A 510(k) is a formal attempt to convince the FDA that the device you want to market (you have to file 90 days before you start marketing) is as safe and effective something equivalent that’s already out there.

Halozyme Therapeutics Files 510(k) Application for Cumulase for In Vitro Fertilization Cumulase is a synthetic version of the cow and sheep enzymes taken from slaughtered animals that are used as an essential part of the the process of intracytoplasmic sperm injection (ICSI) for in vitro fertilization.

IVF grows more and more common around the world. Right now they’re saying this product has a a market 500,000 potential purchases per year worldwide. As treatment gets more effective and less difficult–and less expensive–the marketing will only grow.

A man died recently in Australia of what was thought to be possible “sporadic CJD, an illness that kills about 20 people in Australia each year.” The disease is different from variant CJD (also known as ‘mad cow disease’), but neither variety has a treatment or cure. Death usually occurs within six months of symptoms.

So this brain disease, apparently caused by a rogue protein and able to lie dormant for decades, is causing an uproar. It’s not that someone didn’t follow proper sterilization protocol, but they say if they had known he might have this disease they would have been even more cautious.

The problem is there is no perfect method of sterilization. Bits of tissue, bone or blood, or even water drops, can remain on an instrument that goes into a sterilizer and therefore mask that area enough to prevent sterilization. And of course not all “germs” die in the steaming process.

Add to this the variety of materials now being used for instruments (inlcuding plastics and fiber optics) and you compound the problem. Some companies are making reusable handles that have disposable inserts of various types (as in surgical scissors that uses a variety of disposable jaws).

The debate will always rage. The issues are cost, human safety and environmental friendliness. In non-medical terms, should we soil the environment with disposable diapers or threaten the water supply with the extreme amounts of detergent and bleach needed to clean cloth ones? How about putting garbage in landfills versus using the garbage disposal?

How do you judge which is the lesser of two evils? The number of people placed in danger? The ages of the people put at risk? Do we draw a line and say we shouldn’t go beyond this? These are questions human beings face everyday…some–like medical professionals–more than others.

As I said earlier about the debate on stem cell research, in vitro fertilization and pre-implantation diagnosis, the wisdom of the many must provide answers when the questions are ones that have never had to be asked before. Thank God we have the Internet with which to conduct our debates–makes it much more likely that we’ll hear all our voices.

It was really hard to choose which item to write about today. So many interesting items; so little time. But this one is truly noteworthy from the standpoint of national organizations fostering cooperation between research institutions. This is taking the spirit of sharing and cooperation one step beyond its normal high level in the scientific world.

A partnership between several major players in the bioscience world has been funded by the National Institute of Allergy and Infectious Diseases. “Case Western Reserve University, the Cleveland Clinic and University Hospitals of Cleveland will anchor the consortium, which also will include participation by Emory University, Yale University and the University of Manitoba in Winnipeg. The University of Pennsylvania and Brigham and Women’s Hospital in Boston will form the other two consortiums.”

All these high-powered players will be putting their brain power together to study heart and kidney transplant patients to see if blood or urine tests can predict whether a patient will reject a transplant and hopefully adjust medications to improve outcomes.

This is a huge focus on the future–heart transplants are becoming more common, but the numbers are not huge. Statistics on U.S. transplants:

• There were 2,154 heart transplants performed in the United States in 2002 and 2,199 in 2001.

• Each year thousands more Americans would benefit from a heart transplant if more donated hearts were available.

• In the United States, about 77 percent of heart transplant patients are male; 74 percent are white; 50 percent are ages 50-64 and 19 percent are ages 35-49.

• In 2002 the one-year survival rate was 86 percent; the three-year survival rate was about 77 percent; and the five-year survival rate was 71 percent.

And here are statistics on kidney transplants:

• 9,078 kidney transplants from cadavers in the USA 2001

• 3,048 kidney transplants from living related donor in the USA 2001

• 9,078 kidney transplants from living unrelated donor in the USA 2001

• 56,598 people waiting for kidney donor in the USA 2001

• 2,444 people waiting for kidney and pancreas donor in the USA 2001

It’s possible that the impact of the baby boomers is at work here. As that huge wave of folks hits the 50s, the burning desire to prolong life by replacing faulty parts gets a lot of energy.

A high-risk, high-return drug testing company chose to locate in Northeast Ohio because the principals liked the easy-going Midwest flavor of the region. But they’re finding that along with the slower pace, the investment attitude is extremely conservative and somewhat stuck in the past.

Read this interview with Arnon Chait, CEO of Analiza, Inc. on BioScienceMediator.com

Leave it to a U.S. president to get medical professionals focusing on the fact that their tests are inadequate. Bill Clinton’s close call with death from coronary heart disease has brought powerful focus on whether current testing is doing the job.

Shockingly, the American College of Cardiology issued a report in August that showed nearly 90% of heart attack victims would have tested as only low- to moderate-risk if tested the day before the attack. That means common testing methods pretty much suck.

I know a woman who suffered for years from severe respiratory illnesses (even to being hospitalized) and was repeatedly treated as if she had asthma (though they were not able to diagnose that condition), until one day a combination of circumstances led a physician to look further–only to find the woman had been suffering from valvular heart disease for nearly 10 years. The heart disease caused almost every single respiratory symptom during that time, yet despite pulmonary specialists’ inability to come up with a diagnosis, not one medical professional suspected the heart. This is where holistic thinking could have made a difference: if you can’t find an answer in your own specialty, think about what other related systems might hold the solution.

The thing is researchers have discovered several new, much more effective tests for heart disease–but doctors don’t know about them.

Let’s face it: doctors are like anyone else doing a job. They’re comfortable with what they know. Change is hard for most people. What would make a cadre of doctors want to continually shake up their lives by watching out for–and keeping up with–what researchers are doing?

That kind of thing would require a whole different approach to regulating the medical profession…not a welcome thought I’m sure to those who invested so much blood, sweat and tears in becoming medical professionals so that they would be the experts, not the perpetual students that this new approach might require.

It’s tough asking people to change. If you paid with your soul to get where you are, it’s probably even harder to do it. But eventually we’ll find a way that accommodates the constant learning and doesn’t turn hard-working, dedicated professionals away from medicine.

The debate has been academic for many years. Now, with the soaring rate of in vitro fertilization (100,000 in the US alone), the number of unused embryos is growing–and the space to store them is shrinking. The American Society for Reproductive Medicine earlier this year set a policy saying that it was okay to dispose of embryos after 5 years if all attempts to contact the couple who produced them have failed.

As science advances, humankind is facing ethical questions that never could have been imagined centures, even decades ago. Where do people find guidance? Strict Catholics will follow what the pope says. But many will recall the time when the pope changed the Catholic church’s mind about condemning people to hell for eating meat on Fridays. Generations feared potential eternal damnation of some family member who disobeyed that edict; my own father abandoned the church for many years because of it. His opinion: they had made fools of people.

Even now people “shop” for a priest who will condone what they want to do (such as practice birth control). Some call it situational ethics; others say it’s changing with the times. Either way, these are new and important questions that require the joint wisdom of medical, philosophical, religious and scientific minds.

The fast-growing Bahai religion posits that the will of the majority–consensus–constitutes truth. Until the majority changes its mind. This is the path we are taking to these questions–and it can only be a good one.

In India assisted reproduction is catching on quickly. People who fifteen years ago refused to have any part of it are now agreeing to use donor eggs, or have the male’s sperm taken directly from the testes for the technique of Intra-Cytoplasmic Sperm Injection (ICSI) (a then-unavailable method of injecting sperm directly into an egg).

The article in the Times of India talks about the fact that surrogacy, for instance, is not an irrevocable adoption procedure–the mother who bears the child is still legally its mother and can refuse to give up the child. It also suggests that the day is nearing when the first step to parenthood may be a trip to a lawyer.

How many times have you wondered whether becoming a parent ought to be a privilege that is tested for and licensed–like driving a car or practicing accounting? Someone–in these cases the state and the governing body–decide what basic level of knowledge someone must have in order to be qualified to perform this task or do this work. And they have the power to tell you, no, you can’t drive a car on public streets because you don’t understand the laws or you’re not capable of making a turn without cutting off the curb (and possibly the resident pedestrian).

Who would be the governing body in the case of parenthood? Who is so perfect at it that they could stand in judgment of another? Aren’t we all entitled to reproduce if we want to? Good questions. But the guy who writes the accounting test probably doesn’t practice perfect accounting either. And heaven knows there’s a huge range of quality in drivers–including the ones who write the tests.

But there IS some basic information that every parent ought to know. Like a lawyer, who goes to school for an extra four years NOT, as my ex-husband used to say, to learn everything there is to know. No one could do that. But to learn where to find the answers if you don’t have them. To study precedent and see what wise minds of the past have done.

If we carry this analogy along far enough, we have to include the idea that some people would be told no. Does that mean we would mandate sterilization? That’s already been proven to be untenable by most societies. In 1979 the Chinese people were simply told “you may not have more than one child.” Of course, some of the measures they used to enforce this edict were questionable.

In any case, the rise of the use of assisted reproduction is bringing this question of fitness for parenthood to the forefront. I mean, my daughter works as an adoption counselor for the Chicago Canine Rescue. She refuses people who want dogs all the time because they just don’t understand what’s required…

Another city quietly joins the ranks of those vying for favor as sites for bioscience companies to locate. A coalition of the city economic development department and several companies is starting by building a huge parking garage–nice forethought for building additional research facilities. “Parking has been in short supply on Michigan Hill recently. Grand Valley State University opened a Health Sciences building last year and Spectrum Health is opening a $100 million heart center this fall. Michigan State University also is eyeing the neighborhood as a possible site for some or all of its College of Human Medicine.”

The hope is that building the largest parking facility in the city (2000 spaces) will make the area more inviting.

With all the money that’s being poured into supporting the growth of the bioscience industry, we can hope that tremendous progress will be made in every area and people will benefit from the faster, more intense pace at which discoveries can be made. But it seems all the hoopla isn’t yet translating into support for startup companies. Guess there will have to be a trickle-down effect once everybody finishes jockeying for favor with the bigger, more successful companies.

Interesting article in the recent AARP magazine. There’s a pharmacist who years ago took a stand against where the healthcare industry has been trying to pigeonhole pharmacists–that is, as nothing but the order filler. He set up his practice with a carpeted waiting room and a consultation area. Why?

Because he believes that the pharmacist’s job is to watch out for the patient in ways that many doctors today do not–namely, to be responsible for studying drug interactions and making sure that when they prescribe a drug, it isn’t going to cause a patient problems.

With annual drug costs for the average elderly person in a nursing home hanging at the $18,000 level, this is a serious business concern, too. But he’s worried–and has plenty of evidence for feeling that way–that many elderly people are being made extra miserable by the truckloads of drugs they’ve being fed every day without regard to how they make the person feel.

Tremendous opportunity for bioscience companies working on this issue.

More info for people needing help: The American Society of Consultant Phamacists and SeniorCarePharmacist.com

You may be wondering where the daily posts are. Well, I promise, we posted them, but Blogger, the blogging software that we use to publish this blog, has been intermittently simpy refusing to publish–sometimes at all (have lost several posts this week), and sometimes until some time a day or two or three later when whatever is wrong gets temporarily fixed.

This has been going on all week, and though I’ve sent numerous requests for help to Blogger, no one seems to be at home there.

So if you get this note, the “fix” will be on. But don’t be surprised if then you don’t see anything new again for a couple of days. Until they get this random glitch fixed, we are at their mercy…

And the most amazing part is, this program is Google’s–the absolute giant of online expertise.

Hey, Blogger/Google! Where are you!?