Mania vs. Measure

05/04/2007 07:13 AM |

In recent weeks, several state legislatures have been working feverishly to remove perceived potential conflicts of interest between doctors and pharmaceutical companies. Citing transparency as their goal, state lawmakers in Vermont, Minnesota, New York and elsewhere have passed “marketing-disclosure” laws that require drug companies to divulge all payments made to doctors.

These directives have arisen amid accusations that drug manufacturers have usurped the FDA process, essentially paying doctors to get their drugs on the market before a drug’s safety can be guaranteed.

Imagine if the scientific community had ignored Louis Pasteur’s research on bacteria and fermentation simply because he had received funding from the wine industry. Science would have been set back immeasurably, and you might not be able to buy safe, pasteurized milk in your local supermarket today. Talk about food safety!

The rest of the story can be found at http://www.projo.com under "Opinion." (It's the Providence Journal.)

Have a nice weekend.  Read More & Comment...

A New Deputy in Town (at HHS)...and a new CMS Director

05/03/2007 03:43 PM |

The President intends to nominate Tevi David Troy, of New York, to be Deputy Secretary of Health and Human Services. Dr. Troy currently serves as Deputy Assistant to the President for Domestic Policy. Prior to this, he served as Special Assistant to the President and Deputy Cabinet Secretary. Earlier in his career, he served as Deputy Assistant Secretary for Policy at the Department of Labor. Dr. Troy received his bachelor’s degree from Cornell University and his master’s degree and PhD from The University of Texas at Austin.

Anyone who knows Tevi knows that HHS has gained a great public servant and staunch Yankee fan.

Kerry Weems replaces Leslie Norwalk as CMS Administrator.  Read More & Comment...

The Global View of FDA Reform

05/03/2007 09:11 AM |

Biotech entrepreneuers from India, China, Brazil don't talk about breaking patents, price controls, hating big Pharma...none of the junk that fills the time and effort of the NGOs whose efforts among to -- in the words of one participant "a rounding error" in the war against disease. Rather, it is all about partnerships, raising capital, IP protection and most important...harmonization of regulatory standards with the FDA's Critical Path efforts.

I cannot tell you what excitement the Critical Path effort has stirred among many of the start ups here. The idea of shortening development times, micro-dosings, using biomarkers for toxicity studies, being able to submit a single application to a single standard is the single most important barrier to the development of products for unmet global health needs. Note to the FDA, the Critical Path needs to go global to rev up the global health revolution. Companies overseas DO want to import medicines to the US, but ONLY if they are safe, effective and valuable.  Read More & Comment...

Smart, Timely, Urgent FDA Reform

05/03/2007 06:30 AM |

Our view on the Senate debate over FDA reform: "Bolster medicine safety"

Thoughts and comments most welcome. Now's the time to make a difference.  Read More & Comment...

How about generic drugs from Canada?

05/02/2007 04:41 PM |

New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.

"This report pinpoints the barriers that are limiting the availability of additional generic drug options," said Gary Buehler, R.Ph., director, FDA's Office of Generic Drugs. "We hope these findings will encourage research collaboration, lower these barriers and accelerate access to safe and effective generic drugs."

Before they can be approved, generic drugs must have the same active ingredient, dosage form, strength, and conditions of use as the brand name drug. The drugs must also be absorbed at the same rate and in the same amount, a concept known as bioequivalence.

While straightforward tests of blood plasma levels are sufficient to demonstrate bioequivalence for most generic drug candidates, these common tests generally are not appropriate for certain drugs, including asthma inhalers, nasal sprays, and topical skin applications such as anti-fungal creams. As a result, few generic versions are available in these product categories, resulting in less competition and higher prices.

For example, generic drug products that contain the ozone-depleting substance chlorofluorocarbon will be withdrawn from the market after 2008. The new report will help ensure FDA has an adequate scientific basis to review inhaler applications that use an alternative, hydrofluoroalkane.

The report also calls for research on new bioequivalence methods tailor-made for each challenging drug class. These include lung function tests and molecular level imaging for inhalation drugs; particle size distribution tests for nasal sprays; and methods for direct measurement of drug delivered to the skin.

In addition, the report highlights possible research projects that might lead to new modeling and simulation tools for drug absorption, drug release and other drug development issues and to alternative methods for seeking waivers from clinical bioequivalence studies.

Last year FDA issued the Critical Path Opportunities Report listing 76 specific scientific projects that, if undertaken, would help modernize the Critical Path sciences. This companion document focuses more narrowly on the scientific challenges unique to the development of generic drugs.  Read More & Comment...

Dorgan Organ III

05/02/2007 01:48 PM |

Important to point out that the Dorgan Amendment would allow importation from Canada, Switzerland, New Zealand, Australia, Japan.

And the EU -- "but does not include a member country with respect to which the country's Annex to the Treaty of Accession to the European Union 2003 includes a transitional measure for the regulation of human pharmaceutical products that has not expired."

Nice try. Parallel trade makes the entire EU a free trade zone when it comes to pharmaceuticals. Consider the over 20% of drugs sold in Great Britain that originate in other, lower cost parts of Europe like Greece and Portugal, Latvia and Estonia.

Senator Flickertail's amendment also demands that approved nations "have statutory or regulatory requirements that require the review of drugs for safety and effectiveness by an entity of the government of the country."

Folks, "requirements" can mean a lot of things from nation to nation. What actually happens can be something altogether different.  Read More & Comment...

heart attack death rate

05/02/2007 12:06 PM |

it is hardly suprising to those of us who have watched cardiovascular advances up close in the clinical trenches to find out that the hospital death rate from heart attack or the incidence of severe heart failure is down by almost half. And though we should applaud this affirmation, we shouldn't be derailed from a larger point that death rate is not the only issue. We have known for a long time that patients feel better after angioplasties and stents, and we have seen the medications work to relieve symptoms and stabilize patients. It isn't just a question of survival - it's also a question of survive how? It may be a subtle point, but if we applaud the lower death rate statistic too much, it may undermine the point that this isn't the only criteria for gauging medical success, even if it is an easy thing to measure.  Read More & Comment...

Patents, Patience, Profits & Public Health

05/02/2007 10:07 AM |

Further thoughts on the recent Supreme Court decision on patents, "obvious" innovation, and incremental innovation.

According to the Center for the Study of Drug Development at Tufts University, only 1 in every 5,000 compounds screened becomes an approved medicine. This means of every 5,000-10,000 compounds tested, only 250 enter pre-clinical testing, five into clinical testing and only one achieves FDA approval. Without financial incentives and intellectual property protection, no company, even ones with the most benevolent motivations, would find it feasible to develop new, innovative, lifesaving and life enhancing-products for consumers.

Allowing the private sector to bear both the risk and the reward for successfully developing pharmaceutical, biologic, and medical device products has been and remains the most successful and efficient way to meet our public health goals

Competition among companies, both here in the U.S and abroad, assures a diversity of expertise in various diseases. This competitive model assures that, when a public health crisis is identified, there will be an available pool of talent, experience, and infrastructure to give us enhanced opportunities to successfully identify and produce cures and vaccines in an expedited timeframe.

"Obvious?" Hopefully.  Read More & Comment...

Dorgan Organ II

05/02/2007 09:28 AM |

Flickertail Senator Byron Dorgan continues to pursue his unworkable, unsafe, unwise and, well, just plain foolish amendment on drug importation.

What he should do is spend a few minutes on the FDA website, where he would find this new safety alert ...

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers

The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet. This alert is being issued based on information the agency received showing that 24 apparently related Web sites may be involved in the distribution of counterfeit prescription drugs.

On three occasions during recent months, FDA received information that counterfeit versions of Xenical 120 mg capsules, a drug manufactured by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers from two different Web sites. Xenical is an FDA-approved drug used to help obese individuals who meet certain weight and height requirements lose weight and maintain weight loss.

None of the capsules ordered off the Web sites contained orlistat, the active ingredient in authentic Xenical. In fact, laboratory analysis conducted by Roche and submitted to the FDA confirmed that one capsule contained sibutramine, which is the active ingredient in Meridia, an FDA-approved prescription drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and maintain that loss, it should not be used in certain patient populations and therefore is not a substitute for other weight loss products. In addition the drug interactions profile is different between Xenical and sibutramine, as is the dosing frequency; sibutramine is administered once daily while Xenical is dosed three times a day.

Other samples of drug product obtained from two of the Internet orders were composed of only talc and starch. According to Roche, these two samples displayed a valid Roche lot number of B2306 and were labeled with an expiration date of April 2007. The correct expiration date for this lot number is actually March 2005. Pictures of the counterfeit Xenical capsules provided by Roche can be viewed at http://www.fda.gov/bbs/topics/news/photos/xenical/html

Roche identified the two Web sites involved in this incident as brandpills.com and pillspharm.com. Further investigation by FDA disclosed that these Web sites are two of 24 Web sites that appear on the pharmacycall365.com home page under the "Our Websites" heading. Four of these Web sites previously have been identified by FDA's Office of Criminal Investigations as being associated with the distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from outside of the United States. Consumers should be wary, if there is no way to contact the Web site pharmacy by phone, if prices are dramatically lower than the competition, or if no prescription from your doctor is required. As a result, FDA strongly cautions consumers about purchasing drugs from any of these Web sites which may be involved in the distribution of counterfeit drugs and reiterates previous public warnings about buying prescription drugs online.

Senator Flickertail -- you can't be for safety and against it at the same time.  Read More & Comment...

I Guess All Those Industry Sponsored Studies Were Right ...

05/02/2007 08:40 AM |

As Peter points out below, a new study shows that all those people who are taking medicines based on research conducted by researchers corrupted by Big Pharma about the drugs developed by Big Pharma based on clinical trials skewed by Big Pharma and it's cozy relationship with the FDA are not dying from heart attacks as often as before.

But maybe the study is skewed.

Or as Groucho Marx said: "Either this man is dead or my watch has stopped ticking."  Read More & Comment...

Wow! Indeed

05/02/2007 08:10 AM |

Got an e-mail this morning with a one word subject line, "Wow!"

And "wow" it was. And "wow" it is.

In just six years, death rates and heart failure in hospitalized heart attack patients have fallen sharply, most likely because of better treatment, the largest international study of its kind suggests.

The promising trend parallels the growing use of cholesterol-lowering drugs, powerful blood thinners, and angioplasty, the procedure that opens clogged arteries, the researchers said.

“These results are really dramatic, because, in fact, they’re the first time anybody has demonstrated a reduction in the development of new heart failure,” said lead author Dr. Keith Fox, a cardiology professor at the University of Edinburgh.

The six-year study involved nearly 45,000 patients in 14 countries who had major heart attacks or dangerous partial artery blockages. The percentage of patients who died in the hospital or who developed heart failure was nearly cut in half from 1999 to 2005.

And the heart attack patients treated most recently were far less likely to have another attack within six months of being hospitalized when compared to the patients treated six years earlier -- a sign that the more aggressive efforts of doctors in the last few years are working. There have been other signs that better treatment of heart patients has been saving lives, but not on a scale as large as this international study, the researchers said.

“It’s much more dramatic than we expected, in the course of six years,” Fox said.

The study appears in Wednesday’s Journal of the American Medical Association. It was funded by a grant from Sanofi-Aventis, maker of several heart drugs including Plavix and ACE inhibitors. Fox and several other authors reported getting fees and grants from Sanofi and other drug makers.

Dr. Steven Nissen, former president of the American College of Cardiology and a Cleveland Clinic heart specialist, said the study doesn’t prove the recommended treatments were saving lives but he suspects that’s the case.

“I really am encouraged that those things that appear in our guidelines are being used by physicians around the world,” Nissen said.

Here's a link to a more complete report:

http://www.msnbc.msn.com/id/18417962/from/ET/

And, for your chuckle of the morning, remember the words of Robert Bloch,

"I have the heart of a child. I keep it in a jar on my shelf."  Read More & Comment...

Taking NGO Rhetoric With a Grain of Salt

05/02/2007 08:02 AM |

Blogging from the conference on Mobilizing the Private Sector of Global Health Development....C.K. Prahalad, Prof. University of Michigan drops a bombshell at the beginning. " We can save the lives of millions of children in India if we increase the consumption of iodized salt instead and improving health care delivery systems in small ways through small steps with the private sector rather than focusing on making breakthrough medicines affordable. " Using market systems, we can make anti-bacterial salt, iodized salt, water available and affordable and achieve a huge return on health care dollars to obtain a greater quality of life. Innovation in distribution, education, collaboration is perhaps more important. There is a $5 trillion market comprised of people living on less than $3000 per capita using these products. Pharmaceuticals make up about $100 billion (have to check that since I am writing so fast!) Moreover, the poor are upwardly mobile and willing to adopt technologies, they are not Luddites. They can make complex decisions. The poor are NOT too stupid to choose as liberals would believe.

Also: "All those free medicines are not so free. When people go to those public clinics they have to pay for them. Let's be honest. That's an unspoken truth."

I wonder what MSF, Oxfam, etc would say to that?  Read More & Comment...

Tainted Pet Food: Not Just Chicken Feed

05/02/2007 06:13 AM |

Has anyone drawn the connection between tainted pet food and counterfeit drugs? Anyone? Anyone? There has got to be a quote from Sens. Dorgan, Stabenow, etc.. and all those from the ag states denouncing the FDA for lax inspection...the same bunch who assure us the agency can fan out across the globe monitoring all the various distributors and wholesalers or can assure safety by just inspecting their papers. I mean, after all, no one died from the pet food scandal, right? As Bernie Sanders would say, show us the dead bodies.  Read More & Comment...

the "care" in health care

05/02/2007 05:57 AM |

My article in yesterday's Wash Post was about the need for good doctors to remain true to their professionalism, and practice quality medicine based on committment rather than price. This is becoming rarer, but it is not yet so rare that i wasn't able to find some true artists among those i interviewed. It's interesting to me that so many want "bottom-line thinking" when it comes to medicine, with detached robot-like practitioners, but would never make that mistake with their airlines or cars. I have a Miele dishwasher that never breaks. Why would i trade it in for a GE? The best doctors not only put their professionalism and committment first, they also practice a higher level of care. It is hard to study that, but it is true nonetheless.

http://www.washingtonpost.com/wp-dyn/content/article/2007/04/27/AR2007042702620.html?hpid=sec-health  Read More & Comment...

Comparative Obviousness

05/01/2007 02:33 PM |

The Associated Press reports that. “In a unanimous ruling, the justices said a federal appeals court has gone too far in embracing a standard that addresses one of the most basic issues in patent law: whether a claimed invention is obvious and therefore unworthy of patent protection.”

Justice Anthony Kennedy wrote.

"Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress and may ... deprive prior inventions of their value."

The case in front of the high court was KSR International Co. v. Teleflex Inc. The issue -- a patent for adjustable gas pedals.

The issue, needless to say, transcends this particular innovation.

To again quote the AP, “The legal test at issue in the Teleflex lawsuit has been criticized by the Bush administration as leading to an unwarranted extension of patent protection to claimed inventions that are obvious. Critics of the test say it results in less competition and stifles innovation.”

Adjustable gas pedals are one thing. 21st century medicines are something else entirely – something else with important implications for the future of the public health.

And it’s not good news.

Here’s the rub – what’s “real innovation?” What does “obvious” mean? And what does it mean when one considers the concept of pharmaceutical incremental innovation.

All of a sudden it’s not so obvious.

Let’s face it; there are precious few “Eureka!” occasions in healthcare. Progress is made step-by-step, one incremental innovation at a time. And those incremental innovations require extensive research and are expensive. But, boy, are the important. Why? Because that’s how health care progress is made – not through Hollywood-style “Aha!” moments so popular with politicians and pundits. Obvious? Hardly.

The reason the high court’s ruling is so profoundly disturbing to the future of pharmaceutical innovation is because now it becomes not a leap but a small step to mindless support for healthcare technology assessment aka evidence-based medicine aka comparative effectiveness. After all, if we don’t recognize the concept of incremental innovation as “obvious” – as progress worthy of patent protection – why should we pay for it?
Indeed, why even pursue it? Yikes.

And what’s the alternative -- Jamie Love’s concept of replacing pharmaceutical patents with a “prize” system wherein the government pays an innovator a lump sum amount for its innovation (based on some measurement of the newfangledness) that is then placed in the public domain?

And what might such a measure be? Most likely comparative effectiveness information that misuses and misrepresents data derived from RCTs.

The “prize” model has been used in the past – in the old Soviet Union. It didn’t work. The Soviet experience was characterized by low levels of monetary compensation and poor innovative performance. The US experience isn’t much better. The federal government paid Robert Goddard (“the father of American rocketry”) $1 million as compensation for his basic liquid rocket patents. A fair price? Not when you consider that during the remaining life of those patents, US expenditures on liquid-propelled rockets amounted to around $10 billion.

One wonders if the new Supreme Court ruling would allow that Dr. Goddard’s patent reached the level of “obvious” innovation. But we'll leave the alternative history lesson for another day.

Now consider the fact that Mr. Love’s idea is going to be introduced in federal legislation by the new Socialist Senator from Ben & Jerry’s, Bernie Sanders. Frighteningly, not so fantastical after all.

As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) presciently observed in 2004, “The main beneficiaries in the short-term would be private insurers and public sector purchaser of pharmaceuticals … Governments and insurers are focused myopically on managing health care costs. They are not likely to be strong advocates for funding new drug development that can increase individual quality of life and productivity."

Sound familiar?

To again quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.”

Obvious? Obviously not.  Read More & Comment...

Penelope's Fight For Life

05/01/2007 02:24 PM |

Geeta Anand has a nice piece about the struggle to get a dying child access to an experimental drug. The only problem is that the people she gives credit for supporting the family in pressuring the small start up - Nancy Pelosi -- supports the sort of fear mongering, lawsuits, price controls and FDA fearmongering that make small biotech start ups reluctant to take a risk on a potentially dangerous drug with a dying child.

Still, the article underscores the moral clarity and durability of the Abigail Alliance's position on access to experimental medicines. Some may not agree with the Tiered Approval process but I predict that Frank Burroughs and co. will be victorious. Science and sense of purpose are behind him. While some may believe that patients, companies and the FDA working together is too "cozy", I believe it should be common practice. We need more Frank Burroughs and we need more miracles of medicine.

http://abigail-alliance.org/  Read More & Comment...

Setting The Sights on Science

05/01/2007 01:37 PM |

Andy von Eschenbach is doing the smart and right thing by reaching to a group of academics and industry researchers to see if the FDA's science is up to snuff. It sets the stage for future collaborations and funding requests. Asking Gail Cassell, who was on my FDA Task Force when I was at the Manhattan Institute, to chair this group signals that the FDA is serious. Dr. Cassell is brilliant, well-respected and has taken on a similar task with respect to biodefense issues. What's more, she provides badly needed support to Janet Woodcock to make the review staff at the agency more Critical Path conscious. Look for an overhaul and upgrade of folks who do not want to embrace biomarkers, adaptive trials, Bayesian analyses, etc.

PS...Jacob Goldstein's health blog at wsj.com is great....

http://blogs.wsj.com/health/2007/05/01/fda-science-under-the-microscope/  Read More & Comment...

The Brown Jewels

05/01/2007 10:29 AM |

Senator Sherrod Brown's comment that "the pharmaceutical industry’s 3000 lobbyists oppose S.1082," is just another indication of how entirely politicized the debate over FDA reform has become. This is the latest in a series of hyperbole-driven statements aimed at to garner media attention by slamming the pharmaceutical industry. And truth be damned.

(Attention Senator Brown -- the last time I looked, industry was generally supportive of the bill.)

What we need are thoughtful and insightful comments that advance the cause of FDA reform and, more broadly speaking, the public health -- not more bloviation and grandstanding.  Read More & Comment...

Live Free or ... ?

05/01/2007 07:21 AM |

CONCORD, N.H. -- A federal judge on Monday struck down a state law that makes doctors' prescription-writing habits confidential, saying it violates the First Amendment.

Good call.

Whether or not physician-prescribing data should or shouldn’t be available for marketing purposes is one thing, but the most important thing to remember is that there are important public health reasons why this data must continue to be shared with pharmaceutical companies.

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

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

According to the American Medical Association (AMA), “Restrictions on the use of prescription information will disrupt health care research and its corresponding benefits for patients, government agencies, health planners, academicians, businesses and others.”

In July, the AMA launched a new web-based program specifically designed to address physician concern over inappropriate use of prescribing information. Known as the Prescribing Data Restriction Program (PDRP), the program also ensures that prescribing data remains available for all the reasons previously mentioned. In fact, all companies that purchase data from the AMA will be contractually required to adhere to the PDRP program.

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

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

Northern Exposure: Canadian Seniors Get Less Coverage Than American Counterparts

04/30/2007 11:35 PM |

http://www.wardhealth.com

From Ward Health Strategies....

Access to Innovation

American seniors have better access to prescription drugs under Medicare Part D plans than Canadian seniors under Canadian publicly funded drug plans.

Under Medicare Part D, access to publicly funded drug benefits is now better in the United States than in Canada. American seniors, enrolled in a Medicare drug plan get better access to new medicines than Canadian seniors who rely on publicly funded drug benefits. In Canada, only 42 percent of the 33 drugs assessed by Canada’s Common Drug Review (CDR) were recommended for listing at the end of 2005.

But only 15 percent of the 33 drugs assessed by the CDR by the end of 2005 drugs were listed in Ontario as of January 1, 2006. On average, less than one in four drugs (21 percent) reviewed by the CDR has been listed for reimbursement by participating provincial drug plans. Quebec, which does not participate in the CDR, lists 55 percent of these 33 drugs.
By comparison, 82 percent of these same 33 drugs are listed in U.S. Medicare drug plans.  Read More & Comment...