Platelet e-news – July 16, 2004

Contents:

* The Ketogenic (Very Low Carb) Diet and Bruising
* Study Confirms Watch and Wait Treating ITP in Children
* Clinical Trials in the News
* Mixing Drugs and Herbs Not Always Safe
* Supreme Court Weakens Texas Health Care Liability Act
* Risk Of Rheumatoid Arthritis May Be Reduced With Diet Rich In Vitamin C
* MS Associated Fatigue Reduced With Yoga or Exercise
* Small Recording Device May Make Kids Safer

THE KETOGENIC (VERY LOW CARB) DIET AND BRUISING

A significant increase in bruising or other minor bleeding has been reported in patients treated with the ketogenic diet; a high fat low carbohydrate diet used to control epilepsy. Dr. Berry-Kravis and colleagues used chart review and prospective screening of 51 past and current diet treated patients for symptoms of bruising and bleeding. They report 16 of the 51 patients experienced bruising or minor bleeding symptoms. The researchers suggest that “Patients on the diet undergoing anticoagulation or surgery be evaluated carefully for symptoms of bleeding tendency.”

“Bruising and the ketogenic diet: evidence for diet-induced changes in platelet function” Berry-Kravis E et al. Ann Neurol. 2001 Jan;49 (1)98-103
PMID: 11198302 [PubMed – indexed for MEDLINE]

(The Atkins diet and other very low carbohydrate diets produce a ketogenic state in the body. PDSA does not recommend these diets. See diet results from our survey at http://www.itppeople.com/surveyres/. You can view our diet suggestions at http://www.pdsa.org/articles.htm)

STUDY CONFIRMS WATCH AND WAIT WHEN TREATING CHILDHOOD ITP

A group of 34 patients diagnosed with ITP at age 6 months to 15 years were seen over a period of almost 8 years by Dr Kenneth Charles and colleagues at Eric Williams’ Medical Sciences Complex on the island of Trinidad. Sixteen patients (47%) were managed by observation alone. Five of these patients (14.7%) were discharged from the emergency room and followed as out patients the others were admitted to hospital. All patients managed by observation alone recovered fully. They report “that non-intervention was safe, cost-effective, and acceptable to both children and parents in the <10 years of age group. However, adolescents were more likely to require treatment.” One patient experienced an intracranial haemorrhage and was treated with IVIg. Three of four adolescent girls tested positive for antinuclear antibodies and developed chronic ITP. Dr Lilleyman of the NHS National Patient Safety Agency in London, UK, responded to the correspondence from Trinidad by saying, “the message from this small cohort study is clear; doing more of nothing produces little difference in outcome apart from less time in hospital and less invasive investigations.”

“Medical nemesis and childhood idiopathic thrombocytopenic purpura” British Journal of Haematology, 126: 282-283, 2004.

CLINICAL TRIALS IN THE NEWS

The call for more comprehensive disclosure of the start and outcome of clinical trials is growing. The New York Times reported last month that the leading medical journals are considering a proposal that would require drug companies to disclose trials that shed unfavorable light on their products. Editors at a number of journals declined to discuss the matter but confirmed that the Times report was accurate.

The Washington Post reported earlier this month that the World Health Organization (WHO) wants to start an international registry of clinical trials or drug trials. Full disclosure has been gaining momentum following a recent report that drug companies had not published the results of tests of antidepressant drugs that showed they were ineffective in treating children.

The underreporting is significant. In 2002 the FDA found that only 48% of trials for cancer drugs were registered. The Washington Post reports that a review now indicates that the listing rate for drugs for some other serious diseases may be in the single digits. A 1997 federal law requires drug manufacturers to register clinical trials with the FDA. But the law is not enforced because the statute did not spell out penalties or explicitly give the FDA authority to crack down on violators. Senator Kennedy, who helped create the registry in 1997, plans to seek enforcement provisions.

There are a number of important issues. The drug companies are concerned that more fully complying with registering trials could endanger trade secrets. Critics, on the other hand, hold that the drug manufacturers want to prevent all the evidence from emerging because it could have a negative impact on sales and profits. These issues become all the more important with the turn to evidence based practice and evidence based reimbursement. The evidence based approach will be difficult to justify in an environment where the evidence is so selectively made available by those with an important financial stake in the process.

Shankar Vedantam, “Drugmakers Prefer Silence on Test Data”, Washington Post, July 6, 2004, p A1

S. Vedantam, “WHO Wants to Start Drug Trial Registry” Washington Post July 8, 2004, p A3

“Medical Journals May Force Disclosure of Bad Trials” Reuters Health Information as reported on Medscape, June 23, 2004.

MIXING DRUGS AND HERBS NOT ALWAYS SAFE

Evidence is accumulating that some herbs and food additives when taken along with certain prescription drugs may weaken the effects of the prescription drugs or increase the risk of undesirable side effects. Some examples are garlic intensifying the effects of blood-thinning drugs and echinacea increasing the risk of side effects with some medications. The FDA is funding a study of the effects of Echinacea on birth control regimens. Calcium fortified orange juice and Total cereal may weaken the effects of antibiotics such as Cipro, Noroxin, and tetracycline. Some drug companies are listing herbal interactions on their labels and some herbal companies are printing potential drug interactions on their labels. The available evidence would call for patients to list all herbs and food additives with their physicians when providing medical histories or medications they are using.

Jane Spencer, “The Risks of Mixing Drugs and Herbs, Wall Street Journal, June 22, 2004

SUPREME COURT WEAKENS TEXAS HEALTH CARE LIABILITY ACT

The U.S. Supreme Court ruled unanimously last month that patients can not sue their health insurance carrier in state court; federal courts are their only recourse. The cases ruled on were brought under the 1997 Texas Health Care Liability Act alleging that decisions to deny care were medical, not administrative, and covered by the 1997 Texas law. The court held otherwise. This ruling weakens the Texas law as well as similar laws in other states that have been enacted to give patients the option to sue (in state courts) insurance company decision makers for malpractice damages instead of being limited by the federal law of suing for the cost of the denied treatment.

Health Assistance Partnership, Weekly Email, June 21, 2004.

RISK OF RHEUMATOID ARTHRITIS MAY BE REDUCED WITH DIET RICH IN VITAMIN C

A report this month on the findings from a population-based study of more than 20,000 initially arthritis-free subjects suggests foods high in vitamin C may protect against inflammatory polyarthritis (IP) a rheumatoid arthritis involving two or more joints. Dr. Dorothy Pattison and colleagues found that those reporting low intake of fruits, vegetables, and vitamin C, less than 55.7 mg/day, were 3.3 times more likely to develop IP than the control group who consumed vitamin C at a rate of more than 94.9 mg/day. The findings from this study at the University of Manchester, UK contrast with a recent report based on work using a guinea pig model of osteoarthritis that linked high doses of vitamin C with increased severity of the disease. The researchers pointed out that comparing the results from observational studies with those conducted in a laboratory setting is difficult. Also these contrasting results may suggest different disease mechanisms.

“Vitamin C Rich Diet May Cut Rheumatoid Arthritis Risk”, Annals of the Rheumatic Diseases, 2004; 63:843-847, WebMD Medscape, Reuters Health Information.

MS ASSOCIATED FATIGUE REDUCED WITH YOGA OR EXERCISE

A recent randomized clinical trial found that yoga or exercise “produced improvement in secondary measures of fatigue, including the Energy and Fatigue (Vitality) score on the Short Form (SF)-36 health related quality of life, and general fatigue on the Multi-Dimensional Fatigue Inventory (MFI).” Dr Barry Oken and colleagues at the University of Portland randomly assigned 69 subjects with clinically definite MS to one of three groups. One group attended a weekly yoga class and supplemented this with home practice. The second group did weekly exercise class using a stationary bicycle along with home exercise and the third group was a wait-listed control. While there were no clear changes in mood related to yoga or exercise, there is a possibility that mood improvements contributed to the observed improvements in quality of life and fatigue.

Laura Barclay, MD, “Yoga, Exercise Improve Fatigue Associated with Multiple Sclerosis”, Neurology, June 8, 2004, vol 62, pp2058-2064; and Medscape Medical News.

SMALL RECORDING DEVICE MAY MAKE KIDS SAFER

The availability of the SOS Philips In-Touch Address Recorder was reported recently in Time magazine. The device is available for $20.00 and records up to a 20 second message. The message can include medical information and attaches to a child’s clothing. The recording button is recessed and reasonably tamper proof. Details can be found at www.philipsusa.com, search on In-Touch Address Rercorder.

“A Recording to Help Keep Your Kid Safe”, Time magazine.