Latest Drugwonks' Blog
Proposed diabetes changes leave sour taste
By Theresa Flaherty Managing Editor - 10.29.2010
BALTIMORE - When it comes to diabetes treatment, one size doesn't fit all, stakeholders told CMS medical directors at an Oct. 26 public hearing on the proposed changes to the benefit.
The changes, outlined in a draft local coverage determination (LCD) issued in September, would limit the number of allowed strips, based on frequency of injections, to six per day for insulin-dependent beneficiaries. It would limit the number of allowed strips to one per day for non-insulin dependent beneficiaries.
"It's not that cookie cutter," said Chris Smith, director of policy and regulatory affairs for the National Community Pharmacists Association. "Every individual has different variables that may require them to test more frequently on some days than others."..
But CMS really doesn't care...
"There's a large number of patients we serve that are testing above the (proposed) limits," said Belmonte. "By limiting and not allowing any overages, there could be some clinical implications."
If Medicare won't pay for additional strips, beneficiaries probably won't either, especially those on fixed incomes, Belmonte said.
"I honestly feel that many would choose to sacrifice their health (if they can't) test at what their healthcare provider recommends," she said.
The draft LCD also seeks to require additional documentation regarding physician-beneficiary contact and a testing log maintained by the beneficiary that demonstrates the prescribed frequency for 70% of the testing times.
"(DME providers) can't control what (physicians document) in the record, but without the proper documentation, you are going to have claims denied," said Smith.
Bending the cost curve = sticking it to diabetics, especially those who are poor.
I predict an oversight hearing in January...
www.hmenews.com/
18% from biotech companies..
16% from universities, transferred to biotech.
8% from universities, transferred to pharma.
Orac on what it means to be “anti-vaccine”:
Read more here.
The Republican takeover in the House has drug industry stakeholders watching to see which member becomes chairman of a key committee, Energy and Commerce.
First in line for the committee chair is Texas Republican Joe Barton - ranking member since 2007 after Democrats wrested House control in the 2006 congressional elections.
Barton would need a waiver from the party to take the chair, a move considered unlikely following a gaffe this summer in which he demanded President Obama apologize to BP following the administration's response to the Gulf oil spill.
Reps. Cliff Stearns of Florida and John Shimkus of Illinois also are expected to make a play for the top spot, but Rep. Fred Upton of Michigan is currently viewed by Hill observers as the front runner. Upton's donations to other Republicans' campaigns during this election cycle improved his chances significantly.
In two other key House committees - Oversight and Government Reform and the Appropriations subcommittee with FDA oversight - the current ranking Republican member is expected to take the chair.
California Rep. Darrell Issa likely will take the lead on Oversight from Rep. Edolphus Towns of New York. Issa has been vigorous in his criticism of federal agencies under the Obama administration..
Georgia Rep. Jack Kingston is in line to take the Appropriations Agriculture subcommittee from Rep. Rosa DeLauro of Connecticut, who has been the most vocal and consistent advocate for creating a separate food safety agency from components of FDA, Department of Agriculture and other agencies.
Kingston hasn't been a major player on health care issues. But he has made a point of disagreeing with DeLauro's stances. For example, during a 2008 Ag subcommittee hearing on FDA's Safety First initiative on post-market safety. Kingston is "pro-FDA" and would like to hear "more about successes" there, On the down side, Kingston has continued to speak out in favor of importation.
Let the jockeying begin!
It's called tossing a bone. As in an effort to call off the dogs.
President Obama:
The president said he is still open to hearing some of the Republicans ideas for how to “tweak and make improvements” on the health care system, and mentioned one by name by way of example .
“The 1099 provision in the health care bill appears to be too burdensome for small businesses. It just involves too much paperwork, too much filing. It's probably counterproductive. It was designed to make sure that revenue was raised to help pay for some of the other provisions. But if it ends up just being so much -- so much trouble that small businesses find it difficult to manage, that's something that we should take a look at."
Harry Reid:
" If there's some tweaking we need to do with the healthcare bill, I'm ready for some tweaking," Reid said in an interview on CNN, after Republicans captured the U.S. House of Representatives in Tuesday's midterm elections.
And the media is taking up the term..
Reuters channels Reid:
Republican wins could push healthcare tweaks | Reuters
And NPR has already decided that only "tweaks" to Obamacare are possible:
SIDE EFFECTS: Tweaks To Health Law Likely; Repeal Not
Apparently NPR was too fixated on Juan Williams to notice what the election was all about: George Will provides a take on why "tweaks" are simply the opening bid of the Left to hold on to their taxpayer subsidized sand castles:
The progressive agenda is actually legitimated by the incomprehension and anger it elicits: If the people do not resent and resist what is being done on their behalf, what is being done is not properly ambitious. If it is comprehensible to its intended beneficiaries, it is the work of insufficiently advanced thinkers.Of course the masses do not understand that the only flaw of the stimulus was its frugality, and that Obamacare's myriad coercions are akin to benevolent parental discipline. If the masses understood what progressives understand, would progressives represent a real vanguard of progress?...
Will concludes:
Don Boudreaux agreed that interest-group liberalism has indeed been leavened by idea-driven liberalism. Which is the problem.
"These ideas," Boudreaux says, "are almost exclusively about how other people should live their lives. These are ideas about how one group of people (the politically successful) should engineer everyone else's contracts, social relations, diets, habits, and even moral sentiments." Liberalism's ideas are "about replacing an unimaginably large multitude of diverse and competing ideas . . . with a relatively paltry set of 'Big Ideas' that are politically selected, centrally imposed, and enforced by government, not by the natural give, take and compromise of the everyday interactions of millions of people."
This was the serious concern that percolated beneath the normal froth and nonsense of the elections: Is political power - are government commands and controls - superseding and suffocating the creativity of a market society's spontaneous order? On Tuesday, a rational and alarmed American majority said "yes."
Oops.
Okay, take a breath.
How many times did you hear the words “historic realignment” over the course of this election cycle? How many times did you hear it when President Obama was elected two years ago? How many times when the Democrats took control of Congress four years ago?
We can safely assume that, when it comes to “historic realignment,” the phrase has been overused and is largely rhetorical -- unless you are a fan of the Miami Heat.
But that doesn’t mean the midterms are unimportant or unlikely to deliver some real health care-related fireworks. Au contraire.
When it comes to health care reform and a 21st century Food and Drug Administration (FDA), will the 112th Congress be sanguine or sanguinary? Or is there a third way – of bipartisanship?
- 1- New members – who will need to be educated on many important and arcane policy points;
- 2- New staff – who will have the power to influence the education of their new masters; and,
- 3- New committee and subcommittee chairs – who will have the power to call hearings, select witnesses and wield the power of the gavel over some very exigent issues.
- Take another breath.
Will the 112th Congress usher in a new spirit of bipartisanship on healthcare reform and a 21st century FDA?
That’s the difference between a hearing aid and a hearing problem.
That’s the difference between addressing policy concerns and playing politics.
Winners and losers (and not to mention “enemies”) aside, we’ve got an opportunity to work together on healthcare, FDA and a plethora of other issues.
Or we can all go down with the (partisan) ship. It’s time for pragmatism.
To paraphrase, "Voters, what have you wrought?" "An opportunity -- if you can keep it."
For a complete response to the impact of the election, click here to read CMPI's complete "Midterm Missive."
It is simply a flack for the anti-medical progress and rationing crowd.
The website is a "project" of the Foundation for Informed Medical Decision Making. The Foundation is a pass through for HealthDialog, which has turned the Dartmouth belief that one third of healthcare is wasted into a decision tool health plans use to scare people away from things like prostate cancer surgery, hip replacements and other 'wasteful' activities. Hence, as a project of the Foundation it promote the company line that new technologies should be evaluated in terms of cost and should be covered according to comparative effectiveness methodology. The site has also helpfully put out a manual for health care reporters to 'guide' them in how to report on medical innovations.
Healthnewsreview also provides a list of 'independent' experts on health care. It includes Vera Sharav who runs the Alliance for Human Research Protection.. That's the group that says SSRIs cause suicide. Very objective and scientific. And Peter Breggin, who believes medication does not really work for mental illness.
Also, Marcia Angell, Arnold Relman, Merrill Goozner and a bunch of other people who make their living consulting for trial lawyers who sue drug companies.
The guy who runs this, Gary Schweitzer, is biased, which is ok. But he is trying to pass himself off as the arbiter of objective journalism regarding healthcare.
To me, he is a full blown tabloid medicine machine with lots of dough to support him from a company that makes money by rationing healthcare.
Blood money.
FDA’s new proposed review model would break the process into four distinct phases:
FDA's Proposed Four-Stage Review Cycle |
1. Administrative phase – The agency would validate the application before the review clock starts. 2. Application review phase – Primary and secondary reviews would take place along with the issuing of any discipline review letters. 3. Information sharing phase – The sponsor and the agency discuss how to address issues raised during the initial review. 4. Wrap-up and action phase – Final review activities would be completed. |
Under the proposal the agency would not need some extensions it had previously suggested only because the review clock would be stopped mid-review to address application problems and amendments.
A delay by any other name. This is progress?
The mid-review pause would allow for in-depth discussion between the sponsor and the agency, and appears to be in part a response to an industry request that the review system in the next user fee cycle include a process that makes it easier for sponsors to gain feedback and provide input during an application’s review.
Minutes of an Oct. 12 Prescription Drug User Fee Act negotiation with industry indicated that phase would be used for sponsor meetings with FDA and amendment submissions stemming from reviewers’ issues. The information sharing phase was proposed as a fixed period, although no specific length of time was given.
It would almost certainly be the period where FDA would call its time-out, where the review clock would stop while meetings were conducted.
An application review cycle would begin with the “administrative phase,” where the agency would validate the application before the review clock starts. Primary and secondary reviews would occur in the “application review phase,” along with the issuing of any discipline review letters.
After the sponsor and agency complete the “information sharing phase,” the agency would move to the “wrap-up and action phase,” where final review activities would be completed, including advisory committee meetings, sponsor amendment reviews, risk management agreements, if necessary, and a final decision.
FDA has not determined many details of the new model and minutes called it a “high-level concept.” The agency has not worked out whether the “information sharing phase” would be required for some types of applications that would be considered very likely to be approved or receive a “complete response” letter.
The agency also warned it has not finished refining the concept, so it may not appear superior to the existing review model as it comes into focus. Industry groups at the meeting planned to discuss the new model with their member companies before the next meeting.
The new model is different from any previous compromise FDA has proposed. Agency representatives said in earlier meetings they needed more time than the original PDUFA periods and argued for automatic extensions if advisory committees, foreign facility inspections or certain types of Risk Evaluation and Mitigation Strategies were necessary. The agency also has said any major application amendment should trigger an automatic three-month deadline extension.
Talk about a 90 degree angle!
Under the new review model, the agency would not need three-month extensions for advisory committee meetings or foreign inspections. But it did say a four-month extension still may be needed if complicated REMS was submitted during the review cycle.
Ah – but when during the review cycle should also be a PDUFA reauthorization topic of discussion.
The agency does appear somewhat willing to allow for more Type C meetings in a review cycle, as long as it can control them. “Control” means that the FDA would determine whether a C1 or C2 meeting was appropriate. Industry said sponsors should be allowed to request either classification of meeting, but the agency said it wanted to preserve the standards of what constitutes a Type C meeting. Those standards could be lowered if industry determined the meetings, according to the minutes.
The agency also was concerned the demand for Type C meetings could balloon enough that it would overburden review staff. If the number of meetings eclipsed the 2003 record, the PDUFA workload adjuster, which helps determine annual user fee amounts, would not adequately account for the increase, according to the minutes. If industry accepted the C1 and C2 meetings, the agency said it wanted more resources added early in the PDUFA V cycle to address the workload problem.
Sounds reasonable – but what about a “real time” meeting measurement system to measure if money earmarked results in meetings scheduled?
And what about the issue of so-called “non-binding advice?”
The agency was concerned any provisions allowing non-binding advice would force primary review staff to give advice without supervisory approval or an official record, which could cause an increase in FDA-industry disputes.
Allowing non-binding advice also likely would increase reviewers’ workloads. The agency said some questions that seem simple require input from several reviewers and cannot be answered by one reviewer, according to the minutes.
FDA remained leery about the idea, but was willing to talk about specific parameters where the general scientific discussions that carry no regulatory weight could be allowed, according to the minutes.
Really? Non-binding advice that carries no regulatory weight?
This is progress? This is transparency?
What does “drug safety” mean? All drugs have benefits as well as risks – and that’s why we have, for example, REMS and early safety signal communications (worts and all) as well as the FDA’s “safe use” initiative (wherein a drug is made safer when it is used as intended).
But the unsung hero of “safety” is “quality.”
I recently was invited to visit Pfizer’s Kalamazoo production facility. I expected “yawn” – but what I got was “gee!" -- as in GMPs.
What impressed me more than the gee-whiz production aspects of the facility (of which there were plenty) was the dedication of the people who work there – top to bottom. It actually reminded me a lot of the FDA. Long-term employees dedicated to serving the public health through dedication to quality. And they all took it very personally. Just like at the FDA, the Pfizer folks (many of whom were not only Upjohn legacy employees – but the sons and daughters of Upjohn employees) were on personal missions of quality. There was a lot of pride on display.
It was all about quality 100 ways to Sunday. And innovation.
But innovation with a twist.
The Kalamazoo facility makes (among other things) the API for methyl prednisolone, a corticosteroid long off patent. In fact, it’s been around for about 50 years. To my surprise, the Kalamazoo plant exports the API to both China and India.
A US manufacturing facility of an innovator biopharmaceutical company exporting API to China and India for profit? What’s wrong with this picture?
Well, as it turns out, it’s what’s right – innovation through manufacturing prowess, organic chemistry smarts and green technology. Better. Faster. Cheaper.
And also safer – since Pfizer’s figured out how to manufacturer it without preservatives.
Obvious implications for generic manufacturing standards as well as FOBs.
Pharma’s always bragging on its ever-growing investment in R&D. But when’s the last time you heard about investments in domestic manufacturing? Probably never. And when’s the last time you read about enhanced drug safety through cGMPs and cooperation between industry and the FDA? Not recently. That’s a shame because they’re two important stories.
Sound like an infomercial? Request a plant tour and see for yourself.
For more details on the Kalamazoo facility, see here.
www.npr.org/blogs/health/2010/10/28/130881430/unpleasant-future-looms-for-nice
by JOANNE SILBERNER
Critics of one of the most controversial parts of the British health system may lose their target in a few years.
The National Institute for Health and Clinical Excellence (happily called NICE by critics and supporters alike) decides whether medicines are cost-effective. If NICE says a drug provides too few benefits at too high a price, the National Health Service in England and Wales generally won't provide the drug.
At a drug industry trade group meeting in London earlier this week, Health Minister Lord Howe, Under Secretary of State for Quality, said NICE has become "redundant," and that it should focus on setting quality standards rather than evaluating individual drugs.
NICE has been held up by American critics as an example of what happens when the government rations medical care. There have been complaints that Brits dying of cancer weren't able to get the latest treatments. Another controversial decision from NICE led to restrictions on Alzheimer's drugs that are now being relaxed.
Many folks in England and Wales accept NICE's decisions without complaint, but others have railed against them. The national government as well as local divisions of the National Health Service have on occasion overridden NICE.
Meanwhile, in another blow to the agency’s reputation, the government has said that it's providing £200 million ($318 million) to the NHS to pay for several cancer drugs that NICE has deemed unworthy.
Lord Howe says NICE's advice will still be taken into consideration. But some close watchers of NICE are predicting the agency will be gone by 2013.
While NICE's loss of power would deny headline writers some of their best chances for bad puns, the drug industry may not be completely off the hook.
Lord Howe says the government is working on a new agency that would set drug prices based on a "value-based pricing system." With no details yet available, that could be good news or bad news for drug companies.
Let's repeat that: But some close watchers of NICE are predicting the agency will be gone by 2013.
The NHS knows it has an innovation and quality of life problem because of rationing. Meanwhile in the US the Berwick led CMS is seeking to:
1. Limit how many diabetes testing strips doctors can prescribe each month.
2. Is taking a year to see if it will pay for Provenge, the prostate cancer vaccine.
3. Seeking to restrict what biotech drugs patients can get to what Medicare deems the least costly alternative.
4. Telling hospice patients how many days of care they can receive and what they can receive.
Congress should follow the British example and give the newly created comparative effectiveness bureaucracy the pink slip and eliminate all funding for CER.
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.
