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PHARMA: The Macular Degeneration Rip Off, By PAT AWASH

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Occassionally I get actual patients writing into me at THCB and sometimes it’s worth letting their experience with the system tell a story about how the opaque world of drug and health services pricing comes home to ground level. This is a verbatim email from a 70 year old patient Pat Awash:

Friday, June 9, 2006 I was facing imminent blindness in  one eye and poor vision in the other. Beginning Saturday a miracle began to unfold after an initial injection in my eye of Avastin. Avastin is used to treat mestasticized colon cancer and someone deduced that it might, just might be effective for Age-Related Macular Degeneration, the leading cause of blindness and vision impairment among the elderly.

Due to an undetermined cause, leaking fluid had formed a large blister behind my retina causing four changes in my eye-glass
  prescription between February 24, 1906 and late May, 2006, the last of which
  did not hold for four days. I was frightened to say the least. Only one day after the injection I  experienced a 70% vision improvement. This improvement continues each day and I am using a three-year-old prescription.
 

I am writing in objection to the current policy of the FDA in regard to Avastin. It is an off-label use but the cost is minimal, only $60.00 when provided at cost as my physician does. The same drug company that
  makes Avastin has developed Lucentis which has a slightly different molecular
  structure than Avastin but is basically an analog. Only thing is, Lucentis will cost an expected $1,500.00 per dose. They claim a reported $400 million research cost but I’m wondering what is included in that amount. 

I hope you get the picture. The manufacturer of Lucentis has changed the drug to the degree that it can be classified as a new drug. Whereas Avastin is expensive when used as a cancer drug it is very  inexpensive for eye treatments because the dose is so small, and some would say Lucentis is not as effective. Once approved, Lucentis will be covered by
  Medicare, a windfall for the manufacturer and huge cost to the public considering a rapidly aging population. Gentech could have done the trial on Avastin.
 
  Everything would be ok except Genentech will no longer make Avastin available except to those who exclusively treat cancer patients.
  No off-label applications and no choice for patients. Thankfully, my physician bought a substantial (several month’s) supply prior to the June 1, 2006 cut-off date.
  I find this insane and I think you will too. I am sick and tired of experts saying how much trouble Medicare is in when this kind of shenanigan is going on.

Respectfully, 

Pat Ahwash (a 70-year-old senior citizen)

TECH/CONSUMERS: Anytime, Anywhere Healthcare

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This panel will focus on in-store clinics, and mobile devices in health care

On the panel is Michael Howe, CEO MinuteClinic, Delmer Dukjhart from Technology Center, Cisco & Don Jones, VP Healthcare, Qualcom

Intro from Richard Adler, IFTF—about 100 clinics around the country, small companies but big partners. Most NP run, no doc on site, but some experimenting with that problem. Lots of encouraging data presented about why these clinics are good in terms of cost and convenience. Of course one question is how much $$ per sq. ft can these clinics generate.

Next steps for these clinics? Video visit booth, with only pharmacy tech or EMT tech, remote contact to clinicians. CHCF has funded Mercer to create this.

Mobile health applications….several applications all built on growth in use of cell phones. Now 75% of adults have a cell phone (more than 60% of those in their cellphones) 8% of cell phones in US are smart phone. NOT just a US phenomenon 25% of worlds pop use them, and several other companies use them Italy’s cell phone penetration is 108%. China has 335m cell phones (25%). Lots of progress in medical devices, sensor arm bands, life shirt, etc, etc (Check out medgadget for more of all this). Two new ones are 3G doctor (apparently coming in the UK) and the VeriChip (My note—it is not far out….it already exists and John Hamalka has already got one).

Michael Howe, CEO MinuteClinic. Started because the founder was pissed off at having to wait 3 hours for an urgent care clinic visit for his kid’s ear infection, brought in retail experience (Michael). Have gone from 19 clinics to 84 clinics. Will have 250 clinics by end of years and going to 1000 clinics by end of 2008. It’s meant for binary decisions on confirmations of diagnosis and simple treatment. Cornerstone of the system is an EMR that functions like a pre-flight check list for a pilot. Can also change the algorithm/care for all clinics. Can provide summary of visit back to PCP if they can accept it.

Don Jones; “it’s very slow to drag that health care mule through the water”….but the fun part of his job is remote glucose monitoring, etc.

Del Dukjhart: So much synergy between wireless devices, clinics and the network. Lots of places where telepresence can get access to good quality health care. He thinks technology can solve many of the problems. Telepresence needs to get to be easier to use, that’s the big rock.

Michael—What’s the impact on PCPs? (my question)….there hasn’t been an impact on primary care docs. There’s resistance at first, but then they work as a complement, and then within a year or so they start giving referrals to their clinics. This is about making access and convenience for patients….it also means that patients will get access to maintenance care more easily. He thinks that the primary care doc is a coach who’ll uses resources like MinuteClinic

 

CONSUMERS/TECH: Technology in health in the next decade

Tech trends….

EMR is now banal, aparently its happening, and there’s congestion in hospitals on traffic over WiFi networks.

Personal products Nike has systems that track your health conditions as you run—your new buzz word is the “Body Area network”. Now we have the development of wearable and implantable biosensors. These sensors will be intergrated with sensors in the environment (Matthew’s Note—Intel has several prototype houses where there are sensors checking in on the occupants all the time). He showed us a list of a huge number of sensors announced in the consumer market place in both persona and ambient information over the last 6 months. Plus there’s also gathering more adn more data from “lifesensing”—capturing images and data from every moment of daily life.

Sensemaking is the process of putting all this data together and synthesizing it into results that can be used.

Abundant computing is going to provide the power to put this all together…so one of the most interesting applications is to take all of life data and synthesise it for new resutlts. Accenture labs has designed a persuasive mirror that is designed to change your behavior (eat too much food, get fat, etc—and show you a picture)

Medical telepresence—at “arms length future” we’ll have a critical care facilty at home—doctors can operate robotically on patients at home. He says this is a reach, (My note: actually I dont think so. We already have robotic surgey and we’re slowly seeing the separation of diagnoses and treatment, and the separation of the hands on/therapeutic process).

 

POLICY/TECH: Foodscapes ( cool word, huh!)

More from the IFTF meeting on Global Health….

Food production is a 200 year old paradigm dominated by producers. Food producers are going to have to deal with increasingly active bio-citizens. More than 70% of Americans identify themselves as environmentalists, while only 5% actually act on that in their shopping choice. And even being an environmentalist consumer is difficult, even if there is transparency about where the food came from, how it was grown and what resources were devoted to it. One site (experimental) is iBuyRight which will allow people to scan products with their cell phone and know all about what that food came from.

If health gets to the center of how we treat food, then this bio-citizenship trend may impact everyone  That make make the boundaries of the corporation more porous. That will make things like socially responsible investment mainstream, we may see more impact on trust and branding of products, which may provoke more regulation. Food is no longer social, it’s more and more political, and changing behavior is going to be a major struggle. So can we improve the way individuals behave, but we also need a wider system change (or at least need to develop one). Lots about individual responsibility versus system change.

My comment: All these theories and information are getting lots of attention, but all the indicators (eating, obesity, fat/sugar consumption, etc, increased pollution, etc, etc) are all getting worse….and all the advertising/marketing is mostly going the wrong way.

QUALITY/TECH/POLICY: IFTF meeting on the Global Health Economy

I’m at an IFTF meeting on the Global Health Economy. IFTF has gone a little off into left field on the “health” issue since I left. They’re slowly coming back relating “health” back to the health care system (the stuff that we care about THCB), but the meeting is about personalized health, people opting out of the health care system, “body hacking” and how companies can sell to the health market (which primarily means food!). More later…

TECH: Is Newer Better? It’s a Coin-Toss, by Maggie Mahar

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Last week The Annals of Internal Medicine roiled the medical world by publishing a study suggesting that the drug-coated stents produced by companies like Boston Scientific and J&J may not be quite as miraculous as first advertised.Following a two-year study, researchers at the Cedars-Sinai Medical Center in Los Angeles are now suggesting that the “putative superiority” of drug-coated stents "is founded on questionable premises. Or as The Wall Street Journal put it, the clinical trials of drug-coated stents (mostly funded by manufacturers), may “have exaggerated their real-life advantage.

Stents, you may remember, are those tiny metal scaffolds that cardiologists use to prop arteries open after they have been cleared of fatty deposits. Since they were approved in the early 1990s, manufacturers have made a fortune peddling the devices which, they say, can prevent a future heart attack while avoiding riskier and more invasive bypass surgery Today, stents are used in 85% of all coronary interventions in the United States.

Before turning to the new Cedars Sinai study, it should be said that THCB has long harbored doubts as to whether these cunning devices represented the best solution for quite so many patients. Back in 2003, THCB quoted a Stanford study which suggested that, over the long term, patients with multi-vessel disease would achieve better outcomes, at a lower cost, if they opted for the bypass.In 2005 THCB questioned the cost-effectiveness of the new, improved “drug-coated” stents that are designed to prevent the growth of scar tissue inside the artery. Granted, the drug coating has a real advantage: without it, scar tissue can cause the artery to narrow again. And while there is no proof that the coated stent improves survival (the scaring rarely leads to deaths from heart attack), scarring can affect a patient’s quality of life by causing chest pain. And ultimately, he or she may need to have the area opened up again.

Thus, drug-coated stents have become wildly popular, thanks in part to what The Annals of Internal Medicine describes as “aggressive marketing” and the unbridled expectations of patients Wall Street likes them too. At $2300 a pop (vs. a mere $700 for the uncoated, bare-metal variety), the newer stents are far more profitable. Despite the hoopla, nine months ago THCB was once again forced to ask “Are Stents A Waste of Money?” after reading about a study of 826 patients, published in Lancet, which suggested that the drug-coated stents made by J&J and Boston Scientific aren’t cost-effective for all patients and should be restricted to those at highest risk for heart attack.

A second 2005 study, published in The New England Journal of Medicine, added to the uncertainty about the widespread use of stents by reporting that patients suffering minor heart attacks do equally well with drug therapy. "In a study colliding with established practice, recovery from small heart attacks went just as well when doctors gave cardiac drugs time to work as when they favored quick, vessel-clearing procedures,” the NEJM reported. "The surprising Dutch finding raises questions over how to handle the estimated 1.5 million Americans annually who have small heart attacks – the most common kind. Most previous studies support the aggressive, surgical approach. ‘I think both strategies are more or less equivalent. I think it is more a matter of patient preference, doctor preference, logistics and, in the long run, it could be a matter of cost,’ said the Dutch study’s lead researcher, Dr. Robbert J. de Winter of the University Amsterdam."

Against that background, it should come as no surprise that the newest study published in the Annals last week is making hospitals think twice about using coated stents.

Continue reading…

POLICY: The times they are a changin’?

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By THOMAS R.LEITH

I am not quite sure what to make of this. In this past Sunday’s (18-Jun-2006) edition of the St. Louis (my fair city) Post Dispatch on Page 1, above the fold, was a story headlined  Is your doctor paid to keep you healthy? Probably Not.

Typically, physicians get paid only when their patients receive care, and more complex care often brings bigger paychecks. At the same time, doctors complain that paltry payments for office visits force them to rush through checkups instead of educating patients about their illnesses, medications and healthy living – all of which might lower future medical bills.

It’s a system that gives doctors little financial incentive to keep patients well. And, experts say, it might be contributing to dangerous, unnecessary care as well as high medical bills.

So, the writer (Mary Jo Feldstein) has got the problem identified. Good. The rest of the story is about three things:

  1. Medicare Advantage (“like” an HMO)
  2. Disease Management & Care Coordination
  3. Essence, a Medicare Advantage plan owned by a big medical group here in St. Louis

The article speaks glowingly about “better quality at a lower cost”, acknowledges in passing that Medicare Advantage beneficiaries all go to doctors chosen by the plan, but then (get this) does not dwell on the restriction of “choice”. This is uncharacteristic of this newspaper. Wow. Oh, and Maggie Mahar’s book gets yet another plug in the article. I thought she’d like to know that.Then on the front page of today’s (22-Jun-2006) WSJ, above the fold is a story (sub req’d) about how the New York State Medicaid department has discovered Disease Management. In a deal struck between the state and Mount Sinai Hospital, their outpatient clinics were designated “Diagnostic and Treatment Centers” which brought higher Medicaid reimbursements. In return Mount Sinai runs a DM program around CHF, and the state’s total Medicaid payments to Mount Sinai Hospital have fallen. But this is evidently OK with the hospital: they have been running at 95% capacity, and would much rather have a bed filled by (say) a commercially-insured ortho patient than by a Medicaid CHF patient. Evidently things are working as expected. The government of New York State has begun to pay docs to keep patients — OK, they’re not healthy. Healthier. Or at least out of the hospital and more functional.So? With attitudes towards the loss of “choice” changing evidently among patients and (significantly) the press, and with a new apparent willingness to pay doctors and allied pros to think and talk to and teach patients, maybe — just maybe the stage is being set for a resurgence of `70s idealistic Managed Care Organizations. Toss in a handful of transparency, shake it up a bit, let it marinate a few years and it could be we have an environment where the Enthoven Plan doesn’t look so revolutionary. Or scary.

TECH/QUALITY: Buying Guidant still such a great idea?

“We knew, when we did our due diligence, that the [cardiac rhythm management business] of Guidant hadn’t had its last recall,” Chief Executive Jim Tobin said on a conference call with analysts and investors. He said it will take 18 months to 2 years to resolve all of the issues related to the acquisition.

So that’s what the CEO says but the market doesn’t really believe him. As it is Boston Scientific stock is down about 6% on the latest recall of a Guidant device. And that’s before the real story of the future of the Drug Eluting Stent gets out. (More on that arriving at THCB any day now).

TECH: Barcoding prevalent almost everywhere! (Just kidding)

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Brian Klepper writes to tell me that in today’s almanac

On this day in 1974, bar codes were first used in supermarket checkout lanes. In a Marsh’s supermarket in Troy, Ohio, the first product to be scanned was a 10-pack of Wrigley’s Juicy Fruit chewing gum. It just happened to be the first thing lifted from the cart. Today, the pack of gum is on display at the Smithsonian National Museum of American History in Washington, D.C.
Of course bar coding is used uniformly in every health care establishment now, so why would the fact that retail’s been using bar-coding for 32 years be on this blog? Oh, hang on a minute….
assetto corsa mods