Senators Look into Pfizer Deal for Lipitor

(December 5, 2011) A study published in the September 28, 2011 Journal of the American Medical Association confirmed that the popular herbal supplement palmetto saw extract is no more effective than a placebo in reducing the symptoms of enlarged prostate gland, known as BPH (benign prostatic hyperplasia), found in men usually age 50 and older.

Saw palmetto extract is a popular alternative medicine for the relief of lower urinary tract symptoms in men with enlarged prostates. Previous trials of saw palmetto extract have produced mixed results following standard doses (320 mg. a day), with an early trial showing a positive result, but more recent larger trials have shown no improvement as reported by Michael J. Barry, M.D. from the Department of Medicine Massachusetts General Hospital, Boston.

Although the current study adds to the evidence that saw palmetto extract has no clinical benefit, many men continue to use this herb because natural remedies remain a popular alternative to prescription drugs which can have adverse effects such as sexual dysfunction, according to Allan Pantuck, M.D., associate professor of urology at the University of California, Los Angeles, David Geffen School of Medicine.

“There’s probably no real benefit,” says Simon J. Hall, chairman of the urology department at the Mount Sinai School of Medicine, in New York City.  “Ultimately, the way I would look at it is: Is it worth spending $20 or $30 a month to take something that is probably not going to do anything?”

The otherwise harmless enlargement sometimes causes symptoms such as dribbling after urination, a weak urine stream, and the frequent need to wake up at night to ur(December 3, 2011) New York’s Pfizer’s efforts to protect the sales of its blockbuster cholesterol drug Lipitor have attracted scrutiny from members of congress, according to published reports.  NY Times reported on Thursday that three prominent Senators asked Pfizer and five other companies to provide details of their agreements to prevent dispensing of generic versions of Lipitor (atorvastin) and dispense only the branded version.

Pfizer’s U.S. Patent No. 5,273,995, covering the companies blockbuster cholesterol drug Lipitor, expired recently. It was a day the pharma giant has been dreading for a long time.  This is quite understandable. On average, once a drug goes off patent, the patent holder’s market share typically falls by a staggering 89% in the first six months. However, thanks to several brilliant strategies, Pfizer’s Lipitor, which has enjoyed a generous 40% share in the cholesterol drug market, stands a good chance of being the exception to this trend, according to a recent article in the N.Y. Times “Facing Generic Lipitor Rivals, Pfizer Battles to Protect its Cash Cow”.  Lipitor, the top-selling drug ever, with nearly $11 billion in sales last year, got U.S. generic competition on Wednesday.  For millions of Americans, prescription drugs are about to get a lot cheaper! In an effort to retain as much of that revenue as possible for a while, Pfizer has offered big rebates to insurance plans and companies that process prescriptions – if they require pharmacies to dispense brand-name Lipitor rather than generic copies for the next six months. Pfizer also is offering patients remaining on Lipitor discounts so that their copayment would be equal or lower than what they pay for generics under their health plan.

This is why the three Senators are demanding that Pfizer produce documents about their deal with insurers to get them to cover its cholesterol blockbuster Lipitor, rather than two generic versions just hitting drugstores.

Come next June, additional generic versions will go on sale, prices will plunge, and most of Pfizer’s Lipitor revenue is expected to vanish, along with these deals.  The unprecedented strategy has generated controversy and a couple of media reports claiming the deals would raise costs for health plan sponsors, employers and taxpayers.

The Senators gave the NY based company until December 21, 2011 to provide extensive documents on all deals to block access to generic Lipitor, known as atorvastin.

The senators are concerned that prescription benefit managers and insurance companies “may charge health plan sponsors, including employers and Medicare Part D, full price for brand-name Lipitor … while pocketing the discount from Pfizer.”

The statement also raised concerns that such arrangements will become a trend, deterring generic drugmakers from devoting the time and money needed to get new generic medicines approved and increasing costs to Medicare, which now spends about $65 billion a year on drugs for senior citizens.

In a desperate move to make any money they still can, yet relentlessly control their market-share, Pfizer is trying to go to the pharmacies, doctors, and even insurance companies to entice them to stay loyal to the manufacturers, even if they sell the drug for less than the generic brands. Very rarely does a brand-name drug get sold for less than the generic, so can we really complain? Who knows, maybe in the end, Pfizer’s prices will be so low that they are still the most feasible option, and it will no longer be profitable for the generic brands to market their drugs, once again giving Pzifer sole control of the market.

Saw palmetto extract has long been marketed as a remedy for these bothersome symptoms, but clinical data shows it consistently failed to outperform the placebo.

In the new larger-scale study, researchers randomly assigned 369 U.S. and Canadian men with prostate-related symptoms to take saw palmetto capsules or an identical placebo (or dummy tablet).  After an 18-month period the men taking the palmetto saw were doing no better than those on placebo, even though the dosage of saw palmetto was increased twice during the study, to 960 mg. which is triple the recommended daily dose.

For some people, no matter how many studies are conducted, they still feel better taking a natural supplement even though it has been proven to have no benefit.  So as long as these herbs are harmless, many people will continue taking them in the hopes that they will make a difference in their lives!

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