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Another VA Moment

  • 12.06.2006
In light of my last post about the VA and its waiting times and denial of care...here's a great article by my colleague in Old Europe Johan Hjertqvist who runs the Consumer Powerhouse in Denmark. If the Euros are talking about giving consumers the freedom to go outside THEIR closed systems of care, why are our pols and pundits taking about shoving Americans into a closed VA model which, contrary to reporting, has yet to share or show any data about health outcomes?



Source: The Wall Street Journal
Europe
Date: December 06, 2006
Section: Business Europe
Page: 12
Among European economies, health care consumes roughly 10% of the average nation's GDP. When examined as a service market, the volume is enormous and the advantages great. And that is what EU Health Commissioner Markos Kyprianou might have in mind as he works to create an internal market of health services.

Last week, Commissioner Kyprianou declared his intention to find "a clear legal framework within which patients and health-care professionals have the chance to move freely in Europe " to receive and provide medical services. Such a market would help repair some of the weaknesses of European health care. When my organization analyzed the realities of health care among EU members for our 2006 Euro Health Consumer Index, we made some remarkable, even shocking, discoveries:

-- One in two health-care systems denies patients access to their medical records or to a second opinion.

-- Only one EU country has created a list and ranking of health service providers.

-- Waiting times are common. In three out of four countries, cancer patients likely face waits of more than three weeks to begin treatment.

-- In just a handful of countries can patients find a consumer-friendly, comprehensive catalog of available pharmaceuticals that includes with information about medication options and side effects.

-- In two out of three countries, government delays the introduction of new medicines into the reimbursement system.

A legally regulated internal market will help patients by helping them to cross borders to access better or more timely care than at home, and by encouraging new providers to enter their national market. To entrepreneurs ready to export their services, an integrated market will be of significance. For far too long, political bias and misguided cost-control ideas have prevented new treatments and management concepts from being established around Europe .

Weak access to consumer and patient information is a key problem in Europe . No market functions without information. If the right of mobility is to do any good, patients must be able to compare the treatment options and provider quality in various markets.

To locate the best offers at home, consumers would look for ratings of hospitals with short waiting lists. And to learn more about medication, they might demand advice from sources other than their doctors and pharmacists. To have a real impact, the internal market project will require a significant improvement of information.

But today there is very little -- if any -- reliable information available on the national level. This means that at least four out of five Europeans are denied knowledge of vital health-care conditions, which are available only to an informed elite. (If you understand English and are a skilled Internet user, the situation is far better.) This divide challenges strong European values of equality and justice.

No wonder, then, that the conclusion drawn at the annual EU health policy summit in Austria in October was that there is a need for consumer empowerment through medical guidelines or best practice on the EU level, to address the quality gaps and to improve outcomes. There was even discussion of a pan-European patient safety agency, tackling quality issues becoming even more important as cross-border care will grow. My impression was that the EU "health policy family" represented at the summit wanted the Commission to clarify and regulate the sector so that everyone has the legal, informational and financial resources to be able to cope with this development.

What often is labelled "health tourism" is quickly becoming a reality, as new companies are offering health services that are attractive both for their low cost and their high quality.

A Briton or a Swede can save thousands of euros by going to Poland or Hungary for virtually all dental care beyond regular checkups. The prices in these countries could be as low as half the level they'd find at home. But even these low-cost dentists are worried about Romania , as it is slated to join the EU next year. Once that happens, consulting with a high-quality dentist in Bucharest could save a health tourist an additional 30% off his bill. Such figures indicate the potential for restructuring and price efficiency in favor of the consumer.

The market perspective will bring another dimension into the European arena: the competitiveness aspects of health care. Assuming the present economic stagnation remains, the EU's future looks rather bleak, as the labor market faces increasing pressure to provide for the health-care needs of the Continent's aging population. If managed in an innovative way, health care could instead become the growth industry Europe badly needs. But such a shift requires a different kind of governance, not the least regarding how to reform our health-care systems.

Over time, active consumer choice among providers and therapies will push inferior producers out of the market, or at least force them to improve their performance. This bottom-up pressure to be more productive and efficient is key to improving quality in any industry, and health care is no different. But even though "health-care reform" is much debated across Europe , it is quite evident that the government approach remains top-down.

Rather than long-term consumer empowerment, the focus is on short-term cost-cutting. This is a harmful situation. If consumers had better access to information about their health and how to navigate the health-care system, they would be capable of addressing the inequalities and malfunctions of today.

As such, information is what's needed to developing the health-care systems of Europe . If market information is available to support informed choices, the Kyprianou market strategy can prove successful. Given the power to make decisions regarding their own care, consumers will act to define a new balance between rights, equality and fairness on one side, and access, influence and responsibility on the other.
I got a kick at how the VA's flak-catcher tried to sidestep the fact that nearly 40 percent of it's hostages have bought Part D coverage in addition to holding on to VA coverage.

The AP's Kevin Freking has the VA spin doctors trying to establish the difference as follows: There are also differences in the list of drugs the VA covers compared with the list of drugs a typical Medicare plan covers. Leavitt described the VA's list, or formulary, as "among the most restrictive in the marketplace."
In Medicare, slightly more than half of enrollees are in plans that cover 1,000 to 1,500 medications. Another 35 percent are in plans that cover more than 1,500 drugs, Nelligan said.
Meanwhile, the Veteran's Administration plan covers about 1,300 drugs, Valentino said.
But, he calls the number of drugs on a formulary "almost irrelevant."
He said if a plan covers the top 200 selling drugs, then it's basically covering everyone's needs. When asked if the VA covers the top drugs used by seniors, Valentino said he was confident that it does. (Mike Valentino, VA's pharmacy director.)
"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.


Equally safe and effective?

Mr. Valentino should have heard the presentation by FDA's Janet Woodcock about the myth of therapeutic substitution at Windhover FDA/CMS Summit in Washington this past week.

Or he can ask some of the VA consumers who post about their experiences at the hadit.com Vets forum

You can always get a letter from a Doctor explaing what you need and why and than the VA will have to get it for you. There is a risk though. I tried it a number of years ago and was threatened with losing my fee services....

to get the VA to pay, I will have to schedule umteen appointments first, before approval. Sometimes I wonder if it's worth the hassle.

I simply recieved a call from my VA doc one day, saying the VA pharmacy no longer carries the slow release Oxycontin I had been taking for sometime. It's one of the few I found that works with neurological, (hot ice pick stabs) I get & chronic pain.
His message said they were stopping the med, "imediately" & prescribing "methadone".
I refused it & was told to come in & discuss it with the Doc. (Another 300 mile trip).
I was told by the Doc The VA no longer carries it in our region. This is sort of true, I found out.
The truth is, the "VA" Pharmacy @ the Spokane VAMC told me it's on the formulary list. Meaning, they stock it, but the Doc must specifically request it & it must be approved before you recieve it.

I went through sudden withdrawal symptoms & suffered from symptoms due to MS, Fibromyalgia, Spinal disorders & the list goes on for nearly 6 months, without being treated for neurological pain. The Doc said I can take Meth or do without, because "he" wasn't going to prescribe anything but Meth.
I was eventually put back on 5 mg of Oxycontin. Three, every six hours, as needed & Oxycodone for break through pain.
The doc has since cut the Oxycodone.

I am unable to take triptians such as imitrex, etc., Demerol and morphine. I am able to take Darvocet which helps a little but the best med for me is Stadol. The VA does not carry it! I have a private dr prescribe it and I use the nasal spray. Within 5 mins the pain is gone. Unfortunately, so am I for about 5 hours.

I have not been able to work since February 2004 since I have 3-5 attacks per week. I use ice packs on the top and sides of my head and heat on my neck and it seems to work.

Let me repeat what Mr. Valentino said:

"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.


And this is what the Dems want to inflict on all seniors.

But I guess 2 million VA consumers have signed up for Part D because they like paying twice for equally safe and effective drugs...
"Drug Pirates Leave Death in their Wake." So reads the headline from the Guardian (of London). It's the most recent report on China's role in the growing global threat of counterfeit medicines -- and it's nothing short of international health care terrorism.

Some relevant snippets:

* Last month Peter Mandelson, the EU trade commissioner, revealed that fake birth control pills and HIV retroviral drugs from China had been seized by European customs officers.

* According to Mr. Mandelson, half of all counterfeit pharmaceuticals found inthe EU originate in China.

* The article cites the CMPI report to the effect that that global sales of counterfeit drugs will reach $75bn (£38bn) in 2010 - an increase of more than 90% from 2005.

* Henk Bekedam, representative for WHO in Beijing, said, "Fake drugs are a global problem and there is no reason to believe China is an exception. Piracy is a disease ... we need to report on it, find out where it is coming from, and go and deal with it."

Here's a link to the complete article:

http://business.guardian.co.uk/story/0,,1963095,00.html

And the closing sentence of the story is worth sharing:

"The worst consequences will be a lot more serious than erectile dysfunction."

Passage to India

  • 12.04.2006
Interesting/disturbing article in Sunday's edition of the Washington Times on the growing trend of "medical tourism" -- Americans traveling abroad for surgeries. And this doesn't mean spending a relaxing week in Paris. Hardly. It's more likely a trek to India or Thailand.

Joshua Goldberg, 23, a California man who went to Thailand to be ordained as a Buddhist monk, died at Bumrungrad Hospital in Bangkok after being bitten by a snake. Reports indicated Mr. Goldberg was "simultaneously administered ... six contraindicated and lethal medications," despite warnings to doctors from his father about his allergies to certain drugs.

But our pal Uwe Reinhardt, a health economist at Princeton University, has not heard "one horror story" involving a medical tourist.

Well ignorance is no excuse. Nor is naivete. According to Uwe, "A lot of surgery is just plumbing that requires skill. Given circumstances today, it's much harder to run a hospital in Los Angeles than in India. And while things could go wrong in a hospital in India or another Asian country, they would probably turn out just as well there as here."

Doesn't that make you all warm and fuzzy?

A better, wiser, safer, more practical, and less expensive alternative is to strive to avoid surgery altogether. And the best way to avoid many surgeries is to diagnose disease earlier and provide treatment through non-invasive, domestic pharmaceutical intervention.

Americans would be far better off with proper medication today than a passage to India tomorrow.
This sounds pretty good, says Christopher P. Cannon, a cardiologist at Brigham & Women's Hospital in Boston. He notes that in the data that are available, torcetrapib consistently raises blood pressure, but the change is small and might be treated with other medications. On the other hand, he says, increases in HDL are unparalleled.He says that if studies show the drug clears plaque out of the arteries, it could be very important. This medication would help address a huge unmet need, he says.

http://www.forbes.com/2006/11/30/pfizer-cholesterol-drug-biz-cz_mh_1201pfizer.html?partner=alerts
From AP According to Pfizer spokesman Paul Fitzhenry, 82 patients taking the combination of torcetrapib died, compared to 51 deaths in the arm of the study where patients were taking Lipitor alone. Each arm of the study had 7,500 patients. Pfizer said that the study didn't raise any questions about Lipitor's safety.

Dr. Philip Barter, chairman of the steering committee overseeing the study, said in Pfizer's release that the findings of the data safety monitoring board Torcetrapib were a surprise "in light of prior study results."

We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Barter, Director of the Heart Research Institute in Australia.

Only three patients, all on the combo pill, stopped taking their medicine because of a blood pressure increase. However, a total of 14 patients stopped taking the combo pill for any reason, twice as many as on Lipitor alone..."
A factoid (courtesy of Gabriel Calzada, director of Madrid's well-regarded Instituto Juan de Mariana) for those who think that government control of health care leads to Nirvana:

In a classic case of "do as I say, not as I do," 86% of Spain's bureaucrats opt for private health care versus that provided by their employer, the government.

And, yes, Generalissimo Francisco Franco is still dead.

Ketek Konspiracy

  • 11.30.2006
Days before the advisory committee hearing on Ketek's risk/benefit profile guess who sends a letter to the NEJM claiming that the FDA's use of post market safety data in approving the drug was inappropriate?

David Graham.

But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.

I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.

I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.

He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...

If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.

Really Really Sorry

  • 11.30.2006
Let me remind everyone that Dr. Graham's famous memo on Vioxx did not adequately control for prior cardiovascular illness, obesity, hypertension or mixture thereof and that notwithstanding Grahama found a 1.47 relative risk of a significant cardiac event for low-dose Vioxx usage and 3.58 for high-dose Vioxx usage compared to current use of celecoxib, though the smaller number was not statistically significant, and relative risk compared to other populations was not statistically significance.

Further, it should be pointed that two advisory committees, one conducted by the FDA and another in Canada determined that Vioxx be returned to market. Dr. Graham's presentation at the FDA advisory committee was not as warmly received as the posterior polishing he received during his Senate presentation.

Do I apologize for logging on to our site to see the fake Graham posting and then responding from Israel and then rushing out to spend time with my family without reading the subsequent correction? Absolutely. Do I apologize for calling him a sad sick individual for equating the FDA with Nazi's when in fact he did nothing of the sort. Of course and it sickens me that someone would write some that disgusting using his name or anyone elses. While I strongly disagree with Graham and his approach, no one deserves such treatmen.

Does it bother me that Graham's lawyer implies that I had reckless disregard for the facts and didn't take the time to see if there were an explanation instead of posturing like an aggrieved victim...kind of. Will the threat of a lawsuit stop me from criticizing Dr. Graham in the future if that was the goal?

You be the judge.

Sorry David.

  • 11.30.2006
Just received this letter from David Graham's attorney:

Dear Center for Medicine in the Public Interest:

First, thank you for acknowledging on DrugWonks.com that the opinion piece entitled “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity” was not, in fact, authored by Dr. David Graham.

Having so acknowledged this fact, we would assume that DrugWonks.com would take the honorable and, we believe, legally mandated step of removing all the postings related to this matter that defame Dr. Graham. Not only did this not happen, DrugWonks.com actually posted an item, “My PS to David Graham” by Robert Goldberg, describing Dr. Graham, among other things as “a sad, sick individual,” after acknowledging that Dr. Graham was not the author of the aforementioned opinion piece.

In our view this Goldberg posting, and the failure to remove the prior postings by Peter Pittts related to this matter, exhibit actual malice toward Dr. Graham and an intentional or reckless disregard for the truth or falsity of these postings. Bluntly, they meet the legal standard of defamation.

Therefore, we must demand that, by 4 pm EST today (Tuesday, November 21, 2006):

(1) DrugWonks.com remove all postings associating Dr. Graham with “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity” and any negative insinuations about Dr. Graham related to this matter;

(2) Publish, at the top of the home page of DrugWonks.com, a bold-face, unqualified apology to Dr. Graham as follows: “DrugWonks.com, the Center for Medicine in the Public Interest, Peter Pitts and Robert Goldberg apologize to Dr. David Graham for posting intemperate and insulting comments about Dr. Graham, wrongly attributing to him the authorship of “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity.” We regret any inconvenience or harm this has caused Dr. Graham.”

Well, we want to do the right thing. And we certainly want Dr. Graham and his lawyers to think we're honorable. And, of course, we'd never want to be intemperate and insulting! Furtherest thing from our minds. But, David, you were also clearly inflamed by the article , so we hope you can see where we were coming from.

Please accept our most sincere apologies.
And we regret any inconvenience this has caused you.

And, here's an open offer -- please send us your thoughts on the article that you didn't write and we will run it on drugwonks.com. Since it evidently caused you such grief, we'd like to give you the opportunity to set the record straight.

Your lawyer knows how to reach us.
CMPI

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.

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