Affairs of The Heart: Continued

11/09/2007 11:29 AM |

Which of these is likely to be the per client amount individuals who entered the Vioxx litigation sweepstakes are going to get:

a. $1million
b. $400k
c. $75000
d. $5300

If you picked d) you get a tube of John Edwards' hair gel. That's right. Take the $4.8 billion Merck will fork over, give half of it to all those well meaning trial attorneys and then divide the rest among the 45000 plaintiffs.

CORRECTION: My friend, and consigliere Paul Windels nails me on the math, my estimate of the tort take and my cheap calculator that only runs into the hundreds of milions and wins a case of hair grout with the following email...

Bob -- I think you have a decimal point error here. If there are 45,000 plaintiffs, $5,000 per plaintiff is around 225 million. Your number is correct if there are 450,000 plaintiffs -- on the other hand any plaintiff with a decent case would opt out of the settlement if it were only worth $5,300. I would expect a fee max 33% meaning $3.2 billion net, which would be around $70K per, a much more attractive number. Cheers. Paul.

Did Merck ignore safety signals of Vioxx in a way that made it liable for people dying. No. There are lots of safety signals. Are there better ways to figure out which ones reflect real risk. You bet and that means not having to wait four years to find out about them, which was the point of Eric Topol's original article about Vioxx. Are we any closer to knowing how to manage the risks of COX-2s because of the grandstanding and litigation? No. Could Vioxx been remarketed and sold with tighter restrictions in a saner, less politicized environment. Yes. What will help patients more, better monitoring of risks and benefits of meds post market using 21st century science or a system gripped by fear and controlled by trial lawyers and self proclaimed consumer advocates who dredge data for danger?

On a lighter front, Crestor just got a label for atherosclerosis, a label which simvastatin generic Zocor, Stephanie Saul's drug of choice does not have. Simvastatin also seems to cause sleep problems in some patients which I am surprised Stephanie didn't know about since she is the NYT in house expert on sleep.

I hearken back to her article about Pfizer trying to maintain market share in the face of simvastatin competition and the firm trying to use the fact that patients respond differently to different drugs as a way to keep more people on Lipitor if its good for them in the long run. How about this as a proposition: not what's cheapest, but what is best and has the fewest side effects given our specific health needs. As we move towards personalized medicine those will be the claims that count. Or is that marketing too? In a politicized environment our choice is as follows: A drug that is marketed by drug companies is bad even if it is personalized. A drug dispensed according the musings ofJerry Avorn or some researcher who ignores individual differences in drug response to justify the cheapest (the Soros funded approach of the Institute for Medicine as Profession)..that's great.  Read More & Comment...

And not one cent for tribute

11/09/2007 09:46 AM |

By now you will have surely have heard about Merck's $4.85 billion Vioxx settlement. That comes out to something more-or-less like $100,000 per plaintiff -- and not one cent for tribute to trial lawyers.

To paraphrase -- a billion here, a billion there and pretty soon you're talking about a settlement. My sources confirm that Merck had been spending about $1 billion a year on Vioxx litigation -- and, with no end in sight, $4.85 billion to make it go away is the smart fiduciary play.

That being said, it must stick in the craw of the folks at Merck to pony up this kind of do-re-mi for having done nothing wrong -- money that could (and should) have been spent on R&D.

If anything positive can come out of this travesty it's this -- Merck stood up for what it thought was right, won more than they lost -- and showed the trial bar, pundits, and pols that they weren't going to be doormats for cheap shots and SiCKO soundbites.

And that's a valuable lesson for the rest of the Big Pharma brethren.  Read More & Comment...

Moore-ish Behavior

11/09/2007 07:55 AM |

In case you missed the news, SiCKO is now out on DVD – and it seems that New York Times columnist Paul Krugman made a beeline to Blockbuster.

Call it an early Hanukah present for a true believer.

His column, “Health Care Excuses,” replays the same tried and untrue arguments made in the Moore-ish cult classic. Here’s a link:

http://www.nytimes.com/2007/11/09/opinion/09krugman.html?ref=opinion

Looks like he read our November 5th blog, “Debunking Some Health Care Urban Myths" --

http://drugwonks.com/2007/11/debunking_some_health_care_urban_myths.html

-- where we take many of the more infamous Moore/Krugisms to task.

Well, at least he's reading -- if not learning.

(And we'll keep trying.)  Read More & Comment...

CMS Stands Alone on ESA Dosing

11/08/2007 02:29 PM |

ASCO/ASH, ACCC, EMEA and now the FDA all say the following with respect to ESA dosing

"The dosing recommendations for anemic patients with chronic renal failure have been revised to recommend maintaining hemoglobin levels within 10-12g/dL."

CMS stands alone -- along with insurers who jumped on board to save money -- as the only government agency to limit access based on safety.

Why does CMS think that ESAs are less safe at anything more than 10g/dL when everyone else thinks otherwise? Why does CMS think it can limit doctor discretion?

Here is the FDA label update.

http://www.fda.gov/cder/drug/infopage/RHE/default.htm  Read More & Comment...

Hatikvah: CMPI Co Sponsors Biotech Boot Camp In Israel

11/08/2007 10:07 AM |

Peter and I are leaving for Israel today where will be participating in and co-sponsoring a three day program for Israeli biotech startups designed to help them improved their ability to become full fledged companies. Israel is home to some of the best translational science in the world and providing companies insights to the policy and regulatory environment in the US can help enhance value and improve efficiency. The conference is entitled Health Care Technological Innovation: From Idea to Commercialization. It's co-sponsored by the Israel Life Science Industry, The International Institute for Biotechnology Entrenpreneurship, Tel Aviv University's Recanti School of Business and CMPI.

It's Peter's first trip and as for me, I get to see my son who, as some of you know, is serving in the IDF.



Here's the conference agenda:

http://biomedmanagement.tau.ac.il/

We will blog from Israel!  Read More & Comment...

If it ain't broke -- don't send it to Geneva

11/08/2007 08:56 AM |

Per the current shenanigans going in at the IGWG in Geneva, here's a breath of fresh air -- a thoughtful analysis on the actual state of affairs vis-à-vis drug development and patents. It's by Philip Stevens of the International Policy Network and appears in Investors Business Daily. It's a potent rebuttal of the various and sundry half-truths put forward by Jamie Love, the Pancho Villa of Patents, and his fellow travelers.

If R&D Ain't Broke, Why Break It?

BY PHILIP STEVENS

There is a long list of complaints against the current system of drug development:

• Patents and profits have failed to produce new medications for the diseases of poor countries.

• There are not enough groundbreaking new therapies.

• Profiteering companies routinely make tiny changes to drugs to extend patents and shut out competition.

• Not only that, the patent system allows companies to charge astronomical sums for the drugs they do produce.

These allegations come from a powerful group of ideological nongovernmental organizations, or NGOs, that abhor profit in medicine and are pushing the World Health Organization toward a global treaty that would completely change the way drugs are researched and developed.

But before taking their medicine, we should take a close look at the label — and the nasty side effects.

This Medical Research and Development Treaty, proposed by Brazil and Kenya, would have a central U.N. bureaucracy deciding what diseases to research while allocating funds, contracts and prizes accordingly. Its expert scientists would ensure that all diseases are given appropriate resources, including the handful of "unprofitable" tropical diseases in poor counties.

NGOs, including humanitarian groups such as Medecins Sans Frontieres, hope this scheme will solve the failings of the current system at a stroke.

Because intellectual property would be owned by governments, drug prices would plummet. Less would be spent on frivolous ailments such as erectile dysfunction and baldness, and more on malaria and HIV/AIDS. Resources could be concentrated on groundbreaking "blockbuster" drugs, instead of the small molecular changes that are routinely patented now.

When the WHO first mooted the treaty in May 2006, MSF called it a "breakthrough" that "would ensure that patients' needs rather than profits drove innovation."

If the aim is to punish Big Pharma's stockholders, it will probably work. But as a way of producing cheap innovative drugs for the poor, it fails on several counts.

First, giving such discretionary power to bureaucrats would politicize R&D. In a centrally directed system — as in Britain's health service — resources tend to go to the loudest pressure groups. Other diseases would be neglected in favor of politically high-profile diseases such as HIV/AIDS.

Neither is it clear how an unelected body in Geneva would be better at setting priorities than the thousands of scientists and businessmen whose livelihoods depend on getting these decisions right.

Second, using state-funded prizes as the major incentive for R&D is problematic. The prize committee can never know the true market value of the drug it is hoping to create. If the prize is too low, companies will be reluctant to compete for future prizes, leading to fewer new drugs. If the prize is too high, the new system will squander taxpayers' money and divert effort from other areas of research.

Prizes were much favored in the Soviet Union, but they never resulted in much innovation.

Third, the treaty would turn drug manufacturers into utilities, living off government contracts. Removing the freedom to decide what to sell and at what price will discourage companies from risking capital to reap rewards, which is how innovation happens.

This is a clear lesson from regulated utilities such as water, electricity, telephones and gas. In a minimal-profit sector, companies do the bare minimum to fulfill their contractual obligations.

Most fundamentally, the treaty does not solve the greatest health care problem in poorer countries: how to actually get the drugs to patients in the face of crumbling hospitals and chronic shortages of doctors and nurses.

In 2006, the director of the World Health Organization's HIV division, Kevin De Cock, said "it is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don't exist."

If prices are an issue, why not scrap taxes and tariffs on medicines, which can increase the manufacturer's price by up to 11 times? These taxes on the sick are levied by many poor countries, including Kenya.

Removing commercial incentives will make companies retreat from the difficult and expensive work on cures for cancer and the like, and try to regain lost profits in politically safe "lifestyle" ailments. And governments have yet to demonstrate that they can produce drugs themselves.

All this is worrying for the U.S., which has already allowed the draft treaty to progress too far. There are echoes of the Clinton administration's hapless negotiation of the TRIPS agreement in 1994, which is now coming back to haunt America.

That agreement on Trade-Related Aspects of Intellectual Property Rights includes a clause designed to allow emergency production of essential medicines in poor countries. In practice, its wording is so vague that it allows any government to override the patent on any drug it likes. Middle-income Brazil and Thailand are now doing exactly that.

If the negotiators from the Department of Health and Human Services do not firmly reject the proposals at the WHO's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property in Geneva this week, there won't be any pharmaceutical patent rights worth the name. This will be a body blow to innovation.

The current patent-based R&D model has produced most of the drugs that exist. It has a few problems, but there is no point junking it for an ill-conceived NGO fantasy. The biggest losers will not be stockholders, but patients.

Well said, Philip.  Read More & Comment...

Tops in BioTech Blogging

11/08/2007 07:30 AM |

DrugWonks is proud to have been chosen by BioTech360 (a publication of The Scientist) as the #1 “must read” blog for those in the wonderful world of biotech.

According to Biotech360 blogger Yali Friedman, “As the forum for the Center for Medicine in the Public Interest, Drug Wonks covers policy affecting biotechnology. This blog also tracks and responds to Op-Eds and other news items, providing additional perspective on many important topics.”

His top five list can be found at:

http://www.biotech360.com/biotechArticleDisplay.jsp?biotechArticleId=100039

Thanks Yali.  Read More & Comment...

Two's a Part D, Three's a Crowd Out

11/07/2007 09:15 AM |

Frank Lichtenberg published a study in Health Affairs demonstrating something that we already knew: a lot of the drug coverage of part D crowded out private drug coverage and increased utilization by about 12 percent. Much of the increase was in the area of generic drug spending. So much for the Big Pharma windfall. Part D was essentially what those of us who supported said it would be: a modernization of Medicare the goal of which would be to extend drug coverage to a program that did not have it and to milions of seniors who were poor and were receiving drug coverage through restrictive Medicaid formularies.

So what's the difference between supporting a Part D crowd out and not an SCHIP crowd out? Part D is a step towards privatizing Medicare -- full of choices and pasrt of an effort to get seniors to buy into private plans and everyone knows it. SCHIP is a step towards socializing healthcare and everyone knows it.

Lichtenberg points out also that Medicare Part D has the benefit of reducing Medicare spending overall. We need studies to demonstrate this happening at various income groups and disease states.

http://content.healthaffairs.org/cgi/content/abstract/26/6/1735  Read More & Comment...

Follow On Biologics Loses Momenta

11/07/2007 09:03 AM |

Those screams you heard came from "I hate Big Pharma" being hoisted on the drug safety petard of their own making as Momenta's hard to mimic version of Lovenox was being rejected by the FDA because of concerns that the company hadn't accounted for uncountrolled immune reactions to its version of the product. And of course that doesn't even begin to to address what sort of studies Momenta would have to undertake to deal with safety concerns, what risk mitigation system it would have to put in place, what post marketing surveillance it would have to conduct, what clinical trials data it would have to post, blah,blah blah.

FOBs will hit the market eventually. But it is great to see those who take drug companies to task about safety seek to rationalize rushing FOBs to market without similar consumer protections. And they care more about rushing FOBs to market than accelerating the review of new life saving medicines which Momemta is also working on. It's called I hate pharma hypocrisy.  Read More & Comment...

Oh Say Can you OTC?

11/07/2007 09:00 AM |

Had a look at the Non-Prescription Drug Modernization yet? It was just introduced by Representative Henry Waxman (R, CA), Representative Tom Allen (D, ME), and Senator Ted Kennedy (D, MA.). It’s a well-meaning, but knee-jerk reaction in response to the recent FDA advisory committee vote over banning over-the-counter cough and cold medicines for children under six.

Here’s a link to the legislation:

http://oversight.house.gov/documents/20071106143446.pdf

Among other things, this bill would allow the FDA to ban marketing of the drugs while the rulemaking process was still under way.

That’s right – “ban” advertising.

We’ve already covered how we feel about the recent AdComm vote (see two October 19th posts, “Dosing for Dummies” and “Cough, Sniffle, Sneeze – No OTC Meds for Children, Please”). Per this new legislation, we concur with our friend Adonis Hoffman over at the American Association of Advertising Agencies.

Here’s what Adonis has to say:

"We are all concerned about the cough and cold medications for children that have been in the news reports lately. Nobody benefits from false or misleading advertising of any kind, whether it is for over-the-counter or prescription medications."

He also, wisely, point out that there are already "ample and appropriate regulatory penalties in place to handle these problems. The authority of both the Federal Trade Commission and the Food and Drug Administration is intact. I'm not sure whether there is a need for new changes."

Hopefully this will be a robust debate over how good communications can improve the public health -- not another public flogging of the industry.

Just call us starry-eyed optimists.  Read More & Comment...

Affairs of the Heart

11/06/2007 04:17 PM |

Lots of info coming in about drugs in development then and now showing the (Critical) path forward is towards retargeting, retooling, repositioning drugs to specific groups and for monitoring risks and benefits post market...

1. Research from the studies showing that while Lilly's Prasugrel proved better able to prevent heart attacks than Plavix, the drug led to excess life threatening bleeding compared to Plavix at a statistically significant level in patients with acute coronary syndrome. But Lilly, consistent with a commitment to pharmacogenomics and targeted therapeutics has identified subgroups that are most likely to have that risk. The PI of the study, Dr. Elliot Antman, said that most of the bleeding was driven by two groups -- patients with a history of stroke or transient ischemic attacks and elderly, frail patients (older than 75 weighing less than 60 kg) -- who comprised 20% of the total population.

"For the remaining 80% of the patients, which I would say represented eight of 10 patients undergoing stenting, the drug works very well," Dr. Antman said in an interview.

Moreover, among one high-risk group -- diabetics -- "there was no excess bleeding and a 30% reduction in MIs compared with clopidogrel."

Wall Street sniffs that the market will be minimal. But Plavix goes off patent in 2011 while Lilly's drug could get a Pgx label with improved safety and benefit profiles. How minimal is that?

http://www.medpagetoday.com/MeetingCoverage/AHAMeeting/tb/7217

2. The CETP trilogy. Efforts to raise good cholesterol is the holy grail of the cardiovascular world Pfizer's drug sent torcetrapib chills down the spine of others developing drugs based this target. But further analysis shows that increased blood pressure and changes in electrolytes (which caused the heart attacks in Pfizer's drug study) signal the potential activation of the renin-angiotensin-aldosterone system (RAAS) by torcetrapib. The greater RAAS activation may weaken the benefit of raising HDL."

Translation: if your drug (Merck and BMS) doesn't activate the RAAS pathway or you can develop a blood test that predict who won't or will have that effect you might be able to bring other HDL drugs to market.

http://www.drugresearcher.com/news/ng.asp?n=81155-pfizer-merck-bristol-myers-squib-bms-torcetrapib-cetp
It's biomarker based research at it's best. Good news for patients. Bad news for Merrill Goozner and others who want to claim biomarkers are just a tool for making drugs unsafe.  Read More & Comment...

Lies, Damn Lies, & Press Releases from Jamie Love

11/06/2007 06:56 AM |

Maybe they should call it Médecins Avec Menteurs.

In an e-mail today from the folks over at Médecins Sans Frontières discuss this week's meeting in Geneva of the WHO's Intergovernmental Working Group for Public Health, Innovation, and Intellectual Property (IGWG).

Here's what MSF has to say about the current fight against "neglected" diseases:

"“The R&D system is broken. It is not delivering,” said Dr. Tido von Schoen-Angerer, Director of MSF’s Access to Essential Medicines Campaign."

And here's what the infamous Jamie Love said in an ensuing paragraph:

"We need new mechanisms and institutional responses to move toward a paradigm of innovation plus access, rather than a set of poorly functioning trade-offs. The big ideas in the negotiation are patent pools, prizes and a treaty on medical R&D. They are also the most
controversial."

What a terrific example of the "Big Lie."

Consider what Solomon Nwaka (leader of drug discovery activities at the Special Programme for Research and Training in Tropical Diseases at the WHO) wrote (along with other co-authors from Pfizer) on the subject of finding ways to battle tropical diseases:

"Scaling up drug-discovery capacity for neglected diseases means designing a mechanism that is attractive to all stakeholders — such as industry, academia, governments and international agencies — involved in drug discovery. Despite a lack of market incentive, about half of the research projects currently focusing on neglected diseases are conducted by pharmaceutical companies. Several large companies, most notably GlaxoSmithKline, Novartis, AstraZeneca and Eli Lilly, have founded research institutes dedicated to research into tropical diseases. Industry also makes a substantial contribution in kind to public–private product-development partnerships. Also, in recent years, funding from governments and philanthropic foundations has helped to establish new drug-discovery units for tropical diseases in developed and developing countries."

Here is a link to the complete article in Nature:

http://www.nature.com/nature/journal/v449/n7159/full/449166a.html

And let's not forget what Dr. Margaret Chan, WHO's Director-General had to say about why communicable diseases remain such a large problem in poor countries and are often neglected by research and development. One reason, she said, is that the pharmaceutical industry "has little incentive to develop drugs and vaccines for markets that cannot pay."

Indeedn if a company stands no chance of recouping even a portion of that investment, where is its incentive to tackle the many diseases that ravage the developing world?

And yet, according to MSF, "intellectual property is not a significant factor in contributing to innovation for diseases that disproportionately affect developing countries."

Thomas Carlyle said, "Our main business is not to see what lies dimly at a distance but to do what lies clearly at hand." Mr. Love and his friends at Médecins Sans Frontières are trying to sell a "vision" that, conveniently, blames the West for the problems of the developing world while what "lies clearly at hand" is almost exactly the opposite -- that the rule of law that has allowed for the development of the modern pharmaceutical industry via protection of interllectual property is what lights the road to victory over the scourge of neglected diseases.  Read More & Comment...

Defenseless Against New Bugs: Thanks to the Politics of Fear

11/05/2007 10:12 AM |

Another dividend from the politics of fear: an empty antibiotic pipeline and an FDA that has pushed the safety bar for new drugs against bugs to unachievably high standards.

More people will die because of the absence of new drugs. The policies that have brough this about were built on false premises and false fears. mistrust has become an important source for scientific investigations themselves. Scientists nowadays build a career on technophobia within society. They are the first group who form the
scientific core of the precautionary coalition. They feed this information to consumer groups and politicians who, through the media and policies and hearings institutionalize mistrust, fear and suspicion.

The politics of fear breads both inaction and regulatory paternalism. Nothing is safe so everything must be regulated and tested. More is studied but nothing new is introduced because novelty has unknown risks which are judged more dangerous than the problem it was designed to solve.

So we are left with hardly any new drugs against emerging pathogens. That is the way the Luddites would have it. Better dead people than thriving, profitable drug companies.

http://www.nj.com/business/times/index.ssf?/base/business-3/11941492275600.xml&coll=5  Read More & Comment...

Debunking Some Health Care "Urban Myths"

11/05/2007 09:03 AM |

Like they say, everything you read in the newspaper is true except for those things you know about personally. This isn't always how urban myths begin -- but is certainly one of the most potent ways they are perpetuated.

Three of the most common "urban myths" of American health care (courtesy of folks like Michael Moore, Paul Krugman, et. al.) are that (1) the infant mortality rate in the US "proves" the total inadequacy of our system, (2) there are 47 million uninsured Americans -- proving the inequity of our system, and (3) We spend "too much" on health care -- proving the wastefulness of our system.

As the Ol Perfessor used to say, "Let's look at the numbers."

1. Infant Mortality

According to N. Gergory Mankiw, Professor of Economics at Harvard University, "The United States has lower life expectancy and higher infant mortality than Canada, which has national health insurance." This fact, according to Mankiw, is often taken as evidence for the inadequacy of the U.S. health system. But a recent study by June and Dave O'Neill, economists at Baruch College, from whom these numbers come, shows that the difference in health outcomes has more to do with broader social forces.

According to Manikow, "Americans are more likely than Canadians to die by accident or by homicide. For men in their 20s, mortality rates are more than 50 percent higher in the United States than in Canada, but the O'Neills show that accidents and homicides account for most of that gap. Maybe these differences have lessons for traffic laws and gun control, but they teach nothing about the U.S. system of health care.

Americans are also more likely to be obese, leading to heart disease and other medical problems. Among Americans, 31 percent of men and 33 percent of women have a body mass index of at least 30, the dividing line between overweight and obese, versus 17 percent of men and 19 percent of women in Canada. Research by the Harvard economists David Cutler, Ed Glaeser and Jesse Shapiro concludes that the growing obesity problem in the United States is largely attributable to its ability to supply high-calorie foods inexpensively.

Infant mortality rates also reflect broader social trends, including the prevalence of infants with low birth weight, which is correlated with teenage motherhood. Whatever its merits, a Canadian-style system of national health insurance is unlikely to change the sexual mores of American youths"

2- 47 Million Uninsured

This number from the Census Bureau is often cited as evidence that the health system is failing for many families. Yet, as Mankiw observes, "by masking tremendous heterogeneity in personal circumstances, the figure exaggerates the magnitude of the problem."

The 47 million includes about 10 million residents who are not U.S. citizens. Many are illegal immigrants. Even with national health insurance, they would probably not be covered.

The "Big Number" also includes millions of the poor who are eligible for Medicaid but have not yet applied. Per Mankiw, "they are uninsured in name only."

And about a quarter of the uninsured have been offered employer-provided insurance but declined coverage.

3- We spend "too much" on health care

In 1950, Americans spent about 5 percent of their income on health care. Today the share is about 16 percent. Mankiw believes that "many pundits take the increasing cost as evidence that the system is too expensive.But increasing expenditures could just as well be a symptom of success."

And he hits a homerun with a clear. concise, and uncomplicated explanation. "The reason Americans spend more than their grandparents did is not waste, fraud and abuse, but advances in medical technology and growth in incomes. Medical science has consistently found new ways to extend and improve lives. Wonderful as they are, they do not come cheap."

Consider the question posed by economists Charles Jones of the University of California and Robert Hall of Stanford: "As we grow older and richer, which is more valuable: a third car, yet another television, more clothing - or an extra year of life?"

Perhaps this should be added as a question to the next spate of Presidential debates?  Read More & Comment...

rahm emanuel's unsafe medicines act

11/04/2007 09:26 AM |

Rahm Emanuel wants a stand alone vote on drug importation. So do many erstwhile Republicans like Grassley who have made a mini-career terrorizing the public about the risks of unsafe drugs. How do they square their claim the FDA is unable to protect public against unsafe medicines with a GAO report that the FDA can event inspect the overseas facilities that would import the medicines that Grassley et al assert the FDA is in a position to certify as safe?

Audit: FDA hampered in review of imported drugs

"By Douglas Stanglin, USA TODAY
The Food and Drug Administration can't adequately inspect foreign drug manufacturers because its database is so outmoded it doesn't even know how many foreign firms are shipping drugs to the United States, a government watchdog group and former FDA officials told Congress on Thursday. "

Grassley and Emanuel couldn't be playing politics with drug safety? Neither could AARP or Consumers Union who lead the charge against Kennedy Enzi because it claimed it was too lax and who supports drug importation. Of course not!! The common theme of course: screw drug companies no matter what the impact on patients or the public health because it scores political points.

http://www.usatoday.com/news/health/2007-11-01-fda-imports_N.htm  Read More & Comment...

New Drug Approvals Down

11/02/2007 02:35 PM |

Spending on medicines is down and the number of new drugs reaching the market is declining as well. No one wants to acknowledge the while a cautious FDA is part of the problem the overarching challenge facing industry -- and us -- is just how new all the targets current drug development targets are and how difficult it will be to personalize or tailor treatments to specific groups of patients. And the tools for doing so and improving the preventive capacity of next generation drugs will be snatched from companies if the industry's enemies get their way and blow up the Critical Path before it even gets started. The campaign of disinformation regarding the goals of the Critical Path and the science behind still shocks me. The ideological hatred borders on a psychological disturbance.  Read More & Comment...

Congresswoman DeLauro: Mislead By Goozner and Gang on Reagan Udall

11/01/2007 02:23 PM |

Where did Cong. Rosa DeLauro get her ban the Reagan Udall idea from?...And where did she get the idea that biomarkers are somehow a source of inferior science? this from Kaisernet...

" FDA seems to be moving "with unusual speed" to organize a private-public foundation to help support the agency, and some critics are saying the initiative might be "little more than a front for the industries it regulates," CQ Today reports. The group, known as the Reagan-Udall Foundation, was established in the FDA reauthorization legislation, which President Bush signed into law Sept. 27.

The 14-member board of the foundation must include three academics, two consumer advocates, one health care provider, four industry representatives and four "at-large" members with "experience relevant to the purpose of the foundation." While five of the nominees will be chosen by FDA, some critics are concerned the at-large seats will be filled by industry representatives (Adams, CQ Today, 10/2). FDA began taking nominations on Wednesday (Edney, CongressDaily, 10/3).

The foundation largely will be financed through private donations, including those from food, pharmaceutical and medical device companies, according to CQ Today (CQ Today, 10/2). It is meant to help fund research to modernize the agency, according to CongressDaily.

Critics are concerned that if drug makers gain too much influence on the foundation, the resulting criteria established for evaluating products could be excessively industry-friendly. Merrill Goozner, head of the Center for Science in the Public Interest's Integrity in Science Project, said, "The last thing you want is an industry-run board in which they create a science-sounding rationale before they put the FDA rubber stamp of approval on something that hasn't been proven." Diana Zuckerman, president of the National Research Center for Women & Families, said, "You have a situation where most of the money will be from (industry groups) -- they're going to control the board and therefore they're going to control the executive director, staff and the research."

http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47990

Shame on Goozner and the rest for deliberately misleading Del Lauro and the media on what biomarkers do and can offer people in terms of safer drugs. I was there at Critical Path conference he blogged on when Janet Woodwock patiently explained the difference between a surrogate endpoint (cholesterol levels) and genetic markers that are predictive of disease progression or drug response. He is either dumb or manipulative. Or both. Here's what the FDA recently said in a guidance on drug-induced liver toxicity regarding biomarkers:

"As part of the Critical Path Initiative, 3 the FDA is working with industry, academia, and other experts to broaden our understanding of the biochemical and genetic bases of DILI. In June 2006, the FDA co-sponsored a scientific workshop to determine the feasibility of developing a mathematical (in-silico) model for DILI from which other predictive experimental models can be derived to characterize potential hepatotoxicity. The long-term goal is to develop a model, or models, that can help researchers identify criteria for determining when early clinical intervention (i.e., stopping the drug) is appropriate. It is also hoped that predictive bioassays and biomarkers can be identified that will help determine which patients most likely will suffer liver toxicity from specific compounds.

This urgently needed research is not a regulatory requirement, but is an important opportunity. At present, we are able only to search among patients with drug-induced injury to predict what might happen to others. Ideally, we should seek to identify individuals at increased risk before administering a drug that they cannot tolerate. The goal is to be able to identify persons who should never be exposed to a given drug because they are idiosyncratically hypersusceptible to, or unable to recover from, DILI caused by it. If tests that screen for people susceptible to severe DILI can be developed, a hepatotoxic drug could remain available to people who are not susceptible to severe DILI, instead of having to withdraw the drug from the market, allowing no one to benefit from it.

* In addition, identification of common genotypic characteristics among patients experiencing DILI in response to one or more class-related hepatotoxic agents might permit the development of in vitro or ex vivo tests or genetically altered animal strains that can be used to better predict serious hepatotoxic potential, or the lack thereof, of new drugs belonging to the same or closely related classes. "



Yeah, I guess a foundation that will develop tools designed to screen drugs for safety and effectiveness based on genetic markers and standardize that approach for evaluation is a bad thing. Even worse to have the companies themselves foot the bill.

I give DeLauro a pass for not knowing enough in this instance. (Note to the FDA: Hie thee to Rosa's office for a briefing on what's what. ) Not so Goozner and Zuckerman. Anyone can be wrong. Only idiots persist in their errors. Or miscreants.  Read More & Comment...

What if we called it the "Reagan/Udall/DeLauro Foundation?"

11/01/2007 02:11 PM |

Rosa L. DeLauro. The "L" stands fro "Luddite." Consider this press release that just crossed our desk:

Washington, DC – Congresswoman Rosa L. DeLauro (Conn. – 3), as part of an on-going effort to ensure that science – and not industry interests – informs decisions within the Food and Drug Administration, sent a letter to Dr. Andrew von Eschenbach, FDA Commissioner, expressing concern about the Reagan-Udall Foundation and seeking information about its creation.

“While the intended goals of the Reagan-Udall Foundation are worthy, given that it will be funded primarily by pharmaceutical companies, the FDA would be responsible for ensuring that the Foundation does not further increase the industry’s influence within the FDA,” DeLauro wrote. “Although the mission of the foundation is intended to support research that encourages an expedited FDA approval process, I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.”

We have previously commented on such absurdity on October 15th ("Concerned Scientists") and again on October 17th ("Critical Wrath").

And, yes, this is same Rosa DeLauro who spoke so passionately in favor of H.R. 2693, The Popcorn Workers Lung Disease Prevention Act.

What else can be said?  Read More & Comment...

Hey, I Thought Big Pharma Was Unstoppable....

11/01/2007 01:42 PM |

If you took the industy's more strident, conflicted and ideologically motivated critics at face value (Avorn, Wolfe, Nissen, Angell, Kassirer,Relman, Goozner, Consumers Union, Families USA/Soros, etc. )...the FDA is a rubber stamp, user fees are payoffs that turned the agency into a lapdog for instant approvals of every unsafe and ineffective medicine, marketing is just a series of bribes to doctors to prescribe useless drugs when generics are available...and companies could price every new drug at higher and higher prices.

Oh wait, drug approvals are at an all time low and generic drug use is at an all time high.

If this group was right these would be the best of times because they are uncontrolled monopolies with endless power. Of course if this group was right, kids would not be dying from underuse of SSRIs and VA patients would not be dying sooner than seniors in Part D.

But everything has limits and goes through cycles. Science, competitive strength, even the intelligence of the critics. Check that. Some things never change. To paraphrase Fred Allen, every time they open their mouths they subtract from the sum of human understanding.  Read More & Comment...

Illegal, Unsafe, and More Expensive

11/01/2007 09:41 AM |

FDA Says Consumers Continue to Buy Risky Drugs Online
Self-medication a concern; FDA-approved generics may be cheaper alternative

A yearlong U.S. Food and Drug Administration (FDA) investigation into drugs mailed to the United States from foreign countries suggests that consumers may be buying drugs online to avoid the need for a prescription from their physician. The FDA sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drug products bought over the Internet.

The investigation found 88 percent of the 2,069 drug packages examined appeared to be prescription medicines available in the United States. Of the remaining products, some were dietary supplements, some were foreign products with labeling that was illegible or incomprehensible, and some were medications not available in the United States. More than half (53 percent) of the products sampled have FDA-approved generic versions, likely sold at lower costs, according to earlier studies that have shown generics in the United States to be generally cheaper than a comparable drug in Canada or Western Europe. In fact, approved generic versions of approximately half (47 percent) of the sampled products can be bought for $4 at several national chain pharmacies, a price often lower than the shipping costs for the same drugs purchased online.

"The data lead us to believe that many people are buying drugs online not to save money but to bypass the need for a prescription from their doctor since these Web sites typically do not require the purchaser to have a prescription," said Randall Lutter, Ph.D., FDA's deputy commissioner for policy. "In essence, they seem to be getting and using prescription drugs without a prescription, an intrinsically risky practice."

These data are based on surveys conducted from September 2006 to August 2007 in international mail facilities and courier facilities across the country. At each city, all parcels suspected by customs and border patrol of containing pharmaceuticals were stopped for a period of 24 hours. FDA then recorded data on the contents of these parcels, before handling them in accordance with its usual procedures.

In general, a Web site can appear legitimate, but in fact be a front for an illegal operation. FDA urges consumers to beware of unregulated Internet drug sellers, because many of their products might not contain the correct ingredients and could contain toxic substances. Several drugs found in this survey require special monitoring by physicians or other health care professionals for potential adverse events and to ensure their effectiveness. These include antibiotics, antidepressants, the blood thinner warfarin, and levothyroxine (a thyroid replacement hormone).  Read More & Comment...