Latest Drugwonks' Blog

Dangerous Disconnent on Drug Safety
Sept 30, 2006

This week, scientists completed mapping the mouse brain down to details of individual cells. Because much of the neurochemistry of humans mirrors many of the pathways found in mice and rats, researchers will be able to use this molecular guide to more quickly determine which medicines might work to control or delay the progression of such devastating brain illnesses as Alzheimer's, Parkinson's and Lou Gehrig's disease.
But first some enterprising researcher should use the map to explain the disconnect in the minds of some between the crushing burden such diseases impose on families and society and proposals that that supposedly benefit the public health but in fact delay the development of new medicines. They can also make them more difficult and more expensive to introduce.
One subject of this study should be the Institute of Medicine (IOM), which just released a report on the Food and Drug Administration's ability to monitor the safety of medicines. The study asserts that it is impossible to make a medicine 100 percent safe and harder still to understand (using methods the IOM admits are inaccurate and outdated) why some people react badly and some respond well. Rather than recommending a more computerized and gene-based approach to detecting and predicting safety problems -- which can affect a very small group of patients -- the IOM wants the FDA and companies to spend billions conducting randomized clinical trials that test everybody as if they were the same to discover what current methods rarely find in the first place.
Will this make medicines more expensive to make? IOM is indifferent. Will patients doing great on a drug enroll in a safety study where they have half a chance of not getting the medicine keeping them alive? It never crossed the minds of the IOM solons.
The other subject should be Sen. David Vitter of Louisiana, who sees no connection between barring Customs Agents from inspecting packages of medicines from Canada and the prospect of polluting the entire prescription-drug supply of the United States. Individuals carry much of the illegal narcotics coming into this America under threat of arrest. Thanks to Mr. Vitter's amendment to a Homeland Security bill, counterfeiters and suppliers of controlled narcotics will be able to cross from Canada into America.
A flood of bogus drugs for diseases such as Alzheimer's, heart disease and cancer won't be discovered until they enter the market. By that time it will be too late and too expensive to track the problem. The same can be said for IOM's after-the-fact and outdated approach to drug safety. Both will lead to fewer innovations.
According to a recent Populus survey, when asked what reforms would most likely increase their quality of care, people in eight old and new EU member countries responded by a large margin, “giving patients more information about their illness."

And Brussels may indeed be moving in that direction.

Last March in Brussels I appeared on a panel with James Copping, the Principal Administrator for the EU’s Enterprise and Industry Directorate-General, the body drafting the EU’s go-forward recommendations on a how the EU should address what they refer to as ItP or Information-to-Patients.

One interchange between Jim and me that is worth sharing:

COPPING: "We must find new ways to regulate health care information to patients."

PITTS: "Jim, I think a better way to frame the question is to say that you need to find new ways to facilitate health care information to patients.”

COPPING: "Yes, that’s right.”

Well, it seems as though Mr. Copping has done just that.

According to a report in the The Financial Times, draft recommendations prepared for a pharmaceuticals forum, jointly chaired by the European commissioners for enterprise and health, will call for industry participation in partnerships for "information creation and exchange" on diseases for patients and citizens.

They propose a trial scheme to provide "high-quality health-related information" on diabetes, offering data to the non-specialist in all official EU languages, drawing on authorised disease databases, with input from doctors, patient groups and health insurers as well as industry.

The move would mark a significant shift away from the current ban in Europe of US-style "direct to consumer advertising," which forbids drugs companies from any form of direct communication with patients.

With partial exceptions in the UK and Sweden, European legislation prevents drugs companies from even responding to inquiries from patients, let alone advertising their medicines beyond specialist publications for medical professionals. That has created a situation long decried by the industry, by which patients can find all manner of unreliable information on diseases and treatments on the internet, with the pharmaceuticals manufacturers the only groups banned from providing data.

The initiative comes after previous efforts to ease the rules on pharmaceuticals communication were crushed by health insurers and consumer groups wary of industry influence and manipulation.


Good luck Mr. Copping. We're watching.
If you’re looking for a superb discussion of the unintended consequences of choice controls (aka “price controls”) look no further than the excellent new paper by John Calfee and Elizabeth Depre of the American Enterprise Institute.

Here’s a hot link:

http://www.aei.org/publications/pubID.24889,filter.all/pub_detail.asp

Along with a few thoughts to ponder ...

* As we proceed further down the path of personalized medicine via both targeted therapies and gene testing, those nations (mostly in the EU, but also Canada, Australia and -- to a lesser degree -- Japan) that impose price controls via the threat of compulsory licensing will find that what once was a Thor's hammer has become a toy hammer. More and more pharmaceutical firms will just say no to such blackmail and increasing numbers of patients in these otherwise developed nations will have neither access to nor, for that matter, knowledge (because of the EU's neroses about direct-to-patient information) about cutting-edge treatments.

* As a result, therefore, the overall global prices for these new therapies will go up -- while they go down in the US. Why? Because, minus price controls for these cutting edge therapies, the rest of the world will be forced to carry their fair share of the R&D costs now being carried almost exclusively on the backs of the American health care consumer.

* But you can't get blood from a stone. If EU nations continue to abide by absurd health technology assessment protocols they will simply say there is not sufficient "evidence" to showi that these new, more targeted (and, therefore, safer) therapies are of sufficient "added benefit."

Result? More American health care holidays for those Europeans who can afford it. And for those who cannot -- zero access to 21st century medicine.

Denial is more than just a river in Brussels.

Trasylol

  • 10.01.2006
Totally unacceptable. Just totally unacceptable.

Shameful.

But, sorry Senator Grassley, it does not "prove" that the FDA is "toothless."

In fact, it shows just the opposite.
Grassley, EPA clash on dust limit


Whenever the FDA doesn't do exactly what Senator Charles Grassley thinks is right or issues a ruling on a drug he disagrees with that seems to favor a drug company, he is quick to claim it is another example of how the FDA is sacrificing public health because it has a "cozy" relationship with industry.

So I guess that means when the EPA does not make a special exception to a particular industry in enforcing a public health-type rule and a Senator tries to carve out an exemption, that relationship would be defined as....how? I am sure the EPA has some very good scientific data to support it's position. So I am sure Senator Grassley was not criticizing the integrity or intelligence of EPA scientists when he called the ruling "idiotic" because he has made preserving the intellectual independence of people like David Graham a keystone of his career in the Senate. He would never try to bully or cajole an agency into changing it's stance...that wouuld be inconsistent and political and undermine his morally insufferable position on FDA issues and drug safety...


DES MOINES, Iowa Senator Charles Grassley is clashing with the Environmental Protection Agency.

The dispute comes after the agency reversed its course on exempting agriculture operations from dust regulations.
The Bush Administration says it decided against the exemption because officials could not legally exempt specific industries.
Grassley, a Republican, disagrees with the opinion. He says it is -- quote -- "such an idiotic move for the EPA to take" -- end quote.
The senator has sent a letter to the E-P-A's top administrator inviting him to visit Grassley's farm in Iowa.
He has asked for a response within 24 hours.
Is is my imagination or is the AP Kevin Freking the only journalist in America who refuses to accept that Medicare Part D is a resounding success. See his most recent article entitle Seniors to Get More Medicare Drug Choices. Freking stands alone -- actually with the only person in Washington who can't say anything good about the Part D benefit, Families USA Godfather Ron Pollack -- in asserting that the rollout of more Medicare Part D plans with lower premiums, fewer restrictions, more drug choices and better tools for managing costs is a terrible thing because it's confusing:

"Seniors who complained this year about a dizzying array of choices for a Medicare drug plan may find themselves even dizzier when they shop around for next year.

Federal officials announced Friday that 17 companies have been approved to provide Medicare drug coverage nationally. This year, there were nine."

Actually, since 90 percent of all seniors signed up for the program and a small percentage who hit the donut hole really had a problem after doing so, Freking had to scrape around for a quote from -- who else -- the Don of Part D Doom himself, Ron Pollack to underscore just how crappy the program really is:

"The incredible confusion that persisted throughout this year is about to get considerably worse," said Ron Pollack, executive director of Families USA, an advocacy group. "This is because there will be quite a few more plans to choose from, they will all be different from each other, and seniors will have a much shorter time period to make decisions about enrollment."



Similarly, Freking reaches down to another well paid malcontent, Deanne Beebe," a spokeswoman for the Medicare Rights Center, said that seniors won't be won over by all the additional options.

"They don't want dozens of choices," she said. "They want one affordable drug benefit they can count on when it comes time to fill their prescription."

Yes, Ron annd Deanne compared to the one size fits all system where seniors would wait five years to get many of the newest medicines while the government negotiates prices and restricts access there will be quite a few more plans to choose from. As for seniors not wanting dozens of choices, I propose that Beebe rollout a the VA style approach and try to sell it with the longer waits for drug approvals, fewer drug choices and in some cases, higher out of pocket costs..

The triumph of ideology over compassion and common sense.
This is news?

Well, since it's true it's worth repeating, and since it's based on "a new study" it's worth reporting on. Still, I'm surpised that it even made the UPI wire. So much the better.

Here goes ...

"Patients who leave the doctor's office with a prescription may be leaving something important behind."

Car keys? No, they're leaving, brace yourself, without "the information they need to take their medicines correctly."

In fact, according a new study (see, told you) from UCLA (go Bruins!) doctors only give their patients 62% of five "key pieces" of information:

* Patients were told the name of a new medication only 74% of the time.

* Patients were told why they were taking a new medication only 87% of the time.

* Only 30% of patients were told how long to take the new prescription.

* Only 55% of patients were told how many tablets to take.

* Only 58% for both frequency and appropriate timing (with food, etc.)

And the winner is:

* Doctors told patients about potential adverse events of a new medication only 35% of the time.

To be fair this was a study based on data collected from 185 outpatient visits to 44 physicians, so draw your own "margin of error" conclusions.

(I wonder how are they going to pin this one on the pharmaceutical industry?)

Thar she Breaux's

  • 09.29.2006
Ceasefire Event with David Kendall and Peter Pitts

I'm very excited to participate in the October 11th Ceasefire on Healthcare debate with David Kendall who served on President Clinton's Task Force for Health Care Reform. As you probably know, the forum (led by former Senator John Breaux) seeks to find “common ground” for meaningful, bipartisan change to the nation’s health care system.

I hope you can attend or tune in for the podcast. Here are the details:

Professor James A. Thurber, Director, American University’s Center for Congressional and Presidential Studies, invites you to join him and former Senator John Breaux at a Lunch Forum on Health Care Reform, featuring David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute, and Peter Pitts, Director of the Center for Medicine in the Public Interest (CMPI).

October 11, 2006

12:00pm - 1:30pm
Butler Boardroom, American University


Speakers:

David Kendall, Senior Fellow for Health Policy and Director of the Health Priorities Project, Progressive Policy Institute

Peter Pitts, Director, Center for Medicine in the Public Interest (CMPI)

For more information about the Ceasefire on Healthcare Series, please visit www.ceasefireonhealthcare.org.

Please RSVP to the center (ccps@american.edu) by October 6, 2006.

Contact Melissa Castle, (202) 885-3491, mcastle@american.edu, for more information.
In one week the FDA has been pilloried as being to ineffectual in the effort to make medicines safer and now, in a New York Times article, described as an agency under seige too afraid to approve any new medication in a timely fashion. Has anyone ever written an article commending FDA employees for just doing a good job on behalf of the public health?

The fact is while there are some reviewers and senior officials who are likely to be cautious most people working in the FDA are truly devoted to the public health and have no ax to grind against drug companies.

The fact is, most folks at the FDA -- like those at the drug companies -- know a good drug when they see it and work hard -- without bending rules to make sure a medicine gets a fair shot at approval. To be sure no one at the FDA is going to break new scientific ground in terms of establishing endpoints but the agency is, despite IT limitations, still the single largest repository of information on how to measure the relative risks and benefits of medicines on earth. Which means that they are fairly good, if not always up to date, on how they do their jobs.

The bottom line, at least in 2005, was a reflection of continued effort to use the regulatory tools at hand to make medicines available as quickly as possible. Have there been demands for additional data before going to market? Absolutely. And in some cases companies have volunteered the data while in others the requests are probably better obtained post market through observational studies. But in the main, the demands for data are not all that onerous.

Moreover, if you look at the nature of the medicines approved, they reflect a desire to understand if the risk-safety profile will apply in subpopulations that are likley to receive entirely new medicines.

On the whole, the debate too fast/too slow debate about the FDA has grown tired, empty and irrelevant. The real issue is, will the media and politicos focus on what the agency needs to move drug approvals into personalized and targeted era? Meanwhile, an overview of the accomplishments of Center for Drug Evaluation and Review -- hardly mentioned in the media -- are listed below... And by the way, thanks for your efforts...

Many Americans benefited from last year’s timely reviews of new prescription medicines, over-the-counter medicines and the generic equivalents for both. When we review a medicine, we use the best science available to determine if a medicine’s benefits outweigh its risks for its intended use. An internal study showed that about half of our professional staff time is spent on safety assessment. We oversee the development of new medicines in the United States, and our paramount concern is the safety of patient volunteers in clinical trials.

Highlights for 2005 include:

* 80 new medicines. We approved 78 drugs and two biologics (22 priority and 58 standard reviews).

* 20 truly new medicines. We approved 18 drugs and two new biologics that had never been marketed before in any form in this country (15 priority and 5 standard reviews).

* 141 new treatment options. We approved new or expanded uses for 126 already approved drugs and 15 already approved biologics (36 priority and 105 standard reviews).

* 5 over-the-counter drugs. Our approvals included five new medicines to be sold over the counter without a prescription, and four of them can be used by children. We approved three new uses for existing OTCs, all of which can be used by children.

* 10 “orphan” medicines. Our approvals included nine drugs and one biologic for patient populations of 200,000 or fewer.

* 344 generic drugs. We gave final approval to 344 generic versions of existing drugs and tentative approval to another 108. We received 777 marketing applications for generic drugs.

* User fee goals. We exceeded all our performance goals for the fiscal year 2004 receipt cohort, the latest year for which we have full statistics. We are on track for exceeding most user-fee performance goals for the fiscal year 2005 cohort.
Scott Hensley's article in today's WSJ underscores both the hypocrisy and inherent limitations of so-called evidence based medicine. J&J is hoping to launch a form of risperidal called paliperidone that is described only as being released over a 24-hour period of time and is therefore more tolerable to the liver in some people. One potentially important point Hensley left out of the story is that the form of risperidal JJ seeks to market is known to have a lower concentration of transmembrane transporter P-glycoprotein (P-gp) P-gp potentially limits access to brain tissue of psychoactive substrate which means that the lower concentration could make it more valuable to patients who don't respond well to Risperdal because of they way they metabolize the products. In other words, paliperidone could be a medicine for a small but clinically underserved group of schizophrenics. But JJ is going to have to do to the heaving lifting to demonstrate that is the case.

Meanwhile, Hensley cites the example of the HMO that simply decided it would stop paying for Medium because they are cheaper versions that are as effective. Where are the media skeptics demanding the source of the data for this decision? Isn't this a conflict of interest? What about the fact that the Roche Amplichip allows MDs to distinguish how well patients metabolize difference proton pump drugs? What if you can't handle Prevacid or Protonix? My daughter couldn't take either and she had to be prescribed Nexium. Why should she or anyone else be forced to pay out of pocket because she genetically unable to metabolize other PPIs? Isn't this a form of genetic discrimination?

So much for evidence based medicine. It's evidence when the HMO decides to dump a drug, but conflicted propaganda to promote a me-too drug when a drug company decides to bring a new medicine to market?
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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