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This end-of-year revelation comes after my wife’s emergency appendectomy. Here’s the briefest chronology:
2AM: Horrible stomach pain and other relevant symptoms.
5:45AM: 911 call
5:50AM: EMTs arrive
6:00AM: Arrive at emergency room
6:07AM: Wife in emergency room bed
6:15AM: Nurse takes blood
6:20AM: Initial physician consultation
6:25AM: Wife on saline and anti-nausea drip
7:00AM: Wife gets some morphine
7:00AM – 11:00: Wife rests comfortably waiting for CT scan
11:00AM: CT scan (One machine was out of service, hence the long wait.)
11:10AM: Resident confirms diagnosis of appendicitis
11:15: Initial consultation with surgery resident
1:00PM: Surgery prep
2:00PM: Surgery
3:30PM: Recovery Room
5:00PM: Admitted to empty room
9:30AM (the following day): Released
To use a pain intensity scale analogy – the entire experience was only “moderately painful.”
Which brings me back to the plural of anecdote being reality. As a good resident of the 21st century, I used Facebook to let my friends and family know about my wife’s condition. The Americans were all appropriately sympathetic. The Europeans were mostly amazed. Amazed that we didn’t wait hours for an emergency room bed. Amazed that we saw a doctor in fewer than 5-8 hours. Amazed that we weren’t told to go home and come back at a later date (since her white blood cell count was only slightly elevated and the appendix wasn’t in danger of bursting) and not amazed but astounded that the surgery was done immediately. That there was actually a room available and that it was vacant – at a large urban hospital – they couldn’t even fathom.
Here is one verbatim comment from one continental comrade:
“I waited three days in London to see a GP and 20 hours at ER for an "exploratory op." It burst and I nearly died (to say nothing of the two life-threatening incidents whilst I was being "cared" for). But hey! The public option is better than letting people choose, right?”
So, while the plural of anecdote isn’t data – it is reality. And, in the immortal words of George Santayana, “Those who do not learn from history are doomed to repeat it.”
Speaking of General Santayana, here’s one of his less famous observations – keenly apropos of the current debate on American healthcare reform, “Fanaticism consists in redoubling your efforts when you have forgotten your aim.”
And the occasional anecdote goes a long way to reminding us of that, um, reality.
“The Food and Drug Administration is developing guidelines that will set tougher scientific standards for data from tests on humans that makers of medical devices submit when seeking approval of their products, a top agency official said.
Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, said in a telephone interview on Monday that the F.D.A. most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, he added.
The F.D.A.-sponsored study found that more than 40 percent of the studies used to approve cardiovascular devices had lacked high-quality data about either the treatment or safety goals of the study. In addition, that study also found that about 25 percent of trials had failed to adequately follow the outcomes of a sufficient number of patients, a level the review defined as 90 percent or more of patients initially enrolled in a trial.”
The full New York Times story can be found here.
According to a new report just issued by the Center for Technology and Aging, medical optimization (“med-ops”) via information technology is an important element to improving medication-related errors and improving medication adherence among older adults.
The report says "widespread use" of technology aimed at this population could save thousands of lives and billions of dollars.
"More widespread use of technologies that reduce the cost and burden of medication-related illness among older adults is urgently needed," said David Lindeman, the center's director.
The Institute of Medicine reports that more than 2 million serious adverse drug events and about 100,000 deaths occur annually due to medication use problems. The New England Healthcare Institute estimates that $290 billion in healthcare expenditures could be avoided if medication adherence were improved.
"Medication non-adherence is responsible for up to 33 percent to 69 percent of medication-related hospital admissions and 23 percent of all nursing home admissions," said Lindeman. "As Congress debates ways to improve our healthcare system and lower costs, it will be critical to put in place incentives that encourage providers to accelerate the use of available 'med-op' technologies."
The report addresses three areas of opportunity for medication optimization: reconciliation, adherence and monitoring. It describes the technologies being used or under development within the three areas along with an assessment of their pros, cons, market stage and economics.
Some of the technologies described include:
* Medication kiosks, such as those piloted at the Veterans Health Administration;
* Walgreen's online medication history tool for consumers;
* Cognitive assessment tests like the Mini-Mental State Exam (MMSE);
* "Rex," a talking pill bottle designed by Pittsbugh-based MedivoxRx that assists visually or cognitively impaired patients;
* The Med-eMonitor System, a portable electronic medication-dispensing device from Rockville, Md.-based InforMedix;
* Mobile phone apps with medication management, reporting and trending features; and
* Wireless point-of-care testing devices to monitor medication use.
According to the report, of the 3 billion medication prescriptions issued each year in the United States, 12 percent are never picked up by the patient and 40 percent are not taken correctly.
"And yet, effective tools and technologies already exist to greatly reduce these problems," said Lindeman. "Ultimately, medication optimization technologies can lead to significant improvements in the cost and quality of care for older adults."
Number of words devoted to such concepts in both the House and Senate health reform bills? Zero.
The best that can be said about this cynical exploitation of people and families in hospice settings is that at least there is no Death Panel making coverage decisions. The cut is across the board, one size fits all and designed not to save lives or save Medicare as Senator Reid claims, but to win the support of specific Senators and special interests. Connecticut’s Chris Dodd gets a hospital, New York and Florida get to keep Medicare Advantage, a program that allows poor seniors to get additional services (like hospice) without paying more premiums while millions of other seniors will be tossed from the program. (They will be able, once again, to buy expensive supplemental insurance from AARP, which coincidentally supported the health care bill.) There are very special Medicaid payments for Ben Nelson’s Nebraska, which already gets more dollars per person and a higher federal share of payments than the programs average.
Liberals excuse this behavior by claiming it is the one-time cost of getting a deal done that benefits the nation as a whole. However, such horsetrading – cutting benefits to free up cash for universal healthcare is a central feature of both the House and Senate bills and of government run systems in general.
Healthcare policy and deal making is already a big business.
It is easier to get cuts by force than through regulatory “reform.”
And, when it comes to health care, there seems to be nothing but wild cards. From “the deal” that Billy Tauzin cut with the White House to the future of follow-on biologics, from the “doc fix” to clinical effectiveness, from closing the doughnut hole to paving a pathway for follow-on biologics, there are enough issues in play to offer at least a dozen plausible scenarios. They’re all interesting and important. But some (in a very Orwellian sense) are more important than others.
The most important is the future of innovation.
For the rest of the story, see here.
Late one recent wintry night in the midst of congressional deliberations over healthcare reform, having worked hard on trying to reconcile the many swirling eddies of the current debate, I retired to bed for a few hours of fitful respite. That is until I was awoken from my solemn slumbers by a billowy translucent apparition who identified himself as the Ghost of Healthcares Yet-to-Come.
“Away ye spirit,” I intoned, “for I need my sleep and indeed I see you for what you really are – a detail rep for prescription sleep aids.” “Nay,” replied the apparition. “I am here to reveal to you alternate realities for American healthcares yet-to-come.” And with a wave of his spectral hand appeared a magical black bag. “Look within,” he intoned. “And see how the future of American healthcare can unfold.” “Did you bring a pizza by any chance,” I queried? “Sorry, can’t do that any more,” the ghost replied. “Let our journey begin.”
And so from inside his ebony satchel he ceremoniously withdrew a heavy, leather-bound tome with a caduceus embossed on the cover. “What alchemist’s manual is this?” asked I. “It is,” whispered the spirit, “from the cabinet of doctors Pelosi and Reid. It is the final version of healthcare reform legislation.”
“Oh splendid visitor,” I pleaded. “May I gaze upon these pages and take notes for my blog? “NO!” the ghost sternly admonished. “You may look at the book but may never read what is inside – just like members of Congress before the final vote.”
“Not fair,” said I. “Alas,” the specter replied. “Such is the future when healthcare legislation is focused primarily on politics rather than on advancing the public health.”
“But it need not be that way,” my navigator continued. “Let us move on to an alternate future.” And with that he once again reached down into his black bag, revealing not a book but a Kindle. “Power it up,” he directed. “And see another future for American healthcare.
And it was wondrous. A future of enhanced access, innovation and accelerated approvals. A future where, with appropriate FDA guidance, pharmaceutical companies actively engage in social media. A future where insurance companies reward their customers for medication compliance, weight loss, smoking cessation, and disease prevention. A future with a national standard for electronic medical records and e-prescribing. A future where the insurance industry offers high quality health policies across state lines to the many millions of previously uncovered Americans at significantly lower costs. A future where reimbursement decisions are based on patient-centric concerns rather than 20th century cost-centered models. A future where physicians are compensated fairly by Medicare and Medicaid. A future where, through enhanced transatlantic regulatory harmonization, there is no “approval gap” for drugs, devices, or diagnostics. A future where the only doughnut hole question we consider is cream-filled or regular. A future where drug importation is a side show panel not in the US Senate, but at Ripley’s Believe-it-or-Not.
“Can we peer into the future of the FDA,” I wondered.
“You’re such a wonk,” said my ethereal companion. “If you insist.”
And insist I did. As I browsed further into the magic Kindle I saw an FDA that’s both regulator in protecting the public health and colleague in helping to advance it via the Reagan Udall Foundation. I saw an FDA with a cutting-edge information management system. I saw an FDA that embraces predictability over ambiguity. I saw an FDA that understands the unintended consequences of early risk communications.
“Is such a future possible,” I asked.
“Indeed it is,” the eidolon answered. “It is possible if we believe.”
“If we believe in what,” I asked. “In Santa Claus?”
“No, intoned the wraith, “in the Non-Interference Clause. If we believe in free market competition and personal responsibility; in putting and keeping the patient in the center of every conversation; at long-term rather than short-term savings; in hard facts rather than political platitudes; in allies rather than enemies. If we believe that, in order to save lives, reduce costs, enhance quality, and deliver on the promise of robust health to all groups of Americans, all of the players in the health care debate - including government - must work together as a team, as a unit, as a public health defense force armed and ready to advance the public health.”
“How can we ensure this pathway,” I beseeched.
"Let me tell you,” said the phantasm, “what my friend Ebenezer Scrooge once said to a colleague of mine. He said that men's courses will foreshadow certain ends, to which, if persevered in, they must lead.”
"But,” I asked, “if the courses be departed from, the ends will change. Say it is thus with what you show me."
But, before he could answer, I saw an alteration in the Phantom's hood and dress. It shrunk, collapsed, and dwindled down into a bedpost.
I awoke. Yes! And the bedpost was my own.
"The Food and Drug Administration, the National Institutes of Health, and a new Cure Acceleration Network Board are supposed to work together to facilitate the discovery of such cures and to translate them from bench to bedside. Grants can be made under the project of up to $15 million a year to eligible entities such as academic medical schools, biotech companies, and drug companies, who need only meet a $1 to $3 matching requirement. $500 million is appropriated for this program for 2010. "
Now here's Jost's take:
"This is all well and good and a great idea. But nothing that I can see in the legislation gives the taxpayer any stake in this investment. A drug or biotech company that in fact discovers a blockbuster drug or biologic through the federal government’s investment (perhaps for an off-label use) owes nothing in return. Shouldn’t we the taxpayers get some return on our investment, or at least the promise of reasonable prices?"
So money losing biotech companies develop a cure for, say Alzheimer's, with the help of maybe a $3 million grant and Jost frets about the taxpayer return. Am I missing something? Meanwhile he has no problem with billions being scattered to various Senators and pet demonstration projects that perpetuate current halfway treatment patterns?
If you want to know why health care reform is so....frustrating, just look at Jost's parade of blogs on health policy.
Here's the OMB director to Harry Reid saying all bets are off when it comes to the human cost:
"Based on this extrapolation, CBO expects that Medicare spending under the legislation
would increase at an average annual rate of roughly 6 percent during the next two
decades—well below the roughly 8 percent annual growth rate of the past two decades
(excluding the effect of establishing the Medicare prescription drug benefit). Adjusting
for inflation, Medicare spending per beneficiary under the legislation would increase at
an average annual rate of roughly 2 percent during the next two decades—well below the
roughly 4 percent annual growth rate of the past two decades. It is unclear whether such a
reduction in the growth rate could be achieved, and if so, whether it would be
accomplished through greater efficiencies in the delivery of health care or would reduce
access to care or diminish the quality of care. "
And if so, will it even offset the explosion in costs triggered by tossing money to millions of middle class people for more generous health care or stem the exodus of doctors stuck with a 20-30 percent loss of income...
The impact of this legislation, if implemented, will reverberate through our culture and politics for decades.
Senior White house adviser David Axelrod said the Obama Administration "will push forward on safe re-importation of pharmaceutical drugs after the healthcare reform bill is finished."
According to Axelrod, "Let me be clear: The president supports re-importation, as he said, safe re-importation of drugs into this country. There's no reason why Americans should pay a premium for the pharmaceuticals that other people in other countries pay less for. And we will move forward on it."
If, by using the term “re-importation,” Axelrod means drugs that have been approved for sale in the United States, put on a truck or a plane or a ship and sent overseas – then he’ll be disappointed to find that there are precious few -- if any. If, on the other hand, he means “importation” – then what he’s saying is that the President supports the importation of foreign price controls.
And if, by “safe re-importation,” he means that the FDA can somehow be the guarantor of global drug safety (or even guarantor of drug safety for a dozen or so foreign nations) – then he’d better seek out expert opinion on the matter.
A good place to start would be the FDA.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
