Permission Impossible

02/28/2008 01:25 PM |

After a delicious buffet lunch of tunafish and ice tea, the inaugural meeting of the FDA's Risk Communications Advisory Committee returned to begin the second half of Day One with the open public comment portion of the program.

The first person to speak was a free-lance reporter who bitterly complained about the agency's "permission to speak" rule. This means that FDA employees cannot speak to reporters without permission.

Her main beef was that her calls were not returned promptly (if at all) and that access was often not granted -- at the discretion of a press officer and without explanation or justification.

Okay, a couple of points here.

First, of course FDA employees need permission before they speak to the press. This is appropriate otherwise chaos ensures. However, access should be denied only under the most limited circumstances -- and that denial should not be at the discretion of a press officer. In any event, access should be granted (broadly) or denied (rarely) with alacrity.

When I was at FDA, the press office reported to me. I held a meeting with all of the press officers and my prop was a telephone. I held it up and pointed out to the staff that the phone came with buttons "at no additional charge." My point was that reporter calls should be returned as soon as humanly possible.

A few years later, shortly after I announced that I was leaving the agency, I received a call from an FDA beat reporter who said she was sad I was leaving because, "I returned her calls."

Talk about a low bar.

It's not about "permission to speak," it's about permission to speak regularly -- and on deadline.  Read More & Comment...

Depressing Media Coverage on Depression

02/28/2008 12:12 PM |

While Peter was trying to calm the risk communication waters..here's my suggestion about embedding reporters: Don't.

There was some important research in JAMA about how 60 percent of adolescents don't respond to the first anti-depressants they receive but respond well to the second line of meds and cognitive behavioral therapy. That jives with earlier results of cross-over studies that demonstrate about 60 percent failure rate among depressed adults and their first SSRIs.
Read More


Of course that could explain why, in many studies, you get the zero effect vs placebo. That, and as Fred Goodwin has pointed out, the FDA refuses to allow crossover designs (adaptive trials of a sort) in neuropharm. And of course as genetic testing gets closer in antidepressants, as David Meltzer and others noted at a conference held by the ...that trial, error and miss approach to medication might be history.

But you had to search mightily for that story yesterday in the media or the blogosphere.

Instead, it was a sloppy meta-analysis (meta, as in sort of, analysis as in let the computer do it) of lots of placebo controlled trials of varying quality, design, exclusivity criteria that seemed to suggest what anyone who has taken an antidepressant knows is crap: they don't work. And of course while the media and the blogosphere sneer at the source research funding they are willfully blind to the incredibly poor study design of the meta-analysis in question as well as the limits of meta-analysis in general. Here's one of many hard sci bloggers piling on the silly stew of studies that was passed off as science.

"Way too loose of p-values for false positives in studies, in medicine (and social sciences) compared to natural sciences, is one reason to not read too much into any individual study that claims antidepressants are ineffective, like the Public Library of Science meta-analysis of individual studies did.

P-values of the same looseness as in medicine/social sciences have been used to claim intercessory prayer actually works on sick people (http://www.religioustolerance.org/medical6.htm), for example, or here (http://skepdic.com/refuge/bunk21.html)


"I’m not saying that the results of a meta-analysis are no stronger than the weakest study in its umbrella. I am saying that, with p values as loose as they are in health/medicine (and social sciences), is that no massive amount of individual research studies being included under one meta-analysis will make the meta-analysis’ results anything more than a little bit stronger than the best individual study.

In other words, in medicine, and in social sciences, meta-analysis adds a very modest bump, nothing more. The problem is, most people believe it does much more than that when it doesn’t.

Or, to put it another way, meta-analysis is no better than the material it’s analyzing."
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And here's another question: if they don't work, then why do they have such horrible but rare side effects? Is it really possible that drug companies just pumped drugs that were completely worthless except for the fact that they caused kids to commit suicide?

But that's precisely the mindset of the media and to even more greater extent http://www.pharmalot.com and http://www.fiercepharma.com. Both sites totally ignored the JAMA study and focused on the meta-analysis. The JAMA study was a randomized controlled trial and the meta-analysis...well what can I say except what my high school English teach used to say regarding the difference between Cliff Notes and a novel: that meta-analysis is to real research what masturbation is to sex. Does anyone do any analysis of related analysis anymore or are journalist and bloggers just posting the facts that fit their pre-conceived notions. Does it tell you anything that the meta-analyses are easy to churn out and rush into print just before, say, the next FDA meeting of import?

Such perspectives only encourage people not to take medicines or encourage them to stop taking them because they "don't work." It's irresponsible.

Oh yeah... Here's the study that made antidepressants worthless....
Read More

  Read More & Comment...

Embed with the FDA

02/28/2008 10:58 AM |

Blogging to you directly from the glamorous Gaithersburg Hilton and the inaugural meeting of the FDA's Risk Communications Advisory Committee.

Star of the morning was FDA Commissioner von Eschenbach.

Andy pointed out that the committee's work was "central and core" to the mission of the FDA -- specifically because it speaks to how the FDA crafts messages for the general public. And to that end the Commissioner commented that the FDA has to learn "not only what is the right thing to do -- but how to do it the right way."

The Commissioner spent much of his remarks on the general theme of "putting things into the proper context for the patient," pointing out that "trust is built on communication and dialogue." And he acknowledged that this meeting is taking place "at a time when there is an erosion of consumer trust in the FDA."

Sometimes stating the obvious is the best place to start. Confession, after all, is good for the soul.

"Help us dialogue," the Commissioner asked the committee.

Communications hint to Commissioner: "Dialogue" is not a verb.

To that end he shared that he has floated the idea of "embedded" reporters at the FDA -- and shared that the concept "sent shudders" throughout the agency.

He addressed the need to better balance risk communications so as to avoid unintended consequences, specifically the need to better consider the desire to communicate earlier versus communicating with less evidence and certainty.

Andy also announced that the FDA world shortly announce more details on the Sentinel Network on post-market surveillance. That's good news and long overdue.

The Commissioner also staked a claim to FDA's leadership in educating the American public to what he called "the doctrine of risk," calling for a national dialogue.

Amen again-- and God's Speed.  Read More & Comment...

Absent without Leave

02/28/2008 07:24 AM |

Two cheers for Congresswoman Rosa L. DeLauro for holding yesterday’s FDA oversight hearing.

Throughout her career, Representative DeLauro has expressed a brazen disregard for drug safety, continually calling on policymakers to open our borders to an uncontrollable influx of untested, impure, expired, and counterfeit drugs from around the world.

Today, however, drug importation was noticeably absent from the agenda.

Perhaps importation was left off the agenda because of the recent report that contaminated heparin, manufactured in China, is responsible for at least four deaths. Or perhaps she ignored importation because today’s hearing comes just one year after dozens of cats and dogs died of kidney failure after ingesting contaminated pet food -- and only one year after counterfeit Colgate toothpaste containing diethylene glycol infiltrated the U.S. market.

Regardless of her reasoning, it seems grossly irresponsible to grandstand for drug safety on one day and call for the importation of foreign drugs on another.

Let’s look at the facts. The World Health Organization estimates that eight to 10 percent of today’s global medicine supply chain is counterfeit. According to the Food and Drug Administration, that figure jumps to 50 percent or higher in some countries.

Without legalized prescription drug importation, the number of counterfeit drug investigations has increased four-fold since the late 1990s. Just imagine what will happen if such a thoughtless policy were codified.

Perhaps Representative DeLauro will take this opportunity to publicly denounce drug importation and take action to keep counterfeit drugs out of the U.S. medicine supply.

Perhaps not.  Read More & Comment...

William F. Buckley, Jr. -- A Personal Memory

02/27/2008 01:05 PM |

During my tenure at Hudson Institute, we held a National Press Club shindig in honor of Barry Goldwater. Among those invited was William F. Buckley, Jr. -- and the RSVPs came to me.

Returning from lunch with my father, a "Big L" liberal, I quickly went to check my voicemail as he puttered around my office. The first message caught my Dad's attention.

"Hello Peter. This is William F. Buckley and I will certainly attend the event for Senator Goldwater."

My father just smiled and said that he was proud of me.

Thanks Bill.  Read More & Comment...

The Risk of Risk

02/27/2008 12:46 PM |

According to a story in today’s Washington Post, “If it seems as though the Food and Drug Administration has been issuing a new drug safety warning almost every week, that's because, for the past three months, it has.”

“The uptick in advisories doesn't mean that drugs are more dangerous, says Paul Seligman, director of the FDA's Office of Drug Safety; it simply marks the fulfillment of a 2005 promise by Secretary of Health and Human Services Mike Leavitt to notify the public sooner when the agency learns of adverse reactions to approved drugs.”

"We are trying to act in a responsible way," Seligman says.

According to Representative John Dingell (D-Mich.), head of the House Energy and Commerce Committee, the recent increase in public communications "a quantum improvement." But as our friend Marc J. Scheineson, a former FDA deputy commissioner points out, now, the problem is the opposite, "so patients and their doctors will need to filter the news.''

And that’s the rub, because too much information can be as dangerous as too little.

According to the story in the Post, “Arthur Levin, head of the Center for Medical Consumers in New York, and other patient advocates welcome the information but worry that patients will simply stop taking a drug cited in an advisory. That's what many users of the diabetes drug Avandia did, according to Levin, after a well-publicized study several months ago warned that the drug might be tied to an increased risk of heart disease.”

In other words, fear and misunderstanding leads to non-compliance – a very dangerous unintended (but not unexpected) consequence.

Listen to Richard Platt, a professor of medicine at Harvard Medical School and chairman of the FDA's new Drug Safety and Risk Management Advisory Committee. In most cases, failing to take prescribed drugs "poses a far higher risk of complications and death than staying on a drug about which a question has been posed.”

Hopefully this and other crucial questions will begin to be addressed at tomorrow’s initial meeting of that advisory committee.

Here's a link to the complete article:

http://www.washingtonpost.com/wp-dyn/content/article/2008/02/22/AR2008022202686.html  Read More & Comment...

And the Yankees Need More Pitching

02/27/2008 12:32 PM |

"I think to do what we need to do requires substantially more dollars than what has been invested in the FDA thus far," Dr. von Eschenbach says. "This is a systemic overhaul that must go on over a period of years."  Read More & Comment...

Strange Numbers on Health Care

02/26/2008 04:34 PM |

In the recent on-line version of Health Despair there were two reports that seemed to send the same old messages: more folks unable to pay for increasingly expensive health care premiums. As Boomers move into Medicare, the cost will be unsustainable.

Wrong on both counts.



The U.S. Economy And Changes In Health Insurance Coverage, 2000-2006
John Holahan * Allison Cook insists the eroding insurance coverage is a matter of eroding wages and rising premiums.

Not so simple. Insurance coverage increased for kids and when you back out illegal immigrants the number is of uninsured kids is even lower. (I thought there was a SCHIP crisis!)


During the 2000-2004 period studied, the greatest percentage increase in adult uninsurance was among rich and middle class folks. 3.4 million increase in uninsured adults and children between 2004 and 2006, 700,000 were middle-income Americans and 800,000 were higher-income Americans. The authors fail to point out that there was an increase in people receiving coverage in the private market from 2004-2006 which is about the time HSAs began to expand. All other categories of coverage experience a decline. Except government coverage.

http://content.healthaffairs.org/cgi/content/abstract/hlthaff.27.2.w135v1

Turning to the growth in medical spending in the article: Health Spending Projections
Through 2017: The Baby-Boom Generation Is Coming To Medicare

The article states: "The primary drivers of personal health care spending growth during the projection period are medical prices and utilization, followed by smaller impacts from population growth and the age-sex mix."

Gee, I thought it was disease.

"As a result, health is projected to consume an expanding share of the economy, which means that policymakers, insurers, and the public will face increasingly difficult decisions about the way health care is delivered and paid for."

But what about technologies that reduce the burden of disease even as they increase life expectancy? Here's what another article in Health Affairs noted:

"A sixty-five-year-old with a serious chronic illness spends $1,000-$2,000 more per year on health care than a similar adult without the condition. However, cumulative Medicare payments are only modestly higher for the chronically ill because of their shorter life expectancy."
http://content.healthaffairs.org/cgi/content/abstract/hlthaff.w5.r18

There are signals all over the place that our health care system has reached a tipping point on its own, pushed by consumers, mainly boomers, towards prevention, value, personalized care. The point would be to unleash this power by giving this generation and the next more control over the course of their health and care. Why not reward people for staying healthier, longer? Yet we are setting up a regulatory and reimbursement system that discourages such advances.

The closer we move to prevention and prediction, the more valuable health care becomes. The more we spend on more effective care the better off we are. If we spend 30 percent of out GDP on such things, isn't that better than spending 30 percent of it on services and technologies like heart and lung machines, drugs that only work half the time in half the people? Yet that is exactly where the command and control models of European, Canadian and Medicare want to take us.  Read More & Comment...

Name The Pfizer Replacement...

02/26/2008 09:38 AM |

My choice is Bill Clinton...for three reasons... He went off Lipitor only to have bypass surgery and secondly, who better than to correct "misimpressions" and appease Democrats. (Viagra would be a better choice but...let's keep it real.) Third, Jennifer Garner is way too young even though she can probably do her own rowing...  Read More & Comment...

The Conflict of Interest Police: Pharmaceutical Profiling

02/25/2008 09:49 PM |

The American Diabetes Assn. cautions against making treatment changes based on the differing result of two large studies on glycemic control. So far no on has accused the ADA of making that statement because of their sponsors are. Why the same allegation leveled at specialty groups when it comes to the ENHANCE study. Because the conflict of interest police engage in pharmaceutical profiling...plain and simple.

Want more evidence?

COIPs ignore the conflicts of Steve Nissen because he is their tool.

And when it comes to policing academic conflicts why is it ok for IOM Prez Harvey Fineberg to take money and a free trip to the Caribbean from the same foundation that is underwriting the study on conflicts of interest for the IOM where he hung out with the some of the other people who are also underwriting the rest of the IOM's program in this area only to sit in judgment on the same issue. And these are the people and foundations that are setting the agenda on conflict of interest in continuing medical education? We should take their views on who gets to say what seriously?

And what does that say about those in the media and the bloggers who do nothinb but cover pharmaceutical conflicts?  Read More & Comment...

“Oar" Competencies

02/25/2008 03:24 PM |

Pfizer is yanking the Jarvik Lipitor ad. Done in, it seems, by “OarGate.”

Commenting on the withdrawal of the Jarvik advertising and promotion, Pfizer’s President of Worldwide Pharmaceutical Operations Ian Read said:

“ … the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue on the leading cause of death in the world -- cardiovascular disease. We regret this. Going forward, we commit to ensuring there is greater clarity in our advertising regarding the presentation of spokespeople.”

In other words, the frivolous brouhaha over whether or not Dr. Jarvik can row. A bad creative decision? Certainly. But what are the unintended consequences of this pseudo-debate and Pfizer’s decision to pull the ad? First, it further feeds the resolve of the “Ban DTC” bund and, secondly and more importantly, may very well negatively impact current statin compliance levels while detering people from asking their physicians about high cholesterol.

And so the question to those enjoying the media feeding frenzy on this issue is -- are the negative public health consequences worth it?   Read More & Comment...

General GAO's Chicken Part II

02/25/2008 08:57 AM |

From The Riverside Press-Enterprise ...

For safety's safe, keep out drug imports

Sunday, February 24, 2008

By PETER PITTS

A couple of weeks ago, the Government Accountability Office delivered an alarming message to a congressional panel -- the Food and Drug Administration lacks the resources to ensure the safety of the nation's food, drugs and medical devices.

Congress has vowed to fix the FDA. It plans to boost its funding, which is a good start. But those efforts will be more than undermined if Congress legalizes drug importation, which it may try to do this month. Attempting to screen imported prescription drugs would stretch the FDA's abilities to their breaking point.

Just as the agency's workload has surged, its budget has shrunk. The FDA's congressional appropriations have declined $400 million in inflation-adjusted dollars in the last 14 years. But its responsibilities have increased substantially, thanks to more than 100 congressional measures expanding its regulatory scope over the last two decades.

Those budget cuts translate to 1,311 fewer workers today overseeing an ever-expanding territory. About 80 percent of all drugs sold in the U.S. are manufactured abroad, but the FDA has only 380 inspectors -- a decline of 28 percent since 2003.

Consequently, the FDA cannot inspect the factories of foreign drug makers as frequently as it should. According to the GAO, only 7 percent of the more than 3,000 foreign drug factories registered with the FDA are inspected in any given year -- which means that more than 13 years could pass between inspections.

By contrast, domestic drug makers receive at least one FDA inspection every two years.

The FDA's inability to monitor the 714 Chinese drug makers subject to agency rules is especially worrisome. Just 13 of them -- 1.8 percent -- were inspected in 2007, according to the GAO.

That's not comforting news for American patients. The World Health Organization estimates that 10 percent of the world's drug supply is counterfeit, and many, if not most, of these fakes are made in China.

For example, it was recently reported that a Chinese drug company manufactured an anti-leukemia drug that left nearly 200 Chinese injured. Ordinarily, this would not have raised headlines in America. But the Chinese firm in question was also the sole supplier of the abortion pill RU-486 to the U.S.

Given how few foreign inspections the FDA conducts -- especially in China, where the risks are greatest -- the likelihood of a medical calamity befalling Americans is far too high. How can Congress possibly believe drug importation would be safe? Foreign-made pills would flood U.S. borders.

That means even more foreign packages potentially containing fake or harmful drugs will enter the country without being inspected. The John F. Kennedy Airport Mail Facility receives about 40,000 foreign shipments thought to contain drugs each day. Only 500 to 700 of them are inspected. It makes no sense to expand inspection responsibilities when the FDA can't cover its current ones.

Approving the drug-importation bill might push the agency over the edge. Now is not the time to saddle it even further with the impossible task of adequately screening drug imports. Americans can't afford it.

Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.  Read More & Comment...

Over-Drugged?

02/24/2008 01:17 PM |

For those who believe drug companies are disease mongering....

Memory Loss And Other Cognitive Impairment Becoming Less Common In Older Americans

Memory loss and thinking problems are becoming less common among older Americans. (Credit: iStockphoto)

ScienceDaily (Feb. 23, 2008) — Although it's too soon to sound the death knell for the "senior moment," it appears that memory loss and thinking problems are becoming less common among older Americans. A new nationally representative study shows a downward trend in the rate of "cognitive impairment" -- the umbrella term for everything from significant memory loss to dementia and Alzheimer's disease -- among people aged 70 and older.

The prevalence of cognitive impairment in this age group went down by 3.5 percentage points between 1993 and 2002 -- from 12.2 percent to 8.7 percent, representing a difference of hundreds of thousands of people.

And while the reasons for this decline aren't yet fully known, the authors say today's older people are much likelier to have had more formal education, higher economic status, and better care for risk factors such as high blood pressure, high cholesterol and smoking that can jeopardize their brains.

In fact, among the 11,000 people in the study, those with more formal education and personal wealth were less likely to have cognitive problems.

Interestingly, the more-educated seniors who had cognitive impairment were more likely to die within two years. But the researchers say this may actually result from a protective effect of better education on a person's "cognitive reserve" -- their ability to sustain more insults to their brain before significant thinking problems arise.

The study is published February 20 online in the journal Alzheimer's and Dementia by a team led by two University of Michigan Medical School physicians and their colleagues. The study is based on data from the Health and Retirement Study (HRS), a national survey of older Americans funded by the National Institute on Aging and based at the U-M Institute for Social Research (ISR)....

.....At the same time, the use of cholesterol-lowering drugs, blood pressure medications and other preventive cardiovascular medications and strategies increased dramatically in the 1990s. These factors may have helped protect seniors' brain function by decreasing the incidence of vascular dementia -- cognitive problems brought on by mini-strokes, strokes and decreased blood flow to and within the brain due to "hardened" or clogged arteries.


Better living through chemistry.

http://www.sciencedaily.com/releases/2008/02/080220121317.htm  Read More & Comment...

Tabloid Medicine

02/22/2008 10:08 AM |

Connecting the dots cuts both ways. But we bet we won't see or hear much response...from any quarter. Sometimes shame can be measured in silence.

http://www.washingtontimes.com/article/20080222/EDITORIAL/967933181/1013

Tabloid medicine

February 22, 2008

By Robert Goldberg and Peter J. Pitts

After serving for more than 12 years in the Army and the Army Reserves, 32-year-old Julianna Gehant enrolled at Northern Illinois University last fall. This week she was laid to rest along with four other victims of Steven Kazmierczak's killing spree. To add to the already tragic nature of the story, a former professor described Kazmierczak as a most gentle, quiet guy in the world. Harder still to assign blame or responsibility. Or is it?

Kazmierczak had a history of mental illness, including institutionalization. He did not take his medication regularly, and weeks before the killings he went off his antidepressants.

Much like the killer at Virginia Tech, the signs were all there. So, too, was the groundwork laid by the media, freelance pundits and by some in Congress to irresponsibly scare people away from taking the medicines that very well could have kept such anti-social homicidal behavior in check.

Less then four years ago, there was plenty of media airtime and political effort invested on Capitol Hill trying to scare teenagers and their parents from taking the most commonly prescribed anti-depressants — selective serotonin reuptake inhibitors (SSRI), such as Prozac, Paxil and Zoloft. It was alleged by Rep. Bart Stupak and Sen. Charles Grassley that there was conspiracy of silence between drug companies and the Food and Drug Administration to hide information about SSRIs turning otherwise happy kids into potential suicides.

Here's an inconvenient truth: Suicide is a leading cause of death among young people. The good news is that it's both treatable and preventable — particularly with the timely and appropriate use of antidepressants. But what parent or troubled kid would, in the wake of the concerted campaigns of Messrs. Stupak and Grassley, want to do so? In 2004, for instance, at a hearing where the FDA was accused of conspiring with drug companies to hide data about how SSRIs caused suicides, Mr. Stupak threatened to introduce legislation banning the prescribing of antidepressants to anyone under age 18 "if the FDA didn't act forcefully and swiftly to protect America's children."

Indeed, Mr. Grassley claimed there was a coordinated effort by the Food and Drug Administration to suppress the truth about the suicide risks of antidepressants. He gave top billing to internal FDA studies that looked at the relationship between SSRIs and suicidal thoughts but claimed it looked at suicide.

And so the New York Times dutifully reported the "risks of suicide" posed by SSRI and the Los Angeles Times claimed "Suicide Risk to Children Affirmed."

Not surprisingly, the hearings and the coverage lead to panic and, predictably, noncompliance. Ultimately, the FDA accepted an advisory committee recommendation to require that all antidepressants carrying a Black Box warning that they increase the "risk of suicidal thinking and behavior ... in children and adolescents" with depression and other psychiatric disorders. A decline in SSRI prescriptions followed.

Then, last year, Robert D. Gibbons, director of the Center for Health Statistics at the University of Illinois at Chicago, found that suicide rates among American youths dramatically increased from 2003 to 2004, coinciding with a steep drop in antidepressant use.

The 19 percent increase in suicides among those 19 and younger is the biggest year-to-year increase seen since the Centers for Disease Control and Prevention started tracking the data in 1979. A similar jump in suicide — and decline in antidepressant use — was found in Europe over the same period of time.

Curiously, neither Mr. Stupak nor Mr. Grassley commented on this connection and it was all but ignored by the media and other self-appointed guardians of medical truth.

The FDA's black box is not killing kids. But the collective actions and rhetoric that lead up to it are. Darryl Regier, the former director of the National Institute of Mental Health, notes, "Contrary to expectations, other treatments, such as alternative medicines or psychotherapy, which have limited effects on childhood depression, did not increase to fill the gap."

That gap was created by Congress and irresponsibly spread by sensationalist media coverage. When senior leaders within the FDA to tried to balance benefits and risks on antidepressants they were savaged by Messrs. Stupak and Grassley. And when the FDA tries to explain the complexities of Ketek or Avandia, Mr. Stupak demands resignations — in speeches that still include the claim that that antidepressants cause suicides. Drug-company lobbyists counsel cowardly silence. Science and common sense give way to tabloid medicine.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest. Robert Goldberg is vice president for research programs at the Center for Medicine in the Public Interest.  Read More & Comment...

Weber Grills

02/22/2008 08:18 AM |

Medicine is often practiced in broad strokes where the individual patient is sometimes left out of the equation in determining what kind of treatment is most appropriate.

Based on the findings of randomized clinical trials, physicians may prescribe a medication that has been shown safe and effective – on average -- in large population groups.

Whether an individual actually benefits or suffers from the medication is another question. A drug that may be the acknowledged standard treatment for the many who suffer a given disease could be completely inappropriate, if not lethal, for a specific patient.

Now, a new field has emerged that is starting to revolutionize how medicine is practiced. Advances in the ability to study an individual’s genetic code have enabled researchers and other health professionals to personalize treatment to that patient. Physicians will be able to select the most effective medications that are able to provide the most benefit with the fewest side effects. Moreover, such information can allow doctors to identify pathways for preventing illness long before it starts.

Health policy analysts, physicians, pharmaceutical company executives, business leaders and government officials recently met in Washington at the CMPI-Duke University Patient-Centric Leadership Forum to discuss developments in this exciting field.

A full report will be available shortly. But to whet your appetite, we will begin posting some of the comments made at this event. First off, the introductory remarks of Dr. Michael Weber, Chairman, Center for Medicine in the Public Interest, Professor of Medicine, SUNY Downstate College of Medicine Brooklyn, New York

“Many of us who practice medicine have been living for some time now with what some people call the “burden” of evidence-based medicine, which apparently is derived from the results of large clinical trials.

These trials typically show that the small group of patients who seem to get some particular benefit from one form of treatment might do somewhat better than another small group of patients who might get benefits from another form of treatment. Most patients and their needs are not well addressed by large clinical trials. Too often, these huge studies fail to give clinicians useful guidance in the management of their individual patients. But the whole idea of personalized medicine is going to change that.

In my own field of cardiovascular medicine, we’re told by the National Institutes of Health (the JNC Guidelines) that we should use thiazide diuretics as universal treatment to start off hypertension management. Yet, another government agency, the Veterans Administration, has shown that these drugs are not different from placebo in terms of reducing blood pressure in Caucasians under the age of 60. Why would NIH make the global recommendation to use such a drug? It’s based on so-called evidence-based medicine, where in one large trial (ALLHAT) performed in older patients it was shown that this particular treatment was not significantly inferior to other types of treatment in terms of heart disease and strokes. Unfortunately, issues of study design, uncertainty about the diagnosis of clinical endpoints, differences in outcomes among the patient groups enrolled in the trial and controversies over the interpretation of findings have made this “evidence” of little value to practitioners.

It makes so much sense to talk about personalized medicine, and yet there are major groups of people who don’t necessarily warm to the idea. The big pharmaceutical companies are certainly going to have re-think the blockbuster approach to medicine. It’s very convenient to think of diseases like hypertension, where there are tens of millions of potential candidates for a drug, likewise asthma or diabetes or arthritis or peptic ulcer disease.

But what if we now take these conditions and divide them into 20 or 50 or 100 different subtypes, each of which is going to require a special approach to therapy? Suddenly, Big Pharma is going to be competing with dozens or hundreds of smaller companies, each of which has identified one of these particular small subtypes and has designed a unique treatment for it. Large companies are going to have to change their way of thinking quite dramatically. So will the insurance companies have to rethink where they stand. There is no question that personalized therapies are going to be more expensive, because overall there will be much more work needed to address the multiple patient subtypes, and relatively fewer patients in each case to amortize the cost of investment.

Even practicing clinicians may resist patient-centric medicine in an environment where it’s often necessary to see large numbers of patients every day because reimbursement rates for each patient are so meager. With only a few minutes to spend with a patient, who’s got time to worry about individualized medicine? “Thiazide diuretic for you, my friend, and don’t hurry back!” Changing our approach is not going to be easy.”  Read More & Comment...

Not the real FDA – a Grahamatization

02/21/2008 01:42 PM |

Interesting omnibus piece from by Warren Ross of Medical Marketing & Media on the various slings and arrows being tossed at the worlds premier medical regulatory agency.

Here’s the first paragraph:

The FDA seems to be under fire from all sides these days, with everyone from drug industry pooh bahs to would-be watchdogs nipping at its heels. The agency, some charge, is going slow on approvals due to a risk-averse culture deepened through the experience of Vioxx and other product safety crises. Resignations are up, morale is down and the put-upon bureaucrats are laying low, the story goes. Others complain that reviewers are subject to political and corporate pressure through PDUFA and a nefarious web of relationships.

And here’s a link to the complete article:

http://www.mmm-online.com/Whats-Up-with-the-FDA/article/104861/

Here’s what I had to say about the David Grahmatization of the whistleblower culture:

Pitts also takes a dim view of people who go outside the agency to complain. A professional, he maintains, should not “weep and whine and try to get decisions made that are based on politics rather than on science.” Whistleblowers, he acknowledges, at least deserve “grudging respect” for letting it be known who they are, “but what is truly damaging are the silent leakers” who try to force political pressure on FDA decisions. “The motive may be either to get drugs approved or not approved—it cuts both ways.”

As Jimmy Durante said, “I’m surrounded by assassins.”   Read More & Comment...

There May Be Blood

02/21/2008 11:16 AM |

Previously on drugwonks.com we’ve asked what the difference is between “universal” health care and “government” health care.

We also sent our intrepid intern (dressed as a pill) out to the Macy’s Thanksgiving Day Parade to ask average citizens the same question.

Here's a link to our podcast:

http://www.cmpi.org/OnthestreetDetail.asp?contentdetailid=595&contenttypeid=16

The answer is that the only difference is a rhetorical one.

But in the United Kingdom – there’s a tragic difference, NHS “government care” isn’t universal at all when it comes to the ability of a physician to prescribe the most effective medicine for a patient – because they can’t choose from a “universe” of treatments.

Consider these paragraphs this from today’s New York Times:

Paying Patients Test British Health Care System

LONDON — Created 60 years ago as a cornerstone of the British welfare state, the National Health Service is devoted to the principle of free medical care for everyone. But recently it has been wrestling with a problem its founders never anticipated: how to handle patients with complex illnesses who want to pay for parts of their treatment while receiving the rest free from the health service.

Although the government is reluctant to discuss the issue, hopscotching back and forth between private and public care has long been standard here for those who can afford it. But a few recent cases have exposed fundamental contradictions between policy and practice in the system, and tested its founding philosophy to its very limits.

One such case was Debbie Hirst’s. Her breast cancer had metastasized, and the health service would not provide her with Avastin, a drug that is widely used in the United States and Europe to keep such cancers at bay. So, with her oncologist’s support, she decided last year to try to pay the $120,000 cost herself, while continuing with the rest of her publicly financed treatment.

By December, she had raised $20,000 and was preparing to sell her house to raise more. But then the government, which had tacitly allowed such arrangements before, put its foot down. Mrs. Hirst heard the news from her doctor.

“He looked at me and said: ‘I’m so sorry, Debbie. I’ve had my wrists slapped from the people upstairs, and I can no longer offer you that service,’ ” Mrs. Hirst said in an interview. “I said, ‘Where does that leave me?’ He said, ‘If you pay for Avastin, you’ll have to pay for everything’ ” -- in other words, for all her cancer treatment, far more than she could afford.

Officials said that allowing Mrs. Hirst and others like her to pay for extra drugs to supplement government care would violate the philosophy of the health service by giving richer patients an unfair advantage over poorer ones.

Patients “cannot, in one episode of treatment, be treated on the N.H.S. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs,” the health secretary, Alan Johnson, told Parliament.

But Mrs. Hirst, 57, whose cancer was diagnosed in 1999, went to the news media, and so did other patients in similar situations. And it became clear that theirs were not isolated cases. In fact, patients, doctors and officials across the health care system widely acknowledge that patients suffering from every imaginable complaint regularly pay for some parts of their treatment while receiving the rest free.

“Of course it’s going on in the N.H.S. all the time, but a lot of it is hidden — it’s not explicit,” said Dr. Paul Charlson, a general practitioner in Yorkshire and a member of Doctors for Reform, a group that is highly critical of the health service. Last year, he was a co-author of a paper laying out examples of how patients with the initiative and the money dip in and out of the system, in effect buying upgrades to their basic free medical care.

“People swap from public to private sector all the time, and they’re topping up for virtually everything,” Dr. Charlson said in an interview. For instance, he said, a patient put on a five-month waiting list to see an orthopedic surgeon may pay $250 for a private consultation, and then switch back to the health service for the actual operation from the same doctor.
“Or they’ll buy an M.R.I. scan because the wait is so long, and then take the results back to the N.H.S.,” Dr. Charlson said.

In his paper, he also wrote about a 46-year-old woman with breast cancer who paid $250 for a second opinion when the health service refused to provide her with one; an elderly man who spent thousands of dollars on a new hearing aid instead of enduring a yearlong wait on the health service; and a 29-year-old woman who, with her doctor’s blessing, bought a three-month supply of Tarceva, a drug to treat pancreatic cancer, for more than $6,000 on the Internet because she could not get it through the N.H.S.

Asked why these were different from cases like Mrs. Hirst’s, a spokeswoman for the health service said no officials were available to comment.

Karol Sikora, a professor of cancer medicine at the Imperial College School of Medicine and one of Dr. Charlson’s co-authors, said that co-payments were particularly prevalent in cancer care. Armed with information from the Internet and patients’ networks, cancer patients are increasingly likely to demand, and pay for, cutting-edge drugs that the health service considers too expensive to be cost-effective.

“You have a population that is informed and consumerist about how it behaves about health care information, and an N.H.S. that can no longer afford to pay for everything for everybody,” he said.

In any case, he said, the health service is riddled with inequities. Some drugs are available in some parts of the country but not in others. Waiting lists for treatment vary wildly from place to place. Some regions spend $280 per capita on cancer care, Professor Sikora said, while others spend just $90.

But in a final irony, Mrs. Hirst was told early this month that her cancer had spread and that her condition had deteriorated so much that she could have the Avastin after all — paid for by the health service. In other words, a system that forbade her to buy the medicine earlier was now saying that she was so sick she could have it at public expense.

Mrs. Hirst is pleased, but up to a point. Avastin is not a cure, but a way to extend her life, perhaps only by several months, and she has missed valuable time. “It may be too bloody late,” she said.

Here’s a link to the complete article:

http://www.nytimes.com/2008/02/21/world/europe/21britain.html?_r=1&scp=4&sq=avastin&st=nyt&oref=slogin

As our presidential candidates talk about health care reform here at home, let’s hold their feet to the fire over what “government care” really means.  Read More & Comment...

8-1 Sensicality

02/21/2008 08:38 AM |

One important point to clear up per the Supreme Court’s 8-1 decision in the Medtronic pre-emption case -- when product manufacturers provide fraudulent information to FDA, or deliberately withhold information about safety problems associated with their products, preemption doesn’t offer them protection and they can and should be held accountable.

The problem is that the current liability system doesn’t reward lawyers who focus on these real public health concerns. Instead, the most experienced and well-financed law firms know that the biggest payouts regularly go to those who take advantage of the FDA’s best efforts to promote the safe and effective use of medications and medical technology. More and more often, these “mass tort” firms specialize in taking a new product warning label or withdrawal decision by the FDA, and view it as a signal to go forward with all guns blazing. Their bullets, unfortunately but not unpredictably, hit multiple innocent targets and result in a wounded American health care system.

Upon hearing the Court’s verdict, Senator Kennedy said, “In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.” And Representative Waxman, America’s Oversighter-in-Chief commented that, “The Supreme Court’s decision strips consumers of the rights they’ve had for decades. 'This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation."

“Nonsensical?” To the contrary, entirely sensical. Hence 8-1.  Read More & Comment...

Diabetes Duel

02/20/2008 03:29 PM |

Diabetes Treatment Risk Not Found in 2nd Study

By Rob Stein
Washington Post Staff Writer
Thursday, February 14, 2008; Page A03

"One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk."
http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html


I know why people died in the US study...more drug companies were involved.. More drug companies, more conflicts, more conflicts, less concern for patients. It's all so simple when you don't let science clog up your blog. And connecting the dots -- sort of like accusing someone of a crime without all the facts. Fun!


http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html  Read More & Comment...

Rob Stein Under a Microscope

02/20/2008 03:03 PM |

Are we devoid of any sense of irony?

Rob Stein of the Washington Post pens an article that begins:

One week after U.S. researchers announced that pushing down blood sugar levels as close as possible to normal might be dangerous for high-risk diabetes patients, a preliminary analysis of a similar international study has found no such risk.

And then two days ago writes with a surge of certainty and finality...

"A series of surprising findings about some of the most widely accepted assumptions in medicine has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's leading health problems.

In addition to casting doubt on notions such as lowering cholesterol to prevent heart disease and normalizing blood sugar to protect diabetics, the studies involving well-known drugs such as Avandia and Vytorin have also rekindled concern about whether new medications are being tested adequately before being allowed on the market."

Diabetes and cholesterol drugs are the most widely and heavily studied drugs on the planet next to blood pressure meds. Should every one of those studies been done in clinical trials prior to market? And does Stein see the difference in how he covers the diabetes story --government studies -- and the Vytorin and Avandia cases? I bet he doesn't. What about the Avastin story, the drug left for dead by the FDA and Wall Street only to become a blockbuster?

http://www.washingtonpost.com/wp-dyn/content/article/2008/02/13/AR2008021302722.html

Science is full of surprises...that is the essence of it's enterprise. What's changed is we now have a Tabloid medicine industry comprised of the media, Congress, instant experts like Steve Nissen and nut cases on the Net that seizes on every surprise and turns it into a scandal that was deliberately "hidden" by those conflict-ridden types who conducted the experiment and by the FDA who knew but are too cozy with industry to care.

http://www.washingtonpost.com/wp-dyn/content/article/2008/02/18/AR2008021801942.html  Read More & Comment...