The Empire -- State -- Strikes Back

05/08/2008 08:10 AM |

Gov. David Paterson inherited a $4.4 billion budget deficit. To close part of it, state Assembly members put public health on the chopping block when they passed the budget last month. Of course, they promised that their legislation would ensure that "quality, affordable health care is available for all New Yorkers." But it will have the opposite effect.

One of the budget's more damaging provisions restricts the medicines doctors can prescribe by applying the "Preferred Drug List" — medications physicians are allowed to prescribe to Medicaid recipients — to the more than 500,000 New Yorkers enrolled in Family Health Plus, a state-run health care program for low-income families. The list consists mainly of older, cheaper alternatives to cutting-edge medicines.

Considering that prescription drugs represent only 4.9 percent of the state's Medicaid budget, it's a penny-wise, pound-foolish proposition.

Drugs not on the list aren't covered unless the patient's doctor gets "prior authorization" from the state. This involves a phone call from the doctor to a government office; a process that severely slows down treatment and deters doctors from prescribing unapproved drugs.

This policy isn't anything new. Some drugs have always required over-the-phone approval by New York's Clinical Drug Review Program before they could be prescribed to Medicaid patients. Prior to the new budget, however, drugs on the Preferred Drug List were exempt from this roundabout procedure.

The results of this reform could be worse than anyone realizes. One survey by Project Patient Care and Harris Interactive found that in 2001 alone, drug restrictions caused 1.1 million Americans to experience negative health outcomes and 1.9 million to experience serious side effects because they couldn't get the meds they needed.

The irony is that this cost-saving plan won't even work. Numerous studies have shown that instituting a rigid list of approved medicines doesn't save any money. This seems obvious — if a patient is denied the appropriate drug, he'll end up visiting the hospital and emergency room more often.

The new budget also hits pharmaceutical companies for the right to treat poor patients. In order to get a drug approved and onto the Preferred Drug List, pharmaceutical companies have to pay a large "rebate" to the state. Drugs that aren't heavily discounted by the manufacturer are often left off the approved list.

Fleecing drug companies in this way isn't only unfair, it threatens public health by siphoning money from research and development on tomorrow's cures. In the long run, this lowers the quality of health care for everybody, not just low-income New Yorkers.

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I Dream of Jeannie ... Retracting

05/07/2008 07:51 PM |

Talk about tight Jeannes!

The New York Times

January 17, 2005

Dispute Puts a Medical Journal Under Fire

By BARRY MEIER

Last year was an especially bad one for the pharmaceutical industry, which experienced controversies over how drug studies are disclosed and the implosion of the painkiller Vioxx. Now, as a result of the recent publication of an article about the antidepressant Prozac, it appears that the staid, usually methodical world of medical journals could suffer its own black eye.

On New Year's Day, the British medical journal BMJ published a news article suggesting that "missing" documents from a decade-old lawsuit indicated that Eli Lilly & Company, the maker of Prozac, had minimized data about the drug's risks of causing suicidal or violent behavior.

Within days, the article was cited in hundreds of television and newspaper reports. An outraged Washington lawmaker demanded to know if Lilly had hidden the information from the Food and Drug Administration. While company officials refuted the article's assertions, it was still repeatedly cited. And last Thursday, Lilly spent about $800,000 to run full-page advertisements in 15 major publications to dispute the article.

The incident may prove to be a messy one for the BMJ, which is based in London and owned by the British Medical Association, a professional group. Much of the journal, formerly known as the British Medical Journal, is devoted to research reports about medical issues that are reviewed by experts. But the BMJ, like some other medical journals, also has a separate news section that prints articles like the recent one about Prozac. As it turns out, some of the Eli Lilly documents, which the BMJ said it received from an anonymous source, have been circulating for years. And, Lilly officials said, the BMJ and its reporter declined to provide the company with copies of the documents at issue prior to the article's publication.

The American freelance reporter who wrote the article, Jeanne Lenzer, declined to be interviewed, referring all questions to the BMJ. Officials there did not respond to written questions, but a spokeswoman, Emma Dickinson, said in an e-mail message on Friday that the publication "takes this issue very seriously" and will address Lilly's concerns after reviewing them.

The BMJ, which is considered a leading medical journal, may have little choice. While Lilly has not taken legal action, its lawyers have notified the publication that the company considers the article to be "inaccurate and defamatory," asserting that the records were not missing and that all their relevant data had been previously submitted to the F.D.A. Also, Lilly issued an analysis last week of the 52 pages of records that the BMJ had received, which the company said supported its claims. Lilly said it got the documents from a congressman who received them from the BMJ.

"You put something out on the newswire with the imprimatur of a medical journal and people think it is fact," said Dr. Alan Brier, the chief medical officer of Eli Lilly, which is based in Indianapolis.

The article's appearance follows the recent controversy over whether drug makers adequately disclosed the risks that antidepressants like Prozac posed to pediatric patients. And its comes as a South Carolina teenager faces trial for murder as an adult on charges that he killed his grandparents when he was 12. The teenager, Christopher Pittman, has acknowledged the crime, but his lawyers have based his defense on the argument that he became violent after taking the drug Zoloft, an antidepressant similar to Prozac.

It was in a little-noticed article written by Ms. Lenzer in the Dec. 11 issue of the BMJ about the Pittman case that she first mentioned that the publication had received "a set of documents that mysteriously went missing from a U.S. mass murder case ten years ago."

That article did not go into specifics. But in her article on Jan. 1, Ms. Lenzer wrote that the documents in question were connected to a Prozac-related lawsuit that grew out of a shooting rampage in 1989 by a Kentucky man, Joseph Wesbecker, that left nine people dead, including Mr. Wesbecker.

Lawyers representing the victims sued Lilly, asserting that Mr. Wesbecker's killing spree was caused by Prozac, a drug he had been prescribed just before the crimes. During the 1994 trial of the case, Lilly pointed to Mr. Wesbecker's long history of severe psychological problems and said that Prozac was safe.

To combat those assertions, plaintiffs' lawyers introduced hundreds of Lilly documents. They argued that the records showed that Lilly had fully disclosed to the F.D.A. in the late 1980's the potential of Prozac to produce suicidal thinking or acts of violence, including all the reviews by drug regulators in Germany of the issue at that time. Lilly disputed that.

The jury found in favor of Lilly. But a legal controversy over the trial later erupted when it was revealed that plaintiff lawyers and Lilly lawyers had reached an undisclosed financial deal just before the case went to the jury to effectively settle by agreeing not to appeal the verdict.

A Lilly spokesman, Phil Belt, said that Ms. Lenzer, who lives in Kingston, N.Y., first contacted the company on Dec. 13, a few days after her article about the Pittman case appeared.

Mr. Belt said Ms. Lenzer asked where a published report about the data in a specific 1988 internal Lilly report had appeared. At that time, she also requested an interview with the company's chief executive, Sidney Taurel, to discuss what she described as "missing" Lilly documents, Mr. Belt said.

Mr. Belt said the company told Ms. Lenzer that Lilly needed to see the records at issue before it proceeded. He added that Ms. Lenzer later told Lilly that she could not do so, saying that the source of the documents was anonymous.

As the Christmas and New Year's season approached, Mr. Belt said that Ms. Lenzer told Lilly officials that they could pick up the issue after the holidays.

At some point in December, however, Ms. Lenzer or her editors apparently sent the documents it had received to Congressman Maurice Hinchey, Democrat of New York, and to the F.D.A. And a few days before New Year's, the BMJ distributed Ms. Lenzer's article to other news organizations with the provision they could not write about it until its publication date on Jan. 1 - a practice known as an "embargo."

That article carried the headline, "FDA to Review 'Missing' Drug Company Documents," which caught the attention of other news organizations. Mr. Belt said that when Lilly became aware of the embargoed news release, it tried to reach editors at BMJ but was unsuccessful. Both Ms. Lenzer and the BMJ did not respond to written questions about the publication's interactions with Lilly, including why the documents were not shown to the drug maker.

The only Lilly document specifically mentioned in the BMJ article was a 1988 report that stated that 38 percent of depressed patients taking Prozac during clinical trials experienced side effects like agitation, insomnia and nervousness, a rate twice that of those taking a placebo.

Such side effects, which are sometimes referred to as "activation," reflect the fact that some depressed patients who take Prozac and drugs like it often experience a surge of physical energy well ahead of psychological recovery. Some experts have long expressed concerns that such reactions can be so severe in a few patients that they may ultimately act on suicidal or violent impulses.

For procedural reasons, the 1988 Lilly memo itself was not introduced as evidence in the Wesbecker case, said Nancy Zettler, one of the two plaintiffs' lawyers involved. But Ms. Zettler said that one of her expert witnesses, Dr. Peter Breggin, testified extensively about its contents at that trial.

Ms. Zettler said that she was so perplexed by the BMJ article that she contacted Ms. Lenzer after it appeared. "Her original article made it seem like we had deep-sixed some of this stuff and I was curious," she said.

Both Ms. Zettler and Paul Smith, the other plaintiffs' lawyer in the Wesbecker case, said that Ms. Lenzer did not contact them prior to the article to talk about the records or ask for others from that case.

Another plaintiffs' lawyer who has used Lilly documents in other lawsuits, Arnold Vickery, also said he did not discuss the records with Ms. Lenzer prior to her report. Mr. Vickery and another lawyer are representing Christopher Pittman.

Dr. Breggin has written articles arguing against the use of Prozac and other drugs and has mentioned the 1988 Lilly memo in his writings; he is scheduled to be an expert witness in the Pittman case.

Several pages sent to the BMJ were not produced by Lilly but are photocopies of slides produced by an F.D.A. official who presented them at a 1991 public hearing that reviewed the possible suicide risks of Prozac. After its review, that agency panel decided not to issue any additional warnings.

Ms. Zettler said she still thinks the issue of what Lilly told the F.D.A. in the mid-1980's about Prozac's potential risks is unsettled. But after more than 15 years of the drug's use, numerous lawsuits and public reviews, it may also be largely moot.

As a result of the recent controversy about the potential suicide risks posed by antidepressants to children and teenagers, the F.D.A. last week sent out final new labeling language about those dangers to all makers of such drugs, including Lilly.

A spokeswoman for the agency, which is still reviewing the records sent to BMJ, said that it had not yet found anything new in them. Ms. Dickinson, the publication's spokeswoman, said that it was reviewing Lilly's rebuttal to its article.

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Slate 'n Slime

05/07/2008 06:53 PM |

Drugwonks rarely expects other bloggers to focus on substance . Rather, we are flogged for the source of our contributions as if others uncovered a corrupt connection instead of the truth, which is that we proactively provided information.  We are aware that our critics don't have the intellectual bandwidth or the maturity to actually engage on the issues or respectfully disagree or debate.  Still we expect accuracy and for others to provide some context even as they take their shots as they are entitled to in a free society.  

But we will do what ever it takes, including legal action, when facts are deliberately omitted, misrepresented and distorted and then willfully repeated to set the record straight. 

Shannon Brownlee and Jeanne Lenzer did a smear job  on Peter and Dr. Fred Goodwin in Slate ...  

www.slate.com/id/2190775/pagenum/all/#page_start

... for a segment on the Infinite Mind, called Prozac Nation Revisited ...

www.lcmedia.com/mind524.htm

The Infinite Mind is an award winning NPR show that has covered a wide variety of topics about the brain and cognition for over a decade with foundation funding, private donation and some corporate contributions directly generated by a production company.   Of course none of that information made it into Slate piece. What's more, the piece never challenged the central thesis of the experts, are SSRIs as dangerous as many in the media have made them out to be, i.e., that they cause suicidality and suicides.  Rather, as is their wont, they shift the line of attack to who has funded them, as if Goodwin (a friend and board member, something that we have made public for years) who has been ranked as one of the world's leading clinical researchers in depression and manic depression is just some industry tool.  

Two can play at that game.  Turns out that Lenzer has been on somewhat of a jihad against SSRIs, "reporting" on their dangers as a free lance journalist with the British Medical Journal  for several years.  What prompted the Slate article was likelly the fact that the Inifinte Mind segment questioned whether people in the media like her and members of Congress hyped up SSRIs dangers to the point that the number of kids taking the drugs declined and in turn suicides went up.  That's a point Peter and I made in a Washington TImes article.  The fact that we were targets for Lenzer, along with Fred, who has been fearless in speaking out for the safety of SSRIs in no surprise.

Neither is Lenzer's attack since she was a close ally of Peter Breggin, a vehement opponent of SSRIs who has it out for Fred Goodwin.  You don't need a financial tie to be biased and Lenzer has lots of reasons to go after Goodwin and Peter.  She also has plenty of bias and a track record of twisting the facts.  BMJ was forced to retract one of her articles and admit she slipped court documents to trial lawyers (perhaps via Breggin) in an unethical fashion.   Here is the BMJ retraction AND apology as it pertains to Lenzer's unethical and sleazy behavior. 

"BMJ  2005;330:211 (29 January), doi:10.1136/bmj.330.7485.211-a

Correction and apology, Lenzer, BMJ 330 (7481) 7

Correction and apology

Eli Lilly: Correction and apology

An article by Jeanne Lenzer in our 1 January issue (BMJ 2005;330:7) reported that the US Food and Drug Administration was to review confidential Eli Lilly documents that had been sent to the BMJ by an anonymous source.

The article stated that these documents had gone "missing" during a 1994 product liability suit filed against Eli Lilly.

That statement has been the subject of a detailed investigation conducted by the BMJ following a complaint by Eli Lilly. That investigation has revealed that all of the documents supplied to the BMJ that were either Eli Lilly documents or were in the hands of Eli Lilly had in fact been disclosed during the suit.

At the end of the trial, all the documents were preserved by Court Order or were disclosed by Eli Lilly to the plaintiffs' lawyers in related Prozac claims.

The BMJ did not intend to suggest that Eli Lilly caused these documents to go missing. As a result of the investigation, it is clear that these documents did not go missing. The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims. The BMJ is happy to set the record straight and to apologise to Eli Lilly for this statement, which we now retract, but which we published in good faith.

The same article described Dr Peter Breggin as "the medical witness for the Wesbecker case." He was, in fact, the expert witness for the plaintiffs."

Oh, and Jeannie also works for the plaintiff lawyer funded Government Accountability Project. ... no disclosure there.

As for Ms. Brownlee, she is a fellow at the New America Foundation that has funding from the Soros folks and is pushing a VA health system approach on everyone. 

Now that's context for you. 

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Lord of the Flies

05/07/2008 08:13 AM |

Chinese regulators are accusing Baxter of failing to co-operate in an investigation over deaths linked to impurities in blood thinner heparin.

The State Food and Drug Administration, China’s drugs regulator, said on Tuesday that Baxter had not provided all samples and information requested during a visit last month to its New Jersey plant. The SFDA reiterated its position that there was no proven link between the deaths in the US of patients and “a heparin-like substance” found in the drug.

Denial, as my mother used to say, is more than just a river in Egypt.

Baxter replied: “We have been co-operating with all parties in the heparin situation including SFDA and the Chinese government. We plan to continue co-operating with them to help move the investigation forward. We will seek to understand any concerns to the contrary.”

Here’s the rest of the story, courtesy of the Financial Times:

http://www.ft.com/cms/s/0/3587b9b0-1ba7-11dd-9e58-0000779fd2ac.html

Per the larger issue of “tainted” vs. “counterfeit” ingredients, consider the comments of Robert Parkinson, Baxter’s chief executive, who said that the issue in question “appears to be the target of a deliberate adulteration scheme.”

Translation:  Counterfeiting.

There are a lot of issues here that need to be addressed – most notably criminal opportunism.

Consider the Chinese proverb, “Flies never visit an egg that has no crack.”

We must seal the cracks.

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NICE: Don't ask. Don't tell.

05/05/2008 10:53 AM |

In our post-SiCKO, sound-bite-centered politically-charged environment, we’re hearing a lot about the “wonders” of “European-style” healthcare models.

Well, if we’re going to look at Europe – let’s really look. And let’s start with some recent news from London.

Late last week consumer group campaigners won a landmark victory in the fight to overturn a ban on Alzheimer's drugs for tens of thousands of patients.

The Court of Appeal in London said that NICE (the National Institute for Health and Clinical Excellence) the agency that evaluates the cost-effectiveness of drugs -- had acted unfairly by not fully disclosing how it evaluated Alzheimer's drugs.

In 2006, NICE ruled that drugs such as Aricept, Reminyl and Exelon don't benefit some patients enough to be worth their cost and recommended that the state health service pay for the drugs only in patients with moderate rather than mild Alzheimer's disease.

The Court of Appeal decided the process used by the Government's rationing body to ban use of the drugs - which cost only £2.50 a day - was unfair.

The case could pave the way for the drugs to be re-instated for newly diagnosed patients with 'mild' symptoms of the disease.

The three judges yesterday ruled NICE must release a full version of the economic model which it used to produce the guidance restricting access to the drugs.

By refusing to do so, NICE had put those taking part in consultation - including the Alzheimer's Society - at a significant disadvantage in challenging its reliability.

Experts said the ruling could have wider implications because it showed a key part of NICE's work is secretive, undermining confidence in guidance that has led to other drugs being rationed.

Dr Susan Benbow, former chairman of the Faculty of Old Age Psychiatry of the Royal College of Psychiatrists, said: "The next stage should be to overturn the guidance which was not only reached during an unfair process, but is inequitable on grounds of human justice to patients who should have access to these drugs."

The cost of prescribing the drugs to a patient with the early symptoms of Alzheimer's is £2.50 a day, or around £1,000 a year - but the potential savings to taxpayers and families are huge.

Studies show that full-time care for an Alzheimer's patient is £25,000 a year, or around £520 a week.

But the National Institute for Health and Clinical Excellence used a much lower figure of £18,500 - less than £369 a week - for the costs of full-time care when calculating whether the NHS could afford to fund treatment with the drugs.

For some sobering American pharmaco-economic data, have a look at the CMPI report, “Alzheimer’s Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money?

Professor David Wilkinson, a leading old-age psychiatrist, said: "These drugs can stabilise patients for two or three years and it's perfectly possible for those who respond to gain six months or a year living at home.

Professor Wilkinson said that under the ban, some newly diagnosed patients were being told by their doctor to come back in six months' time, by when their symptoms would have got worse and they would be eligible for treatment.

"Doctors have been put in an impossible position - it goes against everything in our medical training,' he added.

If we’re going to look to Europe – then let’s really look. And if we’re going to talk about comparative effectiveness – let’s really talk.

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NICE Stiffs Arthritis Patient Access To Breakthrough Drug

05/05/2008 08:41 AM |

From the Lancet:

Most notable is the following excerpt --  the importance of individual differences --  which the comparative effectiveness crowd in the US blindly and blithely ignores:

"The new treatment approach is to treat early and aggressively to achieve minimum disease progression and ideally remission, a strategy that achieves the best long-term results. However, there is currently no gold standard to define remission. Progression and response to treatment are extremely variable between patients. A substantial proportion of patients (up to 30%) is not adequately controlled with currently available treatment strategies of non-biological disease-modifying antirheumatic drugs and TNF a inhibitors."


UK, 5/5/2008 - The Lancet has been a longstanding supporter of the National Institute for Health and Clinical Excellence (NICE) in the UK. Its procedures are rigorous, scientifically driven, and publicly accountable. NICE is widely admired by many other western European nations. But consternation and disappointment characterised the reaction by patient groups and the British Society for Rheumatology to NICE's latest judgment. On April 23, NICE rejected an appeal on abatacept for patients with severe rheumatoid arthritis brought by the drug's manufacturer Bristol-Myers Squibb, the British Society for Rheumatology, the Royal College of Physicians, the National Rheumatoid Arthritis Society, and the Royal College of Nursing. The appeal committee upheld NICE's decision of October last year, and the only next possible step is an application to the High Court.

Abatacept is, with rituximab and tocilizumab, one of three new drug classes that have shown clinically significant improvement for the treatment of severe refractory rheumatoid arthritis. Abatacept acts as a selective T-cell co-stimulation modulator, designed to block a key co-stimulatory signal required for T-cell activation, a new approach to halt or reverse the inflammatory process. However, with an incremental cost-effectiveness ratio of about £37?000–£43?000, possibly even higher if different estimates are included in the model, abatacept did not provide cost-effective treatment according to NICE's threshold of £30?000 per quality-adjusted life-year (QALY) gained. Many of these estimates are no more than best guesses based on insufficient or incomplete evidence. The committee stated that “while recognising the innovative nature of the drug, the severity of the disease and the limitations around the use of the HAQ [health assessment questionnaire] in the economic modelling, …abatacept would not be a cost-effective use of NHS [National Health Service] resources for patients in whom rituximab failed or in whom rituximab is contraindicated”.

How does abatacept differ from rituximab? Rituximab, a chimeric human-mouse monoclonal antibody directed at the CD20 antigen expressed on mature B cells and pre-B cells, acts on a different pathway. Like abatacept, rituximab was shown to be effective in patients treated with methotrexate who had not responded adequately to an additional TNF a inhibitor. Again like abatacept, there are no good long-term data and no direct head-to-head trials comparing other strategies with rituximab, yet rituximab was approved in August last year. The simple difference is that rituximab is cheaper. Patients only need two infusions every 6 months compared with 14 infusions of abatacept in the first year and 13 thereafter. The incremental cost-effectiveness ratio of rituximab is estimated as somewhere between £12?000 and £30?000 per QALY gained.

Rheumatoid arthritis is common and debilitating. About 1% of the adult population in developed countries is affected, increasing to 5% for women older than 55 years. About 60% of people are unable to work and are severely restricted in daily activities 10 years after diagnosis. Although progress has been made in understanding the underlying pathogenic mechanisms, the cause of rheumatoid arthritis remains unknown. The new treatment approach is to treat early and aggressively to achieve minimum disease progression and ideally remission, a strategy that achieves the best long-term results. However, there is currently no gold standard to define remission. Progression and response to treatment are extremely variable between patients. A substantial proportion of patients (up to 30%) is not adequately controlled with currently available treatment strategies of non-biological disease-modifying antirheumatic drugs and TNF a inhibitors.

Any new and effective treatment for such a debilitating condition as rheumatoid arthritis should be welcomed with enthusiasm. But NICE is at the sharp end of husbanding NHS resources. It has to balance evidence with cost. And here there is a perilous conflict between its dual clinical and political purpose. There will be occasions when exceptions to strict cost-effectiveness guidelines must be made on clinical grounds. Abatacept is a strong candidate to be such an exception. Worse still, NICE's decision may unwittingly act as a disincentive to industry to develop new medicines in this neglected and poorly understood area. Although NICE will rightly say that it has followed the letter of its cost-effectiveness law, patients and the public may, with justification, feel that it has forgotten the spirit of those same laws—namely, that cost-effectiveness evidence needs to be interpreted with compassion as well as impartial science.  Read More & Comment...

Typical Misreporting on Atypical Use in Kids

05/05/2008 08:28 AM |

The AP's Lyndsey Tanner fans the flames of fear by misconstruing  already breathless data dredging operation by Fariz Rani and others in this mont's Pediatirics. about the "soaring" use of atypicals in the treatment of autism and ADHD in the UK:


"American children take anti-psychotic medicines at about six times the rate of children in the United Kingdom, according to a comparison based on a new U.K. study. Does it mean U.S. kids are being over-treated? Or that U.K. children are being under-treated? Experts say that's almost beside the point, because use is rising on both sides of the Atlantic. And with scant long-term safety data, it's likely the drugs are being over-prescribed for both U.S. and U.K. children, research suggests. "

Beside the point? I mean, it sort of matters if there is over or under treatment. But then again, Tanner has already concluded that the drugs are over-prescribed. But what does a six times the rate mean?

"In the U.K. study, anti-psychotics were prescribed for 595 children at a rate of less than four per 10,000 children in 1992. By 2005, 2,917 children were prescribed the drugs at a rate of seven per 10,000 — a near-doubling, said lead author Fariz Rani, a researcher at the University of London's pharmacy school."

Tanner seems to be talking just about kids diagnosed with ADHD and autism. And she conveniently ignores the number of kids who take the drugs for the same diseases in the US. She also ignores the fact that extensive study has gone into use of these drugs for treating of certain aspects of both disorders. In the case of anti-psychotics, risperadone has FDA approval for use in treating irritability in children with autism from ages 5-16 which most certainly explains why the study in Pediatrics found most of the increase in use overall associated with Risperdal scrips. But you don't see that information in the Tanner article...No. What you get is the implicit accusation that drug companies are promoting unsafe and off-label use of the product. Disgusting. Misleading. Damaging to parents and kids alike.

news.yahoo.com/s/ap/20080505/ap_on_he_me/psych_drugs_children  Read More & Comment...

No soap - radio

05/02/2008 10:46 AM |

Bizzaro non sequitor paragraph in today’s New York Times article on the the Genetic Information Nondiscrimination Act:

“Ultimately unlocking all these genetic secrets will make the whole idea of private health insurance obsolete,” said Karen Pollitz, director of the Health Policy Institute at Georgetown University.

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Value vs. Volume

05/02/2008 07:34 AM |

Yesterday in Chicago HHS Secretary Mike Leavitt kicked off the 28th annual Midwest Business Group on Health conference (smartly themed “Survivor:  Health Benefits Island”).  He made some interesting points:

The first is that we need to redesign our healthcare system so that we reward “value rather than volume.”  No argument there.  It’s also very much in keeping with what Senator McCain is talking about these days.

He then turned his attention to the HHS “efficiency roadmap.”  Lots of good initiatives.  (I know, there are always a lot of “good initiatives.”)  What was missing, however, was how to overcome one of the most significant roadblocks – state lines.  Specifically, in addressing a group made up of large employers, the Secretary didn’t discuss insurance deregulation as a strategy towards more affordable, accessible, and patient-centered coverage.  This must be a key strategy in the “value vs. volume” proposition.

He spent the lion’s share of his remarks (and productively so) talking about the need for inter-operability of healthcare IT platforms – where HHS has helped to both design and implement some successful programs lead the still nascent national dialogue. 

One comment he made is worth repeating for both its wit and honesty.  Leavitt quipped that “the wonderful thing about healthcare standards is that there are so many to choose from.”

And may we all live in interesting times.


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Janet Has A Job For You

05/01/2008 11:42 AM |

Finally the FDA gets the funds and most importantly the fast track hiring authority to add about 1300 new scientists to its payroll.  Much of the problem had to do with the fact that because of bureaucratic mutation created by former HHS Sec Thompson, Woodcock and others had to go through a centralized HHS hiring system that took months, set salaries, etc.   That was fixed by the current HHS team.    Now the question is whether Janet has been the resources to train newcomers consistent with science-based Critical Path approach. 

Credit must also be given to Congressman Dingell, Congresswoman DelLauro and staff for pressing hard for more funding and hiring authority.  Sometimes people can work together for the public health. 

www.reuters.com/article/latestCrisis/idUSN30551443
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The Whining States of America

05/01/2008 09:05 AM |

The Gallup-Healthways Well-being Index claims that 47 percent of all Americans are struggling.  How is that defined?

"The Gallup-Healthways Well-Being Index asks Americans to evaluate their lives by imagining a "ladder" with steps numbered from 0 to 10, where "0" represents the worst possible life and "10" represents the best possible life. Nationally, 49% of Americans say that they presently stand on steps 7 or higher of the ladder. When asked where they will stand about five years from now, Americans report that they expect to stand on steps 8 or higher. Gallup considers this group of Americans to be "thriving." Thriving Americans' have their basic needs (such as food and shelter) met, and they have higher incomes, are less burdened by disease, report fewer sick days, and have better work environments. While nearly half of Americans fall into this category, the percentage of citizens in the thriving group is down from 60% in 2006.

On the low end of the spectrum, 4% of U.S. residents say they presently stand on steps 0 to 4 of the ladder. When asked where they will stand five years from now, Americans in this group report that they expect to stand on steps 0 to 4 of the ladder, as well. Gallup considers this group of Americans to be "suffering." Suffering Americans report that they have less access to basic needs such as food, shelter, and healthcare. They are also more likely to be burdened by disease, report more sick days, and are more likely to be divorced or widowed."

So how does Gallup arrive at a definition of "struggling?"

"Americans that Gallup does not classify as thriving or suffering are considered to be "struggling." The percentage of U.S. residents who are struggling has increased to 47% from 37% in 2006."

Hmmm.  Has anyone  at Gallup read Goldilocks and The Three Bears?  Or is it just that Americans are and always have been a striving culture.  Or is it a function of everyone pursuing happiness?  In any event, none of it explains the comment by CDC director Julie Gerbeding who equates the state with the misleading factoid that the US health care system ranks 37th in the world/....who is writing HER speeches....

Meanwhile here is the most revealing finding of the survey:

"Americans' reported level of happiness and enjoyment peaked on Easter Sunday, March 23, with New Year's Day coming in a close second. Super Bowl Sunday, Feb. 3, was also among the top 10 days that Americans reported the highest levels of happiness and enjoyment."

To me and Peter, any day the Yankees win is a great day...Looks like we will be struggling or suffering through 2008.

www.gallup.com/poll/106906/Nearly-Many-Americans-Struggling-Thriving.aspx

 

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Patent Nonsense

05/01/2008 07:53 AM |

This week, the World Health Organization’s Intergovernmental Working Group on Public Health, Innovation and Intellectual Property is gathered in Geneva to finalize its report to the general body for how the international community can best aid developing countries.
Many attendees support a proposal to replace drug patents with a “prize” system, wherein governments offer monetary rewards for new pharmaceuticals. A central WHO bureaucracy would decide which diseases are worth researching, establish prizes accordingly and then put the formulas into the public domain, allowing anyone to produce generics.

What could justify this overhaul? Proponents argue that patents keep drug prices artificially high and that pharmaceutical firms spend too much money on “lifestyle” drugs aimed at Westerners and too little on treatments for developing-world diseases.

Have a look at this article for further discussion of this foolishness:

www.metro.us/metro/blog/my_view/entry/Theres_a_prize_in_every_box/12382.html

The patent system doesn’t cause firms to ignore the developing world. Roughly half the research projects into Third World diseases are run by drug companies. The claim that prices keep drugs from poor patients is equally untrue. The reality? Developing countries lack the infrastructure for drug distribution. As the WHO’s HIV division director put it in 2006: “It is very obvious that the elephant in the room is not the current price of drugs. The real obstacle is the fragility of the health systems. You have health infrastructure that is dilapidated, and supply chains that don’t exist.”

Prizes might work in industries defined by “eureka” achievements like space travel. But drugs come from a long, incremental process of testing and retesting. Prizes only reward breakthroughs, not intermediate steps. Replacing pharmaceutical patents with a prize system would do untold damage to millions of poor patients.

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Jim Crow Medicine and Comparative Effectiveness

04/30/2008 11:48 AM |

One effect of comparative effectiveness: it locks in racial disparities in the treatment of chronic illnesses that lead to higher rates of death among African-Americans. Cost containment is achieved by letting minorities die more often.

Gene Variant Protects Black Heart Failure Patients

MONDAY, April 21 (HealthDay News) — Researchers have discovered a gene variant carried by about 40 percent of blacks that protects them after heart failure as much as widely used beta blocker drugs do.

The finding explains the puzzling results reported in trials of beta blocker therapy in black people, said Dr. Stephen B. Liggett, a professor of medicine and physiology at the University of Maryland, and co-author of a report in the April 20 online issue of Nature Medicine.

"To our knowledge, this is the first case where a genetic variant mimics the activity of a drug used to treat a disease," Liggett said.

The finding won't have an immediate effect on treatment of heart failure, the progressive loss of ability to pump blood that affects an estimated 5 million Americans, said study co-author Dr. Gerald W. Dorn II, director of the Center for Pharmacogenomics at Washington University in St. Louis. Doctors can continue to prescribe beta blockers for people with heart failure, black or white, since the drugs have little risk, he said.

But there should be an effect on future medical practice, Dorn said. "One idea in the future of drug discovery is that we will not only need to tailor therapy for individual genetic makeup but also take genetic makeup into consideration in drug testing," he explained.

Comparative effectiveness is completely ignoring such advances and the life saving benefits they bring. Remember Nitromed?

In this case people with the variant might not need a beta-blocker or as high dose. Those without will need it, Still other variations might lead to developing other regimens.

Liggett noted: “Our idea is not to replace the physician's judgment, but to give a handle on which drugs they might want to push to higher levels and which are less likely to be helpful for specific individuals.”

Unlike population-based comparative effectiveness which ignores individual differences that – for African Americans suffering from diabetes, hypertension and breast cancer – could mean life and death. 

Which is why comparative effectiveness is just Jim Crow medicine unless it’s put on a personalized path. 

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The McCain Health Care Clinic

04/30/2008 09:56 AM |

Doug Holz Eakin, John McCain's policy chief and Carly Fiorina, McCain campaign chair ran a conference call for the media on McCain's emerging health care vision.  In essence it is this:  give people money to buy coverage and seek out care anywhere that prevents disease and rewards providers and insurers that do the best job treating illnesses.  Instead of an insurance system that profits from finding ways not to cover people, McCain would find ways to get insurers to compete to treat people in high quality settings and get rewarded accordingly.  Consumers would have information and dollars to seek out service in this new market.   How about that?  Sick people being sought after by insurance companies -- much like hungry people are sought after by restaurants and grocery stores.

This is an emerging and provocative vision.  More to come...

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Follow-on O Ship of State

04/29/2008 08:37 AM |

Excellent piece by Bryan Liang in the Los Angeles Times:

Don’t Compromise the Safety of Biotech Drugs

By Bryan A. Liang

A toy plane has a handful of parts. A Boeing 747 has several million. This makes sense. Toy planes are small, simple models, while 747s are large, high-performance aircraft that travel more than 500 mph with thousands of component systems acting together. The model costs a few dollars because it's easy to manufacture. The 747 costs about $225 million because of its highly complex nature, testing and the need to ensure safety.

The comparison is worth keeping in mind as the debate heats up over "follow-on" biologics. Biologics are today's most advanced medicines, fully tested biotechnology protein drugs that provide targeted therapy to victims of cancer and other diseases. Follow-on biologics are the second or subsequent versions, but they are not identical.

U.S. spending on them reflects the importance of these drugs in medicine's arsenal. Biologics represent the fasting-growing sector in the medicines market, with more than $30 billion spent on these drugs each year. Indeed, the top five drugs in terms of Medicare expenditures administered in physicians' offices are biologics. By 2010, worldwide spending on biologics is estimated to grow to $10 billion, and biologics will make up nearly half of all newly approved medicines. Hence, many policymakers are focused on reducing the costs associated with these drugs.

Congressional legislation is pending that would allow the sale of follow-on biologics without requiring extensive testing -- essentially following the same model used for approval of generic forms of traditional prescription drugs.

But most drugs we're familiar with, like the pills we get from the pharmacy, are "small-molecule" drugs -- simple chemical compounds. They can be easily manufactured and identically copied. The anti-convulsant drug valproic acid, for example, has a total of just 26 atoms.

Identical to the brand-name version, these generics can "piggyback" on a brand-name company's testing. That's reasonable. These small-molecule drugs -- which typically are made up of a total of 20 to 100 atoms -- can be copied perfectly. So they don't need independent safety testing, cost less to make and are cheaper -- allowing more patients to obtain the medical benefits.

But biologics are far more complex. The brand-name drug Herceptin, a biologic that's widely used to treat cancer, is made up of a total of roughly 25,000 atoms. Large biologics can have millions of atoms.

Biologics aren't made by combining chemicals in a flask. They're made by life forms such as cells, yeast and bacteria. Like humans, these life forms exhibit diversity in metabolism and composition, making the final product a unique, heterogeneous mix that cannot be copied exactly. So follow-on biologic forms of a drug can only be similar to the original, not identical.

Because of the complexity of biologics, there's more regulation. In comparison with common chemical drugs that can have generic versions -- such as penicillin -- which only require 50 to 60 manufacturing tests for safety and quality, biologics require at least four times that number.

So the policy challenge is to provide incentives for innovation while also ensuring that any follow-on forms of biologics that enter the market are safe.

The key lies in something called "data exclusivity," which is a legal mechanism for allowing a company to keep confidential the data associated with a drug's development. Data exclusivity usually lasts for several years and spurs innovation by protecting new inventions. This is the current rule for small-molecule drugs, and it should be applied to biologics as well. Strong data exclusivity is critical for biologics, which are about 50% more expensive to develop than small-molecule medicines.

However, the current state of science makes ensuring safety of follow-on biologics difficult. Currently, the technology to map out the exact chemical structure and function of one large biologic versus another is not available. That makes safety reviews inexact. And follow-on forms may induce unpredictable adverse reactions.

Several years ago, a fully tested biologic created in the U.S. was cooperatively licensed overseas to be made in Europe. But the new version caused patients to suffer "pure red cell aplasia," whereby their bodies could not make red blood cells. This may have contributed to the deaths of some patients and permanent injury to others. Yet today, after eight years of research, the cause of these reactions is still unknown.

If even cooperative company efforts can result in unpredictable adverse reactions, any follow-on product that does not undergo full testing should be of concern. Recognizing this reality, the European Union has developed a system of assessment that requires clinical testing of follow-on products in Europe before approval.

U.S. policymakers should take note. Relevant clinical data and testing should be required to ensure safety of any follow-on biologic product being considered for patient use in the U.S. And appropriate data exclusivity should be put in place to foster innovation.

If chemical drugs were toy planes, biologics would be 747s, the cutting edge of medicine. Because of their complexity, any follow-on forms must be held to a higher safety standard. As we have learned in aviation, safety is no accident.

Bryan A. Liang is executive director of the Institute of Health Law Studies, California Western School of Law and co-director of the San Diego Center for Patient Safety, UC San Diego School of Medicine.

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Scientific research with an asterisk

04/29/2008 08:31 AM |

From today's edition of the Boston Globe:

Scientific research with an asterisk

By David A. Shaywitz and Dennis A. Ausiello

CONSIDER an academic scientist - we'll call him Louis - who receives funding from the beverage industry, the textile industry, and the livestock industry, and ultimately generates profound new scientific insights, beneficial both to the sponsoring companies and to the world as a whole. Are these accomplishments diminished because the work was industry funded? Should Louis - Pasteur - have an asterisk next to his name?

That's the implication of a recent New York Times profile of three academic researchers from New England who have pledged to decline industry funding and "have lost their asterisks."

The notion that academic researchers who partner with industry are intrinsically tainted reflects a misunderstanding of the importance and quality of industry research, and the role industry plays in bringing new drugs to the patients who need them.

While most of the original insights leading to new drugs and devices likely derive, at least in part, from the work of academic scientists, turning these preliminary advances into FDA-approved treatments required an exceptional investment by industry, and vital partnerships between academic investigators and company scientists.

The gaping distance between promising lab result and approved drug is apparent to anyone who has tried to reconcile the breathless news reports touting "scientific breakthrough" with the paucity of options available for patients suffering from any number of devastating medical conditions. In the last 10 years, for example, there have been more then 7,000 academic papers published on pancreatic cancer, but not a single breakthrough treatment.

The primary reason for this gap: The human body is complicated, and our understanding limited. In many cases, we are still struggling to figure out the molecular basis for important diseases. In other conditions, even when the cause is clear, designing a drug capable of selectively correcting the defect while not causing new problems, is a monumental challenge.

To overcome these hurdles, there is a need for more, not less, interaction between academic physician scientists and their counterparts in industry, engagement that should occur at every stage of the drug development process.

Our own experiences with difficult science and sick patients has convinced us that the battle is not drug companies vs. academics, but rather between dreadful diseases and the medical researchers who are trying to subdue them.

Unfortunately, industry critics often lose sight of the big picture, and routinely stigmatize pharmaceutical researchers and their academic collaborators. Young academic investigators are often counseled against "selling out" and pursuing a career in pharmaceutical research, despite the exciting drug-development opportunities such a choice might afford. Senior university researchers who might contribute considerable wisdom to drug discovery efforts are reviled in the press if they associate with industry in any way, even though these relationships are vital for the creation of new medicines.

Finally, of course, there is the money. Because pharmaceutical companies are for-profit entities, conventional wisdom holds that any data they publish should be suspect. In fact, pharmaceutical research is tightly regulated, and industry-sponsored clinical studies are typically performed in a rigorous, consistent, and transparent fashion that would be the envy of many academics. To the extent some industry studies fall short, the problem generally lies not in the results obtained, but rather in the questions never asked - a critique that applies at least as well to the pharma-bashing studies now so popular in certain medical journals.

Also puzzling is the suggestion that it is improper for drug companies to solicit the perspective of academic experts, and immoral (or at least asterisk-worthy) for experts to accept financial compensation for their time. Expert insight may accelerate the delivery of new treatments to patients, and it seems disrespectful to suggest this time should not be valued.

Still, although the relationship between universities and industry should be broadened, useful and transparent guidelines must be developed to get this relationship right. Ultimately, these interactions must be defined, protected and enhanced if the medical community is to deliver on its commitment to secure the health and well-being of patients.

Dr. David A. Shaywitz is a management consultant in New Jersey. Dr. Dennis A. Ausiello is the physician-in-chief of Massachusetts General Hospital and a director at Pfizer.

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The Moose on the Table

04/29/2008 08:12 AM |

Yesterday Senator McCain made clear the difference between his position on healthcare and that of Senators Clinton and Obama:

Senator McCain believes in free market solutions and he told the American people an important truth – the warm and fuzzy sounding policy of “universal care” is really the harsh reality of “government care.”

He then put the moose on the table – insurance deregulation.  And it’s about time.

Now that’s straight talk.  Express.

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Getting ugly early

04/29/2008 07:55 AM |

Gail Wilensky on what happens if some of the ideas presented by our candidates for the White House fail:

"The real answer is -- we don't know.  But if these ideas don't work the alternatives are largely disturbing:  price controls, stifled innovation and stemming the spread of new technology.  It gets ugly real fast."


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Group Urges Ban on Medical Giveaways

04/28/2008 04:27 PM |

By GARDINER HARRIS
Published: April 28, 2008

Drug and medical device companies should be banned from offering free food, gifts, travel and ghost-writing services to doctors, staff members and students in all 129 of the nation’s medical colleges, an influential college association has concluded.

The proposed ban is the result of a two-year effort by the group, the Association of American Medical Colleges, to create a model policy governing interactions between the schools and industry. While schools can ignore the association’s advice, most follow its recommendations.

Rob Restuccia, executive director of the Prescription Project, a nonprofit group dedicated to eliminating conflicts of interest in medicine, said the report would transform medical education.

Most medical schools do not have strong conflict-of-interest policies, and this report will change that, Mr. Restuccia said.

The rules would apply only to medical schools, but they could have enormous influence across medicine, said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University.

We’re hoping the example set by academic medical colleges will be contagious, Dr. Rothman said.

"Drug companies spend billions wooing doctors” more than they spend on research or consumer advertising. Medical schools, packed with prominent professors and impressionable trainees, are particularly attractive marketing targets."

Okay.

Here are the facts from a November 2006 GAO report:

Drug companies spent less in 2005 on DTC advertising ($4.2 billion) than on promotion to physicians ($7.2 billion) or research and development ($31.4 billion). www.gao.gov/htext/d0754.html

Now some stuff Gardiner left out:

The Prescription Project is funded by trial attorneys who sue drug companies. IMAP gets millions from George Soros.

And the report never uses the word "ban.”

Here's what is does say, courtesy of Thomas Sullivan's blog:

www.policymed.com/

For Continuing Medical Education (CME)

Academic medical centers offering CME programs should develop audit mechanisms to assure compliance with the standards of the Accreditation Council for Continuing Medical Education (ACCME), including those with respect to content validation and meals.

Academic medical centers should establish a central CME office through which all requests for industry support and receipt of funds for CME activity are coordinated and overseen.

To the extent that educational programs for physicians are supported by any commercial entity, including pharmaceutical, device, equipment, and service entities, the programs should be offered only by ACCME-accredited providers according to ACCME standards.

In respect to CME these are all very reasonable recommendations, and most universities have already undertaken significant effort to achieve these goals.

The document covers many other things not directly related to CME including:

• Gifts to individuals (Prohibiting)
• Pharmaceutical samples, (Central Distribution)
• Site access by pharmaceutical representatives, (Limited to appointment or invitation, student participation limited, more MD’s, PhD’s and PharmD’s)
• Site access by device manufacturer representatives, (credentialing, appointment or invitation, disclosure and consent of patients, student participation limited)
• Participation in (Non CME) industry sponsored programs. (Discourage faculty, transparency of payment and fair market value, prohibit attendance, paying for attendance, accepting personal gifts)
• Industry Sponsored Scholarships and other Educational Funds for Trainees (Giving Centrally, no Quid pro quo, selection sole responsibility of the university)
• Food (only for ACCME-Accredited Events)
• Travel (only for legitimate reimbursement or contractual services.
• Ghostwriting (transparency of all involved in the process)
• Purchasing (Disclosure of interest, and recuse from purchasing decisions in COI cases)
• Boards of Directors, Advisory Boards and Consulting (Valuable and Compensation to Reflect Fair Market Value)

All the news that's fit to print?

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PLoS ... or Minus

04/27/2008 05:55 PM |

Important, fascinating, discouraging, and urgent new government-sponsored study (courtesy of Harvard) shows that life expectancy actually declined in a substantial number of US counties from 1983 to 1999, particularly for women. Most of the counties with declines are in the Deep South, along the Mississippi River, and in Appalachia, as well as in the southern Plains and Texas.

The study, published in the journal PLoS Medicine, concluded that the progress made in reducing deaths from cardiovascular disease, thanks to new drugs, procedures and prevention, began to level off in those years. Those gains, as they shrank, were outpaced by rising mortality from lung cancer, chronic obstructive pulmonary disease and diabetes. Smoking, which peaked for women later than for men, is thought to be a major contributor, along with obesity and hypertension.

Some, like former Senator John Edwards, are using the study to further fan the class warfare flames.  And socio-economic conditions are certainly an important part of this issue but, as Sam B. Harper, an epidemiologist at McGill University who has studied the issue commented, “We know from hundreds of studies that income does have an impact on health, but it’s not a simple relationship."

Indeed.  But politicians -- and especially frustrated ones like Senator Edwards, are always looking for simplistic, talking point-friendly answers to complicated problems.

According to  one of the report's authors, Dr. Majid Ezzati, "... life expectancy disparities would have to be addressed through public health strategies directed at reducing the risk factors that cause chronic disease and injuries."

And that means a more deliberate effort at patient-based care -- focusing on earlier diagnosis (and better diagnostics) and more targeted health care (right treatment for the right patient at the right time).  What it does not mean is a knee-jerk move towards "European" style healthcare and the ensuing cost-based rationing that inevitably comes with it.

For more detail on the study, click here: www.nytimes.com/2008/04/27/weekinreview/27sack.html

We mustn't allow the next generation of Americans to be the first in our nation's history to enjoy a shorter life than their parents.  And to achieve that goal we must abandon the rhetoric of  divisiveness and work together (government, academia, and industry) towards this common purpose.
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