Kessler's Exit Raises Questions About Medicine As Profession

12/17/2007 12:28 PM |

David Kessler was fired as dean of Univ of California SanFran Medical School. I have no love for Kessler's reign as FDA commissioner -- at least when Clinton was prez and the Dems controlled Congress. Kessler left the FDA to become dean of Yale medical school where most everyone agreed he did a great job. He took on the UCSF job because it is supposed be a world leader in translational medicine, that is, a powerhouse in doing the sort of work that drug companies are supposed to do and don't according to the Soros funded types.

But Kessler found that UCSF, instead of having about $70 million to build up the integrated translational programs he came to establish was deep in the financial toilet. His efforts to clean things up lead to a slimy charge that he was pocketing dough, a charge that was baseless.

Kessler is stepping down. But his inability to institute changes to make the medical school financially accountable raises troubling questions about the ability of the academic medical institutions to properly oversee clinical trials, drug development, practice guidelines, etc. Academic institutions are less transparent and less accountable than most entities. And now we see with UCSF and other universities financial irregularities if not outright corruption as a result of direct manipulation by politicians. I am thinking specifically of the University of Medicine and Dentistry of NJ where the med school's political overseers have nearly ran that fine institution into the ground with self dealing and indifference.

We now see that Congress has no problem calling members of FDA advisory committees if they don't like a particular decision. Imagine how academics would buckle if their every study was under congressional scrutiny. This is how science should be conducted? This is new order the Reformers would impose on us? The Kessler departure raises serious questions about the ability of academic institutions to handle the serious responsibility of transforming scientific insights into preventive and proactive treatments. They cannot be trusted or asked to do so. And neither can the arrogant leaders of the Hate Pharma movement who have tried to seize the dollars and power to determine the course of medicine for themselves and cronies.

http://www.usatoday.com/news/education/2007-12-14-california-dean_N.htm  Read More & Comment...

Genuine Fakes

12/17/2007 11:25 AM |

You mean that thing about counterfeit drugs is for real! (After all, if it's on the front page of the New York Times it must be important.)

Here's a link to Walt Bogdanich's story in today's Gray Lady:

http://www.nytimes.com/2007/12/17/world/middleeast/17freezone.html?hp

To whet your appetite, here's how it begins ...

DUBAI, United Arab Emirates — Along a seemingly endless row of identical gray warehouses, a lone guard stands watch over a shuttered storage area with a peeling green and yellow sign: Euro Gulf Trading.

Three months ago, when the authorities announced that they had seized a large cache of counterfeit drugs from Euro Gulf’s warehouse deep inside a sprawling free trade zone here, they gave no hint of the raid’s global significance.

But an examination of the case reveals its link to a complex supply chain of fake drugs that ran from China through Hong Kong, the United Arab Emirates, Britain and the Bahamas, ultimately leading to an Internet pharmacy whose American customers believed they were buying medicine from Canada, according to interviews with regulators and drug company investigators in six countries.

The seizure highlights how counterfeit drugs move in a global economy, and why they are so difficult to trace. And it underscores the role played by free trade zones — areas specially designated by a growing number of countries to encourage trade, where tariffs are waived and there is minimal regulatory oversight.

And yet some members of Congress want to decrease regulatory oversight of counterfeiting. Go figure.  Read More & Comment...

WHO Says

12/17/2007 07:46 AM |

An op-ed, from the International Herald Tribune, by Dr. Howard Zucker, assistant director-general of the World Health Organization and chairman of the International Medical Products Anti-Counterfeiting Taskforce.

A plague of bad medicine

There is a silent killer loose in the streets of every major city from Beijing to New York. Each day this menace brings the threat of greater illness and even death to sick patients living on farms in Africa and in the bungalows of South America. The source of this global epidemic is
counterfeit medicines.

Unlike counterfeit purses or watches, there is no demand by consumers for fake drugs. No one - rich or poor, Chinese, American or African - seeks them out; their victims are always duped into believing they have the real thing.

The motivation is simple: counterfeiting drugs is big business today, and quite likely the fastest growing criminal activity on earth. According to the U.S.-based Center for Medicine in the Public Interest, counterfeit drug trafficking will be a $75 billion enterprise by 2010.

Here's the rest of Dr. Zucker's commentary:

http://www.iht.com/articles/2007/12/14/opinion/edzucker.php

An important read.  Read More & Comment...

Positive Pressure

12/14/2007 09:35 AM |

In the spirit of the season, some thoughts on how 2008 can be the year when we all decide to "just get along" and focus on the public health and personalized medicine rather than, well, more personalized agendas.

As far as a "more effective" FDA is concerned, consider this -- effective regulation can’t happen in a vacuum. Unlike in the movies, the best new ideas, be they scientific or otherwise, rarely spring fully-grown from the head of anyone -- even our elected representatives. That means industry and Congress and academia and patient groups and physicians ... and the FDA must have close ties. Ties that bind rather then cut, with relationships built on trust and mutual respect. That's the only way to achieve anything worthwhile. "The beatings will continue until morale improves" isn't working. And while there will always be tension between regulator and regulated, between agency and oversight authority, such tension can be productive, creative tension.

Diamonds, after all, are the result of pressure.   Read More & Comment...

Heartburn, yes. Statins, no.

12/14/2007 07:59 AM |

10-2 against. So it doesn't look like we'll be seeing OTC statins any time soon. All the more reason to carefully watch the FDA's words and actions viz BTC. If all this is giving you heartburn -- well at least those medications you can get without a prescription.  Read More & Comment...

Juiced Baseball:The Bottom Line is No One Really Cared

12/13/2007 11:01 PM |

How did steroids spread through MLB. It started in college and high school where coaches and parents looked the other way. And it continued in The Show where management from the GMs to the owners knew about it and did nothing. Retired players who I know realize that 'roids were and are illegal but have said that a clear no tolerance policy would have wipe them out a long time ago.

Meanwhile Senator Mitchell's report has some very interesting things to say about how easy it is for players -- or anyone -- to get steroids and HGH through internet pharmacies and Canada. What sort of signal does it send when Congress handcuffs the federal law enforcement agencies and the FDA from intercepting such products in it's stupid pursuit of drug importation. The same signal MLB ownership sent to players when it said it wanted to crack down on steroid use but never really got tough.

Here's a link to the Yahoo sport site that in turn has a link to the report.

http://sports.yahoo.com/  Read More & Comment...

Value-Based Insurance Design

12/13/2007 12:27 PM |

Just participated on a "blogger conference call" with Mark Fendrick (University of Michigan) and Michael Chernew (Harvard University). They are the co-directors of the Center for Value-Based Insurance Design.

The VBID Center sounds like an interesting proposition. For more detail check out their website:

http://www.sph.umich.edu/vbidcenter/

Many interesting points were brought up -- not the least of which was the issue of whether or not -- considering the relatively truncated lifespan of any individual's relationship with a given private payer -- Big Insurance can be convinced to offer more efficient programs that incent aggressive preventative and chronic care.

And, since the VBID program is based in the Wolverine State, I asked if they thought the new GM/Union agreement over health care would result in more patient-centric programs. Both Dr. Fendrick and Dr. Chernew demurred from making a prediction. Typical academics!

I think it will. Because (1) These are union employees who (at least in theory) will be with the insurance plan for an extended period -- so additional up-front costs (aka "investments") can be recouped over a longer period of time via enhanced productivity and fewer acute health care events and (2) Unions exist to serve their members rather then themselves (I know -- at least in theory) and should, therefore, be more willing to spend more money upfront.

Whether or not my prediction turns out to be correct -- it's a good initial litmus test for the general theory.

The VBID Center also said all the right things about the value of reimbursing for appropriate diagnostics (genomic and otherwise) -- specifically giving the thumbs up to genetic tests for Warfarin and the BRCAs.

The call lasted about an hour with many intelligent questions from the blogger audience. Strangely though, the VBID folks said their "consultant" had told them to expect a blogger call to last for only 20-25 minutes. Peculiar. But, in any event, it was time well spent.  Read More & Comment...

Shots in the Dark

12/13/2007 09:28 AM |

Per Dr. Bob's post below on vaccines, let me relate what my pediatrician buddy says to parents who don't want their children vaccinated --

"It's your choice. But if you choose not to have your child vaccinated then you cannot be my patient."

This is serious business folks. Voodoo science that scares parents away from accepting childhood vaccinations (and the lawyers who would fan those false flames for profit) is one of the most serious public health risks our nation faces.

And certainly one of the most avoidable.  Read More & Comment...

Vaccine Recall Retort

12/13/2007 08:37 AM |

In her excellent piece about the Merck vaccine recall Linda Johnson anticipates -- correctly -- the coming storm from the crazies who believe that we should really be scared and angry about how the fact that kids don't even need vaccines to begin with:

"The recall is likely to heighten a debate over childhood vaccines, their safety and whether too many are required. Some parents are distrustful and suspect some vaccines of being linked to autism, although scientific studies have not shown a connection. "

Sad but true. And Johnson forgot to mention the barrage of bottom feeding trial lawyers who will try to sue Merck in the wake of the recall.

http://news.yahoo.com/s/ap/20071213/ap_on_he_me/vaccine_recall  Read More & Comment...

Hutt! Hutt! Hutt!

12/13/2007 07:35 AM |

If the recent report of the FDA's Subcommittee on Science and Technology ("FDA Science and Mission at Risk") wasn't enough of a wake-up call -- you should (1) check your pulse and make sure you are still breathing and (2) read the very un-sugar coated comments of Advisory Board member Peter Barton Hutt. They're must reading.

And here they are:

Download file

But Peter, what do you really think?  Read More & Comment...

Why Don't Pregnant Women Tip Over?

12/12/2007 06:00 PM |

There is no punchline...yet. Only the hard work of dedicated scientists seeking a serious answer.

http://news.yahoo.com/s/livescience/20071212/sc_livescience/womenevolvemorespinetocarrybabies

Meanwhile, this guy brings new meaning to the word "suicide bomber"

AP: Man nearly dies downing vodka at airport

A man nearly died from alcohol poisoning after quaffing two pints of vodka at an airport security check instead of handing it over to comply with new rules about carrying liquids aboard a plane, police said Wednesday.

http://news.yahoo.com/s/ap/20071212/ap_on_re_eu/airport_vodka  Read More & Comment...

Evidence-Based Medicine in Theory and Practice

12/12/2007 03:46 PM |

More examples proving that managed care companies are run by people that could never run a real business...

The Wall Street Journal on Wednesday examined how hospitals have begun "taking steps to prevent the most common risk to patients after discharge: landing back in the hospital due to complications that could have been prevented with better follow-up care." According to the Journal, a "revolving door of readmissions is driving up costs for hospitals and causing needless harm to patients, especially elderly people with multiple chronic diseases."

Almost 18% of Medicare beneficiaries who are admitted to a hospital are readmitted within 30 days at a cost of $15 billion, according to the Medicare Payment Advisory Commission. As a result, "readmission rates are coming under increasing scrutiny from regulators, insurers, employers and quality-measurement groups, who are considering methods to tie payment to lower readmissions," the Journal reports.

The Institute for Healthcare Improvement has partnered with several hospitals to reduce readmissions through programs that identify patient risk for readmission, schedule follow-up visits with patients before discharge, send nurses on at-home visits to ensure patient adherence to medication regimens, monitor patients at home, and educate patients and families on adherence to medication and self-care regimens.

Most hospitals currently "don't provide such services" in part because they "aren't paid to coordinate care once a patient leaves," the Journal reports.

However, "that may change" as managed care companies and health insurers experiment with programs that cover the cost of coordination of patient care, according to the Journal. Randall Krakauer, medical director at Aetna, said, "We believe this can improve the quality of care for members and more than pay for itself by reducing the costs of care by a larger amount than the cost of the home visits" (Landro, Wall Street Journal, 12/12).

Don't hold your breath...

Here's how the biggest health plan in Rochester, NY -- along with the VA, a Hillary Clinton model of health care excellence, is now rationing care in penny-wise, pound foolish fashion....

Democrat and Chronicle, Dec. 12, 2007

Doctors seek fair role with Excellus

BY: Patrick Flanigan

Rochester-area doctors must work together and demand "a seat at the table" on the issue of balancing the need for expensive radiology exams with the need to control rising medical costs.

That was the message delivered Tuesday night to about 100 doctors and other medical professionals meeting at the Monroe County Medical Society to discuss a controversial radiology management program.

Excellus BlueCross BlueShield launched a program in October that requires doctors to obtain the insurance company's approval before scheduling exams such as PET scans, CT scans or MRIs.

Those exams, which diagnose conditions including cancer and heart disease, are among the most expensive procedures in modern health care.

Excellus officials have defended the program as a way to cut the rising cost of health care by asking doctors to be more judicious. The insurer spends about $560 million a year on radiology exams.

The doctors said Tuesday they recognize that costs are a problem. But in this case, they said, the quality of patient care is being threatened.

Dr. John Genier, president of the Rochester General Physicians Organization, said doctors must be participants in the discussion about the issue. He also urged his fellow physicians to keep the focus on their patients.

"It's easy to get angry. It's easy to insurance-bash. That will not benefit us," Genier said. "When you get frustrated and feel like you just can't beat a 700-pound gorilla, remember the patients."

Here's the rest of the story:

http://www.democratandchronicle.com/apps/pbcs.dll/article?AID=/20071212/BUSINESS/712120341/1001  Read More & Comment...

Torts, Truth and Transparency

12/12/2007 03:39 PM |

Peter Rost just announced that he's hanging out his shingle as an expert witness for pharma marketing practices on behalf of plaintiff attorneys. Good for him.

Why? First, unlike David Healy and Curt Furberg and others, Peter is transparent about his work. The honesty is refreshing.

Second, as a gun for hire he is offering his services to defendants as well. No takers, yet. Here's his post:

"So I guess it is time to announce that in addition to my ongoing writing career for Brandweek and several international journals, a new business of mine is taking off . . . as litigation consultant and pharmaceutical marketing expert for plaintiff law firms.

Pretty amazing to sit in on those depositions of other marketing executives and read what they wrote in their memos.

So on my two-year anniversary of being fired from Pfizer, I'm getting a lot of use for my marketing experience in a most unusual way. Funny thing is, none of the defendant firms have asked for my help."  Read More & Comment...

Part D Gets an "A"

12/12/2007 11:32 AM |

The Wall Street Journal Online/Harris Interactive survey of U.S. adults age 65 or older, shows 87% of those enrolled in a Medicare drug benefit plan are satisfied with their plan, up from 75% last year, while 6% said they aren't satisfied.

Any questions?

Note to Families USA -- would you like your crow served with a side of humble pie?  Read More & Comment...

Carba Loading

12/12/2007 10:30 AM |

Personalized medicine? Yes please.

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry

Connection of genetic information with medication use can improve safe use of product

The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.

The full FDA press release can be found here:

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01755.html

"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."  Read More & Comment...

Electile Dysfunction

12/12/2007 07:46 AM |

That's the title of Matthew Arnold's cover story in the December issue of Medical Marketing & Media -- "Outlook 2008: Electile Dysfunction."

Here’s how it begins:

"A cautious FDA sweating product safety issues and going slow on new approvals. An election year in which healthcare tops the agenda. Increased oversight, increasingly demanding payors and ever more aggressive generic competition.

Throw in some gloomy global market trends, and 2008 promises to be a tough one for a pharmaceutical industry trying to dig its way out from under a mountain of looming patent expirations on key products. If 2007 was a year of disappointment—with hotly anticipated products like torcetrapib, rimonabant and Galvus failing to make it to market and safety jitters hitting others, like Avandia, Zelnorm and Exubera— 2008 looks like more of the same. For all the talk about acquisitions, big pharma firms sitting on large cash piles might look to Pfizer's inability to translate scale into lasting dominance and think twice—if there were even anything attractive left to buy. And the trickle of really innovative new products coming down the pipe will have to vault high hurdles to make the grade at the FDA, with Rep. Henry Waxman breathing down Andrew von Eschenbach's neck."

And here’s the conclusion:

"At least one FDA watcher is more sanguine. “In a political year, the FDA is going to understand that it needs to be apolitical,” says Peter Pitts, director of the Center for Medicine in the Public Interest. “FDA is in the business of protecting and advancing public health. It's not an agency that wants to deal with politics at all, but it's been buffeted by very potent political winds from the outside.”

The Reagan-Udall Foundation established by the FDA Amendments Act will, together with the FDA's Critical Path Initiative, revolutionize drug development, says Pitts. “By streamlining and improving the science of drug regulation, we can bring drugs to market more rapidly and safely by helping companies fail faster, so that they can reinvest those resources in more successful propositions,” says Pitts. “Ultimately, Critical Path is like a game of Chutes and Ladders, helping companies avoid the chutes and scale the ladders.”

Here's a link to the complete piece:

http://www.mmm-online.com/Outlook-2008-Electile-Dysfunction/article/99533/

And be sure to check out the predictions of the six health care cognoscenti interviewed for the story.  Read More & Comment...

Are you in good hands?

12/12/2007 06:07 AM |

Fromt today's edition of the Wall Street Journal ...

A Health-Insurance Solution
By MERRILL MATHEWS

Why can't people living in New Jersey buy health insurance available to residents of, say, Pennsylvania?

Rep. John Shadegg, an Arizona Republican, thinks they should -- and today will reintroduce legislation to make that possible.

The Health Care Choice Act would allow residents in one state to buy health insurance that is available in and regulated by another state. If enacted, the law would create a competitive, 50-state market for health insurance, likely making it cheaper. It would do this without imposing a large cost on taxpayers and without creating a new government bureaucracy.

This should be a no-brainer for Congress. But a few years ago, Mr. Shadegg went looking for a Democratic cosponsor for his bill. He found one who initially signed on, then withdrew under pressure from Democratic House leaders who wanted to dismiss the Shadegg bill with the excuse that it lacked bipartisan support.

The health-insurance market can be divided into three segments. The first consists of mostly large employers, with self-funded plans, and are regulated by the federal Employee Retirement Income Security Act (ERISA) and thus not subject to state regulation. The two remaining segments of the health-insurance market are heavily regulated by states: those that serve small-group plans (typically covering two to 50 people), and individuals who pay for their own insurance. Mr. Shadegg's bill only applies to the individual market.

Because regulations vary from state to state, the cost of health insurance for these last two segments of the insurance market vary widely. Some states ensure that residents have access to a wide range of affordable policies. Others -- New Jersey, New York, Massachusetts, for instance -- have all but destroyed their individual health-insurance markets with over-regulation.

One of the most expensive state-level regulations is "guaranteed issue," which requires insurers to sell insurance to anyone willing to buy it, regardless of their health, or other factors that may make it much more expensive to cover them. New Jersey, for example, enacted guaranteed issue in 1994. At the time, a family policy could be purchased in the state for as little as $463 a month or as much as $1,076, depending on which of the 14 participating insurers a family chose. Now there are just 10 insurance companies offering plans in the state and the cost has soared to $1,726 per month on the low end and $14,062 on the high end.

In New Jersey then, residents who buy their own insurance have to pay at least $20,000 a year for the cheapest family policy. Meanwhile, in neighboring Pennsylvania similar health-insurance policies cost a third of what they cost in New Jersey. What Mr. Shadegg wants to do is to let New Jersey residents buy what's now for sale in Pennsylvania.

Mandates are another reason the cost of health insurance varies from state to state. States impose those mandates on what an insurance plan must cover -- such as chiropractic care or mental-health services. The Council for Affordable Health Insurance, which tracks mandates, estimates that there are more than 1,900 state mandates nationwide. These mandates can increase the cost of health insurance by as much as 50%, which can then force residents in many states to decide between "Cadillac coverage" -- insurance that covers nearly everything and costs a mini fortune -- or no coverage at all.

Typically, state mandates are justified by the belief that they make health insurance more comprehensive. But consider this: Idaho has just 14 state mandates, the fewest in the nation, while Minnesota, with 63, has the most. Yet, the people of Idaho aren't dying in the streets for lack of mandates.

Critics of the Health Care Choice Act claim that it would limit the ability of states to protect their residents. The assertion is that cross-state health-insurance purchases are a risky experiment. In truth, millions of people already have access to health insurance across state lines. Employees of large companies with plans covered by ERISA are one example.

But there are others. Some small businesses cover employees working across state lines. And, because people are mobile, some people buy individual insurance in one state and then end up moving to another. In many cases, they can take their health-insurance policies with them. A person living in Pennsylvania with an individual policy now could retain that policy even if he moved to New Jersey. Premiums would likely increase, but they would be cheaper than if he had started out with a New Jersey policy.

If states are worried about losing regulatory control over health insurance, they might try making their regulations competitive with other states. Health insurers would likely respond by returning and offering a wide range of affordable policies. As it stands, many states are "protecting" their residents right into the uninsured camp.

The Health Care Choice Act won't solve every problem. But it would increase competition and consumer choices currently denied to residents in many states.

Mr. Matthews is executive director of the Council for Affordable Health Insurance and a resident scholar with the Institute for Policy Innovation.  Read More & Comment...

Of Cardiologists and Glass Houses

12/11/2007 09:34 AM |

My ears weren’t burning but …

It seems that, while I was chairing a conference on the FDA’s Critical Path program (along with notables such as McClellan, Woodcock, and Temple), “Regulator-without-Portfolio” Steve Nissen was calling me names (“obscure flack”) and this blog (www.drugwonks.com) “vile.”

And no one even called the hall monitor.

Well “vile” is in the eyes of the beholder – but better that then servile to the whims of the Patron Saint of Meta-Analysis. (The good news, however, is that (1) Dr. Nissen is reading drugwonks.com and (2) since his nasty comments our traffic has spiked. So, thanks Steve.)

Windhover’s Roger Longman offers this perspective on Steverino’s puerile bellyaching:

“In perhaps the most entertaining of talks, Regulator-without-Portfolio and Cleveland Clinic’s cardiovascular boss Steve Nissen blasted the FDA leadership for soulless toadying to industry. He started at the top with Andrew von Eschenbach – damned as a close Bush friend (admittedly, from our point of view, hardly a recommendation) and a “urologist” (an apparent reference to some religio-medical schema that blesses the cardiovascular as kosher and condemns the urological as treif) …

... There is also this odd fact: the Mafia which, the accusation goes, ran/runs FDA for the benefit of Republicans and Big Pharma, approved a mere trickle of new products while wrapping lots of existing ones with new warnings and restrictions. Were these Mammonites merely incompetent at serving their Master?”

Roger’s complete musings can be found here …

http://therpmreport.com/Free/firsttake.aspx

For more on Dr. Nissen’s “issues” see here:

http://drugwonks.com/2007/06/nissens_plaque_problem.html

Cardiologists who live in glass houses shouldn’t throw epitaphs.  Read More & Comment...

Chuck and Cover

12/10/2007 03:30 PM |

Senator Charles Schumer (D-NY) has introduced legislation to modernize Medicare reimbursement policies for certain laboratory tests such as molecular diagnostics. The Advanced Medical Technology Association said that the legislation would help ensure continued innovation and patient access to important diagnostic tools.

The legislation also has been introduced in the U.S. House of Representatives as the Medicare Advanced Laboratory Diagnostics Act (H.R. 1321), where it is sponsored by Rep. Bobby Rush (D-IL), Rep. Michael Ferguson (R-NJ), Rep. Mike Thompson (D-CA), and Rep. Phil English (R-PA).

Though these tests make up less than 2 percent of hospital costs, their findings influence as much as 70 percent of healthcare decision-making, the group said. It said the current Medicare reimbursement system provides few incentives to develop new tests which are critical to the future of healthcare.

The groups said the bill provides for significant reforms to outdated Medicare reimbursement policies that threaten to stifle innovation and the widespread diffusion of technologies. This includes establishing a demonstration project to test a new Medicare payment system for certain molecular diagnostics, allowing for a process to adjust items still on the Clinical Lab Fee Schedule through an appeals process to correct historic errors that set inadequate reimbursement for diagnostic tests, and improving processes for obtaining adequate reimbursement for new diagnostic lab tests.  Read More & Comment...

The Steve Nissen Prize for Excellence in Meta-Analysis

12/10/2007 02:13 PM |

Our Golden Clipboard awards will be posted shortly but it's just coincidence that drugwonks is also undertaking an effort to carry on the tradition of rigorous scientific research that epitomizes meta-analysis both in terms of the intellectual firepower required to conduct it and the apolitical ways in which its conclusions are used to advance public understanding of the overall risk and benefits of treatments without regard to one's personal or political ambition.

To this end we intend to provide a prize for the best meta-analysis of the cardiovascular risks associated with participation in any clinical trials Steve Nissen has conducted. The only criteria for such research is that scholars must deliberately EXCLUDE any patients who did not have a heart attack or severe cardiovascular event as defined by them in their meta-analysis of Nissen-sponsored research. The events in the trial need not be independently adjudicated or be obtained from raw data. Just take the Ns from any trials you can find on Google, compare the cardiovascular risk of Nissen studies to any other set of studies at the same confidence level Dr. Nissen assigned to Avandia meta-analysis.

Oh -- and you can combine patients from as few as four studies.

Winners will have their studies posted well in advance of even on-line publication dates and handed directly to Henry Waxman if we can get to him.  Read More & Comment...