March 7th, 2009 by Dr. Val Jones in Medblogger Shout Outs, Quackery Exposed
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Dean Ornish writes:
…let’s use science to evaluate ideas that might seem a little weird or offbeat, but deciding a priori that an idea is stupid or worthless just because it doesn’t fit the conventional paradigm is, in my humble opinion, the epitome of being unscientific.
Dr. Benway responds:
There’s weird and then there is weird.
Diet and excercise affecting cancer? Plausible.
Naturopathy? Weird.
Subluxations? Homeopathy? Delusional.
MDs selling self-branded supplements? Embarrassing.
Chelation and coffee enemas for kids with autism? Evil.
I believe you are the plausible wrapping paper surrounding a coalition of crazy, weird, embarrasing, and evil ideas that some want to “integrate” into the universal health care bill.
March 4th, 2009 by Dr. Val Jones in Audio, Expert Interviews
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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 4th, 2009 by Dr. Val Jones in Primary Care Wednesdays
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By Alan Dappen, M.D.
What Goes On In the Back Office
“The Funnel” details how physicians’ must treat patients if they expect to stay in business. Herding patients through “The Funnel” is meant to depersonalize every problem into 10-15 minute slots. It’s not that doctors don’t care, in fact, morale on the assembly line of primary care is terrible. It’s just that there seems to be no solution doctors have found to sustain the financial realities they face under the insurance-driven system. I’d like to show you some cold hard numbers.
The healthcare system has been a gold rush of opportunity. In sixty short years the healthcare has brought wealth to lawyers, drug reps, insurance companies, malpractice coverage, transcriptionists, billing specialists, authorization departments, performance evaluators, and certification organizations, just mention a few. Each fill their niche, presumably to add value and quality to the service. As they’ve tagged along in the healthcare system, the patient’s $20 co-pay covers less and less, while a physician’s office pays for more and more. Those that are making money off of the healthcare system are often predatory, inadvertently driving up the cost to the patient, hence causing insurance premiums to double by 2016.
Below details the monthly expenses for a typical primary care physicians practice (not supporting obstetrics). Most of the expenses listed are in line with a those costs for running a typical business. However, what is alarming are the salaries for administrative, or non-physician, staff salaries, which consume about one third of the incoming money received. Many members of this staff are billing specialists needed to negotiate the ever-changing rules and regulations of the third-party insurance providers and receptionists, as well as schedulers and managers to get you into The Funnel.
Table based on both Medical and Dental Income and Expense Averages, 2004 Report Based on 2003 Data, published by the National Association of Healthcare Consultants; and expense records provided by doctokr Family Medicine.
Doctors, like all of us, can’t work for free, and want to receive a paycheck that will allow them to live comfortably, raise a family and pay off their large debts from medical school. Let’s say the above medical office paid their doctor a yearly salary and benefits of $162,750, the office then would need to bill $36,845 a month to stay in business. Since a doctor can only physically see patients a total of six hours per day (or 120 hours per month), this equates to a doctor needing to bill $307/hour to simply break even. At a more granular level, each minute costs the doctor roughly $5. Doctors have figured out that they can further reduce this per minute cost if they band into larger group practices.
But here’s the rub: the patient pays for 3-4 minutes of the physicians overhead (the $20.00 co-pay), leaving the doctor and his staff to bill and fight for every dollar they can make from the insurance company. Six hours of “patient care” translates to another four hours of uncompensated work while the physician completes medical notes, follows up with hospitals, specialists, and labs, answers patient call and prepares for the next day. The standard work week is 50+ hours before adding nights on call and weekend coverage which is done for free.
How do doctors survive? They employ billing specialists, they speed up their visits, they “upcode” their notes when possible. But most importantly, doctors deploy “The Funnel,” which brings us back to where we’ve started.
Until next week, I remain yours in primary care,
Alan Dappen, M.D.
March 3rd, 2009 by Dr. Val Jones in Announcements, Expert Interviews
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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.
