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or the Gift to the Generic Drug Industry Act...whatever you want to call it...but here's the coup de grace according to an article about the so called Access To Lifesaving Medicines Act in Scrip Magazine:

"The legislation would authorise the FDA to approve abbreviated applications for biologicals that are "comparable" to the reference products approved under the Public Health Service Act.

Comparability means no clinically meaningful differences in safety, purity and potency, based on non-clinical studies and clinical studies as necessary. An applicant also must demonstrate that the comparable product shares the "principal molecular structure features" of the reference product and the same mechanism of action, if known. "

In otherwords, generic firms would have a separate and short track for developing biotech products based on the same mechanism of action without having to go through all the time and expense that a biotech firm has to go through. Which means all you have to do if you are a generic company is a little reverse engineering and try to punch a couple holes in a patent or two of a biotech product and claim you can whip up the same product with the same molecuar structure features --whatever the hell that means.

The bill assumes that biologics are therapeutically interchangeable or can be made so. Actually, the bill deals with this problem by simply avoiding the issue altogether by assuming -- incorrectly -- that the same mechanisms of action equals no clinical meaningful difference or should be the foundation for approval.

The bill gives the generic firms tax breaks and market monopolies as incentives to attack the patents of biotech companies (what else is this aggressive effort to promote interchangeability at any time during the patent period) and ban the ability of biotechs to produce their own biogeneric products even though that might be a safer and more effective product or in fact their might be scientific question as to interchangeability.

This Clinton Schumer bill is a car bomb driven up to door of biotech innovation that will explode years from now. It will lead to massive litigation and game playing. Rather than worrying about the price of biotech products, policymakers should encourage the promotion of personalized and targeted medicine and nanontech delivery systems that will lead to more appropriate dosing for the right patients at the right time.
Yes folks, it’s that time again.

November 15 begins the six-week enrollment season for Part D. The good news is that, in most states, beneficiaries will have 50 to 60 offerings to choose from, at least 10 more than in 2006.

According to an article in today’s edition of The Wall Street Journal, “Who should consider switching? Prime candidates are those who picked plans for this year that provided coverage of the so-called doughnut hole, or who fell into that gap and now want coverage for it. For a higher premium, some plans offer to cover drug expenses through the gap.”

We'll see if smart providers start promoting this alternative.

Also according to the WSJ, “In another shift, many plans are making changes that will reduce the chances that consumers will even reach the $2,400 level where the coverage gap starts. By eliminating co-pays for generic drugs in some plans, for instance, insurers are making such treatments essentially free to patients (at least until they reach the coverage gap). Aetna is dropping co-pays for generics in many of its plans, while Cigna says it is eliminating generic co-pays in all of its most basic drug plans.”

How do we do it? Volume!

Further, the WSJ keys into the fact that, properly leveraged, market forces are increasing both choice and quality. “There may be a huge market of potential shoppers. Only 20% of 3,400 beneficiaries surveyed last month by J.D. Power & Associates said they would definitely stay with the plan they had. About two million Americans will turn 65 in 2007 and also will be eligible. At least another four million, including three million low-income beneficiaries not subject to penalties for missing the deadline earlier this year, have yet to enroll.”

Somewhere Mark McClellan is smiling.
NYT Alex Berenson's recent article " Hope, at $4,200 a Dose" is a bit on the sloppy side when it comes to the facts.

He complains about the price of ABRAXANE which he correctly but not completely describes as "a reformulated version of paclitaxel, a chemical found in the Pacific yew tree that destroys cancer cells. "

To assert that the two products "have similar side effects" is incorrect. He could have looked (and he did) at a Sept 7 FDA Oncological Products Advisory Committee meeting transcript or the data from the clinical trial....both of which had the following language more or less ... Neutropenia on this study was greater for Taxol than it was for Abraxane even though 50 percent more paclitaxel was being administered to the Abraxane patients. This was highly statistically significant and was true whether you looked at all-grade toxicity or just focused on
Grade 4. "

Berenson makes a big deal of how the company that makes Abraxane -- Abraxis -- tried to get the FDA to approve the use of its drug for early stage breast cancer (just like Taxol) by claiming that Abraxane is just Taxol without the toxicities and can be administered more quickly at higher doses. The FDA did not buy that argument since the pharmacokinetics of the two products are completely different and approval of Abraxis in the metastatic setting required a small randomized controlled trial.

In any event, Berenson was trying to use Abraxis' words against them to underscore that generic Taxol costs $150 compared to Abraxane which $4200. And only Bravve Alex is willing to raise the tough question of whether it is worth it to pay $4200 for a drug that is really no different and doesn't increase survival -- the latter measure now being the new gold standard for reporters who want to trash cancer drugs -- all of them it should be noted do not have late stage cancer and it seems are single and don't have kids and spouses to worry about.

Setting aside the fact that it was the New York Times that helped lead the charge about how BMS was gouging the public when Taxol was going for $8000 a treatment cycle, especially because it got the drug at a preclinical stage through a partnership with NIH, the idea the only good cancer drug is a cheap one that adds ten years of life (median) when someone has the advanced form of the disease reflects callousness, misunderstanding or a political agenda or all three.

And to suggest that some public policy could step in to ratchet down prices for unique drugs (Berenson uses the voice of a 'patient' from the National Breast Cancer Coalition on this score) raises the question as to what that mechanism might be. We have seen what "works" in Cananda, the UK, Australia and the VA....just limiting who gets the drug based on some arbitrary criteria that has nothing to do with genomics, compassion or pain. And for Berenson's elightenment, here is what British oncologists had to say about the five years it took for the UK's rationing agency to finally approve of the use of Taxol in a metastatic setting:

"Some health authorities, despite the authoritative advice of leading cancer specialists, have held off from making full use of this licensed medicine . . . . It is regrettable that lives will have been lost while a medicine, which had already proven its clinical value, has had to pass through what is effectively a further approval system before being widely prescribed in the UK."

Now they are doing the same thing with Herceptin, Gleevec, etc.... using the same excuses put forth by Berenson and others. Maybe Carolina Hinestrosa of the National Breast Cancer Coalition would be interested in making the judgement about prices and rationing since she is so keen in finding a public policy mechanism....
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:,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.


  • 10.01.2006
Totally unacceptable. Just totally unacceptable.


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 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?)

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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