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New H1N1 vaccine trials in India too late for anyone's good

January 5, 2010

Analysis of:Zydus Cadila gets nod for clinical trials for swine flu vaccine | www.business-standard.com

H1N1 vaccines, although still in relative shortage, are no longer in extreme deficit due to increased supply and somewhat decreased demand. A new manufacturer receiving marketing approval now might sell out its supply or might not; but this news article regards approval to BEGIN TESTING. It is not a drug approval and there is no guarantee the product will ever be approved.

This is it...

April 28, 2009

Analysis of:As Nations Try to Contain Flu, N.Y. Cases Are Confirmed | www.nytimes.com

The current soon-to-be pandemic of "swine" flu is sweeping the globe.  This past year's vaccine does not include this strain, nor did last year's.  Vaccine manufacturers will have less credibility for selling next year's product; on the brighter side, antiviral manufacturers will sell out their backlogged products.  Hospitals and doctors' offices will be overwhelmed, first by the "worried well" and then by the actually sick.

EMRs are the future but medicine remains mired in the past

March 30, 2009

Analysis of:U.S. Hospitals Slow to Adopt E-Records | online.wsj.com

EMRs have huge potential - improved efficiency, avoidance of medical errors, faster record transfer, improved lab result access, and secure records maintenance.  However, the cost both in raw dollars and in time spent rolling out and maintaining such systems is unimaginable.  Government mandates, carrots and sticks will all be necessary to prod health systems to move forward.

Gardasil for boys? If you're not kidding, at least make it about science this time.

March 30, 2009

Analysis of:A Vaccine Debate Once Focused on Sex Shifts as Boys Join the Target Market | www.washingtonpost.com

HPV vaccination in females makes sense from a moral and medical point of view, and may even be cost-effective in the long run.   HPV vaccination in males is none of these.

Not a unique product except perhaps in India

March 9, 2009

Analysis of:Bharat Biotech launches Comvac5, single shot pentavalent combination vaccine | www.pharmabiz.com

-Combination vaccines are becoming the rule in the US and Europe.  In the U.S. we have the 5-in-1 combination vaccines Pentacel and Pediarix already in use. -In India a combination vaccine may come at too high a cost for widespread use

Pentavalent vaccinations are great if you can purchase them

March 9, 2009

Analysis of:Penta vaccines get high five from pharma players | www.dnaindia.com

-combination vaccines are good for kids, good for nurses, and good for preventing multiple diseases -unfortunately, they are bad for budgets, since they are proprietary products often replacing single products that are soon or already off patent -in India, where will the money come from to pay for combination vaccines for millions of children covered by the National Immunisation Programme?

Likely approval at some point soon

December 10, 2008

Analysis of:Wyeth Submits European Marketing Authorization Application for its 13-Valent Vaccine for the Prevention of Pneumococcal Disease in Infants and Young Children | phx.corporate-ir.net

-Wyeth has submitted its new and improved pneumococcal vaccine for European approval.  Although the current product (Wyeth's Prevnar) works well, the newer version would cover more serotypes of strep pneumo. -Since the original product is Wyeth's, they've been down this road before and know what the issues are likely to be to get approval; odds are very good that the new product will get approved on the first go-round or soon after 

Pediatric well visits at younger ages may be well-suited to group sessions

December 10, 2008

Analysis of:The doctor will see all of you now | www.boston.com

Pediatric well-child visits for infants and young children are one of the less-exciting parts of the job and may be a good fit for group visits. As children get older, their growth, development and interests diverge and may be less appropriate for groups

Financial analysis of the Gardasil-for-Guys question

December 1, 2008

Analysis of:Gardasil, Merck's Cervical Cancer Vaccine, Demonstrated Efficacy in Preventing HPV-Related Disease in Males in Phase III Study | www.fiercebiotech.com

Everyone who expects Gardasil to be approved for general use in males may be very surprised.  Yes, Gardasil prevents HPV in males, but the cost/benefit ratio is completely off compared to women.  The cost is MUCH higher per case of invasive HPV prevented and the benefit is much lower for penile and anal cancer vs. cervical cancer. 

Gardasil for selected men only

November 18, 2008

Analysis of:Gardasil, Merck's Cervical Cancer Vaccine, Demonstrated Efficacy in Preventing HPV-Related Disease in Males in Phase III Study | www.fiercebiotech.com

-Gardasil has been shown effective in men to prevent infection with high-risk HPV subtypes.  This is great news for some men. -Gardasil when given to all women (now currently in roll-out) will interrupt heterosexual HPV transmission.  Sexually active gay/bisexual males will benefit from Gardasil, but cost-effectiveness is another story.  Gardasil for all females is about to break the bank in some state budgets already.  

ER testing for HIV: does anyone else see a problem with this?

November 10, 2008

Analysis of:Rapid HIV Testing in the ER Boosts Diagnoses, Screening | www.medcompare.com

-I'm thrilled to see that a provider evaluating someone for an STD also tests for HIV -but- -I'm appalled that people can be seen in an ER for a suspected STD, just like I would be for those that go for colds and ear infections.  How much did each of those chlamydia and gonorrhea and syphilis diagnoses cost per patient?  And who are we kidding when we pretend that an ER can effectively refer someone for "followup care within 3 days"?  Most adults can't even see their regular PCP within a week.

Your doctor doesn't get a flu shot WHY????

November 4, 2008

Analysis of:Flu shots a tough sell to health care workers | ap.google.com

-A recent informal survey found that many docs and nurses (60% of healthcare workers overall) don't get an annual flu vaccine, despite proven efficacy, easy availability at their place of work, and risk of contagion to patients and colleagues.  -This puts some of the most vulnerable patients at risk of absolutely preventable illness and leaves hospitals liable to claims of medical negligence. -Healthcare emplyers such as hospitals need to take a firmer stand against casual deferral and to start putting patients first.

Parental "choice" against flu vaccine would be unwise

November 3, 2008

Analysis of:Flu Vaccine for Preschoolers | www.nytimes.com

-Parents in NJ are fighting a new state mandate requiring influenza vaccine in preschoolers -Allowing an override of this mandate would be dangerous but parents will have only themselves to blame if their unvaccinated kids get sick

Rotavirus vaccine delivers

November 3, 2008

Analysis of:Vaccine Slashes Diarrheal Ilness in Kids | www.nytimes.com

Rotateq is a great vaccine - it protects both vaccinated patients and also gives some protection to their not-yet-vaccinated peers Although in the US it is rare to die from rotavirus illness, the economic savings on lost school/work days and decreased hospital admissions and ER visits is huge.

Stockpiling flu vaccines at home will never make sense given Americans' sensibilities

November 3, 2008

Analysis of:U.S. looks at whether home drug stockpiles for flu pandemic makes sense | canadianpress.google.com

Most American families are not familiar with signs and symptoms of influenza.  Asking them to use (and not use) a home supply of antivirals would be insanity, stretching thin the amount of antivirals available and depriving them to those in true need.  To ask them to use these meds appropriately for their children would be even more insane - at the first viral URI of the season the meds would be gone and parents would be on the phone for more, convinced that they had successfully fended off avian flu and eager to do it again. 

Who cares?

June 30, 2008

Analysis of:Taro Receives Final FDA Approval For RX Cetirizine Hydrochloride Syrup ANDA | www.medicalnewstoday.com

Taro just got approval for Rx cetirizine - big whoop!  Zyrtec has been OTC in all forms (tablet, chewable and syrup) since 11/07.  Do you know anyone who will write a prescription for an OTC drug or an insurance company that will cover it?

GSK completes pediatric DTP+ line with (awfully named) Kinrix

June 27, 2008

Analysis of:FDA Approves GlaxoSmithKline's New Combination Vaccine For Children | www.medicalnewstoday.com

Glaxo has just gotten approval for Kinrix (DTaP-IPV).  It's products for infants and toddlers, Pediarix (DTaP-HepB-IPV) and Infanrix (DTaP) are used in children under 2; Kinrix will be used for the 4-6 year booster dose, reducing by 1 the number of vacthat children get at this age.

BPA uncertainty will cause short-term opportunity regardless of ultimate conclusions

June 11, 2008

Analysis of:FDA's Chief Scientist Asks Science Board Subcommittee To Review Research On Bisphenol-A | www.medicalnewstoday.com

The FDA is opening investigations into whether the widely used plastic additive bisphenol A may have various effects on humans, based on animal models. Several companies are already touting their "BPA-free" status; as the FDA investigation will take a prolonged period to review and summarize available information, these companies stand to benefit even if there is no actual risk found.

Could be a smart move or could backfire

June 9, 2008

Analysis of:Datacsope stock soars on takeover tlaks | www.northjersey.com

-Datascope has decided to exit the monitor market by selling a chunk of itself off, possibly making itself into a takeover candidate.  The remaining units make stents, balloon catheters and other cardiac equipment.  -One other effect is that it has placed itself into direct (rather than indirect) competition with deep-pocketed industry leaders like Boston Scientific.

Pipeline or Preening for an Aquirer?

June 9, 2008

Analysis of:Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com

-Novartis' press conference discussed a "full pipline" of new vaccines, but the majority are still Phase I. -The meningitis vaccines being developed are not yet ready to go, and the one that is closest to being filed already has a competitor on the market.

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