Drugs and Medications News: November 2006 Archives

BOSTON (Reuters) - Scientists assigned to monitor the ethics of medical studies often help decide whether to approve research even when they have financial ties to the company sponsoring the work, a study shows.

Almost one-third of those polled said they "sometimes" or "always" voted on research projects where they had a relationship with the sponsor or the experiment was sponsored by a company competing with one they were financially linked with.

Under federal regulations, researchers who review medical experiments are supposed to avoid conflicts of interest so that patients who volunteer in studies are not subject to reckless research in which scientists might make a profit.

BEIJING (Reuters) - China, responding to complaints from the public, has banned advertisements for medical treatments and procedures in a bid to halt bogus claims of wonder drugs and clean up an unregulated health industry.

The ban would cover advertising on television, radio and in newspapers and take effect on Jan 1, the Beijing News said on Tuesday.

It would ban guarantees of effectiveness, and the "use of sufferers" and medical personnel to promote treatments and procedures.

The successful synthesis of an antibiotic in a non-native host has provided a team of researchers at the University of Illinois at Urbana-Champaign with the potential for developing new treatments for bacterial infections.

The rapid rise of antibiotic resistance poses a serious threat to human health, and demands new treatments effective against resistant pathogens. Fosfomycin is a natural antibiotic approved by the Food and Drug Administration for the treatment of various bacterial infections, and has proven effective for the treatment of infections that have become resistant to the antibiotics penicillin and vancomycin.

Fosfomycin is a member of a class of compounds called phosphonic acids because they contain a carbon-phosphorous bond. Fosfomycin functions by inactivating an essential enzyme involved in the formation of the bacterial cell wall.

A CHINESE man has been jailed for eight years for making 60 tonnes of fake sex pills, state media reported today as China cracks down on pirates who copy nearly every type of product.

Xi Yongli and his accomplices sold 21.8 million yuan ($3.6 million) worth of America Number One, Male Exclusive, Great Big Brother – the popular Chinese name for Viagra – and other pills and ingredients promising men vibrant sexual lives, a court in central China's Anhui province found, Xinhua news agency said today.

Xi and his gang received sentences spanning from a little over a year to eight years for making and selling medicine without a licence, selling counterfeits, and illegally processing Sildenafil Citrate – the key ingredient in Viagra, Pfizer Inc's top selling male potency pill.

Isotretinoin is a very effective treatment for severe acne, a condition which can be physically, emotionally, and socially disabling. But the drug can also cause severe birth defects if it is taken by pregnant women. What is the best way to prevent pregnant women from taking the drug, and to prevent women taking it from getting pregnant?

A debate article in PLoS Medicine considers the pros and cons of a new Internet-based system, called iPLEDGE (http://www.ipledgeprogram.com/), which tries to tries to ensure that the drug is dispensed only when there is documentary proof that the patient is not pregnant and is using two forms of birth control.

source - Pharma Lexicon 

Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced positive results from the company's Phase 3 clinical trial evaluating SILENOR(TM) (doxepin HCl) in elderly patients with primary sleep maintenance insomnia. SILENOR(TM) demonstrated a statistically significant improvement compared to placebo in the primary endpoint of this trial, subjective Total Sleep Time (sTST) as measured at week one (p<0.0001). Statistical significance was maintained for all timepoints measured throughout the four week treatment period.

This Phase 3 trial was a randomized, double-blind, placebo-controlled, multi-center, parallel group outpatient trial designed to assess the efficacy and safety of 6mg of SILENOR(TM) in elderly patients with primary sleep maintenance insomnia. The trial enrolled 255 elderly subjects with at least a three month history of insomnia. Safety and efficacy were evaluated over a four week period.

Methamphetamine, an illicit drug that took hold in the Western states beginning in the early 1990s and spread eastward, began its journey to the top of the priority list of federal drug agents largely because of its manufacture by Mexican criminal organizations.

As the market for meth expanded, bootleggers discovered an easy source of pseudoephedrine, the base ingredient for their controlled substance of choice -- over-the-counter cold remedies such as Sudafed. It was only a matter of time before special interest groups and law enforcement agencies began to lobby federal and state legislatures to dramatically limit and regulate the public's access to these effective and relatively cheap legal cold medicines. These efforts resulted in state and federal legislative crackdowns on the public's access to theretofore easily-accessible cold remedies.

Have these efforts, which have greatly inconvenienced the American consumer and significantly increased government regulation of lawful drugs, helped stem the tide of methamphetamine abuse? Not really.

The Government's health watchdog faces court action over its decision to deny tens of thousands of patients access to dementia drugs.

Companies involved in the marketing of one of the drugs said they had no option but to seek a judicial review of how the National Institute for Health and Clinical Excellence (Nice) reached its conclusions.

Nice rejected an appeal last month over its guidance that states that sufferers with early or late-stage Alzheimer's disease should not have access to Aricept (donepezil), Reminyl (galantamine) or Exelon (rivastigmine).

An asthma diagnostic from Sydney biotech Pharmaxis is expected to gain marketing approval in the US, despite poorer-than-expected results in a trial with an existing product.

Investors pushed Pharmaxis down 45¢, or more than 13 per cent, after it announced that its product, Aridol, was only marginally better than the existing methacholine.

The US Food and Drug Administration-approved test of more than 500 patients with "predominantly very mild symptoms" showed Aridol detected asthma in 58 per cent of the cases, compared with methacholine's 54 per cent. Analysts said the results would not affect chances of FDA approval because the tests showed the product was safe and at least as efficient as the existing diagnostic.

Pharmaxis shares recovered from an earlier plunge to close 4¢ lower at $3.22.

source -  The Age

Each month, one in four American adults suffers pain for at least 24 hours. That pain lasts for a year in nearly three-fifths of those over 65 and in 37% of those aged 20 to 44.

These numbers are why the CDC has made pain the focus of this year's annual report card on U.S. health.

The painful facts:

• In a 2004 survey, more than one in four American adults reported low back pain in the last three months.
• In 2004, 15% of American adults reported migraine or severe headache in the past three months.
• In 2004, about one-third of adults over 18 and half of adults 65 and older reported joint pain, joint aches, or joint stiffness in the past 30 days. The knee is the most common site of joint pain.

AUSTRALIA - The most prescribed drug in the country is costing patients and taxpayers almost $200 million a year more than it should because of marketing expenses.

Australians spend $94 million a year at the pharmacist's counter on the cholesterol-lowering drug Lipitor, according to Pharmaceutical Benefits Scheme data.

But more than double that figure is spent on marketing the drug, taking the total cost to the taxpayer — after the PBS subsidy is added — to $581.5 million each year.

Bayer HealthCare announced today the official launch of Kogenate FS (Antihemophilic Factor [Recombinant], Formulated with Sucrose) in the Middle East. Kogenate FS is Bayers advanced recombinant factor VIII product for the treatment of hemophilia A, a bleeding disorder characterized by deficient or defective levels of the blood clotting protein known as factor VIII.

The launch was announced at "Hemophilia Care: Past, Present and Future", a medical symposium on the topic of hemophilia and its treatment. The symposium involved more than 100 physicians from across the Middle East who attended to learn more about the latest research and treatment for people living with hemophilia.

LONDON - British scientists have built what they say is the world's first artificial stomach: a shiny, high-tech box that physically simulates human digestion.

Constructed from sophisticated plastics and metals able to withstand the corrosive acids and enzymes found in the human gut, the device may ultimately help in the development of super-nutrients, such as obesity-fighting foods that could fool the stomach into thinking it is full.

"There have been lots of jam-jar models of digestion before," said Dr. Martin Wickham of Norwich's Institute of Food Research, the artificial gut's chief designer, referring to the beakers of enzymes typically used to approximate the chemical reactions in the stomach.

HealthDay News -- The antidepressant Paxil (paroxetine) is effective in treating people with a condition called compulsive hoarding syndrome, researchers report.

This syndrome has three main features: severe anxiety prevents patients from throwing out seemingly worthless items; they're prone to acquiring things, which sometimes leads them into buying sprees; and there's excessive clutter in their homes and work spaces, according to background information in a news release.

Indecisiveness, procrastination and disorganization are other symptoms of the syndrome.

by Dan Starks, 6 News

It has proven to be one of the deadliest drugs in the state, and its killing young people across North Carolina.

You may not even know just how strong it is, and that is a warning parents and teens should heed.

It was one phone call. A deadly pill and William Sigmon’s 19-year-old daughter, Linda, was gone.

"My ex-wife called me and told me I needed to go up to the hospital. I said why? She said its Linda. She was lying on the table. They tried to do CPR and shock her back and everything. She was already dead."

LONDON (Reuters) - Ablynx, a Belgian biotech company using llama DNA to develop a new class of drugs, has signed a deal worth up to $212.5 million with U.S. healthcare group Wyeth, the two companies said on Monday.

The agreement will allow Wyeth to develop a new generation of anti-TNF treatments for diseases such as rheumatoid arthritis using ultra-small antibodies.

Ablynx is pioneering medicines called nanobodies, which it believes could treat conditions including arthritis, thrombosis, cancer and Alzheimer's disease. It expects to start testing them on humans early in 2007.

WASHINGTON - Medicare officials learned an important lesson this year when it came to the new drug benefit, one they hope will lead to fewer headaches for the elderly and disabled come Jan. 1.

Going into the program's first year, officials confidently told beneficiaries to take their time. As long as they enrolled by Dec. 31, they could expect to have insurance coverage for their medicine when they showed up at the pharmacy counter.

But those predictions proved way too optimistic. Many didn't select an insurance plan until just days before the new program took effect. When they showed up at the pharmacy, their application had yet to be processed. Insurers and Medicare operators were swamped with angry phone calls from frustrated pharmacists and patients.

ATLANTA - One hundred years after the first diagnosis of Alzheimer's disease (AD) November 3, 1906, researchers at the Yerkes National Primate Research Center, Emory University, are focusing on neuroscience, immunology and vaccine research to better understand how AD develops and progresses as well as to advance the treatment and prevention of this progressive brain disorder. AD, which currently affects 20 million Americans, gradually destroys memory and the ability to learn, reason, make judgments and communicate.

"The Yerkes Research Center has developed four major areas of Alzheimer's research critical to identifying preventions and treatments to slow the progression or stop the onset of this devastating disease," said Stuart Zola, director of the center. "Along with investigating potential Alzheimer's disease vaccines, our researchers are developing a transgenic model for the disease, conducting comparative aging studies and detecting early symptoms of the disease."

Surprising? Not really. It looks like pharma companies are desperately looking for new markets. Now it's chronic fatigue syndrome. What's going to be next?  Being a loser syndrom? Having a bad day syndrom? Being a lazy ass person syndrom? I admirethe creativity of medical industry which leads to more and morenew "diseases" which are "hard to pin". Nevetherless, the drugs production won't be delayed. And there will be people who will be looking for a quick drug fix (instead of working on physical fitness). And there will be news articles and press releases which will advertise new remedies. From everything.

"Still, there is still no lab test, scan, or examination that can reveal chronic fatigue syndrome. It is diagnosed by a patient's history of illness, and after eliminating other conditions.

Also, there is no drug to cure it. Treatment focuses on bringing some relief from symptoms and the return of normal function."

Read more below 

A Mississauga company has introduced Canada's first dressing for chronic wounds, with a built-in painkiller.

Coloplast Canada is a subsidiary of a Danish company that spent seven years developing the treatment for chronic pain. The product was first introduced in Europe in March.

The dressing, "switches off the pain at the source," said George Baltazar, spokesperson for Coloplast Canada, which has its corporate head offices on Ridgeway Dr. in Erin Mills.

The new dressing, called Biatain-Ibu, delivers ibuprofen directly into the wound.

Cell Therapeutics said late Friday it has halted enrollment in its most important clinical trial because of premature deaths among patients taking its experimental cancer drug.

James Bianco, chief executive of the Seattle company, said the deaths do not appear related to any safety problems with its drug, Xyotax.

In an interview, Bianco would not say how many patients enrolled have died among the 200 women with lung cancer. But he acknowledged there were more deaths in the group receiving Xyotax than another receiving a standard chemotherapy drug. Further analysis is needed to sort out the reasons, he said.

HealthDay News -- New insights into mechanisms controlling the formation of myelin -- the white matter that coats all nerves -- could help lead to treatments for multiple sclerosis (MS) and other myelin-related diseases and injury.

Myelin plays an important role in the overall health and function of the nervous system. MS and other diseases or injuries that damage myelin result in serious problems including uncoordinated movements, neuropathic pain and paralysis.

Researchers at the University of Southern California (USC) and the Institut de Recherches Cliniques de Montreal in Canada found that a protein called Par-3 plays an important role in the formation of myelin during nerve development.

Par-3 acts like a "molecular scaffold" to set up an "organizing center" that brings together proteins essential for the formation of myelin, the researchers said.

 

WASHINGTON, Nov. 2 (UPI) -- Medication for children with attention-deficit/hyperactivity disorder, or ADHD, can now be delivered through a patch, researchers reported Friday.

The patch, called DAYTRANA, is meant for children 6 to 12. It gives physicians greater control over the amount of time a child is on medication, as it is easily administered and removed, said Dr. Timothy E. Wilens, a consultant to Shire, the company that produced the patch and funded the research.

The findings were presented recently at a child and adolescent psychiatrists' convention in San Diego.

"I like this because it gives you an off-switch," said Wilens, who is also in the clinical and research program in pediatric psychopharmacology at Massachusetts General Hospital and an associate professor of psychiatry at Harvard Medical School.

(CP) - Health Canada is warning consumers against taking certain unauthorized natural health products promoted for the treatment of erectile dysfunction because they contain pharmaceutical ingredients that should be used only under medical supervision.

The products - Zimaxx, Actra-Rx, 4Everon, Vigor-25 and Nasutra - could pose serious health risks, especially for people with heart disease, those taking heart medications or those at risk for stroke.

Although not authorized for sale in Canada, Zimaxx, Actra-Rx, 4Everon, Vigor-25 and Nasutra are or may have been sold over the Internet or brought into Canada by travellers for personal use, Health Canada said in an advisory Thursday.

Another article which is promoting drugs as a remedy for depression. Especially, a full variety.

"Thirteen percent of the 123 study participants who did not get better on the first three drugs they tried were helped by a fourth, researchers found. 

But there is a downside to so many attempts: The more tries people made, the more likely it was that they later would relapse and slide back into depression."

What do I think about it? If you don't care about complications, and are looking for a quick fix (i.e. you are lazy about your health), then go for meds. If one doesn't help, take another. This doesn't help? Try another! Continue until your get seriously sick. Cancer maybe an option as well. It's up to you. Those drugs are not guaranteed to help your depression. Period

What are the alternatives to antidepressants, you may ask? I would recommend to look at photo therapy treatment. There are devices which are helping SAD, depression and even Alzheimer's disease.

Outside In, TrueSun, Alaska Northern Lights, FullSpectrum Solutions - these are only few of companies which produce photo therapy devices that work. Give it a shot. But don't forget to consult a specialist before going for it

Read the article below and decide for yourself.

SAN FRANCISCO: More than 40 women sued the makers of a popular birth-control patch, claiming the contraceptive caused serious illnesses and at least one death.

One lawsuit alleges that 43 women suffered from blood clots and other health ailments after taking Ortho Evra, one of the fastest-growing forms of contraception in the U.S.

A second complaint claims that 25-year-old Kelly Bracken of Elk Ridge, Maryland, died of severe blood clots in her lungs and legs after she started wearing the skin patch.

The lawsuits, filed in San Francisco Superior Court on Wednesday, name as defendants the drug's manufacturer, Ortho-McNeil Pharmaceutical Co., a Titusville, New Jersey-based subsidiary of Johnson & Johnson; and San Francisco-based distributor McKesson Corp. The plaintiffs seek unspecified monetary damages.

The cost of insurance protection against Medicare's "doughnut hole" coverage gap for prescription drugs is set to increase substantially next year, a report from a consumer watchdog group concluded Wednesday.

The report also found private insurance companies in 13 states do not offer plans with what it deems "meaningful" gap benefits, because plans covering only generic drugs leave out many brand-name medications widely used by seniors. That could leave seniors to go without the price protection or join a managed care plan to obtain the coverage, the report says.

The 13 states include Florida, New York, and Michigan.

Newswise — Topiramate (Topamax), a drug commonly prescribed to treat seizures and migraine headaches, can increase the propensity of calcium phosphate kidney stones, researchers at UT Southwestern Medical Center have found.

A study – the largest cross-sectional examination of how the long-term use of topiramate affects kidney-stone formation – appears in the October issue of the American Journal of Kidney Diseases.

Several case reports have described an association between topiramate and the development of kidney stones, but this complication had not been well recognized and physicians have not informed patients about the risk, the UT Southwestern researchers said. More important, the mechanism of stone formation was largely unknown previously.

GLENVIEW, Ill. -- A new report from Pain Treatment Topics -- "Methadone Analgesia Safety Overview & Patient Instructions Handout" -- provides essential background information and serves as a gateway to several innovative, evidence-based documents at Pain-Topics.com.

These guide healthcare providers in more safely and effectively prescribing methadone analgesia:

• Safely Dosing Methadone for Chronic Pain
• Avoiding Harmful Methadone-Drug Interactions
• Methadone Cardiac Considerations and Precautions

Additionally, the 12-page "Overview" links to documents discussing the management of opioid-induced constipation, a common side effect, and how to safely discontinue opioid analgesics.

Two popular brands of birth control pills are in short supply across Canada, leaving many women scrambling to fill their prescriptions.

The pills — under the Alesse and Triphasil names — are made by the U.S. company Wyeth Pharmaceuticals. The company temporarily stopped production of the two brands in August, which means some pharmacies have run out, making refills almost impossible to get.

Researchers have identified a brain defect they think is a major contributor to sudden infant death syndrome (SIDS).

The findings provide the strongest evidence yet of a specific neurological cause for SIDS, a little-understood condition that kills roughly 2,500 infants each year in the United States.

In the study, autopsy tissue taken from babies who had died of SIDS and other causes showed abnormalities in the lower brain stems of the SIDS babies. Among other things, this region of the brain is thought to help regulate breathing and arousal.

Esperance Pharmaceuticals Inc., of Baton Rouge, whose nanoparticles target and kill some of the most common types of cancer cells, has secured $9 million in financing from three venture capital firms.

The money will allow Esperance to begin testing its anticancer agent to make sure it is safe and does not have toxic side effects, said Ross P. Barrett, managing partner of Themelios Venture Partners.

Themelios, Louisiana Fund I of Baton Rouge and Research Corporation Technologies Inc. of Tucson, Ariz., put up the $9 million.