Drug Trials Under Scrutiny

You will recall in my review of the book, Overdo$ed America, the author (John Abramson, MD) was pointing out the errors in relying on published results of clinical trials that mislead doctors and the public into using drugs that were ineffective and often harmful.
Title: Caveat lector: Reliance on Published Studies is Risky
<[www.afibbers.org]>

The following article was published in late December '08. I’m just passing it along to increase your awareness and remember the admonition often given by those on the cutting edge of information like this….. if you must take a drug, then hold out for one of the older versions that have a long track record of safety and performance. The newer ones are rushed through the approval process and almost always are much more costly than the old ones. Often, they are recalled for untoward side effects; some, as severe as death. Just be aware.

Knowledge is health,

Jackie

Eye-Opening Information Not Published in Clinical Drug Trials

The Wall Street Journal recently published an article entitled “What You Don’t Know About a Drug Can Hurt You.” They reported that there are currently 2.3 million patients participating in about 50,000 clinical trials, through $58 billion of privately funded drug research. Medical research analysts have concluded that the sheer volume of clinical research has overwhelmed the ability of medicine to assess these trials independently—or even to make those results public. The result is that many clinical studies that test prescription drugs will never see the light of day.

Most people assume the FDA drug approval process includes both testing and disclosure. Unfortunately, the testing is by no means exhaustive, but even that is more rigorous than the disclosure. The FDA acknowledges that many new drugs are approved on the basis of a few studies which include far fewer volunteers than those to which the drug will be prescribed. According to the director of the National Library of Medicine’s online clinical trials registry, Dr. Deborah Zarin, “There is data that you are not seeing. There is a huge problem here if an unknown amount of the information is censored and you don’t even know it is censored.”

While there have been reforms over the past four years, including an online database created by the Pharmaceutical Research Manufacturers Association of America to summarize clinical study results that involve hundreds of prescription drugs, there have been many drug scandals over deceptive marketing, unreported side effects, and hidden payments to drug researchers. And health risks and benefits can be covered by selective reporting and by spin doctoring. A Mayo Clinic medical policy analyst, Dr. An-Wen Chan, said, “Journals want to sell journals; companies want to increase profits; and researchers would like to advance their careers. They can conflict. Sometimes, decisions are not made in the best interest of the patients.”

Researchers now face fines of $10,000 a day and loss of federal research funding if they fail to report basic data about clinical test results on the federal public registry. However, the registry only covers new tests. Serious side effects must be reported to the registry beginning in 2009, though that reporting will not be formally verified, and Dr. Zarin reports, “The companies are still fighting every step of the way.”

Source: Editor, Debra Ray M.T. (ASCP)
American Association for Health Freedom
[aahf.nonprofitsoapbox.com]

Jackie - do you know if Flecanide has been around for awhile now? I'm on it, getting great and much needed relief, and at this point, would like to continue with it.

Thanks ~ Barb

Flecainide (Tambocor) has been around since 1991 and approved for use in afib in 2007 but it has been used off label for that for at least 4 years.

Eisai received approval in Japan for Tambocor(R) for the indication of ventricular tachyarrhythmia in June, 1991. This approval, together with Eisai's other related products including Warfarin(R) (anticoagulant anticoagulant (&#259;n't&#275;k&#333;&#259;g`y&#601;l&#601;nt), any of several substances that inhibit blood clot formation (see blood clotting). agent) and Vasolan(R) (calcium antagonistic antiarrthymic treatment which controls increased heart rate in paroxysmal atrial fibrillation/flutter), will enable Eisai to make further contributions to patients by offering treatment options for managing paroxysmal atrial fibrillation/flutter.