Latest Drugwonks' Blog
I am not even talking about health outcomes. I am talking about the care actually being there.
As Woody Allen once said: "80 percent of success is showing up." So therefore:
How long will families have to wait to see a doctor for both a sick or well check up?
How long will they have to wait to get referred to a specialist or receive authorization for a procedure or medicine?
Studies show that over time increases in SCHIP enrollment have done nothing to reduce the use of emergency rooms as a routine source of care. Has anyone ever care to ask or find out why? We know that "high ED use in some communities also likely reflects generic preferences for EDs as a source of care for nonurgent problems..." but shouldn't SCHIP be organized in ways to reward less expensive but equally effective sources of care? For further details. see here.
This is not a matter of public vs. private as much it is as trying to make sure the health coverage some how translates into better health. Without a sustained effort the promotes competition based on price, quality and convenience, SCHIP will degenerate into Medicaid for the middle class.
According to a story in today’s
Personalized medicine is not about denying care. It’s about providing “the four rights” (the right medicine in the right dose to the right patient at the right time). Personalized medicine can (indeed must!) be both cost-effective and patient-centric.
Yet, on the reimbursement front, many payers aren’t ready to accept the up front expense – even though the longer-term savings can be substantial. For more on this issue see "Diagnostical Materialism.”
Diagnostics reimbursement should be based on value rather than activity.
On the regulatory front greater clarity and predictability are required. At present, FDA guidance on diagnostic approvals are vague. To reinforce the agency’s commitment to personalized medicine, the FDA should embrace ever-greater clarity and commitment to diagnostic tool review. This should be a top priority of the agency’s Critical Path program.
The Critical Path Institute (created in 2005 by the
According to a recent article in the Journal of Life Sciences,
“The United States Diagnostic Standards will offer a voluntary certification for laboratory and pathology diagnostics, much like the Underwriters Laboratories certification for many tools and equipment. Companies already submit their tests to data test sites for evaluation prior to FDA submission, says Jeffrey Cossman, chief scientific officer of C-Path. This would take the place of a data test site.”
This speaks directly to the contentious issue of partnership between the FDA, industry and academia. No one entity can do it alone. This is a core philosophy that will, no doubt be vigorously debated in Congress – and by the next FDA commissioner. We need a stated policy of pragmatic partnerships.
Nobody said it going to be easy.
Relative to FDA oversight of clinical trial investigator conflict of interest, the New York Time opines:
Absolutely. Transparency. Transparency. Transparency. The agency's lack of funding (and ensuing lack of manpower to accomplish the task in a thorough and timely manner) must be remedied. Editorializing about the problem is important -- doing so about the solution, even more so. Want the problem fixed? Show me the money! Otherwise it's just rhetoric.
The Times continues:
Not so fast. Beyond the obvious fact that such a database would help nobody other than trial lawyers, a more dire unintended consequence would be the unfair stigmatization of doctors and scientists who participate in clinical trials sponsored by pharmaceutical companies. Fearful of jeopardizing their reputations, this could motivate many to leave clinical trial research altogether -- making trials more difficult tand more expensive to field in the first place. And this outcome is most definitely not in the best interests of the public health.
Let's do the right thing -- but not get carried away.
The full Times editorial can be found here.
What the Torti appointment does demonstrate (IMHO) is a vote of confidence on the part of the incoming administration in the agency's career staff -- and a polite "mind your business" to certain members of Congress. After all, it was only last month that Representative Bart Stupak wrote to President-elect Obama recommending, " ... not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA."
Thanks Bart. But no thanks.
Sowell continues:
The lure of something for nothing may be seductive when you are in good health. But it can become a bitter irony when you are waiting for months for surgery to relieve your pain or when your life hangs in the balance while some bureaucrat decides whether you can get the best medication or something older and cheaper.
A bitter irony indeed. Remember those words: The promise of something for nothing. These words define the 'universal healthcare' movement.
The lofty promises from "Universal Healthcare" advocates undoubtedly have great appeal to many Americans. That is why in the coming months it is vital that those of us who value a patient-centered, free-market healthcare system step up efforts to effectively counter the false promises being peddled by advocates of government-run healthcare.
The FDA document states that doctors should be made aware of experimental uses for drugs and devices -- even if regulators have not approved them.
"The public health may be advanced by healthcare professionals' receipt of medical journal articles ... on unapproved new uses," the agency states. Such uses may even "constitute a medically recognized standard of care," according to the agency.
Knowledge is power. And information saves lives.
National healthcare spending hit a record high of $2.2 trillion in 2007, according to a report just released by the government. The total accounts for over 16 percent of the nation's GDP, and averages out to a $7,421 bill for each one of us.
These numbers are staggering. President-elect Barack Obama and his Secretary of Health and Human Services nominee, Tom Daschle, need to take immediate steps to make sure the money we spend delivers the healthcare we need.
Unfortunately, many of the incoming administration's reform proposals, although well-intentioned, boil down to a single, destructive policy: Price controls.
Perhaps the most damaging healthcare reform we are likely to see in the coming years is Secretary Daschle's plan for a Federal Health Board. Based loosely on
Daschle has said that the agency will "reduce or deny payment for new drugs and procedures that aren't as effective as current ones." In the past, however, agencies like NICE have unfairly denied treatment to patients by applying a broad definition of "effective."
Have a look at this new op-ed from the pages of the Washington Examiner … and think hard about what we really want American healthcare to look like.
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.
