Weekly Roundup: Back to the Future and Back Again

  • by: |
  • 11/10/2006
In the spirit of bi-partisanship or whatever I am going to reach out to those eager to have the government negotiate directly with drug companies and show them how it's done: all involve the creation of a whole new bureaucracy

Here is the Canadian approach

it reviews factory-gate prices of individual products to determine if they are excessive. To do this, the board has instituted a set of processes, including review of individual drug prices, conduct of investigations, and application of enforcement mechanisms. The PMPRB process is based on the following classification scheme for all patented drugs: Category 1: a new drug product that is an extension of existing or comparable dosage form of an existing medicine, usually a new strength of an existing drug ( line extensions ); Category 2: the first drug to effectively treat a particular illness or that provides a substantial improvement over existing drug products, often referred to as breakthrough or substantial improvement ; and Category 3: a new drug or dosage form of an existing drug that provides moderate, little, or no improvement over existing drugs ( me-toos ).[6]
The board uses several criteria to classify a product. A manufacturer has to submit data (including price) to the PMPRB for classification of any drug. For a drug that is to be considered a breakthrough, the manufacturer al o ha to include reviews of the product in recognized journals (where available), results of two to five well-controlled trials, and results of a complete Medline search of articles and reviews of the drug. Once a drug is classified, its price is reviewed to determine if it is excessive.

Excessive is interpreted based on the following guidelines: (1) The price of an existing patented drug cannot increase by more than the Consumer Price Index (CPI). (2) The price of a new drug (in most cases) is limited so that the cost of therapy with the new drug is in the range of the costs of therapy with existing drugs in the same therapeutic class. (3) The price of a breakthrough drug is limited to the median of its prices in France, Germany, Italy, Sweden, Switzerland, Britain, and the United States. In addition, no patented drug can be priced above the highest price in this group of countries.

Want to know how the VA does it...here's a GAO ruling to determine whether a VA decision to exclude one drug was fair....A Peter Pitts Genius Award (a box of Cracker Jacks) will be bestowed upon the individual who can explain what the hell a GAO lawyer is doing making a clinical decision....

http://www.gao.gov/decisions/bidpro/295888.htm

or this gem....

http://
www.gao.gov/decisions/bidpro/2949442.htm


Or they can go President Clinton's route and set up a breakthrough drug price commission that would have subpoena power to investigate whether the price for a breakthrough was "reasonable."

Just trying to be helpful


Now on to the real future of medicine...

The headlines are full of stories of biomarkers in development to predict drug response and disease risk in new areas...The question is, why are we ignoring this, the ultimate approach to comparative effectiveness and drug safety in favor of the IOM approach of using outdates claims databases to help decide who gets what drug.

Over-_expression Of Cox-2 Can Predict Prostate Cancer Outcome (November 9, 2006) — Researchers say an over-_expression of COX-2 in men with prostate cancer is associated with an increase in PSA after radiation treatment and the spread of the cancer outside of the prostate. That is the result of the first study linking COX-2 with prostate cancer radiation treatment outcomes.

Here are some other exciting developments reported in this month's edition of Drug Discovery and Development

Heading off Lung Transplant Rejection
Using proteomics, mass spectrometry, and bioinformatics, researchers at the University of Minnesota, Minneapolis, identified three proteins that are highly predictive of lung transplant rejection up to 20 months before the rejection occurs. In addition to early identification, the researchers hope to eventually develop a preventative treatment.

Blood Test to Diagnose Alzheimer's?
Groundbreaking research at the Institute of Psychiatry, King's College London, demonstrates that proteins found in the blood can indicate an increased risk of Alzheimer's disease. It is the first time markers for the development of Alzheimer's have been identified in blood and is a step toward developing a blood test to diagnose and measure progression of the disease.

Gene Variant May Explain Antidepressant Failure
Investigators at Weill Medical College of Cornell University, New York, say their work could lead to the first diagnostic test to guide depression treatment. It would involve sampling the patient's DNA seeking a variant of the gene coding a protein called "Brain Derived Neurotrophic Factor" that may indicate that the patient would not respond to treatment with the most commonly used class of drugs.


Yeah, I guess Bruce Psaty who was on the IOM committee and uses claims databases when he consults to HMOs wasn't too self serving and was right when he told the Star Ledger that personalized medicine is 20 years away....

ScienceNewsDaily is always full of interesting articles that cause one to ponder the meaning of life and our place in the universe.....

Decoded Sea Urchin Genome Shows Surprising Relationship To Humans (November 9, 2006) — The Sea Urchin Genome Sequencing Project consortium, led by the Human Genome Sequencing Center at Baylor College of Medicine in Houston, announced today the decoding and analysis of the genome sequence of the sea urchin, Strongylocentrotus purpuratu.

What's surprising is in fact my great-great grandmother's maiden name on my mother's side was in fact "Purpuratu." We are still figuring out how it turned into Goldberg...


Moon's Escaping Gasses Expose Fresh Surface (November 9, 2006) — A fresh look at Apollo-era images combined with recent spectral data leads researchers to re-examine conventional wisdom. Several lines of evidence suggest that the moon may have seen eruptions of interior gasses as recently as one million years ago, rather than three billion years ago -- the date that has been most widely accepted.

Can you imagine having gas for a milion years, let alone 3 billion?
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