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GLG News by this Author

Like all new vaccines, FDA approval precedes insurance coverage

September 1, 2006

Analysis of:Cervical cancer shots hard to find | www.chron.com

-Gardasil was approved for use this summer by the FDA for use in girls 9-26 years but is still awaiting affirmation by the CDC to make it a "routine" vaccine for universal usage.  CDC approval will very likely occur this fall
- Until then, many insurers will not pay for the vaccine becuase there is no implied consensus on whether the vaccine should be used (approval and accepted for routine use are 2 differnet things)
-In universal purchase (UP) states, it may be 1-2 years from now before all of the recently approved vaccines begin to be used because each individual UP state must make specific allowances for vaccine purchases in its fiscal budget.

Gardasil - do most parents REALLY debate its use?

August 31, 2006

Analysis of:HPV Vaccine Creates Parental Challenge | www.washingtonpost.com

-This article examines the internal and external turmoil a mother and daughter face when contemplating vaccination with Gardasil
-This is a level of thought no one really gives to other vaccines
-Most people want Gardasil because it prevents cervical cancer, period.

Local School Boards Begin Weighing in on Gardasil

August 28, 2006

Analysis of:Los Angeles Unified School District "Right" To Offer Merck's HPV Vaccine To Female Middle, Elementary School Students This Fall, Editorial Says | www.medicalnewstoday.com

-The Los Angeles County School District board will begin administering Gardasil to girls beginning this academic year.
-As a non-medical entity, this position is an important endorsement of a monopoly (held by Merck), while recognizing the right of parents to opt out.
-If public awareness of the vaccine's potential is raised by decisions such as this, students and Merck will be the big beneficiaries; however, provision of adequate supplies of the vaccine under federal financing remains to be seen.

New FDA Warnings will not impact ADHD prescribing patterns

August 28, 2006

Analysis of:UPDATE 2-US FDA calls for new warnings on ADHD drugs | yahoo.reuters.com

-New labeling requirements are being issued for stimulants being used for ADD/ADHD regarding potential cardiac and psychiatric side effects, however, in the absence of other equally effective drugs, this will change nothing
-There are already black-box warnings in place for many psychiatric drugs, and they have little effect on the monopoly drugs and drug classes such as stimulants for ADHD
-Parents of children who truly need these drugs are not going to pursue other treatments given the lack of good alternatives, and more adults are being diagnosed and treated with these drugs all the time

Flu vaccines for 2006-7 season do not include Avian flu protection

August 14, 2006

Analysis of:FDA Approves Influenza Vaccines to Be Manufactured for Upcoming Flu Season | www.ptcommunity.com

-The FDA has approved the influenza variants to be included in the 2006-2007 vaccine batch.  These will be produced by manufacturers of injectable flu vaccine as well as the single makes of a nasal flu vaccine (FluMist, by MedImmune)
-For this season, the flu vaccines produced will still confer no protection against avian influenza, despite many researchers working to produce an effective vaccine.
-FluMist nasal flu vaccine will still be approved only for use in the low-risk population for this year (age 5 years to 49 years and those without asthma).

Morning-After Pill Almost Guaranteed This Time Around

August 14, 2006

Analysis of:FDA, Barr to Meet Next Week on Morning-After Pill | www.medscape.com

The FDA has been sending signals that it plans to (finally) approve Plan B morning-after pill combination without a prescription.

-Although the same medication is currently being manufactured under different labeling by several manufacturers, Barr has the only product up for approval, as it is specially packaged for "morning-after" use
-Barr stands to gain from expanded access to this medication by women 18 and over; those under 18 would still need to see a doctor first
-Unlike a newly-approved medication, this newly-approved indication means that the product is already in pharmacies, ready to go.  Insurance coverage issues remain to be worked out, but women will likely pay out of pocket for this as one cannot normally wait for approval.  This could also potentially put more money in Barr's pocket.
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Cautious optimism for Galxo's "breakthrough" avian flu vaccine.

August 2, 2006

Analysis of:Glaxo has bird flu 'breakthrough' | news.bbc.co.uk

-Glaxo reported this week that is had made a significant advance in the push for an avian flu vaccine

-Multiple other companies are also attempting to develop a similar vaccine

-The vaccine has not been submitted to anyone for approval yet, and is not going to be approvable for the coming winter season,  even if further trial results are positive 

No antibiotics for colds is old news in U.S.

August 2, 2006

Analysis of:Antibiotics Not Warranted for Runny Noses | www.forbes.com

-This article "reports" that runny noses (i.e. colds, or URIs) do not justify antibiotics in most cases

-This is widely known in the US and has been standard teaching (at least in pediatrics) for years

-Many doctors prescribe antibiotics knowing that they will have no effect but feel that they are being pressured into prescribing by the patient

Merck becomes the vaccine maker to beat

August 2, 2006

Analysis of:FDA Announces Approval Of HPV Vaccine Gardasil | www.medicalnewstoday.com

-Merck and GlaxoSmithKline are the 2 main manufacturers of vaccines for the US market.
-Merck and Glaxo are both developing vaccines that will compete with each other, but Merck has several current first-to-market products
-With Gardasil, Merck again beat Glaxo's Cervarix to FDA approval

FDA request for more data not unusual but adds delays

August 2, 2006

Analysis of:Medimmune Says FDA Needs FluMist Data | biz.yahoo.com

-MedImmune reported that the FDA requested more data on its new formulation of FluMist before considering it for approval
-Such requests are common, and may require only submission of data that has already been collected; or they may require more data collection (i.e. more studies)
-MedImmune also reported that they will also request (but had not yet done so) an expanded indication, down to age 1 year.

****The company reported today (8/1/06) that it had resubmitted the application, including the request for indication down to age 1 year:  http://www.medicalnewstoday.com/medicalnews.php?newsid=48403&nfid=al

MedImmune resubmits FluMist application for easier storage and younger patients

August 2, 2006

Analysis of:MedImmune Submits Refrigerator-Stable Formulation Of FluMist(R) To FDA For Approval In Younger Children | www.medicalnewstoday.com

-MedImmune is seeking to get approval of a newer version of FluMist nasal flu vaccine which would be easier to store
-The company is also seeking a lower age limit for thew vaccine's use (down to 1 year from the current 5 year old minimum age)
-This "double play" will be a great bonus for the company if approved, but there has already been 1 request by the FDA for more data and this product is already too late for consideration for this year's coming flu season

Opposition to Gardasil HPV vaccine confined to fringe, religious groups

July 31, 2006

Analysis of:The fight against cervical cancer: From Pap smears to vaccines, the battle continues | www.newsday.com

-New York Newsday has published an article that nicely summarizes some of the opposition to Merck's new HPV vaccine
-Some groups that are opposing routine vaccination include Focus on the Family and the Family Research Council (both conservative Christian groups) and the National Vaccine Information Center, an anti-vaccine group.
-All medical experts and groups cited were totally in favor of the vaccine, because it does what it was designed to do - prevent cervical cancer.

 

MedImmune to submit improved nasal flu vaccine for approval

July 24, 2006

Analysis of:New Cold-Adapted FluMist More Effective Than Shots | www.pediatricnews.com

-MedImmune's FluMist, a nasal flu vaccine, has not been the blockbuster drug it hoped to be, mostly because of the difficulty in storage and restrictions on its use
-A newer version that is easier to store and to administer has completed trials and is soon to be submitted to the FDA for review
-The company is also seeking to expand the indications to a lower age (6 months) to include children at higher risk of influenza complications

MedImmune's prospects diminish with only 2 products to sell this year

July 21, 2006

Analysis of:MedImmune Loss widens as sales fall | www.nytimes.com

-MedImmune reported a larger loss this quarter mostly on flat Synagis sales
-Widened indications for the use of Synagis did not materialize
-Synagis' successor, NuMax, will not be available for the upcoming RSV season
-MedImmune has other pipeline products but none are sure things for the next year

Merck's other vaccine success story

June 27, 2006

Analysis of:Notice to Readers: Licensure of a Combined Live Attenuated Measles, Mumps, Rubella, and Varicella Vaccine | www.cdc.gov

-ProQuad (measles, mumps, rubella, and varicella (MMRV)) vaccine was approved last year, but funding in many states was not approved until this year
-ProQuad will be yet another of Merck's products for "routine" use in all children, currently for at least one dose per recipient but likely to be increased to 2 doses for all children in the near future

Daytrana - a new option for ADHD in extended-day schoolchildren

June 27, 2006

Analysis of:FDA Approves Methylphenidate Patch to Treat Attention Deficit Hyperactivity Disorder in Children | www.fda.gov

-Daytrana (methylphenidate patch) has been approved in 10, 20 and 30 mg doses for children with ADHD
-Daytrana's extended-release nature allows for use over a 9 hour (or longer) period. 

Kudos to Buffett; Gates Foundation should focus on HIV

June 27, 2006

Analysis of:Warren Buffett to begin disbursing fortune, most to Gates' foundation | seattletimes.nwsource.com

Warren Buffett's announcement of a 30+ BILLION dollar gift to the Bill and Melinda Gates Foundation has awed the world.  This is probably the one single entity which has the power to fund the HIV vaccine/treatment movement.  Physicians should resoundingly call for this to be the focus of their foundation until a cure/vaccine is found.

Merck has another big seller

June 26, 2006

Analysis of:Rotavirus Vaccine for adults and children | www.cdc.gov

-Merck's rotavirus vaccine Rotateq was approved by the FDA in February and is about to become the next "routine" vaccination for use in all infants
 -Routine use means that use is standard practice for each and every infant, and there is no current competitor in this product category 

Gardasil: how big is the market?

June 16, 2006

Analysis of:Merck's cervical cancer vaccine wins US approval | obgyn.healthcentersonline.com

-A vaccine manufactured by Merck (Gardasil) that prevents infection with viruses that commonly cause genital warts and cervical cancer has been approved
- This will be the first gender-specific vaccine (girls and women only), and one of the first vaccines to prevent cancer
-It is uncertain if the public will embrace this vaccine or not as the main market will be for girls under 18 years old and the product presupposes future sexual activity

MedImmune's Numax: an improvement worth the price?

June 5, 2006

Analysis of:Comparative effects of two neutralizing anti-respiratory syncytial virus (RSV) monoclonal antibodies in the RSV murine model: time versus potency. | www.medscape.com

-MedImmune has a second-generation monoclonal antibody to prevent RSV infection in infants and children.
-The current product, Synagis, is very popular among physicians caring for high-risk patients but it is also very expensive.
-The new product, although seemingly more effective, is likely to be even more expensive and is being trialled for indications unlikely to be adopted widely.

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