Is new always better?

<p>I'm reminded by the craze for formula feeding in the 1960's as being " better" than breastfeeding.
How long did that last?</p>

<p>With the amount of money to develop new medications and the cost of trials,pharma companies have much to gain from developing new formulations to take the place of those which now could be prescribed generically.</p>

<p>But are they being approved too quickly?</p>

More than half of all prescription drugs cause adverse effects—some serious or fatal—that aren't detected until after the FDA approves them, sometimes many years later.
Such delayed detection contributes to the high number of drug-related injuries in the United States. In 2008 alone, the FDA received more than 100,000 reports of serious injuries related to adverse drug events, an increase of about 25 percent over the previous year, according to the Institute for Safe Medication Practices.</p>

<p>Some of the delay is inevitable: It's simply not practical to detect every risk before doctors start prescribing a drug. Doing so would require clinical trials that would be prohibitively large, long and costly. The 2007 FDA Amendments Act promised many changes in the drug-safety system, but whether they will be sufficient remains to be seen. Here's a closer look at why you face these unexpected dangers, and what you can do to protect yourself.</p>

<p>Holes in the preapproval process
Clinical trials submitted to the Food and Drug Administration before approval have several limitations, some of them unavoidable. They can't adequately assess safety because they're:
• Too small.<em>They typically involve only about 500 to 3000 volunteers, enough to spot only the more-common adverse effects. Rarer ones may emerge only after millions of people have taken the drug.
• Too short.</em>The trials may last for just a few months, but some adverse effects develop only after patients take a drug for many years.
• Too unrealistic.*Most trials are conducted under scrupulously controlled conditions, with carefully selected patients in order to demonstrate that the drug actually works. Indeed, randomly-controlled trials are the gold-standard for doing this. Yet adverse events are not the focus of the studies and therefore may not be detected.
In the real world, patients may receive lax care that exposes them to greater risks; moreover, doctors are allowed to prescribe approved drugs for unapproved purposes, sometimes for patients at considerably higher risk than the trial volunteers.


Reports</a> of adverse drug events increase, but the risk can be reduced</p>

<p>EK4 - you and I are both educated consumers. We ask questions of our prescribers when they suggest a new drug and we make informed decisions. I'm sure most people like us also ask more questions when it's a drug we've never even heard of before and then we make an informed decision as to whether or not we want to take the drug (if we have a choice) based on how long it's been available.</p>

<p>What I worry about are the people who do not ask these kinds of questions (I'm thinking more along the lines of people from our parent's generation for the most part).</p>

<p>With a H who works in major pharma, I know how much time it takes to get a new drug to market and it's often frustrating for them, despite what people may think. He really is in it to make lives better for people and when that takes longer than what he'd prefer, there's not much they can do. H works easily 60 hours a week, always has, always will, and still feels like he can't get enough done.</p>

<p>However, as someone who is notoriously known for having side effects to some of the most common meds, even OTC, I rejoice when new formulations come out which allow me to try it again. I would say this mostly applies to me with antibiotics. </p>

<p>I do remember about 15 years ago when I had thyroid surgery at the U of Chicago hospital. I was asked it I'd be willing to participate in a clinical trial as it relates to anesthesia/post-op effects. Of course I never knew whether or not I got the drug, but I felt it was worth the small risk I was taking... well, and aside from the fact that it also earned me a recovery nurse assigned just to me until I was taken to my room!</p>



<p>If you are going to require clinical trials to run for say 20 years to see whether some side effect might show up after 18 years of taking the drug, then the number of new drugs in the US will immediately drop to zero. And you will soon after see wealthy Americans taking regular trips to Canada or even Europe to avail themselves of the new life-saving drugs that will never become available in the US.</p>

<p>Even the "short" trials are hideously expensive, costing millions. No company can afford to pay for trials that would cost 10 or 20 times as much as they do today.</p>

<p>coureur, there is another twist in the quest for new pharmaceuticals - patent protection only lasts for so long... While no trial is perfect, a trial is still better than no trial. However, I'm and will always be skeptical about new drugs that are simply reformulated versions of the old API. A prodrug, which is a NCE, is a totally different story (Acyclovir vs Valcyclovir, for example)...</p>

<p>^^I see much greater value in truly new drugs over reformulated "me too" drugs. But I see no value in erecting regulatory or financial barriers to companies pursuing a "me too" strategy if they want to. </p>

<p>A big part of it is just the companies' desire to offer a comprehensive product portfolio. I mean should the car company that first invented the SUV be the only company allowed to market SUVs forever? We don't mind if each car companies produces its own version of the SUV concept. Except for patent issues, why should drug companies be any different? If one drug is big seller, why should competing companies be somehow forbidden to make their own versions of it and compete in the market place?</p>

<p>Some guys might actually prefer Cialis to Viagra. Even though Cialis is clearly a "me too," it is also an improvement. Similarly, some women actually tolerate the "me too" Actonel better than good ol' Fosamax. Those improvments will never happen if we place artifical restrictions (beyond IP law) on drug companies about what they can and can't pursue.</p>