Latest Drugwonks' Blog
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.
FDA Assistant Commissioner for Policy David Horowitz to become a deputy general counsel at the Department of Health and Human Service's Office of General Counsel.
He’ll be missed.
Another opportunity for Commissioner Peggy to remake the agency in her own image.
(And that's a good thing.)
“If you end up seeing patients that cost you money to see, and you have no other ability to make up for that ... then you have to decide if you’re going to continue to see more Medicaid patients,” said Tom Huber, MD, president-elect of the SDSMA in a March 2009 interview for KELO-TV. “If taking care of more people under
the Medicaid program means my business no longer survives, then I’m doing a disservice to all the other patients, and that’s the dilemma that physicians are facing.
You can read all about how shoving people into Medicaid could very well be the most cynical element of health care reform...
http://www.sdsma.org/documents/MedicaidSummerStudy.final.pdf
London, England (CNN) -- The entire genetic codes of two common types of cancer have been cracked, according to scientists, who say the breakthrough could unlock a new era in the treatment of deadly diseases.
Scientists at the UK-based Wellcome Trust Sanger Institute catalogued the genetic maps of skin and lung cancer and have pinpointed the specific mutations within DNA that can lead to dangerous tumors.
Researchers predict these maps will offer patients a personalized treatment option that ranges from earlier detection to the types of medication used to treat cancer.
The genetic maps will also allow cancer researchers to study cells with defective DNA and produce more powerful drugs to fight the errors, according to the the study's scientists.
"The knowledge we extract over the next few years will have major implications for treatment," Peter Campbell from the Wellcome Trust Sanger Institute said.
"By identifying all the cancer genes we will be able to develop new drugs that target the specific mutated genes and work out which patients will benefit from these novel treatments."
Scientists found that the DNA code for skin cancer contained nearly 30,000 errors and lung cancer DNA contained more than 23,000.
"These are the two main cancers in the developed world for which we know the primary exposure," Mike Stratton, from the Cancer Genome Project said.
"For lung cancer, it is cigarette smoke and for malignant melanoma it is exposure to sunlight.
"With these genome sequences, we have been able to explore deep into the past of each tumor, uncovering with remarkable clarity the imprints of these environmental mutagens on DNA, which occurred years before the tumor became apparent."
The study suggests that an error occurs for every 15 cigarettes that are smoked.
Scientists as part of the International Cancer Genome Consortium in other countries around the world are completing similar studies -- the UK is looking at breast cancer, the U.S. at brain, ovary and pancreatic cancer, and Japan at the liver.
Cancer is a leading cause of death worldwide and claims more than seven million lives each year according to the World Health Organization.
Michael Hiltzik writes in today’s Los Angeles Times:
“The debate over healthcare reform is focused on such a small number of hot issues -- should there be a public option, Medicare buy-in, government-paid mental health counseling for Sen. Lieberman? -- that dozens of other questions are cruising under the radar.”
Well, at least we know where he’s coming from.
Hiltzik continues:
“Here's one worth a lot more attention than it has been getting: Is Congress poised to make a big payoff to biotech firms and their venture backers by hindering the entry of a new class of generic drugs into the marketplace?”
He refers to the Eshoo Amendment. He has a lot of problems with it – most notably the fact that it gives innovator products a dozen years of exclusivity. While it’s hard to take anyone who refers to follow-on biologics as “generics” seriously, a few points on why Mr. Hiltzik is completely wrong about the Eshoo language.
First, the Eshoo legislation puts a priority on patient safety by requiring appropriate and stringent clinical trials and testing. This is necessary because biologic drugs are created from living organisms such as proteins and carbohydrates, and are not as simple to replicate as traditional drugs like aspirin and antihistamines.
Second, by protecting adequate data exclusivity, innovator companies will not be forced to charge more for their biologic treatments.
Third, Eshoo’s legislation rewards new biologic innovation by drug companies because it grants them a longer period of data exclusivity to continue research and development to fight other diseases.
Fourth, Eshoo’s legislation gives hope to those suffering from rare diseases or conditions. If drug companies think they will have a short time before a generic version of their product is on the market, they will only focus on the drugs for major diseases and conditions, potentially ignoring ailments that are less common, but equally as serious, to those suffering.
Follow-on biologic legislation must be about balancing patient safety and cost reduction. To ignore either one — or to unnecessarily rush creating this pathway — will only hurt those patients who depend on follow-on biologics the most.
The complete Hiltzik column can be found here:
http://www.latimes.com/business/la-fi-hiltzik17-2009dec17,0,1929214.column
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.
