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Audio: Interview With ACP President, Dr. Joseph Stubbs, About H1N1 Flu

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stubbsThis year’s influenza season is unique in that there are additional strains circulating, with unclear medical implications for the US population. I interviewed Dr. Joseph Stubbs, president of the American College of Physicians, to get the inside scoop on what to expect this year with the H1N1 and seasonal flu strains. You may listen to the podcast or read a shortened version of the interview below.

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Dr. Val: Why are younger people and pregnant women more susceptible to H1N1 flu?

Dr. Stubbs: What we think is going on with younger people is that some of the genetic material of the H1N1 flu virus was part of the seasonal flu before the 1960’s. Older individuals may have an enhanced immune response to the novel H1N1 virus because their bodies can recognize it and fight it more effectively. Since younger people have never been exposed to this virus before, they’re more susceptible to it.

As far as pregnant women go, we’re not exactly sure why they’re at higher risk for complications from the H1N1 flu, but it’s possible that their susceptibility is related to changes in the immune system associated with carrying a baby. The immune system has to tolerate and accept the growing fetus – which happens to make it less effective at fighting off viruses.

Dr. Val: What’s the latest on the timing of vaccine availability? Do you think we’ll get it in time to head off an epidemic?

Dr. Stubbs: HHS Secretary Sebelius recently announced that the FDA has approved the novel H1N1 flu vaccine, and it appears that it will be effective with one shot. They’re hoping to make it available within the first 2 weeks of October, which is ahead of schedule. However, we still don’t know how much of the vaccine will be available, and how hard we’ll have to ration it. We hope that this will ward off a major pandemic. But here in Georgia, we’ve already been seeing a large number of cases.

Dr. Val: Should physicians prioritize their patients and give the vaccine to the at-risk groups first?

Dr. Stubbs: Right now we are planning to ration the vaccine initially to those who are at risk, which includes: healthcare providers, pregnant women, people who provide care for infants who are less than 6 months old, children 6 months to 24 years of age, and those ages 25-64 who have chronic illnesses that might cause them to have a more severe case of the flu. If we have enough supply then we’ll also vaccinate healthy adults and seniors. But seniors should make sure they get the seasonal flu vaccine this year.

Dr. Val: How does the H1N1 flu differ from the usual seasonal flu?

Dr. Stubbs: The seasonal flu vaccine continues to kill 30,000 of our citizens every year. The people who most need the seasonal flu vaccine are individuals over age 65, immunocompromised, and young infants. We expect the seasonal flu vaccine to be widely available and we recommend that almost everyone get that as soon as possible.

Dr. Val: Is the novel H1N1 flu virus related to the deadly Spanish flu of 1918 in any way?

Dr. Stubbs: They do share some genetic features, but not all.

Dr. Val: Are you concerned about the H1N1 flu virus mutating?

Dr. Stubbs: We certainly are, though we’re concerned about that with any virus. We’re most concerned about the flu becoming resistant to the anti-viral medicines that we have now like Tamiflu – which we use for people with serious cases of the flu.

Dr. Val: How do people know if they have a “serious” case of the flu?

Dr. Stubbs: If someone is experiencing severe shortness of breath within the first 48 hours of getting the flu, or if they have a severe headache and are not acting themselves or if they have uncontrollable diarrhea or vomiting, that requires medical attention.

Dr. Val: What’s the most important thing for Americans to know about the H1N1 flu?

Dr. Stubbs: The most important thing is not to panic. People should not crowd the ERs just because they think they might have the H1N1 flu – they should only go if their illness is severe as I described before. They should wash their hands frequently, and if anyone gets sick, stay home so you don’t spread it to others. The vast majority of people will get better within a few days.

Mercy Charity Flight Programs For Our Veterans: American Airlines & Robert Gates

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gatesjones

Defense Secretary Gates With Dr. Val

I recently wrote about the heroic efforts of volunteer pilots involved in Mercy Medical Airlift and Air Compassion for Veterans. I met Steve Craven on a shuttle to a Red Cross event with US Defense Secretary Robert Gates. Steve kindly explained a little bit about what some airlines are doing to contribute to our active duty and veterans’ medical transportation needs. I was soon contacted by American Airlines to help them with awareness efforts of their own veterans initiatives.

I interviewed Captain Steve Blankenship, the Managing Director of Veterans Initiatives at American Airlines. Feel free to listen to the podcast or read a summary of our discussion below.

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Dr. Val: Tell me a little bit about yourself, Captain.

Blankenship:  Being a veteran myself (20 years with the US Cost Guard) a count it a real privilege to serve our veterans. During my first 8 years with the Coast Guard I was a helicopter rescue crewman doing search and rescue based out of Miami, Florida. I eventually went to navy flight training and retired from the military in 1991 and was hired to fly for American Airlines for the next 14 years. In 2004 I helped to launch their Veterans Initiative.

Dr. Val: Tell me about Operation Iraqi Children and Snowball Express.

Blankenship:  There are so many children who have never been in uniform, but who have paid the ultimate price of losing a mom or a dad in war as they defend our freedoms.  American Airlines is particularly proud to be supporting childrens’ initiatives. The Snowball Express program involves private flights around the country to pick up kids and their surviving parent to take them on a fun-filled trip during the difficult winter holiday season.

Actor Gary Sinise helped to co-found Operation Iraqi Children where we shipped over 25 tons of toys and educational materials to Iraq. Our troops were able to give out 10,000 individually wrapped gifts to young children in Iraq.

Dr. Val: What about American Airlines’ support of the iBot Mobility System for wounded veterans?

Blankenship: The iBot is a special kind of wheelchair (designed by the guy who created the Segway) that allows its user to sit at an eye level with someone standing next to them.  They can also climb stairs. To date we’ve raised over $700,000 to buy these iBot Mobility devices for our wounded warriors.

Dr. Val: What else is American Airlines doing for veterans?

Blankenship: We fly wounded warriors and their families on charter flights from Brooks Army base to Disney World. We have three dedicated “yellow ribbon” airplanes that we use to fly recovering service men and women to events so they can get out of their rehab centers for a period of time and have fun with their families. This kind of charity comes naturally to us because American Airlines was founded by a military veteran and over 10% of our current staff are either active duty military personnel or veterans.

Every day we go to work, we recognize that the right and privilege we have to fly our airplanes and transport our passengers was paid for by the men and women who wear the cloth of our nation. American Airlines is continually looking for ways to thank them and support the efforts of our military.

Dr. Val: How do military and their families find out more about your programs and services?

Blankenship: They can send me an email directly and I’ll make sure they’re referred to the right place.

steve.blankenship@aa.com

Top Medical Bloggers Discuss Healthcare Reform – A Podcast

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Have you been following these bloggers?

Well you’re in for a treat. I had the good fortune of coralling them for a healthcare reform discussion, lead by Dr. Bob Goldberg of CMPI-Advance. Bob’s recent Op-Ed at ABC can be viewed here. I was going to provide a synopsis of what they said, but then – that would spoil the show!

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Wyeth Vs. Levine: FDA Labeling Overuled By Jury Of Lay People

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Bert Rein

Bert Rein

The New York Times has called today’s US Supreme Court ruling in the Wyeth vs. Levine suit the “most important business case in years.” I have been following this case for many months, astonished that a medical malpractice suit had gotten all the way to the Supreme Court. But even more shocking is the fact that the court actually ruled that lay juries may evaluate the accuracy of FDA-approved drug labels written for healthcare professionals.

In other words, after a team of FDA regulators decide on the very best language to describe potential risks of a drug –  Joe Six Pack can overrule their expertise and hold the drug company liable for any deficit (as he interprets it) in label language, awarding millions to anyone who experiences harm, no matter how well disclosed that risk is.

I reached out to Wyeth’s attorney, Bert Rein, for comment. Here’s a podcast of our interview:

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Here are the highlights from the interview…

Dr. Val: The New York Times is calling Wyeth vs. Levine the most important business case in years. Can you summarize what just happened?

Rein: The court determined that Wyeth’s liability for Ms. Levine’s injury was not preempted by the FDA-approved drug label warnings. They were not convinced that the FDA had declined to strengthen the warning language on the label prior to Ms. Levine’s injury, though Wyeth had in fact requested a label change. In addition, the court held that the FDA’s regulatory regime was insufficient to preempt Ms. Levine from suing Wyeth, because the FDA doesn’t have a regulational requirement for all label updates to undergo federal approval. The court therefore ruled that the suit was well founded and that the state of Vermont should decide whether or not Wyeth’s conduct was appropriate.

Dr. Val: So basically this means that juries can decide whether or not a drug label is sufficiently caveated?

Rein: It goes farther than that. Juries don’t have to determine what the label should say, they merely have to decide that the label isn’t “good enough.”

Dr. Val: So jurors without any medical background are supposed to determine whether or not a drug label offers physicians sufficient warning about medication risks?

Rein: Correct. You’re asking lay people not only to make the decision, but to step into the shoes of physicians and say, “Do I think that label is good enough from a physician’s point of view?” By definition, drug labels are not written for lay people, but healthcare professionals. This is asking a lot of lay people, and I think this case is a good illustration of why juries get it wrong. They see an injured person and say “How could the labeling be adequate because somebody’s been hurt?”

Dr. Val: What impact will this court ruling have on the pharmaceutical industry?

Rein: It means that pharmaceutical companies will have to get “clear records” from the FDA on every drug label controversy going forward. This puts a tremendous burden on their already taxed resources. Also if juries can simply say “this drug label is inadequate” then how will the drug company know how to make it better? What drug companies will have to do is forbid the administration of drugs in circumstance that might incur increased risk. That shifts liability to the physician if they administer the drug outside of the prescribed method – and essentially makes the risk benefit decisions on their behalf.

Dr. Val: So won’t drug companies have to create really long drug inserts to prevent juries from misunderstanding the language?

Rein: Yes, that’s the direction that labels were going before the FDA tried to reform the system. When drug labels are that long, no one reads them. Then professionals really don’t get educated on the true risks and benefits of the drug. Long labels are not designed for provider education but for law suits. Jury dominance always results in risk aversion.

Dr. Val: And isn’t this risk aversion going to slow down the drug approval process in general?

Rein: The industry shies away from developing drugs that have massive liability. That’s why we don’t develop drugs for pregnant women, for example. Any time you unleash a potent liability system, it’s going to factor in to where research dollars are spent. The more the FDA is criticized, the more it tries to protect itself with long drug labels – which ends up slowing down the drug approval process and shifting liability to doctors.

Dr. Val: And phenergan has been safely administered over 200 million times… and so the risk aversion is pretty high, even now with this rather safe drug.

Rein: Right, it’s not as if the drug is rampantly causing injury. Twenty incidents out of 200 million applications is not a very high risk profile. And the few cases where it caused injury, the drug was administered incorrectly. But if you have an injured person sitting in front of a jury of lay people, it seems as if the logical conclusion is that if the warnings were adequate, this wouldn’t have happened.

If we take the American Foundation for Justice at its word, their next move is to try to change the law on medical devices so we can go after those as well. The Wyeth vs. Levine case is good for one industry – the lawsuit industry – and not really anyone else.

###

The Supreme Court decision text may be found here.

What Can We Learn From The Military Health System?

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jeffgruenheadshot2Together the Department of Defense and the Department of Veterans Affairs have the largest and most advanced IT infrastructures in US healthcare. As the Obama administration ramps up funding for electronic medical records and other IT initiatives, one might ask what the public and private sectors can learn from the military IT systems (aka AHLTA and VISTA).

I interviewed Dr. Jeff Gruen about the upcoming Military Health Summit at the World Health Care Congress, April 14-16 in Washington, DC.  Jeff is Head of the Global Healthcare Practice at PRTM, a management consulting firm and a Chairman of the Military Health Summit.

You may listen to our conversation by clicking the arrow button, or read a summary of our conversation below.

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Dr. Val: To set the stage, tell me a little bit about the World Health Care Congress, and what the Military Health Summit hopes to achieve.

Dr. Gruen: This is the 6th annual World Healthcare Congress (WHC), and the first year for the Military Health Summit. We expect 1500 to 2000 participants – the WHC is the premiere event for healthcare services and the healthcare system at large. It brings together people from across all sectors of healthcare and in addition to the general summit events we have this exciting Military Health Summit track.

Dr. Val: What does the healthcare system at large have to learn from the military health system?

Dr. Gruen: Three things: first, we can use the military health system as a case study for IT initiatives, since they’ve already achieved broad adoption of an EMR. It’s not perfect, but it’s used widely and is getting better. The DOD and the VA are working hard to make their systems interoperable.  Second, because the military health system is both a payer and a provider, it serves as a wonderful laboratory for inventing new ways of delivering care. Realigning incentives between inpatient and outpatient care or primary and specialty care can be achieved nicely in the military system, which is like a giant, international Kaiser Permanente. Third, the military has developed very advanced battlefield techniques and devices for saving lives – including telemedicine. So it’s fun to hear about these advances.

Dr. Val: How will healthcare reform impact the Military Health System – do you have any predictions based on what you’ve heard on Capitol Hill?

Dr. Gruen: It’s impossible to know exactly, but let me offer a couple of observations. First, there’s a sense of national patriotic commitment to make sure that our service men and women (and their dependents) get the very best care possible. There’s a real desire to apply the best practices from the commercial sector to the military. PRTM feels very passionate about this, especially since one of our own is currently serving in Iraq right now.

There are a few core problems in healthcare, and they all fall under the rubric of “the right care delivered in the right environment by the right provider at the right time.” These problems may be addressed with interventions including providing point of care decision support, tools that would decrease provider practice variation, and connected convergent care – the idea that we have to move from a system that is designed for acute care to one that is very good at managing chronic care. We also need to move to a system where all the data is present in a very transparent way across environments to allow us to apply the same protocols regardless of whether someone’s in the hospital, or at home, or in a nursing home.  The military health system could get these systems in place in a faster and broader way than the general healthcare system.

Dr. Val: Who should attend the Military Health Summit? How do they register?

Dr. Gruen: Those who should attend include: 1) People actively involved in the Military Health system because it offers an opportunity to interact with their luminaries. 2) Anyone on the commercial side of healthcare who’d like to do work with the military 3) Anyone who is interested in health reform 4) People with a particular interest in health IT (disease management and telemedicine in particular) 5) Anyone who wants to hear about the coolest new things coming out of battlefield medicine.

To register, one need only go to the World Health Care Congress website and follow the prompts for the Military Health Summit.

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