Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems

ABC World News (6/28, story 7, 2:20, Sawyer) reported, "Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems."

        The CBS Evening News (6/28, story 10, 0:30, Smith) reported, "FDA experts meet in two weeks to decide whether or not to pull Avandia off the market."

        NBC Nightly News (6/28, story 8, 0:20, Williams) reported, however, that the drug's maker, GlaxoSmithKline, "said today the drug is effective and safe."

        The Washington Post (6/29, Stein) reports that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death."

        The Los Angeles Times (6/29, Roan) reports that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine."

        USA Today (6/29, Marcus) reports that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death."

        The New York Times (6/29, Harris) reports that "the studies were made public Monday in hopes of influencing an expert panel that will convene on July 13 and 14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." The Boston Globe (6/29, Rowland), Bloomberg News (6/29, Cortez), the AP (6/29, Tanner), the Wall Street Journal (6/29, Mundy, Dooren, subscription required), the Washington Times (6/28, Duke), Reuters (6/29, Fox), AFP (6/29), HealthDay (6/28, Gardner),MedPage Today (6/28, Phend), and WebMD (6/28, DeNoon) also covered the story.

        Lawmakers Call For Avandia To Be Pulled From Market. The Hill (6/28, Pecquet) "Healthwatch" blog reported that "Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday called for the diabetes drug Avandia to be pulled from the market in the wake of two new medical studies." In a joint statement, Sen. Grassley said, "The serious issues delineated in these two new, independent reports put additional onus on advisory committee members when they meet in July."

        Bloomberg News (6/29, Peterson, Cortez) reports that "Grassley and Senator Max Baucus, a Montana Democrat, in February released a report that said Glaxo knew Avandia may cause heart damage several years before" a "study documented the risk."

        Rosiglitazone May Reduce Major Cardiovascular Event Risk In Patients With Type 2 Diabetes And Heart Disease.MedPage Today (6/28, Phend) reported that "rosiglitazone (Avandia) reduced major cardiovascular event risk in patients with co-existing type 2 diabetes and heart disease, according to a post-hoc analysis of the BARI 2D trial." This "trial -- sponsored by the National Institutes of Health, GlaxoSmithKline, maker of rosiglitazone, and other drug companies -- found a 29% reduced composite relative risk of death, MI, and stroke with the use of rosiglitazone versus no drug in the thiazolidinedione class (3.79 versus 5.81 per 100 patient-years, P=0.002)." These "findings reported at the American Diabetes Association meeting presented a dramatically different picture than that which emerged from a 56-trial meta-analysis in the Archives of Internal Medicine and a FDA analysis of Medicare patients in the Journal of the American Medical Association released earlier in the day."

Fwd: House Approves 6-Month SGR Patch

June 25, 2010 House applies latest SGR Band-Aid: The House of Representatives last night passed legislation (H.R. 3962) that would provide a 2.2 percent Medicare fee schedule update for physician services through November. This update would replace the 21 percent cut currently in effect, and be applied retroactively to claims for services provided on or after June 1. The Senate approved this bill last Friday. This just in from CMS ... The agency has directed Medicare claims administration contractors to discontinue processing claims at the negative update rates and to temporarily hold all claims for services rendered June 1, and later, until the new 2.2 percent update rates are tested and loaded into the Medicare contractors' claims processing systems. CMS expects to begin processing claims at the new rates no later than July 1. Claims for services rendered prior to June 1, will continue to be processed and paid as usual. Claims containing June 2010 dates of service which have been paid at the negative update rates will be reprocessed as soon as possible. Claims containing June dates of service that were submitted with charges greater than or equal to the new 2.2 percent update rates will be automatically reprocessed. If you submitted claims containing June dates of service with charges less than the 2.2 percent update amount you will need to contact your local Medicare contractor to request an adjustment. Enough is enough! The entire House of Medicine is fed up with these continued temporary patches. Ultimately patients are the ones that suffer, whether it's through higher co-pays, longer wait times or the reduced access to services. Your ACC continues to urge Congressional leaders to find a permanent solution to the current SGR formula before it's too late. Educating Congress about the real-life impacts of these cuts is one such way. Your ACC provides several ways to facilitate interaction with members of Congress, including through the ACC Political Action Committee (ACCPAC), local Chapters and/or through the annual Legislative Conference. Speaking of Legislative Conference ... Registration is now open for the 2010 Legislative Conference to be held at the Fairmont Hotel in Washington, D.C., from Sept. 12-14. This is a great opportunity to meet face-to-face with members of Congress. A limited number of scholarships are available for FITs, CCAs and Practice Administrators. In addition, the ACCPAC has a number of events planned including its annual Texas Hold Em Tournament, a special luncheon featuring political strategist Karl Rove, and a happy hour for FITs, CCAs, and Practice Admins. Email pac@acc.org for more info. Are you enrolled? Beginning July 6, physicians furnishing services to Medicare patients that require a written order or referral from non-Medicare enrolled physicians will not be paid for those services. Your ACC is awaiting additional guidance on the particular types of services affected by this new rule and will let you know as soon as it's available. In the meantime, cardiovascular practices are advised to closely examine Medicare remittances for informational messages that may indicate a problem with payment on or after July 6. If you see these messages on your claims forms, contact your Medicare contractor for additional guidance. For more on Medicare enrollment policies, click here.

ACC Advocacy: Enough is Enough, Congress!

Within the past several weeks, the House and the Senate approved separate legislation preventing a 21.2 percent Medicare physician payment cut from taking effect on June 1. However each Chamber has been unable or unwilling to consider the other's legislation to stop the Medicare payment cuts. As a result of Congress's rancor, the Centers for Medicare and Medicaid Services (CMS) began processing payments with the 21.2 percent cut last Friday. Enough is enough, Congress! Physicians across the country are tired of Congress's short term budgetary solutions to this ongoing physician payment crisis. This year alone, Congress has approved and allowed to expire three short term freezes in Medicare payment without addressing the growing problem. If allowed to continue, the cuts that went in to effect last Friday will impact your patients the most --- leading to less access, higher fees, longer waits, impersonal care.

SGR Update: I could not have said this better myself

June 18, 2010

SGR Update:

This week has been frustrating for any physician in the United States, and perhaps even worse for cardiologists trying to run small businesses. Congressional gridlock is at its best. That being said, the Senate this afternoon by unanimous consent passed a six-month patch that would give doctors a 2.2 percent payment update through November. The agreement will now go to the House, which has adjourned for the week and will not consider it until at the earliest Tuesday of next week.

On the CMS front, the claims hold expired yesterday (June 17). Because legislation was not signed into law before the weekend, contractors have been instructed to begin processing Medicare claims for physician services provided in June at rates that reflect the 21.3 percent cut. Once the House and Senate act to avert the cut, claims will be processed as follows: (1) where the submitted charge is higher than the new rate, the contractor will automatically reprocess the claim; and (2) if the submitted charge is lower than the new rate, the physician should call the contractor. According to the AMA, no one is going to be reviewing the limiting charge for the period that the cut was in place because CMS assumes Congress will ultimately make the fix retroactive.Finally, the OIG and CMS are close to releasing a document to waive patient co-pay requirements for situations such as the retroactive increases that were made to the geographic practice cost index (GPCI) increases. CMS will share that document once it is available.

Questions/Comments contact ACC Advocate Editor Steve Erickson at advocate@acc.org.

How I used my @BlackBerry today

I took a break from my busy Interventional Cardiology (IC) practice (www.cafconline.com - "shameless plug") to attend a conference with other leaders of IC at Mt Sinai Medical Center in NYC.

Leaving in Fairfield, CT, I took the Metro North commuter train into the city. While on the train, I listened to a podcast on @PodTrapper.

While listening to the podcast, I also could spend my one hour train ride doing the following:
- answering emails I had "flagged" for follow-up that I had not had time to digest and process from the day before
- read some interesting articles from @NYTimes through the BlackBerry app
- read my RSS feeds on @Viigo
- read and tweet to @twitter through my favorite twitter client @socialscope

When I arrived in NYC, I used @BlackBerry Messenger (BBM) to let my know I had arrived safely.

While at the conference I was able to keep in touch with the world using the phone, BBM, sms text, and email.

I took lots of notes and photos during the conference and uploaded them to @EverNote.

I met lots of interesting contacts and exchanged contact info with the @DUB app.

Throughout the day, I kept up-to-date on the @fifa @worldcup by following the matches on @scoremobile for blackerry.

Prior to leaving NYC, I checked the Metro North schedule on the web.

On the way home, I relaxed listening to my favorite "John Mayer" station on @Pandora.

As you can see, despite all the hype about @Apple / iPhone and android -- I love my @BlackBerry. Its realiable, powerful and a productivity beast.

This morning, I'm doing the same thing all over again. In fact, I'm writing this from the train now and will be sending it via email to @Blogger

Ultrasound May Add To CV Risk Prediction In Women Thought To Be At Low Risk By Traditional Factors

For some time, I have been using carotid ultrasound and cardiac echocardiography to help assess my patient's cardiovascular risk. I believe that documenting atherosclerosis in the carotid (need for intensive lipid control, diet and exercise) and evidence of hypertension on echo - increased left atrial size or diastolic dysfunction (need for BP control, diet, exercise) is very helpful to reduce my patients future risk of cardiovascular events.

Now it appears that there is definitive evidence that this is the right approach, specifically in women.

MedPage Today (6/16, Phend) reported that "ultrasound imaging of the heart and the main artery to the brain may paint a dramatically different picture of cardiovascular health in women thought to be at low risk by traditional factors," according to a study presented at the American Society of Echocardiography meeting. Investigators found that, "despite being judged at low cardiovascular event risk by the widely-used Framingham risk score, ultrasound imaging of a small cohort of women (most obese or with metabolic syndrome) revealed abnormalities in the carotid artery, in left ventricular or left atrial size, or in diastolic function." The investigators "recommended screening women diagnosed with obesity or metabolic syndrome using selected ultrasound imaging to help further risk-stratify such patients."

In-Hospital Deaths Greater Among Uninsured

Patients who have had an acute myocardial infarction or a stroke are more likely to die in the hospital if they are uninsured or on Medicaid than those with private insurance, researchers found.

http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/20637

Obama Presses Congress to Avert Medicare Pay Cuts

President Obama called for Congress to avert a 21 percent pay cut for doctors who see Medicare patients, saying the move was necessary to ensure the health of older people.



http://feeds.nytimes.com/click.phdo?i=6acb645ec5f3ab45ef2229f59102e853

A Decade Later, Gene Map Yields Few New Cures

The primary goal of the $3 billion Human Genome Project — to ferret out the genetic roots of common diseases like cancer and Alzheimer's and then generate treatments — remains largely elusive.



http://feeds.nytimes.com/click.phdo?i=5ae08d35b7a00ad24dc7af67679d4d79

A copy of my recent letter to Rep. Jim Himes

As a cardiovascular specialist and member of the American College of Cardiology, I would like to thank you for cosponsoring H.R. 4371 to stop the cuts to cardiovascular specialists which came about as a result of CMS's 2010 Final Rule. At this time, I am requesting your assistance once again.

Rep. Charlie Gonzalez (D-TX) is circulating a letter from members of Congress to Ms. Charlene Frizzera, Acting Administrator and Chief Operating Officer of the Centers for Medicare and Medicaid Services (CMS) . This letter urges CMS to phase-in the 2010 cuts to newly bundled nuclear cardiology services in its upcoming proposed rule for the 2011 Medicare Physician Fee Schedule. 

CMS decided to substantially reduce the payment for myocardial perfusion imaging as part of its 2010 Medicare Physician Fee Schedule. Because there was a new code for the service, CMS did not apply the four-year transition of the practice expense cuts (similar to the other cuts included in the 2010 rule) and instead used the fully implemented value. The result was a 26 percent cut in payment for 2010. This change alone accounted for more than one-third of the payment cuts to cardiology in 2010. 

These cuts have had a devastating effect on my patients and my practice. A phase-in is vitally important as my practice tries to adjust to these and the other cuts included in the 2010 rule. I strongly urge you to intercede and ask CMS to phase in these cuts over the next several years. Please contact Julie Hart with Representative Charlie Gonzalez' (D-TX) office at Julie.Hart@mail.house.gov to sign-on to this very important letter as soon as possible. 

I offer myself as a resource should you have any questions. Thank you again for your time.

Allopurinol and chronic angina

A very small but impressive trial was just reported.

Allopurinol, an old medication to treat gout, has been shown to
improve exercise tolerance in patients with chronic angina.

I'm intrigued by this. The drug has been shown to reduce oxygen demand
in heart muscle. The drug has a good safety profile.

I would like to see this proof of concept tested in a larger trial but
I doubt that this will occur because there will be no funding for it.

Low Levels Of Physical Activity, Fitness May Increase Risk Of Developing High Blood Pressure

From ACC Newsletter:

HealthDay (6/1, Gordon) reported that "low levels of physical activity and fitness significantly increase the risk of developing high blood pressure, a 20-year study of young adults shows." The research is published online in the journal Hypertension.

        WebMD (6/1, Hendrick) reported that "hypertension incidence was 13.8% per 1,000 person-years, a calculation found by taking the number of new cases within a specified time period divided by the size of the population initially at risk." The researchers found that "low fitness was associated with an increased risk of developing high blood pressure after adjusting for smoking, age, sex, cholesterol, race, diet, and other factors." The data indicated that "the estimated proportion of high blood pressure that could be prevented if participants moved to a higher fitness category was 34%