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Avorn claims that academic detailing is "evidence based medicine" put to use. But their is very little evidence that anti-innovation detailing improves the health of patients. There are no large scale clinical trials to look at the effect on health outcomes. Or should we just take Avorn's word that his business model is better? A study last year seemed to suggest that doctors who were subject to marketing to use the guidelines from ALLHAT and prescriibe diuretics as the treatment of choice for high blood pressure were more likely to do so. Let's ignore the fact that the claim diuretics reduced death as well or better than other drugs is based on based on secondary endpoints and that the primary endpoint (fatal coronary heart disease and nonfatal myocardial infarction) was similar for the 3 drugs. ALLHAT guidelines also hurt minorities: ALLHAT steered African-Americans to a combination of an ACE inhibitor and a [beta]-blocker in black patients. Blacks randomized to an ACE-inhibitor had 40% excess stroke rate compared to whites which explains the overall benefit of diuretics found in ALLHAT.
So Avorn peddles a protocol whose design kills black patients. He also opposed the FDA approval of BIDil -- combination of two drugs that showed overwhelming reduction in death from heart failure among blacks until scientists conduct a study that tells us why white and black patients differ in response. In doing so he ignored 3 well-controlled trials suggesting or showing a mortality benefit in black patients. As the FDA noted in response to Avorn the was "apparently unimpressed by the 43% mortality risk reduction demonstrated.. and apparently believed that the racial difference hypothesis was based on a post hoc analysis of a single trial." www.annals.org/content/146/1/57.full#ref-list-1
Actually Avorn is not only not unimpressed, he doesn't care. He makes money pushing cheaper drugs and ignoring evidence that would undermine his racket. If it harms minorities in the process, well that's just a cost of doing business.
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Whether it’s allergy medications, treatments for erectile dysfunction or high cholesterol, the issue of Rx-to-OTC switching is complicated, important – and timely.
And not just because of certain high profile LOE dates.
A new draft guidance (issued Sept. 16th) provides a valuable resource for those thinking about proceeding with OTC switches based on self-selection studies. The Pink sheet opines that “support of Rx-to-OTC switches reflects FDA's interest in drilling down for greater insight into consumers' thought processes.”
“Some experts contend there are no more switches for conditions that are relatively easy to self-diagnose, meaning the bar to convince the agency that consumers can appropriately self-select for an Rx drug in an OTC setting has been raised.”
Can a patient self-diagnose and self-dose? Do symptoms hide another, potentially more serious, underlying condition? And what of safety concerns?
Does this open the door for a so-called “behind the counter” (BTC) category? CDER Director Janet Woodcock has spoken out in favor of such strategies since they would allow switch candidates with greater self-selection obstacles to be available without a prescription.
A BTC category would almost certainly reopen the conversation about the “statin quo.”
In 2005, an FDA advisory panel voted down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.
The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.
This is an important debate as well as a "teaching moment" for American pharmacists to communicate the crucial role they play in 21st century American health care.
Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.
At the September 8th meeting focused on efficacy data from the pivotal ROCKET AF study and whether the Factor Xa inhibitor was studied against an appropriate comparator. FDA sought the advisory committee’s input on whether warfarin or dabigatran was the appropriate comparator for rivaroxaban in light of a 1995 agency policy that requires new therapies be “as effective” as approved treatments when the disease at issue is life-threatening or capable of causing irreversible morbidity.
At a Sept. 8 meeting, the majority of panel members said Xarelto’s sponsors should not be required to directly show comparable efficacy to dabigatran, a drug approved 11 months ago.
According to the Pink Sheet, panelists commented that requiring drugs for serious or life-threatening diseases to be compared head-to-head against the newest treatment on the block could “throw a wrench in long-planned and ongoing clinical development programs that use a well-established standard of care as a comparator agent.”
Office of Drug Evaluation I Director Bob Temple on the question as to whether or not the ROCKET AF study population represented a sufficiently different group of patients from those in RE-LY as to render the “as effective” policy inapplicable to rivaroxaban:
“This was not my favorite question.” Dr, Temple then proceeded to point out the bigger issue inherent in applying FDA’s “as effective” policy in a dynamic development and regulatory environment.
“There is an interesting and provocative issue here. Suppose in the course of the study, something new and really hot comes along. Do we ever say, ‘I’m sorry, you compared it to a dog, we have something better now?’ We don’t usually do that, but I wouldn’t rule out the possibility. And this is a little bit about that possibility, but I don’t think we really meant to get too much into that discussion.”
Read More & Comment...PCORI Executive Director Joe Selby wants to be clear that while the institute's main focus will be on patient-centered activities, it will wants participation from all interested parties.
"We want a director of stakeholder engagement to engage providers, caregivers, employers, health plans, health systems, health services researchers and other researchers, government and industry," Selby said September 19th during the PCORI Board of Governors meeting in Seattle.
Good idea. And the selection process (and the selected candidate) should be carefully watched to see how Dr. Selby and the PCORI board defines “interested parties.”
Read More & Comment...Barak Obama is quickly becoming the anti-innovation President.
On Monday, the White House released its deficit reduction plan. Part of the President’s strategy is to impose new rebates on Medicare drugs, strengthen the Independent Payment Advisory Board, and reduce the exclusivity period for innovator biologic drugs.
It’s not class warfare – it’s no-class warfare. And it’s deleterious to the public health.
As the Old Perfessor used to say, let’s look at the record.
First, on the topic of Medicare rebates, why don’t we just call it what it is – a tax. More precisely, an excise tax imposed by Uncle Sam on drug sales.
But wait, it gets worse. The revenues from this tax don’t lower costs for a single patient. Not one. The cash would go into the general fund. It’s not a “rebate” – it’s a tax, plain and simple. A levy imposed on price.
And, hiding behind “deficit reduction,” it’s a tax with a hidden purpose – the introduction of backdoor price controls. And price controls equal cost controls – with or without IPAB.
Speaking of IPAB, the President's plan seeks to lower the threshold at which IPAB would impose Medicare spending cuts; however, the plan doesn't specify what the savings would be. So much for “specifics.” But, specifically speaking, a stronger IPAB further ices the slippery slope towards government price controls and (ultimately) a single payer system.
There’s already the very real risk that IPAB will be insensitive to the needs of Medicare patients. After all, board members are unelected appointees with an incredible amount of power. The IPAB is liable to enact cost-cutting measures that might sound good in the boardroom, but actually lead to worse health outcomes for Medicare patients and strap them with unbearable costs. The President’s proposal makes this twice as bad.
And then there’s the anti-innovation codicil. The President wants to cut innovator biologics exclusivity to seven from the current 12 years.
It’s hugely disappointing that the same man who (as a United States Senator) once said that …
“Realizing the promise of personalized medicine will require continued federal leadership and agency collaboration; expansion and acceleration of genomics research; a capable genomics workforce; incentives to encourage development of genomic tests and therapies; and greater attention to the quality of genetic tests, direct-to-consumer advertising and use of personal genomic information."
… is now advocating a policy that would result in precisely the opposite.
After speaking (during the State of the Union and a widely quoted op-ed in the Wall Street Journal) about the need for America to embrace innovation – President Obama is trying to make it more difficult, specifically when it comes to the desire to invest in pharmaceutical innovation – a sure bet under no circumstances.
Patent exclusivity funds an innovator company’s research and development efforts. If the President’s proposal becomes law, the US would provide less data protection for innovative biologics than Europe.
12 years of exclusivity also gives hope to those suffering from rare diseases or conditions. If innovator companies think they will have a short time before a follow-on versions of their products hit on the market, they will likely only focus on drugs for major diseases and conditions -- potentially ignoring ailments that are less common, but equally as serious, to those suffering.
What’s next – an executive order instructing the FDA to approve biosimilars without clinical trials? Alas – this is unfortunately not a far-fetched idea considering the tone and substance of President’s speech on Wednesday.
If innovation is one of the key answers to our national economic recovery, then the President should abide by what he said, “Our economy is not a zero-sum game. Regulations do have costs; often, as a country, we have to make tough decisions about whether those costs are necessary. But what is clear is that we can strike the right balance. We can make our economy stronger and more competitive, while meeting our fundamental responsibilities to one another.”
As Harvard University health economist (and Obama healthcare advisor) David Cutler has noted: "Virtually every study of medical innovation suggests that changes in the nature of medical care over time are clearly worth the cost."
L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning. Let’s keep our eye on the prize. No, not budget reduction – the real prize: better access to smarter healthcare for all Americans. Innovation that focuses on creating a chronic healthcare culture that embraces prevention and prophylactic care. Rather than wasting time on spin, let’s redouble our efforts on innovation. Then, when we succeed through brainpower and teamwork (and, hopefully some civil bipartisanship), the circus surrounding the President’s deficit reduction proposal will be but a footnote in the history of American healthcare.
Read More & Comment...According to the New York Times, “Hospira, based in Lake Forest, Ill., which has been selling cheaper versions of expensive biologic drugs in Europe for nearly four years, said on Monday that it would begin a final-stage clinical trial in the United States by the end of this year of its biosimilar version of Amgen’s brand-name Epogen in patients with renal dysfunction who have anemia.”
Good news, right? Well – yes. But ...
Yesterday at the 3rd annual Business of Biosimilars & Biobetters Conference in Boston, Naomi Pearce (Director of IP at Hospira) gave a brutally tactical presentation on how to move forward with biosimilars via the “3 C’s – Challenge, Circumvent, Create.” 99.9% of her remarks focused on how to challenge and circumvent patents. The remaining .1% (under the heading of “create”) was limited to “and create something new when it makes good commercial sense.”
Ms. Pearce is a patent attorney and, of course, when you have a hammer every problem looks like a nail. But it does point out many of those looking to enter the biosimilar space are looking at the opportunity as another “generics play.” It reminds me of the time that Israel Makov (the founder and “Big Abba” of Teva) said to me that “Teva isn’t in the pharmaceutical business, it is in the litigation business.”
That was then and this is now? Alas, not so fast.
Read More & Comment...Here are the links to the two performances.. I think I look better on radio than I do on TV.. But you decide.
minnesota.publicradio.org/display/web/2011/09/19/midmorning1/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-2-91611/1355953/
www.nbc.com/the-tonight-show/video/michele-bachmann-part-1-91611/1355952/
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A: When it's a super office.
FR: Janet Woodcock
TO: CDER Staff:
The Office of Medical Policy (OMP) has been reorganized into a Super Office. Within its organizational structure are the Office of Medical Policy Initiatives and the Office of Prescription Drug Promotion. Led by Rachel Sherman and her Deputy, Kathleen Uhl, OMP plays a critical role in directing medical policy programs and strategic initiatives.
This includes directing regulation of prescription drug promotion and advertising, providing leadership and scientific advice on clinical trial design, providing consultation and direction in policy issues related to human subject protection and good clinical practices, supporting the recent Health Care Reform Act that provides new legislation for Biosimilars, and developing regulation, guidance documents, and procedures related to medical policy issues.
· Rachel Sherman, Director, Office of Medical Policy
· Kathleen Uhl, Deputy Director, Office of Medical Policy
· Janet Norden, Associate Director for Regulatory Affairs
The Office of Prescription Drug Promotion
The Division of Drug Marketing, Advertising, and Communications has been reorganized and elevated into the Office of Prescription Drug Promotion (OPDP).
This reorganization will leverage OPDP’s resources and processes to provide for the highly effective oversight of prescription drug promotion.
ODPD consists of an Immediate Office, the Division of Professional Promotion (DPP), and the Division of Direct-to-Consumer Promotion (DDTCP). The new structure will help prevent misleading promotion about prescription drugs and enhance the quality of communications about prescription drugs and other health information developed by companies.
Thomas Abrams, Director, Office of Prescription Drug Promotion
Mark Askine, Associate Director, Office of Prescription Drug Promotion
Marci Kiester, Associate Director of Operations, Office of Prescription Drug Promotion
Catherine Gray, Acting Director, Division of Professional Promotion
Robert Dean, Acting Director, Division of Direct-to-Consumer Promotion
The Office of Medical Policy Initiatives
A newly created Office of Medical Policy Initiatives (OMPI) consists of an Immediate Office, the Division of Medical Policy Programs (DMPP), and the Division of Medical Policy Development (DMPD).
This office will develop and coordinate medical policy regulations and guidances that address the policy and program areas covered by the Super Office. The organization of the divisions supports the continued implementation and successful advancement of the Sentinel Initiative, the Clinical Trials Transformation Initiative (CTTI), and the Patient Medication Information (PMI) Initiative.
Within this reorganization, the Patient Labeling Team (PLT) will be moving from the Office of Surveillance and Epidemiology (OSE), Division of Risk Management (DRISK) to OMPI, Division of Medical Policy Programs. The goal of the Patient Labeling Team is to promote the safe and effective use of prescription medications by providing accurate and easily understood patient medication information. OMPI will reach out to affected offices with procedural details on the PLT's transfer.
Denise Hinton, Director, Office of Medical Policy Initiatives
Richardae Araojo, Deputy Director, Office of Medical Policy Initiatives & Acting Division Director, Division of Medical Policy Programs
Paula McKeever, Division Director, Division of Medical Policy Development
Read More & Comment...It seems that the FDA has decided that biosimilar sponsors will not be required to meet with the agency at specific times or for specific reasons during the IND phase of development, allowing them more flexibility early in the process.
Product development fees would be collected when a biosimilar sponsor files an IND. It is expected to be about 10% of the cost to file for a marketing application review and be charged annually as long as the product remains in active development stages.
FDA wants the earlier infusion of funding to support agency activities during the biosimilar IND stage, which are expected to be more extensive than those for other applications. The agency agreed to discount all product development fee payments from the marketing application fee once it is filed
FDA and the brand and generic industry representatives also may have ended their dispute over whether the biosimilar user fee program should be independent of the other user fee programs.
At an August 8th meeting the agency circulated draft statutory language authorizing creation of the program independent of other user fees. The minutes did not indicate opposition by GPhA on any portions of the proposal. There also was no mention in the minutes of further discussion of the appropriations trigger.
The agency agreed to write a draft commitment letter for discussion at another negotiating session, another indication both sides have moved beyond the issue.
The biosimilar user fee program is expected to be included in an omnibus bill that also will include the Medical Device User Fee and Modernization Act and PDUFA reauthorizations, as well as the new generic drug user fee program.
Read More & Comment...On Wednesday I attended the Washington Post’s event on non-communicable diseases (NCDs), “Sharing the Responsibility.” The event was co-sponsored by Eli Lilly & Co.
(Video clips of this event can be found at www.washingtonpostlive.com)
The title of the conference was crucial as world-class speaker after speaker spoke to the need for cooperation between (as Ann Keeling, the CEO of the International Diabetes Federation and Chair of the NCD Alliance put it) “the three P’s – public, private, and people.”
For a change, the discussion of NCDs wasn’t framed as a battle between “good guys” (generally portrayed in the mainstream media as “civil society”) and “bad guys” (private industry). Rather than being about placing the blame, it was about developing solutions. This position was stated early and eloquently by the event’s opening speaker, Dr. Julio Frank (Dean of the Faculty, Harvard School of Public Health and the key founding father of the Mexican healthcare system). Dr. Frank warned that we must avoid and beware of “reductionist solutions.”
When asked about the role of intellectual property rights and their role in addressing the NCD issue, Dr. Frank said that protecting IPRs is crucial to developing new and innovative global healthcare solutions. While he was answering this question, Ms. Keeling had no comment on the question of IPRs but did comment that, “there are no magic bullets.”
This concept of “shared responsibility” issues many challenges – not the least of which goes out to the “Uncivil Society” movement led by (among others) Jamie Love. Uncivil Society demonizes any role for industry -- except maybe writing checks (which brings to mind Abba Eban’s famous quote about the give-and-take between Israel and the PLO –“We give and they take.”)
As H.L. Mencken famously quipped, “For every complex problem there is an answer that is clear, simple, and wrong.”
Uncivil Society was called out at this event. “Shared responsibility,” means they must cease repeating and repeating and repeating their incessant falsehood that the majority of the Developing World’s healthcare problems could be solved if only we would do away with patents and intellectual property protection.
The petty agenda of Uncivil Society must not be allowed to hijack the important global mission of combating NCDs.
During the panel on “Public & Private Partnerships,” Herb Riband (VP, External Affairs for Medtronic) spoke about a “confluence of interests.” And John Lechleiter (President and CEO, Eli Lilly & Co.) commented that, “There is no substitute for the power of partnership.” And Lilly is putting its money where its mouth is. A day before the Post event they announced the Lilly NCD Partnership, a five-year $30 million commitment to fight the rising burden of non-communicable diseases in developing nations. And it’s not about writing a check, but rather combines the company’s 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.
As Mark Kramer (Senior Fellow, Harvard Kennedy School of Business) said, a key role for private industry is to “broker partnerships that propel progress.”
David Brown (a Washington Post journalist and a physician) commented that we must avoid the “false dichotomies” of NCDs (infectious vs. non-infectious, cure vs. prevention, rich vs. poor). So too must we avoid the false dichotomy of “hero vs. villain.”
The Washington Post conference, held in advance of next week’s historic United Nation’s High Level Meeting on NCDs, made it abundantly clear that, to actively, aggressively, and creatively fight NCDs in the Developing World (and, for that matter, the whole world), there must be partnerships rather than partisanship.
The common ground is shared responsibility.
Read More & Comment...Hm.
Please have a look at this short PSA on why, when it comes to vaccines, celebrity trumps science.
And please, pass this along. Let's make it a YouTube sensation.
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If you have an interest and no pressing conflicts, two important briefings by the CME Coalition (www.cmecoalition.org) to consider attending:
CME Cancer Policy Briefing
On September 27, from 12:00 – 1:00 in the Rayburn House Office Building “Gold Room” (Room 2168), the Coalition will be presenting a program entitled “Continuing Medical Education: A Focus on Breast Cancer Breakthroughs.” This panel will comprise thought leaders in the fields of CME and breast cancer treatment, and will include:
Dr. Jonathan Sackier: Chief Medical Officer, Audax Health Solutions, Visiting Professor of Surgery, University of Virginia, Following positions at Cedars-Sinai and UCLA, he was named Professor of Surgery at George Washington University, in Washington, D.C. where he founded the Washington Institute of Surgical Endoscopy.
Dr. Charles Balch: Professor of Surgery and Oncology and Dermatology, Deputy Director, Johns Hopkins Institute for Clinical and Translational Research, Former CEO of American Society of Clinical Oncology
Dr. Dana Simpler: Primary Care Practitioner, Mercy Medical Center, Baltimore, MD, Has appeared in numerous print and broadcast media, locally, regionally and nationally as a health care thought leader.
And …
CME HIV Policy Briefing
On September 28, from 12:00 – 1:00 in the Senate Commerce Committee Hearing Room (Russell Senate Office Building Room 253), the Coalition will be presenting a program entitled “Continuing Medical Education: A Focus on HIV Breakthroughs.” This panel will comprise thought leaders in the fields of CME and HIV treatment, and will include:
Dr. Jonathan Sackier
Dr. John Bartlett: Professor and Chief of the Division of Infectious Diseases at Johns Hopkins, Internationally renowned authority on AIDS and other infectious diseases and recipient of the prestigious 2005 Maxwell Finland Award for scientific achievement from the National Foundation for Infectious Diseases.
Dr. Alan Wasserman: The Eugene Meyer Professor of Medicine and the Chairman of the Department of Medicine at The GWU School of Medicine and Health Sciences, Chairman of the Board of Trustees and President of The George Washington University Medical Faculty Associates.
Space is limited, however, so kindly RSVP at by September 16th to rsvp@cmecoalition.org or call Shea McCarthy at (202) 688-0225.
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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.
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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.
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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.
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