Latest Drugwonks' Blog
http://www.ama-assn.org/amednews/2009/02/23/prsa0223.htm
"Sunshine" bill sets $100 trigger for disclosing drug industry pay to doctors
The proposal would let states regulate such income even further. Reflecting a growing trend, two universities and a specialist group announce new conflict-of-interest policies.
"Physicians who receive $100 or more from drugmakers or device manufacturers over the course of a year would have those payments posted to the Web under bipartisan Senate legislation introduced in January.The new bill is stricter than a version of the measure circulated last year that received support from industry and organized medicine groups, including the Pharmaceutical Research and Manufacturers of America and the American Medical Association.
The reintroduced legislation, known as the Physician Payments Sunshine Act, came amid another round of disclosure and conflict-of-interest policies announced by doctors and academic health systems."Note that none of these disclosure or conflict of interest policies or limits on marketing announced by academic health systems restrict the ability of academic health systems to uh..market to the public, pay doctors out of central funds, receive and transfer money from insurance companies, hospitals, the for-profit arms of the health systems themselves, the lobbying or law firms that might retain the physicians from the academic health systems for expert legal work. Oh no. That exemption is about a wide as the part on Senator Grassley's scalp.
And since we have no regard for the civil liberties of physicians and their family members...."The bill also would require drug companies or device makers that are not publicly traded to disclose any ownership interest held by physicians or their immediate family members. " Does that mean if Dr. Berkowitz invests his son's Bar Mitzvah money in a hedge fund that also holds a position in a start up seeking to cure cancer that it is the responsibility of the start up to track down that investment?
Some university health systems have gone to idiotic lengths to prove to Grassley how pure they are..."University of Iowa Health Care, a 1,420-physician health system, also announced a stricter financial-conflict plan in January. Among other things, the new policy bars faculty, staff and trainees from seeking, accepting or giving patients product samples under the theory that the free drugs improperly influence prescribing habits." Nice theory. But is it true? And what if samples allow doctors to monitor if patients actually respond well to drugs without burdening patients with out of pocket costs? Doesn't that improperly influence prescribing habits? Since co-pays seem to drive down compliance in many cases isn't this policy harmful to patient health in order to appease Grassley? And meanwhile it hasn't stopped UI from boosting the amount of dough it spends marketing itself to the various insurance providers in the area.
In any event, I agree with Senator Grassley tha "Shedding light on industry payments to physicians would be good for the system. Transparency fosters accountability, and the public has a right to know about financial relationships." So with that, the Sunshine Act should be amended to include any payment to physicians and any financial relationships in the health care industry. That includes when foundations and law firms pay physicians to travel to cushy locations to pontificate about drug and devicemaker influence in Bermuda and when the same pay doctors to conduct studies, publish reports and hold conferences. That includes when doctors are paid as expert witnesses and or receive any sort of gift, food, compensation of any value over $100 to advise, consult on policy or legal matter. That includes when academic health centers and hospitals pay for CME curriculum, as well as travel, food and lodging. That includes any time a physician is paid to conduct research, participate on a panel or advice a government agency, insurance company, benefit manager, HMO, etc that can influence a cilnical decision, guideline development, etc. And why stop at $100. Why not $50 or $25? Why stop at doctors? Why not nurse practitioners, pharmacists, home health workers, infusion specialist, lab technicians?
Here's the beginning to whet your appetite:
If it were not for the great variability among individuals, medicine might as well be a science and not an art.
— Sir William Osler (1892)
Over the past half century, biomedical science has developed randomized, controlled clinical-trial methods that can distinguish treatment effects from the noise of human variability. Positive results from tests of a treatment in a randomized, controlled trial provide great confidence that an intervention improves a prespecified outcome in a population defined by explicit entry criteria. These methods are rightly venerated because they have helped move medicine from anecdote to science and have largely brought about the therapeutic advances of the past 50 years. However, although population-based, randomized, controlled trials of drugs control for disease variability, they generally do not reveal why some people do not have a response to treatment, others have excessive pharmacologic responses, and still others have side effects that occur in a distinctive pattern for a given drug. Addressing this question is our next challenge.
Currently, medicine is addressing this challenge through the lens of genomic technologies. There is considerable debate about the quality, quantity, and type of evidence that would be needed to change clinical practice by introducing pharmacogenetic testing for a given drug. What methods should be used to understand individual responses once an overall population benefit has been shown in randomized, controlled trials?
The full editorial can be found here. It's a timely and important read.
"As a result of this increase in the quantity of relevant information, synthesized information such as systematic reviews, clinical guidelines, and resources (e.g., The Cochrane Library), have become essential tools for the users of the evidence (Druss and Marcus, 2005). However, the number of these products has also grown substantially. For example, as of September 2007, the Agency for Healthcare Research and Quality’s (AHRQ’s) National Guideline Clearinghouse (2007b) listed 54 clinical practice guidelines under the heading “antihypertensives.” In this situation, end users need a mechanism to determine which summaries are the most relevant, valid, and reliable." This is according to an Institute of Medicine study:
Knowing What Works in Health Care: A Roadmap for the Nation (2008) Board on Health Care Services (HCS)
So the key to improving the practice of medicine is to rely on the summaries which are -- according to the HMO-run and beholden institutes that do most of the work for AHRQ and their HMO heavy stakeholder group -- the most relevant, valid and reliable....Or is it about cost?
Jean Slutsky, who will essentially be in charge of the billion or so that AHRQ spends compares her agency favorably to NICE in the UIK among others:
"Health care expenditures are growing faster than incomes for most developed countries, jeopardizing the stability of health care systems globally.1 This trend has led to interest in knowledge about the most effective use of health care worldwide. To increase the value of health care services, many countries have established programs or independent agencies that inform health care decisionmaking through systematic reviews of technologies, pharmaceuticals, and other health care interventions. A few examples include the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom, the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany, the Haute Autorité de Santé (HAS) in France, and the Canadian Agency for Drugs and Technologies in Health (CADTH)"
As I have mentioned here and here AHRQ has a cozy relationship with NICE analogues established by HMOs:
"We have something that looks somewhat analogous in many of the domains in which NICE is working," says Joseph Newhouse, Ph.D., professor of health care policy at Harvard Medical School and a former member and vice-chair of the Medicare Payment Advisory Commission (MedPAC). It's just not "pulled together in one agency with a crisp mandate."
Starting with the private sector, there are a number of technology assessment groups that analyze drugs, devices, and procedures—the most well known of which is the Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). "It has been around for about 10 years and is definitely considered the most rigorous of the groups," says Barbara J. McNeil, M.D., Ph.D., a professor and head of the Department of Health Care Policy at Harvard Medical School who is a member of TEC Medical Advisory Panel.
TEC completes 20 to 25 assessments of drugs, devices, and procedures each year, usually for treatments with increasing requests for coverage but unclear value. A recent example is the use of electron beam CT (computed tomography) for the evaluation of patients with suspected cardiac disease. The TEC staff completes a detailed review and the Medical Advisory Panel uses this information to make a judgment about its clinical effectiveness.
Kaiser Permanente and the Centers for Medicare and Medicaid Services (CMS) are among TEC's clients. Similar groups include ECRI (formerly the Emergency Care Research Institute) and Hayes Inc. Many health plans, including CIGNA HealthCare, have their own internal medical technology assessment groups.
Read more here
It should be noted that ECRI and Hayes Inc. helped write the IOM report on comparative effectiveness and ECRI has also done work on the use of CT scans for heart disease... And I will save my analysis of how TEC and ECRI systematically ignored the predictive value of CT scans in detecting early onset of heart disease better than other treatments for another time. Suffice to say that ARHQ is hell-bent on the summarizing of the "available" evidence as selected by a select few of individuals whose computers seem to have tunnel vision when it comes to searching for the truth.
I have heard the rhetoric of the AHRQ folks in various settings. Some of it sounds good. And some of the studies they have sponsored with respect to alternative evaluation methodologies are valuable but too few to make a difference.
CMPI has even offered to help fund and sponsor conferences to promote patient-centered approaches to comparative effectiveness research. No response from either Clancy or Slutsky. I guess they are content to publish reports that continually claim that there is insufficient evidence for....etc. That disclaiimer is just enough to let health plans say no to any number of existing or new treatments.
It will kill innovation and hurt millions without saving money...
In discussing detailing and CME Horton writes, "Still, industry has an important voice in medicine, one that under the right arrangements doctors should be aware of and hear at all stages of their career."
His main point is that we must dismantle the battlements and embrace of philosophy of "symbiosis not schism." It's what's in the best interest of the patient.
Horton's editorial can be found here. It's worth a read.
Ferguson is chairman and CEO of Ferguson Strategies LLC, a government affairs and business consulting firm based in Washington, D.C. Ferguson served in the House for nearly a decade, representing New Jersey's 7th District.
Peter Pitts, the Center's President and former Associate FDA Commissioner, said Ferguson's appointment demonstrates CMPI's commitment to broaden its scope and influence.
“Congressman Ferguson was a strong advocate in Washington for key health care initiatives during the last decade, and he helped to shape the debate about the future of important reform proposals,” Pitts said. “Congressman Ferguson brings to CMPI his compassion for and commitment to those suffering from illnesses, as well as his wealth of experience on Capitol Hill, and that combines to represent a real value-added for CMPI.”
Robert Goldberg, PhD, will help guide the Center's new initiative, and he said Ferguson will be helpful in advancing the deployment biomedical innovation.
“Under Mike's leadership, the Center will show how medical innovations are the ‘green technologies' that can solve our country's most pressing health care problems and help point out when policies and positions are choking off the entrepreneurship and investment that sustain such progress,” Goldberg said.
Ferguson completed four two-year terms in Congress in January, when he also started Ferguson Strategies.
“I'm looking forward to continuing my efforts to accelerate the translation of medical knowledge into better and more effective ways to prevent and treat disease,” Ferguson said. “Medical innovation is the key to making health care more effective, efficient and affordable. We plan to make this case and develop policies that reward innovation in every part of the health care system.”
In Congress, Ferguson served as vice chairman of the House Energy and Commerce Subcommittee on Health, and he was instrumental in securing passage of the Medicare Part D prescription drug benefit. He also led opposition to efforts that would have allowed drug importation and imposed government-mandated price controls for prescription drugs and rationing of health care services.
Ferguson successfully led the congressional effort to secure House and Senate passage of the Lifespan Respite Care Act – legislation he authored – that authorizes $289 million for states to train volunteers to help an estimated 50 million families caring at home for adults and children with special needs. President Bush signed Congressman Ferguson's bill into law in 2006.
Ferguson was the recipient of the 2006 Legislator of the Year Award from the National Visiting Nurses Association, and the 2007 Congressional Award from the Leukemia & Lymphoma Society.
In addition to the Health Subcommittee, Congressman Ferguson also served on the Telecommunications and the Internet Subcommittee, and the Oversight and Investigations Subcommittee.
A graduate of Delbarton School in Morristown, New Jersey, Ferguson attended the University of Notre Dame in South Bend, Indiana, where he received a bachelor's degree in government. He earned a master's degree in public policy from Georgetown University in Washington, D.C.
The words are nice -- now let's see if the actions lead to NICE.
Here's the House/Senate report language that accompanied the $1.1 billion for a Federal Coordinating Council on Comparative Effectiveness:
"The conferees to not intend for the comparative effectiveness research funding ...to be used to mandate coverage, reimbursement, or other policies for any public or private payers,” and that funding shall be used to evaluate “the clinical outcomes, effectiveness, risk, and benefits of two or more medical treatments and services.” The conferees “further recognize that a ‘one-size-fits-all’ approach to patient treatment is not the most medically appropriate solution to treating various conditions.”
"CE" can mean so many things. It can also mean "Caveat emptor."
Saw this article online (courtesy of Google and the Press Association), and thought it worthy to share:
Doctors could soon be using a Star Trek-style device the size of a BlackBerry to check patients' genetic suitability to different medicines. A prototype of the hand-held device is already being tested by British scientists, who say it could be on the market in two years. The SNP (pronounced snip) Doctor is the kind of gadget that might by have used by Dr Leonard McCoy in the original Star Trek TV series.
From a drop of saliva or cheek swab it can analyse DNA to tell if a patient has the right genetic fit for a particular drug.
The Snip Doctor looks for known single nucleotide polymorphisms (SNPs) - single letter changes in the genetic code - that can affect an individual's response to medical treatment. Each year the NHS spends around £460 million dealing with the 250,000 patients who are admitted to hospital suffering adverse reactions to prescribed drugs. The unwanted side effects can vary in severity from dizziness and nausea to heart palpitations or loss of consciousness. The finished product will be an all-in-one device that can rapidly analyse a sample placed in its cartridge and flash the result up on a screen.
Being able to predict bad responses to drugs such as antidepressants or cholesterol-lowering statins would allow doctors to tailor dosages and types of medication to individual patients. Scientists at Imperial College London and its spin-out company DNA Electronics are now carrying out trials of the Snip Doctor's effectiveness.
The complete article (by Robert Pear) can be found here.
Pear writes, “Under the legislation, researchers will receive $1.1 billion to compare drugs, medical devices, surgery and other ways of treating specific conditions. The bill creates a council of up to 15 federal employees to coordinate the research and to advise President Obama and Congress on how to spend the money.”
Let’s not kid ourselves. This is really about head-to-head drug trials. Is anyone even paying lip service to anything else?
According to Pear, “The program responds to a growing concern that doctors have little or no solid evidence of the value of many treatments.”
Really? No solid evidence? What about all those journal articles? What about professional guidelines? What about the growing availability of outcomes data?
“Little or no solid evidence.” In other words, evidence generated by the pharmaceutical industry doesn’t count -- but government research (like CATIE and ALLHAT) does. Talk about politics trumping science!
Pear reports that, “Women and members of minority groups expressed concern about that approach. Drugs and other treatments can affect different patients in different ways, they said, but researchers often overlook the differences because their studies do not include enough women, blacks or Hispanics … The final bill says that the research financed by the federal government shall include women and members of minority groups.”
That’s nice. But when you use the same 20th century tools for clinical trial design – you get the same 20th century data. It’s important to note that not one cent of the stimulus bill went towards the development of 21st century drug development and regulatory tools – precisely what the FDA’s Critical Path program is designed to address.
Here are a couple of other important issues that are rarely mentioned:
(1) Pharmaceuticals represent about 11.5% of our national healthcare spend – about the same as the rest of the developed world. 7% of that expense is for on-patent drugs.
(2) Generic drugs represent 56% of the volume and 4.5% of the spend. And both of those numbers are growing.
(3) The way to “save lives” is to make sure that the right patient gets the right medicine in the right dose at the right time. Whether or not they save money depends on where you sit and who you ask.
“The new research will eventually save money and lives,” said Representative Pete Stark (D, CA), chairman of the Ways and Means Subcommittee on Health.
Really Congressman? In that order?
Where you stand often depends on where you sit. If you’re a payer (either public or private), saving money can often mean denying expensive end-of-life care. If you’re a patient, well, you might have another view.
Pear writes, “Britain, France and other countries have bodies that assess health technologies and compare the effectiveness, and sometimes the cost, of different treatments.”
“Sometimes?” Come on. As Aldous Huxley wrote, “Facts do not cease to exist because they are ignored.”
Pear repeats what drugwonks.com shared on February 12, that the House Appropriations Committee (in a report accompanying its version of the economic recovery bill) said that research comparing different treatments could “yield significant payoffs” because less effective, more expensive treatments “will no longer be prescribed.” For more on this see “The UnCERtainty Principle.”)
If we want to provide excellent care and save money, there are two crucial public health issues that are being ignored by our elected representatives:
(1) Early diagnosis/prevention. No monies for either of these two items in the stimulus package.
(2) Compliance programs. According to a Harris survey, one in three (33%) U.S. adults who have been prescribed drugs to take on a regular basis report that they are often or very often noncompliant with their treatment regimens for any number of reasons.
Early diagnosis, prevention programs, and compliance issues are huge pieces of the healthcare cost pie – but not, it seems, sexy enough from a political talking point perspective.
No doubt members of Congress will say that such things will be addressed when we debate health care reform.
But isn’t that what we’re doing now?
Having said all that, I applaud Janet Corrigan and Nancy Nielsen for trying to bring order to the quality chaos. But I wonder if the problem is not the orgy of objects to measure but the lack of focus on creating measures that are derived from clinical, as opposed to claims data, biomarkers instead of randomized clinical trials, meaningfully designed systems that help doctors in their daily practice instead of top down systems like the one being conceived by the billion dollar slush fund?
www.ama-assn.org/amednews/2008/12/29/prsd1229.htm
Flounder: Hello!
Dean Vernon Wormer: Zero point two... Fat, drunk and stupid is no way to go through life, son. Mr. Hoover, president of Delta house? One point six; four C's and an F. A fine example you set! Daniel Simpson Day... HAS no grade point average. All courses incomplete. Mr. Blu - MR. BLUTARSKY... ZERO POINT ZERO.
Now let's go to the Stimulus Bill
* Various health IT computer systems of unknown use and impact: $19 billion
* Spending on basic biological research including vaccines, HIV, cancer, etc: $6 billion
* Spending on ways to reduce access to new technologies and treatments chosen by a stakeholder group made up of people from the insurance industry and at the sole discretion of the Secretary of HHS unless there is demonstrable proof as established by a handful of "stakeholders" from those from the insurance industry and those trained at NICE (including Steve Pearson): $1.1 billion
* New spending for the FDA's Critical Path institute, food safety research, collaborations with European, Asian or African partners to harmonize drug safety standards:
Zero point zero.
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.
