Over Use of Drug Eluting Stents

STENTS PLACE MOST PATIENTS AT HIGHER RISK OF MI AND DEATH

For many patients, the implantation of a drug eluting stent will not add years to their lives or prevent an impending heart attack. In fact, the primary purpose for implanting the stent in patients who have not suffered a heart attack is to decrease angina (chest pain). Medication on the other hand has been show to be more effective at reducing heart attacks and death.

In other words, the physician recommends placing a metal device in the coronary artery where there are medication alternatives that provide the same or better long term survival. Despite this fact, patients undergo procedures every day that they would be better off avoiding. The physicians, hospitals and medical device companies in return make billions.

Since the studies have revealed that medication is more effective, angioplasty and stent placements are in decline.

See the NY Times Article for more information.

Digitek Injuries

Digitek, a medication indicated for patients with heart failure and abnormal heart rhythms, was recently recalled by its manufacturer Actavis Totowa LLC. The recall is a Class One FDA nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. A Class One recall is the most serious level of recalls.

The "all lot" recall is due to the serious potential that the pills were manufactured with double the approved thickness, which may contain twice the approved level of active ingredient. As a result, the drug, in its defective form, is recognized to pose a risk of digitalis toxicity in patients. Reports of hypotension, cardiac instability, bradycardia, and death have been reported.

For more informaton, see the following:

1. FDA Notice


2. Activis Consumer Question/ Answer:
   
3. Web MD:
   
   The Lyon Firm is investigating these cases on a local and national basis.

Bush Supports New ADA Requirements

The Bush Administration in an effort to address the needs of the many disabled veterans returning from Iraq is supporting additional changes to the American's with Disabilities Act, a bipartisan piece of legislation that requires businesses to make accommodations for disabled consumers. See today's New York Times Article for additional details:

The support conflicts with the Bush Administration's efforts to limit consumer's rights to challenge big companies when they have been injured by a defective product. Moreover, it is a tacit admission that the numbers of veterans affected by the Iraq war justifies such broad economic measures to assist those soldiers in their return to civilian life.

The U.S. Chamber of Commerce opposes such changes.

Glaxo May Have Mislead FDA on Paxil Suicide Risk

GLAXO'S BLOCKBUSTER DRUG PAXIL HAS BEEN LINKED TO BIRTH DEFECTS AND INCREASED RATES OF SUICIDE

NEW INFORMATION SUGGESTS THAT THE COMPANY MANIPULATED A PIVOTAL TRIAL TO SHOW GREATER EFFICACY IN REDUCING SUICIDE.

When the proper analysis was performed, not only was the drug less effective at reducing suicide, but more participants committed suicide on the drug than on a sugar pill. This is yet another example that may shed additional light on the FDA's inability to adequately regulate Big Pharma.

Additional information on the Paxil links to persistent pulmonary hypertension (PPH).

New questions have emerged whether Glaxo intentionally misrepresented data on suicide risk when it applied to the FDA for approval. The company has denied this charge.

A study underwritten by Harvard and consumer advocates determined that Glaxo's study used for approval showed that the real risk for suicidality was 8 times the risk for un-medicated patients. Glaxo interpreted the data in a misleading fashion, and the FDA relied on the company's conclusions. Had the appropriate conclusion and risk been provided to the FDA when it was originally approved, the FDA would likely have added additional warnings. In 2004, the FDA did add warnings. And in 2006, the company issued a Dear Doctor letter advising the physicians that the drug posed a risk of 6.7 times that of placebo (sugar pill).

Although the true risk is now being disclosed, the delay has allowed for more profits and likely caused the un-necessary loss of lives. In light of the evidence, the studies should also be scrutinized to look for any evidence of birth defects as well.

Cincinnati Medical Malpractice: Unnecessary Drug Eluting Stent Placement

With the introduction of the drug eluting stent (des), the criteria for coronary intervention has broadened. The standard of care for intervention and stent placement involves a clinically significant lesion (>70 percent occluded) with ischemic heart disease --, i.e., upon stress test, blood flow is limited. Please see the American College of Cardiology Guidelines:

However, physicians are closer to the medical device industry than ever, receiving grants, gifts, and are typically reimbursed per vessel; therefore, there is a strong financial incentive to intervene in multiple vessels and place an additional stent during the procedure, even though a lesion may not be symptomatic. This practice is concerning where lesions less than 70 percent occluded are being stented. While it is recognized as malpractice, many physicians argue that this is "clinical judgment".

This argument is not supported by the objective guidlines outlined in the literature or the FDA. The clinical data does not support that stent placements in non acute patients reduces the risk of myocardial infarction (MI) or Death. Therefore there is no clinical benefit to the patient. Nevertheless, the use of stents in "off label", i.e., in patients unapproved by the FDA, has reached 60% of all stent surgeries. This means that 60% of all patients undergoing des placement are undergoing surgery where the available data does not prove it is safe or effective for them. Indeed, the introduction of a stent for these patients may in fact increase the risk of MI and death. Furthermore, patients have to stay on Plavix (a very strong blood thinner) indefinitely, which adds risks of severe bleeding. Please see the FDA comments on "off label" uses:

For those patients who suffered side effects, adverse reaction, including MIs, strokes, or death, they may consider a medical malpractice claim to investigate whether a stent was appropriate in their loved one.