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Saturday, January 1, 2011

Medical News: FDA Puts Pain Drugs on Hold - in Pain Management, Pain Management from MedPage Today

Medical News: FDA Puts Pain Drugs on Hold - in Pain Management, Pain Management from MedPage Today

Development of anti-nerve growth factor drugs at two different companies has been suspended by the FDA after a serious bone disorder occurred in a study participant.
Regeneron, a Tarrytown, N.Y.-based biopharmaceutical firm, noted in a Securities and Exchange Commission filing on Monday that it had been notified by FDA that "a case confirmed as avascular necrosis of a joint was seen in another company's anti-nerve growth factor (NGF) program. The FDA believes this additional case provides evidence to suggest a class effect."
As a result, the agency put REGN475/SAR164877 -- an NGF inhibitor being developed jointly by Regeneron and sanofi-aventis -- on clinical hold, according to the filing.
The FDA defines a clinical hold as "An order issued ... to the sponsor of an investigational new drug to delay or suspend a clinical investigation."

Medical News: Supreme Court to Hear Generic Drug Labeling Case - in Product Alert, Prescriptions from MedPage Today

By Emily P. Walker, Washington Correspondent, MedPage Today
Published: March 26, 2011
WASHINGTON -- The U.S. Supreme Court will hear arguments on Wednesday in a case involving generic drugmakers' responsibility to provide safety information in product labeling.
The case -- Pliva, Inc. v. Mensing (which has been consolidated with Actavis Elizabeth LLC v. Mensing, and Actavis, Inc. v. Demahy) -- centers around Gladys Mensing, a Minnesota woman who was prescribed metoclopramide (Reglan) in 2001 to treat her diabetic gastroparesis. Her pharmacist filled her prescription with a generic version of the drug.
After taking the generic for four years, Mensing developed tardive dyskinesia and sued Pliva and Actavis, the makers of the generic, arguing that although there was growing evidence that long-term metoclopramide use carried a risk for tardive dyskinesia that was far greater than indicated on the drugs' label, no metoclopramide manufacturer took steps to change label warnings.
Mensing had also sued Wyeth Pharmaceuticals, maker of the brand-name drug for fraud, alleging that Wyeth's label didn't accurately reflect the tardive dyskinesia risk, and her physicians consulted that label when writing Mensing's prescription. But a Minnesota appeals court dismissed the suit against Wyeth, because Mensing never took any brand-name metoclopramide.
The Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act provided an abbreviated pathway for generic drugs that doesn't require generic manufacturers to repeat the same costly trials conducted by brand-name manufacturers. But generic drugs must carry identical labels as their branded versions. If a brand-name drugmaker updates its label as new risks become apparent, the generic drugmaker must do the same.
Mensing is arguing the generic makers of metoclopramide knew of the increased risk for tardive dyskinesia.
"The regulatory framework makes clear that a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug," Minnesota appeals court judges argued in an earlier decision.
Identical Labeling Required
Under law, generic manufacturers are subject to the requirement that their labeling "shall be revised as soon as there is reasonable evidence of an association of a serious hazard with a drug." The FDA would have to sign off on the updated labeling.
But the makers of the generic drug argue that they could not have delivered whatever additional warnings state law required while remaining faithful to the Hatch-Waxman amendment, which require a drug's approved labeling be identical to the brand-name drug's approved labeling.
"This is somewhat of a sticky wicket," Bob Billings, interim executive director of the Generic Pharmaceutical Association (GPhA), told MedPage Today. " We are required to label our products the same as the brand is labeled.
"When FDA approves [a generic] we're basing [the generic] on the brand-name clinical trials. Generics don't have to do the clinical trials; that's why they're less costly. In terms of all the proprietary data, we're not privy to that data. We have to rely on what they show on their label."
Billings added that GPhA, which filed a friend-of-the-court brief on behalf of the two generic drug companies involved in the suit -- Pliva, a Croatian company now owned by Barr Laboratories, and Actavis, a Swiss company -- "absolutely 100% believes that patient safety is paramount."
Feds Say FDA Needed Notice
But lawyers for the departments of Justice and Health and Human Services don't buy GPhA's reasoning. The generic manufacturers should have provided the FDA with the relevant safety information and allowed the FDA to determine whether the labeling should be revised, they wrote in a amicus brief filed on behalf of Mensing and Julie Demahy, the other patient in the lawsuit who had a very similar experience to Mensing's.
Generic drugmakers "have a duty under federal law to propose appropriate changes to approved labeling to communicate warnings about serious drug hazards," the administration lawyers wrote.
The case recalls the 2009 Wyeth v. Levine case, in which the Supreme Court sided with Diana Levine, a musician who lost her arm when gangrene developed following injection of the anti-nausea drug promethazine (Phenergan) by IV push. The Court ruled against Wyeth, the maker of Phenergan, in its ruling that FDA approval of a drug and its label does not shield its maker from lawsuits brought by patients injured by use of the drug.
The generic defendants in the current case would argue that the Wyeth case is different because it dealt with brand-name drugs.
But as the Minnesota appeals court judges pointed out in their decision, the Wyeth case highlights the "central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate."
Physician Groups Side With Mensing
In addition to the Obama administration, 42 states and the District of Columbia; the American Medical Association (AMA), along with a number of state medical associations; and the American Association of Justice (AAJ) have all filed amicus briefs on behalf of the injured women in Pliva v. Mensing.
"Interestingly, this case is pretty much the generic drug companies against the world," said Louis Bograd, a lawyer with the Center for Constitutional Litigation, who is arguing before the Supreme Court on behalf of Mensing and Demahy. AAJ held a Thursday afternoon teleconference to discuss the case.
In its brief, the AMA said physicians must rely on knowledge of current and accurate drug safety information in order to safely and effectively prescribe prescription drugs.
"It would disrupt the established patient care system to adopt a policy pursuant to which one member of the healthcare community -- generic drug manufacturers -- was permitted to absolve themselves of their unique and vital role in ongoing drug safety," AMA lawyers wrote.
Christy Graves, MD, the physician who prescribed metoclopramide to Demahy, also filed a friend-of-the-court brief. Graves, a internist in Louisiana, said she never would have continued to prescribe Demahy metoclopramide for four years for her gastroesophageal reflux disorder if she had known of the tardive dyskinesia risk. The metoclopramide label warned only of a very small risk of adverse neurological reactions.
From 1985 through 2009, the warnings on metoclopramide stated it carried a risk of 1 in 500 patients developing a class of neurological side effects called extrapyramidal symptoms, including tardive dyskinesia. But after the risk was found to be much higher, the FDA in 2009 required makers of metoclopramide add a boxed warning to their drug labels regarding the risk of tardive dyskinesia with long-term or high-dose use.
In the GPhA amicus brief on behalf of Pliva and Actavis, the group argues that because generics are essentially the same as the brand-name competitors, "that generic manufacturers thus should not be forced to assume the extraordinary burden of generating, compiling, and continuously revisiting the clinical data necessary to justify the FDA-approved labeling that federal law compels them to put on their products."
If the Supreme Court ultimately rules against the generic companies, it could raise the costs of producing generic drugs, which could be passed on to patients, Billings said

Celebrating Life During Tough Times

Celebrating Life During Tough Times

There is an old saying that advises us to turn the lemons that life deals us into lemonade. No matter what age we find ourselves, life does, on occasion, present us with difficult challenges. I prefer to consider these challenges lessons in growth--and our growth comes in all sizes, shapes, and colors.
Sometimes a birthday is the bugaboo that gets us down. We don’t like the idea that we are turning thirty, forty, or fifty. We see these markers as a delineation of old, no matter which decade we are in. When we are twenty-eight, forty looks ancient. When we are forty-five, sixty-five appears to be over the hill. But let us turn seventy-five years of age, and fifty looks pretty good to us
An impending divorce may be our biggest challenge of the moment. Being thrust back into the working world as a single mom is not appealing. Supporting and caring for children individually makes us quake in our Manolo Blahniks. Being in the dating scene again brings fear, yet facing loneliness is not our idea of fun either.
Living in a home that has become an empty nest is not a pleasant adjustment to make. Gone are the days where the home was a sanctuary that held children bubbling with joy, anticipation, and love for life. Now there is a couple living alone, perhaps having stayed together for the sake of the kids. Maybe there’s an individual with too much time on her hands now that the last child has flown the nest.

Friday, December 31, 2010

Medical News: Placebo Effect Is Real, Not Attempt to Deceive - in Pain Management, Pain Management from MedPage Today

Medical News: Placebo Effect Is Real, Not Attempt to Deceive - in Pain Management, Pain Management from MedPage Today

The placebo effect works -- even when the patient knows it's a placebo -- demonstrating that it is a 'ritual of medicine' and not an attempt to fool patients, according to the results of a small randomized clinical trial.

In the trial of 80 irritable bowel syndrome (IBS) patients, those who took an open-label placebo showed clinically meaningful -- and statistically significantly -- higher global improvement scores and reduced symptom severity compared with those who got the same physician attention but didn't pop a placebo pill, Ted J. Kaptchuk, OMD (Doctor of Oriental Medicine), of the Beth Israel Deaconess Medical Center and Harvard, and colleagues found.

Thursday, December 30, 2010

Five simple eating principles your body is dying to follow

Five simple eating principles your body is dying to follow

(NaturalNews) There are several basic principles of health that your body is dying to follow. Here is a brief discussion of 5 of these, as they pertain to eating, below. If we follow these principles we can be assured of great benefits because indeed an ounce of prevention is worth a pound of cure.

Regularity In Meals

First let's look at regularity in meals. It is ideal to maintain a regular schedule not eating too late or eating at irregular times. By eating at the same time daily, the stomach will get used to eating at a certain time each day. This will encourage rhythm within the stomach. This will facilitate the entire gastrointestinal tract. Many people set the stage for gastrointestinal problems by eating and drinking at irregular times.

Learn more:

Medical News: U.S. Hospitals Facing Largest Drug Shortage in Decades - in Public Health & Policy, General Professional Issues from MedPage Today

Many hospital patients are not getting potentially life-saving treatments because of what may be the largest U.S. hospital drug shortage in more than 20 years.

Most of the drugs in short supply are injectables, including sedating agents such as propofol (Diprivan), the popular blood thinner heparin, and hard-hitting chemotherapy drugs like doxorubicin (Adriamycin).

"I've been in practice more than 30 years and this is the first time I've encountered shortages that may affect patient care," said Dr. Michael Link, president-elect of the American Society of Clinical Oncology.

Limited manufacturing, lagging production time, and lack of profits from these drugs are contributing to the shortage, according to an August 2010 editorial published in the New England Journal of Medicine. The production cost outweighs the profits for some companies.

Medical News: U.S. Hospitals Facing Largest Drug Shortage in Decades - in Public Health & Policy, General Professional Issues from MedPage Today

Wednesday, December 29, 2010

Allergy treatment may cause new allergy

Allergic contact dermatitis from aluminium has previously been considered very unusual. However, there are now reports of pruritic nodules and aluminium allergy arising after vaccinations or treatments for allergies. Researcher Eva Netterlid has studied the problem in a thesis recently defended at Lund University in Sweden.

'Pruritic nodules' are small lumps under the skin that cause itching and which, according to some studies, can remain for several years. A study of  vaccinations in Gothenburg a few years ago showed that almost one per cent of the children developed pruritic nodules in the area of the vaccination. Three out of four of the children who had a reaction with nodules also developed an allergy to aluminium.
"This was completely unexpected. Aluminium has been used as an adjuvant, intensifier, in vaccines for over 70 years with only a small number of reports of pruritic nodules and allergic contact dermatitis", says Eva Netterlid. Her research has been carried out at the Occupational and Environmental Dermatology Unit in Malmö.
There are a number of possible explanations as to why aluminium allergy has become more common.

Tuesday, December 28, 2010

Scientists discover potential strategy to improve cancer vaccines

The promise of vaccines targeted against various types of cancer has raised the hopes of patients and their families. The reality, however, is that these promising treatments are difficult to develop. One of the challenges is identifying a discrete cellular target to stop cancer growth without inactivating the immune system. Scientists at UNC Lineberger Comprehensive Cancer Center report a laboratory finding that has the potential to increase the effectiveness of therapeutic cancer vaccines.

Monday, December 27, 2010

A positive mood allows your brain to think more creatively

People who watch funny videos on the internet at work aren't necessarily wasting time. They may be taking advantage of the latest psychological science -- putting themselves in a good mood so they can think more creatively.

"Generally, positive mood has been found to enhance  solving and flexible yet careful thinking," says Ruby Nadler, a graduate student at the University of Western Ontario. She and colleagues Rahel Rabi and John Paul Minda carried out a new study published in Psychological Science, a journal of the Association for . For this study, Nadler and her colleagues looked at a particular kind of learning that is improved by creative thinking.

Sunday, December 26, 2010

FDA cracks down on illegal supplements

(AP) --  The Food and Drug Administration is cracking down on manufacturers of certain weight loss, body building and sexual enhancement supplements that contain potentially dangerous ingredients.

The FDA said Wednesday that some manufacturers are deceptively labeling products to hide that they contain ingredients known to cause . Other supplements contain ingredients that should only be available by prescription.
"These tainted products can cause serious , including strokes,, and death," said FDA Commissioner Margaret Hamburg. "The manufacturers selling these tainted products are operating outside the law."
 can slip through the regulatory cracks because, unlike drugs, they do not have to be approved by the FDA before they are marketed. Manufacturers are responsible for making sure their products are safe.