Chicago Injury Law Blog

As uncertainty surrounds the safety of the popular diabetes drug Avandia, federal health officials are prohibiting new patients from enrolling in a safety study of the prescription medication because of the associated risks. The TIDE study is designed to give a definite answer to whether or not Avandia holds more risk for heart problems than similar drugs. The Federal Food and Drug Administration (FDA) issued a “partial clinical hold” on the TIDE trial, which Avandia’s manufacturer GlaxoSmithKline agreed to conduct when the drug’s safety was first questioned in 2007. However, patients who are already participating are permitted to continue.

A panel of experts recently voted that although Avandia seems to increase the risk of heart problems, the majority voted to leave it on the market.  Some health professionals are  arguing that the TIDE trial is unethical since there is enough evidence to prove that the drug is more dangerous. Other health professionals have speculated that Avandia will be pulled off the market soon.

The State of Illinois recently reached a court settlement that offers supportive community-based housing and treatment to about 4,500 psychiatric patients who currently reside in nursing homes.  Following this settlement, the Chicago Tribune reported that the American Civil Liberties Union (ACLU) filed court papers stating that Illinois for-profit nursing home operators were using scare tactics to keep psychiatric patients in their facilities, instead of letting them move into supporting community-based housing.  Nursing Home operators deny these allegations and raise concerns about whether the State can provide appropriate housing for such patients.

The current argument between the ACLU and Nursing Home operators stems from the latter’s distribution of “information sheets” which, according to the ACLU, state that the court settlement purposefully lacks details” and may  take away protections for people who do leave the nursing home.  Specifically,  the information sheets state that the settlement does not specify “where you’ll move, how you’ll pay rent, how you’ll be fed, who will help you with your medication and other medical needs, or what happens if you don’t like it and want to return [to the nursing home]”. Nursing Home operators  state the “information sheets” are accurate, and that they are worried the State will not deliver on its promise to care for the psychiatric patients that move into the new community settings.

State officials responded that psychiatric patients are free to choose where they want to go, and that nursing home operators are wrong to deny that the smaller community settings may be less expensive and more therapeutic.

It was recently reported by the Wall Street Journal that one of the members of the government advisory panel who voted to back Avandia last week was on GlaxoSmithKline’s payroll. More specifically, endocrinologist David Capuzzi is a paid speaker for the drug manufacturer.

Avandia, a diabetes drug, has carried the Federal Food and Drug Administration’s (“FDA’s”) strongest warning, a black box warning, regarding its risk for heart problems since 2007.  Last week, a FDA advisory panel met to consider further restrictions on the drug in the wake of new information indicating it to be more harmful than previously thought.  During the meeting of 33 panel members, 12 voted Avandia should be withdrawn; 10 voted its sales should be restricted and warning labels enhanced; 7 voted solely for enhanced warning labels; and 3 voted to keep Avandia on the market with no changes to its warnings.  Because of the lack of unity, it is difficult to predict what the FDA will do with regard to the drug.

According to the Wall Street Journal, Dr. Capuzzi was one of the three panel members who voted to keep Avandia on the market with no changes to its warnings, and defended the drug during the two-day panel meeting.  Dr. Capuzzi has received almost $15,000 in speaking fees from GlaxoSmithKline, but has denied previously speaking about Avandia. The controversy surrounding Dr. Capuzzi and Avandia highlights a problem in the FDA’s regulations: the disclosure form for outside experts who advise the FDA on risky drugs only requires them to list fees from speaking or writing for a drug company for the previous 12 months or that are under negotiation. This is typically too short a period of time to catch most conflicts in the pharmaceuticals business. In Dr. Capuzzi’s case, the FDA’s current requirement would not have captured the majority of GlaxoSmithKline’s payments to him.  

Popular over-the-counter nasal gels may cause loss of smell or anosmia.  Over-the-counter nasal gels, such as Zicam, are generally used to treat common cold symptoms.  Patients use this product by wiping the gel inside the nasal passages.  Doctors state it is likely the nasals gels cause loss of smell because they contain zinc gluconate.  They also express doubt that the products are actually effective at treating common cold symptoms, stating “Multiple trials have found that intranasal zinc is ineffective in preventing or reducing the duration of the common cold.”

Some doctors said that products containing zinc gluconate do nothing to treat the common cold, and any relief experienced after usage is psychological.  As Dr. Terence Davidson of the Nasal Dysfunction Clinic at the University of California, San Diego, School of Medicine says, “When the gel is inserted into the nose, it gives you a little bit of a burn, so it has a nice psychological feel to it.  That’s why it’s ended up becoming popular.” 

At this time, the authors of a new report have suggested increased Federal Food and Drug Administration oversight of zinc-containing nasal gels due to their ineffectiveness and suspected link to loss of smell.

As a follow-up to our previous blog on the current controversy surrounding the popular diabetes drug Avandia, it was recently reported that Avandia’s manufacturer GlaxoSmithCline hid a 1999 study that indicated the drug’s danger.

In the fall of 1999, the manufacturer secretly began a study to test if Avandia was better and safer in terms of heart problem risks than the competing drug Actos. The study showed that Avandia was not better than Actos, and was in fact riskier for the heart. The company did not share these results, but instead tried to cover them up, likely due to fear of lost profits. In most cases, the law requires posting the results in a public forum or submitting them to federal drug regulators. In fact, GlaxoSmithKline has not only hid valuable data regarding Avandia’s safety, it has also manipulated data to make the drug appear less risky.

Avandia went on to become one of the most popular drugs in the world, earning GlaxoSmithKline hundreds of millions in profits.  It was not until May 2007 when a cardiologist at the Cleveland Clinic  disclosed a study that showed an increase risk of heart attacks  associated with Avandia.  Currently, the FDA is debating whether or not to allow a further clinical trial to test the safety risks of the drug proceed.

Contact an Experienced Drug Litigation Attorney

The attorneys at the Pintas & Mullins Law Firm have extensive experience with drug litigation cases.  If you or a loved one has suffered heart problems as a result of taking Avandia, contact us for a free no-obligation consultation to find out about your legal rights.  You can also visit our website to learn more about Avandia.

Recently, Pfizer Inc voluntarily withdrew the drug Mylotarg (gemtuzumab ozogamicin) from the U.S. market. Mylotarg is used to treat patients with acute myeloid leukemia, a bone marrow cancer. Pfizer withdrew the drug at the request of the Federal Food and Drug Administration (FDA) since a new clinical trial yielded both new safety concerns and lack of benefit to patients.

Mylotarg was approved by the FDA in 2000 to treat patients 60 years or older who had recurring acute myeloid leukemiaand were not candidates for chemotherapy. The drug originally obtained “accelerated approval”, which allows the FDA to approve drugs for serious illnesses with little alternative treatment options. based on solely a laboratory measurement or physical sign. The laboratory measurement or physical sign are used in place of a clinical trial which directly measures the drug’s effect on a patient’s health. Usually drugs with accelerated approval are required to conduct clinical trials after approval to properly measure health benefit.

After Mylotarg’s clinical trial was completed, it was observed that no benefit occurred, and a greater number of deaths occurred in patients receiving the drug than those receiving just chemotherapy.

Over the past couple of years, the safety of the popular diabetes drug Avandia has been the source of much debate, due to claims that it increases the risk of heart attack. Recently, it was reported that a clinical trial conducted by Avandia is being increasingly scrutinized by experts.

Some specialists and FDA officials stated that Avandia is too dangerous to stay on the market due to its risks.  As a result, they also contend that the current Avandia trial is unethical, and subjects patients to the increased risk of heart problems. However other experts, as well as manufacturer GlaxoSmithKline, have stated that the drug is not harmful and the clinical trial is essential to providing some definite answers about Avandia’s risks. 

The current controversy surrounding Avandia highlights the difficulties the FDA encounters in protecting consumers when a highly popular and profitable drug is shown to be unsafe. In addition, the problems surrounding Avandia also trigger new questions over the  ethics of using humans to test a drug’s safety.  On July 13, 2010, the FDA will review Avandia and determine the fate of the current clinical trial on its safety.

Recently, the Chicago Tribune reported that Illinois health authorities have moved to revoke the license of Evergreen Health Care Center in Evergreen Park, a southwest suburban nursing home. Evergreen Health Care is partly owned by state Senator Heather Steans, a prominent advocate of reform legislation to improve safety and care standards in Illinois nursing homes. The revocation of its license follows from repeated citations for patient neglect.

Evergreen Health Care was recently added to a federal watch list for nation's most troubled nursing homes. Previous inspections there yielded several safety breaches, such as failure to prevent maggots from infecting the scalp wound of an elderly skin cancer victim. South Shore Nursing & Rehabilitation Center was also recently added to the federal watch list due to safety violations. There are currently five Illinois facilities on the federal watch list.

Contact an Experienced Nursing Home Injury Attorney

The attorneys at the Pintas & Mullins Law Firm have extensive experience with nursing home abuse and neglect cases. If your loved one has suffered from abuse or neglect in a nursing home, contact us for a free no-obligation consultation to find out about your legal rights. You can also visit our website to learn more about nursing home abuse and neglect cases.

Recently,the U.S. Consumer Product Safety Commission (CPSC) issued a recall of entertainment centers due to a fall hazard. About 24,000 units were recalled because the shelves of the entertainment centers can detach and fall when moved. The following modes were part of the recall:

·         Arts and Crafts

·         Vineyard Manor

·         Lake Cottage

·         Studio One

·         West Indies

·         Plantation Cove

The units are sold at Value City Furniture, Rooms Today and American Signature Furniture stores.  So far, the CPSC has received four reports of the shelf collapsing, with two reports of serious injuries. Consumers with the recalled product should contact American Signature Inc. for a free repair kit. Click here to read the CPSC press release regarding the recall.

Consumers who are currently using denture creams containing zinc may not realize the great risks associated with their usage.  Two of the most popular denture creams on the market, Super Poligrip (manufactured by GlaxoSmithKline) and Fixodent (manufactured by Procter & Gamble) have been linked to the development of serious illnesses such as copper depletion that may result in  neurological problems (or nerve damage).

Denture creams have been on the market for several years, and is considered a Class I medical device by the Federal Food and Drug Administration, meaning it does not require a warning label.  However, in 2008, a study published in the medical journal Neurology found that long-term use of denture cream could lead to patients developing neurological problems due to having too little copper in their blood.  The denture cream contains zinc, and too much zinc in one’s diet can lead to depletion of copper in the blood, which affects the spinal cord and causes subsequent nerve damage. Symptoms of nerve damage include numbness, tingling, weakness, difficulty moving the limbs, and difficulty balancing.

In February 2010, GlaxoSmithKline voluntarily stopped its  production of denture creams containing zinc, and began developing zinc-free formulas. As they stated, “We are taking these actions because we have become aware of potential health problems associated with the long-term excessive use of our zinc-containing denture adhesive products.”  However, Fixodent remains on store shelves.

Contact an Experienced Attorney

The attorneys at the Pintas & Mullins Law Firm have extensive pharmaceutical litigation experience. Use of denture creams containing zinc over extended periods of time has shown to lead to serious nerve damage.  The drug manufacturing companies did not adequately warn consumers of these risks.  If you or a loved one has developed any of these conditions, contact our office for a free legal consultation today.