Latest Drugwonks' Blog

BigGovHealth.org

  • 06.16.2008
In our post-SiCKO, pre-election environment, the Center for Medicine in the Public Interest is launching a new program that takes a careful and candid look at just what you get via government-run (aka "Universal") healthcare.

We call our project BigGovHealth.org.

We're beginning our initiative with a short movie that, we believe, shows why Big Government healthcare is the wrong prescription for the United States.

Please join us for the Washington, DC premiere on June 23 , from 6:30 - 8:00PM, at the National Press Club.


We will be joined by Congressman John Shadegg, former Senator Don Nickles and other healthcare players (we've even gotten an RSVP from a presidential candidate).

The complete invitation, along with RSVP information, can be found at the top of this page

When it comes to healthcare reform, BigGovHealth.org is Cinéma-vérité.

Stipulating Bias

  • 06.13.2008

According to a new editorial in the Lancet, “From February to April this year, the European Commission (EC) held a public consultation on proposed legal changes that would allow pharmaceutical companies to provide information to patients about prescription-only drugs via all available media. The Commission's proposal states that the ban on direct-to-consumer advertising (DTCA) in Europe would remain. However, many critics rightly feel that allowing the industry to provide information to patients is effectively DTCA under a different name.”

Who are these critics?  What are the agendas?  Where does their funding come from?  On these questions the Lancet is silent.

The Lancet opines, “Patients' access to quality information is variable across the European Union's 27 member states and the Commission is right to want to address this inequality. But the pharmaceutical industry's obvious financial conflicts of interest mean that drug information provided by them is likely to be prone to bias.”

“Likely to be biased?”  On what do they base this rather strong statement?  Isn’t solid, unbiased information in the best interests of both sales and the public health? Isn’t there a more inherent “bias” by having payers control what information consumers get to see?  And in the EU, “payers” = “government.”

The editorial concludes, “Patients have a fundamental right to access good quality, objective information on medicines. The EC's final proposal, due out later this year, must empower patients and not the drug industry.”

Why not empower the drug industry to empower patients?  That’s what the pending EC directive is all about.

And as far as the Lancet stipulating bias, consider the words of Robert Benchley:

"Tell us your phobias, and we will tell you what you are afraid of."

While the media covers the Grassley stains and Stupak remarks oozing from Congress, Ray Woosley and the C-Path Institute with strong backing from Janet Woodcock at the FDA are remaking the drug development process, transforming it from a hit or miss method to a pathway for personalized medicine. Today C-Path announced a trans-atlantic agreement to use the same drug safety biomarker at the FDA and the EMEA, a historic first. And let's not forget that industry is collaborating, much to the consternation of DeLauro,Goozner, Mahar, Brownlee and pharmalot. Progress towards safer, more effective medicines using more reliable measures. Oh, the humanity.

Read more here

Have NICE Life

  • 06.12.2008

Two Part Harmony

  • 06.12.2008

New from the FDA ...

FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety

Collaborative effort by FDA and EMEA expected to yield additional safety data

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Association (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or “biomarkers” found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

The new biomarkers are KIM-1, Albumin, Total Protein, β2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. For decades, both FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA.

“The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible, and help health care professionals better manage potential kidney damage from drugs.”

Woodcock added that such human tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental drugs from being approved. With more sensitive tests for renal toxicity, FDA could approve such drugs because health care professionals could closely monitor patients and halt the drug if early signs of renal toxicity appear.

Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products.

Researchers from Merck & Co., Whitehouse Station, N.J., and Novartis AG, Basel, Switzerland, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMEA.

The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process.

The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies, and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers.

FDA scientists believe that the seven new tests may provide important advantages over the BUN and creatinine tests. For example, in experiments using rats, the two traditional tests can only detect kidney damage a week after it has begun to occur. The new tests, however, are more sensitive and can detect cellular damage within hours. And while BUN and serum creatinine show that damage has occurred somewhere in the kidneys, the new tests can pinpoint which parts of the kidney have been affected.

The seven new tests were developed and will be carried out initially in rats. These tests were selected because other studies have shown that identical biomarkers are produced in human kidney cells. While the FDA and EMEA will consider these biomarkers in rat studies initially, the PSTC has begun work to further qualify the biomarkers for use in human studies. If successful, the PSTC will present a new biomarker data application to the two agencies to seek acceptance of the human biomarkers.

Nailing Nissen

  • 06.12.2008
CMPI

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.

Blog Roll

Alliance for Patient Access Alternative Health Practice
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog