Rick,
I'd say your #s look good. But is a superior product enough to overcome Abbott et al's greater visibility? (Due to their size, and being first to market).
Exhibit A: another article about PIs and kids. No mention of Agouron or Vertex:
Drug Cos. Mull Drugs For Kids
Source: Associated Press
WASHINGTON - The Associated Press via Individual Inc. : Rosemary
Johnson finally felt healthy thanks to powerful new AIDS drugs. But she was
still in torment _ unable to give her sick daughter the same medicines because
no one knew how they would affect children.
- Since none of the three new and potent medicines revolutionizing AIDS care
is yet approved for child use, pediatricians and parents have begun struggling
on their own to determine safe doses _ fearing that otherwise the children will
die waiting as drug companies study the question.
- ``I looked over to my daughter and thought, `How could I sit here and try to
save my life and not my daughter's?''' Johnson, of Baltimore, angrily told
government AIDS experts last week. ``We are not going to let our children
die without a fight.''
- Under a pediatrician's care, Johnson's 9-year-old now is one of just a
handful of children nationwide taking one of the new drugs. So far, she is
doing well. ``I want other children to have this chance,'' Johnson said.
- Drug makers say they're working hard to get the new drugs, called protease
inhibitors, to children. They have studies planned for early 1997 on everything
from liquid formulas to drug ``sprinkles'' that parents would mix into
applesauce.
- The drug companies say children spit out earlier liquid formulas because they
were too bitter. And the companies had problems getting the right drug
absorption.
- Still, ``in hindsight, perhaps we should have moved forward to get some
experimental data'' sooner, said Dr. Miklos Salgo of Hoffman LaRoche,
maker of the first protease inhibitor, saquinavir.
- The issue doesn't just touch AIDS. Eighty percent of prescription drugs are
sold with no information on how safe or effective they might be for children.
- A little more than 10,000 of the nation's half a million AIDS cases have been
in children and teen-agers. Some 3,156 children under 13 and 1,452 teens
are still alive and in need of medicine compared with tens of thousands of
adults.
- But doctors say it's unethical to ignore children just because there are fewer
victims.
- ``AIDS kills children just like it kills adults,'' said Dr. Nancy Hutton of Johns
Hopkins University's Children's Center. She wants drug makers to test new
AIDS medicine in children as soon they test adults, changing decades of
scientific practice.
- Of the nine AIDS drugs sold, four of the oldest are approved for children.
- But the new protease inhibitors are so effective for adults that pediatricians
want to use them in children. They just don't know how. The Pediatric AIDS
Foundation surveyed over 950 child patients and found only 74 taking
proteases.
- ``I had parents who said, `Well, I'll just give my child some of mine,''' Hutton
recalled.
- That's dangerous, because the wrong dose can cause drug resistance. So
Hutton furiously sought early data from drug makers to calculate her own
doses of ritonavir, the only liquid protease sold, for six very ill children,
including Johnson's 9-year-old daughter.
- A few months later, all six children are doing well, although Hutton warns
that she doesn't know how long the effect will last or what is the best dose.
- Of the three proteases:
- _Merck & Co. began child testing indinavir in July 1995, hoping to seek
Food and Drug Administration approval for children and adults
simultaneously. But one formula didn't dissolve properly in children's
stomachs. Adult-sized capsules did fight HIV in children's blood, but not as
much as they do in adults nor for nearly as long. Children probably metabolize
the drug too fast, theorizes Merck's Dr. Paul Deutsch, who is hunting a better
child's dose.
- _Ritonavir was created as a liquid for children, but Abbott Laboratories
says it believes in ensuring a drug is safe in adults before testing children,
something it says couldn't be done in the three years between ritonavir's
discovery and its sale. A study in 46 children unveiled last summer suggests
500-800 milligrams a day is safe and may fight the virus; confirmatory studies
begin by spring.
- _Not only did Roche's liquid saquinavir taste bitter, it didn't dissolve into
blood properly. So Roche created tiny ``sprinkles'' of saquinavir that children
would swallow in applesauce, providing just mild bitterness if they crunched
the bits. Testing begins by spring.
- The FDA's outside scientific advisers issued a stern warning to drug makers
last week not to seek approval for any more AIDS drugs without at least
preliminary data on children.
- But the FDA says the only way to enforce that is to refuse to approve new
AIDS drugs without child data _ unfair to desperate adults also awaiting the
medicines.
- FDA pediatrician Sam Maldonado says angry parents have more clout.
Their activism, she says, ``creates more pressure than we can.''
[12-02-96 at 15:00 EST, Copyright 1996, The Associated Press] |
