Pharmaceutical/FDA/CDC/CBER

[Teufelhunden]

Lets say, hypothetically, you were diagnosed with chronic hepatitis c in 2003. In 2009 you find out that your hepatitis was caused by an intramuscular immune gamma globulin you received in 1995. You also find out that the FDA ordered all the pharmaceutical companies to test all lots of IGG in 1996 because of hepatitis c contamination and this particular company who manufactured the IGG that you received,  choose to withdraw all their IGG's off the market instead of testing them. You also find out that the lot number of the IGG that you were given in 1995 tested positive by CBER  for hepatitis c in 1996. You also discover 18 other lot numbers that tested positive for HCV. I'm not sure how many injections there are in a lot but you figure in the1,000's. Multiply by 18.  Makes you wonder how many are out there with HCV and don't know it. The intramuscular immune gamma globulin (IGIM) was given to the military, it was given to children, it was given to civilians, whenever there might have been a possibility of a outbreak of hepatitis A and also when people were deficient in their immune system.  The kicker is, because you found out in 2003 that you had hepatitis c, and because you found out in 2009 who and what caused it and why, there is no legal recourse you can take.  Your statute of limitation or repose has run.     I guess those of us infected with hepatitis c also have a statute of limitation imposed on our lives.  The jokes on us.
Teufelhunden

[annieCinMD]

I think it's scary the number of people who are infected and don't know it. Sometimes I wish I never asked for the test and had gone on not knowing sparing me the burden of having to make a decision to keep quiet about it or tell people I have it (I have chosen both options, depending on the situation), or if it's a potential sex partner, having to tell them, no option on this one.

[smaug48]

This is from UC San Fran's HIV site (hivinsite.ucsf.edu/InSite?page=kb-07-02-09#S2X)

In 1995, the risk in the United States of HIV-1 transmission per unit transfused was estimated to be between 1 in 450,000 and 1 in 660,000.(23,24) By 2003, this estimated risk had decreased to between 1 in 1.4 million and 1 in 1.8 million units.(25,26)

HIV antibody tests fail to identify HIV-infected blood donated by HIV-infected persons who have not yet seroconverted. Exclusion of donors is voluntary. Interviews with HIV antibody-positive donors reveal that most recognize their risk but fail to exclude themselves.(27) As a result, laboratory efforts to eliminate HIV-infected donors have continued and testing has improved.

Currently, HIV antibody tests detect both HIV-1 and HIV-2 and detect antibody approximately 22 days (the "window period") after the viremic phase of HIV infection begins. Antigen testing for p24, mandated by the U.S. Food and Drug Administration (FDA) in 1996, shortened the window period to approximately 16 days. The nucleic acid amplification test (NAT), which detects HIV-1 RNA in minipools (16-24 donation samples/pool), was introduced in the United States in 1999 and further reduces the window period of potential HIV transmission to 11 days.(25,26)

As of early 2003, three transfusion recipients are known to have become HIV infected by transfusion of HIV antibody-negative, p24 antigen-negative, and HIV NAT-negative blood from two different blood donors (among 25 million donations).(28)

[jdwithhcv]

Elaine, you are so right.  There should be 0 chance by now, but how can we ever trust the blood supply?  I had to have transfusion during tx, and I faced the same dilemma.  What can we do?

jd

[Teufelhunden]

You know, alot of folks beat themselves up because they have HCV. Me for one. I've rant and raved (to myself), did the guilt thing for awhile, felt ashamed, would always tell people I was going through chemo, never mentioned the  H word. After all, look what was linked to it!  Drug use, sex, sharing needles, cocaine, and on and on and on.  But you'd never hear stuff like intravenous gamma globulin, albumin, FactorIX, Creutzfeldt Jacob disease, intramuscular gamma globulin, Rhogam, Gammagard, Gammar, Gamulin, Armour Pharmaceutical, Baxter, Centeon, Alpha Therapeutic, the Canadian Red Cross, the American Red Cross, the bureaucratic bull s**t that our own government agencies throw out that is suppose to make us feel safe. No, I think alot of us would be pretty shocked to find out exactly how we ended up with it. For now on I'm telling people I was infected with Hepatitis c from a contaminated inoculation that my government ordered and knew it was contaminated, and later tried to downplay the severity of it. Might as well tell it like it is. After all, they can't kill me twice. Teuf  

[Marcia2202]

The joke is definitely on us, as with many other diseases. Unfortunately...

The problem with it that in many countries you have to pay for treatment yourself, so it really sukks that you can't do anything about it legally. Where I am, I am getting treatment free, so it would be irrelevant.

Did you ever hear of the 100 woman in Ireland who received Rhogam from the same batch after giving birth? They all ended up with hep c.

Makes you think, I received Rhogam 6 times until 1991 (that is before they could screen the blood for it) If I hadn't done any drugging right after highschool, I would be almost sure to have gotten it that way.