Live free or ...

05/19/2006 08:06 PM |

When it comes to New Hampshire, “Live free or die” is a great state motto — but it’s terrible health care policy.

Latest case-in-point, HB 1346, a bill just passed by the New Hampshire legislature, that would make it illegal for pharmaceutical companies to have any access at all to physician prescribing data. This is a simplistic solution to a complex problem.

While I agree that physician-prescribing data shouldn’t be available for marketing purposes minus individual physician 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 physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.

According to a spokeswoman, Governor Lynch will be looking at HB 1346’s “impact on health care costs and personal privacy.” That’s fine. But the Governor should also consider its implications on public safety.

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Paying to Stay Alive

05/19/2006 01:19 PM |

Our friend and fellow health care scribbler Sally Satel, MD makes a great case for why we should provide economic incentives for everything health care related including organ transplants in her recent NY Times op-ed“Death’s Waiting List”: Sally writes:“March was National Kidney Month. I did my part: I got a new one. My good fortune, alas, does not befall nearly enough people, and the federal government deserves much of the blame. Today 70,000 Americans are waiting for kidneys, according to the United Network for Organ Sharing, which maintains the national waiting list. Last year, roughly 16,000 people received one (about 40 percent are from living donors, the others from cadavers). More are waiting for livers, hearts and lungs, which mostly come from deceased donors, bringing the total to about 92,000. In big cities, where the ratio of acceptable organs to needy patients is worst, the wait is five to eight years and is expected to double by 2010. Someone on the organ list dies every 90 minutes. Tick. Tick. Tick.Until my donor came forward, I was desperate. I had been on the list only for a year and was about to start dialysis. I had joined a Web site, MatchingDonors.com, and found a man willing to give me one of his kidneys, but he fell through. I wished for a Sears organ catalog so I could find a well-matched kidney and send in my check. I wondered about going overseas to become a ”transplant tourist,” but getting a black market organ seemed too risky. Paradoxically, our nation’s organ policy is governed by a tenet that closes off a large supply of potential organs—the notion that organs from any donor, deceased or living, must be given freely. The 1984 National Organ Transplantation Act makes it illegal for anyone to sell or acquire an organ for ”valuable consideration.” In polls, only 30 percent to 40 percent of Americans say they have designated themselves as donors on their driver’s licenses or on state-run donor registries. As for the remainder, the decision to donate will fall to their families who are as likely as not to deny the hospital’s request. In any event, only a small number of bodies of the recently deceased, perhaps 13,000 a year, possess organs healthy enough for transplanting. The verdict is in: relying solely on altruism is not enough. Charities rely on volunteers to help carry out their good works but they also need paid staff. If we really want to increase the supply of organs, we need to try incentives—financial and otherwise.”The rest of Sally’s excellent article can be found here:http://www.aei.org/publications/pubID.24390,filter.economic/pub_detail.aspAnd we are glad that she is doing great!  Read More & Comment...

WHO. No Clue.

05/18/2006 02:39 PM |

Tomorrow WHO will call for a new policy in clinical trial transparency that is transparently absurd, absurdly transparent, and deleterious to the public health.

In its effort to develop worldwide standards of trial registration, WHO formally launched its International Clinical Trials Registry Platform (ICTRP) in April 2005. Tomorrow WHO plans to go public with its proposed final policy on which trials should be registered, and when. The policy will recommend registration of every “interventional study” (i.e. every trial for every intervention, whether marketed or not; whether randomized or not; and whether early phase or late phase).

Give me a break.

WHO wrongly claims that its policy is justified by the need to meet “ethical obligations to study participants.” Those obligations are already met in full, by disclosures to regulators, to independent review boards and ethics committees overseeing each trial, to every clinical investigator participating in each trial, and most importantly to every patient.

Ironically, while not remedying an ethical issue, WHO’s proposal may create one. In its call for registration of exploratory studies, particularly Phase I studies, WHO would fill the registry with vast amounts of data of no medical value. Every user would be compelled to sift this mountain of chaff to find the kernels of useful information; and might mistake the chaff for wheat. Phase I and other exploratory studies serve a narrow purpose and outside that context their results are inherently unreliable. Registering these trials or disclosing their results would at best confuse patients and encourage false hopes. At worst, where non-experimental drugs are being tested for new indications, physicians might inappropriately rely on disclosed trial information to make prescription decisions before confirmatory safety or efficacy trials have even been started.

From an ethical standpoint it is not at all clear what public health purpose is being served by this disclosure, nor which individuals it will benefit.

And then there are the myriad questions surrounding IP issues.

WHO’s policy of registering all interventional studies will make it harder or impossible for research based companies to secure important IP around selection inventions, manufacturing and formulation claims, and important new uses. Without this protection, sponsors may either abandon such research or else increase their precautionary patent filings at a time of high project attrition. This will drive up the cost of development, reduce the number of projects, and delay the progress of products to the marketplace.

The IOM has a better idea. In a recent workshop report they endorsed a more practical and beneficial guiding principle “Avoid reducing the incentive to do clinical research, whether public or privately funded.”

The net effect of the proposed WHO policy is that patients will wait longer for fewer and more expensive medicines, in exchange for a trial registry policy that benefits nobody.

That’s a Geneva Convention we can do without.

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Why the Critical Path Is So Critical

05/18/2006 12:40 PM |

A recent stufy by the Tufts Center for the Study of Drug Development (home of Red Sox fan Joe DiMasi who is also the lead author of the study) found that “genomic technologies have helped to significantly increase the number of drug candidates that enter clinical trials.” According to the Center, “During 2003-05, the rate at which the 10 top selling U.S. drug companies initiated clinical trials for new drug candidates rose by 52 percent, following a 21 percent decline from 1993-97 to 1998-02.”

In an interview with GenomeWeb News sister publication BioCommerce Week, Tufts Center director Ken Kaitin noted though the study did not seek to learn why R&D productivity increased or to address technological tools that might have helped enable it.” Kenneth Kaitin said discussions he has with officials from big pharma indicate that genomic technologies and methodologies have played “an increasingly important role” in driving the improvement. These tools and methods include mass spectrometry, genome sequencing, gene-expression, high-content screening, and SNP-genotyping.

“I don’t think there is any question [genomic tools are] playing an increasingly important role in candidate selection for products that enter clinical testing,” Kaitin told . “Every company that I speak to now is saying that a significant improvement in their ability to select compounds for clinical development is access to these tools.”

Now the question is: can we apply the same science being used to improve drug discovery — characterized by the emergence of more validated drugs hitting more precise targets — to the process of drug development. The opportunity is enormous. Which is why supporting the Critical Path Initaitve is so critical.

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Penalty Box

05/18/2006 09:07 AM |

The MSM is so predictable. Rather than reporting on the success of Part D enrollment the stories are now all about “the penalty.” As Bob Goldberg has mentioned (see below) this draconian measure averages out to between about $2-$5 a month. But this fact, not surprisingly, hasn’t been reported. The issue that the media, lawmakers, and pundits have missed is that when you don’t have a deadline people who are eligible and entitled to Federal programs don’t sign up. A spot-on example is CHIP. As mayors and governors nationwide have bemoaned — if all of the CHIP-eligible families in the US were actually using the program, the numbers of children without health care coverage would plummet. But, there’s no deadline so there’s no urgency.

And that’s the ultimate penalty.

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Doing the Charleston

05/17/2006 10:20 AM |

West Virginia Governor Joe Manchin has decided not to formally respond to a recent column in the Charleston Gazette by Dr. Alan Sager of Boston University critical of the state’s efforts to implement a 2004 state law intended to curb soaring prescription drug costs.

In the April 27 column, Sager complained that the provisions of the act are being implemented “much too slowly.”

Comment from the Governor’s office …

“We think they’re moving in the right direction,” said Lara Ramsburg, the Governor’s communications director. “We’re not going to spend of lot of time worrying about responses.”

Well I did respond and here’s my letter (which appeared in the May 14 edition of the Gazette) …

Drug comparison useless and wrong
May 14, 2006

Editor:

In his commentary in the April 27 Charleston Gazette, Dr. Alan Sager makes the obscene argument that since the street price of heroin and cocaine has decreased four-fifths between 1981 and 2000, so too should the costs of prescription pharmaceuticals.

His comparison couldn’t be more useless — or more wrong. He points out that in 1981 the “average retail price per pharmaceutical” was $9.50 and that in 2000 the average rose to $40.11. But this is a useless statistic because, one, it begs the question, what’s an average pharmaceutical?; and, two, it supposes that we’re dealing with the same basket of similar products.

In 1981 there were far fewer effective medications for almost every disease (most notably hypertension, high cholesterol and diabetes) and biologic therapies for cancer, multiple sclerosis, etc., were more science fiction than science. We’ve come a long way from bench to bedside in those years, and millions of Americans are leading healthier, more productive lives because of these advances.

In 1981, my parents gave me an electric typewriter for my birthday. It cost $125. Using Sager’s logic, I could make the argument that in 1981 a “word processor” cost $125 and in 2000 it cost $2,500. But would anyone accept that a typewriter and a laptop computer are comparable? I think not.

Peter J. Pitts

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Sparking Unnecessary Concern About Drugs for Rheumatoid Arthritis

05/17/2006 10:07 AM |

Scott Hensley is one of the country’s best health care reporters and his article on the risks and benefits of drugs for RA proves it. Scott’s piece is fairly balanced, however as I noted in an email to him: Not bad as far as most pieces of this genre…but if you had delineated between cancers and put this study into the context of other similar projects if would have made people rest easy rather than give the Grassleys and Sid Wolfes of the world more red meat for slowing down drug development.

For instance, ” Patients with rheumatoid arthritis (RA) are at increased risk of lymphoma, and standardised incidence ratio (SIR) is greatest for those treated with anti-tumour necrosis factor (anti-TNF) therapies; however, differences between therapies are slight, and data are insufficient to establish a causal relationship between RA treatments and the development of lymphoma, a new report indicates.

It has previously been reported that methotrexate (MTX) and anti-TNF therapies might be independently associated with an increased risk of lymphoma. However, small sample sizes and selected study populations in these studies could not confirm this association.

To investigate this issue further, Frederick Wolfe, MD, and Kaleb Michaud, MS, with the National Data Bank for Rheumatic Diseases, Arthritis Research Foundation, in Wichita, Kansas, United States, prospectively studied 18 572 enrolees in the National Data Bank for Rheumatic Diseases (NDB).

Patients were surveyed twice a year. Reported cases of potential lymphoma were further investigated. The expected number of cases of lymphoma was determined by using data from the Survey, Epidemiology, and End Results (SEER) cancer data resource.

Overall, 88 lymphomas were identified, 59 of which occurred prior to NDB enrolment and 29 of which occurred after NDB enrolment and during the period of intensive follow up.

The overall SIR for lymphoma, regardless of treatment, was 1.9. For patients receiving biologics, SIR was 2.9 (95% CI 1.7-4.9). For those taking infliximab, with or without etanercept, the SIR was 2.6 (95% CI 1.4-4.5). For etanercept, with or without infliximab, the SIR was 3.8 (95% CI 1.9-7.5). The SIR for MTX was 1.7 (95% CI 0.9-3.2), and for those not receiving MTX or biologics, the SIR was 1.0 (95% CI 0.4-2.5).

Lymphoma was associated with increasing age, male sex, level of education, and comorbidities. The Cox regression hazard ratios and 95% CIs for these variables were 1.58 per 10-year increase in age (95% CI 1.16-2.18); 3.70 (95% CI 1.79-7.68) for male sex; 1.16 (95% CI 0.99-1.37) for education; abd 1.30 (95% CI 1.10-1.54) and for comorbidity.

“The results of this study show that lymphoma is increased in RA compared with the general population,” Dr. Wolfe and colleagues conclude. However, even a sample of more than 18 500 patients could not demonstrate significant differences among the studied groups, because of the rarity of lymphoma, they note.

“It seems possible that the apparently increased rates of lymphoma are, in fact, reduced by therapy, and that the ‘increase’ may reflect channelling bias whereby patients with the highest risk of lymphoma preferentially receive anti-TNF therapy,” the researchers conclude.

“It appears that neither clinical trial data nor data from the current study are sufficient to establish a causal relationship between RA treatments and the development of lymphoma,” they add.

Arthritis Rheum 2004;50:1740-1751. “Lymphoma in rheumatoid arthritis: The effect of methotrexate and anti-tumor necrosis factor therapy in 18,572 patients”


There is also this study http://www.arthritis-research.org/Documents/breast_ca_ACR2005.ppt

and this one http://www.arthritis-research.org/Documents/lung%20cancer_ACR2005.ppt


PS. The fact that drug companies support research does not make the research wrong. If that were the case, then no drug would work since all research submitted to the FDA is done by drug companies…

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Grassley is Dead Wrong on the Deadline

05/17/2006 09:07 AM |

From a Washington Post Story: ” Grassley said the bill would make up for an estimated $1.7 billion in lost penalty revenue over five years by reducing a “stabilization fund” aimed at helping private managed-care health plans take care of older Americans. “

So let’s see….penalize seniors who sign up early by taking away their discount and take money away from an effort to keep seniors healthy in order to save laggards $2-5 a month? This is election year grandstanding of the worst sort….

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Deadlines make a difference

05/16/2006 12:35 PM |

ON THE HEALTH CARE FRONT: Yesterday, according to Mark McClellan, administrator for the Centers for Medicare and Medicaid Services and the hardest working man in health care, about 40,000 to 50,000 people were on the agency’s Web site site at any given moment.

“We’ve seen a real surge,” McClellan said. “The deadline is making a difference.”

WHILE ON THE POLITICAL FRONT: According to an AP story, Representative. Nancy Johnson (R, CT) took a swipe at Democrats, saying she believes the program has been quite successful, and enrollment might have been closer to 100 percent “if the Democrats had put the welfare of our seniors ahead of their own political ambition.”

You go girl.

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A PAP Gap?

05/15/2006 06:17 PM |

The OIG stance is typically government: make a straightforward program that works well in the private sector a cumbersome and daunting process that discourages consumer participation and then makes any corporate deviation from the regulations or their interpetation by Asst. US attorneys or self-styled consumer groups grounds for criminal investigation or litigation.

Which goes to show you what life would be like if the government took direct control of the Medicare drug benefit….bad enough the nit-wits in OIG have screwed this one act of charity up…what would happen if every part of the pharmaceutical business was under government control?

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Going for the Gold

05/15/2006 09:47 AM |

Excellent article in today’s Financial Times about the impact the rapidly declining cost and increasing precision of clinical informatics is having on prescribing decisions and the Pharma model of simply marketing a drug based on FDA data. The article describes how health plans are developing better post market and predictive decision-making models on who gets what within the framework of disease managment. And it will soon be possible to integrate clinical data with some genomic data as well. Where is Pharma on all this? According to the FT article: “in a world where whoever controls the gold often rules, drugs companies no longer have a firm grasp on the most precious commodity: information.” See the article below..

I have been saying for years that Pharma has to get into the trenches and start looking at how their products actually work and where they work best to stay in the game and stay ahead of the price control crowd. What they spend on traditional marketing should be spent on developing sophisticated data mining and data analysis systems…it would deliver better value to both company and customers alike.

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PDUFA Myth-Busters #1

05/15/2006 06:21 AM |

It’s PDUFA reauthorization time and the usual suspects are trotting out the usual evasive gabble.

PDUFA MYTH #1: Since drug companies provide about 40% of FDA funding via PDUFA, the agency is “beholden” to Big Pharma.

TRUTH: How can FDA be “in the pocket of the pharmaceutical industry” when the industry has nowhere else to go? Where’s the leverage? It’s FDA or nothing pal. The leverage is on the other side.

Proper retort to ignorant comment — “Industry pays FDA to approve drugs.”

Wrong! FDA gets paid to review drugs. (And they certainly don’t all get approved now, do they?)

More myth-busting to follow.

Send me your favorite PDUFA myths and I’ll post them. I can be reached at ppitts@cmpi.org.

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Dumb and Dumber

05/14/2006 11:15 PM |

Here’s a question: In the case where a life is on the line and you need a doctor who would you choose: someone who is world reknown, an expert in saving lives and treating the disease that threatens it but is under scrutiny by the mainstream media and the Left for consutling with drug companies or an untested doctor with no track record by who has done no consulting for biotech or drug firms? Only a dumb person — or a pure ideologue (an oxymoron) — would choose the latter.

Now apply this logic to banning people — regardless of their insight, clinical gifts or peer recognition — from advising the FDA because they consulted for the NIH or private companies. Merrill Goozner argues that there are plenty of oncologists for example that have not consulted for private firms that could serve the FDA. The question is: would excluding those that have consulted advance the public health. Applying the Goozner rule would exlude:
one of the world’s experts in prostrate cancer, one of the pioneers in using biomarkers to measure angiogenesis, a leader in the design of clinical trials for stomach cancer, one of the nation’s leading researchers dedicated to finding drugs that actually stop the progression of bladder cancer., and a Nobel Prize winner to boot…

This is dumber.

Peter and I have a better way that will increase the number of smart people helping the FDA as opposed to proposals that make them feel like criminals.

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TGIF

05/12/2006 06:29 PM |

I am suffering from hypocrisy and stupidy overload….apart from the patently biased reporting on Pfizer’s clinical trials and cancer drug pricing in the WP and WSJ respectively we now have the double standard on the coverage of RU-486 safety. According to recent research, 1 in every 80,000 women who have a medical abortion die. 1 in every 1,000,000 women who have a surgical abortion die. I am not a math whiz but that means that RU-486 increases your risk of death 10 times. If Vioxx had done that, it would have been the subject of a Charles Grassley media orgy. And lost in the reporting is the fact that many of the deathrs attributed to RU-486 recently are linked to off-label use (vaginal vs. oral use). Or was this fact conveniently buried even as the press beats up on other forms of off-label use?

Meanwhile, the AP had this misleading headline : Paxil May Increase Suicide in Teens, FDA and GlaxoSmithKline Warn

Actually, the FDA said that nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.

The FDA reported that there were 11 suicide attempts — none resulting in death — among the patients given Paxil in the trials. Just one of the dummy pill patients attempted suicide.

Given that small number, the results “should be interpreted with caution,” the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.”

Left unsaid of course is that people suffering from major depession are likely to exihbit suicidal behavior and that all medications are associated with an elevation of suicidadility and that use of antidepressants is associated with a decrease in the incidence of suicide among teens.

Meanwhile, USA today ran a story discussing whether Oprah is a modern day Billy Graham.

All of this reminds me of what Thomas Jefferson said: “The man who reads nothing at all is better educated than the man who reads nothing, but newspapers. “

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The (second) Best and the (almost) Brightest

05/12/2006 12:08 PM |

The insanity of not permitting conflict-of-interest (COI) waivers for certain highly qualified members of FDA advisory committees is not only, well, insane, but also quite contrary to the best interests of the public health.

During my tenure at the FDA I was the senior official in charge of advisory committees and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.

Are we really going to pass legislation that bans the best and the brightest from serving the public health because their preeminent expertise has also been viewed as valuable by the pharmaceutical industry?

It looks like we just might. God help us.

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It's (drug development) tool time

05/12/2006 09:08 AM |

Researchers have developed a screening tool for discovering unexpected effects that drugs may have on living cells. It could provide a better way of identifying both potential side effects of and applications for new drugs — and take the serendipity out of the drug discovery process. Published in the current issue of the journal Nature Chemical Biology, the new tool combines modern chemical screening techniques with computer analysis. Using it, pharmaceutical companies could get an early snapshot of the potential uses and possible side effects of particular drugs. Most drugs work by interacting with target proteins to influence their effect on biochemical pathways within cells. But because these pathways and their interactions are complex, a drug can often have side effects — beneficial or toxic. To ferret out these effects, drugs nowadays are usually screened one target protein at a time, says Graeme Milligan, a molecular pharmacologist at the Institute of Biomedical and Life Sciences, University of Glasgow. Although it works, this approach can be costly for the pharmaceutical industry. “Potentially toxic and off-target effects are generally not discovered until a later stage,” he says, after a lot of time, money, and effort have been spent.

Here’s a link to the entire article:

http://www.technologyreview.com/read_article.aspx?id=16827&ch=biotech

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Why is Ron Pollack So Angry?

05/11/2006 09:16 AM |

Godfather Ron Pollack is angry: 37 million seniors have signed up for Medicare Part D, including 10 million of the 14 million seniors without coverage. Best of all 90 percent of low income seniors are enrolled which makes Godfather Ron’s claim that most seniors have better coverage then Part D offers look stupid and silly. On another front, groups of Americans will be able to form their own health insurance associations, using Costco and others to compete with traditional insurers. The Godfather opposes this nationally though he supported such association health plans in Massachusetts.

When good things happen to good people and people in need, count on Families USA and its capo to scowl and pout. For Families USA and Ron Pollack, worse is always better and better is always bad (at least for their agenda).

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Post-Marketing Puissance

05/11/2006 08:31 AM |

Something to think hard about …

WASHINGTON — The Food and Drug Administration could compel drug makers to conduct additional clinical trials after it approves their products under an amendment passed by a US House committee.

To speed drug approvals, the FDA frequently defers some clinical trials until after a product is introduced on the market. But companies have failed to complete two-thirds of the post-marketing studies they pledged to conduct for drugs now sold to millions of Americans. Currently, the FDA does not have the authority to force drug makers to finish the trials.

Under the amendment, which was attached to a must-pass appropriations bill, the agency could begin proceedings to stop the sale of specific drugs if promised clinical trials for those products are not done.

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In Defense of Public Service

05/10/2006 09:21 AM |

Some attack the FDA with malice and ignorance. That’s not helpful. Others attack people at the FDA. And that’s just plain wrong.

Bob and I share our feelings today on NRO. Here’s the link. The title of our remarks is “Miller’s Crossing.”

http://www.nationalreview.com

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Senile and too stupid to choose

05/09/2006 06:45 PM |

Remember all those whiners who said seniors were too old and stupid to choose a drug plan? Now they’re attacking consumer-directed plans and the effort to give people more information on choices — like price and quality. The reason: too much information will overwhelm most of us because we — unlike the health care gods at the Kaiser and Commonwealth Foundation — are too slow and stupid to make intelligent choices. Here’s one of the leaders of the Too Stupid to Choose Coalition, Drew Altman, on the subject of consumer choice:

“It’s not about whether consumers should shop for health care like plasma TVs,” says Drew Altman of the Kaiser Family Foundation. “It’s about two fundamentally different approaches to health care: comprehensive and less comprehensive with high-deductible plans. Which does America want?”

Gee Drew, I guess all health plans are the same with no difference in outcomes, service, cost, etc? Maybe health care isn’t like plasma TVs but it’s obvious you think it should be more like the current black box you want us to shut up and accept. As for the canard that people scared about dying not being able to make a rational decision…where does that happen in real life? In the extreme, hospitals are being judged by how well they treat acute stroke and cardiac arrest and the data is being made available to insurers and consumers. Iin the main, treatment of chronic illness or surgery, people do have the time to make a choice. That goes - heaven forbid — even in the treatment of cancer or other life threatening illnesses. The people I know who struggle with such illnesses are searching for more information to make the best choice possible. But Mr. Altman and his coalition think people are too incompetent to make these choices or that they don’t matter.

And as for seniors, they certainly know how to make a good choice. Just ask them on Election Day.

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