Latest Drugwonks' Blog
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.,
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.
To that end, we thought it would be interesting and important to see what some of the elite 100 think on the topic of American healthcare reform.
So we asked.
Have a look at two new video podcasts with Senator Richard Burr (R, NC) and Senator Bob Corker (R, TN).
Here are the direct links:
Senator Burr: www.vimeio.com/1148600
Senator Corker: www.vimeo.com/1155911
Other newsmaker podcasts can be found at www.cmpi.org
New York State Assemblyman Richard Gottfried has introduced a bill that would place severe restrictions on those who sell prescription drugs.
The goal, no doubt, is to appear tough with drug companies. Given the rising cost of health care, this is politically understandable. Unfortunately, the proposed bill would only make doctors' jobs harder -- depriving them of vital information and undermining their ability to make the best clinical decisions possible. Ultimately, patients will pay the price.
Read the full op-ed from today’s edition of the Albany Times-Union
This back-handed attempt to prohibit off-label prescribing is nothing more than yet another inappropriate government intervention into the doctor's office. Gottfried's bill may make for good political theater, but the grandstanding ignores a fundamental truth: Doctors, not bureaucrats, know their patients' medical needs best.
Pfizer will directly fund basic research in an open-ended collaboration with Univ of Calif San Francisco..I hope this gives the connect dots crowd angina (that drugs developed through this deal with Satan can treat) so that they in turn can refuse them based on the Pharmalot principles:
1. Any drug developed by a collaboration with BIG PHARMA is by definition less effective and more dangerous than literature and FDA documents state and is more dangerous and less effective than bloggers, trial lawyers and unbalanced patients proclaim.
2. Any older drug is safer and more effective than any newer drug even though every older drug was developed in the same fashion as newer drugs.
3. Newer drugs are more dangerous and less effective older drugs because older drugs are made by generic companies who don't market products and newer drugs are approved by an FDA run by a Bush administration appointee.
4. Any research produced by anyone who has ever consulted with or conducted research for a biotech or pharmaceutical firm is tainted and the results, though reproduced and validated by scientific methods, are false.
5. Except Steve Nissen.
6. Or Curt Furberg
www.sfgate.com/cgi-bin/article.cgi
That would be the he Office of Criminal Investigations, the OCI. It seems that many of the usual suspect FDA-bashers (Senator Grassley, Mr. Stupack, Mr. Barton) are “concerned” that the OCI is being pressured to pursue some cases (like the abuse of scheduled medicines such as Oxycontin or ingredients for methamphetamine) while ignoring others (like the brouhaha over Ketek clinical trial oversight).
It's also important to mention the OCI's central role in fighting counterfeit drugs (aka: international healthcare terrorism). But saying "thank you" isn't in the current Congressional lexicon. Too bad. OCI's earned it many times over.
According to the Journal, “Mr. Grassley has already cut into OCI's autonomy. For nearly a decade, OCI worked under a little-known memorandum of agreement that gave OCI precedence over the Inspector General's office at Health and Human Services Department in conducting internal-affairs cases. That authority was withdrawn at the end of 2007 after Mr. Grassley complained that OCI selectively investigated FDA whistleblowers.”
There’s a difference between whistleblowers and felons. Note: Releasing internal FDA documents to the media is a felony.
As if the slight to the very hard working and dedicated OCI staff wasn’t bad enough – the WSJ article singles out the OCI’s director, Terry Vermillion, for particular abuse.
“Mr. Vermillion hasn't been made available for interviews. He came under fire from Democrats and Republicans last year when news reports revealed that large bonuses pushed his take-home pay for 2006 to $198,000, more than that of a member of Congress or a Supreme Court justice."
Note to Alicia Mundy: What about all those Congressional perks? They sure add up --and quite nicely. FDA perks are restricted to parking spaces at HQ. Sloppy reporting. (I assume the Supremes must have pretty nifty perks too.)
Terry is a tough mother you-know-what. Precisely the kind of guy you want running the FDA’s Office of Criminal Investigations. And I say that from personal, first-hand knowledge and experience.
Another shameful show trial? Yes. But what’s worse is that it continues to erode FDA morale and dampen esprit de corps -- just at a time when the agency (and the country) needs it more than ever.
Here are the first two paragraphs from his op-ed in today’s edition of the New York Post:
“FEW relationships are more personal - and private - than the one between patient and doctor. Unfortunately, this fact appears to be lost on
Gov. Paterson is now backing legislation designed to limit the influence drug companies wield over doctors. The goal may sound reasonable - but the bill itself would bring a massive and unnecessary government intrusion into individual medical decisions.”
Click here for the complete article
To see Dr. Weber discuss this and similar issues on a recent CMPI video podcast, click here:
As Dr. Weber writes, “Gov. Paterson means well in promoting these "reforms" - but he's wrong. The bill would only drive up medical costs by producing reams of added paperwork for doctors, patients and administrators alike.”
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.
