Friday, December 24, 2010

Cardiac stents and profit-driven corruption: do anti-fraud rules address the problem?

Turns out that Baltimore may be the McAllen, Texas of cardiac stents. An article published On Monday, December 6, 2010 in the NY Times, “Doctor faces suits over cardiac stents”, by Gardiner Harris, describes the case of Dr. Mark Midei of Baltimore, who is now the target of a Senate Finance Committee investigation following a series of articles in the Baltimore Sun alleging that he put cardiac stents in many people who did not need them. Dr. Midei apparently put in as many as 30 stents per day, 1200 stents per year, in his hospital – numbers that matched hospitals 4 and 5 time as large in the northeast, and the Senate report indicates at least 585 were medically unnecessary, for which he charged Medicare $6.6M and was paid $3.8M. While the hospital, St. Joseph, is also being sued, apparently it and Dr. Midei are accusing each other of being at fault, and of trying to destroy each others’ reputations. Meanwhile, Abbott Laboratories, which manufactures the devices, is lavishing millions of dollars in favors upon Dr. Midei, a small portion of the enormous revenue he has generated for them. The report says that “The serious allegations lodged against Dr. Midei regarding the medically unnecessary implantation of cardiac stents did not appear to deter Abbott’s interest in assisting him.”

There is a lot more to say about this particular case, including a great quote: “After one particularly critical story in The Baltimore Sun, David C. Pacitti, an Abbott executive, wrote in an e-mail, ‘Someone needs to take this writer out and kick his ass.’”, but it would be a mistake to focus too much on this one; there are a lot more corrupt doctors, hospitals, and drug and device manufacturers (Abbott is both) out there.

First, the evidence. While the Times article cites “A landmark 2007 study published in The New England Journal of Medicine showed that many patients given stents would fare just as well without them,” they don’t indicate the article they are referring to (no author or reference given; the link is not to the article), but presumably it is the Swedish study by Lagerkvist, et. al, that showed increased recurrent MI (heart attack) and death with the use of drug-eluting stents compared to bare metal stents.[1] However, there are several articles in the March 8, 2007 issue of NEJM that address the safety of drug-eluting stents (i.e., stents impregnated with a drug to keep them from getting re-clotted, which as a group do not provide a consistent picture. Spaulding, et. al., from Paris, found that there was no difference in outcomes from patients with stents with the drug sirolimus compared to bare metal[2], while Stone and colleagues from Columbia found that drug-eluting stents with both sirolimus and paclitaxel had greater rates of re-thrombosis (though not heart attack or death) than bare metal.[3] Meanwhile, Kastrati and colleagues from Germany, reviewing 14 studies of sirolimus-eluting stents, also found no increase or decrease in heart attack or death, but less need for re-intervention, although at least as much re-thrombosis (clotting) as bare metal stents.[4] There are also two editorials; Farb and Boam, the official one from FDA[5] conclude “The safety and effectiveness of drug-eluting stents as compared with those of alternative treatments deserve continued study.”, while Maisel, head of an FDA committee that reviews these devices, writes “Drug-eluting stents represent an important advance in the management of coronary artery disease and have benefited many patients.“[6]

None of these articles compared stents to no stents, and there is no question that that many, many patients with coronary artery disease benefit greatly from them, getting relief of symptoms without having their chests cut open for surgery (coronary artery bypass grafting, or CABG, pronounced “cabbage”. Cute, huh?). Drug-eluting stents now require the patient take an anti-coagulant, and so the complex decision of whether they are better than bare-metal must be made for an individual patient, based on a variety of patient, stent, and anti-coagulation-risk characteristics. It is also worth noting that either stents or CABG only bypass (or stent open) already-narrowed areas in the coronary arteries. Therefore the risk of recurrent heart attack (MI) and associated death is not only from re-stenosis but the rupture of a cholesterol-laden plaque that might not previously been causing significant obstruction. These are the “sudden” MIs, which account for a larger number of heart attacks than those that come after increasing, gradual narrowing of a coronary artery (and the associated increasing chest pain, called angina pectoris).

Probably even more important are the complex interplay of financial rewards and government regulation that impact on the use of these and other devices, as well as all kinds of other treatments and interventions. There can be no justification for the obviously excessive stent placement by Dr. Midei, or the encouragement of it by Abbott and probably the hospital; as the Times article notes ”… far from questioning cardiologists who perform an unusually high number of stent procedures, many hospital executives celebrate these doctors because of the revenue they bring, which can be more than $10,000 per procedure.” In this context, the reported statement of Senator Max Baucus, Democrat of Montana and chairman of the Finance Committee, that “Hospital patients expect their care to be based on medical need, not profits…Even more disconcerting is that this could be a sign of a larger national trend of wasteful medical device use,” sounds heroic, but is it?

The hospitals have a point too, in their criticism of government regulation. Not all of the investigations by HHS, Medicare, and other government agencies are really meant to uncover such gross overuse or fraud, although this is how they are portrayed. Many of them are just about getting money for the Federal government as aggressively as possible, and if it can be called “fraud” as opposed to a “mistake” they can get huge penalties as well as refunds of Medicare money spent. A major Medicare initiative is Recovery Audit Contractors (RACs), essentially bounty hunters given a license to investigate certain hospitals for fraud. Great, except most of their work seems to be on finding whether patients were (and this is going to seem like a technical subtlety) officially “admitted” to the hospital, when the severity of their illness could have allowed them to be placed in the hospital for a day or more on “observation” status, where they are officially outpatients and reimbursed at a lower rate. If a hospital or doctor were systematically admitting people who should obviously be “observed”, this might be real fraud, what are probably honest minor errors (or differences of opinion) in the assessment of patient condition are blown up so that the RAC (and Medicare) can recover big penalties. Far from trying to systematically defraud Medicare, my hospital, the University of Kansas Hospital (which is very happy with its high cardiac-care rating by US News and is truly one of those hospitals that enjoy the large amounts of money interventional cardiology procedures provide) is spending a bunch of money to have each admission audited by an outside firm to ensure that they don’t violate these criteria and make themselves vulnerable to RAC recoveries.

So who is the “white hat”? Certainly not the drug and device makers, who are really “only in it for the money”, often not the hospitals, and sadly not always (although, honestly, most of the time) the doctors. But also not the government, seeking money to fund its wars in a down economy. Senator Baucus, famous for taking huge amounts from drug companies himself, may not be the one whom we should be trusting, but his statement that “Hospital patients [and, I would add, all patients!] expect their care to be based on medical need, not profits” is certainly a sentiment that I would endorse. Of course, the making of these profits is why the drug companies paid him. Some suspect that this might be partly why his committee, and the Congress overall, and the administration, did not pass a health reform bill that would achieve that result. Fraud is bad, and uncovering fraud is good, but RACs are not an answer to a flawed, profit-driven, health system.

[1] Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L; SCAAR Study Group., Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden., N Engl J Med. 2007 Mar 8;356(10):1009-19. Epub 2007 Feb 12.
[2]Spaulding C, Daemen J, Boersma E, Cutlip DE, Serruys PW., A pooled analysis of data comparing sirolimus-eluting stents with bare-metal stents., N Engl J Med. 2007 Mar 8;356(10):989-97. Epub 2007 Feb 12.
[3] Stone GW, et al., Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents, N Engl J Med. 2007 Mar 8;356(10):998-1008. Epub 2007 Feb 12.
[4] Kastrati A, et. al., Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents, N Engl J Med. 2007 Mar 8;356(10):1030-9. Epub 2007 Feb 12.
[5] Farb A, Boam AB., Stent thrombosis redux--the FDA perspective.,N Engl J Med. 2007 Mar 8;356(10):984-7. Epub 2007 Feb 12.
[6] Maisel WH., Unanswered questions--drug-eluting stents and the risk of late thrombosis, N Engl J Med. 2007 Mar 8;356(10):981-4. Epub 2007 Feb 12.

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