Chinese Checkers

06/01/2007 08:18 AM |

The FDA has determined that not only did tainted heparin from China infiltrate the US drug supply -- it did the same to 11 other nations as well. The facts are indisputable -- 12 different Chinese companies supplied contaminated heparin not only to the United States but to Australia, Canada, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand -- and China.

The response from China -- denial there even were any impurities and then to imply that the problem stems from contaminated vials used in the United States. And, get this, the Chinese authorities won't allow FDA officials to inspect any Chinese facilities unless they can, in turn, inspect the American plants where the product was prepared for distribution.

How do you say "chutzpah" in Mandarin?

It's hard to say what these Chinese Checkers might discover -- but it's likely they'd find that the GMPs in place in the United States are the global gold standard. Whether the tainted ingredients were used in error or to save money doesn't matter. What matters now is that the problem must be identified -- and that means that our trading partners in the Middle Kingdom must allow FDA inspectors in now -- and allow them to inspect plants that produce API or other ingredients bound for US shores.

It's not a question of national sovereignty -- it's a matter of responsibility and public health.

What does all this say about the realities of drug importation? It points out, once again, that it’s nothing other than a dangerous political charade. And when you look at the list of nations impacted by this crisis, they're many of the same countries on the "approved" list for many ill-conceived drug importation bills.

So much for eastern promises.  Read More & Comment...

Chinese Checkers

06/01/2007 08:18 AM |

As any assistant district attorney will tell you, the "some other guy did it" defense generally means "guilty."

Now, it seems, China is blaming Panama for the deaths of 51 people caused by cough syrup containing Diethylene glycol -- a chemical commonly used in antifreeze and brake fluid. But, it seems, there is plenty of blame to go around.

This is just the latest example of China-as-hub for the international trade in counterfeit API (Active Pharmaceutical Ingredient). And connecting the dots to the issue of "safe" drug importation is pretty obvious.

Here's the story off the AP wire:

China blames Panama for deadly tainted drugs

Papers altered to say glycerin was for medical use, Chinese official claims

BEIJING - Businesses in Panama, not China were "mainly responsible" for passing off an industrial chemical as a medical ingredient leading to the deaths of at least 51 people, a senior official in China's product-inspection agency said Thursday.

Wei Chuanzhong, vice minister of the Administration for Quality Supervision, Inspection and Quarantine, said Chinese companies sold the industrial solvent called 'TD glycerin' to Spanish companies who then sold it to Panamanian companies. The product was then used to make cough syrup and other medicine.

"The Panamanian business people are mainly responsible because they changed the scope of use and shelf-life of this product," Wei said.

The deaths in Panama, which began last year, have dramatically added to a growing international alarm about the safety of food and medicines exported by China.

Wei acknowledged that the Chinese manufacturer, Taixing Glycerin Factory, and the Chinese distributor, CNSC Fortune Way, "engaged in some misconduct," because they used the name TD glycerin for a mix of 15 percent diethylene glycol and "other substances."

Diethylene glycol is a chemical commonly used in antifreeze and brake fluid.

Misleading name

"They used the very confusing name of TD glycerin, which will mislead people to think it's glycerin," said Wei. "The markings on the package also used the name glycerin instead of TD glycerin."

But he said the Panama traders bore the brunt of the responsibility for the deadly substance ending up in medicine.

"The Panama trader changed or altered the paperwork to say the substance was medical glycerin that met U.S. standards for use in medical products and changed the shelf life of the already expired product from one year to four years," Wei said. "The responsibility here is very clear."

He said the Chinese investigation found that the Chinese side made it clear in their export paperwork that the material they were selling was for industrial, not medical, use. Wei said Taixing had been punished for its misbehavior but when pressed for details, he said the company was still being investigated. He said China would not continue to allow the use of the name TD glycerin, but no ban has been formally announced.

Glycerin, which is often processed from animal fats and occurs naturally in the human body, is a sweet liquid that can give cough syrup and other remedies thickness while preventing them from dissolving in water. It is used in many kinds of medicines all over the world.

The first documented poisonings were reported in October, but Panamanian authorities said there may have been earlier cases that went undetected. Fifty-one people died after taking the tainted medications and 68 were hospitalized.

Why isn't Senator Bernie Sanders asking, "Where are the dead Panamanians?  Read More & Comment...

Osama ben Nissen

05/31/2007 02:57 PM |

Woke up this morning to the New York Times quoting Curt "No Brainer" Furberg saying, "Safety is just not a high priority for them."

"Them" being the FDA.

That statement is untrue, unjust, and unfair to the staff of the FDA who put their heart and soul into their jobs -- and could walk out the door tomorrow for much better paying, lower stress jobs. And yet they stay.

And this is what people say about them. For shame.

I will go to bed this evening after the Nightline feature on Avandia. Curious to see how ABC edits the interviews they did with Scott Gottlieb and Steve Galson.

In fact, I am more than curious considering the clip of Steve Nissen that ABC has on their web site:

http://abcnews.go.com/Nightline/story?id=3225419&page=1

Dr. N. compares Avandia to 9-11.

Fearmongering at its worst.

And his you-know-what eating smile should tell you all you need to know about how much he's enjoying himself.

For shame.  Read More & Comment...

Nissen Hissy Fit

05/31/2007 01:08 PM |

"Nissen points to his outspoken criticism of Cox inhibitors including Celebrex -- a Pfizer product -- at the time he was the principal investigator for a Pfizer clinical trial."

Can anyone find any criticism of Celebrex by Nissen? Here is the full extent of Nissen's whining in advance of his Nightline puff piece tonight....

http://www.abcnews.go.com/Nightline/Story?id=3225419&page=2

Here is a contemporary account of who was outspoken and when:

"Following the decision to pull Vioxx from the market three years later, Topol continued to publicly criticize Vioxx-maker Merck for its slow response and for its decision to put the dangerous drug on the market in the first place. Dr. Nissen, however, was less vocal.

Subpoenaed in the first federal Vioxx trial in November 2005, Dr. Topol gave a three-hour videotaped deposition attacking Vioxx and accusing Merck of scientific misconduct. Less than a week after that deposition, Topol lost his position at the Cleveland Clinic.

There is one other important point to note here: At the same time Dr. Topol was being demoted, his past partner in protest, Dr. Nissen, was being asked to lead the $100 million study into the safety of Celebrex. "

http://www.newstarget.com/019333.html

Nissen has also voiced support for Pfizer's new ad campaign for Celebrex (we do too!)

I guess silence is golden.  Read More & Comment...

Can You Be Half Conflicted?

05/31/2007 08:52 AM |

Dr. Nissen talks about how he donates all his drug industry honoraria to a private charity -- more on THAT later -- but no much later since he didn't start becoming pure until 2004. As Dr. Nissen wrote in his inaugural letter as Pres. of the American College of Cardiology -- which runs his private charity -- " you will sleep better at night and your favorite charity will be grateful for the support. "  Read More & Comment...

St. Steven? Saints Alive!

05/30/2007 05:09 PM |

Dr. Nissen, it seems, can dish it out. But when it comes to "taking it," that's another thing entirely.

According to the man himself, "While I did spend a sleepless night about this, I'm not backing down."

What's causing Dr. Nissen to lose his zzzzs? An e-mail from an FDA spokesman to reporters challenging Dr. N's motives and credibility.

Yep -- he's losing sleep over a nasty e-mail.

In the correspondance in question, entitled "What are St. Steven's feet made of? Clay, perhaps?," FDA spokesman Doug Arbesfeld forwarded to reporters critical news articles, including an anonymous blog accusing Nissen of playing favorites among drug companies.

It's nice to share, right? Well not if you don't agree with Dr. Nissen.

According to The Man, "I'm a pretty tough guy, but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."

Mommy!

Dr. Nissen, have you heard this one: Do unto others as you would have them do unto you.

This from the same guy who says he donates all his consulting fees to charity -- except that the "charity" resides within the American College of Cardiology -- an organization over which he holds tremendous sway. (Although, in fairness, it is certainly not the same as depositing the money into one's own piggy bank.)

As Mark Twain said, "The rule is perfect: in all matters of opinion our adversaries are insane."

An outrage indeed.  Read More & Comment...

Initial Concepts

05/30/2007 01:27 PM |

Whether it's EBM or HTA or RUM or RUD ... it means the same thing ... putting cost before care. You can tell when this is happening when health ministers begin to act like junior finance ministers. Unfortunately it's happening all the time across the EU and it's pennywise and pound foolish. Oh yes -- it's also bad for patient care. Details. Details.

Don't let the alphabet soup of acronyms fool you -- it all spells care denied.
But you already know that.

Now this dangerous medicine threatens US health care policy with the current phrase de jour, "comparative effectiveness."

No matter how you cut it, evidence-based medicine based on bad evidence is bad medicine.

But you know that already too.

Here's a new paper (published jointly via the Center for the New Europe and the Center for Medicine in the Public Interest) authored by Jacob Arfwedson (a leading European thinker on this topic) and yours truly. The paper discusses where this variously named and initialed concept came from and where it's going not only in Europe but also, via our buddies at the WHO, into the developing world.

http://www.cne.org/pub_pdf/2007_05_arfwedson_pitts_ebm.pdf

And, if you're listening carefully to the rhetoric from inside-the-beltway and from the various presidential campaigns, you'll see that the concept of comparative effectiveness is entering into the general parlance.

But it's more than just another simplistic answer to a complicated question -- it's a signal that we had better start paying attention and offering real, long-term solutions -- like personalized medicine via the Critical Path.

Like we keep saying -- it ain't called "critical" for nothing.  Read More & Comment...

Obviousness-Based Medicine

05/30/2007 12:49 PM |

Smokin!

The National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has recommended Champix (varenicline) for use on the National Health Service for adult smokers who have expressed a desire to quit. This gives smokers across England, Wales and Northern Ireland access to another important treatment option to help them quit smoking.

In its Final Appraisal Determination, NICE concluded that varenicline was “superior to NRT [nicotine replacement therapy] and bupropion in achieving continuous abstinence” and that its use in smoking cessation was “likely to be a cost-effective use of National Health Service resources.”

“This guidance means that smokers who are serious about stopping have another choice from a good range of clinically proven treatments, said Professor Robert West, Professor of Health Psychology at University College London. “Smokers who combine treatments with the right support – for instance from smoking cessation services - could significantly increase their odds of successfully quitting for life.”  Read More & Comment...

Now THAT'S Oversight

05/29/2007 05:05 PM |

Ex-China Drug Regulator to Be Executed

Tuesday May 29, 2007
By AUDRA ANG
Associated Press Writer

BEIJING (AP) - China's former top drug regulator was sentenced to death Tuesday in an unusually harsh punishment for taking bribes to approve substandard medicines, including an antibiotic blamed for at least 10 deaths.

Seeking to address broadening concerns over food, the government also announced plans for its first recall system for unsafe products.

The developments are among the most dramatic steps Beijing has taken to address domestic and international alarm over shoddy and unsafe Chinese goods - from pet food ingredients and toothpaste mixed with induso trial chemicals to tainted antibiotics.

Beijing's No. 1 Intermediate People's Court convicted Zheng Xiaoyu of taking bribes in cash and gifts worth more than $832,000 while he was director of the State Food & Drug Administration, the official Xinhua News Agency said. Those bribes allowed eight companies to get around drug approval standards, it said.

It was not immediately clear if Zheng would appeal. Under Chinese law, a death sentence meted out by an intermediate court automatically will be reviewed by a higher court and ultimately has to be approved by the state supreme court.

The sentence was unusually heavy even for China, which is believed to carry out more court-ordered executions than all other nations combined - and likely indicates the leadership's determination to deal with the recent scares involving unsafe food and drugs.

``The Chinese government attaches great importance to the safety and security of food,'' Foreign Ministry spokeswoman Jiang Yu said at a regular briefing Tuesday when asked about Zheng's case.

We'll see about that.  Read More & Comment...

Takes One To Know One

05/29/2007 03:27 PM |

Curt Furberg calls the idea of taking Avandia off the market "a no brainer." He is familiar with that condition...  Read More & Comment...

Is Nissen Manipulating the Media?

05/29/2007 09:40 AM |

Is the ANY self-examination on the part of the media in the wake of the way the NEJM, Nissen, Furberg and Psaty have colluded to push this false hysteria about Avandia on the public? In the wake of black boxes on SSRI's that are associated with a spike in teen suicides? Anyone?

Anyone reporting on this shoddy affair should read Steve Usdin's article in Biocentury on the Avandia article, Joseph Biederman's (a world expert on ADHD) letter to the NEJM (unpublished) after said journal allowed Nissen to continue his rampage against the use of stimulants to treat the disorder and previous reporting and political reaction to the initial finding of the Women's Health Initiative that taking Prempro (post menopausal women ages 50-79) had a 31 percent higher risk of stroke. PS Subsequent reanalysis of the WHI data showed lots of variation by subpopulation...something Nissen does not control for.

Here's a link to Biederman's scathing letter to the NEJM.....

http://www.massgeneral.org/pediatricpsych/docs/NEJMltr.pdf

And here's Nissen comparing ADHD drugs to ephedra....

"Closely related sympathomimetic amines, such as ephedra and phenylpropanolamine, have been deemed sufficiently risky that the FDA has recommended banning these agents to protect the public health."



Let's see if the media does it's job in the days leading up to the Waxman show trial....  Read More & Comment...

Now Nissen and Nissen Good

05/29/2007 09:40 AM |

How did Representative Henry Waxman (Congress' Oversighter-in-Chief) know about the NEJM's clarion call on Avandia before the FDA?

As Scott Gottlieb opines in today's edition of the Wall Street Journal ...

"NEJM said it rushed to post the study on the Web because of its medical importance, but the FDA, which would need to act on any safety issues, wasn't even given a heads up about the study's publication or its findings. Rep. Henry Waxman (D., Calif.), however, seems to have known in advance that it was coming because he issued a substantive press release immediately after the study was posted online. He was even ready with the date and location of oversight hearings aimed at probing the FDA's 'handling' of the drug safety issues. Mr. Waxman is trying to add new restrictions to the FDA's drug approvals. The study's primary author, Cleveland Clinic Cardiologist Steve Nissen, admitted to The Wall Street Journal that he was in touch with Congress while preparing his analysis. Three days after the study was submitted to NEJM, and before it was published, the FDA commissioner received a letter about Avandia from members of the House Energy and Commerce Committee that seemed to reference the NEJM study."

Dr. Steve Galson, the FDA's superb CDER Director, had some pretty unsubtle comments as well (courtesy of BioCentury's Steve Usdin), "What was the compelling public health purpose that justified rushing this study to publication -- an action that resulted in dozens of near-hysterical press reports ... Medical journals need to take their responsibility seriously to patients and physicians to publish information in a responsible and balanced manner. I'm not sure that responsibility was adeqautely executed in this instance."

Steve -- what do you really think?

Dr. Michael Weber, professor of medicine and associate dean at the State University of New York, Downstate College of Medicine, Brooklyn (and Chairman, we are proud to say, of the Center for Medicine in the Public Interest), was equally blunt. He said that Nissens's paper "verged on the sensational ... It is very disappointing that matters like this become opportunities for grandstanding rather than careful and thoughtful analysis of the data."

Michael -- what do you really think?

And, here's another question -- why weren't either of these high-profile experts interviewed for the first round of stories last week?

The Lancet wrote that, "To avoid unnecessary panic among patients, a calmer and more considered approach to the safety of rosiglitazone is needed. Alarmist headlines and confident declarations help nobody."

Which begs the question -- what do the experts know that the pols and pundits do not? Could the answer be that science is not a binary right/wrong, safe/unsafe proposition.

But the MSM doesn't like complicated -- there is rarely either the understanding or the space. Politicians certainly don't like complicated -- since it doesn't get headlines. Both groups prefer good guys and bad guys.

So much for not politicizing science.

And the Oversighter-in-Chief? Well, if you've got a hammer, every problem looks like a nail.  Read More & Comment...

Reaction to Nissen in perspective

05/27/2007 09:18 AM |

Remember the Women's Health Initiative? It found that healthy post menopausal women who went on HRT had a 41 percent higher risk of stroke than women not on HRT (ages 50-79).

That was a randomized controlled trial.

I don't recall a spate of lawsuits, fearmongers and handwringing headlines about safety then.

Maybe it was all in the delivery. The WHI results were released responsibly and were followed up to allow tailoring of treatment based on new research.

The Nissen data dredging was like shouting death in a crowded doctor's office.  Read More & Comment...

Does your opinion count?

05/27/2007 06:22 AM |

From The Onion.

Study: 38 Percent Of People Not Actually Entitled To Their Opinion

CHICAGO—In a surprising refutation of the conventional wisdom on opinion entitlement, a study conducted by the University of Chicago's School for Behavioral Science concluded that more than one-third of the U.S. population is neither entitled nor qualified to have opinions.

"On topics from evolution to the environment to gay marriage to immigration reform, we found that many of the opinions expressed were so off-base and ill-informed that they actually hurt society by being voiced," said chief researcher Professor Mark Fultz, who based the findings on hundreds of telephone, office, and dinner-party conversations compiled over a three-year period. "While people have long asserted that it takes all kinds, our research shows that American society currently has a drastic oversupply of the kinds who don't have any good or worthwhile thoughts whatsoever. We could actually do just fine without them."

In 2002, Fultz's team shook the academic world by conclusively proving the existence of both bad ideas during brainstorming and dumb questions during question-and-answer sessions.

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

And speaking of the Clintons

05/25/2007 08:46 AM |

“Of course, a guy like me who’s living on Lipitor is in a hard place to criticize the drug companies.”

-- Bill Clinton  Read More & Comment...

People. People who need ... Hillary?

05/25/2007 07:52 AM |

Today's furor, as reported in the New York Times, comes from Italy where consumer groups are decrying high prices, calling them "absurd and shameful."

What they're upset about are ticket prices for the Barbara Streisand concert on June 15. (Prices range from $200 to $1200.)

The horror!

And we concur. After all, comparatively speaking, pretty good seats for the Dylan concert at Jones Beach cost under $200.

And since they're both music concerts by solo artists -- aren't they really the same thing?

Sure. Just like medicines.

That being said, consider the following from Democratic Presidential candidate, Senator Hillary Clinton, "A lot of these so-called blockbuster drugs are no more effective, and sometimes less effective, in treating conditions than old standbys."

In a speech at George Washington University, Senator Clinton said research is finding some drugs aren't worth the cost.

Really? Are some lives not worth saving?

Folks, the battle over the heart and soul of evidence-based medicine is crucial. The battle over what "comparative effectiveness" means is crucial. The battle over measurement tools is crucial.

Why? Because it's a battle between cost and care. Pols, pundits and payors are bashing life-saving medicines by using misleading metrics. And unless and until sound science raises its voice (and the media pays attention to the details) get ready for more of the same.

Ladies and gentlemen, political rhetoric is not the way to address the issue.

Unfortunately, it's rhetoric that is drving the debate and it's rhetoric that the MSM loves to report about.

But nobody said it was going to be easy.  Read More & Comment...

Is more better?

05/25/2007 06:49 AM |

Here's the press release ...

Grassley, Baucus bill would enhance research on pharmaceutical safety and effectiveness

WASHINGTON — Responding to growing concerns about the safety of pharmaceuticals, Sens. Chuck Grassley and Max Baucus introduced legislation today to improve the study of medical treatments, including the effectiveness and safety of drugs.

Their proposal would give researchers at federal agencies and university-based and other research organizations highly controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries.

“The situation that’s unfolding this week with the popular diabetes drug Avandia emphasizes the value of making this sort of rich source of information available to experienced and credentialed researchers,” Grassley said. “The drug trials that go on before the Food and Drug Administration approves a drug are no match for the wealth of information that’s available after a drug is on the market and millions of people start taking it. This legislative initiative will tap that valuable information on behalf of public safety and public health. And, it does so in a way that makes sure the strongest safeguards are in place to protect privacy and confidentiality.”

“Knowledge is power, and this bill will empower our health system to serve Americans better,” said Baucus. “The secure and efficient sharing of Medicare’s vast data among a number of Federal agencies will enable researchers to accurately examine the safety and effectiveness of many treatments patients receive. The data this bill would make available provides information that can create more watchdogs. More eyes might have helped us spot a situation like we learned about just this week with the FDA’s handling of the diabetes drug Avandia. This bill provides for this information-sharing with no other goal than to promote the public’s health and the public good.”

Medicare processes 500 million claims for benefits every year, and millions of prescriptions are filled annually through the new Medicare prescription drug benefit. Grassley said information about these benefits would be a tremendous resource for qualified health services researchers, and it would help them conduct rigorous studies on the safety and effectiveness of various medical treatments.

Grassley and Baucus said that researchers could help policy makers better understand why services that we know can help people maintain good health are not being used and to develop policies to promote their use, for example.

Indeed, knowledge is power. But information without context and power without perspective is dangerous.

Let's watch this one and see where it goes.  Read More & Comment...

Poison Pill -- Not a New Ben & Jerry's Flavor

05/24/2007 05:16 PM |

Bernie Sanders, the Senator from Ben & Jerry's, described Secretarial Certification of foreign drug importation as a "poison pill."

Oddly enough, Senator Sanders' flip comment hits at the very heart of this issue.

Despite the fact that many lawmakers have been advocating drug importation for years, it is precisely the threat of poisonous, counterfeit, and unregulated drugs flooding America that has kept such legislation from passing.

Here's what we have to say about it in today's edition of The New York Sun:

http://www.nysun.com/article/55114

I prefer Cherry Garcia but wonder what the House brand, Dingellberry, may yet bring.  Read More & Comment...

Bridges to Patients

05/24/2007 07:02 AM |

John Bridges that is.

We are pleased to share the good news that Dr. John F.P. Bridges (a CMPI senior fellow) has been named Founding Editor of a new medical journal that's designed specifically to offer insight into patient-centered medicine.

The Patient - Patient Centered Outcomes Research, will be an important new medical journal that puts the spotlight on patient-centered medicine. It will be the first
international medical journal dedicated to using the scientific method for accessing patient perspective of therapy and medical technology. The premier issue is due later this year and will initially be published on a quarterly basis.

According to Dr. Bridges, "At the most fundamental level, our goal is to empower the patient. In the past, we simply looked at ways to make the patient well. Today, there's a shift to a
more holistic approach that looks at the process of treating the patient rather than solely at the outcome. In the end, we're going to help make medicine better for the patient."

Interest in patient-centered approaches is growing at a rapid pace, as is the body of scientific research on the topic. According to a recent study by Dr. Bridges, there has been exponential growth in the number of studies focusing on patient preferences in medicine over the last decade. For example the number of conjoint analyses published in medical journals has grown from one every couple of years a decade ago, to over 20 per year today. The Patient was created to address an unmet area of outcomes research by providing a specialized forum and outlet to help the field flourish.

"The Patient is a unique journal in the field of outcomes research in that it creates a new vehicle for patient-centered research," said Ellen J. MacKenzie, Ph.D., Chair of the Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health.

Congratulations John, and we look forward to reading (and contributing) to the life of The Patient.  Read More & Comment...

avandia

05/23/2007 06:13 PM |

one issue which is once again being overlooked amid the outcry against an unexpected possible side effect of a drug is the efficacy of the drug itself. The reason I am not stopping Avandia on every patient I have who is taking it is not just that the possible deleterious effect on the heart remains unproven, that the association, as Bob Goldberg has said, is not at the level of cause/effect. there is another problem - that the glitazones are great drugs, that we already saw Rezulin tarred and feathered and ultimately hung from a tree until dead. Is Avandia to be the new Rezulin, followed by Actos, arguably the most effective of the three.
By the way, how many lives did Rezulin save because it was an effective diabetes drug verses how many liver deaths were associated with its use? This is not a rhetorical question - it was removed after a handful of possible cases of severe liver damage.
Believe me, I am not championing drug side effects, nor am i against the idea of widening post market initiatives. It is clear that unexpected side effects need to be watched out for, and that drug safety is an ongoing concern that involves more than just the target organ.
But drug safety and cost/benefit analyses mean looking at more than just a weakly observed mathematically determined association. These shadows will be found in many more places the harder we look for them. And great drugs will be unfairly targeted and destroyed. The cost is too high. Two TZDs down. One left to go. By the way, did I forget to mention that these drugs are perhaps the best drugs we have for type 2 diabetes - i see that I began my post this way - so I've come full circle.  Read More & Comment...