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CMPI at Columbus Circle

11.12.2010

CMPI recently hit the streets of New York City to ask people if they expected the health care law to help them.

Watch the video below to hear their answers:

CMPI at Columbus Circle from CMPI on Vimeo.

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MIT enjoying NEWDIGS "over there"

11.12.2010

The European Medicines Agency (EMA) and MIT’s Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals.

Specific questions addressed by this project include how to:

* adapt current regulatory requirements to support the efficient development of safe and effective drugs;

* incorporate patient valuation of health outcomes and benefit-risk preferences into regulatory decision-making;

* implement 'staggered' and 'progressive' approaches to drug approval;

* improve fulfillment of post-marketing regulatory requirements.

The project will explore the feasibility of, priorities for and practical considerations of implementing demonstration projects on some of the issues addressed during the course of the research.

Sound familiar? It's what the FDA's Critical Path program was designed to do -- that is until it hit Congressional treacle embodied by a certain member who will shortly lose her majority status.

The data and recommendations from this project are expected to link to implementation of the Agency's Roadmap to 2015 and the CBI's New Drug Development Paradigms (NEWDIGS) research program.

The project is scheduled to be completed by December 2011.

Hopefully with a new chair at the helm of the House Agriculture (and FDA) Appropriations Committee, funding for the Reagan/Udall Center can be released and FDA can, once again, take a leadership role in developing the tools for 21^st century regulatory science.

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Remembering Our Veterans

11.11.2010

Reagan's D-Day Speech at Normandy Beach still resonates and recalls the courage mustered by everyday Americans to preserve freedom.

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Death rates in U.S. and England

11.11.2010

A new study conducted by the Institute for Fiscal Studies in London and RAND Labor and Population offers an interesting look at both the British and American health care systems.

From the study:

In the new study, researchers examined the prevalence of illness among those 55 to 64 and 70 to 80. They also looked for the first time at the onset of new illnesses in those age groups in the United States and England during the years spanning 2002 to 2006. Finally, researchers examined trends in death rates in each country.

The findings showed that both disease prevalence and the onset of new disease were higher among Americans for the illnesses studied -- diabetes, high-blood pressure, heart disease, heart attack, stroke, chronic lung diseases and cancer. Researchers found that the higher prevalence of illness among Americans compared to the English that they previously found for those aged 55 to 64 was also apparent for those in their 70s. Diabetes rates were almost twice as high in the United States as in England (17.2 percent versus 10.4 percent) and cancer prevalence was more than twice as high in the United States (17.9 percent compared to 7.8 percent) for people in their 70s.

In spite of both higher prevalence and incidence of disease in America, death rates among Americans were about the same in the younger ages in this period of life and actually lower at older ages compared to the English.

Researchers say there are two possible explanations why death rates are higher for English after age 65 as compared to Americans. One is that the illnesses studied result in higher mortality in England than in the United States. The second is that the English are diagnosed at a later stage in the disease process than Americans.

"Both of these explanations imply that there is higher-quality medical care in the United States than in England, at least in the sense that these chronic illnesses are less likely to cause death among people living in the United States," Smith said.

"The United States' health problem is not fundamentally a health care or insurance problem, at least at older ages," Banks said. "It is a problem of excess illness and the solution to that problem may lie outside the health care delivery system. The solution may be to alter lifestyles or other behaviors."

Megan McArdle has further analysis of the study here.

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A Tangled Webb

11.10.2010

Virginia Senator Jim Webb on his conversation with President Obama about the health care bill:

"I told him this was going to be a disaster. The president believed it was all going to work out."

Yet Senator Webb voted in favor of the bill. Apparently talking out of both sides of one’s mouth never goes out of vogue in Congress.

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Long Time Companion (Diagnostics)

11.09.2010

Industry is anxiously awaiting guidance from FDA on the development of companion diagnostics for drugs that will inform efforts to move towards personalized medicine. The agency has vowed to release a draft guidance on companion diagnostics by the end of the year. But the initial document will address development of companion diagnostics for drugs already on the market, not simultaneous drug/diagnostic development for new drugs.

According to Vicki Seyfert-Margolis, FDA’s senior advisor for science innovation and policy:

“One challenge is that multiple centers have to be involved – CDRH and CDER/CBER. The challenge is internal to determine the mechanism for how the applications will come in and how the review is done. I think we are well on our way to figuring out that process between the different centers. With respect to how one designs and qualifies a diagnostic versus a clinical trial, the study design aspects are another challenge.”

“We are also concerned that we will have markers and use patient selection strategies in a clinical trial and then that marker may turn out to be a disease prognostication marker and you may have selected a set of patients that have different metabolisms. There are a myriad of possibilities one could think of that may or may not completely relate to the drug. We just have to be very thoughtful. I think we will evaluate a lot on a case-by-case basis, but we are trying to at least get some information out about what the paths are.”

And then there’s the issue of the “open kimono.”

Ms. Seyfert-Margolis: “One thing I think would be a big win in helping drive personalized medicine and co-development and companion diagnostics will be to open the data. We need to open the data in-house and also strive to get industry to be more transparent and work with us on this. If we took rheumatoid arthritis, for example, and looked across all the trials that have been done with TNF-alphas and evaluated who are the true responders, who are the non-responders, is there anything we can find in all that data that might point to some marker or some diagnostic that could be used, then we could begin to get at least hints about things that could open up new scientific areas for predictive diagnostics.

Amen. Sounds like a good way to involve the Reagan/Udall Foundation.

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WaPo Provenge Piece Gets The Facts Wrong

11.08.2010

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

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

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

Are you wondering about a glaring unintended consequence of health care reform? Read on to learn how everyone becomes a criminal.

By now you've all heard of the government reports of Medicare fraud being three times higher than 17 billion dollars a year previously thought. How you ask? Because an illegible doctor signature is considered fraud and Obama is out to make things right and transparent and accurate. You can pretty much count on every physician in this country being a fraudster.

But what about Medicaid? Does the same fraud problem exist with the Medicaid system? Probably, but you also have to worry about the patient abuse aspect as well. Here's an angle of unintended consequences you may not have considered with health care reform by making preexisting conditions a thing of the past.

I have been told Happy's hospital has a handful or repeat offenders using their family member's Medicaid card to get free health care services in the ER. Why is that possible and why would anyone let their family member use their insurance card? The question you should ask is not why but why not? Why wouldn't every family with Medicaid share their card?

Under a normal insurance program, where you are actually insuring against something, Medicaid isn't really an insurance program. It's a payment program. It takes money from people who pay taxes and gives it to pay for health care (whether it's medically necessary or not) of people who pay little or no taxes and actually make money from the government for breathing. It's the opposite of the breathing tax on the rich.

Medicaid carries no pre existing clause. That means, once you're in, you're in. And you get everything paid for, usually for life, by the Medicaid National Bank. You don't ever have to worry about getting denied health care based on any existing medical condition.

That's a great feeling to have. As an American, I would love to know that I would always have the ability to have my catastrophic health care services paid for should I fall ill. Fortunately, minus the trauma (which could be paid for under insurances other than health), most catastrophic illness is self induced by the lifestyles people choose to live. Nobody is born a smoker. And no babies are born obese. Most cases of stroke, heart disease, diabetes and cancer are induced by the choices we make in life. Most are lifestyle disease. Some say smoking and obesity aren't choices but rather a result of the situation we find ourselves living in.

That's an excuse. Like I said, nobody is born obese and nobody is born a smoker. Hispanic women are some of the poorest folks in our country and they have one of the lowest rates of smoking in the United States. It's not about being poor. It's the culture we live in.

Our current health care reform is a modern day Tuskegee experiment. What we have promised is FREE=MORE. You can get all your health care you need without questions or explanations and you can get it paid for by others if you are too poor to care about what effect your choices have on the economics of those around you. It's class warfare at its finest.

In a land of social solidarity, those with means feel an obligation to provide for those with less resources, outside of government control, but those of limited means also feel a sense of obligation to limit their consumption of resources. In America and America's health care reform, those with means have been taken hostage out of force to pay for those with less resources. However, there is no sense of moral obligation by those receiving the fruits of other's labors to limit their consumption. Watch the tax implications of health care reform unfold before you.

Take witness to the band of Medicaid theives roaming Happy's ER. They use the Medicaid card as their own form of theivery, stealing from me to pay themselves. They aren't Medicaid patients. They are family members using their family member's Medicaid card to obtain fully paid health care services, and sometimes selling the prescription medications they receive on the street.

This is the future peak of what our health care system will look like when pre exisiting conditions are abolished across all health insurance mandates. Nobody will care about what medical condition you have. I can see, for example, families banding together to share their Medicare and Medicaid or even their Blue Cross or United Health insurance cards to get all their care paid through defacto shared family insurance plans. You have a brother or sister who doesn't want to buy insurance? They could just borrow the insurance card from their family.

Why wouldn't you. If there is no risk of being denied health insurance based on your pre existing medical conditions, why wouldn't you share your card with your family? With the biggest expansion ever in the Medicaid program coming down the pipes, why wouldn't families play the Medicaid arbitrage? And why would hospitals or clinics care? What obligation would they have to turn you in? They aren't the police. If given the choice between getting paid with a fake card and not getting paid at all, I'm sure most businesses would look the other way and allow the greatest theft of taxpayer resources that every lived.

Welcome to America's new reality, where everyone becomes a criminal and nobody cares, because everybody gets paid.

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Berwick Sticks It To Diabetics

11.05.2010

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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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.