Government Diabetes Study Increases Risk of Death Not Avandia

02/07/2008 10:54 PM |

In what one hopes will be the death knell for bloated one-size fits population approaches to designing individual treatment, the ACCORD study tried to see if getting everyone down to A1C level of 6 is better than a 7 when most diabetics have a tough time getting their A1C under control. Most people achieved the limit but in the process many high risk people who in the process of reducing their glucose levels suddenly died. The control group had fewer but more fatal heart attacks . That came with great effort on their part.

Some thoughts and observations:

1. After going through the 100 page protocol of the study and the ten year time frame you get the sense that if THIS is what comparative effectiveness research will look like, good luck. It will be a waste of time, money and effort compared to investing in research that attempts to figure out what is the best way to control or prevent disease in individuals.

2. Avandia is redeemed once again in a real world setting, such as it is. As the National Heart Blood and Lung Institute noted: Because of the recent concerns with rosiglitazone (Avandia), which is one of several medications used in ACCORD, researchers specifically reviewed data to determine whether there was any link between this particular medication and the increased deaths. To date, no link has been found. (For more on this issue, see http://public.nhlbi.nih.gov/newsroom/home/GetPressRelease.aspx?id=287 .)

3. But don't expect a mea culpa from Steven Nissen, the media or anyone else involved in this sorry story.

4. The Vice Chair of the Accord Steering committee? John Buse, the very same Buse that Senator Grassley and Rosa DeLauro are 'defending' against Dr. Yamada decade old criticism that Buse was way off base about the cardiovascular risks of....Avandia. Who owes who an apology?

5. Oh, The ACCORD trialists adjusted the protocols to ensure the trials met the endpoints. That is, it change how the trial was run to hit the A1C targets. Imagine if a drug company tried to do that!  Read More & Comment...

Lead, follow, or ...

02/07/2008 11:18 AM |

Check out today’s house editorial in the Washington Times, “Get out of the FDA's way.”

Some tidbits to tantalize your interest …

In respect to the FDA’s Critical Path program and the Reagan/Udall Foundation:

“A program to establish guidelines on how to use genetic tests called biomarkers to predict who responds best to cancer drugs could be delayed for months as the foundation scrounges for money. Worse, Rosa DeLauro is on record as claiming biomarkers are weak measures of a drug's effectiveness even as the director of the NIH National Human Genome Research Institute, Dr. Francis Collins, hails them as the next revolution in medicine.”

And as to where public opinion falls on this matter:

“Most Americans agree with Dr. Collins. A recent survey released by the Center for Medicine in the Public Interest found that nearly 90 percent of all Americans support the Critical Path Initiative and the development of biomarkers. But the congresswoman's attack on the FDA reflects poorly on both her political and scientific judgment. The FDA cannot meet its responsibilities if it has to protect itself from politicians like Rep. Rosa DeLauro.”

Here’s a link to the complete editorial:

http://www.washingtontimes.com/article/20080207/EDITORIAL/47442621/1013/editorial

It's worth a look.  Read More & Comment...

Crew Cut

02/07/2008 08:07 AM |

Page One story in today's New York Times on the continuing saga on Dr. Robert Jarvik and whether or not he can scull.

According to the story, "A newsletter published by the Lake Washington Rowing Club in Seattle describes how one of its rowers was a stunt double in the ad for Dr. Jarvik. The sculler, a professional photographer and rowing enthusiast named Dennis Williams, was picked partly for his size and partly because, like Dr. Jarvik, he has a receding hairline, according to the newsletter, which said a crew filmed the commercial for three days at Lake Crescent, near Port Angeles, Wash.

In the ad, Mr. Williams was shown as a solitary sculler navigating an unspoiled lake. Through deft editing, he appeared to be Dr. Jarvik. But, in fact, the frames that actually included Dr. Jarvik were shot in a rowing apparatus on a platform, according to the newsletter."

Yes, friends, it's "CrewGate."

Here's a link to the complete story:

http://www.nytimes.com/2008/02/07/business/media/07jarvik.html?_r=1&hp&oref=slogin

And here's what Dr. Jarvik had to say for himself, "I accepted the role of spokesman for Lipitor because I am dedicated to the battle against heart disease, which killed my father at age 62 and motivated me to become a medical doctor,” it said. “I believe the process of educating the public is beneficial to many patients, and I am pleased to be part of an effort to reach them.”

Yes, he's a real medical hero -- but he can't scull.

As to why the ad chose to make it look at though he could may be of interest to some -- but is it relevant? Obviously DDMAC didn't seem to think so.

And as far as "All the news that's fit to print," the article didn't point out that DTC advertising drives patients to ask their doctors about important health questions -- like high cholesterol, one of our nation's most under-diagnosed chronic diseases.

Also absent from the article is FDA research that disproves the myth that physicians prescribe a medicine just because a patient saw an ad on television. They don't. And of patients who visited their doctors because of an ad they saw and who asked about that prescription drug by brand name, 88 percent actually had the condition treated by the drug.

According to that same study, in 6 percent of DTC-generated office visits, a previously undiagnosed condition was discovered. Why is this so important? Because earlier detection combined with appropriate treatment means that more people will live longer, healthier, more productive lives without having to confront riskier, more costly medical interventions later on.

Coincidentally, the one word that links both hyperlipidaemia and sculling is ... stroke!   Read More & Comment...

Immune To Reason

02/06/2008 09:25 PM |

Think the latest study showing no connection between vaccines and autism will drive a stake through the heart through a sometimes vicious and violent movement that sought to replace science with emotional assertions?

Think again:

First this (and note the skeptical tone of the lamebrain reporter:

"A University of Kentucky chemist still thinks that a mercury-containing preservative in children's vaccines is behind rising rates of autism in youngsters, despite a recent California report that seems to dismiss the theory.

The California Department of Public Health reported that rates of autism have continued to rise in California, even though the mercury-based preservative thimerosal ostensibly was removed from most child vaccines by about 2001. Some scientists and medical groups are citing the report as disproving the theory that mercury in vaccines causes autism."

But UK's Boyd Haley, a mercury researcher and leading proponent of the mercury-autism connection, maintains that the California study proves nothing because it is based on a "false premise" that children in California haven't been getting any mercury from vaccines over the past several years.

...."They say that mercury was totally out of vaccines in 2001 ... and that's absolutely false," Haley declared.

Haley contends that some child vaccines still contained mercury preservative well after 2001, and that many children might have continued to receive the vaccines because California didn't actually enact a law banning them until 2006. If children were still getting mercury in vaccines after 2001, that could explain why autism rates didn't fall, Haley contends."

Never mentioned in the article is how reclassification of many behavioral diseases have been reclassified as autism, boosting rates.. The article gives "the other side" but barely. And it finishes with this precautionary note from pediatrician Erich Maul:

"Maul says research someday might conclude that mercury in vaccines can cause autism. But he says that evidence hasn't been found yet and that, for now, immunizations are essential to protect young children from serious infectious diseases.

I will continue to respect those parents who don't want it," he said. "But as someone who has a fourth child on the way, I guarantee you that she will be immunized. I've immunized all my kids, and I continue to recommend it."

For those looking for another source of speculation, scapegoating and sensationalism, David Mandell, an epidemiologist at the University of Pennsylvania medical school offer fields of gold. According to a recent article, Mandell "recently surveyed the adult patients in Norristown State Hospital in Eastern Pennsylvania, nearly all of whom are labeled schizophrenic, and found that about 20 percent of them meet the behavioral criteria for being autistic.

While he believes misdiagnosis in the past explains a part of the increase in autism numbers, Dr. Mandell also believes the growth has been too great to be accounted for just by continuing genetic abnormalities.

"The increase is probably too fast to be genetics," he said, "so there probably is something that is environmental, but there is nothing to suggest it's the vaccines."


Off we go.
http://www.kentucky.com/211/story/307394.html
http://www.post-gazette.com/pg/08037/854963-114.stm  Read More & Comment...

ScienceBoarding the FDA

02/06/2008 08:29 AM |

Terrific editorial in today's edition of the Wall Street Journal. And the title says it all, "The Real FDA Scandal."

It puts the FDA Science Board report into the appropriate context -- that despite all of the Congressional bloviating about the FDA "not doing its job," there's plenty of blame to go around -- much of it belonging to those same elected representatives who are the first to throw stones. And you know the proverb.

Here's a link to the complete WSJ editorial:

http://online.wsj.com/article/SB120225742208745785.html?mod=opinion_main_review_and_outlooks

"Scienceboarding" shouldn't be used to torture the FDA and score political points, rather the Science Board report should be recognized and utilized for what it really is -- a clarion call for appropriate budgeting, smart reform, and strong support for the Critical Path program and the Reagan/Udall Foundation.  Read More & Comment...

MapQuest Required for the Straight Talk Express

02/06/2008 07:00 AM |

Senator McCain's chief policy advisor, Douglas Holtz-Eakin, points out that, "The first responsibility of the next president will be to keep this country safe from an enemy that so despises us they would unleash any terror to cause us harm."

Amen.

So it remains a mystery why Senator McCain continues to support drug importation from other nations. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation (which according to the CBO would result in a national health care savings of less than one percent) would only facilitate such actions.

It's time for Senator McCain - truly the candidate with the best national defense bona fides, to rethink his position on drug importation.  Read More & Comment...

A Footnote on Dr. Lederberg and a Question

02/05/2008 10:51 PM |

Josh consulted extensively with biotech and drug firms. So apparently he would be barred by the likes of Daniel Carlat, Relman, Cassirer, Angell, Health Care Renewal bloggers and the Macy Foundation from any participation on FDA Adcomms or CME.

What is the difference between boycotting academics because of their affiliation with industry and boycotting academics because of their affiliation with Israel?

Is this isn't a looming crisis of academic and intellectual freedom, it will be.  Read More & Comment...

Joshua Lederberg Z''l His Memory Should Be A Blessing

02/05/2008 05:04 PM |

I met Joshua Lederberg four years ago when I was at the Manhattan Institute and was nominally the chair of the 21st Century FDA Reform Task Force. The idea for the task force was Dr. Lederberg’s and while he did not want to be chairman, he was it’s driving force. and it was conceived over lunch where I took notes as he spoke about using polymorphism and mechanistic pathways to improve not only the predictability of drug development and medicine but also the science governing reimbursement and legal proceedings shaping health care policy.

I had no clue what he was talking about. All I knew was that here was a Nobel Prize winner willing to spend time with me when he could be in his lab or lecturing. Over the next two years I met with Dr. Lederberg regularly, sometimes in his office, sometimes in his apartment where he made me lunch. Throughout he was too patient with me steep learning curve and too kind to say anything about the initial, rambling drafts of the Task Force report except “I admire your enthusiasm.”

Dr. Lederberg will be remembered for his endless contributions to molecular biology, to public understanding of medical progress and to the medical applications of the genome. Those who had the pleasure and honor of working with him will remember his kindness, his humility and his insistence on finding concrete answers to the difficult questions he often posed to Task Force members.

He once asked Peter (who was on the Task Force and my co-author): Is innovation possible? In posing that question, Dr. Lederberg (almost everyone called him Josh) simultaneously proposed the creation of a non-profit foundation that would fund the transfer of new knowledge of drug development to academics, entrepreneurs and others to accelerate biomedical innovation.

He passed away before that proposal was implemented. The last time I visited with him at his apartment I noticed a volume of Pirkei Avot, a chapter of the Mishnah, which is a compilation of ethical teachings of the rabbis of the Mishnaic period. One particular saying comes to mind: And "He [Rabbi Tarfon] used to say, it is not upon you to complete the task, but you are not free to idle from it. Joshua Lederberg, son of a rabbi, took that teaching to heart. It is now up to us to follow in his footsteps. Zichron l'bracha, his memory should be a blessing for us all.  Read More & Comment...

Forcing People To Choose

02/05/2008 01:25 PM |

Here is HillaryCare as far as I can figure it:

You will be forced to buy health insurance that buys coverage as defined by government and the premiums for that plan will be set by government. The only services and drugs covered by that plan will be those established by a government established Best Practice Institute.

And if you don't want this health care? Your wages are garnished. If you want to set up a health savings account to buy your own health care, in your own way? You can't. HSAs will be illegal under Hillarycare. So too under Obamacare.

I guess that's change.  Read More & Comment...

Senior Moment

02/05/2008 10:16 AM |

When talking with the media last week, Representative Henry Waxman had to be reminded what the Reagan-Udall provision was all about.

Must have been an, er, oversight.  Read More & Comment...

Trust Me, This Won't Hurt A Bit

02/05/2008 07:30 AM |

Here's another great example of comparative effectiveness translated into clinical practice.....This from AP..

"A group of doctors from New Jersey is opposing a plan by Aetna Inc. to drop coverage of a type of anesthesia used during colonoscopies.

Gastroenterologists and other doctors say patients anxious about colorectal screening may balk unless they are assured that their insurance coverage includes the cost of anesthesiologists who administer propofol, an anesthesia the doctors say is effective and comfortable.

"The idea should be to encourage these procedures because of their lifesaving ramifications," said John Fanburg, counsel for the New Jersey State Society of Anesthesiologists and the New Jersey Gastroenterology and Endoscopy Society...

As of April 1, the Hartford-based insurer plans to continue to routinely cover moderate sedation, but limit coverage of so-called monitored anesthesia care by an anesthesiologist to patients who are at higher risk due to illness or other complications.

"Propofol works faster, but whether it results in improved patient satisfaction is difficult to prove," said Robert McDonough, head of Aetna's clinical policy unit."

Translation: We will let you know when there is enough data and what is the definition of improved patient satisfaction. Aetna is telling patients that for $200 they can suffer and worry through their surgery and exam. By the way, if it's difficult to prove, why is the burden of proof on the patient, not Aetna, especially since it's our money?

That my friends is a great metaphor for evidence-based medicine. It's your money and your tuchus but someone else is telling you how the procedure is going to be done because it might save money though in the words of McDonough, whether it does "is difficult to prove."

But for the comparative effectiveness crowd, who see patients as mere cost centers, there is no complaining. Just bend over and take it.

Anti-intellectual freedom. Anti-consumer choice. Is achieving a pharma free, single payer system really worth all this loss of freedom?
http://news.yahoo.com/s/ap/20080205/ap_on_he_me/aetna_colonoscopy_sedation  Read More & Comment...

Thank You For Eating

02/04/2008 09:48 PM |

Why worry about obesity? Turns out it is a very good tool for saving money, along with smoking. So if I get this right, fast food and tobacco companies good because they save money. Drug companies evil because they extend life...
http://news.yahoo.com/s/ap/20080205/ap_on_he_me/obesity_cost  Read More & Comment...

Evidence Based Mediocrity

02/04/2008 09:15 PM |

Anyone who has taken a look at the recent research review Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer should say a prayer that the EBM thought police do not get control over the practice of medicine in America under the banner of cost containment OR conflict of interest. The "guidelines", if you can call them that, are drivel, essentially conceding two points: First, that patient and tumor characateristics heavily influence treatment selections and do so over the course of disease. Second -- and by extension -- that clinical expertise matters. But of course many oncologist with the best expertise fail the holier than thou COI standard imposed by those who hide their agenda under the purity banner (the capitalism=corruption=corrupt medicine coalition). As the panels to decide what is best practice are picked, you can be sure that their will be tribunals, inquests, witchhunts and general suppression of the ability of any one who consults with pharma or biotech companies, anyone who has a research contract or runs a clinical trial for a drug company will be purged of participation. This is nothing short than an attack on intellectual freedom as harsh and as unrelenting as anything seen in the sciences or liberal arts in recent years. And this is not a matter of forcing college kids to do research on reasons why Bush should be impeached. This boils down to a bunch of autocrats trying to dictate to the rest of us a politically correct form of medicine....

For a taste of force-fed medicine to come:

http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=rr&ProcessID=9&DocID=79  Read More & Comment...

Lending an Earmark for the Critical Path

02/04/2008 04:18 PM |

The President's new budget for the FDA allocates $68 million more for drugs and biologics in FY 2009. Backing out user fees which that's a real increase of $10 million. So core functions are finally getting user fee money and some real inflation adjusted increase. But it's not enough. That just allows the FDA to begin to dig into the science deficit years of political neglect have piled on the agency. There is still no additional money for Critical Path or other efforts that actually focus on improving the scientific integrity of the agency.

For starters we could take all the Ag Approp earmarks flowing into the the district of Rosa DelLauro who chairs that subcommittee and who has as her informal science advisers the anti-medical progress Center for Science in the Public Interest and Union of Conceited Scientists. DeLauro hogged $25.4 million in earmarks for herself last session while cutting funding for the Reagan Udall foundation that is established to help the FDA find ways to speed up the translation of basic research into personalized tools for testing cures for cancer and other illnesses that apparently can't be earmarked. DeLauro's earmarks are twice the increase the President has allocated for FDA core operations.

No that earmarks alone would be enough. I think we are coming to a time when the user fee program has outlived it's usefulness in its current structure. This last go round showed that user fee money is better used for Critical Path activities and that the user fee process dwells on the cause de jour to a more orderly and integrated oversight and funding of FDA operations. Maybe that's a starting point for everyone agreeing on a better, less political way to address the FDA's -- and the public's -- long term public health needs.  Read More & Comment...

But the President's Budget says "No"

02/04/2008 04:00 PM |

And speaking of surveys …

Another "survey" came out today -- the President’s budget proposal. No line for Critical Path – and, considering inflation, a decrease in federal appropriations for human drugs.

Here’s what Commissioner von Eschenbach had to say, ““This budget enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products.”

I don’t think so -- and Happy Talk isn't helping.  Read More & Comment...

Critical Path? America says "Yes!"

02/04/2008 07:19 AM |

A new national survey shows that Americans overwhelmingly support the FDA’s Critical Path Initiative. The survey was comprised of a nationally representative sample of 1,049 adults and conducted by Opinion Research Corporation. It was commissioned by the Center for Medicine in the Public Interest and iGuard Inc.

When asked about Critical Path, nine in 10 Americans expressed support. The Critical Path Initiative was launched by the FDA in 2004 to streamline drug development.

The survey also examined attitudes regarding key features of Critical Path. When asked about the FDA's efforts to expand the use of biomarkers to identify which drugs are best for individual patients, 78 percent of those surveyed were supportive.

The survey also found that 77 percent of the public supports partnerships between private companies, the FDA, and academics to create new approaches to drug evaluation and development.

And nearly 80 percent want their member of Congress to support Critical Path.

Survey respondents also expressed support for a voluntary, confidential, online portal where patients could share information about their reactions to different drugs. 87 percent said such a program would boost their confidence in drug safety, and 50 percent said they would take part.

Day in and day out, congressional lawmakers bash the FDA. That may score political points, but the public’s support for this program should send a strong message to Congress: Don’t cut funding from the Critical Path Initiative.

For the full report, click below

http://www.cmpi.org

And then under "Reports" click on "Critical Path National Research Report."  Read More & Comment...

Stone of Arc

02/02/2008 10:07 AM |

Yes, Virginia, while some media will exploit public health myths for their own venal purposes, others can play an important role in advancing the public health.

By now you are certainly familiar with the controversy surrounding the ABC program “Eli Stone” – where the title character (an attorney who has spiritual visions) goes to court to prove that childhood vaccinations cause autism.

Well, rather than piling on to the already crowded anti-pharma bandwagon, here is what the New York Times said in an editorial:

“Nevermind that such authoritative bodies as the Institute of Medicine of the National Academy of Sciences, the Centers for Disease Control and Prevention and the World Health Organization have found no evidence of a causal link. Nevermind that the incidence of autism continued to rise even after mercury preservatives were phased out of almost all childhood vaccines. As far as Eli Stone is concerned, you can’t just rely on science. Sometimes you have to go on faith.

The American Academy of Pediatrics tried unsuccessfully to get the episode canceled, fearing that it could deter parents from getting their children vaccinated, exposing them to far greater dangers from disease. Let’s hope that any parents who watched don’t make that mistake. And let’s hope that in future episodes, Eli Stone and ABC show better judgment in picking causes.”

Here is a link to the editorial in its entirety:

http://www.nytimes.com/2008/02/02/opinion/02sat4.html?_r=1&ref=opinion&oref=slogin

And James Oliphant (Baltimore Sun) points out that good television shouldn’t be driven by bad science:

"In a statement yesterday, the association’s president, Sherman “Tiger” Joyce, said the show has the potential to scare millions of parents away from having their children properly vaccinated against dangerous diseases.”

Joyce cited a report from the Center for Medicine in the Public Interest’s, which offers case studies of real-life personal injury lawyers endangering public health by disseminating unfounded information that convinces some people to avoid drugs or other medical treatments that could improve their health or even save their lives. Now, Hollywood’s latest make-believe lawyer is getting in on the act, too."

Here’s a link to the complete Oliphant piece:

http://weblogs.baltimoresun.com/news/politics/blog/2008/01/a_trial_lawyer_as_a_ood_guy.html

ABC needs a lesson on public responsibility -- and Eli Stone needs to lose his Joan of Arc complex.  Read More & Comment...

The Appearance of a Likelihood Can Be Associated With Suicidality

02/01/2008 06:12 PM |

Talk about tabloid medicine:

"On Nov. 20, 2007, FDA issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients. This is an example of FDA working with drug manufacturers throughout products' lifecycles to keep health care professionals and patients informed of new and emerging safety data."

No, this is an example of an agency that has been unfairly beaten to a pulp and is now trying to cover it's behind.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01788.html

Here's an idea: how about a science-based approach to the issue of smoking and suicide before we jump to any conclusions about broad effects based on "appearances"...

So for instance:

"Cigarette smoking is associated with a higher risk for suicide and attempted suicide, but psychopathological or biological explanations for this association have not been explored. Lower serotonin function and impulsive/aggressive traits are associated with suicidal acts, including completed suicide. The authors hypothesized that the relationship that may exist between cigarette smoking and suicidal behavior may be associated with lower serotonin function and the presence of impulsive/aggressive traits."

Rihmer Z, Döme P, Gonda X, Kiss HG, Kovács D, Seregi K, Teleki Z.

Cigarette smoking and suicide attempts in psychiatric outpatients in Hungary.
Neuropsychopharmacol Hung. 2007 Jun;9(2):63-7.

Or

"The presence of associations between prior smoking and subsequent suicidality, in concert with the lack of associations between prior suicidality and subsequent smoking suggests the existence of an independent pathway from smoking to suicidality."

Bronisch T, Höfler M, Lieb R.
Smoking predicts suicidality: Findings from a prospective community study.
J Affect Disord. 2007 Nov 14; [Epub ahead of print]

Or

"Current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, independent of prior depression and substance use disorders (adjusted odds ratio, 1.82; 95% confidence interval, 1.22-2.69). Additionally, current daily smoking, but not past smoking, predicted the subsequent occurrence of suicidal thoughts or attempt, adjusting for suicidal predisposition, indicated by prior suicidality, and controlling for prior psychiatric disorders (adjusted odds ratio, 1.74; 95% confidence interval, 1.17-2.54)."

Am J Psychiatry. 2003 Apr;160(4):773-9.
Cigarette smoking, suicidal behavior, and serotonin function in major psychiatric disorders.
Malone KM, Waternaux C, Haas GL, Cooper TB, Li S, Mann JJ.


Could Chantix be associated with increased suicidal behavior? Of course. But the key is to focus on what biological pathways would be implicated and identify people most at risk based on their illness, age, family history, etc. I hope Pfizer agrees. And I hope the FDA does too. I am not so sure about about tort lawyers, Senator Grassley, Public Citizen, George Soros or others who regularly dump on the drugwonks blog. They are too giddy about the presence of more pharma blood in the water and the opportunity perhaps to push another drug off the market even if it means -- because of the link between smoking and suicides -- more people dying. I would be delighted to be proven wrong on this latter score.  Read More & Comment...

The Media's Suicide Watch

02/01/2008 01:00 PM |

We add a new category to our posts called "Tabloid Medicine" so we can highlight instances where bloggers, trial lawyers, policians and the media sensationalize and distort medical risks in order to undermine trust in science or medicines.

So here we go again on how drugs being used to treat mental illness "cause" suicides:

Here's the worst offender: Fierce Pharma

"The FDA issued a sobering warning yesterday: the risk of suicide and suicidal behavior doubles for patients taking epilepsy drugs. Millions are--they're prescribed not only for the seizure disorder but for pain and psychiatric illnesses. The 11 drugs affected include such big-name meds as Pfizer's Lyrica, Abbott Laboratories' Depakote and OrthoMacNeil's Topamax."

First...the study, prompted by a lawyer suing Pfizer, looks at suicidal behavior and thoughts which are NOT associated with suicides. So my friends at FP are wrong. And to associate one drug with increased risk of suicide particularly in a patient population such as individuals suffering with bipolar disorders and comorbidities is just sloppy. But they are not the only ones as we shall see...

Second. Yes, the risk appears to have doubled. But from .022 on placebo to .043 if you are on an anticonvulsant. That means your chance of having nothing go wrong in terms of suicidal thoughts or behavior goes from 99.978 percent on placebo to 99.975 percent. Further, it is unclear from these studies whether patients were receiving other drugs. Most bipolar patients do not receive an anticonvulsant only. There is often combination with lithium, an antidepressant or other medications. So these studies by themselves are not indicative. A better question is what drug combination or what drug best reduces the risk of suicide among people with bipolar conditions.

Here's a much better approach to the subject from the NY Times

F.D.A. Finds Increase in Suicide Symptoms for Patients Using Seizure Medications

By GARDINER HARRIS and BENEDICT CAREY
Published: February 1, 2008

Drugs for epilepsy, bipolar illness and mood problems double the risks of suicidal thoughts and behavior, and patients taking them should be watched for sudden behavioral changes, drug regulators have said.

The increased risks, while double in relative terms, are small. The Food and Drug Administration undertook a combined analysis of 199 clinical trials with 43,892 patients and found 4 suicides and 105 reports of suicidal symptoms among the 27,863 patients who were given the drugs compared to no suicides and 35 reports of suicidal symptoms among the 16,029 patients treated with placebos.

Gardiner Harris and Bennett Carey play it straight and gives patients just the facts.

Good for them and the public.

http://www.nytimes.com/2008/02/01/us/01suicide.html?_r=1&ref=us&oref=slogin

And last and certainly least...we have one of those phony consumer webzines that are set up by and for trial attorneys to haul in clients with scary headlines. They include newsinferno.com which sadly Fiercepharma cites in their blog. This one is called consumer news weekly and it has fresh story about loved ones losing their lives due to suicides triggered by Topamax...
http://www.consumernewsweekly.com/

All we need now is a press release from Grassley's office or Stupak's calling for an investigation. But it's Friday.  Read More & Comment...

Part D: Enrollment Up, Costs Down

02/01/2008 08:25 AM |

The three-year-old Medicare Part D drug program is seeing the number of its enrollees climb, even as costs for the program fall.

"Overall, costs for beneficiaries and taxpayers are considerably lower than originally projections, enrollment continues to rise and customer satisfaction remains very high," Kerry Weems, acting administrator at the U.S. Centers for Medicare and Medicaid Services (CMS), told reporters.

According to Weems, the projected cost for Medicare part D is $117 billion lower over the next decade than experts estimated just last summer. "This means that over the 10-year period [from] 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion," he said.
At the same time, he reported, after the third open enrollment period that ended in December, the plan now has an additional 1.5 million people.

"Overall, there are about 25.4 million people enrolled in Part D," Weems said.

Most people surveyed today -- more than 85 percent -- are satisfied with the plan, Weems noted.

Can Part D be made even better -- absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda, but rather because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical intertventions -- which in turn reduces our overall national health care spending.  Read More & Comment...