FDA Stops Short of Pulling Avandia From Market

From today's Star-Tribune:

Diabetes drug can stay, FDA panel says

Despite evidence it increases risk of heart attack, Avandia may only get an added warning label.

By Rick Weiss, Washington Post

WASHINGTON - A pair of Food and Drug Administration advisory panels called Monday for new warnings for the widely used diabetes drug Avandia because of evidence that it significantly raises the risk of heart attack, but they stopped short of recommending that the drug be pulled from the market, as some FDA officials had urged.

The 22-1 vote to allow continued sales of the drug ends years of controversy among regulators, drug company officials, physicians and advocates for patients, who have offered dueling interpretations of contradictory safety studies. The pills are taken by more than 1 million Americans and racked up $3.4 billion in sales last year for their maker, GlaxoSmithKline of North Carolina.

At least enough fuss has been raised about the drug so that people (and their doctors) will be aware of the risk involved. No doubt use of Avandia will decline, especially since there seem to be better alternatives available. Bonzo

Expert Warns Against Diabetes Drug

Further skirmishes on the Avandia front. Mr. B. has been following this situation closely.

Posted on the Time website:

Monday, Jul. 30, 2007

By AP/ANDREW BRIDGES

(WASHINGTON) — The widely used diabetes drug Avandia should be pulled from the market because of heart risks, a federal scientist said Monday.

With concerns raised about heart risks of a popular diabetes drug, GlaxoSmithKline and the FDA scramble to respond

Those risks, combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market, according to a copy of a slide presentation by Food and Drug Administration scientist Dr. David Graham.

The document was distributed at the onset of a daylong meeting of a joint panel of outside experts convened to consider whether the drug should restricted to use in select patients and branded with prominent warnings or removed altogether from sale. Previously, the FDA said information from dozens of studies of the GlaxoSmithKline PLC drug points to an increased risk of heart attack.

Glaxo officials, meanwhile, disputed that conclusion, according to copies of company presentations to be given later Monday.

The FDA isn't required to follow the advice of its advisory committees but usually does.

The FDA moved up the date of Monday's meeting following the May publication of a study by The New England Journal of Medicine that generated new concerns about Avandia's safety. The pooled analysis of 42 studies revealed a 43 percent higher risk of heart attack for those taking Avandia compared with people taking other diabetes drugs or no diabetes medication.

Glaxo, meanwhile, says its own data show no increase in heart risks with Avandia compared with other diabetes drugs, including Actos.

About 1 million Americans with Type 2 diabetes use Avandia to control blood sugar by increasing the body's sensitivity to insulin. That sort of treatment has long been presumed to lessen the heart risks already associated with the disease, which is linked to obesity. News that Avandia, also called rosiglitazone, might actually increase those risks would represent a "serious limitation" of the drug's benefit, according to the FDA.

By this time you would think that Glaxo would have thrown in the towel. Just Google Avandia and see all the lawyers lining up to extract money from them... And no doubt the insurance premium paying Docs will start to think about whether Avandia is a good choice for them (and their patients).

Ciao,

Bonzo

Question of the Week

Driven to Discover

"How can our local government best cope with increasing numbers of physically and memory impaired residents?

More on the Diabetes Drug Avandia (aka rosiglitazone)

Mr. B. has previously posted on this subject: “Avandia flagged by FDA as a possible heart risk five years ago.”

From the Forbes website:

Two Diabetes Drugs Double Heart Failure Risk: Study

FRIDAY, July 27 (HealthDay News) -- Patients taking either of the diabetes drugs Avandia or Actos face twice the risk of developing heart failure compared to people not on the popular medications, a new study finds.

"Both Avandia and Actos double the risk of heart failure," concluded the lead author of the first study, Dr. Sonal Singh, an assistant professor of internal medicine at Wake Forest University School of Medicine. "We know these drugs increase the risk, but we found the risk is more substantial than suspected. This occurs at even the lowest dose and among young patients."

The report follows a U.S. government review released Thursday that found Avandia's heart risks are far higher than Actos'. That report sets the stage for an advisory panel hearing Monday that will examine whether Avandia's cardiovascular risks warrant a stronger warning label.

Avandia (rosiglitazone) and Actos (pioglitazone) are from the same family of diabetes drugs and used by more than 3 million diabetic patients across the United States.

Singh's group, however, found that the risk wasn't limited to patients on insulin, and it was present even among patients without any risk factors for heart failure.

The government study, by a medical and safety review team at the Food and Drug Administration, found that patients are at much higher risk of heart problems if they take Avandia, compared to patients taking Actos. Avandia is especially hazardous to patients who are already on insulin, the report found, whereas Actos users can take insulin as well without fearing cardiac side effects, the New York Times reported.

That data could help decide whether or not Avandia remains on drug store shelves, experts said.

"A critical question to be resolved in determining appropriate regulatory action is whether the anticipated therapeutic benefit of rosiglitazone outweighs the demonstrated cardiovascular risk," one FDA reviewer concluded according to the Times report.

In the Diabetes Care study, Singh's team collected data on more than 78,000 patients taking either of the drugs. These patients were included in previously published studies and in case reports.

Not only did the drugs double the risk of heart failure, but the increased risk was seen with both high and low doses, the team found.

Singh's group suspect that Avandia and Actos may boost heart failure risk by encouraging fluid retention.

Current guidelines allow the use of these drugs in patients with early-stage heart failure. "Based on our information, that may have to change," Singh said.

Singh noted that there are alternative drugs available. "Doctors should be aware of the risk," he said. "Patients who are on these drugs and start developing symptoms of heart failure should see their doctor immediately, and patients not on these drugs should look at alternatives."

One expert believes that patients taking Avandia and Actos face not only an increased risk of heart failure, but also a 43 percent increased risk of heart attack.

"This hazard of heart failure is pretty well known for these drugs," said Dr. Steven E. Nissen, chairman of the department of cardiovascular medicine at the Cleveland Clinic. He noted that, in May, the FDA said it was going to mandate a "black box" warning about heart failure risk on the labels of these drugs.

That same month, Nissen published a paper in the New England Journal of Medicine that found that Avandia increased the risk of heart attack.

On Thursday, Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, which makes Avandia, responded to the new government review by saying the company continued to believe Avandia was safe, the Times reported.

"Across the extensive data we have, the science shows no increase in cardiovascular death, and does not support a difference in heart attack rates between Avandia and the other most commonly prescribed oral antidiabetics," Rhyne told the Times.

Denial – It’s not just a river in Egypt.

Bonzo

A Blast from the Past

Gophers Honored by Sports Illustrated in Listing of Top 25 Non-Drug-Related Athletic Scandals - We're in the Top Ten!

[Downloadable (Word) version available on Best of Bonzo]

Mr. B. has previously quoted Mr. S. : " The evil that men do lives after them; the good is oft interred with their bones." The Gophers have a heavy load to bear in this regard because of past athletic transgressions.

We have accomplished our ambitious aspirations to be one of the top public universities in something, unfortunately it has thus far been athletic cheating. The only other college level athletic scandal to rank above us in the top 25 is the basketball point-shaving scandal of the 1950s. The shame that Gopher basketball cheating under Haskins has brought to BigU should not be forgotten in the midst of the current infatuation of OurLeader with athletics as the engine driving future fundraising efforts.

Speaking about the latest saviour of Gopher athletics, Tubby Smith, one of the celebrity ink stained wretches of GemCities (that would be Sid Hartman) informed us: "The truth of the matter is that Smith, 55, would not have even been interested in the job unless he was encouraged by close friend Clem Haskins, who proved you can win at Minnesota." Arghh...Bonzo circuits going down, down, down, please push reset.

...

Thank you. So Sid, are you saying that the way Clem Haskins did this is ok? Is this little fuss about academics just the proverbial tempest in a teapot? Is BigU's main function to produce bread and circuses? Lord, love a duck.

Infamous Non-Drug-Related Scandals

10 of 25

Minnesota's basketball program committed academic fraud for years under former-coach Clem Haskins. Haskins accepted a $1.5 million buyout in June of 1999 and the university faced a four-year probation and had to vacate its postseason records from the 1993-98 as well as any individual or team honors won during that time.

Ah, even when you screw up at BigU, apparently you can get a 1.5 mil buyout, and that was back in '99 when a mil was real money. But never fear, folks, Joltin' Joel Maturi, BigU AD, is on the case. After the latest scandal in one of the big three revenue producing sports (football, basketball and hockey) he and the new football coach are going to clean things up in Gopher athletics: "I am in full support of the decision of Coach Brewster and I appreciate how he has handled this very difficult situation," Maturi said in the statement. "While this issue is deeply disappointing, the Athletics Department is sending a clear and unmistakable message that it will never compromise its code of conduct."

OurLeader was conspicuously absent during this latest outbreak of hypocritical athletic pomposity, probably off lecturing the gullible about: "One of my key concerns will be the academic issues related to student learning, academic progress and graduation," he said. "We need to do a much better job in ensuring that our students actually graduate when they come as Division I student-athletes." And to have the nerve to say something like this after, as the Star Tribune reported last fall, academics among the Gophers football team under Mason were at the bottom in the Big Ten, with more at-risk students admitted into the Minnesota program than just about any Big Ten school, and with graduation rates the lowest in the conference, especially among African-American athletes.” Should we do as you do, Mr. President, or as you say?

How many times are we going to have to hear something like this again? Actions speak louder than words and at this point more words just aren't going to do it. Please pipe down and demonstrate some integrity. Or is this really just about the money? What's it going to be at BigU, the medallion or the Yugo?

One disgusted gopher - Mr. Bonzo

Help BigU to Fill Twin City Federal Stadium!

A Modest Proposal

Endowed Schieks Football Scholarships

[Downloadable version (Word) available on Best of Bonzo]

 

According to the Strib, BigU has been angling for a million dollar donation from the former owner of Schieks – a strip club –in downtown Minneapolis. The sharp-eyed UD once again beats Mr. B. to the punch line on this one: "Surge in School Pride... as the University of Minnesota goes after a whole new class of stadium donors!"

Bless her. Last night Mr. B. was out having dinner with friends after a long hard day learning about protein crystallography with a quick dash at lunch to "The Temple" in Salt Lake City, where it is still hotter than Hades. And to think that she was toiling away on her blog.

Not too long ago a visit to Schieks was considered de riguer for student-athletes being wooed by BigU..

UD has already done the full Monty on these guys but a few items of special interest from the Strib (italics mine) follow:

University officials involved in the drive to raise $86 million in private money for the $288.5 million stadium, including Joel Maturi, the school's athletic director, declined to comment on the potential gift or Sabes' background with Schieks.

"The university has had a number of discussions with the foundation about opportunities to support our mission, whether it is the stadium or in another way," said Dan Wolter, a university spokesman.

But a university adjunct professor, who said he had approached Sabes' foundation on behalf of the stadium fundraising drive, said the contribution had grown more uncertain even as school officials count it toward the $60 million already raised privately for the stadium. Andy Andrews, an adjunct professor with the Carlson School of Management, said that the foundation had in effect withdrawn its commitment, and that university officials are now scrambling to get the family to reconsider.

Andrews said Sabes' business interests were not part of the university's fundraising discussions, and added that "I don't suppose I gave it much thought. I'm just trying to raise money for the stadium."

 

This situation brought to Mr. B.'s twisted mind an interesting solution to the problem. Because of the long association of Schieks with football players, perhaps it would be appropriate for BigU to name some Schieks scholars to the football team. This endowed scholarship idea comes from the big brain of BigU's AD, Joltin' Joel Maturi. According to him:

"Right now, all the scholarships are paid for [by the university]," Maturi said, "so if a donor comes and says, 'I want to endow a scholarship for $300,000,' the coach is likely to say he or she could use that $300,000 in another way. But that's being shortsighted.

"I tell them that raising more funds isn't going to help Joel Maturi a lot, it's going to help the next athletic director. But that's the right thing to do."

Further, in the interests of maintaining both industry/university cooperation and outreach, Mr. Bonzo proposes that Schieks set aside a section of their establishment for BigU athletes and name it the Gopher Hole. To demonstrate that Schieks has only the best interests of all BigU athletes at heart, the Gopher Hole would be open to non-revenue producing athletes as well as female Gopher athletes. In return for this generosity a private box in Twin City Federal Stadium (TCFS) would be set aside for appropriate Schieks employees at the TCFS. There OurLeader, Joltin' Joel, and other BigU bigwigs could entrap, er… entertain, potential donors to TCFS and the Scheiks scholars program.

This is a win/win situation if ever there was one.

As a grant-writing scientist, Mr. B. always feels obliged to answer the obligatory question: What if your proposed idea doesn't work? Have you got an alternate strategy? Answer: Try Hooters next. I am sure that Hooters would welcome the opportunity to be linked commercially with a world class academic institution such as BigU. The synergy in this combination would be unbeatable. The activities of Joltin' Joel and BigU's athletic fundraisers are totally consistent with Hooter's trademarked self-description: "Delightfully tacky. Yet unrefined."

Ciao, Bonzo from SLC

Question of the Week

Driven to Discover

"What is the meaning of life?"

Ciao, Bonzo

While the Mice Are Away
The Cat Will Clean Up

Mr. B. has been out in Salt Lake City where the temperature is ca 100. And he foolishly thought that since SLC was in the mountains that it would be nice, cool, and pleasant. It really didn't matter though because all day was spent inside in a super air-conditioned room. Today he learned of the wonders of SHELXL and Coot, both of which will make life in the lab a lot easier in the future. The cold lecture hall reminded him of his lab at home where it is so cold in the summer that he has to wear a sweatshirt to function.

But UD has done a marvelous job schoolmarming our ink-stained wretch, Patrick Reusse, who writes on the latest smarmy utterings of BigU's athletic director, Joltin' Joel Maturi. No one has ever accused Reusse of being in the back pocket of the Gopher athletic department. He understood Lou Holtz's game and also how Mason gamed the system. No doubt the latest football coach will soon have reason to loathe and detest Patrick.

UD begins:

Scathing Online Schoolmarm

UD's already told you that Gophers fans are stupid. In so very many ways. But you don't listen to UD, because she's ...well, you know her demographics. So listen to this guy, who writes for the Minnesota Star Tribune. Admittedly he introduces his opinion piece oddly. But in his own way he's making my point.

You'll have to read the rest for yourself if you are interested.

Ciao, a brain fried Bonzo

Dog Days of Summer
Mr. B. Hits the Trail but Gets a Start on Best of Bonzo (BoB)

It is off to Salt Lake City for Mr. B. There he will be attending the American Crystallographic Association meeting. He has just finished a poster for the meeting that describes recent work by Derek Straka and Margo Siorek in the GleasonLab. These things are always fun and this will be a special pleasure because Angelo Gavezzoti will be receiving an award. This means that Doyle and his wife, Judy, as well as Jack Dunitz and his wife, I believe Barbara, will be there. Also, my friend and colleague Vic Young will be attending. Mr. B. first went to a meeting of this group in 1976 in Norman, Oklahoma. There we had an event at the Cowboy Hall of Fame that had a petition AGAINST the metric system in the lobby. Good memories.

So things may be rather slow on the PT.

I have just put some material up on another site which is facetiously referred to as the "Best of Bonzo." Mrs. B. uncharitably refers to it as the worst of Bonzo. But eventually the rants and raves that I think might still be of importance - or at least stimulate some discusion - will be available there in a form more suitable for download.

Ciao, Bonzo

An academically qualified football player?
We couldn't have that at BigU...

Let him go to the Ivy League if he is interested in academics, then maybe he could become a Rhodes Scholar.

From the Star-Tribune:

Letter of the day: For new football culture, look closer to home

Published: July 20, 2007

Tim Brewster, the new coach of the University of Minnesota football team, is right to be trying to create a "culture of integrity" for the Gophers ("Four U football players dismissed from team," July 19).

I know a young man who dreamed of playing for the Gophers. He was captain of his football team, which won the conference title and finished third in the state. He was named to the All-State and Star Tribune All-Metro teams. He also was an academic scholar.

But the coach of the Gophers at that time wanted him to be a "walk on" -- with no scholarship. He had handed out all of the scholarships to players from Ohio.

However, this young man was offered an academic scholarship from an Ivy League school. Ivy League schools do not give scholarships for sports. He is still playing football and very happy to be where he is.

BEVERLY HOIUM, BROOKLYN PARK

 

U football coach dismisses 4 players

By Chip Scoggins, Star Tribune

Last update: July 18, 2007 – 7:05 PM

The attorneys for four Gophers football players accused of being involved in a rape had expressed hope that their clients might be able to return to the team someday. That possibility came to an end Wednesday.

Football coach Tim Brewster dismissed cornerback Dominic Jones, running back E.J. Jones, defensive end Alex Daniels and cornerback Keith Massey from the program for "violations of both team and University of Minnesota student-athlete code of conduct regulations." For now, the players remain on scholarship and enrolled in school, but university officials indicated that could change, too.

Video leads to rape charge against U star

This headline greeted Mr. B. as he groggily retrieved the morning paper. Above the fold, right below the masthead, couldn't miss it, even if you were a BigU administrator or, gasp, athletic director. Mr. B. is in a foul humor after doing a semi allnighter. Many years ago he vowed not to do this upon completion of his student days. Ha, ha, ha…

Mr. B. is actually too depressed about this to write a proper post, but the inimitable UD has done a marvelous job of outlining and commenting on the situation. Highly recommended. Apparently she was up at about 3 am working on the post. What a soft life university faculty lead...

Other links: Pioneer Press story, StarTribune article.

Have a nice day.

Bonzo

Question of the Week

Driven to Discover

"As a commuter, I have often wondered why highway 94 isn't connected to highway 35E southbound. Is this political in any way?"

Everything is political…

Bonzo

The Sleeping Giant Awakens and He is Hungry

Workplan for BigU's MedSchool
to Crack the Top Twenty
Tasked for November

It will soon be a very busy time for BigU's Medical School and the Dean, Dr. Deborah Powell. She has recently established a taskforce to look into conflict of interest between physicians and the pharmaceutical industry. No doubt some ethical paragons at BigU's medical school will be involved, well scrubbed docs, right? Mr. B. has posted on this. See:

BigU MedSchool Task Force to Probe Doctors on the Dole

It also develops that Dr. Powell has been requested by Dr. Frank Cerra to come up with a work plan for moving BigU's medical school from wherever it is considered to be now (one opinion - 39 in research and 13 in family care - may be found here) to number twenty of all medical schools in the US.

A presentation and a pdf of the slide show have been posted on the Academic Health Center Website. It is very interesting listening and reading. If you'd like to see this, I'd suggest looking fast, since I would be surprised if it is up very much longer. Unfortunately Mr. B. does not have the patience to transcribe the talk, but it should prove very informative to stakeholders and other interested parties. Comments are also made about the possible new St. Thomas medical school and the children's hospital situation.

Not much happens at the BigU over the summer. So a November deadline isn't that far away. Could this possibly be yet another famous BigU FastShuffle? Mr. Bonzo thinks this is quite likely.

Ciao, Bonzo

U's Stadium Dream Runs Into Financial Reality

UD Comments On BigU's
Continuing Stadium Saga
Wherein (Joel) Maturi Talks About Himself

Mr. B. gets tired, believe it or not, of ranting about BigU's follies. Makes him seem like a bitter old curmudgeon. Old, maybe, but not bitter. His students are great, even if we are not at the third greatest public research university in the world.

Anyway, the inimitable UD, comments today on the latest developments:

Fat Men Are One Thing.
Stupid Are Another.

Type TCF STADIUM into the Search feature up there and enjoy a full plate of UD posts over a couple of years about the University of Minnesota's fiasco. (Here's a sample.)

And all because men are dumb. They get way excited about big ol' sports stadiums for their universities, and only after spending hundreds of millions of dollars realize that they can't afford them.

"I think Joel Maturi kind of naively thought that there might be, you know, a little bit more success in the corporate world from a philanthropic standpoint," Maturi, the university's athletic director, said as he sat in his office. "We're not giving up." Sadder but wiser Joel refers to his earlier incarnation in the third person. He's worked out his naivete thing, and UD's happy for him.

For those closely involved, the fundraising drive so far has been a lesson in what is possible -- and what is not. The university can only look with envy at places such as Oklahoma State University, where financier T. Boone Pickens pledged $165 million to athletics last year, and at Ohio State University, which completed a $200 million renovation of its landmark 105,000-seat football stadium. [Imagine looking at schools like these with envy. Unlike them, the University of Minnesota used to be intellectually distinguished. People like Joel are seeing to the end of that.]

Mr. Bonzo was thinking about putting something about this up, but it is so hard to keep up with these folks. Reminds me of the whack-a-mole game. Have a look at UD's post. She is an English prof and much better than Mr. Bonzo at making the comfortable uncomfortable.

Ciao,

Bonzo

On the Explosion of New Medical Schools Nationally and The Possibility of a New One Locally

When the University of St. Thomas and Allina first announced that they were exploring the possibility of a new medical school, Mr. B. was surprised. No doubt the administration at BigU was also surprised and perhaps a little worried?

Mr. B. noted in the announcement by UST that a Pittsburgh consulting firm, with local offices in Minneapolis, Tripp Urbach (TUBA) had been retained for the purpose of a feasibility study.

A little web checking ensued.

From the Tripp Urbach website:

“The Tripp Urbach consultants deliver premium customized market research, strategic planning and economic analysis to a broad range of client partners. Since 1990, Tripp Umbach’s accomplished and seasoned research teams have been providing the essential tools and solutions its clients need to compete and succeed in their specific business environments.”

Hmm…

Their client list is quite impressive and includes some heavy, heavy, hitters such as:

The Cleveland Clinic, University of Pittsburgh Medical Center, Mass General, The Mayo Clinic, The Ohio State University Medical Clinic, Lenox Hill Hospital, Children’s Hospital Pittsburgh, Children’s Hospital Boston, Children’s Hospital Chicago, a raft of other tony places and interestingly enough, The University of Minnesota Medical Center.

Noteworthy non-medical school academic clients include: Carnegie Mellon, Cornell, Penn, Virginia, Penn State, Ohio State, North Carolina, Arizona, Michigan State, Pitt, and, interestingly enough, the University of Minnesota.

With a consulting firm such as TUBA, perhaps St. Thomas doesn’t feel that the 150 years of medical school experience that BigU brags about is necessary for them to consult? Especially since BigU itself, as well as its Medical Center, goes to TUBA for advice. Our neighbors at St. Thomas are very smart, they have their own business school and appear to have hired a top notch consulting firm. Perhaps BigU's kvetching at this point appears patronizing? ("Why haven't they consulted us, we have 150 years of experience?" to approximate public statements by our administration.)

Now our leaders at BigU are famous for getting in bed with consulting firms or business school theoreticians. The way this game works is that first you decide what you want and then solicit the appropriate consultant. They tell you what you want to hear and you then go about doing it. Once they know what you want, they can even give you an economic rationalization for it. If things don’t turn out quite right, you can always blame the consultants. Or better yet, just declare the results a success, hope that no one notices, and move on.

The infamous attempt to destroy tenure via the process known as reengineering was the result of a dalliance with the Hammer/Champy crew. Driven to Discover is a commercially inspired enterprise. OurLeader finally let it drop that we are in the middle of a Kotter-inspired change mission. Kotter is a former Harvard Business School type who has decided to live off the gullible in both traditional business and in the business that education has become.

The other development that Mr. B. stumbled upon was the great number of new medical schools on the horizon. Dr. Cerra is correct that the osteopaths are responsible for some of this, but there are plenty of new allopaths (MD’s) on the horizon, much to the delight of premed wannabes and to the consternation of those already in the system who apparently fear the economic competition.

The driving force for most of these new med schools seems to be the production of family practice and internal medicine docs of the type that directly treat patients, or perhaps I should say customers?

There seems to be a feeling that we have enough specialists and researchers, but that general practice docs are in short supply. Given the agonizing experience of most of us in the clinic, perhaps there is actually something to this?

Now, as we are starting to learn at BigU, the usual behavior of the current administration, when there are problems that have been neglected in the past, is to point in some other direction and make a lot of noise.

BigU effectively axes General College, a place with high minority enrollment: “In order to keep minority enrollment up, we’re going to have to cut out of state tuition. That way we can enroll minority students from Illinois, or California, or Florida.”

BigU is at the bottom of the BigTen: “We are going to become one of the top three public research universities in the world.”

We have a shortage of family practice physicians: “The answer is not to turn out more doctors, we need to develop ‘quarterbacks’ for the healthcare system, like pharmacists or nurse practitionsers.”

Medical school tuition at BigU is obscene - the highest of any public university in the country: “We didn’t want to do this, but the legislature made us.”

Good leaders recognize problems early on and do something about them...

Eventually, though, BigU will get dragged, kicking and screaming, into facing and hopefully solving some of our problems. Maybe a kick in the pants from St. Thomas/Allina is not such a bad thing?

Maybe BigU’s medical school should cede the family practice business to St. Thomas and concentrate on turning out specialists and MD/PhDs? As the St. Thomas folks say, they don’t want to compete, just complement.

After all, no one ever became one of the top three public research universities in the world by turning out family practitioners, did they?

Bonzo

BigU MedSchool Task Force to Probe Doctors on the Dole

In an earlier post, Minnesota Doctors on the Dole, Mr. Bonzo, suggested that perhaps BigU’s Medical School should weigh in and give us ethical guidance.

He was, of course, being sarcastic. For background about the controversy over the MedSchoolDean's serving on the Pepsi board, see SourceWatch: A Project of the Center for Media and Democracy.

From the Pioneer Press:

U to probe drug makers' payments to doctors

Conflicts of interest, impact on quality of care at stake

By Paul Tosto and Jeremy Olson

Article Last Updated: 07/07/2007 03:12:07 AM CDT

Concerned about the money some doctors take from pharmaceutical companies, the University of Minnesota Medical School is asking an internal group to take a closer look at those payments and their possible influence on treatment.

Led by two U doctors, the group plans to examine the relationships between university physicians and drug firms and whether money creates conflicts of interest.

The move comes a few months after a Journal of the American Medical Association report showed doctors across Minnesota, including some doctors at the medical school, collected more than $30 million from drug firms between 2002 and 2004 for research, travel, meals, consulting and lectures.

"As we recognize our medical school's strengths," the dean, Dr. Deborah Powell, wrote in a May memo, "we also need to examine an area in which we may have some vulnerabilities: our relationships with pharmaceutical companies."

Powell said she wasn't calling for an immediate ban on payments, but she acknowledged "there are problems when some physicians present educational efforts funded by companies that appear much like marketing."

What is the pharmaceutical industry getting for its money? That's the lingering question.

For some, the payments issue is more about objectivity.

"It's a patient-safety issue," said Josh Lackner, the U medical school student who worked with Public Citizen on the research.

Drug salesmen, he said, befriend doctors because "they're paid by for-profit companies to do this. Befriending doctors is a job, and it's a job because it actually works."

What changes would he like to see?

"A good starting point would be barring faculty from speaking on behalf of pharmaceutical products and to also think about limiting paid positions on pharmaceutical boards," said Lackner, who hopes to land a spot on the U task force.

Let's hope that someone like Lackner is on this task force. Another good person would be Robert Jeffery:

But Robert Jeffery, a nationally known researcher and a director of the Obesity Prevention Center in the U's school of public health, worries Powell's PepsiAmericas duty ultimately may hurt the university.

"There is a level of 'ick' among quite a few faculty and students here," Jeffery said. "There definitely are some sour feelings. When you're talking about some of the most powerful people in the university backing it, it makes it distasteful."

(The above material may be found in a previous post with a citation to the original source that can no longer be directly linked. )

It is a little hard to take advice from an institution that seems to be reluctant to discuss its own apparent ethical problems. Let's just hope that the doctors heading the task force are people respected throughout the community for their integrity, fairness, and independence. Otherwise such a task force is not going to be particularly credible.

Bonzo

Driven to Discover

Question of the Week:

What are the eleven secret herbs and spices in original recipe Kentucky Fried Chicken?

Inquiring minds, want to know...

Bonzo

Bonzo Nights or
A Midsommer Nights Dreame

Mr. Bonzo always has trouble getting a good night’s sleep on the Fourth of July. The firecrackers remind him of gunshots and wars, and people he knew long ago who died in battle unnecessarily. They still do.

This Fourth was no different except for a party featuring Filipino cuisine at the house of some friends, Tom and Andy. Maybe it was the cuisine or the pear cider or Mrs. Bonzo and the lovely Linda, but Bonzo, who rarely dreams, had a dream. Maybe it was a hallucination, who knows? Rough notes upon awakening needed to be sanitized and converted to what passes for Bonzo English.

Disclaimer: Any resemblance to actual persons, living or dead, business establishments, events, or locales is entirely coincidental.

Tom and Andy, young brothers who have established an up-and-coming non-profit organization, enter the large industrial complex of Gopher Boat and Docks (GBD). They are here to visit their Uncle Frank and his business associate, Aunt Debby, in order to have lunch with them at the Village Walk, a nearby restaurant.

A guard escorts them to Uncle Frank’s big office in the Dock Rehab Building. Frank is the VP for R&D at GBD. Inside Uncle Frank and Aunt Debby have been engaged in a heated discussion about how to reverse the submarining fortunes of “the Docks” as they like to refer to their business.

Frank is sitting behind a computer, holding a Diet Coke in one hand, and a mouse in the other. “The Docks used to be a very good operation, we coulda been contenders, but lookaddis now, we’re number thirty-eight and sinking. Whadda we gonna do about dis, Debby, huh? Youse duh technical director of duh Docks division, howbout youse commin up wid a scheme dat puts us back up to, let's say for grins and giggles, number twenty. Our Prez has told duh stockholders dat duh company overall is going to be number tree in the woild. Ain’t dat a yuk? He knows that it will be difficult for Docks to go from thirty-eight to three, but can yuh have a work plan, as dem consultants like to say, by the foist of November? Twenty is about as lowball as we can get away with. After all, Legal is at twenty. Dey are tryin to make us look bad.”

Debby, gulped her Pepsi hard and responded: “Well of course I can do that Frank. As you know, for the right price, I can do anything. Why don’t I contact that consulting firm Frick and Frack? You know them, they’ve done a lot of work for us. They are an ethical consulting firm and their motto is: ‘We can help you justify anything short of larceny.’ I’m sure they can come up with just the plan to get us from thirty-eight to twenty in five years. They can also justify the numbers and come up with a laundry list of new buildings and personnel we need to give those bonzos over in Finance.”

Frank responds with a puzzled look: “Ah, Debby, don’t get all ethical on me. Do we have to use Frick and Frack? They are pansies. Always tellin us we can’t do stuff because we’ll get in trouble.”

To which Debby responded: “Now Frank, you know that we have been in trouble before with those folks from Not Invented Here. That was larceny and we can't do it again. Heads rolled over that one. You'll recall that my predecessor Goliath Black had to resign his Directorship and took a pasteurization position in the skunkworks. Talk about Scooter skating! Goliath was way ahead of his time. Occasionally you still see him skating around in his little white coat. At least Frick and Frack have kept us out of further trouble with Not Invented Here."

Frank, who has been busily integrating the discussion into his latest powerpoint presentation, replied: “Dats why I hired youse Debbie. Youse did not just fall off the turnip truck even though youse came from Kansas. Youse always knows the right consultants to finger. Managers here at The Docks need that skill. That’s why we are where we are today, doin what it is we do, thinkin creative and outtada box, marchin toward greatness, building new buildings, prioritizin our ambitious aspirations, followin da mission, followin da mission, followin da ..”

“Frank, Frank,” Debby said smiling and interrupting, “Your recording is stuck, turn it off and save it for those chumps over in Finance or maybe the dockworkers.” “You’re preaching to the converted, I know how to talk the talk and avoid walking the walk - just like you.”

“Like I said,” Frank replied, “dat’s why I hired youse.”

At this point Tom and Andy arrive and knock loudly.

“Uncle Frank, Uncle Frank, we’re here and ready to walk to the Walk.” said Tom in a loud voice.

“Come in, come in, youse two, I am just finishing up a business discussion wid your Aunt Debby. It's our general policy not to walk to the Walk, that's for the little people like youse, so howabouts we orders out. What would youse guys like? We usually have beluga and Veuve, but whadda youse guys want?” Frank graciously inquired.

“Well, Uncle Frank, our tastes are not quite as expensive as yours, if you don’t want to walk to the Walk, perhaps we could have your personal assistant or Aunt Debbie’s chief of staff phone it in? “ said Andy.

“Sounds like a plan to me,” Frank graciously responded, “I think I’ll have a General Tso’s chicken with a side of spaghet wid marinara. Howzabout you, Debbie?”

“I’m on a diet Frank, the Rochester diet, I’ll just have a yogurt and a round fruit.” said Debbie.

“And youse boys, youse are so hot to walk to the Walk, whaddaya want?” inquired Frank graciously.

“Well,” said Andy, “I know that Tom wants some Singapore curried noodles and I’d like some egg rolls and a cup of sweet and sour.”

“What’s wid you boys? Here youse has duh chance for a nice fancy lunch and you wimp out on us. You got to get up to duh piggy trough when youse got da opportunity. Youse knows the saying about lean years an fat years, capish?” Frank graciously responded. He then summoned his assistant, Teri, to phone in the orders.

“Well boys, while we’re waitin for the grub, you gots anyting on your little minds to talk about?” Frank inquired graciously. “Maybe youse would like a pop while we’re waitin, you know, chill duh pipes so we can make jubjub. Whadill it be? Coke or Pepsi? Ah boys, the eternal question. Youse knows I'm sort of a philosopher and thats one of the subjects I devote my freetime to contemplatin. Sortalike 'To be, or not to be?' By the way, I’d kinda 'preciate it if youse would keep it on the qt that we got Pepsi in here. Duh Docks is a Coke only establishment, but your Aunt Debbie here got a gig wid Pepsi and so she likes to have a can now and then.”

“Uncle Frank,” replied Tom, “you know that stuff is bad for you. Rots your teeth. You finally quit smoking and now you're into drinking pop. What kind of example is that for the children? And Aunt Debbie, what are you doing drinking the stuff. You should know better. With your new bionic parts, you’re in a lot better shape than Uncle Frank. “

“Actually, boys” responded Debbie, “I hate the stuff.” “But for a hundred grand I’ll take a swig now and then. Just like those non-smoking movie stars who will smoke in a film if the price is right. This reminds me, Frank, did you know the contract renewal for pop at the Docks is coming up? I was thinking of challenging the Prez to an arm-wrestling match. If I win it’s Pepsi, he wins - Coke. What do you think?”

“Now Debby, youse got tuh watch out. I know you’re feelin all perky with the new bionic parts, but you got to remember that Our Prez Ruby is a jock from way back. Why he was the captain of his high school crew. It breaks his heart that GBD keeps coming in last in the annual BoatWorks Regatta. He keeps muttering: ‘We’re number one, we’re number one.’ Besides youse godda watchout for conflict of interest. Howse would it look if we allasudden went over to Pepsi, with you on the board of directors and knockin down a hundred grand last year? I tink we butts out.”

Turning to Tom and Andy, Frank graciously said: “So like I was sayin, boys, whats on youse little minds?”

“Uncle Frank,” Tom responded, “As you know we have started a non-profit organization, The Alliance for Edisonian Studies. Our goal is to encourage people to fend for themselves, to learn new entrepreneurial techniques always of course in an ethical fashion. Unofficially we call our operation EthicsRUs. We even have the Tomb of the Unknown Entrepreneur on one of our campuses. You really ought to come over and see it. It’s quite a sight.”

“Well tank you boys, but I godda be frank with youse, pardone the little punyay. I hear rumors on the street that I don’t like... Something about you gettin into da ring with GBD. I’m sure this can't be true, right? This talk is all just a liddle misunderstanding?"

“Well, er, uh,” stammered Andy, "that’s why we are here today seeking your wise counsel about our plans for the future. We wouldn’t want to do anything without running it by you, Uncle Frank, so that’s why we wanted to see you.”

“I am flattered that youse bright boys would seek my wise counsel, but of course that’s the right thing for youse to do. Tiny brains consult big brains, capish? Anyting else would be, ah, not very smart and might lead youse to have a liddle, shall we say...accident?” responded Frank, graciously.

“Well Uncle Frank,” continued Tom, “we were thinking about starting up a little entrepreneurial operation in the, uh, canoe business.”

“WTF, Tommy” responded Frank graciously. “Yuh knows dat duh Docks turns out canoes. Yuh wouldn’t want to compete wid us. Dat might be dangerous to yer health. I wouldn’t want to have to worry about youse. Youse is my own flesh and blood.”

“But Uncle Frank,” Andy replied in a hopeful tone, “You’ve told us before that canoes are a minor piece of your action. The big dough is in yachts and destroyers, you said. Your researchers in the skunkworks are topnotch engineers and designers. Why you even told us that canoes are a nuisance. We’d be taking the burden of producing canoes away from you so that you can concentrate on big boats and make that R&D pay off. Maybe you could become the third largest operation in the world if you didn’t have to worry about the piddly stuff? How about it Uncle Frank?”

“The answer is no, boys. I am shocked, shocked dat youse would think I’d let you get away wid dis. First of all, building a canoe factory is going to cost youse a lot of money which you ain’t got. Second you would be duplicating existing facilities, and not only that but MY existing facilities. And third, as I said before, this would be dangerous to your health.” Frank graciously responded.

“But Uncle Frank,” Andy pleaded, “We were just over at Midwest Mountaineering and the canoes are flying off the shelves, except for the expensive Kevlar ones that you make. The low priced aluminum and polymer canoes are out of there as fast as they can bring them in. The manager told us that we could make a killing and that he could sell everything that we could produce. Also, we’ve found an old factory cheap that would allow us to get into the business pretty reasonably. So, how about it?”

“Boys, you harda hearing?" Frank graciously responded. “Building more canoes ain’t gonna solve the problem. We already got enough canoes. Since folks don’t buy our Kevlar canoes, then there’s obviously no canoe shortage. Let em paddle Kevlar or else shut up about this shortage. Besides, if we used the canoes we got in the right way, we wouldn’t need any more. Dat’s why we are where we are today, doin what it is we do, thinkin creative and outtada box, marchin toward greatness, building new buildings, prioritizin our ambitious aspirations..”

“So boys, I’ll leave youse wid someting to think about in your tiny liddle brains since youse asked me for my wise counsel. I tinks you should figure out a way solve this canoe problem. Notice that I said problem and not shortage. So why don’t you start turnin out what I’m gonna call canoe quarterbacks. Aint dat creative? But dat’s what I do, after all. Dat’s why all of the Docks reports to me, including your Aunt Debbie. Dats why dey call me da decider. Anyhoo, dese canoe quarterbacks can make sure that the canoes are being used efficiently so that this canoe problem goes away, capish?” Frank graciously asked.

“But Uncle Frank,” Tom replied, “There IS a canoe shortage and this quarterback stuff is just your typical blowoff. No one in their right mind would start a canoe quarterback school. What if we were to start building canoes specifically designed for children, how about that?”

“Nope,” responded Frank graciously, “We’se already in dat business and are building a new factory. Unfortunately there is another group of unethical thugs already in the business. Dey are ALSO building a new factory, so we sure as shootin don’t need you boys into da mix. “

“So Uncle Frank,” said Andy, “Does this mean you are duplicating the children’s canoe factory by building another one? You just told us that we shouldn’t build a canoe factory because that would duplicate your operation. Somehow this seems contradictory?”

“Nah, not at all boys,” Frank graciously responded. "I do a lotta readin. I'm a particular fan of Alice in Wonderland - dat's my favorite book. Somewhere in dere it says, and I'm gonna have to paraphrase: 'When I use a word, it means just what I choose it to mean, neither more nor less.' Don't youse guys ever forget dat. It's a powerful concept. Can get you outta lot of tight squeezes, shall we say."

“OK, boys, it's comin up on nap time, so I’ll make youse an offer youse can’t refuse, walk on over to the Walk and have your lunch there. Dat General Tso’s and spaghet wid marinara is on me. I’m gonna have my usual lunch of beluga and Veuve after my nap. Tink about whad I said and stop back when you have come to your senses. Don’t take too long to decide or I’ll have to send over my tailor, Angelo, to fit youse for Portland overcoats. Ha, ha, ha, boys. Don’t go all white and faint on me. That was just a little of my famous humor and good cheer, capish?” Frank graciously said while escorting Tom and Andy to the door.

Outside Tom and Andy walked to the Walk as the color slowly returned to their faces. “Wow, that was a close one” said Tom, “good thing we’ve already talked to Frick and Frack. They've run the numbers and we're in the canoe business. They’re also going to take out Angelo. Since that wouldn't be larceny, it's not against policy. It makes you feel proud to do business with consultants who believe in ethical behavior.”

Clearly this was either a dream or a hallucination, nicht wahr?

Bonzo

U pops the age-old question: Coke or Pepsi?





From the Strib:

With Coke's contract ending, the company will have to fight to defend its control of the campus.

By Jeff Shelman

Last update: July 05, 2007 – 8:44 PM

Coca-Cola has enjoyed exclusive rights to sell its products on the university's campus, after winning the contract from Pepsi-Cola in the mid-1990s. But the contract ends in a little more than a year, and the soft drink giants are gearing up for a rematch.

By the end of this month, the local divisions of Coke and Pepsi are expected to submit proposals as part of the university's food and beverage contract, and a decision will be made in the months that follow. The 1996 contract with Coca-Cola was worth $28 million to the university, and the new contract, which will also include "pouring rights" to the new TCF Bank Stadium, could be even richer.

"We obviously want to get high quality," University President Robert Bruininks said. "We want a lot of choice in this response, and we want good price. "This is a really important contract for us."


The most visible part of the contract has to do with control of the 400-plus drink vending machines and numerous fountain units. This contract -- which is scheduled to run for 10 years and could extend to 16 years -- has the potential to be even more lucrative for the University of Minnesota than the previous deal.

Part of that is because the scope of this contract includes all five campuses. But it's also because the winner will also have a prominent place on scoreboards at TCF Bank Stadium when the on-campus football stadium opens in two years. The company will also receive one suite and eight club seats for the stadium along with the right to use the plaza for "public display or sampling," once a season.

Coca-Cola's corporate practices around the world have come under criticism on a number of campuses. The University of Michigan quit selling the company's products for a while, and protests have occurred at other Big Ten schools, including the University of Illinois and Indiana University.

The University of Minnesota formed a "Coca-Cola working committee" to examine the company's labor practices abroad and, in a December report, found evidence of improper corporate practices "inconclusive."

On the Pepsi side, there have been concerns raised at the university about Dr. Deborah Powell, dean of the medical school, being on the board of directors of PepsiAmericas. Based in Minneapolis, PepsiAmericas handles bottling in part of the United States, Central Europe and the Caribbean.

A different bottling company, Pepsi Bottling Group, will be the unit bidding for the university's business.

Twould be nice if there were some campus discussion on this matter. Don't hold your breath. But as OurLeader states above, a lot of money is involved and we have a stadium to pay for. We wouldn't want little things like corporate bad behavior or conflicts of interest to get in the way of a big contract for BigU, would we?

Bonzo

Ah, those Badgers… It’s Bad Enough That They Beat Us In Football, but Biofuels?

From the Daily:

Research Funding
July 3, 2007

U loses bid for biofuel grant Some officials criticized the Department of Energy's ties with the winning institutions.

By Justin Horwath

The Department of Energy announced three recipients of the most-coveted biofuel grants in the nation last week. The University applied for the funding but did not receive it. Some University officials involved in the application process criticized the selections because of the DOE's ties to research teams receiving funds.

Two of the teams that received the grant are headed by national labs - one in Oak Ridge, Tenn., and the Lawrence Berkeley Laboratory, in Berkeley, Calif.

The third team that received one of the $125 million grants, a University of Wisconsin-Madison team, is not headed by a national lab, but is collaborating with two national labs.

Bob Elde, dean of the College of Biological Sciences, said he was "disappointed, but not shocked," by the announcement.

The Department of Energy's three Bioenergy Research Centers will include:

• The DOE BioEnergy Science Center led by the DOE's Oak Ridge National Laboratory in Oak Ridge, Tenn. Collaborators include: Georgia Institute of Technology in Atlanta; DOE's National Renewable Energy Laboratory in Golden, Colo.; University of Georgia in Athens, Ga.; Dartmouth College in Hanover, N.H.; and the University of Tennessee, in Knoxville, Tenn.

• The DOE Great Lakes Bioenergy Research Center will be led by the University of Wisconsin in Madison, Wis., in close collaboration with Michigan State University in East Lansing, Mich. Collaborators include: DOE's Pacific Northwest National Laboratory in Richland, Wash.; Lucigen Corporation in Middleton, Wis.; University of Florida in Gainesville, Fla.; DOE's Oak Ridge National Laboratory in Oak Ridge, Tenn.; Illinois State University in Normal, Ill.; and Iowa State University in Ames, Iowa.

• The DOE Joint BioEnergy Institute will be led by DOE's Lawrence Berkeley National Laboratory. The institute director will be Jay Keasling, and collaborators include: Sandia National Laboratories; DOE's Lawrence Livermore National Laboratory; University of California-Berkeley; University of California-Davis; and Stanford University in Stanford, Calif.

"It's really clear that the intramural programs of the Department of Energy were themselves highly valued as the lead in partner research organizations for the kind of work that would be done," he said. "I think it reflects the tendency of the Department of Energy to take care of its own facilities and scientists first."

Todd Reubold, associate director of the Initiative for Renewable Energy and the Environment - which brings together faculty and staff at the University to work on renewable energy - said although the science and quality of research was crucial in the selection process, there was a political element. "In the end it was the fact that some of the other institutions had stronger connections to national laboratories, which tipped the scales," he said.

A media contact at the DOE, Megan Barnett, cited comments made by Secretary of Energy, Samuel Bodman, at a June 26 press conference in reference to the DOE's purported ties to grant recipients. "The proposals were thoroughly analyzed and discussed. The three that rose to the top are truly extraordinary," according to an e-mail sent to the Daily containing Bodman's comments. "The quality of the scientific teams that they have assembled … are as good as it gets."

Timothy Donohue, a professor in the bacteriology department at Madison, who will be in charge of the DOE Great Lakes Bioresearch Center lab, said in looking for partners in the proposal, his team thought about the "science we wanted and the issues we wanted to address." "We were not looking for any specific partner," he said. "It was all about science; it wasn't about political positioning."

The ambitious aspiration of the BigU administration to become one of the top three public research institutions in the world seems less and less likely. Competition is extremely tough and even our neighbors, the Badgers, will be difficult to surpass given their excellent track record. Congratulations to them for this extraordinary achievement.

Happy 4th! Bonzo