Archive for the ‘Research’ Category

New Anti-AIDS pill under development

Saturday, January 3rd, 2009

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.

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Serevent and Foradil asthma drugs may be risky

Monday, December 15th, 2008

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 excluded Advair, 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.”
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Free drug samples make you spend more!

Tuesday, March 25th, 2008

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.

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Fosamax associated with unusual fractures of the thigh bone

Friday, March 21st, 2008

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.

Blockbuster anemia drugs may lead to death

Wednesday, March 12th, 2008

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.

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Galvus (vildagliptin) improves glucose control

Thursday, February 21st, 2008

GalvusFor people with type 2 diabetes and moderately elevated blood glucose levels, the medication vildagliptin, sold under the brand name Galvus, can produce long-term improvements in the functioning of the insulin-secreting beta cells in the pancreas along with better glucose control, researchers report.

“Improvement of glucose control, which was a known fact for vildagliptin, is paralleled, and likely caused, by an improvement of beta-cell function,” Dr. Andrea Mari told Reuters Health.

Mari, from the National Research Council, Padova, Italy, and colleagues put 306 patients with type 2 diabetes on vildagliptin or an inactive placebo for a year. The participants had an A1C in the range of 6.2 percent to 7.5 percent, indicating only mild hyperglycemia.

Vildagliptin significantly increased the secretion rate of insulin by 17 percent compared to placebo, the investigators report in the Journal of Clinical Endocrinology & Metabolism.

The spike in glucose levels after a meal improved for patients on vildagliptin treatment but worsened somewhat for those given placebo, as did A1C levels, the researchers found.

The improvements with vildagliptin were fully apparent within 24 weeks of treatment, the investigators say, but none of the effects on beta-cell function remained after 4 weeks once the medication was stopped.

Because of this, Mari’s team concludes that longer studies are needed to see if vildagliptin modifies the progression of type 2 diabetes.

About Galvus

In clinical studies, Galvus has demonstrated significant reductions in blood sugar for one year. Galvus is suitable for once-daily dosing and has been evaluated both as monotherapy and in combination with other anti-diabetes agents. Galvus was not associated with overall weight gain, a key benefit for people with diabetes who struggle to keep their weight under control. The overall incidence of side effects with Galvus including hypoglycemia (excessively low blood sugar) and edema (fluid retention) was similar to placebo. Galvus lowers blood sugar by targeting islet dysfunction, i.e., it improves the ability of the islet’s alpha- and beta-cells to appropriately sense and respond to sugar in the blood.

New drug can help alcoholics

Saturday, February 16th, 2008

New DrugA new drug can help alcoholics overcome their addiction by reducing stress-induced cravings, a study has found.

There is already a drug on the market, Revia, which treats alcoholism by reducing the body’s ability to enjoy its effects.

This new drug cuts cravings by taking the edge off of stressful situations which might push recovering alcoholics to pick up the bottle again.

Behavioral stress is a major factor in extending the “vicious cycle” of alcoholism, said lead author Markus Heilig, clinical director of the National Institute on Alcohol Abuse and Alcoholism.

That’s because alcohol deprivation causes depression and increased sensitivity to stressful situations such as an argument with a spouse or tension at work.

“Alcohol is a particularly nasty drug because it actually makes you feel better, but it pushes you to feel worse once you’re without alcohol,” he told AFP.

The drug Heilig and his team tested targets an area of the brain, the neurokinin 1 receptor, which mediates responses to behavioral stress. It had previously been shown to reduce social anxiety but did not enter the market because results were inconsistent.

Helig and his team first tested its effectiveness on mice and then on a group of 50 alcoholics with anxiety problems who had been through detox and remained hospitalized for the four weeks of the trial.

Half were given a placebo and the other half were given the drug.

Cravings declined over time for all patients in the protected inpatient environment and were minimal in the majority of patients by the end of the study period.

However, those who had been drug showed a more marked improvement in the severity of their cravings when measured by self-reporting questionnaires, the assessment of their clinicians, and tests where they were exposed to socially stressful situations and then told to touch a bottle and smell their favorite alcohol.

Interestingly, there was no impact on anxious or depressive psychopathology which suggests that “the improvements observed might be specific for brain processes related to alcoholism,” the study published online in Science Express concluded.

The drug also led to increased brain responses to positive imagery and lessened responses to negative imagery, something which a recent study showed predicts less alcohol consumption over the next six months, tests using MRI mapping showed.

The next step is larger clinical trials to see if the drug can be of assistance to alcoholics who do not suffer from anxiety problems.

New Drug Suspected Capable of Treating Alcoholism

A study revealed that an existing pill might in aid in the curbing of a person’s appetite for alcohol, simply by reducing the cravings caused by stress.

The new drug reportedly worked by controlling the results of stress, as behavioral stress was a major contributor to the “vicious cycle” of alcoholism.

Study author Markus Heilig of the National Institute on Alcohol Abuse explained that depriving a person of alcohol would lead to depression and increased chances of succumbing to stress.

“Alcohol is a particularly nasty drug because it actually makes you feel better,” Heilig explained, as quoted by AFP, “but it pushes you to feel worse once you’re without alcohol.”

He continued that the drug would control a person’s responses to these effects of stress by targeting a particular part of the brain responsible for the reactions to stressful situations.

Pooling together a total of 50 recovering alcoholics, scientists gave the drug to 25 of them, and placebo pills to the other half.

Their experiment resulted in a 50 percent cut in the craving for alcohol for those who had been given the drug.

Heilig, a director at the National Institute on Alcohol Abuse and Alcoholism, noted that while other studies regarding alcoholism aimed to reduce the pleasure derived from alcohol, their study attempted to reduce the effects of the actual causes of alcoholism.

“It’s a fairly new approach to treating alcoholism treatment,” Heilig said, as quoted by ABC News. “We’re really trying to open up a new category of treatments that would help most people.”

The study received commendations from other scientists, calling it a significant discovery.

“This is a potentially important finding which indicates a novel mechanism for reducing craving in individuals who drink to reduce high anxiety,” said Boris Tabakoff, a professor and director at the University of Colorado and Denver.

Stress-Related Drug May Cut Alcoholics’ Cravings

New Research May Pave Way for New Alcoholism Treatment Therapies

A drug known to inhibit the stress response in the brain may also be a potential weapon against alcohol addiction.

So suggests a small study on recovering alcoholics published in the journal Science.

Researchers with the National Institutes of Health already knew that the drug in question neutralizes the action of a protein called NK1R (short for neurokinin-1 receptor), which is involved in the stress response in the brain. The first hint that the drug might be useful in cutting alcohol cravings surfaced when the investigators noticed that mice who didn’t have NK1R seemed to have less desire to consume alcohol.

To test their suspicions, the scientists gave the NK1R-blocking drug to 25 recovering alcoholics, while giving 25 others an ineffective placebo treatment. They found that those who received the drug reported about 50 percent fewer alcohol cravings.

Lead study investigator Dr. Markus Heilig, clinical director of the NIH’s National Institute on Alcohol Abuse and Alcoholism (NIAAA), says standard drug treatments to help curb drinking urges worked by reducing the pleasure that alcoholics get from drinking. This drug takes a different approach — reducing the anxiety that leads many alcoholics to reach for the bottle in the first place.

“It’s a fairly new approach to treating alcoholism treatment,” Heilig says. “We’re really trying to open up a new category of treatments that would help most people.”

Alcoholism experts not directly involved with the study say the finding offers tantalizing clues for new treatment — as well as hints to the connection between anxiety and drinking urges.

“This is a potentially important finding which indicates a novel mechanism for reducing craving in individuals who drink to reduce high anxiety,” says Boris Tabakoff, professor and chairman of pharmacology at the University of Colorado at Denver.

But even if the findings eventually lead to an effective drug treatment option for alcoholism, some experts say, there is no therapy yet that provides a sure-fire, one-size-fits-all solution to alcohol cravings.

“It may be that this medication would help alcoholics who drink when stressed,” says Dr. Charles O’Brien, vice chair of psychiatry and director of the Treatment Research Center for the University of Pennsylvania Health System. “It is wrong to think of all alcoholics as alike.”

A New Hope for Alcoholics?

Current drug treatments for alcoholism include naltrexone and disulfiram. And it has been shown that these medications offer help for some alcoholics. But Tabakoff says more options are needed.

“The current treatments, although producing statistically significant benefit, are still of modest utility,” Tabakoff says. “New approaches need to be introduced and tested. This represents one such novel treatment that seems to be particularly effective in reducing various measurements of craving.”

The need for another option in drug-based alcoholism treatment is underscored by the fact that the drug treatments that currently exist are each most effective for the relatively small subset of alcoholics who seem to be genetically predisposed to get an extra addictive kick from alcohol.

“Generally, these sorts of new drugs may help 20 percent of alcoholics or addicts initially quit drug use, though I am not sure they would work that well on maintaining abstinence,” says Steve Sussman, professor of preventive medicine and psychology at the University of Southern California.

“While this drug may be of assistance to the extreme users, I wonder about how well it would help the majority.”

Further Study Needed

Despite the apparent success in the human part of the trial, more research will be needed before such a treatment can be considered reliable and safe. For example, the possible interaction effects of the drug with alcohol, just in case users fall off the wagon, must be determined.

And since the new study involved only patients who were under hospital care, it remains to be seen how effective the drug could be in a real-world setting, where temptations for alcoholics abound.

Heilig says additional, broader trials are currently in the works. But even at this early stage, alcoholism experts say it’s possible that the most recent findings may be a sign that, at least for some alcoholics, more help could be on the way.

“The more types of treatment modalities available, the more people with addiction problems can be helped,” Sussman says.

Tabakoff agrees. “All of medicine is moving more and more towards personalized treatments that target subgroups of patients, and I believe this report is one example of that trend,” he says. “This may be an excellent option for a sub-group of alcoholics who also suffer symptoms of anxiety. Neither naltrexone nor disulfiram are focused on these subjects.”

Salsalate may be helpful for young obese adults

Friday, February 15th, 2008

SalsalateA drug approved for the treatment of arthritis may have a role in reducing the risk of diabetes and heart trouble developing in young obese individuals, Harvard researchers report.

Compared with an inactive placebo, the anti-inflammatory drug salsalate reduced glucose levels by an average of 13 percent in 20 non-diabetic adults no older than 30 years of age with a body mass index (BMI) of at least 30 (classified as obese).

For the study, Dr. Allison B. Goldfine of the Joslin Diabetes Center in Boston and colleagues randomly assigned the participants to take 4 milligrams of salsalate daily in two divided doses, or placebo, for 4 weeks.

As well as reducing fasting glucose levels, salsalate decreased the glycemic response after an oral glucose tolerance test, improved insulin sensitivity and curbed markers of inflammation, the researchers report in the medical journal Diabetes Care.

“This proof-of-principle study demonstrates that salsalate reduces glycemia and may improve inflammatory cardiovascular risk indexes in overweight individuals,” Goldfine and colleagues conclude. They say the findings support the idea of targeting inflammation to help prevent diabetes.

“Salsalate is marketed in the United States for the treatment of arthritic pain. It is not approved for use in obesity,” Goldfine emphasized in an interview with Reuters Health.

“The drug has a good safety profile in people with arthritis. We are examining the safety profile specifically in people with this different cluster of disease,” she continued.

Several clinical trials with salsalate are ongoing. “If it is efficacious to treat or prevent diabetes, and/or cardiovascular disease, the health economic implications are exciting,” Goldfine noted, “as the product is inexpensive to manufacture and generic, which is important as the number of persons with these health issues is large.”

Salsalate Drug Information

Generic Name: salsalate
Brand Names: Disalcid, Salsitab

What is salsalate?

Salsalate is in a class of drugs called salicylates. It works by reducing substances in the body that cause pain and inflammation.

Salsalate is used to reduce pain and inflammation caused by conditions such as rheumatoid arthritis, osteoarthritis, and related rheumatic conditions.

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

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

Take salsalate with food, milk, or an antacid to lessen stomach upset, unless you are taking any enteric coated tablet. Do not break, chew, or crush the enteric-coated tablets. Swallow them whole.

Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate damage to the stomach.

Avoid alcohol during treatment with salsalate. Together, alcohol and salsalate may increase the risk of bleeding in the stomach.

What should I discuss with my healthcare provider before taking salsalate?

Before taking this medication, tell your doctor if you

  • have an allergy to aspirin or any other NSAIDs,
  • have an ulcer or bleeding in your stomach,
  • drink more than three alcoholic beverages a day,
  • have liver or kidney disease,
  • have a coagulation (bleeding) disorder,
  • have congestive heart failure,
  • have fluid retention,
  • have heart disease, or
  • have high blood pressure.

You may not be able to take salsalate, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Salsalate is in the FDA pregnancy category C. This means that it is not known whether salsalate will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether salsalate passes into breast milk. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby. Do not use salsalate to treat a child or teenager who has a fever, flu symptoms, or chicken pox without first talking to a doctor. In children younger than 18 years of age, salsalate may increase the risk of Reye’s syndrome, a rare but often fatal condition.

How should I take salsalate?

Take salsalate exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Take salsalate with milk, food, or an antacid to lessen stomach upset.

Do not take salsalate more often than every 4 hours, and do not take more than is recommended. If your condition does not improve within 3 to 4 days, seek medical attention.

Be aware of the salicylate (aspirin) content of other over-the-counter and prescription products. Care should be taken to avoid taking more than the recommended amount of salicylate per dose or per day.
Store salsalate at room temperature away from moisture and heat.

What should I avoid while taking salsalate?

Be aware of the salicylate (aspirin) content of other over-the-counter and prescription products. Care should be taken to avoid taking more than the recommended amount of salicylate per dose or per day.
Avoid prolonged exposure to sunlight. Salsalate may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable. Avoid alcohol during treatment with salsalate. Together, alcohol and salsalate may increase the risk of bleeding in the stomach.

Salsalate side effects

Stop taking salsalate and seek emergency medical attention or contact your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • black, bloody, or tarry stools;
  • nausea, vomiting, or abdominal pain;
  • uncontrolled fever;
  • blood in urine or vomit;
  • decreased hearing or ringing in the ears;
  • seizures; or
  • dizziness, confusion, or hallucinations.

If you experience any of the following less serious side effects, notify your doctor:

  • heartburn or indigestion,
  • faint ringing in the ears,
  • drowsiness, 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 salsalate?

Do not take salsalate without first talking to your doctor if you are taking any of the following medicines:

  • an anticoagulant such as warfarin (Coumadin), heparin, enoxaparin (Lovenox), dalteparin (Fragmin), danaparoid (Orgaran), ardeparin (Normiflo), or tinzaparin (Innohep);
  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Motrin, Advil, Nuprin, others), ketoprofen (Orudis, Orudis KT, Oruvail), naproxen (Naprosyn, Anaprox, Aleve), diclofenac (Voltaren, Cataflam), nabumetone (Relafen), oxaprozin (Daypro), piroxicam (Feldene), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), indomethacin (Indocin), ketorolac (Toradol), sulindac (Clinoril), or tolmetin (Tolectin); or
  • another salicylate such as aspirin (Acuprin, Ecotrin, Ascriptin, Bayer, others) or choline salicylate and/or magnesium salicylate (Magan, Doan’s, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal).

You may not be able to take salsalate, or you may require a dosage adjustment or special monitoring if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with salsalate. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.

Blood pressure drugs reduce Parkinson’s risk

Thursday, February 7th, 2008

Blood pressure drugsPeople taking a certain type of blood pressure medication called calcium channel blockers may also be lowering their risk of getting Parkinson’s disease, according to a study released Wednesday.

A study by Swiss researchers found that people who had been taking a calcium channel blocker medication for an extended period of time had a 23 percent lower risk of developing the incurable neurological disease than people not on this type of drug.

The researchers also assessed several other classes of blood pressure medications, such as ACE inhibitors, AT II antagonists and beta blockers, but none of those appeared to offer the protective effect of calcium channel blockers.

“Long-term use of calcium channel blockers was associated with a reduced risk of developing Parkinson’s disease, while no such association was seen for other high blood pressure medications,” said Christoph Meier, lead author of the paper and a researcher at University Hospital Basel in Switzerland.

Meier and colleagues studied more than 7,000 men and women from the United Kingdom over the age of 40 for the study, but they did not investigate the mechanism by which the drugs lowered the risk of Parkinson’s.

Calcium channel blockers lower blood pressure by preventing calcium from entering the cells of the heart and blood vessels. The net result is that they cause blood vessels to dilate or expand, and they lead to less contraction of the heart muscle.

The class includes drugs such as Dilacor, Adalat, Cardazem, Procardia and Covera.

Parkinson’s is a chronic and progressive disorder that typically afflicts people over the age of 60. The illness stems from the loss or destruction of brain cells that produce the neurotransmitter dopamine, leading to problems with motor control.

Patients typically suffer from tremors and shakes, impaired balance and coordination and also stiffness or rigidity in the limbs or trunk.

High blood pressure medication offers reduced Parkinson’s risk

Calcium channel blockers that are used to treat high blood pressure may cut the risk of Parkinsons disease as well, say researchers.

The researchers say that their findings are based on a study of 7,374 men and women over age 40.

Christoph R. Meier of the University Hospital Basel in Switzerland has revealed half of the subjects had Parkinsons disease, while half were non-sufferers.

The studys author also revealed that nearly half of the participants in both groups used high blood pressure medications like calcium channel blockers, ACE inhibitors, AT II antagonists, and beta blockers.

It was found that people who were currently long-term users of calcium channel blockers to treat high blood pressure lowered their risk of Parkinsons disease by 23 per cent as compared to those who did not take the drugs.

No such effect was found among people taking ACE inhibitors, AT II antagonists and beta blockers.

Long-term use of calcium channel blockers was associated with a reduced risk of developing Parkinsons disease while no such association was seen for other high blood pressure medicines, said Meier.

Meier says that more research is needed to determine why calcium channel blockers appear to offer a reduced risk of Parkinsons disease, while the other high blood pressure medications do not.

New reports on picoplatin from Poniard

Tuesday, January 29th, 2008

Poniard PharmaceuticalsUS-based Poniard Pharmaceuticals has presented encouraging safety data from a Phase I dose-escalation study of picoplatin for the treatment of colorectal cancer.

The data presented at the 2008 Gastrointestinal Cancers Symposium included safety data from a Phase I study of picoplatin in combination with 5-fluorouracil (5FU) and leucovorin (LV) as a first-line treatment for metastatic colorectal cancer (mCRC). The Phase I study seeks to establish the maximum tolerated dose of picoplatin and provide information on the safety of picoplatin when combined with 5FU and LV.

Jerry McMahon, chairman and CEO of Poniard, said: “These study results suggest that picoplatin does not cause severe neurotoxicity, as is commonly seen in mCRC patients treated with the regimen of 5FU and LV with oxaliplatin. Picoplatin has demonstrated both good tolerability and no severe neuropathies when combined with 5FU and LV. We believe picoplatin has the potential to be a preferred platinum for the treatment of colorectal and other cancer indications.”

Picoplatin

Picoplatin is a cytotoxic platinum compound in clinical development for the treatment of patients with solid tumors. It causes apoptosis (cell death) by binding to DNA and interfering with DNA replication and transcription.

Picoplatin is a new generation platinum chemotherapy agent that has an improved safety profile compared to existing platinum-based chemotherapeutics and was designed to overcome platinum resistance. Picoplatin has been evaluated in more than 750 patients and has demonstrated activity in multiple indications with no evidence of significant kidney, nerve toxicity or hearing loss.

Potential Benefits

Platinum drugs destroy cancer cells by binding to DNA. This causes damage that triggers apoptosis (programmed cell death) if the damage is too severe to be repaired by intracellular systems.

However, currently available platinum therapies have significant shortcomings, including toxicities and drug resistance (both intrinsic and acquired) that limit their use.

Picoplatin, which was designed to overcome platinum resistance associated with the treatment of solid tumors, has several potential benefits:

  • Broadly applicable for treatment of solid tumors
  • Demonstrated mechanism for use with new therapies
  • May provide safer alternative to existing platinums
  • Addresses unmet medical need by treating platinum-sensitive, -resistant and -refractory disease
  • Large and growing market for platinum products

Poniard gets Fast Track designation for lung cancer treatment

Poniard Pharmaceuticals has been granted Fast Track status by the FDA for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer.

Picoplatin is currently being studied in the pivotal Phase III SPEAR (study of picoplatin efficacy after relapse) trial in small cell lung cancer (SCLC), which is evaluating overall survival as the primary endpoint and is being conducted under a special protocol assessment agreement with the FDA.

Poniard’s updated data from its Phase II SCLC trial confirmed and extended a median overall survival of 27 weeks (based on an analysis of 63 patients), which compares favorably to a median survival of approximately 17 to 22 weeks for patients who receive other second-line chemotherapy, according to the 2007 national comprehensive cancer network practice guidelines.

“Our receipt of Fast Track designation has the potential to accelerate the development of picoplatin for the treatment of small cell lung cancer, a difficult-to-treat disease, and a patient population with very limited treatment options,” said Jerry McMahon, chairman and CEO of Poniard.

“We are focused on executing our ongoing Phase III SPEAR trial to facilitate the expeditious filing of a new drug application and obtaining the approvals required to make picoplatin available to this severely underserved patient population.”