Friday, December 30, 2011

Boxing Out the Box Office

Last night I went to a local movie theater for the first time in ages.  I had to rely on my daughter to find the theater and where to park at Del Amo mall in Torrance.  That area has certainly changed in recent years including the closing of the large Borders store where we spent many weekends for entertainment when our children were young.  Another "disruption" because of the internet.

I remembered why I do not like seeing movies in the theater anymore.  The place was packed, which is good given that the movie we saw was made by my studio.  But, even though the movie was adult fare,  teenagers still were there, being their teenage selves.  One couple talked out loud throughout the movie and laughed at  two violent scenes where laughter was particularly inappropriate.  And at one of the more dramatic parts of the movie near the end, the house lights came up making it very difficult to see what was happening on the screen.  The air was filled with the odor of popcorn and chemicals meant to simulate "butter flavor".  The previews were embarrassingly violent and silly.

In contrast, I watched another recent movie, a Golden Globe contender, on my HD home flat screen the other night.  That experience was much more enjoyable.  I do not watch as many movies as I once did because strangely I do not have the patience to sit through most of them anymore.  This movie at home however started slow but captured my interest as it went on.  Perhaps I will watch more movies on demand now.

Box office receipts are down this year after a few years of rebound.  However, in the past 10 years, as reported by Ben Fritz and Amy Kaufman in the LA Times today, box office attendance has been regularly dropping,  now about 20% lower than its high point in 2003 and lower than anytime since 1995. See also here and here at page 6, both of which suggest the high point was in 2002. Ticket prices are certainly higher than they were ten years ago but still very reasonable in light of inflation and particularly when compared to other forms of entertainment.  See here at page 12.

Compared to other industries, the entertainment industry is not a high profit margin industry.  In Fortune 500's most recent ranking of industries in 2009, the entertainment industry ranked 51 out of 53 in return on revenues.  In contrast, the internet industry (e.g. Google, Amazon, eBay) was second and pharmaceuticals was third.  This low profitability ranking of the entertainment industry occurred at the same time internet industry supporters were complaining about record box office receipts and the "obvious" lack of impact on the industry by piracy.

The La Times article cited above offers that video on demand is the cause of the decline in theatrical attendance. I like video on demand and I am willing to pay legitimately for it.  Unauthorized downloads and streams of motion pictures that solely profit the pirate sites are another form of video on demand, either for free to the consumer or at a lower price than legitimate video on demand.  If video on demand is indeed driving people away from the theaters, let's not ignore the impact of pirate videos which are another form of video on demand.   To say piracy has had no impact on my industry and the average people who work in it is just dumb.


Thursday, December 29, 2011

Useful Gossip

In reading The Rogue: Searching For the Real Sarah Palin by Joe McGinniss, I have discovered that I love certain types of gossip.  McGinniss' sources for the book, to the person, have some serious issues with Palin. Some seem to engage, at times, in the same "10th grade mean girl" mentality of which Palin is accused.  For example, several sources claim that Palin was an absent and neglectful mother.  One supported the contention by saying that she never showed up at her son's hockey games, notwithstanding her holding herself out as the ultimate "hockey mom" ferrying her son all the time to games all over the place. As a "soccer mom" myself, I spent most of my weekends for a number of years going to soccer games all over the place,  sometimes leaving at ridiculous hours of the morning to get to places two hours away.  But I am not sure I could tell you which parents never showed up although I am sure some did not.  In a more extreme example, one Palin acquaintance said that Palin's children were "dirty"; no one ever cleaned out their ears.  I started to think about whether I regularly cleaned my children's ears.  I certainly bathed them every day but ears?  As I read about people complaining about Palin's children, I felt as if no one in Alaska must ever get out the high school mentality.

The book does however provide new information to me about Palin that is quite disturbing, even given my already low opinion of her.  Here are some things I have learned:

  1. Palin had a history of quitting jobs.  Before she quit as Governor of Alaska, she quit the job she had with the Alaska Oil and Gas Conservation Commission, an appointment she received for her political support of the Governor of Alaska in 2003. Although she made it look like she was resigning to protest ethical problems with one of her fellow commissioners, McGinniss reports that Palin did not like the long commute from Wasilla to Anchorage.
  2. Palin was an uber-evangelical Christian.  She belonged to an Assemblies of God church in Wasilla that was a "rogue" church itself.  Palin believes in witches as a manifestation of evil, and a GPS like system for tracking evil in the world.  She also believes that the earth is only 6000 years old and men walked with the dinosaurs.
  3. Palin's son Track, as a teenager, had trouble with the law and used drugs, including cocaine, and did not graduate from high school.  Sarah and Todd forced him into the Army,  turning him from a political problem into an asset.  I stupidly thought that his going into the army was voluntary and grew out of a crazy love of country nurtured in an ultraconservative family.
  4. The circumstances surrounding the birth of her son Trig have been construed to show that Palin may not be his birth mother.  She apparently did not look pregnant, even on the plane trip back from Texas to Alaska where she gave birth over a day after her amniotic fluid reportedly started to leak during the night.  McGinniss says that he interviewed doctors about her and Todd's actions in response to the leaking fluid and they opined that if she were pregnant those actions would have been gross negligence.  Rather than go to the hospital, Palin gave a speech in the afternoon, flew from Dallas to Seattle , waited for hours in the Seattle airport to continue her flight to Anchorage and then drove to Wasilla where she finally went to the hospital.
  5. Palin was racist as a young woman and acted on her beliefs when she became governor by firing people of color in her administration.  
Janet Maslin dismisses McGinniss' book by saying that most of it is "dated, petty and easily available to anyone with Internet access".  However, she must have followed the nooks and crannies of information about Palin more than I, or anyone I know, did.  I am inclined to agree with McGinniss that mainstream media avoided these issues when Palin was running for national office in 2008 and continue to avoid them today.  So as far as I am concerned, if you push aside the gossipy tone of the book, the book does a public service by bringing more of this information about Palin into the mainstream.  If I wasn't scared before, now I am even more scared.

Saturday, December 24, 2011

Have Yourself A Merry Little Christmas

Our Christmas Tree 2011
Yesterday while I was reading an article about John Rutter, I started to feel a bit of the Christmas spirit.  I must confess that so far this year I have not felt much like celebrating. Christmas has become a bit of a roller coaster. Two years ago I was in the hospital recovering from major surgery, requiring an emergency blood transfusion.  I was starting my cancer odyssey, a journey on which I still travel having just finished another cycle of chemotherapy.  Last year, I was in remission and feeling wonderful to be home for the holidays with my family.

This year, I am missing my son and grandson who just left to return to Micronesia to spend Christmas with my daughter in law and granddaughter.  My daughter and her boyfriend are here, having overlapped with my son and grandson for a few days so we could at least have Christmas 1.0 together last Sunday.   The tree was delivered last Saturday, a bit late and not as nice as the one I got last year, so I felt a bit disappointed.  However, my son stayed up most of the night decorating it and wrapping presents by himself.  It reminded me of the many times I was up into the wee hours, either alone or with my husband, wrapping presents and putting them under the tree.

So it is no surprise that this morning I was flooded with memories of Christmas Eves past.  One year my husband and I spent a chunk of Christmas eve in our local mall picking up last minute gifts because we felt we had not gotten enough for people.  Our children were teenagers at the time and I remember buying overpriced jeans for my daughter just to see the look on her face when she got something so unexpected.  Unfortunately, this year, given our finances, I will have to be satisfied with her adult gratitude, as a poor college student, for anything we get for her.

On another Christmas Eve,  my husband and I found ourselves without a Christmas tree.  We drove all over looking for one, either real or artificial, but kept coming up with nothing.  After a few hours, we found a small lot with a handful of trees left and got a reasonably decent looking tree, thereby salvaging our tradition.

Of course, we had one Christmas Eve like the one in the Jingle All the Way, although not quite as extreme.  Let's just say that someone in this family beat out another parent trying to get the last Teddy Ruxpin in Toys R Us on Christmas Eve.  Our son, then 3 years old, was one happy boy on Christmas morning.

I also, for many years, sent out what I hoped was a funny Christmas letter to friends and family, with a picture of our family.  The last time I did that was about 6 years ago when my grandson was a baby.  These days we don't get many cards anymore at home, and at work I get as many e-cards as I do paper cards.  I wish I could still write a funny letter.  I had an excuse during the years when things were not going so well but this year I have plenty of good things to report.  My daughter has a 4.0 grade point average her first semester at UC Berkeley.  My son is off in Micronesia with his beautiful family, including my grandson and 2 year old granddaughter, after spending two months here with us to be treated for back problems.  He is applying to masters programs for next year.  My husband and I are both in remission from cancer and trying to live life to the fullest.  My mother in law, who still lives us, is puttering along at 86 and my son's sister in law, who also lives with us, is finishing a medical assistant training program which will hopefully allow her to get a job next year.  All good things, but my days of sending out cards are over, just like my days of going to midnight mass and feeling the need to dress up for most occasions.  "When I am an old woman, I shall wear yoga pants and t-shirts, although not in purple"  (apologies to Jenny Joseph)

John Rutter told the reporter, in the article referenced above, that the World War Two song Have Yourself a Merry Little Christmas "encapsulates the aching nostalgia of separated families and treads the fine line between happiness and heartbreak, which is what being human is all about." Perhaps not so surprising after all that this song should put me finally in the Christmas spirit.

ADDENDUM  The original song was apparently quite depressing.  Judy Garland performed  a slightly more positive version in the motion picture Meet Me in St. Louis, and this version was popular during WWII.  Frank Sinatra asked the songwriter to make the song more "jolly" for his version, which is the one we now hear the most.

Saturday, December 17, 2011

Help Keep Other Sisters Alive

Tis the season of giving and I am swimming in things I have received as gifts in the past for which I have no space in my house. So I think many times that the best gift we can give is to find a cause to support wholeheartedly. For two years now, I have sponsored a woman's education toward job skills through Women for Women International (WWI).  I now have sponsored two women and am adding a third for my daughter to sponsor.  The two women I have sponsored are from Africa-- the first from Nigeria was born in 1988, is single and has 1 child . She attended her program in September, 2010 through February 2011. My current "sister" lives in Rwanda, is between 25 and 30 (apparently there are no birth records) and will be supported in the program until August 2012.  I love the fact that they call the women our sisters.  It gives another meaning to Help Keep a Sister Alive.

In case you do not think women in most areas of the world need our attention please take a look at this YouTube video.  It is not produced by WWI but certainly supports the underlying mission of WWI, as well as many other worthy charities for girl's education.  See e.g here 

Tuesday, December 13, 2011

The Last Dosage-- No More Doxil for the Foreseeable Future


Janssen just released the last dosages of Doxil, reportedly enough to treat 1000 people on the waiting list.  Of course, it is too late for me.  I am finished with this course of chemotherapy and hoping for the best so, if my turn on the waiting list comes up, someone will take my place .

As I stated in my last post, European Medicines Agency asked Janssen three weeks ago to notify doctors  to monitor for possible side effects, such as sepsis, in use of Doxil as a result of quality control issues at its contract manufacturer, Ben Venue Laboratories (BVL).  Janssen issued a letter to physicians today, December 12, 2011 with the release of the last doses of Doxil.  Here is what it says about quality control issues:

We are aware of some recent information about the quality shortcomings at this contracted supplier of  DOXIL®. We have performed thorough quality reviews of this additional supply of DOXIL®, which included a review of production procedures and extensive sample testing. Based on these assessments, Janssen Products, LP has now approved release of this supply from BVL for distribution through our patient allocation program.

Note that there is no mention of monitoring side effects whatsoever.  Janssen instead decided to do "extensive quality reviews . . . and extensive sample testing."  I hope they are right.  Sepsis is not something to ignore and of course, physicians receiving this letter may not have been following the warning from the EMA so they would not have the heightened level of concern that EMA wanted Janssen to communicate about Doxil.

Janssen also seems to be softpedaling the "shortcomings" at Ben Venue. The FDA last week issued another 483 report dated December 2, 2011 about extensive quality control problems at Ben Venue, including finding urine in a container, leaky roofs still not repaired and metal particles in a product.  Indeed the EMA broadened their recall to include two additional drugs and issued warnings about another two additional drugs.

And, confirming what I have been saying for some time now, Janssen acknowledges that there will be no Doxil for the foreseeable future. Janssen states in the 12/12/11 letter to physicians  (which is stated in very similar wording in the Janssen President's letter of the same date):

This limited supply represents all of the remaining DOXIL® that had been previously produced by BVL. Please be advised that this modest supply of DOXIL® will not be sufficient to supply everyone on the wait list. We want to emphasize that this limited product availability does not foreshadow the potential for any additional supply of DOXIL® in the immediate future as we have no further information from BVL on when manufacturing will resume at its facility.

The problem, as I also mentioned in earlier blog posts  (see e.g. here) and as Peter Loftus reports, is that other chemotherapies are in shortage.  I read over the weekend on an bulletin board for cervical cancer that women are having trouble getting cis-platin, a mainline treatment also of ovarian cancer. Carboplatin is also in short supply and was repeatedly discussed in last week's Senate Finance Committee hearing on drug shortages.

Members of the Finance Committee seemed to be angling to remove the price increase cap from the Medicare Part B drug schedules so that the marketplace would correct for the shortages because financial incentive would be returned.  Unfortunately, I think the free marketplace is why this issue has come to a head. A report issued in October 2011 by the Assistant Secretary for Planning and Evaluation (ASPE) of the Department of Health and Human Services (HHS) entitled Economic Analysis of the Causes of Drug Shortages suggests that the problem results from generic manufacturers avoiding excess capacity rather than the Medicare Part B cap.  Drug shortages only exist in 10% of sterile injectable generics covered by Medicare Part B and, contrary to testimony before the Finance Committee by the conservative American Enterprise Institute representative, consolidation of the sterile injectable generic drug industry did not cause the shortages.  The report said in a section entitled Supply:

Consolidation at the corporate level would be a significant contributor to drug shortages only if the consolidations have resulted in closures of manufacturing facilities that reduced production capacity.  Conversations with leading generic drug manufacturers, and data from the FDA, indicate that the consolidations have not resulted in decreased production capacity or in the closure of manufacturing facilities.

The ASPE-HHS report concluded that the shortages resulted from long term choices by generic manufacturers to ensure that there would not be surpluses  of certain highly specialized drugs for which they got lower prices because of limited demand.  The report explained in a section entitled "Market Behavior":

Our analysis suggests that this change in capacity utilization stems from a combination of the effects of the increase in volume of chemotherapy drugs used, the expansion of products available for generic manufacturing because of patent expiration, and the complexity of manufacture and requirements for Current Good Manufacturing Practices.  Entry cannot occur quickly in the sterile injectables industry because of the high fixed costs of specialized production and regulatory protections.  Furthermore, because shortages are uncommon and occur in drugs for which capacity is highly specialized, and because there are few penalties for failing to supply contracted drugs, there is no financial return to investing in excess capacity — that is, capacity that is not used outside a supply shortage, and thus earns no revenue except during a supply shortage.

So, according to HHS this is a market driven phenomenon completely relating to drug companies trying to maximize profits and essentially preferentially choosing to manufacture more of higher price drugs.  It is the marketplace at its best and worst, which is why I would advocate that these types of life saving drugs need to be regulated for the long term to ensure their supply when the profit seekers cannot be bothered.

Monday, December 5, 2011

Update on Doxil Production-Possible Quality Issues?

According to the WSJ and our intrepid Doxil shortage reporter, Peter Loftus, the FDA is working with Johnson & Johnson to address the fact the Ben Venue Laboratories has completely shut down production of Doxil as of two weeks ago (November 19, 2011). However, the chances of Doxil being available anytime soon, in my opinion, are slim to none.  I would love to have J&J really explain, other than in the vaguest generalities, why it will take some time to fix this situation but all of these manufacturing processes are shielded by the assertion of confidentiality due to proprietary interests.  The FDA knows a little but they are not permitted to tell.   With something that affects life and death, the lack of transparency is astonishing and disturbing.

Now however we have something new to worry about in the limited supplies of Doxil that are available. In early November 2011  the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) as part a joint inspection with UK, French and US regulators found "significant" contamination and other quality control problems at Ben Venue.  Ben Venue "voluntarily" pulled the plug on itself.  EMA recommended the recall of three drugs: Velcade, (Millennium and J&J) used for multiple myeloma,  Vidaza  (Celgene) used to treat anemia, leukemia and bone marrow disease (MDS) and Busilvex(aka Busulfex), used to treat a form of leukemia.  The Hong Kong regulatory agency has joined in and expanded this recall.  The FDA has NOT issued any recall.

EMA did not recall Doxil (Caelyx) because Ben Venue was the sole source for manufacturing the drug. However, it did recommend that the drug not be used for new patients, an irony given that the drug is essentially not available except for the limited doses that have been distributed.  It also asked that doctors monitor patients for side effects like the deadly sepsis.  Janssen was asked to circulate a letter to that effect to physicians but nothing has yet been posted on the Doxil website as of today, December 4, 2011.  Here is what EMA said about Doxil (Caelyx):

For Caelyx, for which Ben Venue is the only manufacturing source, the CHMP considers the product to be essential only for patients already on treatment. It recommended that supplies should be available to maintain these patients on Caelyx but no new patients should be started on treatment with Caelyx until further notice. The CHMP advised that healthcare professionals should monitor treated patients intensively and immediately notify any relevant safety concerns that could be evidence of a quality assurance problem (particularly any cases of sepsis or suspected sepsis, such as acute pyrexia). The marketing authorisation holder, Janssen, has been asked to circulate a communication to healthcare professionals to reinforce these messages, requesting them to enhance monitoring and report any suspected adverse reaction or complaints that could be evidence of a quality assurance problem with the aseptic filling process. The CHMP will review the situation on a continuous basis.

For those of you who may still be taking Doxil, please check with your doctor about this warning. I suspect Janssen has not yet issued the letter even though EMA posted its findings almost two weeks ago.  Unfortunately, given that emergency injectable antibiotics are also in shortage (13% of all shortages; see page 14 of this FDA report), it may not be worth the risk to take any Doxil now.

Originally posted on my other blog on December 4, 2011