Latest Drugwonks' Blog

On the heels of a report that a state legislator in NY wants to make it illegal to drive while under the influence of Ambien, this piece of chilling news....

There is a massive increase in the number of people who have cars in developing countries where road traffic accidents are the fourth leading cause of death in adults aged 15-59.

Can't you see the connection? It's the Ambien, stupid. Where is Senator Grassley when we need him?
In the November issue of Commentary I make the point that Big Pharma needs to be seen as focusing more on promoting the public health than they do on promoting products.

Pfizer has just taken a significant step in that direction.

The world's biggest pharmaceutucal company has announced a collaboration that gives access to its library of medicinal compounds – the world’s largest – and also brings scientists from developing countries into Pfizer’s laboratories for training in drug discovery techniques.

The collaboration with The Special Program for Research and Training in Tropical Diseases of the WHO (WHO/TDR) is part of a new effort to link the research resources of a major pharmaceutical company to a global network of discovery research, and speed the search for new drugs to combat some of the world’s most deadly parasitic diseases, including malaria, leishmaniasis, African trypanosomiasis, onchocerciasis, schistosomiasis and Chagas' disease.

Under the arrangement, scientists in institutes affiliated with the WHO/TDR-sponsored Compound Evaluation Network are testing thousands of compounds from the Pfizer library. In a process called “screening”, the researchers are seeking to identify “hits” – compounds that show initial activity against a range of tropical parasites.

Well done!
The WSJ reported a day ago that if the Dems take over control of Congress they plan to investigate Republicans who went to work or lobby for drug interests. No limit on how far back they will go. I guess that means William Seward (Lincoln) and Harvey WIley (first FDA commissioner under TR) are fair game.

I think I have a good idea just who ever made this threat had in mind. Let's be clear: this is either settling personal scores or a way to shakedown the GOP leaning lobbying firms in DC to create jobs for Democrat types. As in, we will call off the dogs if you hire our friends. The Republicans did the same thing when Delay pressured lobbying firms to hire more GOPers. The D's are adding a new thuggist wrinkle to the game by using the congressional supeona power as a job search engine for their pals.
According to Mikhail Zurabov, the Russian Health and Social Protection Minister, the number of counterfeit drugs has "significantly" decreased, and now amounts to 3-4% of the Russian drug market. Mr. Zurabov relayed this information at a meeting with Russian President Vladimir Putin at the Kremlin earlier this week.

Most international organizations put the rate of counterfeits in the Russian health care system at 12%. Reducing this exposure to 3-4% is an exaggeration of truly Soviet agitprop proportions.

How did the Comrade Minister accomplish such a feat? Why he changed the law! (And we all know how much the Russian Mafia believes in the rule of law.)

Mr. Zurbov commented, "The penalties for such drugs has been defined and the decision was made to revoke the license of a company producing counterfeit drugs.”

That’s right, they reduced counterfeit medicines almost entirely by threatening to “revoke” the license of counterfeiters.

Surprisingly, the Minister neglected to mention the number of "licenses revoked," people arrested, or counterfeit medicines seized (and to reduce the Russion national volume from 12% to 3% there must have been quite a lot.) Maybe he's just really modest.

In any event, now that Russian drugs are so safe, maybe we should introduce legislation to allow importation into the US market.
I had the opportunity to be briefed by the chair and staff of the IOM committee responsible for the drug safety report that came out recently. I was pretty rough on the study when it first came out and was hoping that a second pass might lead me to a sunnier set of conclusions.

But the thrust of the IOM report -- increasing the amount of time and money the FDA spends on claims data from HMOs to search for safety signals in order to generate post market studies to seek out rare safety problems -- is simply asking for troubling instead of eliminating it in the first place. And worse, it smacks of self dealing: after all once the IOM group decided to have nothing to do with anyone who had expertise in the science of drug development it was left with people that had ties to HMOs and the CERTs who just happen to rely on the purchase of claims data and contracts for data dredging to form the "expert" panel.

And the idea of increasing the number of safety reviews and adding people from the Office of Drug Safety to "restore the balance" between efficacy and safety as IOM safety chair Sheila Burke stated is overkill. What is preclinical, Phase I and Phase II dosing studies but safety related research? Or am I missing something? Maybe Ms. Burke could point to some evidence apart from the so -called culture gap she kept on referring to in her meeting and in the report since it was not to be found.

Finally, the IOM folks claimed that they did not believe that their recommendations would slow down drug approvals in any way and that they were not responsible for the actions of members of Congress who used the IOM report to support their pet regulations....Fat chance. It is already happening.

Following on the heels of Senator Grassley and Congressman Waxman beating up on the FDA for using non-inferiority trials to approve antibiotics we now see the FDA rejecting two new antibiotics just after asking sponsors to provide data that they were as effective as existing drugs. Now the FDA is asking Replidyne for example to conduct four additional trials to demonstrate faropenem's superiority - compared to a placebo or existing drug right after the company had completed 11 late-stage clinical trials and a safety database of more than 5,000 patients. The additional research will take at least two years and require millions more.

The company said it was disappointed. What it was cannot be published on a family blog. And unfortunately it is a harbinger of what will happen when the folks from the Office of Drug Safety empowered and encouraged by Grassley et al make their way on to the committees reviewing drugs will be doing. Drug development, even in those areas where medicines are badly needed, will become more expensive and more time consuming. And why in the world would a company take the Critical Path seriously after a stunt like this?
No matter which party controls Congress, the effort to impose price controls (let's stop pretending that the government negotiates) on drug companies and money losing biotech firms (yes, most drug and biotech companies are not profitable) will be blocked by one the few people in Washington who gets it, President Bush:

October 22, 2006 -- "Who should be making decisions for consumers? Obviously, there's
a group of folks that feel like the government can do a better job than
the consumers themselves. We strongly believe that empowering
consumers is the appropriate way to promote quality in health care. As
a matter of fact, we will resist any changes to weaken the program."
- President Bush on Friday, urging Republican candidates
to talk up his administration's Medicare drug-benefit plan
If you want to know why people would whine about corporate sponsorship of breast cancer awareness and's the reason: they don't like the emphasis on pharmaceutical intervention. To them -- and by them I specifically mean the group Breast Cancer INAction headed up by Barbara Brenner, it's all about the environment.

Brenner had made some of the silliest and emptiest statements about breast cancer or any disease for that matter. Here are two:

"We have to keep in mind that with all of this 'light a candle,' that people are dying," Brenner of Breast Cancer Action explained.

"We have got to just stop throwing money at it. We have been throwing money at it since the early 1970s and we still have no answers.

And her she is on the campaign of linking a share of retail sales to breast cancer research: "I understand that people want to do something," she said. But "if shopping could cure breast cancer, it would be cured by now."

All of these gems pale in comparison to Brenner's claim that regular mammograms for women are actually dangerous and cause cancer.

“The benefit of routine mammograms for healthy premenopausal women is unproven,” Brenner’s group asserts in a Web page entitled “What You Should Know About Mammograms.”

This is a lie. The scientific consensus is that routine mammography -- until something better comes along (and it will) -- reduces the risk of dying of breast cancer in women 50 and older by up to 30 percent.

But here is what Brenner claims:

“Healthy premenopausal women should not have mammograms as a routine matter. The risk of radiation, combined with the high incidence of both false negatives and positives, means that routine mammography for premenopausal women may well do more harm than good,” Breast Cancer Action asserts.

Of course she leaves out the increase chance of survival due to new drugs. That's because Breast Cancer Action endorses the "Prevention First" principle. The group opposes reliance on drugs and stresses the right to safe water, air and food. It claims irrefutable proof that PCBs cause breast cancer. In fact there is no mechanistic or biological evidence and the body of epidemiology work -- including that which has been refined by genotype -- shows an association.

Hence Brenner and her group advise women to avoid mammograms and the medicines that can save their lives and instead ask them -- instead of shopping for products that might contribute to such activities -- to donate to their twisted and life denying movement.

Such a deal.
According to a new study in Health Affairs by (among others) the talented Kelly Hunt (now with the New York State Health Foundation), opinion surveys conducted in 2006 show that health care is an important but second-tier issue in terms of priorities for government action.

“The results suggest that in terms of priority for government action, health care is a second-tier issue. Today it ranks as the fourth most important issue for government to address, behind the war, the economy, and gasoline/oil prices/energy. This is a lower ranking for health care than in 1993, a time of major national debate about health care reform.

In the 2006 survey, health care was one of the top two issues for 13 percent of the population. This compares to 31 percent in 1993, when it was ranked second, and 9 percent in 2002, when it also ranked fourth.”

Here is a link to the full article
Today's New York Times carries a story by Robert Pear on the Pelosi agenda for health care should the Democrats become the majority party in the House after the upcoming midterms. No surprise that top of the list "in the first 100 hours" would be an attempt to repeal the Medicare non-interference clause.

Those first 100 hours are beginning to sound like a real Reign of Terror for the American public health. Does anyone really believe that government can negotiate better than private industry -- for anything? One need only look at the VA system to see how government "negotiating" leads to restricted choice.

That fact, by the way, is not in the Times' story. Neither is the fact that the Part D program is HUGELY popular with American seniors.

Mr. Pear quotes Representative Pete Stark of California (who would be chairman of an important health subcommittee if Democrats were in the majority) as saying, "I don’t know that we could undo all the private plans. But at least we could offer a government-administered drug benefit."

Terrific! If the government thinks it can provide plans that offer as broad a range of choice as those presently available at lower costs, then I say have at it. But this does not require the non-interference clause to be repealed.

If the 100 hour Reign of Terror thinks to replace Part D with a VA-like plan, they will hear about it from the voters. Do they really think they can replace patient choice with price controls?

Here's something else to chew on -- I heard through the inimitable grapevine that Mr. Pear interviewed the executive director of a certain large disease organzation and asked what his biggest concern would be should the Democrats win a House majority. The executive director's answer was "the repeal of non-interference."

That didn't make it into the story either.
We've previously called to your attention "The Emerging Market Dynamics of Targeted Therapeutics," a new paper by Jack Calfee (of AEI and also a CMPI advisory board member) and Elizabeth DuPre (see the October 2nd posting, "Jacks ... or better").

Here's an interesting discussion of that paper in the current edition of the excellent European publication Pharma Marketletter.

Have a look and let us know what you think.

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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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