Latest Drugwonks' Blog

Fiercemarket publishing adds another publication to its lineup today. Along with it's excellent coverage of the business and science of pharma and biotech it will now follow the money in FierceHealthcareFinance. The newsletter will cover managed care reimbursement policies,state and federal regulation, medical billing and coding and IT solutions for finance along with other issues.

Go to fiercehealthcarefinance.com for more information and subscription links.

Best of luck!

Health Care For All

  • 02.12.2008
But not if the special interests, single payer types, stick-in-the-muds get their way...

Here's Benjamin Brewer's column on how he could deliver cheap primary care for $20 a month per person, but can't because of the usual collection of regulations and organized resistance. Reminds me of the obstructionist stance of doctors groups and protectionist fault finding of Health Care Renewal when it comes to retail health clinics..

But it makes sense to me that there be fair payment for primary care services that require a lot of what is now largely uncompensated work beyond an office visit. The cost would be peanuts, and the benefits of improved care could be enormous. What's missing in the debate over our nation's health-care crisis is that primary care is cheap. Cheaper than your cellphone bill. Cheaper than a tank of gas. Cheaper than dinner and a movie. It's so cheap the average person doesn't value it properly. I could have covered my salary for 2007 and the costs of all my staff and overhead for less than $20 per patient per month, including maternity and hospital care. My practice covers 80% to 90% of what the average person would ever need a doctor for. Compare that to what you or your employer is paying for health coverage, and you'll find that the high costs are due largely to catastrophic illnesses, hospital charges and money going to middlemen.

"....Even though I'd like to, I can't offer comprehensive primary care on a subscription basis for $20 per month. The Illinois Department of Insurance would send me to the slammer for running an unlicensed insurance company.

But most Americans could afford a package that combined $20-per-month primary care, $4 generic pharmacy prescriptions and some catastrophic coverage. If the combination was tax-deductible for the individual, then I think it would be a slam dunk. Netflix can rent you 4 movies a month for $23.99, but I'm not allowed to rent you a medical home for less than you'd spend to watch a movie each week. Before we're saddled with an unaffordable national health plan, we should consider renting an affordable medical home...."

But that's the point Dr. Brewer. Screw the fact that you can deliver an affordable and quality product to people who would buy it an open market that you are proud to deliver. It's all about saddling us with national health care. Ideology uber alles...

Oh, and did you disclose your conflicts. The folks at Health Care Renewal -- the arbiters of politically correct speech in the health care arena -- demand to know before you are allowed to give your opinions again.
http://online.wsj.com/article/SB120277184155560513.html

Step Up to Debar

  • 02.12.2008
According to the Pink Sheet:

"The integrity of FDA's drug approval process is being undermined by the agency's failure to actively and consistently prohibit participation by companies and individuals previously convicted of crimes associated with drug approval, the House Energy and Commerce Committee's minority staff concludes in a report released Feb. 11 by Rep. Joe Barton, R-Texas."

Does Mr. Barton have any evidence that folks who should have been disbarred haven't been? Does a lack of disbarments equal a lack of enforcement?

"FDA's debarment authority comes from the Generic Drug Enforcement Act of 1992, which was enacted in response to the generic drug scandal of the late 1980s. It allows debarment of generic drug companies, but FDA has failed to take action against even one firm, the report says."

"The report also notes deficiencies in the law and suggests FDA be given authority to debar brand-name and biologics companies, as well as those that make animal drugs and medical devices, that debarment be allowed for misconduct that occurs after a drug is approved and that incentives be devised to encourage FDA to start and complete debarments more quickly and efficiently."

Is Mr. Barton recommending that "crimes" be broadened to include "misconduct?" What does this mean -- and what does "misconduct" include?

"The report was released the day before the House Energy and Commerce Oversight and Investigations Subcommittee hearings on a fraudulent clinical trial conducted for Sanofi-Aventis' antibiotic Ketek."

Clearly the timing of the report is coincidental.
Here's CMS Medical Director on the CMS policy to restrict ESAs in a one size fits all way:

The American Society of Clinical Oncology, which represents cancer doctors, and the drugs' makers, are continuing to submit new evidence to bolster their argument that the restrictions will boost the risk of blood transfusions, he said.

FERVENT REACTION

Straube said he has seen no convincing evidence to support reversing the decision. A recent poll released by cancer and blood doctors suggesting doctors believe the policy is leading to more blood transfusions will have little sway, he said.

That survey of about 500 oncologists and blood doctors asked about views on Medicare policy and its impact on care.

Straube said there is no evidence in properly controlled trials that blood transfusions could rise based on the policy.

"People don't use surveys to make national coverage decisions," he said. "These were opinions."

Straube said he was "disappointed" and surprised by the fervent reaction of the cancer doctor community.

"Our staff looked at over 800 evidenced-based articles published in the literature," he said. "I doubt seriously whether most clinicians read all 800."


Lest I incur the righteous wrath of Healthcare Renewal, let me restate what I found after going through all the evidence-based articles...

There is no evidence in properly controlled trials that blood transfusions won't rise nor that blood transfusions are safer or could be associated with less cancer. So why is the burden of proof on clinicians and patients? Similarly, where is the evidence that the additional risk of cancer -- the relative risk of which must be established in the context of the existing cancer under treatment and with the recognition that in all the properly conrolled trials excess mortality was not always associated with higher hemoglobin levels -- is not worth the benefit from the patient perspective?

According to Straube, the opinion of a patient or physician no longer counts. Only the judgement of staff who look at evidence-based articles matter. And as for those studies, there is no consistency in trial design, population size, tumor stage, etc. There is a lot of mixing and matching and none of those studies look at the safery and effectiveness of blood transfusions.

Is this how we want medicine to be paid for and practiced in the United States? Should we ignore individual differences in response to drugs and disease in favor of population based studies.

It's a pretty straightforward question. Let me know. Leave the ad hominem attacks out.


http://www.reuters.com/article/Regulation08/idUSN0850178720080208

Hoosier Daddy?

  • 02.11.2008
Oh well, so much for, um, pulling one's own weight.

According to a story in the Chicago Tribune, “Executives at an Indianapolis health-care system, frustrated by rising benefit costs, proposed a new program to get employees fired up about staying healthy.

Rather than offering incentives, Clarian Health Partners would fine employees who didn't try to quit smoking or lower their cholesterol or blood pressure. The threat of hiking their medical premiums by as much as $30 per paycheck surely would get their attention, executives reasoned.

They were right, but the proposal also generated so much resentment that Clarian Health never rolled out the program.”

Here’s a link to the complete article:

http://www.chicagotribune.com/business/chi-sun_health_0210feb10,0,1758041.story

Wonder how these folks in the Circle City feel about another type of health care mandate – government-run health care?
According to a story on the Forbes website, “Just 5 percent of Web pages devoted to breast cancer contain inaccurate information. But pages focused on complementary or alternative medicine are 15 times more likely to make misleading claims and contain other false information, a new study says.

Moreover, standard measures of quality developed to assess the accuracy of Web pages don't really work, said the authors of the study, published in the March 15 issue of the journal Cancer.

According to the study, 44 percent of women recently diagnosed with breast cancer search the Internet for relevant information about the disease. Many visit the Internet before seeing a physician, which means they may be forming opinions and making treatment choices without professional input, the study authors said.”

Here’s a link to the complete article:

http://www.forbes.com/forbeslife/health/feeds/hscout/2008/02/11/hscout612512.html

When it comes to breast cancer or any cancer – or any health condition – caveat emptor is dangerous practice.
My eldest son has Juvenile Myoclonic Epilepsy that is marvelously under control due to the golden combination of the right medication in the proper dose, along with strict and compliant adherence.

So it came as somewhat of a shock at the end of last month when the FDA issued an altert to health care providers on the “Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications.”

Here is a link to the FDA alert:

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

As with many recent FDA risk communications initiatives, the unintended consequences may very well outweigh the need for the communication.

To that end I recommend to you an article from the New York Times, “Making Sense of the Great Suicide Debate.”

According to the article, “Many doctors who treat epilepsy patients said they were bewildered by the recent reports and concerned that regulators were scaring patients away from valuable medications based on limited evidence ... In the case of the epilepsy drugs, the F.D.A. found 4 suicides among some 44,000 people taking the drug in 199 studies, and none among some 28,000 on placebo.”

Here is a link to the complete article:

http://www.nytimes.com/2008/02/10/weekinreview/10carey.html?_r=1&ref=health&oref=slogin

The regulatory policy issue at play here is FDA risk communications and the important (and mostly unaddressed) question of unintended consequences.

Is it important for the FDA to communicate with health care providers and patients (and parents of patients) when relevant safety data becomes available? Yes. But is the agency weighing the risks and benefits of such communications with the appropriate finesse – as they do when they review a drug application – that’s the question.

And it’s a good question for the FDA’s new Risk Communications Advisory Committee to consider when they meet for the first time on February 28.

Make Mine a Rubin

  • 02.09.2008
By way of Forbes, a real "call it like I see it" piece by Paul H. Rubin, Professor of Law and Economics at Emory University and former Chief Advertising Economist at the Federal Trade Commission and Chief Economist at the U.S. Consumer Product Safety Commission. The topic is the important role of drug reps and, more broady, drug marketing> Rubin's article is both important and timely -- and should serve as an education for those who opt for soundbites rather than sound public health policy.

On My Mind: A Free Lunch
Paul H. Rubin

There's nothing wrong with letting drug reps schmooze with doctors. What's the matter with Americans? They think there is something incestuous about the connection between drug companies and doctors.

Politicians tell them that the drugmakers wine and dine physicians while pushing the latest antibiotic or statin. Utterly corrupted, doctors impose those medications on patients, whether or not the drugs are better than cheaper alternatives.

A pending U.S. Senate bill would require drug companies to report gifts to doctors of more than $25; the House is investigating marketing practices. New York State's legislature plans to hold hearings this year on the relationship between doctors and drug companies. One congressional critic has even compared the drug industry with the tobacco industry, and Senator John McCain has called drugmakers the "bad guys."

What drugs are these legislators taking? Drug company reps offer overworked doctors useful, lifesaving information in an efficient manner. The drug companies are of course motivated by profit, but economists have known since Adam Smith that the profit motive is the best way to induce someone to do something useful. (Disclosure: I consult for the drug industry from time to time, most recently for Pfizer.)

Marketing and research are both information activities; they work together to get effective drugs to patients. The two activities are not in competition for resources. The denouncers of drug companies don't understand this. One of the senators sponsoring the bill suggests that "the millions of dollars these companies spend on marketing ... could be put into research." In fact, drug companies would not switch money from marketing to research. If they cannot market drugs in the best way, they will reduce spending on research. What's the point of inventing a new drug if doctors and patients don't know about it?

Academic physicians think that doctors should obtain information by reading medical journals. Practicing doctors do not have time to comb through the International Journal of Medical Sciences or the Annals of Internal Medicine. A meal with a pharmaceutical salesperson is a time-efficient way for a busy doctor to learn about new drugs, or perhaps a better therapeutic alternative, or a drug with easier dosing or fewer side effects than the old drug. Physicians interact with more than one drug rep, so they have competing sources of information.

Another argument made by supporters of the Senate bill is that promotion leads physicians "to prescribe the expensive new drugs that are being marketed to them when a more affordable generic would do," in the words of one senator. There are three things wrong with this argument. First, manufacturers of generics do not promote those drugs, so it might be
difficult for the physician to learn about generics at all. Second, new drugs lead to better health outcomes. They keep people out of the hospital. A 2007 study by business professor Frank Lichtenberg of Columbia University estimated that a prescription for a new drug (5 years from FDA approval) costs an average $18 more than an older one (15 years on the market) but reduces other medical costs, including hospital and office visits, by $129. Finally, by leading consumers to purchase newer drugs, marketing increases investment in innovation and thus makes research more likely.

A widely cited 2000 article in the Journal of the American Medical Association summarized 29 published studies critiquing the interaction between doctors and drug reps. Notable feature of these articles, as quoted in the summary paper: "No study used patient outcome measures."
That is, in all of the medical literature on drug sales, there was no evidence of harm to patients caused by doctors and drug reps breaking bread. These articles were written by physicians who by their oaths put patient welfare at the top of the list, but they were critical of the industry based on analyses that totally ignore this measure.

A recent report shows that the life expectancy of Americans is at its highest level ever and will continue to increase. It is truly amazing that this society keeps coming up with ways to demonize and penalize an industry that has provided us with so many benefits.

Crazy Eddies

  • 02.08.2008
Here’s an (audio-only) link to last night’s NewsHour with Jim Lehrer, where I debated Gail Shearer of Consumer’s Union on the topic of pharmaceutical DTC advertising – and the specific debate swirling around Dr. Robert Jarvik’s inability to scull.

http://www-tc.pbs.org/newshour/rss/media/2008/02/07/20080207_jarvik28.mp3

Feedback, as always, welcome.
According to reports in the Bangkok Post, the World Health Organization led a mission (at the request of the new Thai government) to Bangkok to formulate a report on compulsory licensing and to provide technical advice on various aspects of TRIPS.

But the WHO team is likely to provide more than just “technical” assistance considering that the WHO’s new chief IP official is anti-industry ideologue German Velasquez.

Consider the article Velasquez penned in Le Monde diplomatique not so diplomatically entitled “Unhealthy Profits,”

“After Doha, it is clear that if drugs are considered as goods, health will remain an extension of the market, with remedies and treatments available only to those with enough purchasing power.”

Here’s a link to the complete article (in English):

http://mondediplo.com/2003/07/10velasquez

And here’s another reason to consider the WHO Bangkok mission as slanted -- there wasn’t a single representative from WIPO (the World Intellectual Property Organization).

Hello?

This is Geneva bureaucratic politics at its worst – and blatant disregard for the spirit of international cooperation in both protecting intellectual property rights and advancing public health.
CMPI

Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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