“There was a feeling there was a political and economic agenda as much as a scientific agenda,” said Dr. Michael Weber, a professor of medicine at the Health Science Center at Brooklyn, part of the State University of New York, who had been an investigator in the study but afterward became one of its leading critics. “They pushed beyond what the data allowed them to say.”

"Dr. Clancy (Carolyn Clancy director of the federal Agency for Healthcare Research and Quality) said that her agency was now mainly using insurance records to judge how treatments perform. While clinical trials are the gold standard, she said, they are costly and time-consuming.

Last March (March 4^th to be exact) drugwonks.com commented on the hypocritical disconnect between what medical journals were writing about medical journalism conflict-of-interest and what they were practicing (“New Realism Redefined”) -- “There seems to be a lot of "do as I say not as I do" going on these days.”

A few months later (August 25^th), Steve Usdin of BioCentury weighted in on the same topic.  His article, “Sacred vs. Profane,” began as follows:

“Medical journal editorials routinely attack the pharmaceutical industry, alleging drug companies corrupt the practice of medicine through inappropriate and overly aggressive marketing, while also criticizing doctors for allowing themselves to be influenced.  The journal publishers themselves, however, play a key role in encouraging the behaviors their editors criticize via advertising, sponsored subscriptions and the promotion of reprints of company-sponsored clinical trials.”

(It should also be noted that both JAMA and NEJM declined Usdin’s requests for interviews.)

So it comes as somewhat of a surprise (Really?  No.) that in the current edition of the British Medical Journal (19 November 2008, doi:10.1136/bmj.a2535), much of the same ground is covered – but minus any mention of the sins of medical journals!  Why does this seemingly obvious issue of transparency fail to gain any traction?  Maybe the new Chairman of Energy and Commerce will look into it?

Maybe not.

JAMA. 2003;290:1467-1473.) 

The subject of Grassley's investigation is the following: " A Population-based sample of 20 638 health plan members aged 14 years or older who had at least 1 outpatient diagnosis of bipolar disorder and at least 1 filled prescription for lithium, divalproex, or carbamazepine between January 1, 1994, and December 31, 2001. Follow-up for each individual began with first qualifying prescription and ended with death, disenrollment from the health plan, or end of the study period."

The results?

In both health plans, unadjusted rates were greater during treatment with divalproex than during treatment with lithium for emergency department suicide attempt (31.3 vs 10.8 per 1000 person-years; P<.001), suicide attempt resulting in hospitalization (10.5 vs 4.2 per 1000 person-years; P<.001), and suicide death (1.7 vs 0.7 per 1000 person-years; P = .04). After adjustment for age, sex, health plan, year of diagnosis, comorbid medical and psychiatric conditions, and concomitant use of other psychotropic drugs, risk of suicide death was 2.7 times higher (95% confidence interval [CI], 1.1-6.3; P = .03) during treatment with divalproex than during treatment with lithium. Corresponding hazard ratios for nonfatal attempts were 1.7 (95% CI, 1.2-2.3; P = .002) for attempts resulting in hospitalization and 1.8 (95% CI, 1.4-2.2; P<.001) for attempts diagnosed in the emergency department.

Conclusion  Among patients treated for bipolar disorder, risk of suicide attempt and suicide death is lower during treatment with lithium than during treatment with divalproex.

See how dangerous this is.  No wonder Pharmalot rushed to blog on the Grassley "probe"

Worst Practice? Senate Probes NPR Host’s Firm

Of course, engaging in such activities in identifying risks is ok and individuals with such information should contact Grassley's office or the Church of Scientology or both. (Something tells me that either way the one will get the info to the other. 

"He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias."

Tom Daschle is a terrific choice for HHS for many reasons.  Most importantly, he’s a grown-up. 

Daschle's sure-footed Washington savvy should pretty much shut the door on those Nabobs of Nissenism who are calling on King Steven to ascend to the FDA throne. Secretary-Presumptive Daschle knows better than to take anyone seriously who is so universally disliked among the most senior FDA staff and so generally divisive among almost everyone else.

His other role in the Obama White House, that of Health “Czar,” poses some interesting questions.  Specifically, how will he approach the issue of the Part D Non-Interference Clause – which he (along with Senator Kennedy) drafted in the first place?

Yesterday, at Day II of the IFPMA Assembly, the luncheon speakers were former Senators John Breaux and Trent Lott.  Neither thinks there will be a strong Congressional effort to reverse the Non-Interference Clause.

I am not as phlegmatic.

And to that point, a few things worthy of consideration:

"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School's Alain Enthoven and Kyna Fong

"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06

* 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.

Why?  Marketplace competition.

* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.

* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.

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 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 interventions -- which in turn reduces our overall national health care spending.

We shouldn’t interfere with success.