the "care" in health care

05/02/2007 05:57 AM |

My article in yesterday's Wash Post was about the need for good doctors to remain true to their professionalism, and practice quality medicine based on committment rather than price. This is becoming rarer, but it is not yet so rare that i wasn't able to find some true artists among those i interviewed. It's interesting to me that so many want "bottom-line thinking" when it comes to medicine, with detached robot-like practitioners, but would never make that mistake with their airlines or cars. I have a Miele dishwasher that never breaks. Why would i trade it in for a GE? The best doctors not only put their professionalism and committment first, they also practice a higher level of care. It is hard to study that, but it is true nonetheless.

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/27/AR2007042702620.html?hpid=sec-health  Read More & Comment...

Comparative Obviousness

05/01/2007 02:33 PM |

The Associated Press reports that. “In a unanimous ruling, the justices said a federal appeals court has gone too far in embracing a standard that addresses one of the most basic issues in patent law: whether a claimed invention is obvious and therefore unworthy of patent protection.”

Justice Anthony Kennedy wrote.

"Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may ... deprive prior inventions of their value."

The case in front of the high court was KSR International Co. v. Teleflex Inc. The issue -- a patent for adjustable gas pedals.

The issue, needless to say, transcends this particular innovation.

To again quote the AP, “The legal test at issue in the Teleflex lawsuit has been criticized by the Bush administration as leading to an unwarranted extension of patent protection to claimed inventions that are obvious. Critics of the test say it results in less competition and stifles innovation.”

Adjustable gas pedals are one thing. 21st century medicines are something else entirely – something else with important implications for the future of the public health.

And it’s not good news.

Here’s the rub – what’s “real innovation?” What does “obvious” mean? And what does it mean when one considers the concept of pharmaceutical incremental innovation.

All of a sudden it’s not so obvious.

Let’s face it; there are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, boy, are the important. Why? Because that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits. Obvious? Hardly.

The reason the high court’s ruling is so profoundly disturbing to the future of pharmaceutical innovation is because now it becomes not a leap but a small step to mindless support for healthcare technology assessment aka evidence-based medicine aka comparative effectiveness. After all, if we don’t recognize the concept of incremental innovation as “obvious” – as progress worthy of patent protection – why should we pay for it?
Indeed, why even pursue it? Yikes.

And what’s the alternative -- Jamie Love’s concept of replacing pharmaceutical patents with a “prize” system wherein the government pays an innovator a lump sum amount for its innovation (based on some measurement of the newfangledness) that is then placed in the public domain?

And what might such a measure be? Most likely comparative effectiveness information that misuses and misrepresents data derived from RCTs.

The “prize” model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketry”) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.

One wonders if the new Supreme Court ruling would allow that Dr. Goddard’s patent reached the level of “obvious” innovation. But we'll leave the alternative history lesson for another day.

Now consider the fact that Mr. Love’s idea is going to be introduced in federal legislation by the new Socialist Senator from Ben & Jerry’s, Bernie Sanders. Frighteningly, not so fantastical after all.

As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."

Sound familiar?

To again quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.”

Obvious? Obviously not.  Read More & Comment...

Penelope's Fight For Life

05/01/2007 02:24 PM |

Geeta Anand has a nice piece about the struggle to get a dying child access to an experimental drug. The only problem is that the people she gives credit for supporting the family in pressuring the small start up - Nancy Pelosi -- supports the sort of fear mongering, lawsuits, price controls and FDA fearmongering that make small biotech start ups reluctant to take a risk on a potentially dangerous drug with a dying child.

Still, the article underscores the moral clarity and durability of the Abigail Alliance's position on access to experimental medicines. Some may not agree with the Tiered Approval process but I predict that Frank Burroughs and co. will be victorious. Science and sense of purpose are behind him. While some may believe that patients, companies and the FDA working together is too "cozy", I believe it should be common practice. We need more Frank Burroughs and we need more miracles of medicine.

http://abigail-alliance.org/  Read More & Comment...

Setting The Sights on Science

05/01/2007 01:37 PM |

Andy von Eschenbach is doing the smart and right thing by reaching to a group of academics and industry researchers to see if the FDA's science is up to snuff. It sets the stage for future collaborations and funding requests. Asking Gail Cassell, who was on my FDA Task Force when I was at the Manhattan Institute, to chair this group signals that the FDA is serious. Dr. Cassell is brilliant, well-respected and has taken on a similar task with respect to biodefense issues. What's more, she provides badly needed support to Janet Woodcock to make the review staff at the agency more Critical Path conscious. Look for an overhaul and upgrade of folks who do not want to embrace biomarkers, adaptive trials, Bayesian analyses, etc.

PS...Jacob Goldstein's health blog at wsj.com is great....

http://blogs.wsj.com/health/2007/05/01/fda-science-under-the-microscope/  Read More & Comment...

The Brown Jewels

05/01/2007 10:29 AM |

Senator Sherrod Brown's comment that "the pharmaceutical industry’s 3000 lobbyists oppose S.1082," is just another indication of how entirely politicized the debate over FDA reform has become. This is the latest in a series of hyperbole-driven statements aimed at to garner media attention by slamming the pharmaceutical industry. And truth be damned.

(Attention Senator Brown -- the last time I looked, industry was generally supportive of the bill.)

What we need are thoughtful and insightful comments that advance the cause of FDA reform and, more broadly speaking, the public health -- not more bloviation and grandstanding.  Read More & Comment...

Live Free or ... ?

05/01/2007 07:21 AM |

CONCORD, N.H. -- A federal judge on Monday struck down a state law that makes doctors' prescription-writing habits confidential, saying it violates the First Amendment.

Good call.

Whether or not physician-prescribing data should or shouldn’t be available for marketing purposes is one thing, but the most important thing to remember is that there are important public health reasons why this data must continue to be shared with pharmaceutical companies.

When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor” letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.

Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.

According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.”

In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.

The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.

When it comes to New Hampshire, “Live free or die” is a great state motto — but it’s a terrible health care policy.   Read More & Comment...

Northern Exposure: Canadian Seniors Get Less Coverage Than American Counterparts

04/30/2007 11:35 PM |

http://www.wardhealth.com

From Ward Health Strategies....

Access to Innovation

American seniors have better access to prescription drugs under Medicare Part D plans than Canadian seniors under Canadian publicly funded drug plans.

Under Medicare Part D, access to publicly funded drug benefits is now better in the United States than in Canada. American seniors, enrolled in a Medicare drug plan get better access to new medicines than Canadian seniors who rely on publicly funded drug benefits. In Canada, only 42 percent of the 33 drugs assessed by Canada’s Common Drug Review (CDR) were recommended for listing at the end of 2005.

But only 15 percent of the 33 drugs assessed by the CDR by the end of 2005 drugs were listed in Ontario as of January 1, 2006. On average, less than one in four drugs (21 percent) reviewed by the CDR has been listed for reimbursement by participating provincial drug plans. Quebec, which does not participate in the CDR, lists 55 percent of these 33 drugs.
By comparison, 82 percent of these same 33 drugs are listed in U.S. Medicare drug plans.  Read More & Comment...

My Friend Flickertail

04/30/2007 02:29 PM |

Former Flickertail and current Boston Globe star reporter Diedtra Henderson, points out that Senator Dorgan is from Dickinson, North Dakota -- not Grand Forks (as mentioned below).

We stand corrected.  Read More & Comment...

The Dorgan Organ

04/30/2007 01:35 PM |

Any minute now Senator Byron Dorgan is expected to propose an amendment to PDUFA IV that would allow for (drum roll please) drug importation.

Now Senator Dorgan is tough to reach, so rather than leaving endless phone messages and e-mails, we opted for an op-ed piece in his hometown paper, the Grand Forks Herald.

Here it is ...

Download file

Sorry Senator, those pesky facts keep getting in the way.  Read More & Comment...

Note to Jamie Love: Watch Who You Are Calling A Hypocrite

04/30/2007 08:59 AM |

Jamie Love went on a predictable rant about the exit of Randall Tobias from running the President's Emergency AIDS Program: Tobias is hypocrite for soliciting prostitutes (which Tobias acknowledges) and practicing unsafe sex (how does Love know?) and therefore unfit to run the program which he (again according to the all knowing JL) used to stress abstinence and condoms over HIV drugs.

http://www.huffingtonpost.com/james-love/randy-tobias-risky-sexua_b_47160.html

I heard Desmond Tutu on the radio (Howard Stern, no less www.howardstern.com ) where he told his interviewer about the the ABC's of HIV prevention: Abstain, Be Faithful, Condomise.
So according to Jamie's logic, Desmond Tutu was also getting massages from high priced escort services too.

Also according to Jamie's logic, no one who is sexually promiscuous and practices unprotected sex should be an ambassador on HIV issues. So I guess that excludes Bill Clinton and his Clinton HIV Foundation, right? Should I start in on the Hollywood types that are your co-bloggers Jamie?  Read More & Comment...

Drug Ads and Great Expectations.

04/30/2007 07:47 AM |

"The doctor of the future will give no medicine, but will interest her or his patients in the care of the human frame, in a proper diet, and in the cause and prevention of disease"

-- Thomas A. Edison

Welcome to PiP.

For those of you drugwonks out there who aren't fans of Charles Dickens, here's the Cliffsnotes background on the literary character of the same name ...

Great Expectations is the story of Pip and his initial dreams and resulting disappointments that eventually lead to him becoming a genuinely good man. The significant changes that Pip's character goes through are very important to one of the novel's many themes. Dickens uses Pip's deterioration from an innocent boy into an arrogant gentleman and his redemption as a good-natured person to illustrate the idea that unrealistic hopes and expectations can lead to undesirable traits.

Yes, Pip as an allegory for Pharma.

Now welcome to PiP -- Personalized Information to Patients

As Congress debates the (clearly unconstitutional) idea of granting the FDA authority to ban DTC for any new drug's first two years of availability, the science of personalized medicine will ultimately make this debate meaningless.

As we attain the knowledge to prescribe the right medicine in the right dose for the right patient at the right time, patients and physicians will rely more on gene testing than product advertising. Indeed information will no longer only mean information about a medicine or a disease -- it'll mean information about your personal biochemistry -- hence Personalized Information to Patients.

In the not so distant future, ads for gene tests may very well replace and surpass those for medicines. Talk about disease awareness! Talk about early and accurate diagnosis! Talk about moving from an acute to a chronic care model!

But it needs to be more than just science talk and silly pieces of ersatz legislation. And that's where the FDA's Critical Path program comes into play.

If we want health care advertising to move beyond the current Cliffsnotes of health information -- DTC -- to the real deal -- Personalized Information to Paitents -- PiP -- we must create the regulatory tools that allow it to happen.

Otherwise it's just talk.  Read More & Comment...