Latest Drugwonks' Blog

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.

Download file

Hello Dolley!

  • 10.19.2006
Meat and milk from cloned animals! Calls for absurd, unscientific labeling!

Just another day at the FDA.

According to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals." In other words – GRAS. Plans to regulate cloned animals and food derived from them, should be released by the end of this year.

Does this mean cloned beef in your burger? No. At tens of thousands of dollars per “founder” clone this is hardly likely (at least in the foreseeable future). So, unless you’re in the market for a $25,000 Big Mac, relax.

You want fries with that?

In the future, if and when the technology for animal cloning becomes more cost-efficient, it is possible that the meat of clone progeny could be available at retail. And milk from clones is certainly on the way a lot sooner.

By promulgating this new rule, FDA is working to advance the science of cloning -- an important advance towards creating a better, safer 21st century food supply.

"Cloning allows the possibility of identifying the healthiest and the superior sires or boars that are going to be used for breeding purposes," said Barb Glenn of the Biotechnology Industry Organization.

Dairy producers are worried about what might happen if "clone-free" products start showing up in supermarkets. "We have concerns where people are going to try to draw distinctions and differences where none exist," said Chris Galen, spokesman for the National Milk Producers Federation.

Perhaps this cause will be taken up by a new consumer advocacy organization –

(Sorry about that.)

Thin as a ... Reid

  • 10.18.2006
Here's what Maurice Hinchey (D-Inflated Ego) said about Les Crawford's misdemeanor plea:

"Based on Lester Crawford's apparent disregard for the law, we must find out what other improper actions he took while leading the FDA, which may not necessarily have been illegal, but were inappropriate or unethical. The American public has the right to know what else Lester Crawford may have done in office that could have lasting, detrimental effects on the FDA. "

We could apply that same standard to lots of public officials. Like Harry Reid for instance. Or maybe Hinchey's own dealings with the casino interests allied with Indian tribes in his own Sullivan County. According to the AP the entire Indian casino process is just a pass through for non-Indian interests:

"The tribal preference law gives Indian-owned companies and Seneca joint ventures cost breaks over non-Indian firms on casino projects. But most of the joint venture companies are using Senecas only as brokers or consultants, according to a review by the newspaper of casino contracts, as well as interviews with Seneca leaders, contractors and disgruntled Senecas."

Nothing illegal here. But maybe there is something inappropriate or unethical. Applying Hinchey's sanctimonious standards we can ask....What did Hinchey know about these deals and when did he know it?

As the highly moral Maurice says:

"Leadership starts at the top. "

Or does it start by looking in the mirror?
Good article today in the NY Times by Ron Rabin about NIH recommendations regarding lowering LDL levels....Rabin comments on an article in the Annals of Internal Medicine which recommends trying to hit low levels but warns against a one size fits all approach to doing so.... One of the author is concerned about no one really knows what the "right"combination of drugs will be to achieve that optimal target.

The Times articles quotes another article (hey, someone actually did some research) from Dr. Vincenza Snow that concluded:"
Patients respond differently to statins, with some achieving more success in cholesterol reduction than others, Dr. Snow said. But, she said, “our goal is not necessarily to get to a certain level of cholesterol, but to decrease heart attacks and strokes, and you can reduce that risk with a certain dose of statin.”

Personalized medicine. And for that you need a variety of medications, genetic tests and diagnostics. Simply shoving everyone onto the cheapest or oldest therapy at the lowest dose possible is not likely to be the most effective way to reduce risk. Which is what medicine should be all about.

Lead Balloon

  • 10.18.2006
CMS Floats Trial Balloon for Part D Data Sharing Initiative

Drug Industry Daily
By: Stephen Langel

The Centers for Medicare & Medicaid Services (CMS) is using a proposed rule issued today to test the legal waters for its plan to collect and share prescription drug plan data to base Medicare reimbursements on product comparisons, sources say.

The proposed rule would require any entities offering prescription drug coverage under the Medicare Rx law to provide the CMS with data about the products they offer, including drugs, biologics and medical devices, as part of their contracts with the government. "Through the appropriate use of the new prescription drug claims data, we have an unprecedented resource to help us learn more about prescription drug usage by seniors and how we can help seniors get the most benefit from prescription drugs," former CMS Administrator Mark McClellan said.

The CMS would then use the data, which includes various measures of the products' cost, to improve the workings of the Medicare program, according to the rule. The agency would also share this data with the FDA to "provide protection against adverse drug events" and with HHS' Agency for Healthcare Research and Quality's (AHRQ) to do comparative drug studies.

This development comes weeks after the initiative seemed dead because of questions regarding CMS' statutory authority (DID, Oct. 2). The agency is using the proposed rule to make legal arguments supporting the policy. "We are engaging in this rulemaking in order to resolve the statutory ambiguity," the rule said.

The agency believes that it has "broad authority" under the Medicare Rx law to share such data. Section 1860D-12(b)(3)(D) of the law provides the HHS secretary with the authority to "collect a broad array of data in order to properly carry out his responsibilities," the rule said. But the section also limits use of the data to work necessary to carry out the act.

However, the agency believes the law gives it some leeway, saying that if the secretary believes it is necessary and appropriate to carry out responsibilities even outside the scope of the section, he has the authority to do so.

The proposed rule prompted a strong response by both supporters and opponents of comparative trials. Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, told DID the rule is the foundation for cost-based medical coverage that shortchanges the public and "sets an extremely dangerous precedent." The CMS is "trying to take authority away from the doctors and give it to the accountants."

While McClellan had proposed comparative trials as a way to ensure the best medicines were covered, without him leading the agency this decision will devolve into a purely cost-based decision, Pitts added. "Once he's out the door, there's no guarantee" that this program will be run correctly. McClellan left the CMS last week for the American Enterprise Institute-Brookings Joint Center for Regulatory Studies.

PhRMA is cautiously optimistic about the rule. Comparative data "can offer a valuable source of information," a spokesman said. But research based on that data has a number of limitations, he added.

However, public interest groups such as Consumers Union have long supported this strategy and lauded the rule. "The CMS initiative is very exciting, and holds out the promise for major advances in understanding what works and doesn't work in the world of pharmaceuticals, and where short-term adverse reactions and long-term dangers may be lurking," Bill Vaughan, the group's senior health analyst, told DID.

The key to the program's success is not the rule itself, but the FDA obtaining sufficient funding to use the data, he added. The agency needs money from the Prescription Drug User Fee Act to "mine the CMS data for the gold nuggets of knowledge that it can offer. With adequate support, the FDA can use the CMS database to make the adverse event reporting system and
other postmarket approval monitoring work the way that consumers hope and expect."

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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