A new class of drugs

04/02/2007 09:31 AM |

In my column, Antidote, for M, M & M this month, I discuss Tekturna, the first in a very promising new class of hypertensive drugs. It is no accident that this drug has come in "under the radar" at a time when so much of the main stream media appetite involves bashing drugs and drug companies, rather than championing great discoveries. Of course this climate, while making companies paranoid to dot every "I" and cross every "T" can also negatively effect drug research both short and long term.

Happy Passover to all.

Here's the column:

ANTIDOTE: 4-07 by Marc Siegel MD

Novartis has a new drug that has just been approved by the FDA. It’s called Tekturna. It’s the first new class of hypertensive drugs in ten years, something well worth celebrating. But it’s “coming out party” has received little medical attention.

Why?

It’s not for lack of importance. Tekturna is a first of its kind once a day renin blocker. Hypertension afflicts close to one billion people worldwide, and is uncontrolled in 70%, leading to heart disease, kidney failure, and stroke.

Renin is a crucial hormonal trigger of the renin-angiotensin system which ultimately leads to the production of the important adrenal hormone aldosterone, while at the same time constricting the body’s arteries.

In a clinical trial involving 6,400 patients, Tekturna significantly lowered blood pressure for 24 hours and was also effective in combination with other medications. Considering that the renin-angiotensin system is an essential cause of high blood pressure and heart disease, and that the blockers already on the market that interfere with angiotensin-converting enzyme or block the receptor for angiotensin II have been highly successful and life saving, the need for an effective renin blocker is undisputed.

So now along comes the first drug of its kind, potentially the most powerful drug in the angiotensin axis, and no one pays attention. Is the blood thirsty zeal of drug company attackers so potent that it overwhelms and obscurs all positive reports about a new class of drugs? I’m afraid so. Is it more important to attack Merck over the rare side affect of Vioxx than to champion Novartis for breaking through with a new discovery? I definitely don’t think so.

If we want our drug companies to thrive and spend the billions necessary to break through with a new category of drugs, the least we can do is congratulate them when one succeeds. Those who make an unremitting habit of bashing drug companies about unforeseen side effects could cost them so much money and public embarrassment that it takes the legs out of important projects like the one that led to the birth of Tekturna. In the current climate, it is probably no coincidence that it took ten years to come up with a new category of blood pressure drugs.  Read More & Comment...

Provenge: One Small Step for Cancer Patients

03/30/2007 12:44 PM |

The decision by the advisory committee to both approve Provenge using subpopulation data that ODAC did not readily provide and do so by rewriting the question provided by the FDA (asking if the drug for prostate cancer was effective as opposed to asking was the drug was substantially effective for an entire population.)

And it did so despite the fact that develop Dendreon has hardly begun to enroll patients in the post market trials the FDA and its safety mongering overlords in Congress such Ed Markey, Henry Waxman and Chuck Grassley are demanding.

For this round score it: Cancer patients 1 Postuing fearmongering pols and CYA bureaucrats 0  Read More & Comment...

Healthcare Realpolitik

03/30/2007 12:27 PM |

Some key take-aways from yesterday’s joint Center for Medicine in the Public Interest/Old Dominion University conference on Comparative Effectiveness:

• My opening question to the panel was whether or not comparative effectiveness (aka evidence-based medicine, aka healthcare technology assessment, aka rational use of medicine) was focusing on cost rather than care. Practice variation vs. patient variation.

•Carolyn Clancy (Director of AHRQ) remarked that we need to capture clinical data from off-label prescribing.

• Scott Gottlieb pointed out that the value of studying Avastin vs. Erbitux or Actos vs. Januvia is of no value – but that studying Avastin+ Erbitux and Actos + Januvia would yield important clinical information.

In short – if you don’t ask the right questions, you won’t necessarily get the wrong answers – but you won’t get the answers that will help improve patient care on the clinical level.

There was much conversation about the relative benefits of RCTs vs real life epidemiological data (like off-label prescribing outcomes). Look at it this way – consider each separate pieces of software designed for different purposes. Both are relevant to any discussion of comparative effectiveness – but only one “software” is used – RCTs (by DERP, Consumers Union, etc.). We need to design a software interface that will allow these two data sets to “talk” with each other.

The time for puritanical allegiance to RCTs is coming to an end.

Panelists were also brutally honest when it came to the question of cost-over-care, the new health care realpolitk, agreeing that when it comes to Washington, DC – cost containment will win out over patient care every time.

Unfortunately I agree – that’s the way it is right now. But that has to change. As John Bridges (Johns Hopkins Bloomberg School of Public Health) commented, “There is no health care without the patient.”

When it comes to changing the short term, politically-driven cost-over-care debate to a long term, patient-focused right-care-for-the-right-patient at-the-right-time paradigm, yesterday’s debate wasn’t the end, or even the beginning of the end but, hopefully, the end of the beginning.


And, when that day comes, it will indeed be health care's finest hour.  Read More & Comment...

CBO: Part D gets an A

03/30/2007 09:45 AM |

Attention Drugwonks:

The Congressional Budget Office has lowered the 10 year cost projection of the Medicare drug benefit by $387.2 billion or 32.3 percent as compared to last year's 10 year projection.

The learning is that competition and private negotiations are saving taxpayers and beneficiaries far more money than our worthy, non-partisan government actuaries had anticipated.

And in congressional testimony before the House Budget Committee, CBO Director Orzag recentlsaid that actual prescription drug plan bids for 2007 were 15 percent lower than the bids in 2006.

Imagine that -- a government program that, per capita, actually decreases in cost from year-to-year.

Competition works.  Read More & Comment...

Congress vs Patients

03/30/2007 08:34 AM |

The Washington Times
www.washingtontimes.com
Restricted treatment
By Robert Goldberg
Published March 29, 2007
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This week there were two bits of news that reminded most of us that when it comes to medicine, the real crisis is not safety but the lack of treatments to prevent or at least battle disease effectively.
First, the Alzheimer's Association released revised estimates showing that the number of Americans with Alzheimer's jumped from 4 million to 5 million over the past decade, a trend which, if left unabated by new medicines, will triple to 16 million by 2030.
Second, Elizabeth Edwards and Tony Snow announced that their respective breast and colon cancers had come back and spread. The likelihood of each's survival depends on a complex combination of factors that are increasingly understood, which has translated into better drugs and longer lives. As Allan Lichter, president of the American Society of Clinical Oncologists, said recently, "in the years ahead, doctors will be able to detect cancer early with a blood test, a blood signature, if you will." The same knowledge used to detect cancers at their earliest stage will be used to develop drugs to treat them at that nascent and intimate level, making them increasingly curable. The same goes for Alzheimer's. If caught early, it can possibly be delayed for years.
Don't count on these breakthroughs anytime soon. It is taking longer than ever to bring new medicines to market. The Enhancing Drug Safety and Innovation Act currently under consideration in Congress will ensure that millions of Americans will die waiting for medicines that politicians purport to protect them from.
The act requires that before any drug is approved, a risk-management program (RiskMap) be created. As former FDA Deputy Commissioner Scott Gottlieb points out, this "legislative proposal extends the FDA's ability to restrict which physicians can prescribe a medicine, and which pharmacies can dispense it." Mr. Gottlieb notes that the FDA now limits RiskMaps to about two dozen drugs with very serious or poorly understood side effects. Getting these drugs is burdensome for patients who want them. Severe penalties await doctors and physicians who prescribe and dispense them outside of FDA guidelines.
But Congress wants to extend RiskMAPs in order to prevent possible rare side effects by limiting who can prescribe new drugs, for what uses and to whom. Under the current legislation, doctors and pharmacists who violate a RiskMap are subject to civil penalties. No doubt being accused will lead to criminal proceedings and personal injury cases. All of this means that the current legislation takes the off-label prescribing of new drugs -- though such prescribing is standard for breast cancer, Alzheimer's and mental illness -- and virtually makes it a criminal activity.
I once supported the act, known as Kennedy-Enzi. That was before its authors decided that the best way to protect the public from adverse drug events is to replicate clinical trial conditions in the real world. RiskMap could create the equivalent of a prescription-drug police state, complete with computerized monitoring by the FDA of who gets what. My friend's father was locked out -- literally -- by a computer from receiving a cancer drug on a clinical trial because his pulse was less than a tenth of second off the interval set by the FDA. No access. No treatment. If the doctor had tried giving him the drug, it would have triggered an investigation and closed down the entire trial.
This approach could be applied to millions of Americans as doctors, hospitals and pharmacists, terrified by the threat of FDA oversight, congressional hearings and lawsuits, are bludgeoned into practicing cookbook medicine. Which health plan would dare to pay for a drug that doesn't meet RiskMap mettle? The legislative push is already slowing drug approvals because FDA drug reviewers are afraid of second-guessing by the media and Congress. A new drug for diabetes-related blindness to be approved this year may now be delayed for three more years of study. A drug to treat gram-negative sepsis that was supposed to be tested against the current medicine must now be tested with a group of patients that get a placebo (a sugar pill) to satisfy the demands of Rep. Henry Waxman. Yet, in many cases, gram-negative sepsis is 100 percent fatal.
The FDA is already delaying accelerated approvals of cancer drugs until dying patients are enrolled in double-blind, randomized, placebo-controlled, post-market studies. Kennedy-Enzi wants to make this practice mandatory. That means no accelerated approval at all for cancer or Alzheimer's.
These restrictions will choke off hope, scare off innovation, give trial attorneys control over the health-care system and deny many of us longer life. The congressional assault on medical innovation is not a presidential campaign issue yet. Perhaps, thanks to the courage of Mr. Snow and Mrs. Edwards, it will be.

Robert Goldberg is vice president of the Center for Medicine in the Public Interest..  Read More & Comment...

Comparing Notes on Comparative Effectiveness

03/29/2007 07:54 PM |

CMPI co-sponsored a National Forum on the role comparative effectiveness research should play in health care decisionmaking with Old Dominion University medical school today....

The take away message was put best by Johns Hopkins University professor John Bridges...there is no health care without patients. Any effort to impose a cost-driven comparative effectiveness research agenda on patients will fail. It was also put best by Scott Gottlieb who said comparative effectiveness is not about false choices between two drugs, choices driven by a political agenda.

In the end, the only research that matters of the comparative kind will help determine which treatment works best for which individual and help individuals shape the nature of treatment.

Politicians who proceed otherwise will proceed at their peril.  Read More & Comment...

My Main Man Merrill

03/29/2007 02:23 PM |

Merrill Matthews and I don't see eye-to-eye on everything when it comes to Medicare reform, but there's one thing we do agreed on ... it's working.

Have a look:

http://www.mercurynews.com/search/ci_5537368/nclick_check=1

As always, looking forward to all your thoughts and comments.  Read More & Comment...

my response to Dr. Ross's letter in the WSJ today

03/28/2007 12:37 PM |

To: Gilbert Ross, M.D.
Executive and Medical Director
American Council on Science and Health
New York



Dear Gil,
you did not read my oped carefully,
you have mischaracterized my argument for the benefit of your argument.
I never said that mortality wasn't a worthy endpoint warranting further study, i said it shouldn't be a "solo" endpoint.
I am also not alone among the thousands of internists and pulmonologists who use screening chest ct as part of a strategy for early detection, and then together with a team of top level radiologists, figure out what to do with the results. This is very clearly described in my oped, and you have distorted it.
You also should have admitted to the Journal that you know me personally, that I have done consulting work for your organization, and that this may have affected your motivation in writing this letter.
I have heard from many practicing physicians and top level researchers who have agreed with me and praised my oped. Everyone agrees that the great advances in CT technology have let to a situation where it is capable of diagnosing cancers before they leave the lung, and in the right hands, are much less likely to cause unmanageable false positives.
we can see the advantage of advanced technological screening of breast cancer, a less aggressive cancer, with the current news about MRI.
My core premise is that a practicing clinical physician like myself needs diagnostic tools like this in his arsenal that can be used in conjunction with a proper knowledge of the medical literature.
I always welcome debate with you, and appreciate your invitation for further debate, but i feel that should have occurred before you published an inaccurate letter.

Marc Siegel MD  Read More & Comment...

60 Minutes Is Not Enough To Tell The Whole Truth...

03/28/2007 08:50 AM |

April 1st 60 Minutes will do an "expose" timed to the release of a Center for Public Integrity report showing that the pharmaceutical industry spent nearly $900 million on lobbying and campaign contributions over the past decade. Sounds like a lot right?

But the industry doesn't come close to many others in trying to push their point in a political system that frankly requires money to move messages around. Case in point, Phrma the trade group is way down the list when it comes to spending on lobbying comparrd to many DC trade groups according to CPI.

Using CPI data (1998-2004), pharma (and I don't know if they count biotech in that mix) is about even when it comes to lobbying compared to the aggregated spending of other health care interests that have been under less scrutiny and attack. Both have spent about $650 million on lobbying during that time. Add insurance companies (life and health) and the whole health care financing and delivery system has spent twice as much on lobbying as drug companies and it trade group. Electric utilities alone spent $500 million. Add in all energy related lobbying and you are close to a $ 1 billion. Banking, financing, credit concerns spend as much as pharma. So do defense and aerospace companies.

And so do all manner of government, government officials, public unions,city, county, state, sewer authorities, foreign, you name it.

Lobbying has a Jack Abrahamoff taint to it. And granted there are there are plenty of folks who set up shop and sell themselves and justify a large monthly retainer because they are able to get that all important "ask" from an important member of Congress. But ultimately how we feel about lobbying depends on our opinion on a political issue. Those who claim that the "Israel Lobby" has "too much influence" based on campaign contributions do so because they have a problem with American support for Israel. Those who claim that "Big Pharma" has "too much influence" similarly are likely to support price controls, drug importation, more FDA regulation.

So let's be honest. If you attack the Israel Lobby, you are not a Zionist.

If you attack Big Pharma's lobbying effort, you do not believe free markets are the best way to make new drugs available.

In or out. Simple as that.  Read More & Comment...

The IMAP-Halliburton Connection

03/27/2007 11:15 PM |

The Institute of Medicine As a Profession may not accept money from big money but it does get loot from Haliburton via it's patron George Soros.....I guess hypocrisy goes down easy when it's followed by a lot of zeroes....

Here's the background.....
http://blog.foreignpolicy.com/node/3776
Soros buys Halliburton
Home » blogs » Mike Boyer
Tue, 02/27/2007 - 3:22pm.

Normally, I'm willing to overlook the hypocrisy of the liberal elite. If Al Gore and his Hollywood cronies want to fly around on gas-guzzling, atmosphere-polluting private jets while railing against global climate change, I'm willing to overlook it.

But the latest move by globe trotting, hyper-liberal billionaire George Soros borders on being too much. According to papers filed with the SEC, in the fourth quarter of 2006 Soros purchased nearly 2 million shares of ... hold your breath ... Halliburton. The Halliburton shares reportedly went for an average purchase price of $31.30 a share. That puts Soros' total investment in Halliburton at around $62.6 million, or about 2 percent of his total portfolio.

Soros, of course, is the dean of Democratic money giving. And Halliburton, of course, is the company that embodies everything the Democrats see as evil. Dick Cheney is its former chief, for goodness' sake. But Soros is also a man of contradictions. He supported campaign finance reform for years, only to declare that defeating President George W. Bush was the "central focus" of his life. To prove it, he sunk $24 million of his own "soft" money into the 2004 campaign, helping make that election one of the most divisive in modern history.

Soros' position in Halliburton is reported to be his first, which means he bought it with a full understanding of Halliburton's reputation. Soros may not see a problem with profiting from a company that has been accused of everything from sweatheart deals to cooking the books to serving U.S. troops lousy food in Iraq. The real question, however, is whether MoveOn.org, the Center for American Progress, and other organizations that have benefitted from Soros' charity will see a problem with accepting money earned off Halliburton shares?  Read More & Comment...

The tortious ties of the Prescription Project

03/27/2007 07:20 PM |

As we noted The Prescription Project is " an initiative of the Boston-based nonprofit healthcare advocacy group Community Catalyst, which made headlines a little over a year ago when it sued Pfizer over its marketing claims for Lipitor. The Prescription Project is being conducted in partnership with the Institute on Medicine as a Profession (IMAP) and is funded by a USD 6 million, two-year grant from The Pew Charitable Trusts and money from George Soros.

In addition, the group has assembled a prestigious advisory committee whose members include Cathy DeAngelis, the editor-in-chief of JAMA; Steven Nissen, the president of the American College of Cardiology; and Philip A Pizzo, the dean of the Stanford School of Medicine."

Part of this campaign includes class action lawsuits initiated by the Prescription Action Litigation Project which in turn is comprised of Trial Lawyers Inc (large trial firms that seek huge monetary damages by suing corporations) and their public advocacy front, Public Citizen and various state organizations.

For instance, one mainstay of the PALP is the law firm Hagens Berman Sobol Shapiro (HBSS) which has been going after Pfizer for what is alleges are "false marketing claims by pharmaceutical giant, Pfizer. We are investigating claims made for its cardiovascular disease drug Lipitor, that encouraged doctors to prescribe the drug for patients when it was not necessary or healthy to do so." The firm is claiming that Pfizer encouraged doctors to prescribe the cholesterol drug for hypertension, chronic kidney disease, and many other unapproved illnesses besides the prevention of cardiovascular disease. ...

Hagens, Berman is famous for suing Starbucks for unbridled competition and being slapped with a $10 million penalty for violating their ".. duty of loyalty to three small water bottlers that in 2003 were close to settling a claim with Nestle Waters North America, the owner of Poland Spring Water Co." "Seattle law firm told to pay $10.8 million", Seattle Post-Intelligencer, Mar.24; Lattman, Mar. 24).

Public Citizen and the U.S. Public Interest Research Group (PIRG) works closely with Hagens Berman and other tort firms through Community Catalyst and TPP and other conduits to attack off label prescribing via fishing expeditions, testimony and now legislation at the state level to force doctors to either disclose or disgorge any money obtained from drug or biotech firms for any purpose.

This is not an effort to 'clean up' medicine. This is a witch hunt, a Stalinist effort to purge medicine of any relationship between academia, private industry and clinicians. And it is an effort to presume that off-label prescribing is both hurtful and possibly criminal behavior. Let's be clear: the goal is to create another opportunity for shaking down the drug industry and physicians. All you need are RiskMaps that prohibits and limits off-label prescribing and you have a whole new source of revenue for tort lawyers.....

Sort of like shorting currencies and buying them up. No wonder Soros is involved.  Read More & Comment...

Pauline Chen - humanistic doctors

03/27/2007 05:59 PM |

my book review in NY Post Opinion books on Sunday speaks to the need to retain the patient contact, caring, and deep involvement with patients that is at the heart of good medicine.
This essential quality will be the first thing to be further jeopardized if government mandates for expanded coverage don't take "quality of care" into account. Dr. Chen directs these issues to the essential need to care for dying patients, but it is a universal concern for all health care.

http://www.nypost.com/seven/03252007/postopinion/postopbooks/dying_for_compassion_postopbooks_marc_k__siegel.htm  Read More & Comment...

Just in from the Beeb …

03/27/2007 09:30 AM |

Drugs watchdog faces legal review

The NHS drugs watchdog is to face a judicial review in court for the first time over the guidance it offers.

Two firms have been granted the review over the way the National Institute for Health and Clinical Excellence reached its conclusion on Alzheimer's drugs.

NICE ruled NHS patients with newly diagnosed, mild Alzheimer's disease should not be prescribed the drugs.

Eisai and Pfizer said the process was unfair, but NICE said the claims were without foundation.

NICE guidance in 2001 recommended donepezil, rivastigmine and galantamine - which can make it easier to carry out everyday tasks - should be used as standard.

But in November the watchdog announced people with newly diagnosed, mild Alzheimer's were exempt.

Campaigners have repeatedly argued patients in the early stages of Alzheimer's should also have access to the £2.50-per-day drugs.

Neil Hunt, chief executive of the Alzheimer's Society, which will give evidence in the case, said: "Denying people in the early stages of this debilitating disease access to drug treatments is cruel and unethical.

Why should we care about how the Brits choose care for Alzheimer’s patients Over There? Because their “evidence-based” model is being touted by many Over Here as the right path.

Consider what’s happening Down Under where a similar (although by no means identical) system is also used to limit available treatment for Australians who suffer from Alzheimer’s Disease. The particulars are different – but the message is the same: when government acts to limit therapeutic choices, patients suffer the consequences.

Australia limits coverage of Alzheimer’s medicines to six months of treatment unless the patient shows “significant improvement.” In the US, the decision to continue treatment is based on patient (and care-giver) satisfaction – which includes maintenance of current mental status and prevention of mental decline – quite a difference from “significant improvement.”

Restrictive formularies (yes, like the VA system) and health care systems (such as in the United Kingdom, Australia, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.  Read More & Comment...

Comparative Effectiveness Anyone?

03/27/2007 07:38 AM |

Please join CMPI and Old Dominion University for a robust conversation with Carolyn Clancy, Gail Wilensky, Scott Gottlieb, Stephen Spielberg (no, the one from Dartmouth), Dr. Bob (Goldberg) and distinguished others for a half-day seminar on the role of comparative effectiveness research.

Yes, Senator Baucus was invited.

It's on March 29, from 9am to 2pm at the National Press Club. Full program details can be found at http://www.cmpi.org

To RSVP, please contact Connie Davis, csdavis@odu.com

Hope you can attend.  Read More & Comment...

Anna Nicole-Smith Drug Importation Access Act...

03/27/2007 12:11 AM |

Re-reading the Dorgan-Snowe drug importation legislation in the wake of the laundry list of drugs found in Anna Nicole's blood at time of death leads me to this interesting clause in the bill which takes the definition of the doctor-patient relationship with respect to internet prescribing to Hollywood levels:

(3) QUALIFYING MEDICAL RELATIONSHIP-

`(A) IN GENERAL- With respect to issuing a prescription for a drug for a patient, a practitioner has a qualifying medical relationship with the patient for purposes of this section if--

`(i) at least one in-person medical evaluation of the patient has been conducted by the practitioner; or

`(ii) the practitioner conducts a medical evaluation of the patient as a covering practitioner.

`(B) IN-PERSON MEDICAL EVALUATION- A medical evaluation by a practitioner is an in-person medical evaluation for purposes of this section if the practitioner is in the physical presence of the patient as part of conducting the evaluation, without regard to whether portions of the evaluation are conducted by other health professionals.

`(C) COVERING PRACTITIONER- With respect to a patient, a practitioner is a covering practitioner for purposes of this section if the practitioner conducts a medical evaluation of the patient at the request of a practitioner who has conducted at least one in-person medical evaluation of the patient and is temporarily unavailable to conduct the evaluation of the patient. A practitioner is a covering practitioner without regard to whether the practitioner has conducted any in-person medical evaluation of the patient involved.

And the loophole that will make it easy for any criminal, kiddie-porn site operator or terrorist to set up shop in Canada and source drugs from anywhere:

"An agreement by the exporter to comply with applicable provisions of Canadian law, or the law of the permitted country designated under subsection (a)(4)(D)(i)(II) in which the exporter is located, that protect the privacy of personal information with respect to each individual importing a prescription drug from the exporter under subsection (a)(2)(B)."

Please note that Canada does not vouch for what happens in the scores of export houses up north that import commercial quantities of drugs from Pakistan, Iran, Turkey, etc under a personal use exemption. So all you have to do to comply with the Anna Nicole import bill is be a Rx chop shop in Canada.  Read More & Comment...

The Battle for A Breakthrough

03/26/2007 10:31 AM |

The next time someone who knows nothing about drug development or medicine blathers on about why drug companies don't just focus on breakthrough drugs should read the article in the NEJM about the quest to find a drug that actually reverses atherosclerosis. The statin focused pathway makes a lot of sense and it not dead despite what you will hear because of the complexity that has been discovered in large part because of the huge wager Pfizer made on the torcetrapib molecule.

The "failure" has, as Dr. Nissen and colleagues, article demonstrates, advanced our understanding. I have been a severe critic of Nissen with respect to his pronouncements on the safety of ADHD drugs, but as this article suggests, his handling of the torcetrapib issue has been thoughtful, responsible and in some respects visionary.

http://content.nejm.org/cgi/content/full/NEJMoa070635v1

More needs to be written about this unfolding saga -- as well as other struggles to understand the intimate connection between disease, body, molecule, genetics. It might promote the growth of something lack among those eager to issue pronouncements about how companies should run their businesses: humility. As Derek Lowe of www.corante.com has noted, on a good day scientists walk into a lab not knowing what to expect, The NEJM shows that real money is invested on this proposition every.  Read More & Comment...

These boots were made for walking

03/26/2007 08:17 AM |

I keep getting free pedometer offers from AARP. Now I know why. Their usual harangue about rising drug prices has gotten stale. No one is buying it.

AARP launches ad campaign urging drug-price negotiations

Here's the link to the story in USA Today:

http://www.usatoday.com/news/washington/2007-03-25-aarp_N.htm?csp=34

And keep the pedometer!  Read More & Comment...

There's a caveat to cheaper drugs

03/26/2007 07:29 AM |

Okay -- who's in favor of cheaper drugs?

http://www.santacruzsentinel.com/archive/2007/March/25/edit/stories/05edit.htm

Also -- please see Scott Gottlieb's excellent op-ed in today's WSJ:

http://online.wsj.com/article/SB117486373440048427.html?mod=opinion_main_commentaries

Enjoy.  Read More & Comment...

The $50,000 Question

03/26/2007 07:12 AM |

An excellent commentary from today's edition of the Wall Street Journal ...

Drug Crazy
By RICHARD A. EPSTEIN

In an industry advisory last week, the U.S. Food and Drug Administration announced tough new conflict-of-interest rules against doctors who sit on its advisory committees, which recommend whether the FDA should allow pharmaceutical companies to market their new products. The agency's rationale is that greater transparency is necessary to remove any taint that might undermine the public's confidence in the approval process.

The new rules categorically bar any individual from sitting on any committee to evaluate a drug up for approval when that individual has a financial interest exceeding $50,000. The $50,000 figure includes stock ownership, related research and consulting arrangements. Unfortunately, this measure sweeps too widely by lumping together experts who do clinical trials with those who have a direct economic stake in the success of a drug. The precise measurement of that stake mysteriously turns on the extent that the drug has a "potential for gain or loss" to the committee members or their families. Persons whose financial stakes are less than $50,000 may be allowed to meet with these committees, but not to vote.

The main justification for this new regime is the widespread perception that drug and device makers have "hijacked" the FDA process, allowing dangerous drugs to slip into the market. The most conspicuous illustration involves the various COX-2 inhibitors such as Vioxx and Bextra, when at least 10 members of the FDA advisory panel who voted to leave these drugs on the market had some ties to their respective manufacturers, Merck and Pfizer.

It is here that the difficulties begin. The common perception is that the FDA acted too late in removing these drugs from the marketplace, and indeed should never have approved them at all. That perception rests on a crucial tradeoff: how much of an increased risk of heart attack should people be allowed to run in order to mitigate the ravages of arthritis and other degenerative diseases. One common, but cavalier, notion is that people should learn to cope with pain to stave off the greater potential harm of a heart attack. The evidence on the ground suggests another story.

"Suffering boomers want to fill Vioxx void" is a headline in last Friday's Chicago Tribune. The gist of the story: Baby boomers and others have returned to Pfizer's Celebrex, which reported an 18% increase in sales notwithstanding the FDA's stringent black box warning. Similarly, many individuals stashed away their Vioxx for a rainy day after it was recalled by Merck. These individuals understand the risk they're running, but trust their physicians to minimize its impact.

This evidence should put the FDA's zeal in a new light. Just how do these advisory committees "protect" informed product users by limiting their choices for dealing with crippling chronic conditions?

The FDA's major problem is not laxity, but zealotry. Its current get-tough view on conflict of interest only aggravates the fundamental flaw in its institutional design. Transfixed on the harms drugs can cause, the FDA remains largely oblivious to the harms they can prevent. Any delay in the use of a successful drug is costly: The delay matters little to the FDA, but a great deal to the thousands who plea for compassionate exemptions to try a drug that has not met with FDA approval. Nor is the FDA sensitive, as individual physicians surely are, to the simple fact that a drug which cannot be tolerated by one person works wonders in another.

The current get-tough policy on conflicts of interest only magnifies these costly FDA biases. The agency rules cut out the persons who know most about the drugs, and who could well counter unsound objections by critical committee members. But keeping these experts off the committees also skews the deliberative process in a more subtle and powerful way.

Anyone who consults for drug companies is likely to come with the presumption that new drugs may well fill important therapeutic voids. Once these individuals, as a class, are kept off advisory committees, the remaining drug experts are more likely to have the populist views held by the likes of a Marcia Angell or Sidney Wolfe, who suspiciously view most new drugs as insignificant advances over prior treatments. I tremble at the thought that these "untainted" experts will markedly slow down the FDA approval process. This would be bad news for the tens of millions who suffer from arthritis, and the countless individuals who suffer from other conditions. Nor would a the change go unnoticed by drug manufacturers or venture capitalists.

Right now, we all have a simple expedient to protect ourselves against dangerous drugs that make it to the market: Don't take them. But we have no protection at all when the FDA denies us that choice in the first place. Right now the pace of drug approval is too slow. We don't need the FDA to slow it up still further.  Read More & Comment...

Kultur Kamp

03/24/2007 09:58 AM |

John Kamp weighs in on the Markey/Waxman bill:

Although I have considerable respect for Congressman Markey, I most of the marketing "improvements," in the new Markey Waxman bill are simply marketing restraints. What an irony that two of the most articulate speakers in the U. S. House of Representatives would use censorship to as a way to help patients learn about the safety aspects of medicine.

Take a careful look at a couple of the restrictions.

1. Clearly an across the board ban on DTC the first three years after a drug's approval would be a violation of the First Amendment. The Supreme Court has never approved censorship as a way to promote an informed population. Even more important, it would be a mistake. What if we have a new drug for bird flu about the time of an outbreak? Wouldn't we want the public to know in every possible way? Similarly, don't we want the public to know about any HPV virus drug that could save the life of hundreds of women? Ignorance is never preferable to education.

2. Mandatory review of the all DTC ads before airing is clearly the kind of "prior restraint" government censorship long banned by English common law and recognized by the Supreme Court as a violation of the First Amendment.

The Coalition for Healthcare Communication salutes companies for taking great care in their ads and following the PhRMA self-regulatory principles. We don't salute Congressmen who would make censorship FDA law. Congress should never force Congressman Markey submit his often pithy remarks to a censor before he is allowed to utter them, nor should Congress silence drug companies until some censor can pass judgment.

It's one thing for a speaker to hold his tongue, it's another for the government to tie it in knots.  Read More & Comment...