Old Hickory

• 12.31.2007

On the Presidential election and drug importation as a "hickory stick" to beat the pharmaceutical industry.

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The article's conclusion says it all:

"The facts are not important. This is all about rhetoric. The facts against drug importation as sound health care policy are enormous. The argument for drug importation are political and rhetorical."

Remember the Maine (verdict)

• 12.28.2007

From the pages of the Boston Globe …

Judge shoots down Maine law curbing access to prescription data

BANGOR, Maine—Relying heavily on a ruling in New Hampshire, a federal judge has overturned a new state law that restricts access by medical data companies to doctors' prescription information.

U.S. District Judge John Woodcock concluded that the law, which was scheduled to take effect Jan. 1, would prohibit "the transfer of truthful commercial information" and "violate the free speech guarantee of the First Amendment."

Here’s the rest of the story:

http://www.boston.com/news/local/maine/articles/2007/12/22/judge_shoots_down_maine_law_curbing_access_to_prescription_data/

In addition to First Amendment issues, 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 physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.

When it comes to public health trumping politics -- remember the Maine verdict.

Sicko-San

• 12.28.2007

Hey Michael, I thought this happened only in America

Japanese woman dies searching for care

By CHISAKI WATANABE, Associated Press Writer 37 minutes ago

TOKYO - An 89-year-old woman died after an ambulance crew spent two hours trying 30 hospitals before finding one that would accept her for treatment, Japanese officials said Friday.




http://news.yahoo.com/s/ap/20071228/ap_on_re_as/japan_ambulance_deat

New Poll "Shows" Americans Trust Dems More on Health Care...Of Course They Do

• 12.28.2007

The following article could have been written in any election cycle ...

Pocketbook worries outweigh voters' concerns over war in Iraq
By JIM KUHNHENN and TREVOR TOMPSON, Associated Press Writers

WASHINGTON (AP) — Voters began to worry more about their pocketbooks over the last month — even more than about the war in Iraq....

"...This latest AP-Yahoo! News survey of more than 1,800 people by Knowledge Networks offers a unique opportunity to track changes in public attitudes as the presidential campaign unfolds. The first poll was last month and set a base line to measure national sentiment.

In the new results, men and women approaching retirement were especially attentive to the economy and health care, with six out of 10 ranking both issues extremely important. Politically, the attention to such domestic issues hangs darkly over Republicans. Voters say they are far more likely to trust Democrats to handle the economy and health care."

Consider Linda Zimmerman, a 50-year-old sheep farmer from Thurmont, Md. Her daughter and son-in-law are having trouble keeping up with two mortgages on a town house, she said. One street in her neighborhood has five homes for sale, and one has been on the market for two years.

Registered as a Republican, she's ready to reconsider.

"We're Republicans and I'm very unhappy with them, and I've been watching the Democrats," she said. "We did better when (Bill) Clinton was in than we did with Bush. It's just terrible."

Terrible? Aren't things going better in Iraq? Wasn't that the real downer in America according to the media just a couple of months ago? And how did they ever find a sheep farmer in Thurmont, Md?

As 2008 and the election year approaches, there is really nothing new in the political playbook. For the Dems and the media worse is always better and the good news is always in the past.

http://news.yahoo.com/page/election-2008-political-pulse-voter-worries

Patent Theft Today and Yesterday

• 12.27.2007

Book argues that Bell stole phone idea (AP)

BOSTON - A new book claims to have definitive evidence of a long-suspected technological crime — that Alexander Graham Bell stole ideas for the telephone from a rival, Elisha Gray.

http://tech.yahoo.com/news/ap/techbit_bell_book

Fools on the Hill

• 12.27.2007

Consider the story of Eric Lester, an oncologist in St. Joseph, Michigan, who was trying to find a way save the lives of his patients with advanced lung cancer. Instead of waiting for someone else to develop diagnostic tools, Lester developed his own test to see what kind of genetic factors were causing the cancer to grow. It turned out that epidermal growth factor receptor was the culprit and that a drug called Tarceva, designed to shut off that receptor, would work.

Instead of waiting to use Tarceva when all else was failing, he decided to use it as part of a tailor-made drug cocktail for his patient based on the information from the diagnostic he developed while staying within the bounds of the FDA. The patient fared better than most of the patients Lester sees.

It’s not a cure, but the results of Lester’s experiment—and others like it—are being shared with academic researchers and drug companies to accelerate the development of cancer drugs tailored to variations of growth factors causing lung cancer. Patients like Lester’s would receive tests that look for biomarkers—biochemical indicators of a disease—to see which drug would work best with fewest side effects. Such collaboration could bring about a new generation of cancer-killing treatments in years.

For more check out the Journal of Life Sciences at:

http://www.tjols.com/article-482.html

And that will explain the title.

Socialism Gone Mad

• 12.26.2007

From The Times of London ...

Hospitals fight NHS ban on patients using private drugs

Sarah-Kate Templeton, Health Editor

HOSPITAL chiefs are demanding an urgent review of the government’s policy of withdrawing National Health Service care from patients who pay privately for additional cancer medicines.

The NHS Confederation, which represents hospital chief executives and managers, says denying NHS treatment to patients who pay for top-up drugs is “perverse” and against “common sense”.

The move comes after it emerged that women suffering from breast cancer have been threatened with losing NHS care if they seek to improve their chances by paying privately for an extra drug.

Ministers claim that to allow patients to pay for top-up drugs would be unfair on those who cannot afford them and lead to a two-tier NHS. Their policy was laid down in guidance issued this summer but was criticised last week after The Sunday Times highlighted the case of Colette Mills, 58, from near Stokesley, North Yorkshire.

Mills, a former nurse, has been told that if she pays for the cancer drug Avastin, which the NHS does not fund, she will have to foot the £10,000 total monthly bill for her care.

Another breast cancer patient, Debbie Hirst, 56, from St Ives, Cornwall, has now revealed that she, too, has been told that if she wants to pay for Avastin in addition to her NHS medicines, she will be forced to pay for all her care.

The Royal Cornwall Hospitals NHS Trust issued the threat despite three other patients being allowed to top up their NHS care. The trust says the three had started their private treatment before the guidance was issued.

Hirst, a grandmother, said: “We put our house up for sale in order to pay for this drug. My only option now is to take the treatment they offer on the NHS or go private, which would be totally unaffordable.”

Nigel Edwards, the NHS Confederation’s director of policy, said: “The position appears to run counter to common sense. This should ring alarm bells that something is wrong with the policy.”

Edwards said patients are already regularly combining private and NHS care. For example, thousands mix NHS dental care with treatments available only privately.

Co-payments should be allowed, he said, provided they did not deprive other patients of resources, and those paying for the drugs are well informed of their limitations.

It was also reported yesterday that a 62-year-old woman had won a legal battle for the right to be treated with Avastin for bowel cancer. She will pay for the drug while Cumbria Primary Care Trust funds the rest of her care.

Mills and Hirst are to launch a campaign for all patients to have the right to pay for medicines not funded on the NHS. They are backed by the Patients Association, Doctors for Reform and Saga, the organisation for the over-fifties.

Andrew Goodsell, Saga chief executive, said: “People are less concerned about a two-tier health service than whether they have the opportunity to resolve what can be a life or death situation.”

The health department said: “It is a fundamental principle of the NHS, supported by all the main political parties, that treatment should be free at the point of need. Co-payments would undermine this.”

Buffalo Soldiers

• 12.25.2007

Soldiers, that is, on behalf of the public health.

From the pages of the Buffalo News ...

Innovation can’t survive without ownership

By Peter Pitts

If you wrote a book, would you be happy to see it published under someone else’s name?

What if you spent several years of your life — and invested a large chunk of your savings — developing a new product that made life easier for you and your family? Would you regret having done so if it became “public property” at the stroke of a lawmaker’s pen?

It would probably be the end of your inventing career.

Yet when it comes to lifesaving drugs and treatments, some seem to believe that the rules of human nature and economic reality don’t apply.

In Thailand, the military-appointed government has granted the stateowned Government Pharmaceutical Organization (GPO) the authority to produce generic versions of several patented medicines. The Thai government has claimed that its goal is to provide these drugs to poor Thais, but in reality, government leaders are hoping that the GPO will become a new and highly profitable hub for the manufacture and export of all manner of copycat drugs.

Amazingly, such actions are supported by public health activists and nongovernmental organizations. Earlier this month, representatives from Doctors without Borders, Oxfam International and other organizations defended the Thai junta’s actions at a conference on drug patents held in Thailand.

And earlier this year, 22 members of Congress signed a letter to the U.S. Trade Representative expressing their support for the Thai government’s renegade action. But history demonstrates the folly of such actions.

In India, political leaders long cited former Prime Minister Indira Ghandi’s call for an end to “profiteering from life or death” in defense of their prohibition of patents on medicine. But in 2005, India reversed course and re-established patent protection for pharmaceutical products. The reason? Less than 10 percent of the nation’s estimated 3.5 million AIDS patients were receiving any medicine at all.

In other words, even if the elimination of patent rights makes drugs less costly, it doesn’t produce greater access.

There is a reason why virtually all the world’s “miracle drugs” have been developed in Western countries. It’s called incentive. Because innovation is honored and protected, inventors are rewarded for their work.

Unfortunately, once a lifesaving drug or treatment exists, it’s seductively easy to take it for granted. We sometimes forget the years of toil these things take to develop; the millions spent to bring a new drug or treatment from theory to actuality.

And because we need it, we expect it to be free. But if we allow our emotions to trump reason, and cloud our minds to the realities of human nature and economics 101, we’ll end up with a lot less innovation.

And fewer lifesaving drugs to take for granted.

Temple University

• 12.24.2007

From the pages of FDA News ...

Critical Path Wants Adaptive Clinical Trial Designs, Temple Says

The FDA is encouraging the use of adaptive trials, saying the practice will modernize the development process and shorten the time needed to show a drug is effective. The agency’s associate director for medical policy, Robert Temple, said the Critical Path Initiative encourages the use of this kind of trial when researchers use accumulating data to modify the ongoing trial. Temple, speaking at the Critical Path Executive Briefing sponsored by FDAnews and the Center for Medicine in the Public Interest, said the FDA is working on an adaptive design guidance it promised to release in 2008.

Some of the more familiar adaptations include changing sample sizes based on variance and starting and dropping extra trial groups. When researchers determine a drug effect is present in a population subset, they can adapt the trial by modifying the trial’s entry criteria or increasing the number of patients assigned to receive the effective treatment.

While almost every clinical trial uses enrichment in some way to improve the trial’s patient population, there are more steps that can be taken to increase the chances a drug effect is detected, Temple said. Some enrichment efforts can decrease variants while others can choose high-risk patients or patients more likely to respond to treatment because of some genetic characteristic.

“Everyone agrees about finding the people who are most likely to respond … it enormously enhances the power of the study,” Temple said. Enrichment will help researchers by decreasing heterogeneity and identifying a population that responds to the treatment.
For example, researchers can screen patients with the treatment first and then enroll them in the study if they respond to the drug. In addition, researchers can study a large group of patients and only randomize those with a good response.

Scientists are beginning to be able to search for genetic characteristics or other factors that will predict a patient’s response to a drug, Temple said. Part of the Critical Path Initiative is to identify biomarkers and determine why some patients and not others experience adverse events with the same drug.

Researchers can select trial subjects based on either understanding of a disease or a drug mechanism, but they also can run a trial in patients to link a genetic baseline finding with a drug response, Temple added.

The 2007 Golden Clipboard Awards

• 12.21.2007

Commenting on the current state of 21st century bioinformatics, Dr. Janet Woodcock quipped that, "Today the major tool of modern medicine seems to the clipboard."

And that gave us an idea – a new award for those who impede (unwittingly or otherwise) the advance of medical progress -- "The Golden Clipboard."

Herewith our 2007 honorees …

Honorable Mention: Representative Rosa DeLauro

An honorable mention goes to Representative Rosa DeLauro for her perplexing efforts to embog the work of the Reagan/Udall Critical Path Foundation. Ms. DeLauro has demonstrated a remarkable lack of understanding of the science of drug development and the purpose of the Critical Path in general. She has stated: “I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials. The Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy.” This is all the more surprising and concerning considering the fact that Ms. DeLauro chairs the appropriations subcommittee that funds the FDA.

We hope that Ms. DeLauro’s tenacity towards improving the FDA and passion for protecting the public health can be harnessed and redirected to better purposes in 2008.

The Bronze Clipboard: Representative Henry Waxman

A perennial Golden Clipboard contender, Representative Henry Waxman is best remembered in 2007 as the conduit for Steve Nissen’s half-baked meta-analysis of Avandia. His oversight hearing – during which Mr. Waxman was both measured and civil in his handling of all witnesses – helped blow out of all appropriate proportion fear about drug safety in general and Avandia in particular. He also had a direct hand in undermining the FDA’s sound scientific policy towards “non-inferiority” trials for new antibiotics. The unintended (but not surprising) consequence is that several important antibiotics have been delayed or shelved. Congressman Waxman (we assume, again, unintentionally) helped to politicize the FDA by paving a separate and old score-settling path for those within the agency who disagree with scientific consensus.

In addition to his role as Congressional Oversighter-in-Chief, Mr. Waxman is one of the most knowledgeable members of Congress when it comes to how the FDA works and what it needs to succeed – and we look forward to his efforts to help the agency pursue its mission of both protecting and advancing the public health in 2008.

The Silver Clipboard: Dr. Steven Nissen

Dr. Nissen’s persistent undermining of the FDA came close to winning him Clipboard top honors for 2007. Among many memorable exploits, Dr. Nissen’s most Clipboard-worthy moment was on ABC’s 20/20 program, where he pronounced Avandia to be responsible for “more deaths than 9/11.” A few days later, when asked by Congressman Waxman if he would recommend that doctors take their patients off that drug, he responded, “No.” What’s the frequency, Steve?

Regularly positioning himself as “Dr. Transparency,” Dr. Nissen regularly neglected to come clean about his various consulting arrangements, conflicts and clinical trial activities. That, and his public flailing of drugwonks.com as “vile,” earns him this year’s Silver Clipboard and (at least hopefully) removes his name from any plausible consideration for FDA Commissioner anytime in the 21st century.

AND THE WINNER OF THE 2007 GOLDEN CLIPBOARD GOES TO

(Drum roll please …)

2007 Golden Clipboard Winner: Dr. David Graham

David Graham ostensibly works for the FDA -- but he seems to spend a lot of time in the Halls of Congress advising members and staff about which FDA medical reviewers should be hauled in for polite “conversations.” Setting aside Dr. Graham’s contribution to the Vioxx Populi literature -- which an FDA advisory committee considered to be a rather shoddy piece of research – he also helped push through the statistical analysis and organize the public outcry over SSRIs that resulted in a decline in antidepressant use and a corresponding increase in teen suicides. Graham still maintains that the lipid-lowering drug Crestor should be off the market despite the fact that it has recently received new indications for treatment of fatal heart diseases. And his assertion that Avandia should be taken off the market because an observational study showed that another drug was safer and more effective was both shoddy science as well as remarkably insouciant since he relied on observational data that did not have safety as a primary endpoint – the same sort of science that, when it came to Vioxx, he rejected as insufficient.

Dr. Graham is a man on a mission. AKA “Dr. Precautionary Principle,” he wants the FDA to use meta-analysis to generate safety signals early and often, and stop the clinical testing, prescribing and marketing of medicines until all such signals are explored using large scale randomized clinical trials that use safety as a primary endpoint. In short, he wants fulfillment of his vision at the expense of human life and medical progress.

For his persistence, zeal, and determination to damage not only the FDA but the public health, for his effectiveness in fear mongering and willingness to subordinate medical progress to his ascetic view of safety, we award Dr. David Graham the 2007 Golden Clipboard Award.