Sunday, January 31, 2010

snow day

On Friday night the snow started about 5:45. This was fairly soon after it started.


This was right before we went to bed. It was falling pretty hard.




Yesterday was super cold and really windy so we didn't venture out. At all. I did take a shower but stayed in Jonah clothes all day and didn't put on makeup. It was awesome.

But today I was ready to get out, so we bundled Jonah up (much to his dismay) and went outside. He was not happy. I think he would have liked being outside but HATED having so many clothes on. I put shoes on him for the first time too (several sizes too big so they wouldn't blister his ankles), and I don't think he was diggin' that either.









After we came in I decided to make Chicken and Rice Soup. And then I had leftover chicken so I decided to make Chicken Tortilla Soup too. I had no idea how to make it so I looked it up on allrecipes.com. It was so good.

Here is the recipe:

Ingredients:
2 skinless, boneless chicken breasts
1/2 teaspoon olive oil
1/2 teaspoon minced garlic
1/4 teaspoon ground cumin
2 (14.5 ounce) cans chicken broth
1 cup frozen corn kernels
1 cup chopped onion
1/2 teaspoon chili powder
1 tablespoon lemon juice
1 cup chunky salsa
8 ounces corn tortilla chips
1/2 cup shredded Monterey Jack cheese (optional)

Directions:
1.In a large pot over medium heat, saute the chicken in the oil for 5 minutes. Add the garlic and cumin and mix well. Then add the broth, corn, onion, chili powder, lemon juice and salsa. Reduce heat to low and simmer for about 20 to 30 minutes.

2.Break up some tortilla chips into individual bowls and pour soup over chips. Top with the Monterey Jack cheese and a little sour cream.

I think I would add a can of black beans if Matt liked beans. I'm actually surprised it didn't call for them. I think that would be tasty.

I think we got about seven to eight inches, but I never heard a final total. Our road hasn't been scraped yet, so the melted slush has refrozen. It's really slick and nobody really knows how to drive in the snow here. Who knows when school will be back in session. If our neighborhood is any indication, it could be a while. It's really pretty but I'm about done being homebound.

***********************************

Operation Jonah Eat is on hold. Today didn't go very well, and the second try of solids made him puke up one of his bottles, so I ended up chickening out and giving him four bottles anyway. I just can't take the 162 to 216 calories (not that I'm counting) away from him until I'm sure he'll eat. I know I can't expect a change after just one day, but I started having my doubts today and changed my mind. I think I'm not going to worry about it right now. I'm going to talk to his pediatrician at our next appointment. Thanks for praying. Maybe pray for more bravery and trust for me. :)

His diaper area is still super rough. Today was another bad day, and he is crying every time he urinates. It's heartbreaking, and there's nothing we can do. I hate it.

While You Were Taking a Homeopathic Overdose

In Britain, hundreds of protesters gathered outside branches of the drug store Boots to endulge in a little comedy 'overdose' of homeopathic pills. The sugar rush must've been amazing.

Meanwhile, in Washington, here comes the budget. And it ain't pretty ...

While you were watching a pretend football game ...
  • GSK plans to cut about 4,000 more jobs in the US and Europe, reports the Sunday Times. The official word is expected on Thursday when the Big Pharma reports its 2009 financials.

  • Harvard and Imperial College scientists have elucidated the structure of a key HIV enzyme, integrase, reports Reuters. The findings should aid drug discovery and resistance-prevention efforts.

  • Merck Serono: no timeline yet on FDA resubmission of MS drug oral cladribine.

  • FDA isn't happy about one oft-quoted dermatologist's premature enthusiasm for Dysport in 2007, which hadn't yet been approved. The forum? The women's magazine Allure.
  • UPDATE: Cephalon is buying the Merkle-owned Swiss generics company Mepha for $590 million. The deal doubles the size of Cephalon's overseas business, which until now mainly comprised the assets of former European specialty play Medeus.

image from flickr user shellac used under a creative commons license

Saturday, January 30, 2010

operation jonah eat

Aunt Kim sent Jonah a present with Granny.


He was much more interested than he was at Christmas.



He really liked it.


Like, a lot.
****************************************

Jonah's little boy parts did not blister as badly today. I think we only had to drain two. Desitin works well for us and doesn't seem to hurt him, I just don't know how to stop the blisters. But if I knew that, he wouldn't have EB, I guess. Anyway, it's frustrating, and he's still crying when he pees, but hopefully it will get better soon. Thank you for praying.

I'm going to take a risk tomorrow. I'm beginning Operation Jonah Eat. Jonah is fighting his bottles again and is wanting to cut back on his napping (he used to take four very short ones with every feeding. Now he only seems to want two, so eats poorly when he's not tired). And my Mommy gut is telling me that he's not into solids (AT ALL!) because he's too full on high calorie/rice thickened formula. He doesn't like when I take all the rice out, so I've cut it down by half, but between that and the 27 cal formula (normal mix is 20 cal), I honestly think he's just not hungry enough to want to put in the effort to eat anything else. So...

Operation Jonah Eat is in effect. Tomorrow I'm going to try switching to only three bottles instead of four. And I'm going to try to fill in the gaps with solids. Right now I give him bottles at 9, 12:30, 4, and 8. Tomorrow I'd like to try bottles at 9, 2, and 8, and try solids at 12:30 and 6:30. I don't know. I'm worried because I'm concerned he won't compensate, but even if he doesn't, I don't suppose a couple days will do any permanent damage. And I fully understand that formula is LOADED with nutrition and baby food is pretty much void of anything substantial (except yogurt maybe), so this is not so much for nutrition as it is to see if he has any interest when he's hungrier. If he does get interested, I'll look into more nutritious things, but for now, we're just testing the waters.

At this point, I wouldn't even care if he just ate chocolate pudding and ice cream. I so desperately want him to like eating.

Okay, that's it for me. We're watching 500 Days of Summer, and it's hard to type and follow it at the same time because they keep jumping around. I really like it though and am especially diggin' the music.

DotW: State of the Union



In case you missed it, President Obama peeled back the layers of the onion this week, causing U.S. generals, Supreme Court Justices, and the Republican minority to week. The prez reaffirmed his belief in the necessity of health care reform but offered no concrete specifics about what it would take to actually get a bill signed.

Meanwhile the state of the biopharma union is decidedly mixed. Johnson & Johnson announced the first drop in sales since the Great Depression; Lilly’s earnings were less than stellar thanks to a lagging Effient launch; and AstraZeneca announced additional job cuts across its far-flung organization. (In case you are wondering, R&D will be hit again, as the company seeks to reduce its internal R&D footprint.)

Shareholder activism continues to be the rage in our industry, prompting WWCID moves from Genzyme. The Big Biotech announced it was changing executive compensation, backing away from salaries and bonuses only tied to operating income, and also strengthened the role of its independent director this week. Will such moves appease Icahn and other major institutional investors? It’s hard to say but you can bet Genzyme is paying close attention to events happening at its nearby neighbor Biogen, given Icahn is aiming to put another three members on that company’s board.

The state of biopharma dealmaking was decidedly light this week. Perhaps the flow of information related to the poorly named iPad distracted. Whatever the reason, IN VIVO Blog, in an effort to provide for the common defense and promote the general welfare, brings you another edition of Deals of the Week. (Domestic Tranquility is not, however, insured.)

Flexion/AstraZeneca/Merck Serono/Unnamed Big Pharma: Flexion Therapeutics raised its profile on Jan. 29, announcing it has licensed in four clinical-stage compounds from a trio of drug makers: AstraZeneca, Merc Serono, and an undisclosed drug maker. It topped off its $33 millions Series A with another $9 million from Pfizer Venture Investments. (Oh, corporate venture, how we love you.) According to CEO Mike Clayman, the various deals came together over recent months but the company decided to announce them all at once. Flexion's original model supposed that pharma companies would be more eager to part with their shelved compounds if they held "clawback" rights, but Clayman said only one of its four programs has such a provision. He was unable to disclose which of the candidates it was or any of the financial terms of the various deals. (Want more? Check out this January 2010 IN VIVO feature.) Founded in November 2007 with $3 million in seed funding, Flexion seeks to take advantage of large pharma's excess discovery capabilities by licensing potential high-value specialty compounds and developing them through proof-of-concept and beyond. It's no coincidence that the company's business plan resembles that of Eli Lilly's Chorus unit - Flexion principals Clayman and Neil Bodick founded Chorus before striking out on their own. The company is focused on specialty products so that it won't have to partner them to advance to market, Clayman added.—Joseph Haas

UCB/Sanofi-Aventis/Teva: UCB has slowly but surely been paring down its primary care activities in favor of specialty products, even garnering an IN VIVO Blog Deal of the Year nomination for its emerging markets deal with GSK. Today, the company announced it would accelerate that process by offloading US rights to its soon-to-be-off-patent allergy drug Xyzal to Sanofi-aventis and end its co-promotion around Teva’s albuterol ProAir. The future of UCB now rests largely on the emerged-market performance of its immunology and neurology franchises, dominated by Cimzia, Vimpat and Neupro. It will hang on to Tussionex, its cough remedy, but will cease using a sales force to promote the drug. UCB didn’t mention the terms of either the Sanofi agreement or the Teva deal cancelation, nor how many jobs would be affected by the move. It did note that these moves, along with previously announced restructuring in Europe, would result in a €70 million post tax charge that will lower 2009 earnings accordingly.—Chris Morrison

GlaxoSmithKline/Amgen: Split indications are a potentially messy reality for biologics with potential wide-ranging utility. Amgen knows that all too well given the fracas that ensued over Epogen. But the company seems willing to tread in those churning waters--as long as the partner is Glaxo. In in its second indication-specific deal with the Big Pharma in less than a year (Prolia for PMO was the first), Amgen this week announced a co-promote agreement with GSK's derm division, Stiefel, around its flagship tumor necrosis factor drug Enbrel. The agreement--a defensive move on the part of Amgen designed to help the company maintain its leadership position despite an increasingly competitive and crowded field--has Glaxo's sales reps promoting the drug to U.S. dermatologists. Terms of the deal weren't disclosed. Importantly, the marketing relationship extends only to dermatologists and has no impact on Amgen's existing promotional agreements with Pfizer, which co-markets the TNF-alpha inhibitor with the biotech in the US and has sole marketing rights to the drug in other parts of the world. In the psoriasis market, Enbrel is now the elder statesman, facing stiff competition from other anti-TNFs such as Abbott's Humira as well as more novel agents, including J&J's recently launched Stelara, a first-in-class interleukin-12 and 23 blocker. It's not clear whether the move will be enough to bolster Enbrel's long-term market share, however. While Enbrel remains "the first-choice biologic" for now, Decision Resources analyst Irene Koulinska told "The Pink Sheet" DAILY that she "expect[s] Humira to continue to steal patient share.--Jessica Merrill

Bristol-Myers Squibb/Eli Lilly: Who says earnings calls can't be a source of deal news? (A pox on such cynicism.) In their same day earnings calls on Jan. 28, Bristol and Lilly revealed they'd reached a détente regarding ownership rights to necitumumab, a fully humanized version of the epithelial growth factor blocker Erbitux that has shown encouraging results in Phase II studies in lung and colorectal cancer. Specific details of the co-development/co-promotion agreement weren’t disclosed on the call, “The Pink Sheet” DAILY reports BMS will pay 55% of the costs associated with U.S. clinical studies and 27.5% of the price tag for global trials. Assuming necitumumab actually makes it to the market, BMS will book sales of the drug in the U.S. and Canada and keep 55% of the profits, with marketing costs split evenly between the two firms. In Japan, the two pharmas will split commercialization costs and profits equally as well. Necitumumab became a bone of contention back in 2008 when Lilly won bragging rights as the ultimate acquirer of ImClone Systems for $6.5 billion. Just how important will necitumumab be to Bristol, which is aiming to be a major oncology power house? Bristol didn't offer any guidance on the earnings call, but at least one analyst is predicting peak annual sales of $300 million by 2015. That's hardly a blockbuster.--JH

Sanofi-Aventis/Minsheng Pharmaceutical: Sanofi likey consumer health and emerging markets. And boy, when you can use those two phrases in the same sentence, it’s guaranteed to be a deal. On Jan. 29, the French pharma announced an agreement with Minsheng Pharmaceutical to create a new consumer health care joint venture in China focused on vitamins and mineral supplements. Financial terms of the deal, which has apparently been in the offing since Oct. 2009, weren’t disclosed but Sanofi will own a majority share in the J/V. Minsheng currently produces the most popular supplements in China, including the 21-Super Vita multivitamin-mineral tablets. But the Hangzhou-based firm is struggling to maintain its preeminent sales position, facing growing competition from foreign supplement brands, especially Amway’s Nutrilite and Pfizer/Wyeth’s Centrum. Sanofi’s rationale for the deal is pretty easy to understand: access to one of the fastest growing OTC markets in the world. Analysts estimate the Chinese OTC market, which is dominated by vitamin and mineral products, generated just over $10 billion in 2008. In addition, it is forecast to grow by double-digit percentages over the next 5 years. (That’s a whole lot of gingko biloba.) Moreover, Sanofi has clearly shown its commitment to the consumer sector as a way to diversify away from the development risks associated with its branded pharmaceuticals and the potential vagaries of health care reform. In December the company spent $1.8 billion to buy the OTC and personal care product specialist Chattem to gain a coveted toe-hold in the U.S. consumer space. Beyond Chattem, the company has also in recent months scooped up Medley Pharmaceuticals, Symbion CP Holdings, Laboratoire Oneobiol, Kernpharma, and Laboratorios Gramon in attempt to double its consumer product offerings via bolt-on acquisitions.—Ellen Licking

Friday, January 29, 2010

FOTF Has More Celtics than a Boston Garden Reunion

Boy that Celtic private equity outfit did a lot of deals over the past few weeks. Kolltan, Inspiration, Cantab, Polytherics ... But of course there’s not one, not two, but three Celtic private equity funds. Yes, OK: FOTF will break it down for you.

Once upon a time (around 2004) Stephen Evans-Freke and John Mayo started a private equity group called Celtic Pharma Management (the fund was Celtic Pharma I Holdings). They planned to raise $1 billion to pursue an asset-focused acquisition model (but did acquire companies as well). The fund aspirations were later downsized to $500 million, then again to $250 million. The final fund was $250 million but split into equity/debt.

Evans-Freke and Mayo later went their separate ways, but not before CPM/CPIH (we’ll call it “Pharma One”) made some asset/company investments and acquisitions: Inspiration, Xenova, Idea, etc. Pharma One is the source of some of the recent deal activity (more below).

Evans-Freke (and others) then formed Celtic Therapeutics Management in 2007. We'll call them Therapeutics; that fund has a similar model to Pharma One in that it wants to focus on acquiring assets and then selling them on. How big is this fund? Their web site says it’s a successor to the previous fund with the same strategy but “on a larger scale,” so probably bigger than $250 million. These guys attracted some ex-Pharma hitters like Pfizer’s Peter Corr (now the other General Partner with Evans-Freke).

Meanwhile Mayo (and others) formed Celtic Pharma II Holdings (we’ll call that one “Pharma Two”). Pharma Two has a different strategy, and that is to acquire full or majority ownership in companies. It’s important to note that Pharma One and Pharma Two have completely different ownership structures. Pharma Two is actually owned by a fund-of-funds outfit called Beehive Capital, which holds funds in different sectors (life sci, art, cleantech, communications). We understand the fund is smaller than Pharma One but hasn’t necessarily stopped fundraising.

To make things complicated: Pharma One has a web site that suggests it might still be investing (it isn’t); Pharma Two and Therapeutics use the same logo/font/style (but are not really related); and Pharma One and Pharma Two have the same web site (but have different management and different ownerships—the latter isn’t particularly unusual as any investor’s subsequent funds may have different LPs). See, not so difficult!

On to the deals: Pharma One got the exit from Inspiration, when Ipsen stepped in with its creative deal. Therapeutics was the investor in Kolltan (see below—Therapeutics was also the recipient of the investment from PPD last fall). Pharma Two was the investor/acquirer of Cantab, announced this week (see below). But here there’s an extra-special wrinkle: Pharma One got the exit from Cantab, in a round-about way.

All of which brings us to …



Cantab Biopharmaceuticals: Now there’s a name we hadn’t heard in a while. That Cantab? No, not the Cambridge, Mass. bar where Little Joe Cook and the Thrillers used to entertain with favorites like “Sexy Lady from the Beauty Shop.” We’re talking about the Cambridge, UK biotech that after a rocky dozen years or so was acquired by Xenova in 2001. In 2005, Celtic (Pharma One version) bought Xenova, mainly to access that company’s nicotine vaccine. Pharma One held the ex-Cantab assets, largely around biologics manufacturing processes and IP, but apparently didn’t do much with them (they only wanted the pipeline) and it evolved into a small service business. But Celtic Pharma Two saw some potential, and instead of shutting the operation down, bought Cantab from Pharma One. Earlier this week, Pharma Two announced it was effectively relaunching Cantab as a company, and would fund it with roughly £5 million over the next three years to pursue a strategy it calls “biosuperiors” (we might call them bio-betters or even FOBs, but we admit their term has a certain zing). The next day, Pharma Two said it did a deal with a biotech called PolyTherics to access the latter’s site-specific pegylation technology, which Celtic partner Stephen Parker tells us will be applied to create a long-acting Factor VII.--CM

Kolltan Pharmaceuticals: In a transaction reuniting principals previously involved in Sugen and the development of oncology drug Sutent, Kolltan Pharmaceuticals closed a $10 million Series B on Jan. 20. Celtic *Therapeutics* led the round and Tichenor Ventures also pitched in (See our coverage from “The Pink Sheet” DAILY). The deal is structured as $8.5 million in Series B convertible preferred stock plus a $1.5 million product development option that can be converted into additional Series B stock. Notably the financing doesn’t involve any of Kolltan’s Series A backers. It also appears to represent a shift in strategy away from Celtic Therapeutics asset funding mandate. But Stephen Evans-Freke, managing general partner at Celtic, former biopharma banker and former Sugen founder says the deal isn’t much of a strategic departure. “If you look at our track record, going back to Celtic Pharma, we actually often do a bit of equity as part of or to pave the way for a product development transaction,” he told us. “This is a little earlier-stage than most of them, but that’s because we’re acutely familiar with the technology platform, the science area and the relatively low risks associated with what Kolltan is doing.” And given that familiarity and the past relationships, the transaction begins to look a little less like a departure for Kolltan, a biotech devoted to inhibiting receptor tyrosine kinases (RTK). The company said going into its Series A (backed by private entities like Purdue Pharma and the Pritzker/Vlock families and honored on this year’s Start-Up “A-List”) that it wanted to be in business with family institutions or institutions that are like family.—Joseph Haas

Amag Pharmaceuticals: Although the offering had not closed as Financings of the Fortnight “went to press,” Amag is expected to raise $174 million or more through a follow-on public offering announced Jan. 19. Initially planning to sell 3 million shares, the Lexington, Mass.-based biotech increased its offering to 3.6 million shares at a price of $48.25 per share. The company, which announced better than expected fourth-quarter 2009 sales of its chronic kidney disease drug Feraheme at the J.P. Morgan Healthcare Conference earlier this month, also is granting the underwriters an over-allotment option of 540,000 shares. According to an 8-K filed Jan. 20, underwriters will be able to purchase shares at a discounted price of $46.08 per share. Presumably, Amag will use the funds to further its marketing efforts for its intravenous iron drug in the CKD non-dialysis patient space. The company also is targeting small and mid-sized dialysis centers but does not expect to win a competition against older, lower-priced rivals like Forest’s Ferllecit and Luitpold’s Venofer among the larger providers, like Fresenius and DaVita, because forthcoming CMS bundling reimbursement rules for dialysis will encourage providers to use the cheapest therapeutic option.--JH

Elevation Pharmaceuticals: In 2009, only three companies working in the pulmonary drug delivery space raised venture funding--a total of $25 million out of the $768 million pulled in by all types of drug delivery players, according to Elsevier’s Strategic Transactions database. But 2010 has gotten off to a promising start with Elevation Pharmaceuticals’ $30 million tranched Series A financing, completed on January 21. Canaan Partners, TPG Growth, Care Capital (each of which contributes a new board member), and Mesa Verde Venture Partners were part of the investor syndicate. Elevation says the money will support lead candidate EP101--a long-acting, reformulated bronchodilator delivered via Pari Pharma’s eFlow nebulizer--through mid-stage trials. The drug delivery start-up was founded in 2008 by three individuals who hail from biotech companies—all within the respiratory realm—that have more or less achieved a validating deal or some kind of exit. Chairman Cam Garner, a veteran in both the pharma and device world (and not a stranger to reformulations of existing drugs via other recently established companies like Meritage Pharma and Evoke Pharma), headed up Dura Pharmaceuticals, which was sold to Elan in 2000 for $1.7 billion; president and CEO Bill Gerhart held the same positions at Mpex Pharmaceuticals (which is developing inhaled antibiotics and has a Big Pharma partner in GSK); and SVP/CMO Ahmet Tutuncu, MD, PhD, came from Verus (also co-founded by Garner), a company that divested its assets and now only seems to exist via its relationship with AstraZeneca, which paid $30 million up front and has promised $280 million in earn-outs related to Verus’ pediatric asthma business (though there is the small matter of a lawsuit there).—Amanda Micklus

Thursday, January 28, 2010

this and that

Hi Friends.

This will be a short post because it's 10:15 pm and the first time I feel like I've really relaxed all day. I thought it was cold outside just based on how it felt when I opened the back door first thing this morning. Then my friend, Aimee, came over this afternoon and told me it was in the 50's and beautiful so the three of us went on a walk. And then Jonah cried the whole time, we had to cut the walk short, and he had to be carried back. But that's neither here nor there.

We've had an okay day, but Jonah refused to even take his thirty minute nap in bed today, so literally, the only time he has slept today has been in my arms. I've gotten very little done, but did manage to clean the whole kitchen while Matt gave Jonah his last bottle of the night.

Oh, Katie wanted me to let you guys know that as far as items donated, we are good to go for the auction. I think we have ninety some items, which is just amazing (we were originally hoping we'd get twenty!!!). THANK YOU SO MUCH! This is going to be so great. Now we just have to get the word out so there will actually be enough people to bid on all this great stuff! If you'd like to offer a back-up item in case some of the stuff falls through or donate money to help with shipping costs (so 100% of the bid money can go to DebRA), you can email Katie at jonahsebauction@gmail.com.

And before I end this I would just like to ask for prayers for Jonah tonight. His little boy parts are in very rough shape right now. This happens once in a while, but this time they will not stop blistering. Usually the blistering stops after two or three days, but we've been draining three to five blisters a day in that area for probably the last two weeks. It's really hard for it to start healing when the blisters JUST KEEP COMING. Several times today he would be perfectly happy and then would suck in lots of air and just start crying. I'm pretty sure he's crying at least part of the time when he's urinating. I'm keeping Desitin on him with every diaper change hoping to create a barrier, and I'm sure it's helping some, but the raw areas are so widespread right now... I don't know. I just know it hurts him, and I want it to stop.

As always, thanks so much for praying.

I don't know about you guys, but I am so ready for the weekend. Five to eight inches of snow expected here. I could do without that, but a weekend's a weekend, so I'll take it.

Health Care Reform: Words, Words, Words

We said we had a sense of deja vu going into the State of the Union, but this is ridiculous.

Last night, President Barack Obama devoted 516 words to his call to finish work on health care reform, about five minutes of the talk. That is about 7.2% of the total 7, 127 State of the Union address he delivered. Remarkably, it is exactly the same portion of the speech that he devoted to health care in his first address to Congress 11 months ago (427 out of 5,923 words, if you are keeping score.)

And its about half the percentage that health care represents of the economy.

Stirring though the words may have been, their relative dearth suggests health care is hardly a make-or-break issue for 2010.

All of which means, Big Pharma has to think seriously about the consequences if Obamacare goes away.

Yes, it has reached the point where the US brandname pharmaceutical industry is hoping against hope that it can get someone to take $80 billion.

The famous deal between the Pharmaceutical Research & Manufacturers of America and the White House, which we dubbed "dollars for donuts," is up in the air, just like everything else related to health care reform.

AstraZeneca CEO and PhRMA board Chairman David Brennan made that clear at a press conference today tied to the company's year-end financial report. To Brennan's credit, he has said all along that the prospects for reform are uncertain, and today he underscored that things are more uncertain than ever.

And, in case there is any doubt, the collapse of health care reform would be a bad thing for Big Pharma. It is not just what won't happen--no bolus of newly insured customers, no filling in of the donut hole, no reduction in cost-sharing for existing insured, no new IP protection for biological therapies.

It is also what will happen. It is not like Pharma will just get to keep its $80 billion.

To us, the most important words for industry in the entire address weren't in the health care section at all, but earlier--when Obama called on Congress to tax overseas earnings. A year ago, Obama wanted to use that idea as a way to pay for health care reform, and that--maybe more than anything else--explains the deal PhRMA struck with the Administration. Industry came to the table, and the tax deferral on overseas earnings was taken off of it.

Not any more.

"To encourage these and other businesses to stay within our borders," Obama said last night, "it's time to finally slash the tax breaks for companies that ship our jobs overseas and give those tax breaks to companies that create jobs in the United States of America."

It took just 42 words to express that thought. But those are the words that could really count.

Wednesday, January 27, 2010

eleven months today

Hello World!



Today I turned 11 months old. Mom can’t believe it. She says we’re just one month away from the Celebration of the Century. I have no idea what she’s talking about, but I think I plan to be grumpy that day.

I’m not sure how much I weigh right now since I haven’t been weighed in a while. Last time I weighed 20 lbs. 9 oz., but Mom’s pretty sure I’m weighing more than that now. I’m heavy! I’m getting so big.

I’m too big for my blue chair.



And I'm too big for my swing.



But for some reason Mom keeps putting me in them anyway. Something about I don’t nap and she needs five freakin’ seconds to get some stuff done yadda, yadda, yadda. I don’t really know.

I’ve really come a long way in the last month or so. I’m sitting up really well, although I’m still toppling over when I lean to reach for things that are to the side.



Mom says I may or may not have fallen over as soon as she snapped this picture. And she may or may not have let me fall on my head. She couldn’t rightly say.

She wishes that were the excuse for my hair looking like this…


… but it’s not true. My hair always looks like this, especially in the mornings. I have a double crown in the back and it sure does make my hair do some crazy stuff. And Mom wants to keep it long so it will grow over my bald spots in the back, but it sure is wacky back there. Mom says it’s good that we get bath and dressing change done first thing. It’s still pretty crazy after nap, but not quite as wild.

I’m teething like crazy.



I have two teeth on the top (my second one has just started coming in – VERY crooked) and four on the bottom. You know my Mommy’s busy and distracted because Daddy had to point out my two new bottom ones yesterday, and they’re almost completely through!

Besides Mommy and Daddy, Deac is my best friend.


I think he is the greatest, and every time he pays attention to me or meets us at the top of the stairs I get so excited. I start flapping my arms and kicking my legs like crazy. And I just bust out laughing. Mommy thinks I’m really close to saying “Deac” because I consistently make a “ck” sound when he comes over. She’s always said that she’s pretty sure “Deac” will be my first word. We’ll see. I’m pretty good at proving her wrong.

My favorite shows are Jack’s Big Music Show and, much to Mom’s dismay, Yo Gabba Gabba. When Jack’s comes on and I hear the music, I start smiling so big. Lots of mornings I miss it since we do 7:30 dressing changes a lot so Mom says she might start DVRing it for me. Wow, my very own show on DVR. I’m getting so old.

I’m rolling over from back to tummy and tummy to back now.



I do it all day long. Mommy says she’s so happy I’m out of the “roll on my tummy and then scream about it” stage. I just roll all over the place these days.

I start out like this…


And five seconds later, I'm like this...



I’m really making all sorts of sounds these days, but they’re getting really hard to describe. I’m doing all my normal ma, ba, da, la stuff, but now I’m combining them and putting inflection in my voice. Mom thinks it’s just the cutest thing. I’m very vocal even though I’m not saying words yet. I still refuse to mimic sounds even though I know what the Big People want me to do. Instead, I just look at them like they’re crazy and do as I darn well please. If they want to sound like doofuses, that’s up to them, but don’t expect me to voluntarily repeat it. Who do they think I am?

When I get excited, I kick my legs and flap my arms and it looks like I’m trying to fly. You should see me when my Daddy comes home from work. I go crazy flapping and rocking , bouncing and kicking, and then I start crying until he changes out of his nice clothes and holds me. And Daddy doesn’t complain a bit about having to hold me first thing. Mommy says she knows he waits all day to hold me. It makes us both super happy.

Mom holds me for my morning bottle and nap at 9:15 so I can at least sleep for 45 minutes. If she doesn’t, I immediately wake up and then I am gruuuumpy. For my 12:45 bottle, she takes me up to my room and puts me in bed after I fall asleep. I sleep anywhere from 28 – 32 minutes, and then I’m all done. Sometimes I doze off with my 4:15 bottle, but not always. And if I do, Mom has to hold me again or I wake up and am ill as a hornet. Mom has to do a LOT of sitting around, something she’s not the greatest at. She knows one day she’ll be glad she did all that sitting, holding, and rocking.

But someday she says I’m going to have to learn not to rub my face and to put myself to sleep.
Whaaaat?

Please Mommy...



… that’s silly. You know I like to be held and rocked. AND you know I call the shots around here. Maybe when I move to a big boy bed, you can just come sleep with me. We’ll talk.

I am doing a much better job at sleeping at night though, and I’ll usually sleep three nights in a row and then have a rough night. Mommy thinks it’s funny that most babies start waking up when they are teething, and for me, that’s when I finally learned to sleep through the night… most nights anyway.

It’s been a big month for me, and I’ve changed a lot. Mom and Dad are so proud of me and how I just keep fighting every day. I’m a happy baby considering all the mess I have to go through, and Mom and Dad are so thankful for my fun personality and my resilient attitude. They say that are so excited to see the person I’m becoming. I’m pretty special, they say, and they love me more than they could ever put into words. And even though I can’t say it yet, I love them a lot too. We make each other very happy. Life is good.

Tuesday, January 26, 2010

a letter to nick jr.

Dear Nick Jr. (formerly known as Noggin but still really known as Noggin because I don't know of one single person who calls it Nick Jr because, let's face it, Noggin is just a cuter name, I'm just sayin'),

(inhales)

I am writing to inform you that very soon I will be putting in a call to Social Services to report the gross parental negligence I have observed by many of the residents of your Nickelodeon Neighborhood.

Let's take, for example, Max and Ruby. After 11 months of observation I have never, EVER seen their parents. As in I'm pretty sure they don't even exist. The children are constantly home alone, only being dropped in upon, every once in a while, by their grandmother. Max, obviously a child two or under seeing as how he can only speak one word at a time, is being cared for by his sister, Ruby, who can't possibly be more than six years old seeing as how she's an idiot. I do not feel this is a good environment for either child and thus will be reporting the Bunny Family to the proper authorities. I am glad that Ruby has her ever-true Bunny Scout Leader to guide her although I don't think the party-hosting skills she is being taught are going to prove very beneficial in the raising of her younger brother.

I am also very concerned about Dora the Abnormally Large Headed Exploradora. Although her parents, Sr. and Sra. Marquez, do appear every now and again, she is often seen out on her own, accompanied only by a whiny monkey. She has faced many a foe (a witch, a troll, a fox) with only her backpack to protect her. And I know she always uses her seatbelt "so she can be safe," but am I mistaken that Dora should still be in a car seat? I am fairly certain she does not meet the eight year / 80 pound requirement. Although I suppose this law may not apply when you are traveling to OUTER SPACE, you know, by yourself.

Lastly, I will be reporting ALL of the neglectful animal parents whose children have found themselves in such peril they've had to call on the Wonder Pets. I feel if you are relying on a guinea pig, a turtle, and a baby duck to rescue your children, you have reached a whole new level of inattention. I'm sorry but if you, as a goose, flew off and left your children to be led south by some classroom pets in a plastic boat, don't you think you should be reported? And don't even get me started on the ladybug's parents who let her play in the Venus Fly Trap or the Mama cow who barely reacted when her baby calf was rescued from a tree (that's right, a tree).

The parents of all the Backyardigans are still under observation, and at this point, there is no reason to suspect negligence on their part. So far, the children have stayed within the confines of their backyard, and at least one parent seems to be home during their playtime, offering a delightful yet nutritious snack at the end of their imaginary adventures.

Please be under advisement that the entire Nickelodeon Junior (if that's your real name) populace is being watched.

Yours Truly,
Patrice Williams

P.S. - And as far as DJ Lance is concerned, the whole Gabba Family is currently under investigation for recreational drug use. Second letter to follow.

Victoza Gets Past FDA, But....

There are a few caveats. First, a black box warning for the once-daily GLP-1 analog which includes a potential increased risk of thyroid cancer (despite Novo Nordisk's repeated claims that this applies only to rodents, not monkeys or humans). Second, no first-line usage allowed. Third, significant post-approval requirements, including a CV safety study, a 5-year epidemiological study to evaluate thyroid cancer risks, a 15-year cancer registry to monitor thyroid cancer cases, and a REMS.

As such, "it's a worst case label for the product," concluded Sam Fazeli, an analyst at Piper Jaffray in London. "Bittersweet" was how Jefferies' Jeffrey Holford put it, while Citigroup simply cut to the chase with "Commercial success far from certain."

Things could have been still bleaker, though. At least the US approval has finally happened (the drug was filed in May 2008). It might have been pushed out significantly further, given the regulators' apparent problem with the thyroid cancer risk. And on the up-side, there's no need for calcitonin monitoring during Victoza therapy (calcitonin is the marker used in humans for thyroid cancer) and there are no broad contra-indications for the drug. Only patients with a family history of medullary thyroid cancer, or multiple endocrine neoplasia syndrome, aren't allowed Victoza--and both those indications are very rare.

As such, Novo's management was upbeat during the analyst call announcing the news. The REMS is very remiscent of that recently imposed on Lilly/Amylin's twice-daily GLP-1 analog Byetta, said EVP & CSO Mads Thomsen, and certainly manageable. He added that many diabetes drugs (metformin, the sulphonylureas) have black box warnings, and most new products aren't awarded first-line treatment at their first pass at FDA. Thus, "we're perfectly happy with our monotherapy label," he said. (The product was denied approval as a monotherapy in Europe).

There a big 'but', though--and it's Byetta. That product has not only a five-year head start, but also hasn't got a black box, hasn't got a thyroid cancer risk warning, can be used as an initial therapy, and thus remains "first choice" treatment in this class, according to Fazeli, despite its more frequent administration.

This explains the generally (although not exclusively) down-beat analyst reaction to the news; "we see more room for disappointment than surprise on Victoza," writes Citigroup's Mark Dainty. Never mind the fact that Victoza outperformed Byetta in blood sugar lowering in a recent Phase III head-to-head trial.

Novo's management still thinks it can surprise, however. (They're a confident lot.) They re-iterated their forecasts that Victoza will reach sales of over $1 billion by 2015 (Byetta's currently at about $700 million and it has been on the US market since 2005).

Much will depend on whether follow-on GLP-1 analogs including long-acting Byetta (EQW) and Roche/Ipsen's taspoglutide are stamped with the same thyroid cancer warnings as Victoza. (Amylin's epidemiological study of Byetta is due March 31). Novo's Thomsen is adamant that the thyroid cancer signal seen among rodents is a class-effect among the long-acting GLP-1 analogs, and points to a forthcoming peer-reviewed scientific paper outlining what he claims is a similar pre-clinical effect on thyroid c-cells for Victoza, long-acting Byetta and taspoglutide. "We'll have to live with the notion that long-acting GLP-1 analogs cause c-cell proliferation in rodents," he told The In Vivo Blog. "But there's no reason to believe that these findings have any relevance to higher species," he added.

Whether or not the other long-acting GLP-1s get the same treatment, FDA is unlikely to remove Victoza's black box for several years at least, likely until the 5-year follow-up cancer study data is available.

Meanwhile, though, with its already-expanded US sales force and pricing in line with Byetta at about $8/day for the 1.2mg dose, Novo will be pushing Victoza with all its might and leveraging its wider diabetes franchise where possible. And let's not forget the fundamentals: Victoza is once-daily, can be taken anytime, prompts some weight loss, isn't associated with hypoglycemia or significant nausea, and is relatively easy to titrate.

Those elements may yet trump the worries about cancer in rats.

The State of the Union: The More Things Change…

It is a funny thing: it feels like everything has changed in health care reform, and yet we can’t help but have this crazy sense of déjà vu on the eve of President Obama’s State of the Union Address.

The questions about health care reform today aren’t so different than they were eleven months ago, when President Obama made his first address to a joint session of Congress last February 24. (That address was not, technically, a State of the Union address, but—with apologies to constitutional scholars—that is a distinction without a difference).

A year ago, the big question was: how aggressively would Obama pitch health care reform on his agenda? Where would it fall amid other priorities, most pressingly job creation and the reeling economy? And would he say enough to bring Congress with him for the heavy lifting reform would entail?

That pretty much sounds like what we will be listening for tomorrow night.

Yeah, the circumstances look very different. Then, Obama was the newly elected President riding high on an unprecedented wave of hope if not hype. Today, he is still personally popular, but his policy agenda is bloody and bruised.

On health care, sweeping legislation passed both the House and the Senate, but the election of Republican Scott Brown as the new Massachusetts Senator makes final enactment seem like an insurmountable challenge.

But things really aren’t so different than they were a year ago. In 2009, Obama addressed Congress without a filibuster-proof majority. At the time, in fact, the Democratic caucus had only 58 members: it wasn’t until Arlen Specter switched parties and Al Franken was finally certified as the winner in Minnesota that the Dems had 60.

And Obama was fresh off an embarrassing setback then too: the withdrawal of Tom Daschle from consideration as HHS Secretary and health care reform czar.

A year ago, the question was how far and how fast should Obama push for reform? Would it be comprehensive reform or bust? Or would there be a more measured, scaled down plan, with jobs, energy and other priorities defining the agenda?

Those are the same questions Democrats and health care reform advocates are asking today.

And it is interesting to remember the answer a year ago. Then, Obama announced a “down payment” on health care reform, but declined to define comprehensive reform as the priority—instead saying that a robust, sustainable economic recovery depended on reforming health care, clean energy and education reform.

We will see tomorrow night if maybe Obama decides he was right all along…

Monday, January 25, 2010

griefshare - week one

I'm very tired tonight. Matt watched Jonah yesterday afternoon, and I got to sleep for two hours, and it was glorious. But then I couldn't go to sleep until 12:30 or after (I stopped looking at the clock because I was doing the "If I fall asleep right now, I'll get ____ hours of sleep." It was torturous.) Anyway, I've felt the repercussions of the Sunday Afternoon Nap today, but guess what? It was still worth it. I get the best sleep when I'm napping.

I started a 14 week course called GriefShare at church tonight. It's offered at a couple different churches in our area, but thankfully Pinedale is one of them. A friend and I are doing it together. Matt's keeping Jonah so I can go. I was telling him about it when I got home, and I think it's going to be really good for me. From the time I found out I was pregnant with Jonah, I feel like it's been all about him - worrying about the pregnancy, praying for him, and then after he was born - taking care of him, bandaging him, loving him. And don't get me wrong, I think that's the way it should have been, but when Matt is watching Jonah and I am at GriefShare, I feel like I get to stop, relax, and be sad; sad about everything, but mostly I get to be sad about Gabe. I get to cry and be angry and mourn him. And that is really, really good.

It's also extremely hard and very much a "ripping off the band aid" kind of thing. When we were going around telling our stories, I just told about what happened with Gabe and then about Jonah. I feel like I'm grieving many things - losing Gabe, the loss of "normal," the reality that I'll probably never be pregnant again, having a child that has to suffer. Anyway, I think I'm where I need to be. I think it will be hard, but completely worth it.

On a God Knows What He's Doing note, a lady in our group (of about 12 maybe) came up to me afterwards and said, "You have a blog don't you?" I told her yes, and she said she didn't realize who I was until after I told our story but that she's been reading the blog for a while. We hugged especially tight. It was so neat. Those folks are feeling like family already, and I've literally known them for about two hours.

It's all good. Sad, but good. And a lot tiring. You know how when you cry it just takes you to a new level of tired? Well, I'm there. And it's my night with Jonah, so I'm off to bed. Goodnight.

Sunday, January 24, 2010

dedication sunday

Today was Baby Dedication Sunday at church. Wow. It's been a long road to get here. Last year, on this Sunday, we played hooky and stayed in bed. I knew I wouldn't be strong enough to sit through the service, looking at all the beautiful, healthy, alive babies that had been born in 2008. The weight of Gabe's absence would have been overwhelming.

But this morning, this morning, God finally gave us our day.



Mike (Elder and Sunday School Teacher Extraordinaire) said a little more about Jonah than the typical "name, parents, grandparents" info. He had asked me to email him earlier in the week to let him know what we'd like shared. I knew there would be many folks in the audience who either didn't know about Jonah or were guests, so it was important to me that things be explained a little. Anyway, he explained about Gabe dying and then Jonah being born with EB. And when he gave the stat about the mortality rate being 87% in the first year of life and that Jonah would be celebrating his first birthday on February 27th, the place broke out in (what seemed to be, to my mommy heart, thunderous) applause.

And it was beautiful.

(And I cried.)

Peyton took some video for me, but I can't post it because a) I don't know how to post video recorded to a DVD, b) it is long and I would have to use Vimeo, and I haven't had time to figure that out yet, and c) I have a new video camera and haven't figured out how to finalize videos etc. (It sure used to be easier with those huge video cameras and VHS tapes. I really wish I was tech savvy.)

Anyway, it was a great day, and I can't really put into words what it meant to us to finally be up there, with our baby, committing ourselves to raise him up to know and love Jesus. Preacher Bill kept calling us, the parents, "custodians," explaining that our children belong to God, and we are just the temporary caregivers. Part of the commitment we repeated was that we understood that our kids were only ours for a "short while" and ultimately they are God's.

I think we're just a "show the love" filter - loving our babies the best we can so they'll know what a relationship with God can offer, which is infinitely more than the love we can show them. And I want Jonah to always think, "Can anyone possibly love me more than my mom and dad? That's some kind of love."

I love you, sweet Jonah. I'll never forget today for as long as I live. You did great, and your Mommy held it together pretty well too, ya know, considering.
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