Drugs and Medications News: October 2006 Archives

Sorting out statins

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statinsORLANDO, Fla. -- About 11 million Americans take cholesterol-lowering drugs known as statins. They're the most widely-sold drugs in this country. Some doctors say they're over-prescribed while others say they're not prescribed enough.

Elaine Overton's cholesterol was 260, so her doctor put her on Lipitor. "My cholesterol dropped about 100 points in about six weeks' time," she said. "It was really remarkable."

Statins can lower cholesterol by 40 percent and prevent heart attacks. The newest research shows they also reduce the risk of a second stroke by 16 percent.

drugsIn deciding whether pharmaceuticals are fit for prescribing to patients, the Food and Drug Administration uses agency scientists to review the voluminous submissions from sponsoring companies. For about a third of new drugs,[1] the agency also convenes a meeting of an advisory committee comprised of outside experts whose opinions are expected to be impartial and in the interests of the public health.

Anecdotal evidence suggests that financial conflicts can affect a committee vote. In 2005, the FDA convened a meeting to discuss the toxicity of the COX-2 inhibitors Vioxx, Celebrex, and Bextra. Had the committee members with ties to industry been precluded from voting, the committee would have voted against continued marketing for Vioxx and Bextra; instead all 3 drugs received favorable votes.[2,3]

Group slams CMS cost plan for prostate cancer

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health and moneyWASHINGTON, Oct. 30 (UPI) -- A patient coalition Monday demanded that U.S. Medicare drop its policy of "least costly alternative (LCA)" for prostate cancer patients.

The LCA policy encourages doctors to give patients the treatment that costs the least money in cases where treatments are deemed interchangeable by the Centers for Medicaid & Medicare Services (CMS), which drives providers to make treatment decisions based on cost, rather than clinical factors, said a coalition comprised of the Men's Health Network, the National Prostate Cancer Coalition, the Prostate Health Education Network Inc. and Us TOO.

A Potential Anti-prion Drug With 'Unprecedented' Potency

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orionThe urgent search for a medication to treat prion diseases has led scientists in Germany to synthesize a new group of compounds, including one that is 15 times more potent than an approved drug now being tested in clinical trials.

Their report is scheduled for the Nov. 2 issue of the biweekly ACS Journal of Medicinal Chemistry.

Prions are infectious proteins that cause brain disorders like Mad Cow Disease and Creutzfeldt-Jakob Disease (CJD) in humans. Peter Gmeiner and colleagues note that the recent emergence of a new form of CDJ, linked to consumption of infected beef mainly in Great Britain, intensified the search for anti-prion compounds.

Curry spice extract may have anti-arthritis potential

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curyr spiceThe new study, published in the November issue of the journal Arthritis & Rheumatism (Vol. 54, pp. 3452-3464), is said to be the first to document the efficacy of curcumin-containing extracts for anti-arthritis activity in vivo, as well as demonstrating that the extracts studied are analogous with commercially available turmeric dietary supplements.

"Just as the willow bark provided relief for arthritis patients before the advent of aspirin, it would appear that the underground stem (rhizome) of a tropical plant [turmeric] may also hold promise [against] joint inflammation and destruction," wrote lead author Janet Funk from the University of Arizona in Tucson.

Testing Antidepressant Levels for Teens

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anti-depressants(Ivanhoe Newswire) -- New research may explain why teenagers taking antidepressants become aggressive or kill themselves. Researchers tested hamsters to determine the link between teens, antidepressants, and suicidal tendencies.

Fluoxetine -- commonly known as Prozac -- is the only anti-depression medication approved to treat juveniles. However, controversy has arisen over claims that the drug actually increases suicidal behaviors in children and adolescents.

This seratonin reuptake inhibitor (SSRI) is known to inhibit aggression in adult hamsters. However scientists have discovered that juvenile hamsters -- when given low doses of fluoxetine, or Prozac -- become more aggressive, as opposed to their older counterparts. When juveniles are given high doses of the drug, their behavior is less aggressive. Adult hamsters seem to calm down whether they were given a high or low dose of the drug.

Caution emerges over inhalable insulin

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inhalation

The air is leaking out of what was supposed to be the next big thing in the treatment of diabetes: inhalable insulin.

"While inhalable insulins will see a reasonable level of uptake, they aren't the surefire blockbuster they were hyped to be," says a new study by British market research firm Datamonitor PLC. It points out that the new treatment isn't significantly better than existing therapies, is expensive and its long-term safety in the lungs is unknown.

On the other hand, inhalable insulin represents a convenient and alternative delivery system for diabetics who have a needle phobia, and are reluctant to inject themselves with insulin to control blood sugar levels in the blood.

Herbal Medicine: Cure or Disease?

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SAUDI - The herbal medicine industry is not immune to the manipulation of imposters in the field. People seeking treatment for their ailments are sometimes deceived by practitioners who prescribe harmful herbal medicines and concoctions. An extremely competitive lucrative business has appeared on the markets in Saudi Arabia of late, evidence of which may be seen in the newspapers and pamphlets that advertise remedies claiming to be able to succeed where the jinns and Aladdin’s lamp have failed. Those afflicted are easily manipulated by confident claims to cure diseases that the doctors could not, forking out large sums of money in the vain hope of being relieved of their symptoms. Imposters in the field use plants of an inferior quality and mix them with chemicals to provide immediate positive results. The effects soon wear off however, and it can sometimes be difficult to save the lives of people whose health is severely affected by these bad treatments.

Medicare Part D May Hurt Heart Patients

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The new Medicare Part D program may make it difficult for a significant number of indigent patients with systolic heart failure (SHF) to access evidence-based medical therapies, according to new research.

Researchers followed 382 patients with SHF belonging to Louisiana's Chabert Medical Center's SHF disease management program. Patients had Medicare, and many utilized pharmaceutical-sponsored, medication-assistance programs (MAP) to access their life-saving therapies. MAP programs are potentially threatened as a result of the current change over to Medicare Part D. Patients had a mean age of 66.7 years and a median household income of $11,800 annually.

In total, 95 percent of these patients with SHF used ace inhibitors, 96 percent used beta-blockers, and 65 percent obtained their medications via the MAP. Researchers conclude, that as a result of Medicare Part D payments and copayments, a considerable amount of patients with SHF may lose access to medications.

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Vitamin C May Aid In COPD/Pneumonia Prognosis

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During exacerbation, vitamin C is markedly decreased in inflammatory diseases, such as acute pneumonia and COPD, according to a new study.

Serbian researchers compared the values of serum ascorbate concentration and laboratory inflammation indicators in 60 nonsmoking patients.

The patients were split into three groups: 20 patients with acute pneumonia (group I), 20 patients with stable COPD (group II), and 20 patients with exacerbated COPD (group III). Researchers concluded that patients in groups I and III had significantly decreased levels of vitamin C and increased inflammation before therapy, compared with patients after therapy.

It is suggested that the elevation of vitamin C in serum is a good prognostic parameter for disease evaluation.

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New York, October 27, 2006 - There may be as many as 70 million Americans with prehypertension. If these people can be treated pharmacologically to avoid or delay progression to clinical hypertension, there would be significant benefits to them and the overall health of the population. The recent TROPHY study seems to lead to that conclusion. However, two editorials published in the November issue of the American Journal of Hypertension emphatically argue that the study is flawed and the conclusions reached are misleading.

Persons with prehypertension, generally defined as having a systolic blood pressure in the range of 120-139 mm Hg or a diastolic blood pressure of 80-89, will usually develop hypertension at the rate of about 10% per year. The recent Trial of Preventing Hypertension (TROPHY) examined whether treating patients with candesartan for two years resulted in a sustained reduction in the incidence of high blood pressure after the drug was discontinued. The TROPHY study concluded that the treatment significantly reduced the risk of incident hypertension over the four year study.

Crushing pills could cause adverse effects

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Crushing pills to make them easier to swallow might be fatal because it releases drugs a lot quicker than they are supposed to, warn scientists.

David Wright and fellow pharmacy researchers at the University of East Anglia said crushing pills could increase the risk of side effects, reported the online edition of BBC news.

"Pills often have special coatings that affect how they are released into the body. Crushing them can mean this complex system is disturbed," said Wright.

MONTPELIER — Drug maker Wyeth must pay nearly $6.8 million to a Marshfield woman whose arm had to be amputated after she was injected with one of its medications, the Vermont Supreme Court said Friday, upholding a lower court's ruling.

In a case hailed as a victory by a national consumers' group, the court cited a U.S. Food and Drug Administration rule saying drug companies can issue sterner warnings than required by regulators if they think it's necessary.

The case, which was originally decided by a Washington County Superior Court jury, centered on Diana Levine, who went to the Health Center in Plainfield in April 2000 complaining of nausea stemming from migraine headaches. She was given an injection of Phenergan.

Severe side effects prompt warnings on cancer drug

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TORONTO — Avastin, a drug approved in Canada to treat advanced colorectal cancer, has been linked to two serious complications in a small number of patients, the drug's manufacturer advised Friday.

But Avastin, which works by choking off a tumour's blood supply, is also being tested experimentally for prostate, kidney, pancreatic and ovarian cancer, and is being widely used off-label by eye doctors to treat one form of age-related macular degeneration. (Off-label means doctors can prescribe any approved medication for other purposes.)

Most patients who experienced either of the two complicating conditions red-flagged Friday — hypertensive encephalopathy or RPLS — were being treated for conditions other than advanced colorectal cancer, Hoffmann-La Roche Ltd. said in an advisory to health professionals and the public on Health Canada's website.

Breastfeeding Boosts Mental Health

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A new study has found that babies that are breastfed for longer than six months have significantly better mental health in childhood.

The findings are based on data from the ground-breaking Raine Study at the Telethon Institute for Child Health Research, that has tracked the growth and development of more than 2500 West Australian children over the past 16 years.

Researcher Dr Wendy Oddy said there was growing evidence that bioactive factors in breast milk played an important role in the rapid early brain development that occurs in the first year of life.

A novel combination therapy drastically reduces the infection rate of three viruses -- and risk of death -- in transplant patients with compromised immune systems. The findings, to be reported in the Nov. 1 print edition of Nature Medicine, originate from a study conducted at Baylor College of Medicine, The Methodist Hospital, and Texas Children's Hospital.

The journal has posted the findings online.

The phase 1 trial, funded by the National Heart, Lung, and Blood Institute, one of the National Institutes of Health, tested the first multivirus killer of its kind, called Trivirus-specific cytotoxic T lymphocytes (CTLs), which control infections caused by three commonplace viruses -- cytomegalovirus (CMV), Epstein-Barr virus (EBV), and adenovirus. Although benign in people with normal immune systems, the viruses can cause life-threatening illnesses in transplant patients and others with compromised immune systems.

Diabetes innovation scoops award

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A Scottish scientist has won a major award for a treatment which could allow diabetics to inhale insulin.

Currently, Scotland's 200,000 diabetes patients need daily injections to regulate their blood sugar levels.

Dr Marie-Claire Parker, chief executive of Glasgow-based company XstalBio, has developed tiny particles containing insulin which can be inhaled.

Bristol-Myers Squibb 3Q profit plunges

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Bristol-Myers Squibb Co., one of the nation's biggest drugmakers, said Thursday that its third-quarter earnings plunged 65 percent because two key drugs struggled with generic competition and results a year-ago were swelled by a one-time gain. It also raised earnings guidance for the year and said one of the government investigations into a patent deal has been expanded.

The company earned $338 million, or 17 cents a share, in the July-September period, compared with $964 million, or 49 cents a share, a year earlier when it sold its U.S. and Canadian consumer products business.

Breast cancer drugs added to PBS

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MANY breast cancer suffers will pay less for treatment with two new drugs listed on the Pharmaceutical Benefits Scheme.

The drugs are specifically designed to treat post-menopausal women with a type of breast cancer known as hormone-dependant early breast cancer and will be available at the subsidised rate from December 1.

One of the drugs, Aromasin, is expected to help more than 5500 patients over four years at a cost of more than $10 million.

GP sentenced for morphine death

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Gary Gow, 53, pleaded guilty to the manslaughter of a patient Wayne Ritchie after prescribing him an incorrect type of morphine with inadequate administration instructions, for his chronic back pain.

Mr Ritchie died after injecting himself with 120 milligrams of morphine tartrate on October 3, 2004, at his home in Figtree, near Wollongong.

Dr Gow had accidentally prescribed the morphine tartrate instead of morphine sulphate, the former designed to be administered in extremely small doses over a prolonged period to cancer patients with intractable pain.

Drug chain offers free antibiotics

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In a move that will counter its giant rivals, Meijer stores in Ohio, Michigan, Illinois, Indiana, Michigan and Kentucky have begun offering free generic antibiotics to anyone with a prescription.

The program, which started this week, is primarily aimed at drugs for childhood illnesses. Included are amoxicillin, cephalexin, SMX-TMP, ciprofloxacin, penicillin VK, ampicillin, and erythromycin.

The no-strings program, which will continue indefinitely, comes on the heels of a Wal-Mart Stores Inc. decision to offer certain generic prescription drugs for $4. Later, Target Corp. decided to do the same.

Limits Urged for Effexor Prescriptions

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Doctors should limit the number of Effexor pills they prescribe patients to reduce the risk of overdose, the antidepressant's manufacturer and federal health officials said Wednesday.

There have been reports of deaths and serious injuries in patients who overdosed on Effexor, also called venlafaxine, predominantly when taken with alcohol and/or other drugs, Wyeth and the Food and Drug Administration said.

Pfizer's Torcetrapib Cholesterol Drug May Face Delays

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Pfizer Inc.'s potential blockbuster drug torcetrapib may be delayed until 2011, clouding plans to replace top-selling cholesterol medicine Lipitor when its patent expires.

Officials at New York-based Pfizer, the world's largest drugmaker, said last week that U.S. regulators may want long- term studies showing the drug when combined with Lipitor prolongs lives and prevents disease before approving it. Analysts lowered their profit estimates after the comments on torcetrapib, which is designed to boost levels of so-called good cholesterol that removes plaque from arteries.

The U.S. Food and Drug Administration may not finish until late 2008 its evaluation of imaging studies showing whether the drug shrinks fatty substances that clog arteries and trigger heart attacks, John LaMattina, president of global research and development at Pfizer, said in a conference call. Analysts say the review may run a year later than expected and the drug, which some projected to generate $1.6 billion in sales by 2009, may be delayed by one to three years as a result.

The drug sildenafil, popularly known as Viagra, may help people with chronic obstructive pulmonary disease control the illness-related blood pressure spikes in the heart's pulmonary artery, a new study found.

The medication, in addition to its use as a popular treatment for impotence, has already been approved by the U.S. Food and Drug Administration for the treatment of the chronic version of such blood pressure spikes, known as pulmonary arterial hypertension (PAH). The drug has been marketed specifically for this purpose under the trade name Revatio. Another drug -- bosentan -- is also approved for similar purposes.

Tanox begins latest asthma treatment trial

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Tanox Inc.Tanox Inc. has initiated a new clinical trial of TNX-650 as a potential treatment for moderate-to-severe asthma.

The Phase I trial involves 32 subjects and will study the safety, tolerability and pharmacokinetics of single doses of TNX-650 in healthy volunteers.

Moderate-to-severe asthmatics comprise approximately 35 percent of the estimated 17 million asthma patients in the U.S.

Woman drops lawsuit over Vioxx, Merck says

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Merck & Co. Inc. said today that a Texas woman, who blamed the recalled pain reliever Vioxx for her heart attack, has dropped her lawsuit two weeks before trial.

It was the latest dropped case among at least 27,100 personal-injury cases filed against Merck in the two years since Merck recalled Vioxx due to safety concerns. About 3,000 of the cases, or 11 percent, have been dropped, leaving 23,800 as of Oct. 9, Merck said.

by Bonnie Darves, Medscape, 23 Oct 2006

The abuse of caffeine is increasingly a factor in overdose situations among young people, and the consequences are often severe enough to land teens and college-age youth in the intensive care unit (ICU), especially when concomitant use of other substances — legal or illicit — is involved, according to new research.

In a study presented here at the American College of Emergency Medicine Scientific Assembly, 31 of 265 caffeine-abuse cases presenting to the emergency department (ED) and reported to a Chicago-area poison center necessitated hospital admission. Eighty of the 265 cases involved caffeine abuse in concert with other pharmaceutical products.

Parkinson's Disease Associated With Major Melanoma Risk

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by Caroline Cassels, Medscape, 23 Oct 2006

Patients with Parkinson's disease (PD) have a more than 2-fold increased risk of developing malignant melanoma compared with the general population, a new study has found.

Here at the American Neurological Association (ANA) 131st Annual Meeting, researchers from Creighton University in Omaha, Nebraska presented results of a large multicenter study that included 2106 patients from 31 movement-disorder centers across North America.

SIDS May Have Previously Unsuspected Pathogenesis

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by Norra MacReady, Medscape, 23 Oct 2006

Sudden infant death syndrome (SIDS) may be a result of shock, metabolic acidosis, and loss of homeostasis, according to findings presented here at the annual meeting of the American Society for Clinical Pathology.

These data challenge the notion that respiratory acidosis is the etiology of most, if not all, SIDS cases, the study's author, Hazel L. McGaffey, MD, told Medscape. "Our belief is that it's the metabolic acidosis that causes the heart to stop," said Dr. McGaffey, a retired pathologist at Sacred Heart Hospital in Idaho Falls, Idaho, and a former coroner.

Statins Good for Smokers' Lungs

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MONDAY, Oct. 23 (HealthDay News) -- The millions of Americans who take cholesterol-lowering statin drugs may have another reason to cheer: These medications may also help boost the lung health of smokers and former smokers.

And a second study reported at the American College of Chest Physicians annual meeting in New Orleans found that these drugs -- which include Lipitor, Pravachol and Zocor -- may also protect people with severely clogged carotid arteries, the main blood vessels to the brain.

Banned drugs available in markets

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SOUTH ASIA, DHAKA: Banned drugs prevail in the market due to negligence of the directorate f drug administration (DDA). Many drugs, which were forbidden to take for their harmful effects, were not withdrawn from the market owing to its indifference to them.

It has been observed that the drug administration does not bother to ask the manufacturers to withdraw all the samples of the drugs which have been banned for their harmful effects on patients.

For example, Rofecoxib and Valdecoxib tablets used for musculetal pain were banned in September 2005 for their adverse effects on cardiovascular system.

Transplanted Immune Cells Prolong Life In ALS Studies

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Researchers at the Methodist Neurological Institute (NI) have demonstrated that the immune cells of the spinal cord and brain contribute significantly to prolonging survival in a model of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease that results in paralysis and eventual death, according to a study published today in Proceedings of the National Academy of Sciences U.S.A.

By performing bone marrow transplants in mice that are born without immune systems, transplanted cells slowed the loss of motoneurons and increased life expectancy by 40 percent.

Tamoxifen: new warning label for chemoprevention drug

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by Dalene Entenmann, The Cancer Blog, 21 Oct 2006

MarketWatch is reporting that a panel of experts has recommended that the drug labeling for Tamoxifen be changed to include warnings some women with estrogen-positive breast cancer might be at greater risk for breast cancer recurrence. The recommendation comes as a result of studies that show the drug is not as effective for women with estrogen-positive breast cancer if they also carry an enzyme, called CYP2D6, that does not actively metabolize tamoxifen as it should to make the drug work in preventing breast cancer.

Scientists develop insulin-producing cells

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SAN DIEGO, Oct. 20 (UPI) -- Scientists at a California biotechnology company said they have developed a way to turn embryonic stem cells into insulin-producing pancreatic cells.

Scientists at Novocell in San Diego said years of research remain before a therapy can be developed from their study of using embryonic stem cells to replace cells destroyed by the body's immune system because of juvenile, or type 1, diabetes, the New York Times said Friday.

By Lois M. Collins and Geoffrey Fattah, Deseret Morning News, 19 Oct 2006

Brigham Young University and one of its professors are suing pharmaceutical giant Pfizer, claiming BYU was defrauded of profits of at least $1 billion and credit for work that led to the blockbuster drug Celebrex.

The lawsuit, filed Wednesday in U.S. District Court in Salt Lake City, weaves a tale of a trusting university that didn't know much about patents in biomedical breakthroughs and that was allegedly deceived by an experienced drug company.

The medication, in the non-steroidal anti-inflammatory drugs (NSAID) class, is one of the so-called "super-aspirins." Celebrex and its second-generation drugs have had sales of more than $20 billion. The super-aspirin blocks the COX-2 enzyme, reducing pain and inflammation without triggering the sometimes-deadly gastrointestinal effects of some other NSAIDs, including aspirin. COX is scientific shorthand for the enzyme cyclooxygenase.

Pros, Cons From Ritalin in Preschoolers

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Yes, I am sceptic about all those recently introduced disorders. And yes, I cannot accept the obsession in some people to find the fix to the problem via drugs and medications.

Recent study finds positive and negative sides of using Ritalin by preschool children.

"I hope publication of this does not lead to more overprescribing.. The safety isn't adequately established, the efficacy even less."

Breakthrough Cancer Drug Gleevec Gets Heart Precaution

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Gleevec (by Novartis) may apparently cause some serious heart problems.

The small study detailed how Gleevec inadvertently targets a protein maintaining cells that contract the heart muscle and help to force blood through the body. This means that other drugs in the same class, tyrosine kinase inhibitors, may also damage the heart

At the same time Novartis releases a press release, promoting its drug. There are also side-effects mentioned:


The most common side effects included nausea, superficial edema, muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid retention, as well as neutropenia, thrombocytopenia and anemia....

Rare/serious adverse reactions include: sepsis, pneumonia, depression, convulsions, cardiac failure, thrombosis/embolism, ileus, pancreatitis, hepatic failure, exfoliative dermatitis, angioedema, Stevens-Johnson syndrome, renal failure, fluid retention, edema (including brain, eye, pericardium, abdomen and lung), hemorrhage (including brain, eye, kidney and gastrointestinal tract), diverticulitis, gastrointestinal perforation, tumour hemorrhage/necrosis, hip osteonecrosis/avascular necrosis.



So, you can fight cancer with it, but this drug won't make you healthier.....

Feds go after Merck

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MONTREAL (CP) -- Revenue Canada is seeking $2 billion from pharmaceutical giant Merck Frosst in unpaid taxes, a newspaper report suggests.

Sources said that the federal department sent a notice to the company the first week of October. It is seeking taxes on a portion of the global profits from its popular drug Singulair.

The asthma treatment was developed in Montreal. But Merck transferred a part of its profits from the drug to Barbados.

Merck Frosst is one of the most important pharmaceutical companies in Canada. It employs 1,600 workers, including 1,100 in Montreal.

Study shows how Ebola and Marburg cause disease

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by Kennedy Abwao, SciDev.Net, 19 Oct 2006

Researchers have discovered how the Ebola and Marburg viruses cause illness, paving the way for developing cures for the diseases.

Ebola and Marburg fevers — which have a mortality rate of up to 80 per cent — kill hundreds of people in the tropical forests of Central Africa each year, mainly in the Democratic Republic of Congo. The diseases work by shutting down the patient's immune system.

Vaccine boosts Wyeth earnings

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MADISON, N.J. — U.S. pharmaceutical company Wyeth said Thursday third-quarter net income climbed 33 per cent, helped by sales of the anti-inflammatory drug Enbrel and its Prevnar vaccine.

Quarterly profit grew to US$1.16 billion, or 85 cents per share, in the three months ended Sept. 30 from $869.9 million, or 64 cents per share, during the same period last year.

Results include a four-cent per share charge related to a plan aimed at cutting costs and boosting productivity and a five-cent gain related to the reduction of certain deferred tax asset valuation allowances.

Impact of Psoriasis on quality of life - Survey

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There was the largest survey of people with psoriasis in Europe. And it does show that psoriasis has a profound impact on quality of life.

Read more to know the background, objectives, methods and results of this survey..

Journal Articles Quickly Affect Doctors' Practice

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...and maybe too quickly.

I am pretty sensitive to all news that are touching drugs and medicine safety. This article gives some examples of how do the journals affect doctor's decisions. Which is very scary. The common practice is that a pharma giant sponsors medical journals, and in return gets the articles which are promoting new drugs or methods. This happens as long as journals keep printing articles in favour of the pharmaceutical corporation. If there will be an article which drops a shadow on its face, the sponsorship stops.

Anyways, read below how the article can rapidly influence doctors' practice.

Merck starts Diabetes Race

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As much as I dislike press releases, I think this one is important.

We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels.

Make sure you check the side-effects, highlighted at the very bototm of the article.

Drug Reactions Send 700,000 Yearly to ER

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There are some numbers. Number of people reacting badly to widely used medicines. And these numbers are quite worrying.

Even so, the study authors and other experts agreed that the 700,000 estimate was conservative because bad drug reactions are likely often misdiagnosed.

Unfortunately, this article covers only American patients. Who knows how many misdiagnosed people are all over the world.

Ex-FDA chief to plead guilty in stock case

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Not directly related to Drugs and Medication, but still a very interesting story by MSNBC

The Justice Department accused the former head of the Food and Drug Administration with falsely reporting that he had sold stock in companies when he continued holding shares in the firms governed by FDA rules.

Q3 results: Roche, Trimeris

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Roche and Trimeris report high results for Q32006.

Roche - due to Tamiflu, cancer drug, and anti-influenza drugs.

Trimeris - due to its HIV drug Fuzeon.

Bayer's Big Drug Boo-Boo

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During my search for interesting articles I came across this Brian Lawler's post.

Many people make mistakes. So do pharmaceutical companies. There can be a huge difference between thesethough.

The perception that a pharmaceutical company is withholding information or acting nefariously can be extremely damaging, as it can erode confidence and trust in the whole industry.

Diet May Inspire New Epilepsy Drugs

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Oct. 16, 2006 -- The "ketogenic diet" might be the springboard for a new type of epilepsy drug.

The ketogenic diet strictly limits carbohydrates and may help control seizuresseizures in some people.

That's nothing new. The ketogenic diet has been around since the 1920s (and shouldn't be tried without medical supervision).

China antibiotic maker loses license

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BEIJING - China's national drug regulator has revoked the license of the maker of an antibiotic blamed for at least six deaths and dozens of illnesses, the official news agency said Monday.

Leaders of the Anhui Huayuan Worldbest Biology Pharmacy Co. have also been dismissed, Xinhua News Agency reported. It did not say if the managers would be prosecuted.

DREAM trial to prevent progression of Diabetes

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The results of the latest diabetes-prevention trial, DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication), announced recently how the trial reduced the risk of developing type 2 diabetes by 62 percent relative to placebo among people at high risk of developing type 2 diabetes.

The DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) trial evaluated the likelihood of progression to type-2 diabetes over a three-year period among 5,269 people with a condition known as “pre-diabetes.”1 In pre-diabetes, blood sugar levels are higher than normal, but not yet high enough for a diagnosis of type 2 diabetes.

Quest grows with drug firm trends

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by Gary Haber, The News Hournal, 15 Oct 2006

Pharmaceutical makers are increasingly developing drugs that target specific groups of patients, and a Newark company is playing a leading role.

In recent years, drug companies have launched drugs to treat conditions like a form of leukemia in patients with a genetic condition called Philadelphia chromosome, and a treatment for an aggressive form of breast cancer among women whose genetic makeup makes them less likely to benefit from other drugs.

Hospital mistake paralyzes new mom

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NDIANAPOLIS - A hospital that gave lethal doses of a drug to three premature babies has made another medication mistake, giving a new mother a painkiller 10 times faster than intended and making her temporarily unable to walk.

Amber Baise, 18, of Indianapolis, who received the painkiller during childbirth, has regained some movement in her legs as she recovers from what Methodist Hospital on Friday called a doctor's mistake.

"We remain hopeful that she will receive a full recovery. That is our hope. That is our commitment," said Bill Stephan, a spokesman for Clarian Health Partners, which operates Methodist and Indiana University's hospitals.

Bristol-Myers Squibb Pharmaceuticals Limited (Bristol-Myers Squibb) has welcomed the decision by the Scottish Medicines Consortium (SMC) to accept Baraclude® (entecavir) for use within NHS Scotland for the treatment of chronic hepatitis B virus infection.

In its guidance, the SMC states that "Baraclude is accepted for use within NHS Scotland for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase levels and histological evidence of active inflammation and or fibrosis. Clinical studies have shown that entecavir is more effective than lamivudine in nucleoside-naive HBeAg positive and negative patients and in lamivudine refractory patients." (1)

Government Warns Of Phony Diabetes Test Strips

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Diabetics are being warned about counterfeit versions of test strips commonly used to monitor blood sugar levels.

The Food and Drug Administration says the strips fit various models of LifeScan's OneTouch brand of glucose monitors made by Johnson-and-Johnson.

The FDA says the fakes are a health threat in that they could give incorrect readings leading diabetics to take too much or too little insulin.

New engineered drug may offer prolonged arthritis relief

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DURHAM, N.C. -- Researchers at Duke University have devised a new way to significantly prolong the effects of an anti-inflammatory drug, potentially making it useful for providing longer-lasting treatment for osteoarthritis, the most common form of arthritis.

The modified drug, which would be injected directly into arthritic joints, could last for several weeks rather than just the few hours the unmodified drug would last, the researchers said.

In their study, the researchers modified a drug called interleukin-1 receptor antagonist (IL1RA). They found that the drug, which is a protein, could be improved by attaching a second protein that clumps together at normal body temperatures. The combined drug likewise would assemble into clumps in the body to serve as "drug depots" that gradually release active drug particles, the researchers said.

Antibiotics in Poultry May Pose Risk to Humans

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(HealthDay News) -- Could a turkey sandwich or a bowl of chicken soup be hazardous to your health?

Poultry has that potential, according to research that suggests people who eat drug-treated poultry may be at increased risk of developing antibiotic resistance.

Still, the findings are preliminary and shouldn't make anyone stop eating chicken or turkey, the study's lead investigator said.

"We don't want to suggest to anyone that they should alter their diet based on this," said Dr. Edward Belongia, director of the Marshfield Clinic Research Foundation's Epidemiology Research Center in Wisconsin.

Merck buying rights to Ambrilia HIV compound

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CHICAGO, Oct 12 (Reuters) - Merck & Co. Inc. has agreed to acquire worldwide rights to Canadian biotech firm Ambrilia Biopharma Inc.'s HIV/AIDS protease inhibitor program, Ambrilia said on Thursday.

Merck will pay $17 million on signing and up to $215 million upon successful completion of development, clinical, regulatory and sales milestones, and royalties on all future product sales.

Merck will gain exclusive worldwide rights to Ambrilia's lead compound, PPL-100, which is currently in early clinical trials.

source

Read more HIV/AIDS News on ImmunoDefence.com

Court sides with immigrants on Medicaid

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by Kristen Wyatt, AP, 12 Oct 2006

ANNAPOLIS, Md. - Maryland may not cut off Medicaid benefits to needy pregnant women and children who are legal immigrants until the constitutionality of the move is tested in the courts, the state's highest court ruled Thursday.

The court unanimously upheld an injunction blocking the state from cutting benefits to almost 3,000 recipients, all legal immigrants who have been in the U.S. for less than five years.

The Court of Appeals decision means the benefits will continue while the courts decide whether the cutoff violated Maryland's constitution.

by Richard C.Semelka, Medscape, 12 Oct 2006

The recent release of a warning by the US Food and Drug Administration (FDA) related to the safety (or lack of safety) of high doses of gadolinium chelates being administered in patients with renal failure is the impetus for this month's 2-part Semelka Spin column, which focuses on safety considerations in magnetic resonance imaging (MRI).

Patient safety and service should be a major focus of all radiologists. In earlier writings I outlined the basic tenets of "diagnostic accuracy" and "safety" as the measures by which we should guide our imaging choices. In those Medscape articles I discussed patient safety considerations related to computed tomographic (CT) scanning, with some mention of iodinated contrast used in CT studies. Now, at the risk of alienating the remaining 15% of the radiology community, it is time to discuss MRI safety.

Caterpillars tell us how bacteria cause disease

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Researchers from the University of Bath have discovered a way to sort through large numbers of bacterial gene sequences by testing them in caterpillars to see how their immune systems respond. This new technique known as Rapid Virulence Annotation (RVA) allows them to pinpoint the genes which code for virulence.

With millions of species worldwide, insects provide a massive pool of hosts for bacterial diseases. The immune system of insects is very similar to the inborn immune system of mammals. By living first in insects some bacteria have evolved to survive immune system attack, so when they invade mammals they are equipped to deal with their immune system response and are able to spread rapidly. It is thought this is how bacteria, such as Yersinia pestis – the cause of plague, could have evolved to wreak havoc in humans.

FDA Approvals: FluLaval and Fentora

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October 12, 2006 — The US Food and Drug Administration (FDA) has a trivalent, inactivated split-virion influenza vaccine for the active immunization of adults against disease caused by viral strains likely to cause influenza this season; and fentanyl buccal tablets for the management of breakthrough pain in cancer patients who are tolerant to opioid therapy for their underlying persistent cancer pain.

Study: Some Alzheimer's Drugs Very Risky

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by Linda A. Johnson, AP, 11 Oct 2006

Widely prescribed anti-psychotic drugs do not help most Alzheimer's patients with delusions and aggression and are not worth the risk of sudden death and other side effects, the first major study on sufferers outside nursing homes concludes.

The finding could increase the burden on families struggling to care for relatives with the mind-robbing disease at home.

Mistrial Is Declared in Wyeth Case

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A Pennsylvania judge Wednesday threw out a $1.5-million award to a woman who claimed that drug maker Wyeth's menopause medicines caused her cancer.

Judge Norman Ackerman in Philadelphia declared a mistrial without explanation and discarded the Oct. 4 jury finding that Wyeth's Prempro and Premarin were a cause of Jennie Nelson's breast cancer. The jury last week set compensatory damages at $1.5 million, raising the possibility of punitive damages in a second phase.

by Zosia Chustecka, WebMD, 11 Oct 2006

The largest meta-analysis to date investigating statins and cancer risk has found no decrease in the risk of cancer and concludes that these drugs do not appear to offer a protective effect.

This latest meta-analysis, published online in the Journal of Clinical Oncology on September 25, was performed by Stefanos Bonovas, MD, and colleagues from the University of Athens, Greece. Based on data from 109,143 patients involved in 35 randomized clinical trials, it is "the most extensive and inclusive meta-analysis of its kind," comments an accompanying editorial.

Drug-ads climb 9%

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The Philadelphia Inquirer, 11 Oct 2006

PHILADELPHIA - If you've seen green butterflies gently fluttering everywhere in the last year, you're not hallucinating.

Advertisements for Lunesta, the sleeping pill marketed with an animated butterfly by Sepracor Inc., of Cambridge, Mass., almost single-handedly turned around a slide in the industry's drug-ad spending from the first six months of last year to the same period this year, according to TNS Media Intelligence.

Parkinson disease patients who develop impulse control disorders as a result of treatment are more likely to be depressed, irritable, and have appetite changes, according to a study published in the October 10, 2006, issue of Neurology, the scientific journal of the American Academy of Neurology. These findings could allow early identification of patients at risk for developing this distressing complication of treatment.

Compulsive gambling, hypersexuality, and excessive shopping have been linked to treatment with dopamine agonists in small numbers of patients. It is unknown exactly how many patients experience such an impulse control disorder, although it is believed to be less than 10 percent of those receiving these drugs.

ANN ARBOR, Mich., Oct. 11 /PRNewswire/ -- NanoBio® Corporation, a biopharmaceutical company developing novel products for the treatment and prevention of serious infections, today announced that Ronald M. Cresswell, Ph.D., Hon. D. Sc., F.R.S.E., has been named to its Board of Directors. Dr. Cresswell is the former Senior Vice President and Chief Scientific Officer of Warner-Lambert, and has served on the Board of Directors of Esperion Therapeutics, Inc., Allergan, Inc., Curagen Corporation, and Vasogen, Inc.

"Dr. Cresswell brings decades of experience working with some of the world's most respected pharmaceutical and health care companies," stated James R. Baker, Jr., M.D., Chairman of the Board of NanoBio Corporation. "His addition to the NanoBio Board adds significant value at this important juncture for the company as we move forward with several promising product development programs that represent significant commercial opportunities."

ICU Rooms Help Spread Resistant Infections

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TUESDAY, Oct. 10 (HealthDay News) -- Patients in intensive care unit rooms previously occupied by someone with antibiotic-resistant bacteria may be at heightened risk of acquiring these dangerous infections, a U.S. study finds.

Two kinds of bacteria -- methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) -- are major causes of illness and death in hospitals.

Dopamine Plays Critical Role in Sleep

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TUESDAY, Oct. 10 (HealthDay News) -- The brain chemical dopamine plays an important role in regulating sleep and brain activity associated with dreaming, a Duke University Medical Center study finds.

Dopamine is a neurotransmitter that carries signals between neurons (brain cells).

FDA told to watch nanotech products for risks

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BETHESDA, Md. - The growing number of cosmetics, drugs other products made using nanotechnology need more attention from U.S. regulators to make sure they are safe for humans and the planet, consumer and environmental groups told a government hearing Tuesday.

Nanotechnology is the design and use of particles as small as one-billionth of a meter. A human hair, by contrast, is about 80,000 nanometers across.

Medication possible factor in 21 deaths

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A sign reads 'Office - Emergency Room for changing Lisinopril' at the Metropolitan Hospital on Monday, Oct. 9, 2006. PANAMA CITY, Panama - Panamanian authorities say they suspect a medicine taken to treat high blood pressure may be among the factors leading to the deaths of 21 people since July who have succumbed to a mysterious illness that triggers kidney failure.

The 21st victim died either late Sunday or early Monday morning, said Panamanian public health official Rosario Turner said Monday. She did not specify the exact hour of death, or the age or gender of the patient, but said officials would release more details later.

On Friday, Panama's health minister stopped sales of the medication, Lisinopril Normon, and began removing it from pharmacy shelves. About 9,000 Panamanians take the medicine.

States' share of Medicaid spending rises

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By KEVIN FREKING, AP, 10 Oct 2006

WASHINGTON - States are finally getting relief when it comes to providing health care for the poor. The states' share of Medicaid spending rose by an average of just 2.8 percent in fiscal year 2006, the lowest rate in a decade. Meanwhile, state revenues increased at a 3.7 percent clip.

That's good news for patients, who could see more services covered, and for health care providers, who could conceivably get a raise, according to officials from the Kaiser Family Foundation.

Scientists are reporting discovery in laboratory experiments of a previously unknown molecular mechanism in which the active ingredient in marijuana may slow the progression of Alzheimer's disease (AD).

Scripps Research Institute's Kim D. Janda and colleagues used laboratory experiments to show that delta-9-tetrahydrocannabinol (THC) preserves brain levels of the key neurotransmitter acetylcholine.

Newswise — Two classes of drugs commonly used to treat osteoarthritis – non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors (a newer generation of NSAIDs) – present similar, increased risks of heart attacks while offering about the same level of pain relief, according to a new report by HHS’ Agency for Healthcare Research and Quality.

Newer Schizophrenia Drugs May Be No Better

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FRIDAY, Oct. 6 (HealthDay News) -- Newer, "second-generation" antipsychotic drugs don't appear to be significantly better than older drugs for schizophrenia patients who require a change in medication, British researchers report.

The results contradict the widely held belief that second-generation antipsychotic drugs are safer and more effective in treating schizophrenia than less-costly first-generation antipsychotic medicines, said researchers from the University of Cambridge.

SAN DIEGO--(BUSINESS WIRE)--MultiCell Technologies, Inc. (OTCBB: MCET), a biopharmaceutical company developing first-in-class drugs based on advanced immune system modulation and other proprietary technologies, today announced that its intellectual property portfolio now totals 54 issued or pending patents that cover its novel drug development platform technologies and new drug candidates.

06 Oct 2006

New data from the first study of its kind, show that, in postmenopausal women whose advanced breast cancer is both hormone receptor-positive (HR+) and HER2-positive, a combination of ArimidexTM (anastrozole) plus Herceptin® (trastuzumab) keeps cancer under control for significantly longer than hormonal therapy alone (anastrozole).1 The median progression-free survival was 4.8 months versus 2.4 months, respectively. These data were presented at the 31st European Society for Medical Oncology (ESMO) Congress today.

New Sleep Drug May Be Less Prone to Abuse

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THURSDAY, Oct. 5 (HealthDay News) -- The sleep medication ramelteon (brand name Rozerem), recently approved in the United States to treat insomnia, does not appear to have potential for substance abuse or for motor or cognitive impairment, according to company-funded research.

Currently, sleep medications called benzodiazepine receptor agonists -- which include Xanax, Valium and Halcion -- are commonly used to treat insomnia. But these drugs carry a risk for abuse and can cause problems with cognition (thinking, learning and memory), and motor impairments that may make driving dangerous and increase the risk of falls among older adults, according to background information in the study.

Inhaled Insulin: Overcoming Barriers to Insulin Therapy?

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by Srikanth Bellary and Anthony H Barnett, The British Journal of Diabetes and Vascular Disease, 6 Oct 2006

Abstract

Inhaled insulin is a new route of insulin delivery that can be used in the treatment of type 1 and type 2 diabetes. It offers an alternative and additional means of insulin administration, and has been received with particular satisfaction by patients who dislike injections.

Interferon benefits early multiple sclerosis

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by Will Boggs, 4 Oct 2006

NEW YORK (Reuters Health) - Early and ongoing treatment with interferon beta-1a can provide lasting benefits to patients with relapsing-remitting multiple sclerosis (MS), according to a report in the journal Neurology.

Multiple sclerosis is thought to be an autoimmune disease, a disease that occurs when the body's own immune system attacks a key protein covering on the nerves, resulting in serious movement problems and other symptoms.

Glaxo may have shipped faulty antidepressants

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by Bloomberg News, 5 Oct 2006

GlaxoSmithKline PLC, the world's second-biggest drugmaker, recalled Paxil CR antidepressants last month because the pills may have lacked an active ingredient, and didn't warn patients.

Glaxo doesn't know how many of the 7.5 million recalled pills were missing paroxetine hydrochloride, or how many patients took the pills, spokesman Michael Fleming said yesterday . The company didn't tell patients because testing on a later lot suggested as few as one of the pills lacked the key ingredient, he said.

Hero docs winning war against cancer

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 Finding new ways to beat an old enemy


By Julian Kesner, DailyNews, September 24, 2006

The glittering new Mortimer B. Zuckerman Research Center building at Memorial-Sloan Kettering Cancer Center doubles the size of the city's premier cancer battleground to 650 attending physicians and 445 clinical trials on nearly 60 cancer types.
But that's not the only front in the cancer wars. Across New York, top-flight doctors are working tirelessly to help their patients, bringing the city to the cutting edge of cancer care and science. Here are some of the best:

STOMACH CANCER

Patients who develop a rare stomach cancer called peritoneal mesothelioma usually succumb within a year. But 30% of Dr. Robert Taub's patients at New York Presbyterian Hospital Columbia are disease-free after four years.

J Clin Oncol. 2006 Oct 1;24(28):4587-93
Authors: Ceresoli GL, Chiti A, Zucali PA, Rodari M, Lutman RF, Salamina S, Incarbone M, Alloisio M, Santoro A

PURPOSE

Response evaluation with conventional criteria based on computed tomography (CT) is particularly challenging in malignant pleural mesothelioma (MPM) due to its diffuse pattern of growth. There is growing evidence that therapy-induced changes in tumor [(18)F]fluorodeoxyglucose (FDG) uptake as measured by positron emission tomography (PET) may predict response and patient outcome early in the course of treatment.