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More on Ins. fraud:
http://www.insurancefraudpi.com/index.php?option=com_content&task=view&id=11&Itemid=12
It is virtually impossible to determine an exact value for the amount of money stolen through insurance fraud. By their natures, insurance fraud crimes are designed to be undetectable, unlike crimes such as robbery or murder that are very visible. As such, the number of cases of insurance fraud that are detected is much lower than the number of such acts that are actually committed. The best that can be done is to provide an estimate for the losses that insurers suffer due to insurance fraud. The Coalition Against Insurance Fraud estimates that in 2006 a total of about $80 billion was lost in the United States due to insurance fraud. According to estimates by the Insurance Information Institute, insurance fraud accounts for 10%, or about $30 billion, of losses in the property and casualty insurance industries in the United States. The National Health Care Anti-Fraud Association estimates that 3% of the health care industry's expenditures in the United States are due to fraudulent activities, amounting to a cost of about $51 billion. Other estimates attribute as much as 10% of the total healthcare spending in the United States to fraud-about $115 billion annually. In the United Kingdom, the Insurance Fraud Bureau estimates that the loss due to insurance fraud in the United Kingdom is about £1.5 billion ($3.08 billion), causing a 5% increase in insurance premiums. The Insurance Bureau of Canada estimates that personal injury fraud in Canada costs about C$500 million (497.5 million USD) annually.
Jbog, point conceded (and more is the pity).
aj
Auto repairs vs. Medicine:
There's also the apples vs. oranges comparison here. How many physicians are blatant scam artists who operate unlicensed shops who try to fleece their patients with unnecessary treatment soley for the purpose of generating revenue.
Jbog, this was a poor analogy overall.
aj
OT: Pain Meds
Some time ago, either you or another posted a NYTimes article about pain doctors who aggressively use opioids and the profile of one doctor who was convicted and sent to jail after one of his patients died of a drug overdose. If it can be found, I would like to read that again and would appreciate of you could find it and post it.
aj
AMAG: I've another question, about the utility of IV iron vs. infusion via dialysate (being developed by Rockwell Medical Technologies, RMTI; see PR below). Does anyone know which would be preferred by the nephrologist treating the anemic ESRD patient? The side effect profile of SFP appears to be lower than what one would expect using an IV, xrymd.
http://finance.yahoo.com/news/Rockwell-Medical-Technologies-pz-15066407.html?x=1
WIXOM, Mich., April 29, 2009 (GLOBE NEWSWIRE) -- Rockwell Medical Technologies, Inc. (NasdaqGM:RMTI - News), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ERSD), chronic kidney disease (CKD), and iron deficiency anemia, reported today that patient enrollment has been completed for it's ongoing Phase 2b dose-ranging study for its iron deficiency anemia drug soluble ferric pyrophosphate (SFP). "We are pleased to have achieved this important milestone following two positive safety reviews from the data safety monitoring board (DSMB). We anticipate having study data available in the fourth quarter of 2009 and shortly thereafter commencing our Phase 3 program," stated Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell Medical.
The Phase 2b dose-ranging study is a six-month, controlled multi-center, double-blind study consisting of approximately 130 hemodialysis patients at multiple dialysis centers in the United States and Canada. Subjects are randomized to receive one of several concentrations of SFP or placebo in dialysate during their normal three times/week dialysis regimen. The primary objectives of the study are to evaluate both safety and efficacy of SFP at varying dose levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range.
About SFP:
SFP is a novel, investigational, physiological iron maintenance therapy designed to treat or prevent iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal healthy iron uptake. SFP is designed as a continuous maintenance treatment consisting of small doses administered with every dialysis session to maintain iron status tests stable within target, as per Kidney Disease Quality Outcomes Initiative (KDOQI) recommendations. Clinical trials to date suggest that SFP delivered during each dialysis treatment, via the Company's dialysate, has the ability to maintain optimal iron balance and avoid liver toxicity while decreasing associated pharmaceutical intravenous (IV) iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments. Rockwell has licensed exclusive world-wide rights and has secured patents for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. The total U.S. market for IV iron is approximately $500 million annually while global market potential is approximately $850 million.
"Don't make personal attacks on other posters."
I think that this should be a rule for the board, and that any ad hominen attack should result in the message being deleted. This is generally the most civil stock board that I monitor and would like to see it stay that way.
Anybody agree?
aj
OT: Medicare efficiency:
With all due respect, Jbog, I spend countless hours of diagnostic interview time for referrals sent to me for dementia evaluation from private insurers, THEN have to spend time requesting authorization for the eval. with the insurance co., THEN have to get my secretary to ride the insurance co. (some of them at least) to get a response. For a procedure that costs the ins. co. about $600, we've billed an extra $125 to do the separate diagnostic, and on average, one hour of administrative time bewteen my clinic and the insurer to authorize the test.
NONE of this process occurs with medicare! I've fielded questions from many friends about my opinion about the public option. I am ALL for it. In fact, because I have an HSA and have spent upwards of $70,000 in premiums in the last 10 years (in addition to funding my HSA saving to the tune of $30,000) to cover my family and have never met my $6000 deductable, I will be looking into the public option myself.
Anecdotal evidence is the weakest form scientific rebuttal, but this is a topic that strikes a nerve at several levels.
regards,
aj
JAV and NSS: Thank goodness, for a while, I thought that I was the last to be told that JAV was just a bunch of Notoriously Sad Shit!
I agree that the conspiracy theorists are a laugh and am glad that Mgmt has not pulled that excuse yet. Several of the board members bought in at north of $4/share last year and still think that they can pull a good deal off. That said, I sure am getting tired of waiting for Ereska results.
regars,
aj
JAV: Medchal, what does "NSS" mean?
aj
Quiz answer: arbitrage
aj
OT: Solar thermal energy. This concept is so parsimonious that no one wants to mess with it (IMO). Take a look at the following for what a high school student figured out:
http://xenotechresearch.com/solfurn1.htm
That is a piece of plastic that costs less than a dollar to manufacture (in contrast to photovoltaic cells) and generates 750 watts of power in direct sunlight! Put a couple 100,000 of these on residential roofs (along with a small turbine) and we get a big chunk of our residential power needs met during a sunny day.
Now consider this. Virtually ALL critical business and healthcare infrastructure has backup deisel generator equipment, on standby AND VIRTUALLY NEVER USED. If some smart person could engineer a solar thermal add-on to these generators, they could be used virtually every day (particularly in the south, southwest and west), supplying point source energy, relieving the grid of a considerable energy burden, and it would be virtually carbon neutral.
aj
"I don’t recall seeing the word rival used previously, but the companies are indeed rivals with respect to generic Lovenox insofar as both have ANDA’s pending."
My interest in the characterization is that the press (for what it's worth) is legitimizing a co. 1/100 the size of TEVA by calling it a rival. N'est-ce pas?
aj
"Former Barr Chief Joins Board at Teva Rival Momenta"
Dew, I follow what you posts about MNTA with great interest. I don't recall the press characterizing MNTA as a rival to TEVA before. Is this a new characterization?
aj
JAV:
New Study Shows Javelin Pharmaceutical's DylojectTM Well-Tolerated in High-Risk Patients with Impaired Renal and Hepatic Function
(The interest in JAV has dwindled to almost nil here. Today's PK reseults are positive but beg the question regarding where the anticipated Ereska (inhalable ketamine) P3 results are. Y3maxx is now touting a conspiracy that mgmt is withholding the Ereska results until after the 6/23 annual shareholders' meeting so mgmt can lock in a new round of options at the lowest possible price. aj)
http://finance.yahoo.com/news/New-Study-Shows-Javelin-bw-15523708.html?.v=1
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV - News) today reported encouraging findings from a new Phase I pharmacokinetic (PK) and safety study of Dyloject in patients with mild to moderate renal and mild hepatic impairment. Dyloject was well tolerated in these higher risk patient populations. The elimination rate of Dyloject's active ingredient diclofenac was statistically indistinguishable in all three patient groups compared with matched healthy controls. The Company plans to file a New Drug application for Dyloject in the United States during the fall of 2009, at the same dose used in these studies.
“Historically, IV nonsteroidal anti-inflammatory drugs (NSAIDs) such as ketorolac, the only IV NSAID approved in the US for moderate to severe pain, have been withheld from such patient populations or required major dose reductions because of concern for adverse effects” stated Daniel Carr, M.D., Javelin’s President and Chief Medical Officer. “Dyloject’s excellent tolerability in all study groups, and the insignificant changes in diclofenac distribution and clearance observed in patients with mild to moderate chronic renal insufficiency or mild hepatic impairment are most encouraging. These new PK and safety findings will be included in our NDA filing for Dyloject.”
About The Study:
This Phase I, open-label, single-dose study evaluated the safety and pharmacokinetics of Dyloject 37.5 mg given as an IV bolus over 15 seconds in subjects with mild or moderate chronic renal insufficiency and with mild chronic hepatic impairment compared to matched healthy adult volunteers. Additionally, healthy adult volunteers participated in a randomized, open-label, crossover study in which they received a single dose of Sporanox® (itraconazole 200 mg with 8 gm of the solubilizing agent HPβCD) given as an IV infusion over 60 minutes to compare the PK and safety of HPβCD in the two medications. The 37.5 mg dose of Dyloject is formulated with 0.3 gm of HPβCD. A total of 40 subjects were treated in this study including 13 patients with mild to moderate renal insufficiency (creatinine clearance 30-80 ml/min), 8 patients with mild hepatic impairment and 19 healthy adult volunteers. Patients continued to take their prescribed medications to treat hypertension, diabetes and high cholesterol.
OT:prorating insurance.
"They" also require that drivers with lousy safety records to pay much higher insurance premiums.
Can't drive safely? you pay for it. Can't live a healthy life? you should have to pay for it.
aj
ARAY: Shameless pumping post [ ;) ]
ARAY is breaking out of it $5/share doldrums and there is buzz that it is an acquisition target. At least that's what the OTHER shameless pumpers are saying (I have no shame myself!)
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_A/threadview?m=te&bn=51532&tid=13862&mid=13862&tof=1&frt=2#13862
aj
PMTI: I had no idea just how busy (and lucrative) the laser wrinkle removal market had become until my wife came back from her OB/GYN visit and told me that the wrinkle removal patients outnumbered the OB patients in the waiting room 2:1.
One of our rehab physicians is also seeing more wrinkle patients than rehab patients in his outpatient clinic.
Anyone care to educate me as to the mechanism for wrinkle removal that these lasers provide?
aj
"The thing with HEB's Ampligen is that it cures nothing, but can be used with every and any other medication to make it up to 10x more effective by raising a persons immune system."
So does Wallstarb's suggestion about visiting certain services in Chinatown!
http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/1999/02/04/DD74396.DTL&hw=garchik&sn=415&sc=227
I'd much rather spend my money and take risks (as it were) in those treatment side effects, than take ampligen.
regards,
aj
OT: Stress
"INSANE - so why not just take cancer patients to get a nice massage with a happy ending to relieve stress. $50 anywhere in Chinatown."
It's that kind of attitude that keeps doctors like me in business! Seriously, the stress connection is clear, but the method you suggest is quite ineffective and sexist to boot.
Keep a happy mental health thought and schedule your couples therapy with my office for next week! ;)
aj
PPHM: I've posted something to this effect before. I don't think that PPHM is a scam, but I've tracked it since 1999 and have noted that it has perpetually been in phase 1 or phase 2 research. It has gone to the well many times to raise money, diluting and diluting more of the shareholder's value.
I'd like to see their drugs get to the market, but think that PPHM is an example of good science (relatively speaking) being pissed away by a poorly managed co.
aj
MSBT: Don't know if I'd call a 2 cent gain a "breakout". This is a penny stock and has been nothing but moving down for 3 years. The trading and the PR's smell of pump and dump to me.
I say good luck to you on your investment, but I'll be interested to see it get beyond 25 cents per share.
aj
OT: energy consumption. While white paint might help, the environmental costs for using the computer is great and going to get greater. Witness the cost of performing a google search:
http://technology.timesonline.co.uk/tol/news/tech_and_web/article5489134.ece
I have been "playing" with the new Wolfram Alpha computational knowledge engine. My simple computations are likely to leave a small footprint, but I'm betting that there will be some pretty smart grad students who will be sucking a whole lot of energy out of the grid to perform some in depth computations for free using this site. Check it out:
http://www.wolframalpha.com/
regards,
aj
Quiz answer: annual sales for both cosmetic and noncosmetic uses for Botox were approx 1 billion, not just the cosmetic apps?
aj
OT: Workman's comp
Corpstat, nothing about reimbursement denials surprises me, whether it is work comp or not. It would not surprise me at all that a new carrier has come onto the scene with the goal of driving costs down (particularly for a govt. funded policy where the govt entity is going roke). That is their JOB! It sickens me to know that insurance has become so distorted that denial of coverage has usurped coverage as the raison d'etre for these co.'s
Novacare is no better or worse than any of the others that I've had to deal with. My guess is that they have moved in and are trying to close out "old" cases that are bleeding them. These old, ongoing cases where payment for treatment seems never ending are the ins. provider's worst cases. They want to close them and the ploy in the case you've put might be to force the patient to accept some lump some settlement.
Just some speculation.
aj
OT: Denial of migraine meds
Corpstat, I certainly don't know any of the particulars of the case, but can state that a penetrating head wound would not generally create migraines. The headache pain may be different, or may not exist at all. Work Comp cases (of which I do many) are subject to symptom validity testing and if there is evidence of exaggerated symptom reporting and/or poor effort, the comp carrier often denies coverage for complaints that are not objectively measureable.
Unfortunately, headache pain is one of the most common complaints in work comp head injury cases and is almost completely unmeasurable objectively.
I wish I had some better engineering background because if I could design a piece of equipment that could independently measure headache pain, I would be rich.
regards,
aj
MSON: Here's a little med tech equipment manufacturer that I once held and made some money trading. Their Sonablate HIFU system works well and there was always the buzz (back when I was trading it) that they would be entering the cancer sector with evidence-based use of HIFU to go after tumors. After waiting for some substantive announcements for 4 or 5 quarters, I moved on and haven't kept up with it since.
A quick perusal of their website suggests to me that they are playing the same game. MSON might be a decent trading stock (particularly if they have a decent quarter here and there, boosting their profile) that I would trade out of before they settle back into a low price range. If you were in at 90 cents, I would be out by $3. I don't think you'll see $5-7, and certainly don't think they'll get bought out.
JM2C,
aj
ISIS: Mipomersen
"I'm very skeptical that this drug will get past this niche population."
It's all in how a "niche" is defined. As far as I can see (and anyone can correct me if I'm wrong) the MOA for mipomersen is at the LDL production mRNA level regardless of the cause of the excessive production of LDL. There are plenty of heterogenous familial hypercholesterolemia patients as well as idiopathic hypercholesterolemia patients who would fit this niche product.
If there are 600,000 patients with some form of familial hypercholesterolemia, I would define that as a pretty large niche.
ISIS has one antisense product out, Vitravene for cytomegalovirus retinitis (hits AIDS patients frequently). The cost of each vial for treatment is about $750 as best as I can find. Similar pricing for mipomersen brings a 10% penetration for monthly injections for those 600,000 patients to $540 million in sales.
aj
ISIS: Thanks for the comments, DT, Tinkershaw, RKRW, and PGS.
I agree that for this to be a commercial success, mipomerson should be used for the target population. There are plenty of patients with baseline LDL in the 200-400mg/dL (and even above) who would benefit from this therapy and have little to lose with a trial of the medication. I don't see this as a blockbuster cholesterol intervention and will be very interested in digging deeper into what ISIS is getting per dose for their AIDS drug.
aj
ISIS: Positive Phase III results for mipomersen and the stock takes a 10% haircut. I've tracked this co. for some time and am now that much closer to buying. Does anyone have an opinion about ISIS? Has this become a biotech value?
http://finance.yahoo.com/news/Genzyme-and-Isis-say-apf-15304439.html?.v=2
NEW YORK (AP) -- Genzyme Corp. and Isis Pharmaceuticals Inc. on Wednesday reported successful trial results for mipomersen, as the companies said the cholesterol drug candidate met its primary goal in late stage clinical testing.
Related Quotes
Symbol Price Change
GENZ 59.14 -0.25
ISIS 13.88 -1.60
Mipomersen reduced patients' levels of LDL cholesterol, also called bad cholesterol, by 25 percent after six months, the companies said. Patients who received a dummy injection experienced a reduction of 3 percent.
Genzyme, which is based in Cambridge, Mass., plans to ask the Food and Drug Administration for marketing approval late next year. That is about a year later than originally planned. The companies suffered a setback in early 2008, when regulators said they wanted to see preclinical study data before reviewing the application.
The preclinical studies test whether mipomersen caused cancer. Those tests are still being conducted.
In the trial, patients were injected with either 200 mg of mipomersen or a placebo once a week for 26 weeks. The patients have a condition called homozygous familial hypercholesterolemia, a genetic disorder that prevents them from properly metabolizing LDL cholesterol.
Of the 34 patients treated with mipomersen, 28 finished the drug. The companies said one patient stopped because of elevated levels of a type of liver enzyme called transaminases. Other common side effects included reactions at the site of injection and flu-like symptoms.
Full results from the trial will be presented at a future medical conference.
Isis, which is based in Carlsbad, Calif., discovered the drug, and licensed it to Genzyme in January 2008.
PWRM: I used to track Power 3 medical because they had entered into an agreement with Neogenomics (NGNM) to allow NGNM acquire up to 40% of PWRM if there was enough development of their proteomics tests to generate a marketable product. NGNM backed out a couple of quarters ago, saying that NGNM's interest in the PWRM Breast Ca. proteomics tests was not as far enough along and that PWRM was pursuing their Nueodignostic tests for Parkinson's Dz and Alzheimers more agressively (which NGNM had little interest in).
PWRM's initial results of the Sensitivity and Specificity of their Parkinson's diagnostic test seems reasonable, but the devil is in the details: The sample size is low, the patients already have the identified disease, and the co. continues to report that the Sens/Spec was achieved through two different scoring methods (a similar potential weakness that I saw with their Breast Ca. diagnostics in a prior announcement.)
http://finance.yahoo.com/news/Power3-Medical-Announces-iw-15276277.html
There are very high barriers to producing the type of study necessary to validate PWRM's diagnostic tests including the time involved in following patients who are truly asymptomatic (which may take years before the test can be validated) and the number of patients required for such screening. Their breast Ca. diagnostic had a Sens/Spec only in the 88%/89% range, if memory serves and I stopped following when these numbers came out because I thought that they were too far away from a suite of diagnostics that would actually end up in a clinical lab.
Ira Goldknopf has good science, but the execution of his vision is flagging because of lack of money and results that are not quite as sensitive as the indistry would like, at least for breast ca.
regards,
aj
OT: Manny Ramirez drug suspension. I would be surprised if this was anything other than marijuana or some other recreational drug. When he was with Cleveland, he was widely known to be a party drug using adolescent.
aj
Iloperidone:
Congrats and just goes to show you how little I know about such things.
aj
Re: Invega
Invega is FDA approved. It is simply an extended release formulation of Risperidone. It has the classical side effect profile: extrapyramidal symptoms with the risk of TD and some risk for weight gain/diabetes, but there is no Q-T interval prolongation issue that I am aware of.
Because it is a knockoff with generic risperidone available, I have seen nothing of this drug in the clinic and no reps coming by to market it.
An interesting side note. Abilify, The BMY antipsychotic, has made the journey from "also ran" to blockbuster in the most quiet way that I have ever seen with a psych drug. Their use of low dose to improve refractory depression was a stroke of marketing genius.
aj
VNDA: Iloperidone
Iloperidone did not have the efficacy necessary to distinguish itself from more commonly used antipsychotics that have become the standard. The comparison drug in the Vanda study, Geodon, demonstrated similar efficacy with iloperidone, but iloperidone had inferior efficacy when compared to Risperdal (although I believe that this was simply a paper and pencil exercise of data comparisons). Geodon is rarely used as a clinical intervention for schizophrenia and other psychoses because of the Q-T prolongation issue. There is evidence that Q-T is an issue here as well.
http://www.ncbi.nlm.nih.gov/pubmed/18521091?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
I don't think that the FDA will approve a drug that has cardiac risks when there is a generic drug that is standard care (risperidone) that works better and doesn't have the same risks.
regards,
aj
[OT] Natural-Gas Production Goes from Bust to Boom; Prices Plummet
"The process of fracturing and producing gas shales is primitive and cheap and the shales are extensive so there are a lot of 'mom and pop' companies involved."
Not just a "mom and pop" issue, the process is relatively unregulated. In Little Rock, the disposal of the tailings/mud and deisel waste in a BFI landfill within the city limits has raised a big stink, literally. The city is preparing to ban the spreading of the tailings, particularly after the waste apparently has fouled a major city watershed that has been the successful focus of past cleanup efforts.
http://www.todaysthv.com/news/local/story.aspx?storyid=84183&catid=2
There will ultimately likely be a NIMBY reaction to the disposal of the waste, the development of regulation that will add cost, and the moderation of the boom.
The gas explorers are wildcatting right now. Too bad the chemistry and physics aren't right for using CO2 for fracturing the shales, there's plenty of that to go around.
aj
[OT] Natural-Gas Production Goes from Bust to Boom; Prices Plummet
Louisiana now has the lowest rate of unemployment in the south, largely due to the continued growth of their energy sector. I was just there redfishing and my host reported that energy services jobs were paying above average, for the sector, to get positions filled.
BTW, in AR, recent gas discovery in our Fayetteville shale has had similar impact on employment in the north and west central parts of the state. We are now dealing with some environmental issues related to drilling waste (which is largely mud and shale mixed with deisel fuel and other oily lubricants).
aj
Avodart/Finasteride....same difference
http://www.cancer.gov/cancertopics/factsheet/pcptqa
Both drugs found to have similar cancer incidence lowering effect with robust studies. Dew, you posted on that one as well.(update edit: and I see your comments as well as DrBio's--thanks)
Given the symptom reduction that both drugs provide (for BPH) will this class of drugs become a standard of care for men over age 50? As there are many here that fit that cohort (and I'm moving closer to that 50 year hurdle and tolerance limit with BPH symptoms), I'd like to hear opinions as to the worth of this lifelong treatment.
regards,
aj
C'mon, I get the analogy, if not explicitly, by example.
Tyson doesn't pass on any veterinary meds it buys, it incorporates the meds into their product just like Apple is incorporating a chipset into their computer. I just bought a new Toshiba. I needed a minimum processing speed for the computer and had it custom ordered. I did not, and could not have cared any less about the specific chip that met the need; I didn't buy a chipset, I bought a computer.
aj
OT Re: Margaret Talbot’s New Yorker piece “neuroenhancement”
Is it just me or is this article an indication of some weak journalism allowed to make it to press at TNY because of the topical nature of drug use?
Talbot is just documenting what has been an age old tradition on college campuses, professional offices, and in the Dr's office. Stamping the practice as "cosmetic neurology" is meaningless, at least from where I stand, as the practice is not promulgated by neurologists so much as psychiatrists and primary care physicians. The use of adderall/methylphenidate vs. amphetamine in the past is simply a move to what's most readily available. Adding provigil simply demonstrates that people desperate enough to use an "edge" will try whatever is available to them (I can guarentee that abuse of provigil is very low vs. the stimulants.) Talbot's assertion that the next generation of drugs to enter the manipulated use arena, those being the Alzheimer's drugs, is simply ridiculous as far as I'm concerned. Aricept has absolutely NO short-term efficacy with regard to cognitive efficiency and the college kids already know this after raiding grandma's stock and finding nothing there to help them.
aj
NVS biggest drug end user: Tyson? The largest livestock based food producer in the US?
aj