March 25th, 2009 by Dr. Val Jones in Expert Interviews, Health Policy
Tags: Big Pharma, Billy Tauzin, Healthcare reform, Pharmaceutical Research and Manufacturers of America, Pharmaceuticals, Phrma
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Today I participated in a conference call with Billy Tauzin, CEO of PhRMA (the Pharmaceutical Research and Manufacturers of America). The goal of the call was to let bloggers know about PhRMA’s position on healthcare reform. I counted at least 12 bloggers on the call, and I was the only physician. It pains me to see how few physicians participate in reform discussions and I’d like to get more of us involved.
The salient points, as I understood them, were:
1. PhRMA would like all Americans to have health insurance. They believe that Medicare Part D is a model health insurance program. They do not support a single payer system because it would likely attempt to cut costs by rationing care and denying options to patients. They don’t believe that insurance coverage mandates are a good idea unless the insurance is subsidized to the point of being affordable for all. They favor the current public (Medicare and Medicaid for the elderly, poor, or disabled) private blend of insurance, with roughly 50% of the population in each category.
2. PhRMA would like to support “precision medicine” where treatments are tailored more effectively to the individual. Mr. Tauzin suggested that some FDA-approved drugs are only effective for 30% of the patients in a given disease class. He’d like to see more research devoted to figuring out why that is, and supports comparative clinical effectiveness research insofar as it furthers this agenda.
3. PhRMA wants to preserve the unique features of the American healthcare system – to maintain our leadership in biomedical research and new drug development, and to protect the sacred shared decision-making between physicians and patients (to shield it from government intervention).
4. PhRMA wants to support IT infrastructure that would track patient medication compliance and let physicians know when/if they fill their prescriptions.
Now, the business case for all four of these positions is clear – the pharmaceutical industry benefits from having everyone able to afford medications (i.e. universal coverage), personalized medicine would reward the development of new and innovative drugs and establish a consumer base for many different treatments, protecting the doctor-patient relationship allows for off-label use of medications and a broader array of similar drugs, and IT infrastructure would help to increase drug purchase and compliance with treatment regimens, thus increasing overall sales.
However, the truth is that PhRMA’s positions on healthcare reform – beneficial as they are to themselves – also happen to be beneficial to patients. Increasing the number of insured improves access to medical care, personalized medicine could create more effective treatments with fewer failure rates and side effects, shared-decision making empowers patients to make the right decisions for their circumstances (with their physician’s guidance), and IT solutions that facilitate medication adherence, tracking, and reminder systems could improve patient health outcomes and keep them out of the hospital.
So, in a way pharmaceutical companies, advocacy groups, and physicians are fairly well aligned on many aspects of healthcare reform. Now if certain members of Big Pharma would please give up on those “me-too” drugs, stop creating more expensive medicines by simply combining two perfectly good ones into a new pill, stop hiding negative research studies, and refrain from aggressive direct-to-consumer marketing tactics, we might all really be on the same page.
***
Interesting factoids from call:
- Medicines only account for 10% of total healthcare costs (unchanged from the 1960s), but they “feel” like a larger cost driver because health insurance doesn’t cover their cost as completely as they do hospital fees.
- There are about 750 new cancer drugs in the research pipeline.
- Half of all prescriptions remain unfilled.
- Physicians provide 30 billion dollars a year in free care.
- The United States conducts 70% of the world’s research in biomedicines.
Please check out Billy Tauzin’s amazing story of triumph over cancer.
March 8th, 2009 by Dr. Val Jones in Announcements, Expert Interviews, Health Policy, Medical Art
Tags: Abraham Lincoln, Balad, Exhibit, Forensic, Iraq, Museum, National Museum of Health and Medicine, NCIS, Pathology, Tim Clarke, Walter Reed, Wounded Warriors
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In yet another example of a fortuitous Twitter connection, Tim Clarke, Deputy Director of Communications for the National Museum of Health and Medicine reached out to me after I tweeted about Walter Reed. He graciously offered to give me a guided tour of the museum, located on the Walter Reed campus where I volunteer with the Red Cross.
We spent about an hour reviewing some fascinating exhibits, including the history of body identification techniques. If you’re a fan of NCIS, then you should run (not walk) to this museum to gain insight into the incredible evolution of forensic science over the past 150 years. The exhibit begins with Paul Revere’s dental tools (did you know he was a part-time dentist?) and the story of how he identified the body of a fallen soldier for whom he’d done some unique silver smith work.
The time of death and relative age of human remains can be gauged by bone erosion (they become smoother with age) and material evidence (the type of button found near the remains can be used to identify the season of death – larger buttons were used for heavy winter overcoats for example) among other things.
Did you know that finger print analysis is not automated? Apparently, to this day, a technician must be involved in the computer-generated comparisons because finger prints are too complex for 100% accuracy with computer models.
However, with the advent of DNA analysis, extraordinary advances have been made in our ability to identify remains. In one particularly fascinating case, Charles Scharf’s body was identified after his wife brought in a letter that he’d sent to her from Viet Nam in 1965. She had kept it in a plastic bag in a shoe box since that time. Charles had sealed the letter with his saliva, and because of the excellent condition of the envelope, tiny pieces of DNA remained in the glue. In 2006 pathologists were able to link his remains to his DNA sample, and finally confirm his fate.
Modern autopsies can be performed rapidly with the guidance of CT scanners. The likely internal injury that caused a soldiers death can be identified via CT, and then rapidly confirmed by pathologists. Research into armed forces injuries can result in improved equipment and increased safety. In one case, a retrospective analysis of CT scans demonstrated that military personnel had larger chest cavities (on average) than initially thought – this resulted in the provision of longer needles for chest tubes in trauma bays.
And speaking of trauma bays, the museum has transported an entire trauma tent from Balad Air Force Base in Iraq to memorialize medical care during the war. A 3000 pound concrete slab of flooring provides the base of the exhibit, complete with original blood and betadine stains, gouges in the plastic floor sealant, and duct tape. Original metal tent doors and canvas show evidence of sand storm damage, with sand still coating the tent air ducts. Action photos taken at the trauma bay surround the exhibit. Nothing brings home the reality of war like this living 3-D memorial.
Just to the left of the tent is a large photo of a Black Hawk helicopter and a wounded soldier being carried by EMS through a canvas archway. On the ceiling of the archway is an American flag. I turned to Tim and asked him why the flag was on the ceiling and he said,
“That was so the soldiers could look up from their stretchers as they arrived at the medical facility and know that they were ‘home.’ They were safe now, and were going to be taken care of.”
Tim also introduced me to the Abraham Lincoln exhibit, where the bullet that sealed his fate (along with skull fragments, a tuft of his hair, and his surgeon’s sleeves) are on display. It’s an extraordinary feeling, being so close to history.
I’m really glad that I had the chance to experience history with Tim, and I strongly recommend that you contact him to set up your own guided tour. If you’re a member of a professional society, or are coming to DC for a meeting or event, why not make the National Museum of Health and Medicine a part of your travel plans?
March 4th, 2009 by Dr. Val Jones in Audio, Expert Interviews
Tags: Amputation, Bert Rein, Case, Gangrene, Jury, Legal Case, Phenergan, Preemption, Supreme Court, Wyeth vs. Levine
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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:
[Audio:http://blog.getbetterhealth.com/wp-content/uploads/2009/03/wyethvlevine.mp3]
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.
March 3rd, 2009 by Dr. Val Jones in Announcements, Expert Interviews
Tags: Alain Ochoa Torres, Diario Medico, Dr. Val Jones, El Mundo, Spain, Spanish, Twitter, Twitterview, Unidad Editorial
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Will Twitter wonders never cease? I was recently contacted by one of my Twitter followers from Spain – Alain Ochoa Torres, a journalist with Diario Medico (Spain’s leading publication for healthcare professionals). Alain has spearheaded a creative new social media strategy: the Twitterview. I am the eighth interviewee in a series featured on Twitter. Tomorrow (March 4th) at 10:30am EST I’ll be typing back and forth – live – with Spanish physicians who have questions about American medicine and the media. You can tune in by following me “drval” on Twitter, or by searching for this word on Twitter: #dm8 (that stands for Diario Medico, interview #8).
For those of you who don’t know about Twitter, it’s a micro-blogging platform that is limited to 140 characters per post. That means I’ll have to master the “sound bite” in my interview responses! To see how I do… you can watch the interview live or search for it later on Twitter by entering #dm8 in the search box at the bottom of the Twitter home page.
This is a really innovative use of Twitter technology – and one that brings together physicians from both sides of the Atlantic. I’m really honored and excited to be part of this social media event and hope to do more of them.
And the good news is that this interview will be in English (my Spanish vocabulary is limited to things like “where is the pain?” and “turn your head and cough” – hardly substantial enough for a Twitterview.)
Hope you’ll join the experiment with me.
February 23rd, 2009 by Dr. Val Jones in Expert Interviews, Health Policy, Uncategorized
Tags: AARP, AMA, Becky Patton, Bill Novelli, Dr. Nancy Nielsen, Fiscal Responsibility Summit, Rich Umbdenstock
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Today there was a Fiscal Responsibility Summit held at the White House. Bill Novelli, CEO of the AARP attended the summit as part of the work group on health. Bill reported what he observed in his work group (which consisted of notables such as Senators Baucus, Rangel, and Specter, Nancy Pelosi, Nancy Nielsen, MD, Becky Patton, RN, Rich Umbdenstock and others) on a special media conference call today.
The over-arching theme of the work group discussion, according to Bill, was prevention and wellness. The group agreed that the key to improving Americans’ quality of life and controlling the costs of chronic disease lies in preventive health efforts. In addition to this belief, the group agreed that:
1. Healthcare reform must be achieved as quickly as possible. The path to long term entitlement sustainability requires healthcare reform. Simply expanding access to a broken system is not the solution.
2. The American people need to be engaged in reform efforts – not just as patients, but as tax payers and voters. They need to understand what they will gain and lose.
3. We must reward adherence to best practices and healthcare quality.
4. A public-private partnership is critical to achieving reform.
A few interesting points were raised by various stakeholders in the meeting:
1. Arlen Specter – believes that changes in medical approaches to end-of-life care could decrease costs substantially. He called for more advanced directives, and education about end-of-life care options.
2. Dr. Nancy Nielsen – called for Medicare to fix the physician fee schedule.
3. Becky Patton – called for increasing the nurse and healthcare workforce.
4. Rich Umbdenstock – requested that more attention be focused on pay for performance and administrative simplification initiatives.
I asked Bill how many providers were included in his work group, and he mentioned three (Nielsen, Patton, and Umbdenstock – not really a provider himself). Best I could tell, there was only one physician and one nurse at the meeting. And that is fairly shocking to me.
If healthcare reform is happening without much input from the primary providers of care (doctors and nurses) – will the reform decisions made by these well-intentioned individuals make good clinical sense?
Another reporter asked Bill what he thinks will happen with healthcare reform in the near term. His answer was telling: “We don’t know.”
