About five years ago I began following a small biotech company called Dendreon. I did a great deal of research on the company and began corresponding with people -- urologists, oncologists, researchers and clinicians -- who knew much more than I about the products in their pipeline, the process through which one must move in order to obtain FDA approval, and the conceivable potential of the vaccines that Dendreon was developing.
I became convinced that this company had several blockbuster products in its pipeline, so I purchased shares of the stock, continued to read experts’ opinions, and kept my ear open for developments, both positive and negative.
At the time, Dendreon’s most promising product, which appeared closest to FDA approval, was an anti-prostate cancer vaccine called Provenge. But following closely behind was a second vaccine -- this one for breast cancer -- called Neuvenge. Both vaccines concentrate on one antigen and a revolutionary cassette technology that has the potential to be a powerful tool in confronting many types of cancer. The development of the second vaccine had been sidelined for years due to financial concerns. A small fledgling biotech company is not awash in cash.
The current most common treatment for advanced stage prostate cancer is a chemotherapy treatment called Taxotere, whose side-effects can be torturous – some of which include: low levels of white blood cells, anemia, hair loss, mouth sores, severe fluid retention, nerve pain, weakness, diarrhea, nausea, vomiting, breathing difficulties, joint pain ... and death. And Taxotere’s life-prolonging promise is minimal, at best.
Unlike Taxotere, which is essentially a poison targeted to kill cancer cells before they interfere with regular cells, Provenge attempts to re-engage the body's own immune system, encouraging it to more readily recognize cancer and defend against it … naturally. And its main possible side-effects include mild fever and chills, lasting only a few days (end of list).
Take a good look at the comparable side effects of Taxotere, the only prevalent treatment for late-stage prostate cancer, vs. Provenge. Apologies for the inconvenient fact that I had to break the chart in two and place the right side of it under the left -- it was simply too wide to fit in the space alotted here. You simply have to read the side-effect category and then scroll down to the second image to see how the two treatments compare:
Shortly after I became interested in Dendreon the FDA was advised by its own appointed panel of seventeen experts (oncologists, urologists, and immunologists) that Provenge is unequivocally safe. The vote was unanimous, 17-0. The panel also agreed, 13 to 4, that that there was ‘substantial evidence’ of the drug’s effectiveness, as per FDA parameters.
Three of the panel members who voted on Provenge’s effectiveness had admitted conflicts of interest (which would most likely have rendered them unable to serve on the panel, had the newer FDA rules on conflicts been in effect then). Had they been barred from the decision-making process, the effectiveness vote would then have been a whopping 13 to 1.
Approximately 30,000 men die in the U.S. every year from late stage Androgen Independent Prostate Cancer (AIPC). Once a man has reached this stage, his survival expectancy is approximately nineteen months. And one analysis, performed by the principal investigator of Taxotere, suggested that the combined use of Provenge with Taxotere increased survival by an incredible fourteen additional months, as opposed to survival rates in patients receiving Taxotere alone.
Despite the fact that the FDA follows the recommendations of its advisory panels ninety-eight percent of the time, in May of 2007, the FDA declined to approve Provenge, demanding more evidence of its effectiveness, and requiring further study.
There has been widespread speculation regarding the reason the FDA did not follow its historical record of approving such a safe, effective and revolutionary ‘drug’. Those explanations in which I place credence fall into two categories: (1) the power of Wall Street big money, and (2) the power of the chemotherapy cabal.
(1) There is an historically enormous ‘short interest’ in the stock of Dendreon – big money investors who bet big that this company would fail. At any given time, the short interest in Dendreon’s stock (DNDN) has been as high as 35%. Much ‘naked shorting’ has occurred in this stock – i.e., the selling of ‘phantom shares’, presumably (at least in this case) to artificially drive down the price of the stock in order to (a) prevent those who bet against the company from losing their shirts, or (b) destroy the company itself.
The problems for fledgling biotech companies are many. They are not only required to conduct financially prohibitive research, but, perhaps even more prohibitive, they must battle Wall Street corruption. Hedge funds, naked shorting, and stock analysts with an axe to grind represent a cancer of their own kind.
(2) The deeply entrenched chemotherapy dynasty is a multi-billion dollar business, and the big pharmaceutical giants are not about to relinquish that cash cow without a fight. They have powerful connections in high places.
This past Tuesday, Dendreon announced the results of the extended trial that the FDA demanded when approval was refused two years ago. To simplify those results: the numbers released were astounding – considered by most in the medical community to be a ‘home run’. Urologists and oncologists – some of whom had been sitting on the fence – are now clamoring to be able to use this new tool, and the medical world is describing the expected approval of Provenge as the dawn of a new era in the treatment of prostate cancer. Skeptics have been won over. Numbers don’t lie.
The trial results were announced on Tuesday afternoon. Shortly before those results were made public, a criminal manipulation of DNDN stock occurred on Wall Street. Many are calling it ‘The unexplained DNDN Crash’. Take a look at the chart for DNDN stock that day:
Trading in DNDN was halted by the SEC at 1:27 PM. Just minutes before, the stock fell from $24.60/share to $7.50/share in just over one minute’s time. There were over 4,000 trades placed during that one minute, with about 3 million shares -- about half of an entire day's volume ‘changing hands’ in one minute's time. Keep in mind: this all occurred shortly before blockbuster results of Provenge’s clinical trial were announced.
This is nothing short of Wall Street terrorism.
Many honest retail investors lost a great deal of money in this criminal bear attack -- especially, but not exclusively, those retail investors who were trading in options, and those who had stop loss orders in place. And many back stage Wall Street big-money people covered potential losses. That 'unexplained DNDN crash' decimated the stock's short to mid-term rally.
Had the crash not occurred, once the trial results were announced new buyers and short positions needing to cover would have easily put the stock close to $30 a share and sheer momentum would have taken it higher over the next few days.
The optimism in the stock over the previous few weeks, pending the trial results announcement -- especially on announcement day -- was akin to a balloon being gradually filled with air, and the pressure was at a point where the balloon was about to burst. The 'crash' instantaneously let the air out of the balloon, affecting the stock price not only that day but for weeks to come. Ask yourself how this chart might have looked, had the 'powers that be' not interfered. I suggest that the broken line to the right of the precipice would have had a positive slope, and there would have been no breaks in the ascent. The dotted red line is my speculation as to how the stock price would have trended, post 4/28/09, without the manipulators' interference.
The ‘regulators’ at NASDAQ ‘examined’ -- for all of ten minutes -- the precipitous, unexplained drop in share price and allowed the trades to stand.
I was heartsick when I witnessed the latest blatant attempt to ambush this company and its products – but I, personally, have little to lose but money. Men (husbands, fathers, brothers, sons) worldwide are enduring indescribable physical and mental agony, and are losing their lives to a horrific disease, at the rate of more than eighty of them every day, while this company and its life-enriching product are being played with, as if they were nothing more than plastic disks in a game of tiddly winks.
Is there anything more vile and repugnant in this world than injustice? And is there anything more evil than injustice brought about by human greed and corruption ... and resulting in agony and death for thousands upon thousands of innocent others?
I remember, decades ago, a time when the American people possessed an innate assurance that, no matter what kind of tragedy occurred or what brand of unfairness we had to weather, there was always the promise that someone in power was out there to at least listen to our grievances – and there was a justice system that would, more than likely, see to it that those grievances would be addressed, resulting in ultimate ‘fairness’.
That was a time in which those in power – in the three branches of government, and in the higher echelons of the free market system – had the good of the country, and its citizens, at the top of their list of priorities.
Such is no longer the case. Justice, and the concept of ‘fairness’, have been co-opted by self absorbed men, posing as ‘leaders’, with an unquenchable thirst for wealth and power.
... which is the reason those of us who believe in good science – and, more importantly, good science that appears to have the capability of improving the lot of humankind by alleviating suffering – are having difficulty believing that that science will be allowed to achieve its promise in this unsettled, uncertain era.
Two years ago we witnessed the triumph of greed and corruption over scientific innovation and success. And, in the two years that have elapsed since that infamous ‘triumph’, we have mourned the deaths, and lamented the torment, of nearly sixty thousand men who might have benefited from the science that remains in a greed-and-corruption-authored log jam.
Over the past two years, enemies of Provenge have continued to make end runs around the approval process by lighting brush fires outside of the normal channels -- by using the print medium to stir up controversy. Financial ‘analysts’ and ‘journalists’ continue to quote incorrect facts and make bogus future projections in an effort to stymie approval as well. Conflicts of interest on the part of medical professionals, and huge potential dollar losses on the part of hedge funds and short sellers, appear to represent the stuff of which an alliance continues to me made. And that malevolent alliance appears bound and determined to see to it that reasonable doubt is manufactured as to the credibility of the completed trials, and the future promise, of Provenge.
Now we sit here … having read the amazing numbers that were revealed on Tuesday … numbers that offer continuing proof of this revolutionary technology and its promise in the battle against one of history’s most dreaded diseases.
Dendreon has announced that it intends to file its amended BLA (Biologic License Application) for Provenge to the FDA in the last quarter of the year. They intend to be meticulous -- to cross every T and dot every I, so that nothing can be found amiss in their data or its presentation.
Between now and then there will no doubt be additional sniper fire, and outright ambushes, by those, both on Wall Street, and in the chemotheraphy cabal, who intend to continue to place roadblocks in front of a revolutionary medical breakthrough.
We need to pray that those who know the truth, and whose motives are to alleviate human suffering, are armed to the teeth with the facts – and that the new FDA decision-makers see it as their duty to use those facts to the benefit of the people whose very lives depend on their integrity.