FDA starts e-communicating

Government folks--and many in health care--aren't exactly known for quick pickup on trends, no matter how useful. Something about wheels grinding exceeding slow...

Anyway, good news from the FDA. They'll soon be processing drug approvals with an electronic tool being developed by Global Net Service and Cyclone Commerce. Pharmaceutical makers will shortly be able to abandon inefficient paper submission and start submitting electronic documentation when seeking approval for new drugs.

Starting immediately and finishing in 2006, the new gateway will be the single point for electronic submissions from drug and medical device companies, drug distributors, food makers, health-care organizations and government agencies.

Thank heavens, this is just the beginning. Once everybody realizes just how much easier, faster, and cheaper electronic communication is, the word will get around and, with luck, the entire health care industry will get on the bandwagon. It's always surprising to me--though I guess it shouldn't be--when people and organizations refuse to see the obvious benefits of doing things differently. I guess maybe it's because the nature of human beings is to fear change. And maybe the finance guys have to be beaten over the head with facts and figures before they realize that spending now will result in real savings for the long term.

Oh, yeah, now I remember. It's the American obsession with this quarter's bottom line that enforces the drag-your-feet attitude. Well, we've started copying the Japanese way of making cars. Maybe soon we'll catch on to their "let's-look-ten-years-ahead" philosophy and junk the "we're-down-this-quarter!" panic-attack approach.

Montana throws its hat in--

I wonder if every state in the union will eventually form a partnership to pursue the promise of big bucks in bioscience? Montana's governor hails the formation of the state's bioscience trade association, which makes them automatically a member of BIO, the national trade organization. BIO represents "more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 other nations."

It's so strange to see cities, states and governments of all descriptions jumping all over the potential in this industry, even while many local investors shy away because the risks inherent in the business of experimenting with living things makes the payoff--which can easily be huge--seem perhaps not as worthwhile. After all, they might be saying, who wants to lose everything when someone sues a biomed company, claiming its products have caused severe physical damage, serious illness, or even death?

Catch-22. Risk / reward. Is there any way to protect investors? Well, the North Carolina people (surprise), who, by the way, call themselves "one of the top biotechnology regions in the United States and the world," claim they work constantly to expand public investments in bioscience companies and life-science venture funds, loans for bioscience businesses, and tax incentives for investments and research.
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Is the rest of the world doomed to imitate this self-styled leader (N.B., North Carolina's self-confidence and its flare for marketing seem to inspire a lot of jealousy among certain other states)? Perhaps reading some tips to bio-entrepreneurs could help us learn better how to inspire confidence in investors... The Tech Council of Maryland (another contender) offers this interesting read: Financial FAQs for bioscience companies.

Anybody want to invite insurance companies to throw out some ideas?

Turn it off!

Do you enjoy driving by those gas stations with the horrendously bright lights--sometimes dozens of them? Last night on my way home from the airport I took a different route. And somewhere, I think it was on Miles Road in Warrensville Heights, I passed a new building that was so freaking lit up--at 7:30 pm--that I thought I was driving by a major government interrogation/torture center where they never let you close your eyes or sleep.

Anyway, between our use of gas and those lights, we're screwing up nature's elegant plans. From this Washington Post article comes: "Americans' prodigious energy use -- from the gas that fuels massive SUVs to the coal that keeps the light and heat on in sprawling suburban homes -- comes at a cost. Burning fuel spews carbon dioxide (CO 2 ) into the air, which in turn traps heat and, most scientists believe, is accelerating global climate change that is melting glaciers, altering animals' breeding and migration patterns, and boosting temperatures around the globe. "

If we don't curb ourselves, nature's going to do it for us. Why do we have to put our heads in the sand and wait for a climate crisis? I guess because denial and reactivity are easier than taking a stand before we have to. Sigh.

Science preserving French cuisine

You know, I wrote about this in my Blog for Business yesterday, but it fits for BioMedNews as well. So here goes...

"We're saving French cuisine!" claims the new science of molecular gastronomy. Okay, okay. All it means is that a guy with education and training in hard science is applying his skills to the processes of cooking. Why? Because in France, the very cradle of profoundly delicious food, many of the ordinary restaurants that have always provided extraordinary cooking can no longer afford to pay enough employees to do all the things they once did. This means shortcuts. This means lost flavor. This means, if you believe this Gourmet magazine article writing about scientists at the College of France, the potential crumbling of the very foundations of superb French food--and even, by virtue of its national identity being so completely tied up with its food, France itself.

Monsieur This (pronounced tees) experiments until he can disprove the need for a traditional technique without sacrificing flavor, and thus shave precious minutes from the labor time for preparing a classical dish. Voila...(even if you're not a devoted cook, as a scientist you can appreciate this next bit):

"The paradox of the veloute, for example, is in fact just that. Traditionally, it has been maintained that the foam rising to the surface of a flour-thickened sauce is an impurity. However, M. This has made clinically sterile veloutes from which the foam still rises. Such a discovery might sound inconsequential, but it certainly is not to the kitchen apprentice who has to spend the break between lunch and dinner doing the skimming."

Just one of the many reasons why food in France tastes incredibly good.

The happy part of this is that science is becoming an ally to tradition. These researchers are applying the newest scientific discoveries to finding ways to preserve the most exquisite parts of the past--and keeping a ton of small business owners in France in business.

This, as Martha would say, is a good thing.

Bio-pharm-med reacting to change

Pfizer isn't the only drug company struggling, what with potentially losing some of its big revenue items like Celebrex to patient health concerns and Lipitor and other drugs to patent expirations or challenges. Schering-Plough, Merck & Co. and others face similar hurdles.

This Washington Post reporter wonders whether pushing billion-dollar products is the right business model in an era of dramatically rising concern over drug costs. As we invent more new medicines and treatments, people's health coverage shrinks and the costs must be borne by more patients who are less able to pay.

Pfizer is looking at cutting its sales force and focusing more on internal research. They spent $7.7 billion last year alone--some of it in licensing fees and revenue sharing with other companies (lots of little guys partner with Pfizer for its marketing muscle--they have 2000 alliances which also contribute 1/3 of revenue).

So how would we replace the model of the giant company taking the little guys under its wing? As the government watchdogs ever more closely its researchers' relationships with private companies, the entrepreneurial spirits out there could lose some of their biggest supporters.

Without that kind of help, many in the biomed and biotech sectors may have to start circling the wagons and plotting out their lonely passage across the mountains just as so many entrepreneurs in business and industry have had to start doing in the last decade. It will be interesting to see what effect this might have on the wild and wooly careening of the biomed sector to the top of everyone's hopes for job creation and revenue generation.

Biomed device company turns to defense

Some companies, as we've written recently, are benefiting big-time from the U.S. government's obsession with defense against terrorists. Some of them might even change their names to include "defense" in order to take advantage of the boom in government support dollars. A northeast Ohio device company, formerly called Interwoven Technologies and now known as Stargate Defense Systems Corp, is another recipient of the Department of Defense's largesse. They just received "$1.27 million to explore the feasibility of developing a handheld machine that would detect harmful chemicals, such as nerve or mustard gas, in drinking water."

The good thing about this is that the end results of these negative-energy research projects (let's face it--it's hard to think of devoting your energy and your resources to defending against horrible things you think other people will do to you as anything but negative) will be adaptable to helping the human race in many other ways.

I once attended a class, for example, with a psychologist from Kenya who said, far from worrying about advanced mental health issues, many people in his country still have to be taught not to drink from the polluted waters in which they also defecate and bathe.

So if we can learn to detect bad stuff in water (no matter why we decided to learn it), maybe we can use that discovery to help raise the standard of living for others in our world...let's hope sooner rather than later.

FDA debates genetically engineered generics

Virtual miracles happen with certain biologic drugs like Remicade, which uses engineered versions of naturally occurring proteins to offer powerful relief to sufferers of such ravaging diseases as rheumatoid arthritis and Crohn's disease. But the price tag on such biotech drugs can be huge--imagine a lifetime of taking drugs, only one of which costs $15,000 a year.

Despite the fact that last year about half of all U.S. prescriptions were for generic drugs, the amount spent for these low-priced products was only 8% of the nation's total drug bill. Now, generic drug makers are asking Congress to consider a speeded-up approval process for creating less expensive generic versions. They claim they have all the science and technology necessary to do a good job. Not everyone agrees.

If you miss a critical piece or create the new version ever-so-slightly-wrong--which is incredibly easy to do when you're talking about bio-engineering--you can end up poisoning patients without really understanding where the problem lies. In the case of one anemia drug, it took a company years to figure out that a stabilizing chemical they had added to the "formula" was yielding serious undesirable side effects.

Balancing responsibility with expedience is the name of the bioengineering game. The solution may come down to giving the generic companies permission to duplicate, but then issuing the drugs in "beta" form for the first 5 or 10 years--that is, informing patients, as is done for the expensive process of human clinical trials, that they will use the drugs at their own risk because not all potential side effects are yet known.

When people experience profound relief of pain and suffering, they're often willing to take whatever risks they must. It only seems fair to give them that chance.

Blood clot risk high in cancer--new blood thinner found

Both bad news and good news came in the same batch of American Medical Association information this morning. Patients with malignancies are at least 7 times more likely in the first months after diagnosis to suffer blood clots in the legs or lungs than those without. If it's a blood-related cancer, the likelihood skyrockets to 28 times, according to this Dutch study. Seems that surgery and chemotherapy used to treat cancer also increase the likelihood of clotting.

Happily, a new anti-clotting drug called ximelagatran was found in another study to be better at reducing clot formation while also being less intrusive to administer (patients simply take a pill instead of having injections). The U.S. hasn't approved use of this new drug yet; effects of the liver have not yet been sufficiently gauged.

One step forward, two steps back. Medicine takes an endless succession of potshots--many with unknown consequences--at cancer. Cancers shoot back when the treatments are too strong...when they destroy pieces and parts of the human system needed for other purposes.

It's a dance without end, and our place in the timeline simply a matter of chance. If you have cancer today, you have multiple treatment options that didn't exist for a grandmother with the same disease. And happily, our great-grandchildren will probably have a nearly unimaginable number of options. Let us look forward to the day this dance can end.

Can societal controls make alcohol as undesirable as smoking?

A new report says that alcohol costs society as much in health care as smoking and high blood pressure. As Great Britain prepares to adopt its stay-open-24-hours policy for pubs, bars and clubs, the report says that controlling consumption by restricting times to purchase it would directly reduce the incidence of cirrhosis and other alcohol-related mortalities.

I remember back a couple of decades ago when smoking began to be seriously frowned upon by polite society. When people could still freely pollute the air on tight-spaced places like airplanes. And I used to smoke years ago, so I was just as guilty as others. But eventually, it got to where people simply looked aghast at you for lighting up--and then eventually made bold enough to ask you to go outside if you had to do that.

According to what I've heard from international social work exchange members, in Africa for instance if someone is practicing undesirable behavior (like regularly getting drunk and making trouble), the social network simply spurns the person. The Amish societies "shun" someone who's misbehaving. Since we are all social creatures, being shut out by every member of your society is a powerful punishment that could easily induce you to toe the line (unless you had another readily available social outlet to escape to).

So yes, it makes perfect sense that if society would start frowning on drinking, fewer people would do it and those who did would probably drink less. But there's a lot of money in alcohol, just as there is in cigarettes. Some powerful folks will be fighting to keep our policies as liberal as possible.

One time when a treatment is definitely not creating another problem

We write often here about procedures and treatments that seem to create new health issues even as they treat some existing problem. Here's proof of at least one such procedure that's now been proven NOT to do new damage (at least, no the damage they thought it might be creating). A recent study published in Pacing and Clinical Electrophysiology (PACE) has proven that the use of catheter ablation to treat supraventricular tachycardia (SVT) doesn't cause injury to a patient's cardiac nerves, possibly artificially accelerating heart rates following the procedure.

In some cases, of course, the ablation is being performed in the first place to repair a problem that was caused by a previous heart procedure (e.g., a patient who gets a valvuloplasty (heart valve repair) who only started having occurrences of SVT after the repair procedure has to get an ablation to stop a certain part of the heart from going into overdrive).

Well, when you're working with something as tightly and intricately interwoven as the systems of the human body, anything that helps and doesn't hurt in another way is a victory.

Nitric oxide for infection resistance - Antibiotic resistance redux

Fighting blood clots with the same substance you use to fight pollution in car exhaust fumes seems like a stretch. But both processes use that miracle substance-of-all-trades nitric oxide (NO) as the principal agent. NO is able to "regulate blood pressure, stop thrombosis - blood clotting in the vessels - and is a powerful antibacterial agent," according to one of the UK chemical researchers who's filed a patent application.

Finding ways to deliver the NO--in exactly the right quantitites, to exactly the right sites--is the trick. So far they are testing wound dressings that can protect against infection, even from such as the antibiotic-resistant bacterium Staphylococcus aureus (MRSA which is becoming more common in hospitals).

Antibiotic resistance is a growing issue, and some creative research is being done. For example, one approach is to try to destroy antibiotics in the lower intestines, where resistant bugs are known to keep growing right in the presence of antibiotics.

The fact is, our societal attitudes about medical treatment have set us off on many a crooked path. My pediatrician for years refused to give my children antibiotics without solid proof that they had pneumonia or some other provable-bacterial infection. Eventually he felt unable to help anymore with one child's continuing respiratory issues and sent us to an allergist--who promptly started treating every incident with a different course of antibiotics. Despite my urgent questioning of whether the original doctor agreed with this approach or not, he would not speak against it. Said in fact that his own son took his child to a doctor who freely prescribed antibiotics.

When we believe that medicine can help us, we want to hurry up and get better with it. The problem is that somehow too many of us, patients and medical professionals alike, got convinced that antibiotics were miracle drugs that would cure anything. The pendulum is swinging back--we just have to navigate our way around the consequences we set in motion in the last several decades.

New Ethics Rules changing the look of biotech cooperative ventures

New rules about ethical conduct may encourage more scientists at NIH and other government agencies to head out for greener pastures in private industry.

We've written about this issue before. How close should the relationships be between government-sponsored researchers and the pharmaceutical and other private companies who stand to benefit immensely from resulting discoveries? The answers have been hard to define--but restrictive new regulations against. for example, accepting pay for speaking engagements and/or holding biotech stocks, are forcing some biotech investigators to rethink their plans. Government work doesn't pay as well as private industry, so scientists have looked for outside ways--some of which are now being closed to them--to improve their compensation.

Some in the biotech sector feel this is a good thing--that more creative researchers on the loose will mean more entrepreneurialism and more new private companies. Not all collaborative work will be stopped--the NIH will still partner with private companies for certain functions such as implementing human testing of vaccines.

No matter how some things change, startup companies will continue to receive help and support so there's no increased danger of strangling new research. Free enterprise, government work and ethics have been coexisting a long time--they're bound to find a way through this, too.

Breakthrough approach to treating viral infections

Exciting discovery with immediate application for preventing terrorist attacks with the smallpox virus. Mouse experiments have shown that combining this new drug with a single antibody injection cleared the lungs of a smallpox-like virus in just eight days. The drug fights viral diseases by blocking cellular signaling pathways that viruses depend on for reproduction..."We now have a model of an approach that can potentially be used to treat a wide array of acute viral conditions," according to the study's director.

Targeting cells carries a higher probability of success since they don't mutate with the speed and agility that viruses themselves do--and can allow the body's immune system to do its job more effectively.

Funded by National Institute of Allergy and Infectious Diseases (NIAID) as part of a battle against bioterrorism, it seems that after all, maybe the heavy focus on defense may eventually result in long-term gains for patients at many levels.

Well, none too soon to start countering those new infectious diseases being introduced by those drug-resistant forces we created by overindulging ourselves in antibiotics all these decades...