Andy's Ordeal is Over

12/08/2006 10:21 AM |

With all the self-indulgent holds removed, Andy von Eschenbach finally gets confirmed. If Andy's defense of the integrity of the scientific process and the FDA during the last Grassley contretremps is a signal of what we are in for, it suggests that he see his ultimate responsibility to the employees of the agency, to patients and the scientific community. And it suggests that he will seek to generate more respect for the scientific enterprise that undergirds FDA's activities and transformation. Finally, the FDA will have someone who can set an intelligent and responsible course for the future, one that integrates the Critical Path with post market safety concerns, something that neither Congress or the IOM panel seems interested in or capable of.  Read More & Comment...

EU Tube

12/08/2006 10:03 AM |

Just got back from two very stimulating events. One was in Brussels, the other in Stockholm. Both were launch events for "Coincidence or Crisis," our new book on the issue of counterfeit medicines.

The Brussels event, as you might suppose, was attended by many NGOs, EU commission members, WIPO, government representatives from around the world (Cyprus, the US, Lithuania, etc.), the EAEPC (the association of parallel traders), members of the euro-press (Le Figaro, Le Soir, the Daily Mail etc.), and Bill Newton Dunn, MEP (Member of the European Parliament). Mr. Dunn also contributed an introduction to "Coincidence or Crisis" along with Congressman Mark Souder. The counterfeiting of prescription medicines is, after all, a global problem.

The Stockholm event took a different direction, attended by the media too, but also by members of the Swedish medical media, Swedish regulators, pharmacists, and patient groups. Mr. Finn Bengtsson, a member of the Swedish parliament and a professor of pharmacology also spoke at the event -- and promised to raise this issue within the government.

Here is one of the media reports of the Stockholm event:

http://www2.unt.se/avd2/1,3908,MC=3-AV_ID=558953,00.html

And, as always, more information on the issue of counterfeit drugs, as well as on "Coincidence or Crisis" can be found at http://www.cmpi.org.

Why is the book called "Coincidence or Crisis" -- because there is no such thing as a coincidence.  Read More & Comment...

It's von-derful

12/07/2006 07:37 PM |

That's Commissioner von Eschnebach, folks.

And it's about time.

We here at drugwonks.com certainly hope that the out-to-sea Ocean 11 senators who voted "nay" got the message that the American public wants action on real 21st century FDA reform -- and not just politicking as usual.  Read More & Comment...

Drug Coated Stents Found Safe: Public Citizen Disappointed

12/07/2006 05:59 PM |

The FDA panel reviewing the safety of drug eluding stents found that in high risk patients there was a greater incidence of clotting but that the rate was still quite rare and that the benefits greatly outweighed the risks. Sid Wolfe and Charles Grassley should take the comments of FDA's Andrew Farb to heart and recite them daily: "When we have rare events in relatively small numbers, to come up with sweeping conclusions can raise issues." Such sanity and reason is welcome at a time when the the pols and the IOM Drug Safety amateurs come up with sweeping conclusions about rare events in relatively small numbers.  Read More & Comment...

Can Torcetrapib Be Retooled?

12/07/2006 12:51 PM |

Two great articles about Pfizer's drug torcetrapib. One in the Wall Street Journal the describes the inner workings of the Drug Safety Board -- capturing both the integrity of the scientists who led it and statistical methods that are applied to determine drug safety.

http://www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx?nID=6250&SD=CG1aUlOgoSyl7sR5NDAc%2fA%3d%3d

The other is in Nature.com assessing whether the problem with torcetrapib is rooted in the way the drug itself elevates LDL or the fact that as Moti Kashyap, who directs atherosclerosis research at the VA Medical Center in Long Beach, California points out "When HDLs excrete cholesterol in the liver, they actually rely on LDLs for part of this process. So inhibiting CETP, which prevents the transfer of cholesterol from HDL to LDL, might actually cause an abnormal and irreversible accumulation of cholesterol in the body. "You're blocking a physiologic mechanism to eliminate cholesterol and effectively constipating the pathway," says Kashyap.



http://www.nature.com/news/2006/061204/full/061204-8.html

These articles are well-written, well-researched, balanced and thoughtful. Taken together it raises an important question: wouldn't drug development be helped by developing models that incorporate the off-target effects of medicines earlier in the clinical testing process? And that raises another question. Given the small difference in mortality is it possible to target the drug to people based on genotype variation? Can torcetrapib be retooled?  Read More & Comment...

The IOM Report on Drug Safety: A View from the Iraq Study Group

12/07/2006 11:49 AM |

I might be the only one (actually I know there are many more but they can't say it because it would be politically difficult to do so) who thinks this way, but I am a little tired of the reverence with which the IOM study is being treated.

There is this "emperor has no clothes" sense that pervades the whole report which no one in the media has yet to penetrate. The same thing seems to be going on with the Iraq Study Group report which appears to have taken on an aura of authority well beyond either the expertise or direct investigation of the members. Indeed, at the press conference when the report was released one reporter asked the ultimate question: Since none of the study group members had been beyond the Green Zone in Iraq and had only visited the country once (with the exception of one member) what makes their observations more valid than the commanders on the ground?

It was a really uncomfortable moment. Messrs. Baker and Hamilton hemmed and hawed and talked about how the ISG was the only bi-partisan group and how it had reached a consensus. And then the went back to explaining how if Israel gave back the Golan Heights that would guarantee that Syria would seal the Iraqi border from terrorists. For this we waited 8 months.

The same goes for the IOM study. Not one member of the panel went beyond the Green Zone when it came to drug development: no one who had been involved in clinical trials at any level, no one who had been involved in doing drug reviews or submitting them, no one who had been involved in designing or conducting phase IV clinical trials.

So the question is: why should we follow their advice as opposed to people who are actually in the business of looking at drug safety. How about all the folks who are in charge of Drug Safety Boards like those who had the responsibility of looking at drugs from Phase III to Phase IV? How about companies like Quintiles that have the largest body of Phase IV data in the world?

Sheila Burke claims that she couldn't use any of this expertise because they all had existing involvment with drug companies. That is nonsense. Everyone of the people on her panel had existing or pre-existing ties to insurance companies who do business with drug companies and will benefit from the panel's recommendations to buy insurance company administrative claims databases. Did anyone see anything in the report about the value of such databases relative to other sources of data for improving prescribing and managing risk/benefit. The IOM panel focuses largely on looking for safety signals with such databases, the worst possible use for such datasets since they rarely adjust for severity of illness, comorbidity, etc.

And the IOM report caves in to the unscientific demand for large multi-year randomized clinical trials like ALLHAT and CATIE that ignore patient variation at the genetic level. That means IOM wants to move the FDA in the exact opposite direction from the Critical Path and personalized medicine. Is anyone out there paying attention to this idiocy? Why all the bowing and scraping to recommendations that are retrograde?

Policymakers should listen instead to the reasonable safety reforms put forth by the agency's deputy commissioner for medical and scientific affairs, Dr Scott Gottlieb. According to SCRIP World Pharmaceutical News, Gottlieb told the Windhover FDA/CMS summit in Washington, DC, that legislative and regulatory proposals aimed at promoting continued learning about newly approved medicines had to be flexible to account for changes in the way medicine is practised. "

"Congress and some safety advocates are moving towards multi-decade postmarket study commitments," Dr Gottlieb said. "They may be setting society up for failure because the medical and pharmacological landscape will change so much that most studies designed today will not yield useful data and it will not be feasible or maybe even ethical to complete them...."

So much for the IOM recommendation for ALLHAT like studies.

"Dr Gottlieb suggested that prospective databases, such as those of insurance claims, could present greater opportunities for fulfilling Phase IV commitments for drugs. The agency recently announced plans to develop a series of guidance documents describing the best approaches for using epidemiological datasets to analyse postmarketing safety.

There need to be incentives for collecting and analysing epidemiological data in a more rigorous fashion, the deputy commissioner said. "Prospective databases have really only been used in a punitive way to look for problems and not look for opportunities," he said. "Unless we find a way to allow these things to be used for opportunities, you're not going to have everyone aligned behind the same goal."


There's the difference: Gottlieb is clearly making recommendations beyond the Green Zone. Insurance claims that are beefed up and supported with more rigorous observational studies for Phase IV commitments . The IOM wants to buy claims data to allow David Graham to go fishing for safety problems in order to address the imbalance between safety and efficacy that the IOM panel believes exists. And while other FDA officials want to make Phase IV part of a continuous feedback loop to improve clinical trial design and create predictive drug models, the IOM just regards their recommendations as separate and apart from the drug approval process.

Less reverence and more analysis is in order.  Read More & Comment...

Another VA Moment

12/06/2006 11:41 AM |

In light of my last post about the VA and its waiting times and denial of care...here's a great article by my colleague in Old Europe Johan Hjertqvist who runs the Consumer Powerhouse in Denmark. If the Euros are talking about giving consumers the freedom to go outside THEIR closed systems of care, why are our pols and pundits taking about shoving Americans into a closed VA model which, contrary to reporting, has yet to share or show any data about health outcomes?



Source: The Wall Street Journal
Europe
Date: December 06, 2006
Section: Business Europe
Page: 12
Among European economies, health care consumes roughly 10% of the average nation's GDP. When examined as a service market, the volume is enormous and the advantages great. And that is what EU Health Commissioner Markos Kyprianou might have in mind as he works to create an internal market of health services.

Last week, Commissioner Kyprianou declared his intention to find "a clear legal framework within which patients and health-care professionals have the chance to move freely in Europe " to receive and provide medical services. Such a market would help repair some of the weaknesses of European health care. When my organization analyzed the realities of health care among EU members for our 2006 Euro Health Consumer Index, we made some remarkable, even shocking, discoveries:

-- One in two health-care systems denies patients access to their medical records or to a second opinion.

-- Only one EU country has created a list and ranking of health service providers.

-- Waiting times are common. In three out of four countries, cancer patients likely face waits of more than three weeks to begin treatment.

-- In just a handful of countries can patients find a consumer-friendly, comprehensive catalog of available pharmaceuticals that includes with information about medication options and side effects.

-- In two out of three countries, government delays the introduction of new medicines into the reimbursement system.

A legally regulated internal market will help patients by helping them to cross borders to access better or more timely care than at home, and by encouraging new providers to enter their national market. To entrepreneurs ready to export their services, an integrated market will be of significance. For far too long, political bias and misguided cost-control ideas have prevented new treatments and management concepts from being established around Europe .

Weak access to consumer and patient information is a key problem in Europe . No market functions without information. If the right of mobility is to do any good, patients must be able to compare the treatment options and provider quality in various markets.

To locate the best offers at home, consumers would look for ratings of hospitals with short waiting lists. And to learn more about medication, they might demand advice from sources other than their doctors and pharmacists. To have a real impact, the internal market project will require a significant improvement of information.

But today there is very little -- if any -- reliable information available on the national level. This means that at least four out of five Europeans are denied knowledge of vital health-care conditions, which are available only to an informed elite. (If you understand English and are a skilled Internet user, the situation is far better.) This divide challenges strong European values of equality and justice.

No wonder, then, that the conclusion drawn at the annual EU health policy summit in Austria in October was that there is a need for consumer empowerment through medical guidelines or best practice on the EU level, to address the quality gaps and to improve outcomes. There was even discussion of a pan-European patient safety agency, tackling quality issues becoming even more important as cross-border care will grow. My impression was that the EU "health policy family" represented at the summit wanted the Commission to clarify and regulate the sector so that everyone has the legal, informational and financial resources to be able to cope with this development.

What often is labelled "health tourism" is quickly becoming a reality, as new companies are offering health services that are attractive both for their low cost and their high quality.

A Briton or a Swede can save thousands of euros by going to Poland or Hungary for virtually all dental care beyond regular checkups. The prices in these countries could be as low as half the level they'd find at home. But even these low-cost dentists are worried about Romania , as it is slated to join the EU next year. Once that happens, consulting with a high-quality dentist in Bucharest could save a health tourist an additional 30% off his bill. Such figures indicate the potential for restructuring and price efficiency in favor of the consumer.

The market perspective will bring another dimension into the European arena: the competitiveness aspects of health care. Assuming the present economic stagnation remains, the EU's future looks rather bleak, as the labor market faces increasing pressure to provide for the health-care needs of the Continent's aging population. If managed in an innovative way, health care could instead become the growth industry Europe badly needs. But such a shift requires a different kind of governance, not the least regarding how to reform our health-care systems.

Over time, active consumer choice among providers and therapies will push inferior producers out of the market, or at least force them to improve their performance. This bottom-up pressure to be more productive and efficient is key to improving quality in any industry, and health care is no different. But even though "health-care reform" is much debated across Europe , it is quite evident that the government approach remains top-down.

Rather than long-term consumer empowerment, the focus is on short-term cost-cutting. This is a harmful situation. If consumers had better access to information about their health and how to navigate the health-care system, they would be capable of addressing the inequalities and malfunctions of today.

As such, information is what's needed to developing the health-care systems of Europe . If market information is available to support informed choices, the Kyprianou market strategy can prove successful. Given the power to make decisions regarding their own care, consumers will act to define a new balance between rights, equality and fairness on one side, and access, influence and responsibility on the other.  Read More & Comment...

The VA's New Slogan: Who Do You Think We Are Part D?

12/05/2006 05:11 PM |

I got a kick at how the VA's flak-catcher tried to sidestep the fact that nearly 40 percent of it's hostages have bought Part D coverage in addition to holding on to VA coverage.

The AP's Kevin Freking has the VA spin doctors trying to establish the difference as follows: There are also differences in the list of drugs the VA covers compared with the list of drugs a typical Medicare plan covers. Leavitt described the VA's list, or formulary, as "among the most restrictive in the marketplace."
In Medicare, slightly more than half of enrollees are in plans that cover 1,000 to 1,500 medications. Another 35 percent are in plans that cover more than 1,500 drugs, Nelligan said.
Meanwhile, the Veteran's Administration plan covers about 1,300 drugs, Valentino said.
But, he calls the number of drugs on a formulary "almost irrelevant."
He said if a plan covers the top 200 selling drugs, then it's basically covering everyone's needs. When asked if the VA covers the top drugs used by seniors, Valentino said he was confident that it does. (Mike Valentino, VA's pharmacy director.)
"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.


Equally safe and effective?

Mr. Valentino should have heard the presentation by FDA's Janet Woodcock about the myth of therapeutic substitution at Windhover FDA/CMS Summit in Washington this past week.

Or he can ask some of the VA consumers who post about their experiences at the hadit.com Vets forum

You can always get a letter from a Doctor explaing what you need and why and than the VA will have to get it for you. There is a risk though. I tried it a number of years ago and was threatened with losing my fee services....

to get the VA to pay, I will have to schedule umteen appointments first, before approval. Sometimes I wonder if it's worth the hassle.

I simply recieved a call from my VA doc one day, saying the VA pharmacy no longer carries the slow release Oxycontin I had been taking for sometime. It's one of the few I found that works with neurological, (hot ice pick stabs) I get & chronic pain.
His message said they were stopping the med, "imediately" & prescribing "methadone".
I refused it & was told to come in & discuss it with the Doc. (Another 300 mile trip).
I was told by the Doc The VA no longer carries it in our region. This is sort of true, I found out.
The truth is, the "VA" Pharmacy @ the Spokane VAMC told me it's on the formulary list. Meaning, they stock it, but the Doc must specifically request it & it must be approved before you recieve it.

I went through sudden withdrawal symptoms & suffered from symptoms due to MS, Fibromyalgia, Spinal disorders & the list goes on for nearly 6 months, without being treated for neurological pain. The Doc said I can take Meth or do without, because "he" wasn't going to prescribe anything but Meth.
I was eventually put back on 5 mg of Oxycontin. Three, every six hours, as needed & Oxycodone for break through pain.
The doc has since cut the Oxycodone.

I am unable to take triptians such as imitrex, etc., Demerol and morphine. I am able to take Darvocet which helps a little but the best med for me is Stadol. The VA does not carry it! I have a private dr prescribe it and I use the nasal spray. Within 5 mins the pain is gone. Unfortunately, so am I for about 5 hours.

I have not been able to work since February 2004 since I have 3-5 attacks per week. I use ice packs on the top and sides of my head and heat on my neck and it seems to work.

Let me repeat what Mr. Valentino said:

"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.


And this is what the Dems want to inflict on all seniors.

But I guess 2 million VA consumers have signed up for Part D because they like paying twice for equally safe and effective drugs...  Read More & Comment...

The Great Mall of China

12/05/2006 11:01 AM |

"Drug Pirates Leave Death in their Wake." So reads the headline from the Guardian (of London). It's the most recent report on China's role in the growing global threat of counterfeit medicines -- and it's nothing short of international health care terrorism.

Some relevant snippets:

* Last month Peter Mandelson, the EU trade commissioner, revealed that fake birth control pills and HIV retroviral drugs from China had been seized by European customs officers.

* According to Mr. Mandelson, half of all counterfeit pharmaceuticals found inthe EU originate in China.

* The article cites the CMPI report to the effect that that global sales of counterfeit drugs will reach $75bn (£38bn) in 2010 - an increase of more than 90% from 2005.

* Henk Bekedam, representative for WHO in Beijing, said, "Fake drugs are a global problem and there is no reason to believe China is an exception. Piracy is a disease ... we need to report on it, find out where it is coming from, and go and deal with it."

Here's a link to the complete article:

http://business.guardian.co.uk/story/0,,1963095,00.html

And the closing sentence of the story is worth sharing:

"The worst consequences will be a lot more serious than erectile dysfunction."  Read More & Comment...

Passage to India

12/04/2006 07:08 AM |

Interesting/disturbing article in Sunday's edition of the Washington Times on the growing trend of "medical tourism" -- Americans traveling abroad for surgeries. And this doesn't mean spending a relaxing week in Paris. Hardly. It's more likely a trek to India or Thailand.

Joshua Goldberg, 23, a California man who went to Thailand to be ordained as a Buddhist monk, died at Bumrungrad Hospital in Bangkok after being bitten by a snake. Reports indicated Mr. Goldberg was "simultaneously administered ... six contraindicated and lethal medications," despite warnings to doctors from his father about his allergies to certain drugs.

But our pal Uwe Reinhardt, a health economist at Princeton University, has not heard "one horror story" involving a medical tourist.

Well ignorance is no excuse. Nor is naivete. According to Uwe, "A lot of surgery is just plumbing that requires skill. Given circumstances today, it's much harder to run a hospital in Los Angeles than in India. And while things could go wrong in a hospital in India or another Asian country, they would probably turn out just as well there as here."

Doesn't that make you all warm and fuzzy?

A better, wiser, safer, more practical, and less expensive alternative is to strive to avoid surgery altogether. And the best way to avoid many surgeries is to diagnose disease earlier and provide treatment through non-invasive, domestic pharmaceutical intervention.

Americans would be far better off with proper medication today than a passage to India tomorrow.  Read More & Comment...

Torcetrapib Trial Two Days Ago According To Forbes

12/03/2006 09:51 AM |

This sounds pretty good, says Christopher P. Cannon, a cardiologist at Brigham & Women's Hospital in Boston. He notes that in the data that are available, torcetrapib consistently raises blood pressure, but the change is small and might be treated with other medications. On the other hand, he says, increases in HDL are unparalleled.He says that if studies show the drug clears plaque out of the arteries, it could be very important. This medication would help address a huge unmet need, he says.

http://www.forbes.com/2006/11/30/pfizer-cholesterol-drug-biz-cz_mh_1201pfizer.html?partner=alerts  Read More & Comment...

Torcetrapib Trial Terminated

12/03/2006 09:40 AM |

From AP According to Pfizer spokesman Paul Fitzhenry, 82 patients taking the combination of torcetrapib died, compared to 51 deaths in the arm of the study where patients were taking Lipitor alone. Each arm of the study had 7,500 patients. Pfizer said that the study didn't raise any questions about Lipitor's safety.

Dr. Philip Barter, chairman of the steering committee overseeing the study, said in Pfizer's release that the findings of the data safety monitoring board Torcetrapib were a surprise "in light of prior study results."

We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Barter, Director of the Heart Research Institute in Australia.

Only three patients, all on the combo pill, stopped taking their medicine because of a blood pressure increase. However, a total of 14 patients stopped taking the combo pill for any reason, twice as many as on Lipitor alone..."  Read More & Comment...

The Spanish Prisoner(s)

12/01/2006 07:30 AM |

A factoid (courtesy of Gabriel Calzada, director of Madrid's well-regarded Instituto Juan de Mariana) for those who think that government control of health care leads to Nirvana:

In a classic case of "do as I say, not as I do," 86% of Spain's bureaucrats opt for private health care versus that provided by their employer, the government.

And, yes, Generalissimo Francisco Franco is still dead.  Read More & Comment...

Ketek Konspiracy

11/30/2006 05:37 PM |

Days before the advisory committee hearing on Ketek's risk/benefit profile guess who sends a letter to the NEJM claiming that the FDA's use of post market safety data in approving the drug was inappropriate?

David Graham.

But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.

I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.

I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.

He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...

If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.  Read More & Comment...

Really Really Sorry

11/30/2006 04:00 PM |

Let me remind everyone that Dr. Graham's famous memo on Vioxx did not adequately control for prior cardiovascular illness, obesity, hypertension or mixture thereof and that notwithstanding Grahama found a 1.47 relative risk of a significant cardiac event for low-dose Vioxx usage and 3.58 for high-dose Vioxx usage compared to current use of celecoxib, though the smaller number was not statistically significant, and relative risk compared to other populations was not statistically significance.

Further, it should be pointed that two advisory committees, one conducted by the FDA and another in Canada determined that Vioxx be returned to market. Dr. Graham's presentation at the FDA advisory committee was not as warmly received as the posterior polishing he received during his Senate presentation.

Do I apologize for logging on to our site to see the fake Graham posting and then responding from Israel and then rushing out to spend time with my family without reading the subsequent correction? Absolutely. Do I apologize for calling him a sad sick individual for equating the FDA with Nazi's when in fact he did nothing of the sort. Of course and it sickens me that someone would write some that disgusting using his name or anyone elses. While I strongly disagree with Graham and his approach, no one deserves such treatmen.

Does it bother me that Graham's lawyer implies that I had reckless disregard for the facts and didn't take the time to see if there were an explanation instead of posturing like an aggrieved victim...kind of. Will the threat of a lawsuit stop me from criticizing Dr. Graham in the future if that was the goal?

You be the judge.  Read More & Comment...

Sorry David.

11/30/2006 01:40 AM |

Just received this letter from David Graham's attorney:

Dear Center for Medicine in the Public Interest:

First, thank you for acknowledging on DrugWonks.com that the opinion piece entitled “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity” was not, in fact, authored by Dr. David Graham.

Having so acknowledged this fact, we would assume that DrugWonks.com would take the honorable and, we believe, legally mandated step of removing all the postings related to this matter that defame Dr. Graham. Not only did this not happen, DrugWonks.com actually posted an item, “My PS to David Graham” by Robert Goldberg, describing Dr. Graham, among other things as “a sad, sick individual,” after acknowledging that Dr. Graham was not the author of the aforementioned opinion piece.

In our view this Goldberg posting, and the failure to remove the prior postings by Peter Pittts related to this matter, exhibit actual malice toward Dr. Graham and an intentional or reckless disregard for the truth or falsity of these postings. Bluntly, they meet the legal standard of defamation.

Therefore, we must demand that, by 4 pm EST today (Tuesday, November 21, 2006):

(1) DrugWonks.com remove all postings associating Dr. Graham with “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity” and any negative insinuations about Dr. Graham related to this matter;

(2) Publish, at the top of the home page of DrugWonks.com, a bold-face, unqualified apology to Dr. Graham as follows: “DrugWonks.com, the Center for Medicine in the Public Interest, Peter Pitts and Robert Goldberg apologize to Dr. David Graham for posting intemperate and insulting comments about Dr. Graham, wrongly attributing to him the authorship of “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity.” We regret any inconvenience or harm this has caused Dr. Graham.”

Well, we want to do the right thing. And we certainly want Dr. Graham and his lawyers to think we're honorable. And, of course, we'd never want to be intemperate and insulting! Furtherest thing from our minds. But, David, you were also clearly inflamed by the article , so we hope you can see where we were coming from.

Please accept our most sincere apologies. And we regret any inconvenience this has caused you.

And, here's an open offer -- please send us your thoughts on the article that you didn't write and we will run it on drugwonks.com. Since it evidently caused you such grief, we'd like to give you the opportunity to set the record straight.

Your lawyer knows how to reach us.   Read More & Comment...

Food for Thought ... and Health!

11/29/2006 05:50 AM |

While we are certainly drugwonks, it's important not to forget that one of the most important ways to achieve and maintain good health is through proper diet and nutrition.

Remember, it's the FDA.

I was proud to have been a part of the FDA's Task Force on Consumer Health Information for Better Nutrition. One of our recommendations was that the agency move more swiftly and aggressively to approve qualified health claims for food -- making their value to America's health more transparent and potent from a labeling perspective.

Today's news is that CFSAN (the Center for Food Safety and Applied Nutrition) has received OMB approval for a study on how to best communicate qualified health claims to consumers.

After all, information that isn't properly understood by the consumer isn't worth the label its written on.   Read More & Comment...

Decline In Medicaid Spending: Another Nice Side Effect From Part D?

11/28/2006 08:32 AM |

USA Today reported yesterday that Medicaid spending as a whole actually declined for the first time since 1965. I have not looked at the data yet and plan to but at first glance it would seem to me that increased utilization of medications -- particularly among the dually eligible population and those in nursing homes -- might be saving money in the more labor intensive parts of the health care system.

ere's a link to the article.

http://www.usatoday.com/printedition/news/20061127/1a_lede27.art.htm

The article notes: "The changes include shifting the elderly from nursing homes to less-costly home health care, cracking down on fraud, refining the management of high-cost patients (such as those with AIDS or hemophilia) and cutting some payments to hospitals and doctors. " Unstated is the fact that such changes rely upon increased drug utilization via disease management programs. At the same time, the question has to be raised as to whether states are simply cutting costs by simply denying care in isolated instances. But then again, the Part D experience has moved control of the drug benefit into the hands of consumers and advocates, albeit with some initial bumps and disruptions which CMS and a motivated crew of stakeholders has promised to rectify this enrollment period. All the more reason to shift resources from providers to consumers...


If so, and I promise to follow up on this premise, it is yet another reason why restricting seniors choice of drugs to fill the dough nut hole for rich seniors makes no sense at all. And why the Part D experiment should be expanded to include Medicaid as a common sense coalition of Ds and Rs are proposing in Congress. The link to this article can be found here.

http://www.jsonline.com/story/index.aspx?id=535435

H  Read More & Comment...

The Perfect Part D Storm

11/27/2006 02:39 PM |

At what point will Democrats realize that the pledge to force government to negotiate directly with drug AND biotech companies will rob seniors of their choice of medicines and re-run of Hillarycare when biotech stocks lost 40 percent of their market value?

Interesting how the media is already laying the groundwork for this angle as this series of quotes suggest:

"From a rhetorical perspective, Democrats may feel like they gain a lot with this issue, but there are many substantive hurdles that the government faces in trying to negotiate prices. … If you look historically at the government's experience in trying to regulate prices, it's poor." (Ricardo Alonso-Zaldivar, "On Drug Prices, Are Democrats In A Fix?" Los Angeles Times, 11/26/06)



Marilyn Moon, Health Program Director, The American Institutes For Research: Negotiating Drug Prices Is "A Feel-Good Kind Of Answer, But It's Not One That Is Easy To Imagine How You Put Into Practice." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)




The Wall Street Journal: "It Isn't Clear That A Government-Run Drug Insurance Plan Would Push Prices Down." "Private plans often rely on pharmacy benefit managers, or PBMs, to obtain rebates and discounts with manufacturers and contain costs. But Medicare has traditionally been a fee-for-service program, without much experience in price negotiation." (Jane Zhang, "Why Medicare Drugs May Be Sticking Point," The Wall Street Journal, 11/24/06)


"Leslie Norwalk, acting administrator of the Centers for Medicare & Medicaid Services, the agency that manages Medicare, says she doubts Medicare would do a better job than private insurers in negotiating drug prices. Indeed, the agency probably would contract with PBMs to do the work. 'They are doing that already,' she said at a recent meeting with The Wall Street Journal." (Jane Zhang, "Why Medicare Drugs May Be Sticking Point," The Wall Street Journal, 11/24/06)



Urban Institute President Robert D. Reischauer: "At Some Point You Have To Ask: What Are We Looking For Here?" "Initially, he said, people were worried no private plans would participate. 'Then too many plans came forward,' Reischauer said. 'Then people said it's going to cost a fortune. And the price came in lower than anybody thought. Then people like me said they're low-balling the prices the first year and they'll jack up the rates down the line. And, lo and behold, the prices fell again. And the reaction was, "We've got to have the government negotiate lower prices." At some point you have to ask: What are we looking for here?'" (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)







"The cost of the program has been lower than expected, about $26 billion in 2006, according to the nonpartisan Congressional Budget Office. The cost was projected to rise to $45 billion next year, but Medicare has received new bids indicating that its average per-person subsidy could drop by 15 percent in 2007, to $79.90 a month." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)



Polls Show More Than 80 Percent Of Medicare Drug Plan Participants Are Satisfied. "Polls indicate that more than 80 percent of enrollees are satisfied, even though nearly half chose plans with no coverage in the doughnut hole, a gap that opens when a senior's drug costs reach $2,250 and closes when out-of-pocket expenses reach $3,600." (Lori Montgomery and Christopher Lee, "Success Of Drug Plan Challenges Democrats," The Washington Post, 11/26/06)  Read More & Comment...

Taylor Made

11/27/2006 10:42 AM |

In a new report from London's School of Pharmacy, Professor David Taylor (a contributor to the new CMPI/CNE book “Coincidence or Crisis”) points out: "The present system encourages traders to buy modern medicines cheaply in parts of Europe where governments impose low prices, and sell them on in new packages in EU member states where government controlled prices are higher. People think this saves money. But the evidence explored in our report indicates that it is in fact undermining European economic interests and may, on occasions, have created a pharmacy culture that increases counterfeit medicine hazards."

The report calls for stronger legal penalties for medicine counterfeiting and say they also support reform in other areas, from greater freedom of regulated medicines information provision in Europe to better controls over internet pharmacy and medicines trading. Importantly, the School of Pharmacy backs a strong patent system to fund medicines research and says without assets such as the research-based pharmaceutical industry "Europe's economic future will be bleak."

If you would like a copy of "Coincidence or Crisis," please send an email to ppitts@cmpi.org.  Read More & Comment...