05 March 2011

Crap On Demand Test for Colon Cancer?

I will have to reserve some thoughts on this as I am not sure I could crap on demand. Plus they may be heralding this as the latest and greatest, but to me it is a little like shutting the barn door after the horse is out. I think I would rather have the colonoscopy done prior to cancer than rely on this test. But others may prefer the test if it is indeed successful.

The researchers at the University of Missouri seem quite proud of themselves for their discovery, but I doubt that it will or should eliminate colonoscopies altogether. What has not been answered – will this discover colon cancer before or after it has developed in humans? If after, they they could be barking up the wrong colon (pun intended). Presently, the researchers are claiming before the development of colon cancer.

The researchers may be onto something if they can detect the bacterium that leads to colon cancer before cancer develops. They are making only claims at this point about not needing to stress people and that they can detect things much earlier than before, but they will need to determine the effectiveness on humans and not animals.

They are very probably correct that many people put off having a colonoscopy for longer than they should. Whether this test will encourage people to have the test earlier will remain to be seen. While I will be happy to continue to have a colonoscopy done, I can only hope this is not just another attempt to blow smoke up our backsides.

Read the article from the press release here.

04 March 2011

Healthy Patients Can Be at High Cardiac Risk

Now they are saying that otherwise healthy patients may be at high risk of cardiac death. If this got your attention, it should. Apparently there are people with problems that even they are not aware of, and serious problems even when other cardiovascular indicators are not present.

This little known cause is a type of irregular heart beat and apparently this does not show up on standard tests. Heart rate turbulence, which reflects how well the heart reacts of occasional premature contractions, is an even stronger heart disease risk factor than elevated levels of C-reactive protein (CRP). CRP is a potential heart disease biomarker that has emerged in recent years.

Among the almost 1300 study participants considered at low risk of heart disease based on traditional risk factors were more at risk to die of heart disease by a factor of almost nine times during the 14-year followup period if they had abnormal heart rate turbulence values.

Researchers don't yet know if abnormal heart rate turbulence can be treated or prevented. In the meantime, interest might grow within the medical community in measuring heart rate turbulence in clinical practice. Currently, this type of measurement is not widely available. This is the disturbing part of this discovery.

Heart rate turbulence refers to how smoothly the heart rate returns to normal after a premature ventricular contraction, a fairly common event in which the second portion of a heart beat is triggered too soon. Due to the improper timing between the atrial and ventricular contractions, the ventricles haven’t fully filled with blood, and therefore do not push out enough blood to the body. The brain detects this sub-optimal release of blood and instantly increases the heart rate to pump more blood. This overcompensation raises blood pressure, causing the brain to react again and lower the heart rate until blood pressure returns to normal.

Of all the heart problems that develop, this is a real bummer and the fact that most people are not aware they may have the heart rate turbulence is not good news. Hopefully, the heart doctors will move quickly in finding a treatment that will eliminate or at least mitigate the turbulence.

Read the article here and here.

03 March 2011

Key to Medication Adherence Is Education

This is very interesting, one group saying medication education is the key to adherence and another group saying that limited literacy may reduce medication adherence. Both are saying basically the same thing.

One group is calling for education as a tool for patients to understand their medications and how they help the condition for which they are prescribed. But will this work in the real world, that is the big question. Yes, the Skaggs School of Pharmacy and Pharmacotherapy at the University of California, San Diego says that pharmacists and other health care providers need to assess the patient and include this education as part of their services.

The other study describes the problem of how the way physicians write the prescription and the pharmacist puts the instructions in the package for the patient. The two can often conflict and the patient is left wondering whether the doctor or the pharmacist is correct. They are calling for standardization of the prescription instructions.

Between the two studies, it appears that education needs to begin with the doctor and proceed to the pharmacist and then to the patient. This will require the manufacture to provide an update to the doctors of prescription requirements and possibly allowing the doctor the opportunity to print the prescription instructions for the patient. Most of this would be using standardized formats and then the pharmacist would be able to do the education of the patient. Actually a little education could be done by the doctor, but the bulk of the education would be by the pharmacist since they should be aware of all medications and where conflicts might arise.

In either study, it should be noted that education can be the key to adherence and this should be the emphasis. Read about the study at the University of California, San Diego here. Then read the other study at the University in Chicago, Illinois here. This should be a wake up about the problems that can arise.

02 March 2011

Another Black Eye for the FDA Maybe

Maybe the title should read “follow the money trail”. The FDA is being grilled by our elected representatives in a manner that has to make us wonder who is receiving contributions for their reelection and from what companies. Maybe this should be investigated by the FBI.

The FDA has been tightening the evidence trail after many recalls for defective devices that had cleared the 510(k) premarket clearance process in error and had to be recalled. This is only natural for the FDA to close the door once the horse is out, but the way our elected representatives are acting, they are backing industry investors to open the door for more horses to escape and more recalls to take place.

Of course there are people on both sides of the issue and again the patients will be subjected to over zealous marketers who care more about profits than they do patient safety. A review never hurts, but the nature of the investigation seems to be headed in the wrong direction and leaves open questions about who is paying into reelection coffers for which representatives.

For years the FDA has been negligent and open to influence when money talks, and we have always known this about government, but the situation is becoming a nightmare for patients who cannot rely on safety. This is especially true if the FDA is forced to cave to device investors who are also contributing to reelection funds of our elected officials.

Read the article here and draw your own conclusions.

01 March 2011

LCT Granted Australian Patent

In a press release, Living Cell Technologies announced it has been granted a patent by the Australian Patent Office for IMMUPEL™. This is the industry leading technology for encapsulating living cells prior to transplantation. The granting of the Australian patent provides protection of this crucial intellectual property in advance of possible future clinical trials in Australia. What country will be next?

This selectively permeable system protects encapsulated living cells from immune rejection without the need for immunnosuppressant drugs, while at the same time allowing the transplanted cells to survive and function normally.

This technology has been demonstrated in Russia and in an on-going Phase II clinical trial in New Zealand, the IMMUPEL platform, as used in LCT's DIABECELL® product, has facilitated the effective transplantation of insulin-secreting porcine pancreatic cells into diabetes patients. Russia has approved its use.

Living Cell Technologies' product is the first to show clear efficacy in humans using encapsulated cells derived from another species, in this case from pigs.

So for readers in Australia watch for clinical trials. For those that want further information and to follow press releases, bookmark this. Use the contact to request information.

28 February 2011

The FDA May Deserve This Black Eye

Yes, there is mounting evidence that the FDA is slacking on the duties they should be preforming. I had read about similar things in the past, but to finally have this documented in a graphic way is upsetting.

But I still have an inquiring mind so I will have to ask some questions not covered by the study as researchers can have agendas as well. There also seems to some large gaps in what the study is about.

The article on the study does not state whether they used drugs that were from the same or near same date of manufacture. Also not stated is where the drugs were selected. If they were selected from different countries, how long had they been in the pipeline and were the boxed warnings needed in those countries. This alone could negate the study.

Now if the study is doing things without an agenda, then the FDA may well deserve the criticism for not doing what its own rules indicate that it should. If, and I must emphasize if, the study is correct, then the FDA does need to be corrected and some charges (yes, maybe even criminal) need to be brought by the U.S. Justice Department.

From the article, I do have suspicions that the study was lacking in methodology that is above an agenda and may not be as useful as it might have been. The FDA spokesperson was fairly clear that the FDA may not be without fault, but clearly asked some questions about the study.

Read the article here.