June 30, 2008
The Pharmaceutical Past is Prologue
by Peter Pitts
The Wall Street Journal reports that, “Last year, the FDA approved just 19 new medicines, the fewest in 24 years, and announced about 75 new or revised "black-box" warnings about potential side effects -- the agency's strongest -- twice the number in 2004.”
True. But numbers are just numbers. The story is somewhat different when you put those numbers in perspective.
According to the Journal story, “Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, denies that the agency has become "more conservative" about drug safety. Rather, she says, the industry's faltering research efforts are mostly to blame for the fewer product approvals. She says the agency continues to base its decisions on science, not outside pressures. New methods, she adds, have helped it become more vigilant about side effects. She attributed the increase in black-box warnings primarily to a few large groups of medicines that were relabeled."
Reality bites.
Bringing new drugs to market has always been a scientifically challenging and expensive proposition – and it remains so. But the big difference today isn’t (gasp!) politics – it’s that, while discovery and development embrace 21st century science, regulatory science lags behind. At present, the FDA is using 20th century tools to review 21st century medicines.
This is why the agency’s Critical Path Program and the Congressionally-mandated Reagan/Udall Foundation are so crucial to our 21st century healthcare future -- as well as to the future of the pharmaceutical industry.
The comments of Schering-Plough CEO Fred Hassan (courtesy of the Journal article) are instructive:
“Mr. Hassan believes an intensifying focus on safety and a diminished tolerance for side effects at the Food and Drug Administration have dramatically lowered the odds that the drugs would make it to market -- at least not without a lot of extra time and money.”
Not so fast. It is today as it has been in the past and must be in the future – the quest for appropriate risk/benefit balance. Side effects are “tolerated” insofar as the benefits are appropriate. As to the “extra time and money” comment – there’s no benefit from wishing for the “good old days.” Time marches on and so does science. Perhaps a better focus would be on more innovative clinical trial designs – and on the FDA’s promised guidance on adaptive clinical trial designs.
The past is prologue.
"What will it take to get new drugs approved?" Mr. Hassan asks. "The point is, we don't know."
Yes we do. Better development science and better regulatory tools for the FDA.
Posted by peterpitts at 10:06 AM
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June 02, 2008
"Page" Turner
by Peter Pitts
A few weeks ago I was on a panel with J. Rick Turner, Chairman of the Department of Clinical Research and Director of the Cardiac Education Center at the Campbell University School of Pharmacy. And, as usual, the most interesting part of the conversation happened after the panel was over.
As we were gathering our papers and checking our blackberries, Dr. Turner mentioned that he had written a new book on the issue of “integrated cardiac safety.” I asked him to send me an advance copy. And he did.
They don’t call him “Page” Turner for nothing.
His new book, “Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Post Marketing Surveillance,” is a timely and important addition to the debate over drug safety and, equally important, safe use.
Consider the following brief excerpts:
“A drug’s development in the sense of improving its safety and/or effectiveness profiles does not stop at the point of marketing approval. Data collected during the drug’s use in large patient populations can lead to meaningful improvements in the drug. This term, lifecycle drug development, therefore emphasizes that it is vital to remain vigilant about the drug’s effects from the very beginning of the drug discovery phase throughout the entire time that the drug is on the market and hence available for prescription to patients, and it captures the spirit of this book very well.”
“So too does the term integrated cardiac safety. A central tenet of this book is that it is beneficial to discuss the assessment methodologies used to collect information on cardiac safety at four stages of lifecycle drug development—drug discovery and design, nonclinical development, preapproval clinical development, and postmarketing surveillance—in one book, and to integrate this information to the greatest degree possible.”
“Meta-analyses vary in the number of patients included since this is dependent on the numbers in the individual trials combined in the new analysis. However, typical numbers are also in the thousands. However, it is fair to say that statistical methodology is currently less well developed in the case of epidemiology studies than it is for randomized controlled trials: this is not meant as a pejorative statement, simply a statement of the current state of affairs that will hopefully and very likely change as additional spotlights on and developments in the field of pharmacoepidemiology increase.”
“It should also be noted here that the term nonexperimental is not a pejorative one compared with the term experimental. Piantadosi discussed two fundamental types of study design, experimental and nonexperimental. In experimental studies participants receive random treatment allocation, and observations are made under conditions in which the influence of interest is controlled by the research scientists. In nonexperimental studies the research scientist also collects observations but does not exert control over the influences of interest. Nonexperimental studies are often called ‘observational studies,’ but this term is inaccurate: it does not definitively distinguish between nonexperimental studies and experimental studies, in which observations are also made.”
The book, due out in November of this year is must reading – especially for Steve Nissen.
Posted by peterpitts at 07:54 AM
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May 20, 2008
Deal or No Deal
by Peter Pitts
According to a Bloomberg report, biotechnology acquisitions and licensing deals reached a record $27 billion worldwide last year. In the largest deal of the year, London-based AstraZeneca paid $15.6 billion to acquire MedImmune.
Biotechnology companies also raised $29.9 billion in investments and loans, the most since 2000. The industry attracted a record $39.4 billion in 2000, the year the first draft sequence of the human genome appeared.
IPOs brought in $2.2 billion, a 21 percent increase over the previous year and the highest total since 2000.
The full Bloomberg story can be found here:
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=a6FjDvLrCCgm
The article mentions that, “Large drugmakers are investing in biotechnology to gain new medicines to bolster revenue as patents on top products expire.”
No doubt. But while acquisitions and licensing is the wave of the present, what will drive the future of pipeline, profit … and public health is the Critical Path. To achieve “A” level health care, industry and academia and government must focus on “B” level issues -- Better science and better tools (biomarkers, bioinformatics, and Bayesian statistical analysis) among others.
So, deal or no deal, the Critical Path must not remain the road less traveled.
Posted by peterpitts at 07:52 AM
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April 30, 2008
IMI Shelter
by Peter Pitts
While we dither about funding for the Reagan/Udall Center, the European Commission and the pharmaceutical industry have unveiled a €2 billion partnership to reverse the EU's declining international role in medical research. According to a report in the Financial Times, teams of commercial and not-for-profit researchers will be able to seek support for work on a range of medical projects, on condition that their findings are publicly shared in an effort to stimulate faster and safer drug development.
The Innovative Medicines Initiative (IMI), jointly supported by the Commission and members of the European Federation of Pharmaceutical Industries and Associations (EFPIA), will shortly release details of its first 18 priorities, which will be funded by €123 million in awards to be given out by the spring of 2009.
This is a chance for us to really get back on the right foot," said Arthur Higgins, president of EFPIA and head of Bayer Healthcare of Germany. It was important for patients and the wealth and prosperity of Europe. "We're sending a signal to the US, Japan, China and India that Europe is taking its bioscience sector really seriously."
The first wave of projects includes the development of measurable biomarkers in the body to gauge the side-effects of new medicines on the kidneys and liver, as well as research into the basic mechanisms of pain, severe asthma, psychiatric disorders and neurodegenerative diseases.
The Commission has given €1 billion in funding for the seven-year program, which will be matched by support from pharmaceutical companies through loans of staff, laboratory equipment and libraries of compounds.
It’s time that we take the issue of 21st century medicine just as seriously.
Funding for Reagan/Udall now!
Posted by peterpitts at 08:26 AM
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March 25, 2008
Failed Drugs or Failed Pathways?
by Peter Pitts
Interesting article in the Wall Street Journal on the use of genetic tools to resuscitate failed compounds.
Here how the story begins:
“As pharmaceutical makers find it increasingly difficult to bring new drugs to market, they are turning to genetic tools to seek uses for medicines that failed to make it out of the development pipeline.
The discovery of new links between genes and diseases can help not only to design new treatments, but to salvage drugs that are shelved when they come up short in clinical trials.”
And here’s the rest of the story:
http://online.wsj.com/article/SB120631682077958247.html?mod=dist_smartbrief
The better understanding of genetic tools (via a robust collaboration of industry, academia, and government) will both expedite failure (which lowers the cost of R&D) and provide a broader spectrum for success (which rewards it).
Sound familiar? Correct – the Critical Path.
Posted by peterpitts at 09:01 AM
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December 21, 2007
IMI Shelter
by Peter Pitts
What does the European Commission know that Rosa DeLauro does not?
According to the Financial Times ...
The European Commission is poised to agree a groundbreaking €2bn ($2.9bn, £1.5bn) partnership with the pharmaceutical industry this week designed to win back Europe's place as a centre for global medical innovation.
The Innovative Medicines Initiative, financed equally by the industry and the Commission, will support research by academic and industry groups over seven years designed to speed up the predictable testing of the safety and efficacy of medicines. The move, part of the EU's "Lisbon agenda" to regain competitiveness, aims to boost collaboration between commercial companies, universities and regulators to more rapidly develop "pre-competitive" tests and accelerate the launch of innovative drugs.
Posted by peterpitts at 12:07 PM
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December 17, 2007
Coherent Science or Patchwork Quilt?
by Peter Pitts
Okay, so it isn't ALL about the money -- only mostly.
Critical Path Trickles Downstream To FDA Reviewers
The Pink Sheet, December 17, 2007
BY: Daniel Poppy (d.poppy@elsevier.com)
A lack of interest from agency review staff impedes progress of FDA's Critical Path Initiative, industry members observe.
"What I have seen in my own personal interactions, both when I was at the agency and when I left the agency, is there is still a lot of difficulty getting this pushed down to the reviewers," AstraZeneca's FDA Liaison Office Executive Director Cathie Schumaker said at a Critical Path briefing conference.
"I do appreciate much more now that I'm on the industry side how important it is to translate this from a visionary approach to a regulatory approach." Schumaker is the former deputy director of FDA's Office of Information Management.
"There is a disconnect between what we hear at the highest levels and what is happening down in the trenches," said Brian Harvey, who is VP of regulatory policy at Sanofi Aventis and a former director of FDA's Division of Gastroenterology Products.
At CDER, reviewers adhere to established regulatory standards despite being exposed to, and often agreeing with, innovative ideas about drug development, Harvey said.
FDA Office of Medical Policy Director Bob Temple suggested that progress is being made but sees hesitancy from both industry and regulators.
"Anything new takes a little while for everybody to get used to it," he said. "These things are spreading, and I see them in action all the time. That doesn't mean everybody is ready to change the thing they are doing right away. Drug companies are very conservative that way too."
Addressing concerns that CDER's staff is not implementing aspects of the Critical Path Initiative, Janet Woodcock, the center's acting director, stressed the agency lacks resources, not interest.
"We now have very enthusiastic buy-in participation at FDA amongst the reviewers, and that's a big success," Woodcock said at the conference, which was co-sponsored by FDAnews and the Center for Medicine in the Public Interest.
"We have gotten a tremendous number of proposals from scientists at FDA about additional projects that could be done to improve the development process. Unfortunately that would dwarf any and all appropriated funds."
Woodcock acknowledged that the direction of the initiative is still largely contingent upon funding. Although the initiative is now being targeted for appropriations, Critical Path activities generally have been directed by the interests of external parties willing to collaborate with FDA (1"The Pink Sheet" Jan. 22, 2007, p. 29). A recent report issued by FDA's Science Board's Subcommittee on Science and Technology outlined the effect the lack of resources is having on FDA's ability to assess developments in emerging sciences (2"The Pink Sheet" Dec. 10, 2007, p. 15).
Given the ad hoc nature of the projects undertaken, Woodcock suggests that many of FDA's efforts to improve the drug development process will take time to bear fruit. "In 10 years you are going to see a very uneven field where some pieces have advanced and moved forward very rapidly and others may require more work or clinical effort won't have matured, and so you're going to see not a coherent science but a patchwork. And it is still going to be very challenging for everyone, but a lot better than it is now," she said.
"I am trying to take a long-term, transformative view. I don't think you can turn an ocean liner around in a year, especially if it involves scientific research and changes in scientific methods," she added.
Echoing many of the speakers at the conference, Harvey praised Woodcock. "The fact that Janet Woodcock is now back as the acting CDER director is probably the best thing that could ever happen for Critical Path. She has an incredible vision. She really is able to inspire people. ... There is a lot of optimism."
Of course, Woodcock's tenure as CDER director is most likely short lived. FDA has launched a candidate search for a permanent center director so Woodcock can return to her position as FDA deputy commissioner and chief medical officer (3"The Pink Sheet" Dec. 10, 2007, In Brief).
Posted by peterpitts at 02:09 PM
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December 13, 2007
Carba Loading
by Peter Pitts
Personalized medicine? Yes please.
Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry
Connection of genetic information with medication use can improve safe use of product
The U.S. Food and Drug Administration today announced that the manufacturers of drugs containing the active ingredient carbamazepine have agreed to add to the drugs' labeling a recommendation that, before starting therapy with the drugs, patients with Asian ancestry get a genetic blood test that can identify a significantly increased risk of developing a rare, but serious, skin reaction.
The full FDA press release can be found here:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01755.html
"Science is now letting us individually treat patients based on how their body might react to a drug," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "When being considered for treatment with carbamazepine, genetically high-risk patients can be given a test that will help their health care providers make personalized drug treatment decisions and help avoid potentially serious skin reactions."
Posted by peterpitts at 08:12 AM
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June 26, 2007
WeLLO
by Peter Pitts
As its costs continue to spiral upward, most people now agree that America's health care system is broken. And as the race for the White House heats up, politicians on both sides of the aisle are clamoring to propose ideas that rein in health spending.
Unfortunately, the policies offered thus far are misguided. As counterintuitive as it may sound, the answer to America's health care woes won't be found by harping over the price of care.
Here's the rest of the story via a new op-ed in the Baltimore Sun:
The conclusion?
"Prevention must be health care's first line of defense, as a proper diet and healthy lifestyle can stop many diseases in their tracks.
Failing prevention, earlier diagnosis and care are crucial. There are many effective treatments and maintenance medications that can stop diseases such as hypertension and diabetes from progressing, allowing millions of Americans to lead active and productive lives without breaking the bank.
In the coming weeks, the nation will learn more about the health care plans of each of the major presidential candidates. If lawmakers want to save lives, enhance the quality of care, and reduce costs, the focus needs to shift to prevention and early diagnosis."
SiCKO? How about WeLLO.
Posted by peterpitts at 04:53 PM
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April 04, 2007
Sometimes Safety
by Peter Pitts
Can drug safety be a sometimes thing?
I pose this question based on the recent flurry of media stories on the need for new cancer treatments (see Sunday's NY Times Week in Review section) and the Abigail Alliance lawsuit that calls for greater patient access to investigational new drugs-- not to mention the debate over follow-on proteins.
(Remember, don't call them generic biologics. Words count.)
These are all important stories with significant subtexts -- most of which are entirely ignored by pols and pundits who prefer righteous indignation. Should we strive for new cancer treatment? Of course. Should patients have easier and broader access to investigational new drugs? I think yes, but there serious safety concerns that cannot just be ignored in the quest for a good headline. Follow-on proteins, same thing.
Don't get me wrong, I'm all for righteous indignation but, when it comes to drug safety, can you be for it before you are against it and still expect to be taken seriously?
Lots of well-intended verbiage in, for example Sunday's Times op-eds about the "need' without focusing on the "how," the "who," or the "how much." Many of these articles make it seem as though Big Bad Pharma is holding back on pursuing R&D for new cancer treatments because of concerns over profitability. Others blather on about Big Pharma sitting on potentially potent patents for the same reason -- with quotes from academic researchers who believe the translational gap is nothing more than the manifestation of a lazy pharmaceutical industry.
Sorry fellas -- ain't that easy.
I went through all of the articles (yesterday and today) and also did a Google search of how many times the FDA's Critical Path initiative was discussed.
Yup -- zero.
The Critical Path must not be paved with good intentions alone -- but some acknowledgement would be right and appropriate.
Posted by peterpitts at 04:02 PM
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March 27, 2007
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.
Consider the IDEAL study. 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 peterpitts at 12:09 PM
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November 22, 2006
How Critical is the Critical Path?
by Peter Pitts
New Hearing for Suit Against FDA
Associated Press
A federal court agreed yesterday to rehear a case that aims to get terminally ill patients early access to experimental drugs unlikely to be approved before they die.
The full 10-judge U.S. Court of Appeals for the District of Columbia Circuit will probably hear the case next summer, said Richard A. Samp, chief counsel for the Washington Legal Foundation.
The group, with the Abigail Alliance for Better Access to Developmental Drugs, sued the Food and Drug Administration in 2003. It is seeking broader access to drugs that have undergone preliminary safety testing in as few as 20 people and have yet to be approved by the FDA.
In 2004, a district court dismissed the case. In May, a three-judge appeals panel reinstated the lawsuit in a 2 to 1 decision.
The FDA, in turn, appealed and asked for the full court to rehear the case.
Posted by Peter Pitts at 08:41 AM
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November 14, 2006
Adaptation
by Peter Pitts
Despite the midterms and continued brickbats from Grassley, Waxman, Hinchey, et al., the persistent and quiet revolution going on inside the FDA continues.
The most recent example of this ray of hope is the agency’s championing of adaptive clinical trials. "Traditional" clinical trials that demonstrate a 40% efficacy rate without even attempting to isolate which 40% is expensive in financial terms and only marginally helpful in helping physicians best treat their patients. It also plays into the hands of the Evangelists of Evidence-based Medicine and the Votaries of Me-Tooism. We must think about clinical trials in new ways. It's a crucial aspect of the Critical Path.
Yesterday, Deputy Commissioner Dr. Scott Gottlieb made such a point at a Manhattan Institute talk – and it sure was refreshing.
Scott’s full remarks can be found by clicking the link below:
http://www.fda.gov/oc/speeches/2006/manhattaninst1113.html
Posted by Peter Pitts at 12:30 PM
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November 03, 2006
Unhappy Birthday
by Peter Pitts
One hundred years ago today, on November 3 1906, Alois Alzheimer, psychiatrist and pathologist, presented the first case of the disease that later came to bear his name in Tubingen Germany. The patient, Auguste D, developed dementia in her 50s and was so restless and confused that doctors prescribed balneotherapy - day long immersion in a lukewarm bath - to soothe her. When she was at her worst they knocked her out with chloroform.
According to an article in today's edition of The Independent (London), "A cure remains a distant dream."
We must not allow the walls that stymie progress towards finding better treatments (and, ultimately, cures) to stand. President Bush, Dr. von Eschenbach, Dr. Zerhouni, members of Congress: Tear down these walls.
Aggressive measures are required and one important way we can help advance this agenda is to forcefully support, fund, debate, and participate in the FDA's Critical Path agenda.
Posted by Peter Pitts at 08:51 AM
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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 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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