News News News
ANTI-ACID DRUGS FOUND TO HAVE YET ANOTHER DRAWBACK
Prescribed widely and often for far longer than is necessary, proton pump inhibitors (PPIs) may increase birth defects when taken in the first trimester of pregnancy. Twice as many cardiac defects were found in the newborns of women using PPIs when compared with those who did not. (Family Practice News June 15, 2010 p 38).
PPIs have already been associated with increased fracture risk (Arch. Intern. Med. 2010;170:747-8) as well as increased risk of digestive system infections, including disastrous ones such as clostridia difficile. (Arch. Intern. Med. 2010;170:772-8). Bacterial overgrowth in the small intestine is found in 50% of those using PPIs. (Clin. Gastoenterol. Hepatol. 2010 [doi:10.1016/j.cgh.2009.12.022]).
[Ed.] Alternative treatments which eliminate the need for PPIs are usually my goal for patients in my practice.
SO FAR, “HEALTH REFORM” LAW WILL NOT AFFECT YOUR HEALTH SAVING ACCOUNTS
Some small changes are being made to health savings accounts, but you will still be able to pay for all visits with me as well as prescribed dietary supplements and herbal medicines from your account. So, the advantages of spending pre-tax dollars have remained intact, for now.
CAMOMILE EFFECTIVE FOR ANXIETY
Chamomile extract therapy showed both anxiety relieving and anti-depressive effects in a two-part randomized, controlled, blinded study of 57 patients with mild-to-moderate generalized anxiety disorder.
The initial study, published in 2009, is thought to be the first-controlled clinical trial of oral chamomile (Matricaria recutita) extract for GAD. A substudy presented in a poster at the annual meeting of the Anxiety Disorders Association of America.
(ADAA) investigated the effect of chamomile on depressive symptoms in GAD patients who had comorbid depression, a history of depression, or no depression. Chamomile has long been used as a traditional remedy for its calming effect, and has shown pharmacologic activity in animal models of anxiety.
Its anxiolytic and antidepressive properties may relate to modulation of central noradrenalin, dopamine, and serotonin, and gamma-aminobutyric acid neurotransmission and hypothalamic-pituitary-adrenocortical axis activity, said Mr. Shore and his associates, of the University of Pennsylvania, Philadelphia. (J. Clin. Psychopharmacol. 2009;29: 378-82).
ST JOHN’S WORT ENHANCES EFFECT OF CLOPIDOGREL
The pharmaceutical drug Plavix seems to be ineffective in 20% of patients. Doubling the dose, which increases risk of bleeding, or adding another drug, which adds cost, complexity, and side effects, is the usual response.
However, noting the common observation that depressive disorders are associated with heart pathology, Dr. Wei C. Lau of the University of Michigan found that giving non-responders St. John’s wort improved platelet responsiveness by 20%.
This may offer a way to reduce the risk of clotting due to sticky platelets and treat depression simultaneously with a rational combination of pharmaceutical and plant based medication. (Family Practice News June 1, 2010 P 13).
ACUPUNCTURE REDUCES ANXIETY OF EYE SURGERY
An Italian study has found that patients undergoing cataract removal are less anxious after receiving acupuncture. Participants underwent phacoemulsification, in which the cloudy eye lens is emulsified with an ultrasound probe, before being aspirated and replaced by an artificial lens.
The procedure is carried out under topical anesthesia while the patient is awake and can therefore provoke significant anxiety. In this prospective randomized double-blind controlled trial, anxiety levels were assessed before and after surgery in three groups (no acupuncture, true acupuncture and sham acupuncture) of 25 patients.
Preoperative anxiety levels were significantly lower only in the true acupuncture group. The difference in postoperative anxiety levels between the real acupuncture and no acupuncture groups was also significant. (Sedative effect of acupuncture during cataract surgery: prospective randomized double-blind study. J Cataract Refract Surg. 2006 Nov;32(11):1951-4).
ONCE YEARLY HIGH DOSE VITAMIN D INCREASES FRACTURE RISK IN WOMEN
A single dose of 500,000 I.U. of Vitamin D3 increased the number of falls from 73 per 100 person-years to 83 per 100 person-years and the number of fractures by 26%.
Presently the mechanism for this finding is unknown, though there is speculation from the researchers that such a high dose increases metabolism of vitamin D, reducing blood levels.
Increased activity due by improving physical performance, reducing pain, or improving mood, might place these women at increased risk for falls, or, there may be a negative effect of giving a year’s dosage of vitamin D at once. Appropriate blood levels can usually be achieved by a daily dose of 2000-5000 I.U. of D3.
There seems to be no rationale for giving such high doses of Vitamin D in any case. (JAMA 2010;303:1815-22).
48% OF CHILDREN OBESE OR OVERWEIGHT IN 2007
The U.S. Department of Health and Human Services’ Maternal and Child Health Bureau in Rockville, Md. Reports that nearly half of all U.S. Children were obese or overweight in 2007, the latest year for official statistics.
“It is conceivable that recent trends in dietary factors may have contributed to the increase in childhood obesity at the national level as well as in specific states.”, concluded the head researcher Gopal K Singh, Ph.D.
Meanwhile, the “White House Task Force on Child Obesity” announced its goal to reduce childhood obesity to 5% by promoting the failed strategy of increasing activity and dietary guidelines as already recommended by the American Academy of Pediatrics and every other task force since the 1960’s.
There is no evidence whatsoever that these programs are effective, but as noted in the February 10,2010 editorial, failed strategies are a ripe source of endless employment, grants, and research funding for bureaucrats, academics, and do-gooders.
3 years after this report, it is likely that the numbers are closer to 60%.
WONDER WHAT HAPPENS TO EXPIRED H1N1 VACCINE?
Roughly 40 million expired dosages of the 2010 “swine” flu vaccine are sitting in medical office refrigerators around the country; 32 million more dosages will expire sometime in 2011.
Overall, 44% of the vaccine produced and distributed is likely to expire without being administered. The federal government has a Central Vaccine Recovery Program that allows doctors to return unused vaccine for destruction, and will open again in the fall for shipments. (American Medical News July 25, 2010 p 17).
ACUPUNCTURE & MASSAGE AFTER CANCER SURGERY
Providing massage and acupuncture in addition to usual care results in decreased pain and depressive mood among postoperative cancer patients.
One hundred and thirty eight cancer patients undergoing surgery were randomly assigned to receive either massage and acupuncture on postoperative days 1 and 2 in addition to usual care, or a control of usual care alone, and were followed over three days. Patients' pain, nausea, vomiting and mood were assessed at four time points.
Participants in the intervention group experienced a decrease of 1.4 points on a 0-10 pain scale, compared to 0.6 in the control group, and a decrease in depressive mood of 0.4 (on a scale of 1-5) compared to no change in the control group. (Symptom management with massage and acupuncture in postoperative cancer patients: a randomized controlled trial. J Pain Symptom Manage. 2007 Mar;33(3):258-66).
ACUPUNCTURE IMPROVES NERVE CONDUCTION IN PERIPHERAL NEUROPATHY
A pilot study has evaluated the therapeutic effect of acupuncture on peripheral neuropathy (PN) as measured by changes in nerve conduction and assessment of subjective symptoms.
One hundred and ninety-two consecutive patients with PN as diagnosed by nerve conduction studies (NCS) were evaluated over a period of 1 year. Of 47 patients who met the criteria for PN of undefined etiology, 21 received traditional Chinese acupuncture, while 26 received medical care but no specific treatment for PN.
76% of the acupuncture group improved symptomatically and objectively as measured by NCS, while only 15% of the control group did so. 14% of the acupuncture group showed no change and 10% showed an aggravation, whereas in the control group 27% showed no change and 58% an aggravation.
Subjective improvement was fully correlated with improvement in NCS in both groups. (Acupuncture treatment improves nerve conduction in peripheral neuropathy. Eur J Neurol. 2007 Mar;14(3):276-81).
ELECTRO-ACUPUNCTURE REDUCES POST-STROKE SPASTICITY
A combination of electro-acupuncture and muscle strengthening exercises can significantly reduce the spasticity of the wrist joint in stroke survivors.
In a crossover trial, seven chronic stroke subjects (average age 63) received two six-week treatment regimens: combined electro-acupuncture and strengthening twice a week, and strengthening twice a week only.
Wrist spasticity was reduced significantly in the combined treatment group after the six-week period, but not in the strengthening-only group. (The effect of electro-acupuncture on spasticity of the wrist joint in chronic stroke survivors. Arch Phys Med Rehabil. 2007 Feb;88(2):159-66).
PASS ON THE MILK
It appears that adding milk to tea negates its benefits in preventing cardiovascular disease.
The caseins (proteins) in the milk interact with the catechins in the tea which are responsible for its protective effects.
Sixteen postmenopausal women were asked to drink half a liter of tea (either freshly brewed black tea or black tea with 10% skimmed milk) or boiled water at three different sessions. Ultrasonography was used to measure brachial artery cell function in the forearm before and after consumption.
Black tea significantly improved the ability of the arteries to soften and relax, an effect which disappeared when the tea was taken with milk. The milk also destroyed the antioxidant effects of the tea. (European Heart Journal online, January 9th, 2007).
YOGIS HAVE HEALTHIER HEARTS
Heart rate variability, which is indicative of a healthy heart, has been shown to be higher in yoga practitioners than in non-practitioners, according to Indian research.
The team analyzed the HRV spectra of the electrocardiograms of 42 healthy male volunteers who were not practitioners of yoga, and 42 who were experienced practitioners.
From this they concluded that there was strengthening of parasympathetic (vagal) control in subjects who regularly practiced yoga, which suggests better autonomic control over heart rate and therefore a healthier heart. (A comparative study on spectral parameters of HRV in yogic and non-yogic practitioners. Int. J. Med Engineering Informatics. 2010, 2(1) 1-14).
"Is Anyone Thinking?" Department
EVIDENCE? WE DON’T NEED TO SHOW YOU ANY STINKING EVIDENCE!
The January 2009 newsletter had an entry on the JUPITER study of statin drugs as prevention for those who had not yet developed cardiovascular disease, but were at “risk”. The study was terminated early because there was an “unequivocal reduction in cardiovascular mortality” with statin therapy.
Yet, the JUPITER investigators did not include data on cardiovascular mortality in their published report. This early termination of the study was not justified by the study’s own protocol prespecifications, leading some to speculate that one reason for early termination was to minimize the long term hazards and side effects known to occur with these drugs, and exaggerate the benefits.
In a critique published in the Archives of Internal Medicine, Dr. Michel de Lorgeril points out that there was in fact, identical cardiovascular mortality between the treatment groups. In addition, the JUPITER trial involved several conflicts of interest:
“It was conducted by a sponsor with obvious commercial interests. Nine of 14 authors of the JUPITER article have financial ties to the sponsor. The principal investigator has a personal conflicts of interest as a co-holder of the patent for the C-reactive protein test” that figured prominently in the rationale for statin therapy. In addition, the monitoring board that made the decision to halt the trial early was chaired by an investigator who “has been and still is involved in many other industry-sponsored lipid lowering trials” (Arch. Int. Med. 2010;170:1,032-6).
In a second study detailed on page 1024 of the same issue, Dr. Kausik K. Ray and his associates performed a meta-analysis of 65,229 men and women with approximately 244,000 person-years of follow up. “All cause mortality was not significantly different between patients taking statins and those taking placebo or control therapies.”
In an editorial in that issue, Lee Green M.D., stated: “Tens of billions of dollars of revenue for the sponsor over the patent life of the drug were at stake in the JUPITER trial, as well as potentially millions of dollars in royalties for the principal investigator. And, with three quarters of statin users taking the drugs for primary prevention, enormous revenues are at stake.
The results make it clear that for primary prevention in the short term, statin’s benefits are very small, and in the long term...we really must admit that we do not know” (Family Practice News July 2010 p 10).
Despite this vast chasm of ignorance regarding the long term effects of these expensive and dangerous drugs in adults, the American Acadamy of Pediatrics recommends cholesterol screenings for “high-risk” children ages two and up. “For children who are more than eight years old and who have high LDL concentrations, cholesterol-reducing medications should be considered.” (American Academy of Pediatrics)
There is absolutely no evidence supporting the safety of these drugs in children, and no long term studies. No problem. Pfizer has announced plans to introduce a chewable Lipitor for children in Europe. (CBS Interactive Business Network)
Apparently, the more money and influence you have, the less evidence you need. If pressed, you can just buy the researchers.
CALLING DOCTOR SNITCH
The FDA wants your physician to police the drug companies. I guess a doctor's work is just never done.
The attractive young lady in the picture is using her feminine wiles to convince our stalwart doctor to use an FDA approved drug for "non-approved" uses.
Fortunately, our hero is evidently too old to be enticed (note the ridiculous mirror on his head. Does anyone wear these anymore?), and he knows about the new FDA snitch line where he can report these vile transgressions against the established order.
After cleverly diverting suspicion by extracting some free samples and perhaps a forbidden coffee cup or pen and pencil set, Dr. Snitch quickly reports this sordid episode to the FDA, knowing that highly trained operatives will soon dispatch a SWAT team to round up our fallen angel and send her off to FDA camps for "re-education".
Our hero basks in the glory of a job well done, and his quick and courageous snitching assures his patients that he only prescribes medication for uses duly authorized by the only genuine guardians of truth, the Food and Drug Administration.
Estimates of off-label use ranges from 21 to 67%, so clearly a great many physicians are prescribing drugs for indications that were not submitted to the FDA.
The FDA is clear that they regulate the marketing of prescription drugs and not prescribing. The agency approves drugs for marketing with an official “label” that stipulates an indication, dose, intended population, duration of use, and other specifications. However, physicians and other licensed prescribers are free to prescribe any approved drug for any indication, whether or not the indication is included on the drug’s FDA-approved label.
“Some physicians and health care experts maintain that physicians should know the evidence, not the FDA labeling. However, knowledge about FDA labeling can be important because FDA approval of a drug for a specific indication indicates a clear threshold of evidence supporting that use,” said Donna Chen, MD, Assistant Professor of Biomedical Ethics, Public Health Sciences, and Psychiatry at the University of Virginia.
Perhaps. However, examining the track record of the FDA in approving drugs that are found to be ineffective or dangerous does not generate the confidence that Dr. Chen's statement implies.
Aside from wasting doctor's time to perform the job that the FDA should be doing in the first place, and the almost certain total waste of taxpayer dollars that these types of governmental schemes promote, there are troubling implications to the FDA's program.
The assumption that physicians are incapable of analyzing and observing the effects of drugs, or that innovative new uses for pharmaceuticals from those who work at the front lines of medicine are automatically suspect reveals an attitude of elitism and anti-intellectualism that pervades our top-down, industrialized medical system.
Lack of evidence did not prevent the FDA from approving statins for primary use (see above), nor has it induced them to remove approval for drugs and foods that present clear hazards to the public (think Avandia or bisphenol-A).
Doctors don't need a thought police to keep them from individualizing treatment, nor do we need to establish programs that reinforce the premise that government regulators are the arbiters of legitimate practice.
Doctors have a responsibility to critically evaluate all of the information that they receive from drug companies, medical journals, and insurance company guidelines. If a physician has a reasonable professional opinion that off label use is appropriate and likely to be beneficial for a particular patient, informed consent should be obtained, and the patient should have the freedom to take the advice of the physician of their choosing.