I should charge my phone.
I should start studying for my AP pyschology test tomarrow. I know nothing about what's on the test, but I just don't want to. I want to cuddle with someone that will tell me that I'm not a complete basket case, and that they find me to be an interesting person.
A girl can dream right?
I wish that I can still converse with someone on a daily basis, see him at night. I wish that he didn't have to go, although I should have prepared myself for the loss. I wish that I had spent more time with him, because now that the time is gone, I wish and would give anything for it to come back.
I miss you Grandpa.

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See also:

http://projecto2r.blogspot.com/2011/11/seconds-of-attempts-might-be-buried-to.html
http://tonecarmichael512.blogspot.com/2011/11/one-charge-of-these-open-dunes-is-noe.html

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See also:

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http://jaymesbulkeley414.blogspot.com/2011/11/huggys-far-refrigerator-lost-spelling.html

In HOOKED, I referred to the "Lotronex Story" and elsewhere talked of "regulatory capture," a term I first got from reading the work of British sociologist John Abraham (to describe how an industry that is supposed to be the subject of regulation ends up learning how to manage the regulatory process to its own advantage). Now Abraham and a colleague have gone into much more depth on the Lotronex case and reached some interesting conclusions (subscription required to access article).

Brief recap: alosetron (Lotronex), manufactured by Glaxo Wellcome (later GlaxoSmithKline) was put on the market in 2000, withdrawn later that year, and put back on the market with restrictions in 2002. It was marketed for irritable bowel syndrome, a common condition that is chronic and relatively mild in most cases but is quite disabling for a small percentage of sufferers. It was the first drug specifically aimed at IBS and so attracted a lot of attention because of its novelty.

The initial data presented to the FDA in support of approval were, in hindsight, remarkably skimpy. It seemed that alosetron worked only in women, and only in IBS patients who had mainly diarrhea as the predominant symptom. (When a disease occurs in both sexes but you find that a drug works in only one, that increases the chance that the drug does not really work at all and you're seeing a spurious finding.) At best the FDA data indicated a very mild if any benefit to be expected from the new drug. After it was approved on these skimpy data, reports emerged of ischemic colitis (segments of large bowel dying as a result of blood supply being shut off, due to severe constipation with impacted feces) occasionally requiring surgery and causing some deaths. Eventually the FDA allowed the drug to return to the market with serious restrictions on how it could be prescribed--a financial hit for the manufacturer, who saw a potential $5B blockbuster drug reduced to sales of only about $100M annually.

Let's now see what Davis and Abraham add to this brief recap. They obtained a trove of internal FDA documents via FIOA and also interviewed some of the FDA insiders who worked on the drug application.

They first note that when the reports of deaths from ischemic colitis started to roll in (and of course Glaxo denied at first that their drug had anything to do with these deaths, though virtually no one dies of IBS alone), FDA folks sat down with Glaxo folks and proposed a plan that was quite close to the re-marketing strategy that was finalized in 2002. But Glaxo elected on their own to pull the drug, arguing that ther FDA's restrictions were so onerous that the poor firm could hardly make a buck off the drug that way. The authors comment, "Evidently, providing the drug to the comparatively small number of patients most likely to benefit to reduce the risk to other patients less likely to benefit, together with research into how those risks and benefits could be better understood, was, according to GW, not commercially viable within the constraints of the U.S. capitalist market system." I have not seen a starker comment on the incompatiblility between good scientific medicine and drug marketing.

Once the drug was off the market, the FDA next heard from IBS patients, in a barrage of e-mails. As I reported previously in HOOKED, the barrage was launched by two patient groups, Lotronex Action Group and International Foundation for Functional Gastrointestinal Disorders. I quoted sources available then to report that the LAG appeared to be an independent grassroots organization while the IFFGD was openly and principally funded by Glaxo. However, Davis and Abraham quoted one of their FDA insiders that LAG raised all the red flags in his own mind of an industry-sponsored outfit, even though a connection was never proven.

Davis and Abraham noted that individual patient tesimonials from IBS sufferers who claimed to have had their lives dramatically improved by Lotronex dominated the FDA hearings to discuss re-marketing in April 2002. (No one testified who had nearly died of ischemic colitis.) They argue that despite the scientific nature of the FDA panel, the ensuing discussion within the FDA amounted to a sort of "regulatory capture" as a result of what they label the "emerging patient-industry complex." That is, the available scientific evidence provided no good way to identify either who stood a better chance than average of benefiting from alosetron (if you believed the data, the best guess would be nobody) or who stood at the highest risk of suffering harm. Indeed there was no good evidence that even carefully watching patients with an eye toward the signs and symptoms of ischemic colitis would allow identification of cases early enough to do any good by stopping the drug. Davis and Abraham allege that at this point, anecdotal patient testimonials trumped science in determining the FDA's agenda. And the further research that might have clarified therse matters was being resolutely avoided by Glaxo despite earlier FDA requests that the company proceed with those studies.

What I reported in HOOKED, that Davis and Abraham did not discuss, is how several FDA officers were outraged by bring overruled by agency higher-ups when the drug was re-marketed, and that other officers known to be critical of alosetron were summarily taken off the case.

In conclusion, Davis and Abraham conclude that alosetron generated a perfect storm of confluent forces--the FDA under fire from Republican-led congresses to show that they were not holding up the approval of innovative drugs; industry pressure; and patient advocacy lobbying that in all likelihood was funded and coordinated by industry. Scientific medicine didn't stand any chance in that environment. (The excellent policy question which the authors identify is what to do with patient testimony--it is clearly important in a democracy to validate and accept testimony of personal experience, yet we also know that no one can personally distinguish a drug from a placebo effect, which is worrisome when the "placebo" can kill you.)

Hat tip to my former graduate student and now esteemed colleague Daniel Goldberg of East Carolina University for alerting me to this article.

Davis C, Abraham J. Rethinking innovation accounting in pharmaceutical regulation: a case study in the deconstruction of therapeutic advance and therapeutic breakthrough. Science, Technology & Human Values 36:791-815, November 2011.

The below is in response to US Merck & Co.'s statement, on Facebook (posted just before the vanity URL page's keys were disabled, on Monday night). The Merck US statement read ". . .Earlier today, Facebook announced plans to decommission our vanity URL due to an administrative error on Facebook's part. We want to assure you that our Facebook page will remain active and continue to serve as a helpful resource for information on health and well-being. We thank you for your patience and continued support. . . ."

Facebook users have responded -- as set forth below -- since then:

. . . .Peter Sinnott

So when will the real Merck get the url back?

Yesterday at 11:26am · Likes · 10. . . .

James Hooker

As I understand it, either the two companies must come to some sort of agreement over the URL (one takes ownership, or shared ownership?) or Facebook will prevent the 'Merck' vanity URL from being used at all, forcing each company to create a new URL based on their specific company name (MerckKGaA/MerckCo as examples).

6 hours ago · Likes · 1. . . .

James Hooker

Quite ludicrous in my opinion, seeing as the error was Facebook's, and that the vanity URL was originally registered by the German company.

6 hours ago · Likes · 1. . . .

James Hooker

‎. . . .also, regarding the fault being placed on Facebook, surely you KNEW the page you requested access to did not belong to your company?

5 hours ago · Likes · 1. . . .

[Emphasis supplied.] It seems some people really do get it. This could be rather entertaining.

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Stomach acid is vital to good health. It is the first major step in breaking down your food, which is so critical to proper nutrition. The myth is that you are what you eat. But in fact, you are what you absorb.

Acid is especially important for breaking down proteins into amino acids and is required for the optimal release and preparation of minerals such as calcium, magnesium and iron for absorption. Vitamin B12 also isn’t adsorbed without it. The same cells that produce acid produce intrinsic factor, which is required for B12 absorption. Without B12 you become B12 deficient, leading to fatigue and neurological problems. 
Decreased acid levels can also cause digestive problems further on down the line.

Pancreatic enzymes, bicarbonate and bile are all released in the small intestine in response to the acidic load that normally leaves the stomach. Without these digestion continues to degenerate, resulting in a far less than optimal nutritional gain from your food and potentially damaging byproducts. The pH, now off in the entire digestive tract, damages the environment for billions of normal/good bacteria, critical to proper digestion and good health.

Stomach acid is also your primary defense against food-borne infections. Bacteria don’t usually survive the stomach, therefore decreased acid increases your risk of food poisoning.

Nutrients provide the building blocks for our entire biochemistry. Optimal health requires optimal nutrition. And that is why you need stomach acid.

Surgery for GERD?


Surgery has virtually no role in the management of this mostly physiologic problem and future generations will realize how foolish our current medical model has been by trying to treat GERD with surgery.

GERD is consistently one of the most treatable conditions that I see in my clinical practice. My success rate is well over 90%, and it is quite rare for patients to fail to respond to conservative, non-drug, non-surgical treatments. 



The Digestive System Made Simple - Review

The stomach connects to the small intestine connects to the large intestine ending with the rectum. The liver (waste products), gallbladder (bile and cholesterol) and pancreas (digestive enzymes) dump products into the small intestine to be used, excreted and/or reabsorbed. Nutrients and liquids are absorbed across the intestinal lining.

-----

Image thanks to naturalhomeremedies.com

The nonprecedential CAFC case Gellman v. Tellular reviews caselaw including DDB and Stanford/Roche, and has some interesting dicta about inventor assignment issues.

The question of whether contractual language effects a present assignment of patent rights, or an agreement to assign rights in the future, however, is resolved by the law of this court. DDB Techs., L.L.C. v. MLB Advanced Media, L.P., 517 F.3d 1284, 1290 (Fed. Cir. 2008).

AND

While it is possible for an employee to assign any and all of his rights to future inventions, this court has consistently required that present assignments of future rights expressly undertake the assigning act at the time of the agreement, and not leave it to some future date. See Bd. of Trustees of the Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832, 841–42 (Fed. Cir. 2009) (finding present assignment in the language “I will assign and do hereby assign”), aff’d, 131 S. Ct. 2188 (2011); DDB Techs., 517 F.3d at 1290 (same, for language “agrees to and does hereby grant and assign”); Speedplay, Inc. v. Bebop, Inc., 211 F.3d 1245, 1253 (Fed. Cir. 2000) (“hereby conveys, transfers, and assigns”); FilmTec Corp. v. Allied-Signal Inc., 939 F.2d 1568, 1573 (Fed. Cir. 1991) (“agrees to grant and does hereby grant”). By that measure, the language of the Unsigned Agreement is lacking. Rather than expressly undertake assignment at signing, it expressly delays assignment to some future date, when Mr. Seivert would “execute any and all assignments or other transfer documents” necessary to convey his rights to Cellular Alarm. The district court was therefore correct in its conclusion that the Unsigned Agreement, if enforceable as a contract, could do no more than create an equitable claim for the Lebowitz Trust. And as already mentioned equitable claims do not themselves confer standing.

The same logic applies to Ms. Gellman’s claim that the “hired to invent” doctrine can save her standing. Courts have in some cases held that the inventions of an employee hired to make that invention fairly belong to the employer. See, e.g., Solomons v. United States, 137 U.S. 342, 346 (1890). But this doctrine is expressly equitable, and creates only an obligation for the employee to assign to his employer. Melin v. United States, 478 F.2d 1210, 1213 (Ct. Cl. 1973); see also Banks v. Unisys Corp., 228 F.3d 1357, 1359 (Fed. Cir. 2000). It cannot save Ms. Gellman’s case.

Of some dicta:

These efforts to demonstrate standing, however, fail as a matter of law. At the outset we note that the lack of a signed instrument, while troubling, is not fully dispositive. The Patent Act requires that all assignments of patent interests be in writing. 35 U.S.C. § 261 (2006). But there are means of transferring patent ownership beyond assignment, and not all of them require a writing. Sky Techs. LLC v. SAP AG, 576 F.3d 1374, 1381 (Fed. Cir. 2009). Neither the district court nor the parties expressly addressed whether the contract here (if one were held to exist) would be an assignment subject to the requirements of section 261. Because we conclude that Ms. Gellman’s argument fails for other reasons, we need not reach this issue.

The following IBS case study can also be found on the National Institutes of Health website.

Risk factors for irritable bowel syndrome in Turkish population: role of food allergy.

Goals:

The aim of this study was to determine the prevalence of food hypersensitivity
in Turkish patients with irritable bowel syndrome (IBS).

Background:

The IBS is a chronic disease of the gastrointestinal tract characterized by abdominal pain, distension, meteorism and either diarrhea or constipation. The role of diet in the pathogenesis of IBS remains controversial.

Many investigators have shown that individual foods can trigger symptoms in some patients; nevertheless, the percentage of patients that benefit from dietary manipulation ranges from 15% to 67% in different reports.

Study:

Skin prick test to 11 common allergens, total IgE, eosinophilic cationic protein and eosinophil counts were evaluated in 100 patients satisfying the Rome II criteria and compared with 25 healthy controls. The history and physical examination of the groups were recorded
and Beck Depression and Anxiety Inventories were performed.

Results:

One hundred patients were entered into the study with a mean age of 45.63+/-12.91 years.

Of the patients 53 had constipation predominant, 19 had diarrhea predominant, and 28 had alternating type IBS. Skin prick tests positivity were more common among the IBS patients in comparison with controls (25% and 1%, respectively, P<0.05).

Mean IgE values were higher in patients than controls (70.83+/-66.05 and 15.20+/-14.01 IU/mL, respectively, P<0.000). Eosinophilic cationic protein values were also higher in IBS patients than controls (16.75+/-11.28 and 11.56+/-4.72, respectively, P<0.05)

Evaluation of Beck Depression Inventory showed that tendency to depression in patients with IBS was 38% and 4% in controls (P<0.05).

Conclusion:

According to our results, in patients complaining of IBS it is of importance to search for a food component. Clinical improvements can be observed after the introduction of an adequate exclusion diet.

Department of Internal Medicine, Guven Hospital, Ankara, Turkey.

------

This study also published at NIH.gov
Image thanks to esltogo.wordpress

Do go see a slide-show of all ten, here -- from Iacocca (Chrysler) to Cuneo (Marvel) to Bethune (Continental Airlines):

. . . . No. 2 | Dick Clark. . . .

No. 10 (of 10) | Steve Jobs. . . .

It is not clear whether the list is in reverse order, but as much as I respect Mr. Clark, I'd never rank his efforts ahead of the feat Steve Jobs pulled off, over the last decade -- as he returned to Apple. Of course (as Mr. Iaccocca reminds us!), your mileage may vary.

Another great question, as to whether Merck & Co. (US) might have simply made an innocent mistake, here -- from a new anonymous commenter, below -- let's take a look:

. . . .Anonymous said...
Isn't is possible that this really was just a mistake?

(a different anonymous)

November 30, 2011 12:39 AM

[I] said. . .

Thanks, Anon. No. 2 --

Clearly, as Facebook itself has admitted, Facebook made a mistake. On that, I think we might all agree.

But I am interested in how Facebook came to make that mistake -- how was it induced to do so?

Let us then make out the case most favorable to "mistake" -- on the part of Merck & Co. (US). Is it possible that no one at Merck US bothered to check whether the Facebook vanity page URL "www.facebook.com/Merck" was available, before (entirely innocently!) asking Facebook to open a page in Merck & Co. US's name? I guess that could have happened. . . .

But wouldn't it seem more likely that Facebook told Merck US that the page "already existed" -- Facebok, of course, assuming naively, and incorrectly, that Merck KGaA (Germany) was just an international affiliate of US Merck?

[Most people who hadn't recently read the 1919 Treaty of Versailles might have made the same assumption -- in fact no less an authority than the Wall Street Journal still occasionally does -- HAH! But we must assume that at US Merck's Corporate Communications Department, at least, it knows who it is -- and is NOT, right?]

In any event, wouldn't it also then seem likely that Merck US would simply say Oops! -- "we lost our passwords" -- or some such, and induce Facebook to reset the page, effectively "handing over the keys" to that address, to US Merck?

In sum, what I find hard to believe about this scenario (from US Merck's perspective) is that US Merck didn't even know that German Merck had the Vanity Facebook page address.

If Merck US did know about the German Merck vanity page, it becomes nearly impossible to imagine any set of statements that would be completely truthful -- and free from material omissions -- that would still result in Facebook handing over the keys to US Merck.

Certainly, Facebook (just as in the Salman Rushdie name case -- see link below) would require some evidence that Merck US and German Merck were essentially the same person before resetting the passwords, right?

I mean, think about it -- at almost same time, Facebook was very publicly handling the flap over Rushdie's own "pen" name. [In that case, Facebook required the submission of Rushdie's passport, among other things, before returning to him HIS OWN "PEN" NAME(!).]

Something similar must have been requested of Merck US. And short of a misstatement, the change wouldn't have occurred, in my estimation. That misstatement almost certainly came from Whitehouse Station (i.e., Merck US), in my estimation.

So -- yes, Facebook could very well have made a fairly innocent mistake (and has admitted as much).

If you can, though -- do lay out a plausible competing scenario -- one in which the second largest purveyor of drugs in the world is unaware of the German Merck's existence on Facebook, and is unaware of 92 years of its own confused history with that unaffiliated World War I reparations-seized-entity.

Remember, prior to the Summer of 2011, US Merck already had a page on Facebook -- just not a vanity URL address page. So too, did German Merck, but it ALSO had the vanity address page -- since 2010.

If you can convincingly spin me that tale, I'm all ears (and eyes)!

Thanks -- what a great question!

Namaste!

November 30, 2011 9:20 AM. . . .

I think this one is about done -- for now. Now we wait to see when the German Merck reappears as owner of the vanity URL at Facebook. As of this morning, no one owns it.