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.

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?

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. A 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.

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. 

Bad News, Good News

Even sweet doggies get IVs

Yesterday my gyn/onc and I chatted a bit before I had my third infusion in this course of treatment for recurrent ovarian cancer. He confirmed what I expected--that Cedars Sinai had not received any Doxil and did not know when they would. He said that their pharmacist was dealing with multiple vendors now in an effort to secure some but no success. However, he thought some of the smaller treatment clinics may be getting some small amounts of Doxil. Oddly enough that made me feel good given that many times I have heard from sisters that they could not get either Taxol or platinum drugs at the smaller infusion centers.

So it looks like I will continue my treatment with only carboplatin. The good news is that it is really knocking down my CA 125 numbers. After two infusions I have dropped from 100 to 15, which is almost in my baseline remission zone, which is 8-12. The doctor is optimistic that I will only need one more infusion after the one I got yesterday.

My only nagging concern is that, as Dr. Li confirmed, studies show that average time in remission and overall survival  is better with a combination of Doxil and carboplatin than with Doxil alone. And the longer you are in remission, the more likely you will respond to carboplatin in the future (i.e. be carboplatin sensitive). So there may be some problem in the future for me because I missed Doxil this time but only time will tell whether I am in the average group or as Dr. Li says at the good end of the bell curve with a lengthy remission ahead of me.

Which leads me to a discussion of studies and numbers.  While I was looking for studies about the effects of Doxil in combination with carboplatin on remisssion and survival, I came across a few studies that had not seen in the past.  The first study sent my heart soaring because it said the average five year survival rate for my type and stage (initially IIIa) of ovarian cancer is 45%. (Another report said 41% which also made me feel ok).  I had read in the past survival rates in the 25-30% for my type and stage of cancer.  Hopefully these new stats mean treatments are getting better and hopefully the drug shortages will not cause the stats to decline again.

On the other hand, contrary to what my doctor had told me, my recurrence may mean my survival rate has dropped.  If I am reading these stage criteria correctly, the fact that my cancer has spread to my lymph nodes should mean I am now IIIc.  Staging is done during surgery but it would seem to me that now we know it has spread to the lymph nodes (which the doctor explained to my worried husband that it had nowhere else to go) should the stage not be IIIc?  Another question for the doctor. If I am IIIc, my survival rate just dropped to either 35% or 23%.  Ooops!

My doctor tells me not to look at the stats on the internet.  They are old and they are averages for a population.  They do not predict to the individual, i.e me.  Someone has to be out at the good end of the bell curve.   I know that the statistics do not tell me how long I will live.  I once taught college statistics and have a PhD in psychology which fully covered study design (so don't get me going on some of the medical studies I have cited here).  But it is hard not to feel like I have a five year expiration label on my forehead. No one knows for sure how much time one has.  In the meantime, we need to keep going to make sure that ovarian cancer is recognized as the serious problem it is and that drug shortages are remedied.

I Have a New Blog Site for Cancer Posts!

Please visit my new blog site where I will be posting only about cancer issues. http://helpkeepasisteralive.blogspot.com/

So far I have only republished posts from this blog that concerned cancer.  New posts will be forthcoming!

Awareness is Good; Treatment is Essential

President Obama proclaimed that September is Ovarian Cancer Awareness Month.  He acknowledged that ovarian cancer is still one of our deadliest diseases saying:

Ovarian cancer continues to have one of the highest mortality rates of any cancer, and it is a leading cause of cancer deaths among women in the United States. This month, we remember the mothers, sisters, and daughters we have lost to ovarian cancer, and we extend our support to those living with this disease. We also reaffirm our commitment to raising awareness about ovarian cancer, and to advancing our screening and treatment capabilities for the thousands of American women who will be diagnosed this year.

For those of us living (and hopefully not dying) with ovarian cancer, the lack of recognition for this disease is all too palpable and manifests itself in subtle ways.  For example, the current drug shortages seem to affect ovarian cancer disproportionately.  Not only is Doxil, a key treatment for recurrence of ovarian cancer, currently not available for most women who need it, the mainstay chemotherapies for ovarian cancer--cisplatin, carboplatin and taxol (placitaxel) are also in shortage.  See also the FDA report on shortages here. Some of these drugs are also used to treat breast cancer, also a woman's disease.

I cannot emphasize how important these three mainstay drugs are for ovarian cancer.  They pushed me into a year long remission after I was treated with them for five months in early 2010.  I am only getting carboplatin now to treat a recurrence and it seems to be working so far given that my CA125 numbers have dropped significantly.  I would not be exaggerating to say that I would likely be dead  if those drugs were not available to me in 2010.  It is amazing to me that shortages of such critical drugs are not being addressed at the same time the President is calling for "advancing . . . treatment capabilities" for ovarian cancer.  Yes, we need research for new drugs but we also need access to the drugs that work now to put ovarian cancer into remission.

There have been several good press reports about the drug shortages but unfortunately everyone of them focused on men with cancer rather than the impact of these shortages on women's cancers.  Gardiner Harris' New York Times article  was the best of the bunch by discussing both an ovarian cancer patient who could not get Doxil and a breast cancer patient concerned about the Taxol shortage.  However, the person who was shown in the picture accompanying the article was a man with colorectal cancer.  To the Point interviewed Gardiner Harris, a representative of the generic drug trade association and Senator Klobucher but included as the "cancer patient" experiencing problems with shortages a man with cancer in remission!  And the PBS News Hour coverage of the drug shortage also featured a 55 year old man with acute myeloid leukemia who luckily was in remission despite the shortage of the drug used to treat his type of cancer.

Is it a coincidence that the drug shortage story is told in the press by chronicling its effects on men?  My own view is that the story is more compelling when it affects men than when it is shown to be disproportionally affecting women's cancers--particularly cancer affecting mostly older women who are beyond child bearing age.  The men in these stories are all professionals whose careers are interrupted.  The women are shown as crying about the situation.  It is bad enough that we women have to suffer these shortages but to also be shortchanged by mainstream media in what appears to be not so subtle sexism is beyond comprehension.

The public needs to be made more aware that the drug shortages exist and affect women's cancers in a significant way.  One suggestion I have is to contact the White House to make them aware during this month of ovarian cancer awareness that treatments for ovarian cancer are in critical shortage.  You can write to the White House here with the message that while awareness of ovarian cancer is good, it is essential that these drug shortages end so that women with ovarian cancer can get the critical chemotherapy drugs used for mainline treatment.

ADDENDUM (9/14/11):  I have just learned after some research that cervical cancer is also disproportionately affected by these shortages.  The common drugs used to treat cervical cancer are cisplatin, carboplatin, taxol (placitaxel) and fluorouracil, 5-FU  which 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.

ADDENDUM 2 (9/15/11)  Endometrial cancer is also disproportionately affected by the shortages because its 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.  Prostate cancer, on the other hand, (the most common men's cancer) is typically not treated by chemo and when it is, fortunately for those patients, the chemos used (e.g. docetaxel) do not seem to be in shortage.  Here are links to contact Congress about pending legislation re the drug shortages.
http://www.opencongress.org/bill/112-h2245/text
http://www.opencongress.org/bill/112-s296/show

Sedona on the Rocks

We have been to Sedona many times in the past ten years.  Last week, over Labor Day weekend, was the first time we went in the summer.  And it was so hot! 110 degrees or so every day we were there.  As a result, my plans to do a tour and some hiking were dashed.  Instead we drove around in an air conditioned car and got out in the heat for short periods of time to take pictures.

On route 179  on the way into Sedona from Interstate 17, there is a visitor center for the Red Rock region, which is part of the National Park system.  We stopped to take some pictures, pick up a Red Rock pass and otherwise look around (i.e. shop for trinkets for grandchildren and me).  This year, I remembered my annual N.P. pass which allows me to get the Red Rock pass for free.  I was looking for it in my purse to show the woman at the desk and she asked me if I had the Senior Pass.  I laughed and said, no, I hoped I did not look like I was 62 already.  Then, when I asked her for the map with the rocks she said that was the "Disneyland" map and I really should take the hiking trail map instead.  Apparently being in an air-conditioned building all day made this woman, who was significantly older than I am, delusional about what is appropriate behavior in 110 degree weather.  I took my "Disneyland" map and left to take photos of the rocks, like any good Mickey Mouse tourist.

Three of the rocks shown below are spiritual vortices in Sedona, and reportedly have special energy.  They are Bell Rock,  Cathedral Rock and Kachina Woman.  The fourth vortex, Airport Mesa, is not really a rock  and thus not as photogenic as these other places.

These rocks are named based on what they resemble.  I have followed local conventions as much as possible although sometimes Thunder Mountain is also called Capital Butte, Two Sisters is also known as Twin Nuns and Coffee Pot Rock, from another angle, is called Eagle Rock.  The red color of the rock comes from a mixture of ferrous oxide with sandstone.

I also include a picture of the Chapel of the Holy Cross which is not a rock per se but is viewed in the same light and even deemed by some to be a vortex.  I must agree that it has a special aura when you go inside.

Kachina Woman (Boynton Canyon)

Two Sisters

From left- Chimney Rock, Thunder Mountain, Coffee Pot Rock

Courthouse Butte

Coffee Pot Rock

Madonna and Child

Bell Rock

Cathedral Rock (from Schnebly Hill Road

Chapel of the Holy Cross

Eggs Benedictine- a Matter of Worship

It is a fact.   On vacations, we overeat and eat things we typically do not eat.  As I try to segue into a fully vegan diet, I am constantly tempted, particularly on vacation by delicious egg dishes.  My favorite, of course, is eggs benedict, which I now eat without the meat (ham, bacon etc).  It is chockfull of buttery and eggy goodness from the poached eggs to the lovely hollandaise sauce.  Three times on this trip I have resisted the siren call of the eggs benedict.  First, at Red Rock Cafe where I vaguely remember thinking the sauce was not worth it, I decided against the lovely dish.  Second, I passed at Josephine's in Flagstaff, much to my regret as my husband let me taste his.  The sauce at Josephine's is superb with just the right amount of lemon for my palate.  Third, this morning I skipped them at Yavapai at Enchantment resort and after tasting the sauce remembered why.  It is a bit spicy for my taste although the husband loved it!

It is hard to find acceptable eggs benedict these days, which is probably good for me if I am in fact giving it up. In Los Angeles, there were a few places that made eggs benedict just right but I am afraid those places do not exist in the incarnation when the eggs benedict were king.  We used to go to the Sandcastle in Malibu/Paradise Cove for Sunday brunch and get an excellent eggs benedict.  Now the place is the Beach Cafe and somehow neither the eggs benedict or the atmosphere are the same.  Another place I loved for the dish was Cafe Rodeo in Beverly Hills during the late 80s and early 90s.  I think the restaurant is still there but did not even see regular eggs benedict on the menu.  Recently I tried the Farm in Beverly Hills for eggs benedict.  They put it on a biscuit unless you ask for an english muffin.  Again, not as good as the best I remember.

About eight years ago, my husband, daughter and I took a trip up the California coast.  We started at the Sandcastle and decided, as only our family would, that we would go on an eggs benedict tour up the coast. I do not think we stopped at the Biltmore in Santa Barbara (now the Four Seasons) which also had decent eggs benedict but continued north to Cambria. There unfortunately we could not find the dish but instead found wonderful croissants in a French patisserie.  Next we moved on to Monterey where we found excellent eggs benedict  in an unassuming restaurant on one of the main streets.  In San Francisco, we ventured over the Golden Gate Bridge to a hotel sitting on top of the hill in Sausalito overlooking the bay.  Hands down, that place had the best eggs benedict we ever ate.  Unfortunately, the hotel is long gone, now replaced by a luxury drug rehabilation residential facility, where I suspect they do not serve eggs benedict (although you never know).

The only place where I have been recently that served exquisite eggs benedict was Dean Street Townhouse in London.  The egg was farm fresh with a bright reddish orange yolk, almost unobtainable here in the states unless you keep your own chickens.  And the hollandaise sauce was divine.  Even the english muffin was cooked appropriately--crispy and not soggy or chewy.  Ah, the memories.  Luckily I do not go to London very often.

So if I keep my promise to myself to eliminate dairy and eggs after this course of chemo treatment ends, eggs benedict will be a thing of the past for me.  I will remember my days of worshipping the dish fondly as I move onto other foods that reportedly will keep me healthy.  Salut my old friend.  Maybe I will eat you once again.

ADDENDUM: I tried a taste of eggs Benedict at ABC Bakery this morning in Napa. Pretty good sauce (with a little kick so not for purists) and delicious homemade English muffins.