Medical Device Industry Preemptively Block Regulations

In an unprecedented move, the medical device industry has tried to block a report that examines new regulations on the industry. They are using the usual arguments that there was bias in the scientific report, that industry was not represented, that regulation will slow innovation and kill jobs, and harm patients. Keep in mind that the pro-business group hasn't even seen the report and yet they're attacking it. I've looked at some of the issues with the medical device industry here and here. First, Do No Harm.
Update: Also, it is becoming increasingly difficult to seek redress if you are harmed by a product. See the film Hot Coffee.
July 27, 2011
Study of Medical Device Rules Is Attacked, Unseen
By BARRY MEIER

Allies of the medical device industry are waging an extraordinary campaign in Washington to discredit a coming report by one of the country’s pre-eminent scientific groups that examines possible new regulations on the industry.

The scientific group, the Institute of Medicine, is scheduled to release a report on Friday that could propose a tougher approval process for a wide range of devices like hip implants, hospital pumps and external heart defibrillators. The report, commissioned by the Food and Drug Administration, comes after several well-publicized recalls in recent years of devices that have failed in thousands of patients, causing numerous injuries.

Case Study: PCOS patient, acupuncture and HRV

So PCOS stands for Polycystic Ovarian Syndrome. And HRV stands for Heart Rate Variability, a measure of autonomic balance, or in layman's terms, the stress response or relaxation response.
I wanted to try to illustrate the gist of my research interest. I will start with this particular patient who is in her late 20's and carries a diagnosis of PCOS and even with clomid does not ovulate. So she has been coming to me for acupuncture. I have done some previous posts on PCOS and HRV and the protocols here, here, here.
What these graphs show are some of the treatments I have her following the protocol using 2Hz strong stimulation electroacupuncture. What I would like to see is a decrease in her LFR/HFR ratio during treatment. As you can see the first three graphs from 6.2.2011, 6.20.2011, and 6.27.2011 all show minimal decrease in her LFR/HFR ratio. So I decided to abandon the protocol and do manual acupuncture with more emphasis on traditional treatment with standard TCM (Traditional Chinese Medicine) points. As you can see, she had a better relaxation response with that treatment as reflected in the decrease in her LFR/HFR ratio. Also notice that in the last graph, she also has a lower value of LFR/HFR more between the 1 and 2 range, which is the lower than in the other graphs. (So sorry for the poor quality of the graphs, will try to work on those and repost.)
I called her after analyzing the data to see how she was doing and she said that she had had some spotting, which was new for her. So we will see how she does with time and I'll try to keep you posted. (For more info on my practice, please click here.)

Blood Pressure Management and Acupuncture

This is another case study. This patient had severe peripheral neuropathy in her feet when she presented to the clinic. She suspected that it was due to a statin she was taking so discontinued it. She also had blood pressure that was out of control and wanted to try another approach.
The graph below shows her Blood Pressure the week before she came in to see me. Her first visit was 6/23/2011. Her last visit was 7/11/2011. The blood pressures for those days I took in my clinic. I didn't end up seeing her after those 4 visits, but contacted her to find out how she was doing and she gave me the last three readings.
So the acupuncture helped her blood pressure, but her blood pressure also was lowered because her feet improved dramatically so she wasn't in so much pain. This obviously helped her blood pressure also. (If I can get it together, I'll try to post her HRV readings in a later post since they were fascinating also.)



(For more information about my practice, please click here.)

FDA warns against Atrial Fibrillation drug Multaq. Moral? Wait 7 years before taking any newly released drug.

I'm starting to bore myself with reporting on the dangerous drugs that have been approved and set loose on the market, but here's another one. Link below. Please wait to take any new drug for several years, 7 at least, from the time of release. Let other people be the guinea pigs. (info on my practice here)

F.D.A. Issues Alerts on the Heart Drug Multaq
By DUFF WILSON

American and European regulators issued safety alerts on Thursday about Multaq, a drug approved two years ago to treat abnormal heart rhythms...

Cranberry Juice versus Antibiotics: You Decide

An article from the New York Times comparing cranberry juice versus months of low dose antibiotics. No surprise that the antibiotic helped keep the infections away to a larger degree, and also no surprise that it lead to E Coli resistant strains that are harder to treat. I mentioned in a previous post that I have a patient who was treated for months for bladder infections and ended up with Clostridia Dificile infection, a life threatening intestinal infection. She was hospitalized for days with a few of them in the ICU. So, like I said, you decide...

Downside for a Urinary Infection Remedy
By NICHOLAS BAKALAR

Women with recurrent urinary tract infections sometimes must take low-dose antibiotics for months to control the problem. Many prefer to try something less onerous, like cranberry extract or juice, which several studies have suggested can prevent these infections.

But a new study finds that a commonly used antibiotic works much better than cranberry, with one significant drawback: It encourages the development of resistant strains of bacteria.

Dutch researchers randomly assigned 221 women with a history of infections to two groups. The first took a daily dose of 480 milligrams of Bactrim, an antibiotic, and the second took 1,000 milligrams of cranberry extract.

The study, published Monday in The Archives of Internal Medicine, found that by any of three measures — the number of symptomatic infections, the proportion of patients with at least one infection or the average time to the first infection after starting the regimens — antibiotics controlled the infections more effectively in the study participants.

But when the researchers tested the subjects’ urine and feces, they found a large increase in the presence of antibiotic-resistant strains of E. coli, the most common cause of the infections, in those who used the antibiotic.

Dr. Suzanne E. Geerlings, the senior author and an infectious disease specialist at the Academic Medical Center of the University of Amsterdam, said the findings did not rule out using cranberry and noted that antibiotics have risks. “Antibiotics work better,” she said, “but when you get an infection resistant to antibiotics, you have a bigger problem.”

(For info on my practice, please click here.)