Stedman Drugs

[Rafael Nowning]

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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.

The authors 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.

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.

Stedman Graham was born on March 6, 1951, in Whitesboro, NJ, a community founded in 1901 by a group of prominent African-Americans which included Booker T. Washington and Paul Laurence Dunbar. Stedman attended Middle Township High School where the 6'6" phenom starred on the varsity basketball team.

Athletes Against Drugs 25th Anniversary Celebrity Golf Weekend. From left to right: AAD Founder Stedman Graham, Comedian/Actor Anthony Anderson and Heisman Trophy winner Charles Woodson of the Green Bay Backers at their annual golf celebration in Chicago. (photo credit Larry Englehart, Deja Views)

After earning a Bachelor's degree in Social Work from Hardin-Simmons University, he played professionally in Europe for a few years before returning to the U.S. to work on his Master's in Education from Ball State.

An enduring, high-profile relationship with Oprah Winfrey has perhaps overshadowed the long list of business and charitable accomplishments accumulated over the course of Mr. Graham's impressive career as Chairman and CEO of S. Graham & Associates, a management and marketing consulting firm specializing in the corporate and educational fields. A prolific writer, he is also the author of 10 books, two of which became New York Times bestsellers. And he has taught at several colleges, including a course on leadership at the University of Illinois and one on strategic management at Northwestern.

Most importantly, Mr. Graham has exhibited a lifelong commitment to community via Athletes Against Drugs, a non-profit organization he founded in 1985 which remains dedicated to developing leadership in underserved youth through scholarships and education. Recently, Stedman talked to me about his work with AAD and other projects.

Kam Williams: Hi Stedman, thanks so much for the time.

Stedman Graham: It's my pleasure.

KW: I have a friend, Franklin Moore, who claims he's a cousin of yours. Is that true or has the brother been making it up all these years?

SG: It's true. He's my closest cousin, my favorite cousin. Where do you know him from?

KW: His younger son, Joseph, and my son have been friends since they were in pre-school together.

SG: That's great, Joseph's my godson.

KW: Small world. Tell me what's going on with Athletes Against Drugs?

SG: The focus of the organization, which is really known now as AAD Education, Health and Sports is the positive, not the negative. Being in this business for 25 years has taught us that it's not about the drugs but about providing positive choices, keeping yourself active and keeping yourself busy with activities, the proper curriculum, and special events like taking kids to games. That's how you keep our youth off drugs.

KW: Where is the organization located?

SG: We're operating out of Chicago. That's our home base. But we do programs all around the country in coordination with various teams and various athletes. We provide programming in the schools, class curriculum, tutoring, and sports field trips. And we have athletes come speak in the schools. We've done all that for years. So, we're really strong in terms of programming.

KW: Didn't you have a big event recently?

SG: Well, we had our annual golf tournament where we bring in a lot of athletes. It's one of our fundraisers. This year was our 25th anniversary celebration.

KW: I told my readers I'd be interviewing you, and they sent in a lot of questions. FSU grad Laz Lyles says she heard that you teach at Full Sail University, which she says is an amazing arts college. She wants to know, what attracted you to this school, and what you're teaching there?

SG: I teach identity education and development. I teach people how to find their passion. I do it using a nine step plan. I also teach them how to develop a bigger vision once they have that passion. The thing that attracted me to Full Sail is that they have their passion already. So, what they needed was the other eight steps.

The curriculum that I teach encompasses all that. It's especially pertinent to folks who already have an identity in terms of their job, their future employment or career path. [For more info, see Stedman's book, "You Can Make It Happen: A Nine Step Plan for Success."

KW: Robin Beckham asks what's happening with AAD, but you already answered that. She's another person who says she knows you. She's in public relations in Pittsburgh where she used to be a TV anchorwoman for one of the networks.

SG: Right, absolutely, yeah.

KW: Attorney Bernadette Beekman who is vacationing on a vineyard in Vacqueyras, France as we speak, says, "I know you have a background in education. Do you support early childhood educational programs which help young African-American males bridge the achievement gap, even before the first grade?"

SG: Totally! I have a ten-week program in the high schools, which we'd like to push down to the middle and elementary schools. And we also have a program for parents and teachers. So, we're very much proponents of helping kids develop an identity as early as possible in their lives.

KW: Ella Kegler from Lufkin, Texas asks, what is the lifestyle you see for yourself in ten years?

SG: I'd like to be able to travel around the world working with organizations and institutions to help educate as many people as possible about how to develop an identity for themselves, about how to find out who they are. And I'd like to teach them information making it relevant to their own development.

KW: Jersey boy Larry Greenberg asks, "Do you have any plans to come back to your hometown, Whitesboro, this summer?"

SG: I've been going back to Whitesboro, working in the community where I grew up, for the last 21 years. I haven't missed a Labor Day celebration yet. And I don't expect to this year.

KW: Filmmaker/author Hisani Dubose asks, what is your PR firm's specialty?

SG: We have a marketing and management consulting business. What we do is focus on is the books that I've written and the content that I have, and other projects and ventures, including seminars, speaking engagements, online training and development, and on serving our strong existing client base to set up win-win situations.

KW: Children's book author Irene Smalls asks, what's your goal for the future?

SG: My big goal is to develop a strong operational structure and alliances with our partners to build a better distribution network to deliver our content.

KW: Batala-Ra McFarlane asks, what advice do you have for those who'd like to start their own business in this challenging economic environment?

SG: I would say, make sure you focus on what you love and what you're passionate about, so that when times get tough, you can overcome that obstacle.

KW: Marcia Evans asks are you still associated with Armstrong Williams and do you share his political perspective?

SG: I've known him for a number of years. He's been a friend of mine. I try to not allow my personal relationship with him as a friend get mixed up with his political aspirations. Also, I don't make judgments about people just because they may have a different point-of-view from mine.

KW: Reverend Florine Thonpson asks what is your most powerful, spiritual source of strength?

KW: My most powerful, spiritual source of strength is knowing that God is love. So, when I focus on love, and put that in my heart, then I have the power of a strong, spiritual base and foundation.

KW: Professor Mia Mask asks, do you think President Obama has handled the BP oil disaster well?

SG: I think Obama has done a great job, based on what he was handed at the start of his administration. I also believe that he needs the support of the whole country. There are so many people trying to tear him down. America needs to come together as a country to figure out how we can support him as the President, including the BP disaster

KW: Is there any question no one ever asks you, that you wish someone would?

SG: No, but that's the toughest question I've been asked.

KW: The Tasha Smith question: Are you ever afraid?

SG: I try not to be.

KW: The Columbus Short question: Are you happy?

SG: Happier than I've ever been.

KW: The Teri Emerson question: When was the last time you had a good laugh?

SG: Just today.

KW: The bookworm Troy Johnson question: What was the last book you read?

SG: How the Mighty Fall by Jim Collins.

KW: Heather Covington asks, what are you listening to?

SG: The last thing I listened to was a CD that came with Success Magazine

KW: What is your favorite dish to cook?

SG: Spaghetti!

KW: When you look in the mirror, what do you see?

SG: I see hope!

KW: If you could have one wish instantly granted, what would that be for?

SG: For all the people who have dropped out of school and who don't think they're good enough to understand who they really are and that the process for success is the same for everybody, if you understand it.

KW: The Ling-Ju Yen question: What is your earliest childhood memory?

SG: I was running in the backyard and scraped my leg against a sharp edge of a rusty chair that severed a big piece of meat out of it.

KW: The Tavis Smiley questions. First, how introspective are you?

SG: I'm a Pisces, so I'm all internal.

KW: Second, what do you want your legacy to be?

SG: That I succeeded in teaching people how to maximize their potential as human beings.

KW: Well, thanks again for the interview, Stedman.

SG: Thank you. This was fun. Man, you're good!

KW: I get a lot of help. If you notice, most of my questions come from my readers and from celebrities.

SG: Well, you're the conduit, so you gotta be good to organize it all. Take care.

To order a copy of Stedman's book, "You Can Make It Happen: A Nine Step Plan for Success."

To order a copy of Stedman's book, "Who Are You? A Success Process for Building Your Life's Foundation."

To order a copy of Stedman's book, "Diversity: Leaders, Not Labels: A New Plan for the 21st Century."

To order a copy of Stedman's book, "Build Your Own Life Brand."

To order a copy of Stedman's book, "Teens Can Make It Happen: Nine Steps for Success,"

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