Latest Drugwonks' Blog
Here’s a great op-ed about how politics is undermining the FDA and medical progress …
Wrongly Blaming The FDA
By William Hubbard
Monday, May 8, 2006; Page A19
Last month the Government Accountability Office released another report criticizing the Food and Drug Administration’s efforts to ensure the safety of prescription drugs. It seems to have become great sport for public officials to revel in FDA shortcomings. Time after time in recent years, FDA scientists have warned of threats to the safety of the nation’s food and drugs, sought new resources and tools to deal with those threats, and been duly dismissed. Yet when their predictions have come true, decision makers of all political stripes rush to bemoan the agency’s failures …
The rest of op-ed can be found here
http://www.washingtonpost.com/wp-dyn/content/article/2006/05/07/AR2006050700907.html
Magic marker? Anyting but. It’s science baby!
And that’s why the Path is Critical.
(As a 40-something male this one really strikes close to home.)
Here’s the news
Scientists are reporting that they have detected a variant gene associated with prostate cancer, a finding that may make possible a diagnostic test to help decide which patients are the best candidates for aggressive treatment. The discovery by Decode Genetics, a gene-finding company based in Iceland, may also help explain why African-Americans, in whom the variant is more common, have a greater incidence of the disease.
Here’s a link to the rest of the story …
Soild reporting in today’s LA Times on the current state of affairs surrounding Part D. Here’s a link:
And here are a few of my favorite paragraphs …
WASHINGTON — With the first enrollment deadline a week away, the Medicare prescription benefit apparently is achieving its primary objective: helping millions of Americans get protection they did not previously have against one of the most draining problems of growing older.
By the May 15 deadline, federal officials expect to have more than 20 million seniors enrolled in plans under Medicare Part D, as the benefit program is called. That would include at least 7 million who previously lacked insurance for outpatient prescriptions. Of the millions who have signed up, many are enjoying significant savings, sometimes $1,000 a year or more.
And the performance of the drug plan, offered through private insurers, goes well beyond benefits for today’s seniors. The plan is a test of Bush’s idea that, instead of creating new federal bureaucracies, Washington can use businesses, informed consumers and market competition to solve knotty social problems such as access to healthcare — potentially for all Americans.
“This is the first full test of competition in Medicare,” said Joseph Antos, a health policy expert at the American Enterprise Institute, a conservative think tank. “It’s also a test of consumerism in healthcare.”
Medicare Administrator Mark McClellan said he had been working to make the program more user-friendly, and he pointed to a string of recent agency actions.
They include a directive limiting the ability of insurers to force patients to switch drugs; a standard appeals form doctors can use when a patient is denied a medication; and a set of common computer codes for pharmacists to communicate more easily with drug plans.
Around Health and Human Services headquarters in Washington, the new buzzword is “Version 2.0.” Next year’s Medicare drug benefit will feature fewer plans and better benefits, Leavitt said.
“We will see Medicare Version 2.0 much informed by what we have learned in Version 1.0,” he said.
The WSJ claims that the $40 billion in uncompensated care (75 percent of which is paid for by tax dollars) is only 2.4 percent of total health care spending. A better, more honest denominator is the percentage of total benefits paid by private health insurance premiums or total public health expenditures (which would make it more like 8 percent). But in any event, providing coverage would probably drive up total health care spending overall. But is that an argument for not insuring people? Second,what about the social gain of having people covered?
Conservative are grousing about the community rating and cost of premiums like it’s something that can’t change. Why not do what liberals do and grind away to make RomneyCare and other efforts better? What about conservative claims that CDHC plans are controlling premium increases and encouraging preventive care.
I cannot believe how churlish and intellectually sloppy the response to Governor Romney’s plan has been. If we had reacted this way to Medicare where would we be today?
Here’s a link to the May 2006 cover story of Medical Marketing & Media, “FDA at 100.”
FDA at 100: Alumni take its temperature
It features interviews with an eclectic collection of former FDA senior officials including the talented Dan Troy, “Mr. PDUFA” Marc Scheineson, a grinning Wayne Pines, the quixotic Andrea Kupchyk, Susan “What do I do now?” Wood, and me.
The article delivers what it promises, Parklawn insights — some more insightful than others — through the eyes of six insiders who share a medley of interesting, angering, important, gossipy and, yes, even score-settling comments.
Here’s to the FDA’s second hundred years of protecting and advancing America’s health — with a confimed Commissioner.
SchadenFDAude. noun. Pleasure derived from the misfortunes of the FDA.
Unfortunately it applies to a lot of people (in politics, the media, the public policy world, and even former FDA officials) who would rather enjoy the pleasure than work collectively and collegially to help solve the problem.
Need I name names?
Yesterday NRO posted a beside-the-point editorial by Henry Miller who once again recycled his assertion that all the FDA needs is a strong commander who will kick the asses of drug reviewers who fail to approve new medicines as fast as possible.
http://article.nationalreview.com/?q=YWU5M2MzY2JhODM4M2QyZDljODJiOWMxZTcxMzNjY2Y=
His attacks have no substance and are actually recycled from news articles written by journalists like Alicia Mundy — who is also a fellow at the Soros funded New America Foundation — and ad homimen attacks from people like Donald Kennedy, the last FDA Commissioner to smoke. Miller dredges up the media invented charge that Gottlieb’s appointment is unusual because he had no medical experience. Miller knows better: Gottlieb still sees patients and has been doing so for years. And Miller’s attacks on Andy von Eschenbach and Janet Woodcock are purely second hand.
Has Henry never heard of surrogate endpoints and biomarkers. And does he really believe that the FDA is fully responsible for the decline in new drug approvals? How about poorly validated targets? How about the fact that companies often withdraw drugs after Phase III? He tosses out a laundry list of FDA problems and ignores the efforts of the three people he attacked to undo them with better science and better oversight. To simply say that only leadership matters is to ignore the fact that scientific change is an important tool for forcing change at the FDA and moving the agency away from being risk averse. Had he had read the Critical Path opportunities list? Does he really think that outdate methods of drug evaluation don’t need to be changed? Is anything going on inside Miler’s mind in this regard beyond chatty assaults?
GlaxoSmithKline has announced that elderly and disabled patients who are eligible for Medicare drug benefits that took effect Jan. 1 will not lose the ability to get free drugs under the company’s patient assistant programs. In December, GSK notified patients eligible for Medicare D that they would not qualify for the free drug programs after May 15.
“The Medicare prescription drug benefit is a valuable program for millions of Americans, but we recognize that there are many elderly and disabled low-income patients who need additional help,” said Chris Viehbacher, GSK’s president of U.S. pharmaceuticals.
GSK plans to ask the federal government for an opinion whether patients enrolled in Medicare D can also participate in patient assistant programs.
For now, eligible patients must opt out of Medicare D to participate in GSK’s free drug programs.
About 200,000 of the 565,000 patients in GSK’s free drug programs are eligible for Medicare D.
Dicey TrOOP implications here. Stay tuned.
Sick patients need access to drugs sooner: US court
Tue May 2, 2006
By Susan Heavey
WASHINGTON (Reuters) — The U.S. Food and Drug Administration’s policy to withhold early-stage experimental drugs from terminally ill patient infringes their right to choose, a U.S. appeals court said on Tuesday, sending the case back to a lower court.
The FDA requires developing drugs to undergo a wide battery of tests, ranging from preclinical testing in the laboratory to large, advanced trials with people. Drug companies say the process can take up to 10 years.
But the U.S. Court of Appeals for the District of Columbia sided with two advocacy groups that filed the suit seeking patient access to new cancer drugs after initial tests show they are safe but before they receive FDA approval.
Judge Judith Rogers, writing for the majority, said terminally ill patients should be allowed to decide whether to accept the risks of taking a medication that might help them live longer.
“The key is the patient’s right to make the decision about her life free from government interference,” she wrote.
The ruling overturns a 2004 dismissal by the U.S. District Court for the District of Columbia, which will now have to review the case unless the FDA appeals.
In the lawsuit, filed in 2003, the Washington Legal Foundation and the Abigail Alliance argue patients have the constitutional right to available treatments.
“If death is certain and you have no options, it’s the individual’s option to decide,” Abigail Alliance President Frank Burroughs told Reuters.
While some patients can take experimental drugs as part of a clinical trial or other programs, he added the lawsuit was critical because many patients are excluded.
The court agreed, saying patients are simply looking for the same access that others have.
In a dissenting opinion, Judge Thomas Griffith sided with the FDA regulatory process, saying government has the duty to ensure that drugs are safe and effective before they are sold.
“Although terminally ill patients desperately need curative treatments, their death can certainly be hastened by the use of a toxic drug,” he wrote.
The FDA has moved to review drugs for cancer and other serious conditions faster than other medicines.
FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb said the agency was “sympathetic” to terminally ill patients and was improving its efforts to make such therapies available.
The Washington Legal Foundation said it was hopeful it could work with the agency to develop a new policy.
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.
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.
