Strip Search

08/16/2007 08:19 AM |

China Counterfeit Diabetes Tests Tracked by J&J

By Allan Dodds Frank and Lisa Rapaport

Aug. 16 (Bloomberg) -- A global manhunt launched by Johnson & Johnson has tracked to China counterfeit versions of an at-home diabetes test used by 10 million Americans to take sensitive measurements of blood-sugar levels.

Potentially dangerous copies of the OneTouch Test Strip sold by J&J's LifeScan unit surfaced in American and Canadian pharmacies last year, according to federal court documents unsealed in June. New Brunswick, New Jersey-based J&J, the world's largest consumer-health products maker, learned of the counterfeit tests after 15 patients complained of faulty results last September.

Tipped off by J&J, the U.S. Food and Drug Administration issued a nationwide consumer alert in October without disclosing the link to China. While no injuries were reported, inaccurate test readings may lead a diabetic to inject the wrong amount of insulin, causing harm or death, the agency said. Fake medicines are a $32 billion global business, says the World Health Organization, and the FDA says it ran 54 counterfeit investigations in 2006, almost double the year before.

"Growth in counterfeit medicines and devices is probably the biggest health threat besides infectious disease,'' says Peter Pitts, director of the Center for Medicine in the Public Interest in New York and formerly an FDA official investigating knockoff drugs.

The court filings disclose, for the first time, that China is the source of about one million phony test strips that have turned up in at least 35 states and in Canada, Greece, India, Pakistan, the Philippines, Saudi Arabia, and Turkey.

`China, Through Canada'

``The source was from China, through Canada, to the United States,'' says Steven Gutman, director of the Office of In Vitro Diagnostic Devices and Evaluation at the FDA in Rockville, Maryland. ``As far as we can tell, the counterfeiter has been put out of business in the U.S.''

KEY PHRASE: “As far as we can tell …”

TRANSLATION: Nobody has been caught and they are still very likely in business.

Here’s a link to the rest of the story:

http://www.bloomberg.com/apps/news?pid=20601103&sid=a5XA7.yplw9k&refer=news

Kudos to J&J for aggressively investigating and openly communicating -- and being loud and proud about the quality of the real product.  Read More & Comment...

Would you like some beef with that whine?

08/15/2007 08:50 PM |

Where oh where would some people be if they didn't have the trial bar and the NEJM to give them a platform.

http://content.nejm.org/cgi/content/full/357/7/633?query=TOC  Read More & Comment...

Innovation vs. Importation. Pick One.

08/15/2007 04:49 PM |

And while we're on the topic, check out the new paper "Importation and Innovation," by Columbia University's Dr. Frank Lichtenberg. You can find the paper at this link ...

http://www.nber.org/papers/w12539

For those of you (yes, you Senator Dorgan and Senator Snowe and you Representative Emerson and Representative Emanuel) who think that drug importation is a good idea -- think again.

Think about the unintended consequences of a world without pharmaceutical innovation.  Read More & Comment...

Small Business. Small Minds.

08/15/2007 08:06 AM |

The National Federation of Independent Business (NFIB) has announced its support for the Pharmaceutical Market Access and Drug Safety Act (S. 242 / H.R. 380) to permit drug importation.

According to the NFIB, "Importation offers a means of reducing one of the most rapidly rising healthcare costs facing consumers today - spending on prescription drugs.”

Well, actually, the biggest costs to small business – and large business for that matter – are an aging workforce, an antiquated focus on acute care, and insurance premiums. For every dollar spent on health care in the U.S., only 11.5 cents is for prescription drugs. And medicines, properly prescribed, reduce healthcare costs by keeping people healthy, productive – and out of the hospital.

Consider this, from 1998 to 2003; insurance companies increased their premiums by an average of $104.62 per person. During that same time period prescription-drug costs increased by $22.48. What about the other $82.14? That’s a good question. And America deserves an answer.

The NFIB is thinking short term and being sold a false bill of goods. Here’s how …

"Today's NFIB endorsement reflects a clear consensus among America's small businesses that we must no longer pay the world's highest prices for prescription drugs," Senator Olympia Snowe (R-ME) said. The press release continues, stating that NFIB members “recognize overwhelmingly … that competition will help reduce drug costs and make health care more affordable for all Americans.”

Well, that’s a good point. But it depends what you mean by competition. When the rest of the developed world shackles costs via price controls placing almost the entire burden of pharmaceutical R&D costs on the backs of the American healthcare consumer. This is what members of Congress and the NFIB should be up in arms about.

And as far as “dramatically lowering” costs is concerned, the Congressional Budget Office Study has reported that such a program would reduce the drug spend in the US by less than one percent -- and that doesn't include the monies needed to set up an entirely new, international system for drug regulation.

Of course no such press release would be complete without a list of the usual suspects who support this bozo proposition, including the AARP, AFL-CIO, Consumer’s Union, and Families USA.

And here’s the biggest falsehood, “"The Pharmaceutical Market Access and Drug Safety Act secures a framework for the safe and legal importation of prescription drugs.”

Assure the safety of our drug supply? This is the biggest whopper of them all. How will our domestic medicines supply be "safer" when we open our borders to drugs from Estonia, Latvia, Malta, Greece, and Portugal -- to name only a few? Because that’s what S. 242 / H.R. 380 would allow since, for example, it would allow importation of drugs from the United Kingdom – which also means drugs from all of the 27 EU nations -- many of which have had their own supply chains infiltrated by counterfeits from Russia and elsewhere.

America’s small business owners deserve better, smarter Washington, DC representation.  Read More & Comment...

Abigail Force Winds

08/14/2007 08:42 AM |

The recent court decision by the full D.C. Circuit Court of Appeals (reversing an earlier decision by its own three-judge panel) ruled 8-2 against the Abigail Alliance for Better Access to Developmental Drugs' effort to enshrine as a constitutional right a patient's access to unapproved investigational (non-FDA-unapproved) medicines.

Now, before going any further, it's important to point out that there's been a lot of very heated rhetoric on both sides of the issue. And this shouldn't come as a surprise since this is, in the most literal sense, a matter of life and death.

But over-heated rhetoric generally means that each side demonizes the other and neither is listening.

Nobody believes expanded access to drugs under clinical investigation is a bad idea. That's precisely why, when I was at the FDA, we stopped calling such programs "compassionate use." That outdated phrase makes it sound like the FDA and/or any given pharmaceutical company is doing the patient a favor by "being compassionate." Now don't get me wrong, being compassionate is an admirable trait -- but allowing desperately ill patients into clinical trial programs shouldn't be an act of good will, it should be an act of civil society.

But there has to be oversight. There has to be a responsible body that sets rules. Libertarianism, when it comes to pharmaceutical safety, isn't in the best interests of the public health. Does that mean the status quo works? No.

The FDA has proposed changes to address this issue. Do they go far enough? No. Does that mean "expanded access" should morph into "total access" to experimental drugs? No.

In short, there is no black-and-white/right-wrong answer to this question. But that's not what many folks on both sides of the argument are saying.

The FDA needs to reconsider how it can broaden and facilitate expanded access to experimental drugs beyond the current state of affairs (and the state of pending rules). And the Abigail Alliance and their supporters need to keep up the pressure (legal and otherwise) -- but remember they must also work within the system.

Both sides want the same thing -- expedited expanded access programs. But name calling and bridge burning doesn't bring anyone closer together or experimental drugs to dying patients any faster.  Read More & Comment...

What Paris Hilton and the Commonwealth Fund Have in Common

08/13/2007 04:40 PM |

Paris Hilton told the media that her friend Nicole Ritchie, who will be heading to jail to serve 4 days for a DUI (this after a history of drug abuse) "will be the best mom ever."

The Commonwealth Fund tells us that single payer health systems provide the best health care to the happiest patients anywhere, according to the NY Times.

Except the next day we find out that the courts in the UK say it is just fine for NICE to keep on depriving patients dying of cancer and Alzheimer's access to new medicines. Yes indeed, that's an marker of excellent care.

And as if we needed another example of just how many intellectual underachiever clutter the field of health care policy we get 101 irrelevant and incorrect explanations about why the infant mortality rate in the US is higher than anywhere else. The NY Times citing Michael Moore (!) despaired about how crappy America's health care system is because we do such a lousy job of keeping babies alive -- which in turn drags down our life expectancy.

In fact, if we counted live births like other nations and simply withdrew care from low birth weight babies like the UK, Canada, Netherlands and other places our life expectancy would exceed everyone else. I guess that would make the folks over the Commonwealth Fund and the NY Times really happy which is more important than anything else in the whole wide world.

Let me spell it out: Moore/NYTimes/Commonwealth makes a big deal about how America’s infant mortality rates are lower than El Salvador’s. That is a lie. First, many countries such as France, Switzerland, El Salvador and others do not count the deaths of very small babies as live births which brings the total number of deaths down. Meanwhile American advances in medical treatment now make it possible to save babies who would have surely died only a few decades ago. Until recently, very low birth-weight babies - less than 3 pounds - almost always died. Now, some of these babies survive. While such vulnerable babies may live with advanced medical assistance and technology, low birth-weight babies (weighing less than 5.5 pounds) recently had an infant mortality rate 20 times higher than heavier babies, according to the very same World Health Organization.

The United States devotes about twice as much money keeping each infant alive as most other countries. In some Western countries, doctors do not tell parents when they are withholding care to a vulnerable infant. Still others, countries that offer the “free” universal healthcare such as Britain and Canada set a birth weight and gestational age below which no intensive care is offered. So our infant mortality rate is really a measure of how much we care and the lengths we go to keep vulnerable infants alive just as our cancer expenditures at the end of life are as well.

That applies with greater force to Cuba where infants who are born at less than 28 weeks, weighing less than 1,000 grams or measuring less than 35 centimeters are not counted as live births if they die within seven days. The communist system stressed the need to keep infant mortality low. And in Cuba today hospitals and medical staff face penalties (prison) if they reported increases. As a result, they sometimes report the deaths of babies in their care as miscarriages or stillbirths.

The rest of the Commonwealth Measures -- taken from survey data -- are process measures and highly subjective. Pure junk. Wonder why it ignored stuff like access to new drugs, cancer survival rates, mortality after by-pass surgery, treatment for high blood pressure, etc. Because those are meaningful clinical endpoints which reveal lousy performance in Europe relative to the US of A. Ditto, the comparative rates of increase in glucose and cholesterol levels in UK, France and the US. We are going down, they are going up for the most part. Medicine is doing something about disease either prevention or intervention.

Which is why when either Paris Hilton or the Commonwealth Fund weigh in on a serious subject you can expect a serious answer. Neither are serious. They are 24/7 publicity machines designed to advance one thing: themselves.  Read More & Comment...

Commonwealth of Nations

08/13/2007 09:16 AM |

On Sunday the New York Times ran a 1292 word jihad against the American healthcare system. The thesis of the editorial is that “Many Americans are under the delusion that we have the best health care system in the world” because, in the words of the Gray Lady, we lag "well behind other advanced nations in delivering timely and effective care.”

For its facts and figures, the Times largely relies on “the highly regarded Commonwealth Fund” that has “pioneered” comparative studies with other advanced nations.

Let’s pause for a moment and shed a little light on the Commonwealth Fund and their most recent (heavily touted) comparative study of national healthcare systems.

The “highly regarded” Commonwealth Fund is also the same “highly Liberal” Commonwealth Fund that has been consistently lobbying for a U.S. single-payor healthcare system. It’s also important to note that the “pioneering” comparative study the Times refers to failed to sample in rural areas internationally where health and access disparities show up. And even then, Americans did as well or better than less diverse and urbanized countries in getting prompt care.

Why didn’t the Times mention this? At over 1290 words it certainly wasn’t because of space constraints. It’s worth repeating the old maxim that “research is like a bikini – what it shows you is interesting, but what it conceals is essential.”

There are so many variables when it comes to healthcare. The Times mentions only the ones that fits its thesis. For our national newspaper of record (and on a Sunday, no less) it’s amazingly simplistic. According to the editorial, our system is bad and single payor systems are good. Almost like a print version of SiCKO penned by Paul Krugman on an off-day.

One point of discussion, conspicuous by its absence, is that Americans are the ones paying for global medical innovation. Indeed, what would survival rates for any number of diseases look like if a nation could only use medicines they helped pay to develop? This "disparity" is unfair to the American consumer and not sustainable. The rest of the world must accept its fair share of the burden for healthcarer R&D. Zero discussion of this by Andy Rosenthal and his associates.

Another issue absent from the Times editorial is the general state of healthcare record keeping from country to country. Perhaps the most polite way to address this issue is to say that it is uneven. And to allow the findings of the Commonwealth Foundation to drive the debate, while ignoring other, more detailed European-based research findings (such as those by Populus and the pan-European Stockholm Network) which point to significant dissatisfaction among EU citizens of single-payor nations on a wide swath of healthcare delivery issues is, well, curious.

But, most importantly, it’s crucial that we not allow slanted studies by folks at the Commonwealth Foundation or ill-considered propaganda like SiCKO to sucker us into believing that there is some universal “best” model for the delivery of healthcare – when what we really need to be debating is how to construct a healthcare system that provides the right care for the right patient at the right time. “Comparing” various national healthcare systems through poor research is as dangerous and fruitless as “comparing” the relative effectiveness of medicines using large scale population studies that weren’t designed for that purpose.

Unless, of course, you only want to use research that tells you what you want to hear.  Read More & Comment...

Transparency Does Not Reveal If You Are Full of It...

08/10/2007 08:32 AM |

Case in point...our favorite target, Steve Nissen. He is quite transparent --sort of -- about receiving all sorts of money from drug companies. But such transparency does not reveal his true biases. To wit we now see in print what many were telling drugwonks and the media, that his meta-analyses was a cherrypicking expedition designed to generate headlines but not establish a meaningful hypothesis ...

From the the online, early release of the Annals of Internal Medicine:

Uncertain Effects of Rosiglitazone on the Risk for Myocardial Infarction and Cardiovascular Death

George A. Diamond, MD; Leon Bax, MSc; and Sanjay Kaul, MD


"A recent, widely publicized meta-analysis of 42 clinical trials concluded that rosiglitazone was associated with an approximately 43% increased risk for myocardial infarction and an approximately 64% increased risk for cardiovascular death. The sensitivity of these conclusions to several methodological choices was not assessed. The meta-analysis was not based on a comprehensive search for all studies that might yield evidence about rosiglitazone’s cardiovascular effects. Studies were combined on the basis of a lack of statistical heterogeneity, despite substantial variability in study design and outcome assessment. The meta-analytic approach that was used required the exclusion of studies with zero events in the treatment and control groups. Alternative meta-analytic approaches that use continuity corrections show lower odds ratios that are not statistically significant. We conclude that the risk for myocardial infarction and death from cardiovascular disease for diabetic patients taking rosiglitazone is uncertain: Neither increased nor decreased risk is established."

http://www.annals.org/cgi/content/full/0000605-200710160-00182v1

Anyone care to do an analysis of how many times we called out Nissen in our blog as opposed to how many times his meta-analysis was challenged in the literature but NOT reported in the media? We are being chastised by small minds who are picking fights with us to generate page views. But that's another matter.

Now with respect to this idiotic proposal to require doctors to register every mug and pen with some Gift Registry (maybe the federal government can subcontract the work to Bed Bath and Beyond) let's just restate the obvious...there are many sources of money and many sources of bias. So let's require every doctor, every pharmacist, every epidemiologist, every researcher to list every gift, every speaking engagement, every grant, every affiliation, every incentive, every cash bonus, ever expert witness retainer, every consulting agreement with any foundation, non-profit organization, any voluntary or political affiliation that may be a source of or give an appearance of conflict.

So for example, providing consulting services to members of Congress of one political party should be listed. The sames goes if you are providing consulting services or expert witness services to the plaintiff group suing Eli Lilly regarding the weight gain from Zyprexa. That's you Dr. Furberg. If you are on a board or participate in programs that receive money from the trial bar like Jerry Avorn, you should disclose that. And if you receive money from George Soros and sit on the board of the the liberal Commonwealth Fund and work with the Prescription Project which gets it money from suing drug companies if you serve on an IOM panel looking at drug safety like David Blumenthal, you should disclose that too. Oh, and if you are a blowhard like Sid Wolfe you should have no problem at all detailing just how much cash you get from the trial bar, disclosing if you or the state PIRGs receive any money at all for consulting or working with or for other organizations in advancing legislation at the state level to impose this disclosure restrictions on doctors but not yourself ...  Read More & Comment...

Duck and Cover

08/09/2007 02:43 PM |

Senator Grassley is proposing legislation that would have pharmaceutical companies disclose payments made to physicians for just about eveything. The Senator wants "transparency."

And transparency is a good thing.

Should Big Pharma be disclosing payments or should the burden of transparency be on the physician? Good debate. But here's a bigger question -- if transparency is a good thing when it comes to Big Pharma's payments to doctors, how about transparency for everyone else paying docs in order to influence their prescribing habits?

Specifically, where is the transparency when it comes to the payments insurance companies provide to physicians for switching their patients from brand name to generic medicines?

It's not in the Grassley bill.

Or what about transparency regarding how some state governments are leveraging a physician's prescribing habits via state regulations?

Also not in the Grassley bill.

It seems the Grassley is always greener when it comes to slamming Big Pharma -- but that everyone else with an open wallet (or a tight wallet in the case of state governments) gets a free pass.

If transparency is good for the goose then it's good for the gander.  Read More & Comment...

The Left Against the Public Health

08/09/2007 01:30 PM |

Great piece in the South China Post by Jerry Norris of the Hudson Institute on how the left, again, will let poor people die in order to kill drug companies and capitallism. I guess that's their version of a trade off.

It's politics vs science in global health

July's meeting of the International Aids Society, in Sydney, was another measure of how the global fight against HIV/Aids is falling short. Despite US$31 billion spent since 2003, infection rates continue to rise and political agendas are tragically undermining sound science.

The global health community anticipates having some 2 million people on antiretroviral treatment by the end of the year. The World Health Organisation is promoting a target of 10 million Aids patients under treatment by 2010 - independently of evidence-based medicine, because we know virtually nothing about patient outcomes.

There is a disturbing lack of medical records, and no cost-benefit analysis for each therapy has ever been done by the WHO or its global partner agencies.

Most donors treat people because they are poor rather than because they are sick. Science has been set aside in favour of reaching arbitrary targets as quickly and cheaply as possible, yielding numbers for politicians rather than medical records for clinical review.

Laurie Garrett, a senior fellow at the United States-based Council on Foreign Relations, sees bigger lessons in the global HIV/Aids effort's failures. With so much money that has so many strings attached, all focused on a single disease, we are systematically hobbling low- and middle-income countries' ability to improve their overall health systems.

The international political left has been cynically using the global Aids effort towards its own ends, particularly around basic international drug patent rules. It advocates theft rather than partnership in drug pricing policy, and sees the private sector as the enemy. Major non-governmental organisations, such as Oxfam, have made strange bedfellows to further this political cause.

Oxfam and its allies are persistently working to have the military dictatorship in Thailand become the first government to break patents on antiretroviral and other chronic disease medications. The dominoes are in place to fall, and the impact on new Aids drug development could be devastating.

These political battles are not supported by science, and are sand in the wheels of the mechanisms necessary to overcome HIV/Aids and every other major health threat.

The left must give up its incessant crusade against market economics; the private sector must commit to health care improvements as a strategic investment over the long-term, not mere charity. Deals on drug pricing should not be political footballs but fall under an agreed-upon approach which supports the rule of law, ensures safety and prevents counterfeit products from entering the market.

The lesson of HIV/Aids is a serious warning sign about the giant potential that global public health has, for ill or for good, depending on how we approach it. Failure to make serious progress will have enormous consequences.  Read More & Comment...

Evidence Based Medicine: Save Money. Then Harm Who You Want

08/09/2007 11:12 AM |

A great example of evidence based medicine put to great use....

Doctors Paid To Switch Patients To Generic Drugs
Incentives Raise Ethical Questions


BOSTON
Team 5 Investigates discovered that health insurers are giving doctors incentives, sometimes in cash, to switch patients to generic brands.

NewsCenter 5's Janet Wu reported Wednesday that the payments are legal, but health care experts said they clearly raise ethical questions if patients are not told the reasons behind the switch.

Much of the controversy centers on the cholesterol drug Lipitor, which is the best-selling medicine in the world. It is currently under a patent and does not have a generic version. Thousands of Massachusetts patients recently discovered their insurer won't pay for it anymore or that their out-of-pocket cost has skyrocketed. Other patients told Team 5 Investigates they were switched by their physicians with little explanation. Earlier this year, Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.

“Without saying to the patient, ‘I have a financial incentive in making this decision, which goes along with my professional incentives to do what's right for you,’ it's unethical,” said professor Regina Herzlinger, of Harvard Business School . “It's a clear conflict of interest.”

Team 5 Investigates asked Blue Care Network of Michigan if patients were told of the financial kickback.

Earlier this year, Blue Care Network in Michigan paid 2,400 doctors $2 million to switch their patients from Lipitor to a generic version of its competitor, Zocor. They were paid $100 for each patient they switched from Jan. 1 through March 31, 2007.

“Without saying to the patient, ‘I have a financial incentive in making this decision, which goes along with my professional incentives to do what's right for you,’ it's unethical,” said professor Regina Herzlinger, of Harvard Business School . “It's a clear conflict of interest.”

Team 5 Investigates asked Blue Care Network of Michigan if patients were told of the financial kickback.

A spokeswoman said "not specifically."

In Massachusetts , financial arrangements for switching patients from Lipitor are less blatant, but they do exist.

In a letter obtained by Team 5 Investigates, Partners Community HealthCare's Me dical Director, Dr. Thomas Lee, told his colleagues that "physicians will increasingly be rewarded in our pay-for-performance contracts if we increase the percent of generics we use. Increasing our use of generic statins is therefore very much to our advantage."

Former Lipitor patient Genie Holland told Wu, “I'm shocked. They're paying the doctors? Yes. I'm shocked.”

Holland said she was surprised earlier this year when her doctor switched her from Lipitor to a generic version of Zocor without explanation, “because it had worked for me for so long. I also found that my cholesterol went up after I went on the generic.”

But Herzlinger said the medical efficacy is irrelevant to this debate. “You've got to tell the patient that 'I'm switching you to a generic, not only because it's best thing for you and it's going to save you money out-of-pocket, but because I'm going to make more money as a result of that.'”

This is a priceless example of the counterdetailing that the Priesthood of Purists have proposed. It is also going on in the VA where docs are getting cash to prescribe a la ALLHAT. (I wonder if patients are being told of this kickback "specifically.") This is supposedly evidence-based medicine. But where is the evidence that bribing doctors to practice one size fits all medicine is good for the patient?

Soon to follow: cash prizes to get doctors to use recycled and older hip implants, chloroform for surgery, and amputations instead of diabetes care.

http://www.thebostonchannel.com/news/13800173/detail.html  Read More & Comment...

Whose Life Is It Anyway?

08/09/2007 09:12 AM |

Our friends at the Abigial Alliance "lose" a round in court but sharpen the debate on access to medicines and exposes a glaring weakness in the FDA's -- and Richard Padzur -- argument about why it shoud keep denying dying patients the right to try experimental drugs....

Dying denied right to unapproved drugs
APPEALS COURT SAYS FAMILIES SHOULD ASK CONGRESS TO ACT
By David G. Savage
Los Angeles Times

WASHINGTON - People who are dying do not have the right to obtain unapproved drugs that are potentially life-saving, even if their doctors say the treatment offers their best hope for survival, a U.S. appeals court in Washington, D.C., ruled Tuesday.

In an 8-2 decision, the court said federal drug regulators are entrusted by law with deciding when new drugs are safe for wide use.

Note the term "wide use." I believe the Abigail Alliance and others can make the case that they are not asking for wide use but targeted, tailored and scientifically responsible use that is consistent with their constitutional rights under the Fifth Amendment. This notion that somehow such rights are trumped by Padzur's effort tot take a wrecking ball to accelerated approval is a joke. The FDA is inconsistent on who gets what and when with respect to access to medicines and I don't think the Supreme Court is going to let this "wide use" nonsense pass particularly since the Alliance is not asking for patients to determine when a product is safe but only to have the FDA create a regulatory pathway for allowing dying patients access.

And let's by clear who the real independent operators are: Padzur is one of those free lancers, along with Graham and the now departed David Ross who acted as a FDA of one under the protection of Waxman and Grassley.

http://www.mercurynews.com/healthandscience/ci_6570788?nclick_check=1  Read More & Comment...

A New Path to Better Global Health

08/08/2007 12:55 PM |

The key to is to give consumers in developing countries -- apart from decent public works -- tools and products that make a daily difference in their lives. Which means getting beyond the attack on capitalism and IP. And it means giving entrepreneurs in developing countries capital, reducing regulatory barriers, and promoting distribution of their products globally. It also means retrofitting design specs for medical products so they are affordable.... A combination of cheesecloth, vinegar and a flashlight can be used to detect cervical cancer. This -- a temporary measure until less expensive pap smears are developed -- can be combined with immunizations to reduce cervical cancer worldwide. For instance:

"Officials are already working on a cheaper version of Merck & Co.'s cervical cancer vaccine Gardasil, which currently costs about $360 per dose. Together with stepped-up screening, doctors think that cervical cancer might one day be wiped out as a major health problem for the developing world. Among the places Gardasil is available are the U.S., Europe, Canada, Australia and New Zealand."

Why use the developing world as a political battleground when such approaches can accomplish so much more?

http://www.chron.com/disp/story.mpl/ap/fn/5025324.html  Read More & Comment...

Raj Rage

08/08/2007 08:48 AM |

This week's ruling by the Supreme Court of India institutionalizes that incremental innovation in pharmaceuticals isn't important on the sub-continent -- at least when it comes to patent protection..

Many of the usual suspects (Jamie Love, et al.) applaud this decision. But, in reality, it's a horrible blow to global public health -- and particularly to the Third Word, because economically-driven, short-term decisions have deadly unintended consequences.

As Trevor Jones ( a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out relative to treatments for HIV-AIDS:

"Some that are very similar in chemical compositions have been referred to as me-too products, but all the drugs have been vital to the pandemic ... In fact, we need more, not less, me-too products."

The Indian ruling is only the most recent example of how healthcare technology assessment (HTA) aka: evidence-based medicine (EBM) being used to deny not only appropriate patient care, but now case patent protection.

And this is an important link, because minus patent protection, an innovator company can't earn back what it invested in R&D, ergo they can't reinvest their profits in further R&D -- further delaying crucial incremental innovation which is how medical progress is made.

(But large Indian generic manufacturers can make a bundle.)

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.

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 – and members of the Indian Supreme Court.  Read More & Comment...

Consumers vs Consumers Unions on Vioxx

08/07/2007 08:23 PM |

Article in my hometown (homestate?) paper on consumers who want Vioxx back for various reasons, none of which are good enough for the "true" voice of the consumer, Consumers Union. The condescending tone of the quote from CU's top doc Marvin Lipman is priceless, but then again, when you are an elitist and think most people are idiots easily manipulated by drug companies except (thank goodness) for you, such egotism can be excused:

"These patients argue they -- and not regulators or lawyers -- should decide whether a drug's benefits outweigh its risks, or even whether a drug poses any risks to them at all.

But Marvin Lipman, chief medical adviser for the nonprofit Consumers Union, which has advocated for drug-safety reforms, said such responses, while not unusual, are misguided.

"People do get used to the idea that one drug can help them," Lipman said. "A person's conviction that something is helping them or that only one thing will help them is often erroneous. The impact may be exaggerated."

As opposed to the CU's conviction that the drugs they recommend as Best Buys for Alzheimer's and other drugs are they only things that will help is not erroneous?

http://www.nj.com/starledger/stories/index.ssf?/base/business-7/1186288491133630.xml&coll=1&thispage=2  Read More & Comment...

Personalized Medicine Gets a Reprieve: FDA Approves Mararviroc

08/06/2007 09:16 PM |

Maraviroc would be the first personalized medicine for AIDS because Pfizer would first test patients to determine whether the drug works for them....

http://news.yahoo.com/s/nm/20070806/bs_nm/pfizer_hiv_dc  Read More & Comment...

Best of Luck to Peter Rost. Really

08/06/2007 12:36 PM |

I don't get all the consternation about Peter Rost becoming a journalist as opposed to a blogger. Let the guy make a steady living. At least, unlike others in the media, he makes his viewpoint known, never gets ruffled and is not afraid to fire back when challenged. I don't agree with him but I will look forward to reading him in his new perch. Good luck to the "other" Peter.

http://www.brandweeknrx.com/2007/08/brandweek-shoul.html  Read More & Comment...

Credible or Incredible?

08/06/2007 11:03 AM |

Lots of posts about whether drugwonks is, because of our "style" less or more credible than it could be...

Our attacks have never been ad hominem. They have been pointed and backed up by facts and informed by frustration. And unlike many of our critics, we read all of the material we blog on, not just the headlines. We actually do research before we post. And when we are wrong or over the line we apologize openly and honestly.

As for our handling of Steve Nissen, he deserves the Derek Lowe-inspired Kevin Trudeau treatment. As we have said several times on this blog -- and no one else in the pharma blog community seems to care, he and his crony Curt Furberg trashed the cardiovascular safety of ADHD drugs in a most unprofessional fashion. Their attack on Avandia has caused many people to stop taking the drug just as Furberg's frivolous and media orchestrated attack on CCB's caused people to stop taking those drugs 10 years ago.

Drugwonks is the only, the only, site that is consistently shining a light on the relationship between so-called activists like Nissen, Furberg, etc., the medical journals, the media, certain members of Congress the damage they have done to the public health with respect to women's health, depression, ADHD and now diabetes. We have criticized Democrats, Republicans, drug companies, drug ads, conservatives, liberals and even Michael Moore.

Moreover, through CMPI we are coming up with constructive, patient-centric approaches to make medicine more personalized and value-based. What we do on drugwonks is a small part of what we do and who we are. As anyone who attended our Medicine and Media program saw, we have many outlets and seek out many approaches to promote science based medicine. Want to ignore that stuff and focus on what we post that annoys the hell out of you? Be my guest. If that makes us less credible, trust me I won't lose any sleep over it.

We are ticking everybody off it seems. So I guess we are doing something write.  Read More & Comment...

DTC? ITP? What's the 4-1-1?

08/06/2007 09:02 AM |

One of the biggest complaints about DTC pharmaceutical advertising is that it doesn't give patients (aka: consumers) enough information about either the advertised medicine or about the disease under discussion. Now there's a new twist -- consumers (aka: patients) have access to too much information.

In Europe, where there is no pharmaceutical advertising, the debate is about "information to patients," or "ITP."

But no matter what you call it, there's tremendous value in reading a very thought-provoking article in the Baltimore Sun ...

"At a time when more information than ever is broadly available about illnesses and the effects - positive and negative - of the drugs used to treat them, doctors and patients are facing a growing challenge as they attempt to sort out the benefits and risks of medications and therapies.

Every week, professional journals and other sources report the results of new medical studies - a rising tide of information that sometimes seems contradictory. Patients can read the studies on the Internet, or read about them in newspapers, and bombard their doctors with questions that frequently don't have simple answers.

So many patients go on the Internet now and with what the press bombards them with, they have a lot of information. They need to be able to understand the literature, so they can take it to the doctor and ask informed questions, said Erik Rifkin, a retired environmental consultant and co-author of The Illusion of Certainty, a new book that argues for increased clarity in the reporting of medical research.

Rifkin and his co-author, Edward J. Bouwer, both of whom live in Baltimore, say researchers should state findings in terms that are easier to understand. Statistics used in studies - and repeated in news reports - are often misleading, they say."

Here is a link to the article:

http://www.baltimoresun.com/news/health/bal-id.hs.risk05aug05,0,3165339.story

Is more information better? It depends who you ask. According to one patient interviewed for the Sun story, ""I got so much information that I had to quit because with the Internet, there was so much out there." And that was someone searching for information about a condition that predisposed him to cancer.

Too much? Too little? Too complicated? Too simplified?

Too important not to debate and discuss.  Read More & Comment...

my column on the personal side of medicine

08/05/2007 10:56 AM |

From today's edition of Newsday ...

Lesson from a savvy doctor

BY MARC SIEGEL. Dr. Marc Siegel, an associate professor of medicine at the New York University School of Medicine, is the author of "False Alarm: The Truth About the Epidemic of Fear."

August 5, 2007

You wouldn't know it from the political debate, but health care is much more than just bald statistics about probability, necessity and risk. It is shaped by the quirks and characteristics of its practitioners.

When Dr. Jeffrey Siegel was killed by a hit-and-run motorist and taken last month at age 48 from his life as a prominent Long Island pulmonologist, the world lost a particular sort of physician. Our identities as doctors were molded in the Bellevue Hospital melting pot of the 1980s. He was the Siegel who cooperated; I was the Siegel (no relation) who fought.

Though he was my supervising chief resident for only a few rotations, I remember our clashes, as Jeff Siegel tried to teach me to be more politic and less confrontational. I was often arguing with nurses as well as patients, trying to get my points across, while Jeff was soft-spoken and known to be very persuasive.

Residency training was a cauldron, and as my medical personality was forged I began to learn from Jeff and others that I was often too forceful and that even when a patient's life is on the line it is still possible to negotiate. On the other hand, as I came into my own as a physician I also found that my outrage could help position me as a patient advocate.

Even with all the technology and the growing bottom-line thinking about cost-effective medical care, at the heart of the process are individual doctors who apply their personality traits to patient care. Jeff and I had very different styles, but we shared a tenacity that was essential at a busy city hospital like Bellevue. We were at our best as a team. Even as I was learning to be more politic, he was learning to be more gruff.

Once, a 55-year-old ironworker was admitted to the hospital with a severe heart attack and immediately demanded to leave the same day. As his resident, I was focused on keeping him alive medically.

I was so irritated at his self-destructive refusal of treatment that I began to argue with him relentlessly even as his stretcher was rolling him, still protesting, toward the operating room for cardiac bypass surgery. "You're giving me chest pains," he said, which brought me to my senses as I suddenly realized that I might be jeopardizing his heart further. It took Jeff, as my chief resident, to come by and calmly convince him to agree to the operation.

Afterward, Jeff quietly told me never to raise my voice with a patient, and he left it at that.

The surgery didn't go well, and in the recovery room, as the man's heart ballooned from damage and his lungs continued to fill with fluid, the staff was ready to give up. At which point I erupted in favor of toughing it out, this time directing my blunt insistence not at the patient but at the team working on him. Fortunately, we carried on, and the man's heart began to slowly recover.

I had learned from Jeff that there was little to be gained by yelling at a patient, but I learned for myself there was much to be gained from channeling my strong, stubborn emotions into not giving up. As he recovered, the patient began to see the benefits of my stubbornness on his behalf and grew to like me for it. Of course, he knew that he also owed his life to Jeff's very different intervention. He had strong relationships with both of us, which I am certain helped him get well faster.

Managed care and and health insurance policy arguments can leave us thinking that physicians are just interchangeable, replaceable cogs in a complex machine that doesn't run as well as it used to. Yet the human element remains essential.

Medicine is as much about the developing personalities of those who administer treatment as it is about the technology that measures metabolism. That's the lesson I got from Jeff Siegel's too-short life.

.  Read More & Comment...