Thursday, September 29, 2005

Guidant is off-course

J & J, Take Me Away!

Guidant has been maufacturing cardiac resynchronization therapy (CRT) units, that stimulate different parts of the heart independently. Recently, they have recalled tens of thousands of units due to short-circuiting problems. See this article for some background. Of course, Guidant isn't new to safety fraud...

Seeding trials?

I don't know much about clinical trials for devices, and how much they differ from drug trials, but in one respect, there seems to be a striking similarity. This New York Times article describes a that Guidant allegedly practiced, using an "evaluation" trial as a method to spur sales. This is right out of the pharmaceutical playbook of old. The company paid physicians to fill out a survey about the devices, $1000 for five forms. Chump change for Guidant, it turns out, since the survey resulted in

"...>$2 million in new sales with physicians who are not necessarily Guidant
friendly. We paid each physician who completed all five surveys $1,000 so
total cost was $80,000."
This is what used to be called a seeding trial - using a scientific pretext to generate sales, market share, buzz, or whatever.

Several documents were sent to the Times by someone professing to be an employee of Guidant, but there is no mention of whether there was a protocol for this "evaluation" or whether there was any consultation with IRBs or ethics boards where the participating physicians practiced.

Kick back and read on....

But you can't pay physicians to use your product - that's plainly illegal. So these evaluations have to be considered research to avoid the federal anti-kickback laws. To avoid violating the law, the research purpose for which you pay the physician has to be legitimate. See this presentation to get a better idea of the requirements. To quote:
"Clinical trials or other research with little scientific value implicate the
federal Anti-kickback Statute and IRS requirements. In addition, clinical
trial proposals that offer inducements to physicians to participate implicate
the federal Anti-kickback Statute."
The document then references the AMA definition of "Genuine Research Purpose" which you can find here.
"How can a physician tell whether there is a "genuine research purpose?"
A number of factors can be considered. Signs that a genuine research purpose
exists include the facts that there are (1) a valid study protocol, (2)
recruitment of physicians with appropriate qualifications or expertise, and (3)
recruitment of an appropriate number of physicians in light of the number of
study participants needed for statistical evaluation."
The drug industry has developed, through their trade group PHRMA, a Code for Interactions with Healthcare Professionals. More recently, we have promulgated new standards for clinical trial conduct and communicating their results. The first document was a voluntary code for industry, but has now been incorporated into law, in the sense that the most recent federal regulations on anti-kickback for the drug industry specifically cites the Code for Interactions, considering them to be a minimum standard. We may see similar treatment for the clinical trial standards.

At first blush, this may seem offensive. Since the industry wrote The Code, it sounds like the industry is therefore determining the law of the land for regulating themselves. I mean, who is supposed to write the laws? Should we have all industries write their own "Codes" and simply have the regulators defer to them?

However, we are persuaded that the PHRMA Code is actually not a bad starting point. In fact, we even heard Jim Sheehan, Associate US Attorney for the Eastern District of PA (Philadelphia) and frequent industry foe, refer to The Code as a good start, that fails only in that it does not address certain areas of conduct. In addition, by having The Code cited in the Federal Register, it makes adoption of this voluntary conduct a necessity to industry. No decent compliance or legal department would allow their sales folks to ignore it.

The Ectasy of Device Manufacturers

After a few more Guidant episodes, perhaps we'll see some similar reactions from the Medical Device Manufacturers Association (MDMA). A comparison between their website and PHRMA's website is instructive. PHRMA practices defensive medicine, knowing that it's an industry under siege. There are all kinds of articles and links to items showing how responsible and honorable they think they are. If we keep the pressure on, perhaps someday they'll live up to their own rhetoric.


Anonymous said...

Google-NASA partnership rockets Web debate
As part of Google's just-announced plan to build up 1 million square feet of offices at NASA Ames Research Center near Mountain View, Calif., the two entities will cooperate on research projects such as ...
Find out how you can buy & sell anything, like things related to music on interest free credit and pay back whenever you want! Exchange FREE ads on any topic, like music!

Anonymous said...

News, Resources and Information on Vioxx and its Effectsvioxx help
vioxx help

Anonymous said...

Vioxx health - Merck Earns Fall After Vioxx Withdrawal NEW YORK (Reuters) -

Merck Earns Fall After Vioxx Withdrawal
NEW YORK (Reuters) - Merck & Co. MRK.N on Thursday said first-quarter profit fell 15 percent following the withdrawal of its arthritis drug Vioxx last year. Link to original article
trial vioxx

jon said...

We are trying to find good movie film script to take the kids this weekend. Good movie film script reviews are hard to find

I just stumbled onto your blog while looking. Seems to happen to me a lot since I am a knowledge mooch LOL


Anonymous said...

Your web page is undoubtedly definitely one of the very best . On the whole impact of the blog is probably amazing .
Richardson TX Locksmith
Locksmith In Nashville
Locksmith Cupertino CA
Locksmith Mountain View CA
Newark locksmith
Locksmith Palo Alto
Locksmith RedwoodCity CA
locksmith fort worth
locksmith fort worth
locksmith pembroke pines fl
fort worth locksmiths
fort worth locksmith
locksmith fort worth texas
Locksmith Mesquite tx
miami beach locksmith
aventura locksmith
locksmith miami
irvine ca locksmith
plano locksmiths
Hialeah FL Locksmith
miami locksmiths
Hialeah FL Locksmith
aventura locksmith
miami beach locksmiths
pembroke pines fl locksmith
locksmith fort worth fl
fort worth fl locksmith