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Just because a drug makes it to market does not mean it had a rigorous testing and proper disclosure.
Take the example of Dr Reuben of Massachusetts.
Dr. Scott Ruben, a Massachusetts’s anesthesiologist, falsified over 21 journal articles from his Bay State Medial H ospital. Dozens more of his articles are also questioned. He was a proponent of Celebrex and other Pfizer drugs used for postoperative pain. He was hired by Pfizer to conduct studies to persuade other doctors to prescribe more of the medications.
Researchers get most of their income by getting results favorable toward drug companies. The hospital found he had not received approval to conduct human research, after questions were raised about his last two papers.
Dr Rueben played an important role in many clinical studies. He was considered an expert on postoperative pain management. After this fraud, how many clinical studies conducted under the direction of drug companies can we believe?
Many clinical studies checking up on new prescriptions drugs are never published. You may be taking meds that are less effective than you thought and they may have side effects that have never been published.
A huge amount of information is censored that you never know about. Currently there are over 50,000 clinical trials underway. It is impossible to assess and make public that many commercial trials.
Over the last 4 years there have been drug scandals over deceptive marketing, side effects that go unreported, and hidden payments that go to top medical researchers, as Scott Reuben.
The new law mandates that comprehensive clinical data must be filed to the FDA in order to make market approval of a new drug; safety information must also accompany every prescription drug label, summarizing everything you need: and the FDA sees all the data.
For the first time researchers must post their basic results publicly on the federal online registry at the National Library of Medicine. This registry was established in 2000 as a voluntary guide for you the patient, www. Clinical Trials.gov. It has over 65,000 studies in it at this time.
There were only 350 total studies submitted up to September., 2008. Since the new law, over 350 studies are posted EACH WEEK. Researchers only submit information that they have started a project, but they never give more details about the trials, since they do not want the information to get to competing companies before final drug approval. A lot of data on drugs on the market never gets published.
Many drugs made it to market, despite the fact that, data on only one out of four clinical trials ever get published. Most of the unpublished data make the drug look bad. Only one out of five cancer clinical trials ever gets into a medical journal. You will never get a full picture of whether a drug is good or not. Those clinical data that do get published have biased health risks and benefits, spin on them, and selective reporting-- as noted recently in the Dr Reuben case.
Conclusions are changed, statistics are revised, and outcomes are altered to make the drug treatments look more effective. All the changes made the drug look more favorable and hence more marketable.
Journals rarely publish negative findings. Over a third of published reports don't even mention side effects, and the harmful side effects that are mentioned, fail to be described. All we ever get is the evidence of the clinical trial that the company conducts. There is no fair reporting of the evidence.
Why is so much test data suppressed, overlooked, and discarded? Journals want to sell journals, companies want to make profits, and researchers want to advance their careers. This creates a lot of conflict, and decisions are made that are not in your best interest.
The recent new registry only covers new tests. Serious side effects will not be reported until next year, and then the findings won't be formally verified. It will be another two years before the mandatory reporting requirements really take effect: it may take ten more years before anyone will know whether all this disclosure will actually improve your quality of care. But at least there is now more transparency.
COMMENTS
The medical profession prides itself on the impartiality and vigorous scrutiny of medical data that allows it to reach unquestionable conclusions. It seems the drug company today plays a top role in journal publications and FDA actions. After a couple of years without a director of the FDA, I wish the newly appointed commissioner well. It seems we too have our own Bernie Madoff’s in the medical profession.
Visit www.drneedles for more information on controversial medical subjects. Your comments are always appreciated.
Sources: National Library of medicine registry; FDA, NY Times 3.10.09
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