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The big news today is that a federal judge ordered the Food and Drug Administration to rule on a human growth hormone product made by a Novartis AG unit, adding pressure for the agency to deal with the high-stakes question of generic copies of biotechnology drugs.

The decision by Ricardo M. Urbina, a judge in the U.S. District Court for the District of Columbia, came in response to a suit filed by Sandoz, a generics unit of Novartis, a Swiss pharmaceuticals maker. The suit, which named top officials of the FDA and its parent agency, the Department of Health and Human Services, alleged that the agency violated federal law by failing to either approve or reject Sandoz’s July 2003 application to market Omnitrope, a version of human growth hormone.

The judge’s opinion issued today — saying the agency is required to meet a statutory deadline in its decisions on whether to approve drugs — could strengthen the hands of drug companies. Judge Urbina wrote that the FDA had “identified no compelling reason for this court to excuse its delay.”

Silence, it seems, is not always golden.

Sandoz’s application “remains stuck in the ether,” the judge wrote, citing the “egregiousness of the delay.” The opinion says the FDA must meet statutory requirements, which include the option of giving the company a hearing before the Secretary of Health and Human Services about whether its drug is approvable.

The moral of the story is that delay based on silence doesn’t wash. Nor should it. Silence is the excuse of a weak argument. However, delay based on lack of expertise is a very good reason to defer a decision. Since Judge Urbina offered a hearing before the Secretary as a remedy, I predict that is precisely what will be offered.

Who wins? You make the call.

“Americans United” is a labor and Democrat party funded front group and they are wrong on the facts to boot. Why is there no caveat about where they get their funding at the end of their editorial in today’s USA Today? (See below.)

The design of the drug plan is exactly the same as that designed by President Clinton and supported by Families USA and the Democrats in 1999. How do they explain being for the drug plan before being against it? As for officials not wanting you to know about the enrollment breakdown, it’s right there on the damn HHS website, press release, etc. You would have to be an idiot not to see it … or Brad Woodhouse.

Actually there were 11 million seniors that lacked drug coverage before the program and 8.3 million have voluntarily signed up. My math puts me at 75 percent and we are not at May 15. 70 percent have reaped savings. that’s another way of saying 30 percent have not yet. As for the donut hole, guess what, a large chunk of seniors won’t hit it and those that will have actually purchased coverage that fills it.

The stand alone plans are not perfect. I would like to see drugs used to prevent disease and reduce spending overall in that fashion and you might need integrated health plans for that. But to suggest that the plan is corrupt is baseless beyond belief and comical considering Americans United were going to stoke the fires of resentment about the plan according to Democrat memo….Worse, to propose price controls as a panacea is simply being reduced to having no other message. Forcing biotech firms most of whom have piled up hundreds of milions of dollars of losses to sell half their medicines sold worldwide at the VA price (40 percent below wholesale) will be possible without destroying innovation or denying seniors access to breakthrough medicines is either delusional or writing for Americans United or a labor front group..oh wait that’s the same thing.

17 April 2006 USA Today - By Brad Woodhouse

The Medicare prescription drug program is costly, confusing and corrupt, and it has left millions of Americans to conclude that President Bush and Congress designed the plan with pharmaceutical and health insurance companies in mind, not seniors.

Medicare Part D is so hopelessly flawed that the enrollment deadline of May 15 must be extended to give Congress time to fix this debacle.

The deadline also must be extended to give people more time to sign up without penalty. It would be immoral to penalize seniors and the disabled for their failure to sign up for a plan that should have never been this difficult and confusing in the first place.

The Bush Administration claims that roughly 29 million Americans of the 42 million who are eligible have enrolled. What officials don’t want you to know is that almost three-quarters of those enrolled — some 21 million Americans — were dumped into Part D automatically. Only about half of those eligible for Part D who can voluntarily enroll have done so.

The reasons are clear: cost and confusion. A recent Washington Post/ABC News poll found that more than one in every three Americans who have enrolled reported that they have realized no savings — and when many begin to fall into the infamous “doughnut hole,” that figure is sure to rise.

In addition, millions of Americans have been deterred from enrolling because of the maze of confusion that has been a staple of the prescription drug plan. With more than 500 plans nationally, each with different premiums, co-pays and formularies — all of which are subject to change — it is little wonder that so many have yet signed up.

The fatal flaw in this law is that it prohibits Medicare from negotiating with pharmaceutical companies for lower prices, and from eliminating confusion by offering a simple and affordable plan to seniors directly from Medicare. The deadline must be extended so more people can sign up and so Congress can fix Part D to make it simple, affordable and guaranteed.

Brad Woodhouse is communications director for Americans United, an advocacy organization based in Washington

The amount of conservative complaining about Governor Romney’s health care plan has been nothing short of amazing to me. If you replace the words “health care” in the bill with “Medicare Part D” or “Medicare Advantage” you would have the same sort of vehicle for expanding coverage and promoting competition. Sure, there are things not to like about the Romney plan, including the employer fine and things it does not do, like provide enough low cost, non community rating choices. But how about fighting to fix those? As for the whining that it will be a model elsewhere, how about building our own models?

Finally, conservatives need some to educate themselves about what will really save health care dollars or at least make them more valuable. Health care financing models are only means to an end. The tidal wave of retirement needs to be reversed or transformed by enhancing health or prolonging productivity. Better health and longer life through more personalized medicine and preventive technologies are the key to revolutionizing health care. We need to start talking about and developing approaches that reward and capture these innovations. And we need both the guts and brains to carry the fight through or just get out of the way. It’s easy to gripe, hard to lead, harder to win.

Here at we have frequently commented that one of the basic differences between the various European health care models and our own is one between quality and equality. Europeans, by large margins, believe that equality of care is more important than quality of care while we in the US put quality first. We’ve also commented on the situation in the UK where a woman was denied Herceptin for treatment of her breast cancer because of NHS cost considerations. Well, an appeals court in London has ruled that the health service acted illegally when they denied her access to the drug. It seems that quality counts after all. This is a victory of sanity over philosophy.

The implications for the NHS system are profound, but equally important are the implications for those who would demand a purely evidence-based (read “cost-based”) system in the US. Are formularies limited to only the most cost-efficient treatments truly in the best interest of the public health? Clearly not.

Gil Morgan, chief executive of the NHS Confederation (which represents organizations within the British health care system sums it up NICEly, “These decisions are extremely difficult and best taken as close to the patient as possible.”

And that means in the doctor’s office — not Washington, DC.

While one New York Times article reported on Eliot Spitzer bloviating that, if he is elected governor, research on stem cells and other promising treatments would be the “centerpiece” of the state’s health care policy (I sure hope access is up there too), another article, by Andrew Pollack, reported on a truly important issue — genetic diagnostics.

It’s worth reading. Here’s the link:

Mitt Happens

  • 04.13.2006

The always incisive Grace-Marie Turner (of the Galen Institute) points out some uncomfortable truths about Governor Romney’s universal health insurance program:

Proceed with Caution

The new Massachusetts health plan has dominated the policy conversation over the past week, causing more division among conservatives than liberals.

The law, designed to make the state the first in the nation to achieve universal health coverage, was signed on Wednesday by Gov. Mitt Romney. He was flanked at the invitation-only ceremony by the Democratic leaders of the Massachusetts legislature and by Sen. Ted Kennedy, a long-time advocate of universal health coverage.

The biggest concern among conservatives is the requirement that every individual in the state must purchase health insurance or face financial penalties.

Mandates are almost impossible to enforce, even with the fines and other enforcement provisions in the law. Further, the state must specify what kind of insurance people are required to buy and how much they should pay, taking away the ability of markets to freely compete and for people to purchase the coverage of their choice.

We were also concerned about the back-door employer mandate. The legislature wanted to force employers with 11 or more employees to pay a $295 annual fine for any employee without health insurance. The Governor vetoed the provision, but leaders of the heavily Democratic House and Senate have said they will override.

House Speaker Salvatore DiMasi called the veto disingenuous, saying the law was crafted with concessions and compromise. “To change anything will disturb the delicate balance that made this law possible,” DiMasi said. Note to employers: $295 is only the beginning.

While many conservative groups, like the Pacific Research Institute, the Cato Institute, and the Council for Affordable Health Insurance, have been highly critical of the plan, The Heritage Foundation has been very involved in helping the Governor craft the legislation. The Governor credits Heritage with creating the new FEHBP—ike insurance connector to offer insurance options and collect and distribute premiums. Bob Moffit of Heritage stood behind the Governor at the signing ceremony.

An integral provision is the requirement that every employer with more than 10 employees — think your local automotive garage — must offer a Section 125 cafeteria plan so employees can use pre-tax money for their insurance premium contributions.

And that’s only the beginning of the reporting requirement, mandates, penalties, and other enforcement provisions in the new law, for example:

* The law requires every employer and employee in the state to sign “under oath” a Health Insurance Responsibility Disclosure form, testifying to whether the employer has offered insurance and whether the employee has accepted or declined.

* It creates at least 10 new boards and commissions to create and run the new health system, such as the Health Care Quality and Cost Council, the Payment Policy Advisory Board, and the Health Access Bureau.

* New and existing state agencies will be checking on individuals’ insurance status, monitoring their income to see if they qualify for subsidies, and tracking individual health habits (like smoking and wellness activities) to determine their insurance rating category.

* There also is a major expansion of Medicaid and S-CHIP to cover children up to 300% of poverty, and the state makes it clear that it is doing all it can to maximize collection of federal matching funds to help finance the new plan.

My biggest concern is over the financing. The state says it is just moving money around — redirecting about $1 billion in uncompensated care money to subsidize health insurance for those under 300% of poverty (about $50,000 a year for a family of four).

But there is nothing in the law to keep health insurance costs from soaring. Policies offered through the new health insurance Connector must have first dollar coverage and include all of the 40 coverage mandates on the books, with none of the provisions that are working in the private sector to engage consumers as partners in managing health costs. Estimated premiums are unrealistically low and will quickly lead to higher taxes and “assessments” on individuals and employers.

Nonetheless, newspapers around the country are falling over each other in their effusive praise of a Blue state, led by a Republican governor, building a bridge across the political chasm to go where no other state has gone before.

Gov. Romney’s term ends this year, and he is likely to be spending a lot more time in Iowa and New Hampshire than in Massachusetts as this plan gets up and running. But I worry that he has laid the foundation for what can become a very intrusive, onerous, and expensive health plan for Massachusetts. Other states, which are firing up their Xerox machines now, should wait to see how this works out before rushing to follow the Bay State’s lead.

When it comes to empowering patients to play a more important role in their own health care, our mostly free-market confreres from across the Atlantic can learn from both our failures and our successes — but first they have to stop being afraid of the “A” word. That’s “A” like in “advertising” of the direct-to-consumer kind.

Have a look at the attached op-ed from today’s European edition of the Wall Street Journal.

Download file

Got Science?

  • 04.11.2006

If a pharmaceutical company funds a double-blind clinical trial performed by highly respected medical researchers, are the results relevant?

Not necessarily.

Click below to find out the rest of the story.

Does anyone take Sid Wolfe and Public Citizen seriously anymore? In a pathetic attempt to block the OTC marketing of fat-blocking drug Xenical, Sid and his group — who peddle a scare a day screed called “Worst Pills, Best Pills” as a Christmas gift — are actually arguing that the drug should be pulled because…….the drug allegedly caused precancerous colon lesions in animal studies!!! Sid Vicious forget to mention the mounting evidence that Xenical exhibits antitumor properties towards prostate and breast cancer cells by virtue of its ability to block the lipogenic activity of fatty acid synthase. Oh. I guess bumps in a rat’s rump are more compelling than the ability to block cancer to the good folks at Public Citizen. What dopes.

Why is this week different from all other weeks? Well, it’s Passover for one thing but moreover BIO is meeting in Chicago where plenary sessions are discussion some very critical questions about whether, when personalized medicine matures, government regulators, trial attorneys, and the pols won’t suffocate in pursuit of their own agendas. Cases in point:

The Agency for Health Care Quality and Research — under orders from Congress — is supposed to compare the cost-effectiveness of certain drugs and treatments. (This is a Hillary Clinton pet project.) Bad enough that every day more and more research comes in for specific subgroups that AHQR isn’t looking at. Medical knowledge is not just doubling it is transforming as molecular diagnostics will help tailor preventive strategies for care to the individual or specific pathway. And what if reimbursement decisions are made based on these head to head studies while ignoring genetic variations? I can see a system where people are dying or sicker than they should be under Hillarycare’s new manifestation because it’s cheaper to simply rule on the old data and ignore the new.

What about a federal prosecutor or HHS that makes it a crime to tell patients about novel uses for medicines that are apparent at the molecular or biomarker level but not aproved by the FDA? Does that make sense? Where is the safe harbor for companies? The fact is, docs and researches and patients are already way ahead of the bureaucrats and lawyers in the effort to match targeted treatments to high responders. BUt will the threat of litigation and the refusal to pay for these treatments slow down progress?

Finally, the Critical Path opportunities list has been launched. We need a new commissioner to drive change through the agency and to create momentum for change throughout the regulatory system. The agency needs more resources to retain and hire talented and dedicated scientists to bring about this change and it needs to be involved in the development of the scientific consensus required for such an effort. Technological and societal change requires leadership. Requlations that stifle it will will not fall without such efforts.


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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