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“All animals are equal, but some animals are more equal than others.” A famous line from a famous book with a famous lesson – they’re not.

Today that lesson needs to be relearned. Case-in-point, a Canadian judge’s apparent belief that all patents are equal, but some patents are less equal than others.

Specifically, pharmaceutical patents.

But first a point of order – this is not about the position of the Government of Canada, which is very good on these issues. This is about the actions of an activist judge – the Honourable Mr. Justice Hughes, of the Federal Court of Canada.

It’s about a patent case brought by Novopharm (the large Canadian generics company) against Eli Lilly (the large American pharmaceutical company). But the issue is considerably broader and the precedent is frightening not only for innovator pharmaceutical firms – but for the future of Canadian public health.

The issue, relative to a pharmaceutical patent, “… is the sufficiency of the disclosure in the patent itself…” Judge Hughes’ decision has created a requirement that “… the advantage must be plainly and fully set out in sufficient detail so as to enable a person skilled in the art to know and appreciate what they are.” That is, the judge found that it is “mere rhetoric” to only state the advantages of the invention in the patent specification.

And get this – Judge Hughes ruled on an argument that wasn’t even made by Novopharm. He invented and then ruled on his own argument.

Here's a link to Judge Hughes’ June 5, 2007 decision:

http://decisions.fct-cf.gc.ca/en/2007/2007fc596/2007fc596.html

(PS/ A Canadian appellate court chastised Judge Hughes' decision.)

A couple of crucial points:

Eli Lilly Canada Inc. v. Novopharm Limited raises a significant new question of law and represents a significant shift in the requirement for disclosure in patent applications that has an immediate impact on presently pending applications and patents-in-force in Canada.

Judge Hughes’ ruling is out of step with Canadian law; it violates international IP treaties (TRIPS, PCT), and makes Canada an outlier among all developed and developing countries.

For example, the Patent Cooperation Treaty (PCT) provides for the requirements of a patent specification and states that the “description shall disclose the invention in a manner sufficiently clear and complete for the invention to be carried out by a person skilled in the art.” Considering that Canada is a member of the PCT, it seems that the Federal Court has now made Canada non-compliant with its treaty obligations.

Furthermore, by applying this “super-sufficiency” requirement to a certain class of improvement patents (so-called “selection” patents); the decision also violates the nondiscrimination clauses of TRIPS. TRIPS requires that the standards of patentability for all technology must be the same. In addition, by applying this requirement only to selection patents, the legal requirements in Canada now improperly establish a higher standard of patentability for this type of innovation in contravention of the non-discriminatory clauses of TRIPS.

And, even worse, the Court of Appeals in Canada has created a practice of dismissing any adverse ruling against the pharmaceutical patent as being moot if the generic obtains its marketing approval before the appeal can be heard. So, a generic challenger has their day in court and a full opportunity to appeal a ruling. The innovator pharmaceutical company has their day in court with the first challenger and if there is an adverse ruling will have no opportunity to appeal. To further exacerbate matters, the Court of Appeals has also held that once the first generic challenger has prevailed subsequent challengers should also be granted an approval.

So much for checks and balances.

These actions are manifestly unfair to the research-based pharmaceutical industry and will chill pharmaceutical innovation in the Great White North. This illegal and unfair attitude, if it continues unfettered or unquestioned, will lead to fewer innovative pharmaceutical products being made available to Canadians.

Ah, those pesky unintended consequences.
Whichever party wins the White House in 2008, one truth will prevail at FDA – regulators love ambiguity but can learn to embrace predictability.

A second truth is that FDA decisions are and will continue to be based solely on sound science and its impact on the public health. So, whether red or blue is ascendant, FDA will make its decisions based on the facts.

What might change, depending on who occupies the White House and the FDA Commissioner’s Office, is how the FDA views the concept of time. And it could go either way --because there is real time and there’s FDA time.

There’s an old Washington story that goes like this -- Henry Kissinger asked Chinese leader Chou En Lai whether the French Revolution of 1789 had benefited humanity, to which Chou responded: "It's too early to tell."

Chou would have made a great regulator.

Real time is for the world we live in. The clock we watch – for business, certainly, but also for the rest of us. FDA time is the time it takes to get it right (PDUFA notwithstanding) and, unless there's a trebling of the FDA budget, the only real way to meaningfully accelerate FDA actions without compromising quality (read “safety and effectiveness”) is through collaboration with academe, with industry, and with hybrids like Ray Woosley's Critical Path Initiative.

Will collaboration continue to be embraced by the next President? By the next FDA Commissioner? This is the crucial question.

A related core issue is predictability – the opposite of ambiguity.

Predictability is power in pursuit of the public health. A case in point is the Critical Path initiative and the ways it can reach out and work with non-government partners via the imminent Reagan-Udall Center (pending in still pensile legislation). But ambiguity is bureaucratic power – and too many regulators accept ambiguity as a replacement for responsibility..

(I also believe that too many folks at pharmaceutical companies accept ambiguity as a replacement for responsibility.)

The coming election, relative to the future of the FDA, is a battle between nascent predictability and insidious ambiguity. So, here’s my idea for a bumper-sticker – “I support the FDA and I vote.”
Someone with a twisted mind came up with this headline at CNN.com..

FDA bans import of drugged fish from China
Food and Drug Administration announced a ban on the import of five species of seafood from China due to possible contamination with medications.

http://http://money.cnn.com/2007/06/28/news/international/china_fish/?postversion=2007062815
My prescription: Go see "Live Free and Die Hard" instead.

Read article here
You have to love the way the NEJM and the NY Times treat the issue of drug safety. Steve Nissen runs a crappy meta-analysis of Avandia's supposed dangers and it's rushed to e-print in advance of a Senate hearing and the close of the markets. The NYTmakes it front page news.

A careful study that shows a very low risk of birth defects among women taking anti-depressants while pregnant...? Why, the very same NEJM sees no reason to stop the presses. No Congressional hearings. No publicity whores running to Nightline to talk about the number of suicides and depressed women who affected by the lack of treatment.

And the NY Times? No front page articles linking anti-depressants to "suicides." Because this time it's for real and this time it's a case of telling pregnant women it's ok to take them. (Kudos to http:// pharmalot.com for being one of the first on the web with the good news)

It's page A16, next to a silly story about a congressional proposal setting up a mandatory registry of all "gifts" drug companies provide to doctors. Listen to how the NY Times reports on this NEJM article:

The findings, appearing in two studies in The New England Journal of Medicine, support doctors’ assurances that antidepressants are not a major cause of serious physical problems in newborns.

"But the studies did not include enough cases to adequately assess risk of many rare defects; nor did they include information on how long women were taking antidepressants or at what doses. The studies did not evaluate behavioral effects either; previous research has found that babies suffer withdrawal effects if they have been exposed to antidepressants in the womb, and that may have implications for later behavior.

“These are important papers, but they don’t close the questions of whether there are major effects” of these drugs on developing babies, said Dr. Timothy Oberlander, a developmental pediatrician at the University of British Columbia, who was not involved in the studies. “There are many more chapters in this story yet to be told.”

http://www.nytimes.com/2007/06/28/health/28depress.html?_r=1&oref=slogin

Meanwhile, in responding to a similar study last year Oberlander said: "At present, probably the effect of not treating the women's clinical depression is a much bigger issue for mothers and their infants."


http://www.healthfinder.gov/news/newsstory.asp?docid=530794

Maybe we should do a study looking at the effect of being interviewed by the NYT on the quotes researchers give to reporters. We could call it the Nissen Doomsday Effect.


I digress. Notice all the caveats? Now here's the NYT on Avandia:

"The analysis, based on a review of more than 40 existing clinical studies involving nearly 28,000 patients, showed that Avandia significantly increased the risk of heart attacks, compared with other diabetes drugs or a placebo.

Both the study’s lead author and the editors of The New England Journal of Medicine, in which the article appeared, cautioned that the research method used left the findings open to interpretation. But they said the study nevertheless raised important concerns.

And the publication of the study on the journal’s Web site prompted the Food and Drug Administration to issue a public safety alert and advise users of the drug — an estimated million people in this country and two million worldwide — to consult their doctors about the potential cardiovascular risks.

The journal’s editor in chief, Dr. Jeffrey M. Drazen, said: “We view this as the best publicly available data on a very important question. It shows what we regard as a preliminary, but worrisome, signal about cardiovascular toxicity of this drug.”

http://www.nytimes.com/2007/05/22/business/22drug.html?pagewanted=1&ei=5070&en=dacbc8e498ef3c7d&ex=1183176000

No bias in the media on drug safety. None at all. In light of the increase in teen suicide due to a decline in SSRI use which was triggered by biased reporting, makes you wonder what would happen if drug companies weren't around to provide responsible, peer-reviewed and regulated information about the benefits of their products. And I AM serious about that.
Lest anyone be uncertain that Peter Rost is not a small-minded person who blogs without regard to the totality of the facts, here is the context of Rost's gleeful pursuit of Pfizer's renewed effort to market Viracept, an "old drug" as the consistently vindictive and inaccurate Rost calls the HIV medicine.

Pfizer, according to Rost, was quick to launch marketing materials regarding Viracept. It's materials were not issued and released INTERNALLY consisted with it's own guidelines and the release was shut down. Therefore Rost cannot contain his glee at the expense of the former employe whom he drew a no-show salary from to the tune of over $600K a year while suing them.

But here are some relevant facts, perhaps, just perhaps.
1. The World Health Organization (WHO), drug companies, drug regulators, NGOs and national governments have been working together to minimise the disruption of antiretroviral therapy to individuals affected by the near-global recall of nelfinavir (Viracept).

Although it was initially thought that the recall only affected Europe following the alerts issued by Roche, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMEA) on June 6 th, it has, in fact, affected every country in the world with the exception of the United States and its territories, Canada and Japan.

"A very difficult situation"
On June 14th, WHO issued a statement on the recall, saying that "Roche informed WHO on 8 June 2007 of its global recall of its nelfinavir products (Viracept)." Roche estimates that around 45,000 individuals are affected by the recall globally.

Roche’s International Communications Manager for HIV and Hepatitis, Janet Kettels told aidsmap.com: "This is obviously a very difficult situation, as many people living with HIV/AIDS in the least developed countries do not have easy access to a wide range of alternative treatments."

http://www.aidsmap.com/en/news/EFA4601B-2827-4131-B2E8-6EB722BEE1D9.asp

2. Roche is in Talks With Pfizer Over Viracept Supply Following Recall
As Roche corrects a manufacturing error that resulted in a recall of all batches of its HIV treatment Viracept sold in the European Union (EU) and other world markets, the company is in discussions with Pfizer to supply the antiretroviral as a potential option in expediting the market return of the product, Roche told DID June 20.

www.aidsmap.com

Here's a link to the sludge report.... http://peterrost.blogspot.com/
Two interesting stories today that both reach the same place -- we need to find ways to get the right medicines to the right people at the right time in the right dose. Let's call it "Pharmonic Convergence."

First story comes from the Pink Sheet and their discussion of FDA's genetic test guidelines.

As reporter David Filmore writes vis-a-vis the FDA's genetic test guidelines:

"The agency drafted the guidance document on pharmacogenetic tests and genetic tests for heritable markers to help shorten development and review times for these products, which are attracting growing attention from the medical community as tools to make more precise disgnoses and, in the case of pharmacogenetic tests, more personalized treatment decisions."

Right now, today such tests exist. It is not, as many will derisively tell you, science fiction. It's science fact. And the fact that most insurance companies don't reimburse for such diagnistic tools is short sighted.

To that point, an article from today's New York Times. Gray Lady scribe Milt Freudenheim reports on a new study by the Integrated Benefits Institute that shows, "Employers that shift too much of the cost of drugs to workers in their company health plans could wind up losing more than they save, through absenteeism and lost productivity, according to a study by health policy researchers."

"Among the 17 employers in the study, conducted by the nonprofit Integrated Benefits Institute, more than half the workers with rheumatoid arthritis were not taking their drugs — in many cases because they considered the out-of-pocket co-payments too high.

As a result, the institute’s study found, the employers incurred $17.2 million in costs from lost productivity, 26 percent more than the estimate of what they would have spent if the workers had taken their arthritis drugs."

The lede of the New York Times article reads, "Health penny wise, medical pound foolish?

Indeed.

Okay -- once more with feeling -- patients (otherwise known as "people," aka "voters") need to be on the right medicines for their conditions. And when payors interpose themselves between doctor and patient, when prescribing decisions are made by accountants (read "evidence-based medicine"), health outcomes decline for the individual and costs go up for the payor.

Let's keep our eye on the prize as we strive to move from acute to a chronic care model for 21st century health care. It's nothing short of critical.

And, after all, that's why we have the Critical Path.

Measure THIS!!!

  • 06.27.2007
While the comparative effectiveness cabal try to turn patients into cost-centers and forget that you and I real live human beings, the Integrated Benefits Institutes releases a study that brings the human element back to the delivery of healthcare:

"New Integrated Benefits Institute Report Finds Pharmaceutical Cost Shifting Leads to Increased Disability and Lost Productivity


San Francisco – June 27, 2007 – Medical costs, including drug expenditures, have continued to rise much faster than the rate of inflation, causing employers to use strategies to control costs for pharmaceuticals including higher copays, tiered benefit plans and higher deductibles. A new report released today by the nonprofit Integrated Benefits Institute (IBI) reveals that shifting costs to employees doesn’t save employers money and discourages treatment essential to employees’ health-related productivity and quality of life."

Here's a key quote that all the cost-containers in Washington and those who want to set up a comparative effectiveness board should staple to their forehead, carefully, so all the air doesn't escape:

“As employers understand that providing effective, available health care is an investment in human capital that will pay off in real dollars by decreasing overall health-related costs, they may want to rethink their approach to measuring and investing in employee health and productivity,” said Jack Mahoney, MD, medical director at Pitney Bowes. “This is not only good for employers, but employees can benefit from less shifted costs and better health and quality of life.”

Exactly. Dr. Mahoney articulated the humane, patient centered approach to medicine that the Beltway/Health Affairs/Kaiser/Commonwealth types have turned their backs on. Health care is a human and humane enterprise, not a rationing activity.

Thanks to IBI for restoring a moral and medical compass to the discussion of health care policy.

http://www.ibiweb.org/news/articles/display/7025
From the Daily Sport in the UK

SUBJECT: IF YOU'RE GOING TO BOYCOTT ISRAEL - DO IT PROPERLY!

OK. So I understand that you are ticked off at Israel, and in love with
the Palestinians. That's fine with me, as long as you have truly
weighed all the facts.

So, you want to boycott Israel????? I'll be sorry to miss you, but if
you are doing it - do it properly. Let me help you.

An Israeli company has developed a simple blood test that
distinguishes between mild and more severe cases of Multiple
Sclerosis. So, if you know anyone suffering from MS, tell them to
ignore the Israeli patent that may, more accurately, diagnose their
symptoms.

An Israeli-made device helps restore the use of paralyzed hands. This
device electrically stimulates the hand muscles, providing hope to
millions of stroke sufferers and victims of spinal injuries. If you
wish to remove this hope of a better quality of life to these people,
go ahead and boycott Israel.

Young children with breathing problems will soon be sleeping more
soundly, thanks to a new Israeli device called the Child Hood. This
innovation replaces the inhalation mask with an improved drug delivery
system that provides relief for child and parent. Please tell anxious
mothers that they shouldn't use this device because of your passionate
cause.

These are just a few examples of how people have benefited medically
from the Israeli know-how you wish to block. Boycotts often affect
research.

A new research center in Israel hopes to throw light on brain
disorders such as depression and Alzheimer's disease.

The Joseph Sangol Neuroscience Center in the Sheba Medical Center at
Tel HaShomer Hospital, aims to bring thousands of scientists and
doctors to focus on brain research.

A researcher at Israel's Ben Gurion University has succeeded in
creating human monoclonal antibodies which can neutralize the highly
contagious smallpox virus without inducing the dangerous side effects
of the existing vaccine.

Two Israelis received the 2004 Nobel Prize in Chemistry. Doctors
Ciechanover and Hershko's research and discovery of one of the human
cells most important cyclical processes will lead the way to DNA
repair, control of newly produced proteins, and immune defense
systems.

The Movement Disorder Surgery program at Israel's Hadassah Medical
Center has successfully eliminated the physical manifestations of
Parkinson's disease in a select group of patients with a deep brain
stimulation technique.

For women who undergo hysterectomies each year for the treatment of
uterine fibroids, the development in Israel of the Ex Ablate 2000
System is a welcome breakthrough, offering a noninvasive alternative
to surgery.

Israel is developing a nose drop that will provide a five year flu
vaccine.

These are just a few of the projects that you can help stop with your
Israeli boycott. But let's not get too obsessed with my ducal
research, there are other ways you can make a personal sacrifice with
your anti-Israel boycott.

Most of Windows operating systems were developed by Microsoft-Israel.
So, set a personal example. Throw away your computer!
Computers should have a sign attached saying Israel Inside. The
Pentium NMX Chip technology was designed at Intel in Israel. Both the
Pentium 4 microprocessor and the Centrum processor were entirely
designed, developed, and produced in Israel.

Voice mail technology was developed in Israel.
The technology for the AOL Instant Messenger ICQ was developed in 1996
in Israel by four young Israeli whiz kids.

Both Microsoft and Cisco built their only R. & D. facilities outside
the US in Israel.

So, due to your complete boycott of anything Israeli, you can now
have poor health and no computer.

But your bad news does not end there. Get rid of your cellular phone.
Cell phone technology was also developed in Israel by MOTOROLA which
has its biggest development center in Israel. Most of the latest
technology in your mobile phone was developed by Israeli scientists.

Feeling unsettled? You should be. Part of your personal security rests
with Israeli inventiveness, borne out of our urgent necessity to
protect and defend our lives from the terrorists you support.

A phone can remotely activate a bomb, or be used for tactical
communications by terrorists, bank robbers, or hostage-takers. It is
vital that official security and law enforcement authorities have
access to cellular jamming and detection solutions.
Enter Israel's Net line Communications Technologies with their
security expertise to help the fight against terror.

SO ALL THE NOISE ABOUT THE USA LISTENING TO OUR PRIVATE TELEPHONE
CALLS, YOU SHOULD KNOW IT IS ISRAEL WHO IS DOING THE LISTENING FOR US.

A joint, nonprofit, venture between Israel and Maryland will result in
a 5 day Business Development and Planning Conference next March.
Elected Israeli companies will partner with Maryland firms to provide
innovation to the US need for homeland security.

I also want you to know that Israel has the highest ratio of
university degrees to the population in the world.

Israel produces more scientific papers per capita - 109 per 10,000 -
than any other nation.
Israel has the highest number of startup companies per rata. In
absolute terms, the highest number, except the US. Israel has a ratio
of patents filed.

Israel has the highest concentration of hi-tech companies outside of
Silicon Valley. Israel is ranked #2 in the world for venture capital
funds, behind the USA.
Israel has more museums per capita.

Israel has the second highest publication of new books per capita.

Relative to population, Israel is the largest immigrant absorbing
nation on earth.

These immigrants come in search of democracy, religious freedom or
expression, economic opportunity, and quality of life.

Believe it or not, Israel is the only country in the world which had a
net gain in the number of trees last year.

Even Warren Buffet of Berkshire-Hathaway fame has just invested
millions with Israeli Companies.

So, you can vilify and demonize the State of Israel. You can continue
your silly boycott, if you wish. But I wish you would consider the
consequences, and the truth.

Think of the massive contribution that Israel is giving to the world,
including the Palestinians - and to you - in science, medicine,
communications, security.

Pro rata for population, Israel is making a greater contribution than
any other nation on earth.
Peter's post on his importation briefing is Kafka-esque. You can't make up the kind of rationalizations the pro-importation forces have been reduced to -- because they are driven by polls and pure political objective, not facts, not reason, not concern for public health or safety. I think official Washington has created and thrives on a new form of communication, Truthspeak, where flacks, spin doctors, policy hatchets, et al., will say and do anything that advances their short term interests and/or protects their flank though it may contradict reality or what was said or done the day before. The past -- what once was history -- no longer exists and therefore one is no longer accountable or responsible for deeds or actions other than those in the very present.

This tactic has spread Ebola-like throughout politics as the number of media outlets needing content on a 24/7 basis have multiplied.

The importation forces are lead, not coincidentally by Truthspeaker-in-Chief Rahm Emanuel who turned parsing phrases and weasel words into lethal political weapons for the Clintons. (He's had much less success in helping his buddy, Illinois Governor "Wrong-Way Rod" Blagojevich, have any success in the Prairie State's ill-fated importation schemes.)

If you can convince people to open the US to unsafe practices that don't even save money in Europe -- you can do anything. Well, we hope not.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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