Archive for the ‘plavix’ Category

More on Plavix, Aspirin, Zetia, and Vytorin

Wednesday, January 16th, 2008

The push to promote Plavix took on another dimension when it involved the strange case of “aspirin resistance.” This is a controversial condition, first described in 2002, which is being used to discredit aspirin, a drug first trademarked by Bayer in 1899. So-called aspirin resistance has fueled the rise of companies, such as Accumetrics and Dade Behring, recently acquired by Siemens Healthcare Diagnostics,which develop, manufacture, and market tests for aspirin/platelet resistance. This is but another success story for Plavix and its admirers and a subtle blow against aspirin.

Many doctors get kickbacks for recommending these tests or have them done in house. Insurance companies don’t pay for them, but some heart attack victims are persuaded by their physicians that it makes no sense to take aspirin for the rest of their lives if they are “resistant” and not getting optimal results. Plavix would seem to be the obvious alternative. Another example of Big Pharma abuse is that the Plavix patent was due to expire next month but they got a 3 year extension based on a study in China for another indication. Apotex had approval for a generic to be available the next month but they received $60 million to hold off until eight months before the new patent expiration date in 2011. This plan backfired when the cash payment became the subject of a Justice Department investigation.

Apotex immediately began marketing the drug while the patent was still in force. As a result, the cost of Plavix has already dropping by 50% and may drop another 30% or more. Bristol-Myers-Squibb is now being sued by health plans and other fiscal intermediaries since this deal may violate federal antitrust laws.

The latest news on Zetia and Vytorin came out the other day, and is being featured in the major media: Merck and Schering-Plough released the results of a study (the Enhance Trial) showing these drugs failed to benefit patients in a two-year trial ending in April 2006. The House Energy and Commerce committee is investigating why the companies sat on their findings of this negative study for over 19 months.

Plavix, Coumadin, and Aspirin: The Anticoagulant Network

Friday, January 11th, 2008

Anticoagulants (“blood thinners”) are widely used and overused in medicine. The combined use of these drugs, particularly aspirin with coumadin or Plavix© has received a great deal of attention recently, and increasing apprehension. The supine acceptance by the medical profession of the blood thinner, Plavix, is a frightening example of the results of a pharmaceutical media blitz. Thanks to manipulative marketing, sales of the drug, made by Sanofi-Aventis, distributed here by Bristol-Myers Squibb, are up 60% in the past two years to over $6 billion worldwide, making Plavix second only to Lipitor© as the best selling drug in the world!

But is it possible that Plavix is safe, and at the same time a therapeutic triumph that saves lives? The drug interferes with blood coagulation by a mechanism different from aspirin and is routinely used to prevent clots developing before and after the placement of cardiac stents. However, its safety and superiority over aspirin and heparin in pre-treatment before stent placement has been widely questioned.

Plavix alone or combined with aspirin, is also used for hundreds of thousands, if not millions of patients, who are assumed to be at increased risk for heart attacks and strokes. However, a study of 15,000 patients published last year found that adding Plavix ($1.50-$3.00 a day) to low dose aspirin (2-3 pennies a day) was no more effective than aspirin alone for preventing heart attacks, strokes, and cardiovascular deaths. In fact, Plavix plus aspirin, a risky combination, nearly doubled the heart disease death rate, and caused many patients severe bleeding problems, especially in elderly patients with minor head trauma.

The New England Journal of Medicine (NEJM) published a study three years ago showing that patients taking Plavix, experience more than 12 times as many ulcers as patients who take aspirin plus a heartburn pill. Up to half of those now taking Plavix do so because their doctors assume that Plavix is safer on the stomach than aspirin, said the study’s lead author. Another article in the NEJM (Oct. 3, 2007) pointed out the dangers of dual anticoagulant therapy (Plavix or Coumadin with aspirin) “…Increased risks not always offset by benefit…”, meaning serious or life-threatening bleeding.

The practice of prescribing drugs for a purpose outside the scope of the drug’s approved label, (off-label use) represents another Plavix problem, with an increasing number of physicians using the drug where it is not indicated. John LeCroy, a drug analyst stated “It’s a massive drug right now. It already gets massive use, a lot of it off-label.” The same article reported that the FDA granted fast-track review process for Plavix, that is being considered for an additional use: the treatment of a certain type of heart attack.

The anticoagulant conspiracy represents a new multibillion pharmaceutical dollar growth industry backed by investors inspired by authorization of coverage by Medicare and private insurers. For further revelations and detailed documentation of these and numerous other conflicts of interest and widespread corruption in industry, medical centers, and the medical profession see this site , Dr. Paul Rosch’s, The American Institute of Stress and its Newsletter, especially, the June 2006 issue.

A word of advice: If your doctor has you on aspirin plus coumadin or aspirin plus Plavix, (or Plavix alone for heart or stroke prevention), ask him to tell you the indications, the benefits, and the risks.