Commentary and insight about the complex legal, medical and social issues surrounding pharmaceutical litigation.

Pharmaceutical News Wrap Up: March 2014

March 31, 2014

Here at the Simmons Firm, our pharmaceutical lawyers strive to keep you caught up on the latest pharmaceutical news. Below is a short list of some of the most recent headlines concerning FDA recalls, approvals and warning label changes, medical studies and other pharmaceutical news taking place across the country and world.

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FDA Runs First Widespread Quality & Safety Evaluation on Generic Drugs

March 7, 2014

FDA Runs First Widespread Quality and Safety Evaluation on Generic Drugs

More than 80 percent of prescription drugs in the U.S. are being tested by the Food and Drug Administration (FDA) in its first widespread safety and quality evaluation. The effort will examine generic drugs such as heart medications, ADHD treatments, immunosuppressants, anti-seizure drugs and antidepressants. The evaluation will cost $20 million. It is funded through new fees collected from the generic pharmaceutical industry Congress approved in 2012.

The decision to run this first widespread test is a result of growing concerns over the quality of medications imported from other countries. The evaluation will run through 2017 and will involve dozens of academic centers across the country. Such academic centers participating in the evaluation include Duke University, the University of Michigan, John Hopkins University, the University of Maryland, Brigham & Women’s Hospital and the University of Florida, among others.

While testing has been conducted on a periodic basis, this new evaluation reflects the FDA’s recent emphasis on the quality of “copycat drugs”, according to a Bloomberg article. Medical professionals have also become more concerned about the quality of medications manufactured overseas.

For example, a 2013 study from a Boston-based researcher found numerous problems in copies of Lipitor made outside of the United States. Manufactured by Pfizer, brand drug Lipitor lost its patent protection in November 2011, opening it up to generic competition. Up until that point, the cholesterol medication had been the world’s top-selling drug. The FDA will be reviewing the Lipitor study as part of its new safety evaluation.

Additionally, recent medical studies have linked Lipitor to a dangerous risk of diabetes in women who take the medication. In 2012, the FDA required Pfizer to update Lipitor’s warning label to inform consumers of the increased risk of developing type 2 diabetes.

If you or someone you love took Lipitor and is now dealing with diabetes, take the first step and contact our experienced Lipitor lawyers today.

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Pharmaceutical News Wrap Up: February 2014

February 28, 2014

The pharmaceutical lawyers at the Simmons Firm are committed to keeping you up-to-date on the latest pharmaceutical news. Below is a short list of some of the most recent headlines concerning FDA recalls, approvals and warning label changes, medical studies and other pharmaceutical news taking place across the country and world.

  • Uterine Surgical Technique is Linked to Abnormal Growths and Cancer Spread
    Concerns are arising about the safety of a surgical procedure called morcellation, which is performed on tens of thousands of women each year to remove fibroid tumors from the uterus. Problems associated with the procedure are most likely from the electrical device used by the physician, which has a rapidly spinning blade.
  • FDA Advisers Revisit Heart Risks Posed by Painkillers
    Some pain relievers are safer for the heart than others, according to U.S. health officials. Specifically, the key painkiller in Aleve tends to be safer than other anti-inflammatory drugs such as ibuprofen (Advil and Motrin). Also called non-steroidal anti-inflammatory drugs (NSAIDs), the FDA is discussing potential cardiac risks associated with the class of drugs.
  • Endocrine Society Calls for Longer, Larger Studies on Testosterone
    Not long after the FDA’s decision to further investigate the safety of low T treatments, the U.S. Endocrine Society is calling for a more thorough assessment of the risks and benefits associated with testosterone treatment in older men. This decision follows the results from two new studies linking testosterone treatments to increased heart risks.
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Studies Point to Inconsistencies in FDA Approval Process

February 24, 2014

Three new studies took a deeper look into the U.S. Food and Drug Administration (FDA) regulatory process. Results from the studies found that FDA approval does not necessarily mean the medication or medical device was arduously examined and proven safe beyond all doubt.

Published in the Jan. 22 edition of the Journal of the American Medical Association, the studies reveal an agency under extreme pressure to get drugs into the market in a fast yet responsible manner. Specifically, the studies found:

  1. The FDA does not apply the same standard of evidence to all drugs going through clinical trials. Rather the FDA approves medications based on criteria that vary on a case-by-case basis.
  2. The FDA often approves upgraded versions of current heart devices without necessitating a clinical trial.
  3. The FDA frequently overlooks initial issues in drug trials that later cause substantial delays in the approval of new drugs.

For instance, the first study reviewed publicly available FDA documents and found a wide disparity in the quality of evidence used for the drug approval process. Many of the clinical trials varied in duration and size, as well as the number of participants. This can suggest a lack of consistency in the approval process from one drug to another.

The FDA treats every drug application differently and therefore applies diverse approval standards for each drug, according to a HealthDay article.

"We're not saying that the FDA is not thorough and not rigorous in their evaluation of these new drugs at the time of their approval," said Dr. Joseph Ross, assistant professor of medicine and public health at Yale University and co-author of one of the studies, in the article. "But it should be made clearer to physicians and their patients that when a drug has been approved for use, sometimes we know a lot about it and sometimes we know less. That information needs to be made available."

You can read more about the FDA drug development and approval process here.

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Study Finds Antioxidant Supplements May Accelerate Cancer Growth

Two antioxidants, vitamin E and beta carotene may do more harm than good in lung cancer patients, a new study suggests. Researchers showed that, antioxidants accelerated the progression of tumors in mice with early lung cancer.

Published in Science Translational Medicine, the study did not look at whether antioxidants are responsible for initiating cancer. Rather, it examined the acceleration of already existent tumor growth.

Antioxidants reportedly increased lung tumor growth by 2.8 fold in the mice and caused them to die twice as quick, according to the study. When vitamin E and beta carotene were added to human lung cancer cells, researchers also recorded increased cancer growth.

“Taking extra antioxidants might be harmful and could speed up the growth of (any) tumors,” said biologist and study co-author Martin Bergo in a Reuters article. “If I had a patient with lung cancer, I would not recommend they take an antioxidant.”

Among patients with early lung cancer, antioxidants decrease DNA cell damage to a point where it is undetectable by the cell. The undetected damage means the cell does not release its cancer-defense system, a protein called p53.

Without antioxidants, p53 is able to detect DNA damage and kill the cell before it becomes malignant. When antioxidants allow DNA damage to go unnoticed by the cell and p53 is not released, however, malignancies are able to thrive and grow. In essence, antioxidants allow the cancer to escape the cell’s natural defense system.

Findings from the study add to a growing trend of research that questions the effectiveness of vitamin supplements in cases other than malnutrition.

Researchers note that while the study findings are intriguing, they should not prompt a sudden change in behavior among consumers. Natural antioxidants found in fruits and vegetables are safe and patients should not be confused and cut down on these important foods needed for good nutrition especially during treatment when maintaining a nutritional balance is vital.

It is important that individuals talk to their doctors about the use of antioxidants if they have questions or concerns.

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New Study Verifies Need for Updated Warning Label on Low T Drugs

February 7, 2014

A recent large study backs up findings from previous smaller studies that found low T treatments increase risk of heart attack, stroke or death among men. The new study analyzed data from 55,593 men who had been prescribed low T treatments. Its results may help push the U.S. Food and Drug Administration (FDA) to update the warning labels on such drugs.

Learn about testosterone lawsuits.
Published in PLOS One, the study found that risk of heart attack nearly tripled within the first three months of starting testosterone therapy in men under age 65 who had a history of heart disease. For men over age 65 taking the supplement, risk doubled among those with or without a history of heart disease.

While previous studies concerning testosterone treatments like AndroGel and Androderm have revealed similar results, this new study could garner more attention and demand for an updated warning label due to the large number of patient records reviewed. The FDA announced Friday it has launched an investigation to further review the risks of testosterone treatments as a result of the new research.

The results from this study alone “may not tell us very much,” said Dr. Michael Lauer, the director of cardiovascular services at the National Heart, Lung and Blood Institute, in a NY Times article. “But when you put this together with the rest of the medical literature, this tells us that we potentially have a problem.”

Currently, the labels on testosterone treatments such as AndroGel do not warn of increased cardiovascular risks.

“This study adds an enormous amount to what it known about the risks,” said Sid Wolfe of Public Citizen Health Research Group, in a Forbes article. “It’s an important breakthrough and the implications are sobering, but unfortunately, there is nothing in the current labeling or the med guides for patients.”

Millions of American men are prescribed low T treatments every year, which are often administered in the form of a gel, patch or injection. In addition, a recent report found that many patients using testosterone therapy appear to have normal testosterone levels and do not meet clinical guidelines for use of testosterone medications.

Learn more about low T treatments and testosterone lawsuits from the lawyers at the Simmons Firm today.

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Pharmaceutical News Wrap Up: January 2014

January 31, 2014

The pharmaceutical lawyers at the Simmons Firm are committed to keeping you up-to-date on the latest pharmaceutical news. Below is a short list of some of the most recent headlines concerning FDA recalls, approvals and warning label changes, medical studies and other pharmaceutical news taking place across the country and world.

  • Merck Recalling Drug Combination for Cholesterol
    Pharmaceutical giant Merck announced it was recalling its drug Liptruzet, a combination cholesterol drug, due to defects in the packaging which could reduce the drug’s effectiveness. The recall will wipe out the entire stock of Liptruzet in the United States. Liptruzet is a combination of ezetimibe and atorvastatin. Atorvastatin is the generic name for Lipitor.
  • Testosterone Testing, Treatment Soars Despite Uncertainties
    Rate of testosterone testing and the use of low T treatments have been sky-rocketing in the United States and United Kingdom. While testosterone testing is higher in the U.K., supplementation with testosterone therapy is less frequent in the U.K. compared to the United States.
  • FDA Warns Against High-dose Prescription Acetaminophen
    The Food & Drug Administration is asking medical practitioners to stop prescribing medications that contain more than 325 milligrams of acetaminophen because of the risk of liver damage. It also plans to withdraw approval for any medications in the coming months that still contain more than 325 mg of acetaminophen.
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