tag:blogger.com,1999:blog-90022182321827934932024-03-19T02:26:00.736-07:00PharmaLittleFollowing the end of the extraordinary Pharmalot site...Wait a minute, Ed and Pharmalot are back! That is terrific. See our new "mission statement" below.Unknownnoreply@blogger.comBlogger197125tag:blogger.com,1999:blog-9002218232182793493.post-68800770067968603002009-11-18T05:35:00.000-08:002009-11-18T05:41:36.199-08:00NYT TO PHARMA--FUGGEDABOUDIT<strong><span style="font-size:180%;">Reform for Raising Prices</span></strong><br /><br /><br />Following its earlier report about record-breaking increases on drug prices, the NYT today editorializes that Congress should abandon its "deal" with the drug industry, which traded industry support for healthcare reform for $80 B in price cuts, mainly to Medicare and Medicaid.<br /><br /><a href="http://www.nytimes.com/2009/11/18/opinion/18wed3.html?emc=tnt&tntemail1=y">http://www.nytimes.com/2009/11/18/opinion/18wed3.html?emc=tnt&tntemail1=y</a><br /><br />The industry claims are all those we've heard in every other context in which its interest has needed defending--the price of new drug development, meeting FDA's regulatory demands, etc., etc.. <br /><br />How real was this "deal" ever? Is it time to fuggedaboudit?Unknownnoreply@blogger.com26tag:blogger.com,1999:blog-9002218232182793493.post-68271044700644249342009-11-12T18:36:00.000-08:002009-11-12T18:46:38.637-08:00DEVICE LOBBY TO HOUSE--SUSTAIN PREEMPTION!In a statement released by Advamed, the medical device folks appear to be endorsing significant provisions of health-care reform as passed by the U.S. House. But they go out of their way to warn about compromising FDA preemption, framed in the code language of allowing states to create a variety of standards.<br /><br />See the statement here:<br /><br /><a href="http://presszoom.com/story_150419.html">http://presszoom.com/story_150419.html</a><br /><br />As others have observed, it appears that the language of "tort reform" and "preemption" will be at the core of arguments used by those who would like to "bend the curve" of reform toward their particular interests.Unknownnoreply@blogger.com3tag:blogger.com,1999:blog-9002218232182793493.post-34163024766989677052009-11-04T05:33:00.000-08:002009-11-09T08:40:06.365-08:00Swine flu Vaccine - I think I'll.... nope not for me....About the swine flu pandemic..<br /><br />I am sorry for people who get sick with the flu, I am deeply sorry for anyone who becomes gravely ill and for those families who have lost a loved one.<br /><br />At this point in time though, I am in morning over the missed opportunity we had to yet once again, teach our fellow human beings how to stay healthy. We've been extolled to wash our hands, get the vaccine. It goes much deeper than that. We should be sending flyers to homes about eating healthy, getting out in the fresh air, exercising....No, instead we are opting for the "quick fix solution" - which really isn't a fix at all.<br /><br />Follow the link to the article about how no flu vaccines have actually been proven to work. The well known Cochrane Institute has once again done their homework....<br /><br />However, the flu vaccines have injected lots of money into the health care system, not to mention the big three companies scrambling to meet the demands as a result of all the fear mongering.<br /><br />The response from the pharma industry this week is announcements of job cuts - thanks guys....<br /><br />With CEO salary earnings at some Pharma's reaching some of the highest peaks every reported, well I wonder who is the real "swine" this flu season.<br /><br />On average 41,400 people died each year in the United States between 1979 and 2001 from influenza. Interestingly 44,000 people die prematurely each year in the U.S. from not having access to health care, but I digress...<br /><br />So, read the article in the link and give it some thought then cast your vote on the poll....<br /><br />Are we really a society that uses/abuses the most vulnerable of our population and exploits them as a means to an end?Unknownnoreply@blogger.com10tag:blogger.com,1999:blog-9002218232182793493.post-20774249724564535542009-10-27T18:02:00.000-07:002009-10-27T18:15:07.769-07:00600 Suits Against Medtronic Dismissed<strong><span style="font-size:180%;">The (Preemption) Beat Goes On.....</span></strong><br /><strong></strong><br /><br />FDA preemption in the arena of devices still rules in many cases. Here is a report about a judge in Minnesota who dismissed 600 cases against Medtronic over the Sprint Fidelis pacemaker.<br /><br /><a href="http://massdevice.com/news/minnesota-judge-dismisses-600-sprint-fidelis-suits-against-medtronic">http://massdevice.com/news/minnesota-judge-dismisses-600-sprint-fidelis-suits-against-medtronic</a><br /><br />As most here will know, there is a bill in Congress now that would amend the Medical Device Act in order to allow tort liability for FDA-approved medical devices.<br /><br />It is also well known that "irregularities" in FDA's device approval process increasingly make the news. As we report below, FDA itself publicized the story of a device the review of which was apparently influenced by the intervention of four Democratic congresspeopleUnknownnoreply@blogger.com3tag:blogger.com,1999:blog-9002218232182793493.post-6992805681511188152009-10-18T22:40:00.000-07:002009-10-19T00:01:04.732-07:00THE NEW PHARMALITTLE<strong><span style="font-size:180%;">It's Not Good-bye. It's Onward!</span></strong><br /><strong></strong><br />Friends--Now that our beloved Ed Silverman and Pharmalot have returned, Pharmalittle will refine its focus.<br /><br />Of course, we never imagined we could be more than a small stop-over for a few people. We are glad that we have been that and had some fun along the way. That will continue. But, beginning today, we will devote the lion's share of our reporting and commentary to the issues of accountability in the medical device and drug industries--both nationally and, for drugs, especially in Michigan. That means the issues of FDA preemption and civil liability, of course. But it also includes FDA regulation, Department of Justice actions, incentives for integrity, and examples of self-regulation that we view as terrific.<br /><br />We expect to discuss these issues in detail--not only the law, but the politics, the spin, the tactics, the money, and more. We will connect the dots. And we will do so as advocates. No surprise there.<br /><br />We are also what we have always been--a group of people representing both major political parties, healthcare professionals, academics, folks from industry (yes, that's true), patient advocates, and--above all--concerned citizens.<br /><br />Our discussions will be linked directly to the combined organizations, Americans for Drug and Device Accountability / Justice in Michigan.<br /><br /><a href="http://pharmaccountability.org/index.html">http://pharmaccountability.org/index.html</a><br /><br />Whatever our own positions, we fervently hope that this space will serve as a forum for discussion and debate. In our view, the greatest travesty of all is that most people know nothing about these issues, or what they think they know is simply false.<br /><br />For those who represent perspectives we oppose: If we think you knowingly lied, we will call you a liar, and we will say why. If we think you are arguing sincerely, you will maintain our respect, and we will tell you so. Count on both.<br /><br />Let's hash it out. Let's tell the truth. Let's see what just and rational policy dictates.<br /><br />Onward!Unknownnoreply@blogger.com9tag:blogger.com,1999:blog-9002218232182793493.post-11973877514247245262009-10-13T08:57:00.000-07:002009-10-13T09:08:36.921-07:00WARNING LABEL!!! Tort Reform Attached to Reform BillWhile Americans wait for a bill that will bring about health care reform, some in Congress are working to erode the rights of Americans.<br /><br />Ted Kennedy’s good friend, Sen.Orrin Hatch, supports tort reform and wants to make it part of a health care bill.<br /><br />"I think that this is an important step in the right direction and these numbers show that this problem deserves more than lip service from policy-makers." - <a href="http://transcripts.cnn.com/TRANSCRIPTS/0910/12/ldt.01.html">CNN.com - Transcripts</a><br /><br />A step in the right direction towards Hell, maybe. Perhaps the senator was referring to the number he got from the Insurance Industry. Here’s a letter sent to Hatch from Congress.Org.<br /><br />Subject: Your $600,000 from the insurance industry.<br /><br />To: Sen. Orrin Hatch<br /><br />October 3, 2009<br /><br />"I pledge allegiance to the insurance companies of America …"Following is a list of the money taken from the insurance lobby by United States senators (<a href="http://opensecrets.org/" target="_blank">opensecrets.org</a>). I stopped the list at $500,000. No-one gives this kind of money without expecting something in return, or takes it without the reasonable expectation of being asked to deliver.<br /><br />(From the list):<br /><br />Hatch, Orrin G (R-UT) $672,557<br /><br />For the full list of payees see: - <a href="http://www.congress.org/congressorg/bio/userletter/?id=586&letter_id=4029910426" target="_blank">Congress.org - : Letter to Senator Orrin Hatch (R-Utah): Your $600,000 from the insurance industry.</a><br /><br />Bend over America . You are about to get pricked by health care reform. Might we someday see warning labels on our medicine bottles:<br /><br />“WARNING: The Attorney General has determined that if this medication is harmful to your health, you are S.O.L.”Diannehttp://www.blogger.com/profile/04758857418309913141noreply@blogger.com4tag:blogger.com,1999:blog-9002218232182793493.post-89647233272663901142009-10-12T21:13:00.001-07:002009-10-12T21:21:31.676-07:00DON'T CRY FOR US, ARGENTINA!<strong><span style="font-size:180%;">PhamaLittle Round the World</span></strong><br /><br />Looking at our visitors over the past month, we note one of our first from South America. Welcome, Argentina! We are readying our naked hang-gliding team (PharmaLittle in-joke) for the Olympics. That's a heads-up.<br /><br />We also had visits from every U.S. state with the exception of the Dakotas, Wyoming, Montana, Idaho, Iowa, and Mississippi. Obviously, we have a buffalo problem, including the rare Buffalo du Sud.<br /><br />Our readership appears down in central Europe--we were hot in Slovakia and Slovenia for a while--but western Europe is strong. And we've had visitors from Russia, India, Turkey, and Malaysia. Japan and Australia drop by often. <br /><br />So the sun never sets on PharmaLittle. With the possible exception of an hour or two in the Azores...Unknownnoreply@blogger.com2tag:blogger.com,1999:blog-9002218232182793493.post-51811156759986646212009-10-11T21:17:00.001-07:002009-10-11T21:31:52.246-07:00WHAT GETS PEOPLE HOOKED ON DRUGS?<strong><span style="font-size:180%;">Why Are We Here?</span></strong><br /><br />As the curtain is about to rise on Pharmalot II, and before we start eating each other for breakfast, I started to think about what gets people so hooked on this topic in the first place.<br /><br />Of course, there are those whose interest reflects their work in industry. But, unless they ended up in pharma entirely by accident, there remains the question of why they chose that way.<br /><br />Likewise, those who end up on the regulatory side.<br /><br />And there are those whose lives were saved, or radically improved, by drugs. Or who believe approval of a particular drug will have that impact for themselves and others.<br /><br />And, conversely, there are those who have been injured by drugs--or close to those who have--who become involved as a result of that experience.<br /><br />Still, I think there remains a large number of people, including members of the groups above, who find the topic intrinsically fascinating, almost addicting.<br /><br />How come?<br /><br />As I see it in my students, I believe one factor is that the topic is precisely on the crossroads of issues in the natural sciences, social sciences, and humanities. Or, more specifically, where medicine, politics, economics, ethics, and more all meet. No question there is a "moral drama" inherent in many pharma issues--the promise of such much good; the commission, at times, of very bad--it's a soap opera (or even a high opera) all its own.<br /><br />Perhaps pills are, or have become, doctors in miniature. And they attract the same complex mix, and spectrum, of feelings--hope/trust/uncertainty/mistrust. <br /><br />As I sometimes say to my students, "When a sociologist messes up, nobody gives a fig. But when pharma messes up....."<br /><br />A different story.Unknownnoreply@blogger.com1tag:blogger.com,1999:blog-9002218232182793493.post-72117493400662304312009-10-10T13:38:00.000-07:002009-10-10T13:46:26.620-07:00HE'S BAAAACCCCCK!<strong><span style="font-size:180%;">Ed Has Returned</span></strong><br /><br />OK, we jumped the gun slightly on an earlier post. But this is even better--to let Ed be the one to announce his return.<br /><br />Above all, we hope the whole lawn party comes back as well, and some new folks too. As relayed, it was the talk across perspectives--to the degree it could veer away from the nasty--that was so wonderful about Pharmalot. <br /><br />As Ed has conveyed, the new Pharmalot will be smaller, in terms of posts, than what he created as a full-time gig. But I doubt that will mean it will be any less informative and useful.<br /><br />Here on 'Lil, we are likely to focus on issues of greatest concern to us--device preemption, Michigan's full preemption law, pharma and reform, FDA, and interviews with a variety of peanuts and illicitly promoted drugs. <br /><br />What the heck.Unknownnoreply@blogger.com6tag:blogger.com,1999:blog-9002218232182793493.post-31544372716942053792009-10-06T20:50:00.000-07:002009-10-06T21:08:57.595-07:00OFF-LABEL PROMOTION: WHEN PREEMPTORS THINK "SECOND-GUESSING" THE FDA IS A GREAT IDEA<strong><span style="font-size:180%;">On FDA Preemption and Off-Label Promotion</span></strong><br /><br />As many here will know, the most vociferous defenders of FDA preemption have also been the most vociferous critics of limiting off-label promotion. As replayed in a recent exchange on the Drug and Device Law blog, the argument is that a strong FDA is good (and should trump all civil liability), but not one that interferes with "constitutional right of private speech." So state courts and plaintiffs can't "second-guess" the FDA, but off-label promoters are free to do so.<br /><br />Now, on one level, I'm not sure when speech becomes "private." I suppose the crowded theater is not such a place. How about off-label promotion to representatives of Medicare or the Army? Private or public? And what difference does it make, Constitutionally, if the off-label promotion is knowingly miseleading or outright false--as was alleged in the recent Pfizer cases?<br /><br />These are real questions. For example, Holocaust denial is protected by the Constitution in the U.S., although not in other countries. So how about risk denial or benefit inflation, if engaged in by a company? Does it matter if the consequence of such misinformation may be, not "only" racist hatred, but prescribing that leads to deaths or injuries that would not have otherwise occurred? <br /><br />Or is all of that a separate issue--if "private speech" can be proven to be associated with death or injury, one may suffer consequences--civil or criminal. Be that as it may, however, it is protected by the Constitution. Just as is one's right to risk civil or criminal prosecution--not for the "private" (if fraudulent) speech itself--but for its alleged consequences.<br /><br /><br />What do you all think?Unknownnoreply@blogger.com6tag:blogger.com,1999:blog-9002218232182793493.post-15700452843209291672009-10-05T08:33:00.000-07:002009-10-05T08:40:10.041-07:00AZ TO FDA--BITE ME!<strong><em><span style="font-size:180%;">Astra Asks for "More Teeth" from FDA</span></em></strong><br /><strong><em><span style="font-size:180%;"></span></em></strong><br />In an upcoming speech, AZ's CEO will ask for an FDA with "teeth," so it can do its regulatory job more efficiently. The Times of London has it here:<br /><br /><a href="http://business.timesonline.co.uk/tol/business/industry_sectors/health/article6860949.ece">http://business.timesonline.co.uk/tol/business/industry_sectors/health/article6860949.ece</a>#<br /><br />Readers will remember last year's lurid emails in the WSJ from AZ employeess discussing studies they buried or camouflaged, particularly concerning Seroquel and its links with obesity/diabetes. They are in a post below that I can't find (someone will). So, I suppose, this request makes sense: "Stop me before I sleaze again."<br /><br />Anyway, if the teeth don't cut it, the DOJ may have an alternative approach.Unknownnoreply@blogger.com3tag:blogger.com,1999:blog-9002218232182793493.post-37390671346695068462009-10-03T07:20:00.000-07:002009-10-03T07:29:19.564-07:00NYT ON "SHODDY" FDA APPROVALS<strong>Editorial on Device case</strong><br /><strong></strong><br />Today's NYT carries an editorial on the device case discussed last week on Pharmalittle--the intervention by four Dem congressmen on behalf of a device, its getting fast-track appoval without appopriate review of either safety or efficacy (both of which had gotten thumbs-down by earlier FDA reviewers), and the pols receiving large campaign contributions from the manufacturer soon after. FDA will now do the review it should have done in the first place.<br /><br />The editorial is here<br /><br /><a href="http://www.nytimes.com/2009/10/03/opinion/03sat3.html?_r=1&emc=tnt&tntemail0=y">http://www.nytimes.com/2009/10/03/opinion/03sat3.html?_r=1&emc=tnt&tntemail0=y</a><br /><br />The NYT calls it "shoddy." A little understated in my view. A knee device, like this one, seems unlikely to cause avoidable death. But serious injury, which could lead, in turn, to death, does not seem out of the picture. So this is potentially negligent homicide on the part of the pols and FDA Commish Von Esch who was there at the time, and involved in the bogus approval.<br /><br />If there are any FDA'ers out there, current or former, I wonder if they could estimate how often such approvals occur?<br /><br />Should the facts so indicate, all in this case should be prosecuted. And not for "shoddiness."Unknownnoreply@blogger.com7tag:blogger.com,1999:blog-9002218232182793493.post-58608572750846227052009-09-28T18:35:00.000-07:002009-09-28T19:01:42.030-07:00Enlighten the people…<p><br />On September 22, 2009, the Huffington Post featured a timely article by Anthony Tarricone, President of the American Association for Justice. In his piece, Mr. Tarricone warns about the “bargain” for tort reform being played out in Congress:<br /><br />“As part of a ‘grand bargain’ to create a bipartisan health care bill, some have said tort reform should be included.”<br /><br />Although some in Congress are attempting to include tort reform into the health bill, that inclusion would not be an enhancement for the American people; rather, it would be a disaster for civil rights, health and safety.<br /><br />As Mr. Tarricone points out and, most certainly, Congress is aware:<br /></p><ul><li>"98,000 people dead every year from preventable medical errors, at a cost of $29 billion. (Institute of Medicine). </li><li>To put this into perspective, 98,000 deaths is like two 737s crashing every day for a whole year. </li><li>Countless more are seriously injured with astronomical costs. </li><li>The Congressional Budget Office and Government Accountability Office have looked at tort reform multiple times, and said it will save practically no money. </li><li>They also found no evidence of so-called 'defensive medicine,' finding that doctors run more tests because of the fee-for-service structure, or because of the benefits extra tests have on patient care.</li><li>Additionally, a 2006 study from Harvard found that 97% of cases were meritorious, totally debunking the idea that frivolous lawsuits plague our courts. </li><li>And while 46 states have enacted some kind of tort reform, health care costs have continued to skyrocket, while injured patients or their families often can't seek justice."<br /><br />So, why would a Congressional leader support tort reform, and why would they want it attached to the health bill? And, if it becomes so, will health reform end up sanctioning 98,000 deaths a year?<br /><br />For the welfare of us all, we need to know where our elected officials stand on this issue.<br /><br />Related: PharmaLittle: HOW HEALTH CARE REFORM SAVED FDA PREEMPTION,<br />http://pharmalittle.blogspot.com/2009/09/how-health-care-reform-saved-fda.html<br /><br /></li></ul>Diannehttp://www.blogger.com/profile/04758857418309913141noreply@blogger.com17tag:blogger.com,1999:blog-9002218232182793493.post-86481530799648023252009-09-24T22:41:00.000-07:002009-09-24T22:47:11.191-07:00NEW JERSEY DEMOCRATS ON THE TAKE<strong><span style="font-size:180%;">FDA Cites Pressure from Congressman and Inappropriate Approval</span></strong><br /><br />Since this blog more often criticizes Republicans than Democrats, there is something admittedly gratifying about a story in which Democratic Congressman are described as corrupt as anyone else. <br /><br />Equally interesting is that this conclusion was reached by the FDA itself, in a probe spearheaded by Joshua Sharfstein.<br /><br />It is "ironic," I suppose, that people like Frank Pallone, who have been active against device preemption, would also be active in approving devices outside appropriate FDA review procedures.<br /><br />So reports the NYT:<br /><br /><a href="http://www.nytimes.com/2009/09/25/health/policy/25knee.html?_r=1&emc=tnt&tntemail0=y">http://www.nytimes.com/2009/09/25/health/policy/25knee.html?_r=1&emc=tnt&tntemail0=y</a>Unknownnoreply@blogger.com17tag:blogger.com,1999:blog-9002218232182793493.post-75896560184980258592009-09-23T05:59:00.000-07:002009-09-23T06:37:13.165-07:00Eat, Drink & Be Merry…Consumer Watchdog reports that Congressional members who sit on the five key committees charged with healthcare reform have, this year, been invited to 130 health industry fundraisers:<br /><br />“The fundraisers included donations ranging from a low $500 to attend a ‘Healthcare Industry Reception’ for Rep. Mike Ross (D-AR) in July, a $1,500 Mexican dinner at La Loma with Sen. Mike Crapo (R-ID), to a $5,000 “PAC Gold Host” contribution for a breakfast event benefiting Sen. Tom Coburn (R-OK).”<br /><br />Belgium waffles have really become expensive! Although, probably free for senators.<br /><br />Over the same period of time health industry Political Action Committees (PACs) and individuals donated $30.7 million to committee members.<br /><br />“$30M in Industry Money Clouding Debate, Says Consumer Watchdog.”<br /><br />While the uninvited American taxpayer waits to learn the details of healthcare reform, members of Congress are being wined and dined by lobbyists.<br /><br />“Who can tell which hard decisions on health reform are being made over $1,000 high-balls shared by lobbyists and politicians while the public’s locked out of the room?” - Carmen Balber, Washington Director for Consumer Watchdog<br /><br />Per Consumer Watchdog, Sen. Max Baucus’ plan was under consideration yesterday by his committee. In it, all Americans would be required to have health insurance; however, there would be no cap on what insurance companies could charge. Furthermore, no public option is offered. Under such a plan, middle-class families might be paying almost 20% of their yearly income on health care.<br /><br />“A mandate for individuals to purchase private health insurance with no affordable coverage alternative is exactly what the health care lobby hoped for from health reform.” – Consumer Watchdog<br /><br />Here is something to think about:<br /><br />“Lobbying disclosure filings for the first quarter of 2009 reveal that five of Baucus’ former staffers currently work for a total of twenty-seven different organizations that are either in the health care or insurance sector or have a noted interest in the outcome. The organizations represented include some of the top lobbying organizations in the health sector: Pharmaceutical Manufacturers and Researchers of America (PhRMA), America’s Health Insurance Plans (AHIP), Amgen, and GE Health Care.” See: - <a href="http://blog.sunlightfoundation.com/2009/06/22/the-max-baucus-health-care-lobbyist-complex/">http://blog.sunlightfoundation.com/2009/06/22/the-max-baucus-health-care-lobbyist-complex/</a><br /><br />The Baucus’ plan doesn’t sound like a plan for America. However, it would probably work for Max.<br /><br />Full story: <a href="http://www.consumerwatchdog.org/patients/articles/?storyId=29608">http://www.consumerwatchdog.org/patients/articles/?storyId=29608</a><br /><br />Data analysis of fundraisers, campaign contributions and health care lobbyists:<br /><a href="http://www.consumerwatchdog.org/resources/healthcarefundraisers.xls">http://www.consumerwatchdog.org/resources/healthcarefundraisers.xls</a>Diannehttp://www.blogger.com/profile/04758857418309913141noreply@blogger.com1tag:blogger.com,1999:blog-9002218232182793493.post-38338141033680790732009-09-21T20:54:00.001-07:002009-09-21T21:14:37.702-07:00HAT TIP TO OURSELVES....<strong><span style="font-size:180%;">Pharmalittle to be Honored at White House</span></strong><br /><strong><span style="font-size:180%;"></span></strong><br />OK, so we lied. It's all part of the same strategy. As the impressive badge on the left (suitable for framing) shows, this blog has been named one of the top 100 pharma blogs. Did anyone know there were that many pharma blogs?<br /><br />Anyway, a lot of people out there will wonder how we accomplished this. It's simple. We followed basic marketing principles:<br /><br />1. We promoted the blog for off-label uses. For example, it makes a great eye chart and may help slow the growth of cataracts.<br /><br />2. We gave kickbacks to everyone on the internet. Really.<br /><br />3. We buried studies 34, 57, and 105.<br /><br />4. We changed the endpoints in study 35 and left out the last six months of data.<br /><br />5. We delayed the appearance of generic Pharmalittle (liloxazorx) through a bunch of nuisance suits.<br /><br />6. We intimidated people who read other blogs.<br /><br />7. We hired Key Opinion Leaders like Anonymous to talk us up.<br /><br />8. We funded studies showing all the dangers of other pharma blogs.<br /><br />9. We convinced people that failure to read Pharmalittle will result in the end of innovation in the industry and the complete dissolution of life-saving medications.<br /><br />10. We avoided being bought by Pfizer.<br /><br />11. There is no evidence reading Pharmalittle leads to weight gain, morbid obesity, and diabetes. And anyone who thinks differently will never find Study 57 anyway.<br /><br />12. We don't believe in morbid obesity. If you're going to be obese, at least be up-beat about it.<br /><br />And stuff like that.Unknownnoreply@blogger.com11tag:blogger.com,1999:blog-9002218232182793493.post-80039437491935770262009-09-18T20:43:00.000-07:002009-09-18T20:55:30.283-07:00POST-LEVINE, FDA TO CHANGE PHENERGAN WARNINGS<strong><span style="font-size:180%;">Levine Appears Vindicated</span></strong><br /><br /><br />The NY Times reports that the FDA will require stronger warnings about administering Phenergan via IV push:<br /><br /><a href="http://www.nytimes.com/2009/09/19/health/19drug.html?_r=1">http://www.nytimes.com/2009/09/19/health/19drug.html?_r=1</a><br /><br />Needless to say, this is a fascinating sequel to the Wyeth v. Levine case. The new warnings will apparently be what Diana Levine argued should have been on the label in the first place. The FDA reports the change is based on the number of cases it has received in which IV push administration led to gangrene and amputation--precisely what happened to Levine.<br /><br />There is no suggestion that the label change was based on "new information" per se, but rather a few additional cases along with rethinking the older warning. The Vermont juries that twice upheld Levine agreed with her argument that Wyeth knew enough at the time of her injury, and had the authority, to make precisely such a change on its own (under the "Changes Being Effected" rules). While FDA would have had to agree, there are virtually no instances when it has not under such circumstances. <br /><br />In an interesting closing, Gardiner Harris writes that this change may lend support to FDA's older position--pre-Bush administration--that civil liability and FDA regulation are overlapping, generally complementary, systems of consumer protection.Unknownnoreply@blogger.com13tag:blogger.com,1999:blog-9002218232182793493.post-86693060650452205952009-09-16T17:16:00.000-07:002009-09-16T17:21:54.140-07:00SELLING VYTORIN THROUGH $60 M OF CME<strong><span style="font-size:180%;">Arteries Clogged by Moolah</span></strong><br /><br /><br />Cardiobrief, via Dow Jones newswire, reports on the extraordinary sums MSP provided to CME related to Vytorin. One single grant amount to $6 M.<br /><br />See: <a href="http://cardiobrief.org/2009/09/16/senate-investigation-uncovers-huge-expenditures-for-vytorin-cme/">http://cardiobrief.org/2009/09/16/senate-investigation-uncovers-huge-expenditures-for-vytorin-cme/</a><br /><br />The information emerged through a Senate investigation.<br /><br />I'm glad that pharma is supporting health-care reform.Unknownnoreply@blogger.com4tag:blogger.com,1999:blog-9002218232182793493.post-24466454098336437182009-09-15T22:34:00.000-07:002009-09-15T22:45:29.022-07:00HOW HEALTH CARE REFORM SAVED FDA PREEMPTIONCall this a speculation. That's what it is.<br /><br />As we have heard, "tort reform" has now been included in the Obama administration's package of initiatives. As the Prez indicated in his speech last week, he is in favor of restricting medical malpractice suits in certain locales--yet unspecified--to assess the impact of those limitations. This, of course, was to win a few Republicans. So far, he has won curses, crazies, and a few claps for this particular concept. Claps aren't votes.<br /><br />Med mal is not device preemption. But the "tort reform" agenda as pushed by Bush/Rove kept that distinction as fuzzy as possible. While the fight was for the industry's agenda spearheaded by Dan Troy, the "face" of tort reform was always doctors and nurses. They look a lot better in newspapers.<br /><br />Undoubtedly, Congressional Republicans will also mush med mal issues with FDA preemption, which still fully stands in the device arena. And how much stomach will Congress have for amending the Medical Device Act in a way that could reverse Riegel, with or without the O administration's early statements on agency preemption?<br /><br />I'd say....very, very little.Unknownnoreply@blogger.com5tag:blogger.com,1999:blog-9002218232182793493.post-21475435383857218962009-09-12T23:57:00.000-07:002009-09-13T00:00:09.658-07:00IS THAT REALLY US?<strong>From today's NYT, an op ed by Kristoff</strong><br /><strong></strong><br />September 13, 2009<br />Op-Ed Columnist<br />The Body Count at Home<br />By <a title="More Articles by Nicholas D. Kristof" href="http://topics.nytimes.com/top/opinion/editorialsandoped/oped/columnists/nicholasdkristof/index.html?inline=nyt-per">NICHOLAS D. KRISTOF</a><br />In the debate over health care, here’s an inequity to ponder: Nikki White would have been far better off if only she had been a convicted bank robber.<br />Nikki was a slim and athletic college graduate who had health insurance, had worked in health care and knew the system. But she had systemic lupus erythematosus, a chronic inflammatory disease that was diagnosed when she was 21 and gradually left her too sick to work. And once she lost her job, she lost her health insurance.<br />In any other rich country, Nikki probably would have been fine, notes T. R. Reid in his important and powerful new book, “The Healing of America.” Some 80 percent of lupus patients in the United States live a normal life span. Under a doctor’s care, lupus should be manageable. Indeed, if Nikki had been a felon, the problem could have been averted, because courts have ruled that prisoners are entitled to medical care.<br />As Mr. Reid recounts, Nikki tried everything to get medical care, but no insurance company would accept someone with her pre-existing condition. She spent months painfully writing letters to anyone she thought might be able to help. She fought tenaciously for her life.<br />Finally, Nikki collapsed at her home in Tennessee and was rushed to a hospital emergency room, which was then required to treat her without payment until her condition stabilized. Since money was no longer an issue, the hospital performed 25 emergency surgeries on Nikki, and she spent six months in critical care.<br />“When Nikki showed up at the emergency room, she received the best of care, and the hospital spent hundreds of thousands of dollars on her,” her step-father, Tony Deal, told me. “But that’s not when she needed the care.”<br />By then it was too late. In 2006, Nikki White died at age 32. “Nikki didn’t die from lupus,” her doctor, Amylyn Crawford, told Mr. Reid. “Nikki died from complications of the failing American health care system.”<br />“She fell through the cracks,” Nikki’s mother, Gail Deal, told me grimly. “When you bury a child, it’s the worst thing in the world. You never recover.”<br />We now have a chance to reform this cruel and capricious system. If we let that chance slip away, there will be another Nikki dying every half-hour.<br />That’s how often someone dies in America because of a lack of insurance, according to a study by a branch of the National Academy of Sciences. Over a year, that amounts to <a href="http://www.iom.edu/CMS/3809/4660/17632.aspx">18,000 American deaths</a>.<br />After Al Qaeda killed nearly 3,000 Americans, eight years ago on Friday, we went to war and spent hundreds of billions of dollars ensuring that this would not happen again. Yet every two months, that many people die because of our failure to provide universal insurance — and yet many members of Congress want us to do nothing?<br />Mr. Reid’s book is a rich tour of health care around the world. Because he has a bum shoulder, he asked doctors in many countries to examine it and make recommendations. His American orthopedist recommended a titanium shoulder replacement that would cost tens of thousands of dollars and might or might not help. Specialists in other countries warned that a sore shoulder didn’t justify the risks of such major surgery, although some said it would be available free if Mr. Reid insisted. Instead, they offered physical therapy, acupuncture and other cheap and noninvasive alternatives, some of which worked pretty well.<br />That’s a window into the flaws in our health care system: we offer titanium shoulder replacements for those who don’t really need them, but we let 32-year-old women die if they lose their health insurance. No wonder we spend so much on medical care, and yet have some health care statistics that are worse than Slovenia’s.<br />My suggestion for anyone in Nikki’s situation: commit a crime and get locked up. In Washington State, a 20-year-old inmate named Melissa Matthews chose to turn down parole and stay in prison because that was the only way she could get treatment for her cervical cancer. “If I’m out, I’m going to die from this cancer,” she told a television station.<br />Mr. and Mrs. Deal say they are speaking out because Nikki wouldn’t want anyone to endure what she did. “Nikki was a college-educated, middle-class woman, and if it could happen to her, it can happen to anyone,” Mr. Deal said. “This should not be happening in our country.”<br />Struggling to get out the words, Mrs. Deal added: “The loss of a child is the greatest hurt anyone will ever suffer. Because of the circumstances she endured with the health care system, I lost my daughter.”<br />Complex arguments are being batted around in this health care debate, but the central issue isn’t technical but moral. The first question is simply this: Do we wish to be the only rich nation in the world that lets a 32-year-old woman die because she can’t get health insurance? Is that really us?Unknownnoreply@blogger.com7tag:blogger.com,1999:blog-9002218232182793493.post-70028425036109766712009-09-12T07:16:00.000-07:002009-09-12T07:20:25.637-07:00PhRMA, AMA, AND REFORM<strong><span style="font-size:180%;">CME for the Folks</span></strong><br /><br />The NYT has an interesting piece on the strategies PhRMA, AMA, and others are using to intertwine support of some version of health-care reform and controlling the outcome. <br /><br />None of this is surprising, but it provides a few more particulars.<br /><br /><a href="http://www.nytimes.com/2009/09/12/health/policy/12lobby.html?emc=tnt&tntemail1=y">http://www.nytimes.com/2009/09/12/health/policy/12lobby.html?emc=tnt&tntemail1=y</a>Unknownnoreply@blogger.com1tag:blogger.com,1999:blog-9002218232182793493.post-9912914374110969572009-09-11T05:10:00.000-07:002009-09-11T10:04:21.956-07:00GHOSTEST WITH THE MOSTEST<strong><span style="font-size:180%;">Spooks to Form own Journal--Name it!</span></strong><br /><br />Must be a slow news day. the NYT published yet another piece about how many ghosts write major journal articles, the relevant editors express relevant surprise, and life goes on (even for the ghosts).<br /><br /><a href="http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=1&emc=tnt&tntemail1=y">http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=1&emc=tnt&tntemail1=y</a><br /><br /><br />What you may not know is that the Ghosts are preparing to form their own peer-reviewed medical journal with the hope of competing in the majors. "We're tired of being booed by the media," said one translucent source, until he disappeared. "We're going to float out on our own."<br /><br />The name of the new journal remains uncertain. JAGA, the obvious source, may not be it. A number of Ghosts are also members of the American Science Fiction Writers Association, and so linking up with that organization, perhaps not too publicly, is also a possibility. _Spiritual Medicine_ was rejected as too hippy dippy.<br /><br />There are rumors the look of the new journal may also be different. Instead of the usual covers, there may simply be light white cloth, with a pair of eyes cut out. "But we don't want to be confused with the Klan," said one member. "No problem," said another. "The Klan does it for free."<br /><br />We'll see where all this flits.Unknownnoreply@blogger.com6tag:blogger.com,1999:blog-9002218232182793493.post-9158954811748673862009-09-08T13:26:00.000-07:002009-09-08T13:29:52.510-07:00WAS THE PFIZER SETTLEMENT A GIFT?<strong><span style="font-size:180%;">You Be the Feds....</span></strong><br /><br />Vera Shavner has sent out an interesting post on the recent Pfizer/DOJ settlement that can be accessed at:<br /><br /><a href="http://www.ahrp.org/cms/content/view/634/9/">http://www.ahrp.org/cms/content/view/634/9/</a><br /><br />In essence, Vera suggests that Pfizer got off the hook in the recent settlement because they were not banned from future federal contracts, at least for a period of time, which they were threatened with in the "Corporate Integrity Agreement" regarding Neurontin.<br /><br />Personally, I disagree with Vera's analysis. I will post my response to her. But what do you all think?Unknownnoreply@blogger.com33tag:blogger.com,1999:blog-9002218232182793493.post-71417079244150663892009-09-04T18:14:00.000-07:002009-09-04T18:20:53.815-07:00OUT TO LUNTZ<strong><span style="font-size:180%;">The Spinmeister</span></strong><br /><br />In a thread below, Diane makes the extremely important point that the repeated arguments against healthcare reform have been scripted for some time. Frank Luntz, who has made a career as a propagandist, has indeed been central in writing that script. <br /><br />It is also relevant that some of Luntz's largest clients are the major preemptors--The US Chamber of Commerce, the National Association of Manufacturers (NAM), and the Business Roundtable. NAM has been headed for several years by John Engler, the former Michigan Governor who put our blanket shield law in place.<br /><br />Re: healthcare propaganda, it is noted:<br /><br />"Here are some suggested arguments for Republicans that Luntz calls “clear winners”:<br /><br />—“It could lead to the government setting standards of care, instead of doctors who really know what’s best.”<br /><br />—“It could lead to the government rationing care, making people stand in line and denying treatment like they do in other countries with national healthcare.”<br /><br />-“President Obama wants to put the Washington bureaucrats in charge of healthcare. I want to put the medical professionals in charge, and I want patients as an equal partner.”<br /><br />Read more: <a href="http://www.politico.com/news/stories/0509/22155.html#ixzz0QBro3B2y">http://www.politico.com/news/stories/0509/22155.html#ixzz0QBro3B2y</a>Unknownnoreply@blogger.com37tag:blogger.com,1999:blog-9002218232182793493.post-74849228782027051882009-09-04T07:08:00.000-07:002009-09-04T07:23:53.012-07:00The Eyes of TexasA Reuters’ story tells about John Kopchinski, a Gulf War veteran from Texas who later became a disgruntled sales representative for Pfizer. John found Pfizer’s sales tactics hard to swallow. As he explains it:<br /><br />"In the Army I was expected to protect people at all costs....At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.”<br /><br />Unable to live down to Pfizer’s ethics, he blew the whistle on ‘em.<br /><br />Click link for full story.Diannehttp://www.blogger.com/profile/04758857418309913141noreply@blogger.com1