Drug Products

Low T, Clarus – Are Pharmaceutical Companies Manufacturing Cures?

In yet another clear sign that pharmaceutical companies are manufacturing a cure and have used the media and aggressive marketing to create a market, Clarus Therapeutics announced that they are resurrecting an IPO designed to back the launch of their new low testosterone drug Rextoro.

Clarus first mounted the IPO for Rextoro three years ago but withdrew it due to lack of market interest. Now with Low T clinics opening across the nation Clarus has mounted a bid to raise $86 million in venture capitol to launch Rextoro. In the IPO the company has announced the drug has gone through Phase III studies and was submitted to the FDA in January.

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CDC cost of child abuse


That figure represents what one year of child abuse cases will cost the United States according to the Centers for Disease Control. For context, consider how that dollar amount is more than the annual budgets for 47 of our 50 states.

It may seem crass to speak of child abuse in financial terms but money talks, and perhaps if a cost is put on the long-term damage child abuse does to our society, it will finally become a public health priority.

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Pope Francis Apology

On Friday April 11, shortly before the beginning of Holy Week, Pope Francis did what no Pope before him has ever done and took personal responsibility for the pedophile priests that have plagued the Catholic Church.

In remarks made at his library in the Vatican to members of a Catholic nongovernmental organization, the International Catholic Child Bureau, the Pope for forgiveness and pledged to impose penalties on “men of the church” who have harmed children.

The Pope’s comments are a positive step, but how much change in the church will they really bring? His words mean little to the children who are still being abused by priests around the world. If the Pope is sincere about wanting to end the epidemic of sexual abuse by priests he needs to take immediate action. The Vatican still refuses to open its archives and release records on abusive priests. The Vatican still refuses to fully expose the Bishops who sheltered abusive priests from prosecution and are thereby complicit in the abuse.

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FL MedMal cap

On March 13, the Florida Supreme Court overturned the centerpiece of the 2003 medical malpractice overhaul law. In the opinion the court strongly criticized the Florida Legislature and even went so far as to accuse them of creating an “alleged medical malpractice crisis.”

The justices ruled in the 5-2 opinion that Florida’s controversial 2003 medical malpractice reform violated survivors’ equal protection rights, because hard caps on noneconomic damages were limited to no more than $1 million in the event of a death or permanent vegetative state — regardless of the number of practitioners or survivors.

The 2003 law limited individual family members to damages not determined by the actual pain and suffering they endured but rather by how many other relatives were also entitled to part of the $1 million in noneconomic damages. When multiple parties were found at fault the burden was even further lessened – regardless of severity – because there were more parties to contribute toward the damage award.

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Stryker Rejuvenate and ABG II Modular Neck Lawsuit

There has been an increase in filings in product liability lawsuits against Stryker Orthopedics over the Rejuvenate and ABG II modular neck hip implants. These hip implants were recalled on July 6, 2012. The Stryker Rejuvenate and ABG II were not strictly speaking metal on metal implants because they have a polyethylene on metal interface between the cup and the ball. However, these implant are causing injuries to the hip tissue from metallosis just like the metal on metal implants such as the DePuy ASR, the Wright Converse and the Biomet Magnum.

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Pradaxa Drug Side Effects

Since the FDA approved the blood-thinner Pradaxa in 2010 the drug has
come under scrutiny for adverse bleeding events. In the United States the
drug has exceeded $2 billion in sales. But out of the 850,000 patients it has
been prescribed to it has also been linked to more than 1,000 deaths.
When it was first approved, Pradaxa was the first in a new category of
replacements for Warfarin (Coumadin), the decades-old drug used to prevent
strokes in people with a heart-rhythm disorder known as atrial fibrillation.
Patients prescribed Warfarin needed to be monitored closely, undergoing
frequent blood tests to ensure the drug was working. Pradaxa required
no monitoring and in early tests it appeared to be better than Warfarin at
presenting strokes.

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Androgel And Axiron Low Testosterone Drug Side Effects

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A recent study has provided new evidence that widely prescribed testosterone drugs Androgel and Axiron – advertised as a way to help men improve a low sex drive and reclaim diminished energy – might increase the risk of heart attacks.

The new study, conducted by researchers at the University of California, Los Angeles; the National Institutes of Health; and Consolidated Research, was published last week in the online journal PLoS One. The study provides compelling evidence that testosterone is being overprescribed to American men and that pharmaceutical companies continue to aggressively market the drug in spite of dangerous side effects associated with it.

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Januvia and Byetta Side Effects Lawsuits

Januvia and Byetta are two of the most popular drugs on the market prescribed to treat type 2 diabetes. But ever since their introduction reports of dangerous side effects including pancreatitis and pancreatic cancer have surfaced. These reports spurred concerns of whether the drugs risks outweigh their effectiveness and have led to numerous lawsuits being filed against the drug makers.

This week the American Diabetes Association (ADA) called for a new evaluation of the clinical data on many of the popular drugs used to control blood sugar in patients with type 2 diabetes. These drugs include Merck & Company’s Januvia , Novo Nordisk’s Victoza, Byetta and Onglyza from Bristol-Myers Squibb, and AstraZeneca Plc, among others, and have sales of more than $9 billion annually.

The new evaluation is based on the research of Dr. Peter C. Butler, chief of the division of endocrinology at the University of California, Los Angeles. In his study, and in follow-up studies he found worrisome changes in the pancreases of laboratory rats used in the study that could lead to pancreatic cancer. Based on his studies, both the FDA and the European Medicines Agency have also begun investigations that could lead to new warnings on the drugs, or even to their removal from the market.

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Risperdal update

Risperdal update

Lawsuits over Risperdal continue to move forward. The Arkansas Supreme Court has scheduled oral arguments in Johnson & Johnson’s request to overturn a verdict and $1.2 billion fine over the marketing of the antipsychotic drug Risperdal.

Oral arguments are set for Feb. 27 in Little Rock for the appeal from Johnson & Johnson and its subsidiary Janssen Pharmaceuticals Inc. Attorney General Dustin McDaniel successfully sued the companies, claiming they downplayed and hid risks associated with taking Risperdal.

The Risperdal lawsuit in Arkansas accused Johnson & Johnson and its Janssen Pharmaceuticals unit of concealing the risks associated with the medication. The state also charged that the companies had deceptively marketed Risperdal as being better and safer than competing medications. In 2012, the Arkansas state court judge overseeing the case levied a $5,000 fine against the drug makers for each Risperdal prescription purchased through the state Medicaid program over a 3 ½ year period. The companies were also ordered to pay a fine of $2,500 for each of the more than 4,500 letters Janssen sent to Arkansas doctors to promote the use of Risperdal.

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Stryker Rejuvenate Hip Implant Lawsuit Hip Replacement

Saunders & Walker P.A. Your Source For Accurate Information


Stryker Rejuvenate / revision comparison

With the recent announcement of a $2.47 billion settlement offer from
Johnson & Johnson over its flawed Articular Surface Replacement (ASR)
hip implant, it is important to remember that the ASR, while the most
popular, was only one of many metal-on-metal hip implants on the market.
The Rejuvenate and ABGII hip replacement systems, both made by Stryker,
were recalled in July 2012. More than 30,000 of the Stryker hip systems
have been installed worldwide, 20,000 of them in U.S. patients. The recall
came after the implant was been found to be prone to corrosion, joint
dislocation, and the release of metal ions, which can cause metallosis,
tissue inflammation, necrosis and death. The announcement has since led to
hundreds of lawsuits being filed against Stryker.

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