Thursday, June 4, 2015

Welcome back

Seven years away is way too long.





Janet was a one-woman Motown Records if you think about it.

With Jam and Lewis, she kept the country dancing for decades.

And she's bringing gifted back. 

She's the real deal.

My top three favorite Janet tracks are:

1) "All Right With You"

2) "Miss You Much"

3) "Throb"



Going out with C.I.'s "Iraq snapshot:"

 
Wednesday, June 3, 2015. Chaos and violence continue, Antony Blinken provides a number and creates controversy, Marie Harf refuses to provide numbers and skirts an issue, David Petraeus notes the need for a political solution, the VA doesn't trust the FDA, and much more.


 This afternoon, the Senate Veterans Affairs Committee held a hearing on proposed legislation.  The first panel was made up of the VHA's Dr. Thomas Lynch, Dr. Maureen McCarthy and Susan Blauert.  The second panel was made up of Disabled American Veterans' Adrian Atizado, Medicalodges, Inc's Fred Benjamin, Fleet Reserve Association's Thomas J. Snee and retired SFC Victor Medina.


Senator Patty Murray: To this panel, Dr. Lynch, I wanted to ask you about the Women Veterans Access To Quality Care Act.  I was really pleased to work with Senator [Dean] Heller on this legislation.  As I'm sure you all know the population of women veterans is increasing dramatically.  It's actually doubled since 2001.  This bill will require all VA medical centers to have at least one full time OB-GYN.  And I want to ask you today, how long will it take to meet that standard?  And does the Department usually struggle to recruit OB-GYNs?

Dr. Thomas Lynch: Right now, VA has GYN specialists in 78% of our VA facilities -- about 118.   There are plans to add additional GYN providers, uh, by directive to, I think around 20 more facilities, as part of our operative complexity model.  Uh, the VA has a model of operative complexity that looks at a certain infrastructure required to support surgical services at facilities.  Uh, the mandate would be that all of our complex and intermediate facilities would have a GYN provider.


Senator Patty Murray:  Sure.

Dr. Thomas Lynch:  Some of the smaller facilities -- and, unfortunately, Senator, I don't have the exact count for you --  would have difficult supporting a full time GYN provider and, in some of those case, care is provided through community contract. So I think --

Senator Patty Murray:  So if you do not have an OB-GYN, you do contract out to a community OB-GYN?

Dr. Thomas Lynch:  The expectation would be yes, that we would provide those services in the community if we could not provide them at the VA. 


Senator Patty Murray:  So you can meet the needs of this bill?
Dr. Thomas Lynch: Dr. McCarthy, would you like to?

Dr. Maureen McCarthy:  I-I believe that we could meet the intent.  Uh, which is to do what Dr. Lynch said which is based on the surgical complexity, that there would be a plan to hire for all the facilities, that there would be a certain level of complexity and hire.  But for the facilities, the smaller facilities, there is the expectation that there would be access to care either in the community by contract or by having someone actually come into the facility.

Senator Patty Murray:  Do you have a timeline on how long that would take? 

Dr. Maureen McCarthy:  No, ma'am, I don't.  Some of our facilities are in areas where it may be a challenge to recruit and so I couldn't give you an absolute timeline, I'm sorry. 

Senator Patty Murray:  Okay.  Well if you can give me an estimate, I'd really appreciate it.

Dr. Maureen McCarthy:  Would you be okay if I took that for the record?

Senator Patty Murray:  Yes, you may do it for the record.

Dr. Maureen McCarthy:  Okay.


The VA keeps saying it's aware of the explosion in the number of women veterans but every time they appear before Congress they're offering statements that say otherwise.

At the very least, Lynch should be able to say, "We will have a full time OB-GYN at every VA medical facility who have a need for one or we will have a contract with a private practice provider."

There's a lot of hedging and, honestly, I was bothered that Lynch can't refer to the doctors as OB-GYN and instead goes with GYN.

It's obstetrics and gynaecology -- if you divide it up, you're dividing up what's being practiced.

Just the use of GYN only made me wonder what Lynch sees the practice as.



Murray's long been the leading advocate on women veterans issues as well as on the issue of family planning (highlighting the needs for the VA to cover in vitro fertilization, for example).  Senator Richard Blumenthal is the Ranking Member of the Committee and his addition has allowed one more voice who consistently raises issues that effect women veterans.  Murray is the former Chair of the Committee.  With Republicans in control of the Senate, the Chair is now Johnny Isakson.



Senator Patty Murray: Dr. Lynch, one provision of the Homeless Veterans Prevention Act would allow the grant per diem program to provide payments for dependents who are accompanying homeless veterans.  This is an important change to consider as the number of veterans with dependents -- especially women -- is rising.  Now VA has stated that they support the intent of this part of the legislation but it raised concerns about the need for additional resources to meet the needs of the veterans that would be served.  If this unmet need is still there, why did the VA ask for cuts in the grant per diem program in the budget request?

Dr. Thomas Lynch:  Senator, I'd have to get back to you with the specifics on that. I can't answer it.  I know that we certainly do support the Homeless Veterans Prevention Act.  Uh, we do support, uh, the increase in per diem for veterans participating in the grant per diem program and the transition in place.  Uh, I can't comment specifically on the budget issues that you're speaking to right now.

Senator Patty Murray:  Okay, if you can get an answer back to me?  That's really an important question.

Dr. Thomas Lynch:  We will do that.

Senator Patty Murray:  And finally, Dr. Lynch, it's really essential that we make sure our veterans have seamless transition from DoD to VA's healthcare systems.  But there are still a lot of barriers out there for our service members and veterans.  And one frequent problem for new veterans is having to switch medications when they leave the military and come into the VA because the departments don't carry the same medications.  What are the differences in how the VA and DoD decide which medications to carry?

[Lynch and McCarthy off mike speaking to each other]

Dr. Maureen McCarthy: Senator Murray, the VA formulary is one that is based on published evidence of drug safety and effectiveness.  So there is a process of consideration once a drug is approved by the Food and Drug Administration of whether or not it be included in the pharmacy.  The DoD formulary is one that's statutory -- that anything approved by the FDA is part of the DoD formulary. So the VA formulary is one that has a, uh, a second level review, uhm, for evidence based -- evidence base, efficacy, safety and so forth.  Our formulary process has been reviewed by Inspector General, oh, multiple-multiple Institute of Medicine, multiple people.  And what they say is our-our forumlary is actually a model for the federal government.

Senator Patty Murray: So how come the DoD hasn't done that?  You're probably the wrong people to ask, but you're here.

Dr. Maureen McCarthy: You're probably exactly right about that.  We, uh, we-we feel very strongly that we want to work with DoD and we want to ease those transitions very much but I don't know that the answer is to have exactly the same formulary given that theirs is this statutory formulary by regulation -- then it's everything that's approved.  Uh, for us, it, uhm, it makes sense.  I believe Senator Blumenthal proposed legislation talks about, uhm, the, uhm, medications related to pyschiatric conditions as well as pain.  And I think that's an important place to start.  And in particular his legislation talks about systemic drugs not topical meds which have-have caused some problems in the past.  So systemi- oral meds that we prescribe for psychiatric conditions and pain would be uh-uh a very, uh, important place to start for blending. 

Dr. Thomas Lynch: If I could, Senator, I would just repeat from my opening statement: Right now 90% of mental health medications and 96% of pain medications dispensed by DoD are also on the VA formulary.  And we also mentioned that there was a specific, uh, directive sent to the field, uh, that veterans will be maintained on their discharge medications from the military, uh, when they transfer to the VA if that is clinically approriate.  I would add that qualification.  But we would not take veterans off of medications that they had been receiving from the military if it was felt to be appropriate to continue those medications. 

Senator Patty Murray:  Okay.

Dr. Thomas Lynch:  I realize there are still -- as you will probably hear in the second panel -- there are still areas where we have failed.  We can do better and we need to do better to make sure that that transition occurs. 

Senator Patty Murray:  Okay, we want to make sure there are no barriers but we also want to make sure people are taking the right medications.  I understand the balance.  But we need -- some attention really needs to be focused on this. 

Chair Johnny Isakson:  I thank Senator Murray for raising that question.  And I'll just make an observation.  I'm not a pharmicist or a physician but it doesn't make a lot of sense to me for the formularies to be different from DoD and the Veterans Administration.  And I know Senator [John] McCain is working on that same issue and we've expressed our desire to see if we can't get that worked out, so I appreciate your focus on that issue today.



 That exchange bothered me first and foremost because of the problem it's creating for veterans -- we'll go more into that in a moment.

But I'm also bothered by the notion that the FDA isn't doing its job.

That's what the VA is arguing.

The FDA is tasked with a responsibility and DoD doesn't question it.

But the VA thinks its their role to do so?

The FDA is tasked with determining what is safe for the American public.

But the VA doesn't accept the FDA's verdict.


From the FDA's website:

What does FDA regulate?

The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction; however, this is not an exhaustive list.
In general, FDA regulates:
Foods, including:
  • dietary supplements
  • bottled water
  • food additives
  • infant formulas
  • other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some meat, poultry, and egg products)
Drugs, including:
  • prescription drugs (both brand-name and generic)
  • non-prescription (over-the-counter) drugs
Biologics, including:
  • vaccines
  • blood and blood products
  • cellular and gene therapy products
  • tissue and tissue products
  • allergenics
Medical Devices, including:

  • simple items like tongue depressors and bedpans
  • complex technologies such as heart pacemakers
  • dental devices
  • surgical implants and prosthetics


Those are only some of the duties they're tasked with.

And in February, they made their budget request for 2016 which was $4.9 billion dollars.

Why is the VA 'double dipping' the American tax payer?

It's role is not to determine which drugs are available to Americans.

That's the FDA's role.

But after the FDA rules, the VA then starts its on process (DoD does not).

This is pretty clear cut and I'm disappointed that the Committee didn't see it that way or didn't express it if they did.

The FDA is doing its job.  When it rules, that's it.  That's the ruling the government has made.  The VA should not be wasting time or money testing drugs or trying to determine their safety -- the FDA has already done that.


It is a waste of tax payer money and it is a waste of time -- and the VA has too much of a backlog to be wasting any time on a function that is unneeded.

If they're allowed to continue with this process, it needs to be recognized that they are undermining the FDA.

This is government waste and abuse.

And, again, it does a huge disservice to those transitioning from DoD to VA.


Ranking Member Richard Blumenthal:  I just want to ask you, Dr. Lynch, very quickly about the formulary issue.  I don't know whether you've had a chance to read Mr. Medina's written testimony telling of his struggle to obtain medication that his doctor previously found to work well for him, for him to manage injuries from his Traumatic Brain Injury?  It's a very powerful and compelling story.  And I understand that after learning of Mr. Medina's attempt to testify today the VA reached out to him, offering to cover the medication that was originally prescribed by DoD but, in effect, denied by the VA.  And I'm very pleased and thankful that VA seems to be taking action to remedy the problems of a prior policy.  And my feeling is that the VA -- or perhaps more directly -- veterans treatment options should not be determined by whether or not they have an opportunity to speak in front of Congress.  Earlier this year, the VA issued a directive meant to prevent transitioning soldiers like Mr. Medina from having to stop treatment that's proven effective simply because it isn't in the VA's formulary.  I welcome that directive or policy change. And can you discuss whether you've seen any other improvements -- obviously, Mr. Medina's situation has improved -- since the implementation of this policy?

Dr. Thomas Lynch:  The only reference I would have, Senator, is that when we did look at a series of 2000 veterans, we saw a small percentage did have a problem as they related to the VA-DoD formulary issue.  We've been very aggressive in getting communications to the field  Uh, VA feels strongly that there needs to be an appropriate transfer of medications.  The single qualification would be that there is a certain clinical judgment that has to occur at the time of transfer and there may be some changes under those circumstances but otherwise  I think it's important as the veteran transitions that we do not change medications if clinically appropriate.

Ranking Member Richard Blumenthal:  And that the approach be, in effect, evidence based and that it be consistent with patient safety?

Dr. Thomas Lynch: That-that has been the VA's approach to our pharmacy as we have -- to our formulary as we have developed the forumlary.  It has been evidence based. It has been focused on patient safety. Uh, it has used the best available information to determine what drugs to place on that formulary -- absolutely


We'll note SFC Victor Medina's opening remarks in full:

I proudly served in the United States Army from 1994 to 2012. I have three combat tours: two in support of Operation Iraqi Freedom and one in support Operation Enduring Freedom. On June 29th , 2009 I was wounded while on patrol in Iraq when an Explosive Formed Projectile struck my vehicle. I received the Purple Heart for injuries sustained during this event. I sustained a moderate Traumatic Brain Injury, which affected me both, physically and cognitively. According to my healthcare providers, the effect s of my injuries are expected to worsen over time, and in fact they have. Since 2009, I received approximately 2 years of rehabilitation. Since the beginning of my injury, I was prescribed different medications to attempt to lessen the effects of the cognitive disorder and pain. After several attempts, doctors were able to find the correct medication to lessen the effects of the newly acquired cognitive disorder and pain . To address the cognitive disorders I was finally prescribed Vyvanse, which was a medication that caused no secondary effects, and helped me find a new normalcy. After 3 years with a medication that was working very well, I was forced to changed medications to a less effective formula. Why? Unfortunately, the original medication that was working tremendously with no secondary effects and included in the DoD formulary is not included in the VA limited formulary. This situation forced me to return to a medication that was already discontinued from my care due to the experienced adverse side effects. My healthcare services are provided by El Paso VA Health Center. Particular to my health care facility in El Paso, Texas is that both, the DoD pharmacy and the VA Pharmacy are co-located, they are in the same building. While Vyvanse physically exists in the building, I cannot receive it because the VA does not carry it in its formulary. That means that while I could be receiving the medication with no side effects, I have to settle for a medication that it has been no good to me, only because of a limitation in the VA formulary. In my case the medication, Vyvanse, is intended to help with attention and concentration. This medication was vital in my successful completion of graduate studies and in becoming a Certified Rehabilitation Counselor. So, I am not the case of one a Veteran with a tantrum because of not being able to receive one random medication. I am the case of one Veteran that wants to succeed in life, by having the playing field leveled. My past medication leveled my playing field. Today, I do not come to you as one isolated Veteran . I come to you as the voice of many. I support this bill. It is a bill that is economically sound. This bill may result in the better utilization and allocation of resources, which in turn may reflect in an increased quality of services provided to Veterans. I have come across Veterans with situations similar to mine. These Veterans ask me to be their voice here today. The following Veterans had similar stories to mine; they authorized me to mention their name here today : Fernando Esquivel from Texas, Mike Barbour from Illinois, Zen Cypher from Texas, and, DeWayne Mayer from Ohio. This afternoon, I am saddened as I ask myself: how many Veteran suicides have been related to medications change for the lack of uniformed formularies? We may never know the answer. I only know one thing: I wish I could go back to the medication that worked well and not live for 2 years with daily adverse secondary effects of a medication given to me, solely because it is the only available option to me. Thank you.



Again, the VA's policy is unneeded.  Either America tasks the FDA with the role it has or it doesn't.  VA needs to stick to its role and if a drug is approved by the FDA then that's the end of the discussion.

It's harming veterans and it's wasting money.

On the topic of wasted money, let's go to today's State Dept press briefing moderated by spokesperson Marie Harf.


QUESTION: So can you – on Iraq, can you read out how much the State Department has given Iraq since 2011 in foreign military sales and what kind of military equipment is slated to be delivered in the future?


MS HARF: I’m happy to get you a full list after the briefing.


QUESTION: And given all the weaponry and equipment squandered by the Iraqi forces in the fight against ISIL, do you think giving more will help?


MS HARF: Well, I’d make a few points. First, I don’t agree with your assertion that the Iraqi military is not using what we’re giving them to push back on ISIL. In fact, they are. The Iraqi Armed Forces, including the Kurdish forces, are using the assistance we’re giving them, and we’re going to keep giving them more, because they need that assistance to take on ISIL. They need the kinds of weapons we can provide. They need the kinds of anti-tank weapon systems, as we talked about yesterday, that we can provide.
So one of the major parts of our strategy here is building up the Iraqi forces so they can increasingly take the fight to ISIL. So that’s a key – really a key pillar of what we’re doing.

QUESTION: And then one --


QUESTION: But isn’t it also the case that ISIL/ISIS/Daesh is using the stuff that – the American stuff that they captured or took from --


MS HARF: In some cases, yes.


QUESTION: -- to really take it to the Iraqis and the Kurds, the forces that are fighting them?


MS HARF: Well, they’re certainly using some things they have recovered during battle --


QUESTION: Some? I mean, are we talking about thousands of Humvees, right? Is that --


MS HARF: I don’t have the exact numbers in front of me.


QUESTION: Right.


MS HARF: But in general --


QUESTION: But it’s a lot.


MS HARF: It’s – I can get the exact numbers for you or see if DOD has them. They’re probably the better place to go. But in general, that doesn’t mean we shouldn’t continue to help the Iraqis get better, to help their forces improve, and to give them the kinds of assistance they need.


QUESTION: You say that’s not a dilemma at all for the U.S.? There’s no --


MS HARF: We believe that it’s important to continue assisting the Iraqis here.

Mm-hmm.



Marie Harf couldn't supply numbers.  The State Dept's Anthony Blinken did.  He announced that, in Iraq and Syria, 10,000 Islamic State fighters have been killed.  Jim Miklaszewski, Robert Windrem and Jon Schuppe (NBC News -- link is test and video) report:

 The 10,000 cited by Blinken was a classified estimate that the Department of Defense and the military did not intend to release. It was not clear why he decided to announce it on Wednesday.
Defense officials told NBC News that the "estimated of the number killed is correct but was not intended for release."
NBC News has been told the number is accurate only in the context of the much broader operations carried out by other ISIS opponents. That includes the Kurds, Shiite militias being armed and advised by Iran, Iraqi forces and Syrian forces.

Laith Alkhouri, of security consulting firm and NBC News partner Flashpoint Intelligence, said he didn't believe Blinken's number. The U.S. government hasn't shared any underlying evidence, such as incremental reports of ISIS deaths, to back it up, he said. 


On the topic of death, Margaret Griffis (Antiwar.com) counts 70 violent deaths across Iraq.



Lastly:

This is a moment, I think, when you sit back and say, 'What do we need to do in the military arena? What also do we need to do in the political arena?'

That's David Petraeus, retired US military general and former CIA director, speaking to Charlie Rose in an interview that CBS News is using on various platforms (more of the interview will play Thursday morning on CBS This Morning.



"What we need to do is focus not just on the military," Petraeus said. ["]You can't kill or capture your way out of an industrial strength insurgency like this, Charlie -- really, an industrial strength conventional force, because that's what ISIL has actually come to be. You need to have the political component, and without that, without that, you're not going to solve the problem."
Asked if the U.S.-led coalition is winning or losing against ISIS right now, Petraeus responded, "These are fights where if you're not winning, you're probably losing, because time is not on your side."



June 19th, US President Barack Obama told the world that the only solution to Iraq's crises was a political solution.  15 days away from the one year anniversary mark of that statement, he has nothing to point to that indicates a political solution.







antiwar.com



No comments: