Rimonabant Reduces Lipids, Weight, and Adiposity

Bonnie Darves

June 14, 2005 (San Diego) — Final results of the yearlong RIO-Lipids trial of the novel selective CB1 receptor endocannabinoid blocker rimonabant (Acomplia) suggest that the single-agent approach to treating multiple health issues associated with diabetes may soon become the standard. Rimonabant, the first in the new drug class of CB1 blockers, was found to improve hemoglobin A1c (HbA1c) levels, reduce lipid levels and blood pressure, and reduce weight and waist size, researchers reported here at the American Diabetes Association's 65th Annual Scientific Sessions.

In patients who took the 20-mg dose of rimonabant, HbA1c dropped by 0.7% from baseline levels of 7.3%, and weight reduction and waist circumference were reduced 11.7 lb and 2 in, respectively, compared with those taking placebo. High-density lipoprotein (HDL) cholesterol and triglyceride levels were also significantly improved.

"This offers a new approach to the management of type 2 diabetes by addressing multiple cardioembolic risk factors," said principal investigator Andre Scheen, MD, PhD, head of clinical pharmacology in the division of diabetes, nutrition, and metabolic disorders at Academic Hospital of Liege in Belgium. "What was remarkable was the consistency of the movement of risk factors in the 20-mg [group]." Dr. Scheen also called the "clinically significant HbA1c improvement in a population that was already well controlled" an added benefit of the medication and one of the study's most noteworthy findings. In addition, 43% of patients taking the 20-mg dose achieved HbA1c levels below 6.5%.

The HDL increase was 15.4% in those taking the highest dose of the study drug, compared with 7.1% in the placebo group. The improvement in triglyceride levels in the patients receiving rimonabant was modest compared with placebo, at reductions of 9.1%and 7.3%, respectively. Blood pressure improvement occurred but did not reach statistical significance.

The phase 3 study, the fourth in a series of studies conducted in multiple European centers, included 1,045 obese patients with type 2 diabetes, whose mean age was 54 years and whose mean body mass index was 34 kg/m2. Mean baseline HbA1c was 7.5%. The participants were randomized to receive either 20 mg (n = 315) or 5 mg (n = 303) of rimonabant or placebo (n = 317).

Adverse effects in patients receiving rimonabant were mostly mild and transient. The most common for patients taking the higher 20-mg dose were nausea, which affected 12.1% of patients, dizziness, and diarrhea. Hypoglycemia incidents occurred in 5.3% of patients receiving the 20-mg dose. A small number of patients also reported mood disturbances.

If risks and adverse effects are minimal and the safety and efficacy profiles seen in this study hold up in others, the multiple-target approach being used with drugs like rimonabant may represent a new era in diabetes risk-factor management, according to Richard Kahn, PhD, ADA's chief scientific and medical officer. "Ideally, you want a single drug that controls everything, and people really are looking to the 'poly pills' or 'poly-action' agents," Dr. Kahn says. "But of course it is not that simple. Rimonabant appears to be safe and well tolerated, but we need more experience with this [type of multiple-target] drug, and the fact that there were some mood disturbances may be a concern."

The study was funded by Sanofi-Aventis, the maker of rimonabant.

ADA 65th Annual Scientific Sessions: Abstract 7-LB. Presented June 12, 2005.

Reviewed by Gary D. Vogin, MD

Bonnie Darves is a freelance writer for Medscape.
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Smokers in Reading are being offered help to kick the habit in a local push for No Smoking Day on Wednesday.

Advisors from the town's Stop Smoking Service will be in Broad Street Mall, signing up smokers for four weeks of nicotine replacement therapy.

The service, which also offers six weeks' backup support, says it has recently helped more than 880 quit.

Meanwhile, teenagers at South Reading Leisure Centre are to be shown a jar of tar to show how smoking damages lungs.

By the end of the year, the Stop Smoking Service aims to cut the number of adults in Reading who smoke from 28% to 26%.

Graeme Hoskin, Reading's lead councillor for health, said: "Cancer is the second major cause of death in Reading after heart disease and stroke.

"We want to help as many people as possible to quit smoking and take more care of their health."


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A park and ride scheme aimed at cutting congestion during rush hour is to be piloted on Tyneside.

Commuters signing up for the initiative will be given a parking permit and their own space at the MetroCentre coach park.

They will then be able to travel by bus into Gateshead or Newcastle City centre on dedicated priority lanes.

The scheme will run from Monday to Friday on a trial basis between 26 March and 19 October.

It will be run by bus operator Go North East, supported by Nexus MetroCentre and Gateshead Council.

'Huge impact'

Aimed specifically at commuters' travelling times, it will cost £12 per person per week, reduced to £10 per person if two or more people are using the same car.

There is also a reduction for bookings longer than one week.

All vehicles will run from the MetroCentre along the Tyne on the dedicated bus priority lanes currently used by the X66 CentreLink buses before heading into Newcastle or Gateshead.

Peter Huntley, managing director at Go North East, said: "The plan is to use the existing infrastructure to see whether there is a good appetite among regional commuters for a service like this."

Councillor David Bollands, Gateshead Council's cabinet member responsible for transport, said: "Any scheme which reduces the number of vehicles attempting to use the River Tyne crossings will reduce congestion and improve the environment.

"We believe park and ride schemes could make a huge impact on traffic congestion, and we are currently examining a number of other sites across the borough with a view to bringing more such schemes into use."

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Treatment for Erectile Dysfunction in Patients with Diabetes

Previous Page In This ArticleAbstract and IntroductionPatients and MethodsResultsDiscussionTablesReferencesRelated Links

Discussion

Our team first applied a progressive treatment program for ED in diabetic patients in 1997. In 1998, the US Food and Drug Administration approved the use of sildenafil citrate (Viagra), which was then incorporated into our program, after its contraindications were clarified.[19]

In the present study, a progressive program for the treatment of ED in diabetic patients yielded a complete response for short-term and 91.2% rate of success at the end of 2 y follow-up. Sildenafil and ICI were the most common modalities.

The analysis of a group of 276 patients who received sildenafil shows that 147 (53.3%) responded positively, including nine of 37 (24.3%) receiving insulin. The rate of side effects was 9.1%. A review of the findings in the literature yielded a 62.9% positive response rate in 465 patients with DM evaluated by Carson et al,[21] and a 64.6% rate in the study of Boulton et al,[11] including 36.8% positivity among patients taking insulin. The discrepancy with our results may be explained by the high percentage of diabetic complications and comorbidities in our sample (61.1%), the older age of our sample (43.7% of the patients were in the 61-78 y age group), and the relatively high (13.4%) rate of insulin use. The rate of adverse effects in our study is in line with others.[8,9,20]

Our response rate for the VED (70.4%), as well as the percentage of patients[4,5] with pain, decreased rigidity and temperature are similar to the reports of others investigators.[17,22]

Color Doppler ultrasound in 17 patients with penile rigidity at 1-2 min after cylinder removal showed a significant difference in peak systolic and peak diastolic velocity from 5 min after ICI to 15 min after, similar to the findings of Sarteschi et al.[23]

In the present study, 143 patients received different doses of three vasoactive drugs. Using a dimix of papaverine 30 mg+phentolamine 1.5 mg in patients with DM, Bell et al[8] reported a success rate of 36.4%. Segenreich et al[9] achieved a success rate of 67.4% with papaverine+Regitine in 198 diabetic patients. The use of prostaglandin E1 for failures of the dimix yielded a 41.4% response rate. However, 30.6% of patients reported various grades of pain during erection. The remaining patients with a negative response were given all three drugs trimix, and 64.5% achieved successful coitus. Accordingly, our success rate with the ICI was 72%; after 2 y of follow-up, 39.8% of the patients were still responding to it. Our rate of pain was also high, however (46.2%). We reduced the dose of prostaglandin E1 in the patients with pain. (For this reason, the prostaglandin E1 dose is given throughout as mean±s.d.)

Sildenafil+the ICI, our phase 4, was used for the treatment of ED by McMahon et al[15] in patients who failed sildenafil alone; 47.5% had a positive response. Adverse effects of different severities occurred in 31%. Our success rate with this method was 67.5%; during follow-up, 10% of patients had adverse effects. Our higher positive response may be explained by the more effective dosage used in the present study, namely, papaverine 25 mg, phentolamine 2.0 mg, prostaglandin E1 15.4±5.6 µg. Our lower rate of adverse effects may be explained by lower mean dose of sildenafil.

Use of the ICI followed after 5-10 min by the VED was reported by Chen et al,[14] who noted a mean change in buckle pressure of 117.0±38.5 g after ICI and of 565.0±58.6 g after VED (P<0.0001). We also found the method to be highly effective, yielding a positive response in nine of 13 patients (69.2%). By the end of follow-up, however, this method was used only by two patients (22.2%), mainly because of the complexity of the method and its unsuitability for patients without a regular partner, decrease of temperature in penis especially in glands penis.

Penile implant surgery, which was successful in 15 patients in our study, including 12 (80%) in whom penile rigidity decreased after removal of the VED cylinder and three (20%) who stopped using the VED because their spouse found it uncomfortable, was also found by Carson et al[16] to yield a good response in diabetic patients. The penile prosthesis, however, is associated with a risk of infection, especially in patient receiving insulin,[24] as were six of our patients. Our high surgical success rate was probably attributable to our use of intraoperative antibiotic irrigation and extensive pre- and postoperative administration of antibiotics.

Interestingly, Grunwald et al[25] found no statistically significant change in the retinal vasculature in 15 otherwise healthy men aged 39±8 y using the highest dose (100 mg) of sildenafil citrate on a voluntary basis. Nevertheless, we did not want to risk giving the drug to our eight patients with retinopathy and hypertension. Two of them (25%) responded to the VED, and six to the ICI.

Of the 17 patients who reported spontaneous erections at follow-up, 11 (64.7%) patients had mild-moderate ED before the start of the treatment, and six had moderate ED. None had comorbidities, all were less than 60 y old, and all were married. In all, 12 of them (70.6%) had received the ICI and five (29.4%) sildenafil citrate during the treatment period.

In conclusion, the stepwise, progressive treatment program for ED in patients with mild-to-severe DM proved seems to be very effective yielding in a complete response for short-term and 91.2% rate of success at the end of 2 y follow-up. The more complex, invasive treatments (phases 3-6) were needed mainly by patients taking insulin or with comorbid diseases. Most of the patients who failed to respond on follow-up were older (aged 70-78 y) and had other diseases besides diabetes.

CLICK HERE for subscription information about this journal.Reprint Address

Correspondence: S Israilov, Institute of Urology, Rabin Medical Center, Beilinson Campus, Petah Tiqwa 49100, Israel. E-mail: niv_em@netvision.net il Previous PageSection 4 of 4 
Int J Impot Res.  2005;17(5):431-436.  ©2005 Nature Publishing Group


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Role of the Pharmacist

In addition to dispensing PDE5 inhibitors, pharmacists may be requested to assist in the management of patients with adverse symptoms of PDE5 inhibitor exposure. However, perhaps more important is the role of pharmacists in counseling both health care professionals and patients regarding the risks of improper drug use. Possible prescription drug interactions, relevant dosage adjustments, and proper dosage frequencies may be topics pharmacists should routinely discuss with patients being treated with this class of drugs. However, the potential for high-risk sexual behavior, STD transmission, and adverse effects associated with concomitant illicit drug use are additional counseling points worthy of consideration. Patients should also be warned of the risks of purchasing and consuming PDE5 inhibitors and other medications from the Internet.  Printer- Friendly Email This

J Am Pharm Assoc.  2005;45(1):63-75.  ©2005 American Pharmacists Association
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Friday, 12 March, 1999, 16:57 GMT Clubbers taking Viagra cocktail
Viagra is being taken as part of a drug cocktail in clubs
Clubbers are mixing Viagra with a cocktail of drugs, including poppers, despite health warnings.

The first research into the use of Viagra in nightclubs has found that the anti-impotence drug is being used by clubbers in combination with drugs like Ecstasy, poppers and cocaine.

Fifteen people - 3% of those questioned - at a club in the North West admitted to taking the drug. Ten were men and five were women.

The research was done a month after Viagra was licensed for use in the UK.

It was available on a private basis, but the clubbers all obtained it illegally, mostly through dealers and friends.

One obtained it through the Internet.

Because they did not get the drug legally, none were aware that the manufacturers, Pfizer, warn against mixing it with nitrate-based drugs, such as poppers.

Positive effects

However, all experienced positive experiences with Viagra and said they would use it again.

Effects included increased sexual desire, enjoying sex more, having longer-lasting, better orgasms and feeling generally "loved-up".

Dr Fiona Measham from Manchester University, who was involved in the research, said the effect could have been due to the cumulative effect of Viagra and the other drugs the clubbers had taken.

It could also be psychological because of the hype surrounding the anti-impotence drug.

However, Dr Measham said the medical view was that Viagra did not work on people with no sex problems and none of the clubbers said they had sex problems.

Some researchers have warned that Viagra could destroy penile tissue in healthy men, actually causing impotence.

Negative effects

The only negative side effects reported were headaches, feeling intoxicated and genital soreness.

Dr Measham said the genital soreness could be related to the people having more sex.

The feeling of intoxication and lack of inhibitions on the dance floor could be due to the mixture of different drugs the clubbers were taking.

This included mainly cocaine, cannabis, ecstasy, alcohol and GHB, which has been compared to date rape drug Rohypnol.

Dr Measham said it was known that Viagra and nitrate-based drugs could lower blood pressure to dangerous levels.

But it was not known what the affect of illegal drugs were on Viagra.

"Viagra dilates the blood vessels and stimulants like amphetamines, cocaine and ecstasy put pressure on the circulatory system so there could be long-term physical consequences of using them in combination," said Dr Measham.

"Many are very knowledgeable about some drugs, for instance, they know to take a lot of water with ecstasy, but they don't know what the effect of mixing drugs is. We are all in the dark on this to some extent," she added.

The Viagra research is part of a big two-year study, funded by the Economic and Social Research Council, on the health of clubbers. It will be published next year.

Dr Measham said one of the early findings, reflected in the Viagra research, was how willing young people were to experiment with new drugs.

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Operative and Postoperative Complications

As with any surgical procedure, there are potential complications to watch for when caring for the robotic-assisted surgical patient. The most obvious is the general operative risk associated with anesthesia. Many patients are otherwise healthy males, with no prior medical or surgical history, so it is impossible to predict exactly how they might respond to the anesthetic agents or pain medications. Patients with co-morbidities like heart disease, obesity, chronic obstructive pulmonary disease, diabetes, and hypertension are more likely to have postoperative problems.

Following abdominal surgery, development of a bowel ileus is always possible, so listening for bowel sounds is important in the early postoperative period. If no bowel sounds are noted, the patient is restricted to ice chips only. If bowel sounds are present, clear liquids may be started the evening of surgery, with transition to soft foods by the next morning, followed by a regular diet as tolerated.

Other potential postoperative complications include incisional infection, urinary tract infection, or urinary leak from the anastomosis site. Leaks are often detected when high-volume JP output is recorded over a short period of time. If this occurs, the urinary catheter can be placed on traction (by the surgeon or a trained member of the surgical team) and the leak will heal. If a urine leak is suspected, a creatinine level can be performed by the laboratory on the drainage fluid for a definitive diagnosis. Additionally, a cystogram could be done to visualize the location and extent of the anastomotic leak.

As the number of operative cases that a center performs increases, so does the potential for a range of complications. Centers with well over 100 robotic-assisted patients have reported a range of problems that include bowel injuries, ureteric injury, bladder injury, urine extravasation with leak, urinoma formation, intra-abdominal hemorrhage, lymphorrhea, phlebitis, and port site hernias (Basillote, Ahlering, Skarecky, Lee, & Clayman, 2004). It is important to remember that these are not common occurrences, but rather potential problems.  Printer- Friendly Email This

Urol Nurs.  2006;26(2):129-136.  ©2006 Society of Urologic Nurses and Associates
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Summary

Clinically important PH is common in patients with chronic HF. The optimal approach to these patients is uncertain and therefore must be individualized. When the PH is felt to be in proportion to the HF, therapy is generally focused exclusively on the HF. One exception is the patient with PH and advanced HF for whom mechanical circulatory support or cardiac transplantation is being considered. In this setting PAH-specific therapies may be a useful adjunct, possibly allowing for the potentially curative procedure to be attempted. When the PH is felt to be out of proportion to the HF, initial efforts are again focused on the HF. If the PH (and the symptoms potentially related to it) persists, and the PCWP is maintained in an acceptable range, the use of PAH-specific therapies may be considered. Caution must be used, however, because these agents may precipitate fluid retention and pulmonary edema in patients with HF. Whereas initial studies of PAH-specific therapies were discouraging, more recent ones have suggested promise. The results of several planned or ongoing trials in this area will undoubtedly lend clarity to this challenging clinical question. While awaiting those results, consensus statements from experts in the field will be forthcoming and should provide more guidance.

This activity is supported by an independent educational grant from Actelion.  Printer- Friendly Email ThisAcknowledgements

The author would like to thank Drs. Myung Park and Jeffrey Teuteberg for their critical reviews and suggestions.

Medscape Pulmonary Medicine.  2008; ©2008 Medscape
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Methods

PPAR was a randomized, multicenter, double-blind, two-arm pilot study comparing the effects of rosiglitazone maleate (4 mg BID orally) before and after PCI in patients with obesity and hypertension, dyslipidemia, or glucose intolerance when compared to placebo. Between January 2002 and August 2003, a total of 200 patients from 10 centers were randomized from the population of patients undergoing diagnostic angiography followed by PCI and in those in whom coronary anatomy was known and PCI was planned. Written informed consent was obtained from all patients, and the protocol was approved by the institutional review board at each participating institution.

The primary end point was progression rate in Doppler ultrasound-determined CIMT during the 12 month follow-up. The secondary end points included the net change in CIMT from baseline to 6 and 12 months; the composite of all-cause mortality, MI, stroke, or any coronary vessel revascularization at 12-month follow-up; the composite of all cause mortality, MI, stroke, any coronary vessel revascularization, or rehospitalization for recurrent ischemia; the composite of death, MI, or stroke; net change in angina class and New York Heart Association failure class from baseline to 30 days, 6 months, and 12 months; incidence of symptomatic hypoglycemia (plasma glucose <65 mg/dL); high-sensitivity C-reactive protein (hs-CRP), plasminogen activator inhibitor-1 (PAI-1) activity, PAI-1 antigen, and lipid profile (percent change in low-density lipoprotein [LDL] and high-density lipoprotein [HDL] cholesterol and triglycerides); and glucose levels, insulin levels, hemoglobin A1c (HbA1c), and the homeostasis model assessment (HOMA) of insulin resistance.

The inclusion criteria were as follows: patients 21 to 85 years of age undergoing elective or urgent PCI with angiographic evidence of coronary artery disease who were obese (defined by a body mass index >27 kg/m2 or waist circumference >102 cm [40 in.] in men and >88 cm [35 in.] in women) were enrolled if they had at least one of the following clinical characteristics:Diagnosed or medically treated hypertension determined by patient history or documented blood pressure of ≥130/85 mm Hg but not exceeding 220/120 mm Hg at time of randomization

Dyslipidemia with triglycerides ≥150 mg/dL, HDL cholesterol <40 mg/dL in men or <50 mg/dL in women, or LDL cholesterol >100 mg/dL within the last 12 months

Treated hyperlipidemia

HbA1c >6.0% or fasting glucose ≥110 mg/dL

These entry criteria are slightly different than the criteria used by the World Health Organization or the National Cholesterol Education Panel/Adult Treatment Panel III and are a hybrid between these criteria, with the minimal entry criteria for the current study being obesity. In addition, the use of HbA1c and elevated LDL are not typically parameters in the diagnosis of metabolic syndrome.

Exclusion criteria included diabetes requiring pharmacologic treatment within 3 months before randomization; PCI within 14 days before randomization; primary PCI done for acute revascularization of an MI; clinical cardiac failure as defined by New York Heart Association class II, III, or IV or by current treatment with diuretics or angiotensin-converting enzyme inhibitor for the purpose of prior diagnosis of heart failure; anemia defined as hemoglobin level <11 mg/dL in men or <10 mg/dL in women; current treatment with, or known intolerance to, thiazolidinediones; contraindication or sensitivity to aspirin, clopidogrel, heparin, or intravenous glycoprotein IIb/IIIa inhibitors; and renal insufficiency defined by serum creatinine >2.5 mg/dL or hepatic disease defined by alanine aminotransferase >2.5 times the upper limit of normal.Carotid Intima-medial Thickness

Measurements were recorded on the left and right carotid bulb, common and internal carotid artery segments. Intimamedial thickness maximums and means were collected. Measurements were performed in a blinded fashion. No assumptions were made regarding the statistical power of the sample size to detect a difference in CIMT.Laboratory Analyses

All samples were collected using EDTA-plasma vaccutainers, processed and frozen at -80°F until analyzed. Lipoprotein profiles and glucose and insulin levels were performed on a Hitachi autoanalyzer (Roche Diagnostics, Indianapolis, IN). High-sensitivity C-reactive protein levels were performed by nephelometry (Dade Behring, Inc, Deerfield, IL). Plasma myeloperoxidase levels were determined by the recently Food and Drug Administration-approved CardioMPO test (PrognostiX Inc, Cleveland, OH). Plasma PAI-1 concentration was determined by enzyme-linked immunosorbent assay according to manufacturer instructions (Research Diagnostics, Inc, Concord, MA). PAI-1 activity was determined using the SPECTROLYSE pL PAI-1 activity assay (Trinity Biotech, Bray Co, Wicklow, Ireland).Statistical Analysis

All analyses were performed used the SAS system version 8.0 (SAS Institute, Cary, NC). X2 Tests were performed to assess differences between categorical variables. Wilcoxon rank sum tests were used to test median values in continuous variables. Differences in the percent change of the laboratory values were also assessed in multivariate models adjusting for site and baseline measurement. Kaplan-Meier methods were used in the time-to-event analyses of the clinical end points.

Linear random coefficient models (SAS Proc Mixed), with adjustment for center, were used to summarize the progression rate of CIMT in the placebo and rosiglitazone groups. Progression rate was defined as the slope of the CIMT observations in the linear random coefficient model. To test for treatment effect, an interaction term between treatment and timepoint was used in the model. Statistical significance was defined as P < .05 for all analyses.  Printer- Friendly Email This

Am Heart J.  2007;154(1):137-143.  ©2007 Mosby, Inc.
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Counterfeit drugs are flooding the international marketplace, but Nigeria's Dr Dora Akunyili fights day and night to stop it.

Dora is angry.

Angry because her diabetic sister died from what she is convinced were fake insulin and fake antibiotics.

And angry because so many of her countrymen and women are fighting killer diseases like malaria and tuberculosis with little more than sugar syrup and chalk tablets, cynically packaged to look like the real thing.

When she started her job as director general of Nigeria's National Agency for Drug and Food Administration (Nafdac), she trawled drugs markets, hospitals and clinics and was horrified at what she discovered.

A survey conducted with the World Health Organisation found more than half the drugs on sale in Nigeria were fake or sub-standard.

Nigeria's hospitals were using fake and contaminated drips, surgeons were using fake adrenalin to re-start the heart, anaesthetists were giving sub-strength muscle relaxant to patients in their operating theatres.

"Counterfeit drugs are murder," says Dora. "It is the highest form of terrorism against public health because it kills a mass."

Death threats

Until her arrival, Nafdac, like many other government organisations in Nigeria, had functioned little better than a toll gate. Importers simply paid a bribe to get their products into the market.

That changed.

Last year she closed down the vast open-air medicine market in Kano for three months, after her officers confiscated £140,000 worth of fake drugs.

But in a culture steeped in corruption, she has not had an easy ride.

She built a new team of female inspectors and pharmacists (she believes most men are too easily tempted by bribes) and started to prosecute importers of fake drugs.

When the public saw the dragons she was slaying, she may have become Nigeria's uncrowned queen, but the counterfeiters fought back.

They burnt down Nafdac's offices and threatened to kill her and her children.

When she stood firm, they shot her in her car. The bullet grazed her skull but she survived.

'Injecting water'

Direct proof that a fake drug has killed is hard to find.

However, one particular tragedy in July 2003, is probably as close as it gets.

The International Children's Heart Foundation visited Nigeria to operate on sick children at a teaching hospital in Enugu.

The operations should have been straightforward. The patients' prognosis was good. But when the operations began, things went wrong.

Cardiac nurse Joanne Price recalls: "You give them adrenalin to restart the heart and that normally works. But this time nothing came back. It was water. I felt we were basically injecting water instead of adrenalin."

Four children died as their parents watched and prayed.

Despite being confronted with what seemed to be a hospital cover-up, Dora confiscated supplies and found fake adrenalin, fake muscle relaxant and infected intravenous drips.

The hospital maintain there is no proof to link the deaths of the patients with the drugs used.

International effort

But the problem of fake drugs is not confined to Nigeria, or even the developing world.

In the UK in November 2004, Allan Valentine was imprisoned for manufacturing fake Diazepam and Viagra in his Wembley warehouse where Indian tablet presses and chemicals were found.

In the US, where patented drugs are the most expensive in the world, fakes have penetrated the pharmaceutical chain from drug manufacturers, through wholesalers, to high street pharmacies.

The American Food and Drugs Administration prosecutions have tripled in the last year.

At a conference in Paris about counterfeit medicines, Dora demands concerted global action. "Eradication of counterfeit drugs should be treated as an international health emergency," she says.

She believes that raising public awareness has produced dramatic results in Nigeria and urges other nations to be more open.

Unsurprisingly, drug companies around the world are fearful that their brand will be shunned if news of a fake gets out.

But no matter how tough the situation gets for pharmaceutical industry, Dora will not be leaving any stone unturned.

Bad Medicine was broadcast on Tuesday 12 July 2005 at 2100 BST on BBC Two.
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