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Conflicts Of Interest Within Clinical Trials Can Jeopardize The Participants

Follow the money.

Earlier this week, I blogged about the growing economic relationships and even mutual dependency between medical device manufactures and physicians, citing a pre-emptive strike against an Institute of Medicine report that recommended closer regulation of medical devices before and after they enter the market. Such ties, though, are only one part of a broader medical-industrial complex that has enormous impact on public policy in the United States.

A 2009 White Paper by the Seton Hall’s Center for Health & Pharmaceutical Law & Policy reported that “ drug and medical device companies fund up to 80% to 90% of all clinical trials; in 2005, and that by 2004, three-quarters of all of the clinical trials paid for by industry were in private physician practices or for-profit research centers.” The paper’s authors argue that such trials “create potential conflicts of interest that possibly jeopardize the rights and well-being of research participants as well as the integrity of research results” and that “the goal for public policy should be to structure physician-investigator payment to achieve financial neutrality between treatment and research.”

A recent web posting by a medical billing company unabashedly crows about the extra income doctors can make from clinical trials. Read more »

*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*

Why Is There So Much Less Paperwork In Canadian Health Care?

If you ask internists and their patients what makes them bonkers about the U.S. health care system, paperwork will top the list. Many will point to the federal government as the culprit, citing the many forms, RAC audits, pre-and post-payment reviews, documentation and coding guidelines, HIPAA privacy rules, quality measurement and reporting, Part D drug formularies, and HIT meaningful use requirements imposed by Medicare and other federal programs. (Some put more of the blame on private insurers and pharmacy benefit managers.)

But if paperwork is associated with the degree of government involvement in health care, then Canada–a single payer system–should have more of it than the United States, right? Think again.

A new Health Affairs survey of U.S. physicians and practice administrators found that U.S. physicians spend Read more »

*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*

Why Doctors Should Participate In The Debt Ceiling Debate

Joe Scarborough reminds us that the divisions in American government are hardly new, paraphrasing Benjamin Franklin’s observation that “When you assemble a number of men, to have the advantage of their joint wisdom, you inevitably assemble . . . all their prejudices, their passions, their errors of opinion, their local interests, and their selfish views. From such an assembly can a perfect production be expected?” (This comes from a September 17, 1787 speech by Mr. Franklin to urge ratification of the U.S. Constitution, read on his behalf because he was too ill to deliver it in person. The Constitution was ratified the same day.)

I suppose we should be encouraged that Congress’s prejudices, passions, errors of opinion, local interests and selfish views are as American as apple pie, and the Republic has somehow survived nonetheless. Still, I find it deeply troubling that today’s politicians can’t find their way to agree on the debt ceiling.

No one should expect a “perfect production” to come out of this Congress and this administration, given how far apart they are on the need for tax increases and entitlement reforms. But they need to agree to something, and they need to do it soon.

I will leave it to others, who know a lot more about global economics than me, to explain what likely will happen to the economy if the debt ceiling isn’t increased by August 2. Let’s talk about the impact on health care, something I know quite a bit about—and why physicians especially should be concerned: Read more »

*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*

Doctors And Patients Will Be Harmed By The Debt Ceiling Train Wreck

Watching the negotiations over the debt ceiling legislation is like watching an impending train wreck.

You see a train hurtling down the track, you see an unobservant trucker about to cross, you know that the train engineer and the truck driver have only a few moments to avert disaster, you try to yell and scream to get them to pay attention before disaster strikes—but you have this sinking feeling that your voice won’t be heard until it is too late.

Well, that is how I feel watching the collapsing negotiations over raising the debt ceiling. Responsible persons in both political parties know that a failure by Congress to authorize an increase in the debt ceiling will create incalculable harm to our country, even though some politicians seem to think that default would be no big deal.

But it would be a big deal, and here is why. Read more »

*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*

Severe Paperwork Burden Tempts Physicians To Quit Medicine

For physicians, and especially those in primary care, it seems like there is a form for every purpose imaginable—often for purposes that are hard to imagine.

An ACP member in Rhode Island recently gave this example:

“I was just asked by my Medicare Advantage plan to sign a form for [a well-known pharmacy benefit manager]. This form is to be faxed to them in order for them to send me a prior authorization form for a med. So in other words, I had to complete a form in order to get another form. This is nuts!”

Or how about this, from another ACP member in a private internal medicine practice:

“The documentation that is getting to me, is that documentation that the ‘durable medical equipment people want including repetitive- recurrent documentation, whenever we see a patient to document “continued need”. The list of things we have to document, sign, approve or prior authorize, I believe is what makes most physicians think they chose the wrong field. A PBM letter to me about my prescribing practices today nearly did me in! Luckily I just shredded it. If I am kicked out of this business, I am so close to retirement it would be a blessing!”

Or this: Read more »

*This blog post was originally published at The ACP Advocate Blog by Bob Doherty*

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