Latest Drugwonks' Blog
In response to my last blog, Jamie Love writes: “1st, the Philippines said it would not import anything until the Pfizer patent expires. 2nd, Pfizer does not have a patent on this drug in the Philippines, so how can anyone in India violate a patent that does not exist? It is not as if the USPTO is the Indian patent office (at least, not yet).”
This misses the point…which is the Philippines bringing in an authorized knock off of Norvasc from India where the Norvasc patent is non-existent. Pfizer as I see it is not defending their patent but trying to stop another end-run around the TRIPS agreement. Let’s stop the guerilla attacks on IP and focus on creative ways to promote partnershps at the pre-knowledge and post-market stages that facilitate drug development and increase access.
Real reform at the FDA is being held hostage to politics. People putting a hold on comfirming Andy von Eschenbach claim a permanent commish is important but that it doesn’t trump politicizing Plan B for the sake of political gain.
In fairness, abortion activists see the Plan B decision — dodged earlier by the FDA — as a line in the sand. They have some science on their side. But some of the same people invoking SCIENCE in defense of Plan B also want to impose an artificially rigid standard on what drugs to approve and want to use the FDA as entity for making one size fits all comparative judgements about medicines when science is moving in the direction of personalized medicine. (That means you Senator Clinton.)
What about this as a principle … the FDA and critics on both sides stop trying to use the agency to engineer social policy and simply approve medicines on the best available evidence. Let people decide and promote the use of better tools and techniques for determining which medicines work best for which people. Let’s do a better job not only developing new medicines but using them when and if appropriate. That’s a responsibility everyone has.
In the meantime, let Plan B free and then let the market, physicians, parents and public health officials make the decisions people on both sides of this issue want the FDA to make. Going forward, let’s put politicians and the media on notice when they use and twist the science of drug development for political purposes. If the medical science supports the use of certain drugs or devices in groups of people, let them on the market and then let’s continue to study how they work and for who. Let’s substitute real science for junk politics when it comes to the FDA once and for all.
From today’s edition of the Washington Post …
No Defense For This Insanity
By Sebastian Mallaby
Team Bush could use some fresh domestic policy. Its talk of tax reform has fizzled. Its defeat on Social Security has destroyed its hopes of fixing entitlements. Its feckless energy non-policy has come back to haunt it. Its tax cuts look ever more untenable as Iraq costs escalate. Its proposed expansion of health savings accounts is incompetently muddled. Its bungling of Hurricane Katrina’s aftermath is legendary. Its trampling of civil liberties has been rolled back by the Supreme Court.
Desperate moments call for desperate remedies. President Bush should seize upon the monstrous Vioxx litigation to champion a cause that he believes in: the cause of tort reform.
Here’s a link to the complete op-ed …
Finally, something we can really pin on the pharmaceutical industry …
Annual deaths in U.S. drop in biggest decline in nearly 70 years
In what appears to be an amazing success for American medicine, preliminary government figures showed that the annual number of deaths in the U.S. dropped by nearly 50,000 in 2004 — the biggest decline in nearly 70 years The government also reported that a baby born in 2004 could expect to live to nearly 78 — an increase of almost half a year from 2003. Women now have a life expectancy of 80.4, up from 80.1. Male life expectancy is 75.2, up from 74.8.
Do I hear a call for Congressional hearing?
Did you see Bill Maher’s naive and unfunny op-ed in yesterday’s LA Times? Just incredulous. Check it out if you’ve got a strong stomach for stupidity and a few minutes to waste.
Here’s the letter I just sent in to the LA Times editorial page in response …
RE: “Pill Popper Nation,” April 27, 2006
To the editor:
So now Bill Maher is a health care expert? His opinion piece was so full of errors and vitriol that I could write a treatise. But I will limit my comments to two of his absurdities. First, he characterizes the Citizen”s Petition submitted by the Coalition for Healthcare Communications as from “the drug lobby.” Not only is this not true, but PhRMA, the industry’s trade association, doesn’t even support it. Maher writes that the petition wants to “get rid of the warnings in drug ads.” Also wrong. The petition (which I helped to draft) calls for more user-friendly warnings. After all, warnings that people don’t understand don’t help advance the public health. But what really got my dander up was Mr. Maher’s libelous and mean comment that all the FDA does is “protect the profits of pharmaceutical companies.” This is an unfair, unearned, and unjust attack on the 10,000 overworked, underpaid —and exceptionally devoted staff of the FDA. When it comes to health care, Maher is less.
Peter J. Pitts
Pitts is Director of the Center for Medicine in the Public Interest and a former Associate Commissioner at the FDA
When I was at the FDA and we announced a new draft guidance on DTC print advertising, Dr. McClellan commented that when it came to the brief summary “less may indeed be more.”
Today the agency is calling for more research into this issue — but solid metrics already exist. Right now, as we speak, the FDA possesses a broad body of high quality research that has been conducted on the brief summary — with protocols reviewed and commented on by the folks at DDMAC.
The news item below is all well and good — but calling for more research is a poor excuse for lack of action on this important public health issue.
(FYI — Inside the agency the brief summary is often derided as being like the Holy Roman Empire — it is neither brief nor a summary).
FDA Will Survey Consumers on Brief Summary
The FDA plans to survey consumers on the content and format of the brief summary in direct-to-consumer ads, according to an advance Federal Register notice released April 24. “In recent years, FDA has become concerned about the adequacy of the brief summary in DTC print advertisements” because the detailed, technical prescription drug information geared toward physicians increasingly was used in ads for the public as a way for advertisers to fulfill the vague brief summary requirements, the notice states.
The FDA plans to investigate the role of context in providing useful information to consumers, such as comparing consumer perceptions after viewing mock ads with risk information in chart or paragraph form. The agency also will study whether listing side effects and placebo rates of occurrence influences perception. Additionally, the FDA will survey the effectiveness of brief summary information provided in question-and-answer, highlights and drug facts formats. The agency will accept comments for 60 days after publication in the Federal Register under docket number 2006N-0133.
An unpublished letter by drugwonks commentator Ben Zycher. A loss to Washington Post readers — but a drugwonks.com bonus!
To the Editor of the Washington Post,
Shankar Vedantum’s article (“Comparison of Schizophrenia Drugs Often Favors Firm Funding Study,” April 12) misses the central reason that comparative drug tests funded by a given pharmaceutical producer usually report superiority for that producer’s drugs. The research and development process for new drugs aims to improve upon the clinical experience of existing treatments, which always are weak for some patients and for some of the many dimensions of such disorders as schizophrenia. To the extent that the research and development process is successful, studies conducted to determine whether or not the new treatments offer improvement for some patients in terms of some symptoms will find, quite honestly, that they do indeed.
Moreover, no advertising or promotion of such new drugs may proceed until the data are reviewed and approved by the FDA. And the argument of some that studies funded by government systematically will yield unbiased comparisons is incorrect: The government has powerful incentives to promote certain (older) drugs, the use of which will reduce budget pressures. Pharmaceutical producers have profit incentives not to mislead themselves, and doctors and patients have strong reasons to find the most effective treatments.
Here’s a link to a new paper (by me) discussing how Europe can learn from America’s DTC experiences (both positive and otherwise) to create a more robust 21st century environment for patient empowerment. My premise is that health care communication is the consumer’s Rosetta Stone.
Your thoughts and comments are much appreciated.
Such a revelation! GAO reports that the FDA can do better on post-market surveillance! The headlines and statements from Senator Grassley shout “OMG!” But those in the know remark, “Duh.” The issue, dear Senator must not begin and end with a press conference. (The headlines taste good, but 45 minutes later you’re hungry again.) The debate and road to amelioration must begin with more dollars and authority for the FDA. Senator, for the umteenth time — SHOW FDA THE MONEY!
As for Dr. Goldberg’s comments below, ditto.
Genetic tests that will screen people to see if they are high responders will be used in combo with proteomic or metabolomic tests to develop optimal doses and imaging markers to determine best response. Such work is already going on in cancer and with such drugs as Avastin. More on that later.