3 ms·

I agree that one month is very short to prevent an attack. However, cardiologist De Jong for example showed that a second attack is less likely than you might

I agree that one month is very short to prevent an attack. However, cardiologist De Jong for example showed that a second attack is less likely than you might expect. The severity of the situation leads to significant life changes in regularity of medicine use and healthy eating habits. This guy did not get his wake-up call from Theranos so now he had to get it from mother nature. It must be seen if he had a right on getting the proper information or if he could expect that by using a company with experimental methods he should have taken into account that the results would not be up to par. It also has to be establish how many false negatives a company is allowed to produce.

HeyLaughingBoy 10y ago
if he could expect that by using a company with experimental methods he should have taken into account that the results would not be up to par No! Instruments that have not been validated are allowed to produce results, but those results have to be verified against a validated instrument. An instrument that has been validated is expected to be correct. It doesn't get excused when it's wrong. It's not like a new treatment for a disease that has no other treatment available. Now, instruments will sometimes produce bad results. It happens; nothing's perfect. However, the instrument itself is expected to check its own results as much as it can, and alert if something might be amiss. Also, the lab's (daily/multiple times a day) Quality Control checks will usually catch a misbehaving instrument. When QC fails and it's not the lab's fault, the lab will inform the manufacturer. It's not something they take lightly. By FDA mandate, every manufacturer of a medical device has to respond to Complaints so it will be acted upon. Quickly! Instruments can be recalled for evidence indicating that they might produce a bad result, even if it's never actually happened.
- MrQuincle 10y ago
  From the http://theranos.com/test-menu http://theranos.com/test-menu only HSV1 has been cleared by the FDA. They could do this through a regulatory loophole of "laboratory developed tests". This loophole has also been used by Strand Life Sciences and Pathway Genomics and Admera Health according to a www.theverge.com article.
  - HeyLaughingBoy 10y ago
    That's a good point. I wasn't thinking of lab developed tests. I'm aware of them, but not of the specifics that the FDA expects in terms of safety & efficacy.

HeyLaughingBoy 10y ago

if he could expect that by using a company with experimental methods he should have taken into account that the results would not be up to par No! Instruments that have not been validated are allowed to produce results, but those results have to be verified against a validated instrument. An instrument that has been validated is expected to be correct. It doesn't get excused when it's wrong. It's not like a new treatment for a disease that has no other treatment available. Now, instruments will sometimes produce bad results. It happens; nothing's perfect. However, the instrument itself is expected to check its own results as much as it can, and alert if something might be amiss. Also, the lab's (daily/multiple times a day) Quality Control checks will usually catch a misbehaving instrument. When QC fails and it's not the lab's fault, the lab will inform the manufacturer. It's not something they take lightly. By FDA mandate, every manufacturer of a medical device has to respond to Complaints so it will be acted upon. Quickly! Instruments can be recalled for evidence indicating that they might produce a bad result, even if it's never actually happened.

MrQuincle 10y ago
From the http://theranos.com/test-menu http://theranos.com/test-menu only HSV1 has been cleared by the FDA. They could do this through a regulatory loophole of "laboratory developed tests". This loophole has also been used by Strand Life Sciences and Pathway Genomics and Admera Health according to a www.theverge.com article.
- HeyLaughingBoy 10y ago
  That's a good point. I wasn't thinking of lab developed tests. I'm aware of them, but not of the specifics that the FDA expects in terms of safety & efficacy.