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...

Witch Hunt Against Reagan Udall

12/06/2007 06:22 PM |

Rosa DeLauro continues her mission against any one affiliated with companies who in turn want to work with the Reagan Udall foundation. This time it's president of the Bill and Melinda Gates Foundation Global Health Program, Dr. Tadataka (Tachi) Yamada who leads the foundation’s efforts to help develop and deliver low-cost, life-saving health tools for the developing world. He oversees our global health grant portfolio and Global Health Advocacy.

Before joining the foundation, Yamada served as Chairman of Research and Development and was a member of the Board of Directors at GlaxoSmithKline. Prior to that, he was chairman of the Department of Internal Medicine at the University of Michigan Medical School and Physician-in-Chief at the University of Michigan Medical Center. Yamada is a past president of the American Gastroenterological Association and the Association of American Physicians, a master of the American College of Physicians, and a member of the Institute of Medicine of the National Academy of Science in the United States and the Academy of Medical Sciences in the United Kingdom.

DeLauro wants Yamada's appointment investigated because when he was with GSK nearly ten years ago -- which is yesterday in politics, Yamada complained to John Buse, a University of North Carolina doctor (and now head of the American Diabetes Association) after he said at a 1999 medical conference that Avandia could cause heart attacks. Buse told Yamada to knock it off after Yamada made a phone call to Buse's boss, who Yamada calls "an old friend, so I felt comfortable calling him to probe informally about his opinion of Dr. Buse."  Read More & Comment...

Tamiflu: Facts Triumph Over Fear

12/05/2007 11:40 PM |

Steve Usdin has an excellent piece in this week's Biocentury on how Roche addressed concerns that there was a connection between Tamiflu, influenza and psychiatric problems in children...sort of an SSRI redux. It begins:

"Roche navigated through an important inflection point in the drug safety tempest last week, charting a course that other sponsors might use to overcome concerns that arise when drugs are a s s o c i a t e d with very rare, serious adverse effects.
The company deployed observational data to persuade FDA’s Pediatric Advisory
Committee to recommend that the agency tone down c a u t i o n s about Tamiflu
oseltamivir, an antiviral drug that has been associated with troubling neuropsychiatric events. The Tamiflu story provided an opportunity to test the hypothesis that even in an era when FDA and its advisory committees are loathe to take risks, good data can reverse the slide into the precautionary abyss. It also concretely demonstrated how
difficult it can be to determine causality when apparent drug safety issues emerge."

The data showed that the link between psychiatric problems was linked with the flu and not the drug by following groups that had the flu alone as well as careful tracking of each of the handful of cases among the millions of Tamiflu users world wide."

As Usdin reports:

"During the discussion, committee chair Rappley argued ROG should not be punished
for responding to the advisory committee’s request for additional information
on Tamiflu’s safety. And several committee members said they were pleased by ROG’s response. “This is a case where the system worked. We asked for more information a couple of years ago and a year ago. I feel quite a bit more informed and reassured,” Newman said. “I am reassured by most of what I saw today. I think the system
worked,” Daum said."

Chalk one up for commonsense and science.  Read More & Comment...

Avandia and Osteoporosis: Media Gnaws On An Old Bone

12/05/2007 07:50 PM |

You know it's a slow news cycle when various media outlets stumble over themselves to report what every endo has known for years: long term use of Avandia in women with low bone density can contribute to bone thinning. Easily mitigated by treatment with an osteoporosis drug. Duh. And the Nature Medicine article simply identified the specific receptor the PPAR pathway targeted that caused the degeneration in mice, it did not discover the mechanism of degeneration. That was discovered a long time ago. Not one article suggested that there was a benefit to continuing Avandia or put the bone loss risk in context with blindness, kidney loss, amputation as a result of diabetes.

Here are some sources in case journalists are interested in reading....

Rosiglitazone causes bone loss in mice by suppressing osteoblast differentiation and bone formation.
[Endocrinology. 2005]
Aging increases stromal/osteoblastic cell-induced osteoclastogenesis and alters the osteoclast precursor pool in the mouse.
[J Bone Miner Res. 2005]
Surface-specific effects of a PPARgamma agonist, darglitazone, on bone in mice.
[Bone. 2006]
Netoglitazone is a PPAR-gamma ligand with selective effects on bone and fat.
[Bone. 2006]
Rosiglitazone impacts negatively on bone by promoting osteoblast/osteocyte apoptosis.
[J Endocrinol. 2004]  Read More & Comment...

Revolutionary IGuard

12/04/2007 03:56 PM |

Today CMPI helped with the formal launch of IGuard.org, the first personalized drug safety tool developed for consumers and created by consumers that will tell, in real time, what drugs are working best for what people. iGuard provides patients with free medication safety checks, personalized safety alerts and updates, and the opportunity to share medication experiences with others. And, by monitoring outcomes across its user community, iGuard can help the FDA and other researchers identify problems faster than ever. Who will benefit from iGuard. Consumers who want to learn more about how the medicines, vitamins and supplements they are taking or plan to take will affect them as individuals. Drug companies should want to get involved to learn sooner rather than later about the consumer's experience with a drug, including how they are benefitting, drug-drug interactions, drug-disease interactions, as well as companies who want to communicate with consumers about ways to improve their experience with a medicine. It's a much better way to communicate with customers than through meta-analysis conducted by Steve Nissen.

IGuard is a free service to anyone who signs up and use of information for research purposes is confidential and voluntary.

Registration is free online at www.iGuard.org.  Read More & Comment...

Zugzwang

12/04/2007 05:58 AM |

Jamie Love thinks he has Big Pharma in zugzwang. (That's a chess term referring to a position where one player is reduced to utter helplessness -- but must continue to play even though every additional move makes his position worse.)

Here’s what he has to say this week in Fortune Magazine about his plan to replace pharmaceutical patents with “prizes” …

"It's either going to be price controls or prizes.”

Not so. And even though he's King of the Big Lie -- say it enough times and maybe people will begin to think it’s true -- it just isn't so. There are many alternatives that are, well, sane ones.

But as the article (authored by John Simons) concludes …

“Clearly, if industry wants to avoid this (Jamie Love's) scenario, they had better start fashioning some new ideas of their own.”

How about a more robust discussion of a patient-centric Critical Path program for Comparative Effectiveness?

Here’s the rest of the story from Fortune:

http://money.cnn.com/2007/11/28/magazines/fortune/simons_patent.fortune/index.htm

Next up on this front is just how far Senator Bernie Sanders' Prizes vs. Patents bill gets in the Senate.  Read More & Comment...

When Is Off-Label Promotion Not Off-Label Promotion?

12/03/2007 06:22 AM |

When is off-label promotion not off-label promotion? Well, as with so much in the world of FDA regulations -- it depends.

In this case it depends on the FDA's decision to relace ambiguity with a draft guidance on the matter. But the question remains, is this even within the agency's jurisdiction?

Of course, we can always depend on Henry Waxman (America's Oversighter-in-Chief) for a fair and balanced comment. Here's one sentence from his 11 page letter to the FDA on the leaked draft of the draft guidance:

"It would open the door to abusive marketing practices that will jeopardize safety, undermine public health, and lead to an increase in unapproved uses of powerful drugs."

But Henry, what do you really think?

At the end of the day, shouldn't physicians have free and unfettered access to publicly available, peer-reviewed scientific information?

Oh yes, and then there's that First Amendment thing.  Read More & Comment...

And for an encore...

11/30/2007 01:40 PM |

But Ralph -- what have you done lately?

Many congrats.

Ralph Snyderman, M.D., Chancellor Emeritus at Duke University and Founder and Chairman of Prevents, Inc., receives the 2007 Leadership in Personalized Medicine Award today from the Personalized Medicine Coalition (PMC) for his efforts in advancing predictive and targeted therapies on a national scale.

The annual PMC award recognizes the contributions of a visionary individual whose actions in science, business, or policy have advanced the frontier of personalized medicine.  Read More & Comment...

Gail Force Wins

11/30/2007 01:00 PM |

PRESS ADVISORY: Science Board to the Food and Drug Administration

Date and Time: Monday, December 3, from 8:00 a.m. to 5:30 p.m.
Location: Washington DC North/Gaithersburg Hilton, 620 Perry Pkwy., Gaithersburg, MD 20877, Salons A, B, and C

Key item: Presentation of the report FDA Science and Mission at Risk

12:30 p.m. Report of the Subcommittee on Science and Technology, Gail Cassell, PhD, D.Sc. (hon), Subcommittee Chair

2:00 p.m. Science Board Q&A and Discussion of the Subcommittee Report

PRESS ADVISORY: Media conference call with Dr. Cassell and other authors of: FDA Science and Mission at Risk

Date and Time: Tuesday, December 4, at 10 a.m.

Call-in number: 1-888-622-5357; Participant: 453189#  Read More & Comment...