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June 29, 2007
Pharmonic Convergence
by Peter Pitts
Two interesting stories that both reach the same place -- we need to find ways to get the right medicines to the right people at the right time in the right dose. Let's call it "Pharmonic Convergence."
First story comes from the Pink Sheet and their discussion of FDA's genetic test guidelines.
As reporter David Filmore writes vis-a-vis the FDA's genetic test guidelines:
"The agency drafted the guidance document on pharmacogenetic tests and genetic tests for heritable markers to help shorten development and review times for these products, which are attracting growing attention from the medical community as tools to make more precise disgnoses and, in the case of pharmacogenetic tests, more personalized treatment decisions."
Right now, today such tests exist. It is not, as many will derisively tell you, science fiction. It's science fact. And the fact that most insurance companies don't reimburse for such diagnistic tools is short sighted.
To that point, an article from the June 28th edition of the New York Times. Gray Lady scribe Milt Freudenheim reports on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."
"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.
As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."
The lede of the New York Times article reads, "Health penny wise, medical pound foolish?
Indeed.
Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payors interpose themselves between doctor and patient, when prescribing decisions are made by accountants (read "evidence-based medicine"), health outcomes decline for the individual and costs go up for the payor.
Let's keep our eye on the prize as we strive to move from acute to a chronic care model for 21st century health care. It's nothing short of critical.
And, after all, that's why we have the Critical Path.
Posted by peterpitts at 01:11 PM
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June 27, 2007
Lies. Damn Lies. And Drug Importation
by Peter Pitts
Just because you say it enough times doesn't make it true.
Most recent example that proves this maxim is the attempt by certain members of Congress -- in this case U.S. Representatives Rahm Emanuel (D-IL), Jo Ann Emerson (R-MO), Rosa DeLauro (D-CT), and Marion Berry (D-AR) -- to hide the facts that drug importation is neither safe nor smart.
The Fearsome Four offer the following reasons why drug importation is a good idea. (We offer the facts in bold -- because the truth must be told boldly.)
The Fearsome Four claim that the same brand name drugs cost 35-55% less in other nations then they do in the US.
That's because the nation's of the EU (and Canada) have price controls that equal choice controls for their citizens. Also, the rest of the world unfairly shirks its responsibilities to shoulder their fair share of the burden of research and development. This is what members of Congress should be up in arms about.
The Fearsome Four say that drug importation has been in place in the European Union (where they call it "parallel trade") for more than 20 years with no safety problems.
Believe it or not, their "source" for this is Peter Rost. For the truth I prefer the European Commission who has identified parallel trade as the weak link in the chain for counterfeiters. It's also convenient (although not responsible) to forget that the British regulatory authorities have recently found counterfeit and substandard medicines in their island kingdom -- courtesy of parallel trade.
The Fearsome Four claim the pharmaceutical industry has imported drugs and sold them in the U.S. for decades. In fact, 40 percent of the drugs consumed by Americans today are made in foreign manufacturing plants.
That's right -- in plants authorized and inspected by the FDA. The Four conveniently omit the fact that their legislation would allow in medicines from plants not approved by the FDA. Oops.
The Fearsome Four claim that prescription drug importation will result in $50 billion in direct savings alone over the next decade, a $10 billion benefit to the federal budget.
For this fact they cite a Congressional Budget Office Study. But what the study actually says is that such a program woyuld reduce the drug spend in the US by .01%. And that doesn't include the monies needed to set up an entirely new, international system for drug regulation.
And finally, the Fearsome Four claim that passage of the Pharmaceutical Market Access and Drug Safety Act will finally assure the security of our drug supply.
Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few. Because what the Fearsome Four aren't saying is that "drugs from the United Kingdom" means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere. They should do their homework.
What happens when pesky facts get in the way of political grandstanding?
Good things
Posted by peterpitts at 03:18 PM
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June 26, 2007
WeLLO
by Peter Pitts
As its costs continue to spiral upward, most people now agree that America's health care system is broken. And as the race for the White House heats up, politicians on both sides of the aisle are clamoring to propose ideas that rein in health spending.
Unfortunately, the policies offered thus far are misguided. As counterintuitive as it may sound, the answer to America's health care woes won't be found by harping over the price of care.
Here's the rest of the story via a new op-ed in the Baltimore Sun:
The conclusion?
"Prevention must be health care's first line of defense, as a proper diet and healthy lifestyle can stop many diseases in their tracks.
Failing prevention, earlier diagnosis and care are crucial. There are many effective treatments and maintenance medications that can stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives without breaking the bank.
In the coming weeks, the nation will learn more about the health care plans of each of the major presidential candidates. If lawmakers want to save lives, enhance the quality of care, and reduce costs, the focus needs to shift to prevention and early diagnosis."
SiCKO? How about WeLLO.
Posted by peterpitts at 04:53 PM
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June 20, 2007
Comparative Effectiveness. Compare and Contrast.
by Peter Pitts
Effective for patients or effective for budgeteers?
When pols and pundits say that we need a system of comparative effectiveness measures "like the UK," it's important to understand what that means. Consider the following ...
An international study of patient access to cancer drugs has found that the UK is in the lowest category of 25 countries, which were measured on the uptake of 67 treatments. The study, by the Karolinska Institute and the Stockholm School of Economics, found that the overall performance was best in Austria, France, Switzerland and the USA.
The researchers noted that the biggest variations across the different national markets in the study were for bowel and lung cancer groups. In both cases, the UK ranked with Poland among the worst countries for patient access to drugs.
This is a system we want to adopt? When Representative Emerson, for example, points to saving "billions, maybe trillions, of dollars" what she means (whether or not she understands it) is that those savings come from denying care.
Yes -- even for cancer patients.
The Karolinska Institute and Stockholm School of Economics study was published in the Annals of Oncology.
Posted by peterpitts at 09:02 AM
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June 19, 2007
No Soap
by Peter Pitts
In the movie “Marathon Man,” Lawrence Olivier’s Mengele-inspired dentist threateningly asks, “Is it safe?” That same question, as Congress debates PDUFA reauthorization and FDA reform, has the real threat of crippling medical progress and the freedom physicians have in deciding which treatments are best for their patients. These are frightening thoughts — and attention must be paid lest we find ourselves, micron-by-micron, abdicating the hope of 21st century medicine to politically expedient measures that serve only to further the political aspirations of sound-bite hungry politicians and the voracious appetites of trial lawyers.
In the Wall Street Journal, Scott Gottlieb addresses the fact that …
“A decade ago, we were mostly focused on uncovering the remote risk that certain drugs could, in rare cases, cause immediate, unexpected and potentially life-threatening problems such as liver damage or disturbed heart rhythms. Surfacing these problems was made easier by the fact that the side effects occurred in close proximity to administration of the medicine, so it could be deduced when the drug was at fault.
Now we're focused on unearthing cases where prolonged use of some drugs may prompt small elevations in the risk of otherwise naturally occurring and even common events, like heart attacks. This was the issue that caused the withdrawal of the painkiller Vioxx and the premature flap around the diabetes drug Avandia.
Our heightened vigilance will surely improve the information people have to make informed choices. But finding and proving these kinds of rare and latent problems will often take many years and entail large and rigorous clinical testing. Even then, deciding if such remote kinds of risk outweigh benefits requires an often subjective calculus that is best left for patients and doctors to decide individually.”
In short, rhetoric and politics, and now actual legislation in the form of REMS, are forcing the FDA ever more towards adopting the Precautionary Principle. That’s the one-dimensional dogma that dictates that nothing should be done until everything is understood. Prudent? No, puerile. And the unintended consequences are fatal. Fatal like in no new medicines.
A little harmless politicking? Hardly. Just ask the people who may soon longer have access to the medicines they need, or to those who will suffer needlessly in the wake of Tropical Storm Safety — since the inevitable result of the Precautionary Principle is a dearth of new medicines in the pipeline.
Is it time to recall Ivory Soap? Is it safe? After all, it’s only 99 44/100% pure.
We must not allow safety to be hijacked.
Posted by peterpitts at 09:30 AM
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June 18, 2007
Nulla mensa sine impensa
by Peter Pitts
Translation -- "There is no free lunch.”
More to the point, there is no “cheap” lunch. In other words, there are rarely simple answers to complex questions.
For example -- John Edwards’ suggestion that the government take away patent rights for companies that develop breakthrough drugs and instead, reward them with “prizes” from the government.
Except that, er, it doesn’t work and has significant unintended consequences.
Details. Details.
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!
Does Candidate Edwards really want 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.
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.”
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. Sound familiar? Correct. Evidence-Based Medicine.
To be sure, there will be other unworkable, ill-considered, and precarious suggestions for ways to “fix” the U.S. health care system. But a prize system may be the worse of them all.
Posted by peterpitts at 10:17 AM
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June 08, 2007
WHO: Fake it before you can Make it
by Peter Pitts
Lot of debate going on globally on the subject of compulsory licensing of pharmaceuticals.
Most of the chatter focuses on what's going on in Thailand and Brazil -- but what about Switzerland?
Switzerland? Well actually, to be more specific -- Geneva. And to be even more direct, the World Health Organization (WHO).
The issue at hand is, who's going to make the drugs whose patents have been stolen by Brasilia and Bangkok?
And who's going to certify that these pirated products are safe and effective, manufactured to the highest public health standards?
In many cases, that certification process is handled by the WHO. But, while the WHO does say who passes their GMP tests -- the organization does not say who fails.
According to the folks at WHO, such transparency would deter facilities from applying for certification. That's nonsense. All that allows is for facilities that have failed to gain WHO certification to claim that they have applied for that global imprimatur.
And that allows many substandard facilities to fake it so they can make it. The result -- counterfeit and substandard medications for the less developed world. Not acceptable. Kind of like claiming "patent pending." (But maybe talking about "patents" is a mixed metaphor considering the circumstances.)
(Could you imagine if the FDA only sent out public notification for medicines that the agency approved?)
The folks down in WHOville need to step up to the plate and embrace transparency in their pharmaceutical GMP certification process.
Posted by peterpitts at 03:52 PM
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June 01, 2007
Chinese Checkers
by Peter Pitts
As any assistant district attorney will tell you, the "some other guy did it" defense generally means "guilty."
Now, it seems, China is blaming Panama for the deaths of 51 people caused by cough syrup containing Diethylene glycol -- a chemical commonly used in antifreeze and brake fluid. But, it seems, there is plenty of blame to go around.
This is just the latest example of China-as-hub for the international trade in counterfeit API (Active Pharmaceutical Ingredient). And connecting the dots to the issue of "safe" drug importation is pretty obvious.
Here's the story off the AP wire:
China blames Panama for deadly tainted drugs
Papers altered to say glycerin was for medical use, Chinese official claims
BEIJING - Businesses in Panama, not China were "mainly responsible" for passing off an industrial chemical as a medical ingredient leading to the deaths of at least 51 people, a senior official in China's product-inspection agency said Thursday.
Wei Chuanzhong, vice minister of the Administration for Quality Supervision, Inspection and Quarantine, said Chinese companies sold the industrial solvent called 'TD glycerin' to Spanish companies who then sold it to Panamanian companies. The product was then used to make cough syrup and other medicine.
"The Panamanian business people are mainly responsible because they changed the scope of use and shelf-life of this product," Wei said.
The deaths in Panama, which began last year, have dramatically added to a growing international alarm about the safety of food and medicines exported by China.
Wei acknowledged that the Chinese manufacturer, Taixing Glycerin Factory, and the Chinese distributor, CNSC Fortune Way, "engaged in some misconduct," because they used the name TD glycerin for a mix of 15 percent diethylene glycol and "other substances."
Diethylene glycol is a chemical commonly used in antifreeze and brake fluid.
Misleading name
"They used the very confusing name of TD glycerin, which will mislead people to think it's glycerin," said Wei. "The markings on the package also used the name glycerin instead of TD glycerin."
But he said the Panama traders bore the brunt of the responsibility for the deadly substance ending up in medicine.
"The Panama trader changed or altered the paperwork to say the substance was medical glycerin that met U.S. standards for use in medical products and changed the shelf life of the already expired product from one year to four years," Wei said. "The responsibility here is very clear."
He said the Chinese investigation found that the Chinese side made it clear in their export paperwork that the material they were selling was for industrial, not medical, use. Wei said Taixing had been punished for its misbehavior but when pressed for details, he said the company was still being investigated. He said China would not continue to allow the use of the name TD glycerin, but no ban has been formally announced.
Glycerin, which is often processed from animal fats and occurs naturally in the human body, is a sweet liquid that can give cough syrup and other remedies thickness while preventing them from dissolving in water. It is used in many kinds of medicines all over the world.
The first documented poisonings were reported in October, but Panamanian authorities said there may have been earlier cases that went undetected. Fifty-one people died after taking the tainted medications and 68 were hospitalized.
Why isn't Senator Bernie Sanders asking, "Where are the dead Panamanians?
Posted by peterpitts at 08:49 AM
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