a procedure commonly used to evaluate or treat certain
types of disease in vessels of the heart and other parts of the body. The
procedure involves the insertion of a flexible tube, called a catheter, into
the femoral artery in the leg. The physician will use the catheter to observe
the condition of the coronary or peripheral blood vessels or to treat blockages
in the vessels. Following the procedure, the physician will remove the catheter
and close the femoral artery access site. Over the years, a variety of methods,
such as direct pressure (manual compression), sandbags and mechanical clamps,
have been used to close the puncture site and achieve hemostasis (cessation
of bleeding). Many of these methods have proved less than satisfactory, causing
patients significant discomfort and requiring up to several hours of bedrest.
The Food and Drug Administration warned women not to use or purchase Mommy's
Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif.
The cream, promoted to nursing mothers to help soothe dry or cracked nipples,
contains ingredients that may cause respiratory distress, vomiting and diarrhea
in infants, the agency said. The potentially harmful ingredients in
the cream are chlorphenesin and phenoxyethanol.
The company has stopped selling the cream. The FDA said consumers should
stop using the cream and consult a doctor if they experience problems or believe
that their infant may have experienced problems due to the product. Mothers
whose children may have suffered adverse effects because if this product
should contact the FDA's MedWatch at 800-332-1088.
Cost of ADHD
Attention-deficit hyperactivity disorder (ADHD) can lead to a loss of a
month's worth of work every year for adults with the condition. A Harvard
study published in the online edition of Occupational and Environmental Medicine
suggests that employers screen workers for ADHD and offer treatment. The
study found that the losses for adults with ADHD were mostly in terms of
quantity and quality of work, rather than missing days of work. In the study,
researchers interviewed more than 7,000 workers aged 18 to 44 in 10 countries.
They found that about 3.5% of the workers had ADHD. The rates of ADHD and
lost performance days varied by country, with the U.S. rate at 4.5%, at a
cost of 28.3 days performance on average.
Pfizer Patent Upheld
Pfizer Inc said that the Australian Full Federal Court in Victoria has upheld
on appeal the exclusivity of its basic patent covering atorvastatin, the active
ingredient in Lipitor. The ruling, the culmination of a lawsuit filed
in 2005 by generic drug manufacturer Ranbaxy, preserves Lipitor’s patent coverage
in Australia through May 2012. Ranbaxy can appeal the decision. The
court found that a proposed Ranbaxy generic product would infringe Pfizer’s
basic Lipitor patent (AU 601,981). A second patent covering the calcium salt
of atorvastatin (AU 628,198), which expires in September 2012, was ruled
invalid by the court. Pfizer has the opportunity to appeal that ruling. The
Australian decision will not impact ongoing Lipitor patent actions in other
countries, including the United States. Pfizer said it would continue to
vigorously defend against challenges to its intellectual property, noting
that patents provide the necessary incentive to invest in new and life-saving
medicines that benefit millions of patients globally.
Intellectual property protection, especially short-term patent protection,
is essential for the survival of innovative biopharmaceutical industry and
to develop new drugs seeking answers to some of the world's most urgent medical
needs, which involves about 15 years of research by hard working scientists,
and billions of dollars of investment.
The CAFC affirmed a ruling that the Lovenox patents owned by Aventis were
unenforceable due to a failure to submit important experimental information
during prosecution with an intent to deceive USPTO. The Lovenox patents
are directed toward a heparin based drug used to help prevent blood clots.
The specification includes a particular set of experimental examples that
show an increased half-life of the claimed admixture. During prosecution,
the applicant used those examples along with additional data to prove that
its drug was inherently different from a prior art drug. Aventis did
not report to the PTO that its experiments showing an increased half-life
of the claimed admixture used a different dosage than those testing the prior
art drug. Half-life of a compound does not necessarily depend on its
amount, but the amount and number of times required per day by patient changes
based on the half life of the drug. Judge Rader dissented arguing that
there was also compelling evidence that Aventis did not intend to deceive
the patent examiner.
Ranbaxy and Merck
India's Ranbaxy signed a five-year pact with Merck to develop new anti-infectives.
Ranbaxy, which received an undisclosed upfront payment, says it stands to
earn more than $100 million from each new therapy developed in the five-year
collaboration, which follows a similar deal it signed with GlaxoSmithKline.
Ranbaxy researchers will advance therapies into Phase II, at which point Merck
will take over the development program. Ranbaxy shares jumped more than five
percent on the news. This new deal signals an ongoing effort by big
pharma companies to reduce their expenses by shifting development programs
into China and India. Eli Lilly has also aggressively pursued an Asian strategy
for its R&D work as well.
Indian Generic Drug Makers
Indian drugmaker Ranbaxy Laboratories Ltd has received approval from the
U.S. Food and Drug Administration for muscle relaxant cyclobenzapine hydrochloride
tablets. The FDA has also granted tentative approval to Lupin Pharmaceuticals
Inc, a unit of Lupin Ltd, for ramipril capsules, used in treating cardiovascular
disease and high blood pressure.
Source: The primary sources
cited above, BBC News, New York
Times (NYT), Washington Post (WP),
Mercury News, Bayarea.com, Chicago
Tribune, USA Today, Intellihealthnews, Deccan
Chronicle (DC), the Hindu, Hindustan
Times, Times of India, AP, Reuters,
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