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I HATE the VA ---- What do you all think about this

I HATE the VA ---- What do you all think about this

I got this letter today from the VA and feel they have violated several laws and really ticked me off.
The letter is posted below in part:

Dear Veteran XXXXXX,

The SPRINT trial is a research study that will be looking for veterans who have high blood pressure at the Nashville VA and other Veterans Affairs Medical Centers in the United States.

We are looking for veterans who are concerned about their blood pressure and how low it should be. The research will be comparing normal blood pressure control with more intensified blood pressure control.  Yada yada about why high blood pressure should be controlled

Veterans that decide to join the trial will be randomized ( like a flip of the coin). because of this, some veterans will get intensified control while others will get normal blood pressure control. This research trial will work together with your primary doctor and provide you with better blood pressure control through exams, testing, and medications.

If you join the trial you will be asked to:
    Meet monthly ( the first 3 months) with the SPRINT medical team to manage your blood pressure.
   Come to the SPRINT clinic every 3 months for 4 - 6 years.

These visits will include:
   Blood pressure medications
   Physical exams
   Lab tests
   Memory tests
   EKGs

You will be in the trial for 4 - 6 years. The cost of the trial visits and trail blood pressure medications will be paid for by the trail. There is no cost to you.

To be part of the trail you must:
  Be at least 55
  Have high blood pressure with a systolic ( upper ) number of at least 130
  Have no history of diabetes or stroke
  We will ask you about other health conditions over the phone and at the clinic.

We think you would be a good person to participate. We may come see you at your next clinic visit to the Nashville VA. We want to talk to you about this trial. Contact us if you have any questions. We WILL CONTACT you unless you tell us not to do so. if you DO NOT want to participate call us at XXXXXXXXX

End if letter

The problems I have with this is that the VA has shared some of my medical information with people I have not authorized ( HIPPA ) and that the way this reads is that I am enrolled in this trial without my INFORMED CONSENT as they say I have to call them to not participate.


So what do you people think?

Dennis


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8 Comments Post a Comment
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1658667_tn?1310094982
Did the letter come from a private drug company or the VA? That could make a difference in my opinion. Also, I know my son said as a service member, he is basically "property" of the US government (as he explained it to me). Does this hold true when you are out? You may have signed something (fine print) in a pile of paperwork somewhere that allowed for this to happen. I would check with your VA rep.

I can imagine how you must feel violated. So sorry about that.
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645800_tn?1331502455
The letter came from the VA in Nashville. And no the Government does not own me since I left the Navy.  And even when you are in the service they are still required to keep your medical records private and allow you informed consent.

I have never signed any forms with the VA (other than financial records for eligibility and when having surgery for informed consent to the surgery).

The letter was signed by an MD ( assistant professor of internal medicine and pediatrics, institute of medicine and public health, Vanderbilt University, Staff physician Nashville VA medical center).

And

XXXX BSc ( clinical trials specialist, Nashville VA medical Center)  

Neither of these people should have access to my medical records.

The way this should have worked is for them to contact the Primary Care clinics at the VA and have the doctor check with their patients that have high blood pressure to see if they might be willing to take part in the trial. Then the patient can decide to release their record to the people doing the trial so see if they qualified.

Dennis


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572651_tn?1333939396
Dennis, I understand your point completely.  I imagine there is some HIPPA loophole they have slid through with this one.  Probably all people at the VA have legal right to access your records?  Or the clinic doctors were asked to make referrals?

It doesn't matter, it does seem very out of place that they would have your information and you don't know them.

Lulu
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Avatar_f_tn
Being the widow of a disabled vet (and still have a military ID) , I'd be willing to bet they didn't share any information with anyone but are guaging your interest. Do you remember the hellstorm when those computers disappeared? They would never get away with sharing your info with an outside source. That being said, it would appear that the doc who signed the letter is not considered an "outside source" since he is a VA staff physician.

The doc who signed the letter being a staff doc at the VA, so he could legally access your medical records. Kind of like someone I know who sees a dr at Cleveland Clinic. With a stroke of a key, another doctor can access this person's records. Sounds like he's soliciting for the trial..conflict of interest, maybe?
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987762_tn?1331031553
I'm reading this differently, the only specific medical information is that your a VA patient, it looks to me like the thousands i've received regarding research into Autism. They are generated form letters from their data base, mass produced and they infer more meaning than they actually have.

In the past it was just the letter and people needed to contact to be a part of the research but the participation rate is much much lower than if they also contact and engage the posible participants in the importance of the study. You are never inrolled automatically, its just the way its worded is a bit obscure, you have a right to ask how they got your name etc. But i think you'll find its a purchased data base from the hospital, data bases are worth money, there are ethics involved and medical data bases are usually only medical research or the like.

You could call but if you do nothing they will contact you to see if they can get you involved, its highly possible that they dont even know if you qualify for their project or not. A few years ago I had a reseach group wanting me to put my son into a first faze drug study, you should of heard what i thought of using my child under 10 as a drug guine pig lol

Cheers............JJ

  
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1312898_tn?1314571733
I think they are sending out letters hoping to find subjects for their study.  I mean sort of randomly 'throwing' letters all over hoping to catch a few.  

shoddy practice at best.  

I don't blame you for being upset.
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1045086_tn?1332130022
Dennis, I understand why this makes you uncomfortable but I think your rights are probably intact.

I doubt they want you enrolled in this study if you aren't interested in participating. . Participant compliance is essential if they want to gather meaningful results that translate into reproducible treatment outcomes for the future.

It sounds to me like they plan to explain details and ask about other health conditions (that might be disqualifiers) by phone or during a clinic visit unless you tell them NOW that you already know you are NOT interested in hearing any more about this.  It does mention what will happen and what will be expected of "Veterans that decide to join the trial".

I know there have been abuses of military personnel in the past involving medical research that the individuals were never informed of let alone consented to.  I really don't think this is anything more than data was released indicating the names and contact information for veterans who are in data banks as having received treatment for hypertension.  I'm betting the researchers don't even know the particular of how long, how high, or how treated your hypertension is.

As far as the legal rights guaranteed by HIPAA……

HIPAA (the Health Insurance Portability and Accountability Act) regulates the release of personal health information (PHI).  It does NOT guarantee information will never be revealed without specific consent.  Privacy policies where you receive care explain what types of information that institution will share and the conditions under which information will be released.

PHI with a high degree of sensitivity and potential for damage (things like HIV status, drug/alcohol treatment, some blood diseases, and psychiatric care) are generally given a higher privacy priority.  Inflammatory information usually has NO provision for release.  This is specifically mentioned in the privacy policy of many providers who regularly treat people with those conditions.

Veterans retain rights but there are sometimes special provisions, especially concerning other government agencies.  The SPRINT trial is a huge research project of the NIH (National Institutes of Health) of the US Department of Health and Human Services so it qualifies there.

According to the VHA (Veterans Health Administration) handbook, "VHA records may be used for VA-approved research purposes as authorized by law."   Since the government likely employs enough lawyers to ensure compliance, I'm sure necessary requirements were met and proper Data Use Forms were filed before information was released.  


There are some basics.

For more about the SPRINT study go here
http://www.nih.gov/news/health/oct2009/nhlbi-29.htm

For details of the VHA privacy and release of information procedures go here
http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1423


I realize none of this is likely to make you feel better about the whole situation but I hope it can keep your BP from getting any higher :{    It's clear to me that you can call that number, tell whoever answers not to contact you and have no worry of suffering consequences.

Mary
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1045086_tn?1332130022
FWIW, the fact that a doctor (or anyone else) has physical or computer access to every chart in a hospital's system does NOT mean he has the right to access any of them.  Health care workers are entitled to access ONLY personal health information which is required to properly treat patients who contract with them or are referred for care.  

I believe what you are describing would be a clear violation of both legal and ethical standards.

Mary
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