August 31, 2006
T.S. Eliot and the Critical Path
by Peter Pitts
"We must transcend mindless empiricism. Today medicine is still an empirical science. We still approach it as a one-size-fits-all situation. T.S. Eliot wrote that 'Hell is the place where nothing connects.' We must confront the unacceptable cost of an unconnected healthcare system."
-- George Poste, MD, The Biodesign Institute, ASU
Posted by Peter Pitts at 08:20 AM
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August 29, 2006
Critical Path Made Personal
by Peter Pitts
Here’s a new way to think about whether or not FDA’s Critical Path initiative is important …
… Ask yourself, “What if it was my child?”
And then read this article from today’s edition of the New York Times.
A Conversation With Mary V. Relling
Saving Lives With Tailor-Made Medication
By CLAUDIA DREIFUS
MEMPHIS — In Mary V. Rellinga's office in St. Jude Children’s Research Hospital sits a small ceramic statue of St. Jude Thaddeus, the patron saint of impossible causes.
Dr. Relling, the head of the department of pharmaceutical sciences at St. Jude, has a fondness for impossible causes.
Her own is pharmacogenetics, a clinical discipline in which doctors use high-tech genetic testing to custom-make drugs to patients’ individual needs.
Though pharmacogenetics is controversial and not yet widely done, Dr. Relling, 46, travels the country advocating its use. At St. Jude, patients with leukemia are now routinely given genetic tests to determine their individual response to a medication. “We've seen it save lives here,” she said. “That’s made me a believer.”
When hundreds of patients are given a drug, she continued, “some will get no benefit, others will have terrible side effects, and still others will get benefits with tolerable side effects.”
Gene variants may be the cause.
Q. How is this tailoring of drugs different from the way they’re currently ordered?
A. Till now, there’s been a one-size-fits-all approach. In most cases, an average dose of a medication is ordered, and then, if the patient suffers side effects, the dosage is adjusted. With gene testing, we can customize the prescription.
Here at St. Jude, we’ve been gene-testing every child who comes to us with leukemia. I study acute lymphoblastic leukemia — A.L.L., the most common childhood cancer. When a youngster comes in with A.L.L., we get a sample of their DNA. We put it on a special computer chip that scans a half-million different places on the genome. Mostly, we’re looking for unusual variations of the genes and misspellings of the genetic code.
We have a database from earlier patients that helps us predict a patient’s risk of relapse and which misspellings are likely to result in drug sensitivities.
Q. Are there other diseases where the process might be useful?
A. The same medicine we use to treat leukemia is also prescribed for Crohn’s disease and ulcerative colitis. So that same genetic test could be employed to reduce side effects with those conditions.
At the moment, there seems to be a lot of promise for pharmacogenetics in the treatment of arthritis, heart disease, colon cancer and even psychiatric diseases like depression and schizophrenia.
Q. One can almost hear economists everywhere groaning, “Oh, no! Not another test to add to health care costs!”
A. The basic research behind pharmacogenetics — figuring out which genes are important with the various drugs and diseases — is costly. But on the clinical level, you can save money. With leukemia, we’ve seen that testing costs are minor compared to the savings gained by avoiding drug reactions, blood transfusions and additional hospitalizations.
Q. How widespread is genetic testing for prescriptions?
A. It’s very rarely used. Most probably, you can find it at some academic centers in big cities. And, of course, for many medications, the research isn’t in yet about which genes are important and why. But even where tests have been approved, insurers don’t cover all the costs, and that’s hindered this from growing.
Most prescribers don’t understand genetics very well. The fruits of the Human Genome Project have only been out for about five years, and a lot of doctors and pharmacists did their training before that.
I’ve heard people say that medicine won’t change until there are major lawsuits against prescribers who fail to use tests to individualize therapy.
Q. How have the drug companies responded to the promise of pharmacogenetics?
A. Unfortunately, they are not set up for it. The big pharmaceutical companies have a different business model. They make their money from blockbuster drugs that reach millions of people with standardized doses. They don’t want their markets to fragment, which is the obvious effect of pharmacogenetics.
Genomic testing is going to mean that we define smaller and smaller markets for every drug. Instead of one medication for high blood pressure, a manufacturer will have to produce dozens of variants and combinations.
It’s already difficult to get drugs that benefit smaller numbers of patients. “Orphan” drugs are often not manufactured because they help only a small group.
In pediatric cancer, we see what happens to orphan drugs because children’s cancers are rare and, thus, orphan diseases. Of the nine drugs we regularly use for leukemia, seven have been unavailable for varying periods of time during the last decade.
Q. What can you do in that situation?
A. We’re trying to start making it here at St. Jude. We’re not a drug manufacturer, and it isn’t easy for us to do. We’re also working with pharmaceutical companies to see if we can’t help them make it available. But we can’t depend on market forces for our supply.
We’ve seen that the pharmaceutical companies, if they are interested in cancer drugs at all, are mostly concerned with adult cancers — the larger market.
Q. How did you become a pharmacist?
A. I attended the University of Arizona in the late 1970’s, as a French major. In my freshman year, I took the required chemistry course with a brilliant teacher, William Lippincott. He made chemistry come alive. Becoming a pharmacist seemed like a practical route to a chemistry career, with good job possibilities after graduation.
Even today, it’s a great profession for a young person to consider. There is a tremendous demand.
Posted by Peter Pitts at 08:54 AM
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August 28, 2006
Pharma's Big Blues
by Peter Pitts
Caroline Kovac (IBM’s Princess of Prescience) on what Big Pharma can learn from Big Blue:
“Replace the word blockbuster with mainframe and then we can talk.”
Posted by Peter Pitts at 07:32 AM
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August 23, 2006
Charge it? Nope.
by Peter Pitts
Plastics.
It was good advice in “The Graduate,” but it’s bad news for internet profiteers masquerading as pharmacists.
Both Visa and MasterCard rules prohibit the processing of any illegal transactions such as those from illegal online pharmacies. Both card companies have issued fines for doing so. Several online pharmacy accounts, in fact, were recently terminated as a result of card Association and member bank pressure.
To do business with online pharmacies it is required that the member bank conduct an investigation for every online pharmacy. This will include providing a copy of the pharmacy’s license, a statement that the merchant’s sales activity is in compliance with all applicable laws, proof that valid prescriptions are required before medications are dispensed and proof that only prescriptions from licensed physicians are accepted.
Any questions?
Posted by Peter Pitts at 10:58 AM
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August 22, 2006
The Cost of International Drug Piracy In California
by Peter Pitts
Professor Philip Romero of the University of Oregon, and economic advisor to former California Governor Pete Wilson, has issued a damning report on the negative welfare consequences of normalizing the illegal diversion of prescription drugs into the U.S., as recently proposed by Governor Schwarzenegger. Basically, stripping away drug makers’ rights to enjoy the fruits of their own invention will deestroy investors’ willingness to risk their capital in California’s biotech industry. Up to 100,000 biotech jobs will be lost in the Golden State and $3 billion in economic growth. That’s a heck of a price to pay for a policy that won’t even result in lower-priced drugs in the long term!
Posted by Peter Pitts at 09:32 AM
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August 21, 2006
Data, Data, Whose Got the Data -- & Why?
by Peter Pitts
While I agree that physician-prescribing data shouldn’t be available for marketing purposes minus individual physician consent, there are important public health reasons why this data must continue to be shared with pharmaceutical companies.
When FDA-directed safety warnings are issued, they’re communicated via “Dear Doctor” letters to physicians who have prescribed the drug. This is accomplished quickly and precisely because industry has access to physician-specific prescribing data. And when safety issues arise, that same data helps define the scope of the problem (i.e., how many patients are taking the drug and for how long). Also, FDA-mandated risk management plans, developed for physicians who prescribe higher-risk therapies are targeted through the use of this same prescribing data. It’s also an important tool in clinical trial recruitment, allowing focused efforts towards doctors treating targeted patient populations.
Posted by Peter Pitts at 08:37 AM
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August 18, 2006
Flipping the Bird
by Peter Pitts
Focusing on prescription drug counterfeiting as international health care terrorism is often trivialized by pols and pundits as “just another scare tactic of Big Pharma.” That argument has never held up under the facts (stubborn things those facts) — and here’s a new truth that should further force those who deny the threat of counterfeits to reconsider their position — efforts to control the spread of bird flu in poultry in Southeast Asia are being hampered by the use of ineffective and often fake agricultural vaccines. This according to Robert Webster, a British virologist, animal flu specialist, and director of the World Health Organization’s Collaborating Centre for Studies on the Ecology of Influenza in Animals and Birds. As a result the threat of the virus evolving and being able to pass to humans, triggering a potentially catastrophic pandemic grows. It’s time to wake up and address prescription drug counterfeiting as what it is — international health care terrorism.
Posted by Peter Pitts at 09:34 AM
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August 17, 2006
The Task of the Ask
by Peter Pitts
According to the most recent FDA White Paper on PDUFA, more and more companies are seeking early advice from agency. FDA’s research has shown that this increased communication results in a more informed and efficient drug development process for industry sponsors. Since 1999, requests for meetings to discuss products stalled in development have increased more than 200 percent. Requests for consultations to review clinical milestones and next steps in the development process are up more than 60 percent. In the past two years, the number of industry-requested meetings scheduled between FDA and industry sponsors has almost doubled, from 1642 meetings in 2002 to 2132 meetings in 2004. With more frequent FDA guidance and consultation, the quality of new product applications has improved, and fewer review cycles are needed. Before PDUFA, an average of two review cycles was needed to gain FDA approval for an NDA. In 2004, thus far the majority of NDAs have been approved after just over one review cycle.
Those who think the FDA should view the pharmaceutical industry as the enemy misunderstand (and at great peril) a crucial 21st century regulatory paradigm — collaboration advances the public health. As James Thurber said, “It is better to know some of the questions than all of the answers.”
Posted by Peter Pitts at 08:32 AM
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August 16, 2006
Death is Cheap
by Peter Pitts
Dead people are very cost efficient. They have no need for costly hospital procedures, pharmaceuticals, or home care. On the other side of the pharmacoeconomic spectrum are people who suffer non-fatal medical events like a heart attack or stroke-- and survive due to every kind of help our health care system can provide. Such interventions are often both extensive and extended. But we are compassionate and civilized and value life. Individually and collectively we choose and support expensive care over expedient demise. That’s why it's so urgent that we recognize the exigent issues surrounding our nation’s ill-placed focus on acute care while chronic care issues remain precariously in the background -- in terms of both policy and press coverage.
The recent IDEAL study is only the most recent case-in-point. After a slamma JAMA editorial extolling the findings that Lipitor (80mg) provides incremental reductions in multiple endpoints including non-fatal heart attacks (a whopping 17% decrease in fatalities) and cardiovascular events in high-risk patients compared to simvastatin (20/40 mg) — the mainstream press played down the whole study as only marginally significant. Well, life is lived between such margins — and when it comes to CVD, those margins are pretty wide. In 2005, $393.5 billion was spent on CVD — nearly twice the amount spent on cancer care. Between 1970 and 1990 life expectancy in the US rose an astounding 6.2 years — due largely to new therapies for dealing with CVD.
Today we have the opportunity to further extend our ability not only to live but also to thrive at a high level of performance. And the impact on our health care system — not to mention our society will change the world … but only if we pay attention.
Posted by Peter Pitts at 10:32 AM
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August 15, 2006
Harmed and Dangerous
by Peter Pitts
The global counterfeiting of prescription drugs is nothing short of international health care terrorism — and it needs to be addressed as such.
Here’s a relevant op-ed from today’s edition of the Baltimore Sun:
Remember: Caveat Emptor is bad health care practice — and even worse health care policy.
Posted by Peter Pitts at 09:24 AM
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August 14, 2006
Beijing Supplemental
by Peter Pitts
In case you’re not a regular reader the China People's Daily, here's an important story with potentially significant implications for DSHEA. Tongjitang Pharmaceutical Co. Ltd. of southwest China's Guizhou Province signed a contract with Synarc, a US professional drug test service provider. Synarc will carry out clinical curative effect test on a traditional Chinese medicine to treat osteoporosis. According to Qi Guomin, an official of Ministry of Health, it is for the first time a Chinese herbal medicine will be tested in line with western clinical curative effect standards. Some of the Chinese traditional medicines have passed the FDA's safety test and been sold as "health food" in western countries, Qi said. The test will be carried out in China under FDA's criteria and the result will be released at some point this year.
Note to Congress: When contemplating FDA reform don't forget the urgent need to reform DSHEA -- it's more than just a stadium in Queens.
Posted by Peter Pitts at 08:55 AM
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August 10, 2006
Generics Jihad
by Peter Pitts
In the wake of the centenary of Einstein’s wonder year, we are once again faced with the immutable Theory of Medicare Relativism — when politics wins, patients lose.
We are also, unfortunately, faced with the implications of the Special Theory of Medicare Relativism — price controls = choice controls. The most recent example of these dreaded theorems in action is brought to the American people through the proposals of Senator Charles Schumer, et al. If Senator Schumer gets his way, the category of medicines known as “authorized generics” (also referred to as “branded generics”) will vanish — and drug prices for millions of Americans could go up by as much as 17%. (This calculation is based on a comparison of what consumers actually spent on generics during 180-day exclusivity to what they would have spent to purchase the same quantity of generics at higher prices in the absence of a branded generic launch.)
The deliverable to the American patient? Higher prices and fewer choices. Needless to say, Senator Schumer's “modest proposal” is being greedily embraced by the generics industry. And greedy is hardly hyperbole since profits on generic medicines exceed 45% even when there is a competitive branded generic on the market. This is what we get for Medicare modernization? It’s Voltaire’s famous aphorism come to life, “The art of medicine consists in amusing the patient while nature cures the disease.”
It would be far better if Senator Schumer followed the advice of Professor Einstein who said, “Any intelligent fool can make things bigger, more complex, and more violent. It takes a touch of genius — and a lot of courage — to move in the opposite direction.”
Posted by Peter Pitts at 10:34 AM
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August 09, 2006
News item: Coffee is #1 Source of Antioxidants
by Peter Pitts
New segmentation schema for the food pyramid:
Tall. Grande. Venti.
Posted by Peter Pitts at 08:53 AM
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August 08, 2006
Label Fatigue
by Peter Pitts
The issue of more and ever more black box warnings, beyond any individual therapy or class, is whether the pendulum has swung too far -- and it seems as though that's a real possibility. It's crucial for FDA -- and for those who are irresponsibly calling for "100% safety" -- to realize that pronouncements made in the heat of political debate have serious and deliterious impact on not only the scientific debate, but also on the lives of real people outside the Beltway. Further, as labels become increasingly muddled with more and more warnings, fewer and fewer physicians and patients will pay them any heed. Label fatigue is a real threat to the public health.
Posted by Peter Pitts at 10:55 AM
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