abbott s medical device company

[vark]

www.bostonglobe.com/business/2016/02/01/abbott--medical-test-maker-alere-for-billion/UlDMh4249m28KDlitA0oWO/story.html

maybe this will result in doing more medical device trials down the road. one advantage of device studies is they usually don't have a 30 days washout period. or maybe this will not change at all.

[mike]

This is a conflict of interest, a drug company or device manufacturer conducting trials on their own drug or device? I'm pretty sure the FDA or some other agency has rules against this.

[vark]

It's pretty standard for companies to do their own studies. mostly studies Abbott/ products, WV mostly studies Mylan products; Mylan is the big generic drug co right next door. Lilly used to just study Lilly products. After that girl died they started pharming their studies out to other companies. probably mostly studies products, etc. Some labs like covance specialize in doing contract work for other manufacturers, I don't think Covance makes drugs themselves. But it's not an unlawful conflict of interest. Is it a scientific conflict of interest? Maybe. That's an interesting argument that I could see the class action lawyers using. Say a manufacturer either does its own studies or uses, just as a hypothetical, Covance, and hypothetically Covance covers up bad results by relying on an undercurrent of fear that if you report AE's or rock the boat in any way you can get banned, and then recruits people who are poor and powerless and easily intimidated,and uses a captive IRB that never backs up the subjects, but only does what the company wants, then the class action lawyers might argue the drug maker was negligent or intentional in falsifying study data. It's only billions of dollars that result from when companies rely on these studies to market new drugs. I think Mike has some idea of what he's talking about, although there's no direct FDA rule prohibiting companies from doing their own studies. I don't even know if the FDA requires that studies be scientifically sound.
I definitely get the sense that the companies usually have little interest in the underlying science and are focused on generating the paperwork the FDA wants to see. That's only a sense; the companies don't share their results with me or include me in their higher-level discussions about study design.

[mike]

Well your experience is very different from mine, I can't ever recall doing a study where the product being tested was being made by the same company or a subsidiary of the testing clinic. But I'm sure you're right, as we all know the oversight and regulation of these medical and pharmaceutical companies is very loose, owing to the influence of their billions of dollars and lobbyists. And I did not think that there was an actual criminal or civil conflict, which is why I said "rules" and not "laws". But as you say, if it did come down to an actual trial involving someone who got hurt or died, it would be a sticky wicket for them.

But then of course, how often does this happen? It's probably worth it for them to just do what they want as it would be very rare that they pay any price for it.

[mike]

And I agree with your "sense", in fact I would say with many studies it is more than a sense, it is pretty clear that the study is pretty much just a hoop that the company must jump through before they can start making big duckets off their product.