Update from Peyton Place

09/13/2011 03:17 PM |

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!

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Bachmann Promotes Vaccine Panic

09/12/2011 11:52 PM |

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 6^th 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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Raising (Bio)Shields

09/12/2011 04:13 PM |

Two sobering assessments of the difficulty in bringing forth second generation countermeasures underscore the problems added to the development process when government controls the process. 

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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Nice Package

09/12/2011 06:52 AM |

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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Nonsense on Brain Stents

09/09/2011 12:00 PM |

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. 

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Price Controls? OIG Vey!

09/08/2011 10:25 AM |

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."

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Rick Perry is NOT Anti-Science

09/07/2011 10:16 PM |

It is likely that Rick Perry's statements about Social Security being a "ponzi scheme" and climate change will make and shape the headlines tomorrow (and tonight).   There will be a steady stream of comments about Perry being anti-science.  But Rick Perry is  not anti-science.

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. 
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Doctors vs. anti-vaccine propaganda

09/07/2011 03:44 AM |

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Not Such Great Expectations

09/06/2011 07:51 AM |

"We spent as much money as we could, and got as little for it as people could make up their minds to give us. We were always more or less miserable, and most of our acquaintance were in the same condition.” -- Great Expectations

In terms of “learning” about healthcare reform from our British cousins, here’s lesson #1:  Don’t believe everything (or anything) you heard on SiCKO.  Lesson #2 is seeing CMS Administrator Dr. Donald Berwick in the role of Pip.

According to an investigation in the Daily Telegraph, at least 10 primary care trusts (PCTs) have told hospitals to increase the length of time before they see patients in order to save money.

In one case a manager said the policy keeps patients in line as “short waiting times also create more demand for treatment due to the expectations this raises."

In some areas, patients endured delays of 12 or 15 weeks after GPs decided they needed surgery, even though hospitals could have seen them sooner.

The maximum permitted time between referral and treatment is 18 weeks.

It comes after an NHS watchdog suggested that if patients are forced to wait a long time, they will remove themselves from lists “either by dying or by paying for their own treatment."

Andrew Lansley, the Health Secretary, said: “This practice is simply unacceptable and one of the many reasons we need to modernise the NHS and put patients’ interests first.

The complete article from The Telegraph can be found here.

“Pause you who read this, and think for a moment of the long chain of iron or gold, of thorns or flowers, that would never have bound you, but for the formation of the first link on one memorable day." -- Great Expectations

Hat tip to Helen Evans at Nurses for Reform.

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What we don't need is a little Christmas right this very minute

09/02/2011 06:44 AM |

A sudden bold and unexpected question doth many times surprise a man and lay him open.  – Francis Bacon

The official PDUFA V technical letter contains no surprises.  There are no “Christmas Tree items.”  It is a document full of incremental improvements. It is, in a word, “clean.”  But don’t let that fool you.  There’s a battle ahead.

(The technical letter can be found here.)

Unlike past reauthorization, when industry and agency reached agreement and Congress rubber-stamped it, this year there are going to be questions. Some relevant (predictability and responsibility), some not (greater regulation of consumer marketing practices), some thorny (should biosimilar reviews be covered under PDUFA through fiscal year 2017). It’s a long list.

For many involved in the reauthorization process, one statement that keeps coming up is -- ”The FDA is broken.” But what does that mean? Rather than making blanket statements that cause friction and promote areas of disagreement, one thing everyone can agree to is that the FDA’s must be both ally and accelerator in the advancement of innovation.

Can that be accomplished within the confines of PDUFA V?

PDUFA IV expires Sept. 30, 2012. Senator Tom Harkin (D, IA -- Chairman of the Health, Education, Labor and Pensions Committee) said he hopes PDUFA V will reach Congress by year-end, so that his committee can mark up the legislation in the spring. Representative Joe Pitts (R, PA -- Chairman of the House Energy and Commerce Committee's health subcommittee.) said he hopes to have PDUFA V enacted by June 30, 2012.

Let the battle begin.

For another interesting view on the “deal on the table,” have a look at what Robert Metcalf, Vice President, Global Regulatory Affairs at Eli Lilly & Company, has to say.  His comments can be found here.

The only thing that should surprise us is that there are still some things that can surprise us.  – Francois de La Rochefocauld  Read More & Comment...

The (Clinical) Trial

09/01/2011 08:18 AM |

Life imitates art.  In Franz Kafka’s unfinished story, “The Trial,” a man is arrested and prosecuted by a remote, inaccessible authority, with the nature of his crime revealed neither to him nor the reader.

 

Well – it’s déjà vu all over again -- new Russian regulations making it harder for the Rodina to become an international destination center for clinical trial excellence.  And nobody knows why.

 

As Dr. Meir Pugatch discusses in a new Journal of Commercial Biotechnology article, “The overall, the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.”

 

(More on Dr. Pugatch’s article can be found here.)

 

This is bad news for Russia.

 

New data shows that clinical trial activity in Russia is still on the decline following the introduction of new regulations last year. The total number of trials approved in the first half of 2011 fell by 36% to just 200, with trials conducted locally by domestic sponsors most affected, falling by around 80%, according to the Russian clinical trials organization, ACTO.

 

The slowdown is mainly due to the law on circulation of medicines, which came into effect in September last year. Among other things, the law incorporated local clinical trials into the drug registration process, introduced new trial approval and insurance procedures, and imposed a ban on the import of registered products for use in clinical trials.

 

Not only is this bad news for international investment – but it also has the unfortunate side effects of making it more difficult for Russian companies to conduct clinical trials in their own country. Russian companies wanting to conduct local trials (as opposed to Russian arms of multinational studies) can do so only as part of a drug registration procedure, not as freestanding studies.

 

According to ACTO Executive Director Svetlana Zavidova, she did not know why this distinction had been made, but it was possible that those drafting the law had simply forgotten to state that local clinical trials were also a freestanding kind of study.

Kafkaesque – and with unfortunate results.

The number of local safety and efficacy studies approved in Russia fell by 78.4% to 19 in the first half of 2011, while bioequivalence studies were down by 84.4% to just seven. According to ACTO, the fall in bioequivalence studies is probably due to two factors: there are no approved requirements for such studies, and in some cases generic manufacturers cannot refer to the originator's pre-clinical trial results and are having to carry out their own tests, thereby delaying the bioequivalence study.

 

These developments are somewhat worrying given that the government has made much of its plans to build up the Russian pharmaceutical industry and reduce the country's reliance on imported medicines. "It is remarkable that the implementation of the law had a particularly tough impact specifically on the innovation activity of Russian companies, which is in direct contradiction with the governmental desire for import substitution in pharmaceuticals," ACTO commented.

“Remarkable?”  Not really.  Predictable?  Absolutely.

On the positive side, sponsors of international trials fared better than their Russian counterparts in the first half of 2011, gaining 163 trial approvals compared with 160 in the 2010 period. Nonetheless, they had their own problems, including the lack of new rules on insurance, which should have been in place on 1 January this year, and the ban on importing registered drugs (for use as comparators in clinical trials of experimental drugs).

 

Bad News: The import ban affected not only new studies but also those already under way where stocks of the approved drug were running short, says ACTO, which notes that some new studies were cancelled and transferred to other countries.

 

Good News: The ban was finally lifted in June this year when the health ministry took over responsibility for the importation of both approved and unapproved medicines, while the insurance question was dealt with by a May decree implementing the amended rules.

 

Bad News: Another factor dampening trial activity has been the fact that the authorities are not adhering to the new, shorter timeframes for trial approvals stipulated in the new law.

 

In fact, according to ACTO, things are even worse than they were before the law came into force: in the first six months of 2011, the total time taken to gain approval for a trial and obtain import/export permits amounted to an average of 160 days. This is "twice as long as the maximum period allowed by law and 30.5% longer than the all-time worst results.”

 

Other problems remain, says ACTO, including the fact that foreign companies still have to conduct a local trial (free-standing or as part of an IMCT) when seeking new drug registration in Russia. "Unfortunately, this problem is still on the front burner for us", ACTO’s Zavidova commented.

 

That must be some big front burner.

 

Considering the importance of clinical trials as a leading indicator of international pharmaceutical investment, perhaps Moscow should seek expert advice on the subject.  After all, as the Russian proverb says, “With a helper a thousand things are possible.”

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The Four Percent Solution

08/31/2011 01:28 PM |

Is 4% a lot or a little?  Well – it depends whether you’re one of the 4%.

 

As the AP reports, “Pfizer Inc.'s just-approved drug Xalkori, the first new medicine in more than six years for deadly lung cancer, proves the value of precisely targeting rare diseases linked to gene variants

The drug was approved Friday in the U.S. along with a companion diagnostic test for just a small subset of lung cancer patients. It is the poster-child for the 21^st century strategy of developing medicines for relatively few patients to replace (as the AP puts it) “blockbusters for the masses.”

 

"This is a paradigm shift," Dr. Paul A. Bunn Jr., a University of Colorado professor and cancer researcher involved in testing Xalkori, told journalists during a conference call hosted by Pfizer. "It used to be that everybody with cancer was treated the same," with surgery and chemotherapy.

 

Xalkori, a pill with relatively minor side effects compared to the hair loss and nausea that chemotherapy can cause, was approved for the roughly 4 percent of patients with advanced nonsmall cell lung cancer who have what's called the ALK fusion gene.

 

About 6,000 Americans a year develop this cancer, Pfizer said. Those patients, called ALK positive, now can be identified with a $250 molecular diagnostic test developed by Pfizer's partner, Abbott Molecular Oncology. The test was also approved Friday.

 

According to Dr. Mark Kris, head of the thoracic oncology service at Memorial Sloan-Kettering Cancer Center in New York, "You're going to be sparing individuals side effects (and) the waste of resources, time and drug that really isn't going to help them."

Cost efficient and patient-centric. Bingo.

 

Personalized medicine, targeted therapy – call it what you will.  It’s real.  And it’s a giant step towards achieving the 4 rights – the right medicine in the right dose for the right patient at the right time.

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PCORI? Memento Mori.

08/30/2011 08:43 AM |

For those of you who missed Latin class that day, memento mori means, “remember your mortality.”

 

It seems that the American Medical Association has (albeit a little late in the game) woken up to that fact and gotten religion.

 

The AMA has invited other healthcare groups to sign onto a letter to the Patient Centered Outcomes Research Institute (PCORI) on the types of research that should and should not be conducted under ObamaCare. The AMA is concerned about its proposal to "investigate ... optimizing outcomes while addressing burden to individuals, resources, and other stakeholder perspectives."

 

They should have read the bill before they so aggressively supported its passage.

 

Why the turnaround? Could it be that America’s physicians worry that including cost in the equation will open the door to rationing down the line?

 

"We seek further clarification toward the Board's intentions regarding this last component and whether this includes cost analysis," states a sign-on letter scheduled to be sent later this week to PCORI executive director Joseph Selby. "If that is the case, we do not believe that it is consistent with the PCORI's enabling statute."

 

The issue, at its core, is physician disempowerment. With first insurance companies and now Uncle Sam telling doctors how to practice medicine (step therapy, restrictive formularies, more strident and cumbersome preauthorization requirements, and academic detailing), it’s no wonder that physicians are mad and that the AMA is doing a volte-face on PCORI and comparative effectiveness.

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Of IPRs and In-Flows

08/29/2011 08:42 AM |

My good friend, Professor Meir Pugatch of the University of Haifa, is one of the world’s most respected experts in the role that robust intellectual protection plays in economic development.

 

In a new paper in the Journal of Commercial Biotechnology, Dr. Pugatch asks a crucial question -- To what extent does the strengthening of intellectual property (IP) environments in developing countries lead to greater in-flows of technology transfer in these countries?

 

According to Dr. Pugatch, there is a growing body of statistical evidence suggesting that a stronger IP environment does contribute to an enhanced level of foreign direct investment (FDI) and technology transfer in developing countries.

 

For example, an OECD study finds that in developing countries an increase of 1 per cent in the strength of patent rights resulted in 1.7 per cent increase in FDI flows, which in turn resulted in the transfer of know-how, that is innovative capabilities. Quite an attractive multiplier.

 

Here’s the official abstract:

 

The strength of pharmaceutical IPRs vis-à-vis foreign direct investment in clinical research: Preliminary findings

 

This article examines the effect of the intellectual property (IP) environment in developing countries on the level of foreign direct investment (FDI) and technology transfer occurring in the biopharmaceutical field in these countries. In particular, it considers the correlation between the strength of IP protection in several developing countries (using the Pharmaceutical IP Index) and the number of clinical trials taking place in these countries (as a proxy of biomedical FDI). The article finds that overall, the strength of national pharmaceutical IP environments provide a good estimate of the level of clinical trials taking place in these countries. Accordingly, countries with a more robust level of pharmaceutical IP protection tend to enjoy a greater level of clinical trial activity by multinational research-based companies. In other words, by choosing to improve their level of protection of pharmaceutical IPRs (together with other factors), developing countries may also be exposed to higher levels of biomedical FDI, not least in the field of clinical trials.

 

The full article can be accessed here.

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Why Vaccine Fears Persist

08/26/2011 08:54 PM |

As the recent Institute of Medicine report concludes the scientific evidence about vaccines benefits and microscopic risks is clear and convincing.   Report: Vaccines Are Safe, Hazards Few And Far Between

Yet, politicians of all stripes have indirectly fed the  the unfounded fear of parents who refuse to vaccinate, thereby endangering the lives of others.   the Obama administration has ducked the issue of vaccine safety instead of addressing the issue clearly..  It has missed several opportunities to promote vaccine safety and have, in the past, caved into anti-vaccine forces.  It has given money to anti-vaccine groups.  At the same time it was unfortunate that Rick Perry backtracked on the issue of requiring HPV vaccination, not because mandatory vaccination is appropriate (it should be used sparingly) but because in doing so he did not reaffirm the importance of the vaccine in eradicating many forms of cancer that are increasing in prevalence.   And Washington State, where parents are refusing to immunize their kids in record numbers, has buckled under pressure for anti-vaccine forces and failed to enact a law making it tougher to bail out of vaccinations.   www.kvewtv.com/article/2011/aug/01/wa-leads-nation-parents-opting-out-immunizations/

For many reasons lots of politicians don't want to say they support a government requirement of any form.  (The battle over the individual health mandate is a case in point.)  And they don't want to confront parents who insist vaccines cause autism.  But requiring people to be immunized is a way of protecting the freedom not to be exposed to vaccine preventable illnesses.  Many, if not most, of those who are infected by vaccine choicers and their kids, are infants or immunocompromised children who rely upon others to protect them against disease and death.  

Freedom is not the unfettered right to avoid the dangers dancing in your head at the expense of the health and life of others.   Living in and benefitting from a free society requires not just meeting obligations  but also abiding by norms of thought and collective action that comport with reason and science.  Thomas Jefferson observed:  "The value of science to a republican people, the security it gives to liberty by enlightening the minds of its citizens, the protection it affords against foreign power, the virtue it inculcates, the just emulation of the distinction it confers on nations foremost in it; in short, its identification with power, morals, order and happiness (which merits to it premiums of encouragement rather than repressive taxes), are considerations [that should] always [be] present and [bear] with their just weight."

 

Politicians and public health officials should stand up for medical science and not contribute to what the National Vaccine Advisory Committee calls "the culture of refusal."

 

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Shuren’uff

08/26/2011 03:06 AM |

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NIH Conflict of Interest Rules Criminalize Innovation

08/25/2011 04:29 PM |

The gang that have produced new rules to prevent even the appearance of conflict of interest in medical research have an agenda. 

They single out any relationship involving any resource or transaction that "may" have a monetary value exchanged between drug or device companies and academics.

But health IT companies, HMOs,  trial lawyers, hospitals,  government bureaucrats who hand out dough for comparative effectiveness research are exempt from oversight.  Apparently there is no possibility for any undue influence from such entities.

The NIH are defensive about the impact these regs will have on innovation.  And they should be.

"We want to emphasize that the revisions are not designed to prevent or hinder relationships among government, academia, and industry. Rather,
the revisions are aimed at facilitating such relationships by increasing transparency and accountability so that the resulting research is considered objective and in the interest of the public."

Given that most scientific misconduct and publication bias is a product of career climbing having nothing to do with industry, the emphasis on industry seems misplaced.

Moreover,  who said that people are concerned about objectivity as defined by the Obama administration?   One person's objectivity is another person's bias.   And the new regs simple open up the process of biomedical innovation to more questions about conflict that have nothing to do with quality of the research -- ultimately measured by whether we can prevent or control diseases more effectively -- but everything to do with the cultural and ideological belief that commercialization inherently benefits large companies at the expense of the rest of us and that the commercialization process is inherently corrupt and corrupting.   

The advocates of the regs claim that more oversight and investigation is needed because industry support for research has increased.  Is it the industry support itself or the magnitude?  Where is the evidence that more money means more corruption?  Isn't the opposite outcome as likely:  That is, people with a financial stake in the outcome of a research are more likely to be more scrupulous about research to protect their investment?   Loss of reputation is a huge price to pay for fudging data for starters.   Do the NIH reg advocates believe that industry funded scientists are more likely to lie about the safety and effectiveness of new products even at the expense of  harming people?

The answer is yes.  This culture of mistrust would have ensnared and persecuted the following individuals who had -- under the new guidelines -- the potential or actual presence of a financial conflict:

Louis Pasteur -- wine and beer maker and recipient of wine industry money
Gertrude Elion    
George Hitchings
Sir James Black
Craig Zello
Phil Sharp
Joseph Goldstein
SIr Peter Mansfield
Judah Folkman

Most are Nobel Prize winners.  All used industry money to commercialize devices and medicines that have extended and improved life.   But according to the conflict of interest priesthood, the research they produced was tainted and therefore the results could be not trusted.   They would be required to "report the name of the company or entity in which there’s a conflict of interest, the value of the interest, why it’s a conflict and “some key elements” of how the institution plans to manage the conflict."  

blogs.wsj.com/health/2011/08/23/new-nih-conflict-of-interest-rules-better-than-the-old-rules/

Note there is no room for arguing there is no conflict.  It's a confict.  Acting as if it isn't is a grounds for investigation.   Your only option is to tell the world just how guilty are are or appear to be.  This makes a forced confession easy by comparison.

Meanwhile Andrew Wakefield, who received cash from trial lawyers and his own patients, would be exempt not only from the new NIH rules but the suspicion of the COI kapos.  

Ditto the groups who pushed for this sort of witchhunt.  Money from George Soros, the IOM (a conduit for ideologically tilting foundations) and others are exempt too.

The new rules are the culmination of an ideological assault by those who believe commercialization is inherently corrupt and corrupting and who ignore the fact that as a result of such innovation,  life expectancy and death rates from cancer, heart disease and other illnesses have declined in direct relation to the industrial investment in treatments for death and disease.


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SEO = Search Engine Oops

08/25/2011 09:56 AM |

Google Inc. has agreed to pay $500 million for carrying advertisements by online Canadian pharmacies targeting consumers in the United States, according to the U.S. Justice Department.

 

The ads resulted in the illegal importation of prescription drugs, the Justice Department said.

That's a big oops.

 

The $500 million represents the money Google made from selling the drug ads, plus the revenue earned by Canadian pharmacies from sales to American customers.

As an FDA Associate Commissioner said back in 2003 (on the front page of the Washington Post), "You can't blame them (Google) for accepting commerce. But they really haven't understood the consequences."

They do now.

Who was that prescient FDA guy?

For the answer to that question and further background on this story, see here.
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Are Guidances Good?

08/24/2011 02:43 PM |

The FDA has unveiled, after much hard work,  several guidances on everything from companion diagnostics, to biomarkers, to what safety data has to be included in pre-clinical and Phase I research.   That's on top of yet another proclamation about how the agency is focused on regulatory science (isn't that a contradiction in terms?) that will speed innovation.  We heard and saw that from the FDA about three other times this year.  And everything said or written is a footnote to the Critical Path report that was ignored after the Vioxx hysteria.  

Guidances are okay but they are no substitute for less regulation and more scienced-based common sense, as evidenced by this account of how farmers may soon have to regulate...dust.

blog.heritage.org/2011/08/20/president-obamas-regulatory-dust-up/
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Obamacare Drug Shortage

08/23/2011 12:04 PM |

Call it Obamacare's Final Destination Tour.   While President Obama rests up at Martha’s Vineyard, people whose lives should be saved by new and existing cancer drugs are driving from hospital to hospital in search of medicines in short supply thanks in part to Obamacare’s implementation.

 

Over the past two years shortages have developed for over 180 drugs, including cancer treatments.  The shortfall is the result stricter FDA regulation, government price controls on already discounted but complex drugs, and policies that discourage the use of new medications.   Companies, facing lower prices, tighter regulation and increasing government control over what drugs will be used when, are exiting the US market and investing in product development in china and India where, sadly, it is easier and cheaper to produce next generation medicines than in America.

 

Stockpiling will only add to people's suffering by replacing market reforms with government micromanagement.  Government planners require months, if not years, to produce regulations, bids and supply estimates that are usually overgenerous to compensate for paltry prices.  Government bungling was behind the failure of the smallpox and H1N1 vaccine program and responsible for billions of dollars in flu vaccines and antibiotics being dumped.

 

The same forces pushing stockpiling also believe commercializing medical discoveries is evil.  It’s part of a larger effort to nationalize the development of medicines that under Obamacare is become institutionalized  

 

Indeed, the drug shortage is a product of a more troubling trend: At a time when medical research could yield breakthroughs in the treatment of obesity, Alzheimer's, diabetes, stroke among others, innovation has all but dried up.   Most of the medicines being used today were developed 30 years ago.   Most of them have generic competition.   They have contributed greatly to increased wellbeing but as the return on generic drugs fall, price controls and regulation have created shortages. 

 

Obamacare is making the commercialization of newer drugs and devices more difficult.

Though new and faster methods to determine a technology's safety and effectiveness exist, Obama’s FDA still demands evidence collected with science and statistical methods developed in the 19th century.   To be sure, in the last two years new medicines for AIDS, cancer, lupus and hepatitis have been developed.   Yet, these products should have been available sooner if not for FDA nitpicking.   

 

And now that they are finally approved, patients are finding it next to impossible to access several new drugs and genetic tests that would transform the quality of life and extend survival for such illnesses as lupus, prostate cancer and organ transplantation.  

 

Provenge, the first cancer vaccine, stalled at the FDA for years.  Once approved, it faced 18 months of additional delay while the Obama administration figured out whether to pay for it.  The gauntlet cancer patients face with Provenge is being extended to everyone waiting for a medical breakthrough under Obamacare:  Before a medical innovation can be used or paid for the government will now demand additional research demonstrating that a new product will be more effective and cheaper than existing technologies.  Since most new products come from small start-ups with limited cash, such a requirement means live saving innovations will not be available at all. 

 

Similar regulations have been used to delay and deny access to cancer drugs in England, Canada and Australia.  Drugs such as Avastin, Revlimid and Herceptin are barely used in Britain's cancer wards because government decided they were not valuable.  The people who could not use them are dead. Those -- mostly in America -- that did are alive. 

 

But now this de facto rationing is coming to America.  Before the cancer drug shortage there was the decision that women under 50 should not get mammograms.  Both Provenge and Benlysta, new treatments for prostate cancer and lupus respectively, are hard to come by because of uncertainty about reimbursement by health plans and government. .  

 

The death and suffering flowing from such delays are the result of policies promoted by those who want to use the FDA and increased government control over medicine to slash access to new technologies.  In their mind, rationing of cancer drugs frees up money to expand the welfare state.  The shortage of old drugs is simply one side effect of this malevolent strategy.  

 

It would be simpler to claw back regulations and let markets work.  But stockpiling is part of a larger effort to centralize the development and use of medical services.  The administration has gone silent on the wonders of obamacare even as it issues regulations and hires bureaucrats to replace free choice with government edict.  But it will emerge as a campaign and social issue.   In America no one should go without medicine because they can't afford it.  And it shouldn’t be a nation where people are denied such treatments because their government makes medicine impossible to produce or obtain. 

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