This was a very big week for cancer vaccines. Long time readers of this blog know that I am a proponent of Cancer Vaccines.
First, Dendreon released the full results of the pivotal Provenge trial. As expected, a survival benefit was demonstrated of about 4 months. Now the discussions will begin to focus on the value of a life. From a societal standpoint, is it worth it to save a man's life for 4 months? Some feel the answer is no.
And based on the trial, Dendreon's stock price has soared. Along the way, they have picked up analyst coverage from Needham and Lazard.
But approval of Provenge is far from assured. The FDA doesn't like to admit mistakes - and approving Provenge now will be an acknowledgment of its own past errors. Don’t count out the rouge and shadowy figure Dr. Howard Scher – a man in the shadows, but who still has considerable influence.
I rarely discuss the industry from an investment perspective. But I will do so now. Dendreon is probably over a year from bringing Provenge to market and it will require resources to commercialize. Currently trading at $21.51, I think it’s overvalued. I like Dendreon in the teens, but not now. FDA approval can’t be taken for granted and it will take some time for the company to become profitable. Company insiders have also begun selling shares too. But I’m proud of Dendreon for standing up for patients, bucking an unresponsive agency and giving the finger to physicians who are willing put personal profits in front of patient health.
But Dendreon is not the only player in cancer vaccines right now. If I were into playing the market right now, I like Antigenics. Trading at $0.7099 (although a reverse 1-10 stock split is on the table at their annual meeting), there's risk, but also upside. The technology still needs to be proven, but it has considerable potential. This week Antigenics received orphan drug status from the FDA for glioma. This comes on the heels of receiving orphan drug designation in the EU. The pieces are starting to fall into place for Antigenics.
And the tide is turning for cancer vaccines.
Thursday, April 30, 2009
A Warm Body In The Chair
And HHS finally has a new head. Kathleen Sebelius, former Governor of Kansas, was the last person standing and got the position. Her qualifications for the role aren't immediately clear, but she looks good in her Sarah Palin-esque suits. Having a singular opinion on abortion (one way or the other) isn't a job qualification for this extremely important cabinet position.
While Sebelius was plagued by same tax fraud problems that are ubiquitous among nearly all of Barack Obama's political appointments, she was seen as the least dirty. She only had to pay back nearly $8,000 in back taxes (compared to Daschle's $140,000) and was not punished for her tax fraud schemes. Sebelius used the stupidity defense to escape punishment (she was too dumb to know what she was doing). It doesn’t bode well for her role heading a Government agency responsible for the health and safety of Americans, but in these days of George Bush-Barack Obama political appointments, nothing would surprise me.
Almost immediately PhRMA jumped on the bandwagon to endorse her. PhRMA would have endorsed about anyone with a pulse at this point since they are desperately struggling for a seat at the table.
Sebelius wasn't the best candidate for the job, but a warm body in the chair is better than nothing at all. Hopefully, this will allow the FDA to get off dead center and start making decisions – one way or the other.
While Sebelius was plagued by same tax fraud problems that are ubiquitous among nearly all of Barack Obama's political appointments, she was seen as the least dirty. She only had to pay back nearly $8,000 in back taxes (compared to Daschle's $140,000) and was not punished for her tax fraud schemes. Sebelius used the stupidity defense to escape punishment (she was too dumb to know what she was doing). It doesn’t bode well for her role heading a Government agency responsible for the health and safety of Americans, but in these days of George Bush-Barack Obama political appointments, nothing would surprise me.
Almost immediately PhRMA jumped on the bandwagon to endorse her. PhRMA would have endorsed about anyone with a pulse at this point since they are desperately struggling for a seat at the table.
Sebelius wasn't the best candidate for the job, but a warm body in the chair is better than nothing at all. Hopefully, this will allow the FDA to get off dead center and start making decisions – one way or the other.
Tuesday, April 28, 2009
The Genetic Basis of Autism
The journal Nature is reporting this week on the genetic basis of autism. The journal carries details of two different studies which add further weight to a genetic basis for autism spectrum disorders and is another fatal blow to the legions who believe in the thimerosal myth.
The first study noted that 65% of autism patients share a single genetic mutation in a region of the brain that controls the way brain cells connect. While the second study demonstrates a link between autism and excessive ubiquitin protein.
This kind of genetic research is exactly the kind of science-based inquiry into autism that is critical to finding the root causes of autism spectrum disorders. Instead, organizations like Autism Speaks and it’s founders Bob and Suzanne Wright continue to advocate for scientifically disproven, religious-based theories of autism causes (see Mutiny).
Consider these two Nature studies to be yet another blow to the thimerosal myth. Score two more for science!
Reference: Los Angeles Times
The first study noted that 65% of autism patients share a single genetic mutation in a region of the brain that controls the way brain cells connect. While the second study demonstrates a link between autism and excessive ubiquitin protein.
This kind of genetic research is exactly the kind of science-based inquiry into autism that is critical to finding the root causes of autism spectrum disorders. Instead, organizations like Autism Speaks and it’s founders Bob and Suzanne Wright continue to advocate for scientifically disproven, religious-based theories of autism causes (see Mutiny).
Consider these two Nature studies to be yet another blow to the thimerosal myth. Score two more for science!
Reference: Los Angeles Times
Friday, April 17, 2009
Dendreon Prevails - Tide Turning
In a stunning turn of events, Dendreon has announced that its Provenge cancer vaccine prolongs survival in men with Prostate Cancer. Full data to be announced next week at AUA, but the company is confident. Very confident. And they’ve got an SPA with the FDA, so it looks good for approval these days (of course, the risk is that an SPA doesn’t mean much to the FDA these days).
Point - Dendreon. Embarassment - FDA.
Of course, the history of this is nearly Biblical. The FDA rejected Provenge once before, against the guidance of its own advisory committee and at the urging of Dr. Howard Scher. Provenge should have been approved and it makes me wonder how many men have died because of the FDA-Dr. Death back-room deal.
But the Provenge results represent a tide shift for cancer vaccines overall. The FDA can't ignore Provenge forever (they’ll try, but eventually the embarrassment will win out and they will cave to science). No matter how much may have been given to FDA officials or the lobbying activities by physicians with conflicts of interest, Provenge will get approve. Of course, this will benefit companies like Antigenics and others who are exploring cancer vaccine technologies. Collectively, their stocks have all gained this week.
The tide is turning…
Point - Dendreon. Embarassment - FDA.
Of course, the history of this is nearly Biblical. The FDA rejected Provenge once before, against the guidance of its own advisory committee and at the urging of Dr. Howard Scher. Provenge should have been approved and it makes me wonder how many men have died because of the FDA-Dr. Death back-room deal.
But the Provenge results represent a tide shift for cancer vaccines overall. The FDA can't ignore Provenge forever (they’ll try, but eventually the embarrassment will win out and they will cave to science). No matter how much may have been given to FDA officials or the lobbying activities by physicians with conflicts of interest, Provenge will get approve. Of course, this will benefit companies like Antigenics and others who are exploring cancer vaccine technologies. Collectively, their stocks have all gained this week.
The tide is turning…
Monday, April 6, 2009
HIMSS 2009
Pharm Aid has spent the week in Chicago at HIMSS 2009. Despite the rather sparse attendance, the show had a considerable amount of interest, thanks to President Obama's health IT initiative.
I last attended HIMSS almost 10 years ago. Gone are all of dot com health IT companies and only the large established players remain - GE, McKesson, Siemens and a few others. Noticeably absent was Cerner, once a major player in the field. One has to wonder if the economy has pushed them to the brink.
The tone has also moderated. Gone are the days of the classic "health IT can save the American health system and improve patient care at lower costs" to the more moderated position of "health IT can enable progress and should be an integral part of health reform." Essentially, there is a much healthier tone to the whole industry.
Health IT should play a role in pharmaceuticals as well. So far, pharma and the prescription record is the missing piece in the unified patient medical record. A doctor may prescribe and note it in the patient's EMR. But did the patient actually fill the prescription? How frequently did they go back for a refill (compliance and persistence)? In current EMRs, we know the physician's intent, but not the patient's behavior. Without it, a truly unified view of a patient's health will not be possible.
I last attended HIMSS almost 10 years ago. Gone are all of dot com health IT companies and only the large established players remain - GE, McKesson, Siemens and a few others. Noticeably absent was Cerner, once a major player in the field. One has to wonder if the economy has pushed them to the brink.
The tone has also moderated. Gone are the days of the classic "health IT can save the American health system and improve patient care at lower costs" to the more moderated position of "health IT can enable progress and should be an integral part of health reform." Essentially, there is a much healthier tone to the whole industry.
Health IT should play a role in pharmaceuticals as well. So far, pharma and the prescription record is the missing piece in the unified patient medical record. A doctor may prescribe and note it in the patient's EMR. But did the patient actually fill the prescription? How frequently did they go back for a refill (compliance and persistence)? In current EMRs, we know the physician's intent, but not the patient's behavior. Without it, a truly unified view of a patient's health will not be possible.
Saturday, April 4, 2009
Mutiny
Like many a snowbird, I’ve spent much of the winter in warmer climates. I kept up on the news, but didn’t really feel much like writing. I’m back and rested.
Perhaps one of the more unusual events during my snowbird retreat was the mutiny in the ranks over at the Autism Speaks organization. Allison Singer, executive vice president of Autism Speaks defected very publicly from the organization, citing Autism Speaks’ unfounded and unscientific philosophy. She has acknowledged what most of us have known for years – thimerosal doesn’t cause autism. Yet, I applaud her to taking the steps to correct her past wrongs and re-focus efforts into areas that can actually benefit children with autism. Too bad Bob and Suzanne Wright, Autism Speaks founders, can’t forgo their egos, abandon hubris and try to do something meaningful for children with autism. (A short article from Newsweek can be found here. It is excellent!)
Yet the thimerosal controversy rages on (or so Autism Speaks would have us believe). Actually, there’s not much controversy over autism as the scientific evidence is now irrefutable. Yet, still Autism Speaks struggles on – desperately clinging to the cause, hoping for relevancy and trying to keep the financial gravy-train keeps flowing. This is nothing new to the readers of this blog. I have long argued that the parochial single-mindedness of the Wright clan borders on religious obsession.
Few things would surprise in the autism world these days. After Jenny McCarthy went off the reservation and started claiming B12 vitamin shots could re-arrange the physiology of the brain and cure autism and other diseases, nothing would surprise me.
There are perhaps millions of children worldwide struggling with autism and they need real scientific research to find a cure – not misplaced, emotional voodoo. It is probable that there are multiple causes of autisms (from genetics to environmental factors), but there isn’t one big, bad boogeyman in the closet to blame. For the sake of the children, it’s time we start looking at those other factors and I hope Autism Speaks will finally drop their resistance (intellectual, financial and legal) to other studies into the causes of autism.
Yet Bob and Suzanne Wright trudge on, with ever more desperate actions and ever more bizarre claims. It’s kind of sad really. The kids with autism could really use the help.
[Hat tip to Peter Jung to catching this one and bringing it to my attention.]
Perhaps one of the more unusual events during my snowbird retreat was the mutiny in the ranks over at the Autism Speaks organization. Allison Singer, executive vice president of Autism Speaks defected very publicly from the organization, citing Autism Speaks’ unfounded and unscientific philosophy. She has acknowledged what most of us have known for years – thimerosal doesn’t cause autism. Yet, I applaud her to taking the steps to correct her past wrongs and re-focus efforts into areas that can actually benefit children with autism. Too bad Bob and Suzanne Wright, Autism Speaks founders, can’t forgo their egos, abandon hubris and try to do something meaningful for children with autism. (A short article from Newsweek can be found here. It is excellent!)
Yet the thimerosal controversy rages on (or so Autism Speaks would have us believe). Actually, there’s not much controversy over autism as the scientific evidence is now irrefutable. Yet, still Autism Speaks struggles on – desperately clinging to the cause, hoping for relevancy and trying to keep the financial gravy-train keeps flowing. This is nothing new to the readers of this blog. I have long argued that the parochial single-mindedness of the Wright clan borders on religious obsession.
Few things would surprise in the autism world these days. After Jenny McCarthy went off the reservation and started claiming B12 vitamin shots could re-arrange the physiology of the brain and cure autism and other diseases, nothing would surprise me.
There are perhaps millions of children worldwide struggling with autism and they need real scientific research to find a cure – not misplaced, emotional voodoo. It is probable that there are multiple causes of autisms (from genetics to environmental factors), but there isn’t one big, bad boogeyman in the closet to blame. For the sake of the children, it’s time we start looking at those other factors and I hope Autism Speaks will finally drop their resistance (intellectual, financial and legal) to other studies into the causes of autism.
Yet Bob and Suzanne Wright trudge on, with ever more desperate actions and ever more bizarre claims. It’s kind of sad really. The kids with autism could really use the help.
[Hat tip to Peter Jung to catching this one and bringing it to my attention.]
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