FDA OKs sharing unapproved drug uses with docs
February 12, 2009 - Food and Drug Administration officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses.

Millions More Americans Might Be Placed on Statins
February 12, 2009 - If doctors start taking results of a recent drug company-sponsored trial seriously, 11 million more older Americans might be taking cholesterol-lowering statin medications, experts say.

Study: Vitamin C or E pills do not prevent cancer
December 5, 2008 - Vitamin C or E pills do not help prevent cancer in men, concludes the same big study that last week found these supplements ineffective for warding off heart disease.

More proof needed on costly diabetes drugs
December 5, 2008 - U.S. doctors are using a wider array of newer, more costly drugs to treat diabetes with little long-term proof that they work better than older, cheaper medications, U.S. researchers said on Monday. They said newer treatments boosted the average cost of a diabetes prescription by nearly 40 percent in six years.

Prostate cancer not warded off by supplements: study
December 5, 2008 - Selenium and vitamin E supplements do not prevent prostate cancer and may in fact be a little bit dangerous, U.S. researchers reported on Monday.

Danish study finds HRT does not raise heart attack
October 30, 2008 - Women who take hormone replacement therapy to treat menopause symptoms do not have a higher than usual risk of heart attack, especially if they use a cream or skin patch or take "cyclic" hormone combinations, Danish researchers reported on Tuesday.

High Blood Pressure Is More Prevalent
October 30, 2008 - The bad news is that an increasingly high percentage of Americans have hypertension, or high blood pressure.

Less Than 1 in 5 Cancer Trials Are Published
October 15, 2008 - A medical journal article says the results of many clinical trials in cancer research are never published, maybe because they show the drug or treatment didn't work.

Lipitor Mismarketed To Women
September 30, 2008 - Lipitor has been the top-selling drug in the world and has accounted for over $12 billion in annual sales. It has been prescribed to both men and women to lower cholesterol and reduce the risk of heart attack and stroke in patients with common risk factors for heart disease. However, a new study appearing in the Journal of Empirical Legal Studies was unable to find high quality clinical evidence documenting reduced heart attack risk for women in a primary prevention context. Furthermore, advertising omits label information relevant to women.

Medical schools, journals fight industry influence
September 16, 2008 - Just about every segment of the medical community is piling on the pharmaceutical industry these days, accusing drugmakers of deceiving the public, manipulating doctors and putting profits before patients.

FDA staff note deaths in Pfizer bone drug study
September 16, 2008 - Pfizer Inc pill were more likely to die within five years than others who got a placebo, U.S. drug reviewers said in an analysis released on Thursday.

FDA Notes 2 Byetta Deaths
September 9, 2008 - The FDA today said it plans to strengthen warnings about life-threatening pancreas problems linked to the type 2 diabetes drug Byetta after getting two reports of deaths and four other hospitalizations in Byetta users.

Merck Vioxx study was for marketing: researchers
September 9, 2008 - The primary purpose of a 1999 clinical study that Merck & Co Inc. said was done to test side effects of Vioxx was actually to support a marketing campaign before the now-withdrawn painkiller's launch, according to U.S. researchers.

New Lymphoma Drug Shows Promise
September 9, 2008 - Preliminary results from an early trial of a new immunotherapy suggest that doctors may soon have another weapon for the treatment of non-Hodgkins lymphoma.

Cholesterol Drugs May Protect Memory
August 18, 2008 - Drugs commonly used to fight cholesterol may also ward off dementia and memory loss.

Prostate Cancer Therapy: Mental Impact?
August 18. 2008 - A treatment most often offered for men in late stages of prostate cancer may affect mental functioning.

Trial Intensifies Concerns About Safety of Vytorin
July 30, 2008 - In a clinical trial, the cholesterol-lowering drug Vytorin did not help people with heart-valve disease avoid further heart problems but did appear to increase their risk of cancer, scientists reported Monday.

Study shows 150 percent jump in statin use
July 10, 2008 - Use of cholesterol-lowering drugs called statins rose by 156 percent between 2000 and 2005, with spending jumping from $7.7 billion to $19.7 billion, the U.S. Agency for Healthcare Research and Quality reported on Wednesday.

Bone drug Zometa helps fight breast cancer spread
June 1, 2008 - A drug to prevent bone loss during breast cancer treatment also substantially cut the risk that the cancer would return, results that left doctors excited about a possible new way to fight the disease.

Avastin plus chemo better without Erbitux
May 31, 2008 - Colon cancer patients treated with Genentech Inc's Avastin and chemotherapy lived longer without their disease getting worse than those who were also treated with ImClone Systems Inc's Erbitux, according to a study presented on Saturday.

Glaxo 'downplayed' warning on heart-attack risk from AIDS drug
May 12, 2008 - The multinational drugs company GlaxoSmithKline (GSK) downplayed an early warning about the rising number of people who have suffered heart attacks after using one of its drugs, abacavir. An anti-Aids medication, abacavir is taken by tens of thousands of people worldwide.

EU clears first human bird flu vaccine
May 19, 2008 - European medical regulators have approved the first human bird flu vaccine intended for use before or in the early stages of a pandemic, GlaxoSmithKline, its maker, said Monday. The vaccine, Prepandrix, activates an immune response to the H5N1 strain of bird flu, which experts fear may lead to a widespread human flu outbreak threatening millions of people.

Study finds risks for beta blockers with surgery
May 12, 2008 - People given a blood pressure drug known as a beta-blocker to reduce heart risks before surgery were one-third more likely to die within a month and had double the risk of stroke compared with those given a dummy pill, Canadian researchers said on Monday.

Exforge cuts black patients' blood pressure: Novartis
May 14, 2008 - Novartis AG's Exforge(R) drug significantly reduced blood pressure in difficult-to-treat black patients, the Swiss drug maker said on Wednesday, citing a clinical trial.

Anti-psychotic Drug Use Soars In UK Children, Too
May 5, 2008 - American children take anti-psychotic medicines at about six times the rate of children in the United Kingdom, according to a comparison based on a new U.K. study.

Common Vitamin And Other Micronutrient Supplements Reduce Risks Of TB Recurrence, Study Suggests
April 27, 2008 - New findings show a link between micronutrient supplementation and reduced risk of recurrence during tuberculosis chemotherapy, according to a new study.

Vitamin C Status in Children with Acute Lymphoblastic Leukemia
April 27, 2008 - In a study involving 28 hospitalized children with acute lymphoblastic leukemia (ALL) and 30 apparently healthy controls, children with ALL were found to consume twice as much vitamin C as compared to controls.

Group Urges Ban on Medical Giveaways
April 28, 2008 - Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation�s medical colleges, an influential college association has concluded.

Celebrex Plus Lipitor Could Fight Prostate Cancer
April 14, 2008 - Two widely used drugs - one lowers cholesterol and one is an anti-inflammatory - may be useful in controlling prostate cancer. New research being presented at the American Association for Cancer Research annual meeting in San Diego finds that the painkiller Celebrex and the statin Lipitor, when used together or alone, can stop early prostate cancer before it becomes deadly.

Chemotherapy-induced Anemia Increases Risk Of Local Breast Cancer Recurrence
April 3, 2008 - Patients with breast cancer who developed anemia during chemotherapy had nearly three times the risk of local recurrence as those who did not, according to a study published in the April 1 issue of Clinical Cancer Research. "We speculate that there may be an interaction between chemotherapy/radiotherapy and anemia," said lead researcher.

Heart Failure Drugs Linked to Hip Bone Loss in Older Men
April 15, 2008 - Loop diuretics, drugs commonly prescribed to treat heart failure and hypertension, increase the risk of hip bone loss in older men, says a U.S. study.

Pfizer warns of lung cancer with inhaled insulin
April 9, 2008 - Pfizer Inc and Nektar Therapeutics said on Wednesday clinical trials of the inhaled insulin Exubera found increased cases of lung cancer, leading Nektar to stop seeking a marketing partner for the troubled product and abandon it.

Cancer Drug Trials Often Halted Early
April 11, 2008 - An increasing number of clinical trials for new cancer treatments are being halted before the risks and benefits have been fully evaluated, say Italian researchers, who warn that this growing trend could put patients at risk of harm from new therapies rushed into use.

Tobacco funded Mass. Researchers
March 31, 2008 - The nation's largest cigarette maker has paid for scientific research at four Massachusetts universities since 2000, a practice that critics of the tobacco industry liken to the Mafia underwriting crime fighting.

Some Cancer Trials May Have Incorrectly Reported Success: Review Finds Flaws In Study Design And Analysis
March 26, 2008 - A new study reviewing 75 group-randomized cancer trials over a five-year stretch shows that fewer than half of those studies used appropriate statistical methods to analyze the results. The review suggests that some trials may have reported that interventions to prevent disease or reduce cancer risks were effective when in fact they might not have been.

FDA Reviews Two Major Heartburn Drugs
December 10, 2007 - Patients who suffer from heartburn are not at increased risk for heart problems as a result of taking Prilosec or Nexium, according to a review released Monday by the Food and Drug Administration.

FDA Warns of Potential Link Between Byetta and Pancreatitis
October 17, 2007 - Use of exenatide (Byetta,) may be linked to a risk for pancreatitis, the US Food and Drug Administration warned healthcare professionals.

Drug Industry Cash Flows to U.S. Med Schools: Study
October 5, 2007 - Drug companies and medical device makers cultivate extensive financial relationships with U.S. medical schools, creating worrisome potential conflicts of interest for these institutions, researchers said.

Advertising Prescription Drugs To Consumers In Europe Bad For Public Health, Say Experts
October 5, 2007 - As the European parliament looks at the possibility of allowing pharmaceutical companies more freedom in direct-to-consumer prescription drug promotion, experts caution in this week's British Medical Journal (BMJ) that this could be detrimental for public health.

Report Assails F.D.A. Oversight of Clinical Trials
September 27, 2007 - The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found. In a report due to be released Friday, the inspector general of the Department of Health and Human Services, Daniel R. Levinson, said federal health officials did not know how many clinical trials were being conducted, audited fewer than 1 percent of the testing sites and, on the rare occasions when inspectors did appear, generally showed up long after the tests had been completed.

UPDATE 2-Possible carcinogen found in Pfizer AIDS drug
September 10, 2007 - A potential human carcinogen has been found in batches of Pfizer Inc's AIDS drug, Viracept, U.S. officials and the drugmaker said on Monday. Pregnant women and children who are starting HIV therapy should not be given the drug until further notice, Pfizer and the Food and Drug Administration said. Tests detected the presence of ethyl methanesulfonate, or EMS, a chemical formed during manufacturing, Pfizer said in a statement. EMS is a "potential human carcinogen," the FDA and Pfizer said.

Link Uncovered Between Enlarged Prostate And Common OTC Drugs
September 9, 2007 - Men with slow urine flow from enlargement of the prostate gland (known as benign prostatic hyperplasia or BPH) should avoid anything that makes the situation worse and that includes some medications. The most common offenders are over the counter cold and allergy remedies. Now, some research suggests that nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, may also affect the prostate's function, reports the September 2007 issue of Harvard Men's Health Watch.

FDA: Heartburn Drugs Seem OK for Heart
August 9, 2007 - The popular heartburn drugs Prilosec and Nexium don't appear to spur heart problems, say preliminary U.S. and Canadian probes announced recently. The Food and Drug Administration and its Canadian counterpart began reviewing the drugs, used by tens of millions of people, back in May, when manufacturer AstraZeneca provided them an early analysis of two small studies that suggested the possibility of a risk.

Change Ordered to Warfarin Drug Label
August 1, 2007 - In a new trend, labels on the clot-fighting drug warfarin will now warn that people with certain gene variations may need lower doses of the drug.

It's the first time that the FDA has asked doctors to consider a patient's genetic makeup when prescribing a widely used drug, says Larry Lesko, PhD, director of clinical pharmacology at the FDA.

Diabetes Drug Backed, but With Warnings
July 30, 2007 - A federal drug advisory committee voted overwhelmingly on Monday to recommend that the diabetes drug Avandia remain on the market, even after finding that it raised the risks of heart attacks. The votes — 20 to 3 on the heart attack risk and 22 to 1 on the marketing — were cast after an extraordinary meeting in which officials from the Food and Drug Administration, which brought the committee together, openly disagreed with one another on the course to take.

Two Diabetes Drugs Double Heart Failure Risk: Study
July 27, 2007 - Patients taking either of the diabetes drugs Avandia or Actos face twice the risk of developing heart failure compared to people not on the popular medications, a new study finds. Both Avandia and Actos double the risk of heart failure,” concluded the lead author of the first study, Dr. Sonal Singh, an assistant professor of internal medicine at Wake Forest University School of Medicine. “We know these drugs increase the risk, but we found that the risk is more substantial than suspected. This occurs at even the lowest doses and among young patients.

FDA Panel OKs Osteoporosis Drug to Cut Breast Cancer Risk
July 24, 2007 - Despite concerns over cardiovascular side effects, a U.S. Food and Drug Administration panel on Tuesday recommended the osteoporosis drug Evista (raloxifene) for use in preventing breast cancer in certain high-risk groups of older women. In a vote of 8 to 6, the FDA's Oncologic Drugs Advisory Committee recommended approval of the drug for postmenopausal women with osteoporosis, and, in a 10 to 4 vote, it also recommended the drug for postmenopausal women at high risk for breast cancer.

Chemo best for child brain cancer
July 20, 2007 - Using chemotherapy instead of radiotherapy in children with brain tumours reduces the risk of long-term brain damage, say UK researchers. Radiotherapy was thought to offer the best chance of survival for such tumours, despite a likelihood of future learning difficulties. But a decade-long Lancet Oncology study in young children found safer chemotherapy is as good a treatment

Inappropriate Prescribing for Older Patients a Growing Problem
July 12, 2007 - Too many older people are being prescribed too many medicines or the wrong drugs, and more research needs to be done to find out how to fix the problem, say two papers published in this week's issue of The Lancet medical journal. The complexities of the prescribing process, along with other patient, provider and health system factors, are among the reasons why the use of drugs in elderly patients is often inappropriate.

Antidepressants pose low risk to fetuses
June 27, 2007 - Newborns face little risk of birth defects from antidepressants taken by many women early in pregnancy, say the reassuring findings of the two biggest studies of this controversial link. The research focuses on the class of drugs chosen most often for depression and anxiety, including the brands Prozac, Paxil and Zoloft.

Psychiatrists Top List in Drug Maker Gifts
June 26, 2007 - As states begin to require that drug companies disclose their payments to doctors for lectures and other services, a pattern has emerged: psychiatrists earn more money from drug makers than doctors in any other specialty.

Antidepressants May Speed Bone Loss
June 25, 2007 - Older men and women who take the most widely prescribed antidepressants are at increased risk for bone loss, new research shows, but it is unclear if the bone loss is caused by the drugs. Two newly published studies -- one in men and the other in women -- appear to link the use of selective serotonin reuptake inhibitor (SSRI) antidepressants to age-related bone weakening.

Lipid-Lowering Drugs Protect Against Peripheral Diabetic Neuropathy
June 23, 2007 - A major epidemiological study conducted over eight years in Australia has shown that two classes of lipid- lowering drugs -- statins and fibrates -- significantly lower the risk of developing nerve damage known as peripheral sensory diabetic neuropathy, according to a report presented today at the American Diabetes Association's 67th Annual Scientific Sessions.

Dietary supplements face stricter regulations
June 22, 2007 - For the first time, makers of dietary supplements, including vitamins and herbal pills, will be required to test their products, the Food and Drug Administration said Friday. Under the Dietary Supplement Health and Education Act, which passed in 1994, supplement makers were told they must be able to substantiate the safety of their ingredients.

Estrogen May Lower Younger Women's Heart Risk
June 20, 2007 - Women in their 50s who take estrogen therapy have lower levels of dangerous calcium deposits in their arteries, suggesting they're at reduced heart disease risk, researchers say. The study results should reassure younger women who use supplemental estrogen to lessen their menopausal symptoms, but it shouldn't be seen as a license to use hormone-replacement therapy to prevent heart disease, experts said.

GlaxoSmithKline plans 5 new cancer drugs
June 18, 2007 - GlaxoSmithKline PLC, the world's second-largest pharmaceutical company, said that it expects to introduce five new cancer treatments through 2010.

Prostate Cancer Treatment Can Speed Heart Attacks
June 8, 2007 - The male hormone-suppressing treatment used against aggressive prostate cancer may help bring on earlier heart attacks in older men, new research suggests. "The new finding is that in men who have risk factors for heart attack, even six months of androgen-suppression therapy and maybe as little as three months, can cause a heart attack to occur sooner by about 2.5 years," said lead researcher at the Dana-Farber Cancer Institute and Brigham and Women's Hospital in Boston.

Drug May Help Combat 'Chemo Brain'
June 3, 2007 - A so-called "genius pill" may help breast cancer survivors suffering from the syndrome known as "chemo brain," new research suggests. This drug actually improved complaints of memory and attention deficit with “chemo brain,” said study author at the University of Rochester's James P. Wilmot Cancer Center.

Herceptin Heart Danger Stays Same After Five Years
June 3, 2007 - The chances of developing congestive heart failure as a result of using Herceptin in early-stage breast cancer treatment does not increase over time, new research finds. Herceptin (trastuzumab) reduces the risk of breast cancer recurrence by 52 percent after three years. The compound has proven to be effective in the 20 percent to 25 percent of breast cancer cases that test positive for the HER2/neu receptor. But this benefit comes at a cost: 4.1 percent of people taking Herceptin developed heart failure over a three-year period, vs. 0.8 percent of patients who only received chemotherapy.

F.D.A. Is Delaying Approval of Anemia Drug From Roche.
May 19, 2007 - The Food and Drug Administration has delayed approval of Roche's new anemia drug, as concerns mount about the safety of drugs in its class.

These study findings show that 100 percent of the experts on DSM-IV panels overseeing mood disorders and schizophrenia/psychotic disorders were financially involved with the drug industry. These are the largest
categories of psychiatric drugs in the world, with sales in 2004 of $20.3 billion and $14.4 billion, respectively.

Wolfe is among 60 plaintiffs in four lawsuits that have been filed in Nashville, Tenn. against Merck and Novartis, which makes the bone-strengthening drugs Aredia and Zometa. Fosamax is Merck's second best-selling drug, with last year's revenue at $3.2 billion.

Drug Company Forced to Take Antibiotic Off Market
May 1, 2006 - An antibiotic plagued by serious blood sugar complications is coming off the market. Bristol-Myers Squibb confirmed Monday that it plans to stop making and selling Tequin, a drug prescribed for chronic bronchitis, sinusitis, pneumonia, urinary tract and other infections.

Approved for sale in 1999, Tequin has faced questions about its effects on blood sugar, being associated with both high- and low-blood sugar in some patients. In February, the Food and Drug Administration required increased warnings on the label of the drug. The manufacturer has warned that it should not be used by diabetics and said the elderly and those with kidney disease are more likely to have problems. The spokesperson said that while Bristol-Myers Squibb will stop making and selling the drug, stocks currently available are not being recalled. He urged people using Tequin not to discontinue it until they talk with their physician about an alternative.

Tequin had $150 million in global sales last year including $100 million in the U.S.

FDA Orders More Warning on Heart-Failure Drug
April 19, 2005 – A genetically engineered drug that was hailed as a breakthrough in the treatment of heart failure when it was approved in 2001 might actually raise patients' risk of dying soon after treatment, researchers say.

Pooling results from three studies, the researchers found that hospitalized patients given nesiritide appeared much more likely to die in the first month after treatment than those given traditional medication such as nitroglycerin or dummy pills.

The intravenous drug has been given to more than 600,000 patients nationwide.