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.


DISCLAIMER: THE VIEWS IN THIS POST ARE MY OWN.  THEY ARE NOT MEANT TO BE AND SHOULD NOT BE CONSTRUED TO BE STATEMENTS ON BEHALF OF MY EMPLOYER.

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

 Doxil.com

UPDATED DECEMBER 13, 2011

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 Inspire.com 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

Saturday, November 19, 2011

Shortages of Drugs for Life Threatening Illnesses- An Overview



UPDATED NOVEMBER 21, 2011

If you have followed the news and this blog, you know that there is a nationwide shortage of Doxil, a chemotherapy drug used to treat recurrent ovarian cancer, multiple myeloma and Kaposi’s sarcoma.   News of the shortage first surfaced in July 2011  with new supplies expected in mid or late August, 2011.  However, that prediction from the drug distributor turned out to be wholly inaccurate.

The drug is owned and distributed by Janssen Products, LP, a Johnson & Johnson company.  Ben Venue Laboratories in Bedford, Ohio, the manufacturing arm of Bedford Laboratories and a unit of Boehringer Ingelheim GmbH of Germany, manufactures Doxil under contract to Janssen.

To explain the Doxil shortage, Ben Venue’s representative said that the company is facing "manufacturing capacity constraints" that have held up some products, and it is working diligently to prioritize and expedite manufacturing for current orders." However, Ben Venue Labs has decided to exit the Doxil business and other contract manufacturing to focus more on its business as Bedford Laboratories, a producer of generic injectables, and avoid all the problems that have caused bans from Canada and Europe of Ben Venue products.  In the meantime, as Bedford Laboratories, the company has discontinued manufacture of mainline cancer drugs cisplatin and carboplatin and has significant shortages of Taxol. It appears to focus on commonly prescribed and presumably more profitable drugs such as those that treat migraine (generic Imitrix), indigestion (generic Zantac) and high blood pressure (generic Inderol).

With Ben Venue moving on to greener pastures, who will J&J find to manufacture Doxil and how hard will they try? Doxil reportedly represents less than 1% of Johnson & Johnson revenues.

As of today, there is no indication that the Doxil shortage will end any time soon. Janssen's president, a cancer survivor himself, sympathizes with those affected by having treatment plans interrupted or changed.  However, in 2010, Janssen chose to rely on one manufacturer to produce Doxil, even though in the past, it had a second manufacturer abroad, Schering Plough. Doxil also has no generic competition because it effectively still has patent protection in the US until 2014.  Doxil's patent expired in 2009 but J&J/Janssen still has the monopoly under the Orphan Drug Act as a reward for acquiring the company which produced a drug for a rare condition-one affecting fewer than 200,000 people.

In fact, on November 19, 2011, the Wall Street Journal reported that Ben Venue had stopped manufacturing drugs, including Doxil, altogether:
A troubled contract manufacturer, whose problems caused a shortage of Johnson & Johnson's (JNJ) cancer drug Doxil, has suspended manufacturing and distribution of products from its Ohio plant, saying routine preventive maintenance and other required actions were overdue. . . . Before its decision to halt production, Ben Venue had strained to balance factory remediation efforts with the need to continue supplying critical drugs, a newly released document shows.
See also here.

Janssen knew or should have known that Ben Venue had a history of manufacturing and quality control problems that would lead shortages and thus should not have been the sole manufacturer in the world of Doxil (called Caelyx in other parts of the world.) The FDA recently issued an unusually lengthy 483 report showing complaints about quality control since 2006 and 48 GMP (good manufacturing practices) violations.  Public records of these FDA inspections and an earlier 483  report have been available since  at least 2007.  The European Medicines Agency also inspected Ben Venue and found quality control issues.

Not only is Doxil currently unavailable for most people who need it, the mainstay chemotherapies for ovarian cancer--cisplatin, carboplatin and taxol (placitaxel) are also in shortage.  Cervical cancer and endometrial cancer are also disproportionately affected by these shortages.  The common drugs used to treat cervical cancer,  cisplatin, carboplatin, taxol (placitaxel) and fluorouracil, 5-FU, are all in shortage.  Fluorouracil is also used to treat colorectal cancer and pancreatic cancer, which are obviously gender neutral cancers.  And do not forget that Taxol is one of the mainstay treatments for breast cancer which is diagnosed in about 230,000 women per year in the U.S. with 2.5 million survivors. Endometrial cancer’s mainline chemo treatments are carboplatin, Taxol, doxorubicin and cisplatin, all of which are in short supply.  Unfortunately, another cancer whose treatment is seriously affected is testicular cancer, for which 3 of 4 mainline chemo treatments (Bleomycin, Etoposide, and Cisplatin) have shortages.  The following generic drug companies have mainline chemo shortages:

Taxol-- APP, Bedford, Hospira, Sandoz and Teva
Carboplatin-- APP, Bedford, Sandoz and Teva.
Cisplatin-- APP, Bedford, BMS and Teva.
Fluorouracil--APP, Teva, and Mylan
Bleomycin—APP, Bristol-Myers, Hospira and Teva (Bedford ceased manufacture)
Etoposide—APP, Bedford, Teva

Drug shortages, which according to the American Society of Health-System Pharmacists (ASHP) as of today exceed 200 drugs, (the FDA, who receives voluntary reports of shortages from drug companies, lists over 170) do not just affect people with relatively rare cancers or just people with cancer in general. The shortages include anesthetics, IV propofol used for intubation when someone cannot breathe, injectable antibiotics such as streptomycin,and norepinephrine and labetalol which regulate emergency cases of  low and high blood pressure respectively.  So these shortages may affect any of us and most likely in an emergency setting when you rely on hospitals and medical personnel having the medications necessary to keep you alive. And as shortages of one drug occur, other substitute drugs have increased demand, which then can lead to their shortages.  No relief seems to be in sight.  As NPR says, drug shortages are "the new normal".

A hearing was held on Friday September 23, 2011 in the House Energy and Commerce subcommittee on Health about the drug shortages.

FACTS FROM THE HEARING (as reported by Ovarian Cancer National Alliance):
• 54 percent of shortages are due to quality control issues
• 21 percent of shortages are due to delays in manufacturing or capacity issues
• 99 percent of hospitals report experiencing one or more drug shortage in the first six months of 2011
• 66 percent of hospitals report an oncology drug shortage
• In an April 2011 survey, more than 90 percent of anesthesiologists reported at least one drug shortage at the time of the survey and 98 percent reported a shortage at some time during the past year
• The shortages have cost hospitals $415 million in drug and labor costs

Monday, November 14, 2011

Money, Money, Money, Money . . . Money- More on the Doxil Shortage

"Some people got to have it."

J&J company, Janssen Products, LP, posted an update last week(on 11/9/11) about the Doxil shortage.  Unfortunately there is no indication that the shortage will end any time soon.  Janssen's president, as a cancer survivor himself, sympathizes with those of us affected by having our treatment plans interrupted or,  in my case, changed.  But, we are s#!t out of luck because Janssen chose to rely on one manufacturer to produce a drug which has no generic competition because it effectively still has patent protection in the US until 2014. (Doxil's patent expired in 2009 but J&J/Janssen still has the monopoly under the Orphan Drug Act as a reward for acquiring the company which produced a drug for a rare condition-one affecting fewer than 200,000 people).

According to Janssen,  this shortage has nothing to do with profit.  Here is Janssen's explanation:


Supply Management and Reason for the Current Shortage of DOXIL®



It is our practice to provide early warning of any shortage in supply of our medications so that prescribers, pharmacists and authorized distributors have as much lead time as possible to plan and source alternative treatment options where it may be appropriate. We alerted the U.S. Food and Drug Administration (FDA) and the healthcare community in June when we first determined that DOXIL® might be in short supply for a few weeks. When we learned that the shortage would be longer term, we quickly alerted healthcare professionals and directed them not to start new patients on DOXIL®. We have since continued to provide regular updates on the status of DOXIL® supply. 
The current short supply situation has been caused, in part, by unplanned downtime due to equipment failures at our independent specialty manufacturer. Some have challenged us, asking if our DOXIL® shortage is financially motivated in any way. We appreciate this opportunity to tell you that this is absolutely not the case. 
We are working closely with this supplier to restore uninterrupted access to DOXIL® as quickly as possible. Until that time, we expect product supply to remain intermittent over the next several months as this manufacturer works to return production capacity to the levels necessary to supply all patients in need. DOXIL® is complex to manufacture -- consisting of multi-step processes that require significant production times – which may add to the time it takes to bring us back up to full supply. (Italics added)
I still do not understand how equipment failures would lead to such a long time to restore production.  I am inclined to believe Ben Venue's original explanation to the WSJ in July  2011 that Ben Venue had made decisions to "prioritize" drug production  in response to a loss of production capacity and other production problems at their facility.  To me, this statement makes clear that Ben Venue decided to focus on manufacturing other more profitable drugs than Doxil when production problems arose, which is supported by Ben Venue's decision at about the same time to get out of the Doxil manufacturing business.  Given that  Janssen  had only this one manufacturer and no contingency plan when production stopped, I can only conclude that Janssen did not consider this drug sufficiently important (i.e. profitable), notwithstanding their protestations to the contrary and their orphan drug exclusivity status.

A recent article in the New England Journal of Medicine (The Shortage of Essential Chemotherapy Drugs in the United States,Mandy L. Gatesman, Pharm.D., and Thomas J. Smith, M.D.N Engl J Med 2011; 365:1653-1655 November 3, 2011)  also agrees that the drug shortages are first and foremost caused by profit motive:
The main cause of drug shortages is economic. If manufacturers don't make enough profit, they won't make generic drugs. There have been some manufacturing problems, but manufacturers are not required to report any reasons or timetable for discontinuing a product. Contamination and shortages of raw materials probably account for less than 10% of the shortages.
Janssen still has not told us much of anything about why the Doxil shortage happened and when it will be fixed.  To me, that is completely irresponsible and lamentable.  However, until the health care system in this country is not solely governed by the profit motive, we can expect no other result.

Wednesday, November 2, 2011

Halloween 3.0

My son and grandson are visiting for a while and staying with us.  I love having them here even with the  chaos that inevitably comes from adding more people, including an active child, to the household.  My 6 year old grandson joined me last night to watch an episode of Star Trek TNG which I forced my children to watch when they were growing up during the initial broadcasts.  And my grandson dressed up as a Teenage Mutant Ninja Turtle for Halloween just like his Dad did over 20 years ago.  Ironically I have the old costume from my son's childhood but it got put into deep storage so my grandson got his choice of a new costume.

This year on Halloween I did not participate in handing out candy or going trick or treating with the grand-boy.  Instead I stayed in my room reading and playing on the computer while others took over these Halloween tasks that I have done for so many years.  My son carved a pumpkin which I saw in the kitchen before I went to "hide" in the bedroom.  It looked fantastic and much better than anything I ever did when he was a child.  I could not find our regular tea candles so, after grousing a while, I gave him a more expensive aromatherapy candle to put in the pumpkin to go outside.  A few minutes later I saw the results of his artistry as the candle lit through the etchings on the pumpkin.  However, I did not see it in person.  Instead I saw a picture of it on Facebook.  In addition to clicking "like" I yelled down to my son that the pumpkin looked great!   Are we a modern family or what?

Paradise Pumpkin 10/31/11

Wednesday, October 26, 2011

I BELIEVE . . .

In case you are not a friend of mine on Facebook I wanted to share with you some special writing I did today. My niece posted the following:
 My response, which gives you some idea about my mood, was the following:

I believe in black.
I believe laughing at people is the best medicine.
I believe in telling people to kiss off a lot.
I believe in pointing out when everything is going wrong.
I believe the prettiest girls are the happiest girls and I believe that tomorrow is another day only
for Scarlett O"Hara.
I believe in martinis, not miracles

Thursday, October 20, 2011

Red Herring re Drug Shortages

NBC Nightly News ran a program on October 17, 2011 about how the current drug shortage problem is being exacerbated by profiteers who are buying up available supplies of drugs in shortage and reselling to hospitals at exorbitant prices. There is no question that this price gauging is deplorable. But it is a red herring in my opinion. It shifts the focus away from the real issue which is why are there such extensive drug shortages in the first place. Why has our drug supply system fallen apart such that seriously ill patients cannot get the drugs they need to survive?



The program started with the right message i.e. the current drug shortages are harming children with leukemia as well as other cancer patients. The program properly focused on the fact that shortages will roll back years of progress in survival rates and children's lives  (as well as others) will be lost.  But NBC Nightly News, like the Congressional response thus far, took the left turn toward focusing on those who would profit from these drug shortages by price gauging rather than keeping the focus on the pharmaceutical companies who have caused the drug shortages in the name of maximizing their  profit.

Price gouging is a much easier target for a solution than the capitalist functioning of the pharmaceutical industry.  Only a few diehard conservative economists will justify price gouging but it is a harder sell to talk about regulating an industry to require them to make less profitable drugs solely to save people's lives.  It is a particularly hard sell in Washington D.C. where the pharmaceutical industry trade association PHRMA and individual drug companies are spending record amounts in lobbying this year.

So let's not be distracted by the predators who will feed on the horrible situation of the drug shortage. Let's keep our eye on the real problem and try to make the drug companies accountable for the drug shortages that are only getting worse.

Sunday, October 16, 2011

In the Pink

Two issues have been bothering me lately. One concerns the development of an "us vs them" mentality in the ovarian cancer community, a mentality that I also share even though I feel bad that I do. I have seen on ovarian cancer bulletin boards and websites a lot of posts of fury and frustration about how much airplay breast cancer gets when ovarian cancer is largely ignored. People are upset, for example, that stores had started putting up the pink breast cancer paraphernalia in September, which was Ovarian Cancer Awareness Month. Now that it is October, Breast Cancer Awareness month, you cannot go anywhere without tripping over pink stuff. It is infuriating given that ovarian cancer is a fairly deadly cancer for American women given its frequency- about 15,000 women in the U.S. will die this year of ovarian cancer out of a population of approximately of approximately 177,000 women who have been diagnosed with the disease. In contrast, breast cancer kills more American women in absolute numbers per year, about 40,000. However, there are currently 2.5 million breast cancer survivors-- about 14 times as many as ovarian cancer survivors, whereas the number of breast cancer deaths is less than 3 times the number of ovarian cancer deaths.
Cupcakes for the Cure (after you finish your KFC)

When I am not also feeling annoyed about the prevalence of pink and the absence of teal, I want to urge everyone to focus on the fact that once no one paid any attention to breast cancer either. It has taken over 25 years to build up this much awareness for the disease, largely due to the actions of the Susan G. Komen Foundation ("Komen"). Perhaps teal needs to take a page from the Komen playbook.

Which brings me to the second issue that has been bothering me. Are the methods worth the outcome of increased attention to the disease and money for research and treatment?  Natasha Singer in today's (October 16, 2011) New York Times reports that Komen has raised billions for breast cancer awareness, treatment and research.  Komen started with the Race for the Cure in 1983 but under founder Nancy Brinker's (Susan Komen's sister) salesmanship, Komen moved into commercial endorsements.  Although pink was associated with Komen from the beginning, the ubiquitous pink loop ribbon came out in 1992 as part of an Estee Lauder campaign and taken from another cancer advocate, Charlotte Haley, who first used a peach loop ribbon to solicit breast cancer donations.  And then the corporate sponsorships cascaded and grew until we find all sorts of interesting items in the pink genre-- such as KFCs Buckets for the Cure, Yoplait yogurt (with all its potentially breast cancer causing sugar), Egglands Best eggs (whose "humane" practices have been questioned), cooking appliances (I myself bought the "pink" Kitchenaid mixer because it was on sale for less than the other mixers) and even potentially carcinogenic perfumes.

It troubles me that breast cancer awareness has become big business although it is hard to argue with success.  For my teal sisters, I think we need to look carefully at the Komen model for raising money and awareness but we need to do something rather than feel sorry for ourselves that pink always seems to trump teal.

Saturday, October 8, 2011

Want Not, Waste Not

Before I go in for infusions I do a pass through the house to toss out rotting food so I don't have to deal with it when I am feeling lousy from the chemo.  When I did this pass yesterday, I was feeling bad about the fact that I tend to have eyes bigger than my stomach when I shop and inevitably buy food that winds up in the trash.  For example, last weekend I bought some tofu spring rolls and heirloom tomatoes that I did not eat this week, and likely now are fodder for the trash can.  This week I mostly ate a bean tortilla casserole that I forced myself to make with black beans I cooked last week which otherwise would be destined for the trash.

It seems to me that worrying about overshopping is a luxury that those who do not have enough to eat would envy.  However, NPR has posted a story to make us who waste feel even guiltier.  Citing a research study, NPR reported we Americans waste about 55 million tons of food a year, or 40 percent of the food supply.  This represents about a 50% increase in food waste from 1974 when big Farma was beginning to overtake American agriculture to give us lower food prices.  As food prices went down, increased food waste also accounted for 25% more water consumption, 300 million more barrels of oil a year and substantial increases in methane and CO2.  Another scientist cited in the NPR story concluded that the average family  gave up 1800 pounds of emissions from food wasted at home.  Luckily for some of us who mostly eschew animal products, 35% of the wasted food is chicken, fish and fruit while only 15% is nuts and legumes.  But, not so lucky for the environment because, as I have said elsewhere, food production and processing is the main source (80%) of greenhouse emissions.

All of this data leads me to two conclusions.  First, we need to cut down on production of animal products in the first instance given how much American food production is polluting the earth.  I do my part in trying to eat virtually no animal products, although I am far from perfect in my occasionally use of dairy products and eggs.

Second, and more difficult for me, is getting a much better sense of how much food to buy and what.  I cannot afford the time or energy to go to the store every day.  So I stock up on the weekends.  Inevitably I buy too many perishable fruits and vegetables.  Worse, for 6 months I belonged to a CSA and rarely ate any of the fruits and vegetables I got in my biweekly box.  I hate to cut off a customer for the South Central LA CSA, but I am more disturbed by all the rotting vegetables I throw away. I do not see myself able to donate scraps to farms or zoos, neither of which are nearby. Instead I need to figure out some system of what and how much to buy so I can reduce my waste foot print.  But with food so colorful, available and inexpensive it is hard to say no when the stomach insists it wants that this week. Self discipline and not wanting would seem to be the best answer I have for reducing household food waste.

Thursday, October 6, 2011

Shortages are Getting Worse-- the "New Normal"

In an odd way, I was pleased to see a report on NPR on October 3, 2011 that the drug shortages are worse than initially reported. I have been shouting "the sky is falling" since August, very concerned about the shortages affecting drugs like carboplatin, cisplatin and taxol, which are mainline treatments for several cancers (including taxol for  the ubiquitous Pinks who should join our bandwagon during Breast Cancer Month). The NPR report emphasized that there appears to be only a month's supply left of taxol at Mass General, a major U.S. hospital.

The NPR report also shone a light on the fact that these shortages, now up to 213 drugs, do not just affect people with relatively rare cancers or just people with cancer in general. The shortages include anesthetics, IV propofol used for intubation when someone cannot breathe,  injectable antibiotics such as streptomycin,and norepinephrine and labetalol  which regulate emergency cases of  low and high blood pressure respectively.  So these shortages may affect any of you (or me if I develop other health problems) and  most likely in an emergency setting when you rely on hospitals and medical personnel having the medications necessary to keep you alive.

And more important, as I pointed out in The Real Death Panels?, the shortages are leading to rationing--by the drug manufacturers like Ben Venue who are using an allocation system of only providing Doxil to a limited subset of those who already were in treatment with it, and by the hospitals or infusion centers who are deciding who more critically needs the drug.  (see my blog post Drug Shortages, Ethics and the Scramble to Stay Alive)  For example, as the 10/3/11 NPR report states, hospitals are taking from some patients to give to others.
One reason that Kevin Zakhar [a fifteen year old boy] hasn't been able to get the calcium solution he needs is that hospitals have been reserving it for patients who need it even more desperately than he does. 
Kathy Gura, a pharmacist at Children's Hospital in Boston, points to one of those patients, a tiny infant born only 23 weeks past conception, as premature as a baby can be and still survive. And he wouldn't have survived without the same kind of IV feeding that Kevin Zahkar gets.
Gura and caregivers at other hospitals say they have had to divert scarce electrolytes from other children and adults to save the lives of fragile preemies. Gura calls it "robbing Peter to pay Paul."
See also here for a discussion of one breast cancer fighter's experience with drug rationing.

And as shortages of one drug occur, other substitute drugs have increased demand which then can lead to their shortages.  No relief seems to be in sight.  As NPR says, drug shortages are "the new normal".  My reaction continues to be: how can that be possible in the United States which is known for innovation in science and medication development?  How can it be possible in any civilized society-- to leave your most vulnerable citizens without needed medications?

Monday, October 3, 2011

Picture This!

The other evening I got together with a dear friend of mine.  While we were eating dinner, she pulled out a small album of photographs from her trip to Machu Picchu and surroundings areas.  As I flipped through the album she gave me background information and vignettes about aspects of  the trip which the photos captured.

Old School Photo Album

The last time I showed anyone my pictures from a trip in person, I did it on an iPad.  The person looking at them went through the pictures quickly and did not pause enough for me to give too much background or too many vignettes.  But then, vacation photos have always been something that either you love or hate/tolerate.

Remember sitting through slide shows of pictures of someone's vacation while they narrated each event?  Those slide shows are fodder for many comedians' routines. Anyone who has been through such a slide show will recall the dread of going to someone's house where the slide projector and a screen were set up in the living room. The last "slide show" I saw briefly was on a DVD of old family photos from my husband's family.  My children found it fascinating.  I found something else to do.

These days I typically look at people's pictures online.  I  will peruse online photos of something within a day or so of it happening if the poster gets the photos up right away.  In that way, we are on virtual holiday with the poster.  I also see a lot more photos than if I had to meet the people in person and look at a physical photo album.  And I get to choose what I want to see rather than having it foist upon me a la old school vacation slide show.

The downside, of course, is the lack of information and context about the pictures I see online.  Some people are good about explaining the pictures.  Others do a photo dump and leave you to guess what you are looking at.  And even with the written explanations, nuance and detail just tend to not be there in postings online.

On balance, I think I prefer looking at photos online.  I can take the amount of time I want to look without boring others if I linger or offending if I go fast.  I can zoom in if I want on aspects of the photo that intrigue.  But, as I realized the other day when looking at my friend's photo album, there is clearly something lost in the online experience--the real time human sharing of experiences rather than virtual sharing.  What you get with online sharing is mostly quantity and less quality of experience.  Some would mourn the loss of the quality of the in person photo sharing experience. Perhaps I do a little.

Wednesday, September 28, 2011

More Publicity But No Progress

A new friend of mine who also has ovarian cancer sent me a link to the following video of coverage earlier this week on CBS News of the drug shortage. In it, the woman featured in the CBS News spot I posted earlier is revisited. This time she has somehow been able to get Doxil, but only one dose and she reportedly does not know from month to month whether she will get any more.



Janssen updated its notice on September 23  about availability of Doxil, explaining that they expected to release limited amounts within the next six weeks but reading between the lines correctly this shortage will likely continue for several years. Janssen reiterates that the supplies will not be enough for those on the waiting list.  The Wall Street Journal reported on September 26, 2011 that 2500 people are still on the Doxil waiting list. I am one of those 2500.

The WSJ article also confirmed that Doxil is not a big seller for Johnson & Johnson (Janssen's parent), representing less than 1% of annual revenue.  It was heartening to see the emphasis in the CBS News report on the issue of profit in the decision making creating  these shortages.   I understand from Ovarian Cancer National Alliance (OCNA) that GAO will issue a "definitive report" this fall about the causes.  Somehow I do not think profit will be their explanation.

Here are some other interesting facts reported by OCNA:
FACTS FROM THE HEARINGS
  • Of the 4 billion prescriptions filled in the United States in 2010, 3 billion were generic drugs
  • 54 percent of shortages are due to quality control issues
  • 21 percent of shortages are due to delays in manufacturing or capacity issues
  • The integrity or safety of drugs sold on the gray market cannot be assured
  • The average mark up of drugs on the gray market is 650 percent; one-quarter of drugs sold on the gray market are marked up 2000 percent
  • 99 percent of hospitals report experiencing one or more drug shortage in the first six months of 2011
  • 66 percent of hospitals report an oncology drug shortage
  • In an April 2011 survey, more than 90 percent of anesthesiologists reported at least one drug shortage at the time of the survey and 98 percent reported a shortage at some time during the past year
  • The shortages have cost hospitals $415 million in drug and labor costs

By the way, do you think CBS News read my post The Real Death Panels?  I find it very suspicious that they chose to show Nexium in their report after I featured it in my blog post. ROFLMAO.

Sunday, September 25, 2011

More about Drug Shortages- Get Out Those Scarves and Teal Arm Bands

What if the government and private donations pumped money into the development of drugs to treat a deadly cancer but suddenly when distribution of the drugs became unprofitable the companies making them stopped production.  What happens to the war on cancer then?  Should we just accept that in a capitalist economy, profits determine who lives and who dies?

I have written in other posts that it appears to me that the current chemo shortages are disproportionately affecting ovarian cancer, which is primarily an older woman's disease. I was please to find this American Cancer Society article that confirms my position. Unfortunately the article skews the discussion a bit about what has caused the shortages by also quoting  a large pharmaceutal distributor (McKesson) saying essentially it's all the FDA's fault.  The spokesperson claims that FDA's increased scrutiny on manufacturing processes and quality control have made certain drugs too low in profits to sustain production of those drugs.  The article further states,"McKesson’s Chief Medical Officer Dr. Roy Beveridge, MD, says there is no economic incentive for manufacturers to make or distribute low-priced generic drugs, and that unless the baseline system changes, shortages are going to continue."

J&J Headquarters designed by IM Pei


Ben Venue Labs, the manufacturer of Doxil, a critical treatment for recurrent ovarian cancer, for a subsidiary of Johnson & Johnson, claims that the problem is not one profit. An 9/22/11 article in courier-journal.com by Laura Ungar states:
Jason Kurtz, spokesman for the Ohio-based third-party maker, Ben Venue Laboratories, would only say “we’re facing capacity constraints” with a drug that is complex to make. He wouldn’t specify what type of constraints, but said examples of such problems include unplanned downtime because of machinery breakdowns and capital-improvement projects that limit manufacturing capacity.


However, Ben Venue Labs wants out of the Doxil business (and other contract manufacturing) to focus more on its business as Bedford Labs, a producer of generic injectables, and avoid all the problems that have caused bans from Canada and Europe of Ben Venue products.  Like the WSJ said, it is all about manufacturing priorities. In the meantime, as Bedford Labs, the company has discontinued cisplatin and carboplatin and has significant shortages in production of Taxol. It appears to focus on commonly needed and presumably more profitable drugs such as those that treat migraine (generic Imitrix), indigestion (generic Zantac) and high blood pressure (generic Inderol).

With Ben Venue moving on to greener pastures, who will J&J find to manufacture Doxil and how hard will they try? Doxil reportedly represents less than 1% of Johnson & Johnson revenues.  A few of my ovarian cancer sisters on inspire.com bulletin board noted that J&J makes a lot of money marketing to women, and in particular in women's products.   Here's one list of products that J& J sells.  Perhaps J&J needs to be reminded that they need to focus on Doxil as well, and quickly.  

In addition,  there are all the generic drug companies that have discontinued or have serious shortage in chemo drugs  ovarian cancer patients need. For Taxol, they are APP, Bedford, Hospira, Sandoz and Teva.  For carboplatin, they are APP, Bedford, Sandoz and Teva.  For cisplatin, they are APP, Bedford and Teva.  And with Bedford, now out of the ovarian chemo business for the most part, more of the market power will consolidate in the handful of generic companies left, who will continue to make "allocation decisions" of their manufacturing capacity based on profit. 


What can we do? Big Pharma would have us believe that the causes are all very complicated--increased reliance on outsourced ingredients, Medicare price controls, increased demand from all those pesky cancer patients, complicated manufacturing processes and lack of inspection capacity from the FDA.  But we all know that it boils down to making sure that Big Pharma makes maximum profit, even when lives are at stake.  This is unacceptable in a civilized society.


In my previous posts, I have encouraged people to write to Congress.  A hearing was held on Friday September 23, 2011 in the House Energy and Commerce subcommittee on Health but the human voice of the affected cancer patient was sorely missing. We can continue to try to get our government to take some action in this area which they have been loath to regulate thus far.  Or we can take our message to the streets and protest at the offices of the companies who will not manufacture the drugs we need.  We could show up at J&J corporate offices (and the generic companies too) wearing scarves and teal arm bands, with our message that we are still here, we are still fighting and they have an obligation to get us the drugs that will keep us alive.  Who's up for a road trip to New Brunswick, New Jersey?

Saturday, September 24, 2011

You've Come a Long Way, Baby!

When I first read the LA Times August 26, 2011 op-ed piece  by Eve Weinbaum and Rachel Roth, "Beyond Suffrage: How far have women come since?", my reaction was "a long, long way" (even without our own cigarette now,baby).   My first reading of the article was to pick apart all of the criticisms of what women have not accomplished and focus on how much has changed in the last 90 years.  But, in watching the Gloria Steinem HBO documentary again this evening, I was struck by her quoting Susan B Anthony, "Our job is not to make young women grateful. It is make them ungrateful so they keep going."

I needed to reconcile these two views.  While I agree that making women "ungrateful" and ever aware of their second class status is motivating,  I also believe that ignorance of where we have been and what we have accomplished can zap motivation for more change.  Thus I found myself scrutinizing the Weinbaum/Roth article with both a look to what we have accomplished and what still needs to be done.

The op-ed outlined a four point plan by feminist Crystal Eastman in 1920 for women's freedom now that they had won the vote.  Weinbaum and Roth summarize the four points as follows (for the modern crowd):
[E]conomic independence for women (including freedom to choose an occupation and equal pay), gender equality at home (raising "feminist sons" to share the responsibilities of family life), "voluntary motherhood" (reproductive freedom) and "motherhood endowment," or financial support for child-rearing and homemaking.
Weinbaum and Roth then argue that women have not achieved these four things in the past 90+ years.  For example, women on average still only make $0.77 for every dollar men make (and even less if you are a woman of color).  But, I wanted to remind everyone, women did not make anything working 100 years ago and as recently as 40 years ago only made half of what men made, on average.  Women are able to work in almost every occupation and have equal if not greater access to university educations, as a result of the feminist movements so far. But I know that women still are not well represented in the highest ranks of power either in government or in the boardroom.

To me, the problem is that our society does not really accommodate the fact that women are the ones to give birth rather than men.   All of the inequalities of today stem from that fact (and are magnified by inequalities of income).  Women in the United States, on the whole, do not have reasonable access to childcare either right after birth or as work continues.  They have reproductive freedom that was not available 90 years ago--contraception and abortion, but when a woman chooses to have a child, the support is quite limited.  Two states (California and NJ) provide paid family leave insurance to workers covered by state disability insurance in the form of payment (at 55-65 percent (or less) of regular salary. A handful of other states, such as Rhode Island, New York, and Hawaii, offer temporary disability insurance to mothers to recover from the "disability" of childbirth based on a doctor's certification.  For example, when I had my daughter in the late 80s, which was before California enacted its paid family leave insurance, I got this TDI for eight weeks, which was the maximum time any doctor would give unless there were unusual complications.  Most states, however, do not have such TDI or insurance so that they are only bound by Family and Medical Leave Act, which allows the employee to return after family leave to a job but does not pay for that leave and only applies in organizations with 50 or more employees. Only about half of United States employees are eligible for FMLA.

Private sector generally does not  voluntarily provide paid family leave.  According to one 2011 survey by the Society for Human Resource Management, only 16% of private sector companies in manufacturing and service sectors offer  paid maternity or paternity leave.  Private sector provision of child care is no better. 2007 U.S Department of Labor study reports that only 15 percent of private sector workers had access to employer-provided childcare assistance, including funds, on-site or off-site childcare, and resource and referral services.  Even worse, however, is federal government employees who must use sick leave and other leave for childbirth and new infant care.  A recent federal report recommended against providing 6 weeks of paid leave, claiming the current system of cobbling other leaves together for childbirth and new infant care was "generous"

 Reportedly, Fortune 100 companies do better, with about 75% of them offering paid maternity leave, which raises an interesting question of 25% of the 10 best companies for which to work do not offer paid maternity leave.  However,  Fortune 100 companies in 2011, the 100 "Best Companies to Work For", with roughly 1.5 Million employees, only represent less than 1% of the labor force. And childcare in this rarefied stratosphere is not all that readily available or inexpensive. About 25% of the Fortune 100 companies offer onsite childcare for which you still have to pay $400-$700 per month.

Unfortunately, the lack of support for maternity leave and child care in this country is not just financial, although lower and middle income families keenly feel the lack of financial support .  For those who can afford childcare, there is still the lingering sentiment that children need to be raised by their parents, not child care providers.  The corollary to that belief is that women should do the brunt of raising of children because men make more money, or are not naturally good with children or some other rigamarole.  If there are still those who think that the best child rearing environment involves a stay at home parent, let us free men from the stereotypes that they are not able to do it.

As a matter of practicality in this economy, both men and women have to work for families to survive financially.  Given that reality, our government needs to put behind its stereotypes of the past and take responsibility, like most countries, to pay for a reasonable length maternity and new infant care leave.  Until then, women in the United States will not  experience critical equality.

Monday, September 19, 2011

CBS News Report on Doxil Misses Some of the Point

Gray Kitty wondering about Gray market drugs
Finally, there is  more nationwide focus by CBS News on the nationwide shortage of Doxil and the other shortages in over 200 drugs.  Unfortunately, after starting out strong on the Doxil problem, this show shifts its focus to  the gray market for drug shortages, which is likely a side effect of the shortages rather than a cause.  The CBS piece also suggests that demand for these chemo drugs is up when we know from looking at the ASHP schedules that in fact supply is down. For example, the ASHP report says "Bedford discontinued carboplatin in May, 2011 to concentrate on the manufacturing of other products."  The manufacturers have other drugs to make that are more profitable so cancer patients who need generics like carboplatin, cisplatin, Taxol,  fluorouracil, 5-FU and doxorubicin.  While I deplore those in the gray market profiting from the shortages, let's not lose sight that they did not cause the shortages in the first instance.  Let's keep our focus on the drug companies, who made manufacturing decisions to cut supplies, while demand for certain chemotherapies was going up.