MANILA, March 27, 2006
 (MALAYA) HUNDREDS of new drugs, biologics and devices enter the market each year, giving health consumers fresh hope in their continuing battle against disability and disease.

In 2004 alone, the global pharmaceutical industry was estimated to have spent US$50 billion on research and development, and the cost of bringing a new drug to the market has soared to more than US$800 million from US$100 million in the 1980s. The financial risks for pharmaceutical companies have grown leaps as it usually takes 10-15 years from discovery before a new product gets regulatorsí nod and debuts in the market, and yet only one out of seven million compounds ever reach the point of clinical trial to product approval.

And while thereís still an overwhelming need for further innovation, these medical breakthroughs have nonetheless contributed to making the world a better, safer place. Following is a list of medical breakthroughs that made waves in 2005:

"Smart bomb" for cancer

Doctors may soon be able to use a multi-targeting cancer drug to treat patients of several malignancies. Leading pharmaceutical firm Pfizer, Inc. recently sought USFDA approval for Sutent, a breakthrough oral medication that selectively targets multiple protein receptors and starves tumors of blood and nutrients, thus inhibiting their growth.

During clinical trials for the proposed new cancer drug, where more than 2,000 patients participated, Sutent proved its effectiveness sooner than expected. It is now under consideration for use, either alone or in combination with other medications, in the treatment of breast, lung, prostate, gastrointestinal, kidney-related and colorectal cancers. (Source:

Protecting the cervix

Before the Pap smear was introduced in 1940, cervical cancer killed more women worldwide than any other type of cancer. Regular screening has cut down the rates of cervical cancer in developed countries by as much as 70 percent but remains a big problem in developing countries where Pap smears arenít as widely used.

So to prevent the cancer from even starting, major pharmaceutical firms Merck Sharpe and Dome and Glaxo Smith Kline are now seeking USFDA approval for a cervical cancer vaccine. Respectively dubbed Gardasil and Cervarix, both biologics have undergone large-scale clinical trials that proved their effectivity in preventing the most important strains of the human papillomavirus (HPV), a sexually transmitted virus present in 99.7 percent of all cases of cancer of the cervix. (Source:

Clog-clearing cholesterol

It all began when Dr. Steven E. Nissen, medical director of the Cleveland Clinic Cardiovascular Coordinating Center, discovered a group of related people in Limone sul Garda, Italy with extremely low HDL (good cholesterol). While LDL (bad cholesterol) aids the progress of heart disease by clogging arteries with plaque, HDL helps suppress it.

Yet despite the near-absence of HDL in their blood, the people from Limone were all plaque-free. It seemed that a genetic mutation that creates a sort of supercharged HDL, dubbed Apo A-1 Milano, kept their arteries clean.

Finding the aberration promising, Nissen and his colleagues worked with Esperion Therapeutics (recently purchased by Pfizer) to bioengineer a synthetic form of Apo A-1 Milano, and tested it on a small group of people.

The result? A significant reversal of plaque in the arteries, and a reduction in the risk of heart disease. More testing, however, is needed before the drug can be released to the public. (Source:

Still on good cholesterol

A second HDL therapy, also developed by Pfizer, has already begun clinical trials. In pill form, Torcetrapib uses a different mechanism to help raise the patientís own HDL by as much as 50 to 60 percent.

Torcetrapib can work with Apo A-1 Milano, says Nissen. "We could get a head start on reducing the plaque in a high-risk patient with the powerful but expensive intravenous therapy (Apo A-1 Milano), and then follow it up with the oral drug to sustain the benefit for months or years as needed." Nissen says these therapies will begin to become commercially available in three or four years, assuming study results are positive. (Source:

Genes on a chip

Wouldnít you want to be able to take a new drug without fear of side effects? Aware that adverse drug reactions kill hundreds of thousands of people a year, Affymetrix, a technology company in Santa Clara, California, and Roche Diagnostics teamed up to develop a genetic analysis tool that will help doctors better predict how a patient will respond to certain kinds of medication.

No bigger than a thumbnail, the AmpliChip CYP450 Test contains tens of thousands of DNA strands and can detect about 30 variations in two genes that regulate how people are affected by many commonly prescribed medications, including a number of anti-depressants, beta-blockers and pain relievers. The test is already available in Europe and is currently undergoing FDA review in the United States. (Data Source:

Brain power

Itís now possible for people with nerve or muscular damage to write email, play video games or change the TV channel Ė just by virtue of thought.

Scientists at Brown University and the University of Utah recently developed a system dubbed the BrainGate Neural Interface System that allows a paralyzed patient to direct his thoughts to a cursor on a computer screen.

How? A tiny sensor implanted in his brain picks up electrical signals and sends them through three computers that process them into signals just like those from a computer mouse (these processors currently sit on a cart and are not mobile, but will eventually become wireless and small enough to fit inside the body). When connected, the patient can just "think" the cursor from place to place like the rest of us use a mouse. He can also use the computer connect to other devices, such as a TV set. The system has been tested on a small group of people and is set to undergo a large-scale clinical trial. (Data Source:

Stroke patients move again

A new device is giving stroke patients who have lost the use of hands or arms new hope. Developed by Neuromuscular Electrical Stimulation Systems Ltd. (NESS), an Israeli firm, the NESS H200 is a palm-sized microprocessor that delivers a mild electrical charge that stimulates muscles in the hand and wrist to perform a sequence of movements, allowing patients to utilize their hands.

Made of soft, polymer prosthesis, the device fits the patientís hand and forearm. In addition to improving functional use of the hand, the NESS H200 can also reduce or prevent complications associated with central nervous system disorders, including spasticity, disuse muscles atrophy, pain and edema. (Source:

New childrenís vaccine

Parents have something new to be happy about. New research shows that Merck & Co, Inc.ís investigational vaccine, Rotateq, can safely prevent 98 percent of the viral infection rotavirus. The most common cause of severe diarrhea in children, rotavirus kills an estimated 600,000 children every year.

David O. Matson, M.D., professor of pediatrics at Eastern Virginia Medical School in Norfolk, Virginia, and leader of the ongoing Rotateq study, said: "Development of a safe and effective rotavirus vaccine has been a worldwide priority since the virus was discovered in the 1970s, [as] it became clear at that time that it was one of the major killers of children, and [that] there was no effective treatment." Now it seems that there just might be. (Data Sources: and the New England Journal of Medicine)

Kidney cancer therapy

Kidney cancer has just found itself a new, formidable enemy. Bayer Pharmaceuticals recently obtained USFDA approval for Nexavar, an anti-cancer drug used to treat adults with advanced renal cell carcinoma, the most common type of kidney cancer.

Nearly 208,000 people worldwide are diagnosed with renal cell carcinoma each year and more than 102,000 of them die. If detected early enough, the cancer may be curable surgically. However, tumors that are advanced (i.e., cannot be surgically removed or have spread to other parts of the body) are difficult to treat. "The approval of Nexavar to treat advanced kidney cancer brings a much needed option for this group of cancer patients," said Dr. Steven Galson, Director of FDAís Center for Drug Evaluation and Research. (Data Source:

Arresting aneurysms

The USFDA recently approved a device to treat bulging weak spots in the bodyís main artery, a condition called aortic aneurism. Aneurysms are serious health risks because they can burst or rupture, cause severe internal bleeding, leading to shock or death.

The GORE TAG Endoprosthesis System is designed to make a new path for blood flow around the arterial bulge in order to prevent the aorta (main chest artery) from rupturing. The device, made by Arizona-based W.L. Gore and Associates, is a graft made of a Teflon-like substance that re-lines the inside of the weakened aortic wall. Implantation is less invasive than traditional surgery to treat aneurisms. The FDA said it approved the device after its success was proven during clinical trials involving about 200 people. (Data Source:

Battling blindness

An estimated 500,000 people worldwide lose their vision each year from age-related muscular degeneration (AMD), an eye disease that destroys central vision in older people. Since the number of people over the age of 60 is expected to reach 1.2 billion by 2025 and two billion by 2050, the need for a definitive treatment to combat this disease has steadily grown.

Fortunately, hope is on its way in the form of a pegaptanib sodium injection. Developed and marketed by Pfizer, Inc. under the brand name "Macugen," pegaptanib sodium is the first molecule indicated for the treatment of neovascular (wet) AMD. The largest clinical trial ever conducted for AMD patients showed that Macugen significantly reduced vision loss when compared to a placebo across all AMD patients. It also reduced the rate of vision loss by 70 percent. These results are significant because currently, up to 75 percent of patients with wet AMD do not have a treatment option.

Macugen is expected for release in the local market this year.
(Data source: Pfizer, Inc. and the New England Journal of Medicine).

Chief News Editor: Sol Jose Vanzi

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