Discuss Dentistry » All Posts https://demo.discussdentistry.com/forums/forum/pharmacology-2/feed/ Thu, 30 Oct 2025 19:07:31 +0000 https://bbpress.org/?v=2.6.12 en-US https://demo.discussdentistry.com/forums/topic/lexapro-eases-depression-head-and-neck-cancer-patients/#post-11550 <![CDATA[Lexapro eases depression in head and neck cancer patients]]> https://demo.discussdentistry.com/forums/topic/lexapro-eases-depression-head-and-neck-cancer-patients/#post-11550 Sun, 30 Jun 2013 04:51:49 +0000 drsnehamaheshwari Prophylactic escitalopram reduced the incidence of depression in head and neck cancer (HNC) patients by more than 50% and improved their quality of life, according to a new study in JAMA Otolaryngology — Head & Neck Surgery (June 20, 2013).

Significantly fewer patients taking the antidepressant — a selective serotonin reuptake inhibitor — developed depression when compared with those on placebo (10% versus 24.6%, p = 0.04), according to the study authors, from the University of Nebraska Medical Center in Omaha.

As many as half of HNC patients develop clinical depression within months of their diagnosis, and suicide rates are among the highest in patients with a medical illness, the researchers noted. HNC treatment frequently results in dysphagia, disfigurement, voice alterations, mucositis, need for tracheostomy and feeding tubes, fatigue, and depression.

The randomized, double-blind trial included 148 newly diagnosed HNC patients entering treatment who did not yet have a diagnosis of depression. The patients were stratified by sex, site of disease, stage, and primary modality of treatment (surgery versus radiation).

Half were treated with escitalopram (Lexapro) at a dosage of 10 mg/d for the first week (one tablet) followed by 20 mg/d (two tablets) until week 16, followed by an additional week of 10 mg/d. During the acute phase of the study, dosage was reduced to 10 mg/d when adverse events occurred. Patients not treated with the antidepressant received matching placebo pills.

The researchers found that patients undergoing radiation as their initial therapy were significantly more likely than those who had surgery to develop depression (p = 0.009). In addition, patients who took escitalopram and who completed the study without developing depression rated their overall quality of life as significantly better than those in the placebo group for three consecutive months after ending treatment with the antidepressant.

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https://demo.discussdentistry.com/forums/topic/new-breakthrough-treating-toothache/#post-16593 <![CDATA[NEW BREAKTHROUGH IN TREATING TOOTHACHE]]> https://demo.discussdentistry.com/forums/topic/new-breakthrough-treating-toothache/#post-16593 Mon, 13 May 2013 13:08:37 +0000 drsnehamaheshwari Benzocaine has been used to treat pain for more than a century, but the available data about its efficacy for the relief of tooth pain have long been lacking, prompting the U.S. Food and Drug Administration (FDA) to assign it category I status as an external anesthetic or analgesic for the temporary relief of a number of oral issues, including minor dental procedures, dentures, orthodontic appliances, canker sores, and teething — but not tooth pain.

Instead, the FDA concluded that the available data were not adequate to establish the effectiveness of benzocaine for the temporary relief of toothache pain and assigned it category III status for this indication. Knowing that the FDA would likely recategorize benzocaine for tooth pain if provided sufficient data from well-controlled studies, 19 researchers at nine research centers set out to do just that.

Their results, published in the Journal of the American Dental Association, were definitive in terms of efficacy and safety (May 2013, Vol. 144:5, pp. 517-526). "Both 10% and 20% benzocaine gels were effective in the temporary relief of toothache pain and were well tolerated," the researchers wrote. The stronger dose also acted more quickly.

The study yielded excellent dose-dispensing results as well. Most participants were able to correctly self-apply doses of benzocaine that were at least tenfold below the reported threshold that could lead to methemoglobinemia, the study authors noted. While rare, methemoglobinemia is a concern in children, so much so that the FDA issued a warning in 2011 about treating kids with benzocaine.

For this study, the researchers tested benzocaine’s effectiveness on teeth and soft tissue in double-masked conditions with 576 participants, 100 of whom were minors. After screening them for open caries, periodontal abscesses, the use of short- or long-acting topical or systemic analgesic agents, or contraindications to benzocaine, the researchers randomly assigned the participants a polyethylene glycol vehicle gel (control) or 10% or 20% benzocaine.

Dosage compliance was determined by weighing the tube of test material immediately before and after the participants had read the instructions and applied it with their fingers. Next, they were asked to rate their pain intensity using the dental pain scale and pain relief on a scale of 0 (no relief) to 4 (complete relief) at five-minute intervals during the first 30 minutes and 10-minute intervals from 30 minutes through 120 minutes after application.

The researchers noted when pain relief onset was signaled by the participant hitting a button on a stopwatch. Participants were also asked to indicate when they experienced "meaningful relief."

"Participants completed a five-level ordinal global satisfaction assessment scale used frequently in postsurgical dental pain studies at the conclusion of the 120-minute evaluation period or at the time they dropped out of the study owing to inadequate pain relief," the researchers explained. Then the participants rated their experience as poor, fair, good, very good, or excellent.

The researchers found that both 10% and 20% benzocaine gels were statistically better than the vehicle gel (p = 0.038 and p < 0.001, respectively) with regard to pain relief. They also observed a dose-response relationship: The 20% benzocaine group had 7% more responders than did the 10% benzocaine group (p < 0.047).

In addition, the stronger dose of benzocaine had a more rapid onset of perceptible relief (p = 0.03) than the weaker dose. The two test groups had nearly identical satisfaction responses: 79% of the 20% benzocaine group and 80% of the 10% benzocaine group said that their satisfaction was "good" or better, compared with 61% of the placebo group.

 

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https://demo.discussdentistry.com/forums/topic/now-pain-reliever-anti-viral-drug/#post-11376 <![CDATA[Now, pain-reliever as anti viral drug]]> https://demo.discussdentistry.com/forums/topic/now-pain-reliever-anti-viral-drug/#post-11376 Fri, 22 Mar 2013 05:30:39 +0000 drsnehamaheshwari
The over-the-counter anti-inflammatory drug naproxen may also exhibit antiviral activity against influenza A virus, according to a team of French scientists. The finding, the result of a structure-based investigation, is published online ahead of print in the Journal of Antimicrobial Agents and Chemotherapy.
New influenza vaccines must be developed annually, because the surface proteins they target mutate rapidly. The researchers, led by Anny Slama-Schwok of the Institut National de la Recherche Agronomique, Jouy en Josas, France, found a much more stable, reliable target for anti-influenza activity. The so-called ribonucleoprotein complexes are necessary for replication, and the researchers realized they could target the nucleoprotein, preventing assembly of the complexes. Because of its vital function, the nucleoprotein is highly conserved, making it a good potential target for antiviral drugs.
The nucleoprotein’s 3-dimensional structure, solved in 2006, provided the basis for searching for new drugs that could interfere with its action. The researchers did a virtual screening within the Sigma-Aldrich online catalog of biochemicals. That screening identified Naproxen, better known as the over-the-counter pain reliever Aleve, and as expected, it bound to the nucleoprotein, and impeded RNA binding, says Slama-Schwok. In further testing, it reduced the viral load in cells infected with H1N1 and H3N2 influenza A virus, and in mice it demonstrated a therapeutic index against influenza A that was superior to that of any other anti-inflammatory drug.
Specifically, naproxen blocks the RNA binding groove of the nucleoprotein, preventing formation of the ribonucleoprotein complex, thus taking the vital nucleoproteins out of circulation. The researchers write that naproxen is a lead compound for drug development that could be improved by tweaking the molecule to boost its ability to bind to nucleoprotein.

As an already approved drug, naproxen could become a treatment against influenza relatively quickly, the researchers write. Its status as a non-steroidal anti-inflammatory drug (NSAID), which inhibits the COX-2 pathway, as well as an antiviral would boost its efficacy.

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https://demo.discussdentistry.com/forums/topic/multivitamin-use-among-middle-aged-older-men-results-modest-reduction-cancer/#post-11011 <![CDATA[Multivitamin Use Among Middle-Aged, Older Men Results in Modest Reduction in Cancer]]> https://demo.discussdentistry.com/forums/topic/multivitamin-use-among-middle-aged-older-men-results-modest-reduction-cancer/#post-11011 Wed, 17 Oct 2012 11:53:54 +0000 Drsumitra In a randomized trial that included nearly 15,000 male physicians, long-term daily multivitamin use resulted in a modest but statistically significant reduction in cancer after more than a decade of treatment and follow-up, according to a study appearing in JAMA.
The study is being published early online to coincide with its presentation at the Annual American Association for Cancer Research Frontiers in Cancer Prevention Research meeting.
“Multivitamins are the most common dietary supplement, regularly taken by at least one-third of U.S. adults. The traditional role of a daily multivitamin is to prevent nutritional deficiency. The combination of essential vitamins and minerals contained in multivitamins may mirror healthier dietary patterns such as fruit and vegetable intake, which have been modestly and inversely associated with cancer risk in some, but not all, epidemiologic studies. Observational studies of long-term multivitamin use and cancer end points have been inconsistent. To date, large-scale randomized trials testing single or small numbers of higher-dose individual vitamins and minerals for cancer have generally found a lack of effect,” according to background information in the article. “Despite the lack of definitive trial data regarding the benefits of multivitamins in the prevention of chronic disease, including cancer, many men and women take them for precisely this reason.”
J. Michael Gaziano, M.D., M.P.H., of Brigham and Women’s Hospital and Harvard Medical School, Boston, (and also Contributing Editor, JAMA), and colleagues analyzed data from the Physicians’ Health Study (PHS) II, the only large-scale, randomized, double-blind, placebo-controlled trial testing the long-term effects of a common multivitamin in the prevention of chronic disease. The trial includes 14,641 male U.S. physicians, initially age 50 years or older, including 1,312 men with a history of cancer at randomization, who were enrolled in a multivitamin study that began in 1997 with treatment and follow-up through June 1, 2011. Participants received a daily multivitamin or equivalent placebo. The primary measured outcome for the study was total cancer (excluding nonmelanoma skin cancer), with prostate, colorectal, and other site-specific cancers among the secondary end points.
PHS II participants were followed for an average of 11.2 years. During multivitamin treatment, there were 2,669 confirmed cases of cancer, including 1,373 cases of prostate cancer and 210 cases of colorectal cancer, with some men experiencing multiple events. A total of 2,757 (18.8 percent) men died during follow-up, including 859 (5.9 percent) due to cancer. Analysis of the data indicated that men taking a multivitamin had a modest 8 percent reduction in total cancer incidence. Men taking a multivitamin had a similar reduction in total epithelial cell cancer. Approximately half of all incident cancers were prostate cancer, many of which were early stage. The researchers found no effect of a multivitamin on prostate cancer, whereas a multivitamin significantly reduced the risk of total cancer excluding prostate cancer. There were no statistically significant reductions in individual site-specific cancers, including colorectal, lung, and bladder cancer, or in cancer mortality.
Daily multivitamin use was also associated with was a reduction in total cancer among the 1,312 men with a baseline history of cancer, but this result did not significantly differ from that observed among 13,329 men initially without cancer.
The researchers note that total cancer rates in their trial were likely influenced by the increased surveillance for prostate-specific antigen (PSA) and subsequent diagnoses of prostate cancer during PHS II follow-up starting in the late 1990s. “Approximately half of all confirmed cancers in PHS II were prostate cancer, of which the vast majority were earlier stage, lower grade prostate cancer with high survival rates. The significant reduction in total cancer minus prostate cancer suggests that daily multivitamin use may have a greater benefit on more clinically relevant cancer diagnoses.”
The authors add that although numerous individual vitamins and minerals contained in the PHS II multivitamin study have postulated chemopreventive roles, it is difficult to definitively identify any single mechanism of effect through which individual or multiple components of their tested multivitamin may have reduced cancer risk. “The reduction in total cancer risk in PHS II argues that the broader combination of low-dose vitamins and minerals contained in the PHS II multivitamin, rather than an emphasis on previously tested high-dose vitamins and mineral trials, may be paramount for cancer prevention. … The role of a food-focused cancer prevention strategy such as targeted fruit and vegetable intake remains promising but unproven given the inconsistent epidemiologic evidence and lack of definitive trial data.”
“Although the main reason to take multivitamins is to prevent nutritional deficiency, these data provide support for the potential use of multivitamin supplements in the prevention of cancer in middle-aged and older men,” the researchers conclude.

 

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https://demo.discussdentistry.com/forums/topic/big-pharma-researcher-admits-faking-dozens-research-studies-pfizer-merck-opinion/#post-10987 <![CDATA[Big Pharma researcher admits to faking dozens of research studies for Pfizer, Merck (opinion)]]> https://demo.discussdentistry.com/forums/topic/big-pharma-researcher-admits-faking-dozens-research-studies-pfizer-merck-opinion/#post-10987 Wed, 10 Oct 2012 12:37:20 +0000 drsushant (NaturalNews) It’s being called the largest research fraud in medical history. Dr. Scott Reuben, a former member of Pfizer’s speakers’ bureau, has agreed to plead guilty to faking dozens of research studies that were published in medical journals.

Now being reported across the mainstream media is the fact that Dr. Reuben accepted a $75,000 grant from Pfizer to study Celebrex in 2005. His research, which was published in a medical journal, has since been quoted by hundreds of other doctors and researchers as “proof” that Celebrex helped reduce pain during post-surgical recovery. There’s only one problem with all this: No patients were ever enrolled in the study!

Dr. Scott Reuben, it turns out, faked the entire study and got it published anyway.

It wasn’t the first study faked by Dr. Reuben: He also faked study data on Bextra and Vioxx drugs, reports the Wall Street Journal.

As a result of Dr. Reuben’s faked studies, the peer-reviewed medical journal Anesthesia & Analgesia was forced to retract 10 “scientific” papers authored by Reuben. The Day of London reports that 21 articles written by Dr. Reuben that appear in medical journals have apparently been fabricated, too, and must be retracted.

After being caught fabricating research for Big Pharma, Dr. Reuben has reportedly signed a plea agreement that will require him to return $420,000 that he received from drug companies. He also faces up to a 10-year prison sentence and a $250,000 fine.

He was also fired from his job at the Baystate Medical Center in Springfield, Mass. after an internal audit there found that Dr. Reuben had been faking research data for 13 years. (http://www.theday.com/article/20100115/NWS01/100119833/1047)

Business as usual in Big Pharma

What’s notable about this story is not the fact that a medical researcher faked clinical trials for the pharmaceutical industry. It’s not the fact that so-called “scientific” medical journals published his fabricated studies. It’s not even the fact that the drug companies paid this quack close to half a million dollars while he kept on pumping out fabricated research.

The real story here is that this is business as usual in the pharmaceutical industry.

Dr. Reuben’s actions really aren’t that extraordinary. Drug companies bribe researchers and doctors as a routine matter. Medical journals routinely publish false, fraudulent studies. FDA panel members regularly rely on falsified research in making their drug approval decisions, and the mainstream media regularly quotes falsified research in reporting the news.

Fraudulent research, in other words, is widespread in modern medicine. The pharmaceutical industry couldn’t operate without it, actually. It is falsified research that gives the industry its best marketing claims and strongest FDA approvals. Quacks like Dr Scott Reuben are an important part of the pharmaceutical profit machine because without falsified research, bribery and corruption, the industry would have very little research at all.

Pay special attention to the fact that the Anesthesia & Analgesia medical journal gladly published Dr. Reuben’s faked studies even though this journal claims to be a “scientific” medical journal based on peer review. Funny, isn’t it, how such a scientific medical journal gladly publishes fraudulent research with data that was simply invented by the study author. Perhaps these medical journals should be moved out of the non-fiction section of university libraries and placed under science fiction.

Remember, too, that all the proponents of pharmaceuticals, vaccines and mammograms ignorantly claim that their conventional medicine is all based on “good science.” It’s all scientific and trustworthy, they claim, while accusing alternative medicine of being “woo woo” wishful thinking and non-scientific hype. Perhaps they should have a quick look in the mirror and realize it is their own system of quack medicine that’s based largely on fraudulent research, bribery and corruption.

You just have to laugh, actually, when you hear pushers of vaccines and pharmaceuticals claim their medicine is “scientific” while natural medicine is “unproven.” Sure it’s scientific — about as scientific as the storyline in a Scooby Doo cartoon, or as credible as the medical license of a six-year-old kid who just received a “let’s play doctor” gift set for Christmas. Many pharmaceutical researchers would have better careers as writers of fiction novels rather than scientific papers.

For all those people who ignorantly claim that modern pharmaceutical science is based on “scientific evidence,” just give them these three words: Doctor Scott Reuben.

Drug companies support fraudulent research

Don’t forget that the drug companies openly supported Dr. Scott Reuben’s research. They paid him, in fact, to keep on fabricating studies.

The drug companies claim to be innocent in all this, but behind the scenes they had to have known what was going on. Dr. Reuben’s research was just too consistently favorable to drug company interests to be scientifically legitimate. If a drug company wanted to “prove” that their drug was good for some new application, all they had to do was ask Dr. Reuben to come up with the research (wink wink). “Here’s another fifty thousand dollars to study whether our drug is good for post-surgical pain (wink).”

And before long, Dr. Reuben would magically materialize a brand new study that just happened to “prove” exactly what the sponsoring drug company wanted to prove. Advocates of western medicine claim they don’t believe in magic, but when it comes to clinical trials, they actually do: All the results they wish to see just magically appear as long as the right researcher gets paid to materialize the results out of thin air, much like waving a magician’s wand and chanting, “Abra cadabra… let there be RESEARCH DATA!”

Shazam! The research data materializes just like that. It all gets written up into a “scientific” paper that also magically gets published in medical journals that fail to ask a single question that might exposed the research fraud.

I guess these people believe in magic after all, huh? Where science is lacking, a little “research magic” conveniently fills the void.

The whole system makes a mockery of real science. It is a system operated by criminals who fabricate whatever “scientific evidence” they need in order to get published in medical journals and win FDA approval for drugs that they fully realize are killing people.

What is “Evidence-Based Medicine?”

The fact that a researcher like Dr. Reuben could so successfully fabricate fraudulent study data, then get it published in peer-reviewed science journals, and get away with it for 13 years sheds all kinds of new light on what’s really behind “evidence-based medicine.”

The recipe for evidence-based medicine is quite simple: Fabricate the evidence! Get it published in any mainstream medical journal. Then you can quote the fabricated evidence as “fact!”

When pushers of pharmaceuticals and vaccines resort to quoting “evidence-based medicine” as their defense, keep in mind that much of their so-called evidence has been entirely fabricated. When they claim their branch of toxic chemical medicine is based on “real science,” what they really mean is that it’s based on fraudulent science but they’ve all secretly agreed to call it “real science.” When they claim to have “scientific facts” supporting their position, what they really mean is that those “facts” were fabricated by criminal researchers being paid bribes by the drug companies.

“Evidence-based medicine,” it turns out, hardly exists anymore. And even if it does, how do you know which studies are real vs. which ones were fabricated? If a trusted, well-paid researcher can get his falsified papers published for 13 years in top-notch science journals — without getting caught by his peers — then what does that say about the credibility of the entire peer-review science paper publishing process?

Here’s what is says: “Scientific medicine” is a total fraud.

And this fraud isn’t limited to Dr Scott Reuben, either. Remember: he engaged in routine research fraud for 13 years before being caught. There are probably thousands of other scientists engaged in similar research fraud right now who haven’t yet been caught in the act. Their fraudulent research papers have no doubt already been published in “scientific” medical journals. They’ve been quoted in the popular press. They’ve been relied on by FDA decision makers to approve drugs as “safe and effective” for widespread use.

And yet underneath all this, there’s nothing more than fraud and quackery. Sure, there may be some legitimate studies mixed in with all the fraud, but how can we tell the difference?

How are we to trust this system that claims to have a monopoly on scientific truth but in reality is a front for outright scientific fraud?

Keep up the great work, Dr Reuben

Thank you, Dr Scott Reuben, for showing us the truth about the pharmaceutical industry, the research quackery, the laughable “scientific” journals and the bribery and corruption that characterizes the pharmaceutical industry today. You have done more to shed light on the true nature of the drug industry than a thousand articles on NaturalNews.com ever could.

Keep up the good work. After paying your fine and serving a little jail time, I’m sure your services will be in high demand at all the top drug companies that need yet more “scientific” studies to be fabricated and submitted to the medical journals.

You may be a dishonest, disgusting human being to most of the world, but you’re a huge asset to the pharmaceutical industry and they need you back! There are more studies that need to be fabricated soon; more false papers that need to be published and more dangerous drugs that need to receive FDA approval. Hurry!

Because if there’s one place that extreme dishonesty is richly rewarded, it’s in the pharmaceutical industry, where poisons are approved as medicines and fiction is published as the truth.

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https://demo.discussdentistry.com/forums/topic/alcohol-could-intensify-effects-some-drugs-body/#post-10764 <![CDATA[Alcohol Could Intensify Effects of Some Drugs in the Body]]> https://demo.discussdentistry.com/forums/topic/alcohol-could-intensify-effects-some-drugs-body/#post-10764 Sat, 28 Jul 2012 11:50:22 +0000 Drsumitra Scientists are reporting another reason — besides possible liver damage, stomach bleeding and other side effects — to avoid drinking alcohol while taking certain medicines.

Scientists are reporting another reason — besides possible liver damage, stomach bleeding and other side effects — to avoid drinking alcohol while taking certain medicines. Their report in ACS’ journal Molecular Pharmaceutics describes laboratory experiments in which alcohol made several medications up to three times more available to the body, effectively tripling the original dose.
Christel Bergström and colleagues explain that beverage alcohol, or ethanol, can cause an increase in the amount of non-prescription and prescription drugs that are "available" to the body after taking a specific dose. Alcohol can change how enzymes and other substances in the body interact with many of the 5,000 such medications on the market. Some of these medications don’t dissolve well in the gastrointestinal tract — especially in the stomach and intestines. The researchers sought to test whether ethanol made these drugs dissolve more easily. If so, this would make the drugs more available in the body, possibly intensifying their effects when combined with alcohol.
To find out, the scientists used a simulated environment of the small intestine to test how rapidly medications dissolved when alcohol was and was not present. Almost 60 percent of the 22 medications in their tests dissolved much faster in the presence of alcohol. In addition, they found that certain types of substances, such as those that were acidic, were more affected. Some common acidic drugs include warfarin, the anticoagulant; Tamoxifen, used to treat certain forms of cancer; and naproxen, which relieves pain and inflammation.
The authors acknowledge funding from the Swedish Research Council, the Swedish Governmental Agency for Innovation Systems and the Medical Products Agency — Sweden.

 

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https://demo.discussdentistry.com/forums/topic/new-revolution-creating-drugs/#post-15483 <![CDATA[NEW REVOLUTION IN CREATING DRUGS]]> https://demo.discussdentistry.com/forums/topic/new-revolution-creating-drugs/#post-15483 Sat, 12 May 2012 11:42:24 +0000 Drsumitra A parliamentary panel on heath found that pharma companies are advertising prescription drugs, which is not permitted in India. The Standing Committee also made a shocking revelation that the DCGI is favouring drug manufacturers by approving drugs without conducting mandatory clinical trials

A parliamentary panel which made a shocking revelation that on an average Drug Controller General of India (DGCI) is approving one drug every month without trials has also pointed out that pharmaceutical majors like Ranbaxy, Cipla, USV and Lundbeck are advertising prescription drugs, falling under Schedule H, which is not permitted in India.

The report tabled in the parliament on 8th May by the Standing Committee on Health and Family Welfare said that it has noticed the advertisements of prescription drugs such anti-depressant Deanxit of Lundbeck, USV’s cholesterol lowering Coltro, and also ads of anti-epileptic agent C-Toin (USV), Desval (Ranbaxy) and Lametec DT (Cipla).

The committee, in its report, has recommended to the ministry (health and family welfare) to take action against these companies.

Pointing to the laxity in India’s drugs regulation, the Standing Committee also made a shocking revelation that the DCGI is favouring drug manufacturers by approving drugs without conducting mandatory clinical trials.

Based on information provided by the ministry, the panel said that 31 new drugs were approved in the period between January 2008 and October 2010 without conducting clinical trials on Indian patients. It also said that, "There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO (Central Drugs Standard Control Organization) and some medical experts." The CDSCO is headed by DCGI.

The panel, which investigated and reviewed the drug regulation in India for 18 months, randomly picked up 42 medicines for scrutinising its approval status.

However the ministry could not provide any approval document on three drugs-pefloxacin, lomefloxacin and sparfloxacin, stating that the "files were non-traceable". According to the report, "Strangely, all these cases also happened to be controversial drugs; one was never marketed in the US, Canada, Britain, Australia and other countries which have well developed regulatory systems while the other two were discontinued later on. In India, all the three drugs are currently being sold."

On scrutinising 39 drugs, the Committee found that for 11 drugs, mandatory Phase III clinical trials were not conducted. These drugs includes Switzerland-based Novartis’ Everolimus and Aliskiren; Cipla’s Colistimethate and Pirfenidone, UCB’s Buclizine and GlaxoSmithKline’s Ambrisentan among others.

The report reveals that for two among these drugs, Sanofi’s Dronedarone and
Novartis’s and Aliskiren clinical trials were conducted on just 21 and 46 patients respectively as against the statutory requirement of at least 100 patients; for one drug Irsogladine (Macleods) trials were conducted at just two hospitals as against legal requirement of three to four sites.

The panel found that in case of Novartis’ Everolimus, UCB’s Buclizine, Eli Lilly’s
Pemetexid and Theon’s fixed dose combination of Pregabalin, no expert opinion was sought and they were approved by the non-medical staff of CDSCO. While in case of case of 25 drugs opinion of medically qualified experts was not obtained before approval.

According to the report of the total scunitized drugs, 13, like UCB’s Buclizine for appetite stimulation, fixed dose combination of Tolperisone with Paracetamol (Themis), Nimesulide injection (Panacea), etc, do not have specific relevance to the medical needs of India. Sale of these drugs is banned in countries like the United States, Canada, Britain, etc

The panel also mentioned that in 14 out of 39 drugs, the number of experts consulted was generally three to four, though in isolated cases the number was more. Citing the example of the United States Food and Drug Administration (USFDA) which constituted a panel of 37 experts drawn from all over the country to review just the dose of the popular pain-killer paracetamol and also uploaded the expert opinion on its website, the report remarked that, "In India, every discussion and document is confidential away from public scrutiny. This matter needs to be reviewed to ensure safety of patients, fair play, transparency and accountability."

 

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https://demo.discussdentistry.com/forums/topic/new-revolution-creating-drugs/#post-10510 <![CDATA[NEW REVOLUTION IN CREATING DRUGS]]> https://demo.discussdentistry.com/forums/topic/new-revolution-creating-drugs/#post-10510 Thu, 10 May 2012 11:41:46 +0000 Drsumitra Scientists are pioneering the use of 3D printers to create drugs and other chemicals at the University of Glasgow.

Researchers have used a £1,250 system to create a range of organic compounds and inorganic clusters – some of which are used to create cancer treatments.

Longer term, the scientists say the process could be used to make customised medicines.

They predict the technique will be used by pharmaceutical firms within five years, and by the public within 20.

“We are showing that you can take chemical constituents, pass them through a printer and create what is effectively a chemical synthesiser in which the reaction occurs allowing you to get out something different at the end,” researcher Mark Symes told the BBC.

“We’re extrapolating from that to say that in the future you could buy common chemicals, slot them into something that 3D prints, just press a button to mix the ingredients and filter them through the architecture and at the bottom you would get out your prescription drug.”

‘Revolutionising healthcare’
The 3D printing process involves the use of a robotically controlled syringe which builds an object out of a gel-based “ink”, into which chemicals and catalysts are mixed.

“Chemists normally put chemicals in glassware to create a reaction,” said Prof Lee Cronin, who came up with the idea.

Researchers at Glasgow University develop a revolutionary new process using 3D technology to print drugs
“What we are doing is mixing the concept of the glassware and the chemicals together in the 3D printer to create what we call ‘reactionware’.

“It’s almost like a layer cake – you print the last reactionary agent first and then build other chemical layers above, finally adding a liquid at the top. The liquid goes to layer one making a new molecule which goes to the next layer creating another and so on until at the bottom you get your prescription drug out.”

Until now the researchers have used bathroom sealant to create their reactor, and the substances created have not been suitable for human consumption.

But the scientists say their next step is to switch ingredients and replicate drugs already available in pharmacies. They also hope to work with engineers to increase the printer’s speed and resolution.

If successful, they say doctors and individuals could ultimately download pre-set recipes and even tailor medicines to their individual needs.

“This would not only place traditionally expensive chemical engineering technology within reach of typical laboratories and small commercial enterprises, but also could revolutionise access to healthcare and the chemical sciences in general in the developing world,” they wrote in a paper published in the Nature Chemistry journal.

 

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https://demo.discussdentistry.com/forums/topic/corticosteroids/#post-10465 <![CDATA[CORTICOSTEROIDS]]> https://demo.discussdentistry.com/forums/topic/corticosteroids/#post-10465 Mon, 23 Apr 2012 11:50:05 +0000 Drsumitra These agents are used to treat painful, erythematous, or erosive oral lichen planus lesions.

Betamethasone (Celestone, Soluspan)

Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and reversing increased capillary permeability. Affects the production of lymphokines and has an inhibitory effect on the Langerhans cells.

Fluocinolone (Synalar, Synalar-HP, Fluonid)

Medium potency. Use 0.01% or 0.025% cream, gel, or ointment with or without Orabase. Inhibits cell proliferation, is immunosuppressive, antiproliferative, and anti-inflammatory.

Clobetasol (Cormax, Olux, Temovate)

High potency. Use 0.05% ointment, gel, or cream with or without Orabase. Class I superpotent topical steroid. Suppresses mitosis and increases synthesis of proteins that decrease inflammation and cause vasoconstriction. Ointment is recommended for intraoral use. Most pharmacists mix 15 g of clobetasol with 15 g of Orabase; this mixture should be indicated on the prescription.

Beclomethasone (Beclovent, Vanceril)

Corticosteroid inhalant typically used to treat asthma. Use MDI with 50 mcg per puff. Direct inhaler to sites of greatest erythema or erosion.

Triamcinolone (Amcort, Aristocort, Aristospan)

Medium potency. Use 0.1% triamcinolone acetonide in 1% carboxy cellulose for dental paste. Alternately, use 0.1% cream in Orabase or alone as a cream, ointment, or suspension for intralesional administration.

Prednisolone (Delta-Cortef, Prednisol TBA injection)

Systemic therapy. Decreases inflammation by suppressing migration of polymorphonuclear leukocytes and by reducing capillary permeability.

 

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https://demo.discussdentistry.com/forums/topic/new-breakthrough-treating-toothache/#post-10391 <![CDATA[NEW BREAKTHROUGH IN TREATING TOOTHACHE]]> https://demo.discussdentistry.com/forums/topic/new-breakthrough-treating-toothache/#post-10391 Fri, 16 Mar 2012 12:17:32 +0000 Drsumitra A plant from the Amazon rainforest may revolutionize the way tooth pain is dealt with.

There’s an exotic red and yellow plant that could stop the pain from toothaches, according to scientists. This plant could some day be used instead of anesthetic injections.

There are currently over-the-counter products that can limit tooth pain, but they don’t fully alleviate the pain.

An anthropologist first discovered the plant more than 30 years ago after spending time with a Peruvian tribe. The plant got rid of the pain she dealt with after falling victim to tooth pain on the trip.

The plant, Acmella oleracea, was eventually added to a list of rainforest plants that could be used to cure something. A research team has developed a gel stemming from the plant. The gel stops the transmission of the pain signals to nerve endings.

Early results indicate that the gel has successfully been able to treat teeth stuck behind the gumline. The gel may also be considered an alternative to some of the traditional methods of anesthesia. Based on its effectiveness at relieving the pain, the chances of patients returning for ensuing appointments increased.

It’s conceivable that the gel will be available on the market within a few years.

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