Showing posts with label health care. Show all posts
Showing posts with label health care. Show all posts

Monday, July 9, 2007







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

Wednesday, June 27, 2007



Children as Pawns in the Latest Expensive Healthcare Competition Involving BigU

Mr. B. has noted that a new medical school may be established as a partnership between Allina and St. Thomas. This apparently has gotten knickers in a twist at BigU. (Something about wasteful duplication and osteopaths being the root of all evil...) The children's hospital excesses outlined below involve a potential competition between the BigU/Fairview partnership and Allina. Maybe wasteful duplication is only bad when somebody else does it?

From the Strib:


The Minneapolis renovation is to start this year, with the St. Paul project to follow. The U of M also plans to build a new pediatric facility.

By David Phelps, Star Tribune

Last update: June 26, 2007 – 9:53 PM

Children's Hospitals and Clinics of Minnesota announced Tuesday that it intends to spend $300 million for a major renovation of its campuses in Minneapolis and St. Paul.

The announcement follows one earlier this year by University of Minnesota Children's Hospital that it will build a new $175 million facility on its Fairview Riverside campus.

The dual projects have some in the health care community concerned about the level of competition in the highly specialized world of pediatric medicine.

They worry about what is in store as the two hospitals attempt to recruit staff and patients.

"Both [hospitals] have repeatedly acknowledged that the community would be better off with one world-class pediatric health and medical center which would attract first rate researchers, clinicians and medical educators to serve the needs of our kids and their families," former U.S. Sen. Dave Durenberger said.

He heads the National Institute of Health Policy at the University of St. Thomas.

"On the theory that better beds don't necessarily make better health care, one wonders why the community should invest upwards of $500 million with achieving the 'national center of excellence' it may be eager to support," he added.

The project will be funded through operating cash flow, bonds and philanthropic support, the hospital said.

Children's of Minneapolis and St. Paul accounts for more than half of the region's acute pediatric care admissions. It is the country's sixth largest children's health care provider and the largest in the Upper Midwest.

However, competition for young patients is growing. In addition to the University's planned expansion at Fairview Riverside, the Mayo Clinic just opened its $15 million T. Denny Sanford Pediatric Outpatient Center. South Dakotan Sanford also gave $16 million to Sioux Valley Hospitals in Sioux Falls, S.D., for the Sanford Children's Hospital.

Over the years, hospital organizations in Minnesota have attempted to pool resources to build one comprehensive children's facility but never were able to agree on the details of such a joint operation.

Critics warn that funding for the expansion projects may be difficult to obtain as philanthropic resources are stretched thin by competing fundraising efforts.

Goldbloom is undeterred.

"Competition exists now," he said. "We don't think we're changing the landscape. Facilities to treat children need to be kept up to date."

Peter Gove, co-chair of a Citizen's League committee that looked at medical facilities' decision making last year, said the current system for determining where and when hospitals and other medical centers get built is done without input from those who pay for it: Consumers.

"The system remains supplier driven, and the public policy role is limited," Gove said.

In other words the health care system will try to extract money from us by using our children? Check.

A disappointed Bonzo

Friday, May 25, 2007


Blanket Email from Senior Vice President for Health Sciences
Kudos and Questions for Proposed Medical School


This blog has previously posted on the possible establishment of a new medical school in the Twin Cities by the University of St. Thomas and Allina.

The following blanket email has been sent to BigU AHC faculty. Mr. Bonzo posts it without comment at this time. An earlier blanket email by MedSchoolDean at BigU has also been posted.

Frank B. Cerra Fri, May 25, 2007 at 12:05 PM
Reply-To: "Frank B. Cerra"
To: ALL-AHC-ALL@oris.ahc.umn.edu


Dear Colleague -

May is a remarkably productive month in the Academic Health Center. By the end of last week, we graduated 224 new physicians, 134 new nurses, a record class of 157 new PharmDs, 138 new dentists, 91 new veterinarians, and 187 public health graduates prepared to improve the health of our communities.

All of you deserve a strong pat on the back for the work you've done in preparing this next generation of more than 900 health professionals to care for Minnesotans. This has been our commitment since the University was founded 154 years ago.

For the past couple of weeks, I've been reflecting on that historic commitment as colleagues in the community discuss the feasibility of starting a new medical school. The stated rationale for this fledgling partnership between Allina and the University of St. Thomas is the impending shortage of primary care physicians to care for our aging population.

Much of our work at the University is designed to respond to workforce needs in various health professions. Whether it is a need for pharmacists in rural communities, advanced practice nurses to manage chronic care for patients, training all health professionals to move care upstream into prevention, or modeling new cost effective ways to achieve health, our schools have been responsive with innovative programs and expansions of existing programs to meet workforce needs of Minnesota.

As one who has managed the complexities of this Academic Health Center for more than a decade, I do have some questions that will need to get into the dialogue about this new school.

--Is another medical school truly the solution to the need for access to healthcare for aging Minnesotans?
--Are there other models of care that are more fiscally responsible for the future care of chronic conditions?
--Given the available capacity in our state's training programs, would it be more prudent for the community to work with us to find ways to attract students into health careers who are committed to primary care?

As the state's only public research university, we stand ready to help the community as they pursue the feasibility of starting a new school.

Frank B. Cerra, M.D.
Senior Vice President for Health Sciences
McKnight Presidential Leadership Chair

A public dialog and discussion on this matter is certainly in order. Perhaps some competition from St. Thomas would be good for Bigu? If this dialog does occur, Mr. B. would certainly like to contribute to the conversation.

On this Memorial Day weekend: memento mori.

Bonzo

Tuesday, May 22, 2007

Avandia flagged by FDA as a possible heart risk five years ago

Warning apparently buried


From the LA Times via Star-Tribune:

Diabetes drug Avandia caused concern 5 years ago

FDA reviewers flagged it in 2002 as possibly causing heart failure, yet a safety alert went out for it Monday.

By Ricardo Alonso-Zaldivar, Los Angeles Times

Last update: May 22, 2007 – 9:27 PM

WASHINGTON - Federal investigators warned nearly five years ago that the diabetes drug Avandia might be causing heart failure, according to an internal government memo released Tuesday by a consumer group.

Separately, in fast-moving developments in the latest drug safety investigation, a senior Republican senator said he learned that the Food and Drug Administration's safety office recommended the strongest possible warning for Avandia -- only to be overruled.

"The FDA didn't take that advice," said Sen. Charles Grassley, R-Iowa, a critic of the agency. "Instead, the warning about congestive heart failure risks with this drug is currently buried."

FDA spokeswoman Julie Zawisza said debate and disagreement are not unusual within the agency, "particularly when the science is unclear, complex or emerging."We do not have sufficient understanding of the data at this time to make a regulatory decision," she said.

The FDA issued a safety alert about Avandia on Monday after a study in the New England Journal of Medicine linked the drug to increased risk of heart attacks and death from cardiac disease. The alert underscored less prominent warnings of heart risks in prescribing literature primarily intended to inform doctors.

But a memo from FDA drug safety reviewers -- dated July 16, 2002 -- indicates there were significant concerns much earlier within the agency about Avandia and Actos.

Released by the watchdog group Public Citizen, the memo analyzed 47 early reports to the FDA of patients who went into heart failure and had to be hospitalized while taking one of the drugs. Congestive heart failure, or CHF, is a life-threatening condition that comes about when the heart can't pump enough blood to the rest of the body.

"This case series strongly supports the hypothesis that [these drugs], as a class, may be associated with CHF in diabetics," the memo said.

Monday, May 21, 2007

Not a Pretty Sight
Avandia - aka Rosiglitazone - Another Medical Train Wreck?


[Note: NEJM is a subscriber based service. But Mr. B. logged on to the site - as you can, too - and was given access to an important paper. Extracts are posted below in the belief that they are important and that this is permitted under the fair use doctrine. Please consult the whole article if this is a matter of medical importance to you. If the NEJM is too heavy duty for you, here is a link to an article in Time.]

From the New England Journal of Medicine Web Site:

Published at www.nejm.org May 21, 2007 (10.1056/NEJMoa072761)

Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
Steven E. Nissen, M.D., and Kathy Wolski, M.P.H.

ABSTRACT

Background Rosiglitazone is widely used to treat patients with type 2 diabetes mellitus, but its effect on cardiovascular morbidity and mortality has not been determined.

Methods We conducted searches of the published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline). Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability of outcome data for myocardial infarction and death from cardiovascular causes. Of 116 potentially relevant studies, 42 trials met the inclusion criteria. We tabulated all occurrences of myocardial infarction and death from cardiovascular causes.

Results Data were combined by means of a fixed-effects model. In the 42 trials, the mean age of the subjects was approximately 56 years, and the mean baseline glycated hemoglobin level was approximately 8.2%. In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval [CI], 1.03 to 1.98; P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74; P=0.06).

Conclusions Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes.

From the Discussion

Our study has important limitations. We pooled the results of a group of trials that were not originally intended to explore cardiovascular outcomes. Most trials did not centrally adjudicate cardiovascular outcomes, and the definitions of myocardial infarction were not available. Many of these trials were small and short-term, resulting in few adverse cardiovascular events or deaths. Accordingly, the confidence intervals for the odds ratios for myocardial infarction and death from cardiovascular causes are wide, resulting in considerable uncertainty about the magnitude of the observed hazard. Furthermore, we did not have access to original source data for any of these trials. Thus, we based the analysis on available data from publicly disclosed summaries of events. The lack of availability of source data did not allow the use of more statistically powerful time-to-event analysis. A meta-analysis is always considered less convincing than a large prospective trial designed to assess the outcome of interest. Although such a dedicated trial has not been completed for rosiglitazone, the ongoing Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial may provide useful insights.34

Despite these limitations, our data point to the urgent need for comprehensive evaluations to clarify the cardiovascular risks of rosiglitazone. The manufacturer's public disclosure of summary results for rosiglitazone clinical trials is not sufficient to enable a robust assessment of cardiovascular risks. The manufacturer has all the source data for completed clinical trials and should make these data available to an external academic coordinating center for systematic analysis. The FDA also has access to study reports and other clinical-trial data not within the public domain. Further analyses of data available to the FDA and the manufacturer would enable a more robust assessment of the risks of this drug. Our data suggest a cardiovascular risk associated with the use of rosiglitazone. Until better precision of the estimates of the risks of this treatment on cardiovascular events can be delineated in patients with diabetes, patients and providers should give careful consideration to the risks and benefits of their overall treatment plans.

Dr. Nissen reports receiving research support to perform clinical trials through the Cleveland Clinic Cardiovascular Coordinating Center from Pfizer, AstraZeneca, Daiichi Sankyo, Roche, Takeda, Sanofi-Aventis, and Eli Lilly. Dr. Nissen consults for many pharmaceutical companies but requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction. No other potential conflict of interest relevant to this article was reported.

What a novel concept! BigU MedSchool should hire some people like Dr. Nissen. They could then serve as examples to MedSchoolDean and to other like-minded Med School faculty here at BigU.

The general situation does not look good to Mr. Bonzo. Parallels are already being drawn with Vioxx, e.g. the link to Time noted above.

Health Care Myths and Realities

The Journal of the American Medical Association has an interesting opinion piece from which Mr. B. has extracted the following:

What Cannot Be Said on Television About Health Care

Ezekiel J. Emanuel, MD, PhD

JAMA. 2007;297:2131-2133.

There are 3 phrases that should and can no longer be said about the US health care system without qualification, embarrassment, criticism, or even denunciation: "The United States has the best health care system in the world," "Health care is special," and "New is better."

"Best Health Care System in the World"

The United States has the most expensive system, by far. In 2005 health care cost more than $6000 per person or in excess of 16% of the gross domestic product (GDP). The nearest rival, Switzerland, spends $4077 per person per year, or 11.5% of its GDP (in purchasing power parity). Norway spends $3966 (9.7% of GDP); Germany, $3043 (10.6% of GDP); and South Korea, a mere $1149 (8.2% of GDP). However, Americans are increasingly aware that all of this money is not buying very much. Life expectancy in the United States is 78 years, ranking 45th in the world, well behind Switzerland, Norway, Germany, and even Greece, Bosnia, and Jordan. The US infant mortality rate is 6.37 per 1000 live births, higher than almost all other developed countries, as well as Cuba. Even for white individuals, the numbers are not world class—5.7 infant deaths per 1000 live births—more than double the rate in Singapore, Sweden, and Japan. Even at the individual hospital level, Americans are realizing the care they receive is not of the highest quality. The idea put forth in the Institute of Medicine report To Err Is Human that 100 000 Americans die each year from medication errors in the hospital has taken hold in the public consciousness as emblematic of the problems with the quality of health care.

Within the last few years, the tipping point has been passed. Something has radically changed when the New Yorker claims the system is a mess and when UnitedHealthcare, a corporate pillar of the status quo, opens an advertisement in the Wall Street Journal by boldly stating that:

The health system isn't healthy. There's no denying it. A system that was designed to make you feel better often just makes things worse.

The US health care system is considered a dysfunctional mess. Conventional wisdom has been turned on its head. If a politician declares that the United States has the best health care system in the world today, he or she looks clueless rather than patriotic or authoritative.

"Health Care Is Special"

To many, the specialness of health care meant that cost should not be a consideration in care. Ethical physicians could and should not consider money in deciding what they should do for sick patients. Patients were to receive whatever services they needed, regardless of its cost. Reasoning based on cost has been strenuously resisted; it violated the Hippocratic Oath, was associated with rationing, and derided as putting a price on life, akin to the economist who knew the price of everything but the value of nothing. Indeed, many physicians were willing to lie to get patients what they needed from insurance companies that were trying to hold costs down.

Today, saying that health care is so special that its cost is irrelevant serves to discredit the source. A New York Times reporter learned this lesson the hard way when he praised a study that claimed by "virtually any commonly cited value of a year of life, we found that if medical care accounts for about half the [6.97 year] gain in life expectancy [since 1960] then the increased spending has, on average, been worth it." In response, the reporter "received about 500 e-mail responses from readers, and the most common reaction was a version of a simple question: ‘Why do Americans spend so much more than folks in most other developed countries while getting worse results?’"

"New Is Better"

Americans are enamored with technology, especially health technology. The US Food and Drug Administration has been urged to use surrogate markers to approve drugs and medical devices faster so they can help sick patients. Not only is the United States an early adopter of new health care technologies, many physicians are early "proliferators" of technological innovations.

Increasingly, Americans are beginning to be skeptical about whether new health care technologies are better. The tipping point probably came with the withdrawal of rofecoxib from the US market. Today, the list of drugs and technologies for which new might not be better (and may be even worse) has expanded rapidly: postmenopausal hormone therapy, bare-metal stents, megadose antioxidants, selective serotonin reuptake inhibitors for adolescents, Swan-Ganz catheters, gabapentin for bipolar disorder, erythropoietin for anemia, and the list goes on.

[Addendum, 4:50 pm: To which list can today be added Avandia, which was hoped to be a breakthrough medication for treating type II diabetes.]


The change in language suggests Americans now recognize that the system has deep structural problems. While this recognition is no guarantee of change, it does constitute a critical precondition for comprehensive reform of the system. Reform cannot occur without acknowledging that there is a problem. The next step is for the public to see a solution that they think offers a realistic chance of making the system better.

Now here is language that one would not see in JAMA back in the good old days of rants about the evils of socialized medicine...

Mr. B.