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...

Building a Cassell in the Sky

11/30/2007 08:13 AM |

A subcommittee of the FDA’s Science Board (headed by the talented Dr. Gail Cassell of Eli Lilly & Company) says the agency suffers from a "plethora of inadequacies," including an "appallingly low'' rate of food inspections and a lack of scientists who understand new technologies.

According to a new report issued by the subcommittee, the FDA needs more money, better computer systems, and should be restructured to include a scientific leader.

"Without a substantial increase in resources, the agency is powerless to improve its performance, will fall further behind, and will be unable to meet either the mandates of Congress or the expectations of the American public. This will damage not only the health of the population of the U.S., but also the health of our economy.''

The report describes rapidly developing advances in areas such as genomics, wireless health-care devices and nanotechnology, and says the FDA can't adequately monitor products because it can't keep up with the science. The FDA suffers `"serious scientific deficiencies,'' the report concluded. The subcommittee consulted more than 25 specialists in industry, academics and government

The report blames Congress for requiring the FDA to take on more responsibilities without providing enough funding to hire staff.

Each American pays about 1 1/2 cents a day to fund the FDA, and an increase to 3 cents a day wouldn't "be a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world,'' according to the report.

And that shouldn't be a problem – after all, everybody else seems to want to give the FDA their two cents worth.  Read More & Comment...

Open Source AEs

11/29/2007 07:33 AM |

Mark McClellan (“the hardest working man in American health care") told a gaggle of biotech executives at Lazard Capital Markets' 4th annual health care conference that a new bill passed by Congress will create a vast new database of drug patients by 2012.

McClellan said major health care organizations such as eHealth Initiative, Partners Healthcare and Kaiser Permanente will coordinate with insurers like Wellpoint, Inc.and Unitedhealth Group to gather and collate the data from patients. This initiative is part of the FDA Amendment Act of 2007.

"Most of the evidence on your products will be coming from sources other than you," said McClellan, who sees the information as being more complete and more objective.

If all members of the American health care system can work together and following the same rules (in how they define adverse events and how they use the data) “you've got tens of millions (of people) in the database," said McClellan.  Read More & Comment...

Patent Pending

11/28/2007 08:19 AM |

As any medical scientist will tell you, there are few "Eureka!" moments in health research. Progress comes step-by-step, one incremental innovation at a time. Companies more often profit by improving existing chemicals and making processes more efficient than by revolutionizing the whole field with new products. And even the smallest innovations are made only after large amounts of very expensive research.

How distressing, then, that the U.S. Senate has taken up a bill that would pretty much decimate patents as we know them. The Patent Reform Act of 2007, a version of which has already passed the House, would require every patent application to be published on the Internet only 18 months after filing.

Considering the years of research underlying most medical innovations, it is madness to require pharmaceutical companies to reveal their secrets so early. It seems even more unfair when you consider that it often takes in excess of 36 months after filing a patent to actually have it approved. This means that competitors and criminals will have a window of at least 18 months to replicate new drugs and medical research.

Here’s the rest of the story …

http://www.spectator.org/dsp_article.asp?art_id=12332

Our strong patent law is a major reason why many pharmaceutical companies are still based here, instead of, say, Canada, where laws are weaker. If the Senate passes the Patent Reform Act of 2007, some companies might pack up and leave. Or, more worryingly, they might simply halt research on what could be tomorrow's life-saving cures.  Read More & Comment...

A TRITON Missile from Sidney

11/27/2007 09:24 AM |

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

The Media on Drugs

By SIDNEY TAUREL

When it comes to describing the benefits and risks of prescription drugs, the hyper-competitive, around-the-clock media is rarely at its best. Call the following a case study in the challenge of doing right by doctors and patients -- in spite of the need to feed the media beast with copy.

Our story starts Oct. 24, when several media outlets reported that Eli Lilly and Company had halted two clinical trials for the drug prasugrel -- a possible new therapy for heart-attack patients that Lilly is developing with Daiichi Sankyo. The speculation that followed these reports was that the drug must have failed its initial trials. Within a few days the market capitalization of Eli Lilly fell by about $6 billion.

This speculation was unfounded and, incidentally, false. In early November, the academic TIMI Study Group announced the results of a massive clinical trial showing that prasugrel produced significant improvements in patient outcomes compared with current treatments.

Specifically, the trial, known as TRITON, showed that prasugrel produced a 19% reduction in relative risk for cardiovascular death, nonfatal heart attack, or nonfatal stroke when compared with the drug clopidogrel -- today's standard of care -- and had a favorable benefit-risk profile in a large majority of patients.

Statistical data can be interpreted in different ways. Some experts will reach more nuanced or skeptical conclusions about TRITON. But a Duke University cardiologist told this newspaper, after seeing the trial's results, "If you can't get a drug on the market with that kind of data, we should stop developing drugs."

So what happened in those days after Oct. 24? Lilly's goal was to turn over our prasugrel findings to doctors in a manner that left no doubt as to their scientific rigor and completeness. This meant publishing the findings in a highly respected journal and discussing them directly with top cardiologists, ahead of mass-media reporting. We decided to present these findings to the New England Journal of Medicine (NEJM) and the Annual Scientific Sessions of the American Heart Association (AHA) on Nov. 4.

NEJM and AHA asked for promises from Lilly and its partners, and we agreed, not to disclose any of the results of TRITON prior to Nov. 4. Such guarantees of exclusivity are not only common, but also appropriate, in focusing expert attention on important research. A definitive source and a "zero hour" of first-hand disclosure for complex scientific data help to limit misinformation.

Doctors and scientists at Lilly and Daiichi Sankyo, of course, had begun to analyze the results of TRITON in the weeks leading up to the AHA meeting. In addition to showing strong efficacy, the data also showed that in three small subgroups of patients, the drug at its current dosage raised the risk of major bleeding relative to its effect on preventing heart attacks.

Lilly had two small clinical trials of prasugrel underway for different research purposes, and we had received no reports of safety concerns from them. But when we saw the TRITON results, we put patients first. Based on the small chance that patients in the three identified subgroups might be given prasugrel and experience serious bleeding, we advised our researchers to suspend the two trials pending a review.

Enter the beast. Ten days before our "zero hour," word leaked out, causing us to confirm that the two prasugrel trials had been suspended, although our promises to NEJM and AHA prevented us from explaining why. The media entered a feeding frenzy, catered by commentators on Wall Street and elsewhere who speculated that prasugrel posed broad risks and had probably failed its major trial. Our stock began its trip south and, more seriously, some doctors and patients were left with false impressions.

Unveiling the data at AHA brought some relief. Still swimming against the tide of rumor, a few stories distorted the TRITON results, but most were balanced. In the end, the Food and Drug Administration will not rely on media reports to reach approval decisions. Lilly is confident that prasugrel will be given a chance to help patients on a large scale.

There are a few lessons here that need to be learned. For the pharmaceutical industry: Preserving the integrity of scientific data and protecting the safety of patients are always the right choices. Stock prices recover but trust is much harder to regain. Trust hinges on our openness in sharing everything we know about who should use our products -- along with when, how and at what dose -- and who should not.

For the media, if I may be so bold: Don't trade in leaks and rumors where scientific data are concerned. Damage to public understanding is hard to repair after it's been done. Wait for real numbers, and take the time to explain statistics and benefit-risk analysis, which cannot be conveyed in sound bites alone. And for would-be pundits: If you have not had firsthand exposure to the scientific results or specialized knowledge under discussion, then qualify your comments if you must make them at all.

We all have a stake in taming this beast -- not for the sake of any company or individual discovery, but for the sake of those who ultimately rely on accurate information for the care of patients.

Mr. Taurel is chairman and CEO of Eli Lilly and Company.  Read More & Comment...

Universal Health Care, Government Health Care, and the Macy’s Thanksgiving Day Parade

11/27/2007 08:34 AM |

What's the difference between “universal” and “government” health care? We sent our intrepid podcast camera crew out into the crowd at the Macy’s Thanksgiving Day Parade to find out.

Click here for what some “real people” had to say when asked if they would prefer “universal” or “government” health care:

http://cmpi.org/archives/2007/11/universal_healthcare.php

Our decidedly unscientific sample points to one decidedly obvious conclusion – folks are confused. And the bad news is that politicians are taking advantage of that confusion.

As James Thurber quipped, “You can fool too many of the people too much of the time."

And that’s bad medicine.  Read More & Comment...

Letting the government decide what is unacceptable

11/27/2007 07:34 AM |

Health Affairs is late to the party when it comes to personalized medicine. It has a roundtable of oncologists talking about treating cancers and people differently right off the bat like it was something new. Better late than never. But some people still like using blunt instruments. Here is the managed care view of comparative effectiveness courtesy of Lee Newcomer business leader of Oncology Services at UnitedHealthcare in Minneapolis.

"Newcomer also argues that, following the example of the United Kingdom, the U.S. government should establish cost-effectiveness guidelines: “The government could say that anything more than $40,000 per year of life gained is unacceptable.”

As we all know by now, the UK has the lowest five year survival rates across the board for all cancers and has increasing death rates for many cancers thanks to this approach.

My suggestion to Newcomer: Apply that metric to you and your family. Look them in the face and tell them that their lives are not worth more than a Honda Prius.




http://us.f328.mail.yahoo.com/ym/ShowLetter?MsgId=1664_41790369_156635_1276_12940_0_674597_31516_348646986&Idx=9&YY=53821&y5beta=yes&y5beta=yes&inc=25&order=down&sort=date&pos=0&view=&head=&box=Inbox  Read More & Comment...

Straight story on Vytorin Cholesterol trials? Fat Chance

11/26/2007 11:54 AM |

Here's the right question to ask: Would Merck and Schering-Plough knowingly try to cover up data about their drugs? The logical answer is no. Are delays common in producing results. Yes. Have some of the people that Matt Herper and Alex Berenson been involved in scrubbing or tossing out or re-analyzing clinical trial data? Yes. Must we remind the MSM about Nissen's role in the Atherogenics trial or Matt's coverage of that story?

Well here goes:

http://www.thestreet.com/pf/comment/adamfeuerstein/10195643.html

But AGI-1067 has been dogged by controversy ever since AtheroGenics released interim results from a phase II study known as CART 2 in late September. While AtheroGenics claimed that the interim analysis was positive, critics charged the company with manipulating results in the drug's favor. It was hoped that final data from the CART 2 study would settle the argument.

Data Are Final, but There's More Debate

Monday, those final CART 2 study results were made public, but it doesn't appear as if the controversy over AGI-1067 will subside any time soon.

AtheroGenics said that AGI-1067 was able to reduce the level of arterial plaque by an average of 2.3% over 12 months, a statistically significant amount when compared with the patients' own baseline measurements. Patients in the placebo arm of the study saw only 0.8% reduction in their plaque levels from baseline.

While patients taking AGI-1067 did better than patients in the placebo arm of the study, the relative benefit between the two groups was not statistically significant, AtheroGenics said.

Furthermore, the data from the final analysis were worse than what was reported previously. In the interim analysis, conducted on fewer patients, AGI-1067 produced a 3.8% reduction in arterial plaque.

AtheroGenics said that treatment with AGI-1067 also produced a statistically significant reduction in levels of myeloperoxidase (MPO), an inflammatory biomarker that correlates with future cardiovascular events. High levels of MPO have been linked to increased risk of heart attack, the company said.

But the company did not present any data linking AGI-1067 to reductions in C-reactive protein, a much more widely recognized clinical biomarker for inflammation and cardiovascular risk.

As with the interim analysis, the final analysis was conducted at two leading hospitals -- Montreal Heart Institute and the Cleveland Clinic. The confirmatory analysis conducted by the Cleveland Clinic, not prespecified in the study's protocol, was one of the reasons some critics felt the AGI-10687 data were misleading, especially because doctors at Cleveland Clinic eliminated some patients from the study because their arterial scans were not readable.

In September, Dr. Steven Nissen of the Cleveland Clinic defended his role in analyzing AGI-1067, calling the drug promising if data could be verified in a late-stage study. But Dr. Eric Topol, another leading cardiologist from the Cleveland Clinic, criticized AtheroGenics and the way CART 2 data were analyzed.

There was no comment Monday from Nissen in AtheroGenics' press release and he was missing from the company's conference call. But Dr. Jean Claude Tardif of Montreal Heart, the lead investigator in the CART 2 study, was supportive.

Here's how Herper handled the Nissen involvement in the Atherogenics trial

AtheroGenics first rose to prominence by touting AGI-1067 as a treatment for inflammation of the arteries. The small biotech rushed into its late-stage study, at a cost of more than $40 million, to try to prove the drug reduced heart attacks, strokes, deaths and surgical procedures.

"But the company badly handled its midstage data, eroding investors' trust. One study, called CART-2, was designed to show that AGI-1067 prevented the buildup of cholesterol plaque in the arteries, as measured by an ultrasound probe. For some reason, Medford and his team were troubled by the results.

AtheroGenics brought in a second scientist, Steven Nissen of the Cleveland Clinic, to do a new analysis of the data. Nissen's analysis seemed to show that the drug worked at clearing out artery plaque, but an analysis by Jean-Claude Tardif of the Montreal Heart Institute, who collected the ultrasound data, was inconclusive."

http://www.forbes.com/sciencesandmedicine/2007/03/19/atherogenics-cardiac-heart-biz-bizhealth-cx_mh_0319cardiac.html

As for Berenson who quoted Nissen and Psaty who was rebuked by NCI for scaring people about the cancer risks of calcium channel blockers, the failure to handle the difficulties about conducting randomized clinical trials with all the scans, blood samples, etc and then adding in a comparative element, well....par for the course. At least this garbage is now in the business section.

But all this speaks to is the pressure to sell papers rather than report on "boring" science.The Atherogenics data could use some re-analysis of subpopulations but when you are trying to be a blockbuster you try to be all things to all people and wind up showing no difference.

So in the end the real story is the limited value of randomized clinical trials in an era of personalized medicine. That's not sexy cause it's science and doesn't have good guys or bad guys or advance Nissen's career. But it's closer to the truth. Which is often boring.  Read More & Comment...

The Best Care Anywhere?

11/26/2007 09:17 AM |

Another great example of what Hillary and Paul Krugman were, less than a year ago was the "best care anywhere", namely the VA. Here's Krugman about how great the VA is, particularly in terms of how much it cares about it's patients, the veterans of America:

The key to the V.A.’s success is its long-term relationship with its clients: veterans, once in the V.A. system, normally stay in it for life. This means that the V.A. can ... make much better use of information technology than other health care providers. ... which reduces both costs and medical errors. The long-term relationship ... also lets the V.A. save money by investing heavily in preventive medicine, an area in which the private sector — which makes money by treating the sick, not by keeping people healthy — has shown little interest.

The result is a system that achieves higher customer satisfaction than the private sector, higher quality of care by a number of measures and lower mortality rates — at much lower cost per patient."

http://select.nytimes.com/2006/09/04/opinion/04krugman.html?_r=1&hp&oref=slogin


Easy to get high marks when you are just screening healthy people and sending them away. But arguably you should rate a health care system for how it treats the whole person when they are sick and in distress. So on the heels of data showing that the VA formularies reduce life span and increase suffering, the Congressional Budget Office shows that returning vets are waiting longer for care they never get...

Here's Donna Shalala who co-chairs the federal task force reviewing care for Iraq vets:

"Without designated care coordinators to plan the best treatment path for new patients, an untold number ended up lost.

In addition, injured combatants must go through two antiquated disability assessments -- one by the military and one by the VA -- to determine what treatment options are available. This means that many are forced to jump through bureaucratic hoops that might not even get them to the right place, Dr. Shalala said.

"For veterans' families to give up everything just to coordinate this care themselves is fundamentally unfair," she said. "The process is too old-fashioned. It has nothing to do with modern medicine, and we ought to be embarrassed."

http://www.ama-assn.org/amednews/2007/12/03/gvsa1203.htm


Hey Paul, that gives "long term relationship" a whole new meaning. Sounds like single payer care to me. Krugman's response will likely be to blame Bush for not spending more. That won't wash. Spending on the VA has doubled under his administration. And spending more, as the UK and Canada health systems have shown, doesn't reduce waiting. Or insure that doctors can actually practice effective medicine instead of guideline driven drivel.

If Krugman and others really cared about vets and not ideology they would support the following reform: Giving vets the freedom they were fighting for in Iraq. Let them choose where to go for health care. If they can't get immediate care in the VA, give them cash to buy a policy with a health plan that will offer to do so.

Vets will die waiting for Congress and the VA to act.  Read More & Comment...

You mean it isn’t “free?”

11/26/2007 07:59 AM |

What’s the difference between “universal” health care and “government” health care?

The sad answer is that the first is a good political sound bite and the latter is not. The truth is that they’re the same thing -- and neither is “free.”

There is no such thing as “health care from heaven.” Just ask the citizens of any nation in the EU or Canada. Better yet, ask Illinois’ Governor Rod Blagojevich whose plan for “free” and “universal” coverage in the Prairie State (designed to be funded via a very un-free $7.6 billion gross receipts tax on Illinois businesses) went down in flames in the state legislature 107-0 ... after the Governor came out against his own idea.

As the Wall Street Journal opined, “'Universal' government health care has once again returned as a political cause, with many Democrats believing it's the key to White House victory in 2008. They might want to study last week's news from Illinois, where Democratic Governor Rod Blagojevich's tax increase to finance health care became the political rout of the year."

Some candidates for the presidency are beginning to get the picture – others not so much. Here’s an article from the New York Times that points out the problems of sound-bite health care plans:

http://www.nytimes.com/2007/11/25/us/politics/25mass.html?_health&oref=slogin

There’s no such thing as a free lunch – or “free” health care.  Read More & Comment...

Harvey talks about the Benjamins

11/24/2007 11:03 AM |

Harvey Bale (IFPMA) responds to a recent letter in The Lancet accusing some patient groups of conflict of interest.

Thai MoH's undeclared interest: its profit-making pharma operation

The letter published in the last edition of The Lancet under the title "WHO's web-based public hearings: hijacked by pharma?" expresses surprise that patient groups could advocate "pro-IP" views in internet submissions ahead of last week's WHO Inter Governmental Working Group. It goes on to imply this could only have happened because of the "pharmaceutical industry compromising patient advocacy groups".

If the authors of the paper seek to present this as an issue, it is because they are firmly on the "anti-IP" side of the IGWG debate, but the authors conclude their letter by declaring that they have no conflict of interest.

The first author listed is Suwit Wilbulpolprasert, who correctly presents himself as an employee of the Ministry of Health, Nonthaburi, Thailand. The Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO), the role of which is to manufacture and import medicines and sell them for profit.(1) The GPO made a net profit of one billion baht ($30.8 million) on revenues of 5 billion baht ($154.1 million) in 2005, according to former deputy health minister Anuthin Charnveerakul.(2)

The compulsory licenses that the Thai MoH has issued in the last year allow the GPO to import and sell for profit generic copies of two antiretrovirals and one cardiovascular medicine still under patent. This move raised an international furor and the Thai MoH has so far refrained from implementing its publicly stated intention to implement further compulsory licenses. Any outcome of the WHO IGWG which endorses expanded use of compulsory licensing would support the Thai MoH in issuing more such licenses and so help GPO to increase its profit-making activities. Dr. Wilbulpolprasert's declaration of no conflict of interest does not hold up.

I declare the following interests: I head the international R&D-based pharmaceutical industry association, which believes that adequate intellectual property protection is an essential prerequisite for innovation in medicines and the improvement of global health outcomes. The R&D pharmaceutical industry also believes that patients' voices should be heard in discussions about health policy, and is prepared to contribute financially to help permit this, while accepting that patient groups are free to express their own opinions, even when these might be critical of the industry.

Yours sincerely,

Dr. Harvey Bale

Director General
International Federation of Pharmaceutical Manufacturers & Associations

For more on this issue, see our November 16th blog entry, "Compulsory Hypocrisy" here:

http://drugwonks.com/2007/11/compulsory_hypocrisy.html

As H.L. Mencken once said, when someone says it isn't about money, it's about money.  Read More & Comment...

A NICE Backdoor

11/23/2007 07:42 AM |

According to CMS Chief Medical Officer Barry Straube, the possibility of simultaneous FDA and CMS evaluations of new devices is again under consideration by agency officials. Straube, who also directs the CMS Office of Clinical Standards and Quality, said his agency is working with FDA on a proposal for parallel review, which could be made public in the "relatively near future."

In 2005 FDA officials suggested that a Federal Register notice would soon outline a way for companies to request parallel reviews as a way to streamline the normally sequential marketing-approval and Medicare-coverage processes.

"We came very close to putting together a pilot project two years ago, but it kind of got put to the back burner for reasons I'm not even sure of," Straube said.

Involving CMS in premarket studies "is highly problematic," commented AEI's Scott Gottlieb, in part because CMS lacks expertise in clinical trial design. He also points out that Industry is worried that proprietary data, which FDA must by law protect, will not remain confidential if it is shared early on with CMS, which is subject to different disclosure mandates.

I may have been born at night – but not last night, Dr.Straube. This is a back door to cost effectiveness in the FDA review process, or at the least, that is what it will become if we allow the cost-effectiveness gang to have their way.  Read More & Comment...