Among the most devastating diagnosis a patient can be given is being told he has a brain tumor. The diagnosis is so grim because presently there exists no treatments that can significantly prolong a patient’s life. The reasons are varied. One is that the blood brain barrier makes it difficult to attain the necessary blood concentration levels of anti-cancer drugs. The other is that medicines used to treat cancer are often so toxic to normal cells that they cause widespread damage to surrounding tissues that can impair cognitive functions even more so than the cancer it is trying to contain.

Enter Isis Pharmaceuticals’ (ISIS) anti sense microRNAs (miRNAs) technology.

In January of 2007, shortly after Isis (ISIS) announced its multibillion dollar, collaboration with Genzyme (GENZ), I chided an executive of Pfizer (PFE), asking how they could let rival Genzyme outbid them for the rights to Mipomersen. He (correctly) pointed out that the mode of delivery was the key factor in their decision. Mipomersen is initially slated to be given by injection (albeit weekly) for Homozygous Familial Hypercholesterolemia, although an oral formulation will probably be available for the larger 1.5 to 2 million heterogeneous and poorly controlled hyperlipidemic patient population.

This reluctance on Pfizer’s part was understandable in light of the disastrous multibillion dollar loss with “the sure thing,” Nektar’s (NKTR) inhaled insulin product, that nobody wanted to buy. This fiasco was unfolding while Pfizer and 10 other pharmaceutical companies were engaged in a bidding war to acquire the rights to Mipomersen.

Logic may dictate that Isis Pharmaceuticals' largest multibillion-dollar blockbuster drug is its anti-lipid drug Mipomersen. After all, Genzyme (GENZ) has already paid Isis 325 million dollars upfront, and is scheduled to pay an additional 1.575 billion dollars in milestone payments.

True, Mipomersen has already proven to reverse atherosclerotic plaques in the murine model at unprecedented efficacy (up to 92%). It has also been able to lower lipid levels never achieved with traditional medicines in patients afflicted with homozygous hyperlipidemea.

Once again, the FDA’s actions have left me dumbfounded. It has imposed a potential company- destroying two-year approval delay on Indevus Pharmaceutical's (IDEV) lead product Nebido. Indevus' stock price has plunged 70% to an multi-year low of $1.19/share.

Nebido is a Bayer (BAYRY.PK) originated drug that is a long-acting preparation of testosterone that is used for replacement therapy for men with low levels of testosterone.

 It is known fact that cockroaches need only a few airborne molecules of sugar to detect its location in a kitchen from relatively great distances - even several feet - from its source. Once the sugar pile is pinpointed, a whole swarm of cockroaches soon starts a feeding frenzy while simultaneously spreading their disease-borne feces over the eating surfaces of various culinary utensils.

Mass tort attorneys are like cockroaches. When they get a whiff of money, they swarm over a once-wealthy defendant and feed their gluttonous souls until the carcass of that unfortunate defendant is sucked dry. At the same time they spread their filth, they efficiently contaminate entire industries and saddle them with litigation payout awards that hardly ever trickle down to the individual plaintiffs. The fact is, these lawyers mainly benefit the mass of fellow insect-litigators. Actual victims are often forgotten as soon as the multitude of hourly fees and various other expenses are extracted from the settlement. A case in point of this mass tort madness is the present situation with Pfizer's (PFE) Celebrex.

Eighty-one deaths in the United States have been linked to allergic reactions to a Chinese-concocted contaminant in the widely used blood thinner heparin. The contaminant is an animal cartilage-derived oversulfated chondriotin sulfate. This ersatz non-FDA-approved chemical poorly mimics heparin but costs one one-hundredth of the price of legitimate heparin.

Last month, FDA Commissioner Andrew Von Eschenbach told the US Senate that the replacement of heparin was not inadvertent, but an intentional act that was by “virtue of economic fraud.”