Making sense of the Abbott/St. Joseph's stent situation

There's a lot of buzz this week about an unflattering report from the Senate Finance Committee (Staff Reports on Cardiac Stent Usage at St. Joseph's Medical Center). I don't think this incident is as big a deal as it's being made out to be, but it does provide an opportunity to discuss the broader issues.The Committee highlighted the following points:

• Stent maker Abbott Labs hired cardiologist Mark Midei as a consultant even after he was barred from St. Joseph Medical Center near Baltimore for overuse of stents
• Abbott paid for social events at Dr. Midei's home
• After allegations against Midei were publicized, stent volume fell across the overall Baltimore region
• An Abbott employee, angry at a Baltimore Sun article about the situation, wrote an email asking if the "Philly mob" could be sent to deal with the reporter
• St. Joseph billed payers $6.6 million for questionable stent procedures. Medicare was on the hook for more than half of that
• Three patients who were told they may have had medically unnecessary stenting have had complications, although none has died
• Dr. Midei went to work in Saudi Arabia after losing his privileges at St. Joseph

My thoughts on this particular case are as follows:

• This is a fairly extreme example. Most doctors don't act this way, and medical device companies are not usually looking to work with doctors who get in trouble working with their devices. In the stent world the market can change very fast when persuasive data are published demonstrating the superiority of one approach to another. A case in point is the introduction of the Taxus stent, which went from 0 to 70 percent market share in a couple months because cardiologists thought it was superior
• The dollar amounts paid to Midei are fairly trivial. The consulting fees were about $30,000 (whereas some doctors make more than $1 million from device companies) and the reimbursement for social events (at least $1925 for "crab and barbecue dinners" at Midei's home) and possibly more for  a staff Christmas dinner are a drop in the bucket. If you've planned a wedding or other catered event recently you'll understand what I mean
• The "Philly mob" comment is just a stupid thing to write about in an email and pretty clearly was meant for venting inside Abbott and not as a threat to anyone
• A bigger issue is the millions of dollars paid by insurers for possibly unneeded procedures and the damage to patients from undergoing such procedures. In this instance St. Joseph has paid a $22 million fine so if anything the government came out ahead
• It's not surprising that stent volume dropped in Baltimore after the allegations were published. It's likely patients and primary care doctors began questioning what was going on and physicians decided to err on the side of caution until they learned more about it

Looking beyond this specific case, there are some broader points to make:

• The media (and Congressional investigators) like to lump the medical device and pharmaceutical industries together when they write about financial relationships with physicians. But the two are really quite different. The clinical success of many medical devices --including stents and in particular orthopedic devices-- is dependent on physician technique. It requires a lot of interaction between the device company's R&D and sales people to get the products right and to have them used optimally. Physician feedback is also important for fostering improvements in devices. With pharmaceutical companies it's different. There isn't a lot of specialized technique involved in administering a typical oral product, or even most injectable or infused products for that matter. And there aren't many useful ways clinicians can suggest tweaks to drugs the way they can with devices.
• A large amount of stent use is "off label." In other words, clinical trials are done in one population but the stents are then used in people with different characteristics than those in the trials. It's often not clear cut what is an appropriate use and what isn't, because the data are not available. And insurers tend to pay for what doctors believe is justified.  That's different than the situation with some other medical devices such as implanted cardiac  defibrillators (ICDs), where Medicare's tighter reimbursement policies have led companies to do outcomes studies on broader patient populations, which Medicare has then recognized by allowing wider reimbursement. I expect a trend in the same direction with stents as a result of cases like this
• Stents are high tech and exciting, but there isn't a lot of data to indicate they provide better long-term outcomes than much cheaper medical therapy. As a society we will need to decide whether we are willing to pay tens of thousands of dollars for near term angina relief, which is the principal benefit stents offer over drugs. That's a conversation we don't seem to be willing to have quite yet, but the day is coming
• Disclosure of physician ties with industry --as mandated by health care reform-- will provide opportunities for patients, journalists, health plans and employers to ask legitimate questions about conflicts of interest. Physicians and the device companies will need to figure out how to approach this new world. Some companies have moved out ahead by voluntarily disclosing payment to health care professionals in advance of mandates to do so

Thanks to my MedPharma Partners colleague John Seus for his thoughts on the topic.