Acomplia/Zimulti

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0 height="100%"><tr> <td valign="top" width=210 BGCOLOR="#FFFFFF" TEXT="#080000" bgproperties="fixed" background="112f2f02egerdp.jpg"> <div> <A HREF="index.htm" TARGET="_top" TITLE="_"><U><B><U>HOME</U></B></U></A></div> <div> <TABLE BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="172" BORDERCOLORLIGHT="#C0C0C0" BORDERCOLORDARK="#808080" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP BGCOLOR=#66FFFF HEIGHT= 23 WIDTH="172"><div> <A HREF="id91.htm" TARGET="_top" TITLE="BRUCE ROSEMAN, M.D. 140 WEST 86th Stree"><U>CONTACT ME</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFCC99 HEIGHT= 23 WIDTH="172"><div> <A HREF="id17.htm" TARGET="_top" TITLE="office info"><U>OFFICE INFO</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFFF99 HEIGHT= 24 WIDTH="172"><div> <A HREF="id116.htm" TARGET="_top" TITLE="MEDICATION INFORMATION"><U>DRUG INFO</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#66FF99 HEIGHT= 23 WIDTH="172"><div> <A HREF="id77.htm" TARGET="_top" TITLE="kids"><U>KIDS</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#66FFCC HEIGHT= 23 WIDTH="172"><div> <A HREF="id24.htm" TARGET="_top" TITLE="SPECIALISTS"><U>SPECIALISTS</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFFF99 HEIGHT= 23 WIDTH="172"><div> <A HREF="id75.htm" TARGET="_top" TITLE="research"><U>LOOK IT UP</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#33CCFF HEIGHT= 44 WIDTH="172"><div>  <A HREF="id89.htm" TARGET="_top" TITLE="TEST YOURSELF"><U>TEST YOURSELF</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFFFCC HEIGHT= 23 WIDTH="172"><div> <A HREF="id23.htm" TARGET="_top" TITLE=" RADIOLOGY AND IMAGING"><U>RADIOLOGY</U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FF99FF HEIGHT= 23 WIDTH="172"><div> <A HREF="id47.htm" TARGET="_top" TITLE="HANDOUTS "><U>HANDOUTS </U></A></div> </tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#FFCC99 HEIGHT= 23 ><NOBR><div>  I<A HREF="id53.htm" TARGET="_top" TITLE=" ANATOMY"><U>LLUSTRATIONS</U></A></div> </NOBR></tD> </tR> <tR> <tD VALIGN=TOP BGCOLOR=#33FFFF HEIGHT= 23 WIDTH="172"><div> <A HREF="id22.htm" TARGET="_top" TITLE="PHARMACIES"><U>PHARMACIES</U></A></div> </tD> </tR> </TABLE></div> <bR> <bR> <bR> </td> <td valign="top" BGCOLOR="#FFFFFF" TEXT="#080000" bgproperties="fixed" background="115f0f03.jpg"> <div> <I>Acomplia/Zimulti</I></div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">http://en.sanofi-aventis.com/events/event1/en/index.asp</B><FONT SIZE="2" COLOR="#CC0033" FACE="Arial" ><B>(keep in mind that this is the official Sanofi page)</B></FONT></div> <div> <A HREF="#acomplia_drug_hype_reveals_mythology_of" TITLE="Acomplia/Zimulti"><U><B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Acomplia drug hype reveals mythology of prescription drugs, shortcut philosophy of American culture</B></U></A></div> <div> <A HREF="#acomplia__rimonabant____investigational" TITLE="Acomplia/Zimulti"><U><B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Acomplia (Rimonabant) - Investigational Agent for the Management of Obesity</B></U></A></div> <div> <A HREF="#do_indian_versions_of_diet_drug" TITLE="Acomplia/Zimulti"><U><B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Do Indian Versions of Diet Drug Rimonabant Work the Same as Acomplia?</B></U></A></div> <div> <A HREF="#rimonabant__accomplia__to_treat_obese" TITLE="Acomplia/Zimulti"><U><B><IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Rimonabant (</B></U></A><A HREF="#rimonabant__accomplia__to_treat_obese" TITLE="Acomplia/Zimulti"><U><I><B>Accomplia</B></I></U></A><A HREF="#rimonabant__accomplia__to_treat_obese" TITLE="Acomplia/Zimulti"><U><B>) to Treat Obese, Overweight Patients With Risk Factors</B></U></A><A HREF="#rimonabant__accomplia__to_treat_obese" TITLE="Acomplia/Zimulti"><U> </U></A><A HREF="#rimonabant__accomplia__to_treat_obese" TITLE="Acomplia/Zimulti"><U><B>in Brazil</B></U></A></div> <bR> <bR> <bR> <div> <B> <A NAME="rimonabant__accomplia__to_treat_obese"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></B></div> <div> <B>Rimonabant (</B><I><B>Accomplia</B></I><B>) to Treat Obese, Overweight Patients With Risk Factors</B> <B>in Brazil</B></div> <bR> <div> On April 26, the Brazilian Health Authority approved rimonabant 20-mg tablets (<I>Accomplia</I>;<I> </I>Sanofi-Aventis) for use as an adjunct to diet and exercise in the treatment of obese (body mass index [BMI] = 30 kg/m<FONT SIZE="1" COLOR="#660099" FACE="Arial" >2</FONT>) or overweight (BMI > 27 kg/m<FONT SIZE="1" COLOR="#660099" FACE="Arial" >2</FONT>) patients with associated risk factors such as type 2 diabetes or dyslipidemia. </div> <bR> <div> Rimonabant is the first in a new class of drugs called cannabinoid subtype 1 (CB1) receptor antagonists, which work by selectively blocking receptors in the brain and peripheral organs that play a key role in glucose and lipid metabolism (eg, adipose tissue, the liver, gastrointestinal tract, and muscle). CB1 blockade decreases endocannabinoid hyperactivity, which has been recently characterized as playing an important role in regulating body weight, controlling energy balance, and glucose and lipid metabolism.</div> <bR> <div> The approval was based on a review of data from the phase 3 Rimonabant In Obesity/Overweight (<I>RIO</I>) clinical trial, showing that use of rimonabant, 20 mg/day, significantly decreased weight and waist circumference, HbA<FONT SIZE="1" COLOR="#660099" FACE="Arial" >1c</FONT> levels, and triglyceride levels while increasing high-density lipoprotein (HDL) cholesterol levels. Approximately 50% of the improvements in HbA<FONT SIZE="1" COLOR="#660099" FACE="Arial" >1c</FONT>, triglyceride, and HDL cholesterol levels were beyond that expected from weight loss alone.</div> <bR> <div> In placebo-controlled studies, the most common adverse events leading to discontinuation of therapy included nausea, mood alteration with depressive disorders, anxiety, and dizziness. Rimonabant should not be used in patients with hepatic or renal impairment, or in patients with uncontrolled serious psychiatric illnesses such as major depression.</div> <bR> <div> Rimonabant was previously approved by the European Commission and by Mexico's Ministry of Health in June and November 2006, respectively. A second indication allows its use with metformin or a sulfonylurea to improve glycemic control in overweight patients with type 2 diabetes in Mexico.</div> <bR> <bR> <bR> <div> <B> <A NAME="acomplia__rimonabant____investigational"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></B><B>Acomplia (Rimonabant) - Investigational Agent for the Management of Obesity</B></div> <div> Under development by Sanofi-Aventis, Acomplia (rimonabant) is a selective CB1 endocannabinoid receptor antagonist indicated for the treatment of obesity.</div> <div> "Acomplia is a selective CB1 endocannabinoid receptor antagonist." </div> <div> It works by blocking endogenous cannabinoid binding to neuronal CB1 receptors. Activation of these receptors by endoegenous cannabinoids, such as anadamide, increases appetite. It is the most advanced endocannabinoid receptor antagonist in clinical development and offers a novel therapeutic approach to appetite control and weight reduction.</div> <div> The drug also has potential as a treatment for smoking cessation because the endocannabinoid system is involved in the body's response to tobacco dependence.</div> <div> Acomplia (rimonabant) has been available in Europe since the middle of 2006, following regulatory approval by the EMEA in June 2006 for its use as an adjunct to diet and exercise for obese or overweight patients with associated risk factors, such as type 2 diabetes or dyslipidaeamia. However, it has had a less easy passage through the US regulatory system.</div> <div> Filed for approval with the FDA in April 2005, it has encountered significant delays over the past two years. In February 2007, the company learnt that the FDA had extended their decision on whether or not to approve Acomplia by a further 3 months. Despite the repeated setbacks, analysts remain optimistic that it will eventually be approved in the US as an aid to weight loss. </div> <div> <B>OBESITY PREDISPOSES TO SERIOUS ILLNESS</B></div> <div> Obesity is now the most common nutritional disorder in western industrialised countries. Defined as a body mass index of greater than 30, it arises from the accumulation of excess fat in the body from over consumption of fatty foods. Prevalence of obesity in the US and Europe has reached epidemic levels.</div> <div> Data from the World Health Organisation's MONICA project show that in some parts of Europe over 70% of men aged 55-64 years are clinically obese or overweight (BMI >25) and almost 70% of women in this age group. One in five of all Americans is obese and one in three overweight. Furthermore, increasing rates of childhood obesity are likely to exacerbate the trend towards increasing obesity in adulthood.</div> <div> "The central cannabinoid (CB1) receptors are believed to play a role in controlling food consumption." </div> <div> There is a strong association between obesity and increased risk of cardiovascular disease and diabetes and possibly certain cancers, such as breast and colorectal cancer.</div> <div> The dramatic rise in the incidence of type 2 diabetes is due largely to the increased prevalence of obesity. Increases in body weight lead to changes in blood lipid and cholesterol levels, predisposing to increased risk of atherosclerosis.</div> <div> <B>THERAPEUTIC APPROACHES TO TREATMENT OF OBESITY</B></div> <div> Not surprisingly, the growing prevalence of obesity has stimulated the search for drugs to treat this condition. Various therapeutic strategies have been explored, including:</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Serotonin and noradrenaline reuptake inhibitors (anorectic agents) </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Lipase inhibitors </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">ß 3-adrenoreceptor agonists </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Leptin agonists </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f099006600.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Melanocortin-3 agonists </div> <div> Sanofi-Aventis' approach is completely different to the above. It developed from the knowledge that cannabis smokers often experience extreme hunger pangs, which cannabis smokers refer to as "the munchies". Sanofi-Aventis worked on the premise that if cannabinoids stimulate appetite, blocking cannabinoid receptors in the brain might reduce appetite.</div> <div> The central cannabinoid (CB1) receptors are believed to play a role in controlling food consumption and the phenomena of dependence / habituation. To develop suitable drugs against this target, the human cannabinoid receptor was first cloned and then expressed in cells.</div> <div> Compounds with potential inhibitory activity against this receptor were then screened for inhibitory activity. Rimonabant emerged from this screening process as a potent CB1 receptor antagonist. Preclinical animal studies subsequently showed that it could reduce consumption of fats and sugars, which contribute to weight gain.</div> <div> <B>PHASE III DATA HIGHLIGHT EFFICACY AND SAFETY</B></div> <div> The promising preclinical findings with Acomplia (rimonabant) have been confirmed in a series of clinical studies, including pivotal phase III trials involving over 6,000 obese subjects that were carried out in both the US and Europe. </div> <div> Two-year data from the phase III multicentre Rimonabant In Obesity (RIO) trials, which compared rimonabant at doses of 5mg and 20mg with placebo with respect to weight reduction and prevention of weight gain, showed that the positive results seen after a year's treatment were sustained over the full two-year trial period.</div> <div> "There is a strong association between obesity and increased risk of cardiovascular disease, diabetes and possibly certain cancers." </div> <div> Consistent with the one-year data, the results showed that overweight and obese patients taking rimonabant 20mg/d achieved significant reductions in body weight, waist circumference (an indicator of abdominal obesity) and improved lipid and glycaemic profiles compared with placebo recipients. Rimonabant also had a significant impact on metabolic CVD risk factors, greater than that expected by weight loss alone. </div> <div> Efficacy and safety in long-term use is important feature of any antiobesity drug. Some potential antiobesity medications have proved effective in the first six months of treatment only to lose effectiveness as subjects develop resistance to treatment.</div> <div> Data from the RIO trials suggest rimonabant is effective for maintaining weight loss for periods of at least two years. Long-term safety is also a major concern. In the US, the FDA generally requires two years of safety data before approving antiobesity drugs.</div> <div> Results from the phase III RIO trial programme suggest rimonabant is well tolerated in long-term use. Among patients who were randomly assigned to continue their first-year treatment for a second year, 6.7%, 8.3% and 6.0% discontinued from the placebo, rimonabant 5mg and 20mg groups respectively. </div> <div> The ongoing phase IIIb trial programme for rimonabant includes studies in patients with diabetes (SERENADE), dyslipidaemia (ADAGIO) and cardiovascular disease (STRADIVARIUS, AUDITOR, CRESCENDO).</div> <div> <IMG SRC="424968f0.jpg" border=0 width="150" height="143" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></div> <bR> <bR> <div> Originally published January 4 2005 </div> <div> <B> <A NAME="acomplia_drug_hype_reveals_mythology_of"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></B><B>Acomplia drug hype reveals mythology of prescription drugs, shortcut philosophy of American culture</B></div> <div> by Mike Adams </div> <bR> <div> A new weight loss drug, Acomplia, is all the rage, even though it hasn’t yet been approved! People are talking about the drug with such a degree of excitement that weight loss centers say virtually every patient who comes in is asking for Acomplia. </div> <div> But what is it about this drug that's so appealing? And more importantly, why is news about it spreading in a way that could only be called viral marketing? The answer is that what's being marketed here, what's spreading through word-of-mouth from one person to the next, is not the drug itself, but actually <I>the mythology surrounding the drug.</I> </div> <div> The mythology of the drug has become a living story. And regardless of whether or not the story is true, it is a seductive story. Perhaps you've heard it yourself. The story goes something like this: </div> <div> If you take this drug, <U>Acomplia</U>, you will automatically eat less because your hunger will be turned off. And when you start losing weight, the first place you will lose body fat is your mid-section. The pounds will just melt away. And better yet, your cholesterol will go down and your blood pressure will return to healthy levels. </div> <div> But that's not all. The drug, miraculously, will also help you stop <U>smoking</U>. And if you're addicted to <U>alcohol</U>, it is also said you will stop drinking! But why stop there? The mythology is so seductive that we might as well add more things to the story. Maybe the drug will repair your broken relationships with family members, spouses, and co-workers. Perhaps the drug will quadruple the balance in your bank account. Maybe the drug will even improve your appearance or add ten pounds of lean muscle mass to your body each and every year, without working out at all! I mean, why not? If the drug is going to do all these other things, let's just make the story even more seductive. </div> <div> This is the mythology surrounding Acomplia. And of course, there is nothing in the mythology that is true. In fact, there is not a single clinical trial proving a single one of these suggestions. The drug hasn’t been shown to result in permanent <U>weight loss</U>, lower cholesterol, reduce smoking addiction, or help people stop drinking alcohol. None of these things have been demonstrated with the drug. </div> <div> So why is Acomplia so remarkably popular even before it has been approved by the FDA? The reason it’s popular has nothing whatsoever to do with science or <U>nutrition</U> or health. It has to do with the seductive idea that we as Americans can pursue whatever lifestyles we want and yet have never have to face the consequences for making such decisions. </div> <div> The mythology says that we can eat all the junk foods we want, avoid <U>physical exercise</U>, avoid having to quit the cigarette habit, continue binge drinking, and yet somehow this magic pill will release us from the natural consequences of all those actions. </div> <div> The seduction of Acomplia is that it takes over our responsibilities. It allows us to shift control of our lives from our own conscious intentions to a <U>prescription drug</U> handed out to us by <U>doctors</U>. It is in this very mythology that the danger to Americans hides. Not in the drug itself -- it is the mythology that’s dangerous, not the chemical. The seductive qualities of this drug encourage people to release themselves from responsibility. They encourage people to disempower themselves, to shift their power to external influences. Rather than self-discipline, wisdom or education taking a role in the person's outcome, the only factor that counts, according to the mythology, is the name of the drug you choose to take. </div> <div> Of course, Americans absolutely love this story. They love it because there is a great unwillingness in Western societies, but especially in <U>America</U>, to take responsibility for shaping one's own <U>health outcome</U>. In America, we like to blame everybody else for our situation. We don't want to admit that we put ourselves into the health condition we are currently experiencing. Even our conventional medical system helps us give away our power by saying that it’s our genes, not our actions, that cause <U>chronic disease</U>. That way we can conveniently blame our parents when we get <U>heart disease</U> after eating a lifetime of fried foods and hydrogenated oils. </div> <div> It is a victim mentality, and it is precisely the mentality that pharmaceutical companies would very much like patients to consider integrating into their own lives. Because people who believe they are victims of circumstance always seek external solutions rather than inner transformation. And those solutions more often than not come in the form of <U>prescription drugs</U>. </div> <div> In contrast, people who refuse to be victims look for answers within themselves. They understand that they have the ability to alter their outcomes by making new decisions, by learning new information and by shaping their lives one day at a time, in a way that serves their long-term goals. </div> <div> If Acomplia is approved, will likely be a blockbuster success regardless of whether or not it actually works. It will be a financial success because people are willing to pay almost anything to perpetuate the mythology that prescription drugs can release us from a lifetime of poor decisions. </div> <div> But there's more to this story! Acomplia will likely be a very popular drug, and five or ten years down the road, after tens of millions of Americans have taken it, we may begin to find some problems with it, in the same way that we found serious health problems with Vioxx, Baycol, NSAIDs and antidepressants. People may be harmed by Acomplia in ways that modern doctors and the makers of Acomplia cannot foresee. And when that happens, the very people who are taking the drug will then turn around and blame the drug companies for their problems! </div> <div> Because once again, the takers of the drugs are taking on the role of the victim. They believe they have been victimized by bad genes. They have been victimized by having bad luck in getting chronic diseases like <U>diabetes</U> and heart disease. And they have been victimized, they will claim, by this evil drug, Acomplia, which has given them some strange <U>side effects</U>. And thus the cycle of playing the victim and demanding external recourse and will continue. </div> <div> This cycle will not end until individuals in America and elsewhere around the world have a reckoning -- that the power to shape their lives and their health outcomes rests entirely within themselves. They are responsible for their health outcome. No one else can take that responsibility for them. And if they have not created the health situation they desire, they have no one else to blame. </div> <div> Now certainly, genes can be a factor. There are some people who are born with greater ability to store food as body fat. There are other people born with stronger hearts. Some people didn't get <U>good nutrition</U> when they were infants, because their pregnant mothers didn’t know about good nutrition and didn't feed them well, and thus they may be born with a predisposition to adult onset-diabetes later in life. </div> <div> But these are not points of surrender. These are the realities of life. None of us are born with perfect bodies and perfect circumstances. And if you look around at the most successful people in the world, you will find that they came from less than ideal circumstances. They were forced by necessity to take charge of their own life and create an outcome that would serve them better. It is no excuse to say, 'We don’t have perfect genes.' Or 'We don't have a perfect environment.' We can no longer place this responsibility for our health on these outside factors. </div> <div> Granted, it is seductive, the idea that we can lower our cholesterol not by changing our foods or engaging in physical exercise, but by taking a magic pill called a statin drug. There is another seductive idea that we don't have to take responsibility for our emotional health or our mental state. Instead, we can just take antidepressant drugs and let the chemicals take over for us. I speak in far more detail on this subject in a book called "Health Seduction," found at <U>www.TruthPublishing.com</U>. </div> <div> The real result of this seduction, by the way, is perhaps worse than you think. There are millions of men now who can't even get an erection because they have abused their bodies to the point that their reproductive organs no longer respond! And they have to use Viagra just to make their body parts function in a normal healthy way. And now women are interested in female Viagra. Because they've abused their health, too, and they don’t have the sexual energy they once had when they were younger. And they want it back. They think the answer is to look outside themselves in a pill or a patch or some other drug that will solve their problems for them. </div> <div> The ultimate price of all this, by the way, is that we as individuals have sold our souls. We are no longer human beings that operate in harmony with the natural world, we are people who try to conquer our own internal <U>ecosystems</U> as well as the ecosystems in the natural world around us. And we do that through the use of synthetic chemicals and prescription drugs. </div> <div> The message that we truly need to hear is one I've been repeating for years: being healthy does not require the use of synthetic chemicals. Being healthy is something that your body was designed to achieve naturally, you have a blueprint for health in every cell of your body right now. It's called your <U>DNA</U>. And your DNA was designed and fine-tuned over hundreds of thousands of years of human evolution to thrive and survive in harmony with the natural environment. </div> <div> You come from a long line of survivors -- people who could get erections, people who didn't die from heart disease before they could reproduce. The human body is designed for perfect health. The only reason we are not in perfect health today is because we have given up our power and, instead, put the responsibility for our health on drugs like Acomplia that we think can save us from all of the bad decisions and lifestyle mistakes that we continue to make on a daily basis. </div> <div> Reality folks, is that a drug cannot replace good decisions. A chemical cannot reverse decades of being sedentary and refusing to get off your ass and go work out once in a while. A prescription drug cannot reverse the toxicity of the foods that you have been buying and consuming from grocery stores each and every day of your life. </div> <div> As people take Acomplia in a desperate effort to pursue the mythology of this drug, they are only going to do themselves more harm. They are going to wind up in a situation where they are still obese, they still have body fat, they still have high cholesterol, they still have diabetes and heart disease and cancer. And now they're spending $400/month on a synthetic chemical that has other side effects that are yet unknown. </div> <div> That's the reality of the situation. That's what tens of millions of Americans are aiming for right now in placing so much hope in this unproven synthetic chemical that they believe will excuse them from a lifetime of pursuing unhealthy habits. Call it a deal with the devil if you like. But it really is nothing more complicated than unjustified belief in the mythology of prescription drugs. </div> <div> REVIEW TYPE </div> <bR> <bR> <div> All content posted on this site is commentary or opinion and is protected under Free Speech. Truth Publishing LLC takes sole responsibility for all content. Truth Publishing sells no hard products and earns no money from the recommendation of products. Newstarget.com is presented for educational and commentary purposes only and should not be construed as professional advice from any licensed practitioner. Truth Publishing assumes no responsibility for the use or misuse of this material. For the full terms of usage of this material, visit www.NewsTarget.com/terms.shtml </div> <bR> <div> <U> <A NAME="do_indian_versions_of_diet_drug"><IMG BORDER="0" SRC="1x1.gif" HEIGHT="1" ALIGN="bottom" WIDTH="1" HSPACE="0" VSPACE="0" ></A></U><U>Do Indian Versions of Diet Drug Rimonabant Work the Same as Acomplia?</U></div> <bR> <div> by <U>daniels20</U> @ 2007-05-29 - 08:15:47 </div> <div> With several mid-sized Indian pharmaceutical companies now selling a drug in India that they say is <U>rimonabant</U>, how likely is it that these drugs work exactly the same way as the <U>Sanofi-Aventis drug Acomplia</U>?</div> <div> That, of course, is always the question when drug companies bring out a generic -- an imitator of the innovator drug -- when the original patent obtained by the drug's developer expires. And regulators in the U.S. and Europe then have to decide whether the generic and the original are bioequivalent.</div> <div> In this case, the patent protection that Sanofi has for the drug it markets as <U>Acomplia in Europe </U>and hopes to sell as <U>Zimulti</U> in the United States has many years to run in most of the world. But several Indian pharmaceutical companies are taking the position that Sanofi's patent protection does not apply to India, and have already brought drugs they call rimonabant to the Indian market.</div> <div> Given the rather substantial amount of scientific literature that has been available on rimonabant for some number of years, few doubt the ability of India's increasingly sophisticated pharmaceutical companies to develop a copy of the rimonabant molecule.</div> <div> But an as-yet unanswered question is how the various Indian versions of rimonabant pills actually compare to Sanofi's Acomplia tablets. The fact that Indian pills contain some form of rimonabant as the active ingredient does not necessarily mean they are as effective for weight loss as Acomplia.</div> <div> Two different polymorphic forms of rimonabant were identified by Sanofi during development -- polymorphic form 1 which was used in hard capsules containing rimonabant in the original clinical trials, and polymorphic form 2 identified after the start of the Phase III studies.</div> <div> The Acomplia being sold today consists of film-coated tablets containing 20 mg of the rimonabant polymorphic form 2, and the European Medicines Agency said 'bridging' bioequivalence studies found the differences between these tablets and the hard pills "to be minor and of no clinical significance in the satisfactory performance of the marketed product."</div> <div> However, no information has been provided by any of the Indian pharmaceutical companies selling rimonabant as to how their active ingredient is synthesized, or whether it is the same polymorphic form of rimonabant as that now found in Acomplia.</div> <div> Another issue potentially of interest is the report by the European Medicines Agency that rimonabant is "practically insoluble" in water, requiring that it be turned into an extremely fine powder to "ensure blend homogenity during drug product manufacture."</div> <div> In the case of Acomplia, the European Medicines Agency said "batch analyses confirm the satisfactory uniformity of the product and indicate the manufacturing process is under control."</div> <div> But while several of the Indian pharmaceutical companies selling rimonabant operate WHO GMP certified manufacturing facilities, no information has been provided as to testing to insure that each rimonabant pill contains the same amount of the active ingredient.</div> <div> In addition, all pills normally contain a number of additional inactive ingredients known as excipients. These include fillers, disintegrants, binders, glidants, lubricants, antiadherents, flavors and colorants, which in some cases have the potential to influence the efficacy and side effects of the drug.</div> <div> The only sure way to determine whether the Indian formulations of rimonabant are truly bioequivalent to (and therefore presumably operate the same way as) Sanofi's Acomplia would be through head-to-head clinical studies.</div> <div> Sanofi, of course, has conducted extensive clinical trials involving more than 6,000 participants, with a half-dozen larger trials currently underway.</div> <div> We are unaware of any clinical study where any of the Indian versions of rimonabant have been tested head-to-head against Acomplia.</div> <div> The only report of a clinical study for an Indian version of rimonabant is a trial Torrent Pharmaceuticals said it conducted at its research center for its rimonabant product, which it calls Rimoslim, involving 200 patients.</div> <div> While Torrent said its studies showed that the<U> Rimoslim</U> group had "an average weight reduction of around 6 kilos (13 pounds) in the first few weeks," no information has been made available about the structure of the trial, its duration or the participants.</div> <div> Our sister newsletter, Rimonabant Report, has requested additional information on development and testing of these rimonabant products from Torrent (as well as from Zydus Cadila, developer of Slimona, and Sun Pharmaceuticals, which reportedly also is preparing to sell its own version), and will provide reports as they become available. </div> <bR> <bR> <bR> </td> </tr></table></body>