Is the Web Patient Friendly

06/13/2007 03:35 PM |

Laura Landro has an article on how the web empowers patients. I am not so sure. Unless companies, academics, and other responsible third parties take great pains to roll out solid material, most of the space is taken up by misfits,manipulators and opportunistic feeders as Jay Byrne of V-influence describes them who engage in client shopping, fearmongering and peddling of alternative health solutions. The worst offenders: Consumers Union with their blog campaigns that scare people into noncompliance and hidden campaign to fatten the pocketbooks of trial attorneys, Joseph Mercola and his numerous snake oil solutions and well...the tort sharks themselves who hire firms to set up fake "consumer health site" that offer crappy health info but really collect data that they use to fill the FDA with questionable adverse drug events.

I linked to Jacob Goldstein's blog...one of the more reasonable sources

http://blogs.wsj.com/health/2007/06/13/in-a-switch-online-patient-groups-inform-researchers/

So if we shut down the right of drug companies to advertise then we will be left with all this responsible behavior AND Michael Moore.  Read More & Comment...

A NICE Example of Comparative Effectiveness CMS Style

06/13/2007 03:18 PM |

AEI's Joe Antos in The American on how quickly and conveniently CMS is using post market evidence on cancer drugs to suit it's needs and screw patients: "The CMS action is breathtaking for its speed and its incursion into the practice of medicine. As a long-time observer of CMS, and as a former official in the agency during the 1980s, I have never seen a proposal with this level of detail emerge from the thicket of clearances in such a short period of time. Perhaps CMS has found some new efficiency that permits it to release rules in record time?"

Want an idea of how patients will fare under this farce called a federally funded R and D center for comparative effectiveness, read Balancing the Budget on The Backs of Cancer Patients.

http://american.com/archive/2007/june-0607/balancing-the-budget-on-the-backs-of-cancer-patients  Read More & Comment...

Matt Release

06/13/2007 10:13 AM |

Note: This is Peter's blog...I am posting for him because his computer is experiencing technical difficulties that were not detected by meta analysis.

FDA reform, real reform, requires hard work, partnership, and candor -- not politics-as-usual.

As Matt Herper over at Forbes writes:

"One change that seems inevitable is the creation of more Steven Nissens--that is, more outside scientists looking over the FDA's shoulder. A Senate-passed bill from Senators Edward Kennedy (D--Mass.) and Michael Enzi (R--Wyo.) seeks to force manufacturers to make all study results public. Nissen was able to do his Avandia analysis because Glaxo, in order to get then New York attorney general Eliot Spitzer off its back, agreed three years ago to put drug-trial results up for public viewing. The bill would put all drug firms in this boat.

Think of this as the open-source FDA. Already outsiders have pinpointed valid safety issues, such as Vioxx. But open source can be an invitation to a lynching. AstraZeneca's blockbuster cholesterol pill Crestor was originally maligned over kidney worries but has since been cleared. Expect "a free-for-all" as academic researchers get more access to data from companies and from electronic health records, says FDA Deputy Commissioner Janet Woodcock. “You could imagine tort lawyers running those analyses," she says."

Matt’s article (“Lynch ‘Em”) can be found at www.forbes.com

Herper continues:

"Still, big pharma is backing the Kennedy-Enzi plan, which would also give the FDA more power to change drug labels and force companies to conduct studies. New Pfizer Chief Jeffrey Kindler praised the bill in a speech at the Economic Club of Washington, saying drug firms should absolutely support a bill that requires candor about clinical trials."

And candor is something this debate needs. And honesty and a focus on advancing the public health rather than settling private scores (both within the FDA and elsewhere).

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

Paging Dr. Moore ... Dr. Michael Moore

06/13/2007 07:18 AM |

Welcome to the Age of YouTube.

We will be doing regular podcasts, where we will ask experts as well as average folks what they think about some of the most pressing health care issues we face as a nation.

Oh yes, and some that aren't so pressing -- like whether or not Michael Moore should be trusted to direct American health care.

To view our initial effort, click on the link below and follow it to the "Podcast" box:

http://www.cmpi.org

Enjoy. (We did.)  Read More & Comment...

Accomplia

06/12/2007 01:23 PM |

Before you read any media reports, read Derek's balanced analysis of both the FDA and Sanofi's documents on the risks and benefits on Accomplia. As usual, he tees up the issue with insight and objectivity:

The incidence of suicidality – specifically suicidal ideation – was higher for 20 mg
rimonabant compared to placebo. Similarly, the incidence of psychiatric adverse events,
neurological adverse events and seizures were consistently higher for 20 mg rimonabant compared to placebo. . ."

They're also concerned about other neurological side effects, and seizures as well. The seizure data don't look nearly as worrisome, except in the obese diabetic patients, for whom everything seems to be amplified. And all of this happens at the 20-mg dose, not at the 5 (which doesn't do much for weight, either, as noted above). And for those who are wondering, yes, on my first pass through the data, I find these statistics much more convincing than I did the ones on the Avandia (rosiglitazone) association with cardiac events.

I had my worries about rimonabant a long time ago, but not for any specific reason. It's just that I used to work on central nervous system drugs, and you have to be ready for anything. Any new CNS mechanism, I figured, might well set off some things that no one was expecting, given how little we understand about that area."

Another important element that I think favors approval: Sanofi-Aventis is proposing labeling and prescribing limits to take into account the increased risk of a variety of pyschological side effects ranging from anxiety to suicidal thoughts (primarily among schizophrenics and others with a history of mental illness). Importantly, people in Accomplia trials had to go off antidepressants while on the drug so the label and risk management plan will limit use of the drug to people who are either on antidepressants or who are depressed. In Europe, compliance with such limits is around 95 percent.

Watch the fearmongers rise up and scream that no one should be allowed to have access to a drug that demonstrates the ability to reduce weight and glucose levels safely in a specific population. If Accomplia is NOT approved with the RISKMAP in place, with a pledge for post market studies and surveillance, no DTC ads for at least half a year, then what good is PDUFA?

Accomplia is a litmus test for the backbone of the agency and the political strength of the fearmongers.  Read More & Comment...

"Mo" Nonsense

06/12/2007 01:09 PM |

Previously we have discussed the half-baked and benighted ideas of Representative Maurice Hinchey -- author (along with Representative Bart Stupak) of a bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury (see blog entry "Slo Mo," posted on 5/21/07).

Well, he's at it again. Here's what he had to say yesterday ...

"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate."

This is anticipation of today's sitting of the House Energy and Commerce Subcommittee on Health.

A "Mo" untrue, unjust, and unfair statement is hardly imaginable.

The FDA is staffed with public health professionals on personal public health missions. They care, deeply, about safety and efficacy and about doing the right thing.

Mr. Hinchey, it seems, cares about headlines and hysteria.

An apology is in order.  Read More & Comment...

Rita Rubin Wrong Again

06/12/2007 12:49 PM |

I am trying to be nice... A kinder, gentler post that doesn't take media bias and laziness personally, that doesn't degenerate into childish namecalling...

Oh, screw it.

Rita Rubin's latest assault on the current PDUFA bill gets it exactly wrong.

"The FDA has essentially become the government affairs office of the pharmaceutical industry," Hinchey said in a statement, which called the relationship between the agency and industry "far too cozy and inappropriate." Hinchey is the author, and Bart Stupak, D-Mich., the chief co-sponsor of an FDA reform bill that would prohibit the agency from collecting fees from the companies it regulates. Instead, the money would be deposited into the general fund of the U.S. Treasury.

According to the Appropriations Committee, two officials of the Biotechnology Industry Organization and two officials of the Pharmaceutical Research and Manufacturers Association attended at least half of the 112 meetings."

Hey Rita, what's the punchline? So what? Did you ask how many times Hinchey and Stupak met with the lobbyists of organizations that are looking for earmarks from the Appropriations committee? Why don't Hinchey and Stupak post those numbers?

Now, unlike the done in the dark earmarking orgy, companies and the FDA are legally required to meet as part of the PDUFA reauthorization. But of course, the implication is that the companies run the show. Now if that were the case, if PDUFA were just a way to bend the drug approval process to the companies need, why have the percentage of drugs getting from Phase 1 to Phase 3 actually declined since PDUFA was implemented. Are companies deliberately conspiring with the FDA to take over the agency just to flush as much cash down the toilet as possible. Way to think through the logic, Rita!!!

Now extending that logic, should company representatives not meet with the FDA to discuss design of clinical trials, to explain endpoints, cooperate in sharing data to improve safety, design those safety trials the critics drool over while ignoring the need for new medicines?

I am one of those who actually agree that PDUFA has outlived its usefulness as a funding mechanism. It is too inflexible and keyed to one part of the drug development process. And it has not -- as I noted earlier -- done much to improve the efficiency of overall drug development (and that includes the efficiency of PM surveillance.) But don't believe - as the critics do -- that it has compromised safety. That is a silly and unscientific assertion.

I feel better now.

For the entire article go to: http://www.usatoday.com/news/health/2007-06-11-fda-drugmakers_N.htm  Read More & Comment...

Junk Vaccine Science on Trial

06/12/2007 08:18 AM |

I take strong objection to the AP Headline "Children With Austism Get Day in Court" which Forbes.com helpfully picked up.

Sorry to say, but this headline is misleading. It should be, tragically misguided and overzealous parents with the help of greedy trial lawyers pursue junk science on mercury-autism link. For the facts of the matter, folks should go to http://www.stats.org to see how most of the media coverage is giving way too much credence to the fringe group that has been pursuing this case.

The claim that mercury causes autism has as much science behind as the claim that witches and Jews caused the Black Plague in the middle ages. It has been investigated again and again. Like most safety signals, they were first detected by the same sort of people who see danger lurking in every public health advance, who see a government or corporate conspiracy to first introduce and then cover up the spread of the poison.

The case is only a first step towards a large junk science inspired civil court suit since the hearing this is before a federal vaccine injury compensation board (Rosemary Johan-Liang is now a medical reviewer with this board.:

My colleague Paul Offit, MD who developed the rotavirus vaccine -- who has been threatened with murder by autism conspiracy theorist crazed parents -- has a good article about the stakes in this trial.

http://www.boston.com/news/globe/ideas/articles/2007/06/03/at_risk_vaccines?mode=PF  Read More & Comment...

Blog Smog

06/11/2007 06:16 PM |

Interesting article in today's edition of the New York Times. Authored by David Carr, the column, "Call the Doctor" calls into question whether health care policy blogs help or hinder our national (and international) health care debate. He uses the Avandia situation as an example and, as it turns out, a rather personal one.

He went online looking for information, "And here is what I found: everything except insight."

Ouch? Not necessarily. What he writes is that he found a lot of "polarized discourse." And his point is that, from a patient perspective, it didn't really tell him what to do.

Maybe so, but it clearly made him think.

He quotes from (among others) drugwonks.com, newstarget.com, pharmalot.com, corante.com/pipeline, and peterrost.blogspot.com, so it should come as no surprise that he got a plethora of differing viewpoints. But what's a patient to do?

Here's how Carr ends his column:

"This Wednesday, I will see my endocrinologist. We will chat for a few minutes about Avandia and no doubt he’ll smile when I entertain him with all that I have learned on the Web. Then after he tells me what he thinks, I will follow my doctor’s orders."

And sanity prevails.  Read More & Comment...

3D Blinders

06/11/2007 02:18 PM |

India -- a nation known for its innovation in many areas -- has decided that incremental innovation in pharmaceuticals isn't important -- at least when it comes to patent protection.

In an interesting and important new paper, Trevor Jones (a member of the WHO's Commission on Intellectual Property Rights, Innovation and Public Health) points out that a new Indian law contains a clause (Clause 3D) that restricts innovation through incremental advances.

Here's a link to the complete paper:

http://www.law.gwu.edu/NR/rdonlyres/B1AA54BE-46F2-4203-964C-0430248BA36B/0/InnovationattheCrossroads.pdf

In short, unless the new medicine can show "proven additional efficacy," patent protection can be denied under 3D.

Now, besides being a pretty obvious violation of TRIPS (27-1 -- coincidentally the same clause used to shut down compulsory licensing in Canada, but that's another story), it's another example of how healthcare technology assesment (HTA) aka: evidence-based medicine (EBM) is being used to deny not only appropriate patient care, but now case patent protection.

And the two are linked because if you don't get the patent protection, the 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.

There's another link between 3D and evidence-based (read "cost-based") medicine, and that's the reliance on RCTs as the comparative evidence used to make the decision as to patentability (in the case of Clause 3D) or patient care (in the case of organizations such as NICE).

This is as much a Developing World issue as a First World one. Relative to treatments for HIV/AIDS Jones writes,

"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."

Before we deny care (or patents) to the new medicines that take us down the path of incremental innovation, let's remember that such economically-driven, short-term decisions can have deadly unintended consequences.  Read More & Comment...

FDA Departure Update

06/11/2007 11:51 AM |

Better coverage on Liang leaving the FDA which answers some questions I asked in an earlier post. .....Dr. Johann-Liang is leaving because she wants more regular hours consistent with her responsibilities as a parent with two autistic children. Harris' piece made it sound like she was driven out. Her new job is as a medical safety officer with the Vaccine Compensation Injury Board which of course will review claims of parents who believe their kids are harmed by vaccines and who often believe vaccines cause autism. http://www.usatoday.com/news/health/2007-06-10-fda-insider_N.htm?csp=34  Read More & Comment...

Why is Rosemary Johann-Liang Leaving

06/11/2007 09:45 AM |

She was not fired, though Gardiner Harris makes it seem like she was or at least force it. She is quitting. My prediction: She will reappear at some drug safety shop but not before being a star witness at a Senate hearing on her Avandia's warnings..  Read More & Comment...

Politically Incompatible Goals at the NY Times

06/11/2007 08:30 AM |

Re Gardiner Harris' article about the safety reviewers at the FDA (notice he did not mentioned David Graham):

First of all, I think Harris raises one set of important questions. Unfortunately, the analysis is "old school", the idea that FDA has two cultures nonsense that came out of the clueless and conflicted IOM panel (full of folks who failed to disclosed their connections to trial attorneys, Soros, Chubb,)... And ironically he proves his point: you want safety and efficacy to be reviewed at the same time, especially as you develop tools to make drugs more targeted in terms of risk and benefit..

In the wake of Avandia, companies had better wake up and realize that if they do not get ahead of the curve, stop being defensive about drugs, pretend problems don't exist, stop asking questions because they are afraid of the answers, other people will ask and answer those questions anyway. These questions are going to come fast and furious and will not die down after PDUFA is passed and certainly not in a Democrat administration. So companies had better step up their investment in targeting which drugs work best in which people -- to make medicines safer and to respond to a growing movement to impose comparative effectiveness on Medicare.

But people are also interested in life saving medicines. Would Harris - or has Harris -- ever written about the FDA reviewer leaving because a drug that could extend life or help someone suffering from disease -- where was he on Provenge -- as if he or she were a lonely crusader?

Has he ever looked at the scientific evidence surrounding SSRIs or Ketek ), the drug Ketek replaced (in terms of it's side effect profile) or the impact running to Congress and the media has on public fears about drugs or the drug approval process. In other words, is such reporting responsible? We go back to the fact that fewer kids are using SSRIs and that has been associated with an increase in suicides.

Given that most, if not all, safety signals cannot be confirmed, except through biomarkers and post market surveillance or huge randomized trials, what is the consequence of what is Harris effort to carry water for the IOM-trial attorney wing of the drug safety movement..."no signal too small to scuttle a drug approval or require a randomized clinical trial to establish drug safety" . Everyone knows what this will mean to drug development: fewer drugs that -- because companies are forced to do one size fits all post market studies and can't do adaptive trials for approval -- will have fewer targeted drugs on the market. That means more targets for headline seeking pols and tort seeking trial attorneys. It creates a permanent state of fear at the FDA.

To my way of thinking, people like Johann-Lianng, Ross and Graham aren't leaving fast enough...Let them have their 15 minutes of fame griping to Gardiner. And let them be replaced with biologically-based reviewers who don't think it's a sin to work with industry to improve the risk benefit profile of medicines.

The question is, can the NY Times ever run a story on the FDA that covers the safety story from this angle?

http://www.nytimes.com/2007/06/11/washington/11fda.html?pagewanted=2&_r=1&adxnnl=0&adxnnlx=1181564577-4YOVzl9UTftu+7qzVNmnvg  Read More & Comment...

Paris Hilton's Health Care Crisis

06/08/2007 10:25 AM |

According the NY Post Paris Hilton was ". let go because she was on the verge on a nervous breakdown."

The problem? Inadequate access to appropriate preventive care.

"..Hilton repeatedly pressed a medical-alert button, making herself a major nuisance, inmates said.

The Post quotes a friend: "It's so cruel what has happened to her. She wasn't allowed to wax or use a moisturizer. Her skin is so dry right now!"

If we had universal health care, this would not be a problem..  Read More & Comment...

WHO: Fake it before you can Make it

06/08/2007 09:42 AM |

Lot of debate going on globally on the subject of compulsory licensing of pharmaceuticals.

Most of the chatter focuses on what's going on in Thailand and Brazil -- but what about Switzerland?

Switzerland? Well, actually to be more specific -- Geneva. And to be even more direct, the World Health Organization (WHO).

The issue at hand is, who's going to make the drugs whose patents have been stolen by Brasilia and Bangkok?

And who's going to certify that these pirated products are safe and effective, manufactured to the highest public health standards?

In many cases, that certification process is handled by the WHO. But, while the WHO does say who passes their GMP tests -- the organization does not say who fails.

According to the folks at WHO, such transparency would deter facilities from applying for certification. That's nonsense. All that allows is for facilities that have failed to gain WHO certification to claim that they have applied for that global imprimatur.

And that allows many substandard facilities to fake it so they can make it. The result -- counterfeit and substandard medications for the less developed world. Not acceptable. Kind of like claiming "patent pending." (But maybe talking about "patents" is a mixed metaphor considering the circumstances.)

(Could you imagine if the FDA only sent out public notification for medicines that the agency approved?)

The folks down in WHOville need to step up to the plate and embrace transparency in their pharmaceutical GMP certification process.  Read More & Comment...

Steve Nissen Comparing Avandia to 9-11

06/07/2007 09:28 PM |

Click to view  Read More & Comment...

TB

06/07/2007 08:01 PM |

here's my latest thoughts on the TB patient and what the limited significance of the case is versus the massive importance of TB itself.

This was my Oped in yesterday's Boston Globe.

Flying clear of tuberculosis
By Marc Siegel | June 6, 2007

FOLLOWING the news of Andrew Speaker's honeymoon escapade, where he flew unchecked while harboring a resistant tuberculosis bug, many of my patients have begun to ask me what their risks are of catching TB on a plane. The simple answer I give them is "extremely low." Big HEPA filters screen out more than 99 percent of viral and bacterial particles, including tuberculosis. The risk of Speaker infecting another passenger when he reportedly wasn't coughing, had no fever, and was receiving some treatment is probably less than 1 percent. The chance of an actual case of serious TB resulting from this exposure is even less than that, as there has not yet been a single case of active tuberculosis found to be the result of exposure on a plane.


Speaker suffers from the extensively drug resistant kind of tuberculosis, which is quite rare, with only 49 cases reported in the United States since 1993. TB itself is common, infecting one-third of the world's population, with more than 8 million people getting sick from it every year. Even with billions of airplane passengers every year, the plane is an unlikely place for TB transmission. There have been several small studies that have followed exposure to active TB on planes. From 1992 to 1994, the Centers for Disease Control and Prevention followed six passengers and a crew member who had TB in their sputum and exhibited active symptoms. Of the 2,600 contacts of these TB patients (two were deliberately flying without alerting the airline, the other five didn't know they had TB), only a few people showed subsequent transmission of TB and none got sick.

These patients were not only much sicker than Speaker, they were spewing TB in their sputum. The gold standard of transmissibility is the presence of the tuberculosis bacillus in the sputum or mucous of a patient. Speaker has been tested repeatedly, and his mucous is clear.

I have worked on the Chest Service of Bellevue Hospital where Speaker was briefly interned. It is routine practice for doctors there to remove masks and allow patients to roam the ward and even go home once their mucous tests negative. Speaker was no different. Isolation only became necessary once it was determined that his TB was so resistant that none of the standard treatments work for it. The fact that his brand of TB is so difficult to cure makes it that much more important to prevent spread even to a single person.

Speaker's case is a wakeup call for improved patient compliance. TB drug resistance is a growing problem, in part due to patients stopping their medicines partway through the treatment. It is often the same patients who don't take their medicines who also don't exercise the proper caution and put others at some risk. This is a good time for public health to employ more advanced genetic techniques to detect all drug resistance earlier and then restrict travel on an as-needed basis.

It is also a good time for public health officials to learn to communicate risk through facts rather than fear. Because of media dramatizations of rare killers, we tend to overpersonalize the dangers of the latest mystery bacteria or virus. Worldwide, tuberculosis itself is well worth being afraid of, but the numbers in the United States are much lower (14,000 cases per year). Americans fear it more now because of the hype, much as we once feared anthrax, smallpox, Mad Cow Disease, bird flu, and SARS. It is human nature to fear the unknown, but it is not good science.

Our civil rights should protect us from excess scrutiny every time we board a plane. But fear and distrust tend to erode these rights, which is why it is so important that we draw the right conclusions from the Speaker case.

Tuberculosis, a tiny hook-shaped airborne bacteria, is transmitted by deep coughing and prolonged exposure. Initial infections are generally very mild and TB goes on to cause significant disease in only 5 percent of cases, many of whom suffer from HIV or other chronic diseases.

More than 2 billion passengers fly on planes every year, but there has yet to be a documented case of someone getting sick with TB from an airplane exposure. Though TB kills close to 2 million people per year worldwide and cannot be trivialized, the more important lesson from Speaker is about public and media overreaction to remote risks.  Read More & Comment...

Missin' Nissen...

06/07/2007 07:26 PM |

In case you didn't see it in many press accounts, here's some of the exchanges between Steve Nissen and members of the House Oversight Committee

Patrick McHenry, R-N.C.: At what point did you begin your conversations
with
Chairman Waxman and his staff?

Steven Nissen: In February, I had looked at the DREAM and the ADOPT
study,
but I didn't have enough information actually to answer the question
scientifically. ...At the time, I was discussing with various
congressional
committees the pending legislation around the similar version of the
Kennedy/Enzi bill on the House side, and so I mentioned to them I had
concerns about the cardiovascular safety of Avandia. And I actually
requested their assistance in getting access to the data. I had
essentially
a scientific mystery: I didn't have the means to answer the question in
a
robust scientific way, and I really was looking for help.

McHenry: Did you provide your interim analysis to any member of the
Hill or
staff?

Nissen: There were no interim results. Basically what we had done was a
very
preliminary analysis - nothing formal...

McHenry: Did you provide a preliminary analysis?

Nissen: Yes.

McHenry: At what point did you have that and did you share it with Mr.
Waxman's staff?

Nissen: The same time - February.

McHenry: So they were aware you were going through the process?

Nissen: They were aware.

McHenry: Why didn't you discuss your preliminary analysis with the Food
and
Drug Administration?

Nissen: The Food and Drug Administration had all of these studies on
record.
When you do a study, you submit a study report to the FDA.

McHenry: But you were actually submitting to a medical journal a new
study.
...You proffer your work as original do you not?

Nissen: It is original.

McHenry: Then why didn't you share that study with the Food and Drug
Administration? After all, as members of Congress we have a regulatory
structure we put in place for drug safety. Why didn't you go to the
FDA?

Nissen: This is not how it's done.

McHenry: So, going to Capitol Hill for political purpose to get
publicity
during a hearing is actually the way it is done?

Nissen: With all due respect, sir, this is about patients, and it's not
about politics....

McHenry: If it is about patients, why would you not go to the regulator
who
has the authority and oversight of drug safety?

Nissen: This is about patients - not politics. I had a preliminary
result. I
was looking for assistance to complete the study. When it was
completed, I
did what any scientist would do. I sent that for peer review and for
publication.

McHenry: What peers do you have on the Oversight and Government Reform
staff
- the Democrat staff? Because you shared your findings with them. Is
that
what you consider peer review? Is that what you consider putting
patients
above politics?

Nissen: I did not give out my manuscript to this committee or anybody
else
until it was published.

McHenry: It seems very peculiar to me that if you are considering the
patients first that you not go to the regulator who is overseeing drug
safety, that you would go to Capitol Hill ... and we don't have any
authority to take a drug off the market like the FDA does.

Nissen: The regulatory agency had all of the data that I had and much,
much
more. ...It made no sense for me to take study-level data and submit it
to
the FDA when they already had the patient-level data. So I would not
have
given them anything they hadn't had for many, many months.

Elijah Cummings, D-Md.: I hate that we have to make these accusations
that
people [are] putting politics over the health of the American people.
That
bothers me. ...Dr. Buse and Dr. Psaty you've heard this line of
questioning.
You've heard what Dr. Nissen has said. Do you all have any issues with
the
professionalism that he has [exhibited] doing what he has done to get
this
information published?

John Buse, University of North Carolina: I have no issues at all, and I
think he did a nice job of organizing data and setting out that it was
imperfect but important for people hear about.  Read More & Comment...

What's the 4-1-1?

06/07/2007 10:16 AM |

SO many things of interest from yesterday's House Oversight hearing, but by far the most memorable one was Dr. Steven Nissen answering a direct question with a direct answer.

The question was "Would you tell doctors to stop prescribing Avandia." And his answer was "No."

Indeed, the good doctor made the point that prescribing decisions should be made by a doctor in consultation with his patient and based on the available information.

We agree. It was a considered and measured response -- and under oath.

And we were surprised -- considering that it came from the same guy who a few evenings earlier on Nightline compared Avandia to "9-11."

We don't agree about that. It was a response considered and measured to maximize media coverage.

The take-away here is that there's too much hyperbole and hysteria out there right now -- and none of it's beneficial to anything other than politics. Scaring patients and physicians makes nothing safer. (Unfortunatly, it makes for terrific headlines.)

When it comes to advancing the public health, better to rely on 4-1-1 than 9-11.  Read More & Comment...

And hold the MSG

06/07/2007 09:42 AM |

China said late Tuesday that it was overhauling its food and drug safety regulations and would introduce nationwide inspections.

According to the New York Times, “The announcement, from the State Council, the nation’s highest administrative body, is the strongest signal yet that Beijing is moving to crack down on the sale of dangerous food and medicine and trying to calm fears that some of its exports pose health problems.

The government said in its announcement that it planned by 2010 to place new controls on food and drug imports and exports and to step up random testing on medicines. It also said that it would have information on inspections of 90 percent of all food products, although it was unclear how that would work.

Food and drug safety experts have complained for years about a flawed system that has led to food scares or mass poisonings tied to counterfeit or substandard medicines on the market.”

Here’s a link to the complete article:

http://www.nytimes.com/2007/06/07/business/worldbusiness/07safety.html?hp

If our political leaders are truly concerned about drug safety (as so many are and as many others claim to be) we should hold China’s feet to the fire and make sure these reforms (which sound good) are implemented – and with alacrity.  Read More & Comment...