Friday, April 03, 2009

Generic biologics

Biologic drugs are made by culturing specially engineered organisms, and no approval path for generic versions exists in the U.S.

The producers of these complex generics -- often called biosimilars -- will likely face tough regulatory scrutiny, if a law allowing generic versions of biologics is drafted .

Furthermore, many prominent biotech drugs will remain under patent protection for a number of years.

Under current law, generic drug makers can receive approval of copycat small-molecule drugs,
like cholesterol-fighting statins, after their five years of exclusivity expire.

In applying for approval, small-molecule generics must show they have the same active ingredient and the same action as the brand-name version -- which allows them to rely on the original clinical trial results and avoid having to pay for new trials.

But biologics are large proteins that are sometimes thousands of times bigger than small molecule drugs. Their manufacturing makes them sensitive to minor changes in the process, potentially altering their complicated structures and even how they work in the body.

If generic biologics have their own brands, then pharmacists won't be able to substitute them for the original, which means that generic companies will be forced to market their version of the drugs to physicians. Small-molecule drugs typically see generic substitution as high as 90%, a level not expected with branded generic biologics.

Multiple barriers to entry to sell generic biologics will limit the number of likely participants.

Generic biologics will only be for a few players.

Monday, January 19, 2009

The simple choices that we make in our lifestyle

Many people have a hard time believing that the simple choices that we make in our lifestyle -- what we eat, how we respond to stress, whether or not we smoke cigarettes, how much exercise we get, and the quality of our relationships and social support -- can be as powerful as drugs and surgery.

But they often are. And in many instances, they're even more powerful than breakthroughs in medicine.

Our bodies have a remarkable capacity to begin healing, if we address the lifestyle factors that often cause these chronic diseases.

Wednesday, December 31, 2008

Unconventional therapies

Is there anecdotal evidence that unconventional therapies sometimes yield positive outcomes? Yes. There's also anecdotal evidence that athletes who refuse to shave during winning streaks sometimes bring home championships. It was George D. Lundberg, a former editor of the Journal of the American Medical Association, who said: "There's no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data." We'd do well to keep that in mind as we plot the future of American health care. It's not like we've got billions to waste

Wednesday, December 17, 2008

Exploring treatment options for cancer

Before exploring treatment options for cancer, establish some ground rules.
You'll be more comfortable with any cancer treatment decisions you make if you:

Decide how much you want to know. While most people want to know exactly what their treatment is and their survival chances, others don't. If you don't want to know all the details, let your doctor know, and you and your doctor can devise a strategy that's appropriate for you.

Decide how you'll want to make your treatment decisions. You might want to gather all the information you can and take the lead in the decision-making process. Or you might want to turn all decisions over to your doctor. You might also be somewhere in the middle, sharing the decision process with your doctor.

Have realistic expectations. Your doctor can give you estimates about what you can expect to get from each type of treatment. But what you do with these estimates is up to you. Exactly what side effects you may be willing to put up with will depend on what the benefits of the treatment are likely to be.
Communicate your preferences with your doctor.

Keep the focus on you. Don't let anyone pressure you into a particular treatment option. Pick what you feel most comfortable with.

Accept help. You'll need support throughout your treatment. Support can come from your doctor, your friends and your family. If you don't feel supported in your decision making, contact groups such as the American Cancer Society, which can put you in contact with cancer survivors who can help support you through this process. It might help to write down your expectations and preferences before you meet with your doctor. That might help you better express your hopes for and feelings about your cancer treatment.

Monday, December 17, 2007

Nutritional Genomics

Imagine this scenario : A physician scrapes a sample of cells from inside your cheek
and submit it to a genomic lab.

The lab returns a report based on your genetic profile that reveals which diseases you are
most likely to develop and makes recommendations for specific diet and lifestyle changes
that can help you maintain good health .

You may also be given a prescription for a dietary supplement that will best meet your
personal nutrient requirements.

Such a scenario may one day become reality as scientist uncover the genetic relationship
between diet and disease.

Until then however we need to know that current genetic test kits
commonly available on the Internet are unproven.







Saturday, December 15, 2007

Underweight people.

Underweight is affecting more than 5 percent of U.S. Adults.

Whether the underweight person needs to gain weight is a question of health and , like weight loss, a highly individual matter.

Healthful weight gains can be achieved only by physical conditioning combined with high energy intakes.

Weight-Gain strategies center on :
*Energy-Dense Food
*Regular Meals Daily
*Large Portions.
*Extra Snacks
*Juice and Milk.
*Exercising to Build Muscles.

Thursday, December 13, 2007

We don't expect tall people to shrink

Many people assume that every obese persona can achieve slenderness and should pursue that goal.

First consider that most obese people do not -for whatever reason – successfully lose weight and maintain their losses. Then consider the prejudice involved in that assumption.

People come with varying weight tendencies, just as they come with varying potentials for height and degrees of health, yet we don't expect tall people to shrink or healthy people to get sick in an effort to become normal.