Dear AG Jerry:

About 20 years ago we had a conversation at your home in Oakland in front of your copy machine about how breast cancer treatments did little to save lives and harmed women greatly. These days, most doctors accept this truth and conservative therapy is the standard of practice. But change has been slow, painful, and costly.

I would like you to consider working with me on changing medical care much more quickly and at the same time drastically reducing costs for the state of California, saving billions of dollars. I want to start at the top of the predator chain with the heart surgery business. Would you consider filing as the Attorney General a Qui Tam action? Below is a discussion of how and why.

I am currently working with Tom Amiono's office on AB 1478 which will require informed consent on all forms of heart surgery performed for chronic artery disease and on the medical treatment of type-2 diabetes. For more information see: https://www.drmcdougall.com/misc/2009nl/mar/urgent.htm.

The impact of a Qui Tam action would be much more profound than an assembly bill.

Hopefully I have caught your interest.

Best Wishes,

John
drmcdougall@drmcdougall.com

INTRODUCTION

The ability to perform heart surgery through a heart catheter (angioplasty) was a major technical achievement, which was first performed in 1978.  Such surgery remains a great tool in dealing with an acute coronary episode (heart attacks). It was also initially thought that angioplasties and stent placements with the heart catheter would benefit victims of chronic coronary heart disease.  The plausible theory was that by opening closed vessels of the heart, the risk of future heart attack could be minimized.

However, essentially all long-term major studies have shown that these expensive and elective procedures offer no benefit of extended life or heart attack prevention. We now know that heart attacks occur largely in the regions of younger plaque rather than the older closed regions, which are the sites for these surgeries. Similarly, CABG surgery provides no such benefits either, except for a small benefit to a very small subset of CAD patients with a very specific clinical picture (severe damage to the left lower chamber of the heart).

A legitimate justification for these heart surgeries in patients with chronic disease is relief of incapacitating chest pains (angina) unrelieved by medical therapy (medications and lifestyle changes).  However, most patients operated on do not fulfill even this criterion.  Unaware patients continue to consent to these procedures because of fear of a heart attack, never informed that the proposed surgery will do nothing to protect them in this regard.

In the US in 2006 there were about 1.314 million angioplasties and 448,000 bypass operations performed. Many hospitals derive 80% of their income from the treatment of heart disease. The average total healthcare cost after five years is $100,522 for bypass surgery and $81,790 for angioplasty per patient. These surgeries continue in large numbers for economic rather than medical reasons. The following confirming remark was published in the July 1, 2009 issue of the Journal of the American Medical Association: “…percutaneous coronary intervention is likely being overused in the Medicare population. Contrary to national guidelines, more than half of Medicare patients with stable coronary disease lack noninvasive documentation of ischemia before elective percutaneous coronary intervention.”

Unfortunately, the publicity of ineffectiveness of heart surgery stands in opposition to an entire medical industry dependent upon the procedure for income. Thus, there is little impetus within the community of physicians, hospitals, and drug and medical device companies to bring the facts to light. We pay a tremendous price in terms of dollars and health as a result. This state of affairs presents a great opportunity to the Attorney General, who is well qualified and in an excellent position to right this wrong.

WHY THE ATTORNEY GENERAL IS AN IDEAL PERSON TO ADDRESS THIS PROBLEM

The Attorney General should initiate a Qui Tam action to enjoin all elective angioplasties and stent placements, and almost all coronary artery bypass graft surgeries and to recover the costs for such procedures as have been performed.

The Attorney General is the proper person to initiate such an action.

a) The AG is authorized by law to pursue such actions.

b) The AG maintains a Qui Tam section devoted to such actions.

c) A private person would lack the resources, and might be unwilling to risk retaliation by taking on the entire heart surgery industry.

d) This is a problem of state and national magnitude.

e) Injunction should establish a minimum standard of care for such procedures.

Elective angioplasties and stents should be restricted to patients with incapacitating chest pain unrelieved by medical therapy. Elective CABG should be prohibited except for small subgroups who have proven to benefit from the surgery. All patients should receive informed consent concerning the true benefits and risks of the surgery. In almost all cases, these procedures should be a last resort for treatment of angina pain. 

CONCLUSION

The Attorney General should investigate the possibility of filing a Qui Tam action to enjoin unnecessary cardiac procedures and recover costs to the state for such procedures as have been done without medical justification.  The Attorney General should pursue injunctive relief such that all persons for whom such surgery is proposed are aware of the true facts.

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