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...

Rio? Bravo.

05/23/2007 07:46 AM |

I spent two days in Brazil late last week. Gave a speech in Sao Paulo and another in Rio.

Wonderful country. Smart people.

And especially smart when it comes to the issue of compulsory licensing of pharmaceuticals.

The people I met with (from a wide variety of professions) all agreed that the Brazilian government's move towards expropriating patents was nothing more than a media stunt that might save a few political lives -- but no real ones.

More importantly, the people I met with agreed that, in the long run, such unethical moves were unwise for the future of Brazilian health care -- because what their nation needs are partnerships in health care -- not meaningless confrontations. Allies not adversaries.

So, don't believe everything you hear from certain NGOs. All this running dog lackey health care imperialism blather is nothing more than anti-pharma agitprop.

I was there. I heard it.

(Hear that, Jamie?)  Read More & Comment...

Deja Vu All Over Again

05/22/2007 09:27 AM |

US hearing set on FDA handling of Glaxo drug

By Reuters | May 21, 2007

WASHINGTON (Reuters) - A House committee will hold a hearing on June 6 on the Food and Drug Administration's oversight of the safety of GlaxoSmithKline Plc's diabetes drug, Avandia, the panel's chairman said in a statement Monday.

In a statement, Rep. Henry Waxman, a California Democrat who chairs the House Oversight and Government Reform Committee, said the hearing was called following publication of study that reported Avandia may be associated with an increase in heart attacks and deaths.  Read More & Comment...

Sneak Attack on PDUFA

05/22/2007 09:01 AM |

It is becoming clear that the Nissen article in the NEJM is part of larger effort on the part of a tort lawyer sponsored group of academics who oppose PDUFA. The editorial in support of the Nissen article was written by Curt Furberg and Bruce Psaty who, as this blog has noted in the past, have participated in the efforts of the The Project on Scientific Knowledge and Public Policy (SKAPP), based at the George Washington University to undo current PDUFA legislation. Major support for SKAPP is provided by the Common Benefit Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation.

It's time for the FDA to stand up to the bullying if it wants to retain authority...  Read More & Comment...

SCHIP Ahoy

05/22/2007 07:11 AM |

The Congress is expected to begin debating SCHIP right after the Memorial Day recess, but final decisions are being made now about the legislative proposals that will be considered.

Here are some important things to think about and consider from the Health Policy Consensus Group (of which we are a proud participant) ...

Download file

Have a look and feel free to share.  Read More & Comment...

New England Journal of Manipulation

05/21/2007 01:07 PM |

Speaking of which...the online publication of Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes
Steven E. Nissen, M.D., and Kathy Wolski, M.P.H. signals a new low for both the NEJM and Nissen who's campaign to be FDA commissioner in a Democrat administration makes him look craven and small. http://www.nejm.org

The article proves no direct causal association. As the authors admit "these findings are based on limited access to trial results from publicly available sources, not on patient-level source data." Which means they cannot control for previous risks of heart disease or prior events.

Worse, the authors ignore the extensive literature demonstrating an association between diabetes and death from heart problems. Here's one article it failed to mention.

Diabetes mellitus: the major risk factor in unstable coronary artery disease even after consideration of the extent of coronary artery disease and benefits of revascularization.

Am Coll Cardiol. 2004 Feb 18;43(4):585-91.

Nissen has trawled for trouble before in the area of drugs for ADHD where he was rebuked by people who know better about the medicines benefit/risk profile. Here, he just did some data dredging of the worst sort and then even failed to cover his rear by citing literature about the link between diabetes and heart disease.

We know the NEJM is no longer a credible source of objective information on medicine. The question regarding Nissen is: Is he a real doctor or just playing one in the media?  Read More & Comment...

Pharma Obessive Disorder at the APA

05/21/2007 11:31 AM |

CMPI Board member Fred Goodwin is on a unbalanced panel (in more ways than one) at the APA entitled Uneasy Partners: The Pharmaceutical Industry and the Psychiatric Profession..The point of the panel is to show that clinical studies used to develop clinical guidelines for shrinks have been corrupted by industry, are unscientific and can't be trusted.

The response to that should be twofold: Does that mean no drug is really safe or efficacious given the limits of clinical trials. Second, , why not do head to head studies of treatment approaches developed by "purists" and those "corrupted" by industry and see who does better? We actually have some examples.. ALLHAT and CATIE were run by purists, the UK's NICE system of comparative effectiveness is too.

For the most part, purists are lazy. They simply do meta-analyses of selective group of clinical trials that have exclusion critiera that will produce outcomes they support.

Meanwhile, are the purists, who take money from trial lawyers, left wing foundations funded by George Soros, agenda driven organizations and have their own biases really pure?  Read More & Comment...

Slo Mo

05/21/2007 06:23 AM |

Here's some comic relief ...

Representative Maurice "Slo Mo" Hinchey (D, NY) has introduced legislation that would direct pharmaceutical firms to deposit their PDUFA fees into a general fund of the U.S. Treasury rather than paying them directly to the FDA.

According to Mr. Hinchey, such a relationship would provide an "arms length relationship" between the agency and drug companies.

Hey, Mo -- would the actual applications also be sent from "anonymous?" (Because, er, the names on the NDAs might give the FDA a hint as to whose applications they were reviewing.)

Would meetings between pharmaceutical companies and the FDA take place with FDA employees wearing blindfolds? No, that wouldn't work. After all, how could they take notes or watch PowerPoint presentations? We should probably do away with those earplugs too.

Maybe in mark-up the bill's language could change to require drug company employees attending such meetings to wear dark glasses, wigs, and fake Groucho moustaches.

Slo Mo also wants to create a "Center for Postmarket Drug Safety and Effectiveness" -- which would be apart and independent from the initial drug approval process.

Hey Mo -- that's a good one -- separating safety from effectiveness.

Take my legislation -- please.  Read More & Comment...

Sicko-phant: Michael Moore Scarfs Up Publicity

05/18/2007 11:41 AM |

Can a guy who took a stretch limo to a $3000/day fat farm do a credible movie about health care in America? He can if he plays to people's deeply held stereotypes about scummy business practices and twists the truth in the process....

But Moore is claiming, again, that every fact in his movies are true. Sicko being no exception. So here's a reminder for those of you Sicko-phants about how much Moore has to lie to make his point.

http://www.slate.com/id/2102723/  Read More & Comment...