Now Provenge Activists Target Centers For Medicare
12 CommentsBy Ed Silverman // July 7th, 2010 // 7:08 am
The unending quest to ensure that the Provenge prostate cancer vaccine is approved and readily available to patients has seen a group of activists - some are investors and some are patients - take on various federal agencies, from the FDA and the National Cancer Institute to the Department of Justice and the Securities and Exchange Commission. Along the way, they have filied lawsuits and complaints (background here and here).
Now, they are targeting the Centers for Medicare & Medicaid Services, which last week issued a surprise notice that an analysis would be conducted to determine whether covering the Dendreon vaccine is reasonable and necessary (back story here and here). In announcing its move, CMS indicated it was responding to “informal inquiries,” which Wall Street analysts took to mean questions from Medicare insurers about the novelty of the treatment. The $93,000 price tag may be high, but cost is not supposed to be a determinant.
The activist group, however, wants to know more about these informal inquiries, given they have argued government bureaucrats conspired with financially conflicted cancer specialists and behind-the-scenes investors in rival treatments to continually delay Provenge from becoming available. They point to remarks made by Louis Jacques, the director of the Coverage and Analysis Group at CMS to Forbes last week: “We’ve been getting questions from people. Well, what’s up with Provenge? Is it a drug? Is it a biologic? Is it something else? Does it really work? It has been interesting to look at the evidence around it.”
And so the activist group, known as Care To Live, has filed a freedom of information request (look here) to learn more about those who made the inquiries. “We believe that powerful political forces are still at work and they are the same driving forces behind this,” Kerry Donahue, the group’s lawyer, writes us. “Because we want these people exposed, we believe it important to understand who initiated the inquiries to CMS.”
We asked the CMS for info on the “informal inquiries,” but a spokeswoman didn’t provide a specific answer. She did write to say the coverage analysis was opened because any “treatment for prostate cancer will have a large impact on the Medicare program. We believe a nationally consistent policy for this therapy is warranted.” She added the analysis “may consider other treatments in this category of products and is not limited to Provenge.”
myPharmalotID
When President Obama took office, he issued the following Memorandum:
MEMORANDUM FOR THE HEADS OF EXECUTIVE DEPARTMENTS AND AGENCIES
SUBJECT: Transparency and Open Government
My Administration is committed to creating an unprecedented level of openness in Government. We will work together to ensure the public trust and establish a system of transparency, public participation, and collaboration. Openness will strengthen our democracy and promote efficiency and effectiveness in Government.
http://www.whitehouse.gov/the_press_office/Transparency_and_Open_Government/
Yet, days before Donald Berwick,who professes admiration for Britain’s National Health Service as an “example” for the United States to follow, was to get a recess appointment to head CMS, Dendreon and its shareholders woke up to the announcement that CMS was going to conduct “a national coverage determination (NCD)” for autologous cellular immunotherapy treatment of prostate cancer. The whole matter, apparently, was initiated because “CMS received informal inquiries” regarding Dendreon’s Provenge. Informa Inquiries? Give me a break? From whom? The Tooth Fairy?
Pardon me, but to put it in language even our bureaucrats in Washington can understand, this scandal smells worse than their Blue Plains Sewage Plant on a hot summer day in August. If this doesn’t have the odor of Death Panels written all over it, then pleeeease… enlighten me.
Is CMS now going to take over the FDA’s job and dictate to doctors what they can or can not prescribe for patients and at what stage a drug can or can not be prescribed? Is CMS going to tell those men over 65 years of age who have prostate cancer: “Sorry, you’ll have to wait until you are terminal before you can have this drug.” “Sorry, you’ve had a good life. We can’t help you. Just go away and die in peace.”
If women had prostates, we wouldn’t be having this discussion. Men just don’t “get it” when it comes to their health. Women, on the other hand, do. If Provenge were something THEY needed, I guarantee you, they would be marching on Washington today with the implements needed to castrate more than a few federal officials.
jeff rednor
with obama apponting dr berwick during the senate recess, without any confirmation hearings, our country is now well down the path of a dictatorship. the new cms director is the back door for obama to have the death panels.
JustMe2
Let’s see what skeletons fall out or will it be the same stonewalling and cover-up, we have become accustomed to and so willing to accept from our government agencies.
Thanks Mr. Silverman for going where mainstream news organizations have refused to go. May the transparency begin!! Yes We Can!!
Kerry Donahue
CMS has no fall back here. All they have done is cause confusion. They should immediately issue a statement that indicates that Provenge will absolutely be covered. They know this to be true, but they have caused much confusion with their inconsistent statements.
Can you imagine if chemotherapy or radiation treatments were just approved by the FDA and then CMS stepped in to say it was not covering such treatents. Oh the outrage!
Also consider a treatment such as radiation and how far the sucessful use of radiation has advanced amoung medical professionals. Can any treatment be properly judged in its infancy? CMS has no greater ability to make such judgments than the FDA. Will the Senators have their Provenge paid for when they want it and the subjects..er citizens, be told no they aren’t quite bad enough yet!
The proper course of action for CMS is for an immediate announcement of coverage and a further evaluation in 5 years. By then they can merely ask the patients and/or their urologists.
b.doto
“wow” it is true the goverment is now controling health care right before our eyes. I thought licensed health care providers controlled the necessary care of their patients. Provenge should be available to all candidates in need of treatment. This is a front line and we need to take care of our people..
pharmavet
Folks, how do we dare criticize anyone who comes out of the Holy Cathedral of Medicine, otherwise known as Harvard Medical School. It is no wonder that Dr. Berwick comes from the same place as Dr. Death Panel, AKA Dr. Ezekiel Emanuel. Both are foremost practitioners of the anti-Hippocratic Oath. As a pediatrician, I’d like to know if Dr. Berwick subscribes to Dr. Emmanuel’s theory that health care should be rationed to young children since they have not yet reached their productive years, i.e. Ezekiel’s “Complete Lives” hypothesis.
pharmavet
Since life is about choices, I choose to honor the memory of Dr. Robert Butler, who became known as the “Father of Geriatrics” for his groundbreaking work on healthy aging, and who died several days ago. Let’s hope that the policies of Dr. Berwick et al do not undo the work of this great doctor.
http://pagingdrgupta.blogs.cnn.com/2010/07/07/remembering-the-father-of-geriatrics/?hpt=Sbin
JaT
Shawism:
http://www.youtube.com/watch?v=7WBRjU9P5eo&NR=1
UScitizen
All indications are that US government agencies are not waging a “war on cancer,” but rather a war on novel cancer treatments that threaten the status quo.
Anne PME
What would China or India do? They seem to be the innovators and dealmakers now…maybe the activists could hire them to negotiate with CMS?
kyoto27
Prior to the recess appointment, appears that Dr Berwick “disclosed holding more than a dozen current positions on a government ethics filing, (but only has) one full-time paying job: his 40-hours-per-week position as the president and chief executive of the nonprofit Institute for Healthcare Improvement (IHI), where he earned nearly $900,000 in salary, bonus and deferred compensation last year.” (See below)
So if you look at the About Us tab at the IHI website, there is an interesting note there for Provenge shareholders:
“IHI exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a “quality chasm.” Even though much progress has been made, the current US system remains flawed and increasingly costly. Widespread inefficiencies waste precious resources, best-known science is not reliably applied, and our patients too frequently suffer unintended harm and avoidable deaths.”
Yes, there is a “quality chasm” in the US and Provenge introduction will go a long way towards closing it. So which Dr Berwick will show up at CMS?
http://www.washingtontimes.com/news/2010/jul/6/obama-nominee-heralded-despite-honorary-titles/
SueRae
CMS should absoultely clarify their intentions for Dendreon’s Provenge coverage. Is this review being conducted because Provenge survival rate as far exceed those of Taxotere AND without the debiitating side effects? Is this review being conducted for a ruling on potential off-label usage or for Provenge’s primary indication? The CMS should make that abundantly clear. If the $93,000 price tag for a 3 infusion over 6 week period is expensive, then CMS should compare the TOTAL cost of the dosing of Taxotere and even the newly approved JEVTANA, including, companion medications to head off the numerous side effect, length of treatment, doctor visits and hospitalizations due to treatment toxicity. Provenge is a ONE TIME treatment cost, 3 infusions over 6 weeks. Get it right, CMS. And by the way, when will they do a similar review for JEVTANA???
And I absolutely concur with Kerry Donahue’s request for FOIA on who ordered the review. As a matter of c