Term of Endearment

• 11.24.2008

The U. S. Food and Drug Administration prides itself on being, first and foremost, all about science. So, how did the agency that regulates upwards of 30 percent of the U.S. economy get so caught up in tacking against biting political crosswinds? As a veteran of the regulatory wars, my argument is that the rocky seas began to roil when the position of FDA Commissioner was converted from a career position to a political position in the late 1960s. Prior to that time, the FDA chieftain was generally someone who had advanced through the ranks of the agency gaining experience and seasoning along the way. When the Commissioner’s position became Senate confirmable in the late 1980s, some believe an adverse change took place. Others believe that politics is just more contentious than ever before. Both of these notions are correct.

When one considers the mission of FDA—to independently protect and advance the public health—it is not at all clear whether the Commissioner should be a Senate-confirmed political appointee “serving at the pleasure of the President.” I think that the American people would prefer he or she be nominated by the President for a fixed 6-year term—similar to that of the Director of the FBI. Think about it—why should the safety of food additives, the integrity of the blood and vaccine supply, and decisions on drug labeling indications (to name only a few FDA responsibilities) be considered Democratic or Republican issues? The boss of the FDA Commissioner is and should continue to be the Secretary of Health and Human Services—a politically appointed, Senate-confirmed cabinet officer. This is enough. More politics just leads to regulatory paralysis and discord—neither which protects or advances America’s health. 

Having had the honor to serve our country as an FDA Associate Commissioner, I can unequivocally state that the unwelcome infusion of politics into science makes an already difficult job virtually impossible. To have the job of Commissioner open and only partially filled for extended lengths of time grinds progress to a halt. Low morale, lengthy delays, and even postponements often characterize an open Commissionership. This is not acceptable.

Who becomes the next FDA Commissioner is important. But an important indication of the seriousness with which President-Elect Obama takes that post is how soon in his administration a nomination is made. Let’s hope it’s done swiftly and smartly.

For more on this, have a look at the Journal of Life Sciences.

Quantum of Shamelessness

• 11.21.2008

More info that the New York Times left out of its story on Fred Goodwin:

The Times writes:

"He defended the views he expressed in many of his radio programs and said that, because he consults for so many drug makers at once, he has no particular bias."

“These companies compete with each other and cancel each other out,” he said. This view is dismissed by industry critics, who say that experts who consult widely for drug makers tend to minimize the value of non-drug or older drug treatments."

Here are the facts:

Goodwin consistently studied the effects of lithium a drug that lost it's patent nearly a half century ago and continues to lecture about it's benefits as a front line treatment for manic depression.

Read More

Goodwin also pioneered the use of light therapy to treat season affect disorder.

Meanwhile the Grassley witch hunt continues apace, now "investigating" Goodwin's private consulting business for promoting "off-label" use of lithium. Translation: Publishing an article in JAMA comparing the effect of lithium in reducing suicide among manic depressive patients to marketed products - in partnership with managed care plans and other research organizations -- is now a reason to investigate. And of course just being investigated by Grassley is a crime because taking money from any drug company for any reason at any time makes all of one's research suspect and you a criminal.

Got that?

I can hear the hatchets being sharpened. Shannon Brownlee and Jeanne Lenzer must not be far behind.

Expert Witness

• 11.21.2008

Per today's article in the New York Times on my friend and colleague Fred Goodwin ... why was there no mention of stature in the field of psychiatry?

Here are (only) some of Dr. Goodwin's particulars:

*  Research Professor of Psychiatry at The George Washington University and Director of the University’s Center on Neuroscience, Medical Progress, and Society;

*  Former Director of the National Institute of Mental Health

This was not relevant to the story, why?

Looks like that "all the news that's fit to print" window is getting narrower all the time.  Talk about a lack of fair balance and adequate provision.

Time to contact the Ombusdman.

Generic Attack on Fred Goodwin

• 11.21.2008

Fred Goodwin is one of the leading psychopharmacologists of this century. He is also a practicing psychiatrist. That is reason alone for those bent on driving down the use of medications for mental illness to target Goodwin for being paid to advise pharmaceutical companies who develop products for the treatment of such conditions. Goodwin -- who is my friend and a CMPI board member -- is a pioneer in the successful treatment of schizophrenia and manic depression. His radio show, "The Infinite Mind" covered a wide variety of subjects ranging from dreams, to aging, to depression over the 15 years he was the host.

He is being slimed by the same small-minded group that wants to savage science and replace it with a contorted combination of anger, unmedicated anecdotes and trial lawyer inspired opportunism.

Goodwin will continue to publish, lecture and research, adding value and knowledge to patients lives.

Here's the difference between Goodwin and his attackers:

Fred has helped reduced the number of suicides among the mentally ill. They have helped increase them.

They have to live with their legacy. I am sure Fred will be content with his.

Read New York Times article

Adding the Fuel of Interest to the Power of Genius

• 11.21.2008

Day II of the IFPMA Assembly offered a pastiche of pithy policy pensées.

John Lechleiter (President and CEO, Eli Lilly & Company) spoke on the urgency of making healthcare more personal. A few points from his remarks:

* “The free market hasn’t failed — it just hasn’t been given a chance to work as it should.”

* “With critics of the U.S. system pointing to Europe and other countries for reform guidance — in the past decade, nearly every European country has introduced market-oriented reforms — and has turned to the private sector in their efforts to reduce the health costs of treatments.”

* “We need to build a consumer-driven system — one that instills a sense of personal ownership … and puts the individual consumer in charge of how health care dollars are spent — through such mechanisms as health savings accounts.”

* “Transparency is the lubrication that makes consumer-driven healthcare work.”

* "We need to restructure the system so it is patient-centered … where health care providers, payers, regulators, and innovators work together to answer a single question: What is best for the individual patient?”

* “In a patient-centered system, individuals bear primary responsibility for their own health. And physicians help patients recognize incentives for healthier living … and act as agents on their behalf. In this system, providers compete on value and are measured on quality.”

* “We must build a system that promotes universal access, not by mandate but through free-market solutions that maximize coverage and improve access.”

* “In 2007 — for the first time — we offered U.S. employees consumer-driven options: HSA/HRA. About one-third of employees opted for a health savings account or a health reimbursement account.”

* “This year, roughly two-thirds of enrolled employees — including moi — and dependents chose one of these options. By 2010, our company will offer only consumer-driven options for our active employees.”

Lechleiter’s full remarks can be found here.

In his keynote address, IFPMA President Fred Hassan (whose day job is Chairman and President of Schering-Plough), shared that the IFPMA will commence a global communications effort on the value of IP. And while he didn’t say that IP is a human right, he came very close – pointing out all of the good that solid intellectual property right protection affords civil society. He also quoted Abraham Lincoln (a popular thing in Washington, DC these days), saying that intellectual property rights “add the fuel of interest to the passion of genius.”

Bravo.

Hassan also noted that the IFPMA is going to field a study to determine its image and level of influence in Geneva. (Note to Fred: If you have to ask …)

Rich Bagger (SVP, Worldwide Public Affairs & Policy, Pfizer) was the only speaker to consistently refer to his company as being in the “life sciences” business. Why is this so hard for everyone else to remember ?

One of Rich’s themes was “new roads to access.” And he offered a very early yet tantalizing example – Pfizer’s partnership with the Grameen Bank of Bangladesh (yes – the one run by Nobel Laureate Muhammad Yunus). Pfizer and Grameen are developing a “micro health insurance model” along the lines of Grameen’s well-known micro-credit programs. According to Bagger, a policy might cost $20/month of which $3 would go towards pharmaceutical coverage. That’s consumer-driven healthcare LDC style – and a program that the world’s largest life sciences company should talk about publicly, proudly and often.

Ladies and Gentlemen – the frost is on the pumpkin and it’s time to get to work.

Sitemap

• 11.20.2008

Hello Tom. Goodbye Steve.

• 11.20.2008

Tom Daschle is a terrific choice for HHS for many reasons.  Most importantly, he’s a grown-up. 

Daschle's sure-footed Washington savvy should pretty much shut the door on those Nabobs of Nissenism who are calling on King Steven to ascend to the FDA throne. Secretary-Presumptive Daschle knows better than to take anyone seriously who is so universally disliked among the most senior FDA staff and so generally divisive among almost everyone else.

His other role in the Obama White House, that of Health “Czar,” poses some interesting questions.  Specifically, how will he approach the issue of the Part D Non-Interference Clause – which he (along with Senator Kennedy) drafted in the first place?

Yesterday, at Day II of the IFPMA Assembly, the luncheon speakers were former Senators John Breaux and Trent Lott.  Neither thinks there will be a strong Congressional effort to reverse the Non-Interference Clause.

I am not as phlegmatic.

And to that point, a few things worthy of consideration:

"It is not obvious that allowing the government to negotiate with pharmaceutical companies will lead to lower prices than those achieved by private drug plans. Private plans like Kaiser or United are able to negotiate deep discounts with pharmaceutical companies precisely because of the plans' ability to say no – the ability to include some drugs and to exclude others, allowing the market to judge the resulting formulary. On the other hand, when the government negotiates, its hands are tied because there are few drugs it can exclude without facing political backlash from doctors and the Medicare population, a very influential group of voters. Neither economic theory nor historical experience suggests government price negotiation will achieve lower drug prices. Congressional Democrats need to be careful in making the logical leap from market share to bargaining power. Empowering the government to negotiate with pharmaceutical companies is not necessarily equivalent to achieving lower drug prices. In fact, neither economic theory nor historical experience suggests that will be the outcome. Members should think carefully before jumping on the bandwagon – this promise may bring just the opposite of what was ordered."

Stanford Business School's Alain Enthoven and Kyna Fong

"Both the non-partisan Congressional Budget Office and Medicare actuaries have said they doubt the government could negotiate lower costs than the private sector. The theory behind Part D is that market forces and competition among drug plans, overseen by government, can achieve better results than a government-run program. The multitude of plans allows seniors to pick one that best meets their needs. Government price negotiation could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. Medicare recipients account for half of all drug prescriptions. With that kind of clout, government might try to dictate prices, not just negotiate them. This could leave people without drugs that manufacturers decide aren't sufficiently profitable under the plan. The VA plan illustrates the point. It offers 1,300 drugs, compared with 4,300 available under Part D, prompting more than one-third of retired veterans to enroll in Medicare drug plans."

"Our View On Medicare Part D: Put Brakes On Drug Plan 'Fix,'" USA Today, 11/13/06

The bottom line here is that Part D is a tremendous success – due in no small part to the Non-Interference Clause.  Consider:

* The projected cost for Medicare Part D is $117 billion lower over the next decade than experts estimated just last summer. This means that over the 10-year period from 2008 to 2017, the estimated $915 billion cost of Part D fell to $798 billion.

Why?  Marketplace competition.

* And, according to a study published in the Annals of Internal Medicine, the Medicare drug benefit led to a 17 percent decrease in out-of-pocket expenses, or $9 a month, for seniors who enrolled in the new Medicare Part D benefit in 2006, the first full year prescription coverage became available in the federal health insurance program for the elderly and disabled.

* And the savings amounted to an extra 14 days of medicine for those who signed up, or a 19 percent increase in prescription usage.

Can Part D be made even better? Absolutely. But this is good news worth sharing -- and not because it helps any particular partisan political agenda but because it means that more Americans -- tens of millions of more Americans -- are getting access to the medicines (largely chronic medicines) that will help them live healthier lives. And this, in no small measure, significantly reduces more drastic medical interventions -- which in turn reduces our overall national health care spending.

We shouldn’t interfere with success.

Connections That Count

• 11.19.2008

Of Budget Shortfalls and Snake Oil

• 11.19.2008

As our current financial meltdown forces state governments to consider ugly budget cutbacks, some foolish ideas often get undeserved airtime.

Specifically, drug importation.

It’s worth restating the facts.

State and local importation schemes have been dismal and politically embarrassing. Remember Illinois’ high profile “I-Save-RX”program? Over 19 months of operation, a grand total of 3,689 Illinois residents used the program -- which equals approximately .02% of the population.

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

And what about Springfield, MA and “the New Boston Tea Party?” Well the city of Springfield has been out of “drugs from Canada business” since August 2006. (But that hasn’t stopped Chris Collins – a representative of CanaRX from telling some New York municipalities that, “We’re now saving over $2 million a year in Springfield, MA” (Hamptons.com Sept 30, 2008, reported by Aaron Boyd).

Shameful.

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

PS/ The drugs CanaRX sells to Americans aren’t even legal for sale in Canada.

Oh – and by the way, such programs don’t even save any money. A study by the non-partisan federal Congressional Budget Office (CBO) study showed that importation would reduce our nation’s spending on prescription medicines a whopping 0.1% -- and that’s not including the millions of dollars the FDA would need to set up a monitoring system.

We’re all in deep enough fiscal trouble.  We shouldn’t make it any worse by looking for unsafe, unsound, quick-fix solutions that make for good soundbites -- but bad public policy.

Sachs Appeal

• 11.19.2008

Sorry for the late evening post, but I've been at 24th IFPMA Assembly in Washington, DC. all day.

Some highlights:

The luncheon keynoter was Jeffrey Sachs, Quetelet Professor of Sustainable Development and Professor of Health Policy and Management at Columbia University -- but he's probably better known you drugwonks out there as the Director of the Earth Institute and author of "Common Wealth" and "The End of Poverty." Most of his talk was of the usual garden-variety "more government, please" variety -- but he did say one thing worth mentioning, that although he has some serious issues with pharmaceutical patents, "lifesaving innovation would be impossible without them." Yes -- "impossible." I wonder what Jamie Love will have to say about that?

The best panel of the day featured the health ministers from Kenya and Uganda (Peter Anyang' Nyong'o and Richard Nduhuura respectively), who spoke of their nations' need for enhanced healthcare infrastructure -- and then Alessandro Banchi (Chairman, Boehringer Ingelheim) laid it it out in black and white, "The elephant in the room is the fragility of healthcare systems -- not the price of drugs." Neither of the two ministers objected.

Zhang Weibo (Director, Pharmaceutical & Biological Review, People's Republic of China), spoke on the issue of IP and TCM (Traditional Chinese Medicine) -- an issue that deserves further discussion -- and will certainly get it. (Note to Congress: Better open the fortune cookie and start thinking about DSHEA reform.)

Swati Piramal (Director of Strategic Alliances, Piramal Healthcare, Ltd, India) spoke about India's emergence as a nation of pharmacetical innovation. She said her firm has a few drugs in the pipeline that can be brought to market for under $100,000,000. That got people's attention.

More from the IFPMA Assembly tomorrow.