News, Electronic Health Records Law: The US Gov’t will now monitor your jeans size. In other news, biopharmas that make antiobesity meds are forcasted to make giant slurping sound as they vacuum up money.

Do you want the US government to keep track of how fat you are?

Too bad if you don’t, that ship has sailed, train left the station, done deal.

HHS (Health and Human Services, an agency in the executive branch of the US Gov’t) is implementing the  Health Information Technology laws with a teensy little clause that sez “we get to know your BMI at all times.” §170.302(e) (2).

Set aside the faulty premise that BMI is a relevant proxy for general health (it’s not). Is reducing obesity the best way to reduce health care costs?

Obviously, the very best way to reduce health care costs is to let everyone die (or not be born), because nothing is cheaper than death (or not existing). But, considering that the financial services industry and its lackey consultancies haven’t seriously proposed that one yet, the next best way to reduce health care costs is to have chubby wubbies lose weight because everyone knows that fat = $$$$ on the health care cost menu.

Right?

Oops, also faulty premise. The savings in obesity-related health care costs is offset by living longer once you’re a skinny minnie.  Skinny people live longer and presumably use more resources.   (Here’s the health economics paper). Reducing obesity reduces obesity-related health care costs, not health care costs overall.

The other problem is that lifespan — how long healthy people live — is increasing. (SSA life table for 2006).  As we previously blogged, about 30% of Medicare is spent on last-year-of-life (we also note that this topic got us kicked out of the Research Blogging aggregator in addition to our not being researchy enough).

People, people . . . this has got to stop, people. Increasing lifespan by reducing infant mortality, starvation, epidemics, and violent death, is a terrible idea for reducing health care costs. (Here).  We need to go back to 1632 when 75% of the people died before age 26 to rachet down health care costs.

OKOK, so the premise for the whole “war on fat” is based almost entirely on truthiness.  Moreover, there are incentives to keep people fat: The global diabetes drug-and-accoutrement market is $24B+ , and diabetes in China is like sugar to the flies in biopharma for new markets, to use a glucosey analogy.  (We note in passing that if you want to blame someone for running up health care costs, blame the system that is based on reverse competition  — that is, everyone makes more money the more expensive health care they provide.  Our friend was just showing us a cyst on her finger that her Beverly Hills adjacent plastic surgeon is removing for $1200 on Monday. It looks like a mosquito bite. No other medical professionals in our orbit ever having heard of surgical removal of what looks like a mosquito bite).

Being in the biopharma biz, our own bias is, “If there’s something wrong, take a pill, and in fact, take two.”  But, we have questioned the development of some of the obesity meds, and just recently, the FDA voiced some safety concerns with one of the drugs.

Put it this way: Say you’re fat, and you can choose among the meds in three little clear plastic cups.

In the first cup is Qnexa,  a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax). Phentermine is approved for short term use basically because it’s Schedule 4. (This is the one the FDA had safety concerns with recently, and denied marketing approval unless more safety data is presented).

In the second cup is Contrave,  a combination of bupropion (marketed as Wellbutrin, a psych med acting as a dopamine reuptake inhibitor) and naltrexone (a competitive antagonist for μ- and κ-opioid receptors ). This seems to focus on the reward system, keeping dopamine available longer and pressing the mu opioid receptor buttons. Mu opioids are interesting, and relate to binge eating, for instance. In general, we like this concept, but could see how walking around feeling rewarded all day long might be a not great idea. Sort of like choosing between Lyle and Erik, obesity or new psych conditions.

In the third cup is lorcaserin, a single agent that  is (so far) very safe (an extremely selective serotonin reuptake inhibitor), but not skyrockets on the efficacy. A guess is that efficacy is increased when combined independently with phentermine.

Which one would you take?

We’ve argued here for the third choice (lorcaserin), on the rationale that (a) the clinical trial data are  cleaner if you use a single agent; and (b) patients can independently titrate the phentermine, the part that has safety concerns.  (Here is a compilation of our lorcaserin posts. ) Probably, there will be more specific drugs that act as molecular pincers that pinch off the hypothalmic bad actors giving rise to undue appetite. But for right now, a highly specific single agent like lorcaserin, if it can be demonstrated safe and effective, seems the way to go.

Regardless, going back to the Electronic Medical Health Records regs that have a line item for BMI, you can see this one coming.

An aside about financial analysts:  We fail to understand why the analysts were voting for the combo-psych drug modes, because these simply don’t make sense to us.  Do analysts perform their own independent analysis yet, and if they do, are they scared to report it for fear of losing the underwriting or other business?

What analysis we saw seemed to rely on two points: one, best efficacy wins, outweighing perceived safety issues;  and two, the management team has to be brand name.  On the second point, we note that good science has covered up for a lot of  mediocre management (no names mentioned here), and even the best managers rarely have stellar second acts in this biz.  Moreover, cows could be in the executive suite of a biopharma, if the drug is terrific, has known mode of action, large unmet need, terrific safety profile, and market exclusivity supporting premium pricing. (We’re stealing that line from a ratings agency e mail, that cows could structure finance for a triple A rating).  Gramm-Leach-Bliley provided perverse incentives, and it’s tough to be a CEO who operates in good faith and actually wants the company to succeed, if that conflicts with investment bank trading profits.

In addition, Financial Services get inside baseball information aided and abetted by big pharma and it’s publishing propaganda machinery as the veteran druggie (reporter) Adam Feuerstein reports in TheStreet.com. For those who are unschooled in methods of media manipulation, it goes like this:  Science journals have embargo policies where they send pre-prints and press releases to science reporters confidentially*, about a week in advance of releasing the papers and PR to the general public. Reporters have time to write up an article, and publish the day the papers become publicly available.  Sounds reasonable, no? Except, the big science publishers provide a loophole to big banks, who get to tell their customers about the papers in advance – so their preferred customers can trade on it. (We’ve seen this with leptin). This is all done open and notoriously, without  a care in the world, and staunchly defended . .  . somehow.  Big Science is yet another Big Institution in the pocket of Big Finance, and how these co-conspirators can perform these acts in furtherance of selective disclosures for the express purpose of stock trading is beyond us, and why the SEC considers this within Reg FD is incomprehensible to us.It looks like persons conducting an enterprise with a pattern of racketeering activity (RICO). Is everyone sleeping?

*Here are Neurological Correlates, we appreciate the courtesy of embargoed press releases, but usually don’t bother reporting on them because everyone else already does, viz. , Yogi Berra principle of “no one goes there because it’s too crowded.”  We haven’t requested the JAMA/Big Bank loophole, but suspect they would be unamused:

Tags: Contrave, health care, lorcaserin, medicines, obesity, Pharmaceuticals, Qnexa