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Increasing Government Oversight Of IRBs Could Help Prevent Seeding Trials

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I thought I read the final chapter in the tale of Pfizer’s shady marketing practices for Neurontin years ago. Sadly, there’s at least one more chapter to go.

Recall that in 2008, leaked documents from a US District Court revealed that Pfizer had covered-up the results of a clinical trial which showed the drug didn’t work for chronic nerve pain, even as it promoted off-label use of the anti-seizure drug for that purpose. The next year, it was revealed that Parke-Davis (now a subsidiary of Pfizer) took advantage of lax disclosure policies by certain medical journals to publish 13 articles promoting off-label use of Neurontin that were ghostwritten and funded by the company without disclosing such arrangements.

isthatamisprint 300x200 Neurontin: Seeds of DiscontentNow, it has come to light that Parke Davis’ marketing department sponsored a Seeding Trial of Neurontin back in the day—that is, a trial portrayed deceptively as a patient study but whose real aim was to encourage prescribers to use the drug.

The trial was STEPS, the ‘Study of Neurontin: Titrate to Effect, Profile of Safety’ trial. More than 772 physician ‘investigators’ and 2800 patients participated in STEPS.

The stated objective of STEPS was to study the safety, efficacy and tolerability of Neurontin. However, after reviewing documents compiled for a pair of lawsuits against Pfizer and its subsidiaries, Joseph Ross and colleagues concluded that the actual objective was to increase prescribing rates by ‘investigators’ in the study. Neither the ‘investigators’ nor their patients were informed about the real purpose of STEPS.

The trial worked, from Parke-Davis’ point of view. Read more »

*This blog post was originally published at Pizaazz*

Why Doctors Should Participate In The Debt Ceiling Debate

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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*

Will We Ever See Accountability And Transparency In Our Healthcare System?

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President Obama, where is your promise about transparency and accountability in Obamacare?

A major problem in the healthcare system is the lack of transparency and accountability. It has been unchecked for a very long time.

Both primary and secondary stakeholders act in their self-interest. These stakeholders have had ample opportunity to be non-transparent and non-accountable. All the stakeholders have abused the healthcare system.

I hit a nerve with my last blog “Patients And Physicians Must Control Costs”. Multiple readers responded with the usual comments:

Patients are not smart enough to handle their own healthcare dollars.”

“Your basic idea makes sense, but in reality I doubt that a patient knows enough to make intelligent medical/financial decisions, because there are too many unknowns and variables.”

“Physicians over use the fee for service system in order to make more money.”

“If a physician tells a patient that there is only a 1/10,000 chance that an MRI will yield something useful, if the patient doesn’t have to pay for it, the patient wants the MRI.

Patients (consumers) must be taught and motivated to manage their own healthcare dollars. Patients’ choice Read more »

*This blog post was originally published at Repairing the Healthcare System*

Some Patients Just Won’t Take “No” For An Answer

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62-year-old black man with a two inch (that’s inch; not centimeter) lump under his left arm. It is determined that he needs to have it biopsied in order to tell for sure what it is. The differential diagnosis includes a simple reactive lymph node, lymphoma, leukemia, granuloma, sarcoidosis, and several other more esoteric entities, all of which require tissue for definitive pathologic diagnosis.

The dialogue:

Patient Who Will Not be Reassured: What is it, Doctor Dino?

Me: We won’t know for sure until we get the report from the biopsy.

PWWNBR: But what do you think it is?

Me: I have no idea. We have to see what the pathologist says.

PWWNBR: Could it be cancer?

Me: It could be any one of several different things. Yes, cancer could be one of them, but there’s no way of knowing without the biopsy.

PWWNBR: Dr. Dino, do I have cancer? Read more »

*This blog post was originally published at Musings of a Dinosaur*

Bad Medical Practices On Television

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I watch some TV (and essentially no commercials, thanks to DVRs) and have been enjoying some shows: Necessary Roughness and Covert Affairs. Yes, put a reasonably attractive female in the lead role of a show with some action and I might watch. Demographic shocker.

So, within the last two days I saw one completely egregious professional breach, and one exercise of pretty awful medical judgement (in an ED, which makes it way worse for me), and I will now outline my concerns/gripes.

(Yes, I’m aware they’re TV shows, and are therefore not reality. What I’m unhappy with is the glib way in which these terrible decisions played out, like it’s not a big deal to act against the interests of your patient, even especially, on TV). (I think TV behavior, not the cartoon violence but the everyday mundane stuff, influences how regular people think, which is why I’m writing this: so the zero regular people who watch TV and read this blog have something to consider).

So the Necessary Roughness (episode Anchor Roughness) thing: (Background): the protagonist is a female psychologist hired by a football team to get their star player “TK” (with more than a mild resemblance to “TO“, the former 49ers Eagles Cowboys Bills Browns wide receiver) playing and catching; it’s a TV troubled relationship. (Player is aware she works for the team). In the show TK threatens to leave the team, is convinced not to leave in a bluff by the team to send him to a cold climate, and TK decides to stay with the team. In the denouement, it is revealed that the whole idea for the bluff was the psychologists’ idea, for which she was praised by the team.

Umm, I have an objection. Read more »

*This blog post was originally published at GruntDoc*

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