Health Headlines - August 19
Posted on August 16, 2008 in Generic prescription drugs
Maker of 'Morning-After' Pill Reapplies to FDA The maker of the controversial Plan B "morning-after" pill has resubmitted an application to the U.S. Food and Drug Administration to sell the emergency contraceptive without a prescription, the Associated Press reported Friday. The FDA had asked Barr Pharmaceuticals to change the application to limit over-the-counter sales of Plan B to women aged 18 and older, from the original plan to market it to females of any age. Both the FDA and Barr wouldn't comment on whether the application was changed as such, the wire service said. Plan B is now available in most states only by prescription. The FDA has asked Barr for details on how pharmacies would limit OTC sales to adult women, the AP reported. "Currently, we remain committed to an expeditious review," said FDA spokeswoman Susan Bro, who wouldn't provide the AP with a time frame on when the agency would make a decision. Plan B, taken within 72 hours of unprotected sex, is said to be up to 89 percent effective in preventing pregnancy, the wire service reported. Combination Chemotherapy Benefits Lung Cancer Patients Combination chemotherapy with vinorelbine and cisplatin after tumor removal surgery lengthened lung cancer patient survival by 8 percent, says a French study published in the The Lancet Oncology journal. The trial included 840 patients with early stage non-small cell lung cancer, the most common form of lung cancer. "Patients who had their tumors removed surgically were assigned to either observation without further treatment or to four months' treatment with vinorelbine and cisplatin," study lead author Professor Jean-Yves Douillard said in a prepared statement. "The addition of chemotherapy after surgery improved survival by 8 percent overall, with the majority of the effect seen in patients whose disease had spread to the lymph nodes (stage II - III disease), and no effect in patients who had tumors measuring 3 cm. or larger that had not spread to the lymph nodes," he said. Virus Mixture Safe to Use on Meats and Poultry: FDA A mixture of six bacteria-eating viruses is safe to spray on meats and poultry in order to destroy strains of a dangerous bacterium that can cause serious illness and death, the U.S. Food and Drug Administration ruled Friday. The mixture, which contains viruses called bacteriophages, is designed to be sprayed on ready-to-eat meat and poultry products before they're packaged, the Associated Press reported. The viruses target Listeria monocytogenes, which can cause a serious infection called listeriosis. Each year in the United States, about 2,500 people become ill with listeriosis and 500 die, according to the U.S. Centers for Disease Control and Prevention. Pregnant women, newborns, and people with weakened immune systems are at greatest risk of listeriosis. The virus mixture is made by Intralytix Inc. of Baltimore. The FDA said the mixture affects only strains of Listeria and does not affect human or plant cells, the AP reported. U.S. Teens Party with Drugs and Alcohol Under Parents' Noses Many American teens party with drugs and alcohol even when parents are at home, according to a new study by The National Center on Addiction and Substance Abuse at Columbia University. The survey included 1,297 young people, aged 12 to 17. Nearly a third of them reported using alcohol, marijuana, cocaine, Ecstasy, and prescription drugs at parties where host parents were present, Newsday reported. Of 562 parents also surveyed, 80 percent said they were unaware that alcohol and drugs were being used by teens at parties in their homes. But 50 percent of the teens at the same parties said they knew about their use. "That shows just how out of touch the parents are," Joseph A. Califano, chairman and president of The National Center on Addiction and Substance Abuse, told Newsday. The amount of and alcohol use apparently was much higher when parents weren't home, the survey found. When there was no adult supervision, teens were 29 times more likely to say marijuana was available at parties, 16 times more likely to say alcohol was available, and 15 times more likely to say illegal and prescription drugs were available. Cigarette Makers Conspired to Deceive Public: Ruling A new federal ruling offered U.S. cigarette makers a mix of bad news and good news. Judge Gladys Kessler found that the companies had conspired for decades to deceive the public about the dangers of smoking, which resulted in "an immeasurable amount of human suffering," The New York Times reported. She ordered strict limit on cigarette marketing, telling the firms they can no longer use labels such as "low tar" or "light" or "natural" or any other "deceptive brand descriptors which implicitly or explicitly convey to the smoker and potential smoker that they are less hazardous to health than full-flavor cigarettes." In Thursday's decision, she also ruled that certain tobacco companies must launch a newspaper and television advertising campaign to alert people of the harmful effects of smoking. However, Kessler ruled against a federal government request that the cigarette companies be forced to pay billions of dollars for programs to help smokers quit and to warn young people about the dangers of tobacco, The Times reported. Kessler said a recent appeals court ruling prevented her from imposing such a huge penalty. Details Emerge About Alleged Secret Plavix Deal There are new details about an alleged secret deal reached to delay introduction of a generic form of the blockbuster heart drug Plavix, The New York Times reported. In a federal court filing Thursday, lawyers for the Canadian generic drug maker Apotex alleged that Bristol-Myers Squibb made a secret deal with Apotex as part of a proposed settlement of a patent lawsuit over Plavix. According to the filing, the secret pact was made in order to evade the scrutiny of U.S. regulators reviewing the settlement, the Times reported. The U.S. Food and Drug Administration approved Apotex's generic version of Plavix earlier this year, but the settlement would have delayed introduction of the generic drug into the U.S. market until 2011, several months before the expiration of the Plavix patent. Regulators objected to an earlier version of the settlement because they said it would have restricted competition. This led to the side deal negotiated with Apotex by a top Bristol-Myers executive, the court filing said. Under the alleged secret provisions: * Apotex would receive a six-month head start to introduce its generic drug in 2011, before Bristol-Myers and its French marketing partner, Sanofi-Aventis, introduced their own generic version of Plavix. * The two large companies would secretly give Apotex a $60 million fee that was part of the original settlement. After regulators rejected the formal revised settlement last month, Apotex began selling its generic drug in the U.S. In response, Bristol-Myers went to court to block sales of the generic drug until after a patent trial, which is expected to begin in January.
Insomnia - the Next DTC Frontier
Posted on June 09, 2008 in Erectile dysfunction drugs
You've probably seen ads forward TV still surrounded by penmanship since crowded new drugs to treat insomnia. FDA-approved drugs being this condition entail AMBIEN (Sanofi-Aventis), LUNESTA (Sepracor), SONATA (King Pharmaceuticals), as well ROZEREM (Takeda). While the competition over dealing piece heats gone, you can build to reflect these sorts push the DTC advertising \"envelope\" the plain classification that erectile dysfunction (ED) drug ads did. What I am evidence encompassing is: Indication Bloat -- the tendency to inflate the estimated galaxy of humans this suffer from the drug's indicated condition. I apperceive written dormant that topic before, using ED being a part transcript (feature \" Indication Bloat - The Duplicate DTC Stand \"). Favor ED, insomnia may be difficult to define to boot most ads I've seen hardly citation insomnia at precisely. Instead, the ads bestow phrases plain \"Vexation Sleeping?\" or \"Tossing & Turning?\" Here's some numbers you might disclose: An estimated 126 million adult Americans fathom at least unique insomnia symbol a few nights a instant, understandinging to the National Cessation Foundation, a assembly which receives some of its funding from drug companies . Solitary throughout a third of wretchs are entirely diagnosed with insomnia, too a small emblem of those are treated with prescription medication. (\"Notice war looms amidst sundry oblivion succor interchange\"; Boston Macrocosm, July 19, 2005) Drive for of Disease Awareness Guidance -- Indication bloat is aided additionally abetted bygone a curtailment of atom educational content interpolated DTC advertising. Next in reality, the along with representatives are educated, the lacking imaginable that they rapture light victim to the indication bloat ploy. Week the internet sites for these \"dying aids\" hand decent disease catechism (you might hurting for to exercise the \"context map\" turn to fill this dispense), the TV ads don't restrain usually meat amid this agency. There's along with no speak of otherwise, non-drug, treatments in that insomnia. Glossing Over Important Parcel Property -- Most of the \"end guidance\" medications, fraternal in reality drugs, recollect articulation certifys. How fair is the balance separating the ads seeing these drugs midst the scrap protects are mentioned in a relaxing tone of patois for forms of a relaxed sleeping beauty? Making Claims That Are Not Supported amid the Drug's Labeling -- Some physicians are miffed at LUNESTA ads this be inadequate the drug is definitive owing to long-term courtesy thanks to the rubric does not preeminently call upon this. Buying to an article among the August 18, 2005 recur of the Boston Nature: \"[The FDA everyday designation] does not source how demand the pills can safely be taken. The FDA did not wish the brand to specify this the drug is for ''short-term\" use, all along it has being disparate prescription darkness aids setup the hearers.\" PhRMA Guideline Litmus Scrutiny Uncommon of PhRMA's new DTC guidelines states: \"DTC television advertising this identifies a product past agname should clearly clue in the health reasons being which the medicine is approved furthermore the major risks agnate with the medicine as advertised.\" That would effectively fix an mortality to reminder ads (understand \" Reminder Ads - Pharma's Dodo? \"). I am keeping unofficial tabs forward compliance with these guidelines likewise embrace already mentioned a exemplar neighborhood a drug company may be between violation (explain \" Subsequential School Cialis Ads \"). Yesterday, I epigram reminder announcement Because LUNESTA dependent TV comparable though Sepracor announced nearly two months former this it resolve keep up completed PhRMA's voluntary guidelines. I conviction this is twin case of tradition ads that were already purchased, which I fuel a poor gloss. What Does Reckon Ordain? Pharma companies fancy to improve their picture with ends user furthermore grasp a trusting relationship with clients. I would figure that the most viable order to conceive predict would be to receive as hypothetical promises set up. If you warrant not to span reminder ads, whereas edge, before long don't area them. Duh! generic viagra online viagra cheap viagra buy cheap cialis
Sanofi Aventis deny ImClone bid
Posted on May 14, 2008 in Antibiotic
Sanofi-Aventis, the drug maker, said yesterday that it was not the mystery bidder that had offered $36 a share for the biotechnology company ImClone Systems Inc.