Truth Under Attack At USA Today

01/17/2008 12:26 PM |

Predictably USA Today pushes the panic button on Vytorin

http://www.usatoday.com/news/health/2008-01-16-cholesterol-main_N.htm

But many doctors express frustration. They say they're increasingly asked to prescribe drugs like Vytorin, Zetia and Crestor though the drugs have never have been successfully tested in long-term trials. In the world of billion-dollar medicines, these have a nickname — "me-too" drugs, because they're purportedly like other drugs that have been more extensively tested.

Cholesterol-lowering drugs aren't the only culprits. A number of blood-pressure-lowering ACE-inhibitor drugs are riding on the coattails of the blockbuster Captopril. Zetia and Vytorin are me-too drugs that stretch the limits of the category. Although they were approved on the same basis as statins — for their power to lower bad cholesterol — they aren't statins. They work by an entirely new mechanism that Merck and Schering-Plough promote heavily to doctors and on television, though it's not as well-tested as the statin approach.

Doctors who prescribe them, and patients who use them, take it on faith that the drugs will protect them from heart attacks and prolong their lives, says Yale University cardiologist Harlan Krumholz.

"This is huge," he says. "It's a story of whether or not the profession is going to turn and say, 'We're not going to say me-too drugs are the same unless they prove it.' "


Meanwhile none of the articles picked up on the real reason why most drugs don't work for most people: genetic variations. Nor did they link this story to another important scientific one about cholesterol reported last week.

7 New Cholesterol Genes Found
Genes May Make Good Targets for New Cholesterol Drugs, Experts Say
By Miranda Hitti
WebMD Medical News
Reviewed by Louise Chang, MD

Jan. 14, 2008 -- Scientists have discovered seven genes that affect levels of HDL ("good") cholesterol, LDL ("bad") cholesterol, and triglycerides (another type of blood fat).

Several of those genes "are potentially attractive drug targets" to lower heart disease risk, write the University of Michigan's Cristen Willer, PhD, and colleagues.

Two of the newly identified genes only affect HDL cholesterol, one only affects LDL cholesterol, three only affect triglycerides, and one affects LDL cholesterol and triglycerides.....


....Willer and colleagues also noticed that genes for high LDL cholesterol levels were associated with greater risk of coronary artery disease, which makes heart attacks more likely.

"Nearly all of the gene regions that we found to be involved in higher LDL levels were also involved in coronary artery disease risk," Willer states in a news release. "This is a remarkable result and suggests that new drug therapies that target the genes in these regions will also help prevent coronary artery disease and allow people to live longer and healthier lives."

One day, it may be possible to tailor cholesterol and triglyceride treatments to a patient's gene profile, the researchers note.

Meanwhile, your doctor can check your cholesterol and triglyceride levels and give you advice about how to improve those levels through diet, exercise, and medication, if needed."

Not one article or news account discussed this important factor. It's easier just to make people panic and pick up on the old "me-too" drug issue.
http://www.webmd.com/heart/news/20080114/7-new-cholesterol-genes-found  Read More & Comment...

Google blocked at the NY Times?

01/17/2008 09:37 AM |

912 word story in today's edition of the New York Times under the headline, "Antidepressant Studies Unpublished."

Here's the first paragraph:

"The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found."

And later on:

"The finding is likely to inflame a continuing debate about how drug trial data is reported."

Here's the full story:

http://www.nytimes.com/2008/01/17/health/17depress.html?_r=1&oref=slogin

912 words and not a single one speaking to the fact that Lilly (per Prozac) was the first Pharma company to put all of its clinical trials on a public website.

Is Google blocked at the Grey Lady?  Read More & Comment...

Sanctimony About Vytorin's "Secret" Panel

01/17/2008 09:12 AM |

The increasingly insufferable Roy Poses pontificates again and again and again about how everyone who is a consultant to drug companies cannot be trusted. To point out how zealotry should not be confused with objectivity let us go through the following exercise using the deflation of the self-impressed Dr. Poses as an example, with pharmalot.com giving him the platform: " pretending a panel is independent, when potential or perceived conflicts may exist, is misleading. This only casts more doubt on the willingness of these two drugmakers to let the facts speak for themselves - and not spin or cloak info that should be fully vetted."

So by definition, any financial tie is a conflict or perceived conflict which transmutes into faulty or inaccurate data which cannot be trusted which in turn transforms into a drug that should not be taken. Which is why people should stop taking SSRIs, Avandia, Vytorin,

Now I guess that should also apply to Zocor, the forerunner of simvastatin, the generic version of Zocor, especially if we have a negative risk to benefit result of that drug right? This in keeping with the other Poses or Pharmalot principle that disclosure of all negative trial result are to the public good.

So here is a negative trial reported in JAMA in 2004 on Zocor

he myopathy rate of the 80-mg/d dose of simvastatin observed in the A to Z trial and the previously reported meta-analysis are not particularly surprising. For many years following its introduction, the maximum dose of simvastatin approved by the Food and Drug Administration (FDA) was 40 mg/d. However, in 1997 the manufacturer undertook a development program to study 2 higher doses of simvastatin (80 mg/d and 160 mg/d).8, 19-20 Although a favorable report appeared in the medical literature,20 development of the 160-mg/d dose was abandoned due to high muscle toxicity.8, 19 Although never reported in the scientific literature, the financial community was informed that the rate of muscle-related symptoms was 5.7% for the 160 mg/d dose.19 The dose of 80 mg/d of simvastatin was eventually approved, but in 2002, the FDA product label was modified to include warnings about concomitant medications than inhibit cytochrome P450 3A4, the major metabolic pathway for simvastatin elimination.21 This warning was provoked by cases of rhabdomyolysis when simvastatin was administered with 3A4 inhibitors.21"
It is important to reassure practicing physicians and patients that the unfavorable risk-benefit relationship observed in the A to Z trial does not in any way diminish the value of intensive statin treatment in secondary prevention, including ACS patients. There was a trend toward reduced events in the A to Z trial, a finding that supports the lower is better concept. The increased myopathy rate applies only to a specific dose of a single agent and should not tarnish this remarkable class of drugs.24 It must also be emphasized that simvastatin in doses of up to 40 mg/d has shown excellent safety and efficacy in a series of clinical trials. For now, though, the 80-mg/d dose of simvastatin should be used with caution, particularly because other effective agents are available. Finally, in an era when criticism of selective reporting of positive trial results is common,25 the A to Z investigators are to be commended for their prompt and thorough reporting of a critically important major trial that did not meet its original objectives."

Ok, so we know that high dose simvastatin, the same dose compared in the ENHANCE trial carries risks. But we are reassured that other agents are available and that the 80mg can be used with caution.

Now, the person who wrote that editorial on the A to Z study was a paid consultant to Merck.

Steve Nissen. Who was a consultant to Merck, Astra Zeneca, Pfizer, Sankyo, Sanofi, Eli Lilly, Takeda, Novo Nordisk, Atherogenics, Lipid Sciences, GlaxoSmithKline, Hoffman LaRoche, Kos, and Wyeth. Dr Nissen also has directed clinical trials in collaboration with Astra Zeneca, Pfizer, Sankyo, Eli Lilly, Takeda, Atherogenics, and Lipid Sciences.


The same person now trashing Vytorin.

Sorry to beat the same drug over and over again but the bloggers and MSM keep referring to the same sources as well. Their views are biased and dangerous. I trust the doctors and researchers drug companies pay as advisors ten times more than then the second guessers who would discourage patients from taking drugs because of a built in bias against perceived financial conflicts without even looking at street creds or expertise. That is prejudice, plain and simple. And at a fundamental level it suggests that anyone who consults for drug companies is a prostitute and endangers the public health.

That's not independence or objectivity. That's intellectual thuggery.

http://www.pharmalot.com/2008/01/that-secret-vytorin-panel-truly-independent/



http://forum.lowcarber.org/archive/index.php/t-206955.html









He claims the Vytorin results are doctored  Read More & Comment...

Well If Antidepressants Don't Work There's Always Scientology

01/16/2008 10:10 PM |

Here's Tom Cruise on Scientology's superiority...if this video doesn't make you believe in SSRIs -- or at least Jaegermeister -- nothing will.

http://gawker.com/5002269/the-cruise-indoctrination-video-scientology-tried-to-suppress  Read More & Comment...

Why Trials Are Often Negative

01/16/2008 09:14 PM |

From an editorial in the American Journal of Psychiatry.

Editorial
Demonstrating Drug Action
Carol A. Tamminga, M.D.


The questions that have arisen in the public and scientific literature lately about the use of SSRIs in children and adolescents are addressed for one of the currently available SSRIs by Wagner et al. The issue of whether it is effective to use SSRIs in childhood and adolescent depression has been repeatedly raised over the last years in the context of our field failing to produce clear efficacy answers in children. Depressed children are being treated with SSRIs in greater and greater numbers, without demonstrated efficacy in the age group. The difficulty of demonstrating efficacy with tricyclic antidepressants in children has fueled suspicions that there may exist an age-dependent resistance to treatment. The importance of this well-designed large study for therapeutic strategies in children and adolescents cannot be overstated. It is important that the methodology of this study is solid and the numbers adequate to test the efficacy question asked. The result that citalopram reduced depression more than placebo in this child and adolescent population provides a clear answer for physicians that will (in combination with results from additional studies) guide treatment decisions. It is especially gratifying to see an early onset of action at 1 week of treatment, suggesting an advantage that can be followed up in future studies. This study also set a high methodologic standard for psychiatric diagnosis in pediatric studies. It would be an understatement to say that more such studies are needed.

One would always wish for more in terms of information from drug trials in psychiatric diseases. A common physician complaint about these trials is that they fail to sufficiently inform clinical practice because of restricted entry criteria, fixed-dose design, and limited duration of treatment. It is true that initial registration trials have a goal of demonstrating superiority over placebo to become approved for the market. But this does not rule out additional Phase 4 studies done in large enough patient cohorts to fully inform pressing clinical issues. How do comorbid conditions alter drug response? What treatments are effective in medication nonresponders? What kinds of actions can be expected with long-term treatment? It will be important for industry to address these kinds of Phase 4 questions for clinical use as well as the registration trials.

One particular issue in our field makes informative clinical trials particularly difficult. This is that we do not know what exactly we are treating in terms of its biology. Psychiatric diagnoses are not based on molecular pathology (rather, phenomenology), and new drugs are not directed toward known, disease-related molecules (rather, toward hypotheses). Therefore, we may not be recruiting the correct patient populations for a particular treatment nor have a drug directed toward the disease pathophysiology. Moreover, we may not be measuring anywhere near the optimal outcome measures in our trials (e.g., consider the constraint of only measuring "fatigue" in the treatment of anemia, and not having a RBC count). Nonetheless, even though we do not yet have our molecular targets, we cannot give up on drug development. Indeed, we already have treatments for our diseases, and these may be better treatments than we deserve, based on the state of our knowledge. We need now to hone the treatments that we have and develop the valuable clinical trial methodologies to carry us into the future. Meanwhile, we need to translate the rich basic knowledge accumulating in neuroscience into advances for therapeutics.

http://ajp.psychiatryonline.org/cgi/content/full/161/6/943?etoc  Read More & Comment...

Negative Reporting About Iraqi Vets

01/16/2008 08:45 PM |

Can the NY Times be anymore hypocritical pontificating about drug companies cooking the books on clinical trials when it has transparently done so with respect in it's efforts to depict our soldiers as homicidal maniacs?

And this is not the first time that a so-called objective source has fudged numbers in favor of an agenda. A Soros-funded researcher was behind the oft-stated, inaccurate, but never retracted number of 450,000 deaths due to the Iraq war that ran in Lancet. Read this article from the National Journal about this debacle. In the report the authors also note a study that ran in Lancet by a guy who fakes a story on the heels of the Vioxx scare about the risks of other anti-inflammatory meds. The media bought it hook line and sinker because it wasn't pharma funded. I am sure Health Care ReSewer commented favorably.

Of course the research was not paid for by Pharma so there is no bias.

More on so-called objective no-ax to grind types who criticize us that receive Soros and tort lawyer funding later.  Read More & Comment...

Excuse Me For Being So Negative...

01/16/2008 07:13 PM |

The NEJM of medicine recycles the old story that many of negative studies about antidepressants were not published. That doesn't affect whether the drugs work or not. It does add to the distortion of what a negative study is and why they are negative. Most of the time they are negative because they simply confirm the hypothesis. Other times they are poorly designed or small studies of little statistical power. They don't prove that the drugs fail. There is a difference. Taken together they can often help guide who responds to what medicines or why not...which again is why we need the Critical Path.

To suggest that the failure to publish negative studies is part of a coverup is wrong and leads to fearmongering once again. We have been down this road. And journalists are once again raising unfounded fears about the safety and efficacy of drugs...leading people to die because they stop taking medicines because of the fearmongering the media has engaged in regarding vaccines, SSRIs, Avandia, Vioxx and Vytorin. As for the public relations benefit of publishing negative studies...there is none. Just the opposite. I am afraid the willingness to confuse negative studies with "doesn't work" will lead to further congressional and media assaults on the scientific process. We will all be sicker and more imperiled for it.


To wit:



Lawmakers Have Vytorin Questions
By ANNA WILDE MATHEWS
January 16, 2008 5:08 p.m.


Congress is investigating advertising for the cholesterol-busting drug Vytorin in the wake of a study that suggested the pill may have no advantage over a generic cholesterol-lowering medicine.

In letters dated today and addressed to Schering-Plough Corp. and Merck & Co., which jointly sell Vytorin, and to the U.S. Food and Drug Administration, Reps. John Dingell and Bart Stupak, Michigan Democrats, raised questions about the ads for the medicine. The news was first reported in The Wall Street Journal' Health Blog.


In the letter to the companies, the congressmen wrote that the House of Representatives' Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are probing the "withholding of clinical trial data that may significantly affect the medical management of hypercholesterolemia, as well as the use of misleading statement in direct-to-consumer advertisements for prescription medicines."

Vytorin is in the news this week after the results of a long-awaited study, called Enhance, indicating that the drug may be no better than a generic statin at slowing the progression of heart disease.

http://online.wsj.com/article/SB120051737443695313.html?mod=googlenews_wsj


Or this...courtesy of Time magazine via fearmonger Steve Nissen:

Tuesday, Jan. 15, 2008
Is Vytorin a Failure?
By Alice Park

After nearly two years of waiting, the results came out on Monday on the long-awaited heart drug Vytorin — and the news wasn't good. Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke.

To many experts, the results were both a surprise and a warning. "The fact that the trial showed a huge LDL" — or bad cholesterol — "reduction, and that things were still going the wrong way [as far as plaque buildup went] is stunning," says Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic and an outspoken critic of the delay in the release of the study results. "This study shows that it matters how you lower cholesterol, not just how much you lower cholesterol."

Right. It pays to release negative studies. At least the researchers put their name on the study. The same thing can't be said about Nissen.

http://www.time.com/time/health/article/0,8599,1703827,00.html  Read More & Comment...

Beware of All Innovations, Especially New Ones

01/16/2008 02:35 PM |

A non-addictive drug for chronic pain? A breakthrough that sounds too good to be true. And to make matters worse, it's an "just" an "incremental improvement on an existing medication." And horrors of horrors, the brains behind this Clifford Woolf -- one of the world's experts on the molecular pathways of pain -- has been (sorry to say) a consultant to several drug companies.

So obviously nothing he develops can be trusted. Particularly if it relies on techniques developed through partnerships created to promote the Critical Path via the Reagan Udall Foundation.

A poisoned source will only produce poison. Especially if the funding is from Big Pharma at any point in time it's forever tainted and untrustworthy. Everything else said and done and funded from all other sources can be relied on without a doubt.

So the rule of thumb(s) should be. Let us call them the Poses Postulates in honor of Roy Poses MD of the Health Care Renewal bog who believes that anyone who receives any funding from Pharma cannot be trusted.

Don't trust Pharma research or the researchers they pay.

Don't trust the drugs they produce or market since the FDA is nothing but a tool or client of Pharma.

Don't use any drugs, especially those developed since PDUFA was enacted since that institutionalized the incest.

So if and when these new pain drugs come out...those who abide by this ideological approach to prescribing should avoid these treatments out of precaution and principle.
Read More

Right Dr. Poses?  Read More & Comment...

Gray Lady or Grey Matter?

01/16/2008 01:05 PM |

Who do you trust? The New York Times editorial page or the consensus statement of the American College of Cardiology which said with regard to Vytorin:

"The study involved 720 patients with heterozygous familial hypercholesterolemia and showed no significant difference in the primary endpoint between patients treated with ezetimibe and simvastatin versus patients treated with simvastatin alone over a two-year period. The study was designed to prove that Vytorin could slow the growth of plaque in carotid arteries supplying the brain more than simvastatin alone. Media reports indicate that the results of the trial show no benefit from the combination of ezetimibe (Zetia) and simvastatin (sold together as Vytorin) over simvastatin alone.

The American College of Cardiology recommends that major clinical decisions not be made on the basis of the ENHANCE study alone."

According to the American College of Cardiology (ACC), this study deserves serious thought and follow-up. The overall incidence rates of cardiac events were nearly identical between both treatment groups, and both medicines were generally well tolerated. There should no be reason for patients to panic. The difference in IMT changes between the simvastatin group and the Vytorin group was 0.006 mm vs. 0.011 mm.

Health care professionals should speak to their concerned patients using this drug. The ACC is also releasing a public statement explaining that this is not an urgent situation and patients should never stop taking any prescribed medications without first discussing the issue with their health care professional. Further research will be needed in this area to provide conclusive evidence about which lipid lowering strategy is preferred (statin alone vs. statin plus ezetimibe).

Furthermore, the ACC notes that this trial is an imaging study and not a clinical-outcome study. Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin.

On the subject of endpoints and markers. The Critical Path is not about using surrogate endpoints. Anyone who has listened to Dr. Woodcock more than once knows it is about finding and qualifying biomarkers -- molecular and imaging -- that predict disease progression and outcome as well as response to treatment -- as well as developing novel statistical ways that can be deployed across divisions and technologies to advance understanding of technology impact on disease.

The issue in the ENHANCE study was whether or not imaging studies were accurate measures of disease progression in this small population. Nothing more or less. In this regard, development of better standards and predictive imaging studies will help advance their use in clinical trials. Also let's remember that Dr. Nissen, who has trashed the results might be a bit biased since his own imaging studies demonstrated a regression of atherosclerosis by reducing LDL levels with another drug, something the NY Times failed to point out. And let's remember Dr. Nissen also tossed out imaging studies in another clinical trial looking at plaque regression because they were unreadable, so he just looked at the results of the readable ones.

At the risk of repeating myself again and again -- here's a link to the story we repeated when the MSM was looking for a Vytorin coverup months ago.

http://www.thestreet.com/pf/comment/adamfeuerstein/10195643.html

The problem with the Atherogenic drug that Nissen worked on was the same one -- more or less -- the scientists running the ENHANCE study struggled with. Namely, the statistical correlation was hard to measure because of the unwieldy nature of the biomarker. In each study, patients taking the drug did better than patients taking a placebo on most endpoints, just not on the endpoint most difficult to measure. But unlike the Nissen re-analysis, ENHANCE did not do an interim analysis with fewer patients to produce a benefit. The debate was whether or not to chuck the analysis altogether because of questions about the reliability of the biomarker.

Which is what the Critical Path is all about.

No need to panic or disregard your doctor in favor of the medical advice dispensed by the fearmongers and Pharm-haters on the NY Times editorial page.  Read More & Comment...

Sperm Daddy Author Lectures Artificial Heart Inventor on Ethics

01/16/2008 11:58 AM |

As Mark Twain -- an author of choice here at drugwonks -- once said: "Presume you were an idiot. Then presume you were a member of Congress. But I repeat myself."

Can any be so stupid and petty as to quibble about having the inventor of the artificial heart promoting as important a drug as Lipitor?

Apparently Bart Stupak and John Dingell think it rises to a high enough crime to demand a congressional investigation. And Katie Watson of the Medical Humanities and Bioethics Program at Northwestern University agrees: "To have a celebrity physician associated with cardiac health telling me I need Lipitor and when it costs significantly more than a generic alternative that might be appropriate for me— that's a physician motivated by a paycheck, not by patient health."

Let it be noted that Ms. Watson is famous for her lecture "Playing Doctor: Improvisational Theater & the Medical Encounter" which was presented at the Searle Seminar Room in the Medical Humanites and Bioethics building. That's Searle, as in the drug company, better known as Pharmacia which is now part of...you guessed it...Pfizer.

But I digress. So apparently it is unethical to have a famous doctor who does not practice medicine promoting a brand drug that works. It is ethical to have someone playing doctor promote a generic drug that doesn't? Or how about a Nobel Prize Winner who is no longer licensed promoting a new drug? And how does Ms. Watson know if the Nobel Prize winner is motivated by a paycheck and not patient health? Is it wrong to accept a paycheck in the process of advancing patient care by being a spokesperson.

Back to Ms. Watson. " Katie is also the author of the screenplay Sperm Daddy, and a contributor to the TimeOut Chicago humor back page and the WBEZ news magazine 848." I wonder if she is motivated by a paycheck or patient health?

http://www.sirensimprov.com/katie.html  Read More & Comment...

Scorin' Vytorin

01/16/2008 11:10 AM |

Have a look at today’s New York Times house editorial, “Cholesterol Drug Bombs.”

http://www.nytimes.com/2008/01/16/opinion/16wed2.html?_r=1&ref=opinion&oref=slogin

There are a number of issues going on here, but pay particular attention to these two paragraphs:

“There are reasons to be cautious about interpreting these results. The number of patients was relatively small. And many of them may have used different drug treatments for years before entering the trial, possibly diminishing the effectiveness of adding Zetia …

The findings also raise doubts about the current belief that lowering cholesterol is the key to cardiovascular health. The study showed that Vytorin reduced bad cholesterol significantly more than Zocor alone. The problem was that it failed to reduce the formation of plaque.”

Here’s what well-respected cardiologist (and CMPI board chairman) Dr. Michael Weber has to say:

“The study with Vytorin looked only at surrogate endpoints, not morbidity and mortality. The ongoing clinical outcomes trials will answer the questions definitively. We must hope that the alarmist comments by certain opinion leaders quoted in the lay press will not compromise the integrity of these critical studies by intimidating the patients who have been enrolled. We should not forget that many people simply cannot use statins in full doses due to side effects, so properly studying Zetia and Vytorin is absolutely vital.”

As to whether or not clinical data was withheld (or as the Times writes, “cynically" sat on) is another issue altogether and cannot be allowed to muddy the far more important clinical questions.  Read More & Comment...

Rosa DeLauro's Udder Frustration

01/16/2008 07:04 AM |

Representative Rosa DeLauro has introduced the Cloned Food Labeling Act, which would require the FDA and the Department of Agriculture (USDA) to mandate that all food derived from cloned animals be labeled.

She’s not happy with the FDA’s stance on the safety of food:

“The studies on which the FDA is basing its assessment include very little information on the specific question of whether food from cloned animals is safe."

But, according to the FDA, the agency has "studies that show that the meat and milk from cattle clones and their offspring are as safe as that from conventionally bred animals."

The agency has been studying this issue in great detail for a very long period of time. In fact, many of the world's leading experts on this issue work at the FDA's Center for Veterinary Medicine. During my tenure at the FDA (which ended in 2004), this issue was already being deeply investigated and intensely debated.

Representative DeLauro, rather than shooting from the hip, should call the FDA and ask for a briefing.  Read More & Comment...

Gates Foundation to Invest in Orphan Drug for Global Illness: Yamada Affiliation Questioned

01/15/2008 02:51 PM |

How can we trust that the drugs will be safe or effective? Since Gates Foundation President Yamada is under investigation by Senator Grassley and Cong. DeLauro for his role in talking to Dr. John Buse about Avandia nearly a decade ago, obviously any money he doles out while at Gates must be considered tainted and therefore the results of any studies cannot be trusted. And if the orphan drug for sleeping sickness uses Critical Path steps developed by the Reagan Udall Foundation how do we know they actually are not steps that weaken standards of safety and efficacy to simply line the pockets of the company that the Gates Foundation gave the grant to? We all know that's what the Critical Path is all about: watering down standards so that foundations can give grants to companies who in turn can develop at cost an orphan drug that is neither safe or effective because it uses biomarkers.

http://www.nytimes.com/2008/01/08/health/research/08slee.html?_r=1&ref=health&oref=slogin  Read More & Comment...

How Transparent Should the FDA Be?

01/15/2008 02:39 PM |

I took Senator Grassley to task for suggesting that unhappy reviewers and other malcontents air the grievances and differences with FDA division decisions at AdComm meetings a while back. Now from the other side, people and companies who complain about the lack of consistent or guidance from the FDA regarding the reason for holding up an approval also want transparency.

Transparency is the refuge of those who, short of being able to control the outcome, want to at least try to control perception. The FDA needs less transparency and more consistency based on better science. And it needs leadership regarding the question of "Whose life and health care decision is it anyway?" The Critical Path is designed to help shift that decisionmaking to doctors and individuals.

What I'd like to know is, where do the presidential candidates stand on The Critical Path? Do they care? Or are they more interested in making sure there are cheap knock offs of old drugs and faster FDA inspections for UPS shipments of medicines ordered online?
http://www.fool.com/investing/high-growth/2008/01/14/score-one-for-dendreon-and-disclosure.aspx  Read More & Comment...

The Heart of the Matter on Vytorin

01/15/2008 02:26 PM |

While lots of folks are making much ado about whether or not to readjust the athero endpoint of the Vytorin study because of hard to read ultrasounds (remember Steve Nissen and Atherogenics?) the the results of the study demonstrate, once again, just how hard it is to use statins to get reversal of plaque. We need better drugs. Good article from cnn.com on what the study shows and don't. Ignore the Congressional witchhunt threats and the whining of the "Kill Pharma Even If People Die" bloggers...

http://money.cnn.com/news/newsfeeds/articles/djf500/200801141513DOWJONESDJONLINE000640_FORTUNE5.htm  Read More & Comment...

The Born Identity

01/15/2008 01:42 PM |

My book review of Embryo: A Defense of Human Life...

http://www.nypost.com/seven/01132008/postopinion/postopbooks/the_born_identity_433669.htm  Read More & Comment...

Contempt for Pharmaceutical Companies: The Right Stuff for Being President?

01/15/2008 01:09 PM |

Here are two of the qualities Leon Wieseltier in The New Republic like about about John McCain that make him a nearly ideal presidential candidate. "anxiety over the environment and contempt for pharmaceutical companies."

Contempt for pharmaceutical companies? And how does that translate into good public policy? Pushing for drug reimportation? Patent seizures?

I think there is a bit of projection on Leon's part but what prompts this hatred? What did drug company's do wrong that deserves contempt? I know this will tick off the whack jobs that equate anything that is sponsored by drug companies as a pollutant or a criminal activity, but I really would like to know.  Read More & Comment...

Dear Abby: No Comment

01/15/2008 10:07 AM |

The U.S. Supreme Court has, without comment, opted not to accept an appeal of Abigail Alliance v. von Eschenbach. This means the federal appeals court ruling that patients do not have a constitutional right to experimental drugs stands.

This is a tough, emotional issue and, with such heated rhetoric on both sides, it's easy to lose sight of the fact that everyone wants the same thing -- expanded access to drugs under clinical investigation.

That's precisely why, when I was at the FDA, we stopped calling clinical trials "compassionate use." It sounded too paternalistic. Allowing desperately ill patients into clinical trial programs shouldn't be an act of noblesse oblige it should be an act of civil society.

The question is, how to do so with greater alacrity and responsible, robust oversight.

When it comes to pharmaceutical safety, pure libertarianism isn't in the best interests of the public health. Expanded access to experimental drugs simply can't and shouldn't morph into total, unfettered access.

That doesn't mean the status quo is working. What it means is that the FDA needs to figure out a way to dramatically broaden and facilitate expanded access to experimental drugs under its review. And the Abigail Alliance and its supporters need to keep up the pressure to reform the current system.

We believe this is best done in a spirit of collegiality rather than a confrontational courtroom or in Congress.

And we believe the time for all parties to sit down for serious discussions is immediately. Lives hang in the balance.  Read More & Comment...

Fibromyalgia? What would Hillary say?

01/14/2008 08:52 AM |

Page One story in today's New York Times continues the debate over whether or not fibromyalgia is a "real" disease. After all -- it's just a "women's problem," right?

Why is this on Page One? Surprise! Because one of the storylines is about how evil drug companies (in cahoots with the FDA) are spending money creating and promoting drugs for this faux syndrome.

But there is one paragraph worth sharing. The focus is on why the FDA chose to approve Lyrica (pregabalin) -- with an indication for treating fibromyalgia -- over the objection of some (unnamed) junior reviewers.

“While pregabalin does present a number of concerns related to its potential for toxicity, the overall risk-to-benefit ratio supports the approval of this product,” Dr. Bob Rappaport, the director of the F.D.A. division reviewing the drug, wrote in June 2004.

Risk. Benefit. Fibromyalgia. Millions of women. Millions of dollars. After all, if Pharma can help -- then there must be a hidden agenda. Ergo, pitch it for Page One, baby.

Nonsense. What would Hillary say? Someone should ask her about this during the next debate?

At the end of the day, it's a balanced article and an interesting issue. Alex Berenson does a nice job. But there's nothing new. Isn't there any real news that can be reported on the wood of our nation's newspaper of record?  Read More & Comment...

Insta-Americans: The Television Show

01/14/2008 07:46 AM |

Click here:

http://www.kvue.com/video/index.html?vid=207443

Then look under "HealthVue Video: Experts: Know where your health info comes from."

And we do.  Read More & Comment...