Tampa Bay Personal Injury Lawyer - Drug Products

Respiratory Inhaler May Pose Greater Stroke Risk

Joe Saunders — Wed, 19 Mar 2008 21:05:01 GMT

The FDA is looking into whether Boehringer Ingelheim' respiratory inhaler poses a greater risk of stroke. According to the FDA, the data submitted by the German drug manufacturer, shows that its Spiriva Handihaler poses a greater risk of stroke compared with a placebo. FDA said it has not yet analyzed the figures, which were compiled from 29 patient studies. The FDA has asked doctors to report any adverse patient results while it waits for more data from the company in June.

Originally posted at InjuryBoard by Joe Saunders

Direct-to-Consumer Advertising by Drug Companies

Jim Clark — Thu, 06 Mar 2008 15:36:49 GMT

The idea of drug companies advertising the prescription medicines they manufacture on TV and in other consumer directed media has always been offensive to me. I have often wondered if other consumers like me consider the fact that the drug products these companies advertise are for conditions that never go away. In other words, with few exceptions the products do not heal anything, they just offer symptomatic relief. Why advertise a product that actually heals something? The market for such a product would be short-lived. Pain relievers and allergy medicines are prime examples. Pain is a symptom that may be relieved by the product, but the cause of the pain is not. A runny nose or itching eyes may be relieved by the product, but the symptoms will be back in 8-12 hours, or next week, or next Spring or Fall. And of course you will need more product when the symptoms return. I can actually remember when advertising prescription medicines to the public was unheard of. Medicines were promoted to doctors for their patients and not to patients urging that they ask their doctors for the medicine. This whole process is known as direct to consumer advertising and it has become big business and needless to say, BIG MONEY.

A recent national survey conducted by the Kaiser Family Foundation and the Harvard School of Public Health in cooperation with USA Today noted that spending on direct-to-consumer advertising peaked in 2006 at $4.8 billion, up from $2.6 billion in 2002. The survey noted 44% of physicians prescribed drugs requested by their patients. The president of the Kaiser Foundation commented:

"Our survey shows why the drug companies run all these ads: They work. Many people get drugs they otherwise wouldn't. While there's a debate about whether that's a good thing for patients, it does cost the country more."

My next comments will address the recent Pfizer-Lipitor-Dr. Jarvik whatever....

Originally posted at InjuryBoard by Jim Clark

Heparin Finger Pointing Has Already Started

Brenda Fulmer — Thu, 06 Mar 2008 08:01:42 GMT

"A series of independent assessments, inlcuding one by the agency's own Science Board, have found that the F.D.A. is increasingly overwhelmed by its many responsibilties and is incapable of protecting the public from unsafe drugs, medical devices and food - particularly from China."

While the Food & Drug Administration continues its investigation into contaminated Heparin blood thinner products, the sparring between Baxter Healthcare and its supplier Scientific Protein Laboratories is underway. A March 6, 2008, New York Times article notes the latest findings of the FDA that Baxter's heparin products are contaminated and the investigation continues as to how the contamination occurred, whether it is isolated, why the contamination was not discovered by the product's manufacturer or supplier previously, and whether the nearly 800 reports of adverse reactions and 46 reported patient deaths are attributable to the confirmed contamination.

The article noted that Wayne Pines, a spokesman for Wisconsin-based Scientific Protein Laboratories, wanted to reassure the public that nothing improper had occurred with regard to its procurement and processing of the raw materials utilized in the product, and noted "There is no evidence of counterfeiting or tampering or anything of that nature. No one really knows what happened here." The raw materials supplier also reiterated, again, that "it is premature to conclude that the heparin active pharmaceutical ingredient sourced from China and provided by S.P.L. to Baxter is responsible for these adverse events."

Meanwhile, Baxter and its spokesperson have also entered the fray with finger pointing at Scientific Protein and, perhaps, the FDA. Baxter noted that the contamination problem may not be as isolated as indicated previously, since tained lots of blood thinners came from Scientific Protein Laboratories' processing plants located in China and Wisconsin. According to media reports, Baxter began its investigation into possible contamination in the Fall of 2007 and claims that Baxter's findings "touched on the areas" as those noted in the FDA inspection. Scientific Protein Laboratories, however, questioned the nature of the probems that Baxter contends were noted in the Fall of 2007 and why those problems were not addressed prior to the recent FDA inspections.

The FDA is also under scrutiny with this latest in a long series of serious threats to public safety. The FDA has admitted culpability in failing to properly inspect a Chinese plant implicated in the heparin contamination controversy. There are also concerns about the ability of the FDA to protect consumers from adulterated products. A recent Government Accountability Office report entitled "Preliminary Findings Suggest Weaknesses in FDA's Program for Inspecting Foreign Drug Manufacturers" noted that over a six-year period the FDA was only able to inspect less than 10% of the approximately 700 medical device plants currently operating in China and providing drugs, devices and raw materials to manufacturers in the United States. For years, the FDA has been lamenting that a significant lack of funds and lack of enforcement authority has hampered its ability to properly ensure the safety of the nation's pharmaceutical and medical device products. This is particularly disconcerting as our court system and current administration have been aggressive in their efforts over the past few years to claim that state court actions are pre-empted and to essentially immunize drug and device manufacturers from liability for defective products based upon the obviously false assumption that the FDA has the ability to adequately protect consumers. Hopefully, this latest drug safety failure will refocus attention on this issue, just as the memories of Vioxx are fading, and stem the tide of legal efforts to permit defective drugs to remain on the market and the manufacturers to escape liability or require them to assume proper responsibility to ensure the safety of their products.

Originally posted at InjuryBoard by Brenda Fulmer

FDA issues public health advisory on Chantix

Brenda Fulmer — Tue, 05 Feb 2008 09:23:23 GMT

On February 1, 2008, the FDA issued a public heath advisory (http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html) regarding new safety warnings regarding the smoking-cessation drug Chantix (varenicline) indicating, "It appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms."

Chantix, a non-nicotine prescription medication manufactured by the drug giant Pfizer is used to help people stop smoking. The drug was fast-tracked by the FDA because of the promise it showed during clinical trials and was approved for sale in the United States in 2006. Chantix acts at receptors in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking. The most common side effects according to Pfizer include nausea (30%), trouble sleeping, changes in dreaming, constipation, gas, and/or vomiting. However, some users of Chantix have reported disturbing side effects including behavioral changes in the form of aggression, agitation, disorientation, disassociation, abnormal thinking, mood swings, hallucinations, psychotic disorders, euphoria, and suicidal ideation.

The FDA announcement emphasized that patients should inform their doctors about any history of psychiatric illness prior to starting Chantix, and further recommended that patients, patients' families, and health care professionals closely monitor any changes in mood and behavioral changes during and after Chantix treatment (http://www.fda.gov/cder/foi/label/2008/021928s007lbl.pdf).

Originally posted at InjuryBoard by Brenda Fulmer

Drug Companies Pull Vytorin TV Ad

Joe Saunders — Wed, 23 Jan 2008 14:20:50 GMT

A week after a study showed that Vytorin is no more effective in reducing cholesterol than the company's generic equivalent, Merck and Schering-Plough withdrew their direct-to-consumer marketing ads. Vytorin, a combination of Zetia and Merck's Zocor, lost patent protection in 2006. The marketing campaign was a familiar one to television viewers and was dubbed "food and family" depicting in a light-hearted fashion how heredity and eating habits can affect a person's cholesterol. However, the marketing campaign never mentioned any risks or the fact that its generic equivalent was at the very least, as effective as the expensive Vytorin.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.

Originally posted at InjuryBoard by Joe Saunders

What You and Your Physician Don't Know Can Hurt You

Brenda Fulmer — Tue, 22 Jan 2008 08:33:56 GMT

"When you prescribe drugs, you want to make sure you're working with best data possible; you wouldn't buy stock if you only knew a third of the truth about ."

Over the past several years, drug manufacturers have lauded themselves for their decision to finally come clean, and publish all of their research (whether good or bad for them) in peer reviewed journals in order to ensure that the medical and scientific community can help patients make decisions based upon full and accurate information. A recent New England Journal of Medicine expose, however, indicates that it is still business as usual, and drug companies are still manipulating the science by burying adverse data.

The editors of the NEJM conducted a review of the data provided to the Food & Drug Administration to test its theory that pharmaceuticals companies were continuing to submit only the most favorable research for peer review and publication. This investigation by the journal found, for instance, 74 trials relating to 12 different anti-depressant drugs in the FDA files, but only 31% of those trials were submitted by the drug companies for publication. Not surprisingly, nearly all of the studies that showed favorable results were published. Of the few studies that showed negative results that were actually published, many were written to convey favorable outcomes belied by the actual study data. Drugs used to treat depression earn drug companies over $21 billion each year, and, for many pharmaceutical giants, serve as a bedrock for their companiess . However, these significant financial interests in marketing their products and gaining a competitive edge, does not justify the concealment of critical information or the manipulation of the medical literature into yet another marketing tool rather than the open and honest forum for debate on which so many physicians and patients rely.

On a related noted, Congress has now started an into the actions of Schering-Plough and Merck with regard to the popular cholesterol drugs Vytorin and Zetia. Reports have emerged recently that the manufacturers of these drugs delayed publication of studies that questioned the effectiveness of these expensive medications.

Originally posted at InjuryBoard by Brenda Fulmer

Evidence Mounts on HRT Breast Cancer Dangers

Brenda Fulmer — Tue, 22 Jan 2008 07:56:58 GMT

Yet another study was released earlier this month showing that women who use combination hormone replacement therapy drugs face much greater risks of developing certain types of breast cancer. This latest study from researchers at the Fred Hutchinson Cancer Research Center noted that women taking HRT drugs had a four-fold (400%) increased risk of developing lobular breast cancer and was the first study to focus on lobular cancers and include a review of pathology reports and tissue from tumors (http://seer.cancer.gov/data/). A statistically significant increased risk of ductal-lobular invasive cancers was also noted. This study is also particularly noteworthy in that it found that users of combination HRT drugs (containing estrogen and synthetic progestin) were at significantly increased risk after only three years of exposure, helping to dispel the notion that these drugs are safe if taken for less than 5 years.

Lobular breast cancers are relatively rare, representing only 15% of invasive breast cancers. Unfortunately, lobular cancers are quite virulent in that they are more difficult to detect through mammography and are more likely to be first diagnosed at later stages. Researchers have noted for quite some time, however, that lobular cancers appear to be more prevalent in women who used combination hormone replacement therapy drugs, such as Prempro and Provera taking in combination with Premarin or other estrogen products. This study included 1,044 women (ages 55 to 74) who are part of a Washington State breast cancer registry and who were diagnosed with invasive breast cancer between 2000 and 2004.

Although rates of CHT [combined estrogen and progestin hormone therapy] use have dropped considerably since the publication of the WHI trials, studies of the risks associated with CHT use remain of critical importance given the estimated 57 million hormone therapy prescriptions that are still filled in the United States each year. The results of this study provide further evidence that CHT use increases the risk of ILC (invasive lobular cancer], and they indicate that current use of CHT for as little as 3 years may increase risk of these tumors substantially. Continued research aimed at identifying the biological basis for the relationship between CHT use and lobular carcinoma risk is warranted.

Originally posted at InjuryBoard by Brenda Fulmer

FDA Warns About Anemia Drug Risks

Joe Saunders — Tue, 08 Jan 2008 11:46:40 GMT

In a new warning about certain anemia drugs, the FDA has noted that studies are showing that patients with breast or advanced cervical cancers died more rapidly or their tumors grew at an advanced rate than those who were not treating with anemia drugs known as ESAs (erythropoiesis-stimulating agents). According to the FDA, "all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who did not receive this treatment. In all of these recent studies, ESAs were administered in an attempt to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater, although many patients did not reach that level."

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.

Originally posted at InjuryBoard by Joe Saunders

First Federal Ortho Evra Trials Scheduled

Brenda Fulmer — Mon, 31 Dec 2007 18:05:24 GMT

On December 6, 2007, Judge David Katz, the federal judge who oversees the Ortho Evra multi-district litigation proceedings in Cleveland issued a scheduling order for the first trials to be conducted in the federal system. Judge Katz oversees more than 1,400 lawsuits pending against Johnson & Johnson (http://www.jnj.com/home.htm) and its subsidiaries relating to the controversial Ortho Evra birth control patch. The patch was marketed as an alternative to modern low-dose oral contraceptives, but it is now known that the patches deliver as much as 60 times higher doses of hormones than other alternatives without providing any greater efficacy. Many years ago, birth control pills contained higher doses of hormones, but the dosages have been reduced over the years after high-dose medications were associated with an unacceptable increase in adverse events, including strokes and blood clots. Ortho Evra has also been associated with an increased risk of heart attacks, strokes, and the formation of blood clots in the lungs and legs.

Seven cases involving plaintiffs from Ohio have been selected for the initial (or bellwether) trial process in the federal MDL proceedings. Five of the cases involving plaintiffs who survived their injuries, including the following plaintiffs: a twenty-four year old woman who suffered blood clots in her lungs and brain in July of 2005 after using Ortho Evra for two weeks; a thirty-two year old woman who developed deep vein thrombosis and a pulmonary embolism in April of 2004; a forty-one year old woman who developed a blood clot in her leg and multiple blood clots in her lungs in July of 2005; a twenty-two year old woman who suffered a heart attack after using the Ortho Evra patch for two months; and a twenty-five year old woman from developed a pulmonary embolism after use of the patch for two months in April of 2003. This bellwether trial group also includes a personal injury claim brought by the parents of a 14 year-old girl who used the patch to regulate her menstrual cycle and suffered a deep vein thrombosis in July of 2005. The remaining case is a wrongful death claim filed by the surviving husband and infant son of a university volleyball coach who died of cardiac arrest at the age of twenty-five after using the patch for one month.

The first trial will begin on June 24, 2008, and a second trial will occur on July 22, 2008. The Court has not yet selected the cases to be included in these first trials, and indicated that the cases that are not selected initially will be tried as soon as the Court's calendar permits. The parties have been ordered to complete fact discovery by January 31, 2008 and expert witness discovery by March 28, 2008. A Daubert hearing on scientific issues has been scheduled for April 15, 2008.

Originally posted at InjuryBoard by Brenda Fulmer

Specialized Treatment for HRT Patients With Lobular Breast Cancer

Brenda Fulmer — Mon, 31 Dec 2007 16:15:00 GMT

A study from Turin, Italy published recently in Endocrine Related Cancer noted that former users of hormone replacement therapy drugs who are diagnosed with lobular breast cancers may require specialized treatment based upon the unique characteristics of their tumors. The researchers noted a "growing body of evidence" to "support the association between the use of hormone replacement therapy (HRT) and a higher risk of both invasive lobular carcinoma (ILC) and invasive ductal-lobular mixed carcinoma (IDLC)."

The authors indicated that lobular cancers in HRT users have a different presentation than ductal cancers and are often far more challenging to diagnose early since lobular tumors are generally less concentrated and more disseminated than ductal tumors. The authors suggested that MRI technology may be more precise than traditional mammograms in detecting lobular breast cancers, and that patients with lobular breast cancers may have a greater need to undergo mastectomies than patients with ductal tumors. The authors also concluded that patients with lobular breast cancer tumors associated with their past use of hormone replacement therapy drugs may not have the same response to preoperative chemotherapy as patients with other types of tumors. Finally, the authors concluded that patients with metastatic lobular breast tumors are also unique in that testing often shows that the breast cancer has spread to the gastrointestinal tract, peritoneum, or gynecological organs, a presentation that is not so common with regard to metastases of ductal breast cancers.

Originally posted at InjuryBoard by Brenda Fulmer