Bridges/Jones Diary

02/16/2007 07:26 AM |

That's John F.P. Bridges and Christopher Jones, both of the Johns Hopkins Bloomberg School of Public Health.

Their new paper, "Patient-based health technology assessment: A vision of the future," is a timely discussion of how HTA and EBM can and must be used to advance patient health and reduce long-term health care costs -- rather than how it is currently being used -- as a way to reduce short-term, transitory health care spending.

Here's a link to the paper:

Download file

Some snippets to entice your appetite for real reform:

"Objective: The aim of this study was to develop a working definition of patient-based HTA, to identify the current barriers to adopting a patient-based model, and to formulate a vision of how a patient-based HTA could be used to promote patient empowerment and patient-centered care."

"Whereas EBM categorizes and ranks all types of medical evidence by the quality of the results provided, the randomized controlled trial (RCT) is given preferential recognition because of its ability to identify (average) treatment effects. Unfortunately, RCTs are costly, frequently underpowered, and too often not representative of the broader population of patients who must receive treatments in different settings. In addition, RCTs may not adequately reflect values of patients, as they so often are focused solely on outcomes defined by the scientific and medical community, without consideration of the patient's needs and desires."

This paper delves into the doctines so often treated as dogma, shines a bright light on faulty assumptions, and calls into question the methods of EBM and HTA that have been hijacked to justify limited formularies and price controls.

It's based on a presentation given at the Third Annual Meeting of Health Technology Assessment International, held July 2-5, 2006 in Adelaide, Australia.

And it's worth a careful read.  Read More & Comment...

Berenson's Behavior Gets Top Billing

02/15/2007 10:18 PM |

The NY Times used the First Amendment to keep Alex Berenson -- who seeking to turn his novel into a movie -- from explaining his behavior to federal judge Jack Weinstein, particularly his role in a conspiracy to illegally ferret documents out of a case (which makes him a hero in the addled minds of MindFreedom and other co-conspirators) .

As the following clip from Fox News suggests, Judge Weinstein, no arch-conservative, has found Berenson's contempt for legal procedure, defendant rights and the court, "reprehensible."

Drugwonks was attacked for criticizing those (Berenson included) involved in this sordid mess as well as those that called his accomplices "heroes."

We think we are owed an apology. As is Eli Lilly and Co. who, since we last checked, is still afforded the same rights and protections under the Constitution as any defendant in a civil suit.

We are not holding our breath. Maybe if we contacted the NY Times to steal one out of federal court documents we'd get one sooner.

Here's a link to the clip

FNC_02_14_2007_18.31.44.wmv  Read More & Comment...

So Much For Drug Safety

02/15/2007 09:46 AM |

Waxman, Clinton and Schumer have introduced a bill to allow generic companies to introduce followon biologics sans assurances that they are as safe as the real thing and entrusting the approval process to an agency (FDA) that they say cannot be trusted to assure the safety of pharmaceuticals, let alone biologics.... And it turns out that the money to be saved from dumping these products on the market (assuming that innovator companies will accept the idea that their patents should be seized and can be easily challenged or have already expired) equals the amount $70 billion that Democrats were to extract from Part D price controls and were first use to fill the donut hole and then decided to use to expand SCHIP

Is there a biomarker for detecting hypocrisy?  Read More & Comment...

It must be true, I read it in the newspaper

02/15/2007 09:40 AM |

Two stories that are frightening both because of their content and, even more so, because of their easy acceptance as “main stream.”

The first is about an attempt in the Michigan legislature to allow residents of the Wolverine State to sue pharmaceutical companies if they suffer from an adverse event that is on the label of a prescription medicine. After all, patients shouldn’t be responsible for reading the PI and doctors shouldn’t be responsible for informing their patients about potential risks. The only responsibility, it seems, is to permit more and ever more law- suits.

Here’s the link:

http://www.dfw.com/mld/dfw/business/16697132.htm

The second news item comes from our friend, Congressman Henry Waxman, the U.S. House of Representatives new over-sighter-in-chief. It appears that Mr. Waxman doesn’t think Novartis should challenge an Indian law that trashes their IP protection.

But things, aren’t always as they appear, are they?

Here’s the full story:

http://www.business-standard.com/economy/storypage.php?leftnm=3&subLeft=1&chklogin=N&autono=274764&tab=r

And remember the old saw -- everything you read in the newspaper is true, except for those things you know about personally.  Read More & Comment...

Lean. But Mean?

02/15/2007 08:51 AM |

Gottlieb speaks!

Lean New Pharma

By Scott Gottlieb, M.D.

Forbes Online

With 10,000 jobs and as much as $2 billion in costs set to disappear from Pfizer by the end of 2008, the pharmaceutical giant’s new chief executive is proving that he has a brain for bean counting and a body for Six Sigma.

The promotion of Pfizer’s Jeff Kindler to CEO from his former role as the company’s general counsel is of a piece with similar management makeovers inside big pharma’s boardrooms and may speak as much about where the industry is heading as where it has been.

Merck’s new chief executive, Richard Clark, was the president of his firm’s manufacturing division before he took the top job, and one of Clark’s first orders of business on his ascendancy was to announce the closure or sale of five of Merck’s manufacturing facilities as part of a package of efficiencies aimed at yielding pre-tax savings of up to $4 billion by 2010. About $2 billion of that will come from manufacturing reforms alone.

Once upon a time, a pharmaceutical CEO who did not hail from one of the creative parts of the drug business would have been met with skepticism on Wall Street. Certainly, a drug CEO would have been expected to have been schooled in the sales and marketing side of the business, if not originate from its core competency in research and development of new drugs.

Instead, Clark and Kindler, who have little comparative background in these disciplines, have been cheered. What gives?

Clark and Kindler are professional managers, and the administrative discipline they bring may be in order after the industry bloated itself on mergers--some cobbled together with little long-term vision beyond the urge to capture a few prized medicines. But this focus inside the executive suite on cost cutting cannot help but leave the impression that the drug industry is less a growth story than an aging industrial complex readying itself for life as a regulated public utility. Maybe it’s time the drug firms increase their dividends.

After all, if the prevailing political mood is any indication of the future, then the price of this industry’s core medical products will increasingly be a reckoning of government actuaries working for the Medicare drug benefit. And the Food and Drug Administration has always tightly regulated the manner in which pharma companies develop drugs, setting a close parameter on their cost.

In the end, this cost cutting is not a transformational strategy, just an exercise in defense to maintain the margin. These companies are treading water until they can start to grow again, which begs the question: When will the celebrated slump in the industry’s research productivity start to reverse itself.

Truth is, there have been some spectacular breakthroughs produced in recent years out of big pharma labs, including Merck and Pfizer--drugs aimed at specialized conditions and unmet medical needs. But these medicines have been given short shrift by the mass media because many have not been the kind of big primary care sellers that turn into multibillion-dollar blockbusters. Nevertheless, nobody can mistake the fact that big pharma’s spending on research and development has increased about 150% over the decade from 1993 to 2004, to more than $60 billion today, yet the number of drugs from the industry that reach the market has not changed measurably.

Some blame corporate bloat for the falloff, arguing that the drug companies got too big to be entrepreneurial. Others say the incessant focus on blockbusters prompted companies to prematurely cast aside promising but potentially niche molecules. Optimists say we are at a point when fundamental discoveries made in recent years in genomics and proteomics are just filtering into development programs. We will soon see a surge in productivity, similar to previous periods when the application of new sciences like combinatorial chemistry needed time to mature.

Here’s another theory. All of that increased R&D spending has been dwarfed by inflation. Over the past decade, the regulations on development and the demands of government payers have grown far faster than those research budgets, meaning we are not buying nearly as much science as we used to.

This is a fact of life that the National Institutes of Health has been bemoaning as it sees its own budget flatlined. The NIH has not had its budget “cut,” but it announced last week that it is closing swaths of research nonetheless because a dollar today does not buy nearly as much research as it did a few years ago. The furtive secret is that NIH trials are not even subject to the full brunt of Food and Drug Administration oversight. So they get away a lot cheaper than the industry does.

In this kind of regulated world, where the cost of development and the price of finished goods are increasingly controlled by the government, and where the cost of production goes up even as the selling price goes down, the drug companies will need to find additional ways to cast off more of their fixed costs to focus instead on core competencies in late development, distribution and marketing. This will push drugs firms increasingly toward a more disaggregated model, with work put to a growing legion of smaller outfits--from biotech firms that will continue to do research and early development and offload some of the scientific risks to contract organizations that do the testing and freelancers that sell.  Read More & Comment...

Media Schizophrenia Over Zyprexa-Gate

02/14/2007 07:35 PM |

I am trying to keep track of the arguments the media is making in favor of

1.Alex Berenson orchestrating the 'leaking' of a small slice of documents in a class action trial against Lilly to show that the company 'knew' of a possible relationship between it's atypical and weight gain and tried to cover it up and

2. That returning the illegally obtained documents is somehow a violation of the freedom of press.

According to the AP:

Last week, Judge Weinstein had requested that the reporter, Alex Berenson, appear in court Wednesday to discuss testimony that the judge said had implicated the writer in a "conspiracy" to obtain the documents, which had been placed under seal by the court.

Here's how the NY Times excuses sleazy conduct and avoids at least talking about in a way that they have hounded others to do so (such as Scooter Libby)

"We guard quite zealously our role as a member of a free and independent press and believe quite passionately that, consistent with the principles embodied in the First Amendment, it is not the role of the newspaper or its reporters to submit to cross-examination about such matters even where it may otherwise serve our particular interests in a particular case to do so,"

Note: this was not a cross-examination in open court. It was chance to clear
up what Berenson knew and did and when.

http://online.wsj.com/article/SB117079300102099942.html?mod=googlenews_wsj

Also note that "co-conspirators" like MindFreedom and other web-based ax-grinders now claim that being in possession and posting of stolen documents is okay. And of course none of this is related to lawsuits contemplated by state AGs in Illinois, Vermont and elsewhere to sue Lilly regarding Zyprexa. (Nothing like going to the well again.)

The idea that Lilly tried to hide the risk of weight gain associated with Zyprexa is nonsense. It's in the literature for anyone not lazy enough to search...

J Clin Psychiatry. 1998;59 Suppl 12:17-22. Links
Adverse effects of the atypical antipsychotics. Collaborative Working Group on Clinical Trial Evaluations.

This whole jihad is being driven by crackpots, money hungry state AGs and aided by a newspaper that is willing to sacrifice both national security and the truth to play to its shrinking readership.....  Read More & Comment...

Off-Course Norse

02/14/2007 04:06 PM |

The Kingdom of Norway, one of the world's richest nations (due to oil, not salmon) is rewarding bad behavior. Hans Christian Anderson isn't smiling and neither are many of that nation's best trading partners.

In direct contradiction of the spirit of the TRIPS agreement, the government of King Harald V is apparently unwilling to protect pharmaceutical patents. Now it's one thing when the military junta in Thailand decides to demonstrate jack-boot behavior towards intellectual property rights – it’s quite another when it comes from one of the world's wealthiest countries.

The problem arises from Norway's dual system of patent coverage for pharmaceuticals. Prior to January 1, 1992, Norway granted analogous "process" patent protection that applied only to the manufacturing process for a drug's active ingredient. Though Norway began granting full "product" patents for pharmaceuticals after that date, the great majority of drugs sold in Norway today are still covered by weaker process patents.

Analogous process patents provide much weaker protection than product patents, making branded pharmaceuticals vulnerable to generic "copycat" competition. Generic manufacturers have claimed that they have found alternative methods to produce certain branded products that do not infringe the process patent and are attempting to introduce the copycat drugs into the Norwegian market.

The United States and most European nations provide full product patent protections for pharmaceuticals. European countries where this difficulty once existed have taken remedial measures. Finland, for example, recently took action to rectify an identical weakness in its patent laws respecting pharmaceuticals.

Norway wants the full benefit of international pharmaceutical innovation, but is unwilling to contribute its fair share to global costs of biomedical innovation. This is free-riding of the worst order. And what's worse is that the Kingdom's Jamie Love-like behavior punishes many of its best trading partners (those nations home to innovator pharmaceutical companies) while rewarding countries willing to provide anti-TRIPS drugs (such as India and China).

It's not a complicated proposition. Under TRIPS Article 27, Norway has an obligation to provide protection to “any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”

And Norway has an obligation under TRIPS Article 70.2 to grant enhanced rights to existing subject matter that either is already protected in Norway or which meets the criteria for protection under the provisions of TRIPS. The pharmaceutical products under debate existed and were patentable subject matter on the date that TRIPS first applied in Norway. So, once again, Norway has an obligation to provide patent protection.

Does the government of Norway think that just because they are a major oil producer they can disregard their international agreements in the same fashion the Thai junta treats its international agreements? It's shameful that a First World economy should embrace a Third World philosophy of blatant disregard for intellectual property.

In Norway, if it's war against the patent rights of innovator pharmaceutical firms today, who's next?  Read More & Comment...

Stupak's Safety Show Trial

02/14/2007 01:32 PM |

Bart Stupak had his little show trial on drug safety yesterday with his sidecar of disgruntled FDA numbers crunchers who see an industry-agency conspiracy behind every adverse event. That includes the increasingly insufferable and self-righteous David Graham who, according to USA Today, "more than two years after (telling) a Senate panel that the Food and Drug Administration was "incapable of protecting America against another Vioxx," the FDA scientist was back on Capitol Hill on Tuesday to tell a House panel that "nothing has really changed." Graham made it sound as if he is the sole repository of truth on whether a drug is safe and indeed claimed that the entire class

Actually, Graham has gotten more hypocritical. Here he is on Vioxx before real scientists at the FDA Advisory Committee hearing on COX-2 safety back in Feb 2005 instead of the self-aggrandizing Stupak:

Dr. Abrahamson: There are data that we have seen that ibuprofen might increase risk. We didn't talk about the McDonald and Way paper that in cardiovascular discharge patients, people give ibuprofen had a higher mortality 2-fold. So, as the smoke clears, I am not sure that the simple answer that the coxibs were different was actually supported by your data, nor
your ultimate explanation. Can you defend that?

Dr. Graham: I think you are accurate. I think what you are saying is fair. Maybe a better thing to say is, in the end, that you do need to look at it drug by drug.

Maybe the better thing is to actually run a balanced hearing instead of phoney three-ring circus that bears no relationship to the science.  Read More & Comment...

Mixed Signals on Molecular Diagnostics

02/14/2007 01:23 PM |

The WSJ has an article about how Mayo and Medco are partnering to screen patients BEFORE they take drugs to avoid side effects but meanwhile it sounds like the FDA is making it hard for such diagostics -- critical to the Critical Path and better health -- to get approved (and funding).

This in turn only gives ammunition and power to the critics of the industry and the agency that molecular medicine is not ready for prime time, that user fees are too user friendly, and that most of the money should go to policing products after they are on the market and not before they are developed or dispensed. All of which means fewer dollars spent on getting people new medicines for lifesaving medicines...

The FDA has a responsibility to get its act together on molecular diagnostics but Congress should understand that to drain the agency from money to advance such discussions and developments and invest in IOM-type idiocy will come at the expense of patient health and safety.  Read More & Comment...

Another Angell Error

02/14/2007 12:46 PM |

Marcia Angell claims that Medicare Part D was a giveaway to brand name drug companies and me-too drugs....

According to Business Monitor International..."The US-based Generic Pharmaceutical Association (GPhA) has announced that around 60% of all prescriptions on the Part D benefit programme are for generic drugs."

I wonder if Ms. Marcia's fact checking was any better when she was riding the bull at NEJM  Read More & Comment...

Wiki's Woes: Cautionary Tale

02/14/2007 12:34 PM |

Wikipedia is running out of money. But instead of accepting ads it will pull the plug if it doesn't receive enough donations to keep it going. Which means that the founders will put to sleep the fastest growing common grounds for sharing information around the globe out of principle.
http://www.calacanis.com/2007/02/10/wikipedias-got-3-4-months-to-live-and-wikipedias-technolo/
Sounds a lot like the purists who continue to seek a purge of all industry "sponsored" support of any kind of any medical research or activity. At some point the lack of commercial investment and the possibility of return will cause new information to dry up.

Non-profits and generic firms have much difference incentives. They don't need to "market" new medicines or even want to. They spend very little here or overseas training or explaining to doctors how to use drugs. You won't see Teva investing in new uses for the generic form of Lovenox (regardless of how valid it's recent patent challenge might be) . And you would not see them invest any time or money in putting together the efficacy and safety data for a priority review of a new indication as Sanofi did.
http://www.pharmaceutical-business-review.com/article_news.asp?guid=DDDCA11E-497B-4979-A659-B8759752875E

The zealots don't care, either because they are healthy (and don't care about the need to commercialize innovation) or driven by drug company hatred. That's a disease too.  Read More & Comment...

Hugo Chavez and the King of Siam

02/14/2007 07:23 AM |

Shades of Chavez. And so much for the rule of law in Thailand.

According to the military junta in Bangkok, Thailand is planning to break the foreign patents of 14 HIV/AIDS, cancer and heart drugs.

The 14 drugs targeted by the Health Ministry also included antibiotics.The ministry has announced compulsory licences for three of the 14 drugs, allowing it to buy or make generic versions of the two HIV/AIDS drugs and a heart disease medicine.

Foreign drug makers say Thailand's military-appointed government gave no notice to the affected companies before issuing the compulsory licences.

Last month, the Health Ministry issued compulsory licences for the heart disease drug Plavix, made by Bristol-Myers Squibb and Sanofi-Aventis and Abbott Laboratories' Kaletra to treat HIV/AIDS, after a similar move on another AIDS drug last year.

Under World Trade Organization rules, a government is allowed to declare a national emergency and license the production or sale of a patented drug without the permission of the foreign patent owner.

I suppose a health care system that is a total disaster is an emergency -- but I don't think this is what the WHO had in mind.  Read More & Comment...

Medicine and the Media

02/13/2007 02:43 PM |

Please join FDA Commissioner Andy von Eschenbach, Deputy Commissioner Janet Woodcock, Frank Burroughs of the Abigail Alliance, Dr. Scott Gottlieb, and many notables from the worlds of media and medicine for a day-long conference on how the media reports on medicine. The date is February 21. The place is the Hyatt Regency Capitol Hill in Washington, DC. For more details and a full agenda, please click on the icon on the top of this page.

(We did invite Senator Grassley, but he hasn't sent in his RSVP yet.)  Read More & Comment...

A Clinical Trial Should Not Be a Death Sentence

02/13/2007 10:15 AM |

Great commentary piece on expanding access to experimental therapies by CMPI board member Mark Thornton MD.

Drugwonks understands the need for well designed studies to prove safety and efficacy. But given the extent to which political pressure shapes what tools are used, we are skeptical when demands for longer, slower studies of the randomized type are constantly invoked. And when such studies turn away patients willing to enroll and ignore molecular /genetic diversity that can lead to better treatment, quality of life and knowledge, we are downright cynical...

We have to turn the tide against those who want to spend more gathering data on drugs we already know how to use safely -- starting with the imperious IOM report written by it's conflicted panel ( I will get to this issue, I promise!) --- and increase spending on tools that allow more people to become an "army of one" in the war to defeat cancer and other illnesses.

http://online.wsj.com/article/SB117124379156005353-search.html?KEYWORDS=disease&COLLECTION=wsjie/6month  Read More & Comment...

Denying the Holocaust -- and IP Protection

02/13/2007 09:11 AM |

Thailand confiscates patents before talking to drug companies -- 20 patents under consideration and counting. No doubt the principal beneficiary will be the corrupt and poorly run government drug monopoly. Meanwhile, the military junta is eagerly reaching out to boost it's economic ties to one of the great democracies on the planet...Iran.

TEHRAN (Fars News Agency)- Thailand's Commerce Minister Kroekrai Chiraphaet stressed his country's strong support for Iran's membership in the World Trade Organization (WTO).

Speaking in a meeting with Iranian Ambassador to Bangkok Mohsen Pak Ayeen, the Thai official noted Iran's economic potentials and underlined, "Not only Thailand, but also all other Asian states view Iran's membership in the World Trade Organization positively."

He further voiced pleasure for the increasing volume of the two countries' trade exchanges, and welcomed endorsement of cooperation agreements by Iran and Thailand, particularly in the area of trade.

Chiraphaet reiterated that endorsement of trade contracts by Iran and his country can play a significant role in the boosting of the two sides' trade exchanges.

Highlighting the role of the private sector in the growth of the two sides' trade exchanges, he called for the reinvigoration of trade cooperation and frequent mutual visits by the two countries' private sectors.

For his part, Iran's Ambassador to Bangkok Mohsen Pak Ayeen wished success for the new government of Thailand, and expressed the hope that the two sides' growing trend of relations and cooperation would continue.

He stressed the need for the development of Iran-Thailand trade ties, and viewed holding of the 8th joint economic commission meeting in Bangkok as a crucial step for the strengthening of the two countries' trade cooperation.

Pak Ayeen further underscored that consolidation of relations with Asian countries, particularly with ASEAN member states, sets a priority for Iran's foreign policy.


http://www.irandefence.net/showthread.php?t=5773


Meanwhile, Israel's Natan Sharansky is calling for a world-wide mobilization against Iran and it's economy similar to that brought against South Africa and the USSR for its policies of repression. In Iran's case, it is leading a global effort to wipe out Israel.

http://www.jpost.com/servlet/Satellite?apage=2&cid=1170359835461&pagename=JPost%2FJPArticle%2FShowFull
Where do the NGO's stand on this important issue?  Read More & Comment...

Witch Doctors

02/12/2007 11:43 AM |

Wounded in battle, Alexander the Great's last words were, "I am dying at the hands of too many doctors." I know how he feels.

Marcia Angell weighs in on the Medicare prescription drug benefit, predictably calling it a giveaway to drug companies, claiming that the VA drug lists -- as well as drug formularies throughout the world -- only ditch drugs that are not cost-effective. Like Herceptin, Lipitor, Avastin, Gleevec... Angell is the only person in the world who doesn't know that Medicare Part D is ruthlessly shifting patients to generic medicines by the way, which is why she continues to flog me too drugs..

And she continues to talk about drugs that were first discovered 25 years ago instead of what companies are investing in now. Talking about the future means talking about genomics, targeted therapies, personalized medicine, translational research...all the activities companies are spending dough on. And she continues to perpetuate the lie that companies spend more on things other than R&D by lumping in the total cost (administration) of running a corporation to the cost of marketing.

My question is: what new drug has Dr. Angell invested in, worked on, discovered or developed in her lifetime? How would she make drug discovery and development more effective and efficient? Does she have special pre-knowledge about which medicines will work that other scientists do not? If so, I wish she would stop recycling the same old crappy op-ed and share the recipe for developing breakthrough drugs without have to develop all those me-too medicines...

High cost for me-too drugs

And speaking of recycling crap...Steve Nissen is once again claiming that he courageously warned America about the cardiovascular dangers of taking drugs for ADHD, drugs he still claims -- as someone who knows nothing about ADHD -- are way too overused. This time he is claiming this in front of Bart Stupak's Health subcommittee Feb 13th, joining other luminaries such as David Graham to trash the FDA.

I post a response from Dr. Joseph Biederman from Mass General Hospital, one of the nation's expert on treatment of ADHD and use of stimulants for treating the disease to Nissen's nonsense. I have sent it to members of the Health subcomm so they have an idea of what the facts about the risks and benefits of ADHD meds really are.

http://www.massgeneral.org/pediatricpsych/docs/NEJMltr.pdf  Read More & Comment...

The VA's Pack of Lies

02/08/2007 10:27 AM |

The VA is in full retreat about it's penny-wise pound foolish formulary approach. It presented a power point presentation at an AEI summit on price controls in Medicare and then exported the propaganda to a meeting on drug formularies in Helsinki which is ironically the namesake of protocols designed to protect patients from getting screwed without their knowledge.

http://www.aei.org/events/eventID.1447,filter.all/event_detail.asp

Here's a breakdown of the myth's and fact's that the VA is now pushing:

1. VA offers more individual drugs that Part D

Fact: The VA offers more different varieties of the SAME drug but (formulations, doses, etc). Part D offers more unique new molecular entitites.

2. The VA formulary is not restrictive

Fact: The VA quotes a report written in 1998 (published in 2000) before it began an effort to push prescribers to adhere more tightly to closed formularies.

3. VA system participants live longer lives

Fact: The VA outright lies and uses a chart that is an outright mischaracterization of Frank Lichtenberg's study Older Drugs, Shorter Lives? An Examination of the Health Effects of the Veterans Health Administration Formulary (which I commissioned when at the Manhattan Institute).

http://www.manhattan-institute.org/html/mpr_02_f4.htm

Frank's chart is above. As you can see, he never claims that people in the VA don't live longer than people not in the VA. And he explains why in a footnote to the paper.

While there are some reasons to expect the mean value of Et to be lower than the mean value of the life expectancy of all U.S. males at birth-serving in the military may impair one's future health-there are other reasons to expect it to be greater. Et is based on a population of individuals who have been veterans, i.e., who lived long enough to serve in the armed forces (e.g., did not die in infancy) and who survived serving in the armed forces. It would be more appropriate to compare Et with the life expectancy of all U.S. males at age twenty, for example. Such data are available for some years (it was 73.25 for 1989-1991 and 75.6 in 2002) but are not available annually (Arias, 2004, Table 11).

What Lichtenberg shows is that after the VA formulary was introduced, the increase in life expectancy at any given period declined. He did not compared differences in LE.

But that's not good enough for the VA. It had to fudge the chart itself. So it introduced a chart that compared periodic life expectancy of vets to life expectancy of all Americans at birth in a way that erases the decline in life expectancy.

4. The VA claims it provides better pharmaceutical care.

Fact. There are many health care services that the VA does extremely well. However to the extent that the VA itself seeks to reduce hospitalizations and prevent disease the use of the best pharmaceuticals is critical to maximizing these goals. The failure of the VA to devote its considerable health IT resources to determine what the best drug for the right patient is reflects an insular and outdated view of medicine. It is very good at achieving better results on process measures relative to some commercial health plans and some evidence that the care it provides is a good as private hospitals. But the VA refuses to allow outside researchers examine the impact of formulary restrictiveness on patient outcomes and total health care costs.

5. The VA doesn't use mail order pharmacy.

Fact: According to GAO and the VA itself, the VA fills 83 percent of its prescriptions through mail order.

6. The VA claims newer is not always better

Fact: Does that mean the VA has more older drugs than Medicare Part D. Does that mean older is always better? In fact, most new drugs are associated with an increase in well-being and clinical improvement with some subpopulation. And in the case of the VA it has not added drugs even the FDA regarded as priority medicines, drugs that have a significant therapeutic value, to its formulary.

7. The VA does not have have a three year wait on all new drugs.

Fact: The VA is right on this count. Sort of. It generally waits a year. Or longer. It was only recently, under pressure from Part D, that it began adding new medicines in a timely fashion. It still hasn't added many new cancer drugs.

8. There have not been 1 million Part D defections

Fact: No defections. But 2 million have signed up for Part D in addition to the VA benefits they receive. Why can't the VA just be honest. There are plenty of people who double dip...

9. Drugs not on the VA formulary are in fact available.

No one said they are unavailable. That's a VA strawman. Drugs not on the formulary are just hard to get. It takes anywhere from 3 days to a week to get an answer. Often you have to try a drug for a while before you can ask for a change, which means traveling to see a doctor. As a result, even the VA's own numbers show that less than 5-10 percent of its patients get medicines like Lipitor, Ambien or Protonix.

10. Doctors are satisfied with the restrictive formularies.

Fact. Fully a third of all doctors who took the time to respond to a VA run survey complained it took too long to get requests answered. (Provider perceptions of pharmacy management: lessons from the military health system.
Med Care. 2004 Apr;42(4):361-6. )

Another survey (also self-selected respondents) found that 35 percent of doctors believed the national formulary restricted access to important drugs. Glassman PA, Good CB, Kelley ME, Bradley M, Valentino M, Ogden J, Kizer KW. Related Articles, Links
Free Full Text Physician perceptions of a national formulary.
Am J Manag Care. 2001 Mar;7(3):241-51.  Read More & Comment...

Not So Exclusive After All

02/08/2007 10:22 AM |

Here's something I would like the opponents of authorized generics to explain: Why is it ok for generic drug companies to divy up the profits during the exclusivity period after a Para 4 challenge but not for an innovator company to introduce it's own generic version that does the same thing?

To wit from Beth McClean's article about Apopletic's Bernie Sherman in Fortune:

"Because they (meaning the generic firms) had all filed on the same day, they would have had to share the 180-day period - meaning profits would have been slim even during the period of supposed exclusivity."

The high price of drug patents  Read More & Comment...

Lapp Dance

02/08/2007 09:43 AM |

I've been in Helsinki for the past few days attending a conference entitled, "Financing Sustainable Healthcare in Europe." My fear was that it would devolve into a conference on Sustainable Healthcare Financing in Europe. It didn't.

It didn't, even though there was a presentation by the US Veterans Administration on, among other things, their wonderful formulary.

It didn't, even though there were more than a few presentations on both evidence-based medicine and healthcare technology assessment.

It didn't, even though the issue of information-to-patients and the "empowered consumer" were discussed.

And this was in Europe! A good sign that sanity may yet prevail in the land that brought us such wonderful acronyms as NICE and IQWIG.

It might be overly optimistic to say this was the beginning of a continental debate on ways to save the future of health care in Europe in ways other than just saving money.

It might be overly optimistic -- but it's worth hoping for the best. And the best and the brightest were in attendance in Helsinki.

The event was sponsored by SITRA, the Finnish Innovation Fund, Luxembourg's Ministry of Health, and Pfizer. Attendees came from across Europe and included health ministers and senior government advisors (the health ministers of Finland and Poland and a former prime minister of Finland attended and participated) along with leading academics, decision-makers and thought leaders from both "New" and "Old" Europe, and other points on the map (Finland, Sweden, Demmark, Norway, Estonia, the Czech Republic, Greece, Italy, Malta, the Netherlands, Poland, Cyprus, France, the United Kingdom, Slovenia, Bulgaria, Albania, Luxembourg, the Slovak Republic, Latvia, Lithuania, Romania, Portugal, Hungary, Ireland, Germany).

There was also a minyan or more of senior officials from the European Commission and the European Parliament. In fact, the conference was chaired (and expertly so) by Pat Cox, the former President of the European Parliament.

The bonus of having so many high-profile government types in one room at the same time is that they tell memorable stories. The best came from Aho Esko (the former Finnish PM) who recalled the time when the Premier of Iceland said to the Prime Minister of Israel that their two nations were very different -- Israel being the nation chosen by God. Iceland the one frozen by God.

The presentations from the event should be shortly available at http://www.sustainhealthcare.org

The most important take-away was that many of the presentations focused on the theme that "health is wealth" -- and that, as such, health care is a worthwhile investment.

Wither such positive momentum? Time will tell.  Read More & Comment...

Deja Vu on HIV

02/08/2007 09:11 AM |

How is it that every time the debate on treating AIDS pops up (in this case triggered by a military junta in Thailand seeking to deflect criticism of its regime) it is always a re-run of the drug price issue?

Drugs are the smallest part of the cost of treating people with HIV and countries that do not improve their public health systems or increase spending on training, facilities and infrastructure will not get pills to patients. Similarly, countries that rush pills into production will promote drug resistance...

Here's a great article by Hudson Institute's Jerry Norris that makes the case against deja vu on HIV:

http://www.chinapost.com.tw/editorial/detail.asp?onNews=&GRP=i&id=96521  Read More & Comment...