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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_163"
                     title="Obama Pushs for Change on Biologics in Healthcare Bill"
                     score="-0.004"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/17996?impressionId=1265786174932"
                     
      &lt;p&gt;WASHINGTON  --  President Obama has signaled his support for renegotiating a provision in the healthcare reform bill to allow generic versions of biologics to hit the market more quickly.&lt;/p&gt;
&lt;p&gt;Both the House and the Senate bills include provisions to establish a pathway that would allow generic companies to have biologics approved. Currently, no such pathway exists. The provisions would offer brand-name biologic companies a 12-year period during which generic companies would be barred from introducing a competing product.&lt;/p&gt;
&lt;p&gt;In a Thursday closed-door question-and-answer session with members of the House, Obama suggested that a shorter exclusivity period might be in order, even though &lt;a href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; mce_href=&quot;http://www.medpagetoday.com/PublicHealthPolicy/Washington-Watch/15108&quot; target=&quot;_blank&quot; title=&quot;Biotech&amp;#8200;Industry&amp;#8200;Flexes&amp;#8200;Muscle&amp;#8200;in&amp;#8200;Biologics&amp;#8200;Debate&amp;#8200;on&amp;#8200;the&amp;#8200;Hill&quot;&gt;Senate&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/15336&quot; target=&quot;_blank&quot; title=&quot;Week&amp;#8200;7:&amp;#8200;House&amp;#8200;Panel&amp;#8200;Approves&amp;#8200;Health&amp;#8200;Reform&amp;#8200;Bill&quot;&gt;House&lt;/a&gt; committees voted strongly in support of 12-year exclusivity.&lt;/p&gt;
&lt;p&gt;Members of Congress who have biologic companies in their districts  --  such as Rep. Anna Eshoo (D-Calif.)  --  support the 12-year period, arguing that biologics are so complex that it would take at least that long for generic companies to produce so-called &quot;biosimilars.&quot;&lt;/p&gt;
&lt;p&gt;But some, including Rep. Henry Waxman (D-Calif.), have said the long exclusivity period will harm patients who will have to wait years to see cheaper versions of drugs for diseases like cancer and multiple sclerosis. In addition, some argue that if significantly less expensive biosimilars come to the market earlier, the nation&apos;s drug costs would be reduced.&lt;/p&gt;
&lt;p&gt;The Obama administration has signaled his support for a shorter exclusivity period all along, said &lt;span&gt;&lt;span&gt;Katie Huffar&lt;/span&gt;, a spokesperson for Coalition for a Competitive Pharmaceutical Market (&lt;span&gt;CCPM&lt;/span&gt;), a group comprised of generic drug companies, pharmacies, several insurance companies, and other corporations.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&quot;The administration has been saying they think it&apos;s too much,&quot; she said.&lt;/p&gt;
&lt;p&gt;There don&apos;t appear to be any supporters of the 12-year exclusivity period at the negotiating table as members of the House and the Senate work with the White House to hammer out a final bill. What&apos;s more, Waxman, who is the House&apos;s biggest opponent of the long exclusivity period, has a seat at that table.&lt;/p&gt;
&lt;p&gt;A spokesperson for Waxman declined to discuss details of negotiation process.&lt;/p&gt;
&lt;p&gt;However, the powerful pharmaceutical lobby, PhRMA, supports the longer exclusivity period, and it&apos;s unclear what effect shortening the period would have on the deal that PhRMA struck with the White House earlier in the healthcare reform process. Under that deal, the drug companies agreed to support reform if the White House promised to limit the industry&apos;s losses to $80 billion over 10 years.&lt;/p&gt;
&lt;p&gt;Huffar said her group has been assured that biogenerics were not part of the deal.&lt;/p&gt;
&lt;p&gt;&quot;No one on the government side of that deal shook on 12 years,&quot; she said.&lt;/p&gt;
&lt;p&gt;A spokesperson for PhRMA said the deal hadn&apos;t changed as of Friday, and the group issued a statement reiterating its support for the 12-year period.&lt;/p&gt;
&lt;p&gt;&quot;...At least 12 years of data protection is needed to help recoup the significant development costs for biologic innovators and to fund research on future treatments and cures,&quot; said PhRMA senior vice president Ken Johnson in the statement. &lt;/p&gt;
&lt;p&gt;During Thursday&apos;s Q&amp;amp;A with the president, Eshoo told Obama that Congress had already overwhelmingly backed the 12-year exclusivity period, a source familiar with the exchange told &lt;em&gt;MedPage Today. &lt;/em&gt;&lt;/p&gt;
&lt;p&gt;Indeed, the House Energy and Commerce Committee voted 47 to 11 to add the biologics amendment to the heatlhcare reform bill and the Senate Health, Education, Labor and Pensions Committee approved the amendment 16 to 7.&lt;/p&gt;
&lt;p&gt;Eshoo criticized healthcare reform negotiators&apos; willingness to ditch the 12-year period when other pharmaceutical elements of the reform bill seem to be &quot;sacrosanct,&quot; the source said.&lt;/p&gt;
&lt;p&gt;Obama replied that &quot;nothing is sacrosanct,&quot; according to a House aide.&lt;/p&gt;
&lt;p&gt;In a letter to Speaker of the House Nancy Pelosi (D-Calif.) that is currently gaining signatures, Eshoo writes:&lt;/p&gt;
&lt;p&gt;&quot;While so many issues are still left unresolved in the debate over healthcare in both the House and Senate, this is an issue that has had overwhelming support from both sides. Additionally, it is an issue both Democrats and Republicans have found agreement on. Changing language that is virtually identical for purpose of a final agreement would be unheard of in a traditional conference approach.&quot;&lt;/p&gt;
&lt;p&gt;But healthcare reform is not moving along according to tradition. Congressional leaders decided to &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17812&quot; target=&quot;_blank&quot; title=&quot;Congress&amp;#8200;Likely&amp;#8200;to&amp;#8200;Combine&amp;#8200;Healthcare&amp;#8200;Bills&amp;#8200;Informally&quot;&gt;informally combine&lt;/a&gt; the Senate and House bills instead of using the traditional conference approach, which would likely result in a Republican filibuster.&lt;/p&gt;
&lt;p&gt;As of now, it appears that no deal on the biosimilar language has been reached.&lt;/p&gt;
&lt;p&gt;Negotiators are still finalizing details of the healthcare reform bill and are expected send it to the Congressional Budget Office (CBO) in the next few days for a cost estimate.&lt;/p&gt;
&lt;p&gt;Congressional leaders have promised that the bill would be posted for 72 hours before any major vote is taken on it.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_1037"
                     title="Tumor Data May Block Approval for Diabetes Drug Liraglutide"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Cardiology/Diabetes/tb/13588?impressionId=1265786174932"
                     
       SILVER SPRING, Md., April 2 -- An FDA advisory panel declined to recommend approval for the investigational diabetes drug liraglutide (Victoza), in light of animal studies linking the injection to thyroid cancer. 
                &lt;p&gt; 
                &lt;p&gt;The Endocrinologic and Metabolic Drugs Advisory Committee voted 12-1 that the rodent data could apply to humans. It then split 6-6 (with one member abstaining) on the question of whether the cancer risk should preclude FDA approval.  
                &lt;p&gt; 
                &lt;p&gt;The manufacturer of liraglutide, Novo Nordisk, assured the panel that the C-cell adenomas and carcinomas seen in rats and mice would not occur in humans, but the committee disagreed. 
                &lt;p&gt; 
                &lt;p&gt;&quot;The animal data [were] worrisome,&quot; said panelist Peter Savage, M.D., an endocrinologist at the National Institutes of Health. &quot;We didn&apos;t see enough data in humans.&quot;
                &lt;p&gt; 
                &lt;p&gt;The panel was less concerned, however, about the five cases of papillary thyroid carcinomas -- the most common type of thyroid cancer -- seen in humans in the sponsor&apos;s trials. 
                &lt;p&gt; 
                &lt;p&gt;The panel chalked those cases up to an &quot;ascertainment bias&quot; and voted unanimously that the cases of human thyroid cancers seen in the trials shouldn&apos;t prevent the FDA from approving the drug.
                &lt;p&gt; 
                &lt;p&gt;The committee also narrowly recommended -- by an 8-5 vote -- that the drug&apos;s cardiovascular risks are acceptable.
                &lt;p&gt; 
                &lt;p&gt;An FDA staff review found that cardiovascular events were about the same for liraglutide compared with other diabetes drugs, but slightly more events were seen in the liraglutide group when compared with placebo. Overall event rates were low.
                &lt;p&gt; 
                &lt;p&gt;Liraglutide, an injectable glucagon-like peptide-1 (GLP-1) mimic, is the second diabetes drug to go before a committee since the FDA ramped up its requirements for cardiovascular safety data on such products last June.
                &lt;p&gt; 
                &lt;p&gt;The new standards were issued in the wake of controversy over rosiglitazone (Avandia), which was shown to increase cardiovascular event risks. 
                &lt;p&gt; 
                &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/5701&quot; target=&quot;blank&quot;&gt;Meta-Analysis Links Rosiglitazone (Avandia) to Risk of Myocardial Infarction&lt;/a&gt;)
                &lt;p&gt; 
                &lt;p&gt;The first such drug, saxagliptin (Onglyza), got the committee&apos;s nod yesterday in a 10-2 vote that its safety appeared acceptable.
                &lt;p&gt; 
                &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/13555&quot; target=&quot;blank&quot;&gt;Saxagliptin First Diabetes Drug to Pass FDA Cardiovascular Safety Review&lt;/a&gt;)
                &lt;p&gt; 
                &lt;p&gt;There is already an FDA-approved GLP-1 mimic, exenatide (Byetta). However, exenatide is administered twice daily, whereas liraglutide would be given once daily.
                &lt;p&gt; 
                &lt;p&gt;&quot;Once a day beats twice a day, hands down,&quot; said the panel&apos;s patient representative Rebecca Killian, from Bowie, Md.
                &lt;p&gt; 
                &lt;p&gt;A once-weekly formulation of exenatide is in development.
                &lt;p&gt; 
                &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/EASD/10830&quot; target=&quot;blank&quot;&gt;Once-Weekly Exenatide Equals Drug at Standard Dose&lt;/a&gt;)
                &lt;p&gt; 
                &lt;p&gt;Exenatide, which is very similar to liraglutide, has not been shown to increase cancer in human populations, said Mary Parks, M.D., an endocrinologist with the FDA. 
                &lt;p&gt; 
                &lt;p&gt;Liraglutide is also unique because it does not cause hypoglycemia or weight gain, said panel member Kathleen Wyne, M.D., Ph.D., an endocrinologist from Methodist Hospital Research Institute in Houston. Those are &quot;the two biggest concerns&quot; for type 2 diabetes patients, she said. 
                &lt;p&gt; 
                &lt;p&gt;An FDA analysis suggested the drug might actually contribute to weight loss.
                &lt;p&gt; 
                &lt;p&gt;The ultimate decision on approval is up to the FDA, which does not have to follow the advice of its advisory panels, but usually does. 
                &lt;p&gt; 
                &lt;p&gt;According to Dr. Parks, the agency seldom approves drugs that caused cancer in two different animals across both genders. 
                &lt;p&gt; 
                &lt;p&gt;&quot;A lot of drugs that have multicarcinogenicity are dropped during development,&quot; Dr. Parks said. &quot;It&apos;s very rare for them to be approved when they are multicarcinogenic and multigender.&quot;
    </recommendedItem>
    <recommendedItem id="20090101_19_1056"
                     title="FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/13619?impressionId=1265786174932"
                     
       WASHINGTON, April 6 -- Investigational antipsychotic drug sertindole (Serdolect) is effective at treating schizophrenia, but it may lead to sudden cardiac death, according to an FDA review. 
              &lt;p&gt; 
              &lt;p&gt;The agency released its review in advance of Tuesday&apos;s meeting of the Psychopharmacologic Drugs Advisory Committee, which will decide if the drug&apos;s cardiovascular risk is an obstacle to FDA approval. 
              &lt;p&gt; 
              &lt;p&gt;The advisory panel will also consider the sponsor&apos;s suicide prevention claim, and whether to recommend to the FDA that the drug is safe and effective. The vote will effectively amount to a recommendation of approval or denial.
              &lt;p&gt; 
              &lt;p&gt;Sertindole is already used in other countries to treat schizophrenia. 
              &lt;p&gt; 
              &lt;p&gt;According to the FDA review, led by psychiatrist Phillip Kronstein, M.D., sertindole is effective in treating schizophrenia, but concerns remain about the drug&apos;s potential to prolong the heart&apos;s QT interval, which can lead to sudden cardiac death. That same cardiac risk has been seen in other antipsychotic drugs similar to sertindole. 
              &lt;p&gt; 
              &lt;p&gt;Sertindole is a so-called atypical antipsychotic drug, Its specific mechanism appears to be to inhibit spontaneously active dopamine neurons in the mesolimbic ventral tegmental area without affecting dopamine neurons in the substantial nigra compacta. 
              &lt;p&gt; 
              &lt;p&gt;A recent study found that atypical antipsychotics carry a risk of sudden cardiac death similar to that associated with older schizophrenia drugs.  (See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/12453&quot; target=&quot;blank&quot;&gt;Risk of Sudden Death No Less Likely with Atypical Antipsychotics&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;Sertindole has been approved in the U.K. since 1996. But use of the drug was temporarily suspended after an online database indicated that sertindole might cause more deaths than risperidone (Risperdal). The drug&apos;s manufacturer, Lundbeck, agreed to perform a large randomized parallel-group study comparing all-cause death, cardiac death, and suicide for sertindole versus risperidone.
              &lt;p&gt; 
              &lt;p&gt;Based on results from that nearly 10,000-patient study, which did not show an increase in all-cause mortality with sertindole, the restrictions on the drug were lifted. 
              &lt;p&gt; 
              &lt;p&gt;But in Lundbeck&apos;s analyses to prepare for U.S. approval, the FDA reviewers didn&apos;t think the comparable all-cause mortality data was exactly a home run for sertindole, &quot;given the relatively higher mortality in this population from multiple causes,&quot; Dr. Kronstein said. 
              &lt;p&gt; 
              &lt;p&gt;More relevant are the cardiac deaths, in light of sertindole&apos;s connection to heart problems, he said. The FDA review found that patients taking sertindole had a significantly higher risk of cardiac death compared with those taking risperidone (&lt;em&gt;P&lt;/em&gt;=0.002). 
              &lt;p&gt; 
              &lt;p&gt;Thirteen patients died suddenly from cardiac causes in the sertindole group, compared with three who were taking risperidone. 
              &lt;p&gt; 
              &lt;p&gt;&quot;This is a significant and concerning result, indicating that sertindole-treated patients had an approximately five times higher risk of sudden cardiac death,&quot; according to the review.
              &lt;p&gt; 
              &lt;p&gt;The other major question for the committee is whether Lundbeck can justifiably claim that sertindole prevents suicidality better than other antipsychotic drugs.
              &lt;p&gt; 
              &lt;p&gt;Lundbeck has proposed to include such a claim in the product&apos;s label. In the company&apos;s trials, there were 14 suicide deaths among sertindole patients and 21 in the risperidone group.
              &lt;p&gt; 
              &lt;p&gt;But the FDA&apos;s staff review disagreed with the way Lundbeck examined suicide risk, and requested that the company analyze all suicide attempts instead of only those that succeeded.
              &lt;p&gt; 
              &lt;p&gt;According to the briefing documents for the meeting, this second analysis found that 46 patients attempted suicide during treatment and up to 30 days after in the sertindole group, compared with 62 in the risperidone group, with the difference failing to reach statistical significance.
              &lt;p&gt; 
              &lt;p&gt;The panel is to vote on whether the data show that sertindole reduces suicidality in schizophrenic patients.
              &lt;p&gt; 
              &lt;p&gt;As for the drug&apos;s efficacy in schizophrenia symptoms, two clinical trials have adequately proved the short-term antipsychotic efficacy of between 12 mg and 20 mg daily doses of sertindole, according to the FDA&apos;s Dr. Kronstein. 
              &lt;p&gt; 
              &lt;p&gt;There are no adequate and well-controlled data to address long-term efficacy, he said. 
              &lt;p&gt; 
              &lt;p&gt;The FDA does not have to follow the advice of the panels, but it usually does.
    </recommendedItem>
    <recommendedItem id="20090101_19_1073"
                     title="FDA Concerned About Expanding Quetiapine Use for Mood Disorders"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Psychiatry/Depression/tb/13635?impressionId=1265786174932"
                     
      WASHINGTON, April 7 -- An FDA staff review expressed worries about adding new indications for the antipsychotic drug quetiapine (Seroquel) because of increased risks for metabolic problems.
              &lt;p&gt; 
              &lt;p&gt;The drug&apos;s manufacturer, AstraZeneca, is seeking to have the drug approved for generalized anxiety disorder and major depression.
              &lt;p&gt; 
              &lt;p&gt;Quetiapine is currently marketed for treatment of schizophrenia, acute bipolar depression and mania, and for maintenance therapy of bipolar disorder as an adjunct to lithium or divalproex (Depakote).
              &lt;p&gt; 
              &lt;p&gt;The staff review was released in advance of this Wednesday&apos;s meeting of the FDA&apos;s Psychopharmacologic Drugs Advisory Committee, which will vote on whether to recommend approval for the new indications. 
              &lt;p&gt; 
              &lt;p&gt;Agency staff said that, while the drug has been shown to be an effective treatment for people with anxiety disorder and depression, expanding the drug&apos;s indication could put millions of additional patients at risk for metabolic and cardiovascular problems such as weight gain, diabetes, and sudden cardiac death.   
              &lt;p&gt; 
              &lt;p&gt;The FDA review team also said it was concerned about tardive dyskinesia, an involuntary movement that is considered an &quot;accepted risk in schizophrenia and bipolar patients,&quot; according to Thomas P. Laughren, M.D. director of Division of Psychiatry Products at the FDA. 
              &lt;p&gt; 
              &lt;p&gt;Atypical antipsychotic drugs such as quetiapine were thought to reduce the risk of tardive dyskinesia compared with older schizophrenia drugs such as chlorpromazine (Thorazine). But Dr. Laughren said AstraZeneca had not addressed the risks for tardive dyskinesia in the new patient populations covered by its application.
              &lt;p&gt; 
              &lt;p&gt;Quetiapine may also be associated with sudden cardiac death -- a risk seen in both atypical antipsychotics as well as older drugs. (See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/12453&quot; target=&quot;blank&quot;&gt;Risk of Sudden Death No Less Likely with Atypical Antipsychotics&lt;/a&gt;)
              &lt;p&gt; 
              &lt;p&gt;The FDA reviewers said these risks could likely be &quot;adequately characterized in labeling.&quot; They pointed out that the risks are not unique to quetiapine and are seen in the entire class of atypical antipsychotic drugs. 
              &lt;p&gt; 
              &lt;p&gt;But the analysis suggested stronger concerns about the metabolic effects.
              &lt;p&gt; 
              &lt;p&gt;In responding to the company&apos;s application, the FDA requested and received additional data from AstraZeneca on metabolic changes seen in its clinical studies.
              &lt;p&gt; 
              &lt;p&gt;According to the agency&apos;s analysis of that data, patients taking quetiapine gained an average of 2.6 pounds at 43 days median exposure, while the placebo group gained an average of less than half of a pound. There was some suggestion that weight gain increased over time. 
              &lt;p&gt; 
              &lt;p&gt;Patients receiving quetiapine also had a significant increase in fasting blood glucose and total cholesterol. 
              &lt;p&gt; 
              &lt;p&gt;AstraZeneca recently came under fire when court documents revealed that the drugmaker allegedly tried to minimize the risk of diabetes and weight gain associated with quetiapine in part by cherry-picking data for publication. (See: &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13064&quot; target=&quot;blank&quot;&gt;Negative Data on Seroquel Allegedly Suppressed by Drugmaker&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;According to the FDA review, three clinical studies proved quetiapine is an effective monotherapy, while two studies suggested the drug is an effective adjunctive therapy to an antidepressant. One study showed quetiapine is an effective maintenance therapy, according to the FDA&apos;s clinical review. 
              &lt;p&gt; 
              &lt;p&gt;The FDA does not have to follow its advisory panels&apos; recommendations, but it usually does.
       
    </recommendedItem>
    <recommendedItem id="20090101_19_1082"
                     title="FDA Panel Recommends Limited Use of Investigational Antipsychotic"
                     score="-0.005"
                     href="http://www.medpagetoday.com/Psychiatry/Schizophrenia/tb/13646?impressionId=1265786174932"
                     
       SILVER SPRING, Md., April 7 -- An FDA advisory panel voted to recommend FDA approval for sertindole (Serdolect) to treat schizophrenia, but only for a subgroup of patients that the agency would have to define.
              &lt;p&gt; 
              &lt;p&gt;The lukewarm backing came in part because of studies showing that patients taking sertindole were more than four times as likely to die suddenly, compared with another atypical antipsychotic, risperidone (Risperdal). 
              &lt;p&gt; 
              &lt;p&gt;In fact, the Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that the drug is not &quot;acceptably safe&quot; for the general schizophrenic population.  
              &lt;p&gt; 
              &lt;p&gt;But the panel unanimously agreed the drug is effective and then voted 8 to 2, with three members abstaining, that some patients might benefit from having sertindole as an option. 
              &lt;p&gt; 
              &lt;p&gt;The committee did not clearly identify those patients, however, leaving it to the FDA to decide which patients, if any, should receive the drug, manufactured by Lundbeck and currently marketed in other countries.
              &lt;p&gt; 
              &lt;p&gt;One panelist suggested that sertindole only be prescribed for schizophrenics who have not responded to other drugs, and another suggested performing cardiac tests to give some hint of whether a patient might be at increased risk for heart problems. 
              &lt;p&gt; 
              &lt;p&gt;&quot;I would hope this is a treatment of last resort,&quot; said Gail Griffith, M.S., the consumer representative on the panel.
              &lt;p&gt; 
              &lt;p&gt;Sertindole prolongs the heart&apos;s QT interval, which may lead to major cardiac problems, including sudden death. In the sponsor&apos;s trial, there were 13 sudden cardiac deaths among patients taking sertindole and three among patients taking risperidone (&lt;em&gt;P&lt;/em&gt;=0.002).
              &lt;p&gt; 
              &lt;p&gt;&quot;The cardiovascular risk is real, but I think that is counterbalanced by the need for other treatment,&quot; said Sheryl Kelsey, Ph.D., professor of epidemiology at University of Pittsburgh. Kelsey is a temporary member of the Cardiovascular and Renal Drugs Advisory Committee, which had three of its members voting on Tuesday&apos;s panel. 
              &lt;p&gt; 
              &lt;p&gt;Sudden cardiac death has been seen in other antipsychotic drugs similar to sertindole.
              &lt;p&gt; 
              &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/12453&quot; taraget=&quot;blank&quot;&gt;Risk of Sudden Death No Less Likely with Atypical Antipsychotics&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;The panel also swatted away Lundbeck&apos;s proposed claim that sertindole could help prevent suicide among schizophrenic patients. About half of all schizophrenic patients attempt suicide, according to the drugmaker. 
              &lt;p&gt; 
              &lt;p&gt;But the committee voted 12 to 1 that patients taking sertindole are no less likely to contemplate, attempt, or succeed in taking their lives, compared with those taking antischizophrenia drug risperidone.  
              &lt;p&gt; 
              &lt;p&gt;An FDA analysis found that 36 sertindole-treated patients attempted suicide, compared with 54 in the risperidone group, but the difference failed to reach statistical significance.
              &lt;p&gt; 
              &lt;p&gt;The efficacy data on which the panel based its vote came from the sponsor&apos;s trials involving more than 10,000 patients.
              &lt;p&gt; 
              &lt;p&gt;These studies adequately proved the short-term antipsychotic efficacy of 12- to 20-mg daily doses of sertindole, according to the lead FDA staff reviewer, psychiatrist Phillip Kronstein, M.D.
              &lt;p&gt; 
              &lt;p&gt;The FDA does not have to follow the advice of its advisory panels, but it usually does.  
              &lt;p&gt; 
              &lt;p&gt;(See: &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/Schizophrenia/13619&quot; target=&quot;blank&quot;&gt;FDA Review Questions Cardiac, Suicide Risks for Investigational Antipsychotic&lt;/a&gt;)
    </recommendedItem>
</recommendedContent>