Wednesday, February 27, 2008

Colorado High School Activities Association bars games on Sabbath

The Herzl/Rocky Mountain Hebrew Academy basketball team has had a great season and only needs to win one more game to make the regional championships. Unfortunately, if the team does win that game, they will not be able to compete for the championship because the game is scheduled for Saturday, March 8th. The team, who can not compete during the Jewish Sabbath (Sundown Friday through Sundown on Saturday), requested a schedule change but were denied by the Colorado High School Activities Association (CHSAA). The CHSAA does have a rule barring games from being played on Sabbath but the language really on bars games being played on Sunday (though it is noted that this rule is due to religious reasons). A few state Senators (from both parties) think the CHSAA should be able to come up with some way to accommodate Sabbath observance of both potential championship teams (I dunno, Saturday night perhaps) but, if not, the Hebrew Academy team members will learn that maintaining their integrity is much more important than a trophy.


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Made in China: A Threat Coming To A Pharmacy Near You

It seems as though every couple of months (maybe more often as of late) we get another newsflash about dangerous goods manufactured in China. Until recently, the biggest concern was lead paint used in children's toys that were made in China, but things went downhill went 4 people died & hundreds suffered allergic reactions to Heparin that, unlike the previous Baxter Heparin issues, had been given properly. The problem, it turned out, was due to an active ingredient coming from an unlicensed plant in China. As the story has unfolded, there have been critical mistakes made along the way that lead to this debacle: the plant was not licensed, the correct plant was not inspected by the US FDA, the China's SFDA or Baxter, and Baxter didn't follow standard Chemistry, Manufacturing & Control practices to ensure quality control.

To be blunt, this was a total clusterfuck. Despite
a new agreement that is supposed to enhance safety of food and feed imported from China, the Chinese have made it abundantly clear that when it comes to manufacturing of drugs/ingredients, those who import Chinese goods do so at their own risk.

Ed Silverman, at Pharmalot, notes
"But the case highlights the difficulties both sides face in improving oversight given paltry levels of staffing and funding on both sides. The FDA acknowledged that Changzhou SPL was never inspected by the FDA, contrary to its own regulations, due to what it says was a mix-up with names. The Chinese FDA apparently did not inspect the factory because it was classified as a chemicals manufacturer, not a pharmaceuticals company."
In other words, we may be SOL on this one.


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Tuesday, February 26, 2008

The drugging of America's kids

Every day, thousands of kids are getting pharmacologic treatment with psychotropic drugs they probably don't benefit from and that may well endanger them. New Jersey, like other states, has formed a task force to probe the use of antipychotics in children. Until very recently, these drugs were not evaluated with adequate and well controlled trials in children or approved for use in the pediatric population. To make matters worse, it appears as though children may have been prescribed these medications to treat indications that weren't even studied or approved for adults. It's most likely a majority of these kids may have been given these meds to treat ADHD and the prescriptions were not given by psychiatrists treating significant and/or moderate to severe mental health disorders. I am not a Xenu-phobe, I do not think that psychotropic drugs are evil or should be banned and I am fully aware that there are many people, including some children, that have significant and severe mental health disorders that warrant psychological and pharmacological intervention. I also know that there are some kids whose inability to concentrate/focus is so far from the norm of his/her age group that it is and should be treated as pathological in order to try to get the child back on track - but this is not true for all children diagnosed and treated with ADHD.

I've said it before, and I'll say it again: this is not a problem with psychiatry or even a problem with the Pharmaceutical Industry (though Pharma takes great advantage of it). This excess, injudicious use of medications is a problem with our society.

I don't know why pediatricians and GPs/FPs are willing to capitulate on prescribing these drugs to appease people instead of trying to determine which child really has a significant problem (and then probably turfing them for a psych/neuro consult) and which have the immature frontal lobes that leads to poor impulse control because, as children, their neurological development is ongoing.

Unfortunately, doctors don't seem to be willing to say no to patient/parent demand for a pill to cure our ills (real or imagined). Two things need to happen to rectify this situation:
  1. Physicians need to stop treating patients/parents as clients and start evaluating them clinically to treat them as patients
  2. We, as a society, accept that children are children and that means they will act like children (poor impulse control and all), we will continue drugging those who do not need and are unlikely to benefit from these medications.
Both of the above will have to occur to make any real change, our children and our society will be stuck between the extremes of those who do not want to acknowledge or treat any mental health disorders and those who are too willing to drug others to control them.

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Monday, February 25, 2008

Alabama & Soviet Style Broadcasting

Stories about the shady partisanship behind the investigation, conviction and jail time of former Alabama Govenor Don Siegelman for 32 counts of bribery haven't gotten too much play in the Main Stream Media until last night, when 60 Minutes ran a story on it. The crux of the story is how Karl Rove inappropriately politicized the Dept of Justice, as evidenced by the testimony of whistleblower Dana Jill Simpson (whose house caught fire and who was run off the road in the period of time leading up to her testimony). Other odd things occurred in the time leading up to the Siegelman's trial as weel, like his house being broken into twice and his lawyer's house being burglarized. The weirdness doesn't stop there as Larisa Alexandrova points out on HuffPo: last night's 60 Minutes broadcast was mysteriously blacked out across parts of Alabama, and the blackout problem was limited to the period of time the Siegelman story was being broadcast. Hmmmm. . . .


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Sunday, February 24, 2008

Public vs public: a distinction that needs to be made

I've entered into an interesting (and inadvertent) discussion about religion in public over at Eye Hacker Blog. The topic came up in an exchange when a commenter named Rich who responded to my comments to a post about the impact of religion on medical practice. I noted there, as I had on an inappropriately placed comment at Pam's House Blend, that it is a Health Care Provider's responsibility to navigate the terrain of their professional responsibilities to avoid conflicts between their responsibility to their faith and their responsibility to their patients. Rich took unction at my "secularist" view and went on to indicate [emphasis added]
"Secularists often demand that people of faith abandon their beliefs outside of church and home. That is what hate crimes often try to do (with particular emphasis on homosexuality.)

I think that you are rather naive to think that “What secularists want is for all people to be able to live and act in accordance with their own faith (or lack thereof) without having the faith of others imposed on them.” The mere mention of religious values/belief in public is considered an “imposition of religion” by secularists. I find secularists among the least tolerant in our society."
In reviewing these comments, it comes to mind that there is a big difference between what is "Public" as in maintained at the public expense and under public control, compared to "public" meaning open to the general community. While all things Public are, by and large, public, not all things public are Public. This is critical to understanding any discourse about religion in the public sphere, especially since the two meanings of the word is something the religious right and the conservative pundits willfully and maliciously conflate. Many seemingly thoughtful and intelligent people actually buy into Bill O's favorite type of herring, the sssssssssssecularist war on Christmas, solely because that shameful tactic works not only on the religious right, but it works on those less political who are lead to fear a world without Santa Claus.

The vast majority of people on the left couldn’t care less about Christmas sales, store displays or saying Merry Christmas vs Happy Holidays. While some stores, malls or places of employment may have company policies regarding holiday decorations, etc., those rules are neither legislated by the government nor mandated by some left-wing conspiracy. For better or worse, when those policies are put in place, the decisions are based on how business is (or is perceived to be) affected. Truth be told, it's those who fanned stories of alleged wars on Christmas and Easter that undermine the religious practice of Christianity and serves to draw attention away from the purpose and meaning of its most holy days. Be honest, which do you think is less respectful of Christmas: a store clerk wishing you happy holidays instead saying Merry Christmas, or the AFA action alert to boycott PetSmart for not selling Christmas toys and rawhide?

The secularist movement is not a fight over whether you can say grace before a meal in a restaurant, sing [religious] Christmas Carols while shopping at the mall or read a bible at a park. It's a fight over whether everyone has to overtly support your religious expression by allowing Public displays of religion at tax payer subsidized locations, be subjected to your religious expression when that entails any form of religious witnessing to a captive audience in Public, and/or a requirement we endure an unwelcome encroachment into our personal lives or space.


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Saturday, February 23, 2008

How to control slutty animals

For those of you dismayed when your pets, neighborhood toms and other sexually promiscuous wild-life insist on cavorting around despite the excellence of "abstinence only" education, the fine folks at Texas A & M have a cure for those animals lack of headache: oral contraceptives. Like hormonal contraceptives used in humans, these drugs prevent an ova from being fertilized while maintaining that annoying cycle that serves as a reminder to females that their uterus is what matters and the rest is dispensible
"This approach inhibits maturation of the egg and therefore prevents fertilization. The animals continue to cycle, so it will not yet be ideal for many pet owners. But there is an advantage for use in wild and feral animals." [Duane Kramer, Professor of Veterinary Physiology & Pharmacology]
Phosphdiesterase inhibitors are the first class of drugs being evaluated for this purpose. It will likely be mixed with feed so, if they pharmacodynamic effects of the PDE inhibitors are similar to those in humans, you'll know which animals have been exposed by the increase in the music they make.

Unfortunately, Dr. Zaius was not available for comment at the time of posting


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Friday, February 22, 2008


McCaint (n) - GOP presidential front-runner who ain't quite as pure an honest as he claims he is.


UPDATE: and here I thought I was clever in using the term McCaint but, while fixing an error that hid part of it the post, I came across a funny little blog: "
John McCaint If it mccaint broke mccaint fixit"


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Baby In Bloom

Not only does 3 year old Nico sing & dance better than Asslee, Brit & Paris, he manages to keep his underwear on too! Now as long as his parents don't waste their time getting him out of diapers, he will be 100% ready to become the next celebuwreck.


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Clinical Research - a baby in dire need of a change

This morning, Pharmalot features a post indicating yet another state Attorney General has decided to sue pharmaceutical manufacturers. This time, it's Montana vs AZ and Jansen for pushing antipsychotic meds that are, according to state AG Mike McGrath, “in defective condition and unreasonably dangerous”. Between the product liability suits, fights about state vs federal rights and [legitimate] concerns about obfuscation I think anyone with a conscience must agree that it's time for real transparency in data from clinical studies.

The only way to provide any level of confidence in the data from clinical research would be to mandate public access to the raw data (actual complete listings), data management and statistical analysis plans for clinical trials. Manufacturers will, of course, complain that this requirement would make confidential and proprietary information available to competitors and put them at an unfair disadvantage but since everyone would have to comply to the same standards, what would be created is more akin to a level playing field that may actually improve research standards as well as help people better compare and contrast drug safety and efficacy data.

In making this sugestion, I am making no difference between industry sponsored clinical trials, industry supported "investigator sponsored" studies and truly independent clinical research. In other words, medical/scientific article reviewers and readers alike should have access to review the raw data for these publications to ensure nobody is taking liberties with data.

Also, in addition to requiring lead authors to disclose funding and pharma relationship information for themselves, we should require that info be provided by all authors as well as full disclosure of funding/relationship issues for journal editors and article reviewers. Let us all draw our own conclusions to what potential bias (intentional or not) exists.

If I could, I'd also go so far as requiring IRBs to set up more stringent (routine) site/PI/study auditing requirements for "independent" studies that are not subject to source document & protocol adherence verification.

These suggestions will tick off manufacturers and researchers alike, but implementation is an absolute must if we are to regain any confidence in the medications we use.


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Thursday, February 21, 2008

No bloggers were lynched in the posting of this entry

I know this is an unpopular stance, but this linguistic lunacy resulting from political correctness has got to stop. I understand full well that there are words, certain epithets, that legitimately raise the hackles of the average person but when almost every choice of a colorful descriptor makes people (and the media) start verbally attacking the speaker as making the most horrid of statements, we're in dire need of some real perspective. Earlier this week, Michelle Obama, wife of POTUS candidate Barack Obama, made the following statement [emphasis added]:

“Hope is making a comeback and, let me tell you, for the first time in my adult life, I am proud of my country. Not just because Barack is doing well, but I think people are hungry for change” [Boston Herald]
Now I heard the statement and thought the "for the first time" part was a bit much and a borderline idiotic statement, and just took the comment as the typical overstated supportive excitement of the spouse of a politician and left it at that. Unfortunately, I'm one of the few that thought dissecting the statement was a waste of time as it was only a matter of time before the media, pundits and Cindy McCain (with all the smugness of Lynne Cheney) were jumping all over the statement. It was, yes - I'm going to say it, a bit of a virtual lynching. Was she literally hunted down and executed? No, but there was a a rhetorical pile-up that had the heart and soul of a lynching.

Ironically, Bill O'Reilly (that bloviating buffoon from Faux News), in a rare act of common sense decided not to join the pile on. In response to one cheesed-off caller who indicated she knew Mrs. Obama was an angry woman (noting a friend who had info and was sure Obama was "militant" ), O'Reilly basically told the woman to get some actual evidence to back up her claim and stated:
"I don't want to go on a lynching party against Michelle Obama unless there's evidence, hard facts, that say this is how the woman really feels. If that's how she really feels -- that America is a bad country or a flawed nation, whatever -- then that's legit. We'll track it down." [Media Matters]
This isn't the first time a colorful descriptor has been used figuratively bit it should be the last time or even the last time overly sensitive people decide the figurative use of a word is meant to be injurious and therefor using the word is determined to be some sort of heinous act. If you go looking for a slight, you're going to find (or create) it. That doesn't mean the person taking offense is morally superior, it just means you may be spending too much time looking for a fight.

Pick your battles people, because it's way past time to stop making mountains out of those proverbial mole hills. Use of the word lynch doesn't mean you're racist (or that you really think someone should be attacked), use of the words hystrionic or hysteria isn't sexist and stating that someone is being "pimped out" doesn't their sexual services are being sold by another. These are words and phrases that commonly evoke a meaning that is different from their original and literal meaning and it's time to put the true, tone, tenor, intent and context of the statement ahead of a need to jump on the politically correct bandwagon and focus on more substantial issues.


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Tuesday, February 19, 2008

Little known offensive facts: you must attest to being Christian to hold office in Delaware

I came across a letter to the editor of the Bucks County (PA) Courier Times today in which a reader not only expressed her great relief that the founding fathers were "men of G-d" but gleefully pointed out a little known fact that all Delaware state officer holders must profess faith in Jesus and their status as Christians in accordance to the Delaware state constitution.

Art. 22. Every person who shall be chosen a member of either house, or appointed to any office or place of trust, before taking his seat, or entering upon the execution of his office, shall take the following oath, or affirmation, if conscientiously scrupulous of taking an oath, to wit:

"I, A B, will bear true allegiance to the Delaware State, submit to its constitution and laws, and do no act wittingly whereby the freedom thereof may be prejudiced."

And also make and subscribe the following declaration, to wit:

"I, A B, do profess faith in God the Father, and in Jesus Christ His only Son, and in the Holy Ghost, one God, blessed for evermore; and I do acknowledge the holy scriptures of the Old and New Testament to be given by divine inspiration."

And all officers shall also take an oath of office.
I'd be very curious to know if this article has ever been repealed or, if not, if any non-Christian has ever held state office. It's obvious that anyone who did not take the oath or any non Christian who lied in taking the oath should be removed from office and/or forfeit any benefits associated with holding office (the state should not have to endure any marranos).

I don't know why I'm surprised that this is on the books (or that people would proud enough to boast about it) afterall, not too long ago, the southern part of the state felt no shame in running those pesky christkillers out of town. . .


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Monday, February 18, 2008

PA considers permitting healthcare interference

Yet again, some Pennsylvania lawmakers are out to bring Puritanism back into fashion. Senator John Eichelberger (R-Altoona) has introduced PA Senate Bill 1255 which would not only allow a Health Care Practitioner (HCP) to refuse to treat patients on religious grounds, it would indemnify them from civil, criminal and/or administrative liability for refusing reproductive care. The so-called Conscientious Objection Act is the antithesis of health care. It not only allows the HCP to impose his or her personal religious views on a patient, it changes the terms of employment (they can blatantly disregard hospital or practice policy) and even allows the HCP actively & intentionally harm a patient without impunity.

Ironically, Pennsylvania is an "at will" state meaning that unless you have an employment contract that specifies what reasons you can and can't be fired, your employment can be terminated for any reason except if the negative employment action is a violation of federal EEOC laws. In other words, in PA, someone can be fired because their boss doesn't like the color of their shoes, but a HCP would not be able to be fired (or sued for malpractice) for refusing to terminate an ectopic pregnancy because the HCP's religion doesn't approve of unmarried women having sex.

I've said it before and I'll say it again: If you don't want to be in a position to do something inconsistent with your personal moral and/or religious convictions, don't go out of your way to obtain employment at a facility in which your responsibilities would include involvement in "immoral" or otherwise unconscionable acts.


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Saturday, February 16, 2008

Pharma cries wolf (again)

You have to feel bad for the poor, oppressed pharmaceutical industry. I mean, even politicians are starting to pick on them (mind you, it's an election year, the politicians will probably stop) and support consumer advocacy group requests that safeguards be put in place against the use of journal reprints to promote off-label use. Basically, the way the provision of journal reprints supposedly works is that a pharma Sales Rep or Medical Science Liaison (MSL)* meets with a physician who (of his or her own volition, of course) requests detailed information and specific journal articles about a certain off-label use of a product. Ostensibly, the physician who initiated the request, fills out a form to indicate his or her desire to have these reprints sent and then reads those articles to fulfill his/her intellectual curiosity; sometimes, the physician even considers using the product on his/her own patients based on the information contained in the articles. The way it really works, most likely the pharma company employee meets with the doctor, the subject of off label use comes up and the games begin. Sales Reps are not allowed to discuss off label use at all, compliant reps at complaint companies will address the issue by having a physician information request form filled out (the rep may actually fill out the form and get the doc to sign it to "ensure" compliance and verify that it was the doctor's idea) and then put the doctor in contact with the MSL who can talk about off label use to the company's delight.

Companies state they need to be able to supply these articles to provide a physician with information that will ensure that any use of their product in a non-approved indication will be done safely. To a certain extent that is true. These articles not only provide information about dosing of the medication in the off label use, but may also provide detailed instructions how to administer the medication (this is especially important for injectable drugs such as botulinum toxin, which may be injected into large muscles for an approved indication but require a different technique to inject into smaller muscles, glands, joints, etc. to treat off label).

Randy Lutter, deputy Commissioner of the FDA, inadvertently gives a clear reason of why pharma companies want to provide the reprints and how they increase sales in his description of the current draft FDA guidance about distribution of literature [emphasis added]:
"articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care.” [Pharmalot]
So, you tell me. If these reprints can lead to a new standard of care that includes use of a marketed product to treat an indication for which it has not been adequately tested, let alone undergone a rigorous review of raw datasets (FDA inadequacy aside) and approval, who benefits the most? While Pharma will state the patients and medical community get the benefit, it is actually the manufacturer that gets the great reward at the end of the day. They get increased sales without having to burden the financial cost and safeguards of conducting and monitoring controlled trials or submitting a New Drug Application, and they get it in much less time than it would take to obtain an approval of the drug. They may even end up with limitation in liability since they supposedly do not promote off label and the label doesn't include the indication, the primary liability is the physician's.

If a physician is really curious enough to want information on use of a product for a non approved indication, he or she does have the ability to conduct a literature search and obtain their own copies of a journal article. Removing free, easy, quick access via Pharmaceutical companies does not prevent anyone from obtaining these publications. Whenever I've brought this up to sales reps, MSLs and even on Pharmalot, I've received the same response of "the docs are too busy to do a lit search or get reprints on their own" and/or "not all journal articles are available free of charge". While there is some validity to the charge related to the costs of articles through a publishing company (at least for those not affiliated with academic centers), more articles are available for free these days and one can usually obtain a copy of a reprint from the author free of charge; the cost of articles and subscriptions to medical journals can also be charged to a practice as a legitimate business expense. It is the complaint that the docs don't have the time that concerns me more. If these docs don't have the time to obtain the literature, do they have the time to delve into the articles to critical evaluate what's presented in them? My guess is that, in many cases, pharma companies rely on limited time to spoon feed the information in the articles they want to convey to get the doc prescribing.

To make matters worse, many of these articles are from research paid for by the manufacturer (but called "independent" since it's not sponsored by the company or submitted to a regulatory authority) and the primary purpose is to get a quick and dirty study completed and published in much less time and for much less money than it would take to conduct a truly adequate and well controlled study.

Let's be honest, Pharma is calling this a free-speech issue because they don't like anything that curtails their ability to promote off-label. They'll bite the bullet and pretend they don't directly promote off label but they will not stand for any limitations to indirect routes of off label promotion. It's past time to ensure that real safeguards are put in place, we need actual enforcement and accountability for regulations that are already on the books.

*MSLs are, technically, part of Medical Affairs and are permitted to discuss off label , but are widely seen and used as an arm of sales/marketing

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Monday, February 11, 2008

The copyright on Christ

Just wait til they find a way to sue people to pay licensing fees on "God damn", "Jesus Christ" and all the variations.

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When will this laxative finally poop out?

Adolor's regulatory roller-coaster ride was extended, yet again with a new FDA action date of May 10, 2008. A few years ago, really thought they would wipe out the competition after finally submitting an NDA for Entereg® (alvimopan) for the treatment of post-operative ileus (POI), a condition known to extend hospital stays and, therefor, costs after abdominal surgery. Despite having received fast-track status from the FDA, the drug's development since acquisition by Adolor has been anything but fast (or even moderately efficient). The development program was besieged by delays, primarily in subject recruitment and study completion, which were exacerbated by the fact they pretty much had mixed efficacy results in the multitude of phase III studies. The delays and announcement of negative study results in late 2002/early 2003 even lead to investors filing suit claiming the company had mislead them about the drug in public statements.

Nevertheless, Adolor plodded through and finally submitted a New Drug Application (NDA) for the POI indication to the FDA in 2004. In July 2005 the shit started hitting the fan. The data on the primary end-point was weak (to say the least), so Adolor had to conduct some more studies. While the company did receive an approvable letter, safety concerns came to light based on data from clinical trials of the drug's use in opioid bowel dysfunction (OBD; constipation caused by use of opiates). These issues have continued to dog the company through every round of review. Last month, the FDA advisory panel recommended approval of the drug (which has been co-developed with GSK) for the POI indication. The endorsement from Robert Levine, a Professor of Gastroenterology at SUNY, Syracuse was, underwhelming [emphasis added]
I think for the patient's sake I would agree that the benefits marginally overcome the negative [Reuters]
During the time Adolor (and investors) has focused on Entereg, the company has had 3 other failed compounds (two kappa agonists developed by Adolor R & D failed in phase II, & a sterile lidocaine patch in-licensed from Epicept, which very expectedly flamed out in Phase III development). In the past year, the Adolor's only saving grace was actually the advancement of two delta agonists from the research lab into clinical research that has now provide the company with a much needed cash influx courtesy of a new deal with Pfizer.

Adolor in-licensed the product from Roberts in 1999 (Roberts had previously in-licensed it from Lilly) and I'm pretty sure the patent for use in POI expires in 2011.
With today's announcement of further delays for Entereg, the question remains why even bother at this point?

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Saturday, February 09, 2008


Being the cynic I am, I often look at announcements of a celebrity entering rehab as a publicist's attempt to rehabilitate a star's image, or a star's attempt to take a spa break and gain/maintain media coverage and sympathy in one fell swoop. After all, Celebutardia is the place where fame and infamy are one and the same, so having your name mentioned in even the worst of contexts can serve not only to extend you well past your 15 minute shelf-life, it can actually be used to create a "star" (seriously, Bob Crane must be pissed off that he's missing out on today's Hollywood). Only among the rich and famous is rehab a place of comfort and luxury; one in which patients get passes early into their treatment (for exigent circumstances only, of course).

Considering that Hollywood is still, well, Hollywood, I raised an eyebrow with the sudden announcement that Eva Mendes entered rehab and recent rumors that Kirsten Dunst has followed suit. But then I thought that even celebrities were finally starting to understand that the instructions to keep hands and feet inside the ride at all times were meant for them. Maybe, I reasoned to myself, just maybe Heath Ledger's untimely and shocking death has smacked some common sense into these celebrities and they realized that a rap sheet or tabloid headlines about your drug/alcohol-addled exploits isn't the problem, drug/alcohol abuse is a problem.

Then, I read this.

truth in advertising:

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Friday, February 08, 2008

When HSN and Drug Marketing Collide

A new MTV is in the making but, in this one, the M doesn't stand for Music (not that is does in the original either) it stands for medication. Via Marketing Overdose, it appears as though the EU is on the verge of making the same mistake of allowing Direct-to-Consumer (DTC) advertising of prescription medications to hit the air. Now our friends across the pond can join use in mutual hypchondrical behavior because they too have been brainwashed to think heartburn and GE Reflux are one and the same and, therefor, in need of daily medical intervention; and find out every complaint they have is really a symptom of a medical condition that needs pharmacological intervention.

DTC drug advertising, even that in the form of an informational campaign about a disorder, isn't an advocacy group outreach program to ensure people get the social support they may need, it's a lure to get people to go to their physicians indicating they think they would benefit from a specific drug because they have some or all of the signs/symptoms they've heard are indicators of a disorder that drug can alleviate.

The costs of this increased marketing overseas are likely to have a greater impact on patients in the US as the bulk of that cost will be made up in price increases here since there is strict price control in the EU. Add that to the regular price increases related to marketing costs here and those that are, ostensibly, due to increased [tax deductible] research & development costs (including "independent" research that is used to obtain insurance coverage & publicity for off-label indications, as well maintain good relationships with "Key Opinion Leaders" and other important physicians).

Prescription products are not the same as other consumer products:
  • A Health Care Provider (HCP) licensed to prescribe medications must make a clinical evaluation & decision to administer treatment; then
  • The "consumer" [patient] is provided with a prescription that legally authorizes the patient to obtain the product from another licensed professional. [alternately, the HCP can treat directly the consumer with the product and/or provide samples]
Pharma manufacturers uses DTC advertising because they rely on the fact that some doctors (too many) will write a prescription because a patient asks for it.

Contrary to popular belief, the banning of DTC ads for prescription meds would not be a violation of the right to free speech or an unfair infringement on marketing practices. The decision regarding what is and is not appropriate medical intervention is made by the HCP him/herself. Pharma manufacturers can and do advertise to HCPs (the people who, essentially, control sales). Pharma also finds other creative, often marginally compliant, ways to market their products to HCP which generate extensive sales from patients and non-patients alike.

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Thursday, February 07, 2008

Roger Clemens' Blue Dress Bombshell

In yet another sordid twist to the baseball league's doping debacle, Brian McNamee claims he has the girlish sentimentality of Monica Lewinsky:
Clemens’ former trainer has physical evidence he believes proves Clemens used steroids, as McNamee has alleged. The lawyers would not comment specifically on what the evidence is, but a source said McNamee has syringes he claims contain trace amounts of Clemens’ blood, steroids and growth hormone. [NY Post]
This sort of medical waste is normally disposed of post haste so one has to wonder why trainer not only kept his little trinkets, but why he retained them for so many years. Regardless, McNamee's malice aforethought may well land the pitcher in the pokey.

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Mitt's sleazy surrender

So Mitt bowed out the Republican way, by insinuating that the Democrats and anyone who would vote for a Democrat in the generals is supporting terrorism [emphasis added]:
"In this time of war, I simply cannot let my campaign be a part of aiding a surrender to terror. This is not an easy decision. I hate to lose," the former Massachusetts governor said.

"If this were only about me, I'd go on. But it's never been only about me. I entered this race because I love America, and because I love America, in this time of war I feel I have to now stand aside for our party and for our country." [CNN]
followed by
"If I fight on in my campaign, all the way to the convention, I would forestall the launch of a national campaign and make it more likely that Senator Clinton or Obama would win. And in this time of war, I simply cannot let my campaign, be a part of aiding a surrender to terror," Romney told the Conservative Political Action Conference in Washington. [AP]
Now the only remaining and, ostensibly, viable Republican candidates are the Huckster who, not too long ago, was widely considered one heckuva long-shot, and John McCain.

I have to be honest that, from a rational standpoint, I don't understand Freeper
Disdain for McCain™. While, in the past, McCain has [sorta] worked across party lines, he is a fiscal conservative, supports DOMA and state bans on gay marriage, has now become a bona fide war monger and firm supporter of the current administration king.

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Wednesday, February 06, 2008

She must work in Pharma

"A wail emerges from the cubby -- guttural, vile, the kind of base animalistic shriek only heard at a family member's deathbed. 'Fuck these bitches,' screams Britney, each word ringing out between sobs. She's spitting, growling ... 'Fuck you, fuck people, fuck, fuck, fuck.'" [Rolling Stone]

C'mon, I do this 20 times a day in the ladies' room at work. This just means I'm "employed", not "bi-polar".

[Little Mintz Sunshine on Britney Spears' visit to Betsey Johnson]

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Literally. In what must be the greatest advancement in candy since Preggie Pops, UCLA microbiologist Wenyuan Shi has turned lollipops into the front line in the fight against dental decay.
The orange-flavored, sugar-free lollipop they devised is infused with a natural ingredient found in licorice that kills the primary bacterium causing tooth decay, Streptococcus mutans.

Marketed as Dr. John's Herbal Candy, the lollipop, now available for purchase through a candy manufacturer that licenses the technology from UCLA, is the first therapeutic developed by Shi. But he has many more in the works to target bacteria wreaking havoc in the nose, ear and gut, to name just a few.

University of California, Los Angeles (2008, February 5). Enjoy Candy Without The Cavities: Good Lollipop Kills Bacteria That Causes Tooth Decay. ScienceDaily. Retrieved February 6, 2008, from­ /releases/2008/02/080204144715.htm
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Tuesday, February 05, 2008

I'm not lazy, I have Motivational Deficiency Disorder

Thanks to Ed Silverman at Pharmalot, I've discovered my recent bout of lethargy and what people have been calling sheer, unadulterated laziness isn't my fault. I have a medical condition developed by those crafty marketing types in the Pharmaceutical Industry. Don't worry though, while medical research hasn't found the cure for Motivational Deficiency Disorder, which affects 20% of the population, Big Pharma has found a treatment:

The above is part of Consumers International's Marketing Overdose Campaign. They currently have a campaign ongoing to ban pharma gift giving practices and mandate the creation of a public register of all transactions between drug companies and doctors and medical institutions. This campaign appears to be requesting a higher level of detail than FDAAA. Personally, I'd like to see mandatory disclosure of all research or educational grants awarded broken down by Health Care Provider & Institution (hospitals, academic facilities, research centers and private practices). All companies, regardless of size or sales figures, should be required to make this information public and the information should be 100% transparent so that companies can not hide payments through 3rd party organizations.

Additionally, I think a public registry should be required to include links to the following for any and all grants for investigator sponsored studies:
    • Names of Principal and Sub-investigators
    • Protocol Synopsis/link to study posting on
    • Final Study Report/link to study results on
    • Linked list of all resulting publications
    • Information regarding additional financial support made to attend meetings/present study findings (including arrangements made for medical writing support)

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Monday, February 04, 2008

Much Ado About Something

As most people know, main stream media, the medical community, pharmaceutical industry insiders, bioethicists, consumer protection groups, parent support groups and religious organizations have been engaged in a raging debate regarding the use of psychoactive drugs in the US. The primary focus of the debate has been the use of psychoactive medications in the pediatric population. The concerns are legitimate considering how few of these drugs have actually been evaluated in adequate and well-controlled studies under the Pediatric Rule and recent allegations that "negative" data (i.e., data indicating lack of efficacy and/or significant safety issues) from those studies has been squelched by big Pharma. These headlines and the often tragic tales behind them have left the FDA, pharmaceutical industry and medical establishment with a seriously black eye and advanced the agenda of those in a quest to eradicate psychiatry & psychological therapy (except that conducted under the guise of lucrative and tax-exempt religious activities).

Contrary to the beliefs of Xenu-phobes, psychiatry is not what is drugging our youth, our impatient culture is. Changing thresholds of diagnosis and treatment, development of new (which equates better in Americanese) drugs, DTC advertising coupled with the plethora of "medical" information on the web and a willingness to self-diagnose have lead to an exponential rise in the number of prescriptions for psychotropic medications over the years. My guess is that the majority of prescriptions for psychotropic drugs are being written by GPs and that they are doing so at the behest of teachers/schools, the media, parents and patients alike, all of whom seem to be looking for a cure for what ails them/their children, regardless of whether said ailment is truly present and warrants pharmacological intervention. The ADHD drugs have become the new Haldol (aka "vitamin H"), except they’re being used to quiet children regardless of any actual disorder instead of used to keep the institutionalized mentally ill patient quietly drooling in the corner.

In this country, one of our biggest problems is the dangerous attitude that anything and everything can be corrected if you take a pill. This leads to too many people being prescribed drugs that they don’t need for a condition that they don't have or one in which other modalities of treatment should be sufficient. This attitude is not limited to mental health issues, we have the same attitude about pretty much everything (for the record, that attitude is no small part of the reason why we've been facing a rise in drug-resistant bacteria). Sadly, the resulting onslaught of side-effects to medications used inappropriately may end up hurting those patients who could actually benefit from these drugs by creating new barriers to treatment. As a society, we'll never be able to rectify the situation until we take a more logical and pragmatic approach to addressing [mental] health issues.

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