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...

WSJ Overlooks Stupak Stupor

02/20/2008 10:36 AM |

Anna Mathews puff piece on Bart Stupak paints him as a sometimes overzealous crusader seeking to right wrongs at an out of control FDA...Good thing she didn't include this stirring Stupak statement -- from an LA Times article -- about why Andy von Eschenbach, Sandy Kweder, Janet Woodcock and the FDA's cafeteria guy should resign...

"The drug companies know that this administration ... will do nothing to them. There is no fear of the FDA. With this culture with laissez faire oversight and regulation, I think they should be gone. If we get rid of them, it will put the drug companies on notice."



Is there such a thing as laissez faire regulation?

Last time I checked, drug approvals were at an all-time low and the percentage of IND getting through the FDA had gone from 11 percent to 8 percent over a ten year period. The percent of drugs withdrawn has remained the same over that same time period. Laissez faire?

Oh and has anyone given one tenth of the coverage to the fact that the NIH pulled the plug on the ACCORD study that killed people compared to the ENHANCE trial that did not? In both cases the protocols were changed midstream and ACCORD even had a data safety monitoring board.

I don't see Stupak holding a hearing on that. Maybe it's not a case of laissez faire regulation. Or maybe it's just that you get less media coverage.

http://online.wsj.com/article/SB120347636748679131.html?mod=home_health_right  Read More & Comment...

Dr. Bureaucracy vs.The Sustainable Individual

02/20/2008 07:03 AM |

No, not a new horror movie, a new op-ed from today's edition of The Detroit News:

Bureaucrats threaten personalized medical breakthroughs

American health care has come to a fork in the road.

On the one hand, science is opening up exciting possibilities. The booming field of "personalized" medicine recognizes that every one of us is unique -- not just in some sort of philosophical sense, but in the ways we get sick and the ways we get better.

Personalized medicine can size up our gene sequences to find out what ailments we're likely to get, and even prescribe preventative treatment.

Cancer doctors can now look for "biomarkers" on proteins to detect disease early and determine which treatments are most likely to work.

And this same science can help our doctors understand what medicines are wrong for us, avoiding unnecessary pain, suffering - and expense.

Unfortunately, just as these groundbreaking therapies are coming within reach of consumers, politicians and bureaucrats are threatening to make them off limits. As science makes ever-more-targeted treatment possible, politics could drag us right back to a one-size-fits-all system."

Here's the rest of the story:

http://www.detnews.com/apps/pbcs.dll/article?AID=/20080220/OPINION01/802200397/1008

And to further entice you, here's the concluding paragraph:

We hear a lot about sustainability these days. We want our ecosystem and our economy to be hale and hearty over the long term. But we also need a health care system that creates sustainable individuals. A market-driven system can do that, by bringing all the latest treatments to the public and letting competition drive down prices. Bureaucracies, by contrast, are mainly in the business of sustaining themselves. A move to government health care will take us down the wrong path.  Read More & Comment...

Partnerships? We Don't Need No Stinkin' Partnerships

02/19/2008 09:28 AM |

The Tufts Center for Drug Development -- enemy territory for drugwonks because of its concentration of RedSox rooters -- held a session on business models to improve R and D productivity recently...The takeaway point:

“No company – big, medium, or small pharma, or biotech – will develop new drugs entirely alone,” claimed the Center’s director, Kenneth Kaitin, at a recent panel meeting of industry executives in the US.

“Increasingly, R&D productivity gains will depend on developers focusing on what they contribute best to the drug development value chain and partnering with organisations that provide capabilities that are too expensive to develop or maintain internally, or are outside of the company’s core competence,” he added.
Read More

Meanwhile the Institute on Medicine as Profession, which is leading the purge of all contacts between industry and academia has a new program designed to cut the private sector out of drug development altogether. It is being lead by one of the leaders in drug discovery, David Rothman, PhD. ....Where would the government -- yes the government would be in charge -- get the money? What's in your wallet?
Read More

  Read More & Comment...

Parallel Trade? Don’t ask. Don’t tell.

02/19/2008 07:35 AM |

At a recent London policy conference on parallel trade, Heinz Kobelt (Secretary General of the European Association of Euro-Pharmaceutical Companies – EAEPC) discussed his association’s credo of “know your customer.” This was during a discussion of how parallel trade can actually help to enhance drug safety and security. (More on that absurd canard in a moment.)

But, during the ensuing Q&A it turns out that “know your customer” actually means “don’t ask/don’t tell” when it comes to one of their most important and largest category of customers – wholesalers, specifically those shady entrepreneurs who go beyond legal EU parallel trade into the clearly illegal realm of marketing non-approved drugs to North America.

Case in point: Rimonabant.

Licensed and legally marketed in the EU under the brand name “Acomplia,” this medicine is not approved for use in the United States. But type “Acomplia” into any US search engine and you’ll find no shortage of Canadian internet pharmacies ready, willing, and able to sell it to any American with a credit card.

How is this possible? Because these pharmacies are buying their supplies from European wholesalers – wholesalers who are getting their supplies (legally) from within the EU and then selling them (illegally) outside the confines of the Treaty of Rome.

When confronted with this shady behavior, Mr. Kobelt was at a loss for words, finally saying that it was an issue that should be brought up with the wholesalers.

Heinz – you can’t have 57 flavors of “know your customer,” choosing to "know them" only when it's convenient is a policy that is neither sound nor honest.

As to parallel trade enhancing safety and security, here’s how Heinz spins that one.

During his presentation he pointed out (correctly) that the recent spate of counterfeit drugs that had infiltrated legitimate UK pharmacies had been discovered by a parallel trader. And that’s true. But what he didn’t mention is that those same products had already passed through three other parallel traders without being found.

Some victory for drug safety and parallel trade.

Something else that Heinz didn’t share was that, when the parallel trader found the counterfeits, rather than calling the UK authorities as required (the MHRA in this instance), he called the company whose drug had been counterfeited – so that he could get his supplies replaced.

Parallel trade and altruistic commitment to drug safety? Sure.  Read More & Comment...

Courageous Sanity Triumphs Over Political Inanity

02/16/2008 09:11 AM |

Despite those who believe that the government should control what medical journal articles doctors can read, some courageous sanity from the FDA.

FDA to Guide Off-Label Drug Marketing

By MATTHEW PERRONE AP Business Writer
© 2008 The Associated Press

WASHINGTON — The government on Friday proposed guidelines for how pharmaceutical companies can use medical journal articles to market drugs for unapproved uses.

The Food and Drug Administration guidelines, criticized by some lawmakers as too lenient, have been eagerly anticipated by drug and device companies like Pfizer Inc. and Medtronic Inc. that often use medical literature for marketing.

Companies are not allowed to market products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, under a law that expired in 2006, the agency made an exception for reprints of medical journal articles, which sales people often give to physicians.

Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.
"This guidance should reinforce the point that FDA has no business interposing itself between a doctor and scientific information," said Peter Pitts, president of the Center for Medicine in the Public Interest.

Rep. Henry Waxman released an earlier draft of the guidelines in November without FDA's permission. The California Democrat, who chairs the committee on oversight, said Friday FDA should not issue final guidelines until Congress makes sure the new standards will not jeopardize patients.

"This ill-advised guidance is great news for the drug industry but terrible for public health," Waxman said Friday.

But former FDA Deputy Commissioner Scott Gottlieb said getting the latest medical research to physicians is critical for the patients, since it can take months or even years to update drug labels.

Gottlieb points out that Genentech's breast cancer drug Herceptin showed breakthrough results in early-stage tumors as early as 2005, but wasn't approved for that use until late 2006.

Here’s a link to the FDA statement:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01798.html

And here’s a link to the complete AP story:

http://www.chron.com/disp/story.mpl/ap/fn/5545881.html

Knowledge is power. And information saves lives.   Read More & Comment...

Dr. Stupak on SSRIs and Suicide

02/15/2008 07:18 PM |

Here's Bart Stupak, head of the Health subcommittee on Energy Commerce, who is running the series of show trials on the FDA and the pharmaceutical industry (only anti-industry and FDA malcontents need testify) on the "link" between SSRIs and suicide:

"SSRI’s have not been proven effective in treating adolescent
depression. To the contrary their use may actually increase the suicide rate of its young
patients. In response to these reports of increased suicide rates with SSRI use, FDA
officials suppressed their own post marketing surveillance, prohibited FDA employees
from discussing the report, and launched an investigation to find the person who leaked information to the press. Today, SSRI remain on the market without a clear medical benefit to the patient."

Setting aside the recent tragedy in Northern Illinois where the gunmen went off his meds, went on a shooting spree and killed himself. ...Stupak's statement is not only scientifically incorrect, it is downright misleading and dangerous. There should be a black box warning around everything Stupak says regarding medicines, particularly SSRIs which have been shown to benefit patients and are associated with a decline in suicides. And again, there is no link to SSRIs and in increase in suicides, rather some unclear evidence based on an unvalidated measure called suicidality that includes just talking about self harm in general.

Stupak held several fear-drenched hearing about antidepressants in 2003-2004. He is partially responsible for the decline in SSRI prescription use and the corresponding increase in adolescent suicide. So the question is:

And this guy is head of the Health subcommittee? Why is he being taken seriously? Why isn't he being held accountable?

Here's Bart Stupak on the "link" between SSRI's and suicide

  Read More & Comment...

Importation a "done deal? Don't bet on it.

02/15/2008 06:08 PM |

Like they say, everything you read in the newspaper is true – except for those things you know about personally.

Case in point: the Wall Street Journal reporting that, regardless of which of the remaining three amigos gets elected in November, “drugs from Canada” is a done deal.

Nope. Here’s why not:

(1) It won’t save any money. Let’s not forget the non-partisan CBO study that showed that such policy would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.

(2) The drugs being sent to U.S. customers from Canadian internet pharmacies are not “the same drugs Canadians get.” That bit of rhetoric is just plain wrong. Canadian internet pharmacies – by their own admission – are sourcing their drugs from the European Union. And while they may say their drugs come from the United Kingdom, let’s not conveniently forget that 20% of all the medicines sold in the UK are parallel imported from other nations in the EU – like Spain, Greece, Portugal, and Lithuania.

And the important political point here is that when Americans are asked if they want drugs from nations other than Canada – the answer is a resounding “no thank you.”

(3) The state experience has been dismal and politically embarrassing. Remember the high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population. They don’t call him “Wrong Way” Rod Blagojevich for nothing.

And what of Minnesota and Governor Tim Pawlenty’s RxConnect program? According to its latest statistics, Minnesota RxConnect fills about 138 prescriptions a month. That's for the whole state. Minnesota population: 5,167,101.

And remember Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield is now out of the drugs from Canada business.

(4) National Security concerns. According to a recent report from the federal Joint Terrorism Task Force, a global terrorist ring with ties to Hezbollah, is importing counterfeit drugs into America by way of Canada. They are doing so for profit today - but could just as easily do so for more nefarious and deadly purposes. And legalizing importation would only facilitate such actions.

So while the candidates may opt for “drugs from Canada” as a useful political talking point – a way to say “look how tough I can be on those bad drug companies. The real issue lies elsewhere.

When it comes to health care reform, there’s one major policy difference that sets Senator McCain apart from Senators Obama and Clinton – Senator McCain believes in the strengths of a market economy. He sees drug importation as an access issue. The other side sees it as a way to import price controls and a first step towards government-run health care.

Don’t get fooled by the importation rhetoric. It’s nothing but a side-show. And it ain’t gonna happen. It's more dangerous as a smoke screen.  Read More & Comment...