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...

Rockville-on-Thames

12/10/2007 08:19 AM |

Last week I gave a brief presentation to folks at the MHRA on the current state of affairs at the FDA. It was a Chatham House rules affair, so I don't want to reveal any confidences -- but the first question I was asked is worth sharing,

"How can the FDA earn back its reputation?"

(Nothing like a softball question from Our Regulatory Cousins.)

Without going into too much detail here, suffice it to say that what followed was a rather robust conversation about the best ways to stand up for what's right in light of the Kristelnacht tactics of many on our side of the pond.

There is indeed a "special friendship" between FDA and MHRA -- and we must all find ways to strengthen these important bonds of regulatory solidarity.  Read More & Comment...

The Golden Clipboard

12/10/2007 07:02 AM |

At last week's CMPI/FDA News conference on the Critical Path, Janet Woodcock discussed the urgency of 21st century bioinformatics by lamenting the fact that,

"Today the major tool of modern medicine seems to the clipboard."

This jives with the recent report of the FDA Science Panel that decries the state of IT at the FDA.

To that end, we are announcing a new award for those who stand in the way of medical progress -- "The Golden Clipboard."

2007's winner will be announced shortly.  Read More & Comment...

Baby Genes

12/09/2007 08:38 AM |

Here's an interesting and controversial thought that came from last week's CMPI/FDA News conference on the Critical Path --

What about mandatory gene mapping for all newborns?

After all, if you believe that mandatory vaccinations are appropriate (as we at Drugwonks certainly do), couldn't the same logic be applied to gene maps that could help physicians really understand the needs of their patients?

If you believe (as we at Drugwonks certainly do) that being able to prescribe the right medicine to the right patient in the right dose at the right time is a goal worth pursuring then, perhaps, mandatory gene mapping for all newborns is something worth considering.  Read More & Comment...

A Motto for the Reagan/Udall Foundation

12/08/2007 11:24 AM |

Wither the future of 21st century pharmaceuticals?

Consider what Mark McClellen said Thursday at the CMPI/FDA News conference on the Critical Path,

"The future is not going to be like the past."

(A comment that is much more profound the more you think about it.)

Reagan/Udall Foundation Chairman McClellan also shared this comment,

"Data isn't knowledge."

Now isn't that an apt and memorable motto for the Reagan/Udall Foundation.  Read More & Comment...

CDER Rapids

12/07/2007 02:56 PM |

Now that FDA reform (referred to by many these days as "FDA Cubed") has passed -- many in Congress feel that the job is done.

Hardly.

I'm not specifically referring to the myriad difficuties of operating under a CR, but rather the overly long and circuitous route FDA hires must take before they take their seats and get to work. It just takes too long.

This isn't a problem for Congress, but rather for the White House and OMB. With hundreds of current vacancies at CDER, this is a problem that needs immediate attention. The hiring process must be addressed and truncated.

For those who support an FDA that addresses safety in a more timely way -- the best way to get it done is to have an agency that is properly staffed. And expediting hires of already budgeted slots seems a logical place to start.

Will this really help the agency do a better job? Here's what Bob Temple had to say on the matter at last week's CMPI/FDA News conference -- "Hell yeah."

We second the emotion.  Read More & Comment...

Easy Answers to Big Pharma's Big Problem

12/06/2007 06:57 PM |

"I think the industry is doomed if we don't change." So says Sid Taurel of Eli Lilly.

What's the answer to it's thinning near term pipeline, according to the WSJ?

Biotechnology. As if drug companies have not invested in biotech since it's inception. But biotech has been no more successful in bringing products to market than drug companies, just less profitable in the process. Which is why biotech has escaped government regulation until recently. Government only punishes success. Which is why it is so eager to create a generic biologics industry before a biotech industry really exists.

There are no easy or short term answers. Drug discovery and development is hard and risky. Of course, that's something the hard Left refuses to accept.

http://online.wsj.com/article/SB119689933952615133.html?mod=home_health_right  Read More & Comment...

Track and Trace This...

12/06/2007 06:42 PM |

Somehow the idea that the FDA will get a handle on this by forcing track and trace technology on distributors anytime soon is a joke. When will the importation kool-aid drinkers wake up?

Security concerns raised as China fills U.S. medicine chest
By Tim Johnson, McClatchy Newspapers

BEIJING — The medicine cabinet in the average U.S. home is filling with drugs made in China , and some experts say that could be a prescription for trouble.


China's booming pharmaceutical industry has doubled exports to the United States in the past five years, undercutting competitors and making American consumers reliant on the safety of Chinese factories and captive to any disruptions in Sino-U.S. commerce.

It might seem like merely a trade issue. But industry experts in Europe and the United States say national-security concerns are edging into the debate.

Consider this scenario:

If a major anthrax attack were to occur in the United States — larger than the one in 2001, when five people died— pharmaceutical companies that make the two antibiotics most suitable for treatment, Cipro and doxycycline, would have no choice but to rely on China or India for key ingredients once American stockpiles were exhausted. Those ingredients no longer are made in the West.

A Portuguese company that ramped up doxycycline production in 2001 at Washington's request said China now controlled the flow of its crucial drug component.




http://news.yahoo.com/s/mcclatchy/20071206/wl_mcclatchy/2774948  Read More & Comment...