Good Intentions and Unintended Consequences

07/13/2008 10:30 PM |

Officials with California's state Board of Pharmacy recently announced that they're pushing back the implementation of a controversial law to create an electronic chain of custody for pharmaceuticals. This is welcome news, as the law would have created a logistical and financial nightmare – and significantly raised the price of medicines in California.

Passed in 2004, the law's aim was noble – beat back the rising tide of counterfeit drugs by establishing a statewide system for tracking prescription drug shipments from point-of-production to point-of-sale.

The law's problem, however, was that it would have imposed back-breaking costs on pharmaceutical manufacturers and dramatically inflated drug prices for consumers – while doing little to undermine counterfeiters. That's why, rather than just delay the law, officials should scrap it entirely.

A universal tracking requirement is a shotgun-style solution to a problem better suited for a precision, SWAT-team approach.

Constructing and maintaining tracking technology is expensive. Under the law, every pharmacy in California would have to install equipment costing $10,000 to $40,000 – with no help from the state. Every other business along the distribution chain (drugmakers, hospitals, shipping companies, etc.) would also have to install this technology.

Those increased production costs mean higher drug prices for consumers, and less money for research and development and other promising technological investments like electronic medical records.

It's also unwise for state officials to dictate what kind of tracking technology companies should use. Counterfeiters are devising increasingly sophisticated ways to copy and sell brand-name pharmaceuticals. Drug carriers need to be given the freedom to respond in kind. This law locks them into a technology that could soon be antiquated.

Here's a real solution: Increase the criminal penalties for counterfeiting. As is, punishments aren't proportional to the threat posed to public health. Today, counterfeiting a prescription drug label is punishable with a decade of jail time. Counterfeiting the drug itself? A maximum of three years. That's just not acceptable.

Here’s the rest of the story as it appeared in the Orange County Register:

Orange County Register Op-Ed

Tracking legislation should come from the federal level – a single, uniform system administered by the FDA. A mishmash of state laws is wildly inefficient and will only create weak links in our national chain of custody that will certainly be exploited by criminals who don't think twice before putting counterfeit drugs into Americans' medicine chests.  Read More & Comment...

Grassley's Obsessions

07/13/2008 09:05 PM |

Here’s Senator Chuck Grassley on the APA’s use of money for medical symposia and other activities….

"I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions," Mr. Grassley said.

That’s rich, coming from someone who said: "everything about ethanol is good, good, good."

I have come to understand that money from the soybean and biofuels industry can shape the practices of a Senator from Iowa that purports to be independent in his viewspoints and actions and who makes a career implying that money alone is the sole factor in forming judgments.

Or how about taking responsibility for creating and propping up this monster called ethanol?

“According to the Global Subsidies Initiative of the International Institute for Sustainable Development, ethanol tax credits and incentives will cost U.S. tax payers between $6.3 and 8.7 billion dollars annually between 2006 and 2012. Additionally, according to a study conducted by the Center for Agricultural and Rural Development (CARD) at Iowa State University, the price of ethanol is being held artificially high by import tariffs imposed on foreign producers of ethanol. According to one of the authors, “Removing trade distortions would decrease the price for U.S. ethanol, while the world price would increase, as U.S. demand — and ethanol imports — would increase.” The drop in domestic ethanol prices could be as much as 18%.”

Now, I might be mistaken. But for a guy who is stressed about governmenet officials being too cozy with industry Grassley might want to start with himself. Here’s the record:

“Agribusiness giant Archer Daniels Midland Co. (ADM), the single largest beneficiary of a controversial federal ethanol tax subsidy, contributed more than $3 million in unregulated "soft money" to Republican and Democratic national party committees during the past 10 years, according to a study by Common Cause.

ADM gave direct political action committee contributions to congressional candidates: $700,170 to Democrats and $529,276 to Republicans from Jan. 1, 1987, to Dec, 31, 1997, according to the report.

The top recipient in the Senate was Richard J. Durbin (D-Ill.), who got $34,500. The Senate Republican who received the most was Charles E. Grassley (R-Iowa), with $17,000.”

ADM has been a prime beneficiary of the federal tax credit on ethanol, which the refiner can apply to the tax it pays on corporate income. First implemented in 1978, the tax credit currently stands at 51 cents per gallon of ethanol sold. The Government Accounting Office estimates the subsidies to the ethanol industry from 1980-2000 at $11 billion. As the biggest ethanol producer in the US, ADM has received the largest portion of the government's generosity.


According to the Heritage Foundation:
Senator Charles Grassley (R-IA) has extensive farm interests, as do some members of his immediate family. Listing his home address as Arlington, Vir­ginia, Grassley received $225,041 in USDA subsi­dies for corn and soybeans and disaster assistance between 1995 and 2005.[8]

In New Hartford, Iowa, Senator Grassley's son Robin has received $653,833 in subsidy payments, mostly for corn and soybeans.[9] Patrick Grassley, the Senator's grandson, who also lives in New Hartford, received $5,964 in subsidies in 2005.[10]

In 2003 an energy bill authorized $1.75 billion over seven years in "transition" assistance to MTBE manufactures, including oil companies and refiners, as they scaled back production because of state bans on the product. The bill extended a Senate-proposed federal MTBE phaseout from four years to 10 years.

The largest GOP recipient of cash who in turn supported the measure?

Chuck Grassley.


http://www.firstcoastnews.com/news/news-article.aspx?storyid=10915


Over the years Grassley has received $1.5 million in direct campaign contributions from agribusinesss and energy interests, the largest source of cash next to health insurance companies which has been part of a quid pro quo for all sorts of goodies for Iowa.

Here’s the Washington Post’s Steven Pearlstein on Grassley who objected to parts of the housing bill that might be used to underwrite failing investment banks:

Well, isn’t this rich: Max Baucus of Montana and Chuck Grassley of Iowa, chairman and ranking member, respectively, of the Senate Finance Committee are suddenly in a lather that taxpayer funds might be implicated in the Federal Reserve’s rescue of Bear Stearns.

Would that be the same Max Baucus and Chuck Grassley who have made careers out of protecting and enhancing the lavish system of import restrictions, price supports and other subsidies that have transformed American farming and ranching into a vast socialist enterprise? You betcha.

Washington Post Article


Setting aside the hypocrisy of Grassley’s inquisitions what about their legality or constitutionality. On what grounds does he request information about the funding sources or uses of funds from non-profit organizations, including churches. Should the dislike of a practice be sufficient? Should the assertion “"I have come to understand that money from the pharmaceutical industry can shape the practices of nonprofit organizations that purport to be independent in their viewpoints and actions" be grounds enough to engage in a witch hunt?

Has anyone else found it peculiar that Grassley has gone after psychiatry and churches? Is this the same as going off the deep end?

There are some on Grassley’s staff, what’s left of it, that think so:

(S)enior staffers….have have expressed profound discomfort with Senator Grassley’s actions, and wondered, rightly, whether this was not a simple assault on American religious freedom. If the United States Senate can de facto audit these preachers at whim and absent evidence of wrongdoing, what’s the barrier to doing the same to Catholics, Baptists, Anglicans, Jews, Muslims, or Mormons? Is the standard now one of mere Senatorial dislike? How is this standard not inherently politicized? The conversation ended with both of them expressing displeasure with the Senator, and grave reservations on his sense of proportion — and Constitutional propriety.

Senator Grassley is a fixture in Washington, D.C., and in Iowa politics, and so he is used to getting what he wants. But when even his own office is riven with doubts on his pet causes — on Constitutional grounds, no less — it’s time to ask the good Senator to step back, and check the hubris.”

Then again, as others have noted, you can get Grassley to see your way by making sure your solution is “Iowa-based” if you know what I mean…

The American Psychiatric Association and pharma might be able to solve their problem by dumping every dime of CME into a new Grassley Center for Continuing Medical Education at the University of Iowa which would be run out of a new building that would rise up in flood ravaged downtown Des Moines.

I bet then Grassley’s understanding of how money from pharma shapes nonprofit practices would be transformed….  Read More & Comment...

Tony Snow and Bobby Murcer

07/13/2008 02:57 PM |

Tony Snow and Bobby Murcer had a direct impact on my life.  I knew Tony a little or rather, he touched my life for the better the way he likely touched hundred of other lives.   Over 25 years ago when, as a newly minted assistant to the director of the Civil Rights Commission, holdover radicals appointed by Jimmy Carter forced me to leave for having the audacity of letting the public know certain commissioners suggesting riots were a response to President Reagan's election.  I was sitting in a vacant office at the American Enterprise Institute trying to figure out where I was going to get a job when I got a phone call from someone in the President's office named Tony Snow who then passed my name on to other people in the administration. 

Years later, when Tony was working both for USA Today and Fox he would either quote my articles or chat with me briefly.  I called to thank him and still remember the joy and enthusiasm in his voice for doing battle as well as the genuine feeling of interest he took in me and my writing.   

His turn on Fox News and as the President's press secretary gave him visibility he richly desevered.  His first love was his family and that was the focus of his efforts in the remaining years of his life.

I never knew Bobby Murcer.  As a Yankee fan I had hoped he would be the "next" Mickey Mantle.  But being Bobby Murcer was good enough.  Great clutch hitting,  Excellent outfielder and team leader.  Then being the voice of the Yankees for so many years. 
What many didn't know, even until he was diagnosed with a brain tumor, was that he devoted much of his life after baseball, to raising money for cancer research and for people in the baseball community who needed help paying for mortgages, medical bills etc. 

It has been said by some that new cancer treatments that "only" add a few months of life are not worth the cost.  I think of Tony Snow, who I know did for many what he did for me and who was able to provide for his family with the time science and G-d gave him and of Bobby Murcer who did so much for others suffering from cancer and of limited means and wonder what yardstick is applied by those who would sit on high.   We have lost two great men whose contribution to society and involvement with their families will endure and outweigh the claims imposed by people who would rob us of their presence out of cost considerations.
  Read More & Comment...

SPOT on

07/12/2008 04:37 PM |

FDA Approves New Genetic Test for Patients with Breast Cancer

The U.S. Food and Drug Administration has approved a novel genetic test for determining whether patients with breast cancer are good candidates for treatment with the drug Herceptin (trastuzumab).

The SPOT-Light HER2 CISH kit is a test that measures the number of copies of the HER2 gene in tumor tissue. This gene regulates the growth of cancer cells.

A healthy breast cell has two copies of the HER2 gene, which sends a signal to cells, telling them when to grow, divide and make repairs. Patients with breast cancer may have more copies of this HER2 gene, prompting them to overproduce HER2 protein so that more signals are sent to breast cells. As a result, the cells grow and divide much too quickly.

“When used with other clinical information and laboratory tests, this test can provide health care professionals with additional insight on treatment decisions for patients with breast cancer,” said Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health.

The SPOT-Light test counts the number of HER2 genes in a small sample of removed tumor. The removed piece is stained with a chemical that causes any HER2 genes in the sample to change color. This color change can be visualized under a standard microscope, eliminating the need for the more expensive and complex fluorescent microscopes required to read assays already on the market. Unlike existing tests, the SPOT-Light allows labs to store the tissue for future reference.

Patients who over-produce HER2 protein are typically treated with the drug Herceptin, which targets HER2 protein production. This helps to stop the growth of HER2 cancer cells.

The FDA based its approval of the SPOT-Light test on a study using tumor samples from patients with breast cancer in the United States and Finland. These studies confirmed that the test was effective in determining how many HER2 genes were in these patients.

SPOT-Light is manufactured by Invitrogen Corp. of Carlsbad, Calif. Herceptin is manufactured by Genentech, of San Francisco, Calif.  Read More & Comment...

FDA Panel Votes Against Black Box on Seizure Meds: Lenzer, Brownlee Distraught No Doubt

07/11/2008 01:32 PM |

An FDA Advisory panel voted not to put a black box warning on epilepsy drugs regarding the reporting of suicidal thoughts and feelings of some taking the meds.  The reason? 

"We have to be very careful about scaring the patients into not taking these drugs, and I think we have to be very thoughtful about that," says Rochelle Caplan, MD, a professor of psychiatry at University of California Los Angeles and a member of the expert panel.

Which is precisely why people like Jeanne Lenzer, Shannon Brownlee and the crackpots who cluster at pharmalot.com push for black box warnings on all meds for mental illness and pols like Bart Stupak and Chuck Grassley seek them.  And it's why someone like Steve Nissen would use meta-analysis and press conferences to try to get them for Avandia and drugs for ADHD or demand that Vytorin be yanked from the market.

Fear mongering based on shoddy science advances a political agenda or a financial interest.  

Sadly, I am sure the expert panel exposed themselves to both abuse and threats of physical violence, often stimulated by the kind of reporting or misreporting and blogs I have mentioned above.   When chelation therapy becomes a subject of NIMH funding and black box warnings become a political tool to drive effective drugs off the market based on indiscriminate data amplified through the media and politician's press releases you know that Tabloid Medicine is replacing real science in guiding medical practice.  Once in a while you have some brave souls who follow the facts.  But for how long?
  Read More & Comment...

The Tchatchke Intifada

07/10/2008 10:14 PM |

The really sad thing about the new PhRMA marketing guidelines is that they, basically, match what Senator Charles Grassley is proposing. Talk about inside-the-Beltway groupthink.

Consider this – the big news is (are you sitting down) – no more pens or coffee mugs! Gadzooks.

(Is there a lobby for specialty goods manufacturers? We’ll soon find out.)

What's the attitude of the AMA is on this matter? It should be righteous indignation that the pfolks at PhRMA and too many members of the United States Congress, think that a physician can be bought for trinkets. Good thing these guys weren’t around for the negotiations over Manhattan Island.

But as silly and trivial as this sounds, the more serious issue at play is the caving in by the pharmaceutical industry to misguided political pressure. Silly in the instance of pens and coffee mugs perhaps – but what comes next? A “voluntary moratorium” on DTC advertising? The demonization of published articles on the off-label uses of medicines? It’s a long list.

When is a conflict not a conflict? If the answer is, “When Senator Grassley says so,” then the slope the industry is on is indeed a slippery one.

The only positive thing that will come from the Tchatchke Intifada is that pharmaceutical sales representatives won’t have to schlep them from office to office – thereby lightening their load, improving their gas mileage and decreasing the overall carbon footprint of the industry.

Where’s Nick Naylor when you need him?

  Read More & Comment...

GSK Should Be Careful What It Wishes For

07/10/2008 08:39 PM |

How naive can you get?

British pharmaceutical giant GlaxoSmithKline PLC is taking the unusual step of giving government health-care systems a say in deciding which drugs advance in its research pipeline, a move it hopes will result in more products these customers will pay for.

Glaxo's new chief executive, Andrew Witty, said the effort is part of his drive to help the world's second-largest drug maker adapt to a tough pharmaceutical market. In recent years, soaring health-care costs have led insurers, governments and other drug buyers to tighten their belts.

Was Witty really surprised then by this headline:

"The British government’s medicines advisory body has advised against the use of GlaxoSmithKline’s oral cancer drug Tyverb in the National Health Service, dealing a blow to the UK-based pharmaceutical group in its home country.

The National Institute of Health and Clinical Excellence (Nice) on Monday issued a provisional recommendation that Tyverb for advanced breast cancer did not meet its threshold for clinical and cost effectiveness. That recommendation could effectively rule out the UK market for the GSK medicine."

Tykerb is a pill that targets a subgroup of women who are HER-2 positive for breast cancer. GSK even told NICE it would only accept payment for patients who got better.

It still said no.

What new drugs do regulatory authorities want:

Close your eyes and what do you see?

Witty should know better than to hand the future of his company and that of patients over to those who care only about costs.

  Read More & Comment...

MapQuest for Medicines

07/09/2008 09:57 PM |

It’s always been more art than science to determine the point at which “approvable” letters morph into  “not-approvable” ones.  This has often been held up as Exhibit A in the lexicon of the FDA’s lack of predictability.

And now the agency has addressed it head on.  From now on there will be no more gradations of approvability.  Say hello to the “complete response” letter.

Sound familiar?  It should, it’s the same concept behind BLAs.  In other words, the agency is embracing the concept of consistency.  Good move.

Think of “complete response” letters as pathways to approval – a regulatory MapQuest for drug approvals.
And just as with MapQuest, the other most important variable in reaching the desired destination is … where you begin.    Read More & Comment...

Politico cites CMPI Biggovhealth Site

07/08/2008 02:16 PM |

  Read More & Comment...

Absence of Evidence

07/08/2008 05:20 AM |

I see the NYT is weighing in on the comparative effectiveness issue.

The first target was CT scans which we were told were a waste of money unless bureaucrats decided who got them first. Just like in the UK or Canada where people wait 18 weeks.

Second target was Avastin: The claim is that their is scanty evidence that the new drug does much more than extend lives by a few months and that the quality of life benefits are hard to measure.

The piece by Gina Kolata and Andrew Pollack could have been a lot worse but it could have been better it if had discussed the role personalized medicine will play in addressing the issues the article seems to suggest only a government agency run by economists will solve...

And what's up with their sources?

The series talks about scant evidence for cost effectiveness yet Kolata and Pollack point to NICE as an example of a government institute that decided, based on the "evidence" that Avastin not cost effective based on its cost per year of life extended. But NICE measures the value of an additional disease free year of life at $50000 which has lead them to approve birthing pools for pregnant moms and Accomplia for obese patients, a drug in clinical trials that helped people lose 9-15 lbs than with a placebo but not Avastin. Michael Rawlins the head of NICE bluntly says that the value of the additonal life year is just arbitrary. Talk about scant evidence! (By contrast Topel and Murphy, who did a systematic evaluation came up with a number of nearly $300k).

The article's experts on cost effectiveness, the consumer's providing evidence of what a complete waste of money Avastin is were Barbara Brenner of Breast Cancer Action who is notorious for campaigning against all new drugs and even early screening for breast tumors and Consumer Watchdog, which is headed up by Harvey Rosenfeld. Rosenfeld has made millions by the collection fees for bring administrative charges against insurance, HMO and drug companies in California. As a friend of the court, Consumer Watchdog also gets a cut of any successful lawsuit it participates in such as the one against Univ of Wisconsin's stem cell patents...

I don't where to begin about the claim that Avastin just prolongs life a couple of months. This is just a Grassley-fed lie.
Treating kidney cancer with Avastin prolongs progression free and overall survival by 10 and 17 months respectively compared to placebo.

In colorectal patients adding Avastin to existing treatments also added 23 months of life in peope who responded.

I could go on and will in a later post..

At the end of the day there is no evidence gap. There is a values gap. Either you believe it is worth paying for drugs to advance end stage cancer patients -- and that could be you or someone close to you -- for anywhere from a month to two years depending on how your cancer progresses or you don't. Either you believe after paying thousands of dollars of premiums and not spending much on health care you get to have a say or you don't. Either we continue to make progress, reduce death and increase survival against disease which happens incrementally, or you don't.

And the failure of Kolata and Pollack to acknowledge the promise of personalized medcine to move cancer care from hit or miss to hitting the target skewed the debate away from the science and where the discussion of health care technology assessment and Avastin in particular is already heading.

They should know better.

But it's summer and Madonna is brainwashing A-Rod with Kabbalah so they get a pass.  For now.   Read More & Comment...

MSM on Speed Dial

07/03/2008 04:23 PM |

Further to Bob's post below on Dan Carpenter's pseudo mea culpa, consider this segment from the WSJ article:

"But Mr. Carpenter stood by his conclusions, releasing a 151-page memo and his raw data on the Internet. After a detailed comparison, both sides' records turned out to have been imperfect, he said. "I'll frankly admit that we omitted four or five of the black-box warnings," Mr. Carpenter said. But the FDA "missed a whole bunch of black-box warnings" as well, he said."

Yes, well you know what they say, sins of omission are seldom fun.

"An FDA spokesman said the agency hadn't seen Dr. Carpenter's response until it received a copy from The Wall Street Journal, and hadn't had time to review it."

Sound familiar?  It's strangely  reminiscent of Dr. Nissen's rationale for why he didn't go to the FDA with his now-infamous (and discredited) meta-analysis.

Birds of a feather. Just another sad example of Tabloid Medicine.

  Read More & Comment...

Pfizer's New CME Policy: The Sum of All Fears

07/03/2008 03:37 PM |

According to the logic of Pfizer's new CME policy, commercial speech should be discontinued because of the appearance of conflict of interest. Or rather, the content of commercial speech -- and the freedom to pursue -- shall now be abridged by those who define what the conflict is, namely the academic medical centers, who will also get the cash that once went to for profit companies. Put another way:

Is there a difference in the quality of communication when money is given to a non-profit provider of information, especially when that money is shifted from the objects of criticism to the critics? Or is this simply a matter of turning medical education into hush money?

Can academic medical centers, who have treated primary care issues and primary care physicians as abused stepchildren, really run top quality CME programs? Can medical societies, usually staffed by two people and a temp do the job?

CME is too important -- particularly for the minority community -- to be left to amateurs who think it is a dirty business, not an important component of the public health.

It's one thing to insure that CME is objective and made widely available and affordable to as many clinicians as possible using both online and in person formats. It's another thing to shut down an important avenue for disseminating information: for-profit organizations.

The last time I checked medical schools and AMCs were for grabbing tuition, grants, fees, endowments, spending millions on marketing, ads, endorsements, wooing high profile specialists and practices. And they make no bones making people like you and me, when we have no insurance, paying upfront and top dollar for the quality care the advertise on TV and on the visors they give away at baseball games.

Somehow when a drug company wants to spend millions to educate doctors, not on their drugs, but on disease management, that's a scummy thing to do.

I am sick and tired of the pontification on the one hand and the pharmaceutical cowardice on the other.

Caving in does not buy peace, it only prompts more attacks.

As Thomas Jefferson observed: "A coward is much more exposed to quarrels than a man of spirit. "  Read More & Comment...

A Carpenter's Shoddy Hit Job

07/03/2008 12:44 PM |

Sometimes when you do a hit job on someone you get caught, especially if your target is Bob Temple.  Daniel Carpenter and the self-serving Jerry Avorn tried to claim that there was a higher incidence of black box warnings around drugs approved right before user fee deadlines (they used 2 weeks, an artificial number) than what they considered routine (I guess that means two weeks and one day). 

They got caught when Temple and FDA economists found significant, uh, omissions in their daabase and "rounding" errors that when accounted for essentially eliminated any difference in the number of black box warnings. 

According to the WSJ Carpenter and Avorn did a fix.  If you read the NEJM apology for getting caught by Temple the Carpenter and Avorn fix is this:  they just add new black box warnings gleaned from the "addition of data through December 2007"  Ta-da!  They "found more modest but still significant association between just-before-deadline approvals and safety problems."

Here's the trick:  The black-boxing of a drug is a response to policy pressure as much as  writing an article about black boxes is.  Adding data throughout 2007, when pressure was on the FDA to ADD black box warnings from Grassley and others, data that is not included in  Temple's analysis is a sure-fire way to demonstrate "significant associations."  Even the sloppy Carpenter and Avon admit: most of this difference stems from the different time frames used in the two analyses.

But the media will likelly not pick up on this.  After all the headline of the WSJ article regarding this issue is: Scholar Fixes Flaws, Defends Finding of FDA Errors In Too-Hasty Approvals
The WSJ article missed the sleight of hand Carpenter and Avorn use to 'fix' things...   Read More & Comment...

Blowing Up the Critical Path

07/03/2008 12:21 PM |

The 14-2 vote to add years to the time patients will get new diabetes drugs to search for potential CV risks is a direct attach on the Critical Path.  Long term studies are not needed when new biomarkers and predictive systems can be developed.  But of course, that won't pass muster with the dimwits who followed Nissen off the Critical Path in a 14-2 vote or the  media or pols who construed the choice as follows:

Diabetes drugs should face tougher safety standards that could cost manufacturers millions but protect patients from unforeseen heart risks, a government panel has recommended.

The Critical Path is all about determining who should get what drug based on predictive markers... Nissen, the media and the pols are all about fearmongering.  Test 'em all. 

"The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market. The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars."

Oh really? And which patients will you expose to the additional risk while being treated to diabetes?  Or the so-called risk since it is unclear if there is a risk at all or which patients are at greater risk.  This is the result of Tabloid Medicine driving out good science and medical progress.

Meanwhile Nissen made this incredibly ignorant statement:

FDA is operating under ''the irrational belief that lowering blood sugar using virtually any pharmacological means will produce'' better results for patients."

Actually, that is what Nissen said -- we already have enough drugs to do the job.  The FDA has never practiced medicine but has data showing that reductions in blood sugar do keep people alive longer.  Nissen care to dispute that?

The danger of course is that this brutalization of medical science will spread to other diseases....Will the grownups at the FDA do the right thing and strike a balance for science?

''The fallacy here is that we will never know everything we'd like to about a drug before it goes on the market,'' Dr. Ray Woosley, president of the Critical Path Institute in Tucson, Ariz., said in a phone interview Tuesday. ''If we held up drugs until we did know everything a lot of people would die.''

www.nytimes.com/aponline/health/AP-Diabetes-Drugs-Heart-Risks.html  Read More & Comment...

Knowledge is Dour

07/02/2008 08:17 PM |

Finally!  We're addressing a serious flaw in our healthcare system -- too much CME.

Pfizer, according to the Wall Street Journal. “hoping to temper criticism that it's improperly influencing doctors, is eliminating direct financial support for medical-education courses that are offered by third-party companies.”

"The reason we're not going to directly support them has to do with mitigating the perception of a conflict of interest, if a direct payment is going from a company like Pfizer to them," commented Cathryn Clary, vice president of U.S. external medical affairs.

Okay, so let’s get this straight – this is being done not because anything was amiss or non-compliant or because there’s too much CME going on out there – but because of political pressure.

Senator Chuck Grassley, ranking member of the Senate Finance Committee, said in a written statement: "My goal is to strengthen the system by shedding light on the financial relationships that exist between industry and medical doctors, medical education programs, medical journals, and medical research. … Public scrutiny can do a lot to bring about necessary reforms."

But what it’s brought about is less CME -- fewer opportunities for physicians to hone their skills.

And this is a victory for who?

  Read More & Comment...

When Nissen Loved Vytorin

07/02/2008 02:16 PM |

From a Forbes article in 2003...

Pharmaceuticals
Statin Makers Bet Big On Imaging Technique
Matthew Herper, 11.10.03, 1:01 PM ET

ORLANDO, FLA. - Trying to get a leg up in the $22 billion market for cholesterol medicines, drug companies increasingly are turning to an imaging technique that allows researchers to see how much plaque is building inside arteries. Several of the biggest players are funding major research studies, and--in an unusual twist--many of these clinical trials are being run by the same cardiologist: Steven E. Nissen.

In retrospect, we realize that it is not unusual at all just...business as usual. 

www.forbes.com/2003/11/10/cx_mh_1110merck.html  Read More & Comment...

Nissen Auditions for FDA Commissioner

07/02/2008 01:09 PM |

If anyone in Washington who covers the FDA was paying attention yesterday to Steve Nissen's "compromise" on how to regulate new diabetes drugs they got an idea of how new drug development would fare under Nissen if he had more control over the FDA or became commissioner:

From today's WSJ:

"Cardiologist Steven Nissen of the Cleveland Clinic said the FDA should require companies to prove their drugs don't raise risks of cardiovascular disease before they are approved.

Dr. Nissen said there are more than enough diabetes drugs on the market that lower blood-glucose levels, and now is the time for the FDA to raise its standards.

"Merely lowering blood-glucose levels in diabetes is too simplistic," Dr. Nissen said. "We must reduce the complications of diabetes, including cardiovascular disease."

online.wsj.com/article/SB121495996433621583.html

Dr. Nissen suggested that in addition to requiring more preapproval studies, companies should have large, long-term studies in place when a drug is approved to monitor whether the drug increases the risk of cardiovascular disease.

Why stop at diabetes drugs?  If you apply Nissen's logic to any illness "there are more than enough drugs" out there to treat everything under sun.  And since every drug has some cardiac risk, why not subject them all to increased long term clinical trials (that Nissen would conduct of course) to look at the problem. 

Let's set aside diabetes which is not just killing people here but worldwide.  And let's set aside Nissen's failure to acknowledge that by claiming there are more than enough drugs he is ignoring the fact that diabetes requires individualized treatment but that new medicines will be developed (we hope) around more particular and preventive approaches, etc., etc.  and that diabetes is not just a cardiovascular disease but part of a larger disorder that must be treated with as many tools as possible.   Would you want an FDA commissioner who would say "we have enough drugs for...."?  I am sure there are some who believe that, including Marcia Angell, but not many real physicians and scientists. 

I would love to see that statement thrown back at him.

Next, what are the implications of his approach to access to medicines for patients?

Here's what the lead medical officer who reviews diabetes drugs at the FDA said according to a reporting in Bloomberg News

"Conclusive evidence of cardiovascular benefit hasn't been established for any drug for Type 2 diabetes, despite several large, long-term trials," Hylton Joffe, lead medical officer in the FDA's Division of Metabolism and Endocrinology Products, told the FDA panel yesterday.

Requiring heart assessments, especially before FDA approval, would add years to drug development because it takes that long for damage to show up. There also are ethical and logistical questions about how to organize studies because patients don't want to be in a comparison group getting a dummy pill and usually require multiple medicines as their disease progresses, Joffe said."

www.nj.com/business/ledger/index.ssf
Frankly, I don't think Nissen -- who simply engaged in fearmongering over Avandia and drugs for ADHD -- couldn't care about the ethics of the matter. 

If Nissen were FDA Czar, here's what patients could expect:

Add years and billions to the cost of new drug development.
Say good-bye to the Critical Path.
Let millions of people who are dying of and suffering from any illness with a drug in development that may have a cardiac side effect that can be found in any amount of any correlation wait while some pet meta-analysis is verified.  So that includes drugs for:
Cancer
Alzheimer's
Schizophrenia
Parkinson's
HIV
Diabetes

And stem cell research of any kind...

I hope at least patients are paying attention. 

 



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Springer Spaniels

07/02/2008 12:43 PM |

The following story courtesy of our friend and occasional colleague "Kerfuffle Kate" Rawson of the RPM Report:

FDA Steps Up Security for Advisory Committees 

By Kate Rawson

FDA advisory committee meetings are not supposed to be like episodes of the Jerry Springer show. And for good reason: One is a scientific discussion of the benefit-risk profile of new drug or indication. The other is a television tabloid talk show with topics in such poor taste that our own corporate content filters won’t even let us access the website.

But it was Springer-like behavior at a recent meeting (featuring a threatening rant by an apparently intoxicated speaker during the open public hearing) that led FDA to impose new security measures to protect the agency’s expert panelists. While FDA hasn’t made a formal announcement of the policy changes, Office of New Drug Director John Jenkins discussed the new procedures at the Drug Information Association’s annual meeting last week.

“We have put in place some new measures to help improve security at meetings,” Jenkins said. “If we anticipate that there may be an increased need for security at a particular meeting because it is a particularly controversial topic, we may have additional security procedures.”

Those procedures include:

1) Creating a physical barrier by roping off the committee from the public. The intent, Jenkins said, is “to put some separation between those who might become agitated in the audience and committee members.” (For taxpayers, it carries another benefit—preventing the public from sneaking pastries off the committee’s breakfast tray.)

 

2) Increasing the presence of security guards in the committee room—both in uniform and street clothes.

 

3) Reading a statement at the start of the meeting about “good rules of behavior.”

There have been kerfuffles at advisory committees before, especially when the drug under review would be used to treat a rare or life-threatening condition. The heckling of FDA commissioner David Kessler during the 1996 advisory committee review of Abbott’s ritonavir, the first protease inhibitor for HIV, comes to mind.

And in very rare cases, FDA takes extraordinary steps to protect committee members. That same year, the review of the abortifacient RU-486 was held in an unused warehouse in the middle of a remote industrial park in Maryland. Attendees (or at least the press) were asked to park up to a half-mile away and walk into the meeting.

But this is the first time that FDA has felt the need for a comprehensive plan to ensure the security of advisory committee members. And it’s the biggest change to the advisory committee process since the agency altered its conflict of interest guidelines last year.

The trigger was a May 2007 review of IDM’s mifamurtide (Junovan) for the treatment of osteosarcoma. During the open public meeting, an apparently intoxicated individual made threatening statements to University of Michigan’s Maha Hussain, and was ultimately removed from the room. (You can read FDA’s official transcript of that exchange here.)

Later in the meeting, Hussain and other committee members pointedly suggested that FDA establish greater security measures. (Hussain, it should be noted, has had her share of controversy in committee rooms. Last year, she was also one of four votes against the approval of Dendreon’s Provenge, a decision that led to threatening e-mails, phone calls and letters.)

For drug sponsors, the new procedures aren’t likely to have significant practical implications. But they are indicative of the intense public interest in drug development, and the pressure to discover new cures and keep unsafe products off the market.

We should note that the majority of meetings aren’t controversial and hence don’t require significant security procedures. But, as Jenkins noted, “there have been some incidents where that decorum has not sustained itself, and we’ve felt the need to institute procedures to maintain the safety of our advisors.”

Hence the rope. Of course, roping off the public isn’t the only way FDA can ensure the safety of those present at advisory committee meetings. Given some of the disputes between FDA officials on drug safety issues (remember the Arcoxia meeting? The Avandia meeting?), perhaps that rope could be put to better use elsewhere.

Wouldn’t that make a good Springer show?

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Cheap Canadian Drugs?

07/02/2008 12:31 PM |

From World Health Advocacy... www.whadvocacy.com.

Consumers in Canada spend the same percentage of their income on prescription drugs as consumers in the United States.

Government policies surrounding the pricing and reimbursement of prescription drugs in Canada do not produce lower costs for Canadians compared to Americans. Despite major differences between the Canadian and American healthcare systems, the results of a recent study show that consumers in both countries are spending the same percentage of their incomes on prescription drugs.

The price of generic drugs in Canada is more than double U.S. prices for identical drugs, while brand-name drugs are comparatively cheaper. In currency-equivalent terms, Canadian retail prices for brand-name pharmaceuticals decreased slightly between 2003 and 2007. In the same time frame, generic drug prices in Canada increased by 34% compared to U.S. prices.

The authors of the study state that Canadian government policies insulate generic drug companies and pharmacy retailers from normal market forces that would put downward pressure on prices for generic drugs. A relatively freer market in the United States produces lower prices for generic drugs to encourage consumers to substitute these generics in place of brand-name drugs.

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The NHS New Slogan: Cancer Care As Good As Poland's

07/01/2008 07:19 PM |

I have made much about how lousy the UK five year survival rates are relative to the US.  A  researcher comes up with a statistical explanation for why the survival rates -- while bad -- may  not be as bad as Poland's: 

This is all from a Financial Times article entitled: "Why the UK's Cancer Survival Rates Look Bad"

www.ifpma.org/PressReviewEmail/PressReviewDetail.aspx

"Of the 20-plus countries in the Eurocare survey, only 10 look at the entire population. In 1998, the starting point for the latest five-year figures, Germany's figures covered just 1 per cent of the population, the Czech Republic 8 per cent, Poland 9 per cent and Spain and France 16 and 17 per cent respectively.

Prof Richards says that for instance in Italy, the figures cover only 28 per cent of the population, mainly in the affluent north "so it is almost certain their figures overestimate survival rates".

That's the good news.  And Professor Richard's makes a fair point if he can prove that the smaller slice of cancer patients surveyed are more likely to be over-represented by people who are more likely to survive.  Gee, that's just like infant mortality rates where some countries only count babies as alive if they live for 30 days while in the US we count them from the time they leave the womb. 

Now the bad: 

The UK has 100 per cent coverage, as do the Nordic countries. "Sweden, Norway and Finland do have appreciably better survival rates than we do, while Denmark looks remarkably like the UK across a whole range of factors," he says. "There is a real gap between us and the Nordic countries, and our task is to narrow that."

While the UK is slower than some other European countries to adopt newer cancer drugs, late diagnosis seems to be the real culprit. "Most of it is accounted for by our one-year survival rates," Professor Richards says. "If you get past that, our survival rates look much more like the European average. And one-year survival is most often correlated with advanced disease. There are relatively few cancers that will kill you in a year if they are diagnosed early". Smaller-scale studies also suggest that when patients in the UK seek help their disease is more advanced.

Does anyone have any idea why UK patients get help later when new drugs are less effective?  Anyone?

Prof. Richard suggests:

Some of that may be cultural: stoical Britons may delay seeing a doctor. The government's cancer plan aims to tackle that through better education and better screening, backed by large investments in radiotherapy.

Stoical?  Hardly.  Resigned and outraged is more like it.  But Richards also believes the Eurocare survey understates advances in survival because it is based on old data:

'Prof Richards believes that the reason Britain's figures are not better, despite the huge resources ploughed into tackling the problem, is that the numbers used for international comparisons are out of date, relating to cancers diagnosed in 1999 and 2000. "They predate the UK's big surge in spending after 1999, and any impact from the national cancer plan. We have a problem, but we are tackling it. I am pretty sure we are narrowing the gap".

In fact, many of the methodological problems with the Eurocare survey have been addressed in other articles, notably by Dr. Franco Berrino who took note of them in earlier surveys and adjusted for both over and under estimation of survival by  weighting five year survival rates of all countries studies based on limitations deriving from the quality of registry data.  Berrino, et al also use period analysis instead of the traditional cohort analysis provides long-term survival estimates that also take into consideration survival of more recently diagnosed patients.  By every measure the UK lags behind Western health systems in Europe and the US in particular which has more heterogeneity in its cancer population. 

www.thelancet.com/journals/lanonc/article/PIIS1470204507702462/fulltext  Read More & Comment...