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.

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.

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.

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.

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 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.

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…

Used to hang out at my mom and dad’s farm in Indiana on vacations. Never failed to be astonished at the vast quantities of flies to be found on a farm. Found an article years ago that said absolutely no useful purpose had yet been found for flies. Supposedly, it said, they even inhibit the natural process of waste elimination by consuming the bacteria that decompose manure! Boy, did I get a lot of mileage out of that one when the whole family was congregating down on the farm.

Well, I’m not ashamed to admit when I’m wrong (sometimes, anyway). It’s a pretty roundabout contribution, but scientists are now reporting there’s a protein found in the saliva of black flies that helps wounds and incisions heal faster and more effectively.

Of course, I’m not surprised, since I tend to believe that everything in the universe is here for a reason. I’m just a little sad that I’ve lost the ammunition I used for so long to perpetuate my hate-hate relationship with flies.

I don’t care, though. I still hate the buggers. And I sure don’t want them setting any of those guys loose on any wound of mine…

P.S. Leaving for a brief vacation today. Will be out of blogging range until 1/31. Have a great weeek!

Are the folks at the National Institutes of Health (NIH) so close to the captains of the private publishing industry that they are shortchanging the interests of the public? That’s the question on the table since NIH has pulled a proposed policy of publishing its research for free public consumption within six months of an initial journal writeup.

Research that taxpayers have paid for should be made available to them quickly, say sponsors of the proposal. Friends of the medical/scientific publishing industry claim this early release of information would put them out of business.

Well, we know the government has not previously hesitated to be in the business of keeping certain industries alive–paying farmers not to farm, bailing out savings and loan institutions, etc. But is there a more compelling component when you’re talking about human health? I just wrote about the rise in self-care occurring in our society, so where might this fit in? As we take greater charge of our own health care–and the 45 million uninsured Americans often take sole charge at that–do we have a more pressing right to know what’s being discovered as quickly as possible?

It seems fair to say yes–but with strong cautions. Just as doctors don’t know upfront the full implications of many of their research findings, so we non-professional self-medicators aren’t going to know all the potential–for good or evil–that each discovery carries with it. But as knowledge on every topic becomes more accessible via the magic of the Internet, so human beings ought to be able to have all the presently known facts available when trying to make intelligent choices about their health and their lives.

Seems to be it’s better to be too open than to discover decades later that private corporate scientists did know of potential dangers–say, of tobacco–and deliberately hid them from the public. On that topic, see today’s BlogforBusiness.com story on giant DuPont Corporation hiding the dangers of chemicals contained in Teflon pans and utensils.

“Every individual has some advantage over all others because he possesses unique information of which beneficial use might be made, but of which use can be made only if the decisions depending on it are left to him…”

– Friedrich August Von Hayek, Nobel Laureate, 1945

What an appropriate observation–made so many decades ago by this brilliant mind–about the business of research and investigation. So what does it mean to say that your information is totally unique, but that its benefits will only manifest themselves if you, specifically, have the ability to decide what to do with it?

A powerful idea, indeed, that has implications far beyond the simple sharing of information. Implications about how important is the part that you–just you, not you compared to how important you are in relation to others–play in the shaping of the very universe we inhabit. Implications about the far-reaching effects possible when you empower people. Implications about the waste involved in not recognizing the special contribution of every individual.

Happily in bioscience and other scientific disciplines, recognition for your unique contribution isn’t hard to come by if you’re an investgator. What’s not so easy is recognizing the special contributions of those in less august occupations in the industry, like lab assistant. Or of those in related but less august jobs such as vendor or public relations person.

Human relations mean the world to success, whether we’re willing to admit it or not. But then, I guess we have to discuss what’s the definition of success. And therein might lie the main points of difference…