Golden Years

04/17/2007 07:59 AM |

"AARP Says It Will Become Major Medicare Insurer While Remaining a Consumer Lobby"

That's the headline in today's New York Times story by Robert Pear. The pull quote is more interesting: "Potential for conflicts is seen as a lobbyist plans to expand its insurance role."

Conflicts? Non-issue says AARP. According to the Times story, "AARP officials insisted that its financial interests do not affect the positions it takes on Medicare, Medicaid, Social Security and dozens of other issues on which it lobbies and litigates."

Try this exercise -- take the above paragraph and replace "AARP" with "the insurance industry" and read it out loud.

So, let's pick two items: non-interference and drug importation. AARP supports the revokation of the non-interference clause and supports drug importation. Hmm. Major insurance provider supports price controls both legislated and imported. Conflict?

You be the judge.

On the up side, "the new plans will coordinate care for people with chronic conditions and will develop special programs to treat people with depression."

Big Pharma could learn a lot about spin control from spinmeitster/AARP CEO Bill Novelli.  Read More & Comment...

Yom HaShoa, Clinical Trials and Us

04/16/2007 04:35 PM |

The horrors of medical experimentations in the concentration camps triggered international rules designed to protect the dignity and lives of patients in scientific experiments.

The gruesome nature of the atrocities do not bear repeating. Let us honor the courage of those who survived. Let the memory who died in the Shoa be for a blessing and let us conduct our science and our lives to affirm the principle that each individual's existence has absolute value.

http://www.ushmm.org/research/doctors/twoa.htm
http://www.ushmm.org/research/doctors/Nuremberg_Code.htm  Read More & Comment...

Jerry Avorn Gets It Right on Drug Safety

04/16/2007 12:39 PM |

I am a frequent critic of Jerry Avorn on many issues, but he gets is right -- in my opinion (because I agree with him) in his editorial in Circulation.

He is off-base in his reasoning for opposing the elimination of user fees as a source of funding for FDA activities. See his article in the NEJM. While I tend to agree that user fees are becoming increasing unwieldy -- and should be replaced by public-private partnerships to advance Critical Path -- the implication that companies can't work with FDA to advance science is absurd.

Mark McClellan's editorial in the NEJM saying we have one last chance to get it right on FDA reform is on point. Pair Avorn's Circ article with Mark's NEJM and we have a sensible consensus that is Critical Path focused.

Links to all follow:

http://content.nejm.org/cgi/content/full/NEJMp078041
http://circ.ahajournals.org/cgi/content/full/113/18/2173
http://content.nejm.org/cgi/content/full/NEJMp078057  Read More & Comment...

Finding Fault With Finding More Cancer

04/16/2007 11:52 AM |

Interesting op-ed in the Washington Post raising concern about a stampede of women who will demand the use of MRIs to scope any cancer in lieu of mammograms and other screening tools in light of studies showing MRIs can catch some cancers in subpopulations and high risk patients that mammo's can't.

Let's look at the presupposition: women are hysterical and too stupid and doctors are unable to explain to women what the risks and benefits and limits of MRIs are. Also, let's look at the facts: the number of women who are seeking out mammo's for screening has declined...in part because irresponsible cults like Breast Cancer (In)action have conducted public campaign to discourage such testing....

So let's get a grip and recognize as does that article that the use of MRI's in select cases can reduce the spread of metastatic cancers and save lives or might do so. And we should research the value of such diagnostics in achieving that goal. No one is suggesting a blank check..except the scaremongers who presuppose that all patients are stupid and all doctors are patsies...

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/06/AR2007040601955_2.html?nav=rss_health  Read More & Comment...

Co-Pay's Designed to Improve Health: Maybe We Don't Have To Hold Our Breath

04/16/2007 10:04 AM |

Interesting article about United Health's PBM cutting copays to insure continued use of asthma inhalers -- as opposed to risking decreased use of Rx and increased use of more expensive services...a proposition FUSA Godfather Ron (I take money from George Soros) Pollack finds ridiculous.

The question is.. why not eliminate the huge co-pays for cancer drugs -- which have jumped many times more than the price of drugs themselves -- to promote compliance in other disease areas? Why not value driven health plans across the board? That is what evidence based medicine should really be about..

UnitedHealth cuts co-pay on asthma inhaler
RSS Feed - Health Business - Briefing
Published: April 13, 2007 at 11:07 AM
E-mail Story | Print Preview | License
MINNEAPOLIS, April 13, 2007 (UPI) -- U.S. health insurance giant UnitedHealthcare said Friday it has cut the co-payment for certain asthma inhalers due to high cost and short supply.

The insurer said its pharmacy benefit manager UnitedHealth Pharmaceutical Solutions has reclassified its chlorofluorocarbon-free, asthma inhaler Xopenex to its lowest co-pay tier, meaning plan members will pay between $5 and $10 for the prescription treatment.

CFC-free inhalers are gradually replacing CFC-containing albuterol inhalers, due to CFCs' environmental risks, but the CFC-free products cost more, and there are only a handful currently sold, UnitedHealth said.

The supply shortage of both generic and brand-name CFC-free inhalers is expected to increase until the complete phase-out deadline of Dec. 31, 2008, the company said.

"Asthma patients have relied on albuterol inhalers for years because they provide quick and effective relief of asthma symptoms. However, because of the higher cost for the new brand-name CFC-free inhalers, some patients may avoid continued treatment, which would place their health at serious risk," said Tim Heady, CEO of UnitedHealth Pharmaceutical Solutions.  Read More & Comment...

Revealing the "Con" in Consumer Reports

04/16/2007 07:39 AM |

Seems that at Consumer Reports, the adage “Ask me no questions, I’ll tell you no lies” has been replaced with “Ask loaded questions and there’s no need to lie.” No matter how you slice it, it equals the same thing – dishonest reporting.

Or as my grandmother used to say, "A half-truth is a whole lie."

Consider some of the findings from CR’s new survey:

* More than 60 percent of Americans agree that the Food and Drug Administration and Congress have failed to adequately protect consumers from harmful prescription drugs.

As opposed to what, “safe" prescription drugs? It doesn’t look like the survey asked respondents if they understood that all drugs have risks.

Similarly:

* 84 percent agree that advertisements for a prescription drug with safety concerns should be prohibited, with 59 percent "strongly agreeing" to such limits.

Again, as opposed to what, drugs that have no safety concerns?

* The survey also found that 84 percent of consumers agree that drug companies have too much influence over the government officials who regulate them. More than two-thirds (67 percent) are concerned that much of the FDA's funding comes from the pharmaceutical industry, with more than half--54 percent--"very concerned" about that situation.

How was this question worded? Did it make clear that PDUFA dollars fund review, not approval? I haven’t seen the survey questions, but I imagine it’s a “safe” bet that point wasn’t introduced into the protocol.

* More than half of consumers say they currently take a prescription drug, which translates to 124 million adults. A significant number -- -40 percent--say they have experienced an adverse reaction to a medication.

And what, precisely, did the survey define as an “adverse reaction?” Did they define it at all?

* Three-quarters of consumers (75 percent) agreed that drug ads lead to over-prescribing, with 38 percent "strongly agreeing."

Except that every survey of doctors says otherwise.

Here’s a link to the CR press release:

http://www.consumerreports.org/cro/health-fitness/news/2007/04/consumer-reports-survey-finds-strong-backing-for-drug-reforms-4-07/overview/consumer-reports-survey-finds-strong-backing-for-drug-reforms.htm

The release, BTW, does not say who funded the study or that Consumer Reports receives significant contributions from foundations funded by the generic drug industry. Surprising, considering that another of the “research” results says that Americans are concerned about conflicts of interest. What about CR’s funding conflicts?

Might that explain why CR took a break from testing vacuum cleaners and developed a sudden interest in the public's opinions on drug safety and the FDA? Inquiring minds want to know.

Research, as the saying goes, is like a bikini. What it shows you is interesting but what it conceals is essential.

And what this survey conceals are loaded questions fielded by an organization with an agenda.  Read More & Comment...

The WSJ's Selective Questions About Merck

04/16/2007 07:24 AM |

Isn't everyone getting tired of the "Drug company's overhype products with paid for studies" angle? Or better yet, when are people going to do their own thinking on issues instead of letting journalists with an agenda do it for them?

Carreyrou tries to frame the Merck HPV vaccine mandate issue as whether it is efficacious enough to mandate it's use or more to his point, to justify Merck's effort to support mandatory immunization. He brings in statistician's to question whether it will really be effective in a group not included studied in the clinical trials.

The fact is, no vaccine designed to reduce the spread of a virus is 100 percent effective in preventing disease particularly in those with a pre-existing infection. By Carreyrou's standard then vaccines for HIV, syphillis, TB, denge, herpes should not be mandatory or by other means be part of an aggressive effort to immunize 100 percent of patients.

As my colleague Marc Siegel has pointed out time and again, HPV is a sexually transmitted disease that causes precancerous warts that lead to billions of dollars of screenings, surgeries, etc. For that alone Merck's vaccine makes an important contribution. Whether Merck should have pushed for mandatory immunization (which Peter and I support) is another question. Needless to say, anyone can play the guessing game about real world effectiveness but chances are given the mechanistic understanding of the disease as opposed to fantasy baseball analysis that the epidemiologists often take, I would bet on Merck and not a numbers cruncher John dug up.

In any event, the whole article has the sound and feel of an article from a website called corpwatch.com which lays out the case against Merck in the same way Carreyrou does including an interview with the same Maine legislator who criticizes a woman's legislative groups for taking money from Merck.

You can compare the two articles and decide which is more efficacious:

http://www.corpwatch.org/article.php?id=14401
http://online.wsj.com/article/SB117668541991270825.html?mod=hps_us_pageone  Read More & Comment...

LA. MMA. VA.

04/15/2007 08:26 AM |

Bad Scrabble tiles but good opportunity for a letter to the editor of the Los Angeles Times.

Here's what ran in today's edition:

Price controls on Medicare drugs

Re "Aid for Medicare patients sought," April 11

Although the article states that "Democrats say the government could save money if it used its massive purchasing power to negotiate with pharmaceutical companies," there is little evidence to support their claim.

First, it's not clear that allowing the government to negotiate prices would yield any savings. According to a recent report from the nonpartisan Congressional Budget Office, "Government price negotiation would not yield lower drug prices compared to current law."

Second, Democrats cite the Department of Veterans Affairs' drug benefit as a good model for Medicare Part D. But under the VA model, drug companies must sell their products to the government at a price that is at least 24% less than the non-federal average manufacturer's price. In other words, the VA institutes price controls.

Medicare covers well over 40 million seniors. If price controls are extended to such a large segment of the market, they inevitably would result in reduced consumer choices and stifled drug innovation.

PETER PITTS

Director, Center for Medicine in the Public Interest, New York  Read More & Comment...

Clinical Trials Cause Global Warming...

04/13/2007 11:04 AM |

The following article is NOT a parody. Someone actually wrote this in a serious vein and not as forced confession while being held hostage by Greenpeace...

Clinical trials are saving lives but may be killing the environment
Drug Researcher.com


UK, 4/13/2007 - Clinical trials are saving lives but may be killing the environment due to their 'intensive energy use' and 'substantial contribution to greenhouse gasses.'

Energy use in clinical research premises and trial-related air travel have been identified as the biggest culprits, in an article published in the March 31 issue of the British Medical Journal.

The situation is only set to intensify as the trend towards outsourcing various elements of clinical trials to far flung destinations all over the world continues to gain momentum.

During a one year audit period of a sample clinical trial, the total emission of greenhouse gasses related to the trial was 126 tonnes of carbon dioxide equivalents (CDEs) - an amount that corresponds to that produced by 32 people in one year on the basis of global per capita estimates, said the researchers.

For the entire five-year duration of the sample trial, about 630 tonnes of CDEs were produced - an amount that is equivalent to 525 round trips flights from London to New York for one passenger, the researchers said.

Specifically, the trial coordination centre accounted for the largest proportion of emissions, generating 50 tonnes (39 per cent), with 45 out of the 50 tonnes coming from electricity usage and the remainder from office waste disposal.

The distribution of drugs and documents was the next biggest contributor, with 35 tonnes (28 per cent) and the majority of this stemmed from the airfreight of treatment packs and documents to hospitals.

This was followed closely by trial-related travel, responsible for 29 tonnes (23 per cent) of emissions, with most coming from air travel, as well as hotel stays for site visits, on-site data verification and meetings.

Furthermore, each individual clinical trial employee was found by the researchers to generate 14 tonnes of CDEs each year, compared with the substantially-lower average of 4-6 tonnes for employees in other service industries.

The research was conducted during August 2003 and July 2004 by the Sustainable Trials Study Group, which was convened by the London School of Hygiene and Tropical Medicine to find ways of reducing greenhouse gas emissions from clinical trials.

For the purpose, a 'carbon audit' was conducted on a multicentre international trial being run by the Medical Research Council (MRC), called CRASH.

The CRASH trial involved 10,008 participants at sites in 49 countries over five years and was investigating the effect of corticosteroids on death and disability in adults with head injury.

The trial was coordinated from London; involved a drug made by Pfizer in the US; a placebo made in France; packaging of both study drugs was done in Wales, from where treatment packs were sent to London for distribution to hospitals around the world.

Commenting on the results, the researchers said: "Clinical trials are energy intensive and produce substantial greenhouse gas emissions."

"Our audit provides insights into how to reduce the carbon intensity of clinical trials."

Suggestions given include using renewable energy sources as well as more efficient energy consumption at clinical trial sites, in addition to reducing the number of staff employed, in order to cut emissions.

Other suggestions posed by the researchers were to simplify trial designs to minimise superfluous data collection, coupled with increasing the use of remote electronic data capture; reduce bureaucracy associated with ethics committee- and-regulatory applications; as well as the increased use of teleconferencing and videoconferencing where possible to slash unnecessary travel.

They also made an interesting parting comment: "Trial results should be made publicly available, as the environmental consequences affect us all."  Read More & Comment...

An ounce of preemption

04/13/2007 10:36 AM |

Make that a Troy ounce.

According to the Wall Street Journal …

“Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process trumps state law in how manufacturers of health-care products must warn consumers about their potential risks.”

A victory for Merck, sure – but more importantly, a victory for FDA authority -- and for sanity.

As Dan Troy has written:

“Judgments concerning the need for and formulation of statements in drug labeling and advertising are squarely within FDA’s statutory authority and expertise, and they deserve deference from courts and juries applying state tort law. The agency carefully considers the scientific evidence relating to a proposed warning, as well as the public health consequences of including or omitting particular language from drug labeling or advertising. FDA should not have to act to safeguard its control over the label each time a plaintiff brings a state law action challenging the absence of a particular warning in drug labeling. Where FDA repeatedly has reviewed particular drug labeling and advertising content, state courts and juries should not second-guess the agency’s scientific determinations.”

“FDA’s legal authority over drug labeling and advertising is broad, and its expertise is unmatched. The agency’s decisions on the content of these communications deserve substantial deference from courts applying state tort law in product liability cases that challenge the adequacy of drug warnings.”

Amen.

It should also be noted that the FDA has consistently stood behind the concept of preemption through both Republican and Democratic administrations.  Read More & Comment...

Arcoxia AdComm-edy of Errors

04/13/2007 08:58 AM |

What does the FDA do when a drug is demonstrably safe and efficacious compared to a placebo. It usually approves the drug. In the case of Merck's new COX-2, the AdCom reviewing the drug -- which now includes a lawyer suing Merck -- acknowledged that Arcoxia has the same risk profile as many other painkillers. But the FDA wanted evidence that it met some unmet medical need in a subpopulation.

How about people like me or millions of others who did well on Vioxx or Bextra that have neither?

Tough luck according to the Adcomm who voted 20-1 against Arcoxia in IOM unscientific style.

According to David Felson, one of the panelists, "There is nothing special about this drug that would warrant giving it to patients." Why? Because the risk of heart problems is the same as all other painkillers currently on the market.

In otherwords. .. Adcomm will only approve a drug that is safer. Yet the clinical trial for Arcoxia had a sample size that was designed to demonstrate efficacy . Anyone with half a brain or read the FDA 2005 panel proceedings on COX-2 knows that absent biomarker or proteomic based understanding of the COX-2 mechanism with respect to thrombosis the FDA will need a randomized trial of about 1 million people to validate a safety signal.

Are there any grownups at the FDA with the courage to overturn the Adcomm decision. Merck is getting a fairer, more science-based hearing from the juries hashing out all the Vioxx claims.  Read More & Comment...

Rolling the Dice on Patient Safety

04/13/2007 08:29 AM |

Nevada legislators are once again rolling the dice on patient safety. This time it's not some half-baked and benighted scheme for cheap "Canadian" drugs, but rather an ill-considered plan to build a chinese wall around physician-prescribing data.

Here's the full news story:

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/12/AR2007041201208.html

While physician-prescribing data shouldn’t be available for marketing purposes minus physician knowledge and consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.

When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor” letters to the physicians who have prescribed the drug in question. This is accomplished quickly and precisely because the industry has access to accurate data. And when safety issues arise, that same data helps define the scope of the problem. Because of this data, for example, the FDA can determine how many patients were taking a specific drug and for how long each patient had been taking it.

Further, FDA-mandated risk management plans — developed for physicians who prescribe higher-risk therapies — are physician-targeted through the use of prescribing data. These records are also an important tool in clinical trial recruitment, allowing doctors who are treating targeted patient populations to focus their efforts.

According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.” In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.

The safeguards offered by the AMA’s program offer a much more reasonable and targeted approach to protecting both patients and physicians from unwanted disclosures. And those safeguards come with far fewer unintended consequences than any ill-considered state legislation.  Read More & Comment...

Knock Knock. Who's There? Liberal Bloggers on Health Care.

04/13/2007 07:32 AM |

Liberal bloggers on health care who?

The wonderful proliferation of blogs devoted to health care in general and pharmaceuticals in particular begs the question -- who's doing it?

Just came across a good study by the Institute for Politics, Democracy & the Internet (a part of the George Washington University Graduate School of Political Management).

Many interesting factoids on the issue of political blogs and their readership. Not a lot on health care specifically, but some data did pop out:

* Daily political blog readers are disproportionately "Strong Democrat" and "Strong Liberal."

* Of Democrats who read political blogs daily, 72% agree "strongly" that "Government should provide health insurance for the uninsured." For Democrats who are not daily political blog readers, that number is 53%.

* Same question for Republicans returns a 5% "strongly agree" for political blog readers and 6% for all others.

Perhaps one take-away is that the growing number of health care blogs represent the Democrat "ownership" of the blogosphere. Indeed the study opines that "Some observers have pointed out that conservatives appear to dominate in talk radio while liberals have a greater presence in political blogs."

Ergo, the more blogs on health care and health care related issues (such as the FDA, MMA, Evidence-Based Medicine, etc.) the more disproportionate the liberal (read "anti-Pharma") voice.

Here's a link to the complete report:

http://www.ipdi.org/UploadedFiles/The%20Audience%20for%20Political%20Blogs.pdf

And certainly grist for the mill for those in Big Pharma who don't think they should enter the fray.

As far as I'm concerned -- the more the better.  Read More & Comment...

Woulda/Coulda/Shoulda

04/12/2007 07:07 AM |

People keep telling me that the only major difference between the "first 100 hours" House bill on the abolition of non-interference and the Senator Baucus' pending piece of legislation is that the the House bill says that the Secretary "shall" and the Baucus bill says that the Secretary "can."

No matter how you look at it, it's still momentum in the wrong direction. As Senator John Kyl commented, “I think that Chairman Baucus is in a difficult position. I think he's being required by his caucus to fulfill a campaign promise which is not very wise or popular. We've reduced costs and prices dramatically by the [MMA]. We don't need to mess it up by having direct negotiation by the U.S. government.”

Well said,but there's something else -- comparative effectiveness.

Senator Baucus' bill (which I have not seen -- so my comments here are based on what I've heard) would also require HHS to set comparative effectiveness priorities without mandating additional ressearch. In other words, comparative effectiveness based on existing RCTs.

Another example of evidence-based medicine being hijacked by cost-based medicine -- while patient-centric care goes unnoticed and unheeded.

How about a bill that would fund research into adaptive clinical trial design and the development of gene tests for the purpose of getting the right medicine in the right dose to the right patient at the right time?
  Read More & Comment...

OxFam's Dubious Double Standard on Israel and Thailand

04/12/2007 04:20 AM |

In 2002, Oxfam International announced a boycott of Israeli goods grown or manufactured in what its literature refers to as the "occupied territories." Last year it blamed Tony Blair for his one sided support of Israel in it's war against Hezbollah. Now of course it supports the Thai dictatorship's effort to seize the IP of drug companies even as they give away free drugs to poor countries.

Just my effort to maintain moral clarity.  Read More & Comment...

insect technology

04/11/2007 02:24 PM |

an interesting study about one of a new wave of vaccines for influenza. I am glad to see the move starting away from egg-based technologies to more genetic technologies. It will enable us to respond to an emerging virus rather than have to anticipate one. I am quoted accurately on this here in the HealthDay piece about it:

http://www.forbes.com/forbeslife/health/feeds/hscout/2007/04/10/hscout603589.html  Read More & Comment...

Dem Bones

04/11/2007 12:38 PM |

Catch the last episode of "The Sopranos?" Yeah, the one where Tony and crew go to Canada and discuss how they can make a pile of dough by importing fake/expired Fosamax.

Could James Gandolfini be positioning himself as the next actor to turn politician? After all, since everyone seems to support pols who support "drugs from Canada," his odds for election might be pretty good.

Perhaps the next step will be to see if he's called by the HELP committee to testify on whether or not importation should be written into PDUFA IV.

Bada Bing!

We'll keep a drugwonks eye on Mr. Gandolfini's activities -- cautiously.  Read More & Comment...

Plan B+

04/11/2007 12:02 PM |

On April 9th the New York Times editorial page weighed on the issue of subsidized contraception for university students:

“For almost 20 years, college health centers have been able to purchase contraceptives at nominal prices. This was not a tax-funded subsidy. It was a financial incentive that gave drug manufacturers an exemption from Medicaid pricing rules so they could sell contraceptives and other products to certain charitable groups, like the college clinics, at an extreme discount. In response to concerns that drug companies were abusing this privilege, language was sewn into legislation in 2005 to close a loophole. It also inadvertently slashed this important benefit for clinics and their patients.”

“On some college campuses, the price of brand-name contraceptives has risen from the neighborhood of $5 per month to $40 or even $50. Switching to a generic is an option in some cases, but it can still entail a 300 percent price increase. Generics often run at about $15 per month. Newer contraceptives, like the NuvaRing, which contains a very low hormone dose and does not require a daily action that is easily forgotten, are not yet available generically. Many students are priced out of the market.”

“The spike in price affects more than just consumers of contraceptive devices and pills. College and university health clinics sold these products for a small profit — buying them at, say, $3 and selling them at $5. Even on a small campus, these dollars add up quickly. The money was an important part of health center operating budgets, paying for classes and even subsidizing more expensive medications.”

“The Centers for Medicare and Medicaid Services could reapply these exemptions with the stroke of a pen. If they do not, Congress should restore this much-needed benefit.”

Spot the inconsistency?

How can you be FOR a government program that provides access to new (and more expensive) treatments (like the NuvaRing) while at the same time being FOR a piece of legislation that would create restrictive formularies that would deny access to new (and more expensive) treatments (like on-patent statins)?

This is the same editorial page that is all gung-ho in support of reversing the non-interference clause and embracing comparative effectiveness measures. It seems that the Gray Lady considers contraception more important than cholesterol.

But you can’t have it both ways.

Further, when government dictates prices, what also goes by the boards is the incentive to develop new products at all.

But, when it comes to contraception, it seems there isn't any such thing as a "me too" product.

(And there isn't.)  Read More & Comment...

PBM(J)

04/11/2007 10:41 AM |

Let's get real -- a system in which a federal PBM "competes" with private-sector PBMs is unworkable and, over time, would result in a dysfunctional government monopoly.

PBMJ = Prescription Benefit Misjudgment.

At the most obvious level, some of the costs of a federal PBM would, inevitably, be hidden in other budgets -- the Social Security budget, the HHS budget, the catch-all budget for government office space, the pro-rated share of interest on the national debt, ad infinitum -- so that there would be a cost bias in favor of the federal PBM, except to the extent that federal agencies systematically operate less efficiently than private firms.

At a more subtle level, since the federal government has powerful incentives to emphasize budget savings over formulary expansion, the mythic federal PBM would attract relatively healthy seniors and/or those who disproportionately use less-expensive medicines and are willing to accept sharp formulary limits in exchange for lower premiums.

Private sector PBMs, because of a standard econometric adverse selection process would, obviously, attract those seniors who anticipate the need for more expensive medicines and, therefore, desire broader formularies; and an increase in the premiums charged by the private PBMs would exacerbate the problem by further concentrating high-cost seniors in the private PBM market.

This is quite apart from the problems created by a subsidy formula based on "average" premiums. The end result would be a market without the private PBMs, that is, monopolized by the mythic federal PBM.

Net/Net: a back-door route toward a VA-type pricing system.

Thanks to economist extraordinare Ben Zycher for the deep dive on PBM-land.  Read More & Comment...

AdCom-ical If It Weren't True

04/11/2007 03:30 AM |

This from Biocentury which I thought was a send up or parody of the extremes to which the FDA would have to go or bottoms of the barrels to which they would have to scrape -- you can choose your image -- in a search for untainted members or at least bias balance rather than just finding the best scientific minds to determine the risks and benefits of a medicine:


Arcoxia COI disclosures
The FDA advisory panel committee to review Arcoxia etoricoxib from Merck (MRK) this week has been granted three conflict of interest waivers to academics with commercial ties. The panel also will include two consumer advocates as voting members who have taken public stances against COX-2 drugs but do not require COI waivers under the agency's rules.

"Diane Aronson, the Arthritis Advisory Committee's voting consumer representative, is president of the Road Back Foundation, an organization dedicated solely to advocating the use of antibiotics to treat arthritis, an indication that has not been approved by FDA.

Arthur Levin, a temporary voting member, is director of the Center for Medical Consumers. The center is a participant in the Prescription Access Litigation Project (PAL), which has lawsuits pending against MRK alleging deceptive advertising of Vioxx and a similar suit against Pfizer (PFE) related to Celebrex.

The COI waiver participants include temporary voting member Robert Levine of the State University of New York, who reported ownership of $25,000-$50,000 in MRK stock.

A permanent member, Kenneth Saag of the University of Alabama at Birmingham, received $10,000-$50,000 in the last year as a member of MRK's speaker's bureau for topics unrelated to the meeting and received less than $10,000 from each of two competing companies for consulting unrelated to the meeting.

The University of Washington's Dennis Turk, who will chair Thursday's meeting, received less than $10,000 over the last year for participating on the advisory board of a company that competes with MRK.

According to Levin, the Center for Medical Consumers does not have a financial interest in PAL's litigation against MRK or PFE. "Everyone comes to the meeting with some kind of bias. The best way to deal with it is make sure that any one bias isn't over-represented," he told BioCentury. Nevertheless, Levin said, FDA should not have issued the Arcoxia waivers given controversy over a February 2005 meeting on COX-2 safety.

The three academics would be precluded from voting under new COI guidelines recently proposed by FDA. But Levin and Aronson would not need waivers under either scheme."


So let me get this straight: someone who is suing drug companies regarding the very safety issues that the Adcom will present and a patient who pushing a very different approach to an entirely different disease (RA as opposed to OA) are entitled to weigh in but not everyone else?

We have lost our moral compass on the issue of drug safety. By Levin's definition no one who receives money from companies for any reason can be trusted to engage in scientific enterprises or make a professional judgment that impacts individual or societal health while people who do not take money for companies but who nonetheless are biased in their own ways are therefore entitled to do so?

The Adcom composition is a glimpse of what will be left of the scientific enterprise and decisors if we keep going down this road. The litigators and junk scientists on the one hand and the scientific Stalinists like Marcia Angell, Jerry Avorn, Relman and the rest on the other.... All funded by George Soros and trial attorneys.  Read More & Comment...