Time Should Go To School on Statins and Women

03/24/2010 11:29 AM |

Is it that Time is running out of money or that what's left of the editing there is too busy finding ways to run anti-Israel pieces...but when you start a story about the gender specific risks and benefits of statins, it might be  prudent not to overstate the risks to the point of absurdity and paint an otherwise smart and accomplished woman as a hopeless victime:

Lynne Newhouse Segal was the picture of robustness. At 59, the slim former lawyer was an avid runner, golfer and yoga practitioner. Segal, who lives in San Francisco, was healthy by nearly every measure — except her cholesterol level, which a routine test four years ago revealed was high. High cholesterol is a key risk factor for heart disease, especially in a patient Segal's age and with her family history (several close relatives had had heart attacks), so her doctor put her on a cholesterol-lowering statin drug as a preventive measure.

Oh, but dark clouds soon gather...

But Segal's statin ended up preventing her from living a heart-healthy lifestyle. A month after she started taking the drug, she suffered muscle pain so severe, she had to stop all physical activity and was unable to sleep at night. Although her husband, who was worried about her risk of heart attack, pleaded with her to stay on the drug, she discontinued using it. The muscle pain receded. "My husband was scared for me. Doctors scare you. But I was in so much pain, I told him I would have rather died than stay on them," says Segal.

That grim situation could have been avoided, researchers say.

How about asking for another type of statin?  That's what Marilyn Goldberg, age 75, did after suffering muscle pains so severe she complained to her husband Mort and son Bob (that's me) almost daily... And she did, about 4 or 5 times until she found one that worked.  And now the pains are gone and her cholesterol is really low.

But you see, Marilyn is not a set piece or prop in some Obama-esque sob story about how we the people are screwed by uncaring corporations.  She is a responsible person taking action on her own behalf...

Rather died? 

I don't want to harp on this self-pitying because I am half-convinced that it is only half-true.  That's because much of the "reporting" in the Time article on women and statins is half-baked.   You read the piece sensing that women receive NO benefit from statins and tons of risk.  In fact, there are many sub-groups and many situations where that is not the case.  

The issue at hand is whether statins should be given to women who do not have high cholesterol at all but have other risk factors because cholesterol is not a very good marker for heart disease in women...  (my emphasis)

The JUPITER study was designed to test whether other markers of heart disease in relatively healthy older women and men predicted heart disease by giving them statins to reduce a protein called CRP.   If CRP was reduced and nasty events that lead to hospitalizations or death were reduced after taking a solid dose of the statin then the study could claim to show that CRP testing in combination with statins reduced the incidence of heart disease in relatively healthy women and men.  And since women do not seem to benefit from reduced cholesterol levels (in the absense of other risk factors) the CRP -statin link is a pretty big deal for primary prevention.

As for the side effects.. When you draw the blood for CRP you can also draw blood to see if you will metabolize specific statins in ways that cause muscle pain, blurry vision, etc.   There are tests for that.   The question is whether the statin used in the JUPITER study (Crestor) can be substituted with other statins. 

Now that is what the TIME article should have been about.  But I guess the magazine had to devote resources to another hit piece on Israel.  

Read more: http://www.time.com/time/magazine/article/0,9171,1973295-1,00.html#ixzz0j6iRw0r3

Read more: http://www.time.com/time/magazine/article/0,9171,1973295-1,00.html#ixzz0j6iJUqhy

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Sending Companion Diagnostics out to Pazdur

03/24/2010 09:39 AM |

ChemGenex has agreed to meet with the FDA discuss developing a validated assay test for determining which patients might benefit from its experimental chronic myeloid leukemia (CML) treatment Omapro (omacetaxine mepesuccinate).

"This is a comparative efficacy claim that somebody is making here, so the level of proof has to be there," said Richard Pazdur, director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research. "The message is that the agency is trying to get across is that attention has to be paid to these in vitro diagnostics." ChemGenex announced the initiative shortly after the FDA's Oncology Drugs Advisory Committee voted 7-1 to require such testing before approving Omapro, which is targeted at CML patients who have failed Novartis' Gleevec (imatinib).

Speaking of Novartis, the ChemGenex situation is another important example of the role companion diagnostics can play in bringing new drugs to market.

In August 2009, Novartis’ two-year effort to revive its Prexige pain pill (after it was rejected by the FDA) spurred discussion of developing the first genetic test to identify those who may suffer the liver damage that arises in some patients. The test, according to Michael Nohaile (the head of Novartis’s molecular diagnostics unit) would be obligatory for patients to obtain a prescription.

With a test showing that a certain drug will be safe, Nohaile said, “We can go to doctors and say it moves it out of the realm of choice into the realm of malpractice if you don’t use this drug.

Exciting stuff -- but once these diagnostics are developed, will payers reimburse?  In the wake of the payer disquietude over spending $400 on a diagnostic test to determine whether a patient should be given warfarin, it’s very much an open question. (Even more peculiar considering that conservative estimates project using the warfarin diagnostic -- specifically called out in the amended FDA label -- will prevent 85,000 serious bleeding events and 17,000 strokes annually in the United States. And this “safer use” is estimated to save $1.1 billion annually. 

Stay tuned.

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Now I Understand...

03/23/2010 08:36 AM |

Good thing we've got the important elements of the bill squared away....

Two headlines on the same day... March 22

Major health care changes won’t take place until 2014

Delays could help Obama’s reelection hopes

Key elements of health reform would start soon

  Read More & Comment...

All the news that's unfit to print

03/23/2010 07:47 AM |

The Pink Sheet reports on "renewed optimism" that the European Union's proposed legislation on allowing drug makers to provide information to patients on prescription-only medicines will again start moving through the legislative process. The latest thinking, however, is strongly focused on the rights of patients to receive such information, rather than industry's right to disseminate it.

An interesting and important finesse – the rights of a patient to the information but no “right” for industry to provide it.  Hm.

Suggested amendments emerged on March 10 from European Parliament Member Christofer Fjellner. He's reviewing the proposed legislation for the EU parliament's Committee on the Environment, Public Health and Food Safety.

For patients, Fjellner contends that information on pharmaceuticals should only be made available to patients who are actively searching for it, i.e., information should be "pulled" by the patient rather than "pushed" by industry. Fjellner believes that  companies should not be allowed to make available information on prescription-only medicines on television or in newspapers or magazines. He believes the Internet is the appropriate medium for providing information to patients.

And maybe he's right -- but is there really a difference?  If a pharmaceutical company makes available information on a web page – why is that different than making it available in other media?  Hm. And what about patients who do not have access to the Internet -- what about their rights?

Fjellner's stance comes as a response to a ruling from the European Court of Justice, which concluded in April 2009 that current legislation could be applied to independent journalists. One journalist, Frede Damgaard, was considered to have broken the ban on DTC advertising by writing about a particular prescription-only product, a ruling that has caused an outcry in the media.

For more on this issue, see “Eighty-Sixing Free Speech.” 

The environment committee will vote on the patient information proposals in June. After that a plenary vote of all European Members of Parliament will be held in September. It will then go to the Council of the EU for further consideration.  Read More & Comment...

The Good News

03/22/2010 09:07 AM |

After a feisty year of debate, Congress has passed healthcare reform legislation. Once enacted, it will increase the numbers of Americans with health insurance as well as both the size and scope of government. There’s also the very real danger that the legislation will further erode the stake that physicians have to practice both the art and science of medicine.

And the numbers?  Staggering when you consider they are absurdly under-scored.  According to Douglas Holtz-Eakin (director of the Congressional Budget Office from 2003 to 2005), if you strip out all the gimmicks and games and rework the calculus, a wholly different picture emerges: The health care reform legislation would raise, not lower, federal deficits, by $562 billion.  Even with readjustment, it will make the Social Security trust fund look like Fort Knox.  The day the President signs this into law could be viewed by a near-future generation of Americans as a day of infamy -- if we let it.

So here’s the good news – the solution is innovation.

We have to embrace innovative technologies for medical records and prescribing.  We need innovative clinical trial designs and molecular diagnostics so that we can develop better, more personalized medicines faster and for far less then the current $1 billion plus delivery charge.  We need innovation in access and reimbursement policies that rewards speed-to-best-treatment rather than more lower-cost patients per hour.

Will more people have access to health insurance?  They will and that’s a good thing. But, let’s be honest, we’re not talking about erasing the word “uninsured” from the American healthcare dictionary – we’re just redefining what it means.

We have to embrace the fact that we will all pay more in taxes (yes, all of us) eventually. And, ultimately, we will be okay with that. Americans are always willing to do what’s right for their fellow citizens.  As Winston Churchill said, “Americans always want to do the right thing – after they have tried everything else.”  Even so, many of our fellow Americans will receive less comprehensive healthcare benefits than they are receiving now. 

So we’d better start taking innovation – of both the incremental and discontinuous varieties – seriously.  And that means both spending more on harder developmental R&D (with concomitant higher investment risks). In this regard, the new legislative language on the development of FOBS (follow-on biologics or, if you prefer, biosimilars) is a good thing.  (And don’t ever call them generic biologics!)

There’s lip service to the need for more robust comparative effectiveness – although this is a battle yet to be either defined (comparative effectiveness or cost effectiveness or clinical effectiveness?) or fought (do we need a U.S. version of NICE?). And a battle royal it will be.  In addition, there’s as yet-to-be reconciled language on a Medicare advisory board that could very well morph into a national formulary body. L’audace, l’audace, toujours l’audace. This isn’t even the end of the beginning.

Of course we bid adieu to the infamous Medicare Part D Doughnut Hole.  Pax vobiscum. The Medicare prescription drug benefit is coming in hundreds of millions of dollars under budget already and consistently has 90% + approval ratings by America’s savvy seniors. Medicare Advantage programs?  Don’t ask.

Now insurance companies can’t turn anyone down because of a pre-existing condition (bravo!) but they can’t charge higher premiums for people who have them?  This isn’t an elegant or economically viable solution and will have to change.  Otherwise it’s just a slow march to a single-payer system.

Over the past year, we spent a lot of wasted time throwing around terms like “death panels” but, at the end of the day, we didn’t even begin to address the elephant-in-the-room issue of how much of our national treasure we spend on end of life care.  We will have to address this highly volatile and divisive issue – and sooner rather than later.

The legislation doesn’t do anything really significant about driving young, healthy people into the insurance pool.  The anemic penalties (which don’t even kick-in right away – the demographics and politics aren’t too hard to figure out) actually disincentivize youthful participation.  After all, why not pay the monthly penalty (which is less than even a very affordable monthly insurance premium) if, when you do face a medical emergency, you can’t be turned down or charged more? Nor does the bill create any sort of national insurance pool – where we can all benefit from a 50-state economy of scale insurance marketplace.

Some of the best things about the bill are what is does not do.

No drug importation.  (Sorry! Senator Dorgan.  Hooray! Peggy Hamburg.)  And the Non-Interference Clause remains the law of the land.  When originally drafted (wisely by then Senators Daschle and Kennedy), we knew then what we need to remember now, that (1) direct government negotiations for Medicare drug prices won’t (according to numerous government studies and leading economists) lower Medicare drug prices and (2) it is the next slippery step towards even broader price controls.  And price controls equal choice controls.

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Canaries in the Coal Mine

03/21/2010 11:06 PM |

My early prediction of a healthcare bill death in the wake of Scott Brown's election was premature.  To underestimate the persistence of those who have devoted their lives to government  run health care was a mistake.  And it should be going forward too. 

That applies to the goal of carving up Medicare and controlling healthcare spending through greater government regulation on access to and higher taxes on innovation, with the objective and/or on consequence of discouraging investment overall in order to expand healthcare entitlements:

Washington State, which has made much of it's position as leader in biomedical innovation is a bellweather  of what it to come:

tinyurl.com/ydpvubs

Non-Profits, Investors Worry About Proposed Washington State Tax Surcharge Increase

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Casey at the battlements

03/19/2010 03:40 PM |

It's deja vu all over again.

As the Ol' Perfessor (Casey Stengel) would say, "You can look it up."

Here's what then-Senator Obama had to say in 2005 about reforms in the Temporary Assistance for Needy Families (TANF) welfare program that he and other Democrats opposed:

“The TANF program affects millions of American children and families and deserves a full and fair debate. Under the rules, the reconciliation process does not permit that debate. Reconciliation is therefore the wrong place for policy changes and the wrong place for the proposed changes to the TANF program. In short, the reconciliation process appears to have lost its proper meaning. A vehicle designed for deficit reduction and fiscal responsibility has been hijacked to facilitate reckless deficits and unsustainable debt.”

Yep -- he was against it before he was for it.

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From Bauhaus to the People's House

03/19/2010 08:10 AM |

Bauhaus guru Walter Gropius said, "Less is more." But it was Mies van der Rohe (known to New Yorkers as the designer of the Seagram Building) who opined, "but more tastes better."

The Congressional Budget Office has released its latest estimate of the price tag of the House of Representative's healthcare reform bill. At $940 billion, this version of reform will cost more than the measures passed by the House and Senate late last year. More is not always better.

CBO also says the bill will reduce the deficit by $130 billion over the next 10 years and by $1.2 trillion over the following decade. That’s right. It will reduce the deficit by significantly increasing federal spending.  Only in America.

While they’re at it, they should also predict the weather for the next decade.

Let’s face it: Uncle Sam has a poor track record of forecasting how much new programs will cost. Medicare’s progenitors, for example, stated in 1967 that the entitlement would cost $12 billion by 1990. Actual Medicare spending in 1990 amounted to $110 billion — nearly 10 times the initial estimate. Oops.

CBO’s deficit-reduction estimates are further divorced from reality because they don’t include as much as $371 billion in new spending to fix reimbursement rates for doctors who treat Medicare patients. Imagine that — health reform legislation that doesn’t include payments to doctors. Only in Washington, DC.

Absent congressional action, Medicare reimbursement rates will fall 21 percent next year. Congress has no intention of letting that happen. But the Democrats have decided that they don’t have to include this so-called “doctor fix” in their healthcare reform package — even though it’s critical to preserving Medicare.

No wonder the CBO was able to conclude that the Democrats’ health reform package would reduce the deficit by $130 billion. The bean-counters simply ignored the $371 billion in spending needed to fix Medicare reimbursement rates.

Democrats point to the favorable CBO score as proof that their health reform package is a model of fiscal responsibility. But it’s likely that the next generation of lawmakers will look back on these cost estimates with the same astonishment reserved for Medicare’s naïve forecasters back in 1967.

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What CER Really Means

03/18/2010 10:16 PM |

Underpowered, cut rate head to head studies that prove nothing worlks better than something..  David Nathan's take on NAVIGATOR, a prototype for CER studies that will show no clinical beneift...

http://content.nejm.org/cgi/content/full/NEJMe1002322

The finding that valsartan failed to have an effect on either of the cardiovascular-disease outcomes but had a positive effect on the incidence of diabetes is surprising. Previous studies of ACE inhibitors and ARBs have suggested that these drugs have a beneficial effect on cardiovascular disease in patients with diabetes, and the lower blood pressure achieved would be expected to result in a reduction in cardiovascular disease. In the NAVIGATOR study, the high rates of loss to follow-up (13%), use of off-study ACE inhibitors or ARBs among participants assigned to placebo (24%), and nonadherence to valsartan (34% by study end) could explain the absence of an effect on cardiovascular disease.

The results from the NAVIGATOR study do not support the contention that reducing postprandial hyperglycemia has a specific role in preventing diabetes or reducing cardiovascular disease. Other than increasing the rate of hypoglycemia by a factor of two, nateglinide had little effect. Although the authors suggest that the prevention of diabetes with valsartan might make it a preferred drug as compared with antihypertensive drugs that potentially worsen glycemia, valsartan was relatively weak in preventing diabetes, and it did not lower the rates of cardiovascular disease. The prevention of diabetes remains a critical public health priority, but for now we should steer away from these two drugs and use effective lifestyle interventions and, in selected persons, metformin to combat the epidemic.  Read More & Comment...

Ad(s) Infinitum

03/18/2010 09:16 AM |

PhRMA is supporting a new advertising campaign supporting health care reform legislation.

The new television ad, "Finish," along with two previously-released ads, "Covered" and "You Choose," began airing March 17 in targeted districts across the country where House Democrats undecided on how to vote might need a push to vote in favor of the reform package.

"It's been a long road, but now we've never been closer to common sense health reform," a voice in the "Finish" ad says. "Reform that leaves health care decisions to patients and their doctors, covers pre-existing conditions, and lowers out of pocket costs. A new path that lowers the deficit. Congress, keep fighting for health reform - all the way to the finish."

The 15-second clips in support of health care reform were produced by Americans for Stable Quality Care, a non-profit coalition of a number of organizations - including PhRMA, the Biotechnology Industry Organization, Families USA and the American Medical Association.

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The Big Dig

03/17/2010 06:45 AM |

Health reform is a rough ride, so here’s a germane quote from America’s favorite rough rider -- Teddy Roosevelt:

 

“When you are in a hole – stop digging.”

 

Germane, because of some new poll numbers on health care reform.

 

According to a new national poll from GfK Roper (sponsored by CMPI-Advance), 70% of Americans oppose using budget reconciliation to pass health care reform and 60% believe it is unfair for House leadership to have the option to introduce a procedural rule that would “deem” the Senate health care reform bill as being passed without actually voting on the legislation itself.

 

Americans do not support for increasing Medicare payroll taxes for the high wage earners (46% support, 47% oppose) or reducing what doctors and hospitals are paid for their services (45% support, 48% oppose).  The survey shows that Americans are evenly split in their belief that the Congressional health care proposal will increase taxes and premiums for the 73 million Americans with health insurance (as estimated by the Joint Committee on Taxation).

 

Other findings include:

 

·      81% of those polled strongly oppose health care reforms that would increase insurance premiums for healthy people to offset premiums of people who wait until they are diagnosed with an illness to purchase insurance.

 

·      80% oppose allowing the government to decide what kind of health care coverage Americans are able to purchase.

 

·      87% oppose having a government panel recommend or decide what medical procedures or medical advances your doctor can use or your health plan can pay for.

 

·      84% support reforms that would allow people to buy health insurance across state lines.

 

·      3 out of 4 Americans oppose healthcare reforms that would raise taxes and cut Medicare benefits to pay for health care subsidies for expanded coverage for the uninsured.

 

·      84% support healthcare reforms that would let people get lower premiums for getting or staying healthy.  

 

Complete survey results can be found here.

 

Madame Speaker – stop digging.

 

Survey Methodology

 

GfK Roper completed 1,000 interviews, made up of male and female adults (in approximately equal number), all 18 years of age and over.  The interviews were conducted between March 12 and March 14, 2010. The margin of error for this study is ± 3 percentage points. 

 

Sampling for this study was conducted using a national probability sample of all exchanges and area codes across the continental United States. All interviews were conducted using a computer-assisted telephone interviewing system. Statistical weights were designed from United States Census Bureau statistics.

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A Vote That Really Matters

03/16/2010 11:44 PM |

For some reason neither the media or the NEJM bothered to report on the results of this poll which, more than any other, will have a direct impact on the future of health care.
  Read More & Comment...

Deal of Fortune

03/16/2010 08:00 AM |

From the pages of Politico ...

Pharma tries to protect its deal
By: Chris Frates

As Democrats scramble to finish drafting health reform legislation, drug lobbyists are working overtime to ensure that the final bill doesn’t bust the $90 billion deal they have with the White House and Senate Democratic leaders.

For the past few days, drug industry lobbyists have huddled with Democratic staffers to work out how to structure the fees drug makers will pay under reform while still making good on Democrats’ promise to close the gap in seniors’ drug coverage. Last winter, the industry pledged $10 billion to help close the coverage gap in addition to the $80 billion deal it had struck earlier in the year.

Drug makers were asked to sign off on multiple solutions, giving Democrats backup options should any of the fixes run into problems passing muster with the Senate parliamentarian, who, because of procedural rules, essentially has the final say over what’s included in the legislative package.

With billions of dollars hanging in the balance, there was “real heartburn with the bill over the weekend and over the last week,” an industry source said.

The industry also decided to drop its push to be carved out from an independent Medicare payment advisory board – vowing instead to fight it if it becomes law, sources said. The board would essentially force cost cutting measures on lawmakers, limiting the influence of outside groups like PhRMA to lobby the outcome.

With all the drama of reform coming down to the wire, the players’ nerves are rubbed raw, said one insider. Still, the industry expects its deal to hold.

Democratic are racing to finish a reconciliation bill that could pass the House this week and win Senate approval before Congress breaks for the Easter recess at the end of the month. Democrats are crafting the bill so it only needs 51 votes to pass, bypassing the Republicans’ filibuster threat.

But Republicans pounced on the wheeling and dealing as another symptom of what’s wrong with reform.

“All we hear about is the arm-twisting and the horse-trading that’s going on over there behind the scenes – the mad dash ahead of the big vote. And once again, Americans can’t believe what they’re hearing,” Senate Republican Leader Mitch McConnell said Monday on the chamber floor. “The drug lobbyists were here in the Capitol over the weekend huddling with Democrat staffers to make sure their interests would be protected in the final bill. This is precisely the kind of thing Americans rebelled against after the last vote on this bill.”

Also Monday, senior pharmaceutical industry sources denied a New York Times report that the industry has invested $12 million in new, pro-reform advertising. PhRMA has not signed off on a new ad campaign, no ad copy has been approved, nothing has been done, said the sources, who are intimately familiar with the situation.

"I cannot say this more emphatically, it's not true," said one source, who is not authorized to speak publicly.

In fact, the White House has been leaning on the industry to buy positive ads to provide air cover to wavering House members, whose districts have been inundated with opposition advertising. But the drug makers are holding out until they see, and sign off on, the final reconciliation bill, industry sources said.

As a key White House ally, the drug industry has been the money behind much of the pro-reform advertising this past year. Drug makers' decision to hold out could mean there will be little in the way of pre-vote cover. But, if the industry supports the final bill, it's almost guaranteed a post-vote blitz of thank you ads praising lawmakers who voted yes will air and they will likely see support through Election Day.

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On the table? Off the table? Under the table?

03/15/2010 04:36 PM |

Ad Age reports:

It's looking likely that the Pharmaceutical Research and Manufacturers of America wasted up to $100 million in advertising to promote a health-care-reform bill that will ultimately offer the industry no protection.

Some pharmaceutical-industry observers and blogs are suggesting that the backroom deal made last year by the drug makers' top lobbying group and the White House -- a controversial handshake agreement that limited Big Pharma's share of footing the health-care bill at $80 billion over 10 years -- has fallen apart now that President Barack Obama has introduced a revised form of the bill last in the wake of shifting public opinion. And the deal's architect, PhRMA President Billy Tauzin, a former Congressman from Louisiana, announced his resignation last month. That resignation is effective June 30.

The problem for PhRMA is that it's already honored its end of the deal and can do nothing to stop the terms from changing. The new health-care proposal includes, among other things, a clause that allows the government to negotiate directly for Medicare drug prices. That language was not in the initial health-care bill as part of PhRMA's deal with the White House. And as of now, that $80 billion cap is likely to increase to $90 billion, if not more. Indeed, with no firm deal in place, there's nothing protecting PhRMA at all.

"The deal PhRMA negotiated could still be on the table, but you need to have the other side actively engaged," said longtime pharmaceutical expert Peter Pitts, a former associate commissioner at the FDA and now president of the Center for Medicine in the Public Interest. "The White House is not necessarily in coordination with the Senate and the House, so it's confusing and now it's a bit of a crapshoot."

AARP, also an active player in the advertising business last year in support of health-care overhaul, said this week it would scale back its media spending this time around. "Are we just going to sit on the sidelines? No," David Sloane, senior VP-government relations for AARP, told Roll Call, the newspaper that covers Capitol Hill. "[But] I don't think advertising is the way to secure votes."

Meanwhile, several entities -- all against the health-care legislation -- have launched or are about to launch ad campaigns, the biggest of which is an effort from the U.S. Chamber of Commerce and a coalition of 248 lobbying groups that will spend up to $10 million in measured media over a 10-day period.

The rest of the story can be found HERE
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The Promised Land's Long Waiting Lines

03/14/2010 12:39 PM |

I called my son (who lives in Israel) to talk about the latest "breakthrough" in US-Israel relations and he quickly changed the subject to talk about a persistent GI problem he has been having.  I won't go into details but it's serious enough that it does require a specialist to determine whether he needs medication or an endoscopy.  I had a similar problem (father-son bonding) a couple of weeks ago and was able to schedule an appointment with my GI within 3 days.  My son told me the earliest anyone would see him -- and he has the Israeli equivalent of Obamacare "Gold" coverage -- was three months from now.   Our only choice -- if we don't want to wait until the Messiah arrives --  is to pay out of pocket and see a doctor in his or her private time.

Such delays are routine, even though Israel's health plans regularly discourage patients from using specialists and procedures.  Gatekeeping merely postpones use and could often increase it by making illnesses more severe.   The claim that there are "too many" procedures is made all the time.   The problem is, no one knows with any degree of certainty we feel comfortable with, which are necessary in their place and time and which are not.  All we know is what we are not certain of.   Sooner is better than later especially if it can lead to healthier behavior...
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A Bevy and Tevi

03/13/2010 08:57 AM |

Here's some timely weekend reading for all you drugwonks out there:

The first is a nice omnibus article from the current edition of Nature Biotechnology, "One year in -- Obama's biotech scorecard." 

The next piece is from the Belgian medical publication Le Generaliste. It's focus is on American healthcare reform.  It's in French and is headlined, "USA:  les soins de sante a la croisee des chemins" (US healthcare at a crossroads).

And finally a new piece in Commentary by our good pal Tevi Troy, "Health Care: A Two-Decade Blunder."

Enjoy.
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Fail (not) Safe

03/12/2010 08:23 AM |

As seen on the op-ed page of the Orange County Register

Cheaper medicines not always better

By PETER PITTS
President, Center for Medicine in the Public Interest, former associate FDA commissioner

Savings on drugs often result in higher costs in other areas.

• Videos

The health care reform debate has been focused almost entirely on just two broad issues: the large uninsured population and the rising cost of care. But there's another problem that plagues our health system, and it's just as serious. Doctors are losing their ability to treat patients without being obstructed by outside parties.

Any discussion about improving our health system must recognize that rules which empower bureaucrats to get in the way of the doctor-patient relationship are a serious threat to the quality of medical care.

A strong, trusting relationship between doctors and patients is crucial to a well-functioning health care system. Without such a bond, serious conditions might go misdiagnosed or improperly treated, patients might give inaccurate medical histories, or doctors' orders might be ignored.

This is no small problem. Failing to follow a prescribed treatment regimen – a practice known as "nonadherence" -- costs the U.S. health system over $100 billion a year in avoidable medical costs. And, according to a study published last year in the Annals of Internal Medicine, patients who don't have a close relationship with a single doctor are less likely to receive the proper tests for preventing chronic illnesses.

Yet some policies that are gaining popularity are weakening the doctor-patient relationship by putting treatment decisions in the hands of third parties.

Chief among these schemes is "step therapy." Also called "fail first," this is a policy that is sometimes adopted by insurers and government health programs to save money on pharmaceuticals. It forces patients to try cheaper alternatives to a prescribed drug before they are permitted to get the medicine that their physicians ordered.

So even though a doctor might recommend drug A to treat a patient's hypertension, an insurance company or government program would require the patient first try cheaper drugs B and C, and only after the cheaper drugs are shown to be ineffective can the patient receive the medicine his doctor recommended.

There are several reasons such a policy hurts our health system. For one, it is an assault on the relationship between physicians and patients. When a doctor decides on a treatment, he is employing years of medical experience and weighing countless factors, like the patient's age, diet, and lifestyle. Patients, meanwhile, trust that the doctor knows best.

When it's possible for a health care bureaucrat to override the decision of a trained medical professional, this valuable association between a patient and his doctor breaks down. A patient is no longer under the care of single medical expert, but is now being treated by faceless organization looking to cut corners.

This breeds distrust among patients, but it also results in worse medical outcomes and higher overall costs.

One study of schizophrenia drugs used in Georgia's Medicaid program showed that, while step therapy saved the state close to $20 a month on drugs for every patient, the savings were more than offset by increased costs in other services. Indeed, the program saw a monthly increase of nearly $32 per patient in outpatient care.

Similar studies have shown that private plans utilizing step therapy saw hospital and emergency-room visits increase, resulting in higher overall costs.

What's troubling is that step therapy is becoming more widely adopted. In 2000, 20 percent of private insurance carriers used step therapy. By 2008, it was half.

Reformers need to recognize that policies giving health care administrators control over treatment regimes are hazardous to patient health, and actually inflate overall costs.

The deterioration of the doctor-patient relationship is a serious threat to our health system. Ending step-therapy programs is one way to fortify this relationship.

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Not Joshing

03/11/2010 07:55 AM |

Via the Pink Sheet:

FDA could use more authority to bring negotiations over a drug's Risk Evaluation and Mitigation Strategy to a close, Principal Deputy Commissioner Joshua Sharfstein indicated during a House Energy and Commerce Health Subcommittee hearing on March 10.

The agency can require a REMS, but not specify its contents, he explained, noting the drug sponsor proposes a REMS and negotiates the final strategy with FDA.

"It's very important for us to work with companies to come up with something that works," Sharfstein said. "There's no question there's a lot we learn from the interchange with companies," but it sometimes can take a long time to come to agreement, and a level of consistency between REMS may be desirable if one approach makes sense.

The agency is open to discussions about how it can more effectively move to closure on these strategies designed to protect public health, he said.

Rep. John Shimkus, R-Ill., newly designed as the subcommittee's acting ranking member, suggested a limit on the time allowed for negotiations. Sharfstein noted that if an application is pending, companies have an incentive to finalize a plan; the problem arises particularly with drugs already on the market.

Another area that needs to be addressed, Sharfstein suggested, is the different treatment of brand and generic drugs when it comes to imposing a REMS with a communication plan for alerting health care professionals and patients about a drug's risk. Brand sponsors must implement such a plan, whereas FDA must pay for and operate a communication plan for generic drugs, he noted.

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Supplementary Question

03/11/2010 07:44 AM |

Via AP -- and something to watch:

Stricter government oversight of dietary supplements is moving closer thanks to an agreement among senators to include guidelines in a food safety bill.

Four key areas of “common ground” are outlined in a letter sent by Sens. John McCain, an Arizona Republican, and Byron Dorgan, a North Dakota Democrat, to Sen. Tom Harkin, the Iowa Democrat who chairs the Senate Health, Education, Labor and Pensions Committee.

McCain and Dorgan were co-sponsors of legislation introduced last month, the Dietary Supplement Safety Act, aimed at regulating the industry. This week’s letter to Harkin—also sent to the committee’s top Republican, Sen. Mike Enzi of Wyoming, and Sen. Orrin Hatch, a Utah Republican—talks about incorporating the “areas of agreement” into the FDA Food Safety Modernization Bill

Those provisions include:

— requiring all dietary supplement manufacturing, processing and holding facilities to register with the Secretary of Health and Human Services;

— giving the Food and Drug Administration authority to issue a mandatory recall order if a dietary supplement is adulterated or misbranded or “the use
of such supplement could cause serious adverse health consequences such as death;”

— requiring the FDA commissioner to publish guidelines on new dietary ingredients “as soon as possible;”

— mandating that the FDA notify the Drug Enforcement Administration when a new product contains a synthetic anabolic steroid.

Athletes from various sports have blamed positive drug tests on substances that turn up in dietary supplements even though they aren’t listed as ingredients on the label.

McCain has said his bill would protect professional and Olympic athletes— along with casual sports participants who use supplements.

Pro sports leagues and the U.S. Anti-Doping Agency have been supporting McCain’s efforts on supplements, and USADA chief executive officer Travis Tygart said Wednesday the letter indicates areas in which the new legislative effort “fills holes.”

“These are obviously needed improvements, and the agreement provides additional consumer protections which are certainly important to all athletes and why the pro sports and the Olympic sports came together to push for better regulation,” Tygart said in a telephone interview with The Associated Press. “It also continues to allow all consumers to have access to legitimate supplements. It’s a fair balance, and this step in the process has resulted in a quick and beneficial agreement.”

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Powerful Interests

03/10/2010 08:04 AM |

FDA Commissioner Peggy Hamburg firmly restated the agency’s long-standing opposition to drug importation yesterday in front of Senator Byron Dorgan (D, ND) and the Senate Agriculture Appropriations Subcommittee hearing. She specifically cited safety concerns. 

Agriculture Appropriations Subcommittee Chairman Herb Kohl, (D, WI), suggested there are "powerful interests" blocking legalization to foreign drug importation.

And he’s right – the powerful interests of the public health.
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