WaPo Provenge Piece Gets The Facts Wrong

11/08/2010 03:34 PM |

What did Mark Twain say:  Get the facts right, then distort them as much as you please.

Case in point:  The WaPo piece on Provenge tinyurl.com/36pvsyn makes two major mistakes.. Actually three.  Naw,  make that four.

1.  It gets the price of Provenge wrong.  It is a vaccine that is administered three times at a retail price of $93k.  Not $270K as cited in the article.

2.  To suggest that the total price of the drug equals a quality adjusted life year (QALY) is absurd.  The chart that goes along with the article is inaccurate and misleading.  Moreover,  a QALY is a rule of thumb developed back in 1985 to estimate the value of dialysis care for Medicare.  To write as if $50K or $100K is a cutoff and a scientific one at at is misleading.  Wrong on both counts then. 

3.  The article states: " In a study involving 512 patients with advanced prostate cancer, Provenge increased median survival from 21.7 months to 25.8 months."  Way wrong and way misleading.   There are patients who have lived for more than five years after Provenge.  And as a legal brief from CareToLIve notes:  " Appellee attempts to underwhelm the Court by stressing a 4.5 month “average” extension in survival to Provenge patients. That understates the effectiveness. Average is different from median. It’s an important distinction because misuse of the term "median survival" is one of the deceptive arguments used by those who are against Provenge approval (FDA). When anti-Provenge forces use the "average" terminology and attribute it to the median, they are undercutting the total Provenge beneficial effect. At the time of the committee meeting it is estimated that the actual average survival benefit in the 9901 trial was in the 10-12 month range, judging from the likely survival through Feb/Mar 2007 of 20 out of the 28 three-year survivors from 10/04. These 20 Provenge arm survivors would have lived anywhere from 5.5 to 7 years after their randomization between 1/00 and 10/01. underwhelm the Court by stressing a 4.5 month “average” extension in survival to Provenge patients. That understates the effectiveness. Average is different from median. It’s an important distinction because misuse of the term "median survival" is one of the deceptive arguments used by those who are against Provenge approval (FDA). When anti-Provenge forces use the "average" terminology and attribute it to the median, they are undercutting the total Provenge beneficial effect. At the time of the committee meeting it is estimated that the actual average survival benefit in the 9901 trial was in the 10-12 month range, judging from the likely survival through Feb/Mar 2007 of 20 out of the 28 three-year survivors from 10/04. These 20 Provenge arm survivors would have lived anywhere from 5.5 to 7 years after their randomization between 1/00 and 10/01.

4.   And WaPo has yet to correct these facts.  It did correct the name of the individual who got the Provenge math wrong. 

And a bonus:  It quotes Sean Tunis and Alan Garber without noting they both were on the Institute of Medicine committee setting comparative effectiveness priorities as well as recipients of CER dough.  (If Garber had his way back in 1992, there would have been no new cancer or orphan drugs since he wrote then that the Orphan Drug Act allows the development of drugs that “do not meet traditional cost effectiveness criteria."  See  Benefits vs. profits:  has the Orphan Drug Act gone too far?  Pharmacoeconomics, 5:88- 92, 1994 and Gaucher Disease Edited by Anthony H. Futerman and Ari Zimran, Chapter 28.
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Fantasy Island

11/08/2010 08:06 AM |

The situation in Puerto Rico just gets stranger.

The latest news is that some leaders of the Commonwealth’s labor movement asked the legislature (on Friday) to amend Law 154 and impose a fixed tax of between seven to ten percent on foreign companies doing business on the island .

(Law 154 imposes a special tax of four per cent on non-resident companies.  That means all of the “Big Pharma” firms doing business on the island.  It was enacted minus any public input or comment.)

The head of the Workers Federation of Puerto Rico, and representatives of the Puerto Rico Central Workers Union and the Brotherhood of Ports Authority Workers claim that a permanent 7 percent corporate tax provide the funds to hire back some of the 20,000 public employees fired due to the island’s economic malaise.

To put that into immediate perspective -- According to a 2006 survey, the biopharma sector supports over 94,000 jobs in Puerto Rico. Talk about fuzzy math. Put 94,000 private sector jobs at risk to rehire 20,000 government workers? What’s wrong with this picture? 

Surprising for many reasons, not the least of which is the recent commitment to the Molecular Sciences Center, the BioProcess Training and Development Center, and the Puerto Rico Cancer Center -- part of a larger effort by Puerto Rico to attract research and development in the life sciences. Raise taxes to increase corporate investment?  Where’s that economic theory being taught?  Faber College?

As Patrician Van Arnum wrote in Pharmaceutical Technology, “Puerto Rico competes with other established areas for pharmaceutical manufacturing investment such as Singapore and Ireland. And China and India, although still emerging areas for pharmaceutical investment, are a consideration for future development.”

Someone should mention this to Governor Luis Fortuño.

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Criminalizing the Doctor-Patient Relationship

11/07/2010 04:17 PM |

Courtesy of  The Happy Hospitalist

Unintended Consequences of Health Care Reform: Everyone's a Criminal But Nobody Cares

Posted: 07 Nov 2010 08:59 AM PST

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Berwick Sticks It To Diabetics

11/05/2010 07:29 PM |

Here's an example of how Donald Berwick is living up to his pledge not to harm one hair on a person's head.

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/
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Some Friday reading

11/05/2010 05:27 PM |

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Where you stand depends on where you sit

11/04/2010 08:30 AM |

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!

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The 1099 "Tweak"

11/03/2010 06:03 PM |

Tweak is the operative word that the liberal spin machine is using to demonstrate their willingness to "improve" Obamacare (another operative word).

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."

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For Pete's Sake

11/03/2010 05:26 PM |

In my desire to get our "Midterm Missive" report done in the late hours following the election, I referred to "Pete Sessions and the Rules Committee" -- but what I meant was "Pete Stark and the Ways and Means Committee."

Oops.
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Midterm Missive

11/03/2010 09:36 AM |

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 21^st century Food and Drug Administration (FDA), will the 112^th Congress be sanguine or sanguinary?  Or is there a third way – of bipartisanship? 

A Republican majority in the House of Representatives means three things:

1. 1- New members – who will need to be educated on many important and arcane policy points;
2. 2- New staff – who will have the power to influence the education of their new masters; and,
3. 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.
4.  
5. Take another breath.
   

Will the 112^th Congress usher in a new spirit of bipartisanship on healthcare reform and a 21^st 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."

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Healthnewsreview.org: Propaganda Machine For the Dartmouth Gang

11/02/2010 05:55 PM |

Healthnewsreview.org is the self-styled guardian of objective reporting on medicine and science.

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.

 





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From Phase IV to Four Phase

11/02/2010 12:22 PM |

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?

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The other part of safety & innovation

11/01/2010 08:00 AM |

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.

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As UK Goes From NICE to Nicer US Moving Towards NASTY

10/29/2010 03:47 PM |

The new Conservative Minister of Health in the UK is putting NICE out to pasture:


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. 
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Quotes of the week

10/29/2010 11:13 AM |

“Even when voters emphasize the economy, they generally do so in a way that very much involves ObamaCare. Voters aren't so much angry that their representatives haven't fixed the economy but that they haven't prioritized the economy -- that they passed a $787 billion "stimulus" that merely stimulated the National Debt Clock and then turned their attention to what they cared about most: passing a huge health-care entitlement that a clear majority of Americans opposed.”


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NICE -- but not necessary

10/28/2010 08:35 AM |

Yes Minister.

The British Health Minister, Lord Howe, has affirmed his government’s position that NICE has become “redundant” and would be “moved gradually away from single health technology assessments towards the formulation of quality standards.”

NHS bodies are currently obliged to follow (or at least consider) NICE guidance but the changes will mean its cost-effectiveness reports will in future be purely advisory.

According to his Lordship, “In terms of cost-effectiveness, even though we will rely on NICE’s advise, we will move onto our own value-based pricing system.” He added that the coalition government wants to ensure patients and the NHS are allowed access to the medicines they both want and require.

Lord Howe said: “So that there is no doubt, the current terms of the PPRS (Pharmaceutical Price Regulation Scheme) pricing system will be upheld in full until it comes to an end in 2013,” but after this it will be replaced by the government’s evolving definition of value.

Lord Howe:  “We need a much closer link to the price the NHS pays and the value that a new medicine delivers.”

For more on value-based pricing, see here.

When the new Congress begins its hearings on ways to really reform the US healthcare system, the British decision to denude NICE should be raised relative to many issues – not the least of which is the role and responsibility of PCORI (the Patient-Centered Outcomes Research Institute). 

This isn’t the end of QALY-based cost-effectiveness, nor is it the beginning of the end of CATIE/ALLHAT/STAR-D comparative effectiveness – but it is the end of the beginning of a cost-based care philosophy that places the short-term needs of payers (be they public or private) over the long-term interests of patients.

Outcomes-based clinical effectiveness – now that would be (lower case) nice.

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Location. Location. Location.

10/28/2010 07:59 AM |

Food & Beverage Industry Announces Front-of-Pack Nutrition Labeling Initiative to Inform Consumers and Combat Obesity

(Washington, D.C.)  America’s leading food and beverage manufacturers and retailers joined forces today in the fight against obesity and announced their commitment to develop a new front-of-package nutrition labeling system.  The unprecedented consumer initiative will make it easier for busy consumers to make informed choices when they shop.

This program will add important nutrition information on calories and other nutrients to limit to the front of the packages of many of the country’s most popular food and beverage products.  To appeal to busy consumers, the information will be presented in a fact-based, simple and easy-to-use format.  In the coming months, the Grocery Manufacturers Association (GMA) and the Food Marketing Institute (FMI) will finalize the details of the initiative, including the technical and design elements.  In addition, details will be finalized on how to provide consumers with information on nutrients needed to build a “nutrient-dense” diet and on “shortfall nutrients” that are under-consumed in the diets of most Americans.  GMA and FMI will continue to consult stakeholders on these and other details in the coming weeks.

Consumers will begin to see the new label in the marketplace early next year. 

To build consumer awareness and promote use of the new label, America’s food and beverage manufacturers and retailers have agreed to support the change to their product labels with a $50 million consumer education campaign.  The campaign, to be launched in 2011, will be aimed at parents who are primary household shoppers. 

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IRS: Breast Feeding Doesn't Count As Healthcare

10/27/2010 11:47 AM |

Remember how Obamacare proponents said the IRS would not meddle in medical decisions...

Acne Cream? Tax-Sheltered. Breast Pump? No.
By DAVID KOCIENIEWSKI
Published: October 26, 2010


Denture wearers will get a tax break on the cost of adhesives to keep their false teeth in place. So will acne sufferers who buy pimple creams
A breast pump and various accessories can run about $500 to $1,000 for most mothers a year.
People whose children have severe allergies might even be allowed the break for replacing grass with artificial turf since it could be considered a medical expense.
But nursing mothers will not be allowed to use their tax-sheltered health care accounts to pay for breast pumps and other supplies.
That is because the Internal Revenue Service has ruled that breast-feeding does not have enough health benefits to quality as a form of medical care.

You can't make this stuff up...


www.nytimes.com/2010/10/27/business/27breast.html


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Risk Communications: You make the call

10/27/2010 09:20 AM |

“Anyone who isn’t confused really doesn’t understand the situation.”

--  Edward R. Murrow

On November 2^nd, from 12:15-1pm the FDA is holding a teleconference to discuss the agency’s risk communications research agenda.

45 minutes? 

The teleconference will begin with a presentation by the FDA on its research agenda and its role in supporting the agency’s strategic plan for risk communications by “strengthening the science of risk communications.”

This will be followed by a panel of FDA’s social scientists and a Q&A.

FDA and social science?  Maybe 45 minutes begins to make more sense.

Be there or be square.

“The speed of communications is wondrous to behold.  It is also true that speed can multiply the distribution of information that we know to be untrue.”

 -- Edward R. Murrow

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Showing Pharma the puerto

10/26/2010 10:24 AM |

Talk about biting the hand that feeds you.  Puerto Rico, long home to pharmaceutical manufacturing facilities, has just passed a new law (Law 154) that imposes “special taxes” on non-resident companies.  That means all of the “Big Pharma” firms doing business on the island.

According to a 2006 survey, the biopharma sector supports over 94,000 jobs in Puerto Rico and conducted 425 clinical trials on the island commonwealth.

 It should also be noted that Law 154 was enacted minus any public input or comment.

 Adios.

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Grassley is Criminalizing the Doctor-Patient Relationship

10/25/2010 03:27 PM |

Now it appears that Senator Chuck Grassley believes that he has the right to claim individual doctors are guilty of Medicaid fraud because they prescribe more medications than other doctors.  And when Grassley targets someone or a company,  it is hunted down by the media and the Feds. 

From Business Week:

"A key U.S. Senator is asking federal officials to investigate after reviewing data that shows doctors across the country prescribing alarmingly high numbers of powerful mental health drugs paid for by Medicare and Medicaid..

Grassley did not name the doctor, but state records obtained by The AP show Dr. Fernando Mendez-Villamil wrote an average of 153 prescriptions a day for 18 months ending in March 2009. That's nearly twice the number of the second highest prescriber in Florida, who wrote a little more than 53,000 prescriptions, according to a list compiled by state officials.

The doctor's attorney, Robert Pelier, said his client tried to contact Grassley to explain the data but got no response.

"Dr. Mendez-Villamil is a specialist that has treated the most afflicted and poor in the area" and has never acted improperly, Pelier said. He filed a lawsuit against the state alleging authorities tried to terminate him from being a Medicaid provider "without cause."

Federal officials said they stopped reimbursing Villamil after Grassley inquired about the doctor to HHS in December."

Nice work.  And welcome to another aspect of Obamacare:  Targeting and terminating payment of doctors who are fingered by the feds for providing "too much" treatment..  Having Grassley serve as a bounty hunter is optional.

I thought it would be nice to hear Dr. Mendez-Villami's side of the story since most media accounts gloss over it.   I found this letter he wrote to HHS. You tell me if this sounds like a crook or just one more honest and hardworking doctor who will ultimately bag Medicaid because of the reimbursement cuts and threat of retaliation.   

PS.. Here's something CMS and Grassley overlooked:  No one gets rich writing prescriptions..  Where is the fraud.  Is it a criminal activity to prescribe more than what a Senator regards as "normal?"

Why isn't anyone raising hell about this abuse of power?

Dear Senator Grassley,

I am writing to add a human face -- along with some background information and context -- to whatever image you may have of the doctor in Miami who wrote all those prescriptions for mental health drugs.

I am that doctor. My name is Fernando Mendez-Villamil and I have practiced psychiatry in South Florida since 1998. I received my medical degree from the Universidad Central del Caribe in Puerto Rico and performed my residency in psychiatry in Jackson Memorial Hospital, the public medical center serving metropolitan Miami.

I can only imagine what you thought when you were given information by the Florida Agency for Health Care Administration showing that one doctor wrote close to 97,000 prescriptions for mental health drugs over 21 months. This came to 153 prescriptions a day, 7 days a week for that entire period; twice as many prescriptions in that period as the number 2 Medicaid prescriber in the state.

These numbers may have struck you as an indication something was wrong. Frankly, since I have never stopped to do such a calculation, it seemed a little peculiar to me too. I never felt I was treating an extraordinary number of people or writing an exceptional number of prescriptions.

At the same time, I never thought I would be faulted for working hard or for being very organized and efficient. But now - with this publicity and the questions it has engendered - I have looked at the matter carefully and would like to provide you and the public with some context within which to consider these facts.

First, I want you to know that I take very good care of my patients. My top priority is to improve their conditions.  In more then ten years of practice I have worked with thousands of afflicted individuals. Their conditions have ranged between mild emotional upset to extreme debilitating psychosis. 

By every indication, my patients and their families are pleased with my care.

I may be an oddity as a physician because I do not play golf, I do not have a boat and I seldom leave my practice for extended vacations and am involved in my practice on a daily basis. That is not to solicit sympathy or to appear “noble.” I am simply committed to my patients, profession and enjoy what I do and do not seek distractions.

As to my patients, they share some characteristics.

* Many receive a combination of medications with each drug addressing specific aspects of their condition identified by the use of objective clinical findings along with subjective complaints. Therefore, when I see such patients I must write or renew an average of three or four prescriptions.

* Some patients come to me after having been under the care of other medical providers who prescribed some of these medications. I must evaluate whether those drugs are effective in achieving their treatment objectives, whether some medications should be discontinued and whether additional medications are required. This can be a very difficult process when I am dealing with a mentally ill patient who may not be able to assist fully in the examination process.  I would like you to know that these efforts are in combination with initial and ongoing psychiatric assessments of my patients.

* Ongoing treatment plans with the use of atypical antipsychotic medication is necessary in order to maintain patients stable and effectively responsive to their mental health needs.  I firmly believe that a person’s health should not be placed in danger by erratic or ineffective treatment.

* As a result of my assessments and treatment plans I have initiated; most of my patients are very stable and experience very few changes in behavior or in their medical condition over time.  Of great importance is the fact that hospitalization rates of my patient population are less than 1%.  Hospitalization can be costly and otherwise interrupt the mental health and wellbeing of the patients. While I seek to be alert of subtle variations in my patient’s responsiveness to the treatment or behavior that might indicate a need to alter their regimen,  you may appreciate that my patients are not always able to reliably explain how a drug is affecting them. Chronic mental health patients require complex combinations of medications based on their past treatment, physiological and psychological needs.

As to the specific prescriptions I have written, I have asked the Florida Agency for Healthcare Administration to provide me the information that was presumably provided to you and consequently to media outlets. The department has responded to my request by saying they have not received any recent requests for information about me or my practice and could therefore not furnish me with such information.

The information received from this agency advised that I am not under any sort of investigation. It also appears that the circumstances surrounding the release of the information to you supports this also. This was good to hear because I would hate to think that the government would discourage hard work and efficiency in the delivery of medical care.

In a similar vein, I was very surprised to read in the Miami Herald that Medicare had supposedly stopped payment for my services; and I am very pleased to confirm with Medicare officials that this was NOT true.

As to the numbers of prescriptions that have been cited, let us look at them on a hypothetical basis and see what they show.

Assuming the numbers are correct, I wrote 97,000 prescriptions in 21 months.

AHCA does not indicate how many patients were involved. However, again assuming those numbers are correct I believe the following would outline the pertinent facts in this matter.

Spread over 21 months, on an average six day, sixty to sixty-three hour work week that comes to approximately 4619 prescriptions per month. It is also not uncommon for me to actually work beyond these hours if there patients that need to be seen; as my practice is mainly a walk in, first come first served office.

At my average work schedule of 22-24 days per month, that means I saw between 47-55 patients a day and wrote an average of 210 prescriptions.  That averages to 2-3 prescriptions per patient per appointment.  Please remember that most of my patients are seen every other month; are given refills and my services are focused on the ongoing administration, effectiveness and responsiveness of the medication treatment plan I have prescribed for these patients.  Time wise, I average 10-15 minutes per patient. 

Generally, I work an average workday of 11-12 hours.  Not counting one hour in the aggregate for lunch and other non patient related activities, I see roughly four patients per hour.

Given the stable nature of my patients –these efforts are reasonable and well within the norms of modern psychiatric practice and in treating my patient population. This is especially true given that mine is a psychiatric practice that rarely involves time-consuming psychotherapy, physical contact or examination of the full range of vital signs.  Please keep in mind that the interaction I have with my patients is a combination of patient assessment, monitoring and evaluation of a continuing course of treatment as to the effectiveness of the patient’s medication regimen and/or treatment. 

Senator, I certainly appreciate your efforts to monitor matters such as this. Our country’s health care system is vast and complicated and seemingly includes much inefficiency. I hope you continue your good work with vigilance and determination.

However, in my case I assure you there is absolutely no cause for concern or alarm.

And I probably COULD use a nice vacation.

Respectfully,

Fernando Mendez-Villamil, M.D.

EMAIL: mendezvillamildr@gmail.com

 

cc: The Honorable Kathleen Sebelius

 Secretary, U.S. Department of Health and Human Services

 
Charlene Frizzera
Acting Administrator, Centers for Medicare and Medicaid Services
U.S. Department of Health and Human Services

The Honorable Thomas W. Arnold
Secretary, Agency for Health Care Administration
State of Florida

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