Stedman Drug

[Virgil Gardiner]

Theauthors concluded that available evidence did not suggest an association between loss of seizure control and generic substitution of at least three types of anti-epileptic drugs. In view of the restricted search and limitations in the evidence from diverse studies, the authors' conclusions should be interpreted with caution.

MEDLINE, EMBASE and IPA were searched from 1984 to August 2009 for studies published in English in peer-reviewed journals. Search terms were reported. Reference lists in relevant articles, letters and commentaries were screened.

Randomised controlled trials (RCTs) and observational studies were eligible if they compared the effects of one brand-name antiepileptic drug with at least one alternative version produced by a distinct manufacturer on outcomes related to the number or severity of seizures. Antiepileptic drugs were defined as drugs specifically approved for treating epileptic seizures. Abstracts were excluded.

The RCTs examined generic and brand forms of phenytoin, carbamazepine and valproic acid. Observational studies examined a wide range of antiepileptic drugs, which included some newer agents. Studies included patients with controlled and uncontrolled or refractory epilepsy at baseline; some studies were in newly diagnosed patients. Where reported, mean age of patients ranged from 9.5 to 40 years.

Numbers of seizure-related outcome events were extracted or calculated for each study and used to calculate odds ratios (OR) and 95% confidence intervals (CI). Patients with no observed seizures were classed as controlled and those with at least one seizure were classed as uncontrolled. Where required, authors were contacted for additional data. For studies that evaluated more than one generic version, data for the drug with the most uncontrolled patients was used. Odds ratios and CIs for cross-over studies were calculated using methods described by Elbourne and a marginal approach was used.

The studies were grouped by study design. A weighted average odds ratio with 95% CI was calculated using data from RCTs that provided data on the number of controlled and uncontrolled patients or individual patient data. Heterogeneity was assessed using the Cochrane Q test. Observational studies were combined in a narrative synthesis.

Nine RCTs (n=251) and seven observational studies (n=approximately 228,670, but this included patients who received antiepileptic drugs and non-antiepileptic drugs and may have included duplicate patients) were included. Most studies were funded by pharmaceutical companies.

RCTs: Eight of the nine RCTs were cross-over studies, four were double-blind and three were single-blind. Jadad scores ranged from 2 to 4 out of 5. Sample size ranged from 10 to 64. Treatment duration ranged from four to 28 weeks.

There was no significant difference between brand-name antiepileptic drugs and generic versions in the control of seizures, OR 1.1 (95% CI 0.9 to 1.2; seven RCTs, n=204). No significant statistical heterogeneity was found.

Six of the seven studies attributed the reported increase in seizures (three studies) or increased healthcare utilisation (three studies) with switching from brand-name to generic drugs. The seventh study reported no difference in seizure rates attributed to switching.

Although most RCTs were short-term, available evidence did not suggest an association between loss of seizure control and generic substitution of at least three types of antiepileptic drugs. The association seen in observational studies may be explained by other factors.

The review question was clearly stated and inclusion criteria were appropriately defined. Several relevant sources were searched, but no attempts were made to minimise publication and language biases. Methods were used to minimise reviewer errors and bias in data extraction and validity assessment; it was unclear whether similar steps were taken in study selection. Study validity was assessed and results were reported. Meta-analysis was appropriately restricted to the RCTs and statistical heterogeneity was assessed. Some limitations of the evidence were discussed and included the comment that associations in observational studies did not equate to causation.

In view of the limited search, short treatment duration and small sample size of RCTs, lack of focus of observational studies on seizure outcomes, clinical and statistical heterogeneity and unknown wash-out period in crossover studies, the authors' conclusions should be interpreted with caution.

Practice: The authors stated that until better-quality data were available, it would be appropriate to closely monitor high-risk patients when switching from brand to generic antiepileptic drugs and if seizures occurred to consider other factors that may have influenced seizure control.

Research: The authors stated that prospective studies may identify patients at high-risk when switching from brand-name to generic antiepileptic drugs. Observational studies adjusted for potential confounders may provide some information about groups at risk.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

Contact Person: Bill Watkins (864) 282-2100

Columbia, South Carolina ---- United States Attorney Bill Nettles stated today that Stedman J. Bates, age 26, of Atlanta, Georgia, was sentenced to 135 months for conspiracy to distribute cocaine and marijuana, a violation of Title 21, United States Code, Section 846. United States District Timothy M. Cain of Anderson sentenced Bates.

The evidence at the change of plea hearing established that Bates owned and operated marijuana grow houses in California. He arranged for large quantities of marijuana to be transported to Georgia for redistribution in South Carolina. In addition, Bates also sold kilogram quantities of powder cocaine and used a stash house in Fountain Inn, South Carolina. Bates used various drug couriers to bring his product from Atlanta to Fountain Inn. Once the couriers had delivered the drugs, they would return to Georgia and turn over the money for the drugs to Bates. Law enforcement estimates that Bates arranged for upwards of 50 kilograms of cocaine to be sold in South Carolina.

The case was investigated by agents the federal Drug Enforcement Administration. Assistant United States Attorney Bill Watkins of the Greenville office handled the case.

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Context: Use of generic drugs, which are bioequivalent to brand-name drugs, can help contain prescription drug spending. However, there is concern among patients and physicians that brand-name drugs may be clinically superior to generic drugs.

Study selection: Studies compared generic and brand-name cardiovascular drugs using clinical efficacy and safety end points. We separately identified editorials addressing generic substitution.

Data extraction: We extracted variables related to the study design, setting, participants, clinical end points, and funding. Methodological quality of the trials was assessed by Jadad and Newcastle-Ottawa scores, and a meta-analysis was performed to determine an aggregate effect size. For editorials, we categorized authors' positions on generic substitution as negative, positive, or neutral.

Conclusions: Whereas evidence does not support the notion that brand-name drugs used in cardiovascular disease are superior to generic drugs, a substantial number of editorials counsel against the interchangeability of generic drugs.

Frank Stedman, a lad from Essex was arrested at Heathrow Airport on a flight back from Thailand having fled there to escape capture for his involvement in organised crime. Driven by his greed for money, Frank became a runner for an organised drug trafficking gang. He transported and delivered large sums of money and kilos of drugs across the country until the authorities caught up with him and his co conspirators. He pleaded guilty for his involvement in a 80 million drug supply conspiracy. He was sentenced to nine years in prison. However, there is more to this story. In this episode Frank speaks openly about his experiences and the lessons he learned and is a huge advocate that crime does not pay. He hopes that by sharing his story, he can discourage others from following a similar path.

It is unlikely, for example, that a predator drug dealer would find his way into a treatment court. On the other hand, someone with ties to the community who has slowly descended into criminal behavior as the result of a substance dependence might have the opportunity to enter a diversionary program.

The procedure uses two small balloons to divert blood past the liver for an hour while delivering drugs directly into the organ. Crucially, this avoids causing unnecessary damage to healthy parts of the body.

Once the drug has been delivered, blood from the liver is drained from the patient. It is then processed through a filtration machine to reduce toxicity and returned to the patient via the jugular vein.

Southampton researchers have published findings in the journal Melanoma Research. They found liver cancers were controlled in 88.9% of patients who had received chemosaturation therapy. Around 60% of patients survived for a year and 30% for two years.

Dr Stedman, a consultant interventional radiologist at UHS, said: When we first trialled this treatment on two patients in 2012, I said that the development would be a landmark moment in cancer care. It really has proved to be given these results.

FSDA is a six-week structured program for students who have committed certain controlled substance-related offenses. They may be approved to attend based upon a signed agreement between the administrator, parent, and student. The goal is to create awareness among students regarding the far-reaching effects of alcohol and drug abuse and how this may impact their future.

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