Latest Drugwonks' Blog
I'm very excited to participate in the October 11th Ceasefire on Healthcare debate with David Kendall who served on President Clinton's Task Force for Health Care Reform. As you probably know, the forum (led by former Senator John Breaux) seeks to find â€œcommon groundâ€ for meaningful, bipartisan change to the nationâ€™s health care system.
I hope you can attend or tune in for the podcast. Here are the details:
Professor James A. Thurber, Director, American Universityâ€™s Center for Congressional and Presidential Studies, invites you to join him and former Senator John Breaux at a Lunch Forum on Health Care Reform, featuring David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute, and Peter Pitts, Director of the Center for Medicine in the Public Interest (CMPI).
October 11, 2006
12:00pm - 1:30pm
Butler Boardroom, American University
David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute
Peter Pitts, Director, Center for Medicine in the Public Interest (CMPI)
For more information about the Ceasefire on Healthcare Series, please visit www.ceasefireonhealthcare.org.
Please RSVP to the center (firstname.lastname@example.org) by October 6, 2006.
Contact Melissa Castle, (202) 885-3491, email@example.com, for more information.
The fact is while there are some reviewers and senior officials who are likely to be cautious most people working in the FDA are truly devoted to the public health and have no ax to grind against drug companies.
The fact is, most folks at the FDA -- like those at the drug companies -- know a good drug when they see it and work hard -- without bending rules to make sure a medicine gets a fair shot at approval. To be sure no one at the FDA is going to break new scientific ground in terms of establishing endpoints but the agency is, despite IT limitations, still the single largest repository of information on how to measure the relative risks and benefits of medicines on earth. Which means that they are fairly good, if not always up to date, on how they do their jobs.
The bottom line, at least in 2005, was a reflection of continued effort to use the regulatory tools at hand to make medicines available as quickly as possible. Have there been demands for additional data before going to market? Absolutely. And in some cases companies have volunteered the data while in others the requests are probably better obtained post market through observational studies. But in the main, the demands for data are not all that onerous.
Moreover, if you look at the nature of the medicines approved, they reflect a desire to understand if the risk-safety profile will apply in subpopulations that are likley to receive entirely new medicines.
On the whole, the debate too fast/too slow debate about the FDA has grown tired, empty and irrelevant. The real issue is, will the media and politicos focus on what the agency needs to move drug approvals into personalized and targeted era? Meanwhile, an overview of the accomplishments of Center for Drug Evaluation and Review -- hardly mentioned in the media -- are listed below... And by the way, thanks for your efforts...
Many Americans benefited from last yearâ€™s timely reviews of new prescription medicines, over-the-counter medicines and the generic equivalents for both. When we review a medicine, we use the best science available to determine if a medicineâ€™s benefits outweigh its risks for its intended use. An internal study showed that about half of our professional staff time is spent on safety assessment. We oversee the development of new medicines in the United States, and our paramount concern is the safety of patient volunteers in clinical trials.
Highlights for 2005 include:
* 80 new medicines. We approved 78 drugs and two biologics (22 priority and 58 standard reviews).
* 20 truly new medicines. We approved 18 drugs and two new biologics that had never been marketed before in any form in this country (15 priority and 5 standard reviews).
* 141 new treatment options. We approved new or expanded uses for 126 already approved drugs and 15 already approved biologics (36 priority and 105 standard reviews).
* 5 over-the-counter drugs. Our approvals included five new medicines to be sold over the counter without a prescription, and four of them can be used by children. We approved three new uses for existing OTCs, all of which can be used by children.
* 10 â€œorphanâ€ medicines. Our approvals included nine drugs and one biologic for patient populations of 200,000 or fewer.
* 344 generic drugs. We gave final approval to 344 generic versions of existing drugs and tentative approval to another 108. We received 777 marketing applications for generic drugs.
* User fee goals. We exceeded all our performance goals for the fiscal year 2004 receipt cohort, the latest year for which we have full statistics. We are on track for exceeding most user-fee performance goals for the fiscal year 2005 cohort.
Meanwhile, Hensley cites the example of the HMO that simply decided it would stop paying for Medium because they are cheaper versions that are as effective. Where are the media skeptics demanding the source of the data for this decision? Isn't this a conflict of interest? What about the fact that the Roche Amplichip allows MDs to distinguish how well patients metabolize difference proton pump drugs? What if you can't handle Prevacid or Protonix? My daughter couldn't take either and she had to be prescribed Nexium. Why should she or anyone else be forced to pay out of pocket because she genetically unable to metabolize other PPIs? Isn't this a form of genetic discrimination?
So much for evidence based medicine. It's evidence when the HMO decides to dump a drug, but conflicted propaganda to promote a me-too drug when a drug company decides to bring a new medicine to market?
Note to all those who posture on stem cell funding. It won't do a damn bit of good if we have a 19th century drug development infrastructure for testing products based on such research.
Itâ€™s a very thoughtful and provocative essay about what we, as a society, receive for what many pundit, pols, and MSM savants derisively refer to as â€œspiraling health care costs.â€
Mr. Leonhardt writes, â€œLiving in a society that spends a lot of money on health care creates real problems, but it also has something in common with getting old. Itâ€™s better than the alternative.â€
As David Cutler (our second favorite health economist) points out in â€œYour Money or Your Life,â€ in 1950 the average American spent less than $100 a year ($500 in todayâ€™s dollars) on medical care. That number today is $6000.
And, according to Leonhardt, â€œMost families in the 1950â€™s paid their bills, but they also didnâ€™t expect much in return. After a century of basic health improvements like indoor plumbing and penicillin, many experts thought that human beings were approaching the limits of longevity.â€
Remember what biologist Rene Dubos wrote in the 1960â€™s, â€œModern medicine has little to offer for the prevention or treatment of chronic and degenerative diseases.â€
As Walter Wriston famously quipped, â€œThe future isnâ€™t what it used to be.â€ He was wrong. And so was Monsieur Dubos.
Dan Quayle was more on the mark (kind of) when he said, â€œThe future will be better tomorrow.â€
That's turned out to be surprisingly prescient.
Mr. Leonhardt points out that perhaps â€œspiralingâ€ costs are, well, worth it. â€œA baby born in the United States this year will live to age 78 on average, a decade longer than the average baby born in 1950 â€¦ If you think about this as the return on the investment on medicine, the payoff has been fabulous: Would you prefer spending an extra $5500 on health care every year â€“ or losing ten years of your lifespan?â€
And what do you think the proponents of so-called "rational use of medicine" would have to say about that? Ultimately, they say what Leonhardt points out as both true and frightening -- "that the best way to reduce health care spending is to reduce health care itself."
That is not acceptable in our affluent society. In First World societies health care is precisely how we should spend our money. As David Cutler writes, â€œWe have enough of the basics in life. What we really want are the time and the quality of life to enjoy them.â€
And to do this we must be able to choose the health care (yes â€“ even the pharmaceuticals) that are best suited to our individual needs. Choosing to support spending on health care means choosing life.
Health care: it's where pro-choice meets pro-life.
FDA and Duke Clinical Research Institute Form Partnership to Collaborate on Cardiac Safety Virtual
'Warehouse' of Electrocardiograms Will Serve as Primary Tool In Cutting-Edge Safety Research
The U.S. Food and Drug Administration (FDA) today announced a partnership, under the agency's Critical Path Initiative, with Duke Clinical Research Institute (DCRI) to develop a new generation of tools to identify, as early as possible, the potential effects that drugs and devices may have on the heart -- one of the more ominous side effects associated with such products.
The research will be conducted using a virtual electronic database of more than 200,000 electrocardiograms (ECGs) amassed by the agency from the clinical trial data submitted as part of new drug applications.
"For years we have received generally low-quality copies of ECGs on paper, and we were limited in our ability to use the information to understand why some treatments affected a patientâ€™s heart," said Andrew C. von Eschenbach, M.D., Acting Commissioner of Food and Drugs. "Through the development of digital ECG data standards in 2004, the development of the ECG warehouse in 2005, and this partnership in 2006, we hope to identify patterns that will help to predict which patients are at an increased risk for cardiovascular side effects. This knowledge can guide the development of safer treatments."
FDA and the Duke Clinical Research Institute are developing a consortium with members of academia, patient advocacy groups, other government and non-profit organizations and industry to coordinate and support a variety of research projects involving ECGs obtained in clinical trials. Through the consortium, FDA and DCRI will identify gaps in cardiac biomarkers and prioritize projects based on those needs.
Research shows that women are at higher risk of arrhythmias (abnormal heart beats), but it is not known whether this difference in susceptibility is related to different responses to drugs. Among the first applied projects the consortium will address is a review of gender differences in the effects of drugs on the ECG. A second research project will evaluate the four current methods of measuring ECGs and develop criteria to determine the best method to be used in a particular research study.
"By selecting the most appropriate method for measuring ECGs, we can better assess the impact of a drug or device on patients," said Norman Stockbridge, M.D., Director for CDER's Division of Cardio-Renal Drug Products.
Under the framework of this consortium, Duke and FDA researchers, together with other industry and academic consortium partners, will use the database to identify early indicators for potentially life-threatening cardiac arrhythmias. Strategies will range from the systematic comparison of variants of existing risk-evaluation techniques (to select the most efficient methods) to searching for novel ECG waveform features capable of detecting small adverse drug effects.
"Through its academic mission, the DCRI is committed to identifying and developing more accurate measures of cardiac safety. We will continue to advance the science supporting safety in drug development," said Dr. Robert Califf, Director of DCRI / Vice Chancellor for Clinical Research of the Duke University Medical Center. "This goal is shared with the FDA, and we are proud to be an integral member during the process that will bring a priority area of the Critical Path Initiative from concept to reality."
In October 2005, FDA and the Duke Clinical Research Institute co-sponsored the first in a series of meetings on improving the evaluation of cardiac safety during product development, a high priority under FDA's Critical Path Initiative. The Cardiac Safety and Critical Path Initiative Think Tank brought together representatives of academic research institutions, industry, professional societies, patient advocacy groups, and government agencies as part of a long-term effort to foster the development of tools needed to improve cardiac safety. Another meeting of the group is scheduled for November 3, 2006 at Duke University.
The ECG Warehouse
Following the establishment of an ECG waveform and annotation standard, the FDA partnered with Mortara Instrument Inc., to develop a digital ECG warehouse to support the storage and review of the submitted data. Under the terms and conditions of a Cooperative Research and Development Agreement (CRADA), the FDA's ECG Warehouse was designed and built and contains ECGs submitted as part of submissions to the agency, separated from any personal patient information.
The data standards that enabled this step were a product of Clinical Data Interchange Standards Consortium (CDISC) and Health Level 7 (HL-7), organizations in which FDA and industry are cooperating to develop a comprehensive set of standards for clinical trial data. Through such efforts, the agency expects to enable other similar research opportunities across the full range of data collected in clinical trials of new drugs. Proprietary and nonpublic information will only be disclosed in accordance with FDA regulations and appropriate confidentiality agreements.
So much to catch up on ...
I see that Families USA released a study showing that many kids without health insurance have parents that work. Lots of these kids are eligible for SCHIP and haven't signed up ten years after the program was initiated by the Clinton administration...Families USA Godfather Ron Pollack never attacked President Clinton in the first two weeks of the program rollout about lack of enrollment as he ceaselessly assaulted President Bush during the Medicare part D rollout about poor enrollment. Partisan. Hypocrite. You pick your terms... And by the way...lots of those parents could afford to insure their kids but are too cheap. Sorry, but that's a fact.
Novartis released promising results about a MS drug. According to an AP report
"80 percent of patients taking the drug were found not to have active inflammation according to medical imaging scans. The company also said that patients who had been given a placebo for the first six months of the study showed a marked improvement after they were switched to the treatment, an improvement that was sustained out to the 24th month of the study."
Now let's see, if we follow the IOM recommendations there would be no advertising about the product and its results for five years, there would be an onerous daisy chain of product handling, patient enrollment criteria and bans on off-label prescribing and any expert in MS who had anything to do with Novartis in the past would be excluded from advising them even if they had a Nobel Prize... And that benefits patients how?
Seems to me that since the IOM panel was full of HMO types who do nothing but write guidelines and make formulary decisions all day -- instead of actually conducting clinical trials and seeing patients -- that perhaps, just perhaps its conclusions were a bit biased, narrow and self serving? What about THAT conflict of interest. The IOM recommendations will definitely keep new medicines off HMO formularies. Anyone in the media think of that when writing their articles slamming the FDA?
Feels good to be back.
Go Yankees and L Shana Tova to everyone!
As you can see we are still in the process of making the site pretty. Soon enough. But first things first, right?
A few of the comments we received relative to the hacking incident (names have been omitted to protect the guilty):
"You must really piss people off."
"Somewhere Sid Wolfe is smiling."
And my favorite ...
"Sorry to hear it. Also, congratulations."
I suppose that says it all.
It would be easy enough to let Senator David Vitter (R, LA) et al. claim victory and go home claiming that we have dodged a public health bullet.
But it would be wrong.
Codifying the “personal exemption rule” comes with a container-full of unintended consequences.
It’s important to get one thing out of the way right away. If you walk into a pharmacy in Windsor, Ontario and have your prescription filled by a real pharmacist — the drugs you receive will be both safe and effective. That being said, there are problems.
A Canadian pharmacy cannot fill a prescription written by an American physician unless it is co-signed by a Canadian doctor. Senator Vitter may see this as an added safe-guard — but he would be mistaken.
Most Canadian provinces (including Ontario and Quebec where most of the cross-border drug trafficking takes place) have a provision called the “Touch Law.” An American prescription cannot be co-signed by a Canadian doctor unless that doctor actually examines (“touches”) the patient. But this rarely happens. Most Canadian pharmacies situated near the American border employ physicians who do nothing more than blithely sign their names without even bothering to see what the prescriptions are for or who they are for.
Bad medicine? You bet — and ripe for abuse. Consider this — last year a doctor in Toronto was indicted for co-signing 24,212 prescriptions for American patients he had never seen — at $10 a pop.
Nice work if you can get it.
Mr. Vitter’s amendment, already passed by both House and Senate, would let Americans carry up to a 90-day supply of medication back to the U.S. from Canada without being stopped by Customs agents — codifying this YOYO (“You’re On Your Own”) policy.
So what’s the problem? It very clearly does not allow importation via the Internet or even tacitly approve any of the failed bone-headed schemes introduced by the likes of Pandering Tim Pawlenty or Wrong-Way Rod Blagojevich.
In fact, the truth of the matter is that the 90-day supply “personal exemption” has been the de facto rule since, well, forever.
So why worry about it? Why not just let Senator Vitter get away with what is really nothing more than a Big Shill? Two reasons.
First — it’s already a proven fact that terrorists are playing in this game and this legislation shines a bright light on how they can further exploit a weakened chain of pharmaceutical custody and, second, it sends the dangerous message that full-blown global importation is okay — and the next logical step.
And that you can take that directly from the horse’s mouth.
According to Senator Vitter, this agreement “proves that we have significant majorities in favor of reimporting.” And, “This really breaks the dam, and it shows that it’s only a matter of time before we pass a full-blown reimportation bill.”
All this at the same time the European Union is moving in the opposite direction, trying to design ways to limit cross-border pharmaceutical shipments because of increased safety concerns and a growing problem of counterfeiting.
Senator Vitter’s amendment is more than just a Big Shill; it’s a dangerous and slippery slope.
I predict the following verbiage from the just released IOM report on FDA reform will NOT appear in any mainstream media reporting:
“Some observers believe that drug withdrawals (which are only one potential indicator of drug safety) represent de facto failures of the drug safety regulatory system, or that newly identified unusual and serious adverse events indicate that someone made a mistake in approving the drug. This is not so.”
Thank you, IOM, for that very honest, bold, timely, and necessary statement. Sorry Senator Grassley. Can we now assign David Graham to the dustbin of history?
The IOM report makes many comments and suggestions. Herewith a few of my own (ps/ I have added the appropriate report notation for easy referral):
* Needless to say, the single most important recommendation (and the one that must happen if any of the other ones stand a chance of success) is the very last one — “substantially increased resources in both funds and personnel for the FDA.” (7.1)
* I am glad the that IOM has included in their recommendations my idea of a standing FDA advisory committee on communications. I suggested just such a committee at the November 4, 2005 FDA Part 15 hearing. (6.1)
* A comprehensive review of agency-wide risk communication plans? Absolutely. Lack of centralization has led to overlap, inconsistencies and gaps. Paul Seligman should lead such a program — and immediately. (6.2)
* Similarly, a systematic review of adverse event reporting systems. Yup. When it comes to AERS, we cannot and must not allow miscommunication to lead to health-related unintended consequences. (4.1)
* I certainly agree with the IOM that, when it comes to DTC advertising, the FDA must draw bright lines. But I do not see how a “first five years” moratorium on DTC advertising advances public safety, public health, or public knowledge. Same goes for the black triangle. All that does is triangulate on fear and give trial lawyers a wonderful new weapon in their continued quest for greed. (5.1, 5.3)
* A more timely and comprehensive posting of clinical trials on clinicaltrials.gov? Yes. But as to early stage results — that still needs more debate. (4.11)
* More robust and public discussion of post-market study results. Absolutely. (4.13)
* Adcomm members should be as free of professional conflicts as possible? Duh. But we mustn’t scare away the best and the brightest — as would happen under the proposed Enzi/Kennedy legislation. (4.10)
* Adcomm review of all new NMEs? Shouldn’t that be the decision of the professionals at the FDA? Not all NMEs are alike, so why treat them so? Bad idea. A knee-jerk, Grassley-like suggestion. (4.8)
* Include research capacity in the agency’ s mission statement. This would be a terrific idea if the agency had research capacity — which at present it does not. it should. Fund the Critical Path and then amend the mission statement. (4.7)
* Build a CDER informatics capacity? Totally. (4.6)
* Have the agency work with government partners (such as the VA and DoD), drug companies, public and private insurers, health care provider organizations, and consumer groups to plan, organize and fund confirmatory drug safety and efficacy studies of public health importance. A good idea in theory, but the wording is very vague and could easily lead to a fascist regime of so-called “evidence-based medicine.” Do we really want the editors of Consumers Report telling us which dugs are safe and effective? More debate and clarity needed here. (4.3)
* A 6-year term for the Commissioner of the FDA. Yes. Let the person chosen as Commissioner of the FDA serve as free of the political current as possible. (3.1)
The IOM report has good and bad. But a good next step is to carefully consider them all and expeditiously move forward by taking to heart the words of Goethe that appear on the frontpiece of the report:
“Knowing is not enough; we must apply. Willing is not enough; we must do.”