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...

Meet the Pill

08/03/2007 09:13 AM |

Have a look at our two new podcasts -- and he beginning of our new "Know Your Pills" campaign.

They can be found at http://www.cmpi.org under the "Special Features/Podcasts" section.  Read More & Comment...

Another Reason To Allow Off Label Prescribing....

08/02/2007 10:17 AM |

"Sweden’s English-language news outlet reported in June that the government’s employment service had granted Roger Tullgren, 42, supplemental income benefits based on his illness of addiction to heavy-metal music. Tullgren said he had been addicted for 10 years but finally got three psychologists to sign off on calling his condition a disability. His employer now permits Tullgren to play his music at his dishwashing job."

http://www.kansascity.com/238/story/214321.html

I've heard that Zyprexa can be used to wean people off of Megadeth...  Read More & Comment...

Another Victory for Patients

08/02/2007 09:50 AM |

Tysabri gets Adcomm approval for Chrohn's disease....now it's time to undo the attack on acccelerated approval of cancer drugs that Padzur is leading.

http://www.forbes.com/business/feeds/afx/2007/08/01/afx3974633.html  Read More & Comment...

Phoning It In

08/02/2007 09:42 AM |

Here's how the Journal of Life Sciences introduces it's current web-edition cover story on FDA reform:

The FDA needs to rethink the way it communicates in an age of empowered patients.

MUCH HAS CHANGED over the past 25 years, but one of the immutables has been that FDA tries to communicate important health messages without the resources or attitude necessary to do it well on a consistent basis, according to Peter J. Pitts, president of the Center for Medicine in the Public Interest. A big part of the problem is that not only have communications tools changed, but so have people and society. He says the FDA needs to change as well.

Here's the rest of the story:

http://www.tjols.com/index.jsp

And the good news is that Commissioner von Eschenbach believes in strident and robust constituency outreach.  Read More & Comment...

The Washington Times on Steve Nissen and David Graham

08/02/2007 08:39 AM |

Drug-safety 'advocates'

Earlier this week, a joint session of two Food and Drug Administration advisory committees recommended that Avandia, one of two drugs that reduce insulin resistance, stay on the market with added information about which patients should avoid taking the medicine in order to reduce the risk of heart attacks. The recommendation, based on a careful evaluation of a massive amount of data, focused on whether it was possible to tailor the use of Avandia, which has helped people with diabetes stave off blindness, leg amputations and kidney failure, to groups of patients that might be a higher risk for heart problems.

It remains to be seen whether the measured recommendation puts to rest both the controversy and hysteria surrounding Avandia and the FDA. Dr. Steven Nissen simultaneously released his "study" about Avandia's supposed heart-attack risk and told ABC's "Nightline" that Avandia would kill more people than the September 11 terrorists. Dr. Nissen also shared his data with congressional Democrats and timed his study to come out in advance of the FDA's ongoing review of Avandia, which ultimately proved to be more rigorous, more detailed and more useful in making a decision about clinical use, a decision that ironically mirrors how the drug is being used already.

The fact is, Dr. Nissen and some drug-safety officials at the FDA did nothing to make medicines safer. Rather, their effort is designed to foment fear, politicize science and most immediately gain control over FDA in concert with politicians such as Rep. Henry Waxman and Sen. Charles Grassley. With Avandia, the gimmick was to hype the danger by claiming that meta-analysis, a statistical technique used to cherry-pick and then combine a number of short-term studies, should be the new gold standard for yanking drugs from the market. Such short-term studies were rejected by self-styled FDA whistleblower David Graham and the claims about heart problems associated with Vioxx. Dr. Graham's effort to bolster claims that Avandia could be pulled off the market with safety data on a completely different drug that had not been peer reviewed angered the committee members and exposed Dr. Graham as someone willing to suborn sound science for the sake of power.

It is time to investigate whether these self-proclaimed drug-safety advocates are acting in our best interest.

Nearly 75 percent of diabetes specialists report that their patients on Avandia are concerned, want to go off or have taken themselves off the drug. Many doctors have stopped prescribing or are afraid to prescribe Avandia because of lawsuit concerns. Tort lawyers are using media reports and the Nissen article to build their case against Avandia, though the FDA committee voted to keep it on the market.

Much has been said about the FDA being broken. In truth, those who want to usurp its power have vandalized it. They have undermined the public health and the integrity of medical science. Perhaps the FDA advisory action on Avandia will restore both.

http://www.washingtontimes.com/apps/pbcs.dll/article?AID=/20070802/EDITORIAL/108020002/1013

Thoughts and comments most welcome.  Read More & Comment...

FDA Bonus BS

08/02/2007 08:20 AM |

The hypocritcal statements being made by members of Congress about FDA staff bonuses are incredible. Let's set aside the fact that retention bonuses are used throughout governmenet and private sector. It is a well-known and poor reported fact that underpaid hill staffers get bonuses (usually around Christmas time) and that bonuses are often paid to retain the most senior staffers. If I were Dingell or Barton, I would not want someone to investigate how they have doled out bonuses.  Read More & Comment...

In Canada You Even Have to Wait to Commit Suicide

08/01/2007 05:45 PM |

Not making this one up...

Canadian man rescued after chaining self to tree

Wed Aug 1, 1:19 PM ET

"VANCOUVER, British Columbia (Reuters) - A man has been rescued after he spent nearly a week chained to a tree in a mountain forest near Vancouver in what police believe was a failed suicide attempt.


Hikers searching for a lost dog near the city on Canada's Pacific coast heard the 48-year-old man's calls for help late on Tuesday. They alerted police, who eventually needed a helicopter to pull the man out safety because of the difficult mountain terrain.

West Vancouver Police said the man told them he went to a remote area of the Vancouver suburb six days ago to take his own life and chained himself to the tree in the process.

His injuries were not considered life threatening."

And once again, animals get faster service than humans...  Read More & Comment...