Archive for the ‘ Clinical Trials ’ Category

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1
Mar

New Study Finds Bleeding Risk with Certain Blood Thinners

March 1, 2012

While blood-thinning medications may help patients live a more productive life, they may put those taking the drug at risk of a dangerous side effect. According to an article released in the latest issue of the New England Journal of Medicine, a recent study on the drug dabigatran (Pradaxa), a blood-thinner, discovered that elderly patients are at risk of suffering bleeding episodes from the medication.

The two-month evaluation of the medication and its effects on patients identified 78 specific incidences of 22 patients suffering bleeding episodes. Forty-four of the episodes occurred at hospitals where the researchers worked. The team concluded that four factors contributed to patients being at a higher risk of bleeding:

  • Prescriber Error
  • Impaired Renal Function
  • Patient Age
  • Lack Of An Effect Reversal Agent For The Drug

Two-thirds of participants in the most recent study were over the age of 80-years-old, most had moderate to severe renal impairment and low body weight. The stats on these participants were a far from those that were chosen for the study that got the drug approved. Those patients had a median age of 71-years-old; most didn’t suffer renal impairment and had healthy body weights.

Researchers concluded that better medication education is needed and that patients who have certain risk factors should be evaluated much more closely.

The North Carolina drug injury attorneys with HensonFuerst Injury Lawyers are here to help you if you have been caused harm by a medication prescribed to you by your doctor.

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12
Sep

Duke Sued Over Clinical Trials

According to ABC 11 News and an article on ABClocal.go.com, a lawsuit filed in Durham Superior Court names Duke University, Duke University Health System, and five doctors. They are accused of participating in a fraudulent clinical trial, and exposing participants to unnecessary treatment—including chemotherapy.

The lawsuit alleges the clinical trial relied on the work of former Duke cancer researcher Anil Potti. In 2006, he and colleagues published an article that claimed they had developed a test that could predict which lung cancer patients would benefit from chemotherapy.

But two doctors in Texas reported they could not replicate the results of the study, and the lawsuit filed Wednesday alleges they warned Potti and Duke on multiple occasions about their concerns. Lawyers claim Duke failed to respond.

According to plaintiff’s attorney Thomas Henson of HensonFuerst Attorneys:

“Duke conducted clinical trials on cancer patients that should never have occurred. The trials were based on bad science. Researchers across the country had been telling Duke and warning Duke about the bad science.”

To read the full article, click here:  Duke Sued Over Clinical Trials

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18
Aug

Menthol Cigarettes Harder to Quit Than Regular Cigarettes

August 18, 2011

Although it is known that the urban myth about menthol cigarettes containing fiberglass in order to cause small cuts in smokers’ mouth and throat so that more nicotine and menthol can be ingested is false, new studies are showing the minty smokes may be harder to quit, especially among minorities. A news release issued Monday by the Cancer Institute of New Jersey announced the findings of the organization’s study.

The study focused on the likelihood of quitting among smokers of menthol cigarettes versus non-menthol cigarettes throughout different ethnicities, and the findings were shocking.

Smoking menthols was much more common among African-Americans, with almost 72% of black smokers choosing menthols, than among Hispanics (28.1%) or whites (21%). The study was also one of the first to break the Hispanic population down into sub categories of ethnicity and found Puerto Ricans (62%) were more likely to smoke menthols than other Hispanic groups, such as Mexicans (19.9%).

Races with higher probabilities of smoking menthols also had a harder time quitting. Puerto Ricans who smoked menthols were 43% less likely to quit than those non-menthol smokers. African-Americans also had lower rates for quitting among menthol smokers, with a 19% success rate versus non-menthol smokers.

The Raleigh Personal Injury Lawyers with HensonFuerst would like to encourage all smokers to try to put the pack down. The medical benefits could save you tens of thousands of dollars and many headaches arguing with insurance for coverage of associated medical costs.

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22
Jul

New FDA Warning for Multaq

Multaq (generic name: dronedarone) is a drug used to treat patients who have a common type of abnormal heart rhythm called atrial fibrillation, or atrial flutter.

In January, the U.S. Food and Drug Administration (FDA) warned that some people taking Multaq developed severe liver injury, including two cases of acute liver failure that lead to liver transplant. That was pretty bad, but today’s information is worse.

On July 21, 2011, the FDA notified healthcare professionals that a clinical trial evaluating Multaq was stopped when an early evaluation of the data found a that patients taking the drug had a  two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure.

According to the manufacturer’s website: MULTAQ is a prescription medicine used to lower the chance you would need to go into the hospital for heart problems. Sadly, the drug seems to cause more problems than it solves. Liver failure…stroke…heart failure…death. This is not a mild warning, it is a call to action.

The FDA has this advice:

At this time, patients taking Multaq should talk to their healthcare professional about whether they should continue to take Multaq for non-permanent atrial fibrillation. Patients should not stop taking Multaq without talking to a healthcare professional. Healthcare professionals should not prescribe Multaq to patients with permanent atrial fibrillation.

In addition, patients taking Multaq should watch for signs of liver problems and contact their physician immediately if they experience anorexia (lack of appetite or desire to eat), nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching.

The FDA, Health Canada, and the European Union will all be conducting reviews of the drug and the latest data from the clinical trial. No doubt, this will not be the last we hear about the problems of Multaq.

If you believe that you have suffered injury or severe side effects from taking Multaq and would like to explore your legal options, the lawyers of HensonFuerst are available 24 hours a day, 7 days a week. You can reach us by phone (1-800-4-LAWMED) or by the contact form on our website (www.lawmed.com).

If you have questions, HensonFuerst has answers.

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26
May

Task Force Discusses Giving Back To Victims Of Sterilization Program

May 26, 2011

Imagine having the opportunity to have children being taken away from you, and possibly not fully understanding the procedure that is taking place. That is the reality for around 7,600 North Carolina residents. These individual were sterilized by the state between 1933 and the mid-1970’s, under the now disbanded, North Carolina Eugenics Board. The program was established over a century ago to ensure that people suffering from mental disabilities and other conditions did not procreate.

ABC News reported on the 1968 case of a Windfall, North Carolina, woman who was a victim of the program. At the age of 13-years-old, the woman became pregnant after being raped. The social workers assigned to her case considered her “Promiscuous” and “too feebleminded to be a responsible parent.” After giving birth to the child, she was sterilized without being told.

Read More.

Yesterday, a task force created by Gov. Beverly Perdue discussed reparations for individuals affected by the program. According to The Charlotte Observer , the task force is finding it difficult to track down patients of the program. State archives collections manager, Sarah E. Koonts, presented information to the board showing that case records contain missing and incomplete data on patients.

Read More.

If you, or someone you know, was involved in the in North Carolina’s sterilization program between 1933 and 1978, contact a North Carolina personal injury lawyer with HensonFuerst. We may be able to help you.

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4
Feb

Duke Cancer Trials Details

We have had a lot of concerned patients contact us with questions about the Duke University clinical trials that are currently being investigated by us, as well as by the national Institute of Medicine.

The specific names and NCT numbers of the questioned trials are listed below. The numbers are important because they will be printed on any signed consent forms.

  1. NCT00636441 – Early Stage Breast Cancer. Brief Title: Trial to Evaluate Genomic Expression Profiles to Direct Preoperative Chemotherapy in Early Stage Breast Cancer.   Official title: A Randomized Phase II Trial Evaluating the Performance of Genomic Expression Profiles to Direct the Use of Preoperative Chemotherapy for Early Stage Breast Cancer.
  2. NCT00509366 – Stage IIIB/IV Non-Small Cell Lung Cancer. Brief title: Study Using a Genomic Predictor of Platinum Resistance to Guide Therapy in Stage IIIB/IV Non-Small Cell Lung Cancer (TOP0602).  Official title: Phase II Prospective Study Evaluating the Role of Pemetrexed Plus Gemcitabine Chemotherapy for the Initial Treatment of Select Stage IIIB and IV NSCLC in Patients Using a Genomic Predictor of Platinum Resistance to Guide Therapy.
  3. NCT00545948 – Early Stage Non-Small Cell Lung Cancer. Brief title: Adjuvant Cisplatin With Either Genome-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small Cell Lung Cancer (TOP0703).  Official title: Genome-Guided Phase II Study of Cisplatin Based Adjuvant Chemotherapy With Either Vinorelbine or Pemetrexed for Early Stage Non-Small Cell Lung Cancer.

If you participated in these trials and have any questions about your legal rights, please don’t hesitate to contact HensonFuerst Attorneys at 1-800-4LAW-MED. We’re available 24/7. Or, visit our website at http://www.lawmed.com/.  If you have questions, HensonFuerst has answers.

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