tag:blogger.com,1999:blog-36762711.post5325220231092082220..comments2023-11-03T06:14:58.449-04:00Comments on Drug and Device Law: Preemption Affirmed in ColaciccoRachel B. Weilhttp://www.blogger.com/profile/02251124525069607080noreply@blogger.comBlogger15125tag:blogger.com,1999:blog-36762711.post-46004717377108929832008-04-14T10:13:00.000-04:002008-04-14T10:13:00.000-04:00Traverse.Traverse.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-67250911188273458722008-04-11T16:42:00.000-04:002008-04-11T16:42:00.000-04:00The FDA serves no useful purpose. It impedes progr...The FDA serves no useful purpose. It impedes progress by delaying approvals, and then taking medications off the market for rare side effects. It is run by academic scientist. These are junior to real world clinicians and scientists in experience, intelligence, income. <BR/><BR/>Personal remarks show frustration in the traverse.Supremacy Claushttps://www.blogger.com/profile/03215810467361119756noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-90916080354991562432008-04-11T12:40:00.000-04:002008-04-11T12:40:00.000-04:00Right Wing Santa Claus,You had me at "get rid of t...Right Wing Santa Claus,<BR/><BR/>You had me at "get rid of the FDA." I think that is a fair summary of the reasonableness of your views. I think I'm past this dialogue.<BR/><BR/>Karen Carpender wrote a wonderful song, saying that what "the world needs now, is love sweet love." If she were still with us, I suppose she would change the words to "what the world needs now, if more SSRIs with 30% efficacy." (I don't know that that flows quite as well. But screw it. It is what we all need.)<BR/><BR/>Scienter. I'm just a little curious, how often a day do you use this world.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-69823633569773976382008-04-11T11:06:00.000-04:002008-04-11T11:06:00.000-04:00The ghoulish experiment was done by the left wing ...The ghoulish experiment was done by the left wing extremists and the craven collaborators at the FDA. They deterred the family doctors. The deaths jumped. They interrupted a trend of greater anti-depressant use in adolescents and rapidly dropping suicide rates. That cannot be ignored in the annals of left wing mass murder, with scienter.Supremacy Claushttps://www.blogger.com/profile/03215810467361119756noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-2924815108551499792008-04-11T09:02:00.000-04:002008-04-11T09:02:00.000-04:00Dear Supramcy Clause:"The sole effective method to...Dear Supramcy Clause:<BR/><BR/>"The sole effective method to reduce the suicide rate is long term treatment of the underlying disorders. Counties with higher rates of anti-depressant use have lower suicide rates." For someone who would scream that assocation is not causation, I find this statement funny.<BR/><BR/>The Vioxx cases were very weak on causation in individual cases. No question. But let's not obscure that in a minority of filed cases Vioxx killed people. Since a zillion cases were filed, that small minority is a lot of families who lost someone they love because a company put obscene profits over human beings.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-38501444834572364292008-04-10T21:30:00.000-04:002008-04-10T21:30:00.000-04:00You will not believe this. I am among those who wa...You will not believe this. <BR/><BR/>I am among those who want 1) the FDA gone entirely; 2) all patent terms reduced to 5 years, publish smaller studies of effectiveness and safety, get sued is misleading; 3) end all tort reform, unleash torts on the legal system and government, by ending all lawyer self-dealt immunities, including repealing the Eleventh Amendment or, at least, reverse Hans by federal statute, end incompetent lawyering and judging. <BR/><BR/>The lawyer rent seeking has kept our growth at 3% when it should be 9% a year.Supremacy Claushttps://www.blogger.com/profile/03215810467361119756noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-76196462825673274562008-04-10T20:34:00.000-04:002008-04-10T20:34:00.000-04:00Just to be clear - so no FDA whatsoever?That would...Just to be clear - so no FDA whatsoever?<BR/><BR/>That would certainly take a bite out of preemption?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-85723379771532024692008-04-10T17:30:00.000-04:002008-04-10T17:30:00.000-04:00It is settled law in 6 or more Supreme Court decis...It is settled law in 6 or more Supreme Court decisions. The clinical decision has presumptive validity. The most famous such case was, of course, Roe v Wade. <BR/><BR/>There are two experts, the patient, and the clinician who gets to know the patient. Their decisions have the sole validity. All others, all removals from the market, all black box warnings, all guidelines by quasi-governmental organizations, all weak cases in med mal, all regulation of that encounter, all violate these Supreme Court holdings, and are lawless.Supremacy Claushttps://www.blogger.com/profile/03215810467361119756noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-83227241906341089242008-04-10T10:41:00.000-04:002008-04-10T10:41:00.000-04:00So we should "defer to the expert judgment of scie...So we should "defer to the expert judgment of scientists" (as at the FDA) .... unless they happen to be scientists whose poltical views we presume we know and we opt to detest<BR/><BR/>Very objective standard.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-3920385221103405092008-04-09T23:18:00.000-04:002008-04-09T23:18:00.000-04:00Here is the editorial of this extreme left wing, b...Here is the editorial of this extreme left wing, biased propaganda rag, notorious, in the medical profession. <BR/><BR/>http://www.bmj.com/cgi/content/full/336/7643/515<BR/><BR/>Only 3% of adolescents who committed suicide had anti-depressants in their bodies. This is much lower rate than found in alive adolescents. <BR/><BR/>I do not appreciate your selective quoting, and from a biased, left wing propaganda rag, devoid of any credibility. <BR/><BR/>As you know, even with extreme symptoms, under Brit twit Commie Care, no one gets any care. Adequate care is so rare in England, no conclusion may be drawn. One needs a private investigator to find one's primary care doctor. Specialist care just never happens under that Commie regime. So, in the extreme rarity of care, no effect will ever be evident.Supremacy Claushttps://www.blogger.com/profile/03215810467361119756noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-71034579360063098172008-04-09T22:16:00.000-04:002008-04-09T22:16:00.000-04:00From BMJ editorial, 3/8/08"The two accompanying ob...From BMJ editorial, 3/8/08<BR/><BR/>"The two accompanying observational studies show a lack of connection between antidepressant prescribing rates and suicide rates in adolescents and young adults in the United Kingdom.1 2 Suicide rates declined when antidepressant use steadily increased but continued to decline when the use of antidepressants fell sharply in 2003 and 2004."Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-29553048775815291732008-04-09T18:47:00.000-04:002008-04-09T18:47:00.000-04:00An uninterrupted series of 80 hate filled, anti-me...An uninterrupted series of 80 hate filled, anti-medication extremists demanded the banning of anti-depressants entirely. They scapegoated medication for their failures as parents to control their criminal children. They scapegoated medications for intentional acts of illegal drug users, and mental patients. <BR/><BR/>The sole effective method to reduce the suicide rate is long term treatment of the underlying disorders. Counties with higher rates of anti-depressant use have lower suicide rates. The training of primary care doctors to diagnose and treat depression in a couple of European countries decreased the suicide rates in the surrounding areas. These were depression treatment, not suicide prevention initiatives. The US managed to achieve the reverse by deterring primary care doctors with this idiotic black box warning. Psychiatrist prescribing rates did not budge, because they knew how idiotic the warning was. <BR/><BR/>The members of the committee had a fiduciary duty and an oath to the public, to resist the haters and deniers threatening them. They failed to protect the public from these extremists. They must resign. <BR/><BR/>The medication responders are severely depressed. The lawyers and regulators have caused such patients to be excluded, to prevent litigation and ruinous interruption of trials by deaths. So only the mildest, non-suicidal patients get included. The left wing extremist lawyers attack the drug companies doing proper trials. Then they criticize the lack of additional response compared to placebo when they try to protect themselves from the lawyers. This shows the anti-corporation, America hater agenda is being furthered by the FDA. It must be eliminated entirely with new statutes. <BR/><BR/>Most cases of Vioxx litigation were won by the defense. The company settled out of a calculation of the legal costs of resistance. <BR/><BR/>The Vioxx statistics were similarly weak. The removal from the market disrupted the successful care of millions of people. As there were no suicides nor serious injuries in the anti-depressants trials, so there were no deaths in the Vioxx trials. <BR/><BR/>All medications that work are extremely dangerous, across doses, across individual responses, across time. However, the risks and benefits are to be calculated by the patient and the clinician as they apply to the individual case. They are not to be decided by lawyers, nor by hate filled scapegoaters. <BR/><BR/>As a patient, I would support the formation of patient direct action groups, to bring self-help to the enemies of clinical care. To deter the lawyers, extremists, and regulators.Supremacy Claushttps://www.blogger.com/profile/03215810467361119756noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-65279955298247499352008-04-09T14:54:00.000-04:002008-04-09T14:54:00.000-04:00I would expect Supremacy Claus claim of a vast lef...I would expect Supremacy Claus claim of a vast left wing conspiracy in the White House. That's how silly the notion is of the FDA Psychopharmacology Committee being bullied by left wing extremists. <BR/><BR/>First, is there ANY DATA to support the notion that SSRI decrease the risk of suicide in this country. With approximately a billion of us taking the stuff, suicide rates have remained unchanged in this country. Are you suggesting that suicide rates and SSRI usage has been linked together? Hardly. Even the drug companies don't argue this.<BR/><BR/>Second, go back and look at the minutes of these meetings over the years. First of all, everyone on these freaking committees has some financial stake - directly or indirectly - in the drugs they are passing judgment upon. These people fought the science for years before finally caving. <BR/><BR/>Finally, if you don't think the difference between 4% and 2.5% is meaningful, I assume you also think these drugs should be taken off the market because they are not efficacious. In less than half the cases do they have any impact on the user. So we should keep a drug on the market that works 1/3 or the time yet we should have no concern about someone taking a drug causing almost twice as many suicides? That's insane. In fact, if you are correct that SSRI reduce suicide risk (they don't but I'll play along) then they are killing more people on the drug then the data indicates because some are being saved decreasing the placebo comparisionn, while leading others to suicide. <BR/><BR/>Suggesting that this respponsible decision killed 1000 people is wrong and reckless. <BR/><BR/>Yes, Vioxx was a great drug too. I know, the cases settled for billions because the American people as so dumb. Do you think there have been any dangerous drugs in the history of mankind, Supremacy Claus?Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-36762711.post-14756617099182714822008-04-09T05:57:00.000-04:002008-04-09T05:57:00.000-04:00There is no increased risk of suicide from anti-de...There is no increased risk of suicide from anti-depressants, only of suicidal ideas or gestures. <BR/><BR/>Left wing extremists bullied the FDA Psychopharmacology Committee. It issued a warning on suicidal ideas and gestures in 4% of people on antidepressants and 2.5% of people on placebo. If you slapped your forehead because you could have had a V8, it got recorded as a suicidal gesture. <BR/><BR/>The Committee also has not had 11th grade statistics. The number of patients across many studies was very large, making a clinically trivial difference statistically significant. In 11th grade, one learns about a correction for this effect. They did not apply it. Had they done so, the difference would lose its statistical significance (Same error of statistical ignorance was made in the case of Vioxx, by the Merck leadership. The FDA demanded Vioxx return to market, to their credit.) <BR/><BR/>A black box warning is intended (with scienter) to deter, and to make it less likely for patients to get a medication. It worked. As a result of this warning, in 2004, primary care physicians stopped prescribing anti-depressants to depressed young people. The steeply descending trend in suicide stopped. The rate of suicide in this age group has steadily increased, as the number of tracked prescriptions has decreased. <BR/><BR/>The entire Psychopharmacology Committee and the FDA Commissioner must resign. They are responsible for the foreseeable and preventable deaths by suicide of 100's of young people a year, since the 2004 warning. These cause unusual agony in the bereaved families. If a decision I made at work would kill 1000's of young people needlessly, I would resign.Supremacy Claushttps://www.blogger.com/profile/03215810467361119756noreply@blogger.comtag:blogger.com,1999:blog-36762711.post-19987759754055923842008-04-09T00:04:00.000-04:002008-04-09T00:04:00.000-04:00Narrow indeed. The court took no position on the ...Narrow indeed. The court took no position on the key issues regarding preemption as a doctrine.<BR/><BR/>"Thus, we<BR/>do not decide whether the FDA?s mere approval of drug labeling<BR/>is sufficient to preempt state-law claims alleging that the<BR/>labeling failed to warn of a given danger, whether FDA approval<BR/>of drug labeling constitutes minimum standards in the absence of<BR/>the FDA's express rejection of a specific warning." (p. 33)Anonymousnoreply@blogger.com