I am suffering from hypocrisy and stupidy overload….apart from the patently biased reporting on Pfizer’s clinical trials and cancer drug pricing in the WP and WSJ respectively we now have the double standard on the coverage of RU-486 safety. According to recent research, 1 in every 80,000 women who have a medical abortion die. 1 in every 1,000,000 women who have a surgical abortion die. I am not a math whiz but that means that RU-486 increases your risk of death 10 times. If Vioxx had done that, it would have been the subject of a Charles Grassley media orgy. And lost in the reporting is the fact that many of the deathrs attributed to RU-486 recently are linked to off-label use (vaginal vs. oral use). Or was this fact conveniently buried even as the press beats up on other forms of off-label use?

Meanwhile, the AP had this misleading headline : Paxil May Increase Suicide in Teens, FDA and GlaxoSmithKline Warn

Actually, the FDA said that nearly 15,000 patients treated with both Paxil and dummy pills revealed a higher frequency of suicidal behavior in young adults treated with the drug, according to the letter.

The FDA reported that there were 11 suicide attempts — none resulting in death — among the patients given Paxil in the trials. Just one of the dummy pill patients attempted suicide.

Given that small number, the results “should be interpreted with caution,” the FDA said. Eight of the 11 attempts were made by patients between the ages of 18 and 30. All trial patients suffered from psychiatric disorders, including major depression.”

Left unsaid of course is that people suffering from major depession are likely to exihbit suicidal behavior and that all medications are associated with an elevation of suicidadility and that use of antidepressants is associated with a decrease in the incidence of suicide among teens.

Meanwhile, USA today ran a story discussing whether Oprah is a modern day Billy Graham.

All of this reminds me of what Thomas Jefferson said: “The man who reads nothing at all is better educated than the man who reads nothing, but newspapers. “

The insanity of not permitting conflict-of-interest (COI) waivers for certain highly qualified members of FDA advisory committees is not only, well, insane, but also quite contrary to the best interests of the public health.

During my tenure at the FDA I was the senior official in charge of advisory committees and the final decision-maker on who got a COI waiver and who did not. Many did not — but those who did received their waivers because FDA professional career staff made a strong case that these people weren’t just important to the advisory committee — but critical.

Are we really going to pass legislation that bans the best and the brightest from serving the public health because their preeminent expertise has also been viewed as valuable by the pharmaceutical industry?

It looks like we just might. God help us.

Researchers have developed a screening tool for discovering unexpected effects that drugs may have on living cells. It could provide a better way of identifying both potential side effects of and applications for new drugs — and take the serendipity out of the drug discovery process. Published in the current issue of the journal Nature Chemical Biology, the new tool combines modern chemical screening techniques with computer analysis. Using it, pharmaceutical companies could get an early snapshot of the potential uses and possible side effects of particular drugs. Most drugs work by interacting with target proteins to influence their effect on biochemical pathways within cells. But because these pathways and their interactions are complex, a drug can often have side effects — beneficial or toxic. To ferret out these effects, drugs nowadays are usually screened one target protein at a time, says Graeme Milligan, a molecular pharmacologist at the Institute of Biomedical and Life Sciences, University of Glasgow. Although it works, this approach can be costly for the pharmaceutical industry. “Potentially toxic and off-target effects are generally not discovered until a later stage,” he says, after a lot of time, money, and effort have been spent.

Here’s a link to the entire article:

http://www.technologyreview.com/read_article.aspx?id=16827&ch=biotech

Godfather Ron Pollack is angry: 37 million seniors have signed up for Medicare Part D, including 10 million of the 14 million seniors without coverage. Best of all 90 percent of low income seniors are enrolled which makes Godfather Ron’s claim that most seniors have better coverage then Part D offers look stupid and silly. On another front, groups of Americans will be able to form their own health insurance associations, using Costco and others to compete with traditional insurers. The Godfather opposes this nationally though he supported such association health plans in Massachusetts.

When good things happen to good people and people in need, count on Families USA and its capo to scowl and pout. For Families USA and Ron Pollack, worse is always better and better is always bad (at least for their agenda).

Something to think hard about …

WASHINGTON — The Food and Drug Administration could compel drug makers to conduct additional clinical trials after it approves their products under an amendment passed by a US House committee.

To speed drug approvals, the FDA frequently defers some clinical trials until after a product is introduced on the market. But companies have failed to complete two-thirds of the post-marketing studies they pledged to conduct for drugs now sold to millions of Americans. Currently, the FDA does not have the authority to force drug makers to finish the trials.

Under the amendment, which was attached to a must-pass appropriations bill, the agency could begin proceedings to stop the sale of specific drugs if promised clinical trials for those products are not done.

Some attack the FDA with malice and ignorance. That’s not helpful. Others attack people at the FDA. And that’s just plain wrong.

Bob and I share our feelings today on NRO. Here’s the link. The title of our remarks is “Miller’s Crossing.”

http://www.nationalreview.com

Remember all those whiners who said seniors were too old and stupid to choose a drug plan? Now they’re attacking consumer-directed plans and the effort to give people more information on choices — like price and quality. The reason: too much information will overwhelm most of us because we — unlike the health care gods at the Kaiser and Commonwealth Foundation — are too slow and stupid to make intelligent choices. Here’s one of the leaders of the Too Stupid to Choose Coalition, Drew Altman, on the subject of consumer choice:

“It’s not about whether consumers should shop for health care like plasma TVs,” says Drew Altman of the Kaiser Family Foundation. “It’s about two fundamentally different approaches to health care: comprehensive and less comprehensive with high-deductible plans. Which does America want?”

Gee Drew, I guess all health plans are the same with no difference in outcomes, service, cost, etc? Maybe health care isn’t like plasma TVs but it’s obvious you think it should be more like the current black box you want us to shut up and accept. As for the canard that people scared about dying not being able to make a rational decision…where does that happen in real life? In the extreme, hospitals are being judged by how well they treat acute stroke and cardiac arrest and the data is being made available to insurers and consumers. Iin the main, treatment of chronic illness or surgery, people do have the time to make a choice. That goes - heaven forbid — even in the treatment of cancer or other life threatening illnesses. The people I know who struggle with such illnesses are searching for more information to make the best choice possible. But Mr. Altman and his coalition think people are too incompetent to make these choices or that they don’t matter.

And as for seniors, they certainly know how to make a good choice. Just ask them on Election Day.

Study: Number of Drugs Entering Testing Up

The number of drugs that entered clinical testing surged 52 percent in the three years ended in 2005, signaling the pharmaceutical industry may be emerging from its research and development drought, according to a new study by the Tufts Center for the Study of Drug Development.

The increase represents a jump from the 21 percent decline in medicines entering testing in the five years ended in 2002 from the five-year period ended in 1997, according to a study of 10 pharmaceutical makers

According to the Center the improvement seen in the recent study is a result of new technologies that enable scientists to better judge a drug candidate’s likelihood of success and an increase in products licensed from other companies.

If you’ve heard that one, try this —

The Washington Post story on Trovan in Nigeria conveniently fails to include several pertinent facts, underscoring the victory of headlines over facts.

For example, the article claims that “… the panel said an oral form of Trovan, the Pfizer drug used in the test, had apparently never been given to children with meningitis.”

In fact,while Trovan had never been used in children with meningitis, other antbiotics of the flouroquinolones class had been tested in children with that disease with success.

Here is a summary of one such study ( Ciprofloxacin in preterm neonates: case report and review of the literature. van den Oever HL, Versteegh FG, Thewessen EA, van den Anker JN, Mouton JW, Neijens HJ. Eur J Pediatr. 1998 Oct;157(10):843-5.)

The article also implies that the Trovan trial did nothing to help address the epidemic of meningitis in Nigeria.

Despite optimal therapy, meningococcal meningitis has a 10% fatality rate and at least 15% central nervous system damage. The Post continues to ignore the fact that Pfizer’s treatment resulted in the best survival rate of any treatment then being administered in Kano. While Doctors Without Borders (DWB) treated patients with epidemic meningitis in Kano with a different medication, oily chloramphenicol, which was not approved for use in Nigeria, and succeeded in lowering the death rate to approximately 9.1 percent, Pfizer lowered the mortality rate even further to 6 percent. The rate was the same for the group who were administered Trovan and the group who received the other antibiotic that Pfizer supplied. Pfizer’s rate was also lower than the overall rate for the epidemic which ranged from 10-30 percent.

Nearly 50-100 percent reduction in mortality and Pfizer was ignoring the problem?

Finally, the head of the Nigerian “commission” who did the study has his own problems …

Dr Abdulsalami Nasidi, who chaired the commision looking at the Pfizer conduct is also head of an umbrella body for anti-AIDS groups and government agencies in Nigeria. It turns out that the his group was asking AIDS patients to pay for their drugs, which it got free. Medicins Sans Frontieres’ found nearly half of people on drug treatment in Nigeria did not receive sufficient doses due to lack of funds.

The Post fails to note that Nasidi had opposed the Pfizer trial from the outset. Moreover, the Post failed to discuss the fact that two factions in Nigeria were at war over the trial and that many observers claimed (it’s in the report the Post had) that Pfizer knew it was not wanted in Nigeria…. Indeed it is clear from the report that Pfizer was caught in the crossfire of a political feud and that much of the “testimony” regarding the handling of the study is of the “he-said, she-said” variety with one group saying the trial was conducted properly (those supporting use of Trovan) and those saying it was not (those who opposed the trial from the outset). Yet the Post story reads as if the report consistently slams Pfizer and the researchers.

It doesn’t.

And just last week The Global Fund against AIDS, Tuberculosis and Malaria at the weekend halted US $50 million in grants to Nigeria, citing the country’s failure to meet performance targets.

Fund spokesman Jon Liden said the governing board voted to suspend payment on two five-year grants after just two years because Nigeria had missed targets on anti-AIDS treatment access and other goals.

So let’s see, Nasidi is both the chair of this commission and of the AIDs group criticized for selling drugs it got for free and for missing performance targets.

Nothing like attacking a big, bad pharma company to divert attention from your own incompetence.

The Washington Post got played.

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 …

http://www.nytimes.com/2006/05/07/health/menshealth/07cnd-prostate.html?adxnnl=1adxnnlx=1147049376-ZOSKtUI+AQ83eCJGvmqAQ

Soild reporting in today’s LA Times on the current state of affairs surrounding Part D. Here’s a link:

http://www.latimes.com/news/printedition/front/la-na-medicare7may07,1,5331765.story?coll=la-headlines-frontpage

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.

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.