Latest Drugwonks' Blog
In advance of next week's UN meeting on non-communicable diseases in the developing world, tomorrow I will attend and participate at a Washington Post forum on this very topic.
Today, this relevant news crossed my desk.
Kismet? I don't think so.
Indianapolis, IN – Eli Lilly and Company (NYSE: LLY) announced today a $30 million commitment over five years to fight the rising burden of non-communicable diseases in developing nations. Lilly is launching The Lilly NCD Partnership, which combines the company’s unique resources with the expertise of leading global health organizations, to identify new models of patient care that increase treatment access and improve outcomes for underserved people. The partnership will initially focus on diabetes – a core business area in which Lilly has deep expertise.
Non-communicable diseases (NCDs), known as chronic diseases, include cardiovascular diseases, diabetes, cancer and chronic respiratory diseases. The first phase of The Lilly NCD Partnership will focus on improving diabetes care in targeted communities in Brazil, India, Mexico and South Africa.
“Non-communicable diseases are afflicting nations, communities and families around the world, with the most vulnerable bearing most of the burden,” said John C. Lechleiter, Ph.D., Lilly chairman, president, and chief executive officer. “We believe we have a responsibility – and are uniquely positioned – to assist in the global fight against these diseases. In partnership with leading health organizations, Lilly will contribute its deep expertise and the company’s broad research capabilities to help find solutions for these pressing societal needs.”
Lilly and its partners continue to develop country-specific programs that will launch in early 2012. Lilly and its partners will develop country-specific milestones that, if achieved, will trigger future investments.
Partners include:
• Brazil: Hospital Israelita Albert Einstein – Diagnostic & Preventive
Medicine and Research Institute
• India: The Public Health Foundation of India, Project HOPE, Population
Services International
• Mexico: The Carlos Slim Health Institute – Casalud
• South Africa: The Donald Woods Foundation, Project HOPE
Congratulations to my friends at Eli Lilly & Co. Good luck and good karma.
Now if only Peyton Manning was healthy!
I just wrote (http://spectator.org/archives/2011/09/12/rick-perry-on-science) about how Rick Perry’s position on vaccines was science-based. Sadly, tonight Republican presidential candidate Michele Bachmann (followed by Congressman Ron Paul and former Senator Rick Santorum) tore into Rick Perry about his executive order mandating that girls entering the 6th grade receive a vaccine to prevent against human papilloma virus (HPV), the leading cause of cervical cancer as well as mouth cancer, tongue cancer and other cancers of the vagina, penis and anus.
Yes, HPV is a sexually transmittable disease and the transmission rates for these illnesses have been climbing rapidly. So too have both the prevalence and incidence of these cancers among young adults. Which means they are contracting them at around age 12.
Bachmann, Santorum and Ron Paul accused Perry of ordering mandatory immunizations in exchange for a $5000 campaign contribution from a former lobbyist for Merck, the developer of one version of the HPV vaccine called Gardasil. IN particular, Bachmann alleged that Perry’s decision exposed “little girls” to a dangerous drug. In doing so, Bachmann – and - by extension Santorum and Paul – gave credence to the canard pushed by the anti-vaccine movement that Merck conspired to market a product that was causing girls to go blind, become paralyzed and die.
First, the science and statistics:
- The most prominent argument against the HPV vaccine Gardasil is that it has been linked to 53 deaths (as of June 2009). These reports were made to the Vaccine Adverse Event Reporting System (VAERS). Of these, 30 reported deaths were confirmed to have occurred, but no causal link to the vaccine was found after investigation. Based on the evidence available, therefore, it does not appear that the vaccine causes death. More recent evidence demonstrates the same result.
- A post-market surveillance study by the CDC found that the rate of reported deaths (including anaphylaxis) was 0.1 per 100,000 doses distributed. Their conclusion was that reported adverse events did not differ significantly from vaccines in general.
- Further arguments against Gardasil mention fainting after immunization. This is a known possible side effect of some vaccines and is included in the package insert. The insert also includes recommendations to observe the patient for at least 15 minutes after injection to ensure the patient does not fall or suffer injury.
Then there is the claim – promoted by an anti-vaccine group claiming that Gardasil contains recombinant HPV DNA that can replicate on it’s own and go haywire on the bodies of young girls. SANE Vax Inc. Announces the Discovery of Viral HPV DNA Contaminant in Gardasil. As Respectful Insolence blog points out:
This is utter nonsense. First off…it's not a trivial matter to get recombinant DNA into human cells and expressing the protein that its sequence codes for. It's worth repeating what I described when I first encountered this idiocy in a different context. For rDNA to do what Dr. Lee worries about, the minute amount of rDNA in the HPV vaccine would have to:
- Find its way into human cells in significant quantities, which is highly unlikely given the tiny amount that, even in the worst case, is there.
- Express the protein that it codes for, which would require that the DNA be intact, complete with its promoter and regulatory regions. Again, this is incredibly unlikely, given the amount of DNA we're talking about unlikely.
Finally, there is the objection to the vaccination based on the assertion that it promotes sexual activity among pre-teens. But let’s assume – and hope – that one day a vaccine that prevents HIV is developed. Would Congresswoman Bachmann also object to requiring immunization in that case because it would similarly encourage boys and girls to engage in sexual activity?
Meanwhile Congressman Paul has indulged in the vaccine-autism conspiracy. Congressman Paul, along with Congresswoman Carolyn Maloney (D-NY) and Rep. Maurice Hinchey (D-NY) introduce the "Comprehensive Comparative Study of Vaccinated and Unvaccinated Population Act of 2006," or H.R. 2832. The bill would have required the National Institutes of Health to complete a study to examine the link between autism and thimerasol. The bill has never gone anywhere though it did prove that anti-vaccine stupidity is bipartisan.
http://www.informationliberation.com/?id=22711
Bachmann, Paul and Santorum (to a lesser extent) are spreading vaccine panic with unscientific and untruthful allegations about Gardasil and Merck. The willingness to foment fear in order to score some political points in the short term is depressing by itself. I don’t know what’s more demoralizing: that the fear mongering comes at a time when vaccination rates are dropping because parents believe the same things the candidates espouse or that the media is once again failing to do it’s job and let people know that all vaccines are highly safe and effective. But I guess that would get in the way of focusing on the catfight between Governor Perry and three politicians who have undermined the public health with misinformed and politically motivated assaults on an important tool in preventing cancer.
www.sciencemag.org/content/333/6047/1216.summary
www.biocenturytv.com/fullplayer.aspx#/BC+Show+52%3A+Biodefense/BioCentury+09.11.11+-+[3]+10+Years+After/608459720001/1150255534001/1153307594001
The need for a commercial application of products is critical to making the nation safer. The government drains value from bio-defense, it does not create it.
Nature Biotechnology opines on BIO’s proposal for a renewing and revitalizing the FDA:
Keeping innovation on American soil may also prove a Sisyphean task. BIO states that in 2009, 35% of pharma companies outsourced to Asia, primarily China and India, and almost a third of small US biotech firms have been tapped to move their R&D operations abroad of biochemical, genomic, imaging, metabolite, cellular, physiological and clinical scoring-scale information gathered from clinical trial reports, scientific conferences and public literature.
The complete article can be found here.
When I was at the FDA, we made a conscious effort to stop referring to “compassionate use” because it made it sound like “noblesse oblige.” We began to call it what it should be – expanded access.
In a house editorial, the New York Times misses the mark not only on this point (where they refer to “humanitarian use” – a nonsensical misnomer), but also as it relates to “comparative effectiveness.”
The Gray Lady opines, “This case raises the question of whether the F.D.A. should demand more rigorous trials before a device is granted a humanitarian exemption. It clearly shows the value of conducting rigorous controlled studies with enough patients to provide meaningful results. This is just the kind of comparative effectiveness research that the national health care reforms seek to promote.”
Well, yes and no.
Sure, the FDA should always strive to better understand where expanded access programs may lead. (And, it’s important to note, many patient groups – such as the Abigail Alliance – believe the FDA is already too slow and stingy with such protocols.) But even the best folks at the FDA are only so prescient. I think it wise to give the folks at White Oak the benefit of the doubt. Adoption of the Precautionary Principle (where nothing is done until everything is known) only leads to nothing being done and the death of innovation.
And as far as the “comparative effectiveness” statement is concerned, this situation has nothing to do with it whatsoever. A larger scale trial of these stents uncovered the safety problem -- precisely what such trials are designed to do. It has nothing to do with "comparative effectiveness." When it comes to the FDA -- it's about safety and efficacy.
But when you’ve got a hammer, every problem looks like a nail.
First it was gun slinging against Forest Labs, now the HHS OIG is gunning for price controls.
According to BioCentury, the OIG has recommended that the Obama administration seek authority from Congress to more effectively control Part B drug and biological expenditures. The recommendation came in a report released Wednesday documenting the difference in acquisition cost for Lucentis ranibizumab from Genentech Inc. for wet age-related macular degeneration and Genentech's Avastin bevacizumab, which is used off-label in the indication as a cheaper alternative.
The report said using Avastin instead of Lucentis for wet AMD would have saved Medicare Part B $1.1 billion and beneficiaries $275 million in copayments in 2008-09. In those years, HHS OIG said the average sales price for a dose of Lucentis, a mAb fragment against VEGF-A, was about $1,915 compared to about $7 for an intravitreal dose of cancer drug Avastin, a humanized mAb against VEGF.
The report noted that CMS, which reimburses for both drugs for AMD, does not have the authority to require price concessions or rebates for products covered under Part B. In a written response including in the report, CMS said it is "evaluating our current authorities and will seek additional authorities as necessary."
Genentech said in a statement it will not comment until it finishes reviewing the report. The company added "we do not believe that cost should be the only factor considered when choosing a medicine."
In fact, he made the most sense science-wise of all the candidates.
1. He did not back down on the need or requirement to have children receive a vaccine that can eliminate many forms of cancer. I thought it was a courageous and principled stand when he first called for HPV immunizations for all 12 year old girls. By contrast other presidential candidates -- Bachman, Santorum and Ron Paul in particular -- seem to suggest that parental rights trump immunization requirements in every case. If that is so, then we need to ask these candidates if they oppose immunization requirements for children and if they believe vaccines cause autism. Then we will see who is anti-science.
2. Perry did more to advance medical science in Texas than other governors running for President have done. Not only did he lead in the establishment of Cancer Prevention and Research Institute of Texas (CPRIT), a $3 billion, 10-year cancer research fund, Texas in one. Just recently CPRIT recruited a leading stem cell researcher to establish a pediatric cancer initiative at University of Texas (UT) Southwestern Medical Center at Dallas. The researcher, Sean Morrison, said this about Texas:
While I have been spending the last five to six years arguing with the Legislature about what kind of research would be permitted in the state, in Texas they were looking for ways to invest billions of dollars into medical research..."Texas is clearly an environment that's more supportive generally of research innovation. Three billion [dollars] for cancer research is going to change the landscape."
PS. Perry has never supported proposals to ban stem cell research in Texas either.
Ignoring these aspects of Governor Perry's record while questioning his position that the 'science' behind predictions of global disaster and requires massive government intervention in the economy -- which is what the debate is all about -- is anti-science is simply a tactic to silence that individual. Or make him or her look stupid.
I still would like to know if the candidates who criticized Perry are opposed to mandatory vaccination in any case.
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
