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We here at drugwonks.com are all for “effective†from a patient-centric standpoint (“effective†meaning “most effective in treating a given patient). But we are highly dubious of people hijacking the word to mean “cost effective†(like in “evidence-based medicine†aka “health technology assessment†aka “rational use of medicine.)
It is, therefore, with pleasure that we pass along the following report from today’s edition of Drug Industry Daily(http://www.fdanews.com/did/5_192/cms/60829-1.html)
The future of the Centers for Medicare & Medicaid Services' (CMS) plan to share prescription drug plan data with the FDA in an effort to base Medicare reimbursement on product comparisons is in doubt as the agency determines whether it has the legal authority to share this information, an industry source says.
The CMS has been working with the FDA to develop this new program as a means to ensure the most effective products are covered by Medicare's Part D plan. While CMS Administrator Mark McClellan, the program's primary advocate, is leaving in October, that is not the reason why the program is in trouble, the source said.
The CMS is worried that, while the law gives it the authority to use Part D data for payment purposes, it may not be able to use this information to make comparisons between competing drugs. The CMS is also unsure whether it is able to provide the FDA this data for postmarket surveillance, as it originally planned. Read More & Comment...
"The legislation would authorise the FDA to approve abbreviated applications for biologicals that are "comparable" to the reference products approved under the Public Health Service Act.
Comparability means no clinically meaningful differences in safety, purity and potency, based on non-clinical studies and clinical studies as necessary. An applicant also must demonstrate that the comparable product shares the "principal molecular structure features" of the reference product and the same mechanism of action, if known. "
In otherwords, generic firms would have a separate and short track for developing biotech products based on the same mechanism of action without having to go through all the time and expense that a biotech firm has to go through. Which means all you have to do if you are a generic company is a little reverse engineering and try to punch a couple holes in a patent or two of a biotech product and claim you can whip up the same product with the same molecuar structure features --whatever the hell that means.
The bill assumes that biologics are therapeutically interchangeable or can be made so. Actually, the bill deals with this problem by simply avoiding the issue altogether by assuming -- incorrectly -- that the same mechanisms of action equals no clinical meaningful difference or should be the foundation for approval.
The bill gives the generic firms tax breaks and market monopolies as incentives to attack the patents of biotech companies (what else is this aggressive effort to promote interchangeability at any time during the patent period) and ban the ability of biotechs to produce their own biogeneric products even though that might be a safer and more effective product or in fact their might be scientific question as to interchangeability.
This Clinton Schumer bill is a car bomb driven up to door of biotech innovation that will explode years from now. It will lead to massive litigation and game playing. Rather than worrying about the price of biotech products, policymakers should encourage the promotion of personalized and targeted medicine and nanontech delivery systems that will lead to more appropriate dosing for the right patients at the right time. Read More & Comment...
November 15 begins the six-week enrollment season for Part D. The good news is that, in most states, beneficiaries will have 50 to 60 offerings to choose from, at least 10 more than in 2006.
According to an article in today’s edition of The Wall Street Journal, “Who should consider switching? Prime candidates are those who picked plans for this year that provided coverage of the so-called doughnut hole, or who fell into that gap and now want coverage for it. For a higher premium, some plans offer to cover drug expenses through the gap.â€
We'll see if smart providers start promoting this alternative.
Also according to the WSJ, “In another shift, many plans are making changes that will reduce the chances that consumers will even reach the $2,400 level where the coverage gap starts. By eliminating co-pays for generic drugs in some plans, for instance, insurers are making such treatments essentially free to patients (at least until they reach the coverage gap). Aetna is dropping co-pays for generics in many of its plans, while Cigna says it is eliminating generic co-pays in all of its most basic drug plans.â€
How do we do it? Volume!
Further, the WSJ keys into the fact that, properly leveraged, market forces are increasing both choice and quality. “There may be a huge market of potential shoppers. Only 20% of 3,400 beneficiaries surveyed last month by J.D. Power & Associates said they would definitely stay with the plan they had. About two million Americans will turn 65 in 2007 and also will be eligible. At least another four million, including three million low-income beneficiaries not subject to penalties for missing the deadline earlier this year, have yet to enroll.â€
Somewhere Mark McClellan is smiling. Read More & Comment...
He complains about the price of ABRAXANE which he correctly but not completely describes as "a reformulated version of paclitaxel, a chemical found in the Pacific yew tree that destroys cancer cells. "
To assert that the two products "have similar side effects" is incorrect. He could have looked (and he did) at a Sept 7 FDA Oncological Products Advisory Committee meeting transcript or the data from the clinical trial....both of which had the following language more or less ... Neutropenia on this study was greater for Taxol than it was for Abraxane even though 50 percent more paclitaxel was being administered to the Abraxane patients. This was highly statistically significant and was true whether you looked at all-grade toxicity or just focused on
Grade 4. "
Berenson makes a big deal of how the company that makes Abraxane -- Abraxis -- tried to get the FDA to approve the use of its drug for early stage breast cancer (just like Taxol) by claiming that Abraxane is just Taxol without the toxicities and can be administered more quickly at higher doses. The FDA did not buy that argument since the pharmacokinetics of the two products are completely different and approval of Abraxis in the metastatic setting required a small randomized controlled trial.
In any event, Berenson was trying to use Abraxis' words against them to underscore that generic Taxol costs $150 compared to Abraxane which $4200. And only Bravve Alex is willing to raise the tough question of whether it is worth it to pay $4200 for a drug that is really no different and doesn't increase survival -- the latter measure now being the new gold standard for reporters who want to trash cancer drugs -- all of them it should be noted do not have late stage cancer and it seems are single and don't have kids and spouses to worry about.
Setting aside the fact that it was the New York Times that helped lead the charge about how BMS was gouging the public when Taxol was going for $8000 a treatment cycle, especially because it got the drug at a preclinical stage through a partnership with NIH, the idea the only good cancer drug is a cheap one that adds ten years of life (median) when someone has the advanced form of the disease reflects callousness, misunderstanding or a political agenda or all three.
And to suggest that some public policy could step in to ratchet down prices for unique drugs (Berenson uses the voice of a 'patient' from the National Breast Cancer Coalition on this score) raises the question as to what that mechanism might be. We have seen what "works" in Cananda, the UK, Australia and the VA....just limiting who gets the drug based on some arbitrary criteria that has nothing to do with genomics, compassion or pain. And for Berenson's elightenment, here is what British oncologists had to say about the five years it took for the UK's rationing agency to finally approve of the use of Taxol in a metastatic setting:
"Some health authorities, despite the authoritative advice of leading cancer specialists, have held off from making full use of this licensed medicine . . . . It is regrettable that lives will have been lost while a medicine, which had already proven its clinical value, has had to pass through what is effectively a further approval system before being widely prescribed in the UK."
Now they are doing the same thing with Herceptin, Gleevec, etc.... using the same excuses put forth by Berenson and others. Maybe Carolina Hinestrosa of the National Breast Cancer Coalition would be interested in making the judgement about prices and rationing since she is so keen in finding a public policy mechanism.... Read More & Comment...
Sept 30, 2006
This week, scientists completed mapping the mouse brain down to details of individual cells. Because much of the neurochemistry of humans mirrors many of the pathways found in mice and rats, researchers will be able to use this molecular guide to more quickly determine which medicines might work to control or delay the progression of such devastating brain illnesses as Alzheimer's, Parkinson's and Lou Gehrig's disease.
But first some enterprising researcher should use the map to explain the disconnect in the minds of some between the crushing burden such diseases impose on families and society and proposals that that supposedly benefit the public health but in fact delay the development of new medicines. They can also make them more difficult and more expensive to introduce.
One subject of this study should be the Institute of Medicine (IOM), which just released a report on the Food and Drug Administration's ability to monitor the safety of medicines. The study asserts that it is impossible to make a medicine 100 percent safe and harder still to understand (using methods the IOM admits are inaccurate and outdated) why some people react badly and some respond well. Rather than recommending a more computerized and gene-based approach to detecting and predicting safety problems -- which can affect a very small group of patients -- the IOM wants the FDA and companies to spend billions conducting randomized clinical trials that test everybody as if they were the same to discover what current methods rarely find in the first place.
Will this make medicines more expensive to make? IOM is indifferent. Will patients doing great on a drug enroll in a safety study where they have half a chance of not getting the medicine keeping them alive? It never crossed the minds of the IOM solons.
The other subject should be Sen. David Vitter of Louisiana, who sees no connection between barring Customs Agents from inspecting packages of medicines from Canada and the prospect of polluting the entire prescription-drug supply of the United States. Individuals carry much of the illegal narcotics coming into this America under threat of arrest. Thanks to Mr. Vitter's amendment to a Homeland Security bill, counterfeiters and suppliers of controlled narcotics will be able to cross from Canada into America.
A flood of bogus drugs for diseases such as Alzheimer's, heart disease and cancer won't be discovered until they enter the market. By that time it will be too late and too expensive to track the problem. The same can be said for IOM's after-the-fact and outdated approach to drug safety. Both will lead to fewer innovations. Read More & Comment...
And Brussels may indeed be moving in that direction.
Last March in Brussels I appeared on a panel with James Copping, the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations on a how the EU should address what they refer to as ItP or Information-to-Patients.
One interchange between Jim and me that is worth sharing:
COPPING: "We must find new ways to regulate health care information to patients."
PITTS: "Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.â€
COPPING: "Yes, that’s right.â€
Well, it seems as though Mr. Copping has done just that.
According to a report in the The Financial Times, draft recommendations prepared for a pharmaceuticals forum, jointly chaired by the European commissioners for enterprise and health, will call for industry participation in partnerships for "information creation and exchange" on diseases for patients and citizens.
They propose a trial scheme to provide "high-quality health-related information" on diabetes, offering data to the non-specialist in all official EU languages, drawing on authorised disease databases, with input from doctors, patient groups and health insurers as well as industry.
The move would mark a significant shift away from the current ban in Europe of US-style "direct to consumer advertising," which forbids drugs companies from any form of direct communication with patients.
With partial exceptions in the UK and Sweden, European legislation prevents drugs companies from even responding to inquiries from patients, let alone advertising their medicines beyond specialist publications for medical professionals. That has created a situation long decried by the industry, by which patients can find all manner of unreliable information on diseases and treatments on the internet, with the pharmaceuticals manufacturers the only groups banned from providing data.
The initiative comes after previous efforts to ease the rules on pharmaceuticals communication were crushed by health insurers and consumer groups wary of industry influence and manipulation.
Good luck Mr. Copping. We're watching. Read More & Comment...
Here’s a hot link:
http://www.aei.org/publications/pubID.24889,filter.all/pub_detail.asp
Along with a few thoughts to ponder ...
* As we proceed further down the path of personalized medicine via both targeted therapies and gene testing, those nations (mostly in the EU, but also Canada, Australia and -- to a lesser degree -- Japan) that impose price controls via the threat of compulsory licensing will find that what once was a Thor's hammer has become a toy hammer. More and more pharmaceutical firms will just say no to such blackmail and increasing numbers of patients in these otherwise developed nations will have neither access to nor, for that matter, knowledge (because of the EU's neroses about direct-to-patient information) about cutting-edge treatments.
* As a result, therefore, the overall global prices for these new therapies will go up -- while they go down in the US. Why? Because, minus price controls for these cutting edge therapies, the rest of the world will be forced to carry their fair share of the R&D costs now being carried almost exclusively on the backs of the American health care consumer.
* But you can't get blood from a stone. If EU nations continue to abide by absurd health technology assessment protocols they will simply say there is not sufficient "evidence" to showi that these new, more targeted (and, therefore, safer) therapies are of sufficient "added benefit."
Result? More American health care holidays for those Europeans who can afford it. And for those who cannot -- zero access to 21st century medicine.
Denial is more than just a river in Brussels. Read More & Comment...
Shameful.
But, sorry Senator Grassley, it does not "prove" that the FDA is "toothless."
In fact, it shows just the opposite. Read More & Comment...
Whenever the FDA doesn't do exactly what Senator Charles Grassley thinks is right or issues a ruling on a drug he disagrees with that seems to favor a drug company, he is quick to claim it is another example of how the FDA is sacrificing public health because it has a "cozy" relationship with industry.
So I guess that means when the EPA does not make a special exception to a particular industry in enforcing a public health-type rule and a Senator tries to carve out an exemption, that relationship would be defined as....how? I am sure the EPA has some very good scientific data to support it's position. So I am sure Senator Grassley was not criticizing the integrity or intelligence of EPA scientists when he called the ruling "idiotic" because he has made preserving the intellectual independence of people like David Graham a keystone of his career in the Senate. He would never try to bully or cajole an agency into changing it's stance...that wouuld be inconsistent and political and undermine his morally insufferable position on FDA issues and drug safety...
DES MOINES, Iowa Senator Charles Grassley is clashing with the Environmental Protection Agency.
The dispute comes after the agency reversed its course on exempting agriculture operations from dust regulations.
The Bush Administration says it decided against the exemption because officials could not legally exempt specific industries.
Grassley, a Republican, disagrees with the opinion. He says it is -- quote -- "such an idiotic move for the EPA to take" -- end quote.
The senator has sent a letter to the E-P-A's top administrator inviting him to visit Grassley's farm in Iowa.
He has asked for a response within 24 hours. Read More & Comment...
"Seniors who complained this year about a dizzying array of choices for a Medicare drug plan may find themselves even dizzier when they shop around for next year.
Federal officials announced Friday that 17 companies have been approved to provide Medicare drug coverage nationally. This year, there were nine."
Actually, since 90 percent of all seniors signed up for the program and a small percentage who hit the donut hole really had a problem after doing so, Freking had to scrape around for a quote from -- who else -- the Don of Part D Doom himself, Ron Pollack to underscore just how crappy the program really is:
"The incredible confusion that persisted throughout this year is about to get considerably worse," said Ron Pollack, executive director of Families USA, an advocacy group. "This is because there will be quite a few more plans to choose from, they will all be different from each other, and seniors will have a much shorter time period to make decisions about enrollment."
Similarly, Freking reaches down to another well paid malcontent, Deanne Beebe," a spokeswoman for the Medicare Rights Center, said that seniors won't be won over by all the additional options.
"They don't want dozens of choices," she said. "They want one affordable drug benefit they can count on when it comes time to fill their prescription."
Yes, Ron annd Deanne compared to the one size fits all system where seniors would wait five years to get many of the newest medicines while the government negotiates prices and restricts access there will be quite a few more plans to choose from. As for seniors not wanting dozens of choices, I propose that Beebe rollout a the VA style approach and try to sell it with the longer waits for drug approvals, fewer drug choices and in some cases, higher out of pocket costs..
The triumph of ideology over compassion and common sense. Read More & Comment...
Well, since it's true it's worth repeating, and since it's based on "a new study" it's worth reporting on. Still, I'm surpised that it even made the UPI wire. So much the better.
Here goes ...
"Patients who leave the doctor's office with a prescription may be leaving something important behind."
Car keys? No, they're leaving, brace yourself, without "the information they need to take their medicines correctly."
In fact, according a new study (see, told you) from UCLA (go Bruins!) doctors only give their patients 62% of five "key pieces" of information:
* Patients were told the name of a new medication only 74% of the time.
* Patients were told why they were taking a new medication only 87% of the time.
* Only 30% of patients were told how long to take the new prescription.
* Only 55% of patients were told how many tablets to take.
* Only 58% for both frequency and appropriate timing (with food, etc.)
And the winner is:
* Doctors told patients about potential adverse events of a new medication only 35% of the time.
To be fair this was a study based on data collected from 185 outpatient visits to 44 physicians, so draw your own "margin of error" conclusions.
(I wonder how are they going to pin this one on the pharmaceutical industry?) Read More & Comment...
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 “common ground†for meaningful, bipartisan change to the nation’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 University’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
Speakers:
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 (ccps@american.edu) by October 6, 2006.
Contact Melissa Castle, (202) 885-3491, mcastle@american.edu, for more information. Read More & Comment...
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 year’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 medicine’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 “orphan†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. Read More & Comment...
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? Read More & Comment...
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. Read More & Comment...
It’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 “spiraling health care costs.â€
Mr. Leonhardt writes, “Living 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. It’s better than the alternative.â€
As David Cutler (our second favorite health economist) points out in “Your Money or Your Life,†in 1950 the average American spent less than $100 a year ($500 in today’s dollars) on medical care. That number today is $6000.
And, according to Leonhardt, “Most families in the 1950’s paid their bills, but they also didn’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 1960’s, “Modern medicine has little to offer for the prevention or treatment of chronic and degenerative diseases.â€
As Walter Wriston famously quipped, “The future isn’t what it used to be.†He was wrong. And so was Monsieur Dubos.
Dan Quayle was more on the mark (kind of) when he said, “The future will be better tomorrow.â€
That's turned out to be surprisingly prescient.
Mr. Leonhardt points out that perhaps “spiraling†costs are, well, worth it. “A 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 … 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 – 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, “We 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 – 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. Read More & Comment...
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 patient’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. Read More & Comment...
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! Read More & Comment...
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. Read More & Comment...
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.
Read More & Comment...
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