From now onwards, we will be posting table of contents from major journals and other periodicals as soon as they are published. This way you can keep track of interesting developments in the pharmaceutical field.

Dr. Spicehandler passes away

Jonathan R. Spicehandler, M.D., 57, retired chairman of Schering-Plough Research Institute (SPRI), died recntly following a long battle with cancer.

During his 24 years with Schering-Plough, Dr. Spicehandler was involved in the development of some of the company's most significant pharmaceutical products, including INTRON A (interferon alfa-2b recombinant), PEG-INTRON (pegylated interferon alfa-2b), CLARITIN(loratadine) and ZETIA (ezetimibe), cholesterol-lowering medicines. His contributions to the broader pharmaceutical industry and scientific communities have been widely recognized.

Dr. Spicehandler received his B.A. degree in biology from Union College, Schenectady, N.Y., in 1970. He received his M.D. degree, cum laude, in 1974 from St. Louis University School of Medicine, St. Louis, Mo. He is survived by his wife Debra and their four children.

Asthma inhaler Advair linked to increase in mortality from bronchial asthma

Advair, a combination of salmeterol (Serevent) and fluticasone (Flovent) is one of the best selling drugs in the world. Salmeterol is a bronchodilator which dilates the airways and fluticasone is a steroid which reduces airway inflammation. However, the drug has come under scrutiny because of a recent report that Advair may actually increase asthma deaths. The manufacturer GlaxoSmithKline, however, has rejected the findings and calls the article extremely irresponsible and riddled with inaccuracies.

Forbes magazine had in an article on 6th April, reported that "growing evidence suggests that a small percentage of patients--perhaps 4,000 people a year, by one doctor's estimate--may be dying because of Advair or its Serevent component".

It quotes Dr. Shelley Salpeter, a clinical professor of medicine at Stanford University who argues who says both Advair and Serevent should be recalled. Dr. Shelley reviewed the results of 19 previous trials of Serevent-style drugs and found that patients have twice the rate of asthma hospitalizations, twice the rate of life-threatening asthma and four times as many deaths as patients who are not on those drugs.

Apparently, Advair and Serevent cause four of every five asthma-related deaths each year. "These drugs make asthma worse," Dr. Shelley says. By some estimates, asthma kills roughly 5,000 Americans a year. This extrapolates to 4000 asthma deaths related to these drugs.

In response, Glaxo says its detractors are exaggerating the risks. "The safety and efficacy of Advair are extremely well-established with regulators and physicians across the world," A Glaxo spokeswoman said. "The data we have are inconclusive," says Kathy A. Rickard, a Glaxo vice president, echoing early responses by Wyeth about its Redux diet drug and Merck & Co. about its Vioxx painkiller.

Last month GlaxoSmithKline had reached an agreement with the U.S. regulator to update Advair's label with a new warning advising doctors to limit the use of the drug to patients who don't benefit from other asthma drugs, or who are severe cases.

Drug safety authority was aware of the dangers of TGN1412 drug trial

Before the first human trials of TGN1412, UK Government's drugs safety authority was notified that there was a risk of a catastrophic reaction. The trial left six men in intensive care after they developed a severe reaction.

TeGenero, the German manufacturer of TGN1412, had in its application to the Medicines and Healthcare Products Regulatory Authority (MHRA) reported that there had been previous incidence in which similar drugs had provoked serious adverse reaction in human volunteers. Still the MHRA allowed the trial to go ahead and six men who received the drug developed a "cytokine storm".

An interim report of the inquiry issued last Wednesday said no human error had been found in the manufacture, preparation or dose of the drug. The Investigators Brochure, which summarises evidence for the study, says: "Although not to be expected after TGN1412 administration, a cytokine release syndrome or other immunological complications may occur after infusion of TGN1412".

Tests on animals had revealed no ill effects. Apparently, the MHRA felt that TeGenero's decision to administer to volunteers a 500-fold dilution of the drug provided sufficient protection.

Drug trial victims - How are they doing?

The incident in which 6 healthy men developed a severe immunological reaction after being given TGN1412, an experimental drug, more than 2 weeks back had created a major furore. I was looking for the latest news on their condition.

A report from 28th March says that two of the six men have been discharged. Three others remain as in-patients at Northwick Park Hospital, London. One man is still in a critical condition after being administered an experimental immune treatment more than two weeks ago.

The hospital has not given any futher information on the prognosis for the critically ill patient, but says that he has shown some signs of improvement. The released volunteers will continue to receive treatment and be monitored as out-patients.

The tragedy of the six human "guinea pigs", hopefully, should lead to more stringent controls on new drug trials.

ADHD drugs incease heart risk

It has always been suspected that drugs used for ADHD (attention deficit hyperactivity disorder) cause cardiac side effects. ADHD is a disorder mainly seen in school age children and is characterized by increased activity, an inability to concentrate and poor school performance. Drugs used to treat ADHD are sympathetic stimulants. There have been a few reports of sudden death and myocardial infarction in patients taking these drugs.

The Drug Safety and Risk Management Advisory Committee of the FDA recently reviewed the adverse reports on ADHD drugs. They recommendeded the inclusion of a black-box warning describing the cardiovascular risks of drugs used to treat this condition. However, this recommendation has subsequently been toned down by the Pediatric Advisory Committee of the FDA who felt such a black-box warning will do more harm than good fightening off patients and parents.

Read the full story here

Hopes for new anti-HIV drugs involving natural host defence

BBC reports that scientists have discovered that cells use a previously unknown mechanism to fight off HIV, the virus which causes AIDS. The machanism involves 2 proteins that normally help repair cellular DNA. These proteins were found to destroy DNA made by HIV. The virus requires this DNA to survive inside the cell.

This has raised hopes of a breakthrough that could lead to treatments to which the virus might be less able to adapt. Current treatment of HIV infection uses combinations of drugs that target the virus itself, blocking its ability to reproduce and spread. They have proved to be very effective, but there are concerns that HIV may develop resistance to the drugs.

This study from Ohio State University study appears in Proceedings of the National Academy of Sciences.

Lead researcher Professor Richard Fishel said: "Our findings identify a new potential drug target, one that involves a natural host defence. HIV treatments that target cellular components should be far less likely to develop resistance."

Investigations are at a preliminary stage and it take years for anything useful to come out of this

Read the full story here

Celebrex Passes Cardiac and Gastric Safety Test

Focus has been on the COX-2 inhibitor Celebrex (celecoxib), ever since Vioxx was found to increase thromboembolic events in treated patients.

In a study, conducted by Gurkirpal Singh, MD, and colleagues at Stanford University, published in the March issue of The American Journal of Medicine, Celecoxib has been shown to be as effective for the treatment of osteoarthritis as are non-specific non-steroidal anti-inflammatory drugs (NSAIDs). Additional findings included that Celebrex posed a lower risk of serious gastric effects, while the frequency of cardiovascular thromboembolic events among patients taking Celebrex versus NSAIDs was similar.

The results of the study could mean patients who cannot tolerate NSAIDs can take treatment with Celebrex without fear of adverse cardiac events.

Read the full story here

High dose vitamin C found safe for cancer patients

Scientists from the RECNAC II project have published findings that verify the safety of high dose intravenous vitamin C. In this study, published in the Puerto Rico Health Sciences Journal, a phase one clinical trial with 24 terminal cancer patients receiving between ten and sixty grams of sodium ascorbate daily for eight weeks, adverse effects were reportedly minor.

"The results presented in this manuscript should allay fears about the safety of 'mega-dose' vitamin C," said Dr. Joseph Casciari, co-author of the manuscript.

Read the full story here

Four drug trial victims improving

Latest reports indicate that the conditions of four of six men who reacted violently to an experimental drug TGN1412 in London were improving, but two remained critically ill.

Cholesterol drug reverses heart disease and clears clogged arteries!

A cholesterol-lowering drug has for the first time been shown to shrink the kinds of blockages that cause most heart attacks, indicating that such pills may offer the first non-surgical way to start to clear clogged arteries.

A Cleveland Clinic-led study has found that intensive use of statins, the most commonly prescribed cholesterol-lowering drugs, can reverse the build-up of plaque in coronary arteries. Previous studies have shown only a slowing or halting of the progression of coronary disease, but never regression or reversal. A new study of 500 patients found that high doses of a “statin” drug began to reverse the buildup, causing plaques lining the artery walls to recede. Statins are already widely used to prevent or slow heart disease. This study of more than 500 patients found that after two years of treatment with a high dose of Rosuvastatin, plaque volume was reduced by 7 to 9%.

Read the full story here

Catastrophic immune response may have caused drug trial horror

Staying the drug trial mishap, the New Scientist reproted that a catastrophic over-stimulation of the immune system may have caused the horrific reactions suffered by six men taking part in the first human clinical trial of an experimental drug.

An investigation suggested the possibility of a super-immune response, sending T cells rampaging through the body destroying its own tissues. Several experts contacted by New Scientist agreed to this explanation for the terrible incident which put all six men in hospital intensive care in London, UK, with two in a critical condition. The victims, who were healthy, paid volunteers, are said to have suffered multiple organ failure.

Read the full story here

Parkinsonism drug link to gambling probed

Medical researchers are investigating suspicions that drugs prescribed to treat Parkinson's disease could turn patients into compulsive gamblers, the Washington Post reported on Sunday.

Scientists at the Food and Drug Administration have found a strong association between pathological gambling and the drugs, which boost the level of dopamine in the brain, according to the newspaper. Dopamine, a chemical naturally produced in the human body, plays a key role in the way the brain controls movements. A shortage of dopamine causes Parkinson's disease. But the chemical is also associated with addictive behaviors such as drug use and pleasurable experiences such as sex and food.

Researchers, according to the Washington Post, are looking into the possibility that drugs for treating Parkinson's are turning "some patients into obsessive pleasure seekers." But the article also said no firm links have been made between dopamine enhancers and compulsive gambling.

Read the full story here

Six men seriously ill after UK drug trial fiasco

Six volunteers fell seriously ill while taking part in clinical trials of a new drug in UK. The trial was conducted by German pharmaceutical firm TeGenero AG which said the clinical trials were of TGN1412. The drug is intended to fight leukemia, rheumatoid arthritis and multiple sclerosis.

Eight men were part of the trial at a research unit at the Northwick Park Hospital, and six were given the drug. Two men who received placebo escaped unscathed. Some of the six volunteers have been treated for organ failure and two are critically ill.

The men, who were all healthy, paid volunteers, were admitted to the north-west London hospital and are being treated.

Read the full story here

Two drugs for treating osteoarthritis found ineffective

Osteoarthritis is a degenerative disorder affecting the joints, mainly of the knees. It may cause pain and swelling. Two drugs commonly used for treating this disorder, glucosamine and chondroitin sulfate were evaluated in a trial. The results are published in the prestigious New England Journal of Medicine.

The conclusion of the study was that glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee. But there was a suggestion that combination of glucosamine and chondroitin sulfate may be effective in a subgroup of patients with moderate-to-severe knee pain

Read the full story here

Amantadine and Rimantadine Resistance Very High

Amantadine and rimantadine are anti-viral drugs in the “adamantane” class, commonly used to treat and prevent influenza A. Viral resistance to adamantanes is now alarmingly high, according to a report published on February 2 in the in the Journal of the American Medical Association (JAMA) online.

Researchers Rick A Bright, PhD, and colleagues from the Centers for Disease Control and Prevention (CDC) in Atlanta analyzed influenza samples from people in 26 US states, the study found that 92% of them were resistant to amantadine.

They concluded that amantadine should not be used to treat or prevent influenza A for the remainder of the 2005-2006 flu season and recommended ongoing surveillance of influenza viruses for drug-resistance.

Read the full story here

Herceptin for Breast Cancer: ’Simply Stunning’ Results Tempered by Concern About Side-Effects

In test results researchers describe as “simply stunning”, Herceptin (trastuzumab) – a drug already used in treatment of advanced cancer – has been shown to halve the recurrence of breast tumors after standard therapy.

However, Herceptin works only in women whose breast tumors contain high amounts HER2, a protein that makes the cancer particularly aggressive; moreover, the drug can cause significant effects, according to a report by Reuters on 20 October.

About 20% of women with breast cancer have this type of tumor, so about 42,000 women in the Untied States could benefit from Herceptin treatment, according to Reuters. About 400,000 people worldwide die from breast cancer each year.

Read the full story here

Anti-Cholinergic Drugs Linked to Cognitive Impairment in Elderly

The use of anti-cholinergic drugs by older patients has been linked with mild cognitive impairment, according to a new study in France.

An anti-cholinergic drug is one that opposes or blocks the action of the neurotransmitter acetylcholine. Drugs with anti-cholinergic effects include some bronchodilators, antihistamines, analgesics, anti-hypertensives, antidepressants, antiparkinsonian agents and corticosteroids.

Elderly patients taking any of these drugs may consequently experience "significant deficits in cognitive functioning," according to Marie Ancelin, PhD, a senior research fellow at the French national health research unit.

Read the full story here

FDA Approves Rotavirus Vaccine

Infection with rotavirus is a leading cause of severe diarrhea in infants and young children in the United States and worldwide. A search for a vaccine for this disease has borne fruit with the approval of this new vaccine.

The Food and Drug Administration (FDA) announced the approval of RotaTeq™, a live, oral, vaccine for use in preventing rotavirus gastroenteritis in infants. It is the only vaccine approved in the United States that can help protect against rotavirus, a viral infection that may cause diarrhea, vomiting, fever, and dehydration.

"This vaccine gives health care providers an important new tool that can effectively prevent an illness that affects almost all children within the first few years of life," said Jesse L. Goodman, MD, MPH, director of FDA’s Center for Biologics Evaluation and Research.

The Centers for Disease Control and Prevention (CDC) has estimated that rotavirus infection results in approximately 55,000 hospitalizations annually of infants and young children in this country. Death from rotavirus is rare in the United States. However, in developing countries, rotavirus gastroenteritis has been estimated to cause up to several hundred thousand deaths annually in infants and young children.

Read the full story here

Starting a blog on drugs

New drugs and medical treatments are being discovered on a daily basis. Some of them are found to be real advances, while others are discarded. New things are also being found out about older established drugs. For example, the finding that Vioxx could increase the risks of heart attack had led to a big controversy.

Here we are starting a website to review the new drugs and latest news in the pharmaceutical field.