COMBINING the drug, Herceptin, with hormonal therapy can slow the progress of breast cancer by more than half, a report has revealed.The findings have prompted a call for the treatment to be made available for even more women with breast cancer.

The study found the addition of Herceptin to hormonal therapy kept the cancer under control for a significantly longer time than hormonal therapy alone in patients whose advanced breast cancer was hormone receptor-positive, as well as HER2-positive.

The median progression-free survival was doubled at 4.8 months for patients who received the combination therapy compared with 2.4 months for patients who received hormonal therapy.

Another 15 per cent of high-risk patients treated with the combination therapy remained free from disease progress for at least two years. The results from the study have been presented at a meeting of the European Society for Medical Oncology.

Experts said the study demonstrated Herceptin should be considered the essential component in the treatment of all HER2-positive breast cancers.

HER2-positive breast cancer affects up to 30 per cent of women with the complaint. It is an aggressive form of the disease that requires special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse.

To date, more than 3000 patients with HER2-positive breast cancer, both early and metastatic, have been treated with Herceptin in Australia.

The drug is available on the Pharmaceutical Benefits Scheme.

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There is some evidence that various types of drugs used to treat high blood pressure could hasten or impede the development of type 2 diabetes, but the latest findings don?t support that idea.

According to the results of a study in the medical journal Diabetes Care, the risk of type 2 diabetes does not appear to be increased or decreased in elderly hypertensive patients who use any of the major classes of blood pressure-lowering medications.

Dr. Raj Padwal, of the University of Alberta Hospital, Canada, and colleagues examined the occurrence of type 2 diabetes among previously untreated elderly patients who started treatment for high blood pressure.

A total of nearly 40,000 subjects were on ACE inhibitors, some 20,000 were taking beta-blockers, and about 20,000 were given calcium channel blockers.

More than half of the subjects (53 percent) were excluded from the analysis because of medication discontinuation, and 17 percent were dropped from the study after another medication was added.

The team found that neither ACE inhibitors nor beta-blockers were associated with a significant difference in type 2 diabetes incidence compared to that seen with calcium channel blockers. Similar results were obtained when a sub-analysis looked at patients who were taking a diuretic in addition to another drug. Padwal?s group thinks diabetes should not be a concern when high blood pressure is being treated.

"We suggest that clinicians guide their choice of initial antihypertensive therapy on the basis of more established factors, such as the available evidence regarding efficacy, economic considerations, and the presence of comorbid medical conditions," the researchers conclude.

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Most Medicare prescription-drug plans will stop covering Viagra and other erectile-dysfunction medications next year.

Many beneficiaries are learning of the change this week as they receive materials explaining next year's benefits.

Medicare is a federal health plan available to all Americans age 65 and older, as well as some younger people with disabilities. Enrollment for 2007 will begin Nov. 15.

Medicare's decision follows a similar policy change last year by Medicaid, the nation's health plan for the poor.

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Several insurers who run the drug plans said they supported the change. Dr. Charles Willey, chief executive of Essence Inc. of Creve Coeur, one of the insurers, said paying for the medications was not the best use of the nation's limited health care dollars.

"We have to decide what our priorities are," said Willey, whose Medicare Advantage plan offers drug, physician and hospital coverage under one benefit.

Most health plans offered by Anthem Blue Cross Blue Shield of Missouri, including plans offered to private employers, don't cover erectile-dysfunction drugs, said Deb Wiethop, a spokeswoman. UnitedHealthcare Corp. offers one Medicare plan that covers the drugs. Its other Medicare plans exclude them.

Medicare will continue to cover the drugs, however, if they're used to treat other conditions, such as pulmonary hypertension, for which they've been approved.

There was a heated debate in Washington two years ago as legislators drafting the Medicare prescription-drug bill grappled with whether to include the drugs in the original benefit.

Drug makers and the American Urological Association successfully fought legislators who questioned whether the drugs were more of a lifestyle choice than a necessary medication.

At the time, the Congressional Budget Office estimated coverage of the drugs would cost Medicare almost $2 billion over 10 years. Negotiating discounts and managing usage probably would have helped reduce that figure.

The Department of Veterans Affairs, which covers erectile-dysfunction medications, has negotiated discounts of up to 50 percent for the pills.

For people without insurance, Viagra, Cialis and Levitra typically cost $9 to $11 a pill. Erectile dysfunction is most prevalent among those ages 65 and above; the Congressional Kidney Caucus estimates it affects 30 million men nationwide.

Medicare beneficiaries looking for more information can use a new feature at the agency's Web site, www.medicare.gov. The prescription-drug plan finder, launched Friday, includes information on premiums, covered medications and costs.

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There is widespread support to make medicines for minor illnesses available from pharmacies without a prescription.

In a survey commissioned by the Irish Pharmaceutical Union (IPU) 86% of people supported the idea of allowing pharmacists to provide routine medicines to medical card holders without a GP's prescription. 

Other findings include:

• 90% would like to see increased services, such as blood pressure and cholesterol testing, offered by pharmacists.
• 20% of Irish people are taking 2 or more medications at the same time.
• More than 20% are concerned that they may not be taking their medication correctly.
• Over half of those surveyed said they rely on pharmacists to solve their healthcare problems.

More than 1,000 people were surveyed for the research conducted by Behavior & Attitudes.

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A protein that may help in the development of new anti-tumor drugs has been identified by Mayo Clinic researchers.

The protein -- cyclin-dependent kinase 2 (CDK2) -- acts as a "quality control inspector" during cell division, and also directs cell death for cells that are damaged during division.

Normal cells pause during the division process if they detect an inaccurate genetic code embedded in their DNA. If possible, repairs are made to those mistakes.

When those genetic code errors are irreparable, CDK2 modifies another cellular protein called FOX01 to send a signal that causes the damaged cell to die, the study found.

"Quality control within dividing cells is essential because mistakes during duplication of the genetic code can lead to cancer. CDK2 is a key protein component in the cellular mechanism that leads to repair of damaged DNA," Donald Tindall, co-leader of the Mayo Clinic Cancer Center prostate cancer research program, said in a prepared statement.

This finding offers scientists a potential "bulls eye" for targeting anti-tumor drugs.

The study was published in the current issue of Science

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A new class of diabetes drugs appears to hold promise against sepsis, Texas researchers report.

In animal studies, giving a compound from the family of aldose reductase inhibitors stopped the deadly inflammation of sepsis, which is caused by the overreaction of the immune system to a bacterial infection, according to a report in the Oct. 9 online issue of Circulation.

"Even if you kill all the bacteria, toxin levels are still too high," explained study author Satish Srivastava, a professor of biochemistry and molecular biology at the University of Texas Medical School Branch at Galveston. "Injected into experimental animals, the aldose reductase inhibitor prevented septic shock."

Sepsis killed more than 120,000 hospitalized people in the United States in 2000, and the incidence has been increasing -- from 82.7 cases per 100,000 Americans in 1979 to 240.4 per 100,000 in 2000. "It affects the lungs and kidneys, but the major cause of death in sepsis patients is cardiovascular collapse," Srivastava said.

He has been working for years on aldose reductase, an enzyme that is found throughout the body. It is part of the process by which glucose is converted to fructose and an alcohol called sorbitol. In diabetics, high levels of sorbitol can cause severe eye damage.

Several drug companies have been working on compounds that inhibit aldose reductase activity. One aldose reductase inhibitor, fiderestat, has been approved for use in Japan, and an application for its use in the United States is expected soon.

In the trial reported by the Texas researchers, mice were injected with chemicals that produced the condition of severe sepsis, including severe inflammation and loss of heart function. Injection of an aldose reductase inhibitor called sorbinil restored heart function to near-normal, the researchers reported.

The results were impressive enough for Srivastava to start planning for human trials. "We do plan to go to clinical trials," he said. "We are meeting with people to talk about funding."

The potential for aldose reductase inhibitors in sepsis "is certainly plausible," said Dr. Herbert Wiedemann, chairman of pulmonary, allergy and critical care medicine at the Cleveland Clinic. But, he noted, "there have been many prior approaches that worked in the laboratory and did not work in humans."

In humans, "sepsis is a very complex situation in which the immunological responses play out over time," Wiedemann explained. "In this animal model, treatment was given at one point in time."

Another reason for caution was that the response to the medication appeared to drop off as time passed, he said. The animals were pretreated, and "the efficacy dropped off quite a bit two hours later," Wiedemann said. "In humans, you usually don't have the opportunity to pretreat."

The work does hold promise, and human trials certainly are warranted, he said. One reason for hope is that the aldose reductase inhibitors appear to stop production of all the toxins causing physical damage, Wiedemann said, but he still counseled caution based on previous experience.

"When you look at these papers, the results are so convincing," he said. "When it works in an animal model, we think we're home, but this has been going on for years."

If this latest research does not pan out, work has shown these compounds can reduce the damaging inflammatory processes in colorectal cancer, the Texas researchers added.

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"The drugs, commonly known as 'Chinese Viagra', are supposedly manufactured by Feng Tai Industry and Company, a Chinese firm, and are allegedly being sold as Baiyee, Yang Gang and Cialis," said an official of the ministry's drug control directorate, who did not want to be named.

"It is also claimed that the use of these drugs increase energy levels.

"Satibo Capsule and Tongkat Ali Plus, which are also allegedly available at some cold stores, have also been banned and should not be consumed."

The official said since these drugs were banned in Bahrain early this year, all stocks had been recalled.

"However, we are trying to track down some consignments, which are probably still there in some pharmacies and also trying to ascertain whether some of them have actually been passed on to cold stores to be sold," he said.

The official said some of these have been found at pharmacies and they have been told to take these off their shelves.

"We advise people not to purchase them since they had failed our tests, which showed they contained the chemical Sildenafil, used in Viagra, but is dangerous if used without medical supervision," he said.

The official said health inspectors were aggressively following up and checking on whether all pharmacies and health food stores have complied with the ministry directives.

A doctor at the Salmaniya Medical Complex said using Sildenafil without proper monitoring could lead to severe hypotension (very low blood pressure), myocardial infarction, ventricular arrhythmias, sudden death, stroke and increased intraocular pressure.

He said some common side effects include sneezing, headache, flushing, dyspepsia, prolonged erections, palpitations and photophobia.

"Visual changes including blurring of vision and a curious bluish tinge on the body have also been reported," he said.

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They were considered the most effective weight loss drugs available. But almost a decade after Fen-Phen was pulled off the shelves, researchers are still looking for a formula to slide the scales toward skinny.

Now a new clinical trial shows promise in melting away the pounds.

Like Fen-Phen, the trial combines two drugs already approved by the FDA where the side benefit has been weight loss. The idea is putting the two together will equal greater benefits for the patient.

One of those trying the medication says, "I don't feel as hungry. I feel like I'm more in control of when I'm eating instead of trying to eat everything in sight. I get full and I stop."

In this study, Wellbutrin, an anti-depressant, deals with seratonin, while an anti-seizure drug goes for the dopamine - another messenger that tells the brain the body's full.

Maria Lightford is one of 45 patients who will be followed for the next year. She says the early results are a boost that's helping her get on track to a healthy lifestyle.

And she welcomes whatever help she can get. "If it'll help you lose weight, why not?"

Doctors say the potential side effects of these drugs could include numbness, tingling and a feeling of fogginess.

Another phase of the trial will get underway in a matter of months.

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Non-steroidal anti-inflammatory drugs (NSAIDs) and COX-2 inhibitors (a newer generation of NSAIDs), both commonly used drugs to treat osteoarthritis, 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.

Osteoarthritis is a joint disease that causes erosion of cartilage and leads to friction between bones. Its precise cause is unknown, though it has been linked to aging, specific occupations, trauma, genetics and repetitive, small injuries over time. The rubbing causes pain, swelling, and loss of motion. Osteoarthritis is different from rheumatoid arthritis, an autoimmune disease that causes joint pain and other problems.

The study, based on a review of 360 published studies of arthritis pain medications, revealed that exception is the drug naproxen, commonly sold as Aleve or Naprosyn, a medication that scientific evidence suggests presents a lower risk of heart attack for some patients than other NSAIDs or COX-2 inhibitors.

Researchers say that all drugs pose potential harms along with benefits depending from patient to patient on how they react to drugs, how they prioritize risks, and whether risks are acceptable when compared to a drug's benefits. Patients should talk to their doctors before changing any medications.

Researchers compared the pain medications' effectiveness and health risks, including heart attack and gastric side effects, plus identified topics where more research is needed. While the review yielded important findings about the painkillers, it concluded more studies are needed about the drugs' comparative risks, the consequences of long-term use, and the impact of dosing variations. The authors also suggested that genetic research may one day predict which patients are most likely to develop cardiovascular problems when taking the analgesics.

Osteoarthritis affects mostly older people, but younger people with joint injuries also may be afflicted. About 6 percent of U.S. adults 30 or older have osteoarthritis of the knee, and about 3 percent have osteoarthritis of the hip. In 2003, Americans spent about $36.6 billion on treatments for osteoarthritis and other non-traumatic joint disorders, including hospitalizations, surgeries, diagnostic tests, drugs, home care and other interventions, according to federal estimates. Of this amount, about $5.5 billion was spent on COX-2 inhibitors and $3 billion on other NSAIDs.

The AHRQ report concludes:


All NSAIDs and COX-2 inhibitors can cause or worsen hypertension, congestive heart failure, swelling and impaired kidney function.
No clear difference has been shown in pain-relief effectiveness among NSAIDS and COX-2 inhibitors.
Most NSAIDs and COX-2 inhibitors pose similar increased risks of heart attack.
The NSAID naproxen carries a smaller risk of heart attack than other NSAIDs or COX-2 inhibitors.
The risks of serious adverse gastrointestinal events for users of Celebrex are similar to the risks for users of Motrin, Advil, Voltaren and other NSAIDs.
More scientific evidence is needed to compare the cardiac and gastrointestinal risks of aspirin at doses effective for pain relief versus other NSAIDs.
Acetaminophen (Tylenol) generally reduces pain less effectively than NSAIDs but carries a smaller risk of gastrointestinal problems. One study showed high doses posed heart attack risks similar to NSAIDs.

NSAIDs being the primary treatment for osteoarthritis for years includes prescription medications, such as sulindac (sold as Clinoril) and diclofenac (Voltaren, Cataflam), as well as over-the-counter medicines such as aspirin, and medications with both prescription and over-the counter versions, such as ibuprofen (Motrin, Advil) and naproxen (Naprosyn, Aleve).

Traditional NSAIDs work by inhibiting the action of two related enzymes. One of the enzymes reduces inflammation, eases pain and prevents blood clotting. But the intervention also limits the other enzyme's ability to protect the stomach lining from digestive chemicals and help maintain kidney function. Each year, an estimated 16,500 people die due to NSAID-induced gastrointestinal problems.

Many experts initially expected that COX-2s, which target only the enzyme that stimulates inflammation, would not cause the same stomach problems as traditional NSAIDs. Unexpectedly, the drugs were linked to serious cardiovascular problems. Two COX-2 inhibitors – rofecoxib (Vioxx) and valdecoxib (Bextra) – were voluntarily withdrawn from the market because of heart attack risks. Evidence on a third COX-2 inhibitor, celecoxib (Celebrex), suggests that it does reduce the risk of bleeding and other ulcer complications in patients using the drug for less than 6 months, but it is not clear if it is safer than other NSAIDs when used for longer periods of time.  

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