New Drugs

Two experimental drugs that block a key enzyme in the replication of the hepatitis C virus promise to bring an improvement in therapy for infections with the virus comparable to the improvement in HIV therapy when protease inhibitors were added to drug cocktails for that disease in 1995, researchers said Wednesday. The two drugs, called boceprevir and telaprevir, significantly increase the number of patients who achieve what is known as a sustained viral suppression — effectively, a cure — in patients being treated for the first time and those who did not respond to initial therapy or who suffered a relapse.

Dabigatran (marketed as Pradaxa) is a new drug used by a growing number of Americans with atrial fibrillation. It's both easier to take and more effective at reducing the risk of stroke than warfarin, a drug that's been in use since the 1950s. But a case report published this week underscores a danger with the new medication: If a patient taking it is bleeding into the brain or elsewhere, there is currently no fast, effective way to reverse the blood-thinning agent's effects. For one 83-year-old man who was taken to the University of Utah Hospital's emergency department after falling and hitting his head, the result was death.

In the world of “promising” multiple sclerosis drugs, it’s been quite a week. Two more experimental drugs -- both in pill form, not injected -- are joining the race of new treatments to slow the disease.  A study of multiple sclerosis patients who took the drug laquinimod over two years had 23% fewer relapses -- an attack of new symptoms or worsening of old ones -- compared with patients who took a sugar pill. The group that received the drug also had a 36% reduction in disability progression and a 33% reduction in brain atrophy.

On the growing roster of antibiotic-resistant diseases, gonorrhea is the one that has most recently captured the attention of public health officials. Writing in the New England Journal of Medicine, researchers at the U.S. Centers for Disease Control and Prevention warned last week that 1.7% of certain types of gonorrhea infections show little response to treatment , even with cephalosporins, the last line of antibiotic defense. That might not sound like a lot, but with 600,000 Americans diagnosed annually, resistant cases number about 10,000 a year, and that number has been rising fast.

Chemist Corwin Hansch, who pioneered the field of relating a molecule's chemical structure to its biological activity, an approach widely used in developing new drugs and other commercial chemicals, died in Claremont on May 8. He was 92 and had suffered from a prolonged bout with pneumonia. Hansch was known as the "father of computer-assisted molecule design" for his development of Quantitative Structure Activity Relationships, known colloquially as QSARs, which allow chemists to modify drugs and other molecules in a predictable manner to achieve desired characteristics.

In his July 22 commentary, Sidney Wolfe called FDA approval the world's "gold standard." But Wolfe has struck only fool's gold. Practicing American doctors (who are the real experts in this debate) emphatically disagree with Wolfe. Far from considering FDA an indispensable safety check, they see it as a hindrance in their work to save lives. In a recent poll, 71% of cardiologists said that FDA regulation had compromised their ability to treat their patients, and 65% of cardiologists said the agency is too slow to approve new drugs and devices.

Faster reviews of new medicines bring quicker benefits to patients but also may lead to more drugs being pulled from the market, the head of the U.S. Food and Drug Administration said Tuesday. FDA Commissioner Jane Henney said U.S. approval time for novel medicines has shrunk from an average of about 30 months eight years ago to about 12 months today. Urgently needed treatments come to market in about six months, she said.

After a 50-year drought of new drugs and a string of disappointing failures of potential treatments for lupus, researchers said Monday that they have found an experimental drug that can ameliorate the symptoms of the life-threatening autoimmune disorder that afflicts as many as 1.5 million Americans.

Most travelers bring home souvenirs of their trips. Anthropologist Katherine Milton tucked frog mucus into her suitcase. "It's just second nature to me to always collect," said Milton, an intrepid explorer who found the substance after watching hunters in an unusual ritual she calls "taking frog." The substance is being studied at the National Institutes of Health in Bethesda, Md.

From the beginning, we humans have struggled to understand the world, and those who could profit from our ignorance blocked any change in the status quo that challenged their power, position and profit. We believed for millennia that the world was flat. Over the last 300 years, another big lie has developed. Once again, those who profit don't want to see the lie challenged. That lie is the belief that vivisection--using animals in research--will somehow cure all human illness. The immense vivisection industry is built around obtaining grant money, your tax dollars, for veterinary experiments to produce, in part, billions of dollars' worth of new drugs to pump into our very sick nation.

Chemist Corwin Hansch, who pioneered the field of relating a molecule's chemical structure to its biological activity, an approach widely used in developing new drugs and other commercial chemicals, died in Claremont on May 8. He was 92 and had suffered from a prolonged bout with pneumonia. Hansch was known as the "father of computer-assisted molecule design" for his development of Quantitative Structure Activity Relationships, known colloquially as QSARs, which allow chemists to modify drugs and other molecules in a predictable manner to achieve desired characteristics.

Older epilepsy drugs such as phenobarbital, phenytoin, valproate and carbamazepine can double or triple the risk of birth defects if a pregnant woman ingests them during the first trimester of pregnancy. But going without them can lead to seizures that also endanger the fetus, so managing a pregnancy in an epileptic woman has generally involved walking a fine line between controlling seizures and reducing developmental problems. But a new generation of epilepsy drugs are thought to reduce the risk of birth defects, and a major new study from Denmark confirms that speculation.

In the world of “promising” multiple sclerosis drugs, it’s been quite a week. Two more experimental drugs -- both in pill form, not injected -- are joining the race of new treatments to slow the disease.  A study of multiple sclerosis patients who took the drug laquinimod over two years had 23% fewer relapses -- an attack of new symptoms or worsening of old ones -- compared with patients who took a sugar pill. The group that received the drug also had a 36% reduction in disability progression and a 33% reduction in brain atrophy.

An antibiotic developed by a San Diego firm received a government panel's backing as a treatment for diarrhea caused by increasingly common bacterial infections often acquired in hospitals and nursing homes. The panel of outside experts convened by the Food and Drug Administration voted 13 to 0 that fidaxomicin, marketed under the trade name Dificid by Optimer Pharmaceuticals Inc., is safe and effective in combating symptoms associated with Clostridium difficile , also known as C. diff . The unanimous vote endorsed the FDA's preliminary findings and increases the chances that the agency will approve fidaxomicin.

Every time I come across a big-number statistic about the size or significance of some industrial activity, my nose wrinkles. You know the figures I mean: The porn business takes in $10 billion to $14 billion a year. California's marijuana harvest is worth $14 billion a year, making it the state's biggest cash crop . NCAA March Madness costs employers $1.8 billion in lost productivity . Figures like these have several things in common: They're eye-catchingly big, they're unverifiable by empirical means and they reek of fakery.

Two experimental drugs that block a key enzyme in the replication of the hepatitis C virus promise to bring an improvement in therapy for infections with the virus comparable to the improvement in HIV therapy when protease inhibitors were added to drug cocktails for that disease in 1995, researchers said Wednesday. The two drugs, called boceprevir and telaprevir, significantly increase the number of patients who achieve what is known as a sustained viral suppression — effectively, a cure — in patients being treated for the first time and those who did not respond to initial therapy or who suffered a relapse.

Older epilepsy drugs such as phenobarbital, phenytoin, valproate and carbamazepine can double or triple the risk of birth defects if a pregnant woman ingests them during the first trimester of pregnancy. But going without them can lead to seizures that also endanger the fetus, so managing a pregnancy in an epileptic woman has generally involved walking a fine line between controlling seizures and reducing developmental problems. But a new generation of epilepsy drugs are thought to reduce the risk of birth defects, and a major new study from Denmark confirms that speculation.

Corona-based Watson Pharmaceuticals Inc. said U.S. regulators had begun re-inspecting a factory that they barred from producing new generic drugs after deficiencies were found in 2005. New drugs made at the Davie, Fla., plant haven't been able to gain Food and Drug Administration approval since September 2005, even though the facility has continued to work at a third of its capacity to make existing products.

In the wake of alleged bribe payments, the scandal-plagued California Public Employees' Retirement System has ended contract renewal negotiations with a company that administers prescription drug benefits for 300,000 members. A CalPERS internal investigation report released earlier this week alleged that Medco Health Solutions Inc. paid more than $4 million in what was called "consulting" fees to win the original contract in 2006. The money was allegedly paid in secret to Alfred J.R. Villalobos, a former CalPERS board member turned dealmaker.

WASHINGTON -- The Food and Drug Administration on Wednesday approved Benlysta as the first new drug treatment for lupus in 56 years, offering possible relief from painful symptoms to victims of the sometimes-fatal autoimmune disease. Government approval also sets the stage for likely blockbuster sales for the drug's developer, Human Genome Sciences Inc. The decision was widely expected after an FDA advisory panel voted 13-2 in November to recommend approval of the drug. But the approval has an outsized importance too because it comes after years of failures to develop treatments for lupus, said Sandra Raymond, president of Lupus Foundation of America.