Legal Liabilities

12/19/2006 10:08 AM |

There's been a lot of chatter lately about transparency -- especially when it concens conflicts of interest. And transparency is a good thing.

So why doesn't this same rule apply to, say, tort lawyers and professional medical witnesses?

Yes, as a matter of fact I do have some specific examples in mind.

The first is the justice-seeking tort lawyer featured in Alex Berenson's recent articles in the New York Times. His name is James B. Gottstein, and he is identified as "a lawyer who represents the mentally ill."

That sounds very altruistic. But is he working pro bono? If not, shouldn't the story have disclosed what his potential fee will be if he wins his pending cases? Would the public's perception of the story shift if full disclosure led to a more transparent descriptor for Mr. Gottstein that read, "a lawyer who represents the mentally ill in court cases asking for $25 million in damages of which he will receive a 25% contingency fee of over $6 million?"

I am making these numbers up -- I do not know if Mr. Gottstein is, indeed, working pro bono. I do not know what damages the lawsuits are requesting, nor do I know what his contingency fee is. Guess it's not part of "all the news that's fit to print."

Next example is Dr. David Healy. Dr. Healy recently testified at the FDA hearing on antidepressants. He is a psychiatry professor at Cardiff University in Wales but also, according to the New York Times, has worked for plaintiff's lawyers in cases brought against pharmaceutical companies. That's transparency. When I served as Associate Commissioner at the FDA, Dr. Healy visited with me -- but he never mentioned that he worked for the tort bar. That's dishonesty.

Transparency isn't a sometimes thing -- and if critics of industry and the FDA want more of it, they should do more of it themselves.

"Do as I say, not as I do" is not a workable policy -- a fact that should not be ignored by the MSM.  Read More & Comment...

Alex Berenson's Zyprexa Articles: Towards full disclosure about his sources

12/18/2006 11:41 PM |

It is misleading that Alex Berenson relies upon James Gottstein as the entire source of his two articles on Eli Lilly's marketing practices with respect to Zyprexa. I am not going to even dignify his writing by discussing the scientific basis of using atypicals for illnesses other than mania.

Berenson failed to let you folks you know that Gottstein is not just a "lawyer who represents the mentally ill." What follows are a sample of some of Gottstein's quotes, activities and associates you won't find in Berenson's scribbles....

"...Representatives of mental health and consumer advocacy groups from throughout the USA will hold a peaceful protest and press conference in front of the headquarters of the Pharmaceutical Manufacturers and Researchers of America (PhRMA). Protesters allege that, "The pharmaceutical industry has taken over the mental health system. And we want it back."

MindFreedom International is sponsoring the legal protest at 12 noon on Monday, May 2, 2005 at PhRMA; 1100 Fifteenth Street, NW; Washington, DC.

"Join us and tell PhRMA to stop supporting forced psychiatric drugging! Tell PhRMA to be truthful about the clinical trials and side-effects of the medications that their member companies are profiting from," said Krista Erickson, board member of MindFreedom International.

Another protest speaker, attorney Jim Gottstein of the Law Project for Psychiatric Rights in Alaska, said, "PhRMA represents the Big Lie of Big Pharma, which should be called to account for its despicable sacrifice of people on the altar of corporate profits."

"......Jim Gottstein has been practicing law in Alaska for 25 years, including being an attorney advocate for people labeled with serious mental illness. Among many other things, he served as plaintiffs' counsel in the billion dollar litigation over Alaska's theft of the one million acre Alaska Mental Health Trust. Mr. Gottstein now devotes his time pro bono to the Law Project for Psychiatric Rights (www.PsychRights.org) , whose mission is to organize a serious, coordinated legal effort around the country against forced psychiatric drugging....."

"While the idea of screening kids for mental problems seems like a good idea, it ends up being nothing more than a Drugging Dragnet," says Jim Gottstein

Gottstein is also part of a coalition of anti-psychiatric drug groups including the Scientologists....... http://psychdiagnosis.net/Archive/endorsers.htm  Read More & Comment...

Me in the Washington Times

12/18/2006 11:32 PM |

http://washingtontimes.com/functions/print.php?StoryID=20061217-102008-3698r

Undermining drug safety
By Robert Goldberg
Published December 18, 2006

Recently the Food and Drug Administration updated its warning on the use of oral sodium phosphate products (OSPs) as a cause of kidney failure. What are OSPs? If you had a colonoscopy as I did, you drank an OSP to clear the way for your inspection. In 1998, the FDA limited the OSP bottle size to no more than 90 ml. People were going into toxic shock and dying because they were told to use a bottle of the preparation and used a 240 ml jug instead of the 45 ml or 90 ml container. The FDA just updated warning labels about exceeding recommended doses since OSP-related kidney failure is still a problem.
It seems inconceivable that you or I could find a way to take lifesaving drugs and turn them into lethal weapons. But most drugs and devices wind up causing side effects because of the human inability to follow directions. Indeed, safety problems with drug-coated heart stents boil down to this: Don't put them in patients with really blocked arteries who stop taking clot-busting medicine. The fact is, coated-stent use will be restricted, as it is with many drugs and devices, because we can't be trusted to do as we are told.
This picture of incompetence clashes with the one politicians and the Institute of Medicine peddle to the media of an FDA and drug industry rushing to approve and market medicines without regard to product safety. But a Centers for Disease Control report found that misuse and overuse of a handful of old medicines cause most dangerous side effects. Hundreds of thousands of emergency-room visits occur because of adverse drug events. The CDC notes that "Sixteen of the 18 drugs most commonly linked to adverse drug events in the study have been in clinical use for more than 20 years." The most common drug classes were insulin, painkillers containing opioids, anticlotting drugs (including aspirin), drugs containing the antibiotic amoxicillin and cold remedies.
Yet, the media and politicians pick on pills that are well known rather than risky. Ambien is a classic example. Ambien became famous (or infamous) when Rep. Patrick Kennedy claimed he crashed his car because it caused him to drive while sleeping. Thereafter, Ambien became the target of major articles in the New York Times and Washington Post for being linked to sleeping while shoplifting, midnight snacking, etc. In fact, as the folks at blogcritics.org point out: "In 2004, over 24 million prescriptions for Ambien were written. Let's say that each contained 30 pills. That's 740 million times people took this sinister drug in 2004. Timothy Morgenthaler, a Mayo Clinic researcher, reported five cases of sleepwalking in 2002. Nineteen cases were reported by one center last year. Since 1997, a whopping 207 sleepwalking incidents have been reported, most of which physicians can't link to Ambien. In fact, only 48 have been linked to this killer drug.
"It's well known that adverse incidents are under-reported, so let's assume a factor of 100... That's 4,800 incidents over, say, 8 years or 600 a year. No wonder it got banner headlines. But wait. The drug is used 740 million times a year, which means your odds of sleepwalking from using the drug are 0.00008 percent or something like 1/80,000th of a percent."
Sen. Charles Grassley wants to withdraw an antibiotic called Ketek. His evidence? The drug -- used to treat sinus infections, bronchitis and treatment-resistant pneumonia -- was approved on the basis of the nearly a decade of clinical trials, the drug's five-year safety record in Europe and a 25,000-patient study in America that unfortunately involved one doctor who faked results for about 300 patients. (The doctor was sent to prison and the results discarded.) Some claim the approval ran roughshod over time-honored FDA standards and explains why there are 23 reports of liver injury associated with 10 million Ketek prescriptions since 2003.
In fact, the FDA can approve a drug with the results of one clinical trial and prior experience with a drug. Antibiotics with amoxicillin are more likely to cause liver problems than Ketek. Acetaminophen is the most common cause of liver failure in the United States. The FDA, more concerned about drug-resistant bacteria than are fact-resistant senators, is keeping Ketek on the market.
We have defined down drug safety. What used to be our responsibility is now blamed on a FDA-industry conspiracy. We blame shoplifting and car crashes on Ambien, not on reckless behavior. Suicide, a tragic mystery, is suddenly the result of Prozac-type anti-depressants. Heart attacks are now caused by Vioxx, not by hypertension and smoking. No wonder the current FDA reform bill requires restrictions on the use of every drug that make OSP limits look like child safety locks. We want our drugs -- and our tacos -- to be 100 percent safe. They can be, if we stop making medicines available altogether. I am afraid we are already there.  Read More & Comment...

Health Care Priorities Down Under are Upside Down

12/18/2006 07:12 AM |

Last Friday (12/15) I participated on a joint CHI (California Healthcare Institute)/PRI (Pacific Research Institute) panel called "Evidence, Economics, and Politics: Australia's Experiment in Evidence-Based Medicine."

My fellow panelists included Ruth Lopert (Harkness Fellow in Health Care Policy, George Washington University, and a member of the Pharmaceutical Policy Taskforce, Commonwealth Department of Health and Aging, Canberra, Australia), Marjorie Ginsberg (Executive Director of Sacremento Health Care Decisions), Kwabena O.M. Audbofour, MD (a GP from Stockton, CA), Meryl Comer (journalist and Alzheimer's care giver), and Randy Frankel (VP, Public Affairs, IMS Health).

We used the new IMS report, "Australia’s Centralized Cost-Effectiveness Requirement for Pharmaceuticals: Potential Implications for U.S. Patients" as our point of departure.

Consider the facts and be afraid – very afraid – of the implications.

The IMS study included examination of osteoporosis and Alzheimer’s, where Australians are regularly denied access to medicines available to American patients. According to the new IMS study:

* By 2007, approximately 9.1 million patients in the United States with osteoporosis would be denied access to treatment choices if we adopted the Australian model of cost-based (aka, “evidence-based”) medicine. In Australia, for example, newer medicines for osteoporosis that are not “on the list” for reimbursement may be made available only after a patient suffers a fracture.

* IMS estimates that a 1.6 million Alzheimer’s patients could be impacted if we adopted the same system as Australia. The Aussie guidelines are identical for Aricept (donepezil), Exelon (rivastigmine), and Razadyne (galantamine) – and are highly restrictive compared with US guidelines. Australia also limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.” In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.”

Restrictive formularies that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.

The IMS report can be found at http://www.cmpi.org

CHI will be posting a series of podcasts from the event. When these are available, we will call it to your attention. In the meantime, g'day mate.  Read More & Comment...

Me in the Weekly Standard

12/18/2006 12:59 AM |

My article in the Weekly Standard on the Democrats disastrous Medicare plan entitled
Hillarycare is Back...Here's the link for anyone who cares to read it....HillaryCare Comes Back  Read More & Comment...

Ketek Kurtailed

12/18/2006 12:31 AM |

As some predicted...the joint advisory committee decided to recommend against using Ketek for sinus infections and bronchitis but leave it available for pneumonia. That's a distinction with some clinical difference but not always since at what point do you being antibiotic treatment to prevent pneumonia once you know the source of the community acquire strain of the infection? Do you simply withhold a Ketek type drug in stanching other types of infections leading up to pneumonia that are resistant to other drugs? So my guess is that there will be some retooling on the label....


As for non-inferiority trials...shame on those who call it a lower standard of approval..it is not..it is a different way of obtaining information on effectiveness and it has emerged in recognition of the existence of many new therapies that affect survival or serious morbidity, and that therefore cannot be denied patients by dumping some folks into a placebo group. So that means some people get the standard treatment and others get the new drug...isn't that what Waxman and others who are screaming about non inferiority trials with Ketek have been bitching they want more of? Or am I confused? Or are these pols so hopelessly hypocritically and twisted in knots in order to posture fot the media they don't care or is that they don't even know what an inferiority trial is or consists of? Oh, and it is not a test tube test as one ex-FDAer derided it... And let's not forget it is the basis by which many HIV and cancer drugs are approved...OK? This is what having the David Grahams of the world embedded in CDER review teams -- as the IOM in their finite wisdom has proposed -- would get us....the elimination of active controls;single well controlled trials with confirmatory evidece; creeping Grassleyism at time when personalized medicine should be bustling right along....

As Peter as noted, this is an example of the FDA just not doing a good enough job explaining what they do and how they do and the media letting blowhards like Graham distort science.... Note to Grassley...an epidemiologist does NOT conduct clinical trials or review them or know anything about infectious disease or see patients, particularl if that epidemiologist is David Graham. Rather, he just plays with his large database until he gets attention.  Read More & Comment...

Eye on .. CBS

12/16/2006 02:03 PM |

CBS Reporter Takes Swipe at Drug Industry, Praises Politician in Blog Post
Armen Keteyian lamented 'Big Pharma's' 'control' over Americans.

By Ken Shepherd
Business & Media Institute

“What can be done to break Big Pharma’s growing control of our minds and bodies? I wish I knew,” a critic of the pharmaceutical industry wrote recently on a media blog. But the author of that post was an ostensibly unbiased investigative journalist: CBS correspondent Armen Keteyian.

Network blogs can be a valuable, unfiltered look at reporters’ biases, and Keteyian’s December 14 post to CBS’s “Primary Source” was no exception.

“No matter how you slice it Wednesday was not a great day for the FDA,” Keteyian began his blog post, recounting how the December 13 “Evening News” presented “back-to-back stories” on a new FDA warning label for antidepressants and congressional criticism of FDA’s handling of Ketek, an antibiotic that can result in liver damage to some patients.

While December 13 might not have been FDA’s finest hour for public relations, the CBS reporter failed to account for how his bias could color his perceptions.

Keteyian, a former sportscaster, peppered his blog post with more anti-industry commentary, insisting that “Big Pharma seems in control [of] much of Congress, or at least its legislative agenda” before praising Iowa Republican Charles Grassley as a “straight-talking” senator who has “stood up and called out” pharmaceutical companies.

As the Business & Media Institute documented on December 14, CBS presented a decidedly sensationalistic look at the FDA’s decision to require a “black box” warning on drugs like Paxil and Zoloft when prescribed to patients up to the age of 25. In that December 13 report, Keteyian’s colleague Sharyl Attkisson focused heavily on the grief of distraught widows of suicidal patients while finding no air time for expert medical testimony.

Of course, medical experts such as NBC News’s chief medical editor Dr. Nancy Snyderman have noted that many psychiatrists find medication a crucial part of treating depression for some patients, albeit one with risks that require careful monitoring.

That dose of reality is a bitter pill to swallow for Keteyian, who lamented in his blog post that “America is a drug dependant [sic] nation” that takes pills “for just about every illness known to man or woman.”

What's the frequency ... Armen?  Read More & Comment...

Behind the Breast Cancer Decline

12/15/2006 10:05 AM |

If you want to begin to understand why breast cancer rates declined so suddenly in 2003 -- and remember we are three years behind the reporting curve -- read Tara Parker-Pope's definitive article in the WSJ:

What Made Breast Cancer Decline in 2003?

The Wall Street Journal

USA, 12/15/2006 - After rising for two decades, the number of women diagnosed with breast cancer fell in 2003 by a stunning 7%.

The reasons behind the steep drop -- which translates to about 14,000 women who didn't get breast cancer that year -- aren't entirely clear. Changes in medication use, including a sharp decline in women taking menopause hormones and increased use of calcium supplements and anti-inflammatory drugs, may all have played a role. A 3% drop in mammography screening among menopausal women in the same year could also help explain why fewer breast cancers were found. "

Yes Virginia, our crazed friends at Breast Cancer Action have done a wonderful job of scaring people away from getting mammographies...

Tara takes on the issue of whether the decline in estrogen use is the sole cause, a view most other articles have been pushing despite the fact that not all breast cancers express the same way:

"One possible explanation for the decline in 2003 is that it is tied, at least in part, to the July 2002 release of the Women's Health Initiative study of estrogen and progestin, which linked the hormones with heart attacks and breast cancer in older women. The WHI, which studied Wyeth's estrogen-progestin drug Pempro, scared millions of women into stopping menopause-hormone therapy almost overnight. Since the WHI announcement, menopause-hormone use has fallen by about 30%."

However...

"While the decline in hormone use between 2002 and 2003 was dramatic, it is unlikely that hormones explain the entire drop because the incidence of ER-negative cancers -- or those that weren't boosted by estrogen -- also declined. As a result, researchers are looking at other changes during the time period that could help explain the overall drop in breast cancer. "

And then there are those horrible COX-2 drugs that David Graham proudly help push off the market:

"Other medications may also have played a role. A separate WHI observational study of more than 80,000 women showed that those who used anti-inflammatory drugs for at least five years had a 20% lower risk of breast cancer. In the U.S., prescriptions for popular anti-inflammatory drugs called Cox II inhibitors more than doubled between 1999 and 2003, according to IMS Health, which tracks pharmaceutical sales data. "

And Graham's lawyer got ticked off because I questioned Graham's judgement?

"Another explanation may be the increased use of the drug raloxifene, which is sold by Eli Lilly & Co. as Evista and was approved for the treatment of osteoporosis in 1999."

In sum, Parker-Pope's multi-factorial analysis is excellent and embodies the gold standard of medical reporting.....  Read More & Comment...

Science 2 Scaremongers 0

12/14/2006 08:52 PM |

From the WSJ....The Food and Drug Administration won't call for major changes to the safety labeling for the Sanofi-Aventis SA antibiotic Ketek, but a public meeting today is expected to highlight debate over the agency's handling of the drug.
The agency's newest views about Ketek became public in documents posted in advance of a gathering today and tomorrow of an advisory committee that is expected to weigh safety concerns tied to the drug, along with evidence for its efficacy.

From the WSJ

The Food and Drug Administration's plan to expand warnings about a link between antidepressants and suicidal thoughts and behavior to include young adults is sparking strong push-back from psychiatrists. That, in turn, raises questions about how wide an effect the change would have on prescribing patterns.
Yesterday, the agency proposed to add adults younger than 25 years old to the at-risk groups mentioned in the strong "black box" warning on the labels of antidepressant drugs. Currently, the warning says the medicines "increased the risk" of suicidal tendencies in children and adolescents in studies. But the FDA said its analysis shows the pattern reversed itself for people older than 30, and particularly for those over 65, for whom the drugs were associated with a protective effect against suicidal behavior, a point the agency also plans to add in the black box.
The FDA also reiterated the need for doctors to carefully monitor patients taking antidepressants for the emergence of, or increase in, any suicidal tendencies.
An FDA advisory committee, meeting yesterday, endorsed the agency's latest proposal by a 6-2 vote. But it also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions.

The FDA played it straight with the data and the advisory panel reflected clinical concerns as opposed to the shrieks of the crazies....

Shame on on the shameless Shankar Vedantam of the Washington Post who continues to continue space and legitimacy to the Sciento-illogical soundings of Alliance for Allen Life Form Protection....They still pump out the sewage that there is no biological basis for mental illness, the same crap Tom Cruise dumped on Matt Lauer. It reduced TomKat to a laughing stock. It gets the Alliance more coverage from Shankar...Is there any editorial oversight at the Washington Post?  Read More & Comment...

The TPDTCAPMDSA

12/14/2006 07:58 PM |

That's the acronym for the new agency to replace the FDA.

It stands for the Taco Purity and Direct to Consumer Advertising and Post Market Drug Safety Administration.

The basic functions of the agency will to ensure that the essential public health questions of the day...accuracy of TV drug ads, the conduct of decade long post market drug studies and taco integrity are funded -- not by user fees so as to avoid an corruption by industry -- but by the taxpayer. I mean, with the rise of internet and email and blogs, the agency will need at least 100,000 staffers to police every single communication and post alone. And think of the new inspectors it will need to insure the safety of the taco discovery and development process.....

Drugwonks wants to thank Senators Schumer, Clinton, Kohl, Grassley and Congressmen Waxman and Markey for focusing the public's attention on this urgent issues.  Read More & Comment...

False Negatives

12/14/2006 11:28 AM |

The GAO report on DTC is so chock-full of half-truths that it is breathtaking to behold.

Consider this subhead (page 14 of the report), "Research Suggests DTC Advertising Increases Drug Spending and Utilization." Now to the casual observer (read here "politician" or "many journalists") that means the same thing as "DTC Advertising Increases the Cost of Drugs."

Not so.

It's a GAO solipsism.

A more accurate statement would be that DTC advertising drives patients to their doctors who, in turn, reach a diagnosis and then appropriately prescribe. That DTC helps patients and their physicians diagnose an existing medical condition earlier than might otherwise occur is a tremendously positive and potent public health service.

Is that statement in the GAO report? Nope.

Also, if more people are being appropriately prescribed more medicines -- then , indeed, we will as a nation be spending more on pharmaceuticals. But the GAO report makes this sound like a nepharious scheme. And don't be surprised if this theme is taken up by the usual suspects.

What's interesting is that the GAO doesn't report that, if you look at the "list" price of all the on-patent drugs within a given therapeutic category (which almost nobody pays) and then look at their individual advertising spends, what you will not find is a causal relationship. Oops.

And it's very disturbing that the GAO report didn't even consider FDA's research on DTC and physician prescribing patterns. What the FDA found was that physicians are NOT inappropriately prescribing medicines just because their patients ask for them.

But why worry about facts when you've got rhetoric on your side.  Read More & Comment...

Ad Infinitum

12/14/2006 08:01 AM |

The Government Accountability Office’s new report on DTC states the obvious -- the FDA lacks an effective way to screen, review and track pharmaceutical advertising.

Considering that more than 10,000 ads and Web sites are brought to the agency's attention each year, that DDMAC has but six reviewers, and that the PhRMA DTC guidelines recommend that ALL advertising be submitted for review – makes us underwhelmed by the GAO’s prescience and wisdom.

Once again drugwonks says, “show me the money.”

In a draft of a letter to be sent today to the White House, Senator Herb Kohl, D-Wis., asks President Bush to give the FDA more money to review and regulate direct-to-consumer ads. Kohl, along with Republican Sens. Bill Frist of Tennessee and Charles Grassley of Iowa, requested the GAO report.

''If we are serious about protecting the health of consumers in our country, then we need an FDA capable of reviewing ads and taking swift action when necessary. This report tells us that were nowhere close to that goal,'' said Kohl, who will become chairman of the Senate panel with jurisdiction over the FDA budget.

Hello PDUFA!

Letter Imperfect

On the same topic, the GAO report comments that the FDA is sending out fewer DTC-related NOVs.

Indeed, Waxman Redux.

But the truth is that you can’t count letters and say that enforcement is better or worse. It may just as well be the case that pharmaceutical companies are being more compliant (in a regulatory sense) – as could easily be predicted since the FDA has been more precise in detailing (you should excuse the expression) what “in compliance” means. Not precise enough – but better than before.

GAO also reports that the FDA is taking longer to send out letters. This issue is more complicated, but the bottom line is that sending out poorly lawyered letters more swiftly is a fool’s errand.

Unfortunately, there are a lot of fools out there. Fools on the Hill.  Read More & Comment...

Ten Most Promising Treatments

12/13/2006 10:56 PM |

Excellent article in Scientific American.......

Special Report: 10 Promising Treatments for World's Biggest Health Threats


Cutting-edge pharmaceuticals now being tested could revolutionize the fight against cancer, Alzheimer's, HIV, diabetes, nicotine addiction and other devastating diseases


By Charles Q. Choi


Treatments for diabetes, smoking, Alzheimer's disease and lung cancer are just a few of the potentially lifesaving cures Scientific American has chosen to highlight in this year's roundup of drugs you've never heard of, despite their potentially huge impact on global health.

These 10 treatments, all of which could significantly impact global health and wellness, are currently running the last gauntlet a pharmaceutical must run before it becomes available to the public--the clinical trial. During this trial researchers test the drug on humans, carefully observing its side effects as well as its overall effectiveness.

All of the following substances have already passed phase I safety trials and are proceeding into phase II or III efficacy and toxicity trials. (One caveat: any therapy in development runs a risk of failure, even after passing phase III.)

A number of these trials represent completely novel classes of therapy, such as employing fragments of RNA that interfere with problem genes or developing vaccines meant to quell drug addiction.

Some of this year's candidates target the usual rogues' gallery of killers, such as malaria, lung cancer and HIV.

Many of the disorders targeted by the following treatments are becoming increasingly widespread. These disorders include diabetes, which the Centers for Disease Control and Prevention projects will someday afflict one in three children born today; Alzheimer's, which has become more common as life expectancy has increased; and the dengue viruses, which are causing larger and more frequent epidemics, especially in the tropics.

One of this year's drugs even has the potential to serve as a safer replacement for the painkiller Vioxx.

The link to the entire article and the list of all the drugs in development (until price controls or IOM like FDA reform proposal kill them off) here

http://www.sciam.com/print_version.cfm?articleID=7271FB84-E7F2-99DF-38227214BDE0DE78  Read More & Comment...

The Real Number of Consumers Choosing Consumer Directed Health Plans

12/13/2006 09:32 PM |

The Commonwealth Fund -- why don't they just call themselves the Single Payer Society and get it over with? -- claims there are only 1 million people in consumer directed health plans, that most of them were forced into them at gunpoint and all of them just hate being in them (as opposed to be in a Canadian paradise or something like Medicaid). The Fund ignores data from various plans including UnitedHealth Group showing patients under high-deductible health plans with a health savings account (HSA) are more likely to seek preventive care and are far less likely to visit emergency rooms for non-emergency care.

Moreover, it turns out that half of all people without insurance have chosen to go without despite having been offered it by their employers or by a state run health program. Now that's really consumer directed health care.  Read More & Comment...

Shame on the Scaremongers

12/13/2006 08:39 PM |

On the heels of the hysteria about anti-depressant, suicide and black boxes....


Genes May Alter Antidepressant Effects
Study May Help Find Way to Select Antidepressant Most Effective for Patient
By Miranda Hitti
WebMD Medical News Reviewed By Louise Chang, MD
on Wednesday, December 06, 2006

Dec. 6, 2006 -- Variations in certain genes may affect how well depressed people respond to different antidepressants, new research shows.

The report comes from Francis McMahon, MD, of the National Institute of Mental Health (NIMH).

"Medications to treat depression are widely available, but no one treatment works for everyone," McMahon says in a news release

There is no test to predict which of the various antidepressants will work best for a particular patient. It can take trial and error over weeks or months to find the right one.

"We are seeking to better understand why this is the case, and, using genetic markers, develop personalized treatments that give patients the best chance at remission," McMahon says.

"Ultimately, our goal is to put together a panel of genetic markers that can guide treatment decisions and help doctors choose an antidepressant that will work best for an individual patient," he says.

That panel of genetic markers isn't complete yet. But McMahon's findings may help."

And there is this comment....

"There is a heritable component to suicidal behaviour, encouraging the search for the associated risk alleles. Given the putative role of the 5-HT (5-hydroxytryptamine; serotonin) system in suicidal behaviour, serotonergic genes are leading candidates. "

Psychol Med. 2003 Jul;33(5):775-83. Links
Deliberate self-harm is associated with allelic variation in the tryptophan hydroxylase gene (TPH A779C), but not with polymorphisms in five other serotonergic genes.  Read More & Comment...

Emotion or Science?

12/13/2006 08:52 AM |

According to a report in today's New York Times, "Public health officials, psychiatrists, grieving parents and outraged former patients will fill a hotel ballroom in Silver Spring, Md., this morning to argue the most bitterly divisive question in psychiatry: do the drugs that doctors prescribe to relieve depression make some people more likely to attempt suicide?"

I was at the agency the last time this debate took place. Very emotional. But emotions mustn't get in the way of the facts. Politicians love emotions. The media loves emotions. But science demands facts. Hard facts. Facts that may not tell people what they want to hear.

And anecdotes, even terrible ones, are not science. In June we blogged on a major new study, the first of its kind, finds that rather than boosting suicide rates, SSRIs have actually saved thousands of lives by preventing suicides since they were introduced in 1988.

And before you ask, no, the study was not funded by a pharmaceutical company. The funding came from the NIH and the Dana Foundation. The full study appears in the June issue of the journal PLos Medicine.

For this study, the authors analyzed federal data on suicide rates since 1960, along with sales of fluoxetine (Prozac) since it became available in 1988. Analysis was continued through 2002. Prozac was used as a benchmark for the broader class of drugs.

Between the early 1960s and 1988, suicide rates held relatively steady, fluctuating between 12.2 per 100,000 and 13.7 per 100,000.

Since 1988, however, suicide rates have been on a gradual decline, with the lowest point being 10.4 per 100,000 in 2000. During the same time frame, Prozac prescriptions rose, from 2,469,000 in 1988 to 33,320,000 in 2002.

Using mathematical modeling, the investigators estimated the rates of suicide if the pre-1988 trends had continued, estimating that there would have been an additional 33,600 suicides if the pre-1988 trends had been maintained.

With that in mind, moves to restrict the use of SSRI antidepressantscould have a harmful effect, the authors stated.

“I don’t think these claims that antidepressants increase suicide have a solid base,” said Dr. Julio Licinio, lead author of the study and Chairman of the Department of Psychiatry and Behavioral Sciences at the University of Miami.

“If you have a drug that’s supposed to be causing something, the more of the drug that’s used, the more of the bad outcome you would have. What we show is the converse.”

While this new science will provide little solice to those who have suffered through a suicide, it will help mental health professionals, their patients — and their patients’ loved ones — better understand the value of available therapies.

I grieve, I truly do, for the parents and spouses, friends, and relatives who have lost loved ones to suicide. And their grief is beyond my comprehension. But warping the science to fit anyone's emotional needs is just plain wrong. Hopefully this hearing will be held and reported on based on the science.

But I doubt it. Let's see what tomorrow's news stories focus on. Will the reports focus on the anecdotes of families or the science of anti-depressants? We shall see.  Read More & Comment...

Medicare's Muddled Ground: From the Mind of Pete (Raving) Stark

12/12/2006 07:32 PM |

Pete (Raving) Stark has announced that Democrats will seek a middle ground on pharma and biotech price controls in Medicare Part D next year. No government run plan to compete with private plans says the Stark. That would be perceived as too radical.

"That might draw a veto and then get us accused -- which I don't mind, but most of my colleagues do -- of price-setting and all that. … There's a hesitancy to seem too radical."

Instead, the D's will just instruct the HHS Sec'y to squeeze companies for the VA price and then run and tell Congress what a bunch of price gougers they are relative to what they are charging seniors in the private plans. Drugwonks is sure there won't be any penalties or punishments available for not bringing companies to heel....

And in the hypocrite department...

Stark said he also wanted to reduce the number of private plans available to seniors.

There are now 40 or more plans operating in many markets; Stark would like to reduce that to 15 or 20.

Let's travel back in time to January 2003 and listen to Minority Leader Pelosi on the issue of choice in Medicare:

"In his State of the Union Address last night, President Bush emphasized the importance 'choice.' I agree. Choice is important.

"However, under the President’s plan, our senior citizens may no longer have the choice to go to their own doctor. Seniors may no longer have the choice to fill their prescriptions at their local drug stores. This is particularly harmful to seniors who live in our rural communities."

Drugwonks notes that the reason there are so many plans is that particularly in rural areas you need lots of plans competing to include networks of local pharmacies. But apparently Raving Stark thinks he knows exactly what amount of choice is just right for seniors -- now and in the future, along with what prices will bring forth the appropriate medicines.  Read More & Comment...

More Haiku

12/12/2006 04:35 PM |

Gottlieb is leaving.
Expanded access growing.
Hello PDUFA.  Read More & Comment...

Gray Lady on Gray Market

12/12/2006 01:31 PM |

Editorial from today's edition of the New York Times:

Editorial
Fighting Drug Fakes
Published: December 12, 2006

Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.

In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.

In Panama, dozens of people died after taking counterfeit drugs made with an industrial solvent. Often counterfeiters put in real ingredients for their smell or taste, but heavily diluted. This has sped the emergence of resistant strains of infections, and is probably a big reason some malaria drugs and antibiotics have lost their power.

Drug counterfeiting can be fought. Five years ago, the majority of Nigeria’s drugs were fakes, and the country was a major source of counterfeits abroad. When the Nigerian government donated 88,000 doses of meningitis vaccine to Niger during an epidemic in 1995, the vaccine turned out to be a fake — causing more than 2,500 children to die.

Now the possibility that a drug is fake in Nigeria has dropped to 17 percent, according to the World Health Organization. The country’s drug control agency is informing people through radio and TV jingles about fake medicines. It has also fired corrupt officials, hired a fleet of inspectors to drop in on pharmacies, banned imports from some 30 companies, and begun prosecuting counterfeiters.

One of the problems Nigeria still faces is that the penalty for counterfeiting medicine is as little as a $70 fine — a small price to pay for a crime that can reap a fortune. All over the developing world, governments treat falsifying medicines as a mere copyright infringement, rather than potential murder.

The W.H.O. has recently set up a task force that brings together many groups that work on counterfeit drugs. It is a start. Multinational drug companies — which have been reluctant to report fakes lest they erode consumer confidence in all drugs — need to do more. An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.

Wonder if Senator Vitter will put a "hold" on his subscription to the Gray Lady?

All the news that's fit to print. Amen.  Read More & Comment...

Expanding Expanded Access

12/12/2006 07:53 AM |

As Jennifer Corbett Doore of Dow Jones reports, "The Food and Drug Administration proposed new regulations Monday that the agency hopes will provide broader access to experimental drugs for seriously ill people who have exhausted all other commercially available treatments."

""This proposed reform is carefully designed to balance several objectives," said FDA Commissioner Dr. Andrew C. von Eschenbach. "One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market."

Janet Woodcock, the FDA's deputy commissioner for operations, explained that large patient groups with cardiovascular diseases, cancer and HIV have long been able to access drugs that are currently being developed and are in clinical trials. However, outside of clinical trials, FDA regulations have been confusing and potentially a barrier to small groups and individual
patients who want to receive access to experimental treatments. The new regulations will explain how patients can receive access to such drugs, even though the patients don't fit the exact criteria for participating in the trial.

"FDA hopes this proposal will increase awareness in the health-care community of the range of options available for obtaining experimental drugs for seriously ill patients," Dr. Woodcock said.

The proposed rules are open for public comment for 90 days.

Here's the link:

http://www.fda.gov/cder/regulatory/applications/IND_PR.htm

We will certainly be commenting.  Read More & Comment...