Adaptation

11/14/2006 12:21 PM |

Despite the midterms and continued brickbats from Grassley, Waxman, Hinchey, et al., the persistent and quiet revolution going on inside the FDA continues.

The most recent example of this ray of hope is the agency’s championing of adaptive clinical trials. "Traditional" clinical trials that demonstrate a 40% efficacy rate without even attempting to isolate which 40% is expensive in financial terms and only marginally helpful in helping physicians best treat their patients. It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path.

Yesterday, Deputy Commissioner Dr. Scott Gottlieb made such a point at a Manhattan Institute talk – and it sure was refreshing.

Scott’s full remarks can be found by clicking the link below:

http://www.fda.gov/oc/speeches/2006/manhattaninst1113.html  Read More & Comment...

Gagging on Democrat drug proposals

11/13/2006 09:47 PM |

Medicare Drug Focus reports that new HIV drugs Atripla and Prezista have been quickly adopted by Part D plans. Some have flat co-pays while others have special tier payments until out of pocket costs exceed the catastrophic level.

Two points: Neither drug are on the VA formulary. In fact they are not even available on an off-formulary fashion for at least a year..

Second, if the Dems have their way, patients would have almost no commercial information about such new medicines. Zero. Zip. Is it ethical to impose a gag order on companies that want to tell patients about a medicine that is a critical part of a HIV drug cocktail make sense? What about a new drug for Parkinson's or Alzheimer's or cancer? How about an orphan drug that prevents a kid from dying from a rare metabolic disorder? Should it be against the law for a company to tell parents about such medicine? Put another way, who would trust an HMO to let people know about a new and expensive medication without prompting?  Read More & Comment...

Pause ... NOT!

11/13/2006 09:49 AM |

Revoke non-interference and replace it with "government pricing?"

PAUSE ... NOT!

Says who? See below.

"We are seeing large-scale negotiations with drug manufacturers, but they are conducted by private drug plans, not by the government. … A robust marketplace with a lot of competitors has driven down prices. It's the magic of the market. To assume that the government, in our genius, could improve on this belies the reality of a complex task."

− HHS Secretary Michael Leavitt, The New York Times, 11/13/06

"Both The Non-Partisan Congressional Budget Office And Medicare Actuaries Have Said They Doubt The Government Could Negotiate Lower Costs Than The Private Sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06)

"Government Price Negotiation "Could Leave People Without Drugs That Manufacturers Decide Aren't Sufficiently Profitable Under The Plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06

"Part D Seems To Be Working. Average monthly premiums this year were $24, one-third lower than projected, according to Centers for Medicare and Medicaid Services. More than 75% of seniors say they are satisfied with the benefit, five recent independent surveys found."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06

"It Is Not Obvious That Allowing The Government To Negotiate With Pharmaceutical Companies Will Lead To Lower Prices Than Those Achieved By Private Drug Plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters."

Stanford Business School's Alain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06

"By Acting As One Large Buyer, The Government Will Cause Price Discounts To Become More Expensive For Pharmaceutical Companies. In other words, the minimum price that the pharmaceutical company is able to accept increases. All else equal, this will lead to higher, not lower, prices. When private drug plans are negotiating individually with pharmaceutical companies, those companies have the power to 'price discriminate,' meaning they can charge lower prices to some drug plans and higher prices to others. This ability allows for large discounts."

Stanford Business School's Alain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06

"Neither Economic Theory Nor Historical Experience Suggests Government Price Negotiation Will Achieve Lower Drug Prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School'svAlain Enthoven and Kyna Fong, Op-Ed, "Pelosi On Drugs," The Wall Street Journal, 11/13/06  Read More & Comment...

Health Care Haiku

11/13/2006 08:02 AM |

We've created a new drugwonks category: Health Care Haiku -- and we welcome your submissions. So if the muse inspires your passion for health care progress through poetry, please send in your creations to ppitts@cmpi.org.

Herewith the first few health care haiku:

Non-Interference
Should it stay or should it go?
Ask Mark McClellan

Nancy Pelosi
Has her “First Hundred Hours”
Seniors are watching.

Drug Importation
Is bad for the public health
Who will propose it?

The AARP
Is a big Part D player
Why are they whining?

The VA model
Would give seniors much less choice
Don’t even go there.

The Critical Path
Must be funded by Congress
Gene testing a must.  Read More & Comment...

Subcontinent Counterfeits

11/13/2006 06:28 AM |

Now about those "safe" drugs from Europe ...

According to a new report in the Times of India, over half a million packets of fake medicines, most of them from India, were seized by European customs officials during 2005.

The fake medicines include Viagra, antibiotics, medicines to treat cancer
and high cholesterol and condoms. A sample that was investigated revealed
that what was being passed off as a cardiovascular drug contained a mixture
of brick dust.

"A secret wave of dangerous fakes is threatening the people in Europe," said
Laszlo Kovacs, the EU Taxation Commissioner.

The latest European customs statistics released Saturday said that in 148
operations last year, customs officers intercepted 560,598 packets of fake
medicines. The seizures were double the 2004 rate, but there are fears that
even more counterfeit products may have entered the EU undetected.

Three quarters of the cases involved fake medicines imported from India,
with seven percent from Egypt and six percent from China. Other sources
included Thailand, Argentina, Switzerland, Hong Kong and Indonesia.

The statistics revealed that customs officers across Europe uncovered 26,700
consignments of counterfeit and pirated goods, seizing more than 75 million
items.

"The key is to be faster than the counterfeiters," Kovacs said. "We must
quickly identify, and act to deal with, new routes of fraud and constantly
changing counterfeit patterns to protect our health, safety and the
economy."

Coincidence or Crisis?

(Hint -- There is no such thing as a coincidence.)  Read More & Comment...

Zesty Italian

11/12/2006 02:49 PM |

The grass is always greener, right?

Some US politicians are advocating the adoption here at home of a Euro-style, deny-and-delay health care system -- but, as P.J. O'Rourke has famously quipped, "If you think health care is expensive now, just wait until it's free."

It's never as simple as some politicians make it sound. And that's as true for price controls as it is for things like drug importation.

It's important to remember, as the debate over revoking the non-interference clause gets under way within the "first 100 hours," that price controls = choice controls. Just ask our British cousins how nice NICE is or the Germans about IQWIG or the French about their government's initiative to get their docs to prescribe fewer medicines for the sake of the budget -- and patients be damned (see the November 11, 2006 drugwonks blog "L'Etat C'est Moins)".

And of course, when it comes to the Italians -- you can see for yourself in today's Washington Post what Alberto Mingardi of The Instituto Bruno Leoni has to teach us about wistfully contemplating the adoption of a Euro-style health care system without understanding the significant unintended consequences.

The title says it all.

A Drug Price Path To Avoid
By Alberto Mingardi

Sunday, November 12, 2006; Page B07

The next speaker of the House, Rep. Nancy Pelosi (D-Calif.), has let it be known that within her first 100 hours on the job, she will move to allow the government to negotiate directly with pharmaceutical companies to obtain lower drug prices for Medicare patients.

Her plan would create a Medicare drug program that looks a lot like the system we have in my country, Italy, where drug prices are among the lowest in Europe. And that's pretty low, considering that drugs in Europe average about 60 percent less than in the United States. Even as U.S. prices rose, Italian drug prices decreased by 5 percent last year.

At first glance, this might seem an enviable model for America to follow. But before Pelosi rushes down the road to Italian-style health care, allow me to offer a word of caution. Italy is hardly a health-care paradise. In fact, it's more like a quagmire of red tape.

For the most part, Italy's lower drug prices are the product of government price controls. The state purchases nearly 60 percent of the nation's prescription drugs. And it supposedly negotiates prices directly with pharmaceutical companies. But since the Italian government controls such a disproportionate share of the market, it in effect dictates drug prices.
In Italy, these price controls have created a number of problems.

First, they distort the laws of supply and demand. Because of the country's artificially low drug prices, demand for pharmaceuticals is artificially high -- higher than it would be under free-market conditions.

The point is that the government's attempt to force down drug prices has not reduced overall health-care spending. Rather, it has resulted in a spike in demand -- which is one reason why Italy's health-care spending has skyrocketed, growing nearly 68 percent between 1995 and 2003.

As for the quality of Italy's care, that, too, is suffering. With demand for drugs rising, the Italian government has attempted to save money by adopting reimbursement policies that favor certain drugs over others. Unfortunately, the most innovative products often aren't considered reimbursable by the government precisely because they are the most expensive.

It's a great system if you just need an antibiotic. But if you're hoping to avoid open-heart surgery through access to a miracle drug, it can be a nightmare.

And Italians are lacking more than just choice in cutting-edge drugs. They also lack information. According to a recent survey, more than 50 percent of Italy's patients believe that the national health service cannot even supply adequate information about treatments and drugs.

The economy is also harmed. Because it's simply not profitable for companies to invent cures in Italy, price controls have decimated Italy's pharmaceutical industry. Today not one of the world's 50 largest drug manufacturers has its headquarters in Italy, even though the country is the world's seventh-largest economy. Because most drug and biotechnology companies are outside Italy's borders, there are only 84,000 pharmaceutical workers in Italy's entire drug industry. The industry has become a perfect target for Italy's politicians, because they can rail against it with little political downside. The more we follow this path, the less likely it is for Italian companies to develop valuable innovations -- at great risk for both our economy and our health.

So by attempting to hold down drug prices, the Italian government has deprived its citizens of the best care without reducing health-care spending. And it has deprived the country of what could be a vibrant sector of the economy. In their rush to revamp Medicare, U.S. policy leaders should be careful not to make the same mistake.

The writer is a director of the Istituto Bruno Leoni, an Italian free-market think tank.  Read More & Comment...

Love's Child

11/10/2006 05:34 PM |

Here is a draft of the Jamie Love/Prize vs. Patent legislation I discussed below ("There's a prize in every box," November 10, 2006):

Download file

As I promised to Jamie, I am going to give it a comprehensive redline edit.

Also -- here is Jamie's blog on my visit to his office yesterday. (Do I really look that threatening?)

http://www.cptech.org/blogs/drugdevelopment/2006/11/peter-pitts-on-prizes.html  Read More & Comment...

Weekly Roundup: Back to the Future and Back Again

11/10/2006 04:53 PM |

In the spirit of bi-partisanship or whatever I am going to reach out to those eager to have the government negotiate directly with drug companies and show them how it's done: all involve the creation of a whole new bureaucracy

Here is the Canadian approach

it reviews factory-gate prices of individual products to determine if they are excessive. To do this, the board has instituted a set of processes, including review of individual drug prices, conduct of investigations, and application of enforcement mechanisms. The PMPRB process is based on the following classification scheme for all patented drugs: Category 1: a new drug product that is an extension of existing or comparable dosage form of an existing medicine, usually a new strength of an existing drug ( line extensions ); Category 2: the first drug to effectively treat a particular illness or that provides a substantial improvement over existing drug products, often referred to as breakthrough or substantial improvement ; and Category 3: a new drug or dosage form of an existing drug that provides moderate, little, or no improvement over existing drugs ( me-toos ).[6]
The board uses several criteria to classify a product. A manufacturer has to submit data (including price) to the PMPRB for classification of any drug. For a drug that is to be considered a breakthrough, the manufacturer al o ha to include reviews of the product in recognized journals (where available), results of two to five well-controlled trials, and results of a complete Medline search of articles and reviews of the drug. Once a drug is classified, its price is reviewed to determine if it is excessive.

Excessive is interpreted based on the following guidelines: (1) The price of an existing patented drug cannot increase by more than the Consumer Price Index (CPI). (2) The price of a new drug (in most cases) is limited so that the cost of therapy with the new drug is in the range of the costs of therapy with existing drugs in the same therapeutic class. (3) The price of a breakthrough drug is limited to the median of its prices in France, Germany, Italy, Sweden, Switzerland, Britain, and the United States. In addition, no patented drug can be priced above the highest price in this group of countries.

Want to know how the VA does it...here's a GAO ruling to determine whether a VA decision to exclude one drug was fair....A Peter Pitts Genius Award (a box of Cracker Jacks) will be bestowed upon the individual who can explain what the hell a GAO lawyer is doing making a clinical decision....

http://www.gao.gov/decisions/bidpro/295888.htm

or this gem....

http://
www.gao.gov/decisions/bidpro/2949442.htm

Or they can go President Clinton's route and set up a breakthrough drug price commission that would have subpoena power to investigate whether the price for a breakthrough was "reasonable."

Just trying to be helpful


Now on to the real future of medicine...

The headlines are full of stories of biomarkers in development to predict drug response and disease risk in new areas...The question is, why are we ignoring this, the ultimate approach to comparative effectiveness and drug safety in favor of the IOM approach of using outdates claims databases to help decide who gets what drug.

Over-_expression Of Cox-2 Can Predict Prostate Cancer Outcome (November 9, 2006) — Researchers say an over-_expression of COX-2 in men with prostate cancer is associated with an increase in PSA after radiation treatment and the spread of the cancer outside of the prostate. That is the result of the first study linking COX-2 with prostate cancer radiation treatment outcomes.

Here are some other exciting developments reported in this month's edition of Drug Discovery and Development

Heading off Lung Transplant Rejection
Using proteomics, mass spectrometry, and bioinformatics, researchers at the University of Minnesota, Minneapolis, identified three proteins that are highly predictive of lung transplant rejection up to 20 months before the rejection occurs. In addition to early identification, the researchers hope to eventually develop a preventative treatment.

Blood Test to Diagnose Alzheimer's?
Groundbreaking research at the Institute of Psychiatry, King's College London, demonstrates that proteins found in the blood can indicate an increased risk of Alzheimer's disease. It is the first time markers for the development of Alzheimer's have been identified in blood and is a step toward developing a blood test to diagnose and measure progression of the disease.

Gene Variant May Explain Antidepressant Failure
Investigators at Weill Medical College of Cornell University, New York, say their work could lead to the first diagnostic test to guide depression treatment. It would involve sampling the patient's DNA seeking a variant of the gene coding a protein called "Brain Derived Neurotrophic Factor" that may indicate that the patient would not respond to treatment with the most commonly used class of drugs.


Yeah, I guess Bruce Psaty who was on the IOM committee and uses claims databases when he consults to HMOs wasn't too self serving and was right when he told the Star Ledger that personalized medicine is 20 years away....

ScienceNewsDaily is always full of interesting articles that cause one to ponder the meaning of life and our place in the universe.....

Decoded Sea Urchin Genome Shows Surprising Relationship To Humans (November 9, 2006) — The Sea Urchin Genome Sequencing Project consortium, led by the Human Genome Sequencing Center at Baylor College of Medicine in Houston, announced today the decoding and analysis of the genome sequence of the sea urchin, Strongylocentrotus purpuratu.

What's surprising is in fact my great-great grandmother's maiden name on my mother's side was in fact "Purpuratu." We are still figuring out how it turned into Goldberg...


Moon's Escaping Gasses Expose Fresh Surface (November 9, 2006) — A fresh look at Apollo-era images combined with recent spectral data leads researchers to re-examine conventional wisdom. Several lines of evidence suggest that the moon may have seen eruptions of interior gasses as recently as one million years ago, rather than three billion years ago -- the date that has been most widely accepted.

Can you imagine having gas for a milion years, let alone 3 billion?  Read More & Comment...

There’s a prize in every box!

11/10/2006 01:26 PM |

Yesterday I had the pleasure of debating Jamie Love on the issue of replacing pharmaceutical patents with a “prize” system wherein the government pays an innovator a lump sum amount for its innovation that is then placed in the public domain.

No, really, he’s serious.

The “prize” model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketry”) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.

Certainly not what Schumpeter had in mind when he wrote about “spectacular prizes … thrown to a small minority of winners.” Creative destruction indeed!

Jamie wants to replace a patent system that has allowed the average American lifespan to increase, over the past 50 years, by almost a full decade with a prize program that has a solid record of complete failure.

My argument to Jamie was that, as Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.”

In other words (and to paraphrase Winston Churchill) our pharmaceutical patent system is the worst way to stimulate and support health care innovation – except for every other system. On a list of 100 ideas for ways to improve innovation and access, Jamie’s prize program isn’t even on the list.

Is it a crackpot idea? Well, consider the fact that Mr. Love’s idea is going to be introduced in federal legislation by the new Socialist Senator from Ben & Jerry’s, Bernie Sanders.

Who could support such an idea? Nobody? Wrong! Dangerously wrong. Again, as DiMasi and Grabowski presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."

Sound familiar? Correct. Europe.

Remember these three words: Evidence-based medicine.

There are, to be sure, other unworkable, ill-considered, and precarious aspects of Mr. Love’s child – but we’ll save that for later. Suffice it to say that a prize system is not a Crackerjack idea. In the meantime, I did tell Jamie that I would gladly comment in detail on the Sanders legislation via a thoughtful and considered edit.

I await the attachment.   Read More & Comment...

Wither von Eschenbach?

11/09/2006 01:31 PM |

Rumor has it that the WH is fed up with the Republican holds on Andy's nomination and will seek to pressure Senators Demint and Vitter to drop their craven and politically motivated opposition during the lameduck session. Demint will never get the GAO study he wants looking RU-486 and Vitter will get his importation vote anyways because the Dems are interested in spending billions to turn the FDA into a parcel inspection service for European wholesalers while letting the agency infrastructure for evaluating new medicines fall apart....  Read More & Comment...

Will the Democrats Try to Undo Part D (Redux)

11/09/2006 11:31 AM |

Businessweek's John Carey has a nice article describing the hell awaiting drug companies come January when the Democrats take control of both ends of Congress...the question is, do the companies have what it takes to use meet this challenge and actually exploit the inherent weaknesses and contradictions in the Democrat proposals...


USA, 11/9/2006 - For drugmakers, the Democratic congressional election triumph means a return to the political crosshairs.

Nancy Pelosi (D-Calif.), widely expected to be the new Speaker of the House, has vowed to give the government the power to negotiate—and thus, she hopes, drive down—drug prices for Medicare patients. Henry Waxman (D-Calif.) and John Dingell (D-Mich.), now that they are back in power, "are licking their chops at the prospect of having hearings" on topics such as the sky-high price of some cancer drugs, says analyst Ira S. Loss of Washington Analysis, which assesses the impact of public policy on investors. The industry also may face a higher bar for drug approvals at the Food & Drug Administration.

So it's no surprise that, on the day after the Nov. 7 election, pharmaceutical stocks went down. The AMEX pharma index sank nearly 2%. Losers included everyone from Pfizer and Schering-Plough to Eli Lilly and Merck.

The scrutiny could be intense. In the next Congress, expect hearings—and well-publicized outrage—over the price of drugs like Genentech's cancer treatment Avastin, which can cost more than $50,000 per year. Expect the Pelosi-led House to quickly act on her promise by passing a measure aimed at driving down the cost of drugs in the Medicare program. Expect more talk about importing cheaper drugs from Canada, and more rhetoric about how the FDA may have moved too fast in the past, allowing risky drugs like Merck's Vioxx on the market. "

Well, we will see. The word is that the D's know the vaunted savings can't be had unless you rob seniors of the choice of drugs they do have. And the "third way" Democrats are likely to propose, requiring comparative effectiveness studies and driving prescribing to the drugs of most "value" will be caught up in methodological, biological and clinical disputes and leave them open to charges that they want to government to practice medicine.

I can see a funny ad around seniors trying to get their medicines from the government supply depot or a costco type place where you have to buy your one drug by the caseload...



"In the meantime, the pharmaceutical industry is raking in the profits that are coming from the Medicare drug benefit. One big winner: Lilly, whose third-quarter sales rose 7%, with profits up 10%, in part on the strength of Medicare prescriptions for its mental illness drug Zyprexa. "

"Raking in?" More seniors are using more medicines. Meanwhile the actual price of Zyprexa (not the retail or manufacturer price) has fallen as a result of price competition. Why shouldn't Lilly prosper? If you sell more, you make more. Check the profit margins of genetic drug firms since Medicare came online, particularly Teva and Mylan, generic drug manufacturers that have had about a 50 percent jump in earnings as a result of patent expirations and a switch away from brand drugs.

Why not make a big stink about those margins or the big profits PBMs and pharmacists will make by selling generic drugs at markup?

If the Democrats want eliminate profit from the prospect of increasing sales volume (sell more, don't increase profits) then the road ahead will be rocky indeed.

If I were "Big Pharma" I would run ads pairing patients with Parkinson's, juvenile diabetes and spinal cord injury with scientists from their companies and with scientists from the small money losing biotech firms they are now investing billions with that are doing work in stem cells and Parkinsons. The scientists would disappear one by one as a narrator talks about how Medicare price controls will make future cures disappear.

Drug companies have a lot at stake. If they don't have the backbone to defend their mission, we will all suffer.  Read More & Comment...

L'Etat, C'est Moins

11/09/2006 11:11 AM |

How is the French government cutting national health care costs? Why by asking doctors to prescribe fewer medicines of course. In other words, deny patients the medicines they need in order to save the State a few euros in the short-term.

Don’t you love socialized medicine?

Time for a revival of Le Medecin malgre lui.

The full story can be found at:

http://www.reuters.com  Read More & Comment...

The Letter "P"

11/08/2006 09:37 AM |

So now what happens?

Post-election it’s all about the letter “P.”

I am concerned that, as far as FDA is concerned, we will lose whatever momentum there was towards an agency that was focusing on (as Andy von Eschenbach phrased it) “the three P's of prevention, predictive tools, and the participatory Critical Path” ...

… and we will move to a House of Representatives that is focused on payback and partisan politics. And that means hearings. Lots and lots of hearings couched in the word “oversight.” And that’s deleterious and particularly dangerous right now because of PDUFA.

On the broader health care front the Big P is certainly going to be a debate over whether or not Part D should be redesigned, specifically whether the non-interference clause should be revoked. Our new Speaker, Nancy Pelosi has this on her “First 100 Hours” to-do list. And that’s just a preliminary peroration towards a more frightening parley over price controls and intellectual property (aka: patents).

You can also bet we’ll see more rhetoric over plans for phony importation schemes.

It's very important to remember that this election wasn't fought on health care. And don't let anybody tell you different.

Which means we must redouble our efforts to advance the public health by being peppy, potent, proactive, persuasive, puissant – and most importantly – positive.

America's health is too important to be about partisanship or about profits. It must be about progress, about patients.

We must keep our eyes on the prize and persevere.  Read More & Comment...

Will the Democrats Try to Undo Part D

11/08/2006 12:30 AM |

If the D's take control of both the House and Senate expect legislation to rollback Medicare reforms enacted in 2003 to pass with Republican support. If they do, they will find that such proposals will require robbing seniors of the choice of essential medicines now and in the future and starve biotech firms that are already losing money of markets. If the pharma and biotech industry were politically smart they would link the Democrat support of embryonic stem cell research with the fact funding for the enabling technologies comes from private firms that would be bled to death by Democrat part D proposals. That's a big if....  Read More & Comment...

The Price of Comparative Effectiveness

11/07/2006 09:26 AM |

Gail Wilensky, who ran the Health Care Finance Administration under Bush I (that's CMS now) has an article today calling for a new public-private agency to evaluate the comparative-effectiveness of medical technologies.

Gail is smart and thoughful on health care matter so I can't figure out what she was thinking here. Maybe she thought she could tame the CE crowd which has an agenda.

http://

As the ALLHAT and CATIE studies show, even well funded comparative effectiveness studies will fall into dis-use for every good reasons. They are poorly designed, they are superceded by studies or personalized medicines that are based on a better mechanistic understanding of disease pathways. Applying ALLHAT recommendations to African Americans will kill them for example. And notice that people who promote C-E never talk about genetic testing to determine which medicine works best? That would be like Tower records talking about Itunes...

Indeed, since most C-E are underpowered they do not capture the genetic variations that explain and cause differences in response to medicines or other intereventions so of course "they all look alike" and regress to cheaper is better. Meta analysis only reinforces this one size fits all conclusion. Which is why for example, NICE has never caught an increased survival benefit from any new cancer drug since 1970. Then again, if you post your QALY at 50K survival doesn't mean very much either.

All of which translates into reimbursement decisions and the comparative effectiveness crowd knows it.

Take UK, Germany, Australia and Canada. All take their sweet time reviewing studies. All deny and limit access to new medicines and have fail first policies based on C-E. Have you read any of the VA off-formulary guidances? Take someone who has non-hodgkins's lymphoma. In the private sector, Rituxan is standard therapy. But not in the countries you cite and not in the VA.. Why? According to the comparative effectiveness studies, the reimbursing agencies want you to go through more painful and more toxic treatments first.


Finally, the entire field of medicine is moving toward the molecular and the personalized. Comparative effectiveness in the 21st century boils down to the right treatment for the right person at the right time. The agency Gail proposes is totally unsuited for arriving at that answer. I have read everyone of the AHQR comparative effectiveness studies...They are not usable in the clinical setting for docs because they are one size fits all and retrospective.

We need to invest in developing personalized treatment strategies that are preventive and prospective in nature. All this C-E will make the foundations and liberals that hate drug companies -- who by the way -- are not developing the next generation of new medicines (biotech firms that make no money are, ) happy. But it will hurt patients by delaying access and giving bureaucrats who know nothing about the practice or science of medicine control over care.  Read More & Comment...

A Dose of Reality on Part D

11/06/2006 12:45 PM |

Today the New York Times invokes the myth that drug prices went up an average of 6 percent last year. I think that number comes from an AARP study conducted by the PRIME Institute which used manufacturer prices posted from July 2005 and June 2006.

Well, a little research goes a long way. Going to plans in my home state of NJ, If you look at some of the changes in Medicare part D prices for the Top 25 Brand Name Prescription Products over the same time period, you find that the retail prices have actually gone up slower (4.5 percent) under the AARP than manufacturer prices reported by its own study and out out of pocket share during the initial coverage level has declined by 12 percent! That suggests actual price concessions were deep and that therefore the 6 percent manufacturer price increase (the sticker price) was wishful thinking at best. Prices during the gap under the Humana plan decreased by 4 percent a year and the out of pocket costs during coverage have dropped as well.

And in all cases the retail price of the drug is cheaper than what seniors could get a drugstore.com.

Moving over to the VA model is to see that drugs such as Aricept, Abilify, Evista, Fosamax, Lipitor and Xalatan are not on the VA formulary while they are on the Medicare Part D formulary.

That's just for starters. Which explains why nearly 35 percent of VA seniors tried to join Medicare part D.  Read More & Comment...

Today's Pop Quiz

11/06/2006 09:24 AM |

Good morning class and I hope you had a relaxing and refreshing weekend.

To welcome you back, Professor Drugwonk has decided on a pop quiz. Please do not turn over your paper until I say "go!"

Question: Which article appeared in today's New York Times?

As drug prices climb, Democrats find fault with Medicare plan

For big drug companies, the new Medicare prescription benefit is proving to be a financial windfall larger than even the most optimistic Wall Street analysts had predicted. But those gains may come back to haunt drug makers if Democrats take control of Congress this week.

or ...

Antidepressants tied to lower suicide rates in kids

In US counties with the highest rates of prescriptions for selective serotonin reuptake inhibitors (SSRI), a type of antidepressant, the rate of suicide among children ages 5 to 14 is lower than that observed in counties with lower rates, according to a new report.

First person to get the answer correct wins the new edition of Sid Wolfe's "Worst Pills, Best Pills."

Second person to get the correct answer wins two copies.  Read More & Comment...

Disease Mongering at the CDC?

11/06/2006 09:18 AM |

Yawn?

According to today's edition of the Wall Street Journal, The U.S. Centers for Disease Control and Prevention is aiming to boost awareness of chronic fatigue syndrome.

Chronic fatigue syndrome "is a terrible illness that prevents many people from taking part in everyday activities and participating in the things they enjoy," CDC Director Dr. Julie Gerberding said at a news conference Friday. Early diagnosis and treatment of the disease are important for recovery -- even though it isn't clear what the best treatments are, CDC officials said.

Currently, there is no cure for the syndrome, which is estimated to affect around one million Americans.

Symptoms of the illness, including fatigue, short-term memory impairment, joint and muscle pain, are treated with medications that target the pain or fatigue. Antidepressants are also used.

Although the syndrome was officially recognized by the government in the late 1980s as a medical condition, many people still question whether the condition is a true physical illness.

The lack of knowledge on the causes and treatment of the disease has caused drug companies to stay away from research in the area. Information on the disease can be found at the CDC's Web site, www.cdc.gov/cfs/.

Philadelphia-based Hemispherx Biopharma Inc. plans to seek Food and Drug Administration approval to market Ampligen as a chronic fatigue treatment by the end of the year. If approved, it would be the first drug directly targeted to treat the syndrome.  Read More & Comment...

How Personalized Medicine Can Stop the Bleeding

11/06/2006 08:41 AM |

Important new paper by, among others, my friend and former colleague, Randy Lutter, FDA's Associate Commissioner for Policy & Planning, on why personalized medicine saves lives and saves money.

Here's the executive summary:

Progress towards realizing a vision of personalized medicine—drugs and drug doses that are safer and more effective because they are chosen based on an individual’s genetic makeup—has been slower than once forecast. The Food and Drug Administration has a key role to play in facilitating the use of genetic information in drug therapies because it approves labels, and labels influence how doctors use drugs. Here we evaluate one example of how using genetic information in drug therapy may improve public health and lower health care costs.

Warfarin, an anticoagulant commonly used to prevent and control blood clots, is complicated to use because the optimal dose varies greatly among patients. If the dose is too strong the risk of serious bleeding increases and if the dose is too weak, the risk of stroke increases. We estimate the health benefits and the resulting savings in health care costs by using personalized warfarin dosing decisions based on appropriate genetic testing. We estimate that formally integrating genetic testing into routine warfarin therapy could allow American warfarin users to avoid 85,000 serious bleeding events and 17,000 strokes annually. We estimate the reduced health care spending from integrating genetic testing into warfarin therapy to be $1.1 billion annually, with a range of about $100 million to $2 billion.

Did that last bit get your attention? Good! Here's a link to the entire paper:

http://www.aei-brookings.org/admin/authorpdfs/page.php?id=1337&PHPSESSIS=2b0284fa8e8d5t08bd4e1515ac971482  Read More & Comment...

PD3

11/03/2006 02:12 PM |

Since there's a general belief that the pharmaceutical industry invents new diseases, we thought we'd get in on the fun with Part D Denial Disorder or PD3.

The unfortunate symptoms of PD3 are easy to spot: feelings of inadequacy when it comes to the private sector, the irrational belief that senior citizens have no cognitive abilities and, non-dietary aversion to donut holes. A less severe but related condition has been identified as Pelosian Ideation Syndrome (PIS) -- which can manifest itself through both disorientation and lack of balance.

If you feel you may suffer from PD3 stop reading this blog immediately and log onto the Public Citizen website for immediate relief.

A new study, funded by PhRMA and conducted by the Amundson Group, shows (among other interesting things) that in 2005 the average Medicare beneficiary filled 2.5 prescriptions per month -- but in 2006 (and with Part D coverage) that number jumped to 4.0 prescriptions per month. (The study found that the increase was consistent across all ages.)

The study also measured the average out-of-pocket cost for each day's supply of medication. And to those PD3-free readers, the findings should come as no surprise -- a per unit measure shows a 74% reduction in patients' out-of-pocket costs from $1.58 BPD (Before Part D) to 40 cents APD (After Part D).

More access at lower cost. Pretty sweet double play.

As for positive patient outcomes, the study measured the impact of Part D on access to drugs for specific chronic conditions that are highly prevalent in the Medicare population: Alzheimer's disease, high cholesterol, diabetes, hypertension, and osteoporosis -- all conditions that are often undertreated.

For each of these chronic conditions, the study found that there was a significant increase in the number of prescriptions filled per month -- suggesting that patients with these conditions are getting treatment under Part D that they were not previously receiving.

Note: In rare but advanced cases of PD3, symptoms can also include the belief that chronic disease should not be treated early and aggressively and the inability to differentiate between Santa Claus and the Non-Interference Clause.

If, after reading this blog, you are experiencing feelings of guilt and inadequacy, please consult a specialist -- Dr. Mark McClellan.

To view the complete study, click on the link below:

http://www.phrma.org/files/Amundsen_Study.pdf  Read More & Comment...