Archive for the ‘Drug Companies’ Category

Asthma Medication Recall

More than 34 million people in the United States suffer from asthma. Many of them are children. They depend on inhalers to help them breathe every day. If something goes wrong with an inhaler, an asthma sufferer may only have seconds before their airways close completely, and they’re unable to breathe at all. If a person goes too long without breathing, they will suffer prolonged oxygen deprivation, which can lead to serious health problems, including brain damage, and even death. That’s what makes an asthma medication recall so frightening.
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FDA restricts diabetes drug Avandia trial

The Food and Drug Administration (FDA) has restricted GlaxoSmithKline (GSK) from enrolling new patients in a trial for the drug Avandia (rosiglitazone) after new information about the drug’s serious side effects came to light. Avandia is used to treat type 2 diabetes by controlling blood sugar levels, and can increase the risk of heart attack, a common cause of death in diabetics.

That in itself is not new information. In 2007, the FDA put a black box warning on Avandia when it became apparent through drug trials that the drug increased the risk of heart attack. A black box warning is the strongest warning that can be included in prescription drug package inserts, so named for the bold, black border that surrounds the information. It is used when a drug is found to cause severe or life-threatening adverse effects.

What is new is that GSK may have tainted initial studies in order to control published results. It’s possible GSK knew Avandia was much more dangerous than those trial results showed three years ago.

While the FDA investigates, it has prohibited the drug maker from accepting new patients into current trials. Participants in current trials are not affected by this restriction. On July 14, a 33-member FDA panel reviewing scientific data about Avandia voted on what action should be taken. Twelve panel members voted for Avandia to be taken off the market completely. But others were in favor of simply enhancing the black-box warning, and adding restrictions to the drug’s prescribed use. In short, The FDA has not yet come to a consensus on how to handle the situation.

In the meantime, if you or a loved one is taking Avandia, do not stop taking the drug on your own. This can cause blood sugar levels to become unstable, causing other serious health problems. Talk to your doctor to address your concerns, and perform any drug changes under the supervision of a medical professional.

If the worst has occurred, and you or a family member taking Avandia has suffered a heart attack or other serious side effects related to the drug, you need representation from an Avandia lawyer in Colorado. An attorney can help you determine how to proceed when dealing with this large, possibly dishonest pharmaceutical company.

Oops they did it again. Merck’s asthma drug Singulair under investigation for suicide link by FDA.

Merck is at it again. In March 2008, the FDA opened an investigation into a link between suicidal behavior and mood swings in some users of Merck’s product Singulair. Merck is currently fighting more than 4,200 state and federal Vioxx related lawsuits pending across the country and is appealing a $253.4 verdict jurors awarded to Robert Ernst’s widow, Carol which takes into account her husband’s lost pay as a Wal-Mart produce manager, their mental anguish, her loss of companionship and punitive damages.

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Accutane: a Miracle Drug to Cure Acne or Deadly Remedy?

To most users, Accutane, one of the most potent, effective weapons against acne, is a miracle drug. But, to others Accutane leads to a life filled with pain and discomfort and in some cases, death.

First introduced in 1982 by the drug maker Hoffman-La Roche, Acctutane became of their top sellers with an estimated 1.2 billion dollar in sales.Despite reports as early as 1984 of serious adverse reactions including miscarriages and birth defects, the FDA decided to allow the sale of Accutane relying on doctors’ discretion and wisdom to properly prescribe the drug. Other adverse effects include inflammatory bowel disease, Crohn’s Disease, suicide, loss of bone density and bone fractures, muscle weakness, chapped lips and nose bleeds, Hoffman-La Roche refused to recall their product.

The side effects related to Accutane are so severe that the FDA now requires all patients who take Accutane to sign a consent form. Since 1996, pharmacists are required to give patients a Medication Guide which details the risks. Thalidomide and Mifeprex are the only other drugs that have required a Medication Guide.

In 1997 European authorities placed strict controlling measures on Accutane because of reports of serious psychiatric disorders associated with the drug. But, it wasn’t until the death by suicide in May 2000 of Michigan Congressman Bart Stupak’s son, BJ while taking the drug, that public awareness of the dangerous link between Accutane and suicide emerged. In response, a spokesperson for Roche claims that it has been used safely by over 13 million patients and that severe acne in itself can cause depression.

So, you decide…is Accutane a miracle cure or deadly remedy?

Merck Used Ghostwriters for Vioxx Clinical Studies

Talk about foxes guarding the hen house! A recently published article in the Journal American Medical Association (JAMA) claims the drug maker Merck drafted many of the research studies for their best selling drug Vioxx, then had prestigious doctors put their names on the reports prior to publication.

In 16 of 20 papers that reported on clinical trials, a Merck employee was assigned as the author of the first draft of the manuscript. An outside academic scientist was then listed as the lead author when the study was published.

Researcher based their allegations on documents they discovered from Vioxx lawsuits detailing the industry wide practice of ghostwriting medical research studies that are published in academic journals. Vioxx, sold as a pain reliever, was pulled from the market by Merck in 2004, over evidence linking it to heart attacks and strokes. Late last year Merck agreed to a $4.85 billion settlement to resolve tens of thousands of lawsuits filed by former Vioxx patients or their families.

The lead author of Wednesday’s article, Dr. Joseph S. Ross of the Mount Sinai School of Medicine in New York, said a close look at the Merck documents raised broad questions about the validity of much of the drug industry’s published research, because the ghostwriting practice appears to be widespread. “It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician,” continues Dr. Ross.

Merck has even acknowledged they hire medical writers or use in-house employees to draft research reports that a doctor will later assign his name as lead author. Merck defends this practice by claiming although they may have provided the draft, the doctor was a major contributor and the reports reflects his opinion. So we aren’t necessarily getting an unbiased opinion – essentially the doctor was told what the expected outcome should be.

Dr. Ross is concerned the issues go beyond the authorship of drug research studies, raising questions about the validity of the clinical trials on which the research is based. “Who designed the trial? Who did the trial? Who did the analysis? Who interpreted the analysis?” Dr. Ross asks.

Previous studies have shown drug makes spend almost twice as much marketing a drug as they do on research and development. Now it seems they aren’t really doing the unbiased, untainted research that they should be. The question we should be asking is…if Merck did it with Vioxx, what other research studies are the other drug companies fudging? Let’s get these foxes out of the hen house!

Premarin Risks Keep Stacking Up

For millions of women taking Premarin to ease their symptoms of menopause, including hot flashes, night sweats and vaginal dryness, a newly released study is another blow to finding relief for their discomfort.

According to a new Women’s Health Initiative study published in the Journal of the National Cancer Institute, women who take conjugated equine estrogen are at double the risk of developing benign proliferative breast disease. Tom Rohan, MBBS, Ph.D. of Albert Einstein College of Medicine and his colleagues report benign proliferative breast disease is thought to be an early stage of in the development of breast cancer and may increase the risk of later carcinoma.

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Supreme Court Considers Protecting Drug Companies From Lawsuits

When I read that the Supreme Court is considering protecting drug makers from lawsuits, my first thought was you’ve got to be kidding! This news emerges on the heels of the Baxter heparin recall.

Baxter’s initial partial recall occurred on January 17, 2008. On February 28, 2008, seven weeks later, after 400 cases of adverse reactions and four deaths, they announced a recall of all of their heparin products. Since the latest recall, there are now reports of additional deaths that may be attributed to heparin. Because 4 deaths aren’t enough.

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