The First Circuit Court of Appeals, a federal appeals court, upheld a Maine law restricting the use of prescription information by companies. The law allows doctors to opt out of having their prescriptions tracked by companies, who use the information for marketing purposes. The Court upheld a similar law in New Hampshire last year.

The plaintiffs challenged the constitutionality of 22 Me.Rev.Stat. Ann. tit. 22, § 1711-E(2-A), which allows prescribers licensed in Maine to choose not to make identifying information available for use in marketing prescription drugs to them.  Section 1711-E(2-A) does not directly prohibit marketing, but it prohibits certain entities from using or selling such information for marketing purposes if the prescriber has opted to protect the confidentiality of his prescribing data.

The ruling represents a defeat to the pharmaceutical companies, who use the data to market prescription drugs. This is a step forward for the Unbranded Doctor Campaign. Patterns and preferences in prescribing can be analyzed by companies, who then target doctors for particular prescribing patterns.

You can read the decision here.

NPA Board Member David Grande got a mention in this article in The Harvard Crimson discussing the recent changes to Harvard Medical School’s conflict of interest rules. The new rules prohibit faculty from accepting personal gifts and giving industry-sponsored talks at events where the material is prepared in advance by the company. In addition, when a faculty member is conducting research on technology owned or licensed by a particular company, compensation from that company to the faculty member is now limited to $10,000 annually.

A recent New York Times/CBS Poll found that a large majority of Americans support a government run insurance plan. Politicians not supporting a public-health insurance option, are truly out of touch with their constituents. The current draft in the senate promoting co-ops is frankly a bad idea and won’t really do anything to keep insurance companies in check, improve quality, and bring down costs. We need to demand from our congressmen and women to support a real and robust public health insurance option.  I’m not surprised by the results, we all have so many patients who are disgruntled with private insurance companies. Everyone, please call your congressmen and women and demand real reform which includes a public health insurance option and nothing less!

In Poll, Wide Support for Government-Run Health
By KEVIN SACK and MARJORIE CONNELLY

Americans favor a plan for government-run insurance to compete with private insurers, a Times/CBS poll found.

There’s a great article in the last NYT of 2008 about the new “restrictions” that the pharmaceutical industry is imposing on itself. No mugs, no pens, no trinkety free goodies.

Sounds great, right? Pharma is policing itself.

Well, first of all, these restrictions are all voluntary, which means no penalty for breaking the rules. And rule-breakin’ penalties is one of the reasons we have laws.

Then if we read a little further, there’s some fine print down in grafs eleven and fourteen:

The guidelines, for example, still permit drug makers to underwrite free lunches for doctors and their staffs or to sponsor dinners for doctors at restaurants, as long as the meals are accompanied by educational presentations.

The industry code also permits drug makers to pay doctors as consultants “based on fair market value” — which critics say means that companies can continue to pay individual doctors tens of thousands of dollars or more a year.

Cutting out the pens but leaving the rest is like going on a diet where you only eat Big Macs. They’ve cut out the cheapest and least effective part of their marketing campaigns, while doing nothing about the most expensive and deviously influential elements.

Drug reps can still buy lunches for doctors in their offices; they can still take docs out to dinners, as long as there is some educational component. (I went on one of these “educational dinners” long ago… the talk lasted 5 minutes and then we ate for two hours…)

Also, the companies can still pay “consulting fees” that generally run in the tens of thousands. Some of these consultancies are real. But do you think most of the doctors who receive these consulting payments would continue to get them if those doctors banned drug reps from their offices, banned all lunches and dinners, and stopped prescribing the manufacturer’s drug?

Which leads me to my main point: drug companies should not be allowed to track in precise detail exactly which doctors are prescribing their medicines. They should be allowed to know the rough outlines — by zip code, for example — but allowing them to buy databases with the exact number of prescriptions each doctor has given out for each medicine. . . . there’s too much potential for an unspoken quid pro quo to exist between doctors and drug reps.

I am heartened by one aspect of this: the fact that Pharma is imposing these restrictions voluntarily means that they see the writing on the wall. They are trying desperately to prevent the kinds of laws that New Hampshire passed from spreading across the country. They want to give opponents of reform some ammunition, something to let them point to and say “See? The drug companies have cleaned up their act! Everything is fine now!”

Except in four or five years, when we’re paying attention to something else, the pens and mugs will come creeping back. They’ll come back slowly, a trickle at a time, without the big press release and glowing article in the New York Times.

The time has come to reject the hidden intrusion of Pharma into our lives. Prescriptions belong to doctors and patients, no one else.

(p.s. I’ve started a blog dedicated to this issue: www.prescriptionprivacy.blogspot.com)

It seems that a certain Dr. Goodwin, host of the popular NPR program “The Infinite Mind”, has received over $1.3 million in compensation from pharmaceutical companies for giving lectures about their products. He served as both a journalist and prominent psychiatrist in his role on the NPR show. The show’s since been canceled, after NPR found out about the compensation. But it continues to bring up so many questions. First and foremost: Who can you trust? Here are two examples where things get very sticky:

Dr. Goodwin’s weekly radio programs have often touched on subjects important to the commercial interests of the companies for which he consults. In a program broadcast on Sept. 20, 2005, he warned that children with bipolar disorder who were left untreated could suffer brain damage, a controversial view.

“But as we’ll be hearing today,” Dr. Goodwin told his audience, “modern treatments — mood stabilizers in particular — have been proven both safe and effective in bipolar children.”

Supposedly Dr Goodwin received $2,500 that same day by a pharmaceutical company to promote it’s drug for bipolar syndrome. And…

He said that he had never given marketing lectures for antidepressant medicines like Prozac, so he saw no conflict with a program he hosted in March titled “Prozac Nation: Revisited.” which he introduced by saying, “As you will hear today, there is no credible scientific evidence linking antidepressants to violence or to suicide.”

That same week, Dr. Goodwin earned around $20,000 from GlaxoSmithKline, which for years suppressed studies showing that its antidepressant, Paxil, increased suicidal behaviors.

Check out the article — “Radio Host has Drug Company Ties” — in the New York Times. The good news, though, is that this conflict-of-interest information was revealed by a formal investigation by Senator Charles Grassley (R-Iowa), who has also sponsored the Physician Payments Sunshine Act (S. 2029) of which there is also a version in the House. S. 2029 looks to increase transparency and accountability by requiring drug and medical device companies to publish all gifts and payments over a certain dollar amount, given to physicians.

The National Physicians Alliance is in support of this legislation as part of its Unbranded Doctor campaign. It hosts an informative webpage on this legislation. The legislation is gaining support among legislators, media makers, and conscientious physicians and health systems. It’s music to my ears, because as a health care provider, I believe that I (and the public) have a right to know where conflicts of interest exist. I’d really like to know who I can trust.

(cross-posted at Cure This)

Generally, I lack the time to follow much TV, so it’s been a while that I watched Lost, but I thought the show’s basic and primordial premise – being lost on an island, where no one really knows how they got there, or how to get away (ok, for those who are up to date on this, people seems to have gotten off the island in Season 4) – seems so befitting our current economic situation. Now, I am a physician and not a economist, but most analysts seems to agree with me that the current world economic situation is quite similar to the TV series: we seem utterly lost, every day brings a new turn (together with a 500 up or down in the Dow), no one fully undertsands how we got here (some of the villans, subprimes, clearly not being everything), no one really knows how to get out of the hole.

But that is not the only thing lost. Although I just learned that Ed Kennedy is working on comprehensive heallth care reform (bless him, I wish him well but this may be his parting gift to Congress and the American People), I think that people like Bean, Gingrich and Kerry, who just out forward a suggestions to run medicine like baseball, should do a reality check. Here are some things they wrote that bug me:

Studies have shown that most health care is not based on clinical studies of what works best and what does not, be it a test, treatment, drug or technology. Instead, most care is based on informed opinion, personal observation or tradition (…)  We can do better if doctors have better access to concise, evidence-based medical information (…)  Evidence-based health care would not strip doctors of their decision-making authority nor replace their expertise. Instead, data and evidence should complement a lifetime of experience, so that doctors can deliver the best quality care at the lowest possible cost.

First, apart from the fact that a baseball player can hardly be compared with a doctor, it is not like Evidence Based Medicine is a new concept. It has been around for decades. And the barrier to findings new evidence is not primarlily the lack of will of doctors to accept it, it’s the lack of evidence, caused by a lack of studies, especially unbiased studies. The US government and public have sat back, NIH funding has been insufficient, and we have left it to the drug industry to go and find the evidence. Thus there is a lot of (often biased) evidence of the most lucrative conditions (although the FDA’s orphan drug program has made some difference), like the new diseases everybody seems to have (restless legs, social anxiety, ADHD). Meanwhile, it has become more and more expensive to get a medical education, there is a shortage of physcians, particularly in primary care, the doctors that do work often have no time, and sometimes no funds, for continuing education. Furthremore,  the number of un- and underinsured people is at an alltime high. Although I think it is a great idea, adequately funding the NIH, or some new institution, to run large unbiased clinical trials will have no immediate impact on clinical care: evidence will take years to accumulate and be transplated into practice and it will cost billions that Americans unfortunately are not willing  to pay (more taxes, anyone?).

Everyday I deal with the checkbox mentality of doctors: patient has condition X, so I must check Y and order Z. If I don’t, my hospital gets poor marks on the statistics used to judge their performance, and soon will determine their reimbursement. Furthermore, doctors are trained to think that if they do yet another test, they will not get sued and risk their livelihood and job as a result. Meanwhile, they have not time to talk to the patient, take a good history and review the chart. There is little, if any, evidence that increaseing the ‘batting average” of a doctor to run test Z does anything to make a patient better.  What we need NOW (notn in 5 to 10 years), is to get off the island. Not mb checking boxes, or more tax breaks, but by comprehensive health care reform. Let’s get Un-Lost!

This is so interesting. First, read the NLARx piece on Academic Detailing in ME/NH/VT….I think it is great that my state’s medical association has come out in favor of it (e.g., after opposing the ban on the sale of prescriber data).

As you may also know, the new PhRMA guidelines discourage providing gifts to doctors. I quote from NLRAx piece:

Practices that want to be visited by pharmaceutical company representatives still may do so, Smith (note: Gordon Smith, executive vice president of the MMA) said, although many practices already have eliminated such contacts.

Smith noted that ethics programs for doctors and the pharmaceutical industry have virtually eliminated gift-giving and other enticements to physicians.

“We have cleaned up the relationships between the doctors and the companies a lot, and there was a lot to clean up, including the dinners, the golf, the conferences,” said Smith, who has been doing his job for 28 years.

Even freebies like company-branded coffee mugs and notepads no longer are allowed, he said.

Drugs reps can pay for a “modest lunch in conjunction with a bona fide educational presentation,” Smith said, and that’s about it.

Well, as recent as two weeks ago, Sales Reps from AstraZeneca were hovering in our cath lab break room with some lavish breakfast, and they did not try to give me a bona fide educational presentation (read sales pitch – I would not have wanted one, either). I had to wiggle by them to get to our hospital supplied coffee. Another bona fide presentation by Medtronic took place last week at Hollywood Slots. I was not there, but I heard that a local doctor took away a few paraphernalia he won in a “raffle”. So as has been predicted before, the guideline is not working. So, Mr. Smith, the NPA is glad that more physicians are coming around, but much cleanup remains!

I work in a research clinic at an academic medical center where a significant minority of our funding (probably 10-15%) comes from the pharmaceutical industry. In fact, for the past few years approximately 15% of my salary has come directly from drug company funds for clinical trials. (The other 85% has come from public sources, mainly the National Institutes of Health.) As a liberal doc who took an unpopular stand during residency and spoke out against meals and gifts from Big Pharma, I’m not thrilled about having to take drug company salary support, but I also recognize that the NIH is unlikely to fund clinical trials of investigational drugs, and so pharma will continue to fund them. I also realize that this salary support, whether it had come from pharma or public sources, has helped me to launch a career as a clinical researcher. And, I think that doing research with pharma is qualitatively different than accepting gifts or attending CME talks at fancy venues. In the spirit of full disclosure, my position as medical director at our clinic does require me to attend “investigator meetings” where I am put up at fancy hotels and fed expensive buffet meals. This makes me a bit uncomfortable, but I spend the minimum amount of time possible at these meetings (usually one night and the meeting the next day), since I don’t wish to take anything from these companies other than the science I need to work on the trial. In any case, getting a bit “Pharmed Out” is a compromise I’ve had to make to move forward in my career, but a compromise I’ve been able to accept.

America’s Children are too fat. You cannot deny it (just look outside). They develop diabetes at an alarming rate. There is no doubt that many of them will develop into unhealthy adults and suffer of the  consequences: premature coronary artery disease, chronic pain, disability etc.

16 months ago, the American Academy of Pediatrics endorsed a guideline developed with the AHA in 2006 on how to treat children with disorders that have been shown to put them at risk for prematrue coronary artery disease. The highest risk catergory, which would receive medicines early in the course of treatment, featured conditions fairly rare in childhood (including Diabetes Type I). As recently as July 2007, the US Preventive Services Taskforce concluded that

Several key issues about screening and treatment of dyslipidemia in children and adolescents could not be addressed because of lack of studies, including effectiveness of screening on adult coronary heart disease or lipid outcomes, optimal ages and intervals for screening children, or effects of treatment of childhood lipid levels on adult coronary heart disease outcomes (emphasis added)

Now we are reading that children as young as 8 may be candidates for medications if they have a LDL concentration (“bad cholesterol”) above 160 mg/dl. These risk factors include:

obesity, hypertension, or cigarette smoking or a positive family history of premature CVD (cardiovascular disease)

So maybe the above Task Force – and I  – have missed a recent large outcomes trial that shows that treating an overweight child with a Statin (presumably that, because as the article points out most other medicines are poorly tolerated) will prevent adult heart disease. Furthermore, this articles hopefully compared it with the standard of care… if you find it, let me know. What is the standard of care? Here are a few suggestions by the American Heart Association:

Cholesterol and Atherosclerosis in Children

AHA Scientific Position

There is compelling evidence that the atherosclerosis (…) begins in childhood and progresses slowly into adulthood. Then it often leads to coronary heart disease (…)

Elevated cholesterol levels early in life may play a role in the development of atherosclerosis in adults.

Eating patterns and genetics affect blood cholesterol levels and coronary heart disease risk.

Lowering levels in children and adolescents may be beneficial.

(…)

To reduce fatty buildups in arteries in children (and adults):

Cigarette smoking should be discouraged.

Regular aerobic exercise that lasts at least 30–60 minutes on most days of the week should be encouraged.

High blood pressure should be identified and treated.

Obesity should be avoided or reduced.

Diabetes mellitus should be diagnosed and treated.

Children age 2 years and older should be encouraged to eat at least five servings of fruits and vegetables daily as well as a wide variety of other foods low in saturated fat and cholesterol. Doing this will help them maintain normal blood cholesterol levels and promote cardiovascular health.

No mention of drugs…..

I do not doubt that some children, particulary those with extremely elevated LDL (above 500 or so), may benefit from Statin drugs. But every obese child with a LDL above 160? That may be hundreds of thousands if not millions of young people swallowing expensive pills, with rare but serious side effects, and no proven benefit. It may help (prove it!), but the problem of obesity among children is not one of pill deficiency. How about spending the billions of health care dollars that such a treatment program will presumably cost, and getting more education, physical ed and better nutrition to our kids!

 And then when you read that the lead author Stephen Daniels has a conflict of interest (undisclosed by the journal), you may get nauseated… hey, there is a pill for that, too!

Read more in the New York Times, or LA Times.

According to the New York Times, Avandia, know for recent revelations about its heart risks, is still one of the dominating medicines for diabetes. This from an article that reports on an FDA panel urging more safety testing for these drugs. Just the other day, Pharma complained that the FDA’s safety review is slowing drug development (see Wall Street Journal, and read on Pharmalot for some interesting comment). The same paper reported that part of Pharmas problem was that

“the industry’s science engine has stalled. The century-old approach of finding chemicals to treat diseases is producing fewer and fewer drugs. Especially lacking are new blockbusters to replace old ones like Lipitor, Plavix and Zyprexa.”

According to the FDA’s Janet Woodock, applications for new drugs are down by 1/3. So let’s stop whining, be thankful that we have a lot of generics that work extremely well, and that there are dedicated researchers and companies that bring us truly novel drugs, such as Gleevac.

By the way, one of the recent drugs that was turned down by a 20 to 1 vote, was Arcoxia (etoricoxib) by Merck, Vioxx 2.0 so to speak. The trial meant to approve it, MEDAL, used an old recipe to make drugs look nice and compared etoricoxib to Diclofenac, which is  – as far as I know – one of the NSAIDs with more GI side effects. Do we really need such ‘new’ drugs?

 Writing this is giving me a headache. I’ll just pick up some 5 cent ibuprofen….