Actor Dennis Quaid sues drug maker

Last month, we reported in a blog through our website, how actor Dennis Quaid is involved as a patient advocate, after his newborn twins nearly lost their lives back in 2007, from a medical error that could have very easily been prevented.  Put simply, the precious twins were given two doses of Heparin instead of Hep-lock (an anti-coagulant medication widely used for children).  Why is this significant?  Heparin is a drug one thousand times stronger than what the twins were supposed to have received.

Earlier this week, it was reported in the Contra Costa Times, that Mr. Quaid has filed a lawsuit on behalf of his children.  As far as the extent of his children’s injuries, the article states “The children suffered internal injuries and shock, but the extent of what happened to them will probably not be known for years, according to the suit.”  The lawsuit alleges that vials of the 10,000 unit Heparin should have been recalled previous to what happened to his children, because other infants had already died from similar medication errors.  The suit also claims that the company responsible for making the drug, Baxter Healthcare, “was obligated to warn healthcare providers of the previous medication mistakes.”

We wish the best for the Quaid family, and hope that the discovery in this case shines a light on not only finding out exactly what happened in this case, but also makes information available that may be able to save the lives of other children from future similar medical errors.  We will continue to monitor the course of this case.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

Last week, the FDA and McNeil Consumer Healthcare launched a massive voluntary recall of certain medications for infants and children.  There is a dedicated McNeil website that addresses the recalls.  In addition, the FDA has published a press release that has some of the important information regarding the recall

The following is some basic information concerning the recall, as published by McNeil under the Product Recall Information:

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The investigation into these products, which include, but are not limited to, Infants’ and Children’s Tylenol and Motrin (Please click here for a complete listing) is ongoing.  The Commissioner of Food and Drugs, Dr. Margaret A. Hamburg, states:  “While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”

We will continue to monitor this massive recall.  Please immediately check your homes for the recalled products. We strongly recommend that you read and follow the FDA’s instructions.

Have you ever wondered how people get in clinical trials? Well, you should check this out.

Are you aware of clinical trials that may be in your neighborhood? I just happened to come across this link to clinical trials.  Perhaps you are a lot more savvy than I (which would not surprise me one bit), but you can get ongoing information on these clinical trials by going to a website called Clinical Connection.

For example, there’s one in Baltimore for overweight folks being conducted at Harbor Hospital involving a new investigational medication.

In fact, if you go to this link, you will see that there are over 15 clinical trials for all types of conditions in the Baltimore area alone. If you are willing to travel 50 miles or less, there are even more in which you can enroll.

Do you have moderate or severe pain from osteoarthritis of the hip or knee?  Well Annapolis just might the place for you to visit and try out a new drug.  You have to be  over 18 years of age and according to the website, “study participants may be compensated for time and travel. All study-related care is provided at no cost and health insurance is not required to participate.”  I don’t know what “may be compensated” means – but if you are interested, check it out.

On the national level, the home page of Clinical Connection says there are 105,555 clinical trials underway – and there’s probably at least one in your neighborhood.

Do you suffer from chronic low back pain of greater than 3 months duration? That’s right – there’s a trial for you taking place at 7 locations, including California, Arizona, Florida, Washington and Nevada.

You name the condition – there just may be some free study out there waiting for you to volunteer.

These programs undoubtedly have very extensive packets of information about the study guidelines and the risks and benefits of the drug or therapy under study.  These trials are called clinical trials since the manufacturer has presumablyjumped over the hurdles of early non-clinical research in order to take the next step – how does our product work with real people?

Make sure you understand what you are signing up for before doing so.  Who knows, it may turn out that you get some real benefit from participating – hopefully you will not be a statistic in terms of adverse outcome. Just take time to understand what you are getting yourself into and what rights you are waiving.  If you’re good to go, we wish you well!

Fat-Melting Injections (a.k.a. Lipodissolve) May Not Be As Safe As You Think

According to an article published by WebMD, the FDA reprimanded six U.S. spas (Monarch Medspa in King of Prussia, Pa., Spa 35 in Boise, Idaho, Medical Cosmetic Enhancements in Chevy Chase, Md., Innovative Directions in Health in Edina, Minn., PURE Med Spa in Boca Raton, Fla., All About You Med Spa in Madison, Ind.) and one Brazilian company for making misleading statements about the safety and side-effects of fat-melting therapy (a.k.a. mesotherapy, lipodissolve, lipozap, lipotherapy, or injection lipolysis).

FDA’s Deputy Director of the Division of New Drugs and Labeling Compliance noted:

They make it sound so good and so safe. … [They claim] it dissolves fat — melts it away with no side effects — and they have done thousands of procedures, and it really sells well. … We are really concerned because we have had reports of complications, and we have no good data that say this is safe and this is effective.

Lipodissolve is a process whereby a series of subcutaneous injections are administered (usually injections of phosphatidylcholine and deoxycholate) to a specific part of the body in an attempt to melt the subcutaneous fat. According to the article, some of the reported side-effects of this therapy have been scaring of the skin and the developments of painful subcutaneous knots.

If you are considering Lipodissolve, be aware that this treatment is yet to be approved by the FDA, and there is no medical data or scientific research demonstrating that Lipodissolve is safe for consumers.

Contributing author: Jon Stefanuca

Poisonings From Opioids, Sedatives, And Tranquilizers On The Rise

According to an article published by WebMD, a recent research study revealed a dramatic increase in poisonings from prescription drugs such as opioids, sedatives, and tranquilizers. The study, which was published in the April issue of the American Journal of Preventive Medicine, indicates a 65% increase in such poisonings between 1999 and 2006.

Jeffrey H. Coben, MD, the study author noted:

[Certain prescription drugs] are just as powerful and dangerous as other notorious street drugs, and we need to ensure people are aware of these dangers and that treatment services are available for those with substance abuse problems.

After examining data from about eight million hospitalizations a year, the researchers made the following findings:

• Unintentional poisoning is now the second leading cause of unintentional injury death in the U.S.
• In 2005, unintentional poisoning surpassed motor vehicle crashes as the leading cause of unintentional injury death for people 35 to 54.
• Unintentional poisoning deaths have been on the rise for more than 15 years.
• Intentional poisonings from prescription rose 130% during the seven-year period, compared to 53% in intentional poisonings from other substances.
• The largest increase in the number of hospitalizations was caused by benzodiazepines. Hospitalizations from that class of drug increased 39% during the period studied.
• Hospitalizations for poisoning by barbiturates decreased 41% and hospitalizations for poisoning by antidepressants decreased 13%.
• Hospitalizations for poisoning by other drugs, medicinal, and biological substances increased 33%.
• Unintentional poisonings by other substances increased 21%.
• Unintentional drug-poisoning deaths increased 68% between 1999 and 2004, and the majority of the increase has been attributed to deaths associated with prescription opioids.

If you are currently taking opioids, sedatives, or tranquilizers, ask your doctor if these medications are truly necessary. Many of these drugs are highly addictive. If you have developed an addiction, now is the time to step up and seek help. Ask your primary care physician for assistance and information about available resources.

Contributing author: Jon Stefanuca

Asthma – How to Protect Your Child When the Steroid Inhaler Fails

According to an article published by WebMD, a new study by the National Institute of Health examined the effectiveness of step-up asthma treatment among children who continue to experience asthma attack on steroid inhalers.

Researchers concluded that the success of the step-up treatment varies depending on the population of children. The study focused on 182 children between the ages 6 and 17. All of the children enrolled in the study experienced asthma attacks despite regular steroid treatment. In this population, the following drugs were used: long-acting beta-agonists (LABAs), leukotriene-receptor antagonist (LTRA), and increased doses of inhaled steroids. According to the article:

The drugs with the best chance of success – 45% – are long-acting beta-agonists (LABAs)… . But safety concerns limit the use of these agents, the best known of which are Serevent and Foradil and the combination products Advair and Symbicort. About 30% of kids, the study found, do best either with a leukotriene-receptor antagonist (LTRA, brands include Accolate, Singulair, and Zyflo) or by doubling the dose of the child’s current inhaled steroid medication.

Although the study did not reveal a clear winner, researchers were able to identify the following correlations:

Hispanic and non-Hispanic white children were most likely to have the best response to LABA and least likely to have the best response to doubling inhaled steroid dosage. Black children were equally likely to have the best response to LABA or doubling inhaled steroids and less likely to have the best response to LTRA. Children who did not have eczema were most likely to have the best response to LABA.

Contributing author: Jon Stefanuca

St. Joseph Medical Center Stent Patients Now Face Another Risk: The FDA Requires a Black-Box Warning on Anti-Clotting Drug Plavix

For those of you who have been following the St. Joseph Medical Center stent fiasco, a story in the Los Angeles Times regarding the anti-clotting drug Plavix brings home a new concern for the patients who received this drug as part of the post-procedure therapy. Plavix is used “to prevent clotting of blood in patients who have stents or other prostheses or conditions that predispose them to clotting, and thus strokes and heart attacks.”

The Food and Drug Administration said Friday that it will require a new black-box warning on the label of   the popular anti-clotting drug Plavix to indicate that some patients do not metabolize the drug properly and may receive little benefit from it. The warning indicates that the drug is dangerous only in the sense that it doesn’t work in those patients and thus may leave them unprotected against heart attacks and strokes.

“The new warning appears on the label of the drug in a black box — hence the name — which is considered the most severe form of warning.”  A black box warning is the strongest warning required by the FDA.  The intent of requiring such a warning is to alert physicians and help them treat their patients correctly. “The FDA says between 2% and 14% of Plavix users don’t respond well to the drug and might benefit from alternative treatment.”

According to the FDA press release:

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.

People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

A Wall Street Journal Blog suggests that this situation may actually make the physicians’ job more difficult.

Genetic testing could identify the poor responders. But most doctors aren’t well equipped to do genetic testing. They don’t have quick access to the tests. Even if they did, they might not have time in the cases of many patients to wait for results to come back.

Only one genetic test has been approved by the FDA,  Roche’s AmpliChip, “to look for the variation, but not specifically for determining treatment with Plavix. Many laboratories offer other tests, whose quality the FDA says doctors will have to assess before using. Doctors should make sure the tests are at least 98% accurate, FDA officials told reporters.”

According to Christopher Cannon, a Harvard Medical School associate professor and editor-in-chief of Cardiosource, associations involved with the cardiac-related specialties and sub-specialties “will need to develop protocols for testing and treatment. The alternatives include increasing the dose of Plavix or switching to bloodthinner Prasugrel from Lilly and Daiichi Sankyo, but Cannon says neither has been tested for that purpose.”

“Thus a real conundrum” for patients and their physicians, Cannon said. “I expect mass confusion in response to this FDA warning,” he added.

As we reported in “Eye Opener” on March 13, 2010, St. Joseph Medical Center this past week added another 169 patients to the list of those notified by letter that they had received unnecessary, expensive and potentially dangerous stent procedures.  This brought the number notified to a whopping 538 patients – at least to date.

One has to wonder in all of this, was there a single moment of thought given to the potential risks to the patients at St. Joseph Medical Center when these unnecessary stents were put in hundreds of patients?  Maybe those involved in this tragic story of despicable care were not fully versed in the genetic complication of Plavix (or maybe they were); however, they were most assuredly aware that they were exposing these unwitting patients to a risk of hemorrhage, not to mention the risks associated with having a foreign body unnecessarily placed in their coronary vessels.

Zarontin – The First-Line of Treatment for Children with Absence Epilepsy

According to an article published in WebMD, researchers found that Zarontin, one of the oldest drugs used to treat epilepsy, is also one of the most effective drugs to treat this condition. The research study was published in the New England Journal of Medicine.

As many as 17% of children with epilepsy have absence seizures, also known as petit mal seizures, which involve brief but frequent staring spells that can occur dozens or even hundreds of times a day. These children do not have the convulsions typically associated with epilepsy, but they are at high risk for developing them later in life. During the 10- to 15-second seizure episodes, people with absence epilepsy become unresponsive and may stop walking or talking in mid-sentence. Children with these seizures often perform poorly in school.

Zarontin is the trade name of the anticonvulsant drug Ethosuximide. Ethosuximide is also known as Emeside. In addition to Ethosuximide, a physician’s other options include Valproic Acid and Lamotrigine. The study examined the efficacy of these drugs in treating absence epilepsy.

Lamictal was found to be significantly less effective than Zarontin or Depakote for preventing absence seizures, while treatment with Depakote was more likely to result in concentration problems than treatment with the other two drugs.

Moreover, Zarontin was found to have less of an impact on a child’s concentration and attention. If your child has absence epilepsy, be mindful that the newest and most expensive anticonvulsant on the market may not be your best option. Study co-author Shlomo Shinnar, MD, PhD, of New York’s Montefiore Medical Center noted:

Unless there are reasons not to use it, Zarontin would certainly be my first-line choice.

Contributing author: Jon Stefanuca

Physicians to test new emergency treatment for traumatic brain injuries

Traumatic Brain Injuries (TBIs) occur, sadly, much more frequently than you may think.  The effects are often permanent, life-threatening and/or significant in nature.  TBIs can negatively affect many vital parts of one’s daily living, as well as the people around them.  A recent article discusses a new emergency treatment that may help combat those effects.  This treatment is spear-headed by the Emergency Department of Stanford Hospital and Clinics, as well as the Santa Clara Valley Medical Center, and is more fully detailed below:  

The Stanford team and physicians at 16 other U.S. sites want to test the efficacy of a new drug treatment. In a phase-3 clinical trial that has been approved by the U.S. Food and Drug Administration, patients with traumatic brain injuries would receive progesterone, a hormone normally found in our bodies, to determine if it helps lessen brain swelling and damage.

Animal studies and two small clinical studies have indicated that progesterone may be beneficial in treating TBI patients. Quinn, who is an associate professor of emergency medicine at the Stanford University School of Medicine, also noted that progesterone “has been around a long time, and it’s a substance we know a lot about” because it has been used for birth control and for hormone therapy.

In the trial, TBI patients who are brought to Stanford, Santa Clara Valley Medical Center and the other participating medical centers would be separated randomly into two groups. One group would get an IV mixture that has progesterone, and the other group would get an IV drip without progesterone. Everyone enrolled in the study would receive standard medical care for a brain injury — maintaining blood pressure and providing oxygen — and all patients would be contacted by telephone every month for five months, to check on their progress before returning at six months for final neurological testing.

The proposed trial is unusual because the IV treatment would have to begin within four hours of the onset of an injury — at a time when most TBI patients aren’t alert enough to give consent, and their families can’t get to the emergency department fast enough to give consent. “The people we see in the ED often come in unconscious, and we know from experience that finding family members to give consent for treatment in the emergency setting can be difficult,” Quinn said.

The consent controversy is one that will most likely not go away anytime soon.  The article states that there are federal laws in place, that allow such procedures to occur, without the patient’s informed consent.  With this in mind, Stanford has posted a link for interested individuals to take a survey, in regard to their feelings regarding such a procedure.

We leave you with some somber statistics:

Every 15 seconds, someone in the United States suffers a major traumatic brain injury. Every five minutes, someone is forever disabled as a result of a TBI. Some 52,000 deaths per year are caused by these injuries. TBIs are the leading cause of death in people aged 1 to 44.

Let’s hope these numbers decrease as time goes on, with advances in safe medical technology and innovation.

The Unexpected Killers: Hospital-Acquired Infections

According to an article published by NPR, a recent study found that as many as 48,000 people die each year in the U.S. from hospital-acquired infections. Researchers say that this is the first truly national study of its kind, involving 69 million cases of hospital-acquired infections in 40 states.

This study, unlike its predecessors, specifically isolated cases of hospital-acquired infections from cases involving patients  with possible existing infections at the time of admission. In part, this was accomplished by focusing on patients admitted to undergo elective surgery.

The researchers found the death toll from avoidable pneumonia and sepsis is bigger than from traffic fatalities. It’s more than three times higher than that for AIDS, and roughly twice as much as annual deaths from firearms.

Examples of hospital-acquired infections include: pneumonia, sepsis (infection of the blood), urinary tract infections, gastroenteritis, clostridium difficile (c-diff), tuberculosis, and staphylococcus-related infections.

Most hospital-acquired infections can be effectively treated with the proper choice of antibiotics.  There is simply no justification for such an incredibly high mortality rate  to be associated with a series of preventable and treatable medical conditions. For this reason, the results of the study are truly disturbing.

Contributing author: Jon Stefanuca