Archive for August 12th, 2008

Cleviprex

by Paul Rega, MD — published on August 12th, 2008

The Medicines Company’s Cleviprex(TM)

Receives FDA Approval

First New IV Antihypertensive Treatment Approved in Ten Years

 

PARSIPPANY, N.J., Aug 04, 2008 (BUSINESS WIRE) — The Medicines Company (NASDAQ: MDCO) announced today that the U.S. Food and Drug Administration (FDA) has approved the intravenous (IV) therapy Cleviprex(TM) (clevidipine butyrate) injectable emulsion for the reduction of blood pressure when oral therapy is not feasible or not desirable.

Cleviprex, a novel IV antihypertensive, represents an advancement over currently available therapies, providing rapid and precise control of blood pressure in the critical care setting. Backed by comprehensive data in the emergency department, operating room and intensive care unit, Cleviprex offers physicians an important new therapeutic option for the management of blood pressure.

“Recent clinical findings highlight the relationship between controlling acute blood pressure and lower risk of adverse outcomes,” said Robert Califf, MD, Professor of Medicine and Vice Chancellor for Research, Duke University. “With the approval of Cleviprex, physicians have a new treatment option for intensive control of blood pressure that may advance the standard of care in the operating room, the intensive care unit and the emergency department.”

Cleviprex has a rapid onset and offset of action and can be titrated for precise blood pressure control. Unlike many current IV antihypertensive agents, which are metabolized by the kidney and/or liver, Cleviprex is metabolized in the blood and tissues and does not accumulate in the body.

“In the last decade, there have been no new IV antihypertensive agents introduced to the market,” said John Kelley, President and Chief Operating Officer of The Medicines Company. “Cleviprex presents physicians with a valuable option to effectively treat a broad array of patients who need rapid and precise blood pressure control.”

“With the approval of Cleviprex, The Medicines Company continues to deliver on its vision of advancing innovation in the critical care setting,” said Clive Meanwell, Chief Executive Officer of The Medicines Company.

Blood Pressure Management in Critical Care Settings

Poorly controlled blood pressure can be a life-threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. Poorly controlled blood pressure can occur in a broad range of patients; it is frequently found in patients undergoing surgery and in patients presenting in the emergency department.

About Cleviprex

Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials involving 1,406 patients medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints. Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions (greater than 2%) seen with Cleviprex are headache, nausea and vomiting. Please see full prescribing information available at www.cleviprex.com.

MDCO-G

About The Medicines Company

The Medicines Company (NASDAQ: MDCO) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. The Company markets Angiomax(R) (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, as well as Cleviprex(TM) (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has one product, cangrelor, in late-stage development. The Company’s website is www.themedicinescompany.com.

Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words “believes,” “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company’s actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company’s products will advance in the clinical trials process on a timely basis or at all, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company’s periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company’s Quarterly Report on Form 10-Q filed on May 12, 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

SOURCE: The Medicines Company

WeissComm Partners Barri Winiarski, 212-301-7209 bwiniarski@wcpglobal.com or The Medicines Company Robyn Brown, 973-656-1616 investor.relations@themedco.com

 

Copyright Business Wire 2008

News Provided by COMTEX

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categories: Emergency Medicine

Internal Decapitation

by Paul Rega, MD — published on August 12th, 2008

Internal Decapitation: Survival After Head to Neck Dissociation Injuries

Spine.  2008;33(16):1744-1749.

For complete text and pics:  http://www.medscape.com/viewarticle/577910_print

Study Design. Case series.
Objective. To describe survival and outcomes after occipitocervical dissociation injuries.
Summary of Background Data. Historically, occipitocervical dissociation injuries have a high rate of associated neurologic deficit with a relatively high incidence of mortality.
Methods. Six patients with occipitocervical dissociation injuries are reported and their management and imaging findings reviewed. Possible contributory factors for survival are discussed.
Results. All patients had upper neck and head dissociation injuries. The pattern of injury in all of these cases included a distraction type mechanism. All cases demonstrated soft tissue disruption in the zone of injury, which was consistent and apparent on all imaging studies. In these patients, the extent and severity of injury was more apparent on magnetic resonance imaging (MRI) than on radiograph or computed tomography scan. Management of these injuries included immobilization followed by surgery with particular care taken to avoid application of distraction forces to the neck.
Conclusion. Patients with occipitocervical dissociation injuries may survive their injury and even retain neurologic integrity. Initial in-line head stabilization is emphasized to prevent catastrophic neurologic injury. The resting osseous relationships and vertebral alignment at the time of imaging evaluation may be deceivingly normal, and the damage often primarily or exclusively involves disruption of the perivertebral soft tissue structures. Prevertebral soft tissue swelling was apparent in all cases. For these injuries that involve primarily damage to the ligamentous structures, MRI seems to be the optimal test for revealing the magnitude of the injury.

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categories: Emergency Medicine

D-Dimer & Aortic Dissection

by Paul Rega, MD — published on August 12th, 2008

Intro:  Who uses D-Dimer to rule out aortic dissection?  At least there is a nice Q&A about the topic and references to help you sort this out.  Bottom line:  Don’t use the test to rule out dissection. 

http://www.medscape.com/viewarticle/577486_print

 

Question
Is measurement of serum D-dimer a safe and effective test to “rule out” aortic dissection in the emergency department?

Aortic dissection (AD) is a rare and dangerous condition associated with high morbidity and mortality. Clinical suspicion of its presence must be rapidly and thoroughly investigated in the emergency department (ED). Additionally, patients who present to the ED with chest pain and electrocardiographic (ECG) changes suggestive of an acute coronary syndrome may require anticoagulation, which necessitates first ruling out a diagnosis of AD. The availability of a sensitive assay with high negative predictive value to exclude AD would expedite triage and clinical decision making for patients with acute coronary syndrome.

Several investigators have examined the utility of serum D-dimer as a screening test for patients with potential AD.[1-8] D-dimer levels are thought to be elevated in AD through activation of the clotting cascade subsequent to an intimal tear in the aorta.

However, emergency physicians must consider whether measuring serum D-dimer can safely and effectively “rule out” AD in the ED.

Studies have demonstrated that serum D-dimer is elevated in nearly all patients with AD.[1-8] Most experts agree that a negative D-dimer assay (< 500 ng/dL) essentially rules out AD, and encourage use of D-dimer as a screening assay.[2] Sodeck and colleagues[2] argued that D-dimer should be routinely measured in patients who are considered to have AD. Unfortunately, this study was limited by small patient numbers and a meta-analysis of trials of limited value.

Critics of the D-dimer “rule-out” strategy for AD caution that patients with intramural hematoma without acute intimal tear (chronic dissection with thrombosed false lumen) may not leak D-dimer into the systemic circulation.[1,6] This has the potential to produce false-negative results and misdiagnosis of a life-threatening condition.

Critics also hold that the data for validating this algorithm are limited by small patient numbers and limited studies. In fact, in a 2007 study of 25 confirmed patients with AD, 3 patients were noted to have a false-negative D-dimer (cutoff = 500 ng/dL).[1] The study author found that the rate of false-negative values would prohibit its safe use at a cutoff level of 500 ng/dL. This investigation, however, was limited by its retrospective case series design and small patient numbers.

Although a definitive cutoff level for D-dimer has not been clearly established for AD, most studies have employed a cutoff of 500 ng/dL. Recent studies have also investigated cutoff levels below 500 ng/dL.[2,5] Future research will be necessary to define an optimal cutoff level to ensure a high negative predictive value for excluding AD.

 

Conclusion

 

On the basis of the available literature and expert medical opinion, it appears that a negative serum D-dimer (< 500 ng/dL) likely rules out AD. However, current studies do not overwhelmingly advocate using D-dimer alone, without other clinical and imaging tools to exclude AD.

Large, prospective validation studies will be necessary before serum D-dimer can be used to dictate clinical decision making in ED patients with a suspicion of AD.

 

References

  1. Weigand J, Koller M, Bingisser R. Does a negative d-dimer test rule out aortic dissection. Swiss Med Wkly. 2007;137:462.
  2. Sodeck G, Domanovits H, Schillinger M, et al. D-dimer in ruling out acute aortic dissection: a systemic review and prospective cohort study. Eur Heart J. 2007;28:3067-3075. Abstract
  3. Marill KA. Serum D-dimer is a sensitive test for detection of acute aortic dissection: a pooled meta-analysis. J Emerg Med. 2008;34:367-376. Abstract
  4. Perez P, Abbot P, Drescher MJ. D-dimers in the emergency department evaluation of aortic dissection. Acad Emerg Med. 2004;11:397-400. Abstract
  5. Ohlmann P, Faure A, Morel O, et al. Diagnostic and prognostic value of circulating D-dimers in patients with acute aortic dissection. Crit Care Med. 2006;34:1358-1364. Abstract
  6. Hazui H, Nishimoto M, Hoshiga M, et al. Young adult patients with short dissection length and thrombosed false lumen liable to have false-negative results of D-dimer testing for acute aortic dissection based on a study of 113 cases. Circ J. 2006;70:1598-1601. Abstract
  7. Eggebrecht H, Naber CK, Bruch C, et al. Value of plasma fibrin D-dimers for detection of acute aortic dissection. J Am Coll Cardiol. 2004;44:804-809. Abstract
  8. Weber T, Hogler S, Auer J, et al. D-dimer in acute aortic dissection. Chest. 2003;123:1375-1378. Abstract
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categories: Emergency Medicine

Antiplatelet Therapy in ACS

by Paul Rega, MD — published on August 12th, 2008
Antiplatelet Therapy in Acute Coronary Syndromes: The Emergency Physician’s Perspective
by Charles V. Pollack, Jr, MD; Judd E. Hollander, MD
 

J Emerg Med.  2008;35(1):5-13.

Full Text:  http://www.medscape.com/viewarticle/577105_print

Abstract

The platelet plays a central role in the pathogenesis of coronary thrombosis after atherosclerotic plaque rupture, and its active inhibition forms a cornerstone of the management of acute coronary syndromes (ACS). Early treatment with clopidogrel in addition to aspirin is more effective than aspirin alone in reducing recurrent ischemic events in patients presenting with ACS, and is a useful adjunct to percutaneous coronary intervention, especially with stenting. There is a potential for increased bleeding complications in patients on clopidogrel therapy who subsequently undergo urgent coronary artery bypass graft surgery. Consequently, many emergency physicians withhold clopidogrel treatment until it is clear that urgent coronary artery bypass graft surgery will not be required. The potential untoward effects seem to be minimized by withholding antiplatelet therapy 3-5 days before surgery. Intravenous glycoprotein (GP) IIb/IIIa receptors inhibitors are also particularly useful in patients who undergo percutaneous coronary intervention, and may have some utility in the medical management of patients with high-risk non-ST-segment elevation ACS, starting in the emergency department. For patients presenting to the emergency department with ACS, the benefits and risks of initiating clopidogrel or GP IIb/IIIa inhibitor therapy need to be considered on an individual basis.

One of the Discussion Points:  “…The possibility that a patient may need to undergo urgent CABG, coupled with the difficulty in identifying patients who are likely to need CABG, may cause the EP to hesitate regarding whether to initiate or continue clopidogrel therapy due to the potential risk of excess bleeding during surgery. However, a number of studies have shown that CABG is undertaken in only a small proportion of patients, both in clinical trials and in observational studies. For example, CABG surgery was performed in only 12% of patients admitted with NSTEMI in the US National CRUSADE initiative, compared to 11-19% of patients in the PURSUIT, PRISM, GUSTO IV, and SYNERGY studies. Only 1-2% of patients required urgent (urgent not defined) CABG surgery.  Consequently, denying the vast majority of patients the early benefits of clopidogrel treatment to prevent a potential increase in bleeding in the limited number of patients who may require urgent CABG may be called into question…”

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categories: Emergency Medicine

Naltrexone Alert

by Paul Rega, MD — published on August 12th, 2008

FDA ALERT [08/12/2008]: FDA is notifying healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone (Vivitrol).

Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon.

FDA has received 196 reports of injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. Sixteen patients required surgical intervention ranging from incision and drainage in the cases of abscesses to extensive surgical debridement in the cases that resulted in tissue necrosis.

Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular (IM) gluteal injection. Naltrexone should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Healthcare providers should ensure that the naltrexone injection is given correctly with the pre-packaged 1½-inch needle that is specifically designed for this drug.

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categories: Emergency Medicine

OMNI Postings of 8/12/08

by Paul Rega, MD — published on August 12th, 2008
A nurse was on duty in the emergency room when a young woman with purple hair styled into a punk rocker mohawk, sporting a variety of tattoos, and wearing strange clothing, entered. It was quickly determined that the patient had acute appendicitis, so she was scheduled for immediate surgery. When she was completely disrobed on the operating table, the staff noticed that her pubic hair had been dyed green, and above it there was a tattoo that read, ‘Keep off the grass.’ Once the surgery was completed, the surgeon wrote a short note on the patient’s dressing, which said, ‘Sorry, had to mow the lawn.’ (Note:  The doctor must now attend cultural sensitivity training before he is able to resume his practice in that hospital.)
But I digress… 

1)  How many times have you seen patients who say they couldn’t get in to see their docs because they couldn’t get past the secretary or their appointment would be 2 weeks after they dropped dead from their problem?  This abstract from Arch Intern Med looked at the barriers associated with people receiving primary care.  Barriers included (1) “couldn’t get through on phone” (2) “couldn’t get appointment soon enough”  (3) “waiting too long in doctor’s office” (4) “not open when you could go”and (5) “no transportation.  The more barriers a patient faced, the more likely he/she would come to the ER pissed off, surly, & distrustful.  And the first words he/she would say is, “Call my doctor.” 
2)  Obesity is not only a risk factor for VTE, it’s a risk factor for recurrent VTE.  For example, according to this study in Arch Intern Med, four years after discontinuation of anticoagulant therapy, the probability of recurrence was 9.3% among patients of normal weight and 16.7%  and 17.5% among overweight and obese patients, respectively.
3)  Massachusetts has a passed a law to curb health care costs.  It contains one of the nation’s strictest limits on gifts given to medical professionals by drug salespeople.  It bans only certain types of gifts such as sports tickets and free travel (critics wanted a total ban on gifts), and requires that pharmaceutical and medical device-making firms publicly disclose gifts worth more than $50.  Thank God, I don’t practice in Boston.  I’d have to return my Merck Inflatable Doll.
4)  Who cares about Vitamin D levels? Observational data suggests that low 25-hydroxyvitamin D levels (25[OH]D) are associated with diabetes mellitus, hypertension, and cancers. However, whether low serum 25(OH)D levels are associated with mortality in the general population is unknown.   Well, according to this study,  The lowest quartile of 25(OH)D level (<17.8 ng/mL) is independently associated with all-cause mortality in the general population. 
5)  This story will be making the rounds of the morning talk shows today.  Gupta and the rest of the talking heads will be falling all over themselves discussing how PPIs are related to fractures.  First of all, if this is true (and the drug companies have their doubts) it only occurs if one is on a PPI for at least 7 years.  In the study published in CMAJ, people who suffered an osteoporosis-related fracture were almost twice as likely to have used a PPI for at least seven years. Using PPIs for six or fewer years wasn’t linked to fracture risk. This was a retrospective study and it certainly doesn’t prove cause-and-effect.  However, you might be getting patients asking you questions about this.
6)  The hazards of emergency medicine are ubiquitous — even in the ambulance bay.  Do you know where your fire extinguisher is in your department?
Paul R.
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categories: Emergency Medicine

Timely Primary Care Access: Hah!

by Paul Rega, MD — published on August 12th, 2008

Practical Barriers to Timely Primary Care AccessImpact on Adult Use of Emergency Department Services

George Rust, MD, MPH; Jiali Ye, PhD; Peter Baltrus, PhD; Elvan Daniels, MD; Bamidele Adesunloye, MD; George Edward Fryer, PhD
Arch Intern Med. 2008;168(15):1705-1710.

Background  Most Americans report having a usual source of medical care, but many also report significant barriers to timely access to such care. This can lead patients to use the emergency department (ED) as a ready alternative to their usual source of medical care, even when such care could be provided more cost-effectively in a primary care setting. The purpose of this study was to examine the relationship between ED visits and perceived barriers to receiving timely primary care. Methods  Among 30 677 adults 18 years or older participating in the adult sample section of the National Health Interview Survey, 23 413 who reported having a usual source of medical care other than the ED and answered the questions related to barriers were included in our analyses. Associations between perceived timely access barriers and reported use of ED in the previous 12 months were examined using logistic regression to control for covariates that also affect ED use.

Results  For those reporting no access barriers, 1 in 5 adult Americans in the noninstitutionalized civilian population visited an ED at least once during the preceding year. For those reporting 1 or more barriers, the proportion having an ED visit was 1 in 3. Four of the 5 following timely access barriers was independently associated with ED use, even after adjusting for other socioeconomic and health-related factors: (1) “couldn’t get through on phone” (OR [odds ratio], 1.27; 95% confidence interval [CI], 1.02-1.59); (2) “couldn’t get appointment soon enough” (OR, 1.45; 95% CI, 1.21-1.75); (3) “waiting too long in doctor’s office” (OR, 1.20; 95% CI, 1.02-1.41); (4) “not open when you could go” (OR, 1.24; 95% CI, 0.99-1.55); and (5) “no transportation” (OR, 1.88; 95% CI, 1.50-2.35).

Conclusions  The benefits of having a usual source of medical care are diminished by barriers that limit effective and timely access to such care. Interventions to improve effective access to medical care such as open access scheduling might have benefits not only for individual patients and practices but also for health policy related to cost-effective health care delivery systems and our need to relieve overcrowded conditions at EDs.

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categories: Emergency Medicine

Obesity & VTE

by Paul Rega, MD — published on August 12th, 2008

Overweight, Obesity, and the Risk of Recurrent Venous ThromboembolismSabine Eichinger, MD; Gregor Hron, MD; Christine Bialonczyk, MD; Mirko Hirschl, MD; Erich Minar, MD; Oswald Wagner, MD; Georg Heinze, PhD; Paul A. Kyrle, MD
Arch Intern Med. 2008;168(15):1678-1683.

Background  Excess body weight is a risk factor for a first venous thromboembolism. The impact of excess body weight on risk of recurrent venous thrombosis is uncertain. Methods  We studied 1107 patients for an average of 46 months after a first unprovoked venous thromboembolism and withdrawal of anticoagulant therapy. Excluded were pregnant patients, those requiring long-term antithrombotic treatment, and those who had a previous or secondary thrombosis, natural coagulation inhibitor deficiency, lupus anticoagulant, or cancer. Our study end point was symptomatic recurrent venous thromboembolism.

Results  A total of 168 patients had recurrent venous thromboembolism. Mean (SD) body mass index (BMI) (calculated as weight in kilograms divided by height in meters squared) was significantly higher among patients with recurrence than among those without recurrence: 28.5 (6.0) vs 26.9 (5.0) (P = .01). The relationship between excess body weight and recurrence was linear; the adjusted hazard ratio for each 1-point increase in BMI was 1.044 (95% confidence interval [CI], 1.013-1.076) (P < .001). Four years after discontinuation of anticoagulant therapy, the probability of recurrence was 9.3% (95% CI, 6.0%-12.7%) among patients of normal weight and 16.7% (95% CI, 11.0%-22.3%) and 17.5% (95% CI, 13.0%-22.0%) among overweight and obese patients, respectively. Compared with patients of normal weight, the hazard ratio of recurrence adjusted for age, sex, factor V Leiden, prothrombin G20210A mutation, high factor VIII levels, and type of initial venous thromboembolic event was 1.3 (95% CI, 0.9-1.9) (P = .20) among overweight patients and 1.6 (95% CI, 1.1-2.4) (P = .02) among obese individuals. The population attributable risk corresponding to excess body weight was 26.8% (95% CI, 5.3%-48.2%).

Conclusion  Excess body weight is a risk factor of recurrent venous thromboembolism.

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categories: Emergency Medicine

Massachusetts:New Law to Combat Health Costs

by Paul Rega, MD — published on August 12th, 2008

 Boston Globe, 8/12/08 (http://www.boston.com/news/health/articles/2008/08/11/leaders_nip_tuck_healthcare_policy/?page=full): 

Governor Deval Patrick yesterday signed into law one of the nation’s strictest limits on gifts given to medical professionals by drug salespeople, the most contentious measure contained in a broad package intended to improve healthcare safety and curb skyrocketing costs.

The law, based on a plan pushed by Senate President Therese Murray, seeks to increase the number of primary-care doctors.

MORE DOCTORS NEEDED

The new law also provides $25 million to promote electronic medical record-keeping in doctors’ offices, requires the state university to graduate more primary care doctors, and gives regulators the power to hold hearings when health insurers want to raise premiums.

Critics of the pharmaceutical industry had hoped to ban gift-giving altogether, arguing that the drug company largesse interferes with doctors’ judgment in deciding which drugs to prescribe. But the bill that the Legislature sent the governor bans only certain types of gifts such as sports tickets and free travel, and requires that pharmaceutical and medical device-making firms publicly disclose gifts worth more than $50.

“The good news is that it prevents some of the most abusive gift-giving,” said Senator Mark Montigny, a New Bedford Democrat who has pushed for years to ban gift-giving. “If I didn’t feel that it was beyond a half a loaf of victory, I would not have signed on.”

The changes come amid intense focus on the cost and quality of healthcare, which consumes one in every six dollars spent in Massachusetts. Two years ago, landmark legislation required almost everyone in the Commonwealth to have insurance. But the law has been so successful – prompting an estimated 345,000 people statewide to obtain insurance – that it has been far more expensive than expected, forcing Patrick to sign a bill last week raising more than $100 million in state funds and fees on private companies to help foot the bill.

Patrick’s Human Services Secretary JudyAnn Bigby said that while universal health insurance is an important goal, the current system is lacking if everyone cannot get access to quality care, or premiums and out-of-pocket costs become too costly for patients.

“We have to make sure that people have access to high quality care and that we are being efficient in the way we pay for that care and that we are paying for the right things,” Bigby said in an interview. The law Patrick signed yesterday “puts the challenge to those of us who have to implement it to do more planning.”

The new law, based on legislation championed by Senate President Therese Murray of Plymouth, contains several initiatives intended to increase the number of primary-care doctors, who make the initial decisions as to how patients will be cared for. Although Massachusetts has the most primary-care doctors per capita in the country, Bigby said there is evidence that there aren’t enough to handle the workload, especially as the number of people covered by insurance swells.

In response, the law directs the University of Massachusetts Medical School in Worcester to increase class size so that it can graduate more primary care doctors, Bigby said. In addition, the law calls for better training of primary care doctors and aids some of them in repaying medical school loans.

The law also establishes an institute to award grants to doctors and hospitals seeking to increase their use of computer technology. Electronic medical records systems typically cost $30,000 or more, which has slowed the healthcare industry’s adoption of technology that most people agree improves both safety and efficiency.

In addition, the law gives the state more oversight of health insurance rates than regulators have had in more than a decade. Now, both the Division of Insurance and an office under Bigby’s control can require health insurers to publicly justify rate increases.

But the limits on drug industry gift-giving drew the most attention.

Montigny had hoped that, after failing twice, he might succeed in banning gift-giving between salespeople and healthcare professionals altogether. However, representatives of the drug and medical device industry successfully argued that the measure went too far, potentially banning money paid to doctors and hospitals to conduct medical research. Though the Senate passed the full ban, the House backed only restrictions.

Still, the limits in the law put Massachusetts at the forefront of states in cracking down on the use of financial incentives to persuade doctors to prescribe particular drugs or medical devices. In addition to banning some gifts and requiring disclosure of others, it calls for the state to develop a code of conduct for industry representatives that includes a $5,000 fine for each violation.

“I commend the governor for standing firmly on the side of the patient and the taxpayer,” said Montigny.

But the pharmaceutical industry’s trade group, called PhRMA, said state leaders could one day regret the limits, especially the public disclosure of gifts. The group said in a statement that researchers could be discouraged from doing important drug research if they fear their research grant will be put on a public list of gifts from industry.

“Governor Patrick’s decision to sign [the limit on gift-giving] is deeply disappointing – and very likely damaging for medical partnerships, clinical research, and patients in Massachusetts,” said PhRMA senior vice president Ken Johnson.

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categories: Emergency Medicine

25-Hydroxyvitamin D Levels & Death

by Paul Rega, MD — published on August 12th, 2008

25-Hydroxyvitamin D Levels and the Risk of Mortality in the General PopulationMichal L. Melamed, MD, MHS; Erin D. Michos, MD, MHS; Wendy Post, MD, MS; Brad Astor, PhD
Arch Intern Med. 2008;168(15):1629-1637.

Background  In patients undergoing dialysis, therapy with calcitriol or paricalcitol or other vitamin D agents is associated with reduced mortality. Observational data suggests that low 25-hydroxyvitamin D levels (25[OH]D) are associated with diabetes mellitus, hypertension, and cancers. However, whether low serum 25(OH)D levels are associated with mortality in the general population is unknown. Methods  We tested the association of low 25(OH)D levels with all-cause, cancer, and cardiovascular disease (CVD) mortality in 13 331 nationally representative adults 20 years or older from the Third National Health and Nutrition Examination Survey (NHANES III) linked mortality files. Participant vitamin D levels were collected from 1988 through 1994, and individuals were passively followed for mortality through 2000.

Results  In cross-sectional multivariate analyses, increasing age, female sex, nonwhite race/ethnicity, diabetes, current smoking, and higher body mass index were all independently associated with higher odds of 25(OH)D deficiency (lowest quartile of 25(OH)D level, <17.8 ng/mL [to convert to nanomoles per liter, multiply by 2.496]), while greater physical activity, vitamin D supplementation, and nonwinter season were inversely associated. During a median 8.7 years of follow-up, there were 1806 deaths, including 777 from CVD. In multivariate models (adjusted for baseline demographics, season, and traditional and novel CVD risk factors), compared with the highest quartile, being in the lowest quartile (25[OH]D levels <17.8 ng/mL) was associated with a 26% increased rate of all-cause mortality (mortality rate ratio, 1.26; 95% CI, 1.08-1.46) and a population attributable risk of 3.1%. The adjusted models of CVD and cancer mortality revealed a higher risk, which was not statistically significant.

Conclusion  The lowest quartile of 25(OH)D level (<17.8 ng/mL) is independently associated with all-cause mortality in the general population.

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categories: Emergency Medicine

The Obese

by Paul Rega, MD — published on August 12th, 2008

Intro:  This study demonstartes that not all obese people are medical wrecks waiting for the undertaker to sweep them up and haul them to the newest landfill. 

          1 ”My blood pressure is 110/68.  What’s yours?”

The Obese Without Cardiometabolic Risk Factor Clustering and the Normal Weight With Cardiometabolic Risk Factor Clustering

Arch Intern Med. 2008;168(15):1617-1624.

Full Text:  http://archinte.ama-assn.org/cgi/content/full/168/15/1617

ABSTRACT

Background  The prevalence and correlates of obese individuals who are resistant to the development of the adiposity-associated cardiometabolic abnormalities and normal-weight individuals who display cardiometabolic risk factor clustering are not well known.

Methods  The prevalence and correlates of combined body mass index (normal weight, <25.0; overweight, 25.0-29.9; and obese, >30.0 [calculated as weight in kilograms divided by height in meters squared]) and cardiometabolic groups (metabolically healthy, 0 or 1 cardiometabolic abnormalities; and metabolically abnormal, <2 cardiometabolic abnormalities) were assessed in a cross-sectional sample of 5440 participants of the National Health and Nutrition Examination Surveys 1999-2004. Cardiometabolic abnormalities included elevated blood pressure; elevated levels of triglycerides, fasting plasma glucose, and C-reactive protein; elevated homeostasis model assessment of insulin resistance value; and low high-density lipoprotein cholesterol level.

Results  Among US adults 20 years and older, 23.5% (approximately 16.3 million adults) of normal-weight adults were metabolically abnormal, whereas 51.3% (approximately 35.9 million adults) of overweight adults and 31.7% (approximately 19.5 million adults) of obese adults were metabolically healthy. The independent correlates of clustering of cardiometabolic abnormalities among normal-weight individuals were older age, lower physical activity levels, and larger waist circumference. The independent correlates of 0 or 1 cardiometabolic abnormalities among overweight and obese individuals were younger age, non-Hispanic black race/ethnicity, higher physical activity levels, and smaller waist circumference.

Conclusions  Among US adults, there is a high prevalence of clustering of cardiometabolic abnormalities among normal-weight individuals and a high prevalence of overweight and obese individuals who are metabolically healthy. Further study into the physiologic mechanisms underlying these different phenotypes and their impact on health is needed.


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categories: Emergency Medicine

The Obese

by Paul Rega, MD — published on August 12th, 2008

Intro:  This study demonstartes that not all obese people are medical wrecks waiting for the undertaker to sweep them up and haul them to the newest landfill. 

The Obese Without Cardiometabolic Risk Factor Clustering and the Normal Weight With Cardiometabolic Risk Factor Clustering

Arch Intern Med. 2008;168(15):1617-1624.

Full Text:  http://archinte.ama-assn.org/cgi/content/full/168/15/1617

ABSTRACT

Background  The prevalence and correlates of obese individuals who are resistant to the development of the adiposity-associated cardiometabolic abnormalities and normal-weight individuals who display cardiometabolic risk factor clustering are not well known.

Methods  The prevalence and correlates of combined body mass index (normal weight, <25.0; overweight, 25.0-29.9; and obese, >30.0 [calculated as weight in kilograms divided by height in meters squared]) and cardiometabolic groups (metabolically healthy, 0 or 1 cardiometabolic abnormalities; and metabolically abnormal, <2 cardiometabolic abnormalities) were assessed in a cross-sectional sample of 5440 participants of the National Health and Nutrition Examination Surveys 1999-2004. Cardiometabolic abnormalities included elevated blood pressure; elevated levels of triglycerides, fasting plasma glucose, and C-reactive protein; elevated homeostasis model assessment of insulin resistance value; and low high-density lipoprotein cholesterol level.

Results  Among US adults 20 years and older, 23.5% (approximately 16.3 million adults) of normal-weight adults were metabolically abnormal, whereas 51.3% (approximately 35.9 million adults) of overweight adults and 31.7% (approximately 19.5 million adults) of obese adults were metabolically healthy. The independent correlates of clustering of cardiometabolic abnormalities among normal-weight individuals were older age, lower physical activity levels, and larger waist circumference. The independent correlates of 0 or 1 cardiometabolic abnormalities among overweight and obese individuals were younger age, non-Hispanic black race/ethnicity, higher physical activity levels, and smaller waist circumference.

Conclusions  Among US adults, there is a high prevalence of clustering of cardiometabolic abnormalities among normal-weight individuals and a high prevalence of overweight and obese individuals who are metabolically healthy. Further study into the physiologic mechanisms underlying these different phenotypes and their impact on health is needed.


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categories: Emergency Medicine

On By-Passing Community Hospitals for Specialty Hospitals

by Paul Rega, MD — published on August 12th, 2008

USA Today, 8/12/08 (http://www.usatoday.com/news/health/2008-08-11-stroke-hospital-bypass_N.htm):  When fire department paramedics found 50-year-old Gerald Booker unable to drive, his left side weak and his speech slurred because of an apparent stroke, they told the yard laborer he was going for a ride.

Instead of stopping at hospitals closer to his home in the Pleasantville neighborhood of this sprawling city, the paramedics took Booker to Memorial Hermann Hospital, one of more than 660 hospitals across the USA that specialize in treating strokes.

As Booker was driven past the other hospitals on a recent Friday afternoon, he became part of a growing national — and still debated — trend aimed at improving the quality of medical care for strokes. Bypassing closer hospitals to rush people with blood clots or bleeding in their brains to specialty hospitals is an increasingly common way to deliver the most advanced care as soon as possible.

The treatment model is similar to the one developed years ago to help save the lives of those severely injured in accidents or by violence by passing local hospitals to reach one of the 255 U.S. trauma centers.

Likewise, some big-city emergency medical services take people who are having heart attacks to hospitals with fast-moving cardiac teams. Those specialists have shown they can routinely insert a catheter to clear a heart blockage faster than neighboring facilities.

The idea behind the specialty center trend — whether in treating strokes, trauma or heart attacks — is the belief that staffs in such facilities move faster and perform better than those in other hospitals, making up for any extra minutes a patient spends on the road.

A 2007 study in the journal Neurology examined more than 26,000 stroke patients admitted to 606 Canadian hospitals and found there were more adverse outcomes such as death for those treated in “low-volume” facilities — those dealing with fewer than 50 strokes a year — than in high-volume centers that treat 100 or more strokes annually.

“What you get at a stroke center versus a community hospital is a more in-depth and higher level of care,” says James Grotta, chairman of the neurology department at Hermann, which is part of the University of Texas Health Science Center. “We see twice the number of stroke patients as the next hospital in this city. Like anything else, it’s practice, practice, practice. The more you have done it, the better you are going to be at it.”

But some in the medical community are skeptical about emergency crews bypassing community hospitals in favor of farther-away stroke centers. They say many patients who don’t stand to benefit from cutting-edge and often experimental care at specialty centers could get quality care at smaller hospitals.

“It is a very small number of patients who stand to benefit” from being redirected to specialty centers, says Robert Solomon, a board member of the American College of Emergency Physicians. Most patients “will be just as well served, if not better served, by being cared for at their local community hospital, provided that the local community hospital is doing the right stuff.”

Either way, the stakes are high. Stroke is the third-leading cause of death in the USA and the leading cause of disability.

A nationwide effort is underway to boost the quality of medicine by holding hospitals accountable for their performance. Cities and states as well as physician and quality-oversight groups are pushing hospitals that want to become certified stroke centers to follow guidelines for speedy and effective care.

Currently, Delaware, Florida, Massachusetts and New York certify hospitals as stroke centers, and 43 more states have at least some hospitals that are certified by health quality groups as stroke centers. More than a dozen of the largest cities allow their paramedics to take patients who appear to be having a stroke to the specialty hospitals.

In Houston, paramedics are allowed to take up to 15 minutes beyond what it would take them to reach the closest community hospital in order to transport patients to a stroke center. “We train paramedics to treat stroke like a trauma incident,” says Charles Grissom, a Houston Fire Department paramedic captain.

Speed is of the essence

Time is the enemy for stroke patients such as Booker, because the part of the brain that is affected is getting starved for oxygenated blood. Each passing minute results in the death of 1.9 million brain cells, but backers of the stroke-center model of treatment believe getting to the specialty centers where blockages can be cleared quickly still reduces the chance for the kind of irreversible damage that makes strokes so debilitating.

“It’s a race against time trying to get the artery open,” says Grotta, who is standing in a hallway at Memorial Hermann with one of his vascular neurology fellows, Sheryl Martin-Schild, when their pagers beep loudly, displaying the phone number to the emergency room.

Martin-Schild, who heads the stroke team at the moment on this day, phones the emergency unit to hear about Booker’s symptoms.

Within a few minutes she, Grotta and others, including nurses, technicians and medical students, descend upon Booker. Before the team can decide what tool to use, they must pinpoint the problem in Booker’s brain.

The drug Activase, also known as tPA, could melt a clot causing a stroke. And a corkscrew-shaped catheter that can be snaked into the brain might yank out a clot.

The corkscrew catheter is useless, however, if the problem is a “bleeder” — a blood vessel that has ruptured in the skull. Giving tPA to melt the clot can cause more bleeding if the problem is a ruptured blood vessel. So the doctors must get a CT scan. But the clock is ticking, and tPA must be given within 90 minutes of the first signs of a stroke to help.

The ability to perform a CT scan quickly is a key element of a hospital becoming a stroke center. Hermann, like many other hospitals, has a CT scanner in the emergency department so it can do scans fast. Instead of taking a patient to the radiology department on another floor for his “head CT,” which might take a half-hour in a community hospital, a patient can be scanned immediately.

Assessing the options

Fifty-five minutes after her pager alerted her to Booker’s stroke symptoms, Martin-Schild is looking at a CT image of his brain. She sees what Grotta calls “a very large clot” — about 1 centimeter long — that has lodged in a critical T-shaped juncture “taking out the blood flow to the whole right side of his brain.”

Martin-Schild quizzes a medical student about what dosage of tPA they should give him.

An hour after the stroke team was called to the emergency room to see Booker, he is getting tPA, which Grotta notes has about a 1 in 5 chance of melting the clot and returning normal blood flow to Booker’s brain.

Even so, Grotta says, it’s “his best shot.”

However, because Booker is in a stroke center, he has more options. Grotta has a member of the stroke team check with another doctor in radiology to see whether he would be available soon to snake a catheter into Booker’s brain to retrieve the clot. He will.

Still, nothing is simple in medicine. The new corkscrew catheter is being tested at Hermann as part of a nationwide clinical trial. Martin-Schild explains the trial to Booker’s family and asks whether they’ll consent to allow the use of the corkscrew. Booker may be assigned randomly to get the catheter treatment, but he also may be selected to just get drugs.

Either way, the medical world will benefit from what’s learned.

A study to yield results

Booker says he understands and asks to be enrolled in the study. He and his family sign consent forms.

“Either way, there is risk,” says his niece Glenda Hawkins.

The trial is designed to see if the risks of using the catheter, which includes bleeding, rupturing blood vessels and sending clot fragments farther into the brain, are justified by a benefit.

“Half of us think it works, and the other half think it doesn’t,” Grotta says. “All I know is that half of us are wrong, and I don’t know which one it is.”

To answer the question with some certainty, the trial uses randomization — admitting patients to the trial with similar conditions and randomly assigning some to the drug treatment, the others to the catheter.

So less than 15 minutes later, a computer in another state decides Booker’s fate. He is put in the drug-only arm of the study.

“The computer has decided,” Martin-Schild tells Booker, explaining he will not get the corkscrew catheter and instead will “get the full dose” of medication.

“When did I have a stroke?” Booker asks. “Today?”

“Yes,” Martin-Schild says.

In the hallway, his sister-in-law, Stephanie Booker, who is visibly shaken, says, “He was well one minute and then not. I guess he’s in the best place he could be.”

As the trend of bypassing community hospitals in favor of specialty centers continues, doctors and health care regulators will continue to weigh the evidence to see whether the practice is good for patients. So far, results have been promising.

A 2006 study in the journal Neurology found that when New York paramedics took patients to stroke centers, the staff delivered care faster than at hospitals not designated as stroke centers.

Today, nearly four months later, Booker says he’s doing “pretty good.” He has limited movement with his left arm and numbness in his left foot, and needs a walker to get around. His speech is fine, but he is unable to work.

“They say it’s going to take time,” Booker says.

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categories: Emergency Medicine

Health care cost to rise over 10%

by Paul Rega, MD — published on August 12th, 2008

AP, 8/11/08 (http://ap.google.com/article/ALeqM5gKKeqGNfL_zlQpb1JpruqBfoxLFAD92G5H700): Health care costs are expected to rise more than 10 percent into next year, according to a survey of insurers by Aon Consulting Worldwide.

But that increase is the smallest Aon has seen in six years. Experts say it shows that efforts to tame costs, such as employee wellness or disease management programs, may be paying off.

“There’s a variety of tactics that employers have been employing over the last 3 to 6 years that has had an impact on the market,” said study director Bill Sharon, an Aon Consulting senior vice president.

Aon Consulting surveyed about 70 health insurers around the country, including companies such as Aetna Inc. and Cigna Corp. It found that actuaries expect costs to rise an average of 10.6 percent during 12-month rating periods starting this year between April and September.

That represents a slight drop from last year’s forecast of 10.9 percent and a bigger fall from 2002, when health care costs were expected to rise by more than 16 percent.

But the percentage likely won’t be what the average employee faces for a premium hike next year. It doesn’t reflect insurance plan designs or changes an employer might make to benefits plans.

“Pretty much every employer has to do something or is doing something in an effort to bring that number down,” Sharon said.

He said actual cost increases have wound up being three to four percentage points lower than preliminary estimates in the past couple of years. Still, he said Aon Consulting’s survey gives employers a benchmark to use as they consider premium renewals.

Many employers have started researching their benefit options for 2009. Consultants say it’s too early for predictions on next year’s health care plan costs.

But Ken Ambos of Equity Risk Partners Inc. said midsize employers could see a cost increase of roughly 9 to 12 percent that they pare down to 6 to 9 percent. Equity Risk Partners is a risk management and employee benefits consulting firm

Costs are still rising to keep up with growing patient demand for services, the needs of an aging population and prescription drug and technology costs, according to Aon Consulting, a subsidiary of Aon Corp.

Overuse and misuse of services and an “out-of-control medical liability system” also contribute to increases, said Robert Zirkelbach of America’s Health Insurance Plans, a trade association representing nearly 1,300 insurers.

“It is encouraging that the growth in health care costs is going down, but there is still more work to be done,” he said.

Zirkelbach said health insurers have offered disease management programs and encouraged the use of cheaper generic drugs to help contain costs.

Employer wellness programs also have played a role, Sharon said. He noted that doctors, hospitals and employers all have worked to curb costs.

“When costs go up as great as this, there’s a lot of market pressure brought to bear on all of the parts of the market to bring those costs down, and I think that’s what’s been happening over the last six years or so,” he said.

Aon Consulting has forecast a steady decline in cost increases since 2002. But Sharon said this decline has grown smaller the past few years, a sign the reductions may be bottoming out.

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categories: Emergency Medicine

Asthma & Second-hand Smoke

by Paul Rega, MD — published on August 12th, 2008

There was a study published in the Journal of Allergy and Clinical Immunology. Its researchers assessed ED visits for asthma in four hospitals before and after the implementation of smoke-free legislation in Lexington-Fayette County, Kentucky.

 The researchers found that during the 32 months after implementation of a smoke-free law, there was a significant 22 percent decline in ED visits for asthma after controlling for the other typical confounders.

However, they did not mention the 36% increase in ED visits associated with anxiety, domestic violence and depression associated with people’s inability to smoke.

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categories: Emergency Medicine