3 ms·

Thalidomide was also banned in the US "because rules". Common sense in medicine prioritizes doing no harm. I can provide other notable examples if need be. Th

by apathy 10y ago

Thalidomide was also banned in the US "because rules". Common sense in medicine prioritizes doing no harm. I can provide other notable examples if need be. The bottom line is that all parties need to be confident that the expected benefit of a test or procedure outweighs any expected potential harms. Having multiple layers or peer review is one way to ensure this. I work on clinical trials of "black label" (potentially lethal) agents in patients that typically have no other options. Our pages can be 70-100 pages and we are doing this in our "spare" time (Ha! Ha!). I don't think it's unreasonable for a massively capitalized private company to produce documentation at least up to this standard. It really isn't much to ask, especially for an existential venture like this (something -- anything! -- trustworthy to recover the tremendous amount of credibility they've lost.) Other companies had no problem writing a suitable protocol. Why should peoples' safety be compromised just so that an untrustworthy company can enter the market?

JoeAltmaier 10y ago
We're talking a finger stick here. And a devastating illness that is poised to become a worldwide epidemic.
- apathy 10y ago
  For which other diagnostics exist from companies that somehow managed to submit a proper protocol. Unlike Zika tests, it is extremely rare for patients in the trials I design to have any alternatives. Also unlike Zika, the standard of care in the diseases I work on yields less than 25% 5-year survival. Not birth defects (horrific though they may be) but death from organ failure and infection. Nearly all of the compounds are known or potential teratogens. No alternative sources for most of the drugs. Still need an IRB. You say, "oh it's just a finger stick!" To which I must say, have you looked at the number of physicians and nurses who got Hep C or HIV from an errant finger stick in the hospital?!
  - JoeAltmaier 10y ago
    And I come back again with "Mothers and babies and a worldwide epidemic"

by apathy 10y ago

JoeAltmaier 10y ago

We're talking a finger stick here. And a devastating illness that is poised to become a worldwide epidemic.

apathy 10y ago
For which other diagnostics exist from companies that somehow managed to submit a proper protocol. Unlike Zika tests, it is extremely rare for patients in the trials I design to have any alternatives. Also unlike Zika, the standard of care in the diseases I work on yields less than 25% 5-year survival. Not birth defects (horrific though they may be) but death from organ failure and infection. Nearly all of the compounds are known or potential teratogens. No alternative sources for most of the drugs. Still need an IRB. You say, "oh it's just a finger stick!" To which I must say, have you looked at the number of physicians and nurses who got Hep C or HIV from an errant finger stick in the hospital?!
- JoeAltmaier 10y ago
  And I come back again with "Mothers and babies and a worldwide epidemic"