Every drug has a side effect. For that reason, a drug that doesn’t work must be removed from use. Drugs like Makena, which don’t work and may harm patients, is the reason that both MedShadow and DES Action USA exist. And when it comes to Makena specifically, we’re thrilled to announce we have made massive progress! Thanks to more than a thousand of your signatures on our petition, the FDA’s Center for Drug Evaluation and Research (CDER) recommended on October 5th that the drug be removed from the market. Makena is a hormone given to pregnant women who are told…

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Which side effects are common enough to be mentioned, and which are rare enough to be left unsaid? It’s your body, your appointment and the doctor is your consultant. Ask for the information you want. Once when my mother was visiting me, we went to a dollar store and she bought something that surprised me — a book about pills that discussed which medicines are for what conditions and what their side effects are. As soon as we got home, she pulled out the book and a pill bottle and searched the pages. She nearly wept when she read that…

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A new study finds that nearly 1 out of 3 drugs approved by the FDA has a safety issue after it hits the market. Why is this the case and what can be done? The US prides itself on the fact that the FDA is arguably the best drug regulatory organization in the world. Yet in less than 5 years of being on the market, 32% of new drugs have bad enough side effects and adverse events that the FDA has had to send doctors warnings about safety and/or put “black box” labels on the drugs. And this was after…

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Drug companies, politicians and patient groups are clamoring for faster approval of drugs. But doing so could bring potentially harmful drugs to market. Why NOT rush a drug to market when it might save lives? Here are 2 reasons. First, it could harm more people than it helps. And second, people might take a useless, harmful drug rather than get medicines or care that could help. Whether the drug works or not (efficacy) can be proven fairly quickly, but side effects and adverse events take time to happen and high numbers of people to identify. Drug companies object to extending…

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More than 400 pages of medical research, 11 hours of testimony and a blizzard in March. Welcome to my first FDA Advisory hearing! I am the newly appointed consumer representative on the Drug Safety and Risk Management Advisory Committee for the FDA. On March 13 and 14, our committee was joined with a sister committee. Anesthetic and Analgesic Drug Products, to determine if, based on new postmarketing research, the benefits of Opana ER, an opioid pain med, still outweigh its risks. About a week before the meeting, 4 CDs arrived at my house so I had to clear my calendar…

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Hey Pharma, if you want our attention, give us the facts we need. Do you think that everyone, or even most people, ask their doctors about the drugs they see advertised on TV? Think again. An industry survey shows that only 7% of TV viewers do what the ad asks and “talk to your doctor about…” That’s down from more than 21% of viewers last year. The pharmaceutical industry is asking why, and I’ll answer: We don’t get useful information. There’s info we want, and we suspect you’re hiding it from us. If you tell us what we want to…

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Many people have questioned whether cardiologist Robert Califf, MD, has the ability to maintain (or rebuild, depending on one’s point of view) the wall between the FDA drug approval process and inappropriate intervention from pharmaceutical companies if he is selected to be the next Commissioner of the governmental agency. Dr. Califf has worked closely with most pharma companies and the very fact that those companies aren’t opposing his nomination encourages speculation that the FDA will slip even further into closer alignment with pharma’s goals. Questions regarding Dr. Califf’s ties to the pharmaceutical industry are important and need to be…

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How many people have to report an adverse reaction to a prescription drug to trigger an FDA review? Does the FDA track blockbuster drugs more closely than others? How can you find out if an unanticipated long-term effect is uncovered on a drug you’re taking? We didn’t know either, so we asked the FDA. The FDA not only has the responsibility to approve new drugs before they are marketed, the agency is also required to monitor the performance of the drug in the general population. Before approval drugs undergo short-term testing to make sure they work, that they work better…

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FDA

Following are some wonderfully interesting articles on issues in health care. We did not report on them earlier because MedShadow Foundation’s mission is to gather and share information on the side and long term effects of prescription drugs and these articles study the system of medicine. However, I can’t bear to not share these ideas. One Drug, Two Names, Many Problems, OpEd, New York Times, Dec. 1, 2013 This is an “Of course!” article, first published in the NYT blog, Opinionator, but I found it when published as an OpEd piece. The writer, Theresa Brown, states a problem that I…

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Lemtrada is a proposed new drug for the treatment of relapsing Multiple Sclerosis (MS). It is injected once a year (over the course of 5 days the first year, 3 days subsequent years). It has already been accepted in the European Union, Canada and Australia. However, the FDA has taken the position that the pharmaceutical company Genzyme “has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.” (Genzyme press release) MS is a disease of the central nervous system. The membrane that protects nerve cells becomes damaged by inflammation and…

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