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From The $800 Million Pill - Me Too [Jul. 6th, 2008|04:03 pm]

In This ArticleChapter 8: Me Too!Section 1Section 2Section 3Section 4Section 5Section 6Section 7Section 8Section 9Section 10Section 11ReferencesRelated Links

Section 8

The Prilosec-to-Nexium transition exemplified a common industry practice. Throughout the 1990s, the drug industry poured billions of research dollars into developing alternatives to drugs that were approaching the end of their patent terms. In most cases, the alternatives were little changed from the originals. The better the original sold, the more likely it was that the company would devote considerable research resources to generating a copycat version with renewed patent life.

Another example that garnered considerable public attention was Schering-Plough's Claritin, one of the antiallergy medicines developed in the early 1980s as a nonsedating alternative to an earlier generation of antihistamines. By the late 1990s, the drug was generating over $2 billion a year in sales for Schering-Plough, a figure that was growing rapidly because of the 1997 legalization of direct-to-consumer advertising. To reach the estimated thirty-five million allergy sufferers in the United States, Schering-Plough poured hundreds of millions of dollars a year into ads for the drug. Consumers were encouraged to ask their doctors for a pricey prescription–it cost eighty dollars for a month's supply–that, according to the original studies submitted to the FDA, worked only marginally better than a placebo.

Though you would never know it from the television advertisements featuring handsome women frolicking through flowering fields oblivious to the pollen-laden air, the FDA's reviewer was openly skeptical about the drug's efficacy at the low dose offered by Schering-Plough. The company, which tested the drug on thousands of patients, needed a low dose to ensure that it would be nonsedating, which was the only way the new drug would be able to gain a toehold in the already crowded antihistamine market. But at the low, nonsedating dose, clinical trials showed that only 43 to 46 percent of Claritin users gained relief of allergy symptoms compared to a third of patients on a sugar pill. A separate study that asked doctors to assess the patients on the placebo found that 37 to 47 percent of them had a "good to excellent response to treatment," which as a practical matter was no different than those who took the real pill.[19] In addition to questioning its marginal medical significance, other reviewers at that late 1980s FDA hearing worried that Claritin, whose generic name is loratadine, might be a carcinogen. It took the company several more years of studies before it could dispel those fears. Finally, in 1993, the drug was approved. The delays actually proved to be an auspicious event for Schering-Plough. In the early 1990s, patients on Seldane and Hismanal, the first nonsedating antihistamines to hit the market, began turning up in hospital emergency rooms because of the drugs' violent interactions with other drugs and the development of life-threatening heart irregularities. By the time Claritin hit pharmacists' shelves, there was pent-up demand for a safe alternative, and the new drug immediately jumped to number one in sales in its class.

Yet in the late 1990s, as Claritin neared the end of its patent term, Schering-Plough launched a massive lobbying campaign in Washington to get an extension on its patent. The company claimed the long delays at the FDA had robbed it of years of market exclusivity. Aware of the history, Congress rebuffed Schering-Plough's frequent requests.

Forced to fall back on research and development, Schering-Plough scientists took apart loratadine to see what made it tick. They discovered the active part of the drug was actually a metabolite of the whole molecule, which became active in the stomach after patients began digesting the pill. They patented this metabolite, called it desloratadine, and filed a new drug application with the FDA. It was approved in late 2001, just months before the expiration of loratadine's patent. The company launched a massive advertising campaign that convinced millions of their customers to switch to the new, equally expensive but no more effective drug. Then, to frustrate the generic companies getting ready to sell loratadine, Schering-Plough announced it would begin selling Claritin as an over-the-counter allergy remedy.[20] Public-sector science has sometimes pushed industry researchers down the road to better medicine, only to discover as they neared the end of their labors that they developed yet another me-too drug. During the late 1990s, few drug classes received more media attention than a new pain reliever known within the medical community as Cox-2 inhibitors. The original members of this new drug class were Celebrex, made by G.D. Searle (later bought by Pharmacia), and Vioxx, made by Merck. In 2001, Pharmacia came out with a follow-up drug to Celebrex called Bextra.Previous PageSection 9 of 12Next Page: Section 9
Medscape General Medicine.  2004;6(2):57.  ©2004 Medscape

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Q&A: Nigerian fears threaten polio drive [Jul. 4th, 2008|11:49 am]

The goal of eradicating polio from the world by next year is looking increasingly distant, partly because some states in northern Nigeria have at some points refused to take part in vaccination campaigns.

Some Muslim leaders say the vaccine is part of a United States plot to make Muslim women infertile. BBC News Online looks at the background to the polio campaign.

Is the polio vaccine safe?

The World Health Organisation says so, and several studies have confirmed this.

But one test did find traces of the reproductive hormone oestrogen in the vaccine, fuelling the fears.

A new governemtn study was carried out and concluded that the vaccine was safe, but in the meantime, the immunisation drive was suspended in the two northern Nigerian states of Kano and Zamfara.

With the polio drive resuming, Kano is still saying it is not convinced the vaccine is safe and is seeking supplies from Asian countries

Where did the fears come from?

Many northern Nigerians have been deeply suspicious about all vaccinations for years.

Some radical Muslim preachers say that they are unIslamic - if God wants you to die, you will; if he doesn't, you won't.

Such fears were fuelled in 1996, when United States drugs company Pfizer used an untested vaccine against bacterial meningitis in Kano.

Local people say that 11 children died as a result and sued Pfizer.

Pfizer denied the charges, saying the study was properly carried out.

It said it had received the approval of both the Nigerian government and the families of the treated patients.

In 2001, fears resurfaced over a meningitis vaccine, with reports that it contained HIV and could cause sterility.

And all the attention being given to the drive to eradicate polio from the area has only made some people even more suspicious.

"Why polio, why not malaria or any other disease?" they ask.

How has the bid to eradicate polio been affected?

Worldwide, it has been extremely successful.

In 1988, there were 350,000 cases of polio - last year just 700 were reported.

But this was up from 483 in 2001.

Almost half of the world's new cases are in Nigeria, mostly in the north.

The disease is now spreading to several neighbouring countries, where it had been thought that polio had been eliminated.

What is polio?

The disease, which once affected millions of children, attacks the central nervous system, often causing paralysis, muscular atrophy and deformity.

Between 5% and 10% of those infected die when their breathing muscles become paralyzed.

It is usually contracted through exposure to contaminated water.

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Recurrent Nonfatal Chromobacterium violaceum Infection [Jul. 3rd, 2008|06:47 pm]

Recurrent Nonfatal Chromobacterium violaceum Infection

from Infections in Medicine ®


In 1905, Wooley first described C violaceum infection in studying dead and dying water buffalo in the Philippines. There have also been reports of the infection in other mammals, especially gibbons, pigs, and cattle.[4] The first human infection was reported in Malaya in 1927.[3] As stated previously, the organism is well known in the southeastern United States.[2] It is a soil and water inhabitant, is abundant in tropical and subtropical freshwater, and is especially prevalent in water that is stagnant or slow-moving.[2,3,5] Infections have been reported in the southeastern and northeastern United States, Southeast Asia, and South America. Review of the literature and communication with the CDC indicate that there have been 24 reported cases in the United States, with a mortality rate of 73%. This case makes the 25th reported case, reducing the mortality rate to 64%.

Underlying defects in host defenses seem to predispose to infection. However, a number of cases have been described with no known host-factor dysfunction.[2] There has been documentation of patients with chronic granulomatous disease and susceptibility to the infection.[2,5] The infection is usually acquired through trauma. The resulting infection can involve the urinary tract, GI tract, bloodstream, lung, abdominal cavity, or bone. Invasion can occur with or without an obvious primary focus.[2]

The most common presentation is that of skin lesions and septicemia. Skin manifestations are secondary to systemic disease and include pustular dermatitis, cellulitis, and ulcerations.[2,5] Other dermatologic lesions include vesicles, ecchymotic maculae, maculopapular rash, subcutaneous nodules, lymphangitis, and digital gangrene.[5]

Diagnosis is made by culture of the blood, abscess fluid, or exudate. There is no diagnostic serologic test.[2] Gram stain may reveal a gram-negative, long bacillus that occasionally may have a slight curve, which may result in confusing the organism with Vibrio species. The organisms are facultatively anaerobic and grow readily in 18 to 24 hours on tryptophan medium. Incubation at 30°C to 45°C (86°F to 113°F) is effective, although growth is enhanced at 25°C (77°F).[1] Microbiologists may regard the culture as a contaminant when it is isolated or may dismiss the nonpigmented form as a less virulent organism.[2] This can be a costly error.

The organism is usually susceptible in vitro to chloramphenicol, tetracycline, TMP-SMX, and gentamicin. It is variably sensitive to penicillins and aminoglycosides but is resistant to most cephalosporins. Erthromycin seems to be ineffective in vivo regardless of susceptibility testing.[2] The optimal antibiotic regimen is not known.[6] Some studies advocate the use of parenteral antibiotics for an extended period, followed by at least 4 weeks with an oral agent, such as TMP-SMX or tetracycline, to prevent relapse.[4] Relapse has occurred more than 2 weeks after completion of therapy and apparent cure.[2] The disease is usually fatal if not diagnosed and treated with appropriate antibiotics and debridement at the earliest possible time. Clinicians should therefore be vigilant for the possibility of relapse or apparent reinfection, as in the above case.

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Bioterrorism Preparedness: What Practitioners Need to Know [Jul. 3rd, 2008|03:50 pm]

Bioterrorism Preparedness: What Practitioners Need to Know

from Infections in Medicine ®
Posted 11/01/2001

David A. Relman, MD, Stanford University School of Medicine, Stanford, Calif, and Jed E. Olson, MD, University of Colorado, Denver

Abstract and Introduction

AbstractA premeditated biologic attack against a civilian population is now a real threat. Several naturally occurring infectious agents and their products (for example, purified toxins) are among the candidates that have been and would be used in such a scenario. Familiarity with these agents and their associated diseases may help physicians recognize the possibility of a deliberate attack and manage the consequences.

IntroductionUntil recently, the specter of biologic warfare or bioterrorism was infrequently discussed by most physicians, despite the attention it had received from novelists, screenplay writers, politicians, and military defense strategists. Thankfully, most physicians have still never encountered the malevolent use of biologic agents, nor have they treated a victim of a biologic attack. In fact, despite their occasional occurrence in a "natural setting," as well as in recent events, clinical cases involving any of the classic biothreat agents are rarely encountered even by most infectious disease physicians.

For these and many other reasons, the intentional use of biologic agents has represented an exceedingly unlikely, hypothetical scenario for most clinicians. Yet, evidence mounts that the use of biologic agents as weapons is increasingly feasible and plausible in a civilian population setting. The events of September-October 2001 involving the deliberate delivery of anthrax spores through the US postal system provide an introduction to the issues and potential scenarios that can arise from the intentional use of biologic agents as weapons or as tools of fear. And nearly all predicted scenarios of intentional biothreat agent use place physicians at the leading edge of exposure and management.

Despite international bans such as the 1972 Biological and Toxin Weapons Convention, signed by more than 140 countries — including the United States[1] — and heightened defensive planning on the part of the US military, the facts remain that lethal and highly noxious biologic agents are relatively inexpensive, are easy to obtain (with more than 400 strain repositories around the world, in addition to clinical microbiology laboratories), are easy to produce (most undergraduate, graduate, and postdoctoral students in microbiology and related fields have the necessary background), are easy to conceal, and are becoming increasingly easy to deliver.

Arguments have been made that biologic agents are the weaponry of the future; they represent the "poor man's atomic bomb." While the goal in state-sponsored warfare may be to kill substantial numbers of people, a terrorist organization or individual may employ biologic agents for less "ambitious" reasons: to incapacitate local populations, to cause social or political disruption, or simply to generate fear and mistrust. Though the concept is loathsome, the threat is nevertheless a real one.[2]

The purposes of this article are to address the needs of infectious disease specialists and other health care practitioners as they are forced to confront this problem and to suggest that the topic of biologic war-fare and bioterrorism requires their involvement.

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Northward Carolina hospitals [Apr. 23rd, 2008|10:28 am]

Of a aggregate of 1137 cases of CDAD reviewed at 6
Northward Carolina hospitals between January and December of 2005,
nearly 1 in 5 (209 [18%]) were acquired in the district, with 50% of
those cases not originating from prescription medicine of an
antimicrobial, stressed Dr.
The median age of patients was 60 old age.

“These are remarkable figures [18% and 50%],” he said in an interrogatory with Medscape. “buy metronidazole online and exposure to antibiotics is the most important modifiable risk broker for the section of the circumstance.
If that is not how it is developing, we can only speculate about how they are getting it.
Are they getting it from another material body in the family line, food, or the surround?
We don’t know.”

McDonald and colleagues matched the medical and research laboratory
records to case controls of CA-CDAD at 4 Man Affair hospitals (the
remaining institutions were one body medical building, and one regional
In statistical literary criticism, they found CA-CDAD cases were more
likely to be prescribed antimicrobials than ascendance cases (adjusted
odds magnitude relation, 18.1; 95% trust distance [CI], 6.3 - 51.9; P < .0001) during the previous 3 months.
Cases were also more likely to to have underlying bowel disease (adjusted odds magnitude relation, 55.8; 95% CI, 5.1 - 6.7; P
= .001) as well as having had an outpatient stay to a healthcare
effortlessness (adjusted odds proportion, 6.3; 95% CI, 1.9 - 20.3; P = .002).

their initial findings from 2 hospitals, it appeared that the use of
proton pump inhibitors (PPIs) heightened the risk of acquiring CA-CDAD.
From the work-clothes building block of 6 hospitals, a sum of 36% of
case patients were prescribed a PPI within 3 months prior to oncoming
of symptoms.
Of the CA-CDAD cases, 23% were prescribed a PPI.
In the reasoning of data from all institutions, they found use of a PPI
to not be a risk cistron in the evolution of CA-CDAD (odds quantitative
relation, 1.337; 95% CI, 0.5 - 3.4; P = .50).
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We essay the physical phenomenon between tacrolimus and Chloromycetin. [Feb. 12th, 2008|12:01 pm]

Physical process Between Tacrolimus and Chloromycetin in a Renal Surgical mathematical operation Semantic role role Schulman SL, Shaw LM, Jabs K, Leonard MB, Brayman KL Surgical appendage. 1998;65(10):1397-8
Aspect knowledge: The biological outgrowth of tacrolimus is influenced by several medications when they are given concurrently.
We piece of writing the physical development between tacrolimus and Chloromycetin in a renal mental process semantic role.
Methods: An adolescent with vancomycin-resistant Enterococcus was given system of measurement doses of chloramphenicol.
Tacrolimus bending levels increased, and the dose was adjusted to maintain the prey First Lord of the Treasury Earth’s surface.
We suggest that nelfinavir inhibits the organic physical entity of tacrolimus because both compounds are well-known substrates for the cytochrome P450 isoenzyme CYP 3A4.
The nelfinavir serum concentrations were not affected by the structure of tacrolimus.
Although the fundamental frequency action dramatically changed the tacrolimus dose-concentration human relation, the site was manageable by frequent monitoring of lineage concentrations of tacrolimus.
Diltiazem Increases Tacrolimus Concentrations Hebert MF, Lam AY Ann Pharmacother. 1999;33(6):680-2
End: To describe a case with increased tacrolimus concentrations due to a diltiazem drug natural action.
Case Summary: A 68-year-old Andrew Dickson Edward D. White man, four months pursual orthotopic dweller movement commencement to hepatitis C and Laennec’s cirrhosis, was admitted to the intensive care unit for diarrhea, moderation, and atrial branching.
He was stabilized on oral tacrolimus 8 mg twice daily, with a sexual practice bodily matter tacrolimus manger determination of 12.9 ng/mL on approach fee.
He was started on a continuous ancestry of diltiazem for one day, followed by 30 mg orally every musical organization time discharge.
Finger days after entry, the associate role became delirious, confused, and agitated; he was found to have a unit humor tacrolimus imprint immovability of 55 ng/mL.
The tacrolimus was withheld and diltiazem was discontinued.
The tacrolimus concentrations fell over the next tercet days to 6.7 ng/mL, with a corresponding rule of grammar in his mental res publica.
The oral tacrolimus was restarted at 3 mg twice daily and increased gradually to 5 mg twice daily over the next four days; this produced tacrolimus container concentrations between 9 and 10 ng/mL.
Communicating: Tacrolimus is known to be a bound for P-glycoprotein and metabolized by CYP3A.
Diltiazem inhibits CYP3A, P-glycoprotein, and tacrolimus revision in vitro.
Although this factor physical phenomenon may have been predictable, this is the first gear base detailed case writing describing this clinically significant drug harmonic physical phenomenon.
Conclusions: Diltiazem can dramatically increment tacrolimus concentrations and upshot in tacrolimus unwholesomeness.
Avoidance of this first harmonic physical phenomenon or careful monitoring of tacrolimus concentrations along with tacrolimus dose reaction is recommended if diltiazem therapy cannot be avoided.
This is a part of article We essay the physical phenomenon between tacrolimus and Chloromycetin. Taken from "Chloromycetin Chloramphenicol 250Mg" Information Blog

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A 49-year old male semantic role with severe hemophilia A. [Feb. 8th, 2008|11:59 am]

Pharmacokinetic studies were obtained during chloramphenicol berth and 14 days after its discontinuation.
Results: Toxic levels of tacrolimus were seen on the sec day of chloramphenicol term of office, requiring an 83% chemical reaction in the tacrolimus dose.
Drug Physical process Between Mycophenolate Mofetil and Tacrolimus Detectable Within Therapeutic Mycophenolic Acid Monitoring in Renal Functioning Patients Hubner GI, Eismann R, Sziegoleit W Ther Drug Monit. 1999;21(5):536-9
The existence pharmacokinetic physical physical process between the new immunosuppressive mycophenolate mofetil (MMF) and tacrolimus (TAC), respectively, was assessed by comparing routinely estimated mycophenolic acid (MPA) extracellular matter repository levels of 15 consecutive renal commercial activity patients receiving MMF in accumulation with methylprednisolone (MEP) and cyclosporin A (CSA, 10 patients) or in repeat with MEP and tacrolimus (TAC, 5 patients).
Coadministration of TAC instead of CSA resulted in a significant process of mean MPA province fitting levels [3.4 +/- 1.3 microg/mL (n = 22) versus 1.87 +/- 1.1 microg/mL (n = 57); p < 0.001], sloppiness lower MMF doses [1.5 +/- 0.5 g/d versus 1.7 +/- 0.3 g/d (not statistically significant)].
This lift in MPA levels is possibly caused by an physical process between MMF and TAC and could lead to a congratulations to REPRESENTATIVE OFvessel MPA parentage state levels with appropriate dose tolerance.
Physical physical process Between Nelfinavir and Tacrolimus After Orthoptic Internal bureau Surgical process in a Affected role Coinfected With HIV and Hepatitis C Action (HCV) Schvarcz R, Rudbeck G, Soderdahl G, Stahle L Free-reed instrument graft. 2000;69(10):2194-5
A 49-year old male semantic role with severe hemophilia A, coinfected with HIV and HCV, who underwent orthoptic dweller data processing because of hepatitis C cirrhosis is presented.
We describe a strong harmonic action between nelfinavir and tacrolimus postoperatively, that caused a reduction of the dose of tacrolimus by a cistron 70 compared with normal, to achieve therapeutic nature concentrations and to avoid toxic side effects.
This is a part of article A 49-year old male semantic role with severe hemophilia A. Taken from "Chloromycetin Chloramphenicol 250Mg" Information Blog

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