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Cancer Vaccine, Cancer Treatment and New Cancer Discovery

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First batch of cancer vaccine from Cancer Vaccine Collaborative goes into trial The first batch of NY-ESO-1 recombinant protein produced in a facility supported entirely by non-profit entities has successfully cleared regulatory review and has entered clinical testing.

cancer

Discovery of compounds that selectively kills cancer stem cells The researchers narrowed that list down to a handful of chemicals that they could readily get in sufficient quantities for further testing on normal cancer stem cells. Of those, one called salinomycin was the clear winner.

New method takes aim at aggressive cancer cells The cells, known as cancer stem cells, are thought to enable cancers to spread — and to reemerge after seemingly successful treatment. Evidence is accumulating rapidly that cancer stem cells are responsible for the aggressive powers of many tumors …

Fighting Cancer With Anti-Psychotic Drugs people taking medication for schizophrenia have lower cancer rates than other people. Rapidly-dividing cancer cells require cholesterol and lipids to grow and the researchers suspect that pimozide kills cancer cells by blocking the synthesis or movement of cholesterol and lipid in cancer cells.

OncoGenex Expands Clinical Development of OGX-427 with a Phase 1 Clinical Trial in Bladder Cancer The study, which will enroll up to 36 patients with bladder cancer, is designed to determine the safety and potential benefit of OGX-427 administered directly into the bladder using a catheter, which is called intravesical instillation.

New Lung Cancer Vaccines May Lower Costs, Accelerate Treatment The vaccines, which could be considered “personalized medicine,” are designed to stimulate the body’s natural defenses against cancer. By attacking proteins and molecules associated with cancer development, TCVs have the potential to shrink tumors and slow their growth.

Aspirin Use After Colorectal Cancer Diagnosis Associated With Improved Survival Men and women who were diagnosed with colorectal cancer and began regular use of aspirin had a lower risk of overall and colorectal cancer death compared to patients not using aspirin.

An “off switch” for cancer - Cancer cells divide uncontrollably and can move from one part of the body to another. DeWard and Art Alberts, identified a new mechanism for regulation of formins during cell division. Alberts said. “Our goal now is to exploit this information in the development of strategies to specifically stop the process of uncontrolled cell division that characterizes cancer.”

Scientists take the first step to targeted treatment for stomach cancer - Scientists explored the role of a protein called RAMP in stomach cancer cell lines and tissues, finding that it is more common in these cells compared to surrounding normal tissues.

New Anti-AIDS pill under development

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New anti-aids pillScientists are developing an anti-AIDS pill that can be taken before sex and prevent transmission of the deadly disease.

The successful development of such a treatment would be controversial because it raises ethical questions about the circumstances in which the pill should be taken.

Experts in the disease, which claimed two million lives last year, are involved in scientific trials on antiretroviral drugs that already used to prevent transmission of AIDS from infected mothers to their babies during birth.

Scientists are hopeful that similar protection can be offered during sex.

Three trials of antiretroviral drugs are underway around the world. A report published in the Lancet claims they are “showing great promise” as experts meet in Mexico City for the International Conference on AIDS.

More research has to be done on the side-effects of the pill and the development of resistant strains of HIV before it is made available.

Controversy is bound to arise over who should take the pill and for what reasons. Globally, use would probably have to be restricted to those at greatest risk from AIDS such as sex workers or injecting drug users.

The pill could also have a major impact on the lifestyles at a time when experts have observed that promiscuity is on the rise.

“The party scene involving multiple sexual partners is definitely back in London and probably in most European cities,” said Sheena MCormack, a specialist in HIV prevention and reader in clinical epidemiology at Imperial College London, said.

“There is metrosexual mixing involving gay, bisexual and some heterosexual cases. We estimate new HIV infections in gay men are running at three per cent a year.”

She added: “People could pop a pill on a Friday night and be covered for a whole weekend.”

The trials involve 2,400 drug injectors in Thailand, 1,200 heterosexual men and women in Botswana and 3,000 homosexual men in America, Africa and Asia.

Experiments on primates suggest that the drugs are effective and can prevent the disease being passed. But their success in humans has yet to be proved, the Lancet report by Nancy Padian of Women’s Global Heath Imperative, San Francisco, said.

The trials use tenofovir, a drug currently used to treat AIDS, with a combination of other drugs.

Tenofovir (Trade name Viread) is an anti-HIV drug approved by the FDA (In October of 2001) to be used in combination with other HIV fighting medications. Viread belongs to a new class of drugs called Nucleotide Reverse Transcriptase Inhibitors (NtRTI). These are related to Nucleoside Reverse Transcriptase Inhibitors (NRTI) like zidovudine (AZT, Retrovir). The body converts Viread into a chemical that prevent HIV from reproducing in uninfected cells, but it does not help cells that have already been infected with the virus. As people with HIV lose CD4 cells - one of the immune system’s main defenses - they become more likely to get infections and illnesses.

Self-Dosing Pain Medications - be careful!

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painkillersAllowing patients to control their own pain medication intravenously is four times more likely to cause the patient harm than other medications, a new study says.

The report, published in the December issue of The Joint Commission Journal on Quality and Patient Safety, shows that most mistakes involving intravenous patient-controlled analgesia (PCA) resulted from either human error, equipment issues or communication problems that led to the patient receiving the wrong dosage or drug. PCA errors also tended to be more severe — harming patients and requiring clinical interventions — than other types of medication errors.

“The entire PCA process is highly complex,” lead author Rodney W. Hicks, the UMC Health System Endowed Chair for Patient Safety at Texas Tech University Health Sciences Center in Lubbock, said in a news release issued by the journal’s publisher. “PCA orders must be written, reviewed, and then accurately programmed into sophisticated delivery devices for patients to be pain free. Such complexity makes PCA an error-prone process. Health care organizations should now plan to make the process safer.”

The five-year study uncovered more than 9,500 PCA errors. Patients were harmed in 6.5 percent of these incidents, compared to 1.5 percent for general medication errors.

In PCA, a computerized pump with a syringe of prescribed pain medication is hooked straight into a patient’s intravenous (IV) line. The patient can self-dose by pushing a button.

Hicks and his co-authors make three recommendations to reduce future PCA errors:
Simplify the equipment. Easier step-by-step setup instructions could cut down on programming errors by caregivers setting up the PCA machine’s dosage levels.
Use bar codes and keep an electronic medication administration record. Making a standard practice out of independent double-checks of the PCA orders, the product, and the PCA device could help prevent giving patients’ the wrong medication.
Design and use easy, standardized forms for PCA. Use of universal forms by pharmacists could correct communication issues in the process.

Painkillers Linked to Increase in Overdose Deaths

Deaths from overdoses of prescription drugs, primarily pain relievers, appear to be on the rise throughout the United States, new research suggests.

West Virginia, in particular, has seen a large increase in such unintentional deaths, say government researchers, who have uncovered patterns of “doctor shopping” for drugs and overdosing on medications not used as prescribed.

Serevent and Foradil asthma drugs may be risky

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asthma drugsThe risks of two widely used asthma drugs outweigh their benefits for both children and adults, a U.S. Food and Drug Administration advisory panel said Thursday.

The health panel targeted GlaxoSmithKline’s Serevent and Foradil, made jointly by Novartis AG and Schering-Plough, for restrictions, but it excludedAdvair, Glaxo’s biggest-selling drug in the class of medications known as long-acting beta-agonists. It also left alone a fourth such drug, AstraZeneca’s Symbicort.

The health experts did not say that the use of Serevent and Foradil should be abandoned altogether. Instead, they said the medications’ labeling should be reworded to urge doctors to use the drugs along with an inhaled corticosteroid — as guidelines already recommend.

That may help explain why Advair and Symbicort were spared. Serevent contains just one active ingredient, salmeterol, while Foradil contains only formoterol. Advair is a combination of both salmeterol and fluticasone (an inhaled cortocosteroid), while Symbicort contains formoterol and another steroid (budesonide). All of these drugs relax airway muscles, letting asthma patients breathe more easily.

The controversy over these drugs has been going on for several years, with two FDA officials recently calling for banning the use of these drugs for anyone under 17. The results of studies noting a rise in asthma-related deaths by people using the medications have already resulted in a black-box warning that use could “increase the risk of asthma-related death.”

The advisory panel voted 10 to 17 on whether the benefits of Serevent outweighed its risk as maintenance therapy for adults, and voted 6 to 21 on the same question for adolescents ages 12 to 17, Dow Jones reported. Foradil received similar votes on the same questions: 9 to 18 for adults and 6 to 21 for adults.

The panelists were unanimous in voting that the benefits of the two drugs did not outweigh risks when used for children ages 11 and younger.

The announcement followed a two-day meeting on the issue by the expert advisory panel. The FDA is not obligated to follow the advice of its advisory panels but usually does so.

Speaking before Thursday’s decision, one expert said the problem is not with the drugs, but with their misuse.

“This is an over-interpretation of the risk without adequate consideration of benefit,” said Dr. Miles Weinberger, a professor of pediatrics at the University of Iowa. “However, there has been irresponsible marketing of the products, salmeterol and formoterol, and irresponsible prescribing by many physicians.”

“Since most patients with chronic asthma can be controlled with inhaled steroids alone, using these more expensive combination formulations as first line is inappropriate but strongly encouraged by marketing practices” of drug makers, Weinberger said.

In the panel’s first day of hearings on Wednesday, FDA officials themselves were split over the risks of the drugs.

One official told the panel members that more than 14,000 people may have died since 1994 after taking the drugs, while another suggested that an even greater number might have died without them, according to The New York Times.

Last week, two FDA officials, who work in the agency’s safety division, posted an assessment on the agency Web site, saying asthma sufferers of all ages should not take the medicines. But a third FDA official concluded that Advair and Symbicort are safe for adults, but that all four drugs should no longer be used by children 17 and younger, the Times said.

The panel was reviewing an FDA study of 110 trials that included 60,954 people and found an increase in asthma-related hospitalization, asthma-related intubation, and asthma-related death in asthmatic patients with the use of these drugs. The risk varied, however, depending on the particular drug studied.

For example, there were 20 asthma-related deaths, 16 among people taking long-acting beta agonists compared with four patients not taking these drugs. All the deaths were in patients taking Serevent, the FDA notes.

The increased risk wasn’t seen when a long-acting beta agonist was used along with an inhaled corticosteroid, the agency found.

The greatest risk appears to be among children aged 4 to 11; women also appeared to be at greater risk than men.

Weinberger thinks that long-acting beta agonists should be used only in combination with inhaled steroids.

“All trials of the combination of long-acting beta agonists and an inhaled steroid demonstrate substantial additive effect for patients not fully controlled on the inhaled steroid alone,” Weinberger said. “The sensible approach is to use the combination products only after inadequate control is observed with an inhaled steroid alone.”

For their part, the drugs’ manufacturers said they believe there is adequate evidence that their products are safe and effective when used properly.

In a joint statement issued after the panel voted, Novartis and Schering-Plough said both companies “remain confident in the safety and efficacy of Foradil.” The statement added, “Novartis and Schering-Plough strongly disagree with the Joint Advisory Committees view that the benefits of Foradil do not outweigh its risks in patients using it according to current product labeling for the maintenance treatment of asthma. We believe this opinion is inconsistent with clinical evidence supporting the benefit/risk profile of Foradil in patients not adequately controlled on other asthma-controller treatments.”

In its statement before the vote, AstraZeneca said the company “believes that Symbicort exhibits a favorable benefit-risk profile in patients 6 years of age and older. Symbicort offers an important therapeutic option for asthma patients who cannot be adequately controlled on other asthma controller medications [low- to medium-dose inhaled corticosteroids] or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.”

Inhaled insulin Exubera may cause lung cancer

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Exubera insulinUS drugmakers Pfizer Inc and Nektar Therapeutics on Wednesday warned of cases of lung cancer in clinical trials of their inhaled insulin Exubera.

The findings led Nektar to announce it was abandoning its search for a new marketing partner for the troubled drug, effectively signaling Exubera’s demise after entering the market in January 2006.

Pfizer, the world’s largest pharmaceutical company, announced last October it stopped marketing Exubera, saying it did not meet customer needs or the financial expectations of the company.

The rise in lung cancer apparently linked to Exubera led Pfizer to update the medication’s warning label to include information “about lung cancer cases observed in patients who used Exubera,” the company reported in a statement.

It said that over the course of the clinical trial, six out of 4,740 Exubera-treated patients developed lung cancer, versus one of the 4,292 patients not treated with Exubera.

An additional case of lung cancer in an Exubera-treated patient was discovered after the drug’s debut on the market following its approval by the US Food and Drug Administration.

The updated label states that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were “too few cases to determine whether the development of lung cancer is related to the use of Exubera.”

“Some patients continue to take Exubera, including those enrolled in extended transition programs or clinical trials,” Pfizer chief medical officer Joe Feczko said in the statement.

“We are working closely with patients and their physicians to ensure the continued orderly transition from Exubera to alternative therapies,” he added.

Nektar announced it was stopping all spending on the drug, including research and marketing.

“The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners,” said Nektar president Howard Robin on the company’s website.

Diabetes affects 230 million people worldwide, including 21 million in the United States, according to Pfizer. Exubera is a short-acting insulin breathed in through an inhaler that helps control high blood sugar in people with diabetes.

Pfizer warns Exubera patients about risk

Pfizer Inc. said Wednesday it is warning patients using its inhaled insulin product Exubera about the risk of lung cancer, leading Nektar Therapeutics to terminate its inhaled insulin programs.

Nektar had been Pfizer’s partner on Exubera from 1995 until Pfizer discontinued the drug in October 2007 after lackluster sales. Some patients continue to take the drug, however, including some enrolled in extended transition programs or clinical trials.

On Wednesday, Pfizer said it updated the U.S. product labeling for Exubera Inhalation Powder to include a warning about lung cancer cases observed in patients who used the inhaled insulin treatment.

Over the course of Exubera’s clinical trial program, 6 of the 4,740 patients treated with Exubera developed lung cancer, compared with 1 of the 4,292 patients not treated with the drug.

There was also a post-marketing report of lung cancer in one Exubera-treated patient.

The label notes that all patients who developed lung cancer had a prior history of cigarette smoking, and that there were too few cases to determine whether the cancer is related to use of Exubera.

Pfizer said the data was reviewed by the company and the Food and Drug Administration.

Nektar said it will stop all spending associated with its inhaled insulin programs and will not incur any additional charges related to the action.

“The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners,” said Howard W. Robin, president and chief executive of Nektar, in a statement. “Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin.”

Exubera

Generic Name: insulin inhalation
Brand Names: Exubera

What is Exubera?

Insulin inhalation (Exubera) was withdrawn from the U.S. market in 2007 due to lack of consumer demand for the product. No drug safety concerns were cited in this withdrawal.

Exubera is a rapid-acting form of human insulin that is inhaled through the mouth. It works by lowering levels of glucose (sugar) in the blood.

Viagra’s 10th anniversary

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Ten years ago this month the lives of millions of men and women were changed almost overnight by the advent of a little blue pill — the first oral treatment for impotence.

Viagra pillsViagra, developed by accident by scientists at Pfizer Laboratories, was first approved for use by the US Food and Drug Administration on March 27, 1998.

“Originally, we were testing sildenafil, the active drug in Viagra, as a cardiovascular drug and for its ability to lower blood pressure,” said Dr Brian Klee, senior medical director at Pfizer.

“But one thing that was found during those trials is that people didn’t want to give the medication back because of the side effect of having erections that were harder, firmer and lasted longer.”

Since Viagra went on the market it has been used by 35 million men around the globe, and it took impotence off the taboo list, making it infinitely easier to treat.

Urologists’ waiting rooms became busier as news got round that the condition, which was rechristened with a new, scientific name — erectile dysfunction, or ED — could be treated with a triangular blue pill.

Previous treatments had involved surgically inserting a prosthesis into the penis, injecting a substance into the male sex organ or using urethral suppositories.

“Viagra brought a lot more people into the office because of the ease of treatment,” Dr Irwin Shuman, a urologist of 40 years’ experience in Washington, told AFP.

“In the old days, when we didn’t have much in the way of treatment, we would do a lot more evaluation, looking for answers as to why somebody had the problem,” he said.

In one test, men would be observed while sleeping to see if erections occurred.

Men who failed to get the usual five to six erections per night were deemed to have a physical problem, and those who did get nocturnal erections were said to have a psychological problem and were sent to see a sex counsellor.

So Viagra helped move impotence out of the psychological realm and into the world of physical illnesses. “What we have come to understand in the past 10 years is that ED is a vascular disease,” said Klee.

“What happens is veins and arteries that deliver and remove blood from the penis are not working the way they should, and Viagra allows those vessels to dilate and increase blood flow to the penis,” he said.

Dr Abraham Morgentaler, director of Men’s Health Boston, and associate clinical professor of urology at Harvard Medical School, hailed Viagra as a “benefit to medicine.”

But, he added, the drug has not delighted all those who took it.

“There are two truths to Viagra: for those who refill (get a new prescription), it’s wonderful and they’re happy,” Morgentaler told AFP.

“But a lot of people look to Viagra for personal happiness, thinking a hard penis can resolve relationship issues,” and they end up disappointed, added the doctor and author of the book “The Viagra Myth.”

Some patients say taking Viagra “does not correspond to the way they want to have sex,” Morgentaler said.

Viagra works best on an empty stomach or after eating a low-fat meal, the medication’s official website says. It kicks in about 30 minutes after being taken, works for four hours, and only with sexual arousal, the website says.

But it’s not the answer for everyone. Morgentaler said he had a 78-year-old patient in his office who “didn’t like the idea of programming sex. Guys, and often women, too, don’t necessarily want to compromise the ideal of sex as something magical, spontaneous, romantic.”

Morgentaler also spoke of the darker side of Viagra, which has evolved since it and two other ED treatments became easily available over the Internet.

“It’s the use of Viagra by healthy young men who don’t need it,” he said.

“These young men take a pill whenever they go out … Maybe because they are inexperienced or shy and Viagra makes them more confident, or maybe because they have inflated ideas about what sex is supposed to be like from seeing Internet porn, which they also have easy access to, and they want to heighten their feelings of masculinity,” he said.

“I am concerned — not that these young men will get addicted physically, but that they will become psychologically dependent on Viagra,” said Morgentaler.

“Sex is an entree into a relationship, and most often what we want from a relationship is to be loved for what we are.

“But some of these young men feel they have to take a pill to be acceptable, and I fear they are potentially missing the opportunity to have true emotional connections with a partner, based on reality, not mythology.”

Viagra celebrates its 10th birthday

The potency enhancing drug Viagra has been on the market for 10 years. In 1998, pharmaceutical company Pfizer introduced the erection drug that was to change millions of lives at a stroke. A solution to erectile dysfunction had been found, and the taboo surrounding impotence was largely a thing of the past.

The little blue pill that enabled millions of couples to reawaken their sex lives was discovered by accident, says sexologist Vera Steenhart of the Dutch Sexology Association. Pfizer was actually looking for a drug for the heart problem angina pectoris. The pills didn’t appear to be benefiting the test subjects, but they refused to give them back. Ms Steenhart:

“The manufacturers found this strange. On further investigation, they found the drug gave the male patients an erection. They were extremely happy about it.”

Effect
The forerunner to Viagra was developed to make blood vessels relax. The test subjects were given the drug to improve blood circulation to the heart to reduce the chance of heart failure. Viagra has the same effect on the penis. When the man is sexually stimulated, the blood supply is improved and it becomes easier for him to maintain an erection.

It’s a myth that the pill can produce an unwanted erection. The user does actually have to be in the mood, so Viagra has little or no effect if he is unwilling to have sex or feels anxious about it. In that case it would be more appropriate for him to have a good talk with his partner or pay a visit to a psychologist or sexologist.

Free drug samples make you spend more!

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Free drug samplesPatients who receive free drug samples from their doctors end up having significantly higher out-of-pocket costs for their prescription drugs than people who don’t receive free samples, a new study finds.

In fact, patients who received free samples spent about $166 in out-of-pocket costs on prescription drugs in the six months before receiving the samples, $244 for the six months in which they received samples, and $212 for the six months following receipt of the free drugs, the study found.

But patients who didn’t get free samples spent about $178 on prescription drugs over six months.

“This is a curious finding because one would think, intuitively, that if you receive a free sample, one’s out-of-pocket prescription cost would be lower, not higher,” said lead researcher Dr. G. Caleb Alexander, an assistant professor of medicine at the University of Chicago Medical Center.

There are several possible explanations for the finding, Alexander said. One is that patients who receive free samples may be sicker than patients who don’t get samples.

“The second possibility is that patients who receive free samples may go on to receive and fill prescriptions for the very same medicine that were initially begun as free samples,” Alexander said. “We know that drugs that are available as free samples are those that are being widely marketed and promoted and these drugs are more expensive than their older, less promoted counterparts.”

The study findings are published in the March 24 issue of the journal Medical Care.

For the study, Alexander’s team collected data on 5,709 patients who had participated in the Medical Expenditure Panel Survey. The survey was done by the U.S. Agency for Healthcare Research and Quality and the patients were followed for up to two years.

Seventy-six percent of the patients had private health insurance. During the study period, 14 percent of them were given at least one drug sample. A total of 2,343 samples were distributed during the period, the researchers found.

Patients who received free samples were more likely to be younger and have private insurance, while patients with Medicaid were less likely to receive samples, the researchers noted.

The findings follow earlier research, reported in the February issue of the American Journal of Public Health, in which Harvard University researchers showed that more than 80 percent of free drug samples were given to wealthy and insured patients, not to uninsured and poorer patients.

Alexander said there are many ways doctors and patients can work together to reduce drug costs, but giving away free samples may not be the best one.

“Doctors and patients both should be encouraged to consider alternative ways to reduce patients’ out-of-pocket costs,” he said. “There are many other strategies doctors can use, such as prescribing a three-month rather than a one-month supply, such as using greater numbers of generic medicines, and discontinuing non-essential medicines.”

Dr. David Katz, director of the Yale University School of Medicine’s Prevention Research Center, said free samples aren’t designed to help lower drug costs, but rather to sell newer and more expensive drugs.

“Almost every clinician’s office is stocked with drug samples,” he said. “For patients and providers alike, these free drugs can take on the aura of Halloween goodies. Passing them out feels like giving a gift.”

But, Katz added, “free samples are by no means a long-term solution to high prescription drug costs. Rather, they are at least, in part, a marketing device, a chance to sample the wares.”

The pharmaceutical industry had this to say: “Free pharmaceutical samples are beneficial to patients of all income levels. Patients are able to try out a new therapy - gaining valuable first-hand experience of its benefits and side effects - without making a co-payment,” said Pharmaceutical Research and Manufacturers of America (PhRMA) senior vice president Ken Johnson.

“What’s more, contrary to statements made by critics, America’s physicians prescribe medicines based on a wide range of factors, not simply receipt of free prescription drug samples,” Johnson added in a prepared statement.

Free Drug Samples? Bad Idea, Some Say

Everyone loves freebies, and patients are no exception. So drug company sales representatives try to keep sample cabinets in medical offices well stocked with the latest medications, for doctors to dispense as the need arises.

Patients like going home with free samples because it saves them a trip to the drugstore and a co-pay, and doctors are happy to oblige, because samples help patients get started on treatment right away.

But now some leading academic medical centers are restricting the use of samples, and a smattering of physician practices are shutting down the sample cabinet. These critics say doctors should be choosing the most appropriate medication for a patient based on the best scientific evidence available — not just grabbing something from the office stash that happens to fit the bill.

“The doctor will say, ‘Here, start on this, and let’s see how it works,’ ” said David J. Rothman, president of the Institute on Medicine as a Profession, a research group at Columbia. “The question to the doctor is: If you didn’t have it in your drawer, would that have been your drug of choice?”

The crackdown on free samples comes amid growing concern about the close ties between physicians and drug companies. Critics like Dr. Rothman say physicians don’t realize the extent to which their medical judgment is influenced by their acceptance of the samples. They point to studies like a 2002 paper in the journal Annals of Family Medicine finding that the number of doctors who treated high blood pressure with the “first line” drugs recommended by national guidelines was low, but increased sharply when free samples were removed.

So far, the University of Michigan Health System has banned free samples altogether, and the University of Pennsylvania and Stanford University medical schools have prohibited staff members from accepting them (though samples can be given to Stanford’s pharmacy for use in free clinics).

Some medical groups and solo practitioners have also changed their policies. Dr. Jonathan Mohrer, an internist in Forest Hills, Queens, said he closed his sample cabinet in part because his office was overrun with sales representatives. “It was totally spinning out of control,” Dr. Mohrer said. “They were meeting each other and schmoozing in the waiting room — it was like a party.”

His office staff had to spend time arranging the cabinet, throwing out expired medications and rummaging around for the right drug. Patients were kept waiting while sales representatives were whisked in.

But there’s an upside to the samples. Using samples, a doctor can see if a patient can tolerate a new medication before the patient goes out and buys a 30-day supply. Physicians who treat poor people like to have samples on hand for them, and for uninsured patients.

Samples also provide patients with the convenience of one-stop shopping, said Dr. Hema A. Sundaram, a dermatologist in suburban Washington. “Usually a patient has waited some time to see a doctor and rearranged their whole working schedule, and then it may be another four or five days before they can fill a prescription,” she said. “They’re often busy, working people, with family responsibilities. I feel there shouldn’t be any further delay.” (Dr. Sundaram acknowledges that she is paid for speaking on behalf of drug companies.)

And many physicians say they like using samples because the sales representatives are an important source of medical education, helping to keep the doctors up to date on the latest therapies.

“Doctors who are shutting the door to sales reps are cutting themselves off from a lot of valuable information,” said Scott Lassman, senior assistant general counsel for the Pharmaceutical Research and Manufacturers of America, a trade association. “Sales reps can explain when it’s right to use a drug, when it’s not right to use the drug, which patients might benefit and which patients it might not work for.”

Some doctors are skeptical. “The sales reps are nice people, and they try to do a really good job,” said Dr. Judith Chamberlain, medical director of the Bowdoin Medical Group, a practice near Portland, Me., that banned samples this year. “But their job is to get you to use their product.”

A 1995 study in The Journal of the American Medical Association found that 11 percent of the statements drug company representatives made during presentations were inaccurate, and all of the inaccuracies were skewed in favor of their products.

The drugs promoted through free samples tend to be the newer medications that doctors are less familiar with, experts say. Some critics of samples say they prefer using older drugs anyway, because their side effects are better known. Critics also point out that helping poor and uninsured patients is not the intent of the sample distribution, and they add that developments like Medicare’s prescription-drug coverage, the proliferation of generic drugs and improvements in drug company patient-assistance programs have eased access to medication.

As for the bottom line, it’s not at all clear that samples save patients money. Critics say they may actually drive up the cost of health care in the long run, because the drugs being promoted are the most expensive brand-name medications. Since many conditions require lifelong treatment, the patient would have to buy the medicine sooner or later.

“You’re going to be paying more, because you’re taking the new, advanced drug,” Dr. Rothman said. “And you may have done just fine on the old-fashioned generic.”

Do free drug samples influence residents’ prescribing decisions?

When a pharmaceutical company puts drug samples into the hands of residents as a form of marketing, how does it influence their prescribing behavior? To what extent are treatment decisions based on which samples are available and further, what are the implications for patient care as well as resident education? While this is a frequently debated issue, there has been little objective data describing how drug samples affect resident physicians. In a study published in the August issue of The American Journal of Medicine, researchers from the University of Minnesota and Abbott Northwestern Hospital conducted a randomized study of 29 internal medicine residents over a 6-month period in an inner-city primary care clinic. Highly advertised drugs were matched with drugs commonly used for the same indication that were less expensive, available over-the-counter, or available in generic formulation. By random selection, half of the residents agreed not to use available free drug samples. The authors observed 390 decisions to initiate drug therapy in five drug class pairs.

Fosamax associated with unusual fractures of the thigh bone

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FosamaxIn the latest research to cast a shadow on the safety of a popular bone-strengthening medication, researchers report that long-term use of Fosamax is associated with unusual fractures of the thigh bone.

The fractures were low-energy fractures, meaning that they all occurred from a fall from standing height or less, and the bone cracks were in an unusual horizontal pattern. About one-third of women with these types of fractures were on long-term therapy to prevent osteoporosis, the researchers noted. Of these women, two-thirds were taking Fosamax (alendronate), for an average of more than seven years.

Fosamax is a bisphosphonate, a class of drugs used to increase bone mass and reduce the risk of fracture in those who have osteoporosis.

“These were peculiar fractures that would occur when the women were basically doing nothing,” said the study’s senior author, Dr. Joseph Lane, chief of metabolic bone disease at the Hospital for Special Surgery at Weill Cornell Medical College in New York City.

Fifteen women were included in Lane’s analysis. The average time on Fosamax was 5.4 years before they experienced the unusual femur fracture. Of these 15, 10 women had similar, atypical fractures. These women had been taking Fosamax for an average of 7.3 years, while the remaining five had only been on the drug for an average of 2.8 years.

“Our results provide further evidence of a potential link between alendronate use and low-energy fractures of the femur,” the authors said in a letter reporting their findings, which is published in the March 20 issue of the New England Journal of Medicine. But, the authors acknowledge the limitations of their retrospective analysis and suggest that these findings need to be confirmed in a prospective study.

Lane said there are several theories as to how alendronate could be related to these fractures. One is that the drug slows down the development of new collagen, and he said new collagen is very strong. Another could be because there is slower bone turnover on the medications. That could mean there may be accumulated microdamage in the bone, making it more susceptible to fracture in certain women.

Lane said that women taking this medication should keep taking it, and these findings shouldn’t cause them alarm. “This is a great drug that does wonderful things. Bisphosphonates have dropped the rate of hip fractures,” he added.

Ron Rogers, a spokesman for Merck, which manufactures Fosamax, said, “Fosamax has not been associated with an increased risk of fracture at any skeletal site.” Rogers also noted that this study didn’t prove a cause and effect relationship between the drug and these unusual fractures, and that the researchers noted that 63 percent of women treated for low-energy fractures weren’t taking bisphosphonates at all.

Dr. Loren Wissner Greene, co-director of the osteoporosis and metabolic bone disease program at the New York University School of Medicine, agreed that this study has just pointed out an association between Fosamax use and these fractures, not proven a causal relationship.

Still, Greene said she believes these atypical breaks probably are related to the medication, although she added, “If this is a related complication, it appears to be very rare.”

Like Lane, she said, “Alendronate is still a very valuable drug in decreasing the risk of hip fracture.” But, she said, what would be helpful is a test that could identify who is in the sub-population that might have a problem on this medication.

Lane said that women who’ve been taking this medication for a long time and have test results that suggest low bone turnover, may want to take a “bone holiday,” and stop taking the medication for a year. But, he added, this shouldn’t be done on your own. “If you’ve been on alendronate for a long time, talk to your doctor,” he suggested.

The U.S. Food and Drug Administration in January issued an alert to physicians about the possibility of severe bone pain occurring as a result of bisphosphonate therapy. Additionally, last year Fosamax was also implicated in some cases of atrial fibrillation — a serious type of irregular heartbeat — though the FDA hasn’t found evidence to support this association.

Fosamax

Generic Name: alendronate

What is the most important information I should know about Fosamax?

Do not take an Fosamax tablet if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus (the tube that connects your mouth and stomach). You will need to stay upright for at least 30 minutes after taking this medication.

Take the Fosamax tablet first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine.
Take each dose with a full glass (6 to 8 ounces) of water. Use only plain water (not mineral water) when taking an Fosamax tablet.

For at least the first 30 minutes after taking an Fosamax tablet, do not lie down or recline; do not eat or drink anything other than plain water; and do not take any other medicines including vitamins, calcium, or antacids.

Some people using medicines similar to Fosamax have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, and taking calcium and vitamin supplements. Follow your diet, medication, and exercise routines very closely.

What is Fosamax?

Fosamax is in the group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body. Fosamax slows bone loss while increasing bone mass, which may prevent bone fractures.

Fosamax is used to treat or prevent postmenopausal osteoporosis and steroid-induced osteoporosis. Fosamax is also used to treat Pagets disease of bone.

Fosamax may also be used for purposes other than those listed in this medication guide.

What should I avoid while taking Fosamax?

Do not take any other medicines including vitamins, calcium, or antacids for at least 30 minutes after taking an Fosamax tablet. Do not lie down for at least 30 minutes after you take an Fosamax tablet.
What are the possible side effects of Fosamax?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Fosamax and call your doctor at once if you have any of these serious side effects:

  • chest pain;
  • difficulty or pain when swallowing;
  • pain or burning under the ribs or in the back;
  • new or worsening heartburn;
  • severe joint, bone, or muscle pain; or
  • jaw pain, numbness, or swelling.

Continue using Fosamax and talk with your doctor if you have any of these less serious side effects:

  • mild heartburn or stomach upset;
  • diarrhea, gas, or constipation;
  • joint pain or swelling;
  • swelling in your hands or feet;
  • back pain; or
  • dizziness, weakness, or headache.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Fosamax?

Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Fosamax. If you use these other medicines, do not that take them for at least 30 minutes after taking an Fosamax tablet.

Before using Fosamax, tell your doctor if you also use aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), diflunisal (Dolobid), ibuprofen (Motrin, Advil), indomethacin, ketoprofen (Orudis), ketorolac (Toradol), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

There may be other drugs that can affect Fosamax. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Tyverb is back in Europe

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Tyverb is back in EuropeThe European Commission has referred GlaxoSmithKline Plc’s breast cancer treatment Tyverb back for a fresh assessment by drugs regulators following new data from Europe’s biggest pharmaceuticals company.

Glaxo said on Tuesday that Tyverb, which is already on sale in the United States under the name Tykerb, had been referred back to the EU’s Committee for Medicinal Products for Human Use (CHMP) for further discussion.

It said the new information was from a standard pharmacovigilance review of clinical trial and post-marketing data.

Glaxo’s Tyverb Referred for More Discussion in Europe

GlaxoSmithKline Plc’s Tyverb breast cancer drug was sent back to a European regulatory panel after new data showed the medicine may raise the risk of liver damage, slowing final approval.

The European Commission returned the application to the region’s health-care regulator for further discussion, probably during its April 21-24 meeting, London-based Glaxo said today in an e-mailed statement. An agency committee recommended approval of Tyverb following a review in December.

Tyverb is one of the medicines Glaxo is relying on to help counter slowing growth in sales of its top-selling asthma drug Advair and diabetes pill Avandia and the loss of patent protection on other products. The commission was expected to issue a final decision on the breast cancer drug between Feb. 22 and March 8, Glaxo said.

“It’s not particularly good news,” analyst Nick Turner of Mirabaud Securities in London said in a telephone interview. “This is a drug that promised much but isn’t likely to deliver.”

The new data showed signs that the medicine can raise the level of liver enzymes in patients, a possible warning sign for damage to the organ. Elevated liver enzymes were seen in four out of 1,000 patients, and “generally returned to normal” after they stopped using the drug, according to the U.K. company.

Positive Profile

“GSK believes these data do not change the positive benefit-risk profile for Tyverb in the proposed indication,” Glaxo said in the statement.

Glaxo shares rose 38 pence, or 3.7 percent, to close at 1,054 pence in London trading.

The European Medicines Agency said in December that it recommended conditional approval of Tyverb for breast cancer that has advanced or spread to other parts of the body in patients with the HER-2 gene, which makes the disease more aggressive. Conditional approval is valid for one year while the company obtains more information about the medicine and its effectiveness, EMEA said at the time.

Heparin being tested again

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HeparinU.S. health officials have ordered all imports of the blood thinner heparin, and its raw ingredient, stopped at the border for testing to detect a contaminant linked to 19 deaths.

The Food and Drug Administration announced the move Friday, the latest step in its widening investigation of hundreds of allergic-type reactions linked to Baxter International’s heparin injections.

The FDA found the contaminant in 20 of 28 samples of raw heparin that the agency tested from Baxter’s main supplier, a Chinese factory owned by Wisconsin-based Scientific Protein Laboratories.

A different brand of heparin also has been recalled in Germany after 80 patients there got sick, and the German manufacturer said Friday that it was narrowing down the source of contamination to another Chinese supplier.

FDA announced some good news Friday, saying it had learned of no additional deaths and just two more allergic reactions since Baxter recalled the last of the suspect heparin late last month.

Scientists don’t yet know exactly what the contaminant is, except that it mimics heparin so closely that standard drug-purity tests won’t catch it. Nor is it certain that the contaminant is to blame for the allergic reactions, although it is the prime suspect.

But the FDA is “very close” to identifying the substance, a step that should help tell if the contaminant got into heparin by accident or by fraud, said FDA drug chief Dr. Janet Woodcock.

Heparin is derived from pig intestines, and China is the world’s leading supplier. Tiny family-run workshops near slaughterhouses send batches of raw ingredients to larger middlemen before they reach factories like SPL’s in Changzhou. The FDA hasn’t yet inspected those workshops, saying that was something under discussion with Chinese officials.

Two weeks ago, the FDA urged all remaining U.S. heparin manufacturers to start using more sophisticated tests to be sure their products were contaminant-free. Friday, the agency said worldwide testing had begun.

The added hurdle for imports “will improve our safety net,” Woodcock said. “We will get a much better picture of whether there’s any contaminant existing, and we can trace it back” to its source.

Most of the actual import testing will be done by five of the nation’s leading heparin manufacturers, which will be cleared to sell their products once the FDA receives those test results.

The FDA itself will test any remaining shipments that arrive from abroad.

The FDA wouldn’t name the five companies that will do their own testing, and acknowledged it has no plans to do spot checks of the quality of those companies’ tests.

Herapin recalled by Japanese firms

Three Japanese firms recalled the active ingredient in the blood thinner herapin as a “precaution” over concerns of ties to Chinese factories, officials said.

The U.S. Food and Drug Administration announced that three unnamed Japanese firms recalled the active ingredient in herapin manufactured by Scientific Protein Laboratories based in Wisconsin.

At least four people died from allergic reactions to the drug and hundreds suffered life-threatening reactions in the United States and Germany, though none of these reactions stem from products manufactured at Scientific Protein, the Chicago Tribune reported Tuesday.

“The three Japanese companies made clear that the recall was simply a precaution, as there has not been a pattern of adverse reactions to heparin reported in Japan similar to what has been observed in the U.S. and Germany,” Scientific Protein said in a statement Monday.

FDA officials said it found “herapin-like” substances in recalled batches of herapin sold by Baxter International Inc. linked to production facilities in rural China.

The supply chain for herapin production begins in unregulated family-owned pig farms in rural China before reaching Scientific Protein’s Chinese facilities.

Complications of Heparin Therapy

Heparin comes in many forms and is commonly used in cancer patients. Since its discovery in 1923, heparin has been the primary parenteral anticoagulant used worldwide for the prevention and treatment of blood clots and for maintaining patency of catheters. The most frequent side effect of heparin therapy is bleeding. However, a less common but potentially devastating complication of heparin exposure, immune-mediated heparin-induced thrombocytopenia (HIT), is now well described. Paradoxically, immune-mediated HIT is associated with the development of new thrombosis or worsening of preexisting thromboses rather than bleeding.

A mild decline in the platelet count occurs commonly in patients receiving heparin and is most often non-immune mediated. This generally occurs within 5 days after institution of the drug and is not associated with thrombosis. Heparin can be safely continued and the platelet count generally returns to normal within a few days.

Immune-mediated HIT, on the other hand, is characterized by a more significant decline in platelets defined as either a drop in the platelet count to under 150,000 or greater than 50% decline in the platelet count following the initiation of heparin therapy. It typically develops after 4-10 days of heparin therapy but can suddenly occur within 24 hours of heparin exposure if the patient has been sensitized to heparin within the preceding three months. For these reasons, all patients receiving heparin should have their platelet count monitored.

The frequency of HIT may be as high as 3% in patients treated with heparin for at least 4 days. The likelihood that HIT will develop depends upon the source and dose of heparin. Therapeutic doses of heparin are more likely than prophylactic doses to cause HIT and it is most common with unfractionated heparin. In fact, HIT has only rarely been associated with low molecular weight heparin.

HIT is caused by antibodies directed against an antigen complex that is composed of heparin and platelet factor 4. This antibody-antigen complex binds to the surface of platelets resulting in platelet activation and aggregation. It also indirectly leads to the generation of thrombin, further promoting the onset or extension of thrombosis through activation of the coagulation cascade.

In patients who develop HIT, an alarming 50-60% will develop thrombotic complications within 30 days following the diagnosis without further therapy. Venous thromboses are far more likely than arterial thromboses.

Serologic testing should be ordered to confirm the clinical suspicion. However, the results typically are not available for several days, making HIT a clinical diagnosis initially. Indeed, if one waits for the results of the confirmatory tests to act, it may be too late to prevent or effectively treat thrombosis. Laboratory tests include functional assays (serotonin release assay, heparin-induced platelet activation) and an antigenic assay (ELISA). When the functional and antigenic assays are combined both sensitivity and specificity exceeds 90%.

Blockbuster anemia drugs may lead to death

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Amgen Anemia DrugsDrug maker Amgen Inc. said Friday it expanded black box warnings about risks of death and tumor growth of its blockbuster anemia drugs.

The warnings approved by the Food and Drug Administration state that the company’s drugs increased death and accelerated tumor growth in patients with early stage breast cancer and cervical cancer. Earlier labeling warned of similar risks in other types of cancer.

The changes apply to Thousand Oaks, Calif.-based Amgen’s Aranesp and Epogen, as well as Johnson & Johnson’s Procrit. The drugs treat the blood-disorder anemia in patients with kidney failure and those on chemotherapy. Amgen manufacturers all three, though New Brunswick, N.J.-based J & J sells Procrit.

The language states that the problems occurred when doctors treated patients with elevated levels of the drugs, which increase red blood cell levels.

The action came less than a week before a meeting where government advisers are scheduled to review the risks of the blockbuster medications.

Since FDA began scrutinizing the drugs last March, shares of Amgen have sunk 27 percent. U.S. sales of its anemia treatments fell more than 10 percent to $6.3 billion for the year.

Wall Street analysts expect sales to fall further in 2008 following next week’s review by FDA’s cancer experts. The panel could recommend halting use of the drugs for certain types of cancers, or in all cancer patients. Recommendations will not apply to Amgen’s Epogen, which is used almost exclusively by kidney failure patients on dialysis.

If FDA removes only some cancer indications, Amgen’s anemia drug sales could lose between $150 million to $250 million for 2008, according to estimates by Goldman Sachs’ analyst May-Kin Ho.

FDA twice updated anemia drug labels last year, most recently in November. Amgen disclosed new data in December on the drugs’ risks in early stage breast cancer and cervical cancer patients, sending shares downward nearly 20 percent. The new label incorporates detail from those studies.

Bear Stearns analyst Mark Schoenebaum said the effect of Friday’s changes would be minimal for Amgen, since cervical cancer accounts for about 1 percent of the Aranesp market. He also noted that the previous label already highlighted the breast cancer risks.

But Stanford Group Co. analyst Gregory Frykman said the new warnings could attract tougher regulations from Medicare, the government’s health plan for seniors. Last summer Medicare ruled that it would only pay doctors to administer anemia drugs if they were prescribed at low levels.

Frykman said the new warnings could convince Medicare to scale back its policy again, perhaps only paying for the drugs when used in certain types of cancer.

Wall Street reacted positively to the news, sending shares up 1.02 cents, or 2.3 percent, to $45.20 in after-hours trading. Shares fell 14 cents to close at $44.18 in regular trading.

Reference Material on Anemia

Anemia, condition in which the concentration of hemoglobin in the circulating blood is below normal. Such a condition is caused by a deficient number of erythrocytes (red blood cells), an abnormally low level of hemoglobin in the individual cells, or both these conditions simultaneously. Regardless of the cause, all types of anemia cause similar signs and symptoms because of the blood’s reduced capacity to carry oxygen. These symptoms include pallor of the skin and mucous membranes, weakness, dizziness, easy fatigability, and drowsiness. Severe cases show difficulty in breathing, heart abnormalities, and digestive complaints.

One of the most common anemias, iron-deficiency anemia, is caused by insufficient iron, an element essential for the formation of hemoglobin in the erythrocytes. In most adults (except pregnant women) the cause is chronic blood loss rather than insufficient iron in the diet, and, therefore, the treatment includes locating the source of abnormal bleeding in addition to the administration of iron.

Pernicious anemia causes an increased production of erythrocytes that are structurally abnormal and have attenuated life spans. This condition rarely occurs before age 35 and is inherited, being more prevalent among persons of Scandinavian, Irish, and English extraction. It is caused by the inability of the body to absorb vitamin B12 (which is essential for the maturation of erythrocytes).

There are several conditions that cause the destruction of erythrocytes, thereby producing anemia. Allergic-type reactions to bacterial toxins and various chemical agents, among them sulfonamides and benzene, can cause hemolysis, which requires emergency treatment. In addition, there are unusual situations in which the body produces antibodies against its own erythrocytes; the mechanism triggering such reactions remains obscure.

A year ago:

FDA issues new warnings on widely used anemia drugs

Federal health officials have issued stern new warnings for doctors to more carefully prescribe widely used anemia drugs that can increase the risk of death and other serious problems in patients with cancer and kidney disease.

Have they really invented a miracle pill that will let you eat as much as you want and STILL lose weight?

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It is every dieter's dream - a pill that allows you to lose weight safely without actually going on a diet.

But such fat-fighting drugs are already the stuff of reality, according to researchers.

They say tablets widely used to lower blood pressure could help melt away unwanted pounds as well.

Experiments suggest that ACE inhibitor pills can speed up the metabolism, allowing excess weight to be lost quickly.

Scroll down for more...

Fat buster: Scientists may have made a breakthrough that could pave the way for fat-burning drugs that will reduce the need to exercise to lose weight

The findings could lead to the pills, taken by millions to combat hypertension, being repackaged as fat-burners.

Ultimately, they, or similar drugs, could allow the overweight to shed flab without even setting foot

in a gym. With up to a quarter of Britons thought to be trying to lose weight and obesity rates the highest in Europe, such a pill would have mass appeal.

Australian researchers made the breakthrough in experiments on mice genetically altered to lack an enzyme found in fat cells.

Those lacking this angiotension-converting enzyme, as it is known, weighed 20 per cent less than other mice and had up to 60 per cent less body fat.

The GM mice were no more active than the other creatures and ate just as much food but their metabolism was faster.

They also processed sugar more quickly, suggesting they were at lower risk of diabetes, says a report in the journal Proceedings of the National Academy of Sciences.

The finding raises the possibility that drugs that block the enzyme, such as blood pressure-lowering ACE inhibitors, could be used to help humans lose weight.

Warning that more work needs to be done before the prescription-only pills are used to fight fat, researcher Dr Michael Matthias said: "The drugs are out there because they are used for hypertension.

"So we know their safety and their tolerability. What we don't know is whether or not they will work in humans."

The researcher, from Melbourne University, told BBC Radio 4's Today programme: "I don't think this will replace the need for careful control of diet and encouraging more exercise.

"If people look at increasing their food intake then all that will do is cancel out the beneficial effects of increasing metabolic rate."

Dr Ian Campbell, medical director of the British charity Weight Concern, said: "All the evidence we have is that nothing works better than a healthy diet and increased physical activity, with or without weight loss drugs."

• You're overweight. But as the scales tip a little too far in the wrong direction, you console yourself-with that great run you just did around the park. Unfortunately, simply being active isn't enough to guarantee your health.

Doctors now say it is not possible to be "fat and fit". An 11-year study in the U.S. of almost 40,000 women found those who were overweight yet active were still more than 50 per cent more likely to develop heart disease than those of normal weight who did similar amounts of exercise.

The findings showed that while exercise can counter some of the ill-effects of over-indulgence, it cannot erase them.

The researchers, from The Beth Israel Deaconess Medical Centre in Boston, concluded: "Even high quantities of physical activity are unlikely to fully reverse the risk of coronary heart disease in overweight and obese women without concurrent weight loss."

Another involved in the study rammed home the point. "If you're overweight or obese, you can't really get back to that lower risk with just physical activity alone."


Read more: http://www.dailymail.co.uk/news/article-562761/Have-really-invented-miracle-pill-let-eat-want-STILL-lose-weight.html#ixzz0OzIJf3RJ

Tomato pill to prevent heart disease?

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A new health pill containing the same chemical found in tomatoes could prevent heart disease on a global scale, scientists claim.

The supplement, which contains the chemical lycopene also found in the skin of tomatoes, has been shown to clean the blood from nearly all harmful fats within just eight weeks, a new study has found.

Known as Ateronon, each pill is the equivalent of eating three kilos of ripe tomatoes each day. The pill, which is being hailed as a medical breakthrough, is being launched this June and will cost £35 for a monthly dose.

‘Miracle pills’ may be controversial, but are the natural remedies that claim to help us stop smoking, lose weight, de-stress, relax and even stop our hair falling out, a viable – and safe - alternative?