Virginia Beach Personal Injury Lawyer - FDA & Prescription Drugs

Ghost-writers Hired by Drug Companies Write Journal Articles, Then Find the Medical Authors

Rick Shapiro — Wed, 28 Oct 2009 22:45:41 GMT

An amazing series of documents were unsealed by a court in a dangerous drug injury case involving Prempro, a hormone drug. Injured plaintiffs argue that the drug causes breast cancer and other medical problems, but the bomb drop is not the allegations, but what drug giant Wyeth did to "help" create medical journal articles about the safety of its drug.

But the court documents reveal scandalous email and correspondence which purportedly shows that Wyeth "fraudulently and intentionally polluted the scientific literature related to hormone therapy in general and their hormone drugs in particular" in that Wyeth hired ghostwriter physicians or scientists to “author” biased scientific and medical journal articles-but the articles were largely written before the “author” was on board.

A medical journal PLoS Medicine posted about 1,500 of the documents on a website (www.plosmedicine.org/static/ghostwriting.action ). It was through the action of the medical journal and the New York Times that the court decided to unseal a massive number of documents which reveal exactly how the ghostwriting was done for the drug manufacturer-reaching the suggested conclusions well before a “reputable” doctor was ever part of the “study” findings as the study's author.

As further related in an article in Trial Magazine, American Association for Justice, October 2009, PLoS Medicine editors wrote an editorial that stated

"the story told in these documents amounts to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the healthcare decisions of physicians and the general public."

Here is how the ghostwriting generally occurs:

1. A drug manufacturer hires a professional medical writing or communications company which prepares a preferred title, outline and a possible draft of an article;

2. The drug company or its ghostwriters later find the names of proposed medical or scientific authors for the pre-determined article including its slant or bias;

3. The outline or draft is sent to the selected author for approval.

Can we imagine the day that newspaper advertisers write the headlines for newspaper’s and direct the content of the news stories? Or, if Newsweek magazine allowed the advertisers to dictate the topic of stories in exchange for ads in the magazine? But, the Medical journal ghost-writing issue is really more dangerous—as physicians are regularly prescribing medications based on the questionable results of ghost-written articles. It is fairly sickening.

In the Prempro litigation, Wyeth claims that the author, even if pre-selected, substantially controlled the editorial review of the originally ghostwritten articles and that there was no inaccurate science. The attorneys for the victims argue that the drug company exercised clear control over the message of the articles and that ghostwritten articles either downplay, dismiss or minimize a particular drug's adverse health effects. But, according to one physician, Adriane Fugh-Berman M.D, quoted in a Science Daily article, she was approached to be an “author” and the ghost writers often use an “intermediary” medical education company and the true party behind the article is fuzzy or obscured. Fugh-Berman believes that the current voluntary standards for declaring conflicts of interest to readers of medical journals and audiences at medical conferences are inadequate, and that a public database detailing physicians’ and researchers’ conflicts of interest is needed.

The most distressing part of the Prempro ghostwriting scandal is that physicians around the country must do research on the safety and on the health effects of prescription and over-the-counter drugs and look to journal articles as a respected source of information. If peer reviewed medical articles that downplay safety or health concerns seem legitimate, how is a family doctor or internist to know the difference in an unbiased, valid medical journal article or one that is simply ghostwritten on behalf of a drug manufacturer? The answer is there is no easy way to make this determination from reading a journal article that appears in any respected magazine or publication.

One of the ghosting company's indicates it attempts to "develop a consensus statement from [an expert] forum that would be endorsed by a national organization such as the American Heart Association."

A brochure released as part of litigation over health effects of Paxil, an antidepressant drug, also described a program that helped sales representatives facilitate having articles ghostwritten. The brochure said that publishing such articles "will benefit the sales force by expanding the database of published data to support Paxil."

PLoS Medicine in the above-referenced editorial has attacked the process of ghostwriting and called on medical journal editors to "decide whether they want to roll over and just join the marketing departments of pharmaceutical companies" or police the entire process in a more transparent way. Universities and medical journals have policies on ghostwriting but the policing of the process is far from reaching a level of transparency so that consumers as well as physicians can rely upon findings in a medical journal article.

This may require congressional action, because "self-policing" has a snowballs chance of gaining traction. U.S. Senator Charles Grassley has written a letter in August 2009 to the National Institute of Health asking for an investigation of this particular problem and specifically he noted that one or more ghostwriters were actually researchers who had obtained federal funds under NIH grants.

My Take: This is a troubling and growing problem that requires further investigation in order to keep the public safe from dangerous drugs. It has been only recently that the drug companies were forced to stop providing gifts and meals to doctors to foster prescriptions and the systematic "infection" of planted journal articles may be the next area requiring reforms.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and we have experience handling dangerous drugs and prescription drug errors. Check out our case results to see for yourself. Our primary office in based in Virginia Beach, Virginia (VA) and we have another office in Elizabeth City, North Carolina (NC). Our injury attorneys also host an extensive injury law video library on Youtube. Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

Originally posted at InjuryBoard by Rick Shapiro

FDA Recalls Weight Loss Supplements Due to Hidden Ingredient

Emily Mapp Brannon — Mon, 10 Aug 2009 21:02:00 GMT

The FDA announced a recall on four weight loss supplements – Slimbionic, One Weight Loss Pill, Slim Demand, and Botanical Weight Loss due to the discovery of the ingredient sibutramine. None of the supplements list sibutramine as an ingredient which is a violation of the Food Allergen Labeling and Consumer Protection Act of 2004.

As an injury lawyer who works for a law firm that's represented clients hurt by medications, it’s always frustrating to hear about companies selling supposed health supplements in a dubious manner.

Clearly, failing to list all of your ingredients is a major issue and puts people’s lives at risk. This is especially true for sibutramine which is an FDA-approved ingredient in prescription drugs, but is known to increase blood pressure and is very volatile for individuals with a history of coronary artery disease, congestive heart failure, arrhythmias (disorders of heart rate or rhythm), or stroke.

Here’s a video discussing sibutramine in weight loss products, along with other hidden ingredients…

http://www.youtube.com/watch?v=SdQRC2HBx-4

All four weight loss supplements were produced by the Young You Corporation. I believe the FDA should investigate this organization and see if they’re affiliated with any other questionable products or manufacturers.

About the Editors: Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia (VA), near the NE North Carolina (NC) border and handles car,truck,railroad, and medical negligence cases and more. Our lawyers proudly edit the Virginia Beach Injuryboard, Norfolk Injuryboard, and Northeast North Carolina Injuryboard as a pro bono public information service. Lawyers licensed in: VA, NC, SC, WV, DC, KY.

Originally posted at InjuryBoard by Emily Mapp Brannon

TNF Blocker Prescription Medications Raise Risk of Cancer in Kids

Jim Lewis — Wed, 05 Aug 2009 21:59:00 GMT

If you’ve used a TNF (tumor necrosis factor) Blocker prescription medication for 30 months or longer, this article is for you. According to the FDA, taking these types of drugs may increase the risk of cancer in children and teenagers.

The TNF Blocker prescription medications - Remicade, Humira, Cimzia, and others - are designed to combat juvenile rheumatoid arthritis, psoriasis, Crohn's disease, ankylosing spondylitis, and other autoimmune diseases, according to WebMD. These diseases affect over 20 million people across the globe.

The medications already carry a warning label about possible side effects, but the FDA is mandating an additional caution regarding the cancer risks for young individuals.

Here’s a video discussing the link between TNF Blocker prescription medications and cancer…

http://www.youtube.com/watch?v=YCDh0WCX6aA

As an injury lawyer who’s represented clients adversely affected by certain prescription drugs, I’m surprised when a medication that’s supposed to help someone fight a disease or ailment winds up causing even worse side effects or an even worse ailment. It’s especially troubling when the potential adverse side effects afflict children and teenagers.

I believe a thorough examination of these prescription drugs should be conducted and a potential removal from the market may be warranted. When a medication could cause cancer, it’s a very serious issue that requires immediate attention.

Originally posted at InjuryBoard by Jim Lewis

Avoid Body Building Supplements Containing Synthetic Steroids and Steroid Alternatives

Emily Mapp Brannon — Mon, 03 Aug 2009 18:26:00 GMT

Many men and women who participate in intense workouts and body building are aware of the dangers associated with steroids. Therefore, a popular strategey is to take steroid alternatives or synthetic steroids in the hopes these supplements will provide physical gain without the side effects. Unfortunately, these supplements are just as dangerous as the real thing and should be avoided.

Our firm has experience writting about the dangers associated with certain supplements.

The FDA recently issued a public health advisory on supplements containing synthetic steroids and steroid alternatives due to their link with side effects comparable to traditional steroid use including liver failure, altered hormone production, hair loss, testicular shrinkage, and stroke, according to the FDA.

The products mentioned in the advisory include TREN XTreme, ESTRO XTreme, MASS XTreme (containing an ingredient called Madol), and many others. Jeff Novitzky, the lead investigator for the FDA, stated in an affidavit that “Tren” and “Madol” are legally classified as anabolic steroids based on his interpretation of federal law, according to Iron Magazine.

I applaud Mr. Novitzky’s effort to highlight the dangers associated with supplements containing synthetic steroids and steroid alternatives. Many people took these supplements under the premise that they were safe substitutes.

If you’ve taken these types of products, I strongly urge you to not only seek medical attention but also consult with an attorney.

Originally posted at InjuryBoard by Emily Mapp Brannon

Electronic Cigarettes Not an “Alternative” to Cigarettes, Use Ingredient Found in Antifreeze

Jim Lewis — Thu, 23 Jul 2009 21:12:00 GMT

The FDA performed an analysis of increasingly popular electronic cigarettes (also known as e-cigarettes). The analysis found carcinogens and toxic chemicals including diethylene glycol, which is found in antifreeze. E-cigarettes are marketed to young people and sold predominantly in malls and online.

I’m disturbed by the lack of an FDA-approved warning label on the E-cigarette packets. The manufacturers argue that since their product is electronic in form, they do not need to comply with FDA regulations. However, given these devices provide carcinogens and other chemicals in an almost identical fashion to cigarettes, the FDA should take steps to enforce some form of regulation.

The manufacturers tout E-cigarettes are a healthier alternative to cigarettes and can even help people wean themselves off of cigarettes. This proclamation is not exactly accurate.

Here’s a video from the Associated Press describing E-cigarettes…

http://www.youtube.com/watch?v=fIUWXwIfyFc

Michael Eriksen, ScD, director of the institute of public health at Atlanta's Georgia State University and former director of CDC's office of smoking and health recently stated, "I have seen no evidence that people switch from tobacco cigarettes to e-cigarettes or other smokeless tobacco products. If you look at how smokeless products are marketed, they are sold as something to use at times you can't smoke. The implication is you will increase nicotine exposure, not reduce smoking,” according to WebMD.

Given this new evidence, it's not unreasonable to conclude E-cigarettes are an unhealthy product marketed to young people in a dubious manner. A warning label needs to be implemented and a full vetting of the chemical ingredients in E-cigarettes is needed.

Originally posted at InjuryBoard by Jim Lewis

Asthma Medication Xolair May Increase Risk of Heart Attacks

John Cooper — Tue, 21 Jul 2009 22:37:00 GMT

The data from a report studying the effects of the prescription drug Xolair on individuals with moderate to severe asthma indicates a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, etc. according to the FDA. The study compared individuals taking Xolair compared and those not given the drug.

15 percent of individuals who used Xolair required hospitalization and there were 48 cases of people suffering severe allergic reactions, according to WebMD. Fortunately, no deaths have been reported with Xolair yet; though that doesn’t mean it won’t happen.

It’s interesting to note Xolair was approved by the FDA in 2003 but the study didn’t begin until 2004. I’ve always found it puzzling the FDA would approve the sale of a prescription drug without doing extensive tests on its potential adverse effects on people. It would make more sense for the FDA to flip the process – test first then release it to the public.

Here’s a video of the FDA warning over Xolair…

http://www.youtube.com/watch?v=Z3Yz73Hbrgo

Xolair is produced by Genentech. This company is no stranger to controversy. In 2008, a former Genentech employee filed a lawsuit against the company claiming they were discriminated against due to age and health problems. The plaintiff claims they were fired the day it was revealed they were diagnosed with a heart ailment, according to The Examiner.

As a personal injury lawyer with 20 years of experience representing clients who’ve been injured by prescription drugs, I believe a clear warning is necessary and a potential removal of Xolair from the prescription drug market in order to fully examine its effects on the human body. If you’ve suffered an allergic reaction using Xolair, I strongly recommend you consult an attorney.

Originally posted at InjuryBoard by John Cooper

Zicam Permanent Side Effects: Nasal Spray Causes Loss of Smell and Serious Injuries Due to Loss of Smell

John Cooper — Thu, 18 Jun 2009 17:28:00 GMT

If you’re currently taking Zicam nasal spray or have taken Zicam nasal spray, consult your physician immediately. The FDA recently warned consumers about Zicam and its connection to a permanent side effect – the complete loss of smell, known clinically as anosmia.

Matrixx Corp. produces Zicam nasal spray and has been entangled in legal battles over the harmful side effects of their product. In 2006, Maxtrixx agreed to a $12 million settlement with over 300 plaintiffs in a class action lawsuit, according to newsinferno.com.

Approximately 400 lawsuits have been filed against Matrixx Corp. due to Zicam nasal spray since 2003, according to The Washington Post. There were even some users who stated they lost their ability to smell and taste after using Zicam nasal spray just one time.

In August of 2005, Matrixx settled a Zicam lawsuit that went to trial, brought by a 42-year-old Los Angeles computer consultant. An undisclosed payment was awarded to the plaintiff.

Here’s a video of people talking about their loss of smell due to Zicam:

Video

Medical experts have known since 1938 that zinc can harm smell tissue in high doses. In fact, Canadian doctors used a zinc nasal solution to kill the sense of smell in children as part of an experiment to prevent polio, according to The Washington Post.

This isn’t the first-time a zinc-based nasal spray caused serious side effects. Cold-Eeze, a nasal spray with zinc as its primary ingredient, had lawsuits brought against the manufacturer a few years ago. Cold-EEze was removed from the market in 2004 after just one year.

As a personal injury lawyer who’s been practicing for over 20 years, I’m always distressed when I hear about these horrible side effects associated with popular, over-the-counter medications. It’s clear the Matrixx should have done studies to see what side effects occur when injecting zinc gluconate into nasal passages. People’s lives are being forever altered because of Matrixx’s irresponsible actions.

Originally posted at InjuryBoard by John Cooper

Tendon Damage Associated With Certain Antibiotics

Jim Lewis — Mon, 15 Jun 2009 11:36:00 GMT

Levaquin, Cipro, Avelox, Noroxin and Floxin are broad-spectrum antibiotics used to help treat infections. They may also cause tendon ruptures and tendonitis, according to spokesman.com. The FDA ordered the manufacturers of these drugs, including Merck, Bayer, Oscient, and Ortho-McNeil-Jannsenn, to include information on the labels regarding the potential tendon problems associated with usage.

In general, tendon ruptures and tendonitis occur in roughly one in 100,000 people. Tendons are vital to proper mobility since it is the fibrous tissue that attaches muscle to bone in the human body. The forces applied to a tendon may be more than 5 times your body weight, according to emedicinehealth.com..

A substance known as fluoroquinolones is commonly found in the antibiotics listed above and it increases the risk of tendon ruptures and tendinitis by up to four times, according to the FDA. A petition by Public Citizen’s Health Research Group theorized the ruptures may be occurring because fluoroquinolones are toxic to tendon fibers and potentially restrict blood supply in tendons.

This is a good video illustrating the risks associated with these antibiotics

Video

Achilles tendons were reportedly the most frequently ruptured, according to naturalnews.com. This injury is known to cause sudden, severe pain and increased difficulty with walking. In addition, tendon ruptures in rotator cuffs, shoulders, biceps, hands and thumbs were also reported.

As a personal injury attorney with over two decades of experience representing clients who’ve had their health damaged by prescription medications, I strongly advise you to speak with your physician if you’ve been prescribed any of these drugs and consult with an attorney.

Originally posted at InjuryBoard by Jim Lewis

Remain Aware of Swine Flu Symptoms and Take Necessary Precautions

Jim Lewis — Sat, 16 May 2009 12:35:00 GMT

The hysteria surrounding the H1N1 virus, commonly referred to as Swine Flu, has somewhat dissipated, but that does not mean the threat is gone. CNN reported on five new cases of the H1N1 virus in New York City schools on May 14, 2009 prompting Mayor Michael Bloomberg to close the schools.

As the proud father of two daughters, it’s heart breaking to hear about a child being stricken with an illness. The decision for Mayor Bloomberg to close down the schools in New York was prudent considering the potential for further spread of the virus. Also, speaking as an injury lawyer, it’s best to contain a potential volatile situation involving people’s health.

The threat of swine flu isn’t relegated to New York. WAVY.com reported three cases of Swine Flu in Hampton Roads. One of the cases involved a child in Norfolk, Virginia (VA). This brings the total number of Swine Flu cases in the state of Virginia (VA) up to 19.

In response to the concern over Swine Flu, the city of Virginia Beach created a special web page with general information regarding the outbreak of the virus and its existence in Virginia.

This isn’t the first time I’ve written about Swine Flu. Earlier this month I wrote about nine cases of Swine Flu in North Carolina (NC).

Here is some general information about Swine Flu that you need to know, including symptoms, according to The Centers for Disease Control and Prevention:

Swine flu symptoms in humans are similar to the symptoms of regular human seasonal influenza.

These symptoms include fever, lethargy, lack of appetite and coughing.

Other potential symptoms include runny nose, sore throat, nausea, vomiting and diarrhea.

Here’s what you can do to avoid catching Swine Flu, according to the CDC:

Cover your nose and mouth with a tissue when coughing or sneezing

Wash your hands regularly

If you feel ill, do not go into work or school and consult your doctor.

Originally posted at InjuryBoard by Jim Lewis