Latest Drugwonks' Blog
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.
As we continue to furrow our collective brows pondering the eternal quandary of risk/benefit, I thought you’d enjoy the comments below (which I received this afternoon via e-mail from a respected physician who shall remain nameless):
TO ALL THE KIDS WHO SURVIVED THE 1930s, 40's, 50's, 60's & 70's
First, we survived being born to mothers who smoked and/or drank while they were pregnant.
They took aspirin, ate blue cheese dressing, tuna from a can, and didn't get tested for diabetes.
Then after that trauma, we were put to sleep on our tummies in baby cribs covered with bright colored lead-based paints.
We had no childproof lids on medicine bottles, doors or cabinets and when we rode our bikes, we had no helmets. Not to mention the risks we took hitchhiking.
As infants & children, we would ride in cars with no car seats, booster seats, seat belts or air bags.
Riding in the back of a pick up on a warm day was always a special treat.
We drank water from the garden hose and NOT from a bottle.
We shared one soft drink with four friends, from one bottle and NO ONE actually died.
We ate cupcakes, white bread and real butter and drank Kool-Aid made with sugar, but we weren't overweight because we were always outside playing.
We would leave home in the morning and play all day, as long as we were back when the streetlights came on.
No one was able to reach us all day. And we were O.K.
We would spend hours building our go-carts out of scraps and then ride down the hill, only to find out we forgot the brakes. After running into the bushes a few times, we learned to solve the problem.
We did not have Playstations, Nintendo's, X-Boxes, no video games at all, no 150 channels on cable, no video movies or DVD's, no surround-sound or CD's, no cell phones, no personal computers, no Internet or chat rooms.
We had friends and we went outside and found them!
We fell out of trees, got cut, broke bones and teeth and there were no lawsuits from these accidents.
We ate worms and mud pies made from dirt, and the worms did not live in us forever.
We were given BB guns for our 10th birthdays, made up games with sticks and tennis balls and, although we were told it would happen, we did not put out very many eyes.
We rode bikes or walked to a friend's house and knocked on the door or rang the bell, or just walked in and talked to them!
Little League had tryouts and not everyone made the team. Those who didn't had to learn to deal with disappointment. Imagine that!
The idea of a parent bailing us out if we broke the law was unheard of. They actually sided with the law!
These generations have produced some of the best risk-takers, problem solvers and inventors ever!
The past 50 years have been an explosion of innovation and new ideas. We had freedom, failure, success and responsibility, and we learned HOW TO DEAL WITH IT ALL!
FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events
The first data offering health care professionals a better look into the genetic basis of certain types of adverse drug events was released today by the FDA and the International Serious Adverse Event Consortium (SAEC). The data are focused on the genetics associated with drug-induced serious skin rashes, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, and helps better predict an individual’s risk of developing these reactions.
Both skin conditions appear as allergic-like skin reactions associated with blistering and peeling, and are considered life-threatening. Medications causing these serious allergic reactions should be discontinued; and if such signs and symptoms are not quickly recognized, these reactions can be fatal.
“The SAEC has fulfilled a key goal of the Critical Path Initiative by providing the research community with public access to new genomic data on adverse drug events,” said Janet Woodcock, M.D., director, the FDA’s Center for Drug Evaluation and Research. “This consortium has taken a significant step forward by promoting open sharing of drug safety data. This type of cooperation has the potential to lead to more personalized approaches to medicine that can reduce a patient’s risk for experiencing an adverse drug event.”
The SAEC is a nonprofit partnership of pharmaceutical companies, the Wellcome Trust, and academic institutions focused on research relating to the genetics of drug-induced serious adverse events. The samples from the initial serious skin rash cases and matched controls were collected by GlaxoSmithKline plc, London, U.K., and donated to the consortium for this research.
By pooling these samples, the SAEC has identified numerous genetic associations that may contribute to an individual’s risk of developing serious drug-induced skin reactions. The data was compiled and analyzed just 16 months after the consortium was launched.
“We are pleased to be able to provide these invaluable data to the research community to both improve the productivity of drug development and to begin the critical process of developing validated biomarkers to forecast patients who may be at risk for drug-induced serious adverse events,” said Arthur Holden, founder and chairman of the SAEC. “We continue to believe the application of genomics to research the genetic basis of serious adverse events will prove to be one the most productive early applications of this technology.”
The consortium will publish its initial research results later this year.
Researchers who enter in to a data use agreement can obtain free access to the data to generate custom data inquiries and obtain immediate results on the genetic basis of adverse drug events.
For more information on the International Serious Adverse Event Consortium see www.saeconsortium.org.
For information on the FDA’s Critical Path Initiative see http://www.fda.gov/oc/initiatives/criticalpath/
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.
